Land: Australien
Språk: engelska
Källa: Department of Health (Therapeutic Goods Administration)
norethisterone acetate, Quantity: 2.7 mg (Equivalent: estradiol, Qty 50 microgram; Equivalent: norethisterone acetate, Qty 140 microgram); estradiol, Quantity: 0.62 mg (Equivalent: estradiol, Qty 50 microgram)
Sandoz Pty Ltd
Drug delivery system, transdermal
Excipient Ingredients: oleic acid; dipropylene glycol; povidone; polytrimethylhydrosilylsiloxane; xylene; ammonia; toluene; 1,1,1-trimethyl-N-(trimethylsilyl)silanamine; dimeticonol; polyethylene terephthalate; polyvinylidene flouride; ethyl acetate; ethanol; acrylates/VA copolymer; ethylene/vinyl acetate copolymer
Transdermal
2 patches sample pack, 8 patches
(S4) Prescription Only Medicine
For the short-term treatment of symptoms of oestrogen deficiency in menopausal women who have an intact uterus. For prevention of postmenopausal bone mineral density loss in women with an increased risk of future osteoporotic fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of 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 future fracture and who are intolerant of, or contraindicated for non-oestrogen products approved for prevention of bone mineral density loss. Lifestyle modifications and the risk-benefit profile of Estalis Continous should be taken into careful consideration and discussed with the patient to allow the patient to make an informed decision prior to prescribing. Combination HRT should not be used in hysterectomised women because it is not needed in these women and it may increase the risk of breast cancer.
Visual Identification: An off-white translucent patch with a removable pre-cut liner: 9cm2 round patch.; Container Type: Sachet; Container Life Time: 30 Months; Container Temperature: Store at 2 to 8 degrees Celsius
Licence status A
1999-10-11
ESTALIS ® CONTINUOUS _estradiol / norethisterone acetate (NETA)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about the menopause (the "change of life"), hormone replacement therapy and Estalis Continuous. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available. YOU SHOULD ENSURE THAT YOU SPEAK TO YOUR PHARMACIST OR DOCTOR TO OBTAIN THE MOST UP-TO-DATE INFORMATION ON THE MEDICINE. YOU CAN ALSO DOWNLOAD THE MOST UP-TO- DATE LEAFLET FROM WWW.NOVARTIS.COM.AU. Those updates may contain important information about the medicine and its use of which you should be aware. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will provide. IF YOU HAVE ANY CONCERNS ABOUT THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHEN YOU MUST NOT USE ESTALIS CONTINUOUS DO NOT USE ESTALIS CONTINUOUS OR OTHER ESTROGENS, WITH OR WITHOUT A PROGESTOGEN 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 progestogen 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 combinations of estrogens and progestogens. Therefore, you should assume the risks will be si Läs hela dokumentet
1 AUSTRALIAN PRODUCT INFORMATION ESTALIS® CONTINUOUS (ESTRADIOL/NORETHISTERONE ACETATE) WARNING Estrogens and progestogens 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 progestogens were not studied in the WHI Section 5.1 PHARMACODYNAMIC PROPERTIES 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 progestogens should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman. 1 NAME OF THE MEDICINE Estr Läs hela dokumentet