Abilify 1mgml oral solution

국가: 영국

언어: 영어

출처: MHRA (Medicines & Healthcare Products Regulatory Agency)

유효 성분:

Aripiprazole

제공처:

Otsuka Pharmaceuticals (U.K.

ATC 코드:

N05AX12

INN (국제 이름):

Aripiprazole

복용량:

1mg/1ml

약제 형태:

Oral solution

관리 경로:

Oral

수업:

No Controlled Drug Status

처방전 유형:

Valid as a prescribable product

제품 요약:

BNF: 04020100; GTIN: 5012712003663

환자 정보 전단

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ABILIFY 1 MG/ML ORAL SOLUTION
aripiprazole
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What ABILIFY is and what it is used for
2.
What you need to know before you take ABILIFY
3.
How to take ABILIFY
4.
Possible side effects
5
How to store ABILIFY
6.
Contents of the pack and other information
1.
WHAT ABILIFY IS AND WHAT IT IS USED FOR
ABILIFY contains the active substance aripiprazole and belongs to a
group of medicines called
antipsychotics. It
is used to treat adults and adolescents aged 15 years and older who
suffer from a
disease characterised by 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 is used to treat adults and adolescents aged 13 years and
older who suffer from a condition
with symptoms such as feeling "high", having excessive amounts of
energy, needing much less sleep
than usual, talking very quickly with racing ideas and sometimes
severe irritability. In adults it also
prevents this condition from returning in patients who have responded
to the treatment with ABILIFY.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ABILIFY
DO NOT TAKE ABILIFY
•
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 before taking ABILIFY.
Suicidal thoughts and

제품 특성 요약

OBJECT 1
ABILIFY ORAL SOLUTION 1 MG ML
Summary of Product Characteristics Updated 24-Apr-2018 | Otsuka
Pharmaceuticals (UK) Ltd
1. Name of the medicinal product
ABILIFY 1 mg/ml oral solution
2. Qualitative and quantitative composition
Each ml oral solution contains 1 mg of aripiprazole.
Excipients with known effect (per ml)
200 mg fructose, 400 mg sucrose, 1.8 mg methyl parahydroxybenzoate
(E218), 0.2 mg propyl
parahydroxybenzoate (E 216)
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral solution
Clear, colourless to light yellow liquid solution.
4. Clinical particulars
4.1 Therapeutic indications
ABILIFY is indicated for the treatment of schizophrenia in adults and
in adolescents aged 15 years and
older.
ABILIFY is indicated for the treatment of moderate to severe manic
episodes in Bipolar I Disorder and
for the prevention of a new manic episode in adults who experienced
predominantly manic episodes and
whose manic episodes responded to aripiprazole treatment (see section
5.1).
ABILIFY is indicated for the treatment up to 12 weeks of moderate to
severe manic episodes in Bipolar I
Disorder in adolescents aged 13 years and older (see section 5.1).
4.2 Posology and method of administration
Posology
_Adults _
_Schizophrenia:_ the recommended starting dose for ABILIFY is 10 or 15
mg/day (i.e. 10 or 15 ml
solution/day) with a maintenance dose of 15 mg/day administered on a
once-a-day schedule without
regard to meals. ABILIFY is effective in a dose range of 10 to 30
mg/day (i.e. 10 to 30 ml solution/day).
Enhanced efficacy at doses higher than a daily dose of 15 mg has not
been demonstrated although
individual patients may benefit from a higher dose. The maximum daily
dose should not exceed 30 mg.
_Manic episodes in Bipolar I Disorder:_ the recommended starting dose
for ABILIFY is 15 mg (i.e. 15 ml
solution/day) administered on a once-a-day schedule without regard to
meals as monotherapy or
combination therapy (see section 5.1). Some patients may benefit from
a higher dose. The maximum
daily