Land: Israel
Sprog: engelsk
Kilde: Ministry of Health
ARIPIPRAZOLE AS MONOHYDRATE
LUNDBECK ISRAEL LTD
N05AX12
POWDER AND SOLVENT FOR PROLONGED-RELEASE SUSPENSION FOR INJECTION
ARIPIPRAZOLE AS MONOHYDRATE 400 MG/VIAL
I.M
Required
H.LUNDBECK A/S, DENMARK
ARIPIPRAZOLE
Abilify Maintena is indicated for maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole.
2015-04-01
PATIENT LEAFLET IN ACCORDANCE WITH PHARMACIST ’ S REGULATIONS (PREPARATIONS) 1986 The medicine is marketed according to doctor ’ s prescription only. ABILIFY MAINTENA® 300 MG ABILIFY MAINTENA® 400 MG POWDER AND SOLVENT FOR PROLONGED-RELEASE SUSPENSION FOR INJECTION Composition: Each pre-filled syringe of ABILIFY MAINTENA 300 MG contains aripiprazole 300 mg (as Monohydrate). Each pre-filled syringe of ABILIFY MAINTENA 400 MG contains aripiprazole 400 mg (as Monohydrate). Inactive ingredients: See section 6 - READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THIS MEDICINE. This leaflet contains essential information about this medicine. If you have any further questions, consult your doctor or pharmacist. - This medicine was prescribed to treat your illness. Do not pass it to others. It may harm them even if it seems to you that their illness is similar to your own. - This medicine is not intended to be used by children and adolescents under 18 years of age. 1. WHAT IS THE MEDICINE BEING USED FOR? For maintenance treatment of schizophrenia in adult patients stabilized with oral aripiprazole. THERAPEUTIC GROUP: antipsychotics 2. BEFORE USING THIS MEDICINE DO NOT TAKE THIS MEDICINE IF: You are sensitive (allergic) to the active ingredient or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or nurse before you are given Abilify Maintena - Suicidal thoughts and behaviours have been reported during aripiprazole treatment. Tell your doctor immediately if you are having any thoughts about hurting yourself. BEFORE USING ABILIFY MAINTENA, TELL YOUR DOCTOR IF YOU SUFFER FROM: - _ _an acutely agitated state or a severely psychotic state - heart problems or have a history of stroke, especially if you know that you have other risks factors for stroke - high blood sugar (characterised by symptoms such as excessive thirst, passing of large amounts of urine, increase in appetite and feeling weak) or family history of diabetes. - fits (seizures) since you Læs hele dokumentet
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection in pre-filled syringe Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection in pre-filled syringe 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection Each vial contains 300 mg aripiprazole. Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection Each vial contains 400 mg aripiprazole. Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection in pre-filled syringe Each pre-filled syringe contains 300 mg aripiprazole. Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection in pre-filled syringe Each pre-filled syringe contains 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 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. 2 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 Læs hele dokumentet