国家: 新西兰
语言: 英文
来源: Medsafe (Medicines Safety Authority)
Ethinylestradiol 30ug; Levonorgestrel 150ug
Bayer New Zealand Limited
Ethinylestradiol 30 µg
Tablet
Active: Ethinylestradiol 30ug Levonorgestrel 150ug Excipient: Calcium carbonate Glycerol Glycol montanate Iron oxide yellow Lactose monohydrate Macrogol 6000 Magnesium stearate Maize starch Povidone Purified talc Sucrose Titanium dioxide Calcium carbonate Glycol montanate Lactose monohydrate Macrogol 6000 Magnesium stearate Maize starch Povidone Purified talc Sucrose
Blister pack, 1 x 28 physician sample, 28 tablets
Prescription
Prescription
Bayer AG
Oral contraception.
Package - Contents - Shelf Life: Blister pack, 1 x 28 physician sample - 28 tablets - 60 months from date of manufacture stored at or below 25°C - Blister pack, 3 x 28 - 84 tablets - 60 months from date of manufacture stored at or below 25°C
1997-02-25
NZ LEVLEN ED CMI VX1.0 1 LEVLEN ® ED (LEV ⋅ LEN EE ⋅ DEE) Contraceptive tablets for women _ethinylestradiol and levonorgestrel_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Levlen ED. 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 Levlen ED 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 LEVLEN ED IS USED FOR Levlen ED is a combined oral contraceptive, commonly known as a ‘birth control pill’ or ‘the Pill’. Levlen ED is used to prevent pregnancy. 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. Some conditions such as pelvic inflammatory disease, ovarian cysts, ectopic pregnancy (where the foetus is carried outside of your womb), lumpy breasts, acne and cancer of the uterus (womb) and ovaries may be less common in women taking the Pill. When taken correctly, Levlen ED prevents you from becoming pregnant in several ways, including: • inhibiting ovulation (egg release) • changing the cervical mucus consistency, making it more difficult for the sperm to reach the egg • changing the lining of the uterus, making it less suitable for implantation. When the Pill is taken by women under close observation in clinical trials, it is more than 99% effective in preventing pregnancy. However, in real life the Pill is around 92% effective. This is because pills might have been missed, may have been taken with medicines that interfere with their effectiveness, or may not be absorbed due to vomiting or diarrhoea. Like all oral contraceptives, Levlen ED is intended to preven 阅读完整的文件
LEVLEN DS VX1.0 1 DATA SHEET 1. LEVLEN® ED Levlen ED 30 micrograms ethinylestradiol and 150 micrograms levonorgestrel tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One active tablet contains 30 micrograms ethinylestradiol and 150 micrograms levonorgestrel. Each blister pack contains 21 active tablets and 7 hormone-free tablets. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Sugar-coated tablets The active tablets are beige, biconvex, round and 5.7mm in diameter. The hormone-free tablets are white, biconvex, round and 6.8mm in diameter. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Oral contraception. 4.2. DOSE AND METHOD OF ADMINISTRATION Combined oral contraceptives (COCs), such as Levlen ED, when taken correctly, have a failure rate of approximately 1% per year. The failure rate may increase when pills are missed or taken incorrectly. _HOW TO TAKE LEVLEN ED _ Tablets must be taken in the order directed on the package every day at about the same time with some water as needed. Tablet-taking is continuous following the directional arrows. One tablet is to be 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 hormone-free tablets and may not have finished before the next pack is started. _HOW TO START LEVLEN ED _ START WITH THE FIRST TABLET FROM THE GREEN SECTION MARKED WITH THAT DAY OF THE WEEK, in accordance with one of the following: 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). Starting on days 2 - 5 of the menstrual cycle is allowed, but during the LEVLEN DS VX1.0 2 first cycle an additional barrier contraceptive method is recommended for the first 7 days of tablet-taking._ _ Changing from another combined oral contraceptive (COC), vaginal ring or transdermal patch The woman should start with Levlen ED 阅读完整的文件