Depixol Conc 100mg/1ml solution for injection ampoules

Land: Storbritannien

Språk: engelska

Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiva substanser:

Flupentixol decanoate

Tillgänglig från:

Lundbeck Ltd

ATC-kod:

N05AF01

INN (International namn):

Flupentixol decanoate

Dos:

100mg/1ml

Läkemedelsform:

Solution for injection

Administreringssätt:

Intramuscular

Klass:

No Controlled Drug Status

Receptbelagda typ:

Valid as a prescribable product

Produktsammanfattning:

BNF: 04020200; GTIN: 5702157120307

Bipacksedel

Package leaflet: Information for the patient
DEPIXOL
® CONC. 100 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 CONC. INJECTION IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE DEPIXOL CONC. INJECTION IS GIVEN
3.
HOW DEPIXOL CONC. INJECTION IS GIVEN
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE DEPIXOL CONC. INJECTION
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT DEPIXOL CONC. INJECTION IS AND WHAT IT IS USED FOR
The name of your medicine is Depixol Conc. 100 mg/ml solution for
injection (called
Depixol Conc. Injection in this leaflet).
Depixol Conc. Injection contains the active substance flupentixol
decanoate. Depixol Conc.
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 Conc. Injection is used for the treatment of schizophrenia and
other psychoses.
Your doctor, however, may prescribe Depixol Conc. Injection for
another purpose. Ask your
doctor if you have any questions about why Depixol Conc. Injection has
been prescribed for
you.
2.
WHAT YOU NEED TO KNOW BEFORE DEPIXOL CONC. INJECTION IS GIVEN
DEPIXOL CONC. 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 m

Produktens egenskaper

OBJECT 1
DEPIXOL 20 MG/ML SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 06-Apr-2017 | Lundbeck
Limited
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.
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