NORDITROPIN NORDIFLEX INJECTION 10 mg1.5 ml

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Somatropin

Available from:

NOVO NORDISK PHARMA (SINGAPORE) PTE LTD

ATC code:

H01AC01

Dosage:

10 mg/1.5 ml

Pharmaceutical form:

INJECTION

Composition:

Somatropin 10 mg/1.5 ml

Administration route:

SUBCUTANEOUS

Prescription type:

Prescription Only

Manufactured by:

Novo Nordisk A/S

Authorization status:

ACTIVE

Authorization date:

2003-03-05

Patient Information leaflet

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

Summary of Product characteristics

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