Insuman · 4.3 Contraindications · 6

HOS-083690 · has-adverse-reaction-information · PDF-Seite 28

Summary of the safety profile Hypoglycaemia, in general the most frequent adverse reaction of insulin therapy, may occur if the insulin dose is too high in relation to the insulin requirement. In clinical studies and during marketed use, the frequency varies with patient population and dose regimens. Therefore, no specific frequency can be presented. Tabulated list of adverse reactions The following related adverse reactions from clinical investigations are listed below by system organ class and in order of decreasing incidence: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. MedDRA system Common Uncommon Not known organ classes Immune system Shock Immediate type disorders allergic reactions (hypotension, angioneurotic oedema, bronchospasm, generalised skin reactions); Anti-insulin antibodies Metabolism and Oedema Hypoglycaemia; nutrition disorders Sodium retention Eye disorders Proliferative retinopathy; Diabetic retinopathy; Visual impairment Skin and subcutaneous Lipodystrophy; tissue disorders

Auszug; vollständigen Abschnitt im Original lesen.

HOS-083678 · has-adverse-reaction-information · PDF-Seite 6

Summary of the safety profile Hypoglycaemia, in general the most frequent adverse reaction of insulin therapy, may occur if the insulin dose is too high in relation to the insulin requirement. In clinical studies and during marketed use, the frequency varies with patient population and dose regimens. Therefore, no specific frequency can be presented. Tabulated list of adverse reactions The following related adverse reactions from clinical investigations are listed below by system organ class and in order of decreasing incidence: very common (≥1/10); common (≥1/100 to <1/10); uncommon 6 (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. MedDRA system Common Uncommon Not known organ classes Immune system Shock Immediate type disorders allergic reactions (hypotension, angioneurotic oedema, bronchospasm, generalised skin reactions); Anti-insulin antibodies Metabolism and Oedema Hypoglycaemia; nutrition disorders Sodium retention Eye disorders Proliferative retinopathy; Diabetic retinopathy; Visual impairment Skin and subcutaneous Lipodystrophy; tissue disorders

Auszug; vollständigen Abschnitt im Original lesen.

HOS-083720 · has-adverse-reaction-information · PDF-Seite 88

Summary of the safety profile Hypoglycaemia, in general the most frequent adverse reaction of insulin therapy, may occur if the insulin dose is too high in relation to the insulin requirement. In clinical studies and during marketed use, the frequency varies with patient population and dose regimens. Therefore, no specific frequency can be presented. Tabulated list of adverse reactions The following related adverse reactions from clinical investigations are listed below by system organ class and in order of decreasing incidence: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 88 MedDRA system Common Uncommon Not known organ classes Immune system Shock Immediate type disorders allergic reactions (hypotension, angioneurotic oedema, bronchospasm, generalised skin reactions); Anti-insulin antibodies Metabolism and Oedema Hypoglycaemia; nutrition disorders Sodium retention Eye disorders Proliferative retinopathy; Diabetic retinopathy; Visual impairment Skin and subcutaneous Lipodystrophy; tissue disorders

Auszug; vollständigen Abschnitt im Original lesen.

HOS-083708 · has-adverse-reaction-information · PDF-Seite 64

Summary of the safety profile Hypoglycaemia, in general the most frequent adverse reaction of insulin therapy, may occur if the 64 insulin dose is too high in relation to the insulin requirement. In clinical studies and during marketed use, the frequency varies with patient population and dose regimens. Therefore, no specific frequency can be presented. Tabulated list of adverse reactions The following related adverse reactions from clinical investigations are listed below by system organ class and in order of decreasing incidence: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. MedDRA system Common Uncommon Not known organ classes Immune system Shock Immediate type allergic disorders reactions (hypotension, angioneurotic oedema, bronchospasm, generalised skin reactions); Anti-insulin antibodies Metabolism and Oedema Hypoglycaemia; nutrition disorders Sodium retention Eye disorders Proliferative retinopathy; Diabetic retinopathy; Visual impairment Skin and subcutaneous Lipodystrophy; tissue disorders Cutaneous amyloidosis General disorders and Injection site reactions Injection site urticaria Injection site administrati

Auszug; vollständigen Abschnitt im Original lesen.

HOS-083726 · has-adverse-reaction-information · PDF-Seite 100

Summary of the safety profile Hypoglycaemia, in general the most frequent adverse reaction of insulin therapy, may occur if the insulin dose is too high in relation to the insulin requirement. The frequency of this reaction varies with patient population and dose regimens. Tabulated list of adverse reactions From experience gained in a 6-month comparative phase III study (HUBIN_L_05335) with Insuman Implantable administered via the Medtronic MiniMed Implantable Pump in 84 patients aged 26 to 80 years (see section 5.1) and from clinical experience with insulin human 100 IU/ml and 40 IU/ml, the following adverse reactions were observed. The following adverse reactions from clinical investigations are listed below by system organ class and in order of decreasing incidence: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 100 Table 1: Adverse reactions observed in HUBIN_L_05335 study with insulin human 400 IU/ml and clinical experience with insulin human 100 IU/ml and 40 IU/ml. MedDRA system Common Uncommon Not known organ classes Immune system Shock Immediate type disorders allergic reactions (hypotension, angioneurotic oedema, bronchospasm, generalised skin reactions); Anti-insulin antibodies Metabolism and Hyperglycaemia; Sodium retention nutrition disorders Hypoglycaemia; Hypoglycaemic seizure; Hypoglycaemic unconsciousness;

Auszug; vollständigen Abschnitt im Original lesen.

