Κλαύδιος Γαληνός
Δωρεάν εγγραφή Αποκτήσετε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του galinos.gr για έναν μήνα
Γαληνός Office Χρησιμοποιήστε δωρεάν το νέο cloud πρόγραμμα διαχείρισης κάθε σύγχρονου ιατρείου
Έλεγχος συγχορήγησης Ελέγξτε την αγωγή σας για αντενδείξεις και αλληλεπιδράσεις μεταξύ των φαρμάκων
Πρόγραμμα συνδρομητών Μάθετε περισσότερα για τα οφέλη και τις επιπλέον παροχές των συνδρομητικών προγραμμάτων
Γαληνός Mobile Κατεβάστε τη δωρεάν εφαρμογή και απολαύστε τις υπηρεσίες του galinos.gr σε κινητό ή tablet
Γνωρίζατε οτι... Μοιραζόμαστε μαζί σας γεγονότα της πορείας του galinos.gr από το 2011 μέχρι σήμερα
 

SPC: ZYPREXA Powder for solution for injection (2019)

Αναφορές

Βιβλιογραφική αναφορά

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

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

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

Πηγαίο έγγραφο

Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:

File
application/pdf - 485,8 KB