LG Follimon™ 75 IU. i.m, i.c
HIGHLY Purified FSH (urofollitropin)
Anovulation (including PCOS):
The objective of treatment with LG Follimon™ is to develop a single
mature Graafian follicle from which the ovum will be released
after the administration of chorionic gonadotrophine (hCG).
LG Follimon™ can be administered daily. In menstruating patients
treatment should be started within the first 7 days of the
menstrual cycle. The treatment should be adjusted to the
individual patient's response as assessed by measuring the
follicle size by ultrasound and/or oestrogen levels. A commonly
used regimen commences at 75-150 IU of FSH per day and is
increased if necessary of 37.5 IU (up to 75 IU), with intervals
of 7 or 14 days, in order to achieve a satisfactory but not
excessive response. Daily dosage of FSH should not exceed
225 IU. If a patient fails to adequately respond after 4
weeks of treatment, the cycle should be abandoned and the
patient should recommence at a higher initial dose than in
the previous cycle.
When an ideal response is obtained a single injection of 5000
IU-10000 IU of hCG should be administered 24-48 hrs after the
last LG Follimon™ injection. The patient should be recommended
to have coitus on the hCG injection day and the following day.
In the event of an excessive response treatment should be suspended
and hCG withheld (see Warnings) Treatment should recommence
in the next cycle at a lower dose than in the previous cycle.
Females undergoing controlled ovarian stimulation during ART:
A commonly used protocol for superovulation involves the administration
of 150-225 IU of LG Follimon™ daily commencing on days 2 or 3 of
the cycle. The treatment is continued until sufficient follicular
development has been achieved and assessed by monitoring of
serum oestrogen concentrations and/or ultrasound examination
with the dose adjusted according to the patient's response
(usually not higher than 450 IU daily). Adequate follicular
development is usually achieved by the tenth day of treatment
(range 5-20 days).
A single injection of 5,000 IU-10,000 IU of hCG should be administered
24-48 hours after the last Fostimon injection to induce follicular
maturation.
Pituitary down-regulation in order to suppress the endogenous
LH surge and to control tonic levels of LH is now commonly
achieved by administration of a gonadotrophin releasing hormone
(GnRH).
In a commonly used protocol the administration of LG Follimon™
is started approximately two weeks after the start of the agonist
treatment, both being continued until adequate follicular development
has been achieved. For example, following two weeks of pituitary
down-regulation with agonist, 150-225 IU of LG Follimon™ are administered
for seven days. The dose is then adjusted according to the
patient's ovarian response.
Method of administration:
LG Follimon™ is intended for intra muscular and subcutaneous administration.
The powder should be reconstituted immediately prior to use with
the solvent provided. In order to avoid injection of large volumes
up to 3 vials of LG Follimon™ 150 IU may be dissolved in 1 ml of
solvent.
Subcutaneous injections can be self-administered by the patient,
provided the physician's instructions are strictly followed.