Nazione: Nuova Zelanda
Lingua: inglese
Fonte: Medsafe (Medicines Safety Authority)
Estradiol hemihydrate 1.17mg equivalent to 75 µg per 24 hours
Sandoz New Zealand Limited
Estradiol hemihydrate 1.17 mg (equivalent to 75 µg per 24 hours)
75 mcg/24h
Transdermal patch
Active: Estradiol hemihydrate 1.17mg equivalent to 75 µg per 24 hours Excipient: Acrylic adhesive Dipropylene glycol Oleyl alcohol Povidone Silicone adhesive
Sachet, aluminium foil, laminate;, 2 patches
Prescription
Prescription
Aspen Oss B.V
The Estradot regimen is indicated for the following: - Oestrogen replacement therapy for the treatment of the symptoms of natural or surgically induced menopause. - Prevention of postmenopausal osteoporosis (see Dosage and Administration and Warnings and Precautions).
Package - Contents - Shelf Life: Sachet, aluminium foil, laminate; - 2 patches - 24 months from date of manufacture stored at or below 25°C protect from light - Sachet, aluminium foil, laminate; - 8 patches - 24 months from date of manufacture stored at or below 25°C protect from light - Sachet, aluminium foil, laminate; - 24 patches - 24 months from date of manufacture stored at or below 25°C protect from light
2001-09-06
__________________________________________________________________________________________________ Estradot® 1 ESTRADOT ® _oestradiol_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about the menopause ("change of life"), hormone replacement therapy and Estradot. 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.MEDSAFE.GOVT.NZ. 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 Estradot against the benefits they expect it will provide. IF YOU HAVE ANY CONCERNS ABOUT USING 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 ESTRADOT DO NOT USE ESTRADOT OR OTHER OESTROGENS, 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 oestrogens 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 oestrogens and MPA. There are no comparable data currently available for other doses of conjugated oestrogens and MPA or other combinations of oestrogens and progestogens. The Leggi il documento completo
1 NEW ZEALAND DATA SHEET 1 PRODUCT NAME ESTRADOT® (oestradiol) 25, 37.5, 50, 75 & 100 mcg/24* hrs Transdermal Patches 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 2.1.1.1.1 Active moiety Oestradiol 2.1.1.1.2 Active substance(s) Estradot is available in three sizes: • 2.5 cm2 patch containing 0.39 mg oestradiol (as hemihydrate) with a nominal in vivo release rate of 25 micrograms oestradiol per day. • 5 cm2 patch containing 0.78 mg oestradiol (as hemihydrate) with a nominal in vivo release rate of 50 micrograms oestradiol per day. • 7.5 cm2 patch containing 1.17 mg estradiol hemihydrate with a nominal in vivo release rate of 75 micrograms estradiol per day. • 10 cm2 patch containing 1.56 mg oestradiol (as hemihydrate) with a nominal in vivo release rate 100 micrograms oestradiol per day. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Transdermal patch. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The Estradot regimen is indicated for the following: • Oestrogen replacement therapy for the treatment of the symptoms of natural or surgically induced menopause. • Prevention of postmenopausal osteoporosis (see Dosage and Administration and Warnings and Precautions). In women with an intact uterus, oestrogens should always be supplemented by administration of a progestogen. 2 4.2 DOSAGE AND METHOD OF ADMINISTRATION 4.2.1.1.1 Adults and geriatric patients Hormone replacement therapy (HRT) involving either oestrogen-only or oestrogen-progestogen combined therapy should only be continued as long as the benefits outweigh the risks for the individual. Estradot should be applied every 3 to 4 days (i.e. twice weekly). 4.2.1.1.2 Climacteric symptoms Treatment should be initiated with the lowest dose. Depending on the clinical response the dose should be adjusted to the woman’s individual needs. If, after three months, there is an insufficient response in the form of alleviated symptoms, the dose should be increased. If symptoms of overdose arise (e.g. tender breasts) the dose must be d Leggi il documento completo