ABILIFY MAINTENA POWDER AND SOLVENT FOR PROLONGED RELEASE SUSPENSION FOR INJECTION 400 MG

Država: Singapur

Jezik: angleščina

Source: HSA (Health Sciences Authority)

Aktivna sestavina:

Sterile Aripiprazole monohydrate 416mg/vial equivalent to anhydrous Aripiprazole

Dostopno od:

LUNDBECK SINGAPORE PTE. LTD.

Koda artikla:

N05AX12

Farmacevtska oblika:

INJECTION, POWDER, FOR SUSPENSION, EXTENDED RELEASE

Sestava:

Sterile Aripiprazole monohydrate 416mg/vial equivalent to anhydrous Aripiprazole 400mg/vial

Pot uporabe:

INTRAMUSCULAR

Tip zastaranja:

Prescription Only

Izdeluje:

Otsuka Pharmaceutical Co.Ltd

Status dovoljenje:

ACTIVE

Datum dovoljenje:

2017-03-14

Navodilo za uporabo

SG Abilify Maintena 400mg Package Insert & Instructions For Use
Portrait Format
1.
NAME OF THE MEDICINAL PRODUCT
Abilify Maintena 400 mg powder and solvent for prolonged-release
suspension for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 416 mg aripiprazole monohydrate equivalent to 400mg
aripirazole. 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.
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 with 10 mg to 20 mg oral
aripiprazole should be continued for 14 consecutive days to
maintain therapeutic aripiprazole concentrations during initiation of
therapy.
If there are adverse reactions with the 400 mg dosage, reduction of
the dose to 300 mg once monthly should be considered.
Missed doses
_Missed doses _
IF 2
ND
OR 3
RD
DOSE IS MISSED AND TIME SINCE LAST INJECTION IS:
ACTION
> 4 weeks and < 5 weeks
The injection should be administered as soon as possible
and then resume monthly injection schedule.
> 5 weeks
Concomitant oral aripiprazole should be restarted for 14
days with next administered injection and then resume
monthly injection schedule.
IF 4
TH
OR SUBSEQUENT DOSES ARE MISSED (I.E., AFTER ATTAINMENT
OF STEADY STATE) AND TIME SINCE LAST INJECTION IS:
ACTION

Lastnosti izdelka

1.
NAME OF THE MEDICINAL PRODUCT
Abilify Maintena 400 mg powder and solvent for prolonged-release
suspension for injection
Abilify Maintena 400 mg powder and solvent for prolonged-release
suspension for injection in pre-filled syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Abilify Maintena 400 mg powder and solvent for prolonged-release
suspension for injection
Each vial contains 416 mg aripiprazole monohydrate equivalent to 400mg
aripiprazole.
Abilify Maintena 400 mg powder and solvent for prolonged-release
suspension for injection in pre-filled syringe
Each pre-filled syringe contains 416 mg aripiprazole monohydrate
equivalent to 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
-
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
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For patients who have never taken aripiprazole, tolerability with oral
aripiprazole must occur prior to initiating treatment with
Abilify Maintena.
Titration of the dose for Abilify Maintena is not required.
The starting dose can be administered by following one of two
regimens:
•
One injection start: On the day of initiation, administer one
injection of 400 mg Abilify Maintena and continue treatment
with 10 mg to 20 mg oral aripiprazole per day for 14 consecutive days
to maintain therapeutic aripiprazole concentrations
during initiation of therapy.
•
Two injection start: On the day of initiation, administer two separate
injections of 400 mg Abilify Maintena at separate
injection sites (see method of administration), along with one 20 mg
dose of oral aripiprazole.
After the injection start, the recommend