Abilify Maintena

国: ニュージーランド

言語: 英語

ソース: Medsafe (Medicines Safety Authority)

有効成分:

Aripiprazole monohydrate 312.05mg equivalent to aripiprazole 300 mg;  

から入手可能:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN（国際名）:

Water for injection

投薬量:

300 mg

医薬品形態:

Injection with diluent

構図:

Excipient: Water for injection Active: Aripiprazole monohydrate 312.05mg equivalent to aripiprazole 300 mg   Excipient: Carmellose sodium Mannitol Monobasic sodium phosphate monohydrate Sodium hydroxide

処方タイプ:

Prescription

適応症:

For maintenance of clinical improvement in the treatment of schizophrenia

製品概要:

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 - 300 mg - 36 months from date of manufacture stored at or below 30°C. Do not freeze.

承認日:

2015-01-27

製品の特徴

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