“We use cookies on this website to enhance your user experience and to personalise content. By clicking any link or continuing to use our Website you agree to our cookies as per our Privacy Policy. Read More” Ok, I agree

Hepatitis B Immune Globulin (Human) (Hepagam B)

Trade Name : HepaGam B

Aptevo BioTherapeutics LLC

INJECTION, SOLUTION

Strength 312 [iU]/mL

HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN Human Immunoglobulin [EPC],Passively Acquired Immunity [PE],Virus Neutralization [MoA],Virus-specific Hyperimmune Globulins [EXT],Immunoglobulins [CS]

Delivery Process

We’ll Get in Touch

Once we review your request, we’ll send you an estimated price for the medicine within 2-5 days.

Confirmation and Payment

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Submit a Request

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Hepatitis B Immune Globulin (Human) (Hepagam B) which is also known as HepaGam B and Manufactured by Aptevo BioTherapeutics LLC. It is available in strength of 312 [iU]/mL per ml. Read more

Hepatitis B Immune Globulin (Human) (Hepagam B) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Inquire directly from our website and get 5% off on any medicine!

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Read more

About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Read more
  • No data
  • Dosage and Administration, Preparation ()u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a01/2012
  • Warning and Precautions, Thrombotic events ()u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a01/2012
  • Clinical Trials in Liver Transplant Patients ()u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a01/2012
  • HepaGam B [Hepatitis B immune globulin intravenous (Human)] is an intravenous immune globulin indicated for the following:
  • For Intravenous or Intramuscular Administration Only
  • Prevention of Hepatitis B recurrence following Liver Transplantation in HBsAg-positive liver transplant patients ().
  • Postexposure Prophylaxis () in the following settings:ntttttttttn
  • Prevention of Hepatitis B recurrence following liver transplantation ()
  • Postexposure Prophylaxis ()
  • 1.0 milliliter sterile solution; single use vial (> 312 IU per milliliter). ()ntttttttt
  • 5.0 milliliters sterile solution; single use vial (> 312 IU per milliliter). ()
  • The measured potency of each lot is stamped on the vial label.
  • No data
  • History of anaphylactic or severe systemic reactions to human globulins ()
  • IgA deficient individuals may have the potential to develop IgA antibodies and have an anaphylactoid reaction. ()
  • IM injections may be contraindicated in patients with coagulation disorders. ()
  • No data
  • Hypersensitivity ()nttttttttt
  • Interference with Blood Glucose Testing ()nttttttttt
  • Monitoring: Serum Anti-HBs Antibody Levels ()nttttttttt
  • Infusion Reactions ()nttttttttt
  • Transmissible Infectious Agents ()
  • Coagulation Disorders ()
  • Thrombotic Events ()
  • The only adverse reactions observed in clinical trial subjects were hypotension and nausea (2% of clinical trial subjects).
  • The only adverse reactions observed in clinical trial subjects were hypotension and nausea (2% of clinical trial subjects). ()ntttttttt
  • To report SUSPECTED ADVERSE REACTIONS, contact Aptevo BioTherapeutics at 1- 844-859-6675 or FDA at 1-800-FDA-1088 or n
  • No data
  • Efficacy of live attenuated virus vaccines may be impaired by immune globulin administration; revaccination may be necessary. ()
  • Antibodies in HepaGam B may interfere with some serological tests. ()
  • Maltose in HepaGam B may interfere with non-glucose specific blood glucose testing systems. ()
  • No data
  • Pregnancy: No human or animal data. Use only if clearly needed. ()
  • Nursing mothers: Caution should be exercised ()
  • Consequences of an overdose are not known. For intramuscular administration of HepaGam B, the only manifestations of overdose would be pain and tenderness at the injection site.
  • HepaGam B, Hepatitis B Immune Globulin Intravenous (Human), is a solvent/detergent-treated sterile solution of purified gamma globulin containing anti-HBs. It is prepared from plasma donated by healthy, screened donors with high titers of anti-HBs that is purified by an anion-exchange column chromatography manufacturing method. HepaGam B is formulated as a 5% (50 milligrams per milliliter) protein solution with 10% maltose and 0.03% polysorbate 80 at pH 5.6. It is available in 1 milliliter and 5 milliliters single dose vials. The product appears as a clear to opalescent liquid. HepaGam B does not contain mercury. It contains no preservatives. This product is intended for single use. HepaGam B may be administered intravenously or intramuscularly dependent upon indication [see ]. The source plasma used in the manufacture of this product was tested by FDA licensed Nucleic Acid testing (NAT) for HIV-1, HBV and HCV and found to be negative. Plasma also has been tested by in-process NAT for hepatitis A virus (HAV) and parvovirus B19 (B19) via minipool testing and the limit for B19 in the manufacturing pool is set not to exceed 10 IU of B19 DNA per milliliter.
  • The manufacturing process contains two steps implemented specifically for virus clearance. The solvent and detergent step (using tri-n-butyl phosphate and Triton X-100) is effective in the inactivation of enveloped viruses, such as hepatitis B, hepatitis C and HIV. Virus filtration, using a Planova 20N virus filter, is effective for the removal of viruses based on their size, including some non-enveloped viruses. These two viral clearance steps are designed to increase product safety by reducing the risk of transmission of enveloped and non-enveloped viruses. In addition to these two specific steps, the process step of anion-exchange chromatography was identified as contributing to the overall viral clearance capacity for small non-enveloped viruses.
