ABILIFY MAINTENA aripiprazole (as monohydrate) 300 mg powder and solvent for prolonged release suspension for injection pre-filled syringe

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

aripiprazole, Quantity: 300 mg (Equivalent: aripiprazole monohydrate, Qty 312.05 mg)

Dostupno od:

Lundbeck Australia Pty Ltd

Farmaceutski oblik:

Injection, powder for

Sastav:

Excipient Ingredients: carmellose sodium; mannitol; monobasic sodium phosphate monohydrate; sodium hydroxide; water for injections

Administracija rute:

Intramuscular

Jedinice u paketu:

1

Tip recepta:

(S4) Prescription Only Medicine

Terapijske indikacije:

For the acute and maintenance treatment of schizophrenia in adults. For maintenance treatment to prevent the recurrence of manic or mixed episodes of bipolar I disorder in adult patients as monotherapy.

Proizvod sažetak:

Visual Identification: pre-filled dual chamber syringe consisting of a front chamber that contains the lyophilized powder and a rear chamber that contains sterile water for injections; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status autorizacije:

Registered

Datum autorizacije:

2018-05-07

Svojstava lijeka

ABILIFY MAINTENA
®
(aripiprazole monohydrate)
1 of 52
AUSTRALIAN PRODUCT INFORMATION – ABILIFY
MAINTENA (ARIPIPRAZOLE MONOHYDRATE)
PROLONGED-RELEASE SUSPENSION FOR INJECTION
1
NAME OF THE MEDICINE
Aripiprazole monohydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Aripiprazole is present in Abilify Maintena as aripiprazole
monohydrate. Abilify Maintena is
presented as either a pre-filled dual chamber syringe or a therapeutic
kit. Both presentations
contain 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 per
400-mg/syringe or vial strength or 300 mg of aripiprazole per
300-mg/syringe or vial
strength. Both the pre-filled dual chamber syringe and the therapeutic
kit presentations
contain the following excipients: carmellose sodium, mannitol,
monobasic sodium phosphate
monohydrate and sodium hydroxide.
3
PHARMACEUTICAL FORM
Abilify Maintena (aripiprazole) 300 mg powder and solvent for
prolonged-release suspension
for injection in pre-filled dual chamber syringe*
Abilify Maintena (aripiprazole) 400 mg powder and solvent for
prolonged-release suspension
for injection in pre-filled dual chamber syringe*
Abilify Maintena (aripiprazole) 300 mg powder and solvent for
prolonged-release suspension
for injection (Therapeutic Kit)
Abilify Maintena (aripiprazole) 400 mg powder and solvent for
prolonged-release suspension
for injection (Therapeutic Kit)
*Not currently marketed.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the acute and maintenance treatment of schizophrenia in adults.
For maintenance treatment to prevent the recurrence of manic or mixed
episodes of bipolar I
disorder in adult patients as monotherapy.
_ _
ABILIFY MAINTENA
®
(aripiprazole monohydrate)
2 of 52
4.2
DOSE AND METHOD OF ADMINISTRATION
RECOMMENDED DOSAGE AND DOSAGE ADJUSTMENT
Abilify Maintena is intended for intramuscular injection only. For
patients who have never
taken aripiprazole, establish tolerability with o