SCITROPIN A somatropin (rbe) 10mg/1.5mL solution for injection cartridge

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Somatropin, Quantity: 6.67 mg/mL

Available from:

SciGen Australia Pty Ltd

INN (International Name):

Somatropin

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: dibasic sodium phosphate heptahydrate; monobasic sodium phosphate dihydrate; poloxamer; phenol; glycine; phosphoric acid; sodium hydroxide; water for injections

Administration route:

Subcutaneous

Units in package:

2 cartridges, 1 cartridge

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Omnitrope is intended for the long term treatment of children (above three years of age) with, growth disturbance due to insufficient secretion of pituatary growth hormone, growth disturbance associated with gonadal dysgenesis (Turner Syndrome), growth disturbance associated with chronic renal insufficiency.

Product summary:

Visual Identification: Clear, colourless solution; Container Type: Cartridge; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Authorization date:

2010-09-29

Patient Information leaflet

Page 1 of 4
SCITROPIN A
™
SOMATROPIN (RBE) (RECOMBINANT HUMAN GROWTH HORMONE, R-HGH)
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about SciTropin A.
It
does
not
contain
all
of
the
available
information.
It
does
not
take the place of talking to your
doctor or pharmacist.
All
medicines
have
risks
and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you or your child.
IF YOU HAVE ANY CONCERNS ABOUT
USING
THIS
MEDICINE,
ASK
YOUR
DOCTOR OR PHARMACIST.
KEEP
THIS
LEAFLET
WITH
THE
MEDICINE.
You may want to read it again.
WHAT SCITROPIN A IS USED
FOR
This medicine is used to treat:
•
short stature in children due to
growth hormone deficiency
•
girls
with
growth
disturbance
associated
with
Turner
Syndrome
•
growth
disturbance
in
children
with chronic renal insufficiency.
It
contains
the
active
ingredient
somatropin.
Somatropin
is
a
biosynthetic
human
growth
hormone
which
is
a
protein
molecule
occurring
naturally
in
humans.
SciTropin
A
is
identical
to
the
body's own growth hormone.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS
ABOUT
WHY
THIS
MEDICINE
HAS
BEEN
PRESCRIBED
FOR YOU OR YOUR CHILD.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
This medicine is available only with
a doctor’s prescription.
BEFORE USING SCITROPIN A
_ _
_WHEN YOU MUST NOT USE IT _
_ _
DO NOT USE THIS MEDICINE IF YOU HAVE AN ALLERGY TO:
_ _
•
somatropin, the active ingredient
•
any of other ingredients listed at
the
end
of
this
leaflet
under
Product description.
Some
of
the
symptoms
of
an
allergic reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash,
itching
or
hives
on
the
skin.
DO NOT USE THIS MEDICINE IF YOU
HAVE
ANY
OF
THE
FOLLOWING
MEDICAL CONDITIONS:
•
active tumours or evidence of
tumour growth.
•
serious
injury
or
illness,
or
surgical
procedures,
requiring
in

Summary of Product characteristics

Page 1 of 15
AUSTRALIAN PRODUCT INFORMATION
SCITROPIN A™ (SOMATROPIN (RBE)) SOLUTION FOR INJECTION
1.
NAME OF THE MEDICINE
Somatropin (rbe) (recombinant human growth hormone, r-hGH)
_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
SciTropin A 5 mg/1.5 mL Solution for Injection contains 3.33 mg/mL
somatropin (rbe).
SciTropin A 10 mg/1.5 mL Solution for Injection contains 6.67 mg/mL
somatropin (rbe).
_List of excipients with known effect: mannitol (SciTropin A 5 mg/1.5
mL solution for injection _
_preparations) _
_ _
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.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
SciTropin A Solution for Injection is a clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC
I
NDICATIONS
SciTropin A is intended for the long term
treatment of children (above three years of age)
with:
•
growth disturbance due to insufficient secretion of pituitary growth
hormone
•
growth disturbance associated with gonadal dysgenesis (Turner
syndrome)
•
growth disturbance associated with chronic renal insufficiency
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
Therapy with somatropin should be initiated and monitored by
physicians who are
experienced in the diagnosis and management of patients with growth
hormone deficiency.
The dose is based on body weight and must always be adjusted
individually in accordance
with the response to therapy.
Daily administration by subcutaneous injection in the evening is
recommended. The
injection sites have to be rotated to minimise the risk of local
lipoatrophy.
Patients and caregivers have to receive appropriate training and
instruction on the proper use
of the SciTropin A vials and the pen, from their physician or other
suitably qualified health
professionals.
Page 2 of 15
_GROWTH