  • The inactivation and reduction of known enveloped and nonu2013enveloped model viruses were validated in laboratory studies as summarized in . The viruses employed for spiking studies were selected to represent those viruses that are potential contaminants in the product, and to represent a wide range of physiochemical properties in order to challenge the manufacturing processu2019s ability for viral clearance in general.
  • The product potency is expressed in international units (IU) by comparison to the World Health Organization (WHO) standard Hepatitis B Immune Globulin. Each vial contains greater than 312 IU per milliliter. The measured potency of each lot is stamped on the vial label [].
  • No data
  • A clinical trial examined the effectiveness of HepaGam B in the prevention of hepatitis B recurrence following liver transplantation. The study was a multi-center, open-labeled, superiority study involving HBsAg-positive/HBeAg-negative liver transplant patients. The study included two arms, an active treatment group of patients enrolled to receive the described dosing regimen of HepaGam B starting during transplant and continuing over the course of a year, and a retrospective untreated control group of historical patients with data gathered by chart review.
  • There were 27 liver transplant patients who received HepaGam B and 14 retrospective untreated control patients. The patients in both groups were HBsAg-positive/HBeAg-negative liver transplant patients who met similar entry criteria, had similar medical history and had similar status at transplant based on MELD and/or ChildPugh-Turcotte scores.
  • In the active treatment group, HepaGam B intravenous doses of 35 milliliters were initiated during transplant according to the regimen identified in [see ]. As a result of the targeted potency of 550 IU per milliliter at the time of manufacture [], the 35 milliliter doses of HepaGam B used in this study actually contained between 17,000 and 23,000 IU anti-HBs. These 35 milliliter doses consistently yielded anti-HBs trough levels > 500 IU per liter (99% of all anti-HBs levels were > 500 IU per liter; see (). Patients received HepaGam B doses diluted with 50 mL of saline.
  • Figure 1: Frequency Histogram of Trough anti-HBs Levels more than 30 days after Transplant
  • Values below the target trough were only observed in the 2 patients with HBV recurrence who had anti-HBs levels <150 IU per liter at the time of seroconversion.
  • For the efficacy endpoint of the proportion of patients with HBV recurrence (HBsAg positive and/or HBeAg positive after 4 weeks post-OLT), a significant treatment effect was observed. As summarized in , HBV recurrence was seen in 2/24 or 8.3% of HepaGam B patients compared to 12/14 or 86% of retrospective untreated control patients (see ). Two of the HepaGam B patients who died within 28 days post-transplant were excluded from all efficacy analyses, but included for safety analyses. The deaths were not HBV or study drug related.
  • The conclusion that HepaGam B monotherapy post-OLT is effective at preventing HBV recurrence post-OLT is further supported by the secondary endpoints of time to recurrence, survival, anti-HBs levels, biochemical markers of liver inflammation, and liver biopsy. Time to recurrence for the HepaGam B treatment group was 358 days for two HBV recurrent patients. In comparison, the retrospective untreated control patients had a median time to recurrence of 88 days with a 95% confidence interval of 47 to 125 days. Survival calculations showed that 96% (23/24) of patients in the active treatment group survived for at least 1 year post-OLT compared to 43% (6/14) retrospective control patients. The endpoints for HBV recurrence were supported by an observed drop in anti-HBs levels, elevated liver function tests, and abnormal liver biopsy result at the time of recurrence.
  • HepaGam B is recommended in patients who have no or low levels of viral replication at the time of liver transplantation. The clinical trial evaluating HepaGam B in liver transplant patients selected patients with no or low replication status only. HepaGam B therapy has not been evaluated in combination with antiviral therapy post-transplantation.
  • No data
  • NDC 70504-0052-2; a carton containing a 1.0 milliliter single dose vial (>312 IU per milliliter; measured potency of each lot is stamped on the vial label) and a package insert.
  • NDC 70504-0051-2; a carton containing a 5.0 milliliter single dose vial (>312 IU per millileter; measure potency of each lot is stamped on the vial label) and a package insert.
  • Store at 36 to 46 u00b0F (2 to 8 u00b0C). Do not freeze. Do not use after expiration date. Use within 6 hours after the vial has been entered.
  • HepaGam B [Hepatitis B Immune Globulin Intravenous (Human)] Sterile Solution for Injection and any and all Aptevo BioTherapeutics LLC brand, product, service and feature names, logos, slogans are trademarks or registered trademarks of Aptevo BioTherapeutics LLC. All rights reserved.
  • PLANOVA is a registered trademark of Asahi Kasei Medical Co., Ltd, TRITON is a registered trademark of Union Carbide Corporation.
  • Manufactured by:ntttttttAptevo BioTherapeutics LLC ntttttttBerwyn PA, 19312 ntttttttU.S. License No. 2054ntttttt
  • No data
  • No data
  • No data
  • No data

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Desogestrel And Ethinyl Estradiol (Emoquette)

Manufacturer: REMEDYREPACK INC.

Presentation: KIT

Strength:

Pack Size:

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Manufