Depixol Injection

国家: 马耳他

语言: 英文

来源: Medicines Authority

有效成分:

FLUPENTIXOL DECANOATE

可用日期:

Lundbeck Limited

ATC代码:

N05AF01

INN（国际名称）:

FLUPENTIXOL DECANOATE

药物剂型:

SOLUTION FOR INJECTION

组成:

FLUPENTIXOL DECANOATE 20 mg/ml

处方类型:

POM

治疗领域:

PSYCHOLEPTICS

授权状态:

Authorised

授权日期:

2006-04-18

资料单张

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DEPIXOL® 20 MG/ML SOLUTION FOR INJECTION
FLUPENTIXOL DECANOATE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or
nurse
-
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, pharmacist or nurse.
This includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. WHAT DEPIXOL INJECTION IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE DEPIXOL INJECTION IS GIVEN
3. HOW DEPIXOL INJECTION IS GIVEN
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE DEPIXOL INJECTION
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT DEPIXOL INJECTION IS AND WHAT IT IS USED FOR
The name of your medicine is Depixol 20 mg/ml solution for injection
(called Depixol Injection in this
leaflet).
Depixol Injection contains the active substance flupentixol decanoate.
Depixol Injection belongs to a group
of medicines known as antipsychotics (also called neuroleptics).
These medicines act on nerve pathways in specific areas of the brain
and help to correct certain chemical
imbalances in the brain that are causing the symptoms of your illness.
Depixol Injection is used for the treatment of schizophrenia and other
psychoses.
Your doctor, however, may prescribe Depixol Injection for another
purpose. Ask your doctor if you have any
questions about why Depixol Injection has been prescribed for you.
2. WHAT YOU NEED TO KNOW BEFORE DEPIXOL INJECTION IS GIVEN
DEPIXOL INJECTION IS NOT GIVEN IF YOU

are allergic (hypersensitive) to flupentixol, other thioxanthene drugs
or antipsychotic drugs or any of the
other ingredients of this medicine (listed in section 6)

are feeling less alert than usual or are drowsy or sleepy, or have

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Depixol® 20 mg/ml solution for injection
Depixol® Conc. 100 mg/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Depixol Injection:
20 mg/ml flupentixol decanoate in thin vegetable oil.
Depixol Conc. Injection:
100 mg/ml flupentixol decanoate in thin vegetable oil.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection.
Depixol Injection:
Clear, colourless to slightly yellowish oil, practically free from
particles.
Depixol Conc. Injection:
Clear, yellowish to yellow oil, practically free from particles.
Oily solution for deep intramuscular injection.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The treatment of schizophrenia and other psychoses.
Use of Depixol should be restricted to those stabilised on oral
therapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
The usual dosage of flupentixol decanoate lies between 50 mg every 4
weeks and 300 mg every 2 weeks, but
some patients may require up to 400 mg weekly. The maximum single dose
at any one time is 400 mg. For
example, 800 mg ever 2 weeks should not be given.
Other patients may be adequately maintained on dosages of 20-40 mg
flupentixol decanoate every 2-4
weeks. In patients who have not previously received depot
antipsychotic, treatment is usually started with a
small dose (e.g. 20 mg) to assess tolerability. An interval of at
least one week should be allowed before the
second injection is given at a dose consistent with the patients’
condition.
Depixol Injection 20 mg/ml is not intended for use in patients
requiring doses of greater than 60 mg (3 ml) of
flupentixol. Injection volumes of 2 – 3 ml should be distributed
between two injection sites.
More concentrated solutions of flupentixol decanoate (Depixol Conc
Injection or Depixol Low Volume
Injection) should be used if doses greater than 3 ml (60 mg) are
required.
The injection volumes selected for Depixol Conc Injection or Depixol
Low Volume Injection sh