País: Nova Zelanda
Idioma: anglès
Font: Medsafe (Medicines Safety Authority)
Estradiol hemihydrate 0.41mg;
Viatris Limited
25 mcg/24h
Transdermal patch
Active: Estradiol hemihydrate 0.41mg Excipient: Acrylic adhesive Dipropylene glycol Oleyl alcohol Pegoterate Polyolefin Povidone Silicone adhesive
Prescription
Estradiol is indicated for the following: - Oestrogen replacement therapy for the treatment of the symptoms of natural or surgically induced menopause. - Prevention of postmenopausal osteoporosis.
Package - Contents - Shelf Life: Sachet, 25#C1S paper/7.5# LDPE/0.00035?foil/adhesive/2.0 mil PET pouch in cardboard carton - 8 patches - 24 months from date of manufacture stored at or below 25°C. Label states condition as 20°C to 25°C - Sachet, 35# C1S paper/7# LDPE/0.00035" foil/adhesive/1.25 mil Barex film pouch in cardboard carton - 8 patches - 24 months from date of manufacture stored at or below 25°C. Label states condition as 20°C to 25°C
2023-05-16
Page 1 of 7 NEW ZEALAND CONSUMER MEDICINE INFORMATION ESTRADIOL TRANSDERMAL PATCHES (MYLAN) _ESTRADIOL TRANSDERMAL PATCHES 0.025 MG/DAY, 0.05 MG/DAY, 0.075 MG/DAY, _ _0.1 MG/DAY_ WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start using Estradiol Transdermal Patches. This leaflet answers some common questions about Estradiol Transdermal Patches . 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 Estradiol Transdermal Patches against the benefits they expect it will have for you. 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. WHAT ESTRADIOL TRANSDERMAL PATCHES IS USED FOR Estradiol Transdermal Patches are a type of treatment called hormone replacement therapy (HRT). It is a stick-on patch that contains a hormone called Estradiol. Estradiol Transdermal Patches is used for the short-term relief of symptoms of the menopause. HRT is not used for the long-term maintenance of general health or to prevent heart disease or dementia. Estradiol Transdermal Patches is not suitable for birth control and it will not restore fertility Estradiol (also known as oestradiol) is a natural female sex hormone called an oestrogen. It is the same hormone that your ovaries were producing before the menopause. The menopause occurs naturally in the course of a woman's life, usually between the ages of 45 and 55. It may happen sooner if the ovaries are removed by surgery (e.g. total hysterectomy). After menopause, your body produces much less oestrogen than it did before. This can cause unpleasant symptoms such as a feeling of warmth in the face, neck and chest, "hot flushes" (sudden, intense feelings of heat and sweating throughout the body), sleep problems, irritability and depression. Some women also have problems with dryness of the vagina causing discomfort Llegiu el document complet
Page 1 of 13 NEW ZEALAND DATA SHEET ESTRADIOL TRANSDERMAL PATCHES (MYLAN) 1. PRODUCT NAME Estradiol, 0.025 mg/day, 0.05 mg/day, 0.075 mg/day, 0.1 mg/day, Transdermal Patches 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Estradiol Transdermal Patch contains 0.025 mg/day, 0.05 mg/day, 0.075 mg/day, 0.1 mg/day of estradiol (also known as oestradiol). • The 0.025 mg/day is available as a 2.5 cm 2 system containing estradiol, USP hemihydrate equivalent to 0.41 mg of estradiol for nominal delivery of 0.025 mg of estradiol per day. • The 0.05 mg/day is available as a 5.0 cm 2 system containing estradiol, USP hemihydrate equivalent to 0.82 mg of estradiol for nominal delivery of 0.05 mg of estradiol per day. • The 0.075 mg/day is available as a 7.5 cm 2 system containing estradiol, USP hemihydrate equivalent to 1.23 mg of estradiol for nominal delivery of 0.075 mg of estradiol per day. • The 0.1 mg/day is available as a 10.0 cm 2 system containing estradiol, USP hemihydrate equivalent to 1.64 mg of estradiol for nominal delivery of 0.1 mg of estradiol per day. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM 0.025 mg/day – Each rectangular patch with rounded corners consists of an opaque, white to cream adhesive layer, matte film backing randomly printed with ‘Estradiol 0.025 mg/day’ in brown ink, and a clear release liner. The patch is contained in a square, flat, notched, pouch. 0.05 mg/day – Each rectangular patch with rounded corners consists of an opaque, white to cream adhesive layer, matte film backing randomly printed with ‘Estradiol 0.05 mg/day’ in brown ink, and a clear release liner. The patch is contained in a square, flat, notched, pouch. 0.075 mg/day – Each rectangular patch with rounded corners consists of an opaque, white to cream adhesive layer, matte film backing randomly printed with ‘Estradiol 0.075 mg/day’ in brown ink, and a clear release liner. The patch is contained in a square, flat, notched, pouch. 0.1 mg/day – Each rectangular patch with ro Llegiu el document complet