Država: Avstralija
Jezik: angleščina
Source: Department of Health (Therapeutic Goods Administration)
estradiol hemihydrate, Quantity: 2.07 mg (Equivalent: estradiol, Qty 2 mg); norethisterone acetate, Quantity: 1 mg
Novo Nordisk Pharmaceuticals Pty Ltd
estradiol hemihydrate,Norethisterone acetate
Tablet, film coated
Excipient Ingredients: lactose monohydrate; maize starch; hyprolose; purified talc; magnesium stearate; hypromellose; triacetin
Oral
28 tablets
(S4) Prescription Only Medicine
Short term symptomatic treatment of postmenopausal oestrogen deficiency (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 profile of Kliogest 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. Kliogest is for use in postmenopausal women with an intact uterus. In perimenopausal women treated with Kliogest the incidence of vaginal bleeding is unacceptably high and therefore therapy should not be initiated sooner than one year after the last menstrual period.
Visual Identification: 28 white tablets, 6 millimetres in diameter engraved 'Novo 281'.; Container Type: Dial Dispenser Pack; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2011-06-17
Kliogest ® Tablets Page 1 of 7 Kliogest cmi-v12 KLIOGEST ® _Estradiol/Norethisterone acetate _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET WHEN YOU MUST NOT USE KLIOGEST ® . 1 WHAT KLIOGEST ® IS USED FOR ............. 1 BEFORE YOU TAKE KLIOGEST ® .............. 1 HOW TO TAKE KLIOGEST ® .................... 4 WHILE YOU ARE TAKING KLIOGEST ® ..... 4 SIDE EFFECTS ....................................... 4 STORAGE ............................................. 6 PRODUCT DESCRIPTION ....................... 6 FURTHER INFORMATION ....................... 6 USER INSTRUCTIONS ............................. 7 This leaflet answers some common questions about Kliogest ® , 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 Kliogest ® 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. Kliogest ® is available only by prescription at pharmacies. WHEN YOU MUST NOT USE KLIOGEST ® DO NOT USE KLIOGEST ® 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 other Preberite celoten dokument
Kliogest-pi-v12 Page 1 of 20 AUSTRALIAN PRODUCT INFORMATION KLIOGEST ® ESTRADIOL 2 MG (AS HEMIHYDRATE) AND NORETHISTERONE ACETATE 1 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 du Preberite celoten dokument