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
®
 

ABILIFY Solution for injection (2018)

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

ABILIFY 7.5 mg/ml solution for injection.

Qualitative and quantitative composition

Each ml contains 7.5 mg of aripiprazole. Each vial contains 9.75 mg aripiprazole. For the full list of excipients, see section 6.1.

Pharmaceutical form

Solution for injection. Clear, colourless, aqueous solution.

Therapeutic indications

ABILIFY solution for injection is indicated for the rapid control of agitation and disturbed behaviours in adult patients with schizophrenia or with manic episodes in Bipolar I Disorder, when oral therapy ...

Posology and method of administration

Posology The recommended initial dose for ABILIFY solution for injection is 9.75 mg (1.3 ml), administered as a single intramuscular injection. The effective dose range of ABILIFY solution for injection ...

Contraindications

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

Special warnings and precautions for use

The efficacy of ABILIFY solution for injection in patients with agitation and disturbed behaviours has not been established related to conditions other than schizophrenia and manic episodes in Bipolar ...

Interaction with other medicinal products and other forms of interaction

No specific interaction studies have been performed with ABILIFY solution for injection. The information below is obtained from studies with oral aripiprazole. Due to its α<sub>1</sub>-adrenergic receptor ...

Fertility, pregnancy and lactation

Pregnancy There are no adequate and well-controlled trials of aripiprazole in pregnant women. Congenital anomalies have been reported; however, causal relationship with aripiprazole could not be established. ...

Effects on ability to drive and use machines

Aripiprazole has minor to moderate influence on the ability to drive and use machines due to potential nervous system and visual effects, such as sedation, somnolence, syncope, vision blurred, diplopia ...

Undesirable effects

Summary of the safety profile The most commonly reported adverse reactions in placebo-controlled trials were nausea, dizziness and somnolence each occurring in more than 3 % of patients treated with aripiprazole ...

Overdose

No cases of overdose associated with adverse reactions were reported in clinical studies with ABILIFY solution for injection. Care must be taken to avoid inadvertent injection of this medicinal product ...

Pharmacodynamic properties

Pharmacotherapeutic group: Psycholeptics, other antipsychotics ATC code: N05AX12 Mechanism of action It has been proposed that aripiprazoles efficacy in schizophrenia and Bipolar I Disorder is mediated ...

Pharmacokinetic properties

Absorption Aripiprazole administered intramuscularly as a single-dose to healthy subjects is well absorbed and has an absolute bioavailability of 100%. The aripiprazole AUC in the first 2 hours after an ...

Preclinical safety data

Administration of ABILIFY solution for injection was well tolerated and produced no direct target organ toxicity in rats or monkeys after repeated dosing at systemic exposures (AUC) that were 15 and 5 ...

List of excipients

Sulfobutylether β-cyclodextrin (SBECD) Tartaric acid Sodium hydroxide Water for injections

Incompatibilities

Not applicable.

Shelf life

Shelf life: 18 months. After opening: use product immediately.

Special precautions for storage

Keep the vial in the outer carton in order to protect from light. For storage conditions after first opening of the medicinal product, see section 6.3.

Nature and contents of container

Each carton contains one single-use type I glass vial with a rubber butyl stopper and a tear-off aluminium seal.

Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

Otsuka Pharmaceutical Netherlands B.V., Herikerbergweg 292, 1101 CT, Amsterdam, Netherlands

Marketing authorization number(s)

EU/1/04/276/036

Date of first authorization / renewal of the authorization

Date of first authorisation: 04 June 2004 Date of latest renewal: 04 June 2009

Πηγαίο έγγραφο

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