국가: 몰타
언어: 영어
출처: Medicines Authority
SOMATROPIN
NovoNordisk A/S Novo Alle, DK – 2880 Bagsvaerd, Denmark
H01AC01
SOMATROPIN 3.3 mg/ml
SOLUTION FOR INJECTION
SOMATROPIN 3.3 mg/ml
POM
PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES
Authorised
2014-08-18
1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE USER NORDITROPIN FLEXPRO 5 MG/1.5 ML SOLUTION FOR INJECTION IN PRE-FILLED PEN 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 FLEXPRO IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USE NORDITROPIN FLEXPRO 3. HOW TO USE NORDITROPIN FLEXPRO 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE NORDITROPIN FLEXPRO 6. CONTENTS OF THE PACK AND OTHER INFORMATION INSTRUCTIONS ON HOW TO USE NORDITROPIN FLEXPRO 1. WHAT NORDITROPIN FLEXPRO IS AND WHAT IT IS USED FOR Norditropin FlexPro 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 FLEXPRO 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 FLEXPRO IS USED AS A GROWTH HORMONE REPLACEMENT IN ADULTS In adults Norditropin FlexPro is used to replace growth hormone if their growth hormone production has been decreased since childhood or has been lost in adulthood because of a tumour, treatment of a tumour, or a disease that affect 전체 문서 읽기
1 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Norditropin FlexPro 5 mg/1.5 ml, solution for injection in pre-filled pen Norditropin FlexPro 10 mg/1.5 ml, solution for injection in pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ Norditropin FlexPro: 5 mg/1.5 ml One ml of solution contains 3.3 mg somatropin Norditropin FlexPro: 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 pre-filled pen 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. 3 Adult onset growth hormone deficiency 전체 문서 읽기