ABILIFY MAINTENA 300 MG

देश: इसराइल

भाषा: अंग्रेज़ी

स्रोत: Ministry of Health

सक्रिय संघटक:

ARIPIPRAZOLE AS MONOHYDRATE

थमां उपलब्ध:

LUNDBECK ISRAEL LTD.

ए.टी.सी कोड:

N05AX12

फार्मास्यूटिकल फॉर्म:

POWDER AND SOLVENT FOR PROLONGED-RELEASE SUSPENSION FOR INJECTION

रचना:

ARIPIPRAZOLE AS MONOHYDRATE 300 MG/VIAL

प्रशासन का मार्ग:

I.M

प्रिस्क्रिप्शन प्रकार:

Required

द्वारा बनाया गया:

H. LUNDBECK A/S, DENMARK

चिकित्सीय क्षेत्र:

ARIPIPRAZOLE

चिकित्सीय संकेत:

Abilify Maintena is indicated for maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole.

प्राधिकरण की तारीख:

2020-03-31

सूचना पत्रक

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उत्पाद विशेषताएं

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Abilify Maintena 300 mg powder and solvent for prolonged-release
suspension for injection
Abilify Maintena 400 mg powder and solvent for prolonged-release
suspension for injection
Abilify Maintena 300 mg powder and solvent for prolonged-release
suspension for injection
in pre-filled syringe
Abilify Maintena 400 mg powder and solvent for prolonged-release
suspension for injection
in pre-filled syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Abilify Maintena 300 mg powder and solvent for prolonged-release
suspension for injection
Each vial contains 300 mg aripiprazole.
Abilify Maintena 400 mg powder and solvent for prolonged-release
suspension for injection
Each vial contains 400 mg aripiprazole.
Abilify Maintena 300 mg powder and solvent for prolonged-release
suspension for injection
in pre-filled syringe
Each pre-filled syringe contains 300 mg aripiprazole.
Abilify Maintena 400 mg powder and solvent for prolonged-release
suspension for injection
in pre-filled syringe
Each pre-filled syringe contains 400 mg aripiprazole.
After reconstitution each ml of suspension contains 200 mg
aripiprazole.
For the full list of excipients, see section 6.1.
.
3.
PHARMACEUTICAL FORM
Powder and solvent for prolonged-release suspension for injection
Powder: white to off-white
Solvent: clear solution
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Abilify Maintena is indicated for maintenance treatment of
schizophrenia in adult patients
stabilised with oral aripiprazole.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For patients who have never taken aripiprazole, tolerability with oral
aripiprazole must occur
prior to initiating treatment with Abilify Maintena.
The recommended starting and maintenance dose of Abilify Maintena is
400 mg.
2
Titration of the dose of this medicinal product is not required. It
should be administered once
monthly as a single injection (no sooner than 26 days after the
previous injection).
After the first injection, treatment