ZYPREXA Powder for solution for injection (2019)
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Περιεχόμενα
Name of the medicinal product
ZYPREXA 10 mg powder for solution for injection.
Qualitative and quantitative composition
Each vial contains 10 mg olanzapine. After reconstitution each ml of the solution contains 5 mg olanzapine. For the full list of excipients, see section 6.1.
Pharmaceutical form
Powder for solution for injection. Yellow lyophilised powder.
Therapeutic indications
Adults ZYPREXA powder for solution for injection is indicated for the rapid control of agitation and disturbed behaviours in patients with schizophrenia or manic episode, when oral therapy is not appropriate. ...
Posology and method of administration
Adults For intramuscular use. Do not administer intravenously or subcutaneously. ZYPREXA powder for solution for injection is intended for short term use only, for up to a maximum of three consecutive ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients with known risk of narrow-angle glaucoma.
Special warnings and precautions for use
The efficacy of IM olanzapine has not been established in patients with agitation and disturbed behaviours related to conditions other than schizophrenia or manic episode. Unstable medical conditions ...
Interaction with other medicinal products and other forms of interaction
Interaction studies have only been performed in adults. IM olanzapine has not been studied in patients with alcohol or drug intoxication (see section 4.4). Caution should be exercised in patients who consume ...
Fertility, pregnancy and lactation
Pregnancy There are no adequate and well-controlled studies in pregnant women. Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during treatment ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. Because olanzapine may cause somnolence and dizziness, patients should be cautioned about operating machinery, including ...
Undesirable effects
Summary of the safety profile A common (≥1/100 to <1/10) undesirable effect associated with the use of intramuscular olanzapine in clinical trials was somnolence. In post marketing reports, temporal association ...
Overdose
Signs and symptoms Very common symptoms in overdose (>10% incidence) include tachycardia, agitation/aggressiveness, dysarthria, various extrapyramidal symptoms, and reduced level of consciousness ranging ...
Pharmacodynamic properties
Pharmacotherapeutic group: psycholeptics, diazepines, oxazepines, thiazepines and oxepines ATC code: N05AH03 Pharmacodynamic effects Olanzapine is an antipsychotic, antimanic and mood stabilising agent ...
Pharmacokinetic properties
In a pharmacokinetic study in healthy volunteers, a dose of 5 mg of ZYPREXA powder for solution for injection produced a maximum plasma concentration (C<sub>max</sub>) approximately 5 times higher than ...
Preclinical safety data
Acute (single-dose) toxicity Signs of oral toxicity in rodents were characteristic of potent antipsychotic compounds: hypoactivity, coma, tremors, clonic convulsions, salivation, and depressed weight gain. ...
List of excipients
Lactose monohydrate Tartaric acid, E334 Hydrochloric acid Sodium hydroxide
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. Olanzapine for injection should not be combined in a syringe with diazepam injection because ...
Shelf life
Powder: 3 years. Solution (after reconstitution): 1 hour. Do not freeze.
Special precautions for storage
Do not store above 25°C. Store in the original package in order to protect from light. For storage conditions of the reconstituted medicinal product, see section 6.3.
Nature and contents of container
Type I, 5 ml glass vial. One carton contains 1 or 10 vial(s). Not all pack sizes may be marketed.
Special precautions for disposal and other handling
Reconstitute ZYPREXA only with water for injections using standard aseptic techniques for reconstitution of parenteral products. No other solutions should be used for reconstitution (see section 6.2). ...
Marketing authorization holder
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.
Marketing authorization number(s)
EU/1/96/022/016 – ZYPREXA Powder for solution for injection. 1 vial EU/1/96/022/017 – ZYPREXA Powder for solution for injection. 10 vials
Date of first authorization / renewal of the authorization
Date of first authorisation: 27 September 1996 Date of latest renewal: 12 September 2006
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