ABILIFY Solution for injection (2018)
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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
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
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