Depixol 20mg/ml Solution for Injection

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

FLUPENTIXOL DECANOATE

थमां उपलब्ध:

Lundbeck ( Ireland ) Limited

ए.टी.सी कोड:

N05AF; N05AF01

INN (इंटरनेशनल नाम):

FLUPENTIXOL DECANOATE

डोज़:

20 milligram(s)/millilitre

फार्मास्यूटिकल फॉर्म:

Solution for injection

चिकित्सीय क्षेत्र:

Thioxanthene derivatives; flupentixol

प्राधिकरण का दर्जा:

Marketed

प्राधिकरण की तारीख:

1976-06-21

सूचना पत्रक

Package leaflet: Information for the user
DEPIXOL 20 MG/ML SOLUTION FOR INJECTION
( (cis-(Z) 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 YOU USE DEPIXOL INJECTION
3.
HOW TO USE DEPIXOL INJECTION
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
Depixol contains the active substance flupentixol.
Depixol Injection belongs to a group of medicines known as
antipsychotics.
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.
This medicine is used for the treatment of schizophrenia and other
related psychoses.
Ask your doctor if you have any questions about why this medicine has
been prescribed for
you.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE DEPIXOL INJECTION
DO NOT USE DEPIXOL INJECTION IF YOU:

are allergic to flupentixol or any of the other ingredients of this
medicine (listed in
section 6). Consult your doctor if you think you might be

have a reduced level of alertness due to any cause (this includes
reduced alertness
after the consumption of alcohol or drugs such as opiates (e.g.
morphine) or
barbiturates)

are an older person who suffers from confusion

are receiving emergency treatment to support your blood circulation

are a

उत्पाद विशेषताएं

Health Products Regulatory Authority
24 November 2021
CRN00CN8J
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Depixol 20mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1ml ampoule contains 20 mg (2% w/v) cis(Z)-flupentixol decanoate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection (injection)
Clear, colourless to slightly yellowish oil, practically free from
particles.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The management of schizophrenia and allied paranoid psychoses.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
The usual dosage is between 20 to 40 mg every two to four weeks.
Larger doses may be used if necessary, distributed between
two injection sites.
In patients who have not previously received depot neuroleptics,
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.
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 be sufficient to prevent
relapse.
The appropriate presentation of Depixol should be selected to achieve
an injection volume, which does not exceed 2 ml.
Volumes greater than 2 ml should be distributed between two injection
sites.
When transferring patients from oral to depot neuroleptic treatment,
the oral medication should not be discontinued
immediately but gradually withdrawn over a period of several days
after administering the first injection.
_Older people_
Older people should receive dosages in the lower end of the dosage
range.
_Reduced renal function_
Flupentixol decanoate can be given in usual doses to patients with
reduced renal function.
_Reduced hepatic function_
Dose reduction (relative to the degree of hepatic impairment) should
be considered. If possible, where assay