Abilify Maintena
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
20-07-2023
Charakterystyka produktu
(SPC)
20-07-2023
Sprawozdanie z oceny publicznego
(PAR)
02-12-2020
Składnik aktywny:
aripiprazole
Dostępny od:
Otsuka Pharmaceutical Netherlands B.V.
Kod ATC:
N05AX12
INN (International Nazwa):
aripiprazole
Grupa terapeutyczna:
Psycholeptics
Dziedzina terapeutyczna:
Schizophrenia
Wskazania:
Maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole.
Podsumowanie produktu:
Revision: 20
Status autoryzacji:
Authorised
Data autoryzacji:
2013-11-14
Ulotka dla pacjenta
68
B. PACKAGE LEAFLET
69
PACKAGE LEAFLET: INFORMATION FOR THE USER
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
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 your doctor
immediately if you are having any thoughts or feelings about hurting
yourself.
Before treatment with Abilify Maintena, tell your doctor
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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.
3
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
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