Land: Singapur
Sprache: Englisch
Quelle: HSA (Health Sciences Authority)
Somatropin
NOVO NORDISK PHARMA (SINGAPORE) PTE LTD
H01AC01
10 mg/1.5 ml
INJECTION
Somatropin 10 mg/1.5 ml
SUBCUTANEOUS
Prescription Only
Novo Nordisk A/S
ACTIVE
2003-03-05
PROFESSIONAL PACKAGE LEAFLET NORDITROPIN ® NORDILET ® 10 MG/1.5 ML STF 2012 8-2081-00-007-1 1 1 NAME OF THE MEDICINAL PRODUCT NORDITROPIN ® NORDILET ® 10 MG/1.5 ML Pre-filled pen, solution for injection 2 COMPOSITION Norditropin ® NordiLet ® is a solution for injection into the skin in a multi-dose disposable pre-filled pen. Norditropin ® NordiLet ® contains biosynthetic human growth hormone (somatropin), which is the active substance. Other ingredients are: mannitol, histidine, poloxamer 188, phenol, water for injections, hydrochloric acid and sodium hydroxide for pH adjustment. 3 PHARMACOTHERAPEUTIC GROUP Somatropin is an endocrine hormone with metabolic and growth promoting effects. 4 INDICATIONS _CHILDREN: _ Growth failure due to growth hormone insufficiency, growth failure in girls due to gonadal dysgenesis (Turner syndrome), growth retardation in prepubertal children due to chronic renal disease. Growth disturbance (current height standard deviation score (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 standard deviation (SD), who failed to show catch-up growth (height velocity standard deviation score (HV SDS) <0 during the last year) by 4 years of age or later. _ADULTS: _ Pronounced growth hormone deficiency in known hypothalamic-pituitary disease (one other deficient axis, other than prolactin), demonstrated by one provocative test after institution of adequate replacement therapy for any other deficient axis. Childhood onset growth hormone insufficiency, reconfirmed by two provocative tests. In adults, the insulin tolerance test is the provocative test of choice. When the insulin tolerance test is contraindicated, alternative provocative tests must be used. The combined arginine-growth hormone releasing hormone is recommended. An arginine or glucagon test may also be c Lesen Sie das vollständige Dokument
1. NAME OF THE MEDICINAL PRODUCT NORDITROPIN NORDIFLEX ® 10 MG/1.5 ML Solution for injection in pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Norditropin NordiFlex ® : 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 insufficiency, growth failure in girls due to gonadal dysgenesis (Turner syndrome), growth retardation in prepubertal children due to chronic renal disease. Growth disturbance (current height standard deviation score (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 standard deviation (SD), who failed to show catch‐up growth (height velocity standard deviation score (HV SDS) <0 during the last year) by 4 years of age or later. Adults: Pronounced growth hormone deficiency in known hypothalamic‐pituitary disease (one other deficient axis, other than prolactin), demonstrated by one provocative test after institution of adequate replacement therapy for any other deficient axis. Childhood onset growth hormone insufficiency reconfirmed by two provocative tests. In adults, the insulin tolerance test is the provocative test of choice. When the insulin tolerance test is contraindicated, alternative provocative tests must be used. The combined arginine‐growth hormone releasing hormone is recommended. An arginine or glucagon test may also be considered; however, these tests have less established diagnostic value than the insulin tolerance test. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Norditropin ® should only be prescribed by doctors with special knowledge of the therapeutic indication of use. Posology The dosa Lesen Sie das vollständige Dokument