HOS-083684 · has-adverse-reaction-information · PDF-Seite 16

Summary of the safety profile Hypoglycaemia, in general the most frequent adverse reaction of insulin therapy, may occur if the insulin dose is too high in relation to the insulin requirement. In clinical studies and during marketed use, the frequency varies with patient population and dose regimens. Therefore, no specific frequency can be presented. 16 Tabulated list of adverse reactions The following related adverse reactions from clinical investigations are listed below by system organ class and in order of decreasing incidence: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. MedDRA system Common Uncommon Not known organ classes Immune system Shock Immediate type disorders allergic reactions (hypotension, angioneurotic oedema, bronchospasm, generalised skin reactions); Anti-insulin antibodies Metabolism and Oedema Hypoglycaemia; nutrition disorders Sodium retention Eye disorders Proliferative retinopathy; Diabetic retinopathy; Visual impairment Skin and subcutaneous Lipodystrophy; tissue disorders

Auszug; vollständigen Abschnitt im Original lesen.

HOS-083696 · has-adverse-reaction-information · PDF-Seite 39

Summary of the safety profile Hypoglycaemia, in general the most frequent adverse reaction of insulin therapy, may occur if the insulin dose is too high in relation to the insulin requirement. In clinical studies and during marketed 39 use, the frequency varies with patient population and dose regimens. Therefore, no specific frequency can be presented. Tabulated list of adverse reactions The following related adverse reactions from clinical investigations are listed below by system organ class and in order of decreasing incidence: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. MedDRA system Common Uncommon Not known organ classes Immune system Shock Immediate type disorders allergic reactions (hypotension, angioneurotic oedema, bronchospasm, generalised skin reactions); Anti-insulin antibodies Metabolism and Oedema Hypoglycaemia; nutrition disorders Sodium retention Eye disorders Proliferative retinopathy; Diabetic retinopathy; Visual impairment Skin and Lipodystrophy; subcutaneous tissue

Auszug; vollständigen Abschnitt im Original lesen.

HOS-083702 · has-adverse-reaction-information · PDF-Seite 52

Summary of the safety profile Hypoglycaemia, in general the most frequent adverse reaction of insulin therapy, may occur if the insulin dose is too high in relation to the insulin requirement. In clinical studies and during marketed use, the frequency varies with patient population and dose regimens. Therefore, no specific frequency can be presented. Tabulated list of adverse reactions The following related adverse reactions from clinical investigations are listed below by system organ class and in order of decreasing incidence: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. MedDRA system Common Uncommon Not known organ classes Immune system Shock Immediate type disorders allergic reactions (hypotension, angioneurotic oedema, bronchospasm, generalised skin reactions); Anti-insulin antibodies Metabolism and Oedema Hypoglycaemia; nutrition disorders Sodium retention Eye disorders Proliferative retinopathy; Diabetic retinopathy; Visual impairment Skin and Lipodystrophy; subcutaneous tissue Cutaneous amyloidosis

Auszug; vollständigen Abschnitt im Original lesen.

HOS-083714 · has-adverse-reaction-information · PDF-Seite 77

Summary of the safety profile Hypoglycaemia, in general the most frequent adverse reaction of insulin therapy, may occur if the insulin dose is too high in relation to the insulin requirement. In clinical studies and during marketed use, the frequency varies with patient population and dose regimens. Therefore, no specific frequency can be presented. Tabulated list of adverse reactions The following related adverse reactions from clinical investigations are listed below by system organ class and in order of decreasing incidence: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. MedDRA system Common Uncommon Not known organ classes Immune system Shock Immediate type disorders allergic reactions (hypotension, angioneurotic oedema, bronchospasm, generalised skin reactions); Anti-insulin antibodies Metabolism and Oedema Hypoglycaemia; nutrition disorders Sodium retention Eye disorders Proliferative retinopathy; Diabetic retinopathy; Visual impairment Skin and Lipodystrophy; subcutaneous tissue Cutaneous amyloidosis

Auszug; vollständigen Abschnitt im Original lesen.

HOS-083722 · has-contraindication-information · PDF-Seite 96

Insuman Implantable Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Other routes of administration (e.g. injection). Medtronic MiniMed Implantable Pump Hypersensitivity to titanium alloy, polysulfone or silicone materials used in the implanted components of the pump. Use of other insulin medicinal products with the Medtronic MiniMed Implantable Pump. Use in paediatric patients who have not reached adult size due to the large size of the pump (see section 4.2 and 4.4). Implantation of the pump in patients who reside permanently at elevations above 2439 meters (8000 feet) (see section 4.4).

HOS-083704 · has-contraindication-information · PDF-Seite 61

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-083686 · has-contraindication-information · PDF-Seite 24

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 24

HOS-083710 · has-contraindication-information · PDF-Seite 74

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-083698 · has-contraindication-information · PDF-Seite 49

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-083680 · has-contraindication-information · PDF-Seite 13

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-083692 · has-contraindication-information · PDF-Seite 36

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-083716 · has-contraindication-information · PDF-Seite 85

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-083674 · has-contraindication-information · PDF-Seite 4

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-083703 · has-indication-information · PDF-Seite 60

Diabetes mellitus where treatment with insulin is required.

HOS-083709 · has-indication-information · PDF-Seite 72

Diabetes mellitus where treatment with insulin is required.

HOS-083685 · has-indication-information · PDF-Seite 23

Diabetes mellitus where treatment with insulin is required.

HOS-083673 · has-indication-information · PDF-Seite 2

Diabetes mellitus where treatment with insulin is required. Insuman Rapid is also suitable for the treatment of hyperglycaemic coma and ketoacidosis, as well as for achieving pre-, intra- and post-operative stabilisation in patients with diabetes mellitus.

HOS-083691 · has-indication-information · PDF-Seite 35

Diabetes mellitus where treatment with insulin is required.

HOS-083721 · has-indication-information · PDF-Seite 93

Insuman Implantable is indicated for the treatment of adult patients with type 1 diabetes mellitus that cannot be controlled with subcutaneous insulin (including pump) therapy, presenting with frequent, otherwise unexplained severe hyper-and/or hypoglycaemia.

