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Norditropin
®
SimpleXx
®
Page 1 of 4
Lnorcmi10.doc
NORDITROPIN
®
SIMPLEXX
®
5MG, 10MG, AND 15MG
_Somatropin (rbe) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
WHAT NORDITROPIN
®
SIMPLEXX
®
IS USED FOR .................................. 1
BEFORE USING NORDITROPIN
®
SIMPLEXX
®
................................. 1
USING NORDITROPIN
®
SIMPLEXX
®
2
WHILE YOU OR YOUR CHILD IS USING
NORDITROPIN
®
SIMPLEXX
®
.......... 3
SIDE EFFECTS................................. 3
STORAGE....................................... 3
PRODUCT DESCRIPTION ................. 4
FURTHER INFORMATION................. 4
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
®
Si
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製品の特徴
Product Information
page 1 of 17
Norppi15.docx
PRODUCT INFORMATION
NORDITROPIN
®
SIMPLEXX
®
5 MG, 10 MG AND 15 MG
NORDITROPIN NORDIFLEX
®
5 MG, 10 MG AND 15 MG
NORDITROPIN
®
FLEXPRO
®
5 MG, 10 MG AND 15 MG
NAME OF THE MEDICINE
Somatropin (rbe). Biosynthetic human growth hormone.
DESCRIPTION
Norditropin
®
(somatropin) is a polypeptide hormone of recombinant DNA origin.
The
hormone is synthesized 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.
Norditropin
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. ATC: H
01 AC 01.
1 mg of somatropin corresponds to 3 IU (International Units) of
somatropin.
For excipients, see ‘Presentations and Storage Conditions.’
PHARMACOLOGY
PHARMACODYNAMICS
Norditropin increases the growth rate in humans by stimulation of
protein synthesis and other
metabolic processes.
_Growth_
The primary and most intensively studied action of somatropin is the
stimulation of linear
growth. This effect is demonstrated in patients with somatropin
deficiency.
Skeletal growth - the measurable increase in bone length after
administration of
somatropin results from its effect on the cartilaginous growth areas
of long bones.
Studies _in vitro_ have shown that the incorporation of sulphate
into proteoglycans is not
due to a direct effect of somatropin, but rather is mediated by the
somatomedins or
insulin-like growth factors (IGF). The somatomedins, among
them somatomedin-C
(otherwise known as IGF-1), are polypeptide hormones which are
synthesised in the
liver, kidney and various other tissues. Somatomedin-C (IGF-1) is low
in the serum of
hypopituitary dwarfs and hypophysectomised humans or animals, but its
presence can be
demonstrated after tre
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