Depixol Low Volume 200mg/1ml solution for injection ampoules

Country: Велика Британија

Језик: Енглески

Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активни састојак:

Flupentixol decanoate

Доступно од:

Lundbeck Ltd

АТЦ код:

N05AF01

INN (Међународно име):

Flupentixol decanoate

Дозирање:

200mg/1ml

Фармацеутски облик:

Solution for injection

Пут администрације:

Intramuscular

Класа:

No Controlled Drug Status

Тип рецептора:

Valid as a prescribable product

Резиме производа:

BNF: 04020200; GTIN: 5702157120406

Информативни летак

Package leaflet: Information for the user
DEPIXOL
® LOW VOLUME 200 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 of the 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 LOW VOLUME INJECTION IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE DEPIXOL LOW VOLUME INJECTION IS GIVEN
3.
HOW DEPIXOL LOW VOLUME INJECTION IS GIVEN
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE DEPIXOL LOW VOLUME INJECTION
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT DEPIXOL LOW VOLUME INJECTION IS AND WHAT IT IS USED FOR
The name of your medicine is Depixol Low Volume 200 mg/ml solution for
injection (called
Depixol Low Volume Injection in this leaflet).
Depixol Low Volume Injection contains the active substance flupentixol
decanoate. Depixol
Low Volume 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 Low Volume Injection is used for the treatment of
schizophrenia and other
psychoses.
Your doctor, however, may prescribe Depixol Low Volume Injection for
another purpose.
Ask your doctor if you have any questions about why Depixol Low Volume
Injection has
been prescribed for you.
2.
WHAT YOU NEED TO KNOW BEFORE DEPIXOL LOW VOLUME INJECTION IS GIVEN
Depixol Low Volume Injection is not given if you
•
are allergic (hypersensitive) to flupentixol, other thio

Карактеристике производа

OBJECT 1
DEPIXOL LOW VOLUME INJECTION
Summary of Product Characteristics Updated 06-Apr-2017 | Lundbeck
Limited
1. Name of the medicinal product
Depixol
®
Low Volume 200 mg/ml solution for injection
2. Qualitative and quantitative composition
200 mg/ml flupentixol decanoate in thin vegetable oil.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection
Clear, yellowish 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 should not
exceed 2 ml.
Adequate control of severe psychotic symptoms may take up to 4 to 6
months at high enough dosage.
Once stabilised lower maintenance doses may be considered, but must