Differences between the original iron sucrose complex Venofer and the iron sucrose similar Sucrofer

نویسنده

  • Sucrofer Shah
چکیده

Sucrofer (an Iron Sucrose complex) is one of the widely used Indian preparations for treatment of Iron deficiency anemia. The study was conducted to determine the possible efficacy and safety differences between the innovator’s Venofer and Indian similar (Sucrofer). Thirty rats were divided into three groups and assigned to receive Sucrofer, Venofer or isotonic saline solution (control). Five single intravenous doses of iron (40 mg iron/kg) or saline (equivalent volume) were administered every 7 days for 4 weeks. Blood and urine samples were collected for biological assessment prior to sacrifice (day 28) after which kidney, liver, and heart homogenates were collected for determination of antioxidant enzyme levels. Immmunohistochemistry techniques were used to identify tissue ferritin, TNFα and IL-6. Systolic blood pressure, creatinine clearance as well as proteinuria were not significantly altered by sucrofer as compared to Venofer throughout the study. Post 28 days treatment, serum levels of AST, ALT and ALP were also not altered by sucrofer as compared to both vehicle and Venofer group. Liver, heart and kidney catalase, thiobarbituric reactive species, CuZn-superoxide dismutase and glutathione peroxidase activity, and reduced to oxidized glutathione ratio were also not significantly altered by sucrofer as compared to venofer at 4 weeks of treatment. Serum iron and percentage transferrin saturation were elevated in both treatment groups (except control) and no differences in haemoglobin concentration were observed. Liver, kidney and heart TNFα and IL-6 were not significantly altered in both treatment groups as compared to control group on day 28. These findings suggest that both Venofer and Sucrofer have similar safety and efficacy profile.

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

منابع مشابه

Bioavailability and stability of intravenous iron sucrose originator versus generic iron sucrose AZAD.

CONTEXT Severe iron deficiency requires intravenous iron supplementation to replenish iron stores. Intravenous iron sucrose has been used for decades for the treatment of anemia. New generic iron sucrose products are now marketed for the use in several countries and there is an ongoing discussion about the safety and efficacy of iron sucrose similars. OBJECTIVE In this study, we compared the ...

متن کامل

Biodistribution and predictive hepatic gene expression of intravenous iron sucrose.

INTRODUCTION We have examined iron biodistribution and hepatic gene expression in rats following administration of the generic Iron Sucrose Azad (ISA) or the reference iron sucrose drug Venofer®. METHODS ISA and Venofer® were administered intravenously to normal, non-anemic, male rats at 15 mg/kg (a supra-therapeutic dose-level). To evaluate biodistribution, tissue iron levels were determined...

متن کامل

Medication practice in hospitals: are nanosimilars evaluated and substituted correctly?

Introduction This study investigates the drug selection and dispensing behaviour of hospital pharmacists of intravenous iron products including iron sucrose and iron sucrose similar, with special emphasis on substitution and interchangeability in France and Spain. Iron-carbohydrate complex drugs represent different available intravenous iron drugs and are part of the non-biological complex drug...

متن کامل

A randomized, open-label trial of iron isomaltoside 1000 (Monofer®) compared with iron sucrose (Venofer®) as maintenance therapy in haemodialysis patients

BACKGROUND Iron deficiency anaemia is common in patients with chronic kidney disease, and intravenous iron is the preferred treatment for those on haemodialysis. The aim of this trial was to compare the efficacy and safety of iron isomaltoside 1000 (Monofer®) with iron sucrose (Venofer®) in haemodialysis patients. METHODS This was an open-label, randomized, multicentre, non-inferiority trial ...

متن کامل

Randomized double-blind safety comparison of intravenous iron dextran versus iron sucrose in an adult non-hemodialysis outpatient population: A feasibility study.

BACKGROUND Intravenous iron therapy is a treatment option for iron deficient patients who are intolerant to oral iron or where oral iron is ineffective, but with possible adverse effects. Currently, prospective studies comparing different intravenous iron formulations are needed to determine safety and efficacy of these agents. METHODS We conducted a prospective, double-blind, randomized cont...

متن کامل

ذخیره در منابع من


  با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

عنوان ژورنال:

دوره   شماره 

صفحات  -

تاریخ انتشار 2013