Pays: Nouvelle-Zélande
Langue: anglais
Source: Medsafe (Medicines Safety Authority)
Levonorgestrel 52mg
Bayer New Zealand Limited
Levonorgestrel 52 mg
52 mg
Intrauterine contraceptive device
Active: Levonorgestrel 52mg
Individual wrap, 1 dose unit
Prescription
Prescription
Bayer AG
Contraception
Package - Contents - Shelf Life: Individual wrap, - 1 dose units - 36 months from date of manufacture stored at or below 30°C
1997-03-11
MIRENA ® CMI Vx4.0 1 MIRENA ® (MI·RAY·NA) _ _ _levonorgestrel intrauterine delivery system _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Mirena. 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 Mirena 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. You may need to read it again. WHAT MIRENA IS USED FOR Mirena consists of a small T- shaped frame made from a plastic called polyethylene. This carries 52 mg levonorgestrel, a hormone used in many contraceptive pills. The hormone is contained within a substance called dimethylsiloxane/methylvinylsil oxane cross linked elastomer and is surrounded by a membrane (skin) also made of the same elastomer. This structure provides a system for releasing the hormone gradually into the womb (uterus). There are two fine threads, made of iron oxide and polyethylene, attached to the bottom of the frame. These allow easy removal and allow you or your doctor to check that the system is in place. Mirena may be used as a long term and reversible method of contraception, for the treatment of excessive menstrual bleeding (menorrhagia) or for protection from endometrial hyperplasia (excessive growth of the lining of the womb) during hormone replacement therapy. It is placed inside the womb where it slowly releases the hormone (at an initial rate of 20 micrograms per 24 hours) over a period of five years or until it is removed. Mirena works in the treatment of excessive monthly bleeding and as protection in estrogen replacement therapy by slowly releasing the progestogen hormone levonorgestrel, within the womb. Levonorgestrel suppresses the response of the cells in the lining of the womb to estrogen making the lining of the womb insensitive to circulating estradiol. Th Lire le document complet
MIRENA Data Sheet Vx4.0, CCDS 25 1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME MIRENA 52 mg intrauterine contraceptive device (release rate: 20 microgram/24 hours) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION MIRENA is an intrauterine system (IUS) containing 52 mg levonorgestrel. For details of release rates, see Section 5.2. For the full list of excipients, see Section 6.1. 3. PHARMACEUTICAL FORM MIRENA consists of a white or almost white drug core covered with an opaque membrane, which is mounted on the vertical stem of a T-body. The vertical stem of the levonorgestrel intrauterine system is loaded in the insertion tube at the tip of the inserter. Inserter components are an insertion tube, plunger, flange, body and slider. The white T-body has a loop at one end of the vertical stem and two horizontal arms at the other end. Brown coloured removal threads are attached to the loop. The T-body of MIRENA contains barium sulfate, which makes it visible in X-ray examination. The IUS and inserter are essentially free from visible impurities. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Contraception Treatment of idiopathic menorrhagia provided there is no underlying pathology. Prevention of endometrial hyperplasia during estrogen replacement therapy MIRENA Data Sheet Vx4.0, CCDS 25 2 4.2 DOSE AND METHOD OF ADMINISTRATION MIRENA is inserted into the uterine cavity. One administration is effective for five years. The _in vivo_ dissolution rate is approximately 20 microgram/24 hours initially and is reduced to approximately 18 microgram/24 hours after 1 year and to 10 microgram/24 hours after five years. The mean dissolution rate of levonorgestrel is about 15 microgram /24 hours over the time up to five years. In women under hormone replacement therapy, MIRENA can be used in combination with oral or transdermal estrogen preparations without progestogens. MIRENA, when inserted according to the insertion instructions, has a failure rate of approximately 0.2% at 1 year and a cumulative failure rate of approximately 0.7 % at Lire le document complet