Riik: Singapur
keel: inglise
Allikas: HSA (Health Sciences Authority)
Sterile Aripiprazole monohydrate 416mg/vial equivalent to anhydrous Aripiprazole
LUNDBECK SINGAPORE PTE. LTD.
N05AX12
INJECTION, POWDER, FOR SUSPENSION, EXTENDED RELEASE
Sterile Aripiprazole monohydrate 416mg/vial equivalent to anhydrous Aripiprazole 400mg/vial
INTRAMUSCULAR
Prescription Only
Otsuka Pharmaceutical Co.Ltd
ACTIVE
2017-03-14
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 Lugege kogu dokumenti
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 Lugege kogu dokumenti