Saizen solution for injection 8.00mgml (20mg in 2.50ml)

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Somatropin

Available from:

MERCK PTE. LTD.

ATC code:

H01AC01

Dosage:

20mg/ml

Pharmaceutical form:

INJECTION, SOLUTION

Composition:

Somatropin 20 mg/2.5 ml

Administration route:

SUBCUTANEOUS

Prescription type:

Prescription Only

Manufactured by:

Merck Serono S.p.A

Authorization status:

ACTIVE

Authorization date:

2013-11-06

Patient Information leaflet

NAME OF THE MEDICINAL PRODUCT 
Saizen® Solution for Injection 5.83mg/ml (6mg/1.03ml) 
Saizen® Solution for Injection 8mg/ml (12mg/1.50ml) 
Saizen® Solution for Injection 8mg/ml (20mg/2.50ml) 

QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each cartridge of Saizen® Solution for
Injection contains Somatropin* (recombinant human growth
hormone). 
*produced by recombinant DNA technology in mammalian cells 

PHARMACEUTICAL FORM 
Solution for injection. 

Clear to slightly opalescent solution with pH of 5.6-6.6
and osmolality 250-450 mOsm/kg 

CLINICAL PARTICULARS 
THERAPEUTIC INDICATIONS 
Saizen® is indicated in the treatment of: 
• growth failure in children caused by decreased or
absent secretion of endogenous growth hormone. 
• growth failure in girls with gonadal dysgenesis
(Turner Syndrome), confirmed by chromosomal analysis. 
• growth disturbance (current height SDS < -2.5 and parental
adjusted height SDS < -1) in short children born 
small for gestational age (SGA) with a birth weight
and/or length below – 2 SD, who failed to show catch-up 
growth (HV SDS < 0 during the last year) by 4 years of age or
later. 
• replacement therapy in adults with pronounced growth hormone
deficiency as diagnosed by a single 
dynamic test for growth hormone deficiency. Patients must
also fulfil the following criteria: 

Childhood Onset: 
Patients who were diagnosed as growth hormone
deficient during childhood, must be retested and their 
growth hormone deficiency confirmed before replacement
therapy with Saizen® is started. 

Adult Onset: 
Patients must have growth hormone deficiency as
a result of hypothalamic or pituitary disease and at least 
one other hormone deficiency diagnosed (except
for prolactin) and adequate replacement therapy instituted, 
before replacement therapy using growth hormone may begin. 

POSOLOGY AND METHO

Summary of Product characteristics

NAME OF THE MEDICINAL PRODUCT
Saizen® Solution for Injection 5.83mg/ml (6mg/1.03ml)
Saizen® Solution for Injection 8mg/ml (12mg/1.50ml)
Saizen® Solution for Injection 8mg/ml (20mg/2.50ml)
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each cartridge of Saizen® Solution for Injection contains Somatropin*
(recombinant human growth hormone).
*produced by recombinant DNA technology in mammalian cells
PHARMACEUTICAL FORM
Solution for injection.
Clear to slightly opalescent solution with pH of 5.6-6.6 and
osmolality 250-450 mOsm/kg
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Saizen® is indicated in the treatment of:
•
growth failure in children caused by decreased or absent secretion of
endogenous growth hormone.
•
growth failure in girls with gonadal dysgenesis (Turner Syndrome),
confirmed by chromosomal analysis.
•
growth disturbance (current height SDS < -2.5 and parental adjusted
height SDS < -1) in short children born
small for gestational age (SGA) with a birth weight and/or length
below – 2 SD, who failed to show catch-up
growth (HV SDS < 0 during the last year) by 4 years of age or later.
•
replacement therapy in adults with pronounced growth hormone
deficiency as diagnosed by a single
dynamic test for growth hormone deficiency. Patients must also fulfil
the following criteria:
Childhood Onset:
Patients who were diagnosed as growth hormone deficient during
childhood, must be retested and their
growth hormone deficiency confirmed before replacement therapy with
Saizen® is started.
Adult Onset:
Patients must have growth hormone deficiency as a result of
hypothalamic or pituitary disease and at least
one other hormone deficiency diagnosed (except for prolactin) and
adequate replacement therapy instituted,
before replacement therapy using growth hormone may begin.
POSOLOGY AND METHOD OF ADMINISTRATION
Saizen® 5.83mg/ml and Saizen® 8mg/ml are intended for multiple dose
use.
Saizen® dosage should be individualised for each patient based on
body surface area (BSA) or on body weight
(BW).
It is recommende