OMNITROPE somatropin (rbe) 5mg/1.5mL injection cartridge

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

Somatropin, Quantity: 3.3 mg/mL

Dostupno od:

Sandoz Pty Ltd

Farmaceutski oblik:

Injection

Sastav:

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

Administracija rute:

Subcutaneous

Jedinice u paketu:

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

Tip recepta:

(S4) Prescription Only Medicine

Terapijske indikacije:

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.

Proizvod sažetak:

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

Status autorizacije:

Licence status A

Datum autorizacije:

2004-10-11

Svojstava lijeka

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