ZOMACTON Powder and Solvent for Solution for Injection 4 mg

Land: Singapore

Sprog: engelsk

Kilde: HSA (Health Sciences Authority)

Aktiv bestanddel:

Somatropin

Tilgængelig fra:

FERRING PHARMACEUTICALS PRIVATE LIMITED

ATC-kode:

H01AC01

Dosering:

4 mg

Lægemiddelform:

INJECTION, POWDER, FOR SOLUTION

Sammensætning:

Somatropin 4 mg

Indgivelsesvej:

SUBCUTANEOUS

Recept type:

Prescription Only

Fremstillet af:

Wasserburger Arzneimittelwerk GmbH (Powder & Solvent)

Autorisation status:

ACTIVE

Autorisation dato:

2013-06-10

Indlægsseddel

ZOMACTON
®
 4 MG 

COMPOSITION  
Somatropin* 4 mg 
(1.3 mg/ml or 3.3 mg/ml after reconstitution) 
* Produced in_ Escherichia coli _cells by recombinant DNA
technology 
List of excipients: 
Powder: Mannitol 
Solvent: Sodium chloride,
benzyl alcohol and water for injections. 

PHARMACEUTICAL DOSAGE FORM 
Powder and solvent for solution for injection. 
ZOMACTON
®
 4 mg is a white to off-white lyophilised powder in a vial. The 
solvent in ampoule is clear and colourless. 

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

DOSAGE AND ADMINISTRATION 
ZOMACTON
®
 4 mg therapy should be used only under the supervision of
a 
qualified physician experienced in the management of patients with growth 
hormone deficiency. 
The dosage and schedule of administration of ZOMACTON
®
 4 mg 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  -�

Produktets egenskaber

ZOMA4-I-SG-09.01
NAME OF THE MEDICINAL PRODUCT
ZOMACTON
®
4 mg, powder and solvent for solution for injection
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial of powder contains: Somatropin* 4 mg
(corresponding to a concentration of 1.3 mg/ml or 3.3 mg/ml after
reconstitution)
* Produced in_ Escherichia coli _cells using recombinant DNA
technology
List of excipients:
Powder: Mannitol
Solvent: Sodium chloride, benzyl alcohol, water for injections
PHARMACEUTICAL FORM
Powder and solvent for solution for injection, 4 mg
ZOMACTON
®
is a white to off-white lyophilised powder.
The solvent in ampoule 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/kg bodyweight or 1.40 - 1.63 mg/