NORDITROPIN NORDIFLEX somatropin (rbe) 15mg (10mg/mL) injection-solution multidose cartridge

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

Somatropin

Disponible des:

Novo Nordisk Pharmaceuticals Pty Ltd

Estat d'Autorització:

Registered

Fitxa tècnica

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AUSTRALIAN PRODUCT INFORMATION
Norditropin
®
SimpleXx
®
, Norditropin
®
NordiFlex
®
and Norditropin
®
FlexPro
®
(somatropin)
injection solution
1.
NAME OF THE MEDICINE
Somatropin (rbe). Biosynthetic human growth hormone.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Somatropin is a polypeptide hormone of recombinant DNA origin. The
hormone is synthesised
by a special strain of
_E coli_
bacteria that has been modified by the addition of a plasmid which
carries the gene for human growth hormone. Somatropin contains the
identical sequence of 191
amino acids constituting the naturally occurring pituitary human
growth hormone with a
molecular weight of about 22,000 Daltons.
Norditropin SimpleXx contains somatropin (rbe) 5 mg, 10 mg or 15 mg in
1.5 mL.
Norditropin NordiFlex contains somatropin (rbe) 5 mg, 10 mg or 25 mg
in 1.5 mL.
Norditropin FlexPro contains somatropin (rbe) 5 mg, 10 mg or 15 mg in
1.5 mL.
1 mg of somatropin corresponds to 3 IU (International Units) of
somatropin.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Solution for injection.
Colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Children
Treatment of growth failure in children due to pituitary growth
hormone deficiency.
Treatment of growth failure in girls due to gonadal dysgenesis (Turner
Syndrome).
Treatment of growth failure in children due to chronic renal
insufficiency whose height is on
or less than the twenty-fifth percentile and whose growth velocity is
on or less than the twenty-
fifth percentile for bone age. Chronic renal insufficiency is defined
as a glomerular filtration
rate of < 30 mL/min/1.73 m
2
.
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Treatment of severe growth failure due to intrauterine growth
retardation (i.e., children born
small for gestational age (birth weight and/or length < -2 SD) without
spontaneous catch up
growth by 2 years of age).
Adults
Treatment of adults with severe growth hormone deficiency as diagnosed
in the insuli