OMNITROPE 15 MG1.5 ML

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

SOMATROPIN RECOMBINANT

Available from:

NOVARTIS ISRAEL LTD

ATC code:

H01AC01

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

SOMATROPIN RECOMBINANT 15 MG / 1.5 ML

Administration route:

S.C

Prescription type:

Required

Manufactured by:

SANDOZ GmbH, AUSTRIA

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 (height SDS<2.5 and parenteral adjusted height SDS < -1) in short children born SGA (SGA - small for gestational age i.e. born small in relation to the length of the fetus development) with a birth weight and/or length < 2 SD who failed to show catch up growth (HV SDS < 0 during the last year) by 4 years of age or later. Prader willi syndrome (PWS) for improvement of growth and body composition. Adults: For adults who have suffered from growth-hormone deficiency since childhood. For adults who have acquired growth hormone deficiency due to a pituitary pathology causing hypopituitarism.

Authorization date:

2017-02-14

Patient Information leaflet

PATIENT PACKAGE INSERT
IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS
(PREPARATIONS) - 1986
The medicine is dispensed with a
doctor’s prescription only
OMNITROPE
5 MG/1.5 ML
OMNITROPE
10 MG/1.5 ML
OMNITROPE
15 MG/1.5 ML
SOLUTION FOR
SUBCUTANEOUS INJECTION
The active ingredient: SOMATROPIN
For use with the SurePal
TM
pen injector
OMNITROPE 5 MG/1.5 ML:
A cartridge which contains 5 mg
somatropin (15 international units) in
1.5 ml solution for injection.
OMNITROPE 10 MG/1.5 ML:
A cartridge which contains 10 mg
somatropin (30 international units) in
1.5 ml solution for injection.
OMNITROPE 15 MG/1.5 ML:
A cartridge which contains 15 mg
somatropin (45 international units) in
1.5 ml solution for injection.
Inactive ingredients - see section “Further
Information” in the leaflet.
READ THIS LEAFLET CAREFULLY IN ITS
ENTIRETY BEFORE USING THE MEDICINE:
This leaflet contains concise information
about the medicine; if you have further
questions, refer to the 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.
WHAT SHOULD YOU KNOW BEFORE USING
OMNITROPE?
Before using this medicine, you should
be trained by a certified medical team
regarding how to prepare and inject the
medicine.
For information about side effects, please
refer to section 4.
1. WHAT IS THE MEDICINE INTENDED
FOR?
IN CHILDREN:
Treatment of growth problems in children
caused by inadequate or complete lack
of secretion of growth hormone from the
pituitary gland (hypophysis).
∙ Growth problems due to Turner
syndrome
∙ Growth delay in children due to kidney
failure
∙ Children born small for gestational age
(SGA)
∙ Prader-Willi Syndrome
IN ADULTS:
1. For adults suffering from growth
hormone deficiency from childhood.
2. For adults suffering from growth
hormone deficiency due to a problem
with the pituitary gland.
THERAPEUTIC GROUP: Growth hormone
Omnitrope is a recombinant growth
hormone (also called SOMATROPIN)
2. BEFORE USING

Summary of Product characteristics

1
OMNITROPE
1. NAME OF THE MEDICINAL PRODUCT
Omnitrope 5mg/1.5m l, 10mg/1.5m l, 15mg/1.5ml solution for injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Omnitrope 5mg/1.5m
Each ml of solution contains 3.33mg of somatropin* (corresponding to
6.67IU). One cartridge contains 1.5ml corresponding to 5m somatropin*
(15IU)

Omnitrope 10mg/1.5m
Each ml of solution contains 6.67mg of somatropin* (corresponding to
20IU) One
cartridge contains 1.5ml corresponding to 10mg somatropin* (30IU)

Omnitrope 15mg/1.5m
Each ml of solution contains 10mg of somatropin* (corresponding to
30IU) One cartridge contains 1.5ml corresponding to 15mg somatropin*
(45IU)
* produced in Escherichia coli by recombinant DNA technology.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection in a cartridge for SurePal 5, 10 & 15
The solution is clear and colourless
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Infants, children and adolescents
Growth disturbance due to insufficient secretion of growth hormone
(growth hormone deficiency,
GHD).

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 (height SDS<2.5 and parenteral adjusted height SDS
< -1) in short children born
SGA (SGA - small for gestational age i.e. born small in relation to
the length of the fetus development)
with a birth weight and/or length < 2 SD who failed to show catch up
growth (HV SDS < 0 during the
last year) by 4 years of age or later.

Prader Willi syndrome for improvement of growth and body composition

The diagnosis of PWS should be confirmed by genetic analysis.
2
Adults

For adults who have suffered from growth-hormone deficiency since
childhood.

For adults who have acquired growth hormone deficiency due to a
pituitary pathology causing
hypopituitarism.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Diagnosis and therapy with somatropin should be initiated and
monitored by