GENOTROPIN FOR INJECTION 16 iu (5.3 mg) ml

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Somatropin Recombinant

Available from:

PFIZER PRIVATE LIMITED

ATC code:

H01AC01

Dosage:

16 iu (5.3 mg)/ml

Pharmaceutical form:

INJECTION, POWDER, FOR SOLUTION

Composition:

Somatropin Recombinant 5.3 mg/ml

Administration route:

SUBCUTANEOUS, INTRAMUSCULAR

Prescription type:

Prescription Only

Manufactured by:

Vetter Pharma-Fertigung GmbH & Co. KG

Authorization status:

ACTIVE

Authorization date:

1990-12-24

Patient Information leaflet

1. NAME OF THE MEDICINAL PRODUCT
GENOTROPIN
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Somatropin (INN) recombinant DNA-derived human growth hormone produced
in _E. coli_.
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. After reconstitution, one cartridge
contains 5.3 mg (16 IU)
somatropin in 1 mL. The two-chamber cartridge is supplied for use
sealed in a disposable
multidose pre-filled pen (GoQuick).
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Children
Growth disturbance due to insufficient secretion of growth hormone and
growth disturbance
associated with Turner syndrome.
Adults
Replacement therapy in adults with pronounced growth hormone
deficiency.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The dosage and administration schedule should be individualized.
Somatropin should be
given subcutaneously and the injection site varied to prevent
lipoatrophy.
_Growth disturbance due to insufficient secretion of growth hormone in
children: _Generally, a
dose of 0.07-0.10 IU/kg (0.025-0.035 mg/kg) body weight per day or
2.1-3.0 IU/m
2
(0.7-1.0
mg/m
2
) body surface area per day is recommended. Even higher doses have
been used.
_Growth disturbance due to Turner syndrome:_ A dose of 0.14 IU/kg
(0.045-0.050 mg/kg)
body weight per day or 4.3 IU/m
2
(1.4 mg/m
2
) body surface area per day is recommended.
TABLE 1: DOSAGE RECOMMENDATIONS FOR PEDIATRIC PATIENTS
IU/KG body
weight
MG/KG
body weight
IU/M
2
body
surface area
MG/M
2
body
surface area
dose
per day
dose
per day
dose
per day
dose
per day
Growth hormone
deficiency in
children
0.07 - 0.10
0.025 - 0.035
2.1 - 3.0
0.7 - 1.0
Turner syndrome
0.14
0.045 - 0.050
4.3
1.4
_Growth hormone deficient adult patients:_ The recommended starting
dose is 0.45 - 0.90 IU
(0.15 - 0.30 mg) per day. The final dose should be individually
titrated as needed with respect
to age and gender. The daily maintenance dose seldom exceeds 4 IU
(1.33 mg

Summary of Product characteristics

1. NAME OF THE MEDICINAL PRODUCT
GENOTROPIN
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Somatropin (INN) recombinant DNA-derived human growth hormone produced
in
_E. coli_
.
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. After reconstitution, one cartridge
contains 5.3 mg (16 IU)
somatropin in 1 mL. The two-chamber cartridge is supplied for use
sealed in a disposable
multidose pre-filled pen (GoQuick).
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Children
Growth disturbance due to insufficient secretion of growth hormone and
growth disturbance
associated with Turner syndrome.
Adults
Replacement therapy in adults with pronounced growth hormone
deficiency.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The dosage and administration schedule should be individualized.
Somatropin should be
given subcutaneously and the injection site varied to prevent
lipoatrophy.
_Growth disturbance due to insufficient secretion of growth hormone in
children: _
Generally, a
dose of 0.07-0.10 IU/kg (0.025-0.035 mg/kg) body weight per day or
2.1-3.0 IU/m
2
(0.7-1.0
mg/m
2
) body surface area per day is recommended. Even higher doses have
been used.
_Growth disturbance due to Turner syndrome:_
A dose of 0.14 IU/kg (0.045-0.050 mg/kg)
body weight per day or 4.3 IU/m
2
(1.4 mg/m
2
) body surface area per day is recommended.
TABLE 1: DOSAGE RECOMMENDATIONS FOR PEDIATRIC PATIENTS
IU/KG
body
weight
MG/KG
body weight
IU/M
2
body
surface area
MG/M
2
body
surface area
dose
per day
dose
per day
dose
per day
dose
per day
Growth hormone
deficiency in
children
0.07 - 0.10
0.025 - 0.035
2.1 - 3.0
0.7 - 1.0
Turner syndrome
0.14
0.045 - 0.050
4.3
1.4
_Growth hormone deficient adult patients:_
The recommended starting dose is 0.45 - 0.90 IU
(0.15 - 0.30 mg) per day. The final dose should be individually
titrated as needed with respect
to age and gender. The daily maintenance dose seldom exceeds 4 IU
(1.33