OMNITROPE somatropin (rbe) 5mg/1.5mL injection cartridge with pre-assembled cartridge holder

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

Somatropin, Quantity: 3.3 mg/mL

זמין מ:

Sandoz Pty Ltd

INN (שם בינלאומי):

Somatropin

טופס פרצבטיות:

Injection

הרכב:

Excipient Ingredients: poloxamer; dibasic sodium phosphate heptahydrate; benzyl alcohol; sodium hydroxide; monobasic sodium phosphate; mannitol; water for injections; phosphoric acid

מסלול נתינה (של תרופות):

Subcutaneous

יחידות באריזה:

1 cartridge of solution for injection, 5 cartridges of solution for injection, 10 cartridges of solution for injection.

סוג מרשם:

(S4) Prescription Only Medicine

סממני תרפויטית:

OMNITROPE is intended for 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's syndrome); & growth disturbance associated with chronic renal insufficiency.

leaflet_short:

Visual Identification: Clear to turbid, colourless solution.; Container Type: Cartridge; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

מצב אישור:

Licence status A

תאריך אישור:

2014-10-28

עלון מידע

OMNITROPE
®
1
OMNITROPE
®
_Somatropin (rbe) (recombinant human growth hormone, r-hGH) _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Omnitrope.
It does not contain all 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 need to read it again.
WHAT OMNITROPE 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.
Omnitrope 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 YOU USE
OMNITROPE
_WHEN YOU MUST NOT USE IT _
DO NOT USE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
somatropin, the active ingredient
•
any of the 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
intensive care
•

מאפייני מוצר

210803-Omnitrope-pi
Page 1 of 17
AUSTRALIAN PRODUCT INFORMATION
OMNITROPE
® (SOMATROPIN (RBE)) SOLUTION FOR INJECTION AND
POWDER FOR SOLUTION FOR INJECTION
1.
NAME OF THE MEDICINE
Somatropin (rbe) (recombinant human growth hormone, r-hGH)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Omnitrope 5 mg/1.5 mL solution for injection contains 3.33 mg/mL
somatropin.
Omnitrope 5 mg/1.5 mL solution for injection for SurePal 5 contains
3.33 mg/mL somatropin.
Omnitrope 10 mg/1.5 mL solution for injection contains 6.67 mg/mL
somatropin (rbe).
Omnitrope 10 mg/1.5 mL
solution for injection for SurePal 10
contains
6.67 mg/mL
somatropin (rbe).
Omnitrope 15 mg/1.5 mL solution for injection for SurePal 15 contains
10 mg/mL somatropin
(rbe).
Omnitrope
1.33
mg
powder
for
injection
contains
1.33
mg/mL
somatropin
(rbe)
on
reconstitution.
Omnitrope 5 mg powder for injection contains 5 mg/mL somatropin (rbe)
on reconstitution.
_List of excipients with known effect_
: mannitol (Omnitrope 5 mg/1.5 mL solution for injection
preparations)
Omnitrope
®
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
Omnitrope solution for injection is a clear, colourless solution.
Omnitrope powder for injection is a white to off-white powder.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Omnitrope 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 diagnos