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Reiferon Retard ® Ampoules

Reiferon Retard is the 3rd Worldwide Novel Pegylated Hansenula-derived Recombinant Interferon alfa-2a for subcutaneous administration.

Ingredient: Pegylated Hansenula-derived recombinant interferon alfa-2a 160 µg.
Multinational Partner: Rhein Biotech
Launch Date: July 1, 2006
Pack: A box containing one vial for subcutaneous administration.

Product General

Disease Area

Reiferon Retard® is indicated for the treatment of chronic hepatitis C in adult patients who are positive for serum HCV‐RNA, including patients with compensated cirrhosis. The optimal way to use Reiferon Retard® in patients with chronic hepatitis C is in combination with Ribavirin. The combination of Reiferon Retard® and Ribavirin is indicated in naive patients and patients who have failed previous treatment with interferon alpha (pegylated or non‐pegylated) alone or in combination with Ribavirin.

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COMPOSITION:

Pegylated Hansenula‐derived recombinant interferon alfa‐2a 160 μg

Excipients: /ml

  • Sodium chloride 8.00 mg
  • Polysorbate 80 0.05 mg
  • Benzyl alcohol 10.00 mg
  • Sodium acetate trihydrate 2.62 mg
  • Acetic acid 0.05 mg

INDICATIONS:

Chronic hepatitis C:

Reiferon Retard® is indicated for the treatment of chronic hepatitis C in adult patients who are positive for serum HCV‐RNA, including patients with compensated cirrhosis. The optimal way to use Reiferon Retard® in patients with chronic hepatitis C is in combination with ribavirin. The combination of Reiferon Retard® and ribavirin is indicated in naive patients and patients who have failed previous treatment with interferon alpha (pegylated or non‐pegylated) alone or in combination with Ribavirin.

Monotherapy is indicated mainly in case of intolerance or contraindication to ribavirin.

DOSAGE AND ADMINISTRATION:

Chronic hepatitis C:

The recommended dose of Reiferon Retard® when used in combination with ribavirin is one vial (160 μg) once weekly or as indicated by the prescribing physician.

The daily dose of ribavirin is 800 mg to 1200 mg administered orally in two divided doses. The dose should be individualized to the patient depending on baseline disease characteristics (e.g. genotype), response to therapy and tolerability of the regimen. Since absorption of ribavirin increases when administered with a meal, patients are advised to take ribavirin with food.

Publications

1-Documents Section

Journal of “The Voice of Harm Reduction” issued by “Eurasian Harm Reduction Network”- Hepatitis C Edition.November 2012. P. 6&7.


Report of “Médecins Sans Frontiers” titled “Diagnosis and Treatment of Hepatitis C: A Technical Landscape”. April 2013 (presented in EASL 2013). P. 12-14


The official page of “Hepnile… Fighting hepatitis in Egypt”. February 2013.


“HCV.HIV.TB Pipeline Report” titled “Low- and Middle-Income Countries Defuse Hepatitis C, the “Viral Time Bomb”. June 2013. P. 2&5


Journal of “Clinical Infectious Diseases” titled “Expanding Access to Treatment for Hepatitis C in Resource-Limited Settings: Lessons From HIV/AIDS”.


Hany M. Shehab, Tamer M. Elbaz and Dalia M. Deraz. Nitazoxanide plus pegylated interferon and ribavirin in the treatment of genotype 4 chronic hepatitis C, a randomized controlled trial. The abstract book of EASL conference, Amsterdam, April 2013 And published in ”Liver International” 2013.


Evaluation of a novel pegylated interferon alpha-2a (Reiferon Retard®) in Egyptian patients with chronic hepatitis C – genotype 4 G. Esmat,*, S. Abdel Fattah b. a Faculty of Medicine, Cairo University, Cairo, Egypt. b Medical Military Academy, Cairo, Egypt


Awad A, El-Ray A, El-Ghannam M, Mounir B: Efficacy and Safety of the Novel Pegylated Interferon alfa-2a (Reiferon Retard®) in Egyptian Patients with Chronic Hepatitis C- Genotype 4. Can J Gastroenterol 2010;24(10):597-602.


Nasser H, Esmat G: Efficacy and Safety of hansenula-derived Peg-IFN α-2a 160 µg plus ribavirin in chronic HCV-genotype 4 Egyptian patients. Abstract book of MASL, Naples, Italy, 2010:13.


Dr. Mohamed Abdel-Hamid. Efficacy and clinical response to Reiferon Retard® in patients with chronic hepatitis C in Egypt. BIT’s 1st World Congress of Virus and Infections 2010.


Amer M, El-Sayed A, Afifi M, Awad S: Response to combination therapy with a novel Hansenula-derived Pegylated-Interferon alpha-2a & Ribavirin in Naïve Egyptian Patients with Chronic Hepatitis C- Genotype 4. Gut 2010;59(Suppl III) A321.


Sadek Y, El-Nawasany A: Predictive Value of Pretreatment Liver Histology and Viral Kinetics on Sustained Virological Response in HCV Patients treated with Hansenula-derived pegylated Interferon Alpha-2a 160 µg with Ribavirin. Gut 2011;60(Suppl 3) A250.


Prof. I. WAKED, Dr. A. SABRY, Dr. E. EL-SHIMI. Failure of Nitazoxanide to Improve Response of Hepatitis C Patients to Pegylated Interferon and Ribavirin Therapy.Abstract book of EASL- AASLD Special Conference, Prague, September, 2012: 159.


Mohamed Tamer Afifi , Ahmed El-Gohary. Evaluation of the Efficacy and Safety of Pegylated Interferon α-2a 160µg (Reiferon Retard®) and Ribavirin Combination in Chronic HCV Genotype 4 patients. The abstract book of Asian Pacific Digestive Week, Malaysia, September 2010.


Alaa Awad Taha. Efficacy of Novel Pegylated Interferon alfa-2a Derived from Hansenula polymorpha, Ribavirin and Amantadine Combination in Treatment of Egyptian Patients with Chronic Hepatitis C Genotype 4: Randomized Trial. The abstract book of 17th International Meeting on Hepatitis C & related viruses, Japan, September 2010.

Guidelines
EASL 2011, AASLD 2011, and AASLD 2009 Clinical Practice Guidelines

Attached Files

2011 EASL.pdf
2011 AASLD.pdf
2009 AASLD.pdf

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