HOS-083679 · has-indication-information · PDF-Seite 12

Diabetes mellitus where treatment with insulin is required.

HOS-083697 · has-indication-information · PDF-Seite 47

Diabetes mellitus where treatment with insulin is required.

HOS-083715 · has-indication-information · PDF-Seite 84

Diabetes mellitus where treatment with insulin is required.

HOS-083718 · has-interaction-information · PDF-Seite 87

A number of substances affect glucose metabolism and may require dose adjustment of human insulin. Substances that may enhance the blood-glucose-lowering effect and increase susceptibility to hypoglycaemia include oral antidiabetic medicinal products, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase (MAO) inhibitors, pentoxifylline, 87 propoxyphene, salicylates and sulphonamide antibiotics. Substances that may reduce the blood-glucose-lowering effect include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, oestrogens and progestogens (e.g. in oral contraceptives), phenothiazine derivatives, somatropin, sympathomimetic medicinal products (e.g. epinephrine [adrenaline], salbutamol, terbutaline), thyroid hormones, protease inhibitors and atypical antipsychotic medicinal products (e.g. olanzapine and clozapine). Beta-blockers, clonidine, lithium salts or alcohol may either potentiate or weaken the blood-glucose-lowering effect of insulin. Pentamidine may cause hypoglycaemia which may sometimes be followed by hyperglycaemia. In addition, under the influence of sympatholytic medicinal products such as beta-blockers, clonidine, guanethidine and reserpine, the signs of adrenergic counter-regulation may be reduced or absent.

HOS-083682 · has-interaction-information · PDF-Seite 16

A number of substances affect glucose metabolism and may require dose adjustment of human insulin. Substances that may enhance the blood-glucose-lowering effect and increase susceptibility to hypoglycaemia include oral antidiabetic medicinal products, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase (MAO) inhibitors, pentoxifylline, propoxyphene, salicylates and sulphonamide antibiotics. Substances that may reduce the blood-glucose-lowering effect include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, oestrogens and progestogens (e.g. in oral contraceptives), phenothiazine derivatives, somatropin, sympathomimetic medicinal products (e.g. epinephrine [adrenaline], salbutamol, terbutaline), thyroid hormones, protease inhibitors and atypical antipsychotic medicinal products (e.g. olanzapine and clozapine). Beta-blockers, clonidine, lithium salts or alcohol may either potentiate or weaken the blood-glucose-lowering effect of insulin. Pentamidine may cause hypoglycaemia which may sometimes be followed by hyperglycaemia. In addition, under the influence of sympatholytic medicinal products such as beta-blockers, clonidine, guanethidine and reserpine, the signs of adrenergic counter-regulation may be reduced or absent.

HOS-083706 · has-interaction-information · PDF-Seite 64

A number of substances affect glucose metabolism and may require dose adjustment of human insulin. Substances that may enhance the blood-glucose-lowering effect and increase susceptibility to hypoglycaemia include oral antidiabetic medicinal products, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase (MAO) inhibitors, pentoxifylline, propoxyphene, salicylates and sulphonamide antibiotics. Substances that may reduce the blood-glucose-lowering effect include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, oestrogens and progestogens (e.g. in oral contraceptives), phenothiazine derivatives, somatropin, sympathomimetic medicinal products (e.g. epinephrine [adrenaline], salbutamol, terbutaline), thyroid hormones, protease inhibitors and atypical antipsychotic medicinal products (e.g. olanzapine and clozapine). Beta-blockers, clonidine, lithium salts or alcohol may either potentiate or weaken the blood-glucose-lowering effect of insulin. Pentamidine may cause hypoglycaemia which may sometimes be followed by hyperglycaemia. In addition, under the influence of sympatholytic medicinal products such as beta-blockers, clonidine, guanethidine and reserpine, the signs of adrenergic counter-regulation may be reduced or absent.

HOS-083688 · has-interaction-information · PDF-Seite 27

A number of substances affect glucose metabolism and may require dose adjustment of human insulin. Substances that may enhance the blood-glucose-lowering effect and increase susceptibility to hypoglycaemia include oral antidiabetic medicinal products, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase (MAO) inhibitors, pentoxifylline, propoxyphene, salicylates and sulphonamide antibiotics. Substances that may reduce the blood-glucose-lowering effect include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, oestrogens and progestogens (e.g. in oral contraceptives), phenothiazine derivatives, somatropin, sympathomimetic medicinal products (e.g. epinephrine [adrenaline], salbutamol, terbutaline), thyroid hormones, protease inhibitors and atypical antipsychotic medicinal products (e.g. olanzapine and clozapine). Beta-blockers, clonidine, lithium salts or alcohol may either potentiate or weaken the blood-glucose-lowering effect of insulin. Pentamidine may cause hypoglycaemia which may sometimes be followed by hyperglycaemia. In addition, under the influence of sympatholytic medicinal products such as beta-blockers, clonidine, guanethidine and reserpine, the signs of adrenergic counter-regulation may be reduced or absent.

HOS-083700 · has-interaction-information · PDF-Seite 51

A number of substances affect glucose metabolism and may require dose adjustment of human insulin. Substances that may enhance the blood-glucose-lowering effect and increase susceptibility to hypoglycaemia include oral antidiabetic medicinal products, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase (MAO) inhibitors, pentoxifylline, propoxyphene, salicylates and sulphonamide antibiotics. Substances that may reduce the blood-glucose-lowering effect include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, oestrogens and progestogens (e.g. in oral contraceptives), phenothiazine derivatives, somatropin, sympathomimetic medicinal products (e.g. epinephrine [adrenaline], salbutamol, terbutaline), thyroid hormones, protease inhibitors and atypical antipsychotic medicinal products (e.g. olanzapine and clozapine). Beta-blockers, clonidine, lithium salts or alcohol may either potentiate or weaken the blood-glucose-lowering effect of insulin. Pentamidine may cause hypoglycaemia which may sometimes be followed by hyperglycaemia. In addition, under the influence of sympatholytic medicinal products such as beta-blockers, clonidine, guanethidine and reserpine, the signs of adrenergic counter-regulation may be reduced or absent.

