Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Apidra

Apidra 100 Units/ml solution for injection in a vial Apidra 100 Units/ml solution for injection in a cartridge Apidra SoloStar 100 Units/ml solution for injection in a pre-filled pen · Abschnitt 4.3 · PDF-Seite 4

HOS-113137 · Präparat HOS-093863

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

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Apidra

Apidra 100 Units/ml solution for injection in a vial Apidra 100 Units/ml solution for injection in a cartridge Apidra SoloStar 100 Units/ml solution for injection in a pre-filled pen · Abschnitt 4.5 · PDF-Seite 5

HOS-113138 · Präparat HOS-093863

Studies on pharmacokinetic interactions have not been performed. Based on empirical knowledge from similar medicinal products, clinically relevant pharmacokinetic interactions are unlikely to occur. A number of substances affect glucose metabolism and may require dose adjustment of insulin glulisine and particularly close monitoring.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): glucose (HOS-088412)

Wechselwirkungen · Apidra

Apidra 100 Units/ml solution for injection in a vial Apidra 100 Units/ml solution for injection in a cartridge Apidra SoloStar 100 Units/ml solution for injection in a pre-filled pen · Abschnitt 4.5 · PDF-Seite 5–6

HOS-113139 · Präparat HOS-093863

5 Substances that may enhance the blood-glucose-lowering activity and increase susceptibility to hypoglycaemia include oral antidiabetic medicinal products, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors (MAOIs), pentoxifylline, propoxyphene, salicylates and sulphonamide antibiotics. Substances that may reduce the blood-glucose-lowering activity include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, phenothiazine derivatives, somatropin, sympathomimetic medicinal products (e.g. epinephrine [adrenaline], salbutamol, terbutaline), thyroid hormones, oestrogens, progestins (e.g. in oral contraceptives), 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 activity 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.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): propoxyphene (HOS-086140) olanzapine (HOS-085937) protease (HOS-085623) clonidine (HOS-088594) diazoxide (HOS-088588) pentoxifylline (HOS-088586) disopyramide (HOS-085595) danazol (HOS-085473) fluoxetine (HOS-085946) somatropin (HOS-088591) epinephrine (HOS-088592) clozapine (HOS-086149) pentamidine (HOS-085605) guanethidine (HOS-088596) lithium (HOS-085952) terbutaline (HOS-085475) isoniazid (HOS-088590) reserpine (HOS-088597) glucagon (HOS-088589)

Nebenwirkungen · Apidra

Apidra 100 Units/ml solution for injection in a vial Apidra 100 Units/ml solution for injection in a cartridge Apidra SoloStar 100 Units/ml solution for injection in a pre-filled pen · Abschnitt 4.8 · PDF-Seite 6

HOS-113149 · Präparat HOS-093863

Summary of the safety profile Hypoglycaemia, the most frequent adverse reaction of insulin therapy, may occur if the insulin dose is too high in relation to the insulin requirement.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Apidra

Apidra 100 Units/ml solution for injection in a vial Apidra 100 Units/ml solution for injection in a cartridge Apidra SoloStar 100 Units/ml solution for injection in a pre-filled pen · Abschnitt 4.8 · PDF-Seite 6

HOS-113150 · Präparat HOS-093863

Tabulated list of adverse reactions The following related adverse reactions from clinical studies were listed below by system organ class and in order of decreasing incidence (very common: ≥1/10; common: ≥1/100 to <1/10; uncommon:

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Apidra

Apidra 100 Units/ml solution for injection in a vial Apidra 100 Units/ml solution for injection in a cartridge Apidra SoloStar 100 Units/ml solution for injection in a pre-filled pen · Abschnitt 4.8 · PDF-Seite 6–7

HOS-113151 · Präparat HOS-093863

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).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Apidra

Apidra 100 Units/ml solution for injection in a vial Apidra 100 Units/ml solution for injection in a cartridge Apidra SoloStar 100 Units/ml solution for injection in a pre-filled pen · Abschnitt 4.8 · PDF-Seite 7

