Cetrotide

Država: Novi Zeland

Jezik: engleski

Izvor: Medsafe (Medicines Safety Authority)

Aktivni sastojci:

Cetrorelix acetate 3.12mg equivalent to 3.00 mg cetrorelix

Dostupno od:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International ime):

Cetrorelix acetate 3.12 mg (Equivalent to 3.00 mg cetrorelix base)

Doziranje:

3 mg

Farmaceutski oblik:

Injection with diluent

Sastav:

Active: Cetrorelix acetate 3.12mg equivalent to 3.00 mg cetrorelix Excipient: Mannitol Water for injection

Jedinice u paketu:

Combination pack, powder vial/diluent syringe, 1 dose unit

Razred:

Prescription

Tip recepta:

Prescription

Proizveden od:

Peptisyntha SA

Terapijske indikacije:

Prevention of premature luteinization and ovulation in patients undergoing a controlled ovarian stimulation, followed by oocyte pick up and assisted reproductive techniques.

Proizvod sažetak:

Package - Contents - Shelf Life: Combination pack, powder vial/diluent syringe - 1 dose units - 24 months from date of manufacture stored at or below 25°C - Syringe, glass, - 3 mL -   - Vial, glass, single dose, Type I glass - 3 mg - 24 months from date of manufacture stored at or below 25°C

Datum autorizacije:

1998-06-03

Uputa o lijeku

CETROTIDE®
1
CETROTIDE®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING CETROTIDE?
CETROTIDE contains the active ingredient cetrorelix (as acetate).
CETROTIDE is used to prevent premature ovulation (the release
of an egg from the ovary) in women undergoing an assisted reproduction
cycle, such as in vitro fertilisation.
For more information, see Section 1. Why am I using CETROTIDE?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CETROTIDE?
Do not use if you have ever had an allergic reaction to CETROTIDE or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
CETROTIDE?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with CETROTIDE and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE CETROTIDE?
•
CETROTIDE is given as a subcutaneous (under the skin) injection in the
lower abdomen.
•
The contents of one vial of CETROTIDE 250 microgram are given once
daily, at 24-hour intervals, either in the morning or in
the evening. It is given over several days. Your doctor will tell you
how much CETROTIDE to use and when to inject it.
More instructions can be found in Section 4. How do I use CETROTIDE?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING CETROTIDE?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
CETROTIDE.
•
Tell your doctor if you become pregnant while using CETROTIDE.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine suddenly without telling your doctor.
•
Do not change the dose unless your doctor tells you to.
•
Do not give CETROTIDE to anyone else, even if

Svojstava lijeka

Version: A012-0623 Page 1 of 9 Supersedes: A011-0320
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
CETROTIDE
®
250 microgram powder for injection vial with diluent syringe.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 250 microgram of cetrorelix (as acetate). After
reconstitution with the
solvent provided, the concentration of cetrorelix is 250 microgram/mL.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Cetrorelix acetate is an amorphous white powder, moderately soluble in
water and poorly
soluble in organic solvents.
CETROTIDE is a lyophilised powder for injection. The powder contains
mannitol as excipient.
The packs also contain solvent (water for injections) in pre-filled
syringes.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prevention of premature luteinisation and 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
gonadotrophin (HMG), however
limited experience with recombinant FSH suggested similar efficacy.
4.2
DOSE AND METHOD OF ADMINISTRATION
CETROTIDE should only be prescribed by or under the supervision of a
specialist experienced in
this field.
CETROTIDE is for subcutaneous injection into the lower abdominal wall.
The first administration of CETROTIDE should be performed under the
supervision of a
physician. 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.
Facilities for the treatment
of such reactions should be immediately available.
Subsequent injections with CETROTIDE may be self-administered as long
as the patient is made
aware of the signs and symptoms that may include hypersensitivity, the
consequences of such a
reaction and the need for immediate intervention.
The contents of 1 vial of CETROTIDE 250 microgram are to be
administered once daily, at 24-
hour intervals, either in the morning or in