HOS-083694 · has-interaction-information · PDF-Seite 39

A number of substances affect glucose metabolism and may require dose adjustment of human insulin. Substances that may enhance the blood-glucose-lowering effect and increase susceptibility to hypoglycaemia include oral antidiabetic medicinal products, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase (MAO) inhibitors, pentoxifylline, propoxyphene, salicylates and sulphonamide antibiotics. Substances that may reduce the blood-glucose-lowering effect include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, oestrogens and progestogens (e.g. in oral contraceptives), phenothiazine derivatives, somatropin, sympathomimetic medicinal products (e.g. epinephrine [adrenaline], salbutamol, terbutaline), thyroid hormones, protease inhibitors and atypical antipsychotic medicinal products (e.g. olanzapine and clozapine). Beta-blockers, clonidine, lithium salts or alcohol may either potentiate or weaken the blood-glucose-lowering effect of insulin. Pentamidine may cause hypoglycaemia which may sometimes be followed by hyperglycaemia. In addition, under the influence of sympatholytic medicinal products such as beta-blockers, clonidine, guanethidine and reserpine, the signs of adrenergic counter-regulation may be reduced or absent.

HOS-083676 · has-interaction-information · PDF-Seite 5

A number of substances affect glucose metabolism and may require dose adjustment of human insulin. 5 Substances that may enhance the blood-glucose-lowering effect and increase susceptibility to hypoglycaemia include oral antidiabetic medicinal products, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase (MAO) inhibitors, pentoxifylline, propoxyphene, salicylates and sulphonamide antibiotics. Substances that may reduce the blood-glucose-lowering effect include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, oestrogens and progestogens (e.g. in oral contraceptives), phenothiazine derivatives, somatropin, sympathomimetic medicinal products (e.g. epinephrine [adrenaline], salbutamol, terbutaline), thyroid hormones, protease inhibitors and atypical antipsychotic medicinal products (e.g. olanzapine and clozapine). Beta-blockers, clonidine, lithium salts or alcohol may either potentiate or weaken the blood-glucose-lowering effect of insulin. Pentamidine may cause hypoglycaemia which may sometimes be followed by hyperglycaemia. In addition, under the influence of sympatholytic medicinal products such as beta-blockers, clonidine, guanethidine and reserpine, the signs of adrenergic counter-regulation may be reduced or absent.

HOS-083712 · has-interaction-information · PDF-Seite 76

A number of substances affect glucose metabolism and may require dose adjustment of human insulin. Substances that may enhance the blood-glucose-lowering effect and increase susceptibility to hypoglycaemia include oral antidiabetic medicinal products, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase (MAO) inhibitors, pentoxifylline, propoxyphene, salicylates and sulphonamide antibiotics. Substances that may reduce the blood-glucose-lowering effect include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, oestrogens and progestogens (e.g. in oral contraceptives), phenothiazine derivatives, somatropin, sympathomimetic medicinal products (e.g. epinephrine [adrenaline], salbutamol, terbutaline), thyroid hormones, protease inhibitors and atypical antipsychotic medicinal products (e.g. olanzapine and clozapine). Beta-blockers, clonidine, lithium salts or alcohol may either potentiate or weaken the blood-glucose-lowering effect of insulin. Pentamidine may cause hypoglycaemia which may sometimes be followed by hyperglycaemia. In addition, under the influence of sympatholytic medicinal products such as beta-blockers, clonidine, guanethidine and reserpine, the signs of adrenergic counter-regulation may be reduced or absent.

HOS-083724 · has-interaction-information · PDF-Seite 99

A number of substances affect glucose metabolism and may require dose adjustment of human insulin. Substances that may enhance the blood-glucose-lowering effect and increase susceptibility to hypoglycaemia include oral antidiabetic medicinal products, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase (MAO) inhibitors, pentoxifylline, propoxyphene, salicylates and sulphonamide antibiotics. Substances that may reduce the blood-glucose-lowering effect include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, oestrogens and progestogens (e.g. in oral contraceptives), phenothiazine derivatives, somatropin, sympathomimetic medicinal products (e.g. epinephrine [adrenaline], salbutamol, terbutaline), thyroid hormones, protease inhibitors and atypical antipsychotic medicinal products (e.g. olanzapine and clozapine). Beta-blockers, clonidine, lithium salts or alcohol may either potentiate or weaken the blood-glucose-lowering effect of insulin. Pentamidine may cause hypoglycaemia which may sometimes be followed by hyperglycaemia. In addition, under the influence of sympatholytic medicinal products such as beta-blockers, clonidine, guanethidine and reserpine, the signs of adrenergic counter-regulation may be reduced or absent.

HOS-083707 · has-pregnancy-information · PDF-Seite 64

Pregnancy For insulin human, no clinical data on exposed pregnancies are available. Insulin does not cross the placental barrier. Caution should be exercised when prescribing to pregnant women. It is essential for patients with pre-existing or gestational diabetes to maintain good metabolic control throughout pregnancy. Insulin requirements may decrease during the first trimester and generally increase during the second and third trimesters. Immediately after delivery, insulin requirements decline rapidly (increased risk of hypoglycaemia). Careful monitoring of glucose control is essential. Breast-feeding No effects on the suckling child are anticipated. Insuman Comb 30 can be used during breast-feeding. Breast-feeding women may require adjustments in insulin dose and diet. Fertility No clinical or animal data with insulin human on male or female fertility are available.

