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Injection Optipeg A 135 mcg/0.5 ml

8,800

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About the Product

Full Description

Presentation
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Optipeg-A 180 prefilled syringe injection: Each pre-filled syringe contains 0.5 ml sterile solution which contains Pegylated Interferon alfa-2a BP 180 microgram
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Optipeg-A 135 prefilled syringe injection: Each pre-filled syringe contains 0.5 ml sterile solution which contains Pegylated Interferon alfa-2a BP 135 microgram.
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Description
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Peginterferon alfa-2a is a covalent conjugate of recombinant alfa-2a interferon with a single branched bis-monomethoxy polyethylene glycol (PEG) chain . The PEG moiety is linked at a single site to the interferon alfa moiety via a stable amide bond to lysine. Peginterferon alfa-2a has an approximate molecular weight of 60,000 daltons. Interferon alfa-2a is produced using recombinant DNA technology in which a cloned human leukocyte interferon gene is inserted into and expressed in Escherichia coli.
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Indications
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Chronic Hepatitis C : Peginterferon alfa-2a alone or in combination with Ribavirin, is indicated for the treatment of adults with chronic hepatitis C (CHC) virus infection who have compensated liver disease and have not been previously treated with interferon alpha.
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Chronic Hepatitis B : Peginterferon alfa-2a is indicated for the treatment of adult patients with HBeAg positive and HBeAg negative chronic hepatitis B who have compensated liver disease and evidence of viral replication and liver inflammation.
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Dosage & Administration
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Chronic hepatitis C: The recommended dose of Peg interferon is 180 mcg once weekly for 48 weeks by subcutaneous administration on abdomen or thigh
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Chronic hepatitis B: The recommended dose of Peg interferon is 180 mcg once weekly for 48 weeks by subcutaneous administration on abdomen or thigh
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Hepatitis C Genotype 1 & 4
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Optipeg-A Monotherapy: 180 mcg once weekly for 48 weeks
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Optipeg-A dual therapy: Optipeg-A: 180 mcg once weekly for 48 weeks; Celbarin: < 75 kg= (400+0+600) mg, > 75 kg= (600+0+600) mg.
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Hepatitis C Genotype 2 & 3
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Optipeg-A Monotherapy: 180 mcg once weekly for 48 weeks
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Optipeg-A dual therapy: Optipeg-A: 180 mcg once weekly for 24 weeks; Celbarin: (400+0+400) mg.
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Side Effects
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? Depression, suicide, relapse of drug abuse and bacterial infection
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? Flu like symptoms: Fatigue, pyrexia,
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? Gastrointestinal: Nausea/Vomiting, diarrhea, abdominal pain
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? Metabolic and Nutritional: Anorexia
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? Musculoskeletal: Myalgia, arthralgia
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? Neurological: Headache, dizziness, insomnia
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? Psychiatric reactions: Irritability, anxiety
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? Injection site reaction, skin problems, hair loss
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? Endocrine: Hypothyroidism
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Precautions
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? Patients who have failed alpha interferon treatment with or without ribavirin
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? Liver or other organ transplant recipients
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? Hepatitis B patients coinfected with HCV or HIV
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? Hepatitis C patients coinfected with HBV or coinfected with HIV with a CD4+ cell count < 100 cells/?L
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? Caution should be exercised in initiating treatment in any patient with baseline risk of severe anemia.
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Use in Pregnancy & Lactation
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Pregnancy Category C: Peginterferon alfa-2a monotherapy
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There are no adequate and well controlled trial on pregnant women & developing fetus due to teratogenic effects. Peginterferon alfa-2a is recommended for use in women of childbearing potential only when they are using effective contraception during therapy.
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Pregnancy Category X: Use with Ribavirin
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It is not known whether peginterferon or ribavirin or its components are excreted in human milk. Because of the potential for adverse reactions from the drugs in nursing infants, a decision must be made whether to discontinue nursing or discontinue peginterferon and ribavirin treatment.
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Drug Interaction
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? Drugs metabolized by CYP1A2: monitor for increased serum levels of theophylline and adjust dose accordingly
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? Methadone: monitor for signs and symptoms of methadone toxicity
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? Nucleoside analogues: closely monitor for toxicities and dose reduce or discontinue Peginterferon alfa 2a/ Ribavirin or both should event worsen
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? Zidovudine: monitor for worsening neutropenia and/or anemia with peginterferon alfa/rifavirin
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? Azathioprine.
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Over Dose
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There are limited experiences of overdose. There were no serious reactions attributed to overdose. There is no specific antidote. Dialysis is not effective.
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Storage
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Peginterferon should be stored at 2? to 8 ?C and shaking should be avoided. Protect from light.
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Commercial Pack
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Optipeg-A 180 prefilled syringe injection: Each box contains 1 pre-filled syringe containing 0.5 ml sterile solution of peginterferon alfa-2a INN 180 mg
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Optipeg-A 135 prefilled syringe injection: Each box contains 1 pre-filled syringe containing 0.5 ml sterile solution of peginterferon alfa-2a INN 135 mg.
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