Abilify Maintena 400mg powder and solvent for prolonged-release suspension for injection pre-filled syringes

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Aripiprazole

Available from:

Otsuka Pharmaceuticals (U.K.

ATC code:

N05AX12

INN (International Name):

Aripiprazole

Dosage:

400mg

Pharmaceutical form:

Powder and solvent for suspension for injection

Administration route:

Intramuscular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: ; GTIN: 5038256000463

Patient Information leaflet

_PACKAGE LEAFLET: INFORMATION FOR THE USER_
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_
_aripiprazole_
_READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU RECEIVE THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT _
_INFORMATION FOR YOU._
_- _
_Keep this leaflet. You may need to read it again._
_- _
_If you have any further questions, ask your doctor or nurse._
_- _
_If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects _
_not listed in this leaflet. See section 4._
_WHAT IS IN THIS LEAFLET_
_1. _
_What _
Abilify Maintena
_is and what it is used for_
_2. _
_What you need to know before you are given _
Abilify Maintena
_3. _
_How _
Abilify Maintena
_is given_
_4. _
_Possible side effects_
_5. _
_How to store _
Abilify Maintena
_6. _
_Contents of the pack and other information_
_1. _
_WHAT _ABILIFY MAINTENA _IS AND WHAT IT IS USED FOR_
Abilify Maintena
_contains the active substance aripiprazole and belongs to a group of
medicines _
_called antipsychotics. It is used to treat schizophrenia - a disease
with symptoms such as hearing, _
_seeing or sensing things which are not there, suspiciousness,
mistaken beliefs, incoherent speech and _
_behaviour and emotional flatness. People with this condition may also
feel depressed, guilty, anxious _
_or tense._
Abilify Maintena
_is intended for adult patients with schizophrenia who are
sufficiently stabilised _
_during treatment with oral aripiprazole._
_2. _
_WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN _ABILIFY MAINTENA
_DO NOT USE _ABILIFY MAINTENA_:_
_- _
_if you are allergic to aripiprazole 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 y

Summary of Product characteristics

OBJECT 1
ABILIFY MAINTENA 400 MG POWDER AND SOLVENT FOR
PROLONGED-RELEASE SUSPENSION FOR INJECTION IN PRE-
FILLED SYRINGE
Summary of Product Characteristics Updated 05-Feb-2018 | Otsuka
Pharmaceuticals (UK) Ltd
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
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
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
Powder and solvent for prolonged-release suspension for injection in
pre-filled syringe
Powder: white to off-white
Solvent: clear solution
4. Clinic