HOS-083683 · has-pregnancy-information · PDF-Seite 16

Pregnancy For insulin human, no clinical data on exposed pregnancies are available. Insulin does not cross the placental barrier. Caution should be exercised when prescribing to pregnant women. It is essential for patients with pre-existing or gestational diabetes to maintain good metabolic control throughout pregnancy. Insulin requirements may decrease during the first trimester and generally increase during the second and third trimesters. Immediately after delivery, insulin requirements decline rapidly (increased risk of hypoglycaemia). Careful monitoring of glucose control is essential. Breast-feeding No effects on the suckling child are anticipated. Insuman Rapid can be used during breast-feeding. Breast-feeding women may require adjustments in insulin dose and diet. Fertility No clinical or animal data with insulin human on male or female fertility are available.

HOS-083689 · has-pregnancy-information · PDF-Seite 27

Pregnancy For insulin human, no clinical data on exposed pregnancies are available. Insulin does not cross the placental barrier. Caution should be exercised when prescribing to pregnant women. It is essential for patients with pre-existing or gestational diabetes to maintain good metabolic control throughout pregnancy. Insulin requirements may decrease during the first trimester and generally increase during the second and third trimesters. Immediately after delivery, insulin requirements decline rapidly (increased risk of hypoglycaemia). Careful monitoring of glucose control is essential. Breast-feeding No effects on the suckling child are anticipated. Insuman Basal can be used during breast-feeding. Breast-feeding women may require adjustments in insulin dose and diet. Fertility No clinical or animal data with insulin human on male or female fertility are available.

HOS-083677 · has-pregnancy-information · PDF-Seite 6

Pregnancy For insulin human, no clinical data on exposed pregnancies are available. Insulin does not cross the placental barrier. Caution should be exercised when prescribing to pregnant women. It is essential for patients with pre-existing or gestational diabetes to maintain good metabolic control throughout pregnancy. Insulin requirements may decrease during the first trimester and generally increase during the second and third trimesters. Immediately after delivery, insulin requirements decline rapidly (increased risk of hypoglycaemia). Careful monitoring of glucose control is essential. Breast-feeding No effects on the suckling child are anticipated. Insuman Rapid can be used during breast-feeding. Breast-feeding women may require adjustments in insulin dose and diet. Fertility No clinical or animal data with insulin human on male or female fertility are available.

HOS-083713 · has-pregnancy-information · PDF-Seite 76

Pregnancy For insulin human, no clinical data on exposed pregnancies are available. Insulin does not cross the placental barrier. Caution should be exercised when prescribing to pregnant women. It is essential for patients with pre-existing or gestational diabetes to maintain good metabolic control throughout pregnancy. Insulin requirements may decrease during the first trimester and generally increase during the second and third trimesters. Immediately after delivery, insulin requirements decline rapidly (increased risk of hypoglycaemia). Careful monitoring of glucose control is essential. Breast-feeding No effects on the suckling child are anticipated. Insuman Comb 50 can be used during breast-feeding. Breast-feeding women may require adjustments in insulin dose and diet. Fertility No clinical or animal data with insulin human on male or female fertility are available. 76

HOS-083701 · has-pregnancy-information · PDF-Seite 51

Pregnancy For insulin human, no clinical data on exposed pregnancies are available. Insulin does not cross the placental barrier. Caution should be exercised when prescribing to pregnant women. It is essential for patients with pre-existing or gestational diabetes to maintain good metabolic control throughout pregnancy. Insulin requirements may decrease during the first trimester and generally increase during the second and third trimesters. Immediately after delivery, insulin requirements decline rapidly (increased risk of hypoglycaemia). Careful monitoring of glucose control is essential. Breast-feeding No effects on the suckling child are anticipated. Insuman Comb 25 can be used during breast-feeding. Breast-feeding women may require adjustments in insulin dose and diet. Fertility No clinical or animal data with insulin human on male or female fertility are available. 51

HOS-083695 · has-pregnancy-information · PDF-Seite 39

Pregnancy For insulin human, no clinical data on exposed pregnancies are available. Insulin does not cross the placental barrier. Caution should be exercised when prescribing to pregnant women. It is essential for patients with pre-existing or gestational diabetes to maintain good metabolic control throughout pregnancy. Insulin requirements may decrease during the first trimester and generally increase during the second and third trimesters. Immediately after delivery, insulin requirements decline rapidly (increased risk of hypoglycaemia). Careful monitoring of glucose control is essential. Breast-feeding No effects on the suckling child are anticipated. Insuman Comb 15 can be used during breast-feeding. Breast-feeding women may require adjustments in insulin dose and diet. Fertility No clinical or animal data with insulin human on male or female fertility are available.

HOS-083719 · has-pregnancy-information · PDF-Seite 88

Pregnancy For insulin human, no clinical data on exposed pregnancies are available. Insulin does not cross the placental barrier. Caution should be exercised when prescribing to pregnant women. It is essential for patients with pre-existing or gestational diabetes to maintain good metabolic control throughout pregnancy. Insulin requirements may decrease during the first trimester and generally increase during the second and third trimesters. Immediately after delivery, insulin requirements decline rapidly (increased risk of hypoglycaemia). Careful monitoring of glucose control is essential. Breast-feeding No effects on the suckling child are anticipated. Insuman Infusat can be used during breast-feeding. Breast-feeding women may require adjustments in insulin dose and diet. Fertility No clinical or animal data with insulin human on male or female fertility are available.

