F.S.H
Follicle Stimulating Hormone Injection
FSH ampoulesComposition:
Each ampoule of lyophilized powder contains:
Follicle Stimulating Hormone (F.S.H)...............75 IU

Each ampoule of solvent contains:
Sodium chloride (0.9%).................................1 mlProperties:
F.S.H is one of the potent human menopausal gonadotropic hormones secreted by the anterior lobe of the pituitary gland together with luteinising hormone .
F.S.H stimulates the secretion of sex hormones in both men without primary testicular failure and women without primary ovarian failures so it induces spermatogenesis in men as well as ovulation in women.
Pharmacokinetics:
It has an absorption rate limited from the body following SC or IM injection.
It has an absolute bioavailability about 70-80%.
It has a peak plasma concentration about 12 hours after injection .
It has a terminal half-life about 12-70 hours. 1/8 of the given dose is excreted in urine .

Indications:
Fertility disorders in males and females.
Assisted reproductive technology program for ovulatory patients.

Contra-indications:
Hypersensitivity to the active ingredient or any of the excipients .
Uncontrolled thyroid or adrenal dysfunction.
Ovarian cyst or enlargement of undetermined origin .
Abnormal uterine bleeding of undetermined origin .
Pituitary and sex hormone-dependant tumors e.g. endometrial carcinoma.
Pregnancy and pediatric use.

Precautions:
Before treatment, medical and endocrinological level, exclude primary ovarian testicular failure and pregnancy.
Evaluation of partner's fertility potential. Monitoring carefully the ovarian response 10 minimize the risk of hyperstimulalion syndrome and multiple births via ulrasonography and serum estradiol measurement.
During lactation, the drug is used only for clearly needed due to lack of well-controlled studies.

Adverse reactions:
It is well tolerated, only in large doses it may cause uncomplicated mild- moderate ovarian enlargement, ovarian cyst, intermenstrual bleeding, female breast and pelvic pain headache, nausea, abdominal pain, diarrhea, flatulence, upper respiratory tract infections, sinusitis, gain weight and gynaecomastia.


The Reconstitution:
Inject 1 ml of solvent (0.9% sodium chloride) into the ampoule of F.S.H lyophilized powder.
DO NOT SHAKE, but gently swirl until the solution is clear.
After reconstitution use immediately and discard unused solution .

Dosage and administration:
The dose can be administered by SC or IM injection & is individualized according to the patients need and response .
Initial dose in fertility disorders : 75-150 IU/day for 7-14days.

In absence at an endogenous LH :
A single dose of 5000-10000 IU human choria1ic gonadotrophin (HCG) should be given one day after the last dose of F.S.H until final foIicular maturation and induction of ovulation (women) or spermatogenesis (men).
In vitro fertilization or other assisted reproductive technologies:
150 - 225 IU day up to 450 IU are generally given in the early follicular phase (cycle day 2 or 3), for up to 10 days, then dose is adjusted according the ovarian response .

Warning:
Keep in refrigerator or at temperature not exceeding 25°C, away from light.
Keep medicine out of reach of children.

Packing:
Box of one ampoule Lyophilized + one ampoule solvent.