Kraj: Izrael
Język: angielski
Źródło: Ministry of Health
ZUCLOPENTHIXOL ACETATE
LUNDBECK ISRAEL LTD.
N05AF05
SOLUTION FOR INJECTION
ZUCLOPENTHIXOL ACETATE 50 MG/ML
I.M
Required
H.LUNDBECK A/S, DENMARK
ZUCLOPENTHIXOL
ZUCLOPENTHIXOL
Acute psychoses.
2020-04-30
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 Przeczytaj cały dokument
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 Przeczytaj cały dokument