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ABILIFY Tablets (2018)

Αναφορές

Βιβλιογραφική αναφορά

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα

Name of the medicinal product

ABILIFY 5 mg tablets. ABILIFY 10 mg tablets. ABILIFY 15 mg tablets. ABILIFY 30 mg tablets.

Qualitative and quantitative composition

ABILIFY 5 mg tablets: Each tablet contains 5 mg of aripiprazole. Excipient with known effect: 67 mg lactose per tablet. ABILIFY 10 mg tablets: Each tablet contains 10 mg of aripiprazole. Excipient with ...

Pharmaceutical form

Tablet. ABILIFY 5 mg tablets: Rectangular and blue, engraved with A-007 and 5 on one side. ABILIFY 10 mg tablets: Rectangular and pink, engraved with A-008 and 10 on one side. ABILIFY 15 mg tablets: Round ...

Therapeutic indications

ABILIFY is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. ABILIFY is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder ...

Posology and method of administration

Posology Adults Schizophrenia The recommended starting dose for ABILIFY is 10 or 15 mg/day with a maintenance dose of 15 mg/day administered on a once-a-day schedule without regard to meals. ABILIFY is ...

Contraindications

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

Special warnings and precautions for use

During antipsychotic treatment, improvement in the patients clinical condition may take several days to some weeks. Patients should be closely monitored throughout this period. Suicidality The occurrence ...

Interaction with other medicinal products and other forms of interaction

Due to its α<sub>1</sub>-adrenergic receptor antagonism, aripiprazole has the potential to enhance the effect of certain antihypertensive medicinal products. Given the primary CNS effects of aripiprazole, ...

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 akathisia and nausea each occurring in more than 3% of patients treated with oral aripiprazole. ...

Overdose

Signs and symptoms In clinical trials and post-marketing experience, accidental or intentional acute overdose of aripiprazole alone was identified in adult patients with reported estimated doses up to ...

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 is well absorbed, with peak plasma concentrations occurring within 3-5 hours after dosing. Aripiprazole undergoes minimal pre-systemic metabolism. The absolute oral bioavailability ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development. ...

List of excipients

Tablet core: Lactose monohydrate Maize starch Microcrystalline cellulose Hydroxypropyl cellulose Magnesium stearate Tablet coat: ABILIFY 5 mg tablets: ndigo carmine aluminium lake (E132) ABILIFY 10 mg ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

Store in the original package in order to protect from moisture.

Nature and contents of container

Aluminium perforated unit dose blisters in cartons of 14 1, 28 1, 49 1, 56 1, 98 1 tablets. Not all pack sizes may be marketed.

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)

ABILIFY 5 mg tablets: EU/1/04/276/001 (5 mg, 14 1 tablets) EU/1/04/276/002 (5 mg, 28 1 tablets) EU/1/04/276/003 (5 mg, 49 1 tablets) EU/1/04/276/004 (5 mg, 56 1 tablets) EU/1/04/276/005 (5 mg, 98 ...

Date of first authorization / renewal of the authorization

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

Πηγαίο έγγραφο

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