ABILIFY MAINTENA 300 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ARIPIPRAZOLE AS MONOHYDRATE

Available from:

LUNDBECK ISRAEL LTD

ATC code:

N05AX12

Pharmaceutical form:

POWDER AND SOLVENT FOR PROLONGED-RELEASE SUSPENSION FOR INJECTION

Composition:

ARIPIPRAZOLE AS MONOHYDRATE 300 MG/VIAL

Administration route:

I.M

Prescription type:

Required

Manufactured by:

H.LUNDBECK A/S, DENMARK

Therapeutic area:

ARIPIPRAZOLE

Therapeutic indications:

Abilify Maintena is indicated for maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole.

Authorization date:

2015-04-01

Patient Information leaflet

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

Summary of Product characteristics

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