Country: Australia
Bahasa: Inggeris
Sumber: Department of Health (Therapeutic Goods Administration)
Tamoxifen citrate
AstraZeneca Pty Ltd
Medicine Registered
NOLVADEX ® _Tamoxifen citrate_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET In this leaflet, NOLVADEX means Nolvadex or Nolvadex-D tablets. This leaflet answers some of the common questions people ask about NOLVADEX. It does not contain all the information that is known about NOLVADEX. 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 NOLVADEX 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 NOLVADEX IS FOR NOLVADEX is used to treat breast cancer. NOLVADEX blocks the actions of oestrogen. Oestrogen is a natural female sex hormone. In some types of breast cancer, oestrogen can help cancer cells to grow. Your doctor will have explained why you are being treated with NOLVADEX and told you what dose to take. FOLLOW ALL DIRECTIONS GIVEN TO YOU BY YOUR DOCTOR. 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. NOLVADEX is not addictive. BEFORE YOU USE NOLVADEX _WHEN YOU MUST NOT USE IT_ DO NOT USE NOLVADEX IF YOU ARE PREGNANT, TRYING TO BECOME PREGNANT OR ARE BREASTFEEDING. We do not know if it is safe for you to take it while you are pregnant. It may affect your baby if you take it at any time during pregnancy. Your baby may take in NOLVADEX from breast milk if you are breastfeeding. Do not use NOLVADEX if you are allergic to tamoxifen or any of the other ingredients in NOLVADEX. DO NOT GIVE NOLVADEX TO CHILDREN. There is no experience of its use in children. DO NOT TAKE AFTER THE USE BY (EXPIRY) DATE PRINTED ON THE PACK. It may have no effect at all, or worse, an entirely unexpected effect if you take it after the expiry date. DO NOT TAKE NOLVADEX IF THE PACKAGING IS TORN OR SHOWS SIGNS OF TAMPERING. DO NOT U Baca dokumen lengkap
NOLVADEX Product Information ONC.000-313-413.9.0 1(8) NOLVADEX ® tamoxifen PRODUCT INFORMATION NAME OF THE MEDICINE Tamoxifen citrate. C 26 H 29 NO , C 6 H 8 O 7 MW: 563.6 CAS No: _54965-24-1_ DESCRIPTION NOLVADEX (tamoxifen) is the trans-isomer of 1-[4-(2-dimethylaminoethoxy) phenyl]-1,2-diphenyl-1-butene. NOLVADEX (tamoxifen) is a non-steroidal, triphenylethylene-based drug which displays a complex spectrum of oestrogen antagonist and oestrogen agonist-like pharmacological effects in different tissues. In breast cancer patients, at the tumour level, tamoxifen acts primarily as an antioestrogen, preventing oestrogen binding to the oestrogen receptor. PHARMACOLOGY PHARMACOKINETICS _ABSORPTION _ Tamoxifen is absorbed from the gastrointestinal tract. However, the site and extent of absorption is not known. Peak serum levels of 15 to 25 nanogram/mL were observed three to six hours after administration of a single oral dose of 10 mg tamoxifen. Steady state serum levels are achieved after approximately 4 weeks therapy. Mean steady state values after dosing at 20 mg twice daily were 285 ± 19 nanogram/mL and 477 ± 35 nanogram/mL for tamoxifen and N- desmethyltamoxifen respectively. _BIOAVAILABILITY _ No information available. NOLVADEX Product Information ONC.000-313-413.9.0 2(8) _DISTRIBUTION _ Little information is available in humans. It has been found in the uterus and ovary, particularly in the endometrium and corpus luteum. Radioactivity studies in animals show high levels in the liver, lung, ovary and spleen. Low levels have been found in the pituitary, eyes and brain. _PROTEIN BINDING _ The drug appears to be bound to an unknown degree to cytoplasmic protein receptors in all oestrogen target tissues, and is highly protein bound to ser Baca dokumen lengkap