Somatropin Biopartners
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
27-04-2017
Fachinformation
(SPC)
27-04-2017
Öffentlichen Beurteilungsberichts
(PAR)
01-12-2017
Wirkstoff:
somatropin
Verfügbar ab:
BioPartners GmbH
ATC-Code:
H01AC01
INN (Internationale Bezeichnung):
somatropin
Therapiegruppe:
Pituitary and hypothalamic hormones and analogues, Somatropin and somatropin agonists
Therapiebereich:
Growth
Anwendungsgebiete:
Somatropin Biopartners is indicated for the replacement therapy of endogenous growth hormone in adults with childhood- or adult-onset growth-hormone deficiency (GHD).Adult-onset: Patients with GHD in adulthood are defined as patients with known hypothalamic-pituitary pathology and at least one additional known deficiency of a pituitary hormone excluding prolactin. These patients should undergo a single dynamic test in order to diagnose or exclude a GHD.Childhood-onset: In patients with childhood-onset isolated GHD (no evidence of hypothalamic-pituitary disease or cranial irradiation), two dynamic tests should be performed after completion of growth, except for those having low insulin-like-growth-factor-I (IGF-I) concentrations (< -2 standard-deviation score (SDS)), who may be considered for one test. The cut-off point of the dynamic test should be strict.
Produktbesonderheiten:
Revision: 3
Berechtigungsstatus:
Withdrawn
Berechtigungsdatum:
2013-08-05
Gebrauchsinformation
81
B. PACKAGE LEAFLET
Medicinal product no longer authorised
82
PACKAGE LEAFLET: INFORMATION FOR THE USER
SOMATROPIN BIOPARTNERS 2 MG POWDER AND SOLVENT FOR PROLONGED-RELEASE
SUSPENSION FOR INJECTION
SOMATROPIN BIOPARTNERS 4 MG POWDER AND SOLVENT FOR PROLONGED-RELEASE
SUSPENSION FOR INJECTION
SOMATROPIN BIOPARTNERS 7 MG POWDER AND SOLVENT FOR PROLONGED-RELEASE
SUSPENSION FOR INJECTION
FOR ADULTS
Somatropin
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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 Somatropin Biopartners is and what it is used for
2.
What you need to know before you use Somatropin Biopartners
3.
How to use Somatropin Biopartners
4.
Possible side effects
5.
How to store Somatropin Biopartners
6.
Contents of the pack and other information
1.
WHAT SOMATROPIN BIOPARTNERS IS AND WHAT IT IS USED FOR
Somatropin Biopartners contains human growth hormone, also called
somatropin. Growth hormone
regulates the growth and development of cells.
This medicine is used to treat adults with a lack (deficiency) of
growth hormone who
-
already had growth hormone deficiency when they were children or
-
do not have enough growth hormone during adulthood.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE SOMATROPIN BIOPARTNERS
DO NOT USE SOMATROPIN BIOPARTNERS
-
if you are allergic to somatropin or any of the other ingr
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Fachinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Somatropin Biopartners 2 mg powder and solvent for prolonged-release
suspension for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial delivers 2 mg of somatropin* (corresponding to 6 IU).
_ _
After reconstitution, 0.2 mL of suspension contains 2 mg somatropin
(10 mg/mL).
_ _
*produced in Saccharomyces cerevisiae by recombinant DNA technology
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for prolonged-release suspension for injection.
White or almost white powder. The solvent is a clear, oily liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Somatropin Biopartners is indicated for the replacement therapy of
endogenous growth hormone in
adults with childhood- or adult-onset growth hormone deficiency (GHD).
Adult-onset: Patients with GHD in adulthood are defined as patients
with known
hypothalamic-pituitary pathology and at least one additional known
deficiency of a pituitary hormone
excluding prolactin. These patients should undergo a single dynamic
test in order to diagnose or
exclude a GHD.
Childhood-onset: In patients with childhood-onset isolated GHD (no
evidence of
hypothalamic-pituitary disease or cranial irradiation), two dynamic
tests should be performed after
completion of growth, except for those having low insulin-like growth
factor-I (IGF-I) concentrations
(< -2 standard deviation score (SDS)), who may be considered for one
test. The cut-off point of the
dynamic test should be strict.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Diagnosis and therapy with this medicinal product should be initiated
and monitored by physicians
adequately experienced in the diagnosis and man
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