HOS-113152 · Präparat HOS-093863

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. MedDRA Very common Common Uncommon Rare Not known Organ system classes Metabolism Hypoglycaemia Hyperglycaemia and nutrition (potentially disorders leading to Diabetic ketoacidosis(1)) Skin and Injection site Lipodystrophy Cutaneous subcutaneous reactions amyloidosis tissue Local disorders hypersensitivity reactions General Systemic disorders and hypersensitivity administration reactions site conditions

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Apidra

Apidra 100 Units/ml solution for injection in a vial Apidra 100 Units/ml solution for injection in a cartridge Apidra SoloStar 100 Units/ml solution for injection in a pre-filled pen · Abschnitt 4.8 · PDF-Seite 7

HOS-113153 · Präparat HOS-093863

(1) Apidra 100 Units/ml solution for injection in a vial: Most of the cases were related to handling errors or pump system failure when Apidra was used with CSII.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Apidra

Apidra 100 Units/ml solution for injection in a vial Apidra 100 Units/ml solution for injection in a cartridge Apidra SoloStar 100 Units/ml solution for injection in a pre-filled pen · Abschnitt 4.8 · PDF-Seite 7

HOS-113154 · Präparat HOS-093863

Description of selected adverse reactions • Metabolism and nutrition disorders Symptoms of hypoglycaemia usually occur suddenly. They may include cold sweats, cool pale skin, fatigue, nervousness or tremor, anxiousness, unusual tiredness or weakness, confusion, difficulty in concentration, drowsiness, excessive hunger, vision changes, headache, nausea and palpitation. Hypoglycaemia can become severe and may lead to unconsciousness and/or convulsions and may result in temporary or permanent impairment of brain function or even death.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Apidra

Apidra 100 Units/ml solution for injection in a vial Apidra 100 Units/ml solution for injection in a cartridge Apidra SoloStar 100 Units/ml solution for injection in a pre-filled pen · Abschnitt 4.8 · PDF-Seite 7

HOS-113155 · Präparat HOS-093863

Apidra 100 Units/ml solution for injection in a vial Cases of hyperglycaemia have been reported with Apidra when used with CSII (see section 4.4) that has led to Diabetic Ketoacidosis (DKA); most of the cases were related to handling errors or pump system failure. The patient should always follow the Apidra specific instructions and always have access to alternative insulin delivery system in case of pump system failure.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Apidra

Apidra 100 Units/ml solution for injection in a vial Apidra 100 Units/ml solution for injection in a cartridge Apidra SoloStar 100 Units/ml solution for injection in a pre-filled pen · Abschnitt 4.8 · PDF-Seite 7

HOS-113156 · Präparat HOS-093863

• Skin and subcutaneous tissue disorders Local hypersensitivity reactions (redness, swelling and itching at the injection site) may occur during treatment with insulin. These reactions are usually transitory and normally they disappear during continued treatment. Lipodystrophy and cutaneous amyloidosis may occur at the injection site and delay local insulin absorption. Continuous rotation of the injection site within the given injection area may help to reduce or prevent these reactions (see section 4.4).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Apidra

Apidra 100 Units/ml solution for injection in a vial Apidra 100 Units/ml solution for injection in a cartridge Apidra SoloStar 100 Units/ml solution for injection in a pre-filled pen · Abschnitt 4.8 · PDF-Seite 7

HOS-113157 · Präparat HOS-093863

• General disorders and administration site conditions Systemic hypersensitivity reactions may include urticaria, chest tightness, dyspnoea, allergic dermatitis and pruritus. Severe cases of generalized allergy, including anaphylactic reaction, may be life-threatening.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Apidra

Apidra 100 Units/ml solution for injection in a vial Apidra 100 Units/ml solution for injection in a cartridge Apidra SoloStar 100 Units/ml solution for injection in a pre-filled pen · Abschnitt 4.8 · PDF-Seite 7

HOS-113158 · Präparat HOS-093863

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.