Composition: |
 |
Each ampoule of lyophilized
powder contains:
Follicle Stimulating Hormone
(F.S.H)...............75 IU
Each ampoule of solvent contains:
Sodium chloride (
0.9%).................................1 ml
|
| Properties: |
►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 Iactation, 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. |
|
Related Topics: |
|
Follicle Stimulating Hormone
|