HOS-083725 · has-pregnancy-information · PDF-Seite 99

Pregnancy For insulin human administered via subcutaneous route, no clinical data on exposed pregnancies are available. Insulin does not cross the placental barrier. For Insuman Implantable administered via the intraperitoneal pump, the safety profile has not been established in pregnancy. Women of childbearing potential, implanted or candidates for implantation, should inform their physician if they are contemplating pregnancy. Caution should be exercised when prescribing to pregnant women. Insuman Implantable should not be used during pregnancy unless the clinical condition of the woman requires treatment with Insuman Implantable. 99 It is essential for patients with pre-existing or gestational diabetes to maintain good metabolic control throughout pregnancy. Insulin requirements may decrease during the first trimester and generally increase during the second and third trimesters. Immediately after delivery, insulin requirements decline rapidly (increased risk of hypoglycaemia). Careful monitoring of glucose control is essential. Breast-feeding No effects on the breastfed child are anticipated. Insuman Implantable can be used during breast-feeding. Breast-feeding women may require adjustments in insulin dose and diet. Fertility No clinical or animal data with insulin human on male or female fertility are available.

HOS-083699 · has-warning-information · PDF-Seite 49

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Patients hypersensitive to Insuman Comb 25 for whom no better tolerated preparation is available must only continue treatment under close medical supervision and – where necessary – in conjunction with anti-allergic treatment. In patients with an allergy to animal insulin intradermal skin testing is recommended prior to a transfer to Insuman Comb 25, since they may experience immunological cross-reactions. In case of insufficient glucose control or a tendency to hyper- or hypoglycaemic episodes, the patient's adherence to the prescribed treatment regimen, injection sites and proper injection technique and all other relevant factors must be reviewed before dose adjustment is considered. Transfer to Insuman Comb 25 Transferring a patient to another type or brand of insulin should be done under strict medical supervision. Changes in strength, brand (manufacturer), type (regular, NPH, lente, long-acting, etc.), origin (animal, human, human insulin analogue) and/or method of manufacture may result in the need for a change in dose. The need to adjust (e.g. reduce) the dose may become evident immediately after transfer. Alternatively, it may emerge gradually over a period of several weeks. Following transfer from an animal insulin to human insulin, dose regimen reduction may be required in particular in patients who - were previously already controlled on rather low blood glucose levels, - have a tendency to hypoglycaemia, - previously required high insulin doses due to the presence of insulin antibodies. Close metabolic monitoring is recommended during the transition and in the initial weeks thereafter. In patients who require high insulin doses because of the presence of insulin antibodies, transfer under medical supervision in a hospital or similar setting must be considered. Patients must be instructed to perform continuous rotation of the injection site to reduce the risk of developing lipodystrophy and cutaneous amyloidosis. There is a potential risk of delayed insulin absorption and worsened glycaemic control following insulin injections at sites with these reactions. A sudden change in the injection site to an unaffected area has been reported to result in hypoglycaemia. Blood glucose monitoring is recommended after the change in the injection site, and dose adjustm

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HOS-083717 · has-warning-information · PDF-Seite 85

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Patients hypersensitive to Insuman Infusat for whom no better tolerated preparation is available must only continue treatment under close medical supervision and – where necessary – in conjunction with anti-allergic treatment. 85 In patients with an allergy to animal insulin intradermal skin testing is recommended prior to a transfer to Insuman Infusat, since they may experience immunological cross-reactions. In case of hypoglycaemia, the insulin pump should temporarily be turned off, at least until the patient has recovered complete consciousness. In case of insufficient glucose control or a tendency to hyper- or hypoglycaemic episodes, the patient's adherence to the prescribed treatment regimen, injection sites and proper injection technique and all other relevant factors must be reviewed before dose adjustment is considered. Transfer to Insuman Infusat Transferring a patient to another type or brand of insulin should be done under strict medical supervision. Changes in strength, brand (manufacturer), type (regular, NPH, lente, long-acting, etc.), origin (animal, human, human insulin analogue) and/or method of manufacture may result in the need for a change in dose. The need to adjust (e.g. reduce) the dose may become evident immediately after transfer. Alternatively, it may emerge gradually over a period of several weeks. Following transfer from an animal insulin to human insulin, dose regimen reduction may be required in particular in patients who - were previously already controlled on rather low blood glucose levels, - have a tendency to hypoglycaemia, - previously required high insulin doses due to the presence of insulin antibodies. Close metabolic monitoring is recommended during the transition and in the initial weeks thereafter. In patients who require high insulin doses because of the presence of insulin antibodies, transfer under medical supervision in a hospital or similar setting must be considered. Patients must be instructed to perform continuous rotation of the injection site to reduce the risk of developing lipodystrophy and cutaneous amyloidosis. There is a potential risk of delayed insulin absorption and worsened glycaemic control following insulin injections at sites with these reactions. A

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HOS-083711 · has-warning-information · PDF-Seite 74

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Patients hypersensitive to Insuman Comb 50 for whom no better tolerated preparation is available must only continue treatment under close medical supervision and – where necessary – in conjunction with anti-allergic treatment. In patients with an allergy to animal insulin intradermal skin testing is recommended prior to a transfer to Insuman Comb 50, since they may experience immunological cross-reactions. In case of insufficient glucose control or a tendency to hyper- or hypoglycaemic episodes, the patient's adherence to the prescribed treatment regimen, injection sites and proper injection technique and all other relevant factors must be reviewed before dose adjustment is considered. Transfer to Insuman Comb 50 Transferring a patient to another type or brand of insulin should be done under strict medical supervision. Changes in strength, brand (manufacturer), type (regular, NPH, lente, long-acting, etc.), origin (animal, human, human insulin analogue) and/or method of manufacture may result in the need for a change in dose. The need to adjust (e.g. reduce) the dose may become evident immediately after transfer. Alternatively, it may emerge gradually over a period of several weeks. Following transfer from an animal insulin to human insulin, dose regimen reduction may be required in particular in patients who - were previously already controlled on rather low blood glucose levels, - have a tendency to hypoglycaemia, - previously required high insulin doses due to the presence of insulin antibodies. Close metabolic monitoring is recommended during the transition and in the initial weeks thereafter. In patients who require high insulin doses because of the presence of insulin antibodies, transfer under medical supervision in a hospital or similar setting must be considered. Patients must be instructed to perform continuous rotation of the injection site to reduce the risk of developing lipodystrophy and cutaneous amyloidosis. There is a potential risk of delayed insulin absorption and worsened glycaemic control following insulin injections at sites with these reactions. A sudden change in the injection site to an unaffected area has been reported to result in hypoglycaemia. Blood glucose monitoring is recommended after the change in the injection site, and dose adjustm

