País: Austrália
Língua: inglês
Origem: Department of Health (Therapeutic Goods Administration)
goserelin, Quantity: 10.8 mg
AstraZeneca Pty Ltd
Implant
Excipient Ingredients: polyglactin
Subcutaneous
1 syringe
(S4) Prescription Only Medicine
Prostate Cancer: Palliative treatment of metastatic or locally advanced prostate cancer , where suitable for hormonal manipulation. Adjuvant and neo-adjuvant therapy in combination with radiotherapy for the management of locally advanced prostate cancer in men suitable for hormonal manipulation.
Visual Identification: White to cream coloured cylindrical pieces of rigid polymeric material which are free or practically free from visible impurities.; Container Type: Syringe; Container Material: Plastic; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
1996-05-22
ZOLADEX ® 10.8MG IMPLANT SAFESYSTEM™ _Goserelin acetate_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions people ask about ZOLADEX 10.8mg implant. It does not contain all the information that is known about ZOLADEX 10.8mg. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor will have weighed the risks of you taking ZOLADEX 10.8mg against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT ZOLADEX IS FOR ZOLADEX can treat prostate cancer in some men. It is not a cure for prostate cancer. ZOLADEX lowers the amount of sex hormones in the body. In men it reduces the level of testosterone. Your doctor will have explained why you are being treated with ZOLADEX 10.8mg and told you what dose you will be given. FOLLOW ALL DIRECTIONS GIVEN TO YOU BY YOUR DOCTOR CAREFULLY. They may differ from the information contained in this leaflet. Your doctor may prescribe this medicine for another use. Ask your doctor if you want more information. ZOLADEX 10.8mg is not addictive. BEFORE YOU ARE GIVEN ZOLADEX 10.8MG _WHEN YOU MUST NOT BE GIVEN_ _IT_ ZOLADEX 10.8MG WILL NOT NORMALLY BE USED IN FEMALES. There is not enough evidence to support its use in women. ZOLADEX 10.8MG WILL NOT BE GIVEN TO CHILDREN. There is no information on its use in children. IT WILL NOT BE USED AFTER THE USE BY (EXPIRY) DATE PRINTED ON THE PACK. It may have no effect at all, or worse, an entirely unexpected effect if it is used it after the expiry date. ZOLADEX 10.8MG WILL NOT BE USED IF THE PACKAGING IS TORN OR SHOWS SIGNS OF TAMPERING. _BEFORE YOU START TO USE IT_ YOU MUST TELL YOUR DOCTOR IF: • you have allergies to any ingredients listed at the end of this leaflet or any other substances If you have an allergic reaction, you may get a rash, hay fever, difficulty breathing or feel fa Leia o documento completo
ZOLADEX 10.8 mg IMPLANT Product Information Doc ID-002714194 v11.0 1(11) ZOLADEX 10.8 MG IMPLANT goserelin PRODUCT INFORMATION NAME OF THE MEDICINE Goserelin acetate. It is a Gonadotrophin Releasing Hormone Agonist (GnRH Agonist) - [also known as Luteinising Hormone Releasing Hormone Agonist (LHRH Agonist)]. CHEMICAL STRUCTURE: Structural Formula: N H N H N H N H N H N H N H O H N H N H 2 N H N H O N H O H N N H N H N H 2 O O O O O O O O O O N N H O t B u Goserelin acetate HOAc CAS Registry Number: 65807-02-5 (Goserelin base) Molecular Formula: C 59 H 84 N 18 O 14 (base) Molecular Weight: 1269 (base) DESCRIPTION ZOLADEX 10.8 mg SafeSystem™ Implant contains goserelin acetate in an amount equivalent to 10.8 mg of goserelin base. A sterile white to cream coloured cylindrical sustained release implant in which goserelin acetate is dispersed in a polyglactin co-polymer biodegradable matrix. The implant is supplied in a single dose syringe applicator. The SafeSystem™ incorporates a protective needle sleeve that automatically locks in place following administration of the implant to aid in the prevention of needle stick injury. ZOLADEX 10.8 mg IMPLANT Product Information Doc ID-002714194 v11.0 2(11) PHARMACOLOGY Goserelin acetate is a potent synthetic decapeptide analogue of luteinising hormone releasing hormone (LHRH). When given acutely, goserelin acetate will release luteinising hormone (LH) from the pituitary gland. However, following chronic administration, goserelin acetate is a potent inhibitor of gonadotrophin production resulting in gonadal suppression and consequently sex organ regression. In animals and humans, following an initial stimulation of pituitary LH secretion and a transient elevation in serum testosterone, chronic administration results in inhibition of gonadotrophin secretion. The result is a sustained suppression of pituitary LH occurring within approximately 3 weeks after initiation of therapy, and a reduction in serum testosterone levels in males to a range normally seen in surgically castr Leia o documento completo