NUTROPIN AQ somatropin recombinant DNA 10mg/2mL solution for injection cartridge

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Toimeaine:

Somatropin, Quantity: 5 mg/mL

Saadav alates:

Ipsen Pty Ltd

INN (Rahvusvaheline Nimetus):

Somatropin

Ravimvorm:

Injection, solution

Koostis:

Excipient Ingredients: water for injections; phenol; polysorbate 20; sodium citrate dihydrate; citric acid; sodium chloride

Manustamisviis:

Subcutaneous

Ühikuid pakis:

3 cartridges, 1 cartridge

Retsepti tüüp:

(S4) Prescription Only Medicine

Näidustused:

Long-term treatment of children with growth failure due to inadequate endogenous growth hormone secretion. Long-term treatment of growth failure associated with Turner syndrome. Treatment of prepubertal children with growth failure associated with chronic renal insufficiency up to the time of renal transplantation. Treatment of adults with severe growth hormone deficiency as diagnosed in the insulin tolerance test for growth hormone deficiency and defined by peak GH concentrations of less than 2.5 ng/mL.

Toote kokkuvõte:

Visual Identification: A clear colourless solution.; Container Type: Cartridge; Container Material: Glass; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Volitamisolek:

Registered

Loa andmise kuupäev:

2006-07-10

Infovoldik

NUTROPINAQ
®
_10MG (5MG/ML)_
_(Somatropin (INN) recombinant DNA origin, Escherichia coli.)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before you use NutropinAq.
This leaflet answers some common
questions about NutropinAq. 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 NutropinAq
against the benefits he/she expects it
will have for you.
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 IS NUTROPINAQ?
The active substance of NutropinAq
is somatropin. Somatropin is human
growth hormone, which is made by
genetic engineering using the
bacterial micro-organism Escherichia
coli. The structure of somatropin is
identical to human growth hormone
of pituitary origin.
Somatropin has effects that are
equivalent to human growth hormone
of pituitary origin. Growth hormone
exerts significant effects directly on
the production of other hormones,
e.g. IGF-1, and on metabolic actions.
The anabolic and growth-promoting
effects of somatropin are in some
part indirect effects mediated by
IGF-1.
WHAT NUTROPINAQ IS
USED FOR?
NutropinAq is used for:
•
Long-term treatment of children
with growth failure due to
inadequate endogenous growth
hormone secretion.
•
Long-term treatment of growth
failure associated with Turner
syndrome.
•
Treatment of prepubertal children
with growth failure associated
with chronic renal insufficiency
up to the time of renal
transplantation.
•
Replacement of growth hormone
in adults with growth hormone
deficiency originating in either
childhood or adulthood.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS WHY NUTROPINAQ HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
BEFORE YOU USE
NUTROPINAQ
_DO NOT USE NUTROPINAQ:_
•
in case of hypersensitivity to
somatropin or any

Toote omadused

Product Information V7, 23 June 2021
1
AUSTRALIAN PRODUCT INFORMATION
NUTROPIN AQ SOMATROPIN SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
somatropin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
NutropinAq contains somatropin recombinant DNA 10 mg (30 IU) in 2 mL
Somatropin is a human growth hormone (hGH) produced by recombinant DNA
technology.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Solution for injection
NUTROPIN AQ is a clear colourless solution in a 2 mL cartridge.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
Long-term treatment of children with growth failure due to inadequate
endogenous
growth hormone secretion,
-
Long-term treatment of growth failure associated with Turner syndrome,
-
Treatment of prepubertal children with growth failure associated with
chronic renal
insufficiency up to the time of renal transplantation,
-
Treatment of adults with severe growth hormone deficiency as diagnosed
in the
insulin tolerance test for growth hormone deficiency and defined by
peak GH
concentrations of less than 2.5 ng/mL.
Product Information V7, 23 June 2021
2
4.2
DOSE AND METHOD OF ADMINISTRATION
RECOMMENDED DOSAGE:
GROWTH FAILURE IN CHILDREN DUE TO INADEQUATE GROWTH HORMONE SECRETION:
0.025 - 0.035 mg/kg bodyweight given as a daily subcutaneous
injection.
GROWTH FAILURE ASSOCIATED WITH TURNER SYNDROME:
Up to 0.05 mg/kg bodyweight given as a daily subcutaneous injection.
GROWTH FAILURE ASSOCIATED WITH CHRONIC RENAL INSUFFICIENCY:
Up to 0.05 mg/kg bodyweight given as a daily subcutaneous injection.
Somatropin therapy may be continued up to the time of renal
transplantation.
GROWTH HORMONE DEFICIENCY IN ADULTS:
At the start of somatropin therapy, low initial doses of 0.15 - 0.3 mg
are recommended, given as a
daily subcutaneous injection. The dose should be adjusted stepwise,
controlled by serum Insulin-
Like Growth Factor-1 (IGF-1) values. The recommended final dose seldom
exceeds 1.0 mg/day.
In general, the lowest efficacious dose should be administered. In
ol