CLOPIXOL ACUPHASE 50 MGML

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ZUCLOPENTHIXOL ACETATE

Available from:

LUNDBECK ISRAEL LTD.

ATC code:

N05AF05

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

ZUCLOPENTHIXOL ACETATE 50 MG/ML

Administration route:

I.M

Prescription type:

Required

Manufactured by:

H.LUNDBECK A/S, DENMARK

Therapeutic group:

ZUCLOPENTHIXOL

Therapeutic area:

ZUCLOPENTHIXOL

Therapeutic indications:

Acute psychoses.

Authorization date:

2020-04-30

Patient Information leaflet

העדוה
העדוה
לע
לע
הרמחה
הרמחה
(
(
עדימ
עדימ
ןולעב )תוחיטב
ןולעב )תוחיטב
ל
ל
אפור
אפור
ךיראת
18.8.2014
םש
רישכת
_תילגנאב
CLOPIXOL ACUPHASE 50 MG/ML
רפסמ
םושיר
047-80-25490-00
םש
לעב
םושירה
קבדנול
לארשי
מ"עב
םיטרפ
לע
םי/יונישה
םי/שקובמה
טסקט
שדח
טסקט
יחכונ
קרפ
ןולעב
4.6
FERTILITY , PREGNANCY AND
LACTATION
_Pregnancy_
Zuclopenthixol acetate should not be
administered during pregnancy unless the
expected benefit to the patient outweighs
the theoretical risk to the foetus.
Neonates exposed to antipsychotics
(including zuclopenthixol acetate) during
the third trimester of pregnancy are at risk
of adverse reactions including
extrapyramidal and/or withdrawal
symptoms that may vary in severity and
duration following delivery. There have
been reports of agitation, hypertonia,
hypotonia, tremor, somnolence, respiratory
distress, or feeding disorder.
Consequently, newborns should be
monitored carefully.
Animal studies have shown reproductive
toxicity (see section 5.3)
_Breast -feeding _
As zuclopenthixol is found in breast milk in
low concentrations it is not likely to affect the
infant when therapeutic doses are used. The
dose ingested by the infant is less than 1%
of the weight related maternal dose (in
mg/kg). Breast-feeding can be continued
during zuclopenthixol acetate therapy if
considered of clinical importance but
observation of the infant is recommended,
particularly in the first 4 weeks after giving
birth.
_Fertility_
4.6
FERTILITY ,
PREGNANCY AND
LACTATION
_Pregnancy_
Zuclopenthixol acetate
should not be
administered during
pregnancy unless the
expected benefit to the
patient outweighs the
theoretical risk to the
foetus.
The newborns of mothers
treated with neuroleptics
in late pregnancy, or
labour, may show signs
of intoxication such as
lethargy, tremor and
hyperexcitability and
have a low apgar score.
Neonates exposed to
antipsychotics (including
zucl

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Clopixol-Acuphase 50 mg/ml solution for injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Zuclopenthixol acetate 50 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
Acute psychoses.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_Adults _
Dosage should be individually adjusted according to the condition of
the patient.
The dose range would normally be 50-150 mg (1-3 ml) i.m., repeated if
necessary,
preferably with a time interval of 2 to 3 days. In a few patients an
additional injection
may be needed 24 to 48 hours following the first injection.
Zuclopenthixol acetate is not intended for long-term use and duration
of treatment
should not be more than two weeks. The maximum accumulated dosage in a
course
should not exceed 400 mg and the number of injections should not
exceed four.
In the maintenance therapy, treatment should be continued with oral
zuclopenthixol or
zuclopenthixol decanoate i.m., after the following guidelines:
_1) Change to oral zuclopenthixol_
2 to 3 days after the last injection of zuclopenthixol acetate a
patient who has been
treated with 100 mg zuclopenthixol acetate, should be started at an
oral dosage of
about 40 mg daily, possibly in divided dosages. If necessary the dose
can be further
increased by 10-20 mg every 2 to 3 days up to 75 mg daily or more.
_2) Change 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.
Zuclopenthixol acetate and zuclopenthixol decanoate can be mixed in a
syringe and
given as one injection (co-injection).
Subsequent doses of zuclopenthixol decanoate and interval between
injections should
be adjusted according to the