Ovidrel Solution for Injection 250 mcg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Choriogonadotropin alfa

Available from:

MERCK PTE. LTD.

ATC code:

G03GA08

Dosage:

250 mcg

Pharmaceutical form:

INJECTION, SOLUTION

Composition:

Choriogonadotropin alfa 250 mcg

Administration route:

SUBCUTANEOUS

Prescription type:

Prescription Only

Manufactured by:

Merck Serono S.p.A.

Authorization status:

ACTIVE

Authorization date:

2004-07-13

Patient Information leaflet

 
250 MICROGRAMS/0.5 ML 
SOLUTION FOR INJECTION 
IN A PRE-FILLED PEN 

QUALITATIVE AND QUANTITATIVE COMPOSITION 
Choriogonadotropin alfa is produced by recombinant DNA technology in Chinese Hamster
Ovary 
cells. 

A dose of 250 micrograms in 0.5 ml. (equivalent to approximately 6500 IU) 

PHARMACEUTICAL FORM 
Solution for injection 
Clear colourless solution. 

CLINICAL PARTICULARS 

THERAPEUTIC INDICATIONS 
Ovidrel® is indicated in the treatment of 
•  Women undergoing superovulation prior to assisted reproductive techniques such as in vitro 
fertilisation (IVF): Ovidrel® is administered to trigger final
follicular maturation and luteinisation 
after stimulation of follicular growth, 
•  Anovulatory or oligo-ovulatory women: Ovidrel® is administered to trigger
ovulation and 
luteinisation in anovulatory or oligo-ovulatory patients after stimulation of
follicular growth. 

POSOLOGY AND METHOD OF ADMINISTRATION 
Ovidrel® is intended for subcutaneous administration. 

Treatment with Ovidrel® should be performed under the supervision of a physician experienced in 
the treatment of fertility problems. 

The following dosing regimen should be used: 
•  Women undergoing superovulation prior to assisted reproductive techniques such as in vitro 
fertilisation (IVF): One pre- filled pen of Ovidrel® (250 micrograms) is administered 24 to 48 
hours after the last administration of an FSH- or hMG
preparation, i.e. when optimal stimulation 
of follicular growth is achieved, 
•  Anovulatory or oligo-ovulatory women: One pre-filled pen of
Ovidrel® (250 micrograms) is 
administered 24 to 48 hours after optimal stimulation of
follicular growth is achieved. The 
patient
is recommended to have coitus on the day of, and the day after, Ovidrel injection. 

CONTRAINDICATIONS 
Ovidrel�

Summary of Product characteristics

PAGE 1
N54G1402F
QUALITATIVE AND QUANTITATIVE COMPOSITION
Choriogonadotropin alfa is produced by recombinant
DNA technology in Chinese Hamster Ovary cells.
A dose of 250 micrograms in 0.5 ml. (equivalent to
approximately 6500 IU)
PHARMACEUTICAL FORM
Solution for injection
Clear colourless solution.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Ovidrel® is indicated in the treatment of
•
Women undergoing superovulation prior to assisted
reproductive technologies (ART) such as in vitro
fertilisation (IVF): Ovidrel® is administered to trigger
final follicular maturation and luteinisation after
stimulation of follicular growth,
•
Anovulatory or oligo-ovulatory women: Ovidrel® is
administered to trigger ovulation and luteinisation
in
anovulatory
or
oligo-ovulatory
patients
after
stimulation of follicular growth.
POSOLOGY
Treatment with Ovidrel® should be performed under the
supervision of a physician experienced in the treatment
of fertility problems.
The maximum dose is 250 micrograms. The following
dosing regimen should be used:
•
Women
undergoing
superovulation
prior
to
assisted reproductive technologies (ART) such as
in vitro fertilisation (IVF): One pre- filled pen of
Ovidrel® (250 micrograms) is administered 24 to
48 hours after the last administration of a follicle
stimulating hormone (FSH) or human menopausal
gonadotropin (hMG) preparation, i.e. when optimal
stimulation of follicular growth is achieved.
•
Anovulatory
or
oligo-ovulatory
women:
One
pre-filled
pen
of
Ovidrel®
(250
micrograms)
is
administered
24
to
48
hours
after
optimal
stimulation of
follicular
growth is
achieved.
The
patient is recommended to have coitus on the day
of, and the day after, Ovidrel® injection.
METHOD OF ADMINISTRATION
For subcutaneous use. Self-administration of Ovidrel®
should
only
be
performed
by
patients
who
are
adequately trained and have access to expert advice.
Ovidrel® is for single use only.
For
instructions
on
the
administration
with
the
prefilled pen, see ‘Instructions for Use’.
CONTRAINDICATIONS
•