Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
human chorionic gonadotrophin
Merck Sharp & Dohme (Australia) Pty Ltd
Registered
PREGNYL ® _Human chorionic gonadotrophin (hCG)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Pregnyl. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Pregnyl against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS INFORMATION WITH YOUR MEDICINE. You may wish to read it again. WHAT PREGNYL IS USED FOR Pregnyl belongs to a group of hormones known as gonadotrophins which play an important part in human fertility and reproduction. It only works if it is injected. FEMALES: Pregnyl is used with other medicines to ripen an egg cell in the ovaries and to release the egg (ovulation). MALES: Pregnyl is used to increase sperm count. It is also used in young boys with un-descended testicles. Your doctor may have prescribed Pregnyl for another reason. Pregnyl is not addictive. A doctor's prescription is required to obtain this medicine. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. BEFORE YOU USE PREGNYL THE ACTIVE INGREDIENT OF THIS PREPARATION IS EXTRACTED OF HUMAN URINE. THEREFORE THE RISK OF A TRANSMISSION OF A PATHOGEN (KNOWN OR UNKNOWN) CANNOT BE COMPLETELY EXCLUDED. _WHEN YOU MUST NOT USE IT_ DO NOT USE PREGNYL IF: • you are allergic (hypersensitive) to human gonadotrophins or any of the ingredients listed at the end of the leaflet. • you have a known or suspected cancer or tumour of the ovary, breast , uterus in the female and prostate or breast carcinoma in the male. • you have malformations of the reproductive organs which make a normal pregnancy not possible • you have fibroids in the uterus which make a normal pregnancy not possible • you have heavy or irregular vaginal bleeding, other than menstrual bleeding, without a diagnosed cause. DO NOT USE PREGN Read the complete document
PREGNYL PI A170424 v6 AMP 1 PRODUCT INFORMATION NAME OF THE MEDICINE PREGNYL ® (HUMAN CHORIONIC GONADOTROPHIN) DESCRIPTION AND PHARMACOLOGY Pregnyl is a preparation of human chorionic gonadotrophin (hCG) obtained from the urine of pregnant women. It stimulates steroidogenesis in the gonads by virtue of a biologic effect similar to that of LH (luteinising hormone, which is the same as interstitial cell stimulating hormone). In the male it promotes the production of testosterone and in the female the production of estrogens and particularly of progesterone after ovulation. In certain cases, this preparation is used in combination with a follicle stimulating hormone (FSH) containing preparation. Because hCG is of human origin, no antibody formation is to be expected. INDICATIONS IN THE FEMALE: Sterility due to the absence of follicle-ripening or ovulation. IN THE MALE: Hypogonadotrophic hypogonadism. Delayed puberty associated with insufficient gonadotrophic pituitary function. Cryptorchism, not due to an anatomic obstruction. Sterility, in selected cases of deficient spermatogenesis. CONTRAINDICATIONS Hypersensitivity to human gonadotrophins or any of the ingredients in Pregnyl (see PRECAUTIONS). Known or suspected sex hormone-dependent tumours, such as ovary, breast and uterine carcinoma in female and prostatic carcinoma or mammary carcinoma in the male. Malformations of the reproductive organs incompatible with pregnancy. Fibroid tumours of the uterus incompatible with pregnancy. Abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause. PRECAUTIONS The active ingredient of this preparation is extracted from human urine. Therefore the risk of a transmission of a pathogen (known or unknown) cannot be completely excluded. PREGNYL PI A170424 v6 2 FOR MALES AND FEMALES: _ _ Hypersensitivity reactions: Hypersensitivity reactions, both generalised and local; anaphylaxis; and angioedema have been reported. If a hypersensitivity reaction is suspected, discontin Read the complete document