ZOMACTON Powder and Solvent for Solution for Injection 10mg

Maa: Singapore

Kieli: englanti

Lähde: HSA (Health Sciences Authority)

Aktiivinen ainesosa:

Somatropin

Saatavilla:

FERRING PHARMACEUTICALS PRIVATE LIMITED

ATC-koodi:

H01AC01

Annos:

10.0 mg

Lääkemuoto:

INJECTION, POWDER, FOR SOLUTION

Koostumus:

Somatropin 10.0 mg

Antoreitti:

SUBCUTANEOUS

Prescription tyyppi:

Prescription Only

Valmistaja:

Wasserburger Arzneimittelwerk GmbH (Powder)

Valtuutuksen tilan:

ACTIVE

Valtuutus päivämäärä:

2013-06-10

Pakkausseloste

ZOMACTION 10mg – PI – 55-I-SG-03.01; Created
by MELM; 24-Sep-2014 
ZOMACTON
®
 10 MG/ML 

COMPOSITION   
1 vial of powder contains 10 mg Somatropin
(10 mg/ml after reconstitution with solvent). 
1 prefilled
syringe contains 1 ml of solvent for reconstitution. 

List of excipients:   
Powder: Mannitol, disodium phosphate dodecahydrate
and sodium dihydrogen phosphate dihydrate. 
Solvent: Metacresol and water for injections. 

PHARMACEUTICAL DOSAGE FORM 
Powder and solvent for solution for injection 
ZOMACTON
®
 is a white to off-white lyophilized powder. The
solvent in pre-filled syringe is clear and colourless.   

INDICATIONS   
ZOMACTON
®
 is indicated for: 
-  the long-term treatment of children who have growth
failure due to inadequate secretion of growth hormone. 
-  the long-term treatment of growth retardation due
to Turner’s Syndrome confirmed by chromosome analysis. 

DOSAGE AND 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

Valmisteyhteenveto

ZOMA10-I-SG-06.02
1
NAME OF THE MEDICINAL PRODUCT
ZOMACTON
®
10 mg/ml, powder and solvent for solution for injection
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial of powder contains: Somatropin* 10 mg
(10 mg/ml after reconstitution)
* Produced in _Escherichia coli_ cells using recombinant DNA
technology
List of excipients:
Powder:
Mannitol,
disodium
phosphate
dodecahydrate,
sodium
dihydrogen
phosphate
dihydrate
Solvent: Metacresol, water for injections
PHARMACEUTICAL FORM
Powder and solvent for solution for injection, 10 mg/ml
ZOMACTON
®
is a white or almost white lyophilized powder.
The solvent in prefilled syringe is clear and colourless.
THERAPEUTIC INDICATIONS
ZOMACTON
®
is indicated for:
-
the long-term treatment of children who have growth failure due to
inadequate secretion of
growth hormone
-
the long-term treatment of growth retardation due to Turner’s
Syndrome confirmed by
chromosome analysis.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ZOMACTON
®
therapy should be initiated and monitored by physicians who are
appropriately
qualified and experienced in the management of patients with growth
hormone deficiency.
The dosage and schedule 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.
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/k