Clopixol Conc 500mg/1ml solution for injection ampoules

Ország: Egyesült Királyság

Nyelv: angol

Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktív összetevők:

Zuclopenthixol decanoate

Beszerezhető a:

Lundbeck Ltd

ATC-kód:

N05AF05

INN (nemzetközi neve):

Zuclopenthixol decanoate

Adagolás:

500mg/1ml

Gyógyszerészeti forma:

Solution for injection

Az alkalmazás módja:

Intramuscular

Osztály:

No Controlled Drug Status

Recept típusa:

Valid as a prescribable product

Termék összefoglaló:

BNF: 04020200; GTIN: 5702157109357

Betegtájékoztató

Package leaflet: Information for the patient
CLOPIXOL
® CONC. 500 MG/ML SOLUTION FOR INJECTION
ZUCLOPENTHIXOL 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, please 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
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
WHAT CLOPIXOL CONC. INJECTION IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CLOPIXOL CONC. INJECTION
3.
HOW CLOPIXOL CONC. INJECTION IS GIVEN
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE CLOPIXOL CONC. INJECTION
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT CLOPIXOL CONC. INJECTION IS AND WHAT IT IS USED FOR
The name of your medicine is Clopixol Conc. 500 mg/ml solution for
injection (called
Clopixol Conc. Injection in this leaflet). Clopixol Conc. Injection
contains the active
substance zuclopenthixol. It 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.
Clopixol Conc. Injection is used for the treatment of schizophrenia
and other psychoses.
Your doctor, however, may prescribe Clopixol Conc. Injection for
another purpose. Ask
your doctor if you have any questions about why this medicine has been
prescribed for you.
2.
WHAT YOU NEED TO KNOW BEFORE CLOPIXOL CONC. INJECTION IS GIVEN
Clopixol Conc. Injection is not given
•
If you are allergic (hypersensitive) to zuclopenthixol, other
thioxanthene drugs or
antipsychotic drugs or any of the other ingredients of this medicine
(listed

Termékjellemzők

OBJECT 1
CLOPIXOL 200 MG/ML SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 26-Jan-2017 | Lundbeck
Limited
1. Name of the medicinal product
Clopixol 200 mg/ml solution for injection.
Clopixol Conc. 500 mg/ml solution for injection.
2. Qualitative and quantitative composition
_Clopixol Injection:_
Zuclopenthixol decanoate 200 mg/ml.
_Clopixol Conc. Injection: _
Zuclopenthixol decanoate 500 mg/ml.
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Solution for injection.
Clear, yellowish oil, practically free from particles.
4. Clinical particulars
4.1 Therapeutic indications
The maintenance treatment of schizophrenia and paranoid psychoses.
4.2 Posology and method of administration
Posology
_Adults_
Dosage and dosage interval should be adjusted according to the
patient's symptoms and response to
treatment.
The usual dosage range of zuclopenthixol decanoate is 200 - 500 mg
every one to four weeks, depending
on response, but some patients may require up to 600 mg per week. The
maximum single dose at any one
time is 600 mg. For example, 1200 mg every 2 weeks should not be
given. In patients who have not
previously received depot antipsychotics, treatment is usually started
with a small dose (e.g. 100 mg) to
assess tolerance. An interval, of at least one week should be allowed
before the second injection is given
at a dose consistent with the patient's 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.
Injection volumes of greater than 2 ml should be distributed between
two injection sites.
_Older patients_
In accordance with standard medical practice initial dosage may need
to be reduced to a quarter or half
the normal starting dose in the frail or older patients.
_Paediatric population_
Clopixol is not recommended for use in children due to lack of
clinical experience.
_Patients with renal impairment_
Clopixol can be giv