CETROTIDE cetrorelix 250 microgram (as acetate) powder for injection vial with diluent syringe

देश: ऑस्ट्रेलिया

भाषा: अंग्रेज़ी

स्रोत: Department of Health (Therapeutic Goods Administration)

सक्रिय संघटक:

cetrorelix, Quantity: 0.25 mg

थमां उपलब्ध:

Merck Healthcare Pty Ltd

फार्मास्यूटिकल फॉर्म:

Injection, powder for

रचना:

Excipient Ingredients: mannitol

प्रशासन का मार्ग:

Subcutaneous

चिकित्सीय संकेत:

INDICATIONS: prevention of premature luteinization 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.

उत्पाद समीक्षा:

Visual Identification: White, lyophilised cake in a glass vial closed with an elastomeric stopper with an aluminium flip-top cap.; Container Type: Multiple containers; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

प्राधिकरण का दर्जा:

Registered

प्राधिकरण की तारीख:

2000-12-19

सूचना पत्रक

CETROTIDE
®
_Cetrorelix (as acetate)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about CETROTIDE.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using CETROTIDE
against the benefits it is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR, NURSE OR PHARMACIST.
KEEP THIS INFORMATION WITH YOUR
MEDICINE.
You may need to read it again later.
WHAT CETROTIDE IS
USED FOR
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
(IVF).
Ovulation that is too early, before the
egg has fully matured, is undesirable
during hormone treatment for ovarian
stimulation, because only mature egg
cells are suitable for fertilisation.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY CETROTIDE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
CETROTIDE is available only with a
doctor's prescription.
CETROTIDE is not habit-forming.
BEFORE YOU ARE GIVEN
CETROTIDE
_WHEN YOU MUST NOT USE IT_
DO NOT USE CETROTIDE IF YOU
HAVE AN ALLERGY TO:
•
Cetrorelix acetate
•
Mannitol
•
Exogenous peptide hormones
(medicines similar to
CETROTIDE).
Symptoms of an allergic reaction
may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin.
DO NOT USE CETROTIDE IF YOU
HAVE, OR HAVE HAD, ANY OF THE
FOLLOWING MEDICAL CONDITIONS:
•
liver disease
•
kidney disease.
DO NOT USE CETROTIDE IF YOU
HAVE ALREADY REACHED MENOPAUSE.
DO NOT USE CETROTIDE IF YOU ARE
PREGNANT OR SUSPECT THAT YOU MIGHT
BE PREGNANT.
DO NOT BREASTFEED WHILE YOU ARE
USING CETROTIDE.
It is not known whether
CETROTIDE passes into breast
milk. The potential effects on
breastfe

उत्पाद विशेषताएं

Version: A015-0420
1
Supersedes: A014-0419
AUSTRALIAN PRODUCT INFORMATION – CETROTIDE
®
(CETRORELIX (AS
ACETATE))
1
NAME OF THE MEDICINE
Cetrorelix (as acetate)
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 t