Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Lonapegsomatropin
Ascendis Pharma Endocrinology Division A/S
H01AC09
lonapegsomatropin
Pituitary and hypothalamic hormones and analogues
Growth and Development
Growth failure in children and adolescents aged from 3 years up to 18 years due to insufficient endogenous growth hormone secretion (growth hormone deficiency [GHD]),
Revision: 4
Authorised
2022-01-11
69 B. PACKAGE LEAFLET 70 PACKAGE LEAFLET: INFORMATION FOR THE USER SKYTROFA 3 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IN CARTRIDGE SKYTROFA 3.6 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IN CARTRIDGE SKYTROFA 4.3 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IN CARTRIDGE SKYTROFA 5.2 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IN CARTRIDGE SKYTROFA 6.3 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IN CARTRIDGE SKYTROFA 7.6 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IN CARTRIDGE SKYTROFA 9.1 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IN CARTRIDGE SKYTROFA 11 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IN CARTRIDGE SKYTROFA 13.3 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IN CARTRIDGE lonapegsomatropin This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU OR YOUR CHILD. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Skytrofa is and what it is used for 2. What you or your child need to know before you or your child use Skytrofa 3. How to use Skytrofa 4. Possible side effects 5. How to store Skytrofa 6. Contents of the pack and other information 1. WHAT SKYTROFA IS AND WHAT IT IS USED FOR Skytrofa is a medicine that contains the active substance lonapegsomatropin. This is a substance that the body can convert into somatropin, also called human growth hormone (hGH). Som Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Skytrofa 3 mg powder and solvent for solution for injection in cartridge Skytrofa 3.6 mg powder and solvent for solution for injection in cartridge Skytrofa 4.3 mg powder and solvent for solution for injection in cartridge Skytrofa 5.2 mg powder and solvent for solution for injection in cartridge Skytrofa 6.3 mg powder and solvent for solution for injection in cartridge Skytrofa 7.6 mg powder and solvent for solution for injection in cartridge Skytrofa 9.1 mg powder and solvent for solution for injection in cartridge Skytrofa 11 mg powder and solvent for solution for injection in cartridge Skytrofa 13.3 mg powder and solvent for solution for injection in cartridge 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Skytrofa consists of somatropin transiently conjugated to a methoxypolyethylene glycol carrier (mPEG) via a proprietary TransCon Linker. The strength of Skytrofa always indicates the quantity of the somatropin moiety. Skytrofa 3 mg powder and solvent for solution for injection in cartridge Each dual-chamber cartridge contains 3 mg of somatropin* equivalent to 8.6 mg of lonapegsomatropin and 0.279 mL of solvent. After reconstitution the concentration based on somatropin** protein is 11 mg/mL. Skytrofa 3.6 mg powder and solvent for solution for injection in cartridge Each dual-chamber cartridge contains 3.6 mg of somatropin* equivalent to 10.3 mg of lonapegsomatropin and 0.329 mL of solvent. After reconstitution the concentration based on somatropin** protein is 11 mg/mL. Skytrofa 4.3 mg powder and solvent for solution for injection in cartridge Each dual-chamber cartridge contains 4.3 mg of somatropin* equivalent to 12.3 mg of lonapegsomatropin and 0.388 mL of solvent. After reconst Przeczytaj cały dokument