Omnitrope

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

somatropin

Available from:

Sandoz GmbH

ATC code:

H01AC01

INN (International Name):

somatropin

Therapeutic group:

Pituitary and hypothalamic hormones and analogues

Therapeutic area:

Turner Syndrome; Prader-Willi Syndrome; Dwarfism, Pituitary

Therapeutic indications:

Infants, children and adolescentsGrowth disturbance due to insufficient secretion of growth hormone (GH).Growth disturbance associated with Turner syndrome.Growth disturbance associated with chronic renal insufficiency.Growth disturbance (current height standard-deviation score (SDS) < -2.5 and parental adjusted SDS < -1) in short children / adolescents born small for gestational age (SGA), with a birth weight and / or length below -2 standard deviations (SDs), who failed to show catch-up growth (height velocity (HV) SDS < 0 during the last year) by four years of age or later.Prader-Willi syndrome (PWS), for improvement of growth and body composition. The diagnosis of PWS should be confirmed by appropriate genetic testing.AdultsReplacement therapy in adults with pronounced growth hormone deficiency. Patients with severe growth hormone deficiency in adulthood are defined as patients with known hypothalamic pituitary pathology and at least one known deficiency of a pituitary hormone not being prolactin. These patients should undergo a single dynamic test in order to diagnose or exclude a growth hormone deficiency. In patients with childhood-onset isolated GH deficiency (no evidence of hypothalamic-pituitary disease or cranial irradiation), two dynamic tests should be recommended, except for those having low insulin-like-growth-factor-I (IGF-I) concentrations (SDS < -2) who may be considered for one test. The cut-off point of the dynamic test should be strict.

Product summary:

Revision: 22

Authorization status:

Authorised

Authorization date:

2006-04-12

Patient Information leaflet

87
B. PACKAGE LEAFLET
88
PACKAGE LEAFLET: INFORMATION FOR THE USER
OMNITROPE 1.3 MG/ML POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
somatropin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Omnitrope is and what it is used for
2.
What you need to know before you use Omnitrope
3.
How to use Omnitrope
4.
Possible side effects
5.
How to store Omnitrope
6.
Contents of the pack and other information
1.
WHAT OMNITROPE IS AND WHAT IT IS USED FOR
Omnitrope is a recombinant human growth hormone (also called
somatropin). It has the same structure
as natural human growth hormone which is needed for bones and muscles
to grow. It also helps your
fat and muscle tissues to develop in the right amounts. It is
recombinant meaning it is not made from
human or animal tissue.
IN CHILDREN OMNITROPE IS USED TO TREAT THE FOLLOWING GROWTH
DISTURBANCES:
•
If you are not growing properly and you do not have enough of your own
growth hormone.
•
If you have Turner syndrome. Turner syndrome is a genetic disorder in
girls that can affect
growth – your doctor will have told you if you have this.
•
If you have chronic renal (kidney) insufficiency. As kidneys lose
their ability to function
normally, this can affect growth.
•
If you were small or too light at birth. Growth hormone can help you
grow taller if you have not
been able to catch up or maintain normal growth by 4 years of age or
later.
•
If you have Prader-Willi syndrome (a chromosomal disorder). Growth
hormone will help you
grow taller if y

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Omnitrope 1.3 mg/ml powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution, one vial contains 1.3 mg somatropin*
(corresponding to 4 IU) per ml.
* produced in _Escherichia coli_ by recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
The powder is white.
The solvent 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).
-
Growth disturbance associated with Turner syndrome.
-
Growth disturbance associated with chronic renal insufficiency.
-
Growth disturbance (current height standard deviation score (SDS) <
-2.5 and parental adjusted
height SDS < -1) in short children/adolescents born small for
gestational age (SGA), with a
birth weight and/or length below -2 standard deviation (SD), who
failed to show catch-up
growth (height velocity (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. The
diagnosis of PWS should be confirmed by appropriate genetic testing.
Adults
-
Replacement therapy in adults with pronounced growth hormone
deficiency.
-
_Adult onset:_ Patients who have severe growth hormone deficiency
associated with multiple
hormone deficiencies as a result of known hypothalamic or pituitary
pathology, and who have at
least one known deficiency of a pituitary hormone not being prolactin.
These patients should
undergo an appropriate dynamic test in order to diagnose or exclude a
growth hormone
deficiency.
-
_Childhood onset:_ Patients who were growth hormone deficient during
childhood as a result of
congenital, genetic, acquired, or idiopathic causes. Patients with
childhood onset GHD should
be re-evaluated for growth hormone secretory capa