Cetrotide

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

cetrorelix (as acetate)

Available from:

Merck Europe B.V.

ATC code:

H01CC02

INN (International Name):

cetrorelix

Therapeutic group:

Pituitary and hypothalamic hormones and analogues

Therapeutic area:

Ovulation; Ovulation Induction

Therapeutic indications:

Prevention of premature ovulation in patients undergoing a controlled ovarian stimulation, followed by oocyte-pick-up and assisted-reproductive techniques.In clinical trials, Cetrotide was used with human menopausal gonadotropin (HMG), however, limited experience with recombinant follicule-stimulating hormone (FSH) suggested similar efficacy.

Product summary:

Revision: 27

Authorization status:

Authorised

Authorization date:

1999-04-12

Patient Information leaflet

18
B. PACKAGE LEAFLET
19
PACKAGE LEAFLET: INFORMATION FOR THE USER
CETROTIDE 0.25 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Cetrorelix
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
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 Cetrotide is and what it is used for
2.
What you need to know before you use Cetrotide
3.
How to use Cetrotide
4.
Possible side effects
5
How to store Cetrotide
6.
Contents of the pack and other information
How to mix and inject Cetrotide
1.
WHAT CETROTIDE IS AND WHAT IT IS USED FOR
WHAT CETROTIDE IS
Cetrotide contains a medicine called ‘cetrorelix’. This medicine
stops your body from releasing an egg
from your ovary (ovulation) during your menstrual cycle. Cetrotide
belongs to a group of medicines
called ‘anti-gonadotropin-releasing hormones’.
WHAT CETROTIDE IS USED FOR
Cetrotide is one of the medicines used during ‘assisted reproductive
techniques’ to help you get
pregnant. It stops eggs being released straight away. This is because
if the eggs are released too early
(premature ovulation) it may not be possible for your doctor to
collect them.
HOW CETROTIDE WORKS
Cetrotide blocks a natural hormone in your body called LHRH
(‘luteinising hormone releasing
hormone’).
•
LHRH controls another hormone, called LH (‘luteinising hormone’).
•
LH stimulates ovulation during your menstrual cycle.
This means that Cetrotide stops the chain of events that leads to an
egg being released from your
ovary. When your eggs are ready to be collected, another medicine will
be given to you that will
release

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Cetrotide 0.25 mg powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 0.25 mg cetrorelix (as acetate).
After reconstitution with the solvent provided, each mL of the
solution contains 0.25 mg cetrorelix.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
Appearance of the powder: white lyophilisate
Appearance of the solvent: clear and colourless solution
The pH of the reconstituted solution is 4.0-6.0.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prevention of premature ovulation in patients undergoing a controlled
ovarian stimulation, followed
by oocyte pick-up and assisted reproductive techniques.
In clinical trials Cetrotide was used with human menopausal
gonadotropin (HMG), however, limited
experience with recombinant follicle-stimulating hormone (FSH)
suggested similar efficacy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Cetrotide should only be prescribed by a specialist experienced in
this field.
Posology
The first administration of Cetrotide should be performed under the
supervision of a physician and
under conditions where treatment of possible allergic/pseudo-allergic
reactions (including
life-threatening anaphylaxis) is immediately available. The following
injections may be
self-administered as long as the patient is made aware of the signs
and symptoms that may indicate
hypersensitivity, the consequences of such a reaction and the need for
immediate medical intervention.
The contents of 1 vial (0.25 mg cetrorelix) are to be administered
once daily, at 24 h intervals, either in
the morning or in the evening. Following the first administration, it
is advised that the patient be kept
under medical supervision for 30 minutes to ensure there is no
allergic/pseudo-allergic reaction to the
injection.
_ _
_Elderly _
There is no relevant use of Cetrotide in the geriatric population.
_Paediatric populat