Ország: Ausztrália
Nyelv: angol
Forrás: Department of Health (Therapeutic Goods Administration)
levonorgestrel, Quantity: 19.5 mg
Bayer Australia Ltd
Levonorgestrel
Drug delivery system, intrauterine
Excipient Ingredients: dimethylsiloxane/methylvinylsiloxane cross linked elastomer
Intrauterine
1 x intrauterine drug delivery system
(S4) Prescription Only Medicine
Contraception for up to 5 years
Visual Identification: Intrauterine DDS system consisting of a whitish or pale yellow drug reservoir mounted on the vertical stem of a T-body. A silver ring is attached to the stem. The T-body has a loop at one end & two blue removal threads are attached to the loop.; 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
Licence status A
2017-01-18
KYLEENA ® CMI Vx2.0 1 KYLEENA ® (KAI·LEE·NA) _ _ _levonorgestrel intrauterine delivery system _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Kyleena. 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 Kyleena 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 AND THE CARD DESCRIBING THE DATE OF INSERTION, BATCH NUMBER, AND LATEST DATE OF REMOVAL IN A SAFE PLACE. You may need to read it again. WHAT KYLEENA IS USED FOR Kyleena consists of a small T- shaped frame made from a plastic called polyethylene. This carries 19.5 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 uterus (womb). There are two fine threads, made of blue pigment 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. Kyleena is used for the prevention of pregnancy. It is placed inside the womb where it slowly releases the hormone over a period of five years or until it is removed. The hormone in Kyleena prevents pregnancy by: • controlling the monthly development of the womb lining so that it is not thick enough to support a pregnancy • making the normal mucus in the cervical canal (opening to the womb) thicker, so that the sperm cannot get through to fertilise the egg • there are also local effects on the lining of the womb caused by the presence of the T-shaped frame - since Kyleena is an intrauterine system (IUS) • affecting the movement of sperm inside the wom Olvassa el a teljes dokumentumot
KYLEENA PI Vx2.0, CCDS 6 1 AUSTRALIAN PRODUCT INFORMATION KYLEENA ® (LEVONORGESTREL) INTRAUTERINE DRUG DELIVERY SYSTEM 1 NAME OF THE MEDICINE Levonorgestrel 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Kyleena is an intrauterine delivery system (IUS) that contains 19.5 mg levonorgestrel as the active ingredient. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Intrauterine drug delivery system Kyleena consists of a whitish or pale yellow drug core covered with a semi-opaque membrane, which is mounted on the vertical stem of a T-body. In addition, the vertical stem contains a silver ring located close to the horizontal arms. The white T-body has a loop at one end of the vertical stem and two horizontal arms at the other end. Blue coloured removal threads are attached to the loop. The vertical stem of the IUS is loaded in the insertion tube at the tip of the inserter. The inserter consists of a handle and slider that are integrated with flange, lock, pre-bent insertion tube and plunger. The removal threads are located within the insertion tube and handle. KYLEENA PI Vx2.0, CCDS 6 2 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Contraception for up to 5 years. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE Kyleena is inserted into the uterine cavity and is effective for up to five years. The _in vivo_ release rate is approximately 17.5 µg/24 hours after 24 days and is reduced to approximately 15.3 µg/24 hours after 60 days and to 9.8 µg/24 hours after one year. It then declines progressively to 7.4 µg/24 hours after five years. The average levonorgestrel _in vivo_ release rate is approximately 12.6 µg/24 hours over the first year and 9.0 µg/24 hours over the period of five years. Care must therefore be given to adequate training in the correct insertion technique and the availability of appropriate instruments for the insertion of Kyleena. For further information regarding training providers, please contact Bayer Australia Ltd. METHOD OF ADMINISTRATION _Medical Exami Olvassa el a teljes dokumentumot