NORDITROPIN NORDIFLEX® 5MG1.5ML

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

SOMATROPIN, BIOSYNTHETIC

Boleh didapati daripada:

NOVO NORDISK PHARMA (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

SOMATROPIN, BIOSYNTHETIC

Unit dalam pakej:

1.5 ml

Dikeluarkan oleh:

NOVO NORDISK A/S

Risalah maklumat

1
NORDITROPIN NORDIFLEX
®
_Consumer Medication Information Leaflet (RiMUP) _
Somatropin (5 mg/1.5 ml)
WHAT IS IN THIS LEAFLET
1.
What Norditropin NordiFlex
®
is
used for
2.
How
Norditropin
NordiFlex
®
works
3.
Before
you
use
Norditropin
NordiFlex
®
4.
How
to
use
Norditropin
NordiFlex
®
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
Norditropin NordiFlex
®
8.
Product Description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of revision
1.
WHAT NORDITROPIN NORDIFLEX
®
IS USED FOR
Norditropin
NordiFlex
®
contains
a
biosynthetic human growth hormone
called somatropin which is identical
to
the
growth
hormone
produced
naturally in the body. Children need
growth hormone to help them grow,
but
adults
also
need
it
for
their
general health.
2.
HOW NORDITROPIN NORDIFLEX
®
WORKS
NORDITROPIN NORDIFLEX
® IS USED TO
TREAT GROWTH FAILURE IN CHILDREN:
►
If
they
have
no
or
very
low
production
of
growth
hormone
(growth hormone deficiency)
►
If they have Turner syndrome (a
genetic problem which may affect
growth)
►
If
they
have
reduced
kidney
function
►
If they are short and were born
small for gestational age (SGA).
NORDITROPIN NORDIFLEX
® IS USED AS
A GROWTH HORMONE REPLACEMENT IN
ADULTS:
Norditropin
NordiFlex
®
is
used
to
replace
growth
hormone
if
the
production has been decreased since
childhood
or
is
lost
in
adulthood
because of a tumour, treatment of a
tumour or a disease that affects the
gland,
which
produces
growth
hormone. If you have been treated for
growth hormone deficiency during
childhood, you will be retested after
completion
of
growth.
If
growth
hormone
deficiency
is
confirmed,
you should continue treatment.
3.
BEFORE
YOU
USE
NORDITROPIN
NORDIFLEX
®
_-_
_ _
_WHEN _
_YOU _
_MUST _
_NOT _
_USE _
_NORDITROPIN NORDIFLEX_
_®_
_ _
_ _
DO NOT USE NORDITROPIN NORDIFLEX
®
►
If you are
ALLERGIC
to somatropin,
phenol or any other ingredients in this
medicine.
►
If
you
have
had
a
KIDNEY
TRANSPLANT
.
►
If
you
have
an
ACTIVE
TUMOUR
(CANCER)
. Tumours must be inactive
an

Ciri produk

Norditropin NordiFlex
®
5 mg/1.5 ml Professional Leaflet EN-May-2022 8-2040-00-004-1
Based on EU text : 20210506_QRD_Norditropin+NordiFlex_Version_27-3
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 deficiency (GHD)
Growth failure in girls due to gonadal dysgenesis (Turner syndrome)
Growth retardation in prepubertal children due to chronic renal
disease
Growth disturbance (current height 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 SD, who failed to show catch-up
growth (HV SDS <0 during the last year) by 4 years of age or later.
Adults:
Childhood onset growth hormone deficiency:
Patients with childhood onset GHD should be re-evaluated for growth
hormone secretory capacity after
growth completion. Testing is not required for those with more than
three pituitary hormone deficits, with
severe GHD due to a defined genetic cause, due to structural
hypothalamic pituitary abnormalities, due to
central nervous system tumours or due to high-dose cranial
irradiation, or with GHD secondary to a
pituitary/hypothalamic disease or insult, if measurements of serum
insulin-like growth factor 1 (IGF-1) is <-2
SDS after at least four weeks off growth hormone treatment.
In all other patients an IGF-1 measurement and one growth hormone
stimulation test is required.
Adult onset growth hormone deficiency:
Pronounced GHD in known hypothalamic-pituitary disease, cranial
irradiation