Cetrotide 250microgram powder and solvent for solution for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Cetrorelix acetate

Available from:

Merck Serono Ltd

ATC code:

H01CC02

INN (International Name):

Cetrorelix acetate

Dosage:

250microgram

Pharmaceutical form:

Powder and solvent for solution for injection

Administration route:

Subcutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06070200; GTIN: 5018431590019 5018431590071

Patient Information leaflet

56368071
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 acetate’.
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 them (ovulation induction).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE CETROTIDE
DO NOT USE CETROTIDE
•
if you are a

Summary of Product characteristics

OBJECT 1
CETROTIDE 0.25 MG
Summary of Product Characteristics Updated 21-Dec-2017 | Merck
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 follicule-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 ge