ZOMACTON 10 MG

Ország: Izrael

Nyelv: angol

Forrás: Ministry of Health

Aktív összetevők:

SOMATROPIN

Beszerezhető a:

FERRING PHARMACEUTICALS LTD

ATC-kód:

H01AC01

Gyógyszerészeti forma:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Összetétel:

SOMATROPIN 10 MG

Az alkalmazás módja:

S.C

Recept típusa:

Required

Gyártó:

FERRING GmbH ,GERMANY

Terápiás csoport:

SOMATROPIN

Terápiás terület:

SOMATROPIN

Terápiás javallatok:

Children :Short stature due to inadequate or failed secretion of pituitary growth hormone or Turner's syndrome. Short stature in children with renal insufficiency.

Engedély dátuma:

2015-08-31

Betegtájékoztató

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
The dispensing of this medicine requires a doctor’s prescription
ZOMACTON
® 10 MG
Powder and solvent for reconstituting a solution for subcutaneous
injection.
COMPOSITION:
Each vial of powder contains somatropin 10 mg.
After adding the solvent, the vial contains a somatropin solution with
a concentration
of 10 mg/ml.
INACTIVE INGREDIENTS: See section 6 ‘Additional Information’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains
concise information about this medicine. If you have further
questions, refer to your
doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It
may harm them, even if it seems to you that their illness is similar
to yours.
1. WHAT IS THIS MEDICINE INTENDED FOR?
CHILDREN:
short stature due to non-secretion or inadequate secretion of
pituitary growth
hormone
or
Turner’s
syndrome.
short stature due to renal insufficiency.
THERAPEUTIC GROUP: Somatropin is a recombinant growth hormone.
2. BEFORE USING THIS MEDICINE
DO NOT USE THE MEDICINE:
If you are sensitive )allergic( to the active ingredient or to any of
the other
ingredients
that
this
medicine
contains
(see
section
6).
Do not use Zomacton 10 mg and tell your doctor if you have an active
malignant
tumor. Malignant tumors must be inactive before beginning treatment.
You must
complete anti-cancer treatment before beginning treatment with
Zomacton 10 mg.
In children where bone growth is completed (with closed epiphyses).
If you have a severe illness following complications of an open heart
or abdominal
surgery, multiple injuries from an accident or respiratory failure.
In children with chronic kidney disease at the time of kidney
transplantation.
SPECIAL WARNINGS ABOUT USING THIS MEDICINE:
BEFORE TREATMENT WITH THE MEDICINE, CONSULT YOUR DOCTOR
Treatment with Zomacton 10 mg must be conducted under supervision of a
doctor
who is specialized in treating patients wit

Termékjellemzők

1.
NAME OF THE MEDICINAL PRODUCT
ZOMACTON 10 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ZOMACTON 10 mg:
Somatropin*
…..……………………………………………………………..10
mg
(10 mg/ml after reconstitution for one vial)
* Produced in E
_scherichia coli _
cells using recombinant DNA technology
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
Zomacton is a white to off-white lyophilised powder. The solvent is
clear and colourless.
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 renal insufficiency.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Zomacton therapy should be used only under the supervision of a
qualified physician experienced in
the management of patients with growth hormone deficiency.
The dosage of administration of Zomacton should be individualised for
each patient.
The duration of treatment, usually a period of several years will
depend on maximum achievable
therapeutic benefit.
The subcutaneous administration of growth hormone may lead to loss or
increase of adipose tissue at
the injection site. Therefore, injection sites should be alternated.
_Growth Hormone Deficiency _
Generally a dose of 0.17 – 0.23 mg/kg bodyweight (approximating to
4.9 mg/m
2
– 6.9 mg/m
2
body
surface area) per week divided into 6 - 7 S.C. injections is
recommended (corresponding to a daily
injection of 0.02 – 0.03 mg/kg bodyweight or 0.7 – 1.0 mg/m
2
body surface area).
The total weekly dose of 0.27 mg/kg or 8 mg/m
2
body surface area should not be exceeded
(corresponding to daily injections of up to about 0.04 mg/kg).
_Turner’s Syndrome _
Generally a dose of 0.33 mg/kg/bodyweight (approximating to 9.86 mg/m
2
/body surface area) per
week divided into 6 - 7 S.C.. injections are recommended
(corresponding to daily injection of 0.05
mg/kg/bodyweight or 1.40-1.63 mg/m
2
/body surface a