NORDITROPIN SIMPLEXX somatropin (rbe) 10mg (6.67mg/mL) injection-solution multidose cartridge

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

Somatropin

Tilgjengelig fra:

Novo Nordisk Pharmaceuticals Pty Ltd

Autorisasjon status:

Registered

Informasjon til brukeren

NORDITROPIN
® SIMPLEXX
® 5 MG, 10 MG, AND 15 MG
_Somatropin (rbe) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET ................ 0
WHAT NORDITROPIN
® SIMPLEXX
®
IS USED FOR .................................. 0
BEFORE
USING
NORDITROPIN
®
SIMPLEXX
® ................................. 0
USING NORDITROPIN
® SIMPLEXX
® 1
WHILE YOU OR YOUR CHILD IS USING
NORDITROPIN
® SIMPLEXX
® .......... 2
SIDE EFFECTS ................................. 2
STORAGE ....................................... 2
PRODUCT DESCRIPTION ................. 3
FURTHER INFORMATION ................. 3
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
Norditropin
®
SimpleXx
®
. 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
®
SimpleXx
®
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
®
SIMPLEXX
® IS USED FOR
Norditropin
®
SimpleXx
®
is human
growth
hormone
[also
called
somatropin (rbe)], 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
®
SimpleXx
®
promotes catch-
up growth and increases final
height.
•
Chronic kidney disease
•
Turner
syndrome,
a
genetic
condition in girls
2.
growth hormone deficiency in
adults
You or your child may have been
prescribed
Norditropin
®
SimpleXx
®
for another reas

Preparatomtale

norditropin-pi-v19.0.docx
VV-LAB-086720
Page 1 of 17
AUSTRALIAN PRODUCT INFORMATION
Norditropin
®
SimpleXx
®
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 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/