Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
Etonogestrel
PCO Manufacturing Ltd.
G03AC08
Etonogestrel
68 milligram(s)
Implant
Product subject to prescription which may not be renewed (A)
etonogestrel
Authorised
2012-05-04
_ _ _ _ _ _ _ _ _ _ _ _ PACKAGE LEAFLET: INFORMATION FOR THE USER IMPLANON NXT ® 68 MG IMPLANT FOR SUBDERMAL USE etonogestrel READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor, pharmacist or nurse. • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. Your doctor will give you a Patient Alert Card that contains important information you need to be aware of. Store the card in a safe place, and show it to your healthcare professional at any visits related to the use of your implant WHAT IS IN THIS LEAFLET: 1. What Implanon NXT is and what it is used for 2. What you need to know before you use Implanon NXT 3. How to use Implanon NXT 4. Possible side effects 5. How to store Implanon NXT 6. Contents of the pack and other information 7. Information for the healthcare professional 1. WHAT IMPLANON NXT IS AND WHAT IT IS USED FOR Implanon NXT is a contraceptive implant preloaded in a disposable applicator. Safety and efficacy have been established in women between 18 and 40 years of age. The implant is a small, soft, flexible, plastic rod, 4 cm in length and 2 mm in diameter, which contains 68 milligrams of the active substance, etonogestrel. The applicator allows the healthcare professional to insert the implant just under the skin of your upper arm. Etonogestrel is a synthetic female hormone resembling progesterone. A small amount of etonogestrel is continuously released into the bloodstream. The implant itself is made of ethylene vinyl acetate copolymer, a plastic that will not dissolve in the body. It also contains a small amount of barium sulphate which renders it visible under X-ray. IMPLANON NXT IS USED TO PREVENT PREGNANCY HOW DOES IMPLANON NXT WORK The implant is inserted just below the skin. The active compound, etonogestrel, work Lees het volledige document
Health Products Regulatory Authority 06 November 2023 CRN00DWX7 Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Implanon NXT, 68 mg implant for subdermal use 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Implanon NXT is a radiopaque, non-biodegradable, progestagen-only, flexible implant preloaded in a sterile, disposable applicator. Each radiopaque implant contains 68 mg of etonogestrel; the release rate is approximately 60-70 µg/day in week 5-6 and has decreased to approximately 35-45 µg/day at the end of the first year, to approximately 30-40 µg/day at the end of the second year and to approximately 25-30 µg/day at the end of the third year. The applicator is designed to be operated with one hand and to help facilitate correct subdermal insertion of the implant. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Implant for subdermal use _Product imported from Portugal and France_ Non-biodegradable, white to off-white, flexible rod. 4 CLINICAL PARTICULARS As per PA23198/017/001 5 PHARMACOLOGICAL PROPERTIES As per PA23198/017/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Implant _ _ Core: Ethylene vinylacetate copolymer (28% vinyl acetate, 43 mg) barium sulfate (15 mg), magnesium stearate Skin: Ethylene vinylacetate copolymer (14% vinyl acetate, 15 mg) _Product imported from France_ _ _ Ethylene vinylacetate copolymer, barium sulfate, magnesium stearate 6.2 INCOMPATIBILITIES Not applicable 6.3 SHELF LIFE The shelf life expiry date of this product shall be the date shown on the blister pack and outer packaging of the product as marketed in the country of origin. Implanon NXT should not be inserted after the expiry date as indicated on the primary package. Health Products Regulatory Authority 06 November 2023 CRN00DWX7 Page 2 of 2 6.4 SPECIAL PRECAUTIONS FOR STORAGE This medicinal product does not require any special storage conditions. Store in the original blister package. 6.5 NATURE AND CONTENTS OF CONTAINER The pack contains one implant (4 cm in le Lees het volledige document