NORDITROPIN NORDIFLEX INJECTION 5 mg1.5 ml

Land: Singapur

Sprache: Englisch

Quelle: HSA (Health Sciences Authority)

Wirkstoff:

Somatropin

Verfügbar ab:

NOVO NORDISK PHARMA (SINGAPORE) PTE LTD

ATC-Code:

H01AC01

Dosierung:

5 mg/1.5 ml

Darreichungsform:

INJECTION

Zusammensetzung:

Somatropin 5 mg/1.5 ml

Verabreichungsweg:

SUBCUTANEOUS

Verschreibungstyp:

Prescription Only

Hergestellt von:

Novo Nordisk A/S

Berechtigungsstatus:

ACTIVE

Berechtigungsdatum:

2003-03-05

Gebrauchsinformation

PROFESSIONAL PACKAGE LEAFLET 
NORDITROPIN
®
 NORDILET
®
 5 MG/1.5 ML STF 2012 8-2080-00-007-1 

1
1 NAME OF THE MEDICINAL PRODUCT 
NORDITROPIN
®
 NORDILET
®
 5 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 and short 
children born small for gestational age (SGA). 
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 (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 recomm

Fachinformation

1
1. NAME OF THE MEDICINAL PRODUCT
NORDITROPIN NORDIFLEX
® 5 MG/1.5 ML
Solution for injection in pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Norditropin NordiFlex
®
: 5 mg/1.5 ml
One ml of solution contains 3.3 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 and short
children born small for gestational age (SGA).
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 (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
therapeut