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HOS-083675 · has-warning-information · PDF-Seite 4

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Patients hypersensitive to Insuman Rapid for whom no better tolerated preparation is available must only continue treatment under close medical supervision and – where necessary – in conjunction with anti-allergic treatment. In patients with an allergy to animal insulin intradermal skin testing is recommended prior to a transfer to Insuman Rapid, since they may experience immunological cross-reactions. In case of insufficient glucose control or a tendency to hyper- or hypoglycaemic episodes, the patient's adherence to the prescribed treatment regimen, injection sites and proper injection technique and all other relevant factors must be reviewed before dose adjustment is considered. Transfer to Insuman Rapid Transferring a patient to another type or brand of insulin should be done under strict medical supervision. Changes in strength, brand (manufacturer), type (regular, NPH, lente, long-acting, etc.), origin (animal, human, human insulin analogue) and/or method of manufacture may result in the need for a change in dose. The need to adjust (e.g. reduce) the dose may become evident immediately after transfer. Alternatively, it may emerge gradually over a period of several weeks. Following transfer from an animal insulin to human insulin, dose regimen reduction may be required in particular in patients who - were previously already controlled on rather low blood glucose levels, - have a tendency to hypoglycaemia, - previously required high insulin doses due to the presence of insulin antibodies. Close metabolic monitoring is recommended during the transition and in the initial weeks thereafter. In patients who require high insulin doses because of the presence of insulin antibodies, transfer under medical supervision in a hospital or similar setting must be considered. Patients must be instructed to perform continuous rotation of the injection site to reduce the risk of developing lipodystrophy and cutaneous amyloidosis. There is a potential risk of delayed insulin absorption and worsened glycaemic control following insulin injections at sites with these reactions. A sudden change in the injection site to an unaffected area has been reported to result in hypoglycaemia. Blood glucose monitoring is recommended after the change in the injection site, and dose adjustment of

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HOS-083681 · has-warning-information · PDF-Seite 13

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Patients hypersensitive to Insuman Rapid for whom no better tolerated preparation is available must only continue treatment under close medical supervision and – where necessary – in conjunction with anti-allergic treatment. In patients with an allergy to animal insulin intradermal skin testing is recommended prior to a transfer to Insuman Rapid, since they may experience immunological cross-reactions. 13 In case of insufficient glucose control or a tendency to hyper- or hypoglycaemic episodes, the patient's adherence to the prescribed treatment regimen, injection sites and proper injection technique and all other relevant factors must be reviewed before dose adjustment is considered. Transfer to Insuman Rapid Transferring a patient to another type or brand of insulin should be done under strict medical supervision. Changes in strength, brand (manufacturer), type (regular, NPH, lente, long-acting, etc.), origin (animal, human, human insulin analogue) and/or method of manufacture may result in the need for a change in dose. The need to adjust (e.g. reduce) the dose may become evident immediately after transfer. Alternatively, it may emerge gradually over a period of several weeks. Following transfer from an animal insulin to human insulin, dose regimen reduction may be required in particular in patients who - were previously already controlled on rather low blood glucose levels, - have a tendency to hypoglycaemia, - previously required high insulin doses due to the presence of insulin antibodies. Close metabolic monitoring is recommended during the transition and in the initial weeks thereafter. In patients who require high insulin doses because of the presence of insulin antibodies, transfer under medical supervision in a hospital or similar setting must be considered. Patients must be instructed to perform continuous rotation of the injection site to reduce the risk of developing lipodystrophy and cutaneous amyloidosis. There is a potential risk of delayed insulin absorption and worsened glycaemic control following insulin injections at sites with these reactions. A sudden change in the injection site to an unaffected area has been reported to result in hypoglycaemia. Blood glucose monitoring is recommended after

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HOS-083687 · has-warning-information · PDF-Seite 25

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Patients hypersensitive to Insuman Basal for whom no better tolerated preparation is available must only continue treatment under close medical supervision and – where necessary – in conjunction with anti-allergic treatment. In patients with an allergy to animal insulin intradermal skin testing is recommended prior to a transfer to Insuman Basal, since they may experience immunological cross-reactions. In case of insufficient glucose control or a tendency to hyper- or hypoglycaemic episodes, the patient's adherence to the prescribed treatment regimen, injection sites and proper injection technique and all other relevant factors must be reviewed before dose adjustment is considered. Transfer to Insuman Basal Transferring a patient to another type or brand of insulin should be done under strict medical supervision. Changes in strength, brand (manufacturer), type (regular, NPH, lente, long-acting, etc.), origin (animal, human, human insulin analogue) and/or method of manufacture may result in the need for a change in dose. The need to adjust (e.g. reduce) the dose may become evident immediately after transfer. Alternatively, it may emerge gradually over a period of several weeks. Following transfer from an animal insulin to human insulin, dose regimen reduction may be required in particular in patients who - were previously already controlled on rather low blood glucose levels, - have a tendency to hypoglycaemia, - previously required high insulin doses due to the presence of insulin antibodies. Close metabolic monitoring is recommended during the transition and in the initial weeks thereafter. In patients who require high insulin doses because of the presence of insulin antibodies, transfer under medical supervision in a hospital or similar setting must be considered. Patients must be instructed to perform continuous rotation of the injection site to reduce the risk of developing lipodystrophy and cutaneous amyloidosis. There is a potential risk of delayed insulin absorption and worsened glycaemic control following insulin injections at sites with these reactions. A sudden change in the injection site to an unaffected area has been reported to result in hypoglycaemia. Blood glucose monitoring is recommended after the change in the injection site, and dose adjustment of

