Kraj: Australia
Język: angielski
Źródło: Department of Health (Therapeutic Goods Administration)
conjugated estrogens, Quantity: 0.45 mg; bazedoxifene acetate, Quantity: 22.56 mg (Equivalent: bazedoxifene, Qty 20 mg)
Pfizer Australia Pty Ltd
Bazedoxifene acetate,conjugated estrogens
Tablet, modified release
Excipient Ingredients: lactose monohydrate; hypromellose; microcrystalline cellulose; hyprolose; macrogol 400; magnesium stearate; sucrose palmitate; ascorbic acid; powdered cellulose; calcium phosphate; sucrose; propylene glycol; purified water; isopropyl alcohol; iron oxide black; titanium dioxide; iron oxide red; polydextrose; povidone; hyetellose; maltitol solution; poloxamer
Oral
7 Tablets Sample Pack, 28 Tablets
(S4) Prescription Only Medicine
DUAVIVE is indicated for treatment of moderate to severe vasomotor symptoms associated with menopause in women with a uterus.,- DUAVIVE should be used for the shortest duration consistent with treatment goals and risks for the individual woman.,- Experience in women older than 65 years is limited.
Visual Identification: A pink, oval shaped, tablet marked on one side with 0.45/20; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2016-12-15
DUAVIVE ® 0.45/20 _Conjugated estrogens/bazedoxifene_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Duavive. 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 taking DUAVIVE against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT DUAVIVE IS USED FOR This medicine is used for the treatment of symptoms, such as "hot flushes" and sweating, which are associated with menopause in women who still have their uterus (womb). _HOW DUAVIVE WORKS_ This medicine contains two active substances called conjugated estrogens and bazedoxifene. Conjugated estrogens belong to a group of medicines called menopausal hormone therapy (MHT). Bazedoxifene belongs to a group of non-hormonal medicines called selective estrogen receptor modulators (SERMs). Menopause occurs naturally in women, typically between the ages of 45 and 55. During menopause, your body produces less estrogen than it did beforehand. This can cause symptoms such as "hot flushes". ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is not addictive. This medicine is available only with a doctor's prescription. BEFORE YOU TAKE DUAVIVE _WHEN YOU MUST NOT TAKE IT_ DUAVIVE SHOULD ONLY BE TAKEN IF YOU HAVE BEEN FULLY INFORMED OF THE RISKS. The decision to take DUAVIVE should be based on your particular needs and health and made after a careful medical evaluation. TALK REGULARLY WITH YOUR DOCTOR ABOUT WHETHER YOU STILL NEED TREATMENT WITH DUAVIVE. DO NOT TAKE DUAVIVE IF YOU HAVE AN ALLERGY TO: • any medicine containing conjugated estrogens or bazedoxifene • any of the ingredients listed at the end of this l Przeczytaj cały dokument
Version: pfpduavt10619 Supersedes: pfpduavt11216 Page 1 of 25 AUSTRALIAN PRODUCT INFORMATION – DUAVIVE 0.45/20 (CONJUGATED ESTROGENS/BAZEDOXI- FENE) WARNING THE RISK ASSOCIATED WITH DUAVIVE IS UNKNOWN DUE TO THE LACK OF LONG TERM SAFETY DATA (SEE SECTIONS 4.3 CONTRAINDICATIONS, 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE AND 4.8 ADVERSE EFFECTS (UNDESIRABLE EFFECTS), DESCRIPTION OF SELECTED ADVERSE REACTIONS). THE WOMEN’S HEALTH INITIATIVE (WHI) ESTROGEN-ALONE SUBSTUDY REPORTED INCREASED RISKS OF STROKE AND DEEP VEIN THROMBOSIS (DVT) IN POSTMENOPAUSAL WOMEN AGED 50 TO 79 YEARS (MEAN AGE 63.6 YEARS) DURING 7.1 YEARS OF TREATMENT WITH CONJUGATED ESTROGENS (0.625 MG/DAY) ALONE THERAPY RELATIVE TO PLACEBO. ESTROGEN-ALONE THERAPY IS ALSO ASSOCIATED WITH AN INCREASE RISK OF OVARIAN CANCER. 1. NAME OF THE MEDICINE Conjugated estrogens/bazedoxifene. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each DUAVIVE 0.45/20 modified release tablet contains 0.45 mg of conjugated estrogens (CE) and bazedoxifene acetate equivalent to 20 mg of bazedoxifene. EXCIPIENT(S) WITH KNOWN EFFECT Each tablet contains 96.9 mg sucrose (includes 0.7 mg sucrose as sucrose palmitate), 59.8 mg lactose monohydrate and 0.2 mg maltitol solution (a component of Opaglos 2 Clear) (see Section 4.4 Special warnings and precautions for use, Other conditions). For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Modified release tablet. DUAVIVE 0.45 mg/20 mg is a pink, oval shaped, tablet marked on one side with “0.45/20”. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATION DUAVIVE is indicated for treatment of moderate to severe vasomotor symptoms associated with menopause in women with a uterus. • DUAVIVE should be used for the shortest duration consistent with treatment goals and risks for the individual woman. Version: pfpduavt10619 Supersedes: pfpduavt11216 Page 2 of 25 • Experience in women older than 65 years is limited. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE The recommended dose is as a singl Przeczytaj cały dokument