SciTropin A 10mg1.5ml (30 IU) Cartridge Solution for Injection

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

RECOMBINANT HUMAN SOMATROPIN

Boleh didapati daripada:

UNITED ITALIAN TRADING (M) SDN BHD

INN (Nama Antarabangsa):

RECOMBINANT HUMAN SOMATROPIN

Unit dalam pakej:

1.5ml mL

Dikeluarkan oleh:

Sandoz GmbH, Biochemiestrasse

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
SCITROPIN A
TM CARTRIDGE SOLUTION FOR INJECTION
Somatropin (5mg/1.5mL (15IU), 10mg/1.5mL (30IU))
1
WHAT IS IN THIS LEAFLET
1. What SciTropin A
TM
is used for
2. How SciTropin A
TM
works
3. Before you use SciTropin A
TM
4. How to use SciTropin A
TM
5. While you are using SciTropin A
TM
6. Side effects
7. Storage and Disposal of SciTropin
A
TM
8. Product description
9. Manufacturer and Product
Registration Holder
10. Date of revision
11. Serial number
WHAT SCITROPIN A™ IS USED FOR
The name of your medicine is
SciTropin A™. It contains a
biosynthetic human growth hormone
known as Somatropin, which is a
protein molecule occurring naturally
in humans.
SciTropin A™ is identical to the
body’s own growth hormone. It is
used to treat children who grow too
slowly because of a deficiency of
growth hormone, chronic renal
failure, Prader
‐
Willi syndrome,
Turner syndrome, children born small
for gestational age and as a
replacement therapy in adults with
pronounced growth hormone
deficiency.
Your doctor, however, may have
prescribed SciTropin A™ for another
purpose. Ask your doctor if you have
any questions about why SciTropin
A™ has been prescribed for you.
This medicine is available only with a
doctor’s prescription.
SciTropin A™ is not addictive.
HOW SCITROPIN A™ WORKS
SciTropin A™ is produced using
recombinant DNA technology. The
active substance Somatropin
(biosynthetic human growth
hormone, rDNA
‐
derived human
growth hormone [r
‐
hGH]) is
produced in cell culture by
Escherichia coli cells bearing the
gene for human growth hormone
BEFORE YOU USE SCITROPIN A™
_- When you must not use it _
Do not use SciTropin A if:
1. You are allergic to Somatropin or
to any of the excipients (benzyl
alcohol). Some of the symptoms of
an allergic reaction may include skin
rash, itching, difficulty breathing or
swelling of the face or lips.
2. You have evidence of cancer or
tumour.
3. You have a serious injury or
illness.
4. The child being treated has closed

Ciri produk

SCITROPIN A
™
Somatropin (rbe) (recombinant human growth hormone, r-hGH) Solution
for Injection
in cartridge 5 mg/1.5 mL (15 IU) and 10 mg/1.5 mL (30 IU)
DESCRIPTION
SciTropin A
™
is produced using recombinant DNA technology. The active substance
somatropin
(biosynthetic
human
growth
hormone,
rDNA-derived
human
growth
hormone [r-hGH]) is produced in cell culture by Escherichia coli cells
bearing the
gene for human growth hormone.
SciTropin A
™
Solution for Injection is a clear, colourless solution.
SciTropin A
™
is a biosimilar product of Genotropin ®. SciTropin A™ has been
shown
to have a comparable quality, safety and efficacy profile to
Genotropin ®.
COMPOSITION
_SciTropin A_
_TM_
_ 5 mg/1.5mL (15 IU) Solution for Injection _
Each cartridge (1.5 mL) contains 10 mg recombinant somatropin. Other
ingredients: sodium phosphate dibasic heptahydrate 1.34 mg, sodium
phosphate monobasic dihydrate 1.56 mg, poloxamer 188 3.0 mg, phenol
4.50 mg,
glycine 27.75 mg and water for injection ad 1.5 mL.
_SciTropin A_
_TM_
_ 10 mg/1.5mL (30 IU) Solution for Injection_
Each cartridge (1.5 mL) contains 10 mg recombinant somatropin. Other
ingredients:
sodium phosphate dibasic heptahydrate 1.34 mg, sodium phosphate
monobasic
dihydrate 1.56 mg, poloxamer 188 3.0 mg, phenol 4.50 mg, glycine 27.75
mg and
water for injection ad 1.5 mL.
CLINICAL
TRIAL
DATA
FOR
THE
BIOSIMILAR
DESCRIBING
CLINICAL SIMILARITY TO THE REFERENCE PRODUCT
In three sequential clinical trials, involving a total of previously
untreated 89 GHD
children the efficacy and safety of SciTropin A™ were compared with
another
somatropin (Genotropin ®) product approved for growth hormone
deficiency
(GHD) in pediatric patients.
44 patients received SciTropin A
™
powder for solution for injection (p.f.s.f.i.) 5.8
mg/ vial and 45 patients received Genotropin ® for 9 months. After 9
months of
treatment patients who had received Genotropin ® product were
switched to SciTropin
A
™
solution for injection (s.f.i.) 5 mg/1.5 mL. After 15 months of
treatment, all pa