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HOS-083693 · has-warning-information · PDF-Seite 36

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. 36 Patients hypersensitive to Insuman Comb 15 for whom no better tolerated preparation is available must only continue treatment under close medical supervision and – where necessary – in conjunction with anti-allergic treatment. In patients with an allergy to animal insulin intradermal skin testing is recommended prior to a transfer to Insuman Comb 15, since they may experience immunological cross-reactions. In case of insufficient glucose control or a tendency to hyper- or hypoglycaemic episodes, the patient's adherence to the prescribed treatment regimen, injection sites and proper injection technique and all other relevant factors must be reviewed before dose adjustment is considered. Transfer to Insuman Comb 15 Transferring a patient to another type or brand of insulin should be done under strict medical supervision. Changes in strength, brand (manufacturer), type (regular, NPH, lente, long-acting, etc.), origin (animal, human, human insulin analogue) and/or method of manufacture may result in the need for a change in dose. The need to adjust (e.g. reduce) the dose may become evident immediately after transfer. Alternatively, it may emerge gradually over a period of several weeks. Following transfer from an animal insulin to human insulin, dose regimen reduction may be required in particular in patients who - were previously already controlled on rather low blood glucose levels, - have a tendency to hypoglycaemia, - previously required high insulin doses due to the presence of insulin antibodies. Close metabolic monitoring is recommended during the transition and in the initial weeks thereafter. In patients who require high insulin doses because of the presence of insulin antibodies, transfer under medical supervision in a hospital or similar setting must be considered. Patients must be instructed to perform continuous rotation of the injection site to reduce the risk of developing lipodystrophy and cutaneous amyloidosis. There is a potential risk of delayed insulin absorption and worsened glycaemic control following insulin injections at sites with these reactions. A sudden change in the injection site to an unaffected area has been reported to result in hypoglycaemia. Blood glucose monitoring is recommended a

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HOS-083723 · has-warning-information · PDF-Seite 96

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. The Medtronic MiniMed Implantable Pump should not be implanted in patients who have medical or mental conditions that make them unable to program modifications to the pump based on glucose readings or to take appropriate corrective actions in case of pump system problems. Patients implanted with a Medtronic MiniMed Implantable Pump must receive comprehensive instruction in the use of the pump, and the necessary actions in case of illness, hypoglycaemia and hyperglycaemia or pump failure. The patient should read and follow the instructions in the Patient Manual accompanying the infusion pump. For further details on handling see section 6.6. Medical imaging technique Patients who expect to need frequent or routine MRI or therapeutic ultrasound should not be implanted with the Medtronic MiniMed Implantable Pump. Hypersensitivity Patients hypersensitive to Insuman Implantable for whom no better tolerated preparation is available must only continue treatment under close medical supervision and – if necessary – in conjunction with anti-allergic treatment. In patients with an allergy to animal insulin, intradermal skin testing is recommended prior to changing to Insuman Implantable, since they may experience immunological cross-reactions. In case of insufficient glucose control or a tendency to hyper- or hypoglycaemic episodes, the patient's adherence to the prescribed treatment regimen and all other relevant factors must be reviewed before dose adjustment is considered. Hypoglycaemia Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement. Clinically relevant over-delivery of insulin was not observed during a 4 year period of evaluation of the Medtronic MiniMed Implantable Pump; however, this does not exclude the potential for such an occurrence. In case of severe hypoglycaemia, patients should immediately contact their physician trained to perform pump investigations and the pump should then be investigated by the physician for possible catheter occlusion leading to accumulation of insulin with subsequent release of this accumulated insulin (see section 6.6). During a refill procedure, a very small amount of insulin may be deposited subcutaneously, possibly resulting in hypoglycaemia. Patients must be informed to closely monitor blood glucose levels

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HOS-083705 · has-warning-information · PDF-Seite 61

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. 61 Patients hypersensitive to Insuman Comb 30 for whom no better tolerated preparation is available must only continue treatment under close medical supervision and – where necessary – in conjunction with anti-allergic treatment. In patients with an allergy to animal insulin intradermal skin testing is recommended prior to a transfer to Insuman Comb 30, since they may experience immunological cross-reactions. In case of insufficient glucose control or a tendency to hyper- or hypoglycaemic episodes, the patient's adherence to the prescribed treatment regimen, injection sites and proper injection technique and all other relevant factors must be reviewed before dose adjustment is considered. Transfer to Insuman Comb 30 Transferring a patient to another type or brand of insulin should be done under strict medical supervision. Changes in strength, brand (manufacturer), type (regular, NPH, lente, long-acting,etc.), origin (animal, human, human insulin analogue) and/or method of manufacture may result in the need for a change in dose. The need to adjust (e.g. reduce) the dose may become evident immediately after transfer. Alternatively, it may emerge gradually over a period of several weeks. Following transfer from an animal insulin to human insulin, dose regimen reduction may be required in particular in patients who - were previously already controlled on rather low blood glucose levels, - have a tendency to hypoglycaemia, - previously required high insulin doses due to the presence of insulin antibodies. Close metabolic monitoring is recommended during the transition and in the initial weeks thereafter. In patients who require high insulin doses because of the presence of insulin antibodies, transfer under medical supervision in a hospital or similar setting must be considered. Patients must be instructed to perform continuous rotation of the injection site to reduce the risk of developing lipodystrophy and cutaneous amyloidosis. There is a potential risk of delayed insulin absorption and worsened glycaemic control following insulin injections at sites with these reactions. A sudden change in the injection site to an unaffected area has been reported to result in hypoglycaemia. Blood glucose monitoring is recommended af

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