Choragon 5000U and Choragon Solvent

Active Ingredient

Each ampoule with dry substance contains chorionic gonadotrophin EP corresponding to 5000 units.

Powder for injection and solvent for parenteral use.

In the female

In the management of anovulatory infertility.

In the male

In the management of delayed puberty, undescended testes and oligospermia.

Treatment should only commence after expert assessment.

In the female

Induction of ovulation: 10000 units mid-cycle if plasma oestrogen levels are favourable following follicular stimulation.

In the male

Delayed puberty: Dose should be titrated against plasma testosterone, starting with 500 units twice weekly. Treatment should be continued for 4 - 6 weeks.

Undescended testes: Treatment should begin before puberty, the optimum age range being 7 - 10 years. 500 units three times weekly is a suitable starting dose. This may be increased to 4000 units if necessary. Treatment should continue for 6 - 10 weeks.

In males over 17 years of age a commencing dose of 1000 units twice weekly can be given. Treatment should be continued for one or two months after testicular descent.

Oligospermia: Dose should be titrated against seminal analysis starting with 500 units two or three times weekly. Treatment should be continued for 16 weeks.

Choragon is given by intramuscular injection.

hCG should not be given to patients with disorders that might be exacerbated by androgen release.

hCG should be given with care to patients in whom fluid retention might be a hazard, as in asthma, epilepsy, migraine or cardiac or renal disorders.

Allergic reactions may occur and patients thought to be susceptible should be given skin tests before treatment.

hCG preparations should only be used under the supervision of a specialist having available adequate facilities for appropriate laboratory monitoring.

In the female - Use in induction of ovulation may result in ovarian enlargement or cysts, acute abdominal pain, superovulation or multiple pregnancies, particularly if endocrine monitoring is inadequate.

In the male - Treatment for undescended testes may produce precocious puberty; use should cease immediately. Gynaecomastia has been reported. A growth spurt may also be associated with use and this should be kept in mind particularly where epiphyseal growth is still potentially active.

None known.

Not applicable as only recommended in females for infertility.

None known.

Headache, tiredness and mood changes have been described.

See “Warnings”.

Gonadotrophin.

hCG is not effective when taken orally and is administered by intramuscular injection.

There are no preclinical data of relevance to the Prescriber which are additional to those already included in other sections of the SPC.

Dry substance: Mannitol, sodium hydroxide for pH-adjustment.

Diluent: Isotonic sodium chloride solution (0.9% w/w), dilute hydrochloric acid for pH-adjustment.

None stated.

36 months as packaged for sale.

Protect from light and store below 25ºC

Each pack contains ampoule(s) with 5000 units of hCG powder for solution for injection packaged together with ampoule(s) of 1ml Choragon solvent. Ampoules are assembled in boxes containing either 1 pair, 3 pairs or 5 pairs of ampoules and solvents.

The dry substance must be reconstituted with the solvent prior to use.

Ferring Pharmaceuticals Limited

The Courtyard

Waterside Drive

Langley

Berkshire

SL3 6EZ

PL 03194/0065

15/08/96

29 April 2009