Ceziboe 0.25 mg solution for injection in pre-filled syringe

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Cetrorelix

Dostupno od:

Sun Pharmaceutical Industries Europe B.V.

ATC koda:

H01CC02

INN (International ime):

Cetrorelix

Doziranje:

0.25 milligram(s)

Farmaceutski oblik:

Solution for injection in pre-filled syringe

Područje terapije:

cetrorelix

Status autorizacije:

Not marketed

Datum autorizacije:

2021-02-12

Uputa o lijeku

V001
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
CEZIBOE 0.25 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
cetrorelix (as acetate)
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 Ceziboe is and what it is used for
2.
What you need to know before you use Ceziboe
3.
How to use Ceziboe
4.
Possible side effects
5.
How to store Ceziboe
6.
Contents of the pack and other information
1.
WHAT CEZIBOE IS AND WHAT IT IS USED FOR
WHAT CEZIBOE IS
Ceziboe contains a medicine called ‘cetrorelix acetate’. This
medicine stops your body from releasing
an egg from your ovary (ovulation) during your menstrual cycle.
Ceziboe belongs to a group of
medicines called ‘anti-gonadotropin-releasing hormones’.
WHAT CEZIBOE IS USED FOR
Ceziboe 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 CEZIBOE WORKS
Ceziboe 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 Ceziboe 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 them (ovulation induction).
2.
WHAT YOU NEED TO KNOW BEFORE Y

Svojstava lijeka

Health Products Regulatory Authority
03 November 2021
CRN00CDJH
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ceziboe 0.25 mg solution for injection in pre-filled syringe
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe of 1 ml solution contains 0.25 mg cetrorelix
(as acetate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection in pre-filled syringe.
Clear, colourless solution free from visible particles with a pH from
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 cetrorelix 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
Cetrorelix should only be prescribed by a specialist experienced in
this field
Posology
The first administration of cetrorelix 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 syringe (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 cetrorelix in the geriatric population.
_Paediatric population_
There is no relevant use of cetrorelix in the paediatric population.
Method of a