VENOFER

Country: Indónesía

Tungumál: indónesíska

Heimild: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Virkt innihaldsefni:

IRON SUCROSE

Fáanlegur frá:

COMBIPHAR - Indonesia

INN (Alþjóðlegt nafn):

IRON SUCROSE

Skammtar:

20 MG/ML

Lyfjaform:

CAIRAN INJEKSI

Einingar í pakka:

DUS, 5 AMPUL @ 5 ML

Framleitt af:

IDT BIOLOGIKA GMBH - Germany

Leyfisdagur:

2019-05-27

Vara einkenni

3005174-01
INJECTION
_IRON SUCROSE COMPLEX_
COLOURS/FLATS
Black
PRODUCT
Venofer Ampoules
COUNTRY
Indonesia
MANUFACTURER
IDT
SAP NUMBER
3005174-01
MIN. VER.: 03
MANUFACTURER IDENTIFICATION NUMBER
3030812101
FONTS
Univers (min. 8.5 pt)
DIMENSIONS
170 x 295 mm
NON-PRINTED COLOURS
Dye Cut
Not printet Color
COMPOSITION
Each 5 mL ampoule contains 20 mg/mL Iron as Iron Sucrose
corresponding to 100 mg Iron per ampoule.
MODE OF ACTION
PHARMACOLOGICAL PROPERTIES
PHARMACODYNAMIC PROPERTIES
The ferrokinetics of Venofer labelled with
59
Fe and
52
Fe were
assessed in 5 patients with anaemia and chronic renal failure.
Plasma clearance of
52
Fe was in the range of 60 to 100 minutes.
52
Fe was distributed to the liver, spleen and bone marrow. At
two weeks after administration, the maximum red blood cell
utilisation of
59
Fe ranged from 62% to 97%.
PHARMACOKINETIC PROPERTIES
Following intravenous injection of a single dose of Venofer con-
taining 100 mg Fe (III) in healthy volunteers, maximum iron lev-
els, averaging 538 µmol/L, were obtained 10 minutes after injec-
tion. The volume of distribution of the central compartment
corresponded well to the volume plasma (approx. 3 Litres).
The iron injected was rapidly cleared from the plasma, the ter-
minal half-life being approx. 6 h. The volume of distribution at
steady state was about 8 Litres, indicating a low iron distribu-
tion in the body fluid. Due to the lower stability of iron sucrose
in comparison to transferrin, a competitive exchange of iron to
transferrin was observed. This resulted in iron transport of
approx. 31 mg Fe (III) / 24 h.
Renal elimination of iron, occurring in the first 4 h after injection,
corresponds
to
less than 5% of the total body clearance. After
24 h the plasma levels of iron were reduced to the pre-dose iron
level and about 75% of the dosage of sucrose was excreted.
PRECLINICAL SAFETY DATA
There are no preclinical data of relevance to the prescriber that
are additional to information already in other sections of the
SPC.
INDICATIONS
ADULT
Venofer is i