OVITRELLE 250 MICROGRAMS

País: Israel

Língua: inglês

Origem: Ministry of Health

Ingredientes ativos:

CHORIOGONADOTROPIN ALFA

Disponível em:

MERCK SERONO LTD

Código ATC:

G03GA08

Forma farmacêutica:

SOLUTION FOR INJECTION

Composição:

CHORIOGONADOTROPIN ALFA 250 MCG / 0.5 ML

Via de administração:

S.C

Tipo de prescrição:

Required

Fabricado por:

MERCK SERONO S.P.A., ITALY

Grupo terapêutico:

CHORIOGONADOTROPIN ALFA

Área terapêutica:

CHORIOGONADOTROPIN ALFA

Indicações terapêuticas:

- For women undergoing superovulation prior to assisted reproductive techniques such as in vitro fertilization (IVF) : Ovitrelle is administered to trigger final follicular maturation AND luteinisation AFTER stimulation of follicular growth. - Anovulatory OR oligo-ovulatory women: Ovitrelle is administered to trigger ovulation AND luteinisation in Anovulatory OR oligo-ovulatory patients AFTER stimulation of follicular growth.

Data de autorização:

2020-03-31

Folheto informativo - Bula

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
Ovitrelle
®
250 micrograms
Solution for subcutaneous injection
Pre-filled syringe
Pre-filled pen
The active ingredient and its quantity:
Choriogonadotropin alfa 250 mcg/0.5 ml equivalent to 6500 IU
Inactive ingredients — see section 6.
Read this leaflet carefully in its entirety before using the medicine.
This leaflet contains
concise information about the medicine. If you have further questions,
refer to the doctor or
pharmacist. Keep this leaflet at hand; you may need to read it again.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if it seems to you that their medical condition is similar.
If you experience any side effects, speak to your doctor or
pharmacist. This includes any
possible side effect not listed in this leaflet.
1.
WHAT IS THE MEDICINE INTENDED FOR
Ovitrelle
contains
a
medicine
called
choriogonadotropin
alfa,
which
is
produced
by
recombinant DNA technology. Choriogonadotropin alfa is similar to a
hormone naturally
found in the body called chorionic gonadotropin, which is associated
with the reproductive
system and fertility.
Ovitrelle is used together with other medicines:
•
To help develop and ripen several follicles in women undergoing
fertility treatment such
as in vitro fertilization (IVF). Other medicines will be given first
to bring about the
development of several follicles.
•
To help release an egg from the ovary in women who do not ovulate, or
women who
ovulate infrequently. Other medicines will be given first to develop
and ripen the follicles.
Therapeutic group:
Gonadotropin hormones.
2.
BEFORE USING THE MEDICINE
Do not use the medicine if:
•
you are sensitive (allergic) to the active ingredient
choriogonadotropin alfa, or to any of
the ingredients of the medicine (see section 6).
•
you have a tumor in the hypothalamus or pituitary gland (both are
parts of the brain).
•
y

Características técnicas

PRESCRIBING INFORMATION
OVITRELLE
® 250 MCG
1.
NAME OF THE MEDICINAL PRODUCT
OVITRELLE
® 250 micrograms/0.5 ml, solution for injection in a pre-filled syringe
OVITRELLE
® 250 micrograms/0.5 ml, solution for injection in a pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe contains 250 micrograms Choriogonadotropin
alfa* (equivalent to
approximately 6,500 IU) in 0.5 ml solution.
Each pre-filled pen contains 250 micrograms Choriogonadotropin alfa*
(equivalent to approximately
6,500 IU).
* recombinant human chorionic gonadotropin, r-hCG produced in Chinese
hamster ovary (CHO) by
recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection in pre-filled syringe.
Solution for injection in pre-filled pen.
Clear, colourless to slightly yellow solution.
The pH of the solution is 7.0 ± 0.3, its osmolality 250-400 mOsm/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ovitrelle
®
is indicated in the treatment of:
(i)_ _
Adult Women undergoing superovulation prior to assisted reproductive
technologies (ART)_ _
such as _in vitro_ fertilisation (IVF):_ _Ovitrelle is administered to
trigger final follicular maturation
and luteinisation after stimulation of follicular growth,
(ii)
Anovulatory or oligo-ovulatory adult women:_ _Ovitrelle is
administered to trigger ovulation and
luteinisation in anovulatory or oligo-ovulatory women after
stimulation of follicular growth.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Ovitrelle should be performed under the supervision of
a physician experienced in
the treatment of fertility problems.
Posology
The maximum dose is 250 micrograms. The following dose regimen should
be used:
•
Women undergoing superovulation prior to assisted reproductive
technologies (ART) such
as _in vitro_ fertilisation (IVF):
One pre-filled syringe/pen of Ovitrelle (250 micrograms) is
administered 24 to 48 hours after the last
administration of a follicle stimulation hormone (FSH) or human
menopausa