Clopixol Conc. 500 mg/ml Solution for Injection

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

ZUCLOPENTHIXOL DECANOATE

Saatavilla:

Lundbeck Limited

ATC-koodi:

N05AF; N05AF05

INN (Kansainvälinen yleisnimi):

ZUCLOPENTHIXOL DECANOATE

Annos:

500 milligram(s)/millilitre

Lääkemuoto:

Solution for injection

Prescription tyyppi:

Product subject to prescription which may not be renewed (A)

Terapeuttinen alue:

Thioxanthene derivatives; zuclopenthixol

Valtuutuksen tilan:

Marketed

Valtuutus päivämäärä:

1983-10-12

Pakkausseloste

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you might be pregnant or
planning to have a baby, ask your doctor for advice before taking this
medicine.
Pregnancy
If you are pregnant or think you might be pregnant, tell your doctor.
Clopixol should not be used during pregnancy, unless clearly
necessary.
The following symptoms may occur in newborn babies, of mothers
that have used Clopixol in the last trimester (last three months of
their
pregnancy): shaking, muscle stiffness and/or weakness, sleepiness,
agitation, breathing problems, and difficulty in feeding. If your baby
develops any of these symptoms you may need to contact your doctor.
Breast-feeding
If you are breast-feeding, ask your doctor for advice. You should not
use
Clopixol when breast-feeding, as small amounts of the medicine can
pass into the breast milk.
Fertility
Animal studies have shown that Clopixol affects fertility. Please ask
your
doctor for advice.
Driving and using machines
There is a risk of feeling drowsy and dizzy when using Clopixol,
especially
in the beginning of the treatment. If this happens do not drive or use
any
tools or machines until these effects wear off.
3. How to use Clopixol
A small volume of Clopixol is drawn up into a syringe and then
injected
into the muscle of your buttock.
Your doctor will decide on the correct volume of medicine to give, and
how often to give it.
The medicine is slowly released from the injection that you receive in
your buttock such as a fairly constant amount of medicine gets into
your
blood between injections.
The recommended dose is:
Adults
The usual dose is about 1 ml (but may vary between 0.5 ml and 1.5 ml)
and the interval between injections will usually be 1 to 4 weeks.
If you have been treated with Clopixol tablets and you are being
transferred to Clopixol injection you may be asked to continue taking
the
tablets for several days after the first injection.
Your doctor may decide to adjust the amount given, or the interval
between injections, from time to

Valmisteyhteenveto

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Clopixol Conc. 500 mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 500 mg zuclopenthixol decanoate
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, yellow, oily, practically free from particles.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The management of schizophrenia and allied psychoses.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
The dosage should be adjusted according to the severity of the
patient’s symptoms. The usual dose range is 250-500 mg
every 1-4 weeks depending on the response of the individual patient.
The maximum recommended dose is 600 mg weekly. Patients who have not
previously received depot neuroleptics are
usually started on an initial dose of 100 mg.
A few patients may need higher doses or shorter intervals between
doses. Injection volumes exceeding 2 ml should be
distributed between two injection sites.
When changing the medication from oral zuclopenthixol or
zuclopenthixol acetate i.m. to maintenance treatment with
zuclopenthixol decanoate the following guidelines should be used:
_1) Change from oral zuclopenthixol to zuclopenthixol decanoate_
x mg p.o. daily corresponds to 8x mg decanoate every two weeks.
x mg p.o. daily corresponds to 16x mg decanoate every four weeks.
Numerical example:
10 mg p.o. daily corresponds to 80 mg decanoate every two weeks.
10 mg p.o. daily corresponds to 160 mg decanoate every four weeks.
Oral zuclopenthixol should be continued during the first week after
the first injection but in diminishing dosage.
_2) Change from zuclopenthixol acetate to zuclopenthixol decanoate_
Concomitantly with the (last) injection of zuclopenthixol acetate (100
mg), 200-400 mg (1-2 ml) of zuclopenthixol
decanoate 200 mg/ml should be given intramuscularly and repeated every
2nd week. Higher doses or shorter intervals
may be needed.
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