Venofer Solution for Injection 20mgml

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

IRON (III)- HYDROXIDE SUCROSE COMPLEX

Available from:

ZUELLIG PHARMA SDN BHD

INN (International Name):

IRON (III)- HYDROXIDE SUCROSE COMPLEX

Units in package:

5ml x 5ampoule Ampoules

Manufactured by:

Siegfried Hameln GmBH

Summary of Product characteristics

VNF_LFT_01S_AMP_MY/XXXXX/XX/XX
COLOURS/FLATS
Black
PRODUCT
Venofer Ampoules
COUNTRY
Malaysia
MANUFACTURER
SGD
SAP NUMBER
VNF_LFT_01S_
AMP_MY
MIN. VER.: 02
MANUFACTURER IDENTIFICATION NUMBER
XXXXX/XX/XX
FONTS
Univers (min. 8 pt)
DIMENSIONS
148 x 600 mm
NON-PRINTED COLOURS
Dye Cut
1. NAME OF THE MEDICINAL PRODUCT
Venofer, 20 mg iron per ml, solution for injection or
concentrate for solution for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml ampoule of Venofer contains 100 mg iron
as iron sucrose [iron(III)-hydroxide sucrose com
-
plex] corresponding to 20 mg iron per ml.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection or concentrate for solution for
infusion.
Venofer is a dark brown, non transparent, aqueous
solution.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Venofer is indicated for the treatment of iron defi
-
ciency in the following indications:
•
Where there is a clinical need for a rapid iron
supply
•
In patients who cannot tolerate oral iron
therapy or who are non-compliant
•
Where oral iron preparations are ineffective
(e. g., in active inflammatory bowel disease)
Venofer should only be administered where the
indication is confirmed by appropriate investiga
-
tions.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The cumulative dose of Venofer must be calculated for
each patient individually and must not be exceeded.
_Calculation of dosage_
The total cumulative dose of Venofer, equivalent to
the total iron deficit (mg), is determined by the hae
-
moglobin level (Hb) and body weight (BW). The
dose of Venofer must be individually calculated for
each patient according to the total iron deficit cal
-
culated with the following Ganzoni formula, for
example:
TOTAL IRON DEFICIT [MG] = BW [KG] X (TARGET
HB – ACTUAL HB) [G/DL] X 2.4* + STORAGE IRON [MG]
Below 35 kg BW:
Target Hb = 13 g/dl and storage iron = 15 mg/kg BW
35 kg BW and above:
Target Hb = 15 g/dl and storage iron = 500 mg
*
Factor 2.4 = 0.0034 (iron content of Hb = 0.3