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ISS Claims of Venofer equivalency.

Myth and Reality

Latest development
Comparison of Oxidative Stress and
Inflammation Induced by Different
Intravenous Iron Sucrose Similar (ISS)
Preparations in a Rat Model1.
Physico-chemical analyses showed that the
molecular structure of most of the ISSs differed
greatly from that of the ISORIG.
These differences may be responsible for
the organ damage and oxidative stress
observed in the ISS groups.
1. Inflammation & Allergy - Drug Targets, 2012, 11,
66-78

The real difference


1.Venofer, Vifor (International), Switzerland
2. ISSFERP (Ferplex SS, Himont Pharmaceuticals, Lahore, Pakistan),
3. ISSFERI (Ferijet, Akson Pharmaceuticals, Azad Kashmir, Pakistan),
4. ISSFERO (Ferosoft S, Hilton Pharma Ltd., Karachi, Pakistan),

1. Inflammation & Allergy - Drug Targets, 2012, 11,


66-78

The Study Conclusion:

1. Inflammation & Allergy - Drug Targets, 2012, 11,


66-78

Current Medical Research & Opinion 2012

ISSs differ from the iron sucrose


originator in safety and efficacy
profiles.
Current Medical Research & Opinion Vol. 28, No.
2, 2012, 241243

Importance of Therapeutic
equivalency
Administration of 200mg of Venofer results in
increase in hemoglobin equivalent to 1gm/dl.
Equivalent amount i.e. 200mg of ISS do not
gives the same results.

Q. Where the rest of the iron


goes?

Venofer - The Global brand


36 generic copies of Venofer in
Pakistan
Few copies in India.
2 Copies in Taiwan
Venofer Price in US - $68 per injection
No copy of Venofer in US till to date, (12
years)

FDA Guideline for Iron sucrose


Generics:

Thank you

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