DECAPEPTYL triptorelin acetate 100 micrograms/1 mL solution for injection in 1mL pre-filled syringe with integrated needle

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

triptorelin acetate, Quantity: 100 microgram (Equivalent: triptorelin, Qty 95.6 microgram/mL)

Commercializzato da:

Ferring Pharmaceuticals Pty Ltd

INN (Nome Internazionale):

triptorelin acetate

Forma farmaceutica:

Injection, solution

Composizione:

Excipient Ingredients: glacial acetic acid; water for injections; sodium chloride

Via di somministrazione:

Subcutaneous

Confezione:

7 x 1 mL prefilled syringes

Tipo di ricetta:

(S4) Prescription Only Medicine

Indicazioni terapeutiche:

DECAPEPTYL 100 micrograms/1 mL is indicated for down-regulation and prevention of premature luteinising hormone (LH) surges in women undergoing controlled ovarian hyperstimulation for assisted reproductive technologies (ART).,In clinical trials DECAPEPTYL 100 micrograms/1 mL has been used in cycles where urinary and recombinant human follicle stimulating hormone (FSH) as well as human menopausal gonadotrophin (HMG) were used for stimulation.

Dettagli prodotto:

Visual Identification: Clear, colourless solution in a 1 mL pre-filled glass type I syringe with integrated needle.; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Stato dell'autorizzazione:

Licence status A

Data dell'autorizzazione:

2015-03-04

Foglio illustrativo

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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 DECAPEPTYL?
DECAPEPTYL is used in assisted reproductive technology (ART) cycles to
reduce the risk of cycle cancellation. It does this by
preventing an early surge in luteinising hormone (LH), which can occur
in women undergoing ART. DECAPEPTYL contains the
active ingredient triptorelin acetate, which is a synthetic version of
natural gonadotropin releasing hormone (GnRH).
For more information, see Section 1. Why am I using DECAPEPTYL? in the
full CMI starting from page 2.
2.
WHAT SHOULD I KNOW BEFORE I USE DECAPEPTYL?
Do not use DECAPEPTYL if you have ever had an allergic reaction to it
or to any of the ingredients listed at the end of the CMI, see
Section 7. Product details.
There are several circumstances in which a person should not use this
medicine or may need to use with caution. It is important to
understand if these circumstances apply to you before using
DECAPEPTYL.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS OR TAKE
ANY OTHER MEDICINES. For more information, see Section
2. What should I know before I use DECAPEPTYL? in the full CMI
starting from page 2.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Tell your doctor, or pharmacist if you are taking any other medicines,
including any medicines, vitamins or supplements that you buy
without a prescription from your pharmacy, supermarket or health food
shop.
Some medicines may interfere with DECAPEPTYL and affect how it works.
For more information, see Section 3. What if I am taking
other medicines? in the full CMI starting from page 2.
4.
HOW DO I USE DECAPEPTYL?
You should only use DECAPEPTYL under the supervision of a doctor
experienced in the treatment of infertility.
Always use this medicine exactly as your doctor has told you. You
should check with your doctor if you are not sure. Your doctor will
determine when to

Scheda tecnica

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AUSTRALIAN PRODUCT INFORMATION - DECAPEPTYL
®
(TRIPTORELIN ACETATE) 100 MICROGRAMS/1 ML SOLUTION FOR
INJECTION
1. NAME OF THE MEDICINE
Triptorelin acetate
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
DECAPEPTYL is for subcutaneous (s.c.) injection.
It consists of a clear, colourless solution containing 100 micrograms
of triptorelin acetate
(equivalent to 95.6 micrograms of triptorelin free base) in a
pre-filled syringe. The concentration of
triptorelin is 95.6 micrograms/1 mL (equivalent to triptorelin acetate
100 micrograms/1 mL).
DECAPEPTYL contains sodium chloride, glacial acetic acid and Water for
injections.
3. PHARMACEUTICAL FORM
Triptorelin is a white to off-white powder, freely soluble in acetic
acid, and soluble in water and in
diluted acids and bases.
Appearance of the injection: Clear colourless solution.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
DECAPEPTYL 100 micrograms/1 mL is indicated for down-regulation and
prevention of
premature luteinising hormone (LH) surges in women undergoing
controlled ovarian
hyperstimulation for assisted reproductive technologies (ART).
In clinical trials DECAPEPTYL 100 micrograms/1 mL has been used in
cycles where urinary and
recombinant human follicle stimulating hormone (FSH) as well as human
menopausal
gonadotrophin (HMG) were used for stimulation.
4.2 DOSE AND METHOD OF ADMINISTRATION
The dosage regimen of DECAPEPTYL is 100 micrograms given once daily as
a 1 mL
subcutaneous injection into the lower abdominal wall. Treatment with
DECAPEPTYL 100
micrograms/1 mL should be initiated under the supervision of a
physician experienced in the
treatment of infertility. 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.
Subsequent injections of DECAPEPTYL may be self-administered by the
patient. In this instance
the patient should first be instructed on appropriate self-injection
technique and be made awar