NORDITROPIN 10 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

SOMATROPIN

Available from:

NOVO NORDISK LTD., ISRAEL

ATC code:

H01AC01

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

SOMATROPIN 10 MG / 1.5 ML

Administration route:

S.C

Prescription type:

Required

Manufactured by:

NOVO NORDISK A/S, DENMARK

Therapeutic group:

SOMATROPIN

Therapeutic area:

SOMATROPIN

Therapeutic indications:

Children: * Short stature due to inadequate or failed secretion of pituitary growth hormone or Turner`s syndrome. * Short stature in children with renal insufficiency. * 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 < during the last year) by 4 years of age or later.* Children with short stature associated with Noonan syndrome.Adults: Treatment of adults with Hypothalamic-pituitary disease resulting from organic disease or pituitary tumors treated medically surgically or radiotherapy or patients with childhood onset of G.H. deficiency.

Authorization date:

2020-05-31

Patient Information leaflet

Patient leaflet in accordance with the Pharmacists' Regulations
(Preparations) – 1986
This medicine is dispensed with a doctor's prescription only
Norditropin
®
15 mg
NordiFlex
®
Solution for injection in pre-filled pen
Active ingredient
somatropin 15 mg/1.5 ml
Inactive ingredients and allergens in the preparation: see section 6 -
Further information.
Read the entire leaflet carefully before you start using this
medicine. This leaflet
contains concise information about this medicine. If you have any
further questions, consult
your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if it seems to you that their medical condition is similar to
yours.
This leaflet contains instructions for using your Norditropin
NordiFlex pen.
1.
What is this medicine intended for?

In children:

to treat children with short stature due to failed or inadequate
secretion of growth
hormone by the pituitary

to treat children with short stature due to Turner syndrome

to treat children with short stature due to renal insufficiency

to treat children with short stature associated with Noonan syndrome

growth disturbance in short children born small for gestational age
(SGA) who failed to
show catch-up growth by 4 years of age.

In adults:
To treat adults with hypothalamic-pituitary disease due to an organic
problem or pituitary
tumours, treated medicinally, surgically or by radiotherapy or
patients with childhood
onset of growth hormone deficiency.
Therapeutic group: somatropin and somatropin agonists
Norditropin 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; However, adults also need it for their
normal health.
2.
Before using the medicine
Do not use this medicine if:
•
you are sensitive (allergic) to somatropin, to phenol, or to any of
the other
ingredients in this medicine (see section 6)
•
you have had a

Summary of Product characteristics

1
NOR NOR SPC
July21-Notification
1.
NAME OF THE MEDICINAL PRODUCT
NORDITROPIN
® 10 MG
NORDITROPIN
® 15 MG
NORDIFLEX
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Norditropin NordiFlex: 10 mg/1.5 ml
One ml of solution contains 6.7 mg somatropin
Norditropin NordiFlex: 15 mg/1.5 ml
One ml of solution contains 10 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:
•
Short stature due to inadequate or failed secretion of pituitary
growth hormone or
Turner`s syndrome.
•
Short stature in children with renal insufficiency.
•
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.
•
Children with short stature associated with Noonan syndrome.
Adults:
•
Treatment of adults with Hypothalamic-pituitary disease resulting from
organic disease or
pituitary tumors treated medically surgically or radiotherapy or
patients with childhood onset
of G.H. deficiency.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Norditropin should only be prescribed by doctors with special
knowledge of the therapeutic
indication of use.
2
NOR NOR API JUL21-Notification
Posology
The dosage is individual and must always be adjusted in accordance
with the individual's
clinical and biochemical response to therapy.
_Generally recommended dosages: _
_Paediatric population_:
Growth hormone insufficiency
0.025-0.035 mg/kg/day or 0.7-1.0 mg/m
2
/day
When GHD persists after growth completion, growth hormone treatment
should be continued
to achieve full somatic adult development including lean body mass and
bone mineral
accrual (for guidance o