onse is monitored by ultrasound assessment. The concurrent determination of serum oestradiol levels may also be useful. When ultrasound assessment indicates the presence of at least three follicles of 16-20 mm, and there is evidence of a good oestradiol response (plasma levels of about 300-400 picograms/ml (1000-1300 pmol/l) for each follicle with a diameter greater than 18 mm), the final phase of maturation of the follicles is induced by administration of hCG. Oocyte retrieva l is performed 34-35 hours later.
Dosage in the male
Puregon should be given at a dosage of 450 IU/week, preferably divided in 3 dosages of 150 IU, concomitantly with hCG. Treatment with Puregon and hCG should be continued for at least 3 to 4 months before any improvement in spermatogenesis can be expected. To assess the response, semen analysis is recommended 4 to 6 months after the beginning of treatment. If a patient has not responded after this period, the combination therapy may be continued; current clinical experience indicates that treatment for up to 18 months or longer may be necessary to achieve spermatogenesis.
Paediatric population
There is no relevant use of Puregon in the paediatric population for the approved indication.
Method of administration
Puregon solution for injection in cartridges has been developed for use in the Puregon Pen and should be administered subcutaneously. The injection site should be alternated to prevent lipoatrophy.
Using the pen, injection of Puregon can be carried out by the patient, provided that proper instructions are given by the physician.
4.3 Contraindications
For males and females
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
• Tumours of the ovary, breast, uterus, testis, pituitary or hypothalamus.
• Primary gonadal failure
Additionally for females
• Undiagnosed vaginal bleeding.
• Ovarian cysts or enlarged ovaries, not related to polycystic ovarian syndrome (PCOS).
• Malformations of the reproductive organs incompatible with pregnancy.
• Fibroid tumours of the uterus incompatible with pregnancy.
4.4 Special warnings and precautions for use
Antibiotic hypersensitivity reactions
• Puregon may contain traces of streptomycin and/or neomycin. These antibiotics may cause hypersensitivity reactions in susceptible persons.
Infertility eva luation before starting treatment
Before starting treatment, the couple's infertility should be assessed as appropriate. In particular, patients should be eva luated for hypothyroidism, adrenocortical insufficiency, hyperprolactinemia and pituitary or hypothalamic tumours, and appropriate specific treatment given.
In females
Ovarian Hyperstimulation Syndrome (OHSS)
OHSS is a medical event distinct from uncomplicated ovarian enlargement. Clinical signs and symptoms of mild and moderate OHSS are abdominal pain, nausea, diarrhoea, mild to moderate enlargement of ovaries and ovarian cysts. Severe OHSS may be life-threatening. Clinical signs and symptoms of severe OHSS are large ovarian cysts, acute abdominal pain, ascites, pleural effusion, hydrothorax, dyspnoea, oliguria, haematological abnormalities and weight gain. In rare instances, venous or arterial thromboembolism may occur in association with OHSS. Transient liver function test abnormalities su
