GENOTROPIN 12 MG

País: Israel

Idioma: inglés

Fuente: Ministry of Health

Ingredientes activos:

SOMATROPIN

Disponible desde:

PFIZER PHARMACEUTICALS ISRAEL LTD

Código ATC:

H01AC01

formulario farmacéutico:

POWDER FOR SOLUTION FOR INJECTION

Composición:

SOMATROPIN 12 MG

Vía de administración:

S.C

tipo de receta:

Required

Fabricado por:

PFIZER MANUFACTURING BELGIUM NV/SA

Grupo terapéutico:

SOMATROPIN

Área terapéutica:

SOMATROPIN

indicaciones terapéuticas:

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 witght 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. Adults: For adults who have suffered from growth-hormone deficiency since childhood. For adults who have aquired growth hormone deficiency due to a pituitary pathology causing hypopituitarism.

Fecha de autorización:

2021-02-28

Información para el usuario

Genotropin GQ 5.3mg, Israel, PIL CC 04 July 2022
2021-0068728
1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
GENOTROPIN
® 5.3 MG
POWDER AND SOLVENT FOR RECONSTITUTION OF SOLUTION FOR SUBCUTANEOUS
INJECTION
A GENOTROPIN
5.3 MG INJECTION PEN CONTAINS:
SOMATROPIN RECOMBINANT 5.3 MG/ML
For a list of inactive ingredients and allergens, see section 6
‘Further information’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE 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.
WHAT SHOULD I KNOW ABOUT GENOTROPIN?
•
Before using this medicine you must be trained by a qualified
healthcare professional about preparing the
medicine and injecting it.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
In children:
•
Treatment of growth problems in children due to failed or insufficient
secretion of growth hormone by the
pituitary.
•
Growth problems due to Turner syndrome.
•
Retarded growth in children due to renal insufficiency.
•
Prader-Willi syndrome.
•
Children born small for gestational age (SGA).
In adults:
•
Adults who have had growth hormone deficiency since childhood.
•
Adults who have growth hormone deficiency due to a problem in their
pituitary.
THERAPEUTIC GROUP:
growth hormone.
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE:
•
If you are sensitive (allergic) to the active ingredient or to any of
the other ingredients
that this medicine contains (see section 6).
•
If you have an active tumor (cancer). Tumors must be inactive and you
must have
finished your anti-tumor treatment before you start your treatment
with GENOTROPIN.
•
If you are seriously ill (for example, complications following open
heart surgery,
abdominal surgery, acute respirato

Ficha técnica

Genotropin 5.3mg and 12mg, Israel CC 12 July 2022
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2021-0068728
_ _
1.
NAME OF THE MEDICINAL PRODUCT
GENOTROPIN 5.3 mg,
GENOTROPIN 12 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
GENOTROPIN 5.3 mg powder and solvent for solution for injection, with
preservative. One cartridge
contains 5.3 mg somatropin*. After reconstitution the concentration of
somatropin is 5.3 mg/ml.
GENOTROPIN 12 mg powder and solvent for solution for injection, with
preservative. One cartridge
contains 12 mg somatropin*. After reconstitution the concentration of
somatropin is 12 mg/ml.
* produced in
_Escherichia coli _
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. In the two-chamber
cartridge there is a white powder in
the front compartment and a clear solution in the rear compartment.
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 chronic renal insufficiency.
Growth disturbance (height SDS< -2.5 and parental 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. In
Prader-Willi syndrome (PWS) to improve
growth and body composition.
The diagnosis of PWS should be confirmed by genetic analysis.
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
The dosage and administration schedule should be individualized.
The injection should be given subcutaneously and the site varied to
prevent lipoatrophy.
Genotropin 5.3mg and 12mg, Israel CC 12 July 2022
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