Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Zyprexa

ZYPREXA 10 mg powder for solution for injection · Abschnitt 4.8 · PDF-Seite 27

HOS-086006 · Präparat HOS-083234

Musculoskeletal and connective tissue disorders Arthralgia9 Rhabdomyolysis11 Renal and urinary disorders Urinary incontinence, urinary retention Urinary hesitation11 Pregnancy, puerperium and perinatal conditions Drug withdrawal syndrome neonatal (see section 4.6) Reproductive system and breast disorders Erectile dysfunction Amenorrhea Priapism12 in males Breast enlargement Decreased libido in Galactorrhea in males and females females Gynaecomastia/breast enlargement in males General disorders and administration site conditions Asthenia Fatigue Oedema Pyrexia10

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

Nebenwirkungen · Zyprexa

ZYPREXA 10 mg powder for solution for injection · Abschnitt 4.8 · PDF-Seite 27–28

HOS-086007 · Präparat HOS-083234

27  Investigations Elevated Increased alkaline Increased total plasma phosphatase10 bilirubin prolactin High creatine levels8 phosphokinase11 High Gamma Glutamyltransferase 10

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

Nebenwirkungen · Zyprexa

ZYPREXA 10 mg powder for solution for injection · Abschnitt 4.8 · PDF-Seite 28

HOS-086008 · Präparat HOS-083234

High Uric acid 10 1 Clinically significant weight gain was observed across all baseline Body Mass Index (BMI) categories. Following short term treatment (median duration 47 days), weight gain ≥ 7% of baseline body weight was very common (22.2 %), ≥ 15 % was common (4.2 %) and ≥ 25 % was uncommon (0.8 %). Patients gaining ≥ 7 %, ≥ 15 % and ≥ 25 % of their baseline body weight with long-term exposure (at least 48 weeks) were very common (64.4 %, 31.7 % and 12.3 % respectively). 2 Mean increases in fasting lipid values (total cholesterol, LDL cholesterol, and triglycerides) were greater in patients without evidence of lipid dysregulation at baseline. 3 Observed for fasting normal levels at baseline (< 5.17 mmol/l) which increased to high (≥ 6.2 mmol/l). Changes in total fasting cholesterol levels from borderline at baseline (≥ 5.17 - < 6.2 mmol/l) to high (≥ 6.2 mmol/l) were very common. 4 Observed for fasting normal levels at baseline (< 5.56 mmol/l) which increased to high (≥ 7 mmol/l). Changes in fasting glucose from borderline at baseline (≥ 5.56 - < 7 mmol/l) to high (≥ 7 mmol/l) were very common. 5 Observed for fasting normal levels at baseline (< 1.69 mmol/l) which increased to high (≥ 2.26 mmol/l). Changes in fasting triglycerides from borderline at baseline (≥ 1.69 mmol/l - < 2.26 mmol/l) to high (≥ 2.26 mmol/l) were very common. 6 In clinical trials, the incidence of Parkinsonism and dystonia in olanzapine-treated patients was numerically higher, but not statistically significantly different from placebo. Olanzapine-treated patients had a lower incidence of Parkinsonism, akathisia and dystonia compared with titrated doses of haloperidol. In the absence of detailed information on the pre-existing history of individual acute and tardive extrapyramidal movement disorders, it cannot be concluded at present that olanzapine produces less tardive dyskinesia and/or other tardive extrapyramidal syndromes. 7 Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea and vomiting have been reported when olanzapine is stopped abruptly. 8 In clinical trials of up to 12 weeks, plasma prolactin concentrations exceeded the upper limit of normal range in approximately 30% of olanzapine treated patients with normal baseline prolactin value. In the majority of these patients the elevations were generally mild, and remained below two times the upper limit of normal range. 9 Adverse event identified from clinical trials in the Olanzapine Integrated Database. 10 As assessed by measured values from clinical trials in the Olanzapine Integrated Database. 11 Adverse event identified from spontaneous post-marketing reporting with frequency determined utilising the Olanzapine Integrated Database. 12 Adverse event identified from spontaneous post-marketing reporting with frequency estimated at the upper limit of the 95% confidence interval utilising the Olanzapine Integrated Database.

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

Nebenwirkungen · Zyprexa

ZYPREXA 10 mg powder for solution for injection · Abschnitt 4.8 · PDF-Seite 28–29

HOS-086009 · Präparat HOS-083234

28  Undesirable effects listed and observed following administration of oral and LAIM olanzapine, 13

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

Nebenwirkungen · Zyprexa

ZYPREXA 10 mg powder for solution for injection · Abschnitt 4.8 · PDF-Seite 29

HOS-086010 · Präparat HOS-083234

which may also occur following administration of RAIM olanzapine.

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

Nebenwirkungen · Zyprexa

ZYPREXA 10 mg powder for solution for injection · Abschnitt 4.8 · PDF-Seite 29

HOS-086011 · Präparat HOS-083234

Long-term exposure (at least 48 weeks) The proportion of patients who had adverse, clinically significant changes in weight gain, glucose, total/LDL/HDL cholesterol or triglycerides increased over time. In adult patients who completed 9-12 months of therapy, the rate of increase in mean blood glucose slowed after approximately 6 months.

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

Nebenwirkungen · Zyprexa

ZYPREXA 10 mg powder for solution for injection · Abschnitt 4.8 · PDF-Seite 29

HOS-086012 · Präparat HOS-083234

Additional information on special populations In clinical trials in elderly patients with dementia, olanzapine treatment was associated with a higher incidence of death and cerebrovascular adverse reactions compared to placebo (see section 4.4). Very common adverse reactions associated with the use of olanzapine in this patient group were abnormal gait and falls. Pneumonia, increased body temperature, lethargy, erythema, visual hallucinations and urinary incontinence were observed commonly.

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

Nebenwirkungen · Zyprexa

ZYPREXA 10 mg powder for solution for injection · Abschnitt 4.8 · PDF-Seite 29

HOS-086013 · Präparat HOS-083234

In clinical trials in patients with drug-induced (dopamine agonist) psychosis associated with Parkinson’s disease, worsening of Parkinsonian symptomatology and hallucinations were reported very commonly and more frequently than with placebo.

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

Nebenwirkungen · Zyprexa

ZYPREXA 10 mg powder for solution for injection · Abschnitt 4.8 · PDF-Seite 29

HOS-086014 · Präparat HOS-083234

In one clinical trial in patients with bipolar mania, valproate combination therapy with olanzapine resulted in an incidence of neutropenia of 4.1%; a potential contributing factor could be high plasma valproate levels. Olanzapine administered with lithium or valproate resulted in increased levels (≥ 10%) of tremor, dry mouth, increased appetite, and weight gain. Speech disorder was also reported commonly. During treatment with olanzapine in combination with lithium or divalproex, an increase of ≥ 7% from baseline body weight occurred in 17.4% of patients during acute treatment (up to 6 weeks). Long-term olanzapine treatment (up to 12 months) for recurrence prevention in patients with bipolar disorder was associated with an increase of ≥ 7% from baseline body weight in 39.9% of patients.

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

Nebenwirkungen · Zyprexa

ZYPREXA 10 mg powder for solution for injection · Abschnitt 4.8 · PDF-Seite 29

HOS-086015 · Präparat HOS-083234

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.

Wechselwirkungen · Insuman

Insuman Rapid 40 IU/ml solution for injection in a vial Insuman Rapid 100 IU/ml solution for injection in a vial · Abschnitt 4.5 · PDF-Seite 6

HOS-088587 · Präparat HOS-083671

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).

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): olanzapine (HOS-085937) protease (HOS-085623) diazoxide (HOS-088588) danazol (HOS-085473) somatropin (HOS-088591) epinephrine (HOS-088592) clozapine (HOS-086149) terbutaline (HOS-085475) isoniazid (HOS-088590) glucagon (HOS-088589)

Wechselwirkungen · Insuman

Insuman Rapid 100 IU/ml solution for injection in a cartridge Insuman Rapid SoloStar 100 IU/ml solution for injection in a pre-filled pen · Abschnitt 4.5 · PDF-Seite 16

HOS-088613 · Präparat HOS-083671

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).

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): olanzapine (HOS-085937) protease (HOS-085623) diazoxide (HOS-088588) danazol (HOS-085473) somatropin (HOS-088591) epinephrine (HOS-088592) clozapine (HOS-086149) terbutaline (HOS-085475) isoniazid (HOS-088590) glucagon (HOS-088589)

Wechselwirkungen · Insuman

Insuman Basal 40 IU/ml suspension for injection in a vial Insuman Basal 100 IU/ml suspension for injection in a vial Insuman Basal 100 IU/ml suspension for injection in a cartridge Insuman Basal SoloStar 100 IU/ml suspension for injection in a pre-filled pen · Abschnitt 4.5 · PDF-Seite 27

HOS-088633 · Präparat HOS-083671

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).

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): olanzapine (HOS-085937) protease (HOS-085623) diazoxide (HOS-088588) danazol (HOS-085473) somatropin (HOS-088591) epinephrine (HOS-088592) clozapine (HOS-086149) terbutaline (HOS-085475) isoniazid (HOS-088590) glucagon (HOS-088589)

Wechselwirkungen · Insuman

Insuman Comb 15 100 IU/ml suspension for injection in a vial Insuman Comb 15 100 IU/ml suspension for injection in a cartridge Insuman Comb 15 SoloStar 100 IU/ml suspension for injection in a pre-filled pen · Abschnitt 4.5 · PDF-Seite 39

HOS-088652 · Präparat HOS-083671

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).

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) diazoxide (HOS-088588) pentoxifylline (HOS-088586) disopyramide (HOS-085595) danazol (HOS-085473) fluoxetine (HOS-085946) somatropin (HOS-088591) epinephrine (HOS-088592) clozapine (HOS-086149) terbutaline (HOS-085475) isoniazid (HOS-088590) glucagon (HOS-088589)

Wechselwirkungen · Insuman

Insuman Comb 25 40 IU/ml suspension for injection in a vial Insuman Comb 25 100 IU/ml suspension for injection in a vial Insuman Comb 25 100 IU/ml suspension for injection in a cartridge Insuman Comb 25 SoloStar 100 IU/ml suspension for injection in a pre-filled pen · Abschnitt 4.5 · PDF-Seite 51

HOS-088671 · Präparat HOS-083671

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).

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): olanzapine (HOS-085937) protease (HOS-085623) diazoxide (HOS-088588) danazol (HOS-085473) somatropin (HOS-088591) epinephrine (HOS-088592) clozapine (HOS-086149) terbutaline (HOS-085475) isoniazid (HOS-088590) glucagon (HOS-088589)

Wechselwirkungen · Insuman

Insuman Comb 30 100 IU/ml suspension for injection in a vial Insuman Comb 30 100 IU/ml suspension for injection in a cartridge Insuman Comb 30 SoloStar 100 IU/ml suspension for injection in a pre-filled pen · Abschnitt 4.5 · PDF-Seite 64

HOS-088691 · Präparat HOS-083671

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).

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): olanzapine (HOS-085937) protease (HOS-085623) diazoxide (HOS-088588) danazol (HOS-085473) somatropin (HOS-088591) epinephrine (HOS-088592) clozapine (HOS-086149) terbutaline (HOS-085475) isoniazid (HOS-088590) glucagon (HOS-088589)

Wechselwirkungen · Insuman

Insuman Comb 50 40 IU/ml suspension for injection in a vial Insuman Comb 50 100 IU/ml suspension for injection in a vial Insuman Comb 50 100 IU/ml suspension for injection in a cartridge Insuman Comb 50 SoloStar 100 IU/ml suspension for injection in a pre-filled pen · Abschnitt 4.5 · PDF-Seite 76

HOS-088710 · Präparat HOS-083671

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).

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): olanzapine (HOS-085937) protease (HOS-085623) diazoxide (HOS-088588) danazol (HOS-085473) somatropin (HOS-088591) epinephrine (HOS-088592) clozapine (HOS-086149) terbutaline (HOS-085475) isoniazid (HOS-088590) glucagon (HOS-088589)

Wechselwirkungen · Insuman

Insuman Infusat 100 IU/ml solution for injection in a vial · Abschnitt 4.5 · PDF-Seite 88

HOS-088729 · Präparat HOS-083671

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.

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): olanzapine (HOS-085937) protease (HOS-085623) clonidine (HOS-088594) diazoxide (HOS-088588) danazol (HOS-085473) somatropin (HOS-088591) epinephrine (HOS-088592) clozapine (HOS-086149) pentamidine (HOS-085605) lithium (HOS-085952) terbutaline (HOS-085475) isoniazid (HOS-088590) glucagon (HOS-088589)

Wechselwirkungen · Insuman

Insuman Implantable 400 IU/ml solution for infusion · Abschnitt 4.5 · PDF-Seite 99

HOS-088750 · Präparat HOS-083671

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).

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): olanzapine (HOS-085937) protease (HOS-085623) diazoxide (HOS-088588) danazol (HOS-085473) somatropin (HOS-088591) epinephrine (HOS-088592) clozapine (HOS-086149) terbutaline (HOS-085475) isoniazid (HOS-088590) glucagon (HOS-088589)

Wechselwirkungen · Lantus

Lantus 100 units/ml solution for injection in a vial Lantus 100 units/ml solution for injection in a cartridge Lantus SoloStar 100 units/ml solution for injection in a pre-filled pen · Abschnitt 4.5 · PDF-Seite 6

HOS-091009 · Präparat HOS-084169

Substances that may reduce the blood-glucose-lowering effect include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, oestrogens and progestogens, phenothiazine derivatives, somatropin, sympathomimetic medicinal products (e.g. epinephrine [adrenaline], salbutamol, terbutaline), thyroid hormones, atypical antipsychotic medicinal products (e.g. clozapine and olanzapine) and protease inhibitors.

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): olanzapine (HOS-085937) protease (HOS-085623) diazoxide (HOS-088588) danazol (HOS-085473) somatropin (HOS-088591) epinephrine (HOS-088592) clozapine (HOS-086149) terbutaline (HOS-085475) isoniazid (HOS-088590) glucagon (HOS-088589)