দেশ: নিউ জিলণ্ড
ভাষা: ইংরেজি
সূত্র: Medsafe (Medicines Safety Authority)
Drospirenone 3mg (micro 15); Ethinylestradiol betadex clathrate 0.02mg (ethinylestradiol betadex clathrade amount equivalent ethinylestradiol 0.02mg)
Bayer New Zealand Limited
Drospirenone 3 mg (micro 15)
3mg/0.02mg
Tablet
Active: Drospirenone 3mg (micro 15) Ethinylestradiol betadex clathrate 0.02mg (ethinylestradiol betadex clathrade amount equivalent ethinylestradiol 0.02mg) Excipient: Lactose monohydrate Magnesium stearate Maize starch Opadry pink 02A34744 Hypromellose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Purified talc Titanium dioxide Hypromellose Lactose monohydrate Magnesium stearate Maize starch Povidone Purified talc Titanium dioxide
Blister pack, PVC/aluminium (starter pack), 28 tablets
Prescription
Prescription
Bayer AG
YAZ is indicated for use as: - an oral contraceptive. - treatment of moderate acne vulgaris in women who seek oral contraception. - treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who have chosen oral contraceptives as their method of birth control. The efficacy of YAZ for PMDD was not assessed beyond 3 cycles. YAZ has not been evaluated for treatment of PMS (premenstrual syndrome).
Package - Contents - Shelf Life: Blister pack, PVC/aluminium (starter pack) - 28 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC/aluminium - 84 tablets - 36 months from date of manufacture stored at or below 30°C
2008-02-22
Yaz CMI VX1.0 1 YAZ ® Contraceptive tablets for women _drospirenone and ethinylestradiol (as betadex clathrate) _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about YAZ. 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 YAZ against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS, OR ARE UNSURE ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST FOR MORE ADVICE. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT YAZ IS USED FOR YAZ is a combined oral contraceptive, commonly known as a ‘birth control pill’ or ‘the Pill’. YAZ is used to prevent pregnancy. It is also used to treat moderate acne and symptoms of premenstrual dysphoric disorder (PMDD) in women seeking oral contraception. You may also experience the following benefits: • more regular and lighter periods – potentially resulting in a decrease in anaemia (iron deficiency) • a decrease in period pain • improvement in symptoms like bloating, swelling or weight gain related to fluid retention Some conditions such as pelvic inflammatory disease, ovarian cysts, ectopic pregnancy (where the foetus is carried outside of your womb), lumpy breasts and cancer of the uterus (womb), and ovaries may be less common in women taking the Pill. When taken correctly, it prevents you from becoming pregnant in several ways, including: • inhibiting the egg release by stopping it maturing • changing the cervical mucus consistency, making it more difficult for the sperm to reach the egg. YAZ has 24 active (hormone) tablets and 4 inactive tablets, rather than the traditional 21 active tablets and 7 inactive tablets. This means that with YAZ, you take the active (hormone) tablets for three more days. This helps your hormone levels to stay even. When the Pill is taken by women under close observation in clin সম্পূর্ণ নথি পড়ুন
YAZ DS VX1.0 1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME YAZ ® 20 micrograms / 3 mg film coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each active light pink tablet contains: Ethinylestradiol (as betadex clathrate) 20 micrograms Drospirenone 3 mg For full list of excipients, see section _6.1 List of excipients_. 3. PHARMACEUTICAL FORM YAZ ACTIVE TABLET Light pink round film-coated tablets marked on one side with the letters "DS" in a regular hexagon, each containing drospirenone 3 mg and ethinylestradiol 20 µg. YAZ PLACEBO TABLET White round film-coated tablets marked on one side with the letters "DP" in a regular hexagon. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS YAZ is indicated for use as: • an oral contraceptive. • treatment of moderate acne vulgaris in women who seek oral contraception. • treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who have chosen oral contraceptives as their method of birth control. The efficacy of YAZ for PMDD was not assessed beyond 3 cycles. YAZ has not been evaluated for treatment of PMS (premenstrual syndrome). See _5.1 Pharmacodynamic properties_. 4.2 DOSE AND METHOD OF ADMINISTRATION Combined oral contraceptives, when taken correctly, have a failure rate of approximately 1% per year. The failure rate may increase when pills are missed or taken incorrectly. Tablets must be taken in the order directed on the package every day at about the same time with some liquid as needed. Tablet-taking is continuous. One tablet is taken daily for 28 consecutive days. Each subsequent pack is started the day after the last tablet of the previous pack. Withdrawal bleeding usually starts on Day 2 - 3 after starting the white placebo tablets and may not have finished before the next pack is started. YAZ DS VX1.0 2 HOW TO START YAZ • NO PRECEDING HORMONAL CONTRACEPTIVE USE (IN THE PAST MONTH) Tablet-taking has to start on Day 1 of the woman’s natural cycle (i.e. the first day of her menstrual bleeding). The woman should be instructed to take a সম্পূর্ণ নথি পড়ুন