Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
somatrogon
Pfizer Europe MA EEIG
H01AC08
somatrogon
PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES
Growth and Development
Indicated for the long-term treatment of paediatric patients with growth disturbance due to insufficient secretion of growth hormone
Revision: 4
Authorised
2022-02-14
28 B. PACKAGE LEAFLET 29 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT NGENLA 24 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN somatrogon 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 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. - This medicine has been prescribed for you or the child in your care only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours or those of the child in your care. - If you or the child in your care 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. WHAT IS IN THIS LEAFLET 1. What Ngenla is and what it is used for 2. What you need to know before you use Ngenla 3. How to use Ngenla 4. Possible side effects 5. How to store Ngenla 6. Contents of the pack and other information 1. WHAT NGENLA IS AND WHAT IT IS USED FOR Ngenla contains the active substance somatrogon, a modified form of human growth hormone. Natural human growth hormone is needed for bones and muscles to grow. It also helps your fat and muscle tissues to develop in the right amounts. Ngenla is used to treat children and adolescents from 3 years of age who do not have enough growth hormone and are not growing at the normal rate. The active substance in Ngenla is made by 'recombinant DNA technology'. This means that it is grown in cells that have been modified in the laboratory so that they can produce it. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE NGENLA DO NOT USE NGENLA - If you or the child in your care are allergic to somatrogon (see Warnings and precautions) or any of the other ingredients of this medicine (l Прочетете целия документ
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 Ngenla 24 mg solution for injection in pre-filled pen Ngenla 60 mg solution for injection in pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ngenla 24 mg solution for injection in pre-filled pen One mL of solution contains 20 mg of somatrogon*. Each pre-filled pen contains 24 mg somatrogon in 1.2 mL solution. Each pre-filled pen delivers doses from 0.2 mg to 12 mg in a single injection in 0.2 mg increments. Ngenla 60 mg solution for injection in pre-filled pen One mL of solution contains 50 mg of somatrogon. Each pre-filled pen contains 60 mg somatrogon in 1.2 mL solution. Each pre-filled pen delivers doses from 0.5 mg to 30 mg in a single injection in 0.5 mg increments. *Produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cells. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection). The solution is a clear and colourless to slightly light yellow solution with a pH of 6.6. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ngenla is indicated for the treatment of children and adolescents from 3 years of age with growth disturbance due to insufficient secretion of growth hormone. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated and monitored by physicians who are qualified and experienced in the diagnosis and management of paediatric patients with growth hormone deficiency (GHD). Posology The recommended dose is 0.66 mg/kg body weight administered once weekly by subcutaneous injection. 3 Each pre-filled pen is capable of setting and delivering the dose prescribed by the physician. Dose may be rounded up or down based on the physician’s expert knowledge of the individual patient Прочетете целия документ