Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
triptorelin embonate, Quantity: 19.32 mg
Ipsen Pty Ltd
triptorelin embonate
Injection, diluent for
Excipient Ingredients: water for injections
Intramuscular
1
(S4) Prescription Only Medicine
Diphereline is indicated for the treatment of hormone-dependent locally advanced or metastatic prostate cancer.
Visual Identification: ; Container Type: Multiple containers; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2006-08-28
This medicine is subject to additional monitoring in Australia due to approval of an extension of indications. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems DIPHERELINE ® _triptorelin embonate_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you are given DIPHERELINE. This leaflet answers some common questions about DIPHERELINE. 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. Sometimes new risks are found even when a medicine has been used for many years. Your doctor has weighed the risks of you being given DIPHERELINE against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT DIPHERELINE IS USED FOR The name of your medicine is DIPHERELINE. It contains the active ingredient triptorelin embonate. In adult men, DIPHERELINE is used to treat prostate cancer that has spread into surrounding tissue and/or to other parts of the body. It is not a cure for prostate cancer. In children, DIPHERELINE 22.5 mg is used to treat puberty that occurs at a very young age (Precocious Puberty). This is called “early puberty” in the rest of this leaflet. DIPHERELINE belongs to a group of medicines called Gonadotrophin Releasing Hormone agonists (GnRHa). In males, DIPHERELINE works by lowering the production of testosterone . Testosterone is the natural male sex hormone. In some types of prostate cancer, testosterone may help the cancer cells to grow. By lowering testosterone, DIPHERELINE may slow or stop the growth of cancer. In females, DIPHERELINE lowers the levels of the hormone oestrogen. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICI Read the complete document
DIPHERELINE Product Information v4, 1 September 2021 1 This medicinal product is subject to additional monitoring in Australia due to approval of an extension of indications. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems. AUSTRALIAN PRODUCT INFORMATION DIPHERELINE TRIPTORELIN (AS EMBONATE) 3.75 MG, 11.25 MG & 22.5 MG POWDER FOR SUSPENSION 1 NAME OF THE MEDICINE Triptorelin embonate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION DIPHERELINE 3.75MG 1 MONTH FORMULATION Each vial contains a triptorelin content which allows the administration of an effective dose of 3.75 mg triptorelin. After reconstitution in 2 mL of solvent, 1 mL of reconstituted suspension contains 1.875 mg of triptorelin. DIPHERELINE 11.25MG 3 MONTH FORMULATION Each vial contains a triptorelin content which allows the administration of an effective dose of 11.25 mg triptorelin. After reconstitution in 2 mL of solvent, 1 mL of reconstituted suspension contains 5.625 mg of triptorelin. DIPHERELINE 22.5MG 6 MONTH FORMULATION Each vial contains a triptorelin content which allows the administration of an effective dose of 22.5 mg triptorelin. After reconstitution in 2 mL of solvent, 1 mL of reconstituted suspension contains 11.25 mg of triptorelin. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Powder and solvent for suspension for injection, prolonged release granules. White to off-white powder 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Diphereline is indicated for the treatment of hormone-dependent locally advanced or metastatic prostate cancer. ▼ DIPHERELINE Product Information v4, 1 September 2021 2 DIPHERELINE 22.5MG 6 MONTH FORMULATION ONLY: Diphereline 22.5 mg is indicated for the treatment of children 2 years and older with central precocious puberty (CPP). 4.2 DOSE AND METHOD OF ADMINISTRATION DIPHERELINE 3.75MG - 1MONTH FORMULATION The recommended dose of Diphere Read the complete document