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HEPAGAM   HEPAGAM
 

 



The world renowned drug manufacturer known as Cangene Corporation have developed and manufactured the HepaGam B which is the first of its kind in intravenous Hepatitis B Immune Globulin that has been authenticated by the Food and Drug Administration to be used for the prevention of Hepatitis B reappearance following the liver transplantation in HBsAg – positive liver transplant patients. HepaGam B is the liquid product that is available in the packing sizes of 1 ml and 5 ml vials which is >312 IU/ml.


HepaGam B has also been licensed by the FDA for the treatment of acute exposure to Hepatitis B infection. Also for the treatment of acute exposure to blood containing HbsAg, perinatal exposure of infants that are born to HbsAg-positive mothers, sexual exposure to HbsAg-positive persons and household exposure to persons having acute HBV infection such as household exposure of infants of less than 12 months of age whose mother or preliminary care giver is reported positive for HBsAg test.

Cangene Corporation’s HepaGam B is Hepatitis B immune globulin intravenous (human) which is the purified antibody or hyper-immune which is especially made for the Hepatitis B virus. The people who have undergone Hepatitis B related liver transplantation need long-term treatment with Hepatitis B immune globulin after specific transplantation. The clinical trial revealed that HepaGam B was most effective in preventing Hepatitis B recurrence.

HepaGam B is the sterile solution of purified gamma globulin-IgG fraction of human plasma that contain antibodies to Hepatitis B surface antigen-anti-HBs. HepaGam B is produced from the plasma accumulated from the healthy, screened donors with high titres of anti-HBs, which is generally purified by the anion-exchange column chromatography process.

HepaGam B has also received the formal approval by Health Canada for the treatment of prevention of Hepatitis B recurrence after the liver transplantation in the adult patients having Hepatitis B as found under the Health Canada’s Notice of Compliance with Conditions – NOC/c policy.
 

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