Страна: Новая Зеландия
Язык: английский
Источник: Medsafe (Medicines Safety Authority)
Levonorgestrel 75mg (Micronised)
Bayer New Zealand Limited
Levonorgestrel 75 mg (Micronised)
150 mg
Subcutaneous implant
Active: Levonorgestrel 75mg (Micronised) Excipient: Dow Corning QCF-7-4910 dimethylsiloxane/methylvinylsiloxane external tubing (373-TW) Polysiloxane Adhesive type A
Blister pack, 75mg rods, 2 implants
Prescription
Prescription
Bayer AG
Long-term contraception
Package - Contents - Shelf Life: Blister pack, 75mg rods - 2 implants - 60 months from date of manufacture stored at or below 30°C. Unopened
2003-05-21
JADELLE CMI Vx1.1 1 NEW ZEALAND CONSUMER MEDICINE INFORMATION JADELLE ® _levonorgestrel-releasing implant 75 mg x 2 _ WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start using Jadelle. This leaflet answers some common questions about Jadelle. 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 Jadelle 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 JADELLE IS USED FOR Jadelle is a contraceptive implant, used to prevent pregnancy. Contraceptive implants such as Jadelle are for long term (up to five years) use. The implants contain a synthetic hormone, levonorgestrel, which is also one of the active ingredients used in many oral contraceptives. Immediately after the insertion of Jadelle implants, low doses of the hormone start to be released continuously into your body. Jadelle prevents pregnancy through a combination of mechanisms. The most important of these are inhibition of the egg release by stopping it maturing and changing the cervical mucus consistency, making it more difficult for sperm to reach the egg. Other mechanisms may also be involved. When Jadelle implants are removed, your fertility will resume. Jadelle is inserted just beneath the skin on the inside of your upper arm and is performed by your doctor. Although the implant may be removed at any time, it must be removed no later than five years after insertion. If you weigh over 60 kg, your doctor may recommend that you have the implant removed or have a new implant inserted after the 4 th year. Your doctor may have prescribed Jadelle for another reason. Ask your doctor if you have any questions about why Jadelle has been prescribed for you. BEFORE YOU USE JADELLE _ _ _WHEN YOU MUST NOT USE IT _ JADELLE CMI Vx1.1 2 DO NOT USE JADELLE Прочитать полный документ
JADELLE DS Vx1.1; CCDS 6 Page 1 of 12 NEW ZEALAND DATA SHEET 1 PRODUCT NAME JADELLE® levonorgestrel 2 x 75 mg subcutaneous implants 2 QUALITATIVE AND QUANTITATIVE COMPOSITION JADELLE consists of two implants to be inserted subdermally. Each implant contains 75 mg levonorgestrel. The release rate of levonorgestrel is about 100 microgram/day at one month after insertion, declining to about 40 microgram/day within one year, to about 30 microgram/day within three years and to about 25 microgram/day within five years. For full list of excipients, see List of excipients. 3 PHARMACEUTICAL FORM Subcutaneous implant. The implants are flexible, sealed, white to off-white rods, about 43 mm in length and 2.5 mm in diameter 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Contraception. 4.2 Dose and method of administration _For subcutaneous use. _ JADELLE is a contraceptive method for long-term (up to five years) use (see Special warnings and precautions for use). _Insertion and Removal/Replacement _ The patient must be informed that JADELLE implants may be removed at her request at any time. Before insertion, the woman must be informed of the efficacy, risks, side effects and bleeding pattern changes to be expected with JADELLE. This discussion should include the information that a small proportion of women (17/1100 or 1.5%) experienced adverse effects from the removal of JADELLE including multiple or long incisions, pain, difficult removals and/or additional visits for the removal. Training is required for the insertion and removal procedures, which should preferably be done by a healthcare professional and the given instructions must be followed closely. The implants are inserted with the disposable, sterile Trocar just beneath the skin. Important: the disposable JADELLE Trocar is for single use only. After insertion, the Trocar must be disposed of in an appropriate sharps container. Strict asepsis must be observed here. The implants are inserted in the inner aspect of the upper left arm in right-handed women and in th Прочитать полный документ