Valtropin

Pays: Union européenne

Langue: anglais

Source: EMA (European Medicines Agency)

Ingrédients actifs:

somatropin

Disponible depuis:

BioPartners GmbH

Code ATC:

H01AC01

DCI (Dénomination commune internationale):

somatropin

Groupe thérapeutique:

Pituitary and hypothalamic hormones and analogues

Domaine thérapeutique:

Turner Syndrome; Dwarfism, Pituitary

indications thérapeutiques:

Paediatric poulationLong-term treatment of children (2 to 11 years old) and adolescents (12 to 18 years old) with growth failure due to an inadequate secretion of normal endogenous growth hormone.Treatment of short stature in children with Turner syndrome, confirmed by chromosome analysis.Treatment of growth retardation in pre-pubertal children with chronic renal insufficiency.Adult patientsReplacement therapy in adults with pronounced growth hormone deficiency of either childhood- or adult-onset aetiology.Patients with severe growth hormone deficiency in adulthood are defined as patients with known hypothalamic-pituitary pathology and at least one additional 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 growth hormone 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-1 (IGF-1) concentrations (< 2 standard deviation score (SDS)), who may be considered for one test. The cut-off point of the dynamic test should be strict.

Descriptif du produit:

Revision: 5

Statut de autorisation:

Withdrawn

Date de l'autorisation:

2006-04-24

Notice patient

B. PACKAGE LEAFLET
20
Medicinal product no longer authorised
PACKAGE LEAFLET: INFORMATION FOR THE USER
VALTROPIN 5 MG/1.5 ML POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Somatropin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Valtropin is and what it is used for
2.
Before you use Valtropin
3.
How to use Valtropin
4.
Possible side effects
5.
How to store Valtropin
6.
Further information
1.
WHAT VALTROPIN IS AND WHAT IT IS USED FOR
Your medicine is called Valtropin. It is a human growth hormone, also
called somatropin. It has the
same structure as the growth hormone that the body produces in the
pituitary glands (glands located at
the base of the brain). Growth hormone regulates the growth and
development of cells. When it
stimulates growth of cells in the long bones of the legs and spine, it
causes an increase in height.
VALTROPIN IS USED
-
to treat children
(2 to 11 years old) and teenagers (12 to 18 years old) who do not
develop to
their normal height because of poor bone growth caused by growth
hormone deficiency (relative
lack of growth hormone), Turner syndrome, or ‘chronic renal
insufficiency’ (a condition in
which the kidneys gradually lose their ability to perform their normal
functions, such as the
removal of wastes and extra fluid from the body).
-
to treat adults
with severe growth hormone deficiency who already had growth hormone
deficiency when they were children or who do not have enough growth
hormone during their
adult years for some other reason.
In this leaflet the patient is addressed as ‘you’. Caregivers
administering Valtropin to their ch

Résumé des caractéristiques du produit

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1
Medicinal product no longer authorised
1.
NAME OF THE MEDICINAL PRODUCT
Valtropin 5 mg/1.5 ml powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial of powder contains 5 mg somatropin (corresponding to 15 IU).
After reconstitution with 1.5 ml solvent, 1 ml contains:
somatropin* 3.33 mg (corresponding to 10 IU)
_* _
produced in
_Saccharomyces cerevisiae_
cells by recombinant DNA technology
_. _
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
White or almost white powder. The solvent is a clear solution.
After reconstitution with the solvent provided, Valtropin has a pH of
approximately 7.5 and an
osmolality of approximately 320 mOsm/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Paediatric population
-
Long-term treatment of children (2 to 11 years old) and adolescents
(12 to 18 years old) with
growth failure due to an inadequate secretion of normal endogenous
growth hormone.
-
Treatment of short stature in children with Turner syndrome, confirmed
by chromosome
analysis.
-
Treatment of growth retardation in pre-pubertal children with chronic
renal insufficiency.
Adult patients
-
Replacement therapy in adults with pronounced growth hormone
deficiency of either childhood-
or adult-onset aetiology.
Patients with severe growth hormone deficiency in adulthood are
defined as patients with known
hypothalamic-pituitary pathology and at least one additional 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 growth hormone
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-1 (IGF-1)
concentrations (< 2 standard deviation score (SDS)), who may be
considered for one test. T