Abilify Maintena

देश: न्यूज़ीलैंड

भाषा: अंग्रेज़ी

स्रोत: Medsafe (Medicines Safety Authority)

18-01-2018

इस उत्पाद के लिए कुछ दस्तावेज़ वर्तमान में उपलब्ध नहीं हैं, आप हमारी ग्राहक सेवा को अनुरोध भेज सकते हैं और जैसे ही हम उन्हें प्राप्त करने में सक्षम होंगे, हम आपको सूचित करेंगे।
अनुरोध भेजा।

सक्रिय संघटक:

Aripiprazole monohydrate 416.07mg equivalent to aripiprazole 400 mg;

थमां उपलब्ध:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (इंटरनेशनल नाम):

Aripiprazole monohydrate 416.07 mg (equivalent to aripiprazole 400 mg)

डोज़:

400 mg

फार्मास्यूटिकल फॉर्म:

Injection with diluent

रचना:

Active: Aripiprazole monohydrate 416.07mg equivalent to aripiprazole 400 mg Excipient: Carmellose sodium Mannitol Monobasic sodium phosphate monohydrate Sodium hydroxide Water for injection

प्रिस्क्रिप्शन प्रकार:

Prescription

द्वारा बनाया गया:

Otsuka Pharmaceutical Co Ltd

चिकित्सीय संकेत:

For maintenance of clinical improvement in the treatment of schizophrenia

उत्पाद समीक्षा:

Package - Contents - Shelf Life: Combination pack, (powder + diluent) - 1 dose units - 36 months from date of manufacture stored at or below 30°C. Do not freeze 4 hours reconstituted stored at or below 25°C - Vial, glass, single dose, Type 1 with FluroTec(R) Plus laminated bromobutyl rubber stopper - diluent - 2 mL - 48 months from date of manufacture stored at or below 30°C. Do not freeze. - Vial, glass, single dose, Type 1 with teflon laminated chlorobutyl rubber stopper - powder for suspension - 400 mg - 36 months from date of manufacture stored at or below 30°C. Do not freeze.

प्राधिकरण की तारीख:

2015-01-27

उत्पाद विशेषताएं

NEW ZEALAND DATA SHEET
ABILIFY MAINTENA®
1 NAME OF THE MEDICINE
Abilify Maintena Injection with diluent 300 mg
Abilify Maintena Injection with diluent 400 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Abilify Maintena Injection with diluent 300mg: each vial contains 300
mg aripiprazole.
Abilify Maintena Injection with diluent 400 mg: each vial contains 400
mg aripiprazole.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Aripiprazole monohydrate is a white-to-off-white crystalline powder.
Aripiprazole monohydrate is
practically insoluble in water.
Abilify Maintena is presented as a sterile, single-dose, lyophilised
powder for reconstitution with water
for injections to give a prolonged-release suspension for injection to
deliver 400 mg of aripiprazole in
400-mg/vial strength or 300 mg of aripiprazole in 300-mg/vial
strength. Abilify Maintena is intended
for intramuscular injection only.
Abilify Maintena powder and solvent for prolonged-release suspension
for injection is available as a
one-month convenience kit. Each convenience kit contains one vial of
lyophilised powder, one vial of
water for injections, one 3 mL sterile syringe with a 21 gauge needle
for reconstitution, one sterile
syringe without a needle, one 1.5-inch (38 mm) and one 2-inch (51 mm)
21 gauge sterile safety needle
for injection and one vial adapter.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For maintenance of clinical improvement in the treatment of
schizophrenia.
4.2
DOSE AND METHOD OF ADMINISTRATION
_RECOMMENDED DOSAGE AND DOSAGE ADJUSTMENT _
For patients who have never taken aripiprazole, establish tolerability
with oral aripiprazole prior to
initiating treatment with Abilify Maintena.
The recommended starting and maintenance dose of Abilify Maintena is
400 mg. Titration of the dose
of Abilify Maintena is not required. Abilify Maintena is to be
administered by a healthcare professional
only, once-monthly as a single injection (no sooner than 26 days after
the previous injection). After the
first Abilify Main

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