Clopixol 200 mg/ml Solution for Injection

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

ZUCLOPENTHIXOL DECANOATE

Inapatikana kutoka:

Lundbeck Limited

ATC kanuni:

N05AF; N05AF05

INN (Jina la Kimataifa):

ZUCLOPENTHIXOL DECANOATE

Kipimo:

200 milligram(s)/millilitre

Dawa fomu:

Solution for injection

Dawa ya aina:

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

Eneo la matibabu:

Thioxanthene derivatives; zuclopenthixol

Idhini hali ya:

Marketed

Idhini ya tarehe:

1977-06-13

Taarifa za kipeperushi

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 1-3 ml and the interval between injections will
usually
be 1 to 4 weeks.
If your dose is exceeding 2 ml of medicine it will probably be divided
between two injection sites.
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

Tabia za bidhaa

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Clopixol 200 mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 200 mg zuclopenthixol decanoate
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 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 200-400 mg
every two to four weeks depending on the response of the individual
patient.
If volumes larger than 2-3 ml of the 200 mg/ml solution are required,
the more concentrated solution (zuclopenthixol
decanoate 500 mg/ml) should be preferred.
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.
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