Nazione: Australia
Lingua: inglese
Fonte: Department of Health (Therapeutic Goods Administration)
ganirelix, Quantity: 0.25 mg
Theramex Australia Pty Ltd
Injection, solution
Excipient Ingredients: glacial acetic acid; water for injections; mannitol; sodium hydroxide
Subcutaneous
5 prefilled syringes, 1 prefilled syringe
(S4) Prescription Only Medicine
For the prevention of premature luteinisation and ovulation in patients undergoing controlled ovarian stimulation, followed by oocyte pick up and assisted reproductive techniques
Visual Identification: GANIRELIX THERAMEX (ganirelix as acetate) is presented as a sterile, ready for use, clear and colourless aqueous solution; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2022-12-20
GANIRELIX THERAMEX ® G A N I R E L I X T H E R A M E X ® V e r s i o n 1 . 0 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 GANIRELIX THERAMEX? Ganirelix Theramex contains the active ingredient ganirelix (as acetate). Ganirelix Theramex is used together with other medications to regulate hormone response in women undergoing Assisted Reproductive Technology such as in vitro fertilisation (IVF). For more information, see Section 1. Why am I using Ganirelix Theramex? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE GANIRELIX THERAMEX? Do not use if you have ever had an allergic reaction to ganirelix 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 Ganirelix Theramex? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Ganirelix Theramex 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 GANIRELIX THERAMEX? • Treatment with Ganirelix Theramex should be started under the supervision of a fertility specialist • Ganirelix Theramex is given as a subcutaneous (under the skin) injection in the thigh or stomach • The usual dose is the contents of one pre-filled syringe of Ganirelix Theramex once a day on specific days of the menstrual cycle. More instructions can be found in Section 4. How do I use Ganirelix Theramex? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING GANIRELIX THERAMEX? THINGS YOU SHOULD DO • Remind any doctor, dentist, or pharmacist you visit that you are using Ganirelix Theramex. THINGS YOU SHOULD NOT DO • Do not stop using this medicine without telling your doctor. • Do not change the dose unless Leggi il documento completo
GANIRELIX THERAMEX ganirelix (as acetate) 250 µg/0.5 mL solution for injection Theramex Australia Pty Ltd Version 1.0 Page 1 of 9 AUSTRALIAN PRODUCT INFORMATION GANIRELIX THERAMEX (GANIRELIX (AS ACETATE)) 250 ΜG/0.5 ML SOLUTION FOR INJECTION 1 NAME OF THE MEDICINE Ganirelix (as acetate) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION GANIRELIX THERAMEX 250 μg ganirelix (as acetate)/0.5 mL solution for injection GANIRELIX THERAMEX contains the synthetic decapeptide ganirelix (INN) as its acetate salt, with high antagonistic activity to the naturally occurring gonadotropin releasing hormone (GnRH). Each prefilled syringe contains 250 μg ganirelix (as acetate) in 0.5 mL. For the full list of excipients, see Section 6.1 List of excipients 3 PHARMACEUTICAL FORM Solution for injection. GANIRELIX THERAMEX (ganirelix acetate) is presented as a sterile, ready for use, clear and colourless aqueous solution intended for subcutaneous administration. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the prevention of premature luteinisation and ovulation in patients undergoing controlled ovarian stimulation, followed by oocyte pick up and assisted reproductive techniques. 4.2 DOSE AND METHOD OF ADMINISTRATION GANIRELIX THERAMEX should only be prescribed by a specialist experienced in the treatment of fertility. DOSAGE GANIRELIX THERAMEX is used to prevent premature LH surges in patients undergoing Controlled ovarian hyperstimulation (COH). COH with FSH may start at day 2 or 3 of menses. GANIRELIX THERAMEX (0.25 mg) should be injected subcutaneously once daily, starting from day 5 or day 6 of FSH administration depending on the level of ovarian response. GANIRELIX THERAMEX should not be mixed with FSH but both preparations should be administered approximately at the same time. Daily treatment with GANIRELIX THERAMEX should be continued up to the day that sufficient follicles of adequate size are present. Final maturation of follicles can be induced by administering hCG. Because of the half-life of ganirelix, the time betwe Leggi il documento completo