Valsts: Austrālija
Valoda: angļu
Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)
estradiol hemihydrate, Quantity: 1.03 mg (Equivalent: estradiol, Qty 1 mg); norethisterone acetate, Quantity: 0.5 mg
Novo Nordisk Pharmaceuticals Pty Ltd
Tablet, film coated
Excipient Ingredients: maize starch; copovidone; lactose monohydrate; purified talc; hypromellose; triacetin; magnesium stearate
Oral
28 tablets
(S4) Prescription Only Medicine
Short term treatment of menopausal symptoms related to oestrogen deficiency in women more than one year after menopause (see DOSAGE AND ADMINISTRATION and CLINICAL TRIALS). For the prevention of postmenopausal bone mineral density loss. When prescribed solely for the prevention of postmenopausal bone mineral density loss, therapy should only be prescribed for women who are at high risk of osteoporosis and future fracture and who are intolerant of, or contraindicated for, non-oestrogen products approved for prevention of osteoporosis. Life style modifications and the risk benefit profiles of Kliovance should be taken into careful consideration and discussed with the patient, to allow the patient to make an informed decision prior to prescribing. See PRECAUTIONS and DOSAGE AND ADMINISTRATION.
Visual Identification: White, round, film-coated tablets 6mm in diameter. Tablets are engraved with NOVO 288 on one side and the Novo Nordisk logo on the other.; Container Type: Dial Dispenser Pack; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
1999-08-30
Kliovance ® Page 1 of 7 Kliovance cmi-v10 KLIOVANCE ® _Estradiol/Norethisterone acetate _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET WHEN YOU MUST NOT USE KLIOVANCE ® 1 WHAT KLIOVANCE ® IS USED FOR ........... 1 BEFORE YOU TAKE KLIOVANCE ® ............ 1 HOW TO TAKE KLIOVANCE ® .................. 4 WHILE YOU ARE TAKING KLIOVANCE ® ... 4 SIDE EFFECTS ........................................ 4 STORAGE .............................................. 6 PRODUCT DESCRIPTION ........................ 6 FURTHER INFORMATION ........................ 6 USER INSTRUCTIONS .............................. 7 This leaflet answers some common questions about Kliovance ® , the menopause (the ‘change of life’), and hormone therapy. 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. Your doctor has weighed the risks of you using Kliovance ® against the benefits they expect it will have for you. ASK YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. Kliovance ® is available only by prescription at pharmacies. WHEN YOU MUST NOT USE KLIOVANCE ® Do not use Kliovance ® or other estrogens, with or without a progestagen, to prevent heart attacks, stroke or dementia. A study called the Women’s Health Initiative indicated increased risk of heart attack, stroke, breast cancer, and blood clots in the legs or lungs in women receiving treatment with a product containing conjugated estrogens 0.625 mg and the progestagen medroxyprogesterone acetate (MPA). The researchers stopped the study after 5 years when it was determined the risks were greater than the benefits in this group. The Women’s Health Initiative Memory Study indicated increased risk of dementia in women aged 65-79 years taking conjugated estrogens and MPA. There are no comparable data currently available for other doses of conjugated estrogens and MPA or othe Izlasiet visu dokumentu
Kliovance pi-v12 Page 1 of 23 AUSTRALIAN PRODUCT INFORMATION KLIOVANCE ® ESTRADIOL 1 MG (AS HEMIHYDRATE) AND NORETHISTERONE ACETATE 0.5 MG TABLET DIAL DISPENSER PACK WARNING Estrogens and progestagens should not be used for the prevention of cardiovascular disease or dementia. The Women’s Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5 years of treatment with conjugated estrogens (0.625 mg) combined with medroxyprogesterone acetate (2.5 mg) relative to placebo (see ‘Section 5.1 Pharmacodynamic Properties’ - ‘Clinical trials’ and ‘Section 4.4 Special Warnings and Precautions for Use’). The WHI study reported increased risks of stroke and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 6.8 years of treatment with conjugated estrogens (0.625 mg) relative to placebo (see ‘Section 5.1 Pharmacodynamic Properties’ - ‘Clinical trials’ and ‘Section 4.4 Special Warnings and Precautions for Use’). The Women’s Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 to 5.2 years of treatment with conjugated estrogens, with or without medroxyprogesterone acetate, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women (see ‘Section 5.1 Pharmacodynamic Properties’ - ‘Clinical trials’ and ‘Section 4.4 Special Warnings and Precautions for Use’). Other doses of conjugated estrogens and medroxyprogesterone acetate, and other combinations and dosage forms of estrogens and progestagens were not studied in the WHI clinical trials and, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, estrogens with or without progestagens should be prescribed at the lowest effective doses and for the shortest durat Izlasiet visu dokumentu