Country: অস্ট্রেলিয়া
ভাষা: ইংরেজি
সূত্র: Department of Health (Therapeutic Goods Administration)
levonorgestrel, Quantity: 52 mg
Bayer Australia Ltd
Drug delivery system, intrauterine
Excipient Ingredients: dimethylsiloxane/methylvinylsiloxane cross linked elastomer
Intrauterine
1 plus insertion device
(S4) Prescription Only Medicine
Contraception. Treatment of idiopathic menorrhagia. Prevention of endometrial hyperplasia during oestrogen replacement therapy.
Visual Identification: The intrauterine drug delivery system consists of a white or almost white hormone sleeve, mounted on a T-body and covered with opaque tubing.; Container Type: Sachet; Container Material: Other composite material; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2000-07-24
MIRENA ® CMI Vx3.0 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 oestradiol. T সম্পূর্ণ নথি পড়ুন
MIRENA PI Vx3.0, CCDS 25 1 AUSTRALIAN PRODUCT INFORMATION MIRENA ® (LEVONORGESTREL) INTRAUTERINE DRUG DELIVERY SYSTEM 1 NAME OF THE MEDICINE Levonorgestrel 2 QUALITATIVE AND QUANTITATIVE COMPOSITION MIRENA 20 microgram per 24 hours intrauterine delivery system contains 52 mg levonorgestrel, a progestogen, as the active ingredient. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Intrauterine drug delivery system MIRENA intrauterine delivery system (IUS) 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 white T-body has a loop at one end of the vertical stem and two horizontal arms at the other end. Brown removal threads are attached to the loop. The T-body of MIRENA contains barium sulfate, which makes it visible in X-ray examination. The vertical stem of the IUS is loaded in the insertion tube at the tip of the inserter. The IUS and inserter are essentially free of visible impurities. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS MIRENA is indicated for: • Contraception • Treatment of idiopathic menorrhagia • Prevention of endometrial hyperplasia during estrogen replacement therapy. MIRENA PI Vx3.0, CCDS 25 2 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE The _in vivo_ dissolution rate is approximately 20 microgram/24 h and is gradually reduced to approximately 10 microgram/24 h after five years. The mean dissolution rate of levonorgestrel is about 14 microgram/24 h over the time up to five years. Special instructions for insertion are in the package. The insertion technique differs to that for other intrauterine devices. Care must therefore be given to adequate training in the correct insertion technique and the availability of appropriate instruments for the insertion of MIRENA. METHOD OF ADMINISTRATION _Medical Examination _ Before insertion, the woman must be informed of the efficacy, risks and side effects of MIRENA. A physical examination including pelvic examination and e সম্পূর্ণ নথি পড়ুন