Pergoveris Powder and Solvent for Solution for Injection 150iu75iu

Երկիր: Սինգապուր

Լեզու: անգլերեն

Աղբյուրը: HSA (Health Sciences Authority)

Ակտիվ բաղադրիչ:

Follitropin alfa (r-hFSH); Lutropin alfa (r-hLH)

Հասանելի է:

MERCK PTE. LTD.

ATC կոդը:

G03GA30

Դոզան:

150 IU

Դեղագործական ձեւ:

INJECTION, POWDER, FOR SOLUTION

Կազմը:

Follitropin alfa (r-hFSH) 150 IU; Lutropin alfa (r-hLH) 75 IU

Կառավարման երթուղին:

SUBCUTANEOUS

Ռեկվիզորի տեսակը:

Prescription Only

Պատրաստված է:

Merck Serono S.A. (Drug product and solvent manufacturer)

Լիազորման կարգավիճակը:

ACTIVE

Հաստատման ամսաթիվը:

2011-07-18

Տեղեկատվական թերթիկ

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page 4
pp-1279   Black
page 1
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Pergoveris should be initiated under the 
supervision of a physician experienced in the treatment of 
fertility problems.
Pergoveris is intended for subcutaneous administration. 
The powder should be reconstituted immediately prior to 
use with the solvent provided.
In LH and FSH deficient women (hypogonadotrophic 
hypogonadism), the objective of Pergoveris therapy is to 
develop a single mature Graafi an follicle from which the 
oocyte will be liberated after the administration of human 
chorionic gonadotrophin (hCG). Pergoveris should be 
given as a course of daily injections. Since these patients 
are amenorrhoeic and have low endogenous oestrogen 
secretion, treatment can commence at any time.
Treatment  should  be  tailored  to  the  individual  patient’s 
response as assessed by measuring follicle size by ultrasound 
and oestrogen response. A recommended regimen 
commences with one vial of Pergoveris daily. If less than 
one vial of Pergoveris daily is used, the follicular response 
may be unsatisfactory because the amount of lutropin 
alfa may be insuffi
  cient (see section on pharmacodynamic 
properties).
If  an  FSH  dose  increase  is  deemed  appropriate,  dose 
adaptation should preferably be after 7-14 day intervals 
and preferably by 37.5-75 IU increments using a licensed 
follitropin alfa preparation. It may be acceptable to extend 
the duration of stimulation in any one cycle to up to 5 
weeks.
When an optimal response is obtained, a single injection 
of 5,000 IU to 10,000 IU hCG should be administered 24-
48 hours after the last Pergoveris injection. The patient is 
recommended to have coitus on the day of, and on the day 
following, hCG administration. Alternatively, intrauterine 
insemination (IUI) may be performed.
Luteal phase support may be

Ապրանքի հատկությունները

PAGE 1
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Pergoveris is indicated for the stimulation of follicular
development in women with severe LH and FSH
deficiency.
In clinical trials, these patients were defined by an
endogenous serum LH level < 1.2 IU/l.
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Pergoveris should be initiated under
the supervision of a physician experienced in the
treatment of fertility problems.
Pergoveris
is
intended
for
subcutaneous
administration. The powder should be reconstituted
immediately prior to use with the solvent provided.
In LH and FSH deficient women (hypogonadotrophic
hypogonadism), the objective of Pergoveris therapy
is to develop a single mature Graafian follicle
from which the oocyte will be liberated after the
administration of human chorionic gonadotrophin
(hCG). Pergoveris should be given as a course of daily
injections. Since these patients are amenorrhoeic and
have low endogenous oestrogen secretion, treatment
can commence at any time.
Treatment should be tailored to the individual patient’s
response as assessed by measuring follicle size by
ultrasound and oestrogen response. A recommended
regimen commences with one vial of Pergoveris daily.
If less than one vial of Pergoveris daily is used, the
follicular response may be unsatisfactory because
the amount of lutropin alfa may be insufficient (see
section on pharmacodynamic properties).
If an FSH dose increase is deemed appropriate,
dose adaptation should preferably be after 7‑14 day
intervals and preferably by 37.5‑75 IU increments
using a licensed follitropin alfa preparation. It may be
acceptable to extend the duration of stimulation in
any one cycle to up to 5 weeks.
When an optimal response is obtained, a single
injection of 5,000 IU to 10,000 IU hCG should be
administered 24‑48 hours after the last Pergoveris
injection. The patient is recommended to have
coitus on the day of, and on the day following,
hCG
administration.
Alternatively,
intrauterine
insemination (IUI) may be performed.
Luteal pha