Pays: Nouvelle-Zélande
Langue: anglais
Source: Medsafe (Medicines Safety Authority)
Conjugated estrogens 0.625mg; ; Conjugated estrogens 0.625mg (Includes 3% overage); Conjugated estrogens 0.625mg
Pfizer New Zealand Limited
Conjugated estrogens 0.625 mg
0.625 mg
Tablet
Active: Conjugated estrogens 0.625mg Excipient: Calcium sulfate Carnauba wax Glyceryl mono-oleate Lactose monohydrate Macrogol 20000 Magnesium stearate Methylcellulose Microcrystalline cellulose Opaglos clear 98Z19173 Shellac Stearic acid Sucrose Titanium dioxide Urethane dimethacrylate luting resin Active: Conjugated estrogens 0.625mg (Includes 3% overage) Excipient: Calcium sulfate Carnauba wax Glyceryl mono-oleate Lactose monohydrate Macrogol 20000 Magnesium stearate Methylcellulose Microcrystalline cellulose Opacode Opalux maroon AS-3910 Shellac Stearic acid Sucrose Titanium dioxide Active: Conjugated estrogens 0.625mg Excipient: Carnauba wax Hyprolose Hypromellose Lactose monohydrate Macrogol 400 Magnesium stearate Microcrystalline cellulose Opacode white NS-78-18011 Opadry Maroon 03B16083 Sucrose
Blister pack, 1 x 14, 14 tablets
Prescription
Prescription
Pfizer Global Manufacturing
Package - Contents - Shelf Life: Blister pack, - 14 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, - 28 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, 2 x 28 - 56 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, 3 x 28 - 84 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, 4 x 28 - 112 tablets - 24 months from date of manufacture stored at or below 25°C
1969-12-31
PREMARIN 1 PREMARIN ® _Conjugated estrogens Tablets_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions about PREMARIN Tablets. It does not contain all of 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 PREMARIN against the benefits this medicine is expected to have for you. 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. WHAT PREMARIN IS USED FOR PREMARIN is a type of treatment called hormone replacement therapy (HRT) and contains the hormone estrogen in the form known as conjugated estrogens. PREMARIN helps to relieve the discomfort many women feel during and after menopause, including symptoms such as "hot flushes", sweating and vaginal dryness. It helps to prevent thinning of the bones (osteoporosis), which can cause fractures. PREMARIN is also used to treat women where either the ovary does not function properly or has been removed. If your doctor thinks you will need to take estrogens for a long time, including for the prevention of osteoporosis, he or she will have considered the benefits and risks of other treatments before prescribing PREMARIN for you. _HOW IT WORKS_ 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". Some women also have problems with dryness of the vagina causing discomfort during or after sexual intercourse. Some women develop osteoporosis during or after menopause. This is a thinning of the bones making them weaker and more likely to break, especially the bones of the spine, hip and wrist. Conjugated estrogens are like the hormones produced by the ovaries before menopause. When given during or after menopause, they can help control the symptoms. estrogen is u Lire le document complet
Version: pfdpremt10119 Supersedes: pfdpremt10716 Page 1 of 18 NEW ZEALAND DATA SHEET 1. PRODUCT NAME Premarin ® 0.3 mg, 0.625 mg tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Premarin tablet contains 0.3 mg or 0.625 mg conjugated estrogens. Conjugated estrogens (CE) is a mixture of natural estrogens (of equine origin) composed principally of the sodium salts of water soluble sulfate esters of estrone, equilin, and 17 alpha-dihydroequilin, together with smaller amounts of 17 alpha-estradiol, equilenin, and 17 alpha-dihydroequilenin, 17 beta-dihydroequilin, 17 beta-dihydroequilenin, 17 beta-estradiol and delta 8, 9-dihydroestrone. EXCIPIENT(S) WITH KNOWN EFFECT Each Premarin 0.3 mg tablet contains 61.7 mg lactose monohydrate and 45 mgsucrose. Each Premarin 0.625 tablet contains 54.1 mg lactose monohydrate and 45 mg sucrose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Premarin 0.3 mg tablet is dark green, oval biconvex sugar-coated and marked with “0.3 ” in white ink. Premarin 0.625 tablet is maroon, oval biconvex sugar-coated and marked with “ 0.625 ” in white ink. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 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. Premarin is indicated: AS REPLACEMENT THERAPY FOR ESTROGEN DEFICIENCY STATES ASSOCIATED WITH CLIMACTERIC MANIFESTED BY: • moderate to severe vasomotor symptoms associated with the estrogen deficiency in natural and surgical menopause (sweating, hot flushes). Version: pfdpremt10119 Supersedes: pfdpremt10716 Page 2 of 18 • atrophic vaginitis due to menopause. When prescribing solely for the treatment of symptoms of vaginal atrophy, topical vaginal products should be considered. There is no evidence that estrogens are effective for anxiety or depression without associated vasomotor symptoms, and they should not be used to treat such conditions. FOR THE PREVENTI Lire le document complet