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

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Somatropin, Quantity: 10 mg/mL

Available from:

Novo Nordisk Pharmaceuticals Pty Ltd

INN (International Name):

Somatropin

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: histidine; phenol; poloxamer; mannitol; water for injections

Administration route:

Subcutaneous

Units in package:

1 x 1.5mL cartridge

Prescription type:

(S4) Prescription Only Medicine

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's 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 glomerular filtration rate of less than 30 mL/min/1.73 m2. 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 insulin tolerance test for growth hormone deficiency and defined by peak growth hormone concentrations of less than 2.5 nanogram/mL. In order to establish Childhood Onset [CO] growth hormone insufficiency, reconfirmation by one provocative test is recommended. In order to establish isolated growth hormone deficiency two provocative tests are recommended. 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 or the glucagon test may also be considered; however these tests have less established diagnostic value than the insulin tolerance test.

Product summary:

Visual Identification: Colourless solution for injection in Type I glass cartridge with bromobutyl plunger, aluminium cap, and bromobutyl / polyisoprene rubber cap, pre-sealed into disposable plastic syringes with dial-a-dose metering.; Container Type: Cartridge; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2011-05-09

Patient Information leaflet

Norditropin
®
FlexPro
®
Page 1 of 9
Norditropin FlexPro-15mg-cmi-v3.doc
NORDITROPIN
® FLEXPRO
® 15 MG
_Somatropin (rbe) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET ................ 1
WHAT NORDITROPIN
® FLEXPRO
® IS
USED FOR ...................................... 1
BEFORE
USING
NORDITROPIN
®
FLEXPRO
® .................................... 1
USING NORDITROPIN
® FLEXPRO
® .. 2
WHILE YOU OR YOUR CHILD IS USING
NORDITROPIN
® FLEXPRO
® ............. 3
SIDE EFFECTS ................................. 3
STORAGE ....................................... 3
PRODUCT DESCRIPTION ................. 4
FURTHER INFORMATION ................. 4
INSTRUCTIONS FOR USE ................. 5
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
Norditropin
®
FlexPro
®
. It does
not
contain
all
the
available
information. It does not take the
place of talking to your doctor or
pharmacist.
All
medicines
have
risks
and
benefits.
Your
doctor
has
weighed the risks of you or your
child using Norditropin
®
FlexPro
®
against the benefits they expect it
will have.
IF YOU HAVE ANY CONCERNS ABOUT
USING
THIS
MEDICINE,
ASK
YOUR
DOCTOR OR PHARMACIST.
KEEP
THIS
LEAFLET
WITH
THE
MEDICINE.
You may need to read
it again.
WHAT NORDITROPIN
®
FLEXPRO
® IS USED FOR
Norditropin
®
FlexPro
®
is a pre-
filled dial-a-dose pen containing
Norditropin
®
, a solution of human
growth
hormone.
Norditropin
®
[also called somatropin (rbe)], is
used to treat:
1.
growth
failure
in
children,
which may be due to:
•
a
condition
called
Growth
Hormone
Deficiency,
where
the gland at the base of the
brain
(pituitary
gland)
does
not
make
enough
growth
hormone
•
a
condition
called
either
Small
for
Gestational
Age
(SGA) or Intrauterine Growth
Retardation
(IUGR),
where
growth failure started during
the
mother’s
pregnancy.
Children with SGA/IUGR do
not lack growth hormone and
are therefore not treated for
growth
hormone
deficiency.
Treatment with Norditropin
®
FlexPro
®
promotes
catch-up
growth
and
increases
final
height.
•
Chronic

Summary of Product characteristics

AU-Norditropin
®
-PI-VV-LAB-086720
_ _
_ _
Page 1 of 2
AUSTRALIAN PRODUCT INFORMATION
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 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
.
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 insulin
tolerance
test
for
growth
hormone
deficiency
and
defined
by
peak
growth
hormone
concentrations of less than 2.5 nanogram/mL.
In order to establish Childhood Onset [CO] growth hormone
insufficiency, reconfirmation by
one provocat