Држава: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
Somatropin
Novo Nordisk A/S
H01AC; H01AC01
Somatropin
10mg/1.5ml
Solution for injection in cartridge
Product subject to prescription which may not be renewed (A)
Somatropin and somatropin agonists; somatropin
Not marketed
1999-10-15
8 PACKAGE LEAFLET: INFORMATION FOR THE USER NORDITROPIN SIMPLEXX 10 MG/1.5 ML SOLUTION FOR INJECTION IN CARTRIDGE somatropin 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 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 NORDITROPIN SIMPLEXX IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USE NORDITROPIN SIMPLEXX 3. HOW TO USE NORDITROPIN SIMPLEXX 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE NORDITROPIN SIMPLEXX 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT NORDITROPIN SIMPLEXX IS AND WHAT IT IS USED FOR Norditropin SimpleXx contains a biosynthetic human growth hormone called somatropin which is identical to the growth hormone produced naturally in the body. Children need growth hormone to help them grow, but adults also need it for their general health. Norditropin SimpleXx comes as a solution in a cartridge ready for you to inject after you have put it in the matching NordiPen injection pen. NORDITROPIN SIMPLEXX IS USED TO TREAT GROWTH FAILURE IN CHILDREN: • If they have no or very low production of growth hormone (growth hormone deficiency) • If they have Turner syndrome (a genetic problem which may affect growth) • If they have reduced kidney function • If they are short and were born small for gestational age (SGA) • If they have Noonan syndrome (a genetic problem which may affect growth). NORDITROPIN SIMPLEXX IS USED AS A GROWTH HORMONE REPLACEMENT IN ADULTS: In adults Norditropin SimpleXx is used to replace growth hormone if their growth hormone production has been decreased since childhood or has been l Прочитајте комплетан документ
Health Products Regulatory Authority 14 December 2022 CRN00CXMJ Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Norditropin SimpleXx 10 mg/1.5 ml, solution for injection in cartridge 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Norditropin SimpleXx 10 mg/1.5 ml One ml of solution contains 6.7 mg somatropin Somatropin (recombinant DNA origin produced in E-coli) 1 mg of somatropin corresponds to 3 IU (International Unit) of somatropin For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection in cartridge Clear, colourless solution 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Children: Growth failure due to growth hormone deficiency (GHD) Growth failure in girls due to gonadal dysgenesis (Turner syndrome) Growth retardation in prepubertal children due to chronic renal disease Growth disturbance (current height SDS < -2.5 and parental adjusted height SDS < -1) in short children born small for gestational age (SGA), with a birth weight and/or length below -2 SD, who failed to show catch-up growth (HV SDS < 0 during the last year) by 4 years of age or later. Growth failure due to Noonan syndrome. Adults: Childhood onset growth hormone deficiency: Patients with childhood onset GHD should be re-evaluated for growth hormone secretory capacity after growth completion. Testing is not required for those with more than three pituitary hormone deficits, with severe GHD due to a defined genetic cause, due to structural hypothalamic pituitary abnormalities, due to central nervous system tumours or due to high-dose cranial irradiation, or with GHD secondary to a pituitary/hypothalamic disease or insult, if measurements of serum insulin-like growth factor 1 (IGF-1) is < -2 SDS after at least four weeks off growth hormone treatment. In all other patients an IGF-1 measurement and one growth hormone stimulation test is required. Adult onset growth hormone deficiency: Pronounced GHD in known hypothalamic-pituitary disease, cranial irradiation and traumatic brain Прочитајте комплетан документ