Ovitrelle 250micrograms0.5ml solution for injection pre-filled syringes

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Choriogonadotropin alfa

Available from:

Merck Serono Ltd

ATC code:

G03GA08

INN (International Name):

Choriogonadotropin alfa

Dosage:

500microgram/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Subcutaneous

Class:

Schedule 4 (CD Anab)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06050100; GTIN: 5018431700012

Patient Information leaflet

N54G0201J
PACKAGE LEAFLET: INFORMATION FOR THE USER 250 MICROGRAMS/0.5 ML
SOLUTION FOR INJECTION IN A PREFILLED SYRINGE
Choriogonadotropin alfa
•
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Ovitrelle is and what it is used for
2.
What do you need to know before you use Ovitrelle
3.
How to use Ovitrelle
4.
Possible side effects
5.
How to store Ovitrelle
6.
Contents of the pack and other information
1. WHAT OVITRELLE IS AND WHAT IT IS USED FOR
WHAT OVITRELLE IS
Ovitrelle contains a medicine called ‘choriogonado­
tropin alfa’, made in a laboratory by a special
recombinant DNA technique. Choriogonadotropin alfa
is similar to a hormone found naturally in your body
called ‘chorionic gonadotropin’, which is involved in
reproduction and fertility.
WHAT OVITRELLE IS USED FOR
Ovitrelle is used together with other medicines:
•
To help develop and ripen several follicles (each
containing an egg) in women undergoing Assisted
Reproductive Techniques (procedure that may
help you to become pregnant) such as _‘in vitro_
fertilisation’. Other medicines will be given first to
bring about the growth of several follicles.
•
To help release an egg from the ovary (ovulation
induction) in women who cannot produce eggs
(‘anovulation’), or women who produce too few
eggs (‘oligo­ovulation’). Other medicines will be
given first to develop and ripen the follicles.
2. WHAT DO YOU NEED TO KNOW BEFORE YOU USE
OVITRELLE
DO NOT USE OVITRELLE:
•
if you are allergic to choriogonadotropin alfa or
any of the other ingredients of this medicine (listed
in section 6).
•
if you have a tumour in a part of your brain called
the ‘hypothalamus’ or ‘pituitary gland’.
•
if you have large ovaries or sacs of fluid within the
ovaries (ovarian cysts) of unknown origin
•
if you have unexplained vaginal bleeding
•
if you have cancer of your ovaries, womb or breast
•
if you have had a pr

Summary of Product characteristics

OBJECT 1
OVITRELLE 250 MICROGRAMS/0.5 ML PREFILLED SYRINGE
Summary of Product Characteristics Updated 16-Dec-2016 | Merck
1. Name of the medicinal product
Ovitrelle 250 micrograms/0.5 mL solution for injection in pre-filled
syringe
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.
* recombinant human chorionic gonadotropin, r-hCG produced in Chinese
hamster ovary (CHO) cells by
recombinant DNA technology
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection in pre-filled syringe.
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
• Adult women undergoing superovulation prior to assisted
reproductive techniques such as in vitro
fertilisation (IVF): Ovitrelle is administered to trigger final
follicular maturation and luteinisation after
stimulation of follicular growth,
• 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
techniques such as in vitro fertilisation
(IVF):
One pre-filled syringe of Ovitrelle (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 syringe of Ovitrelle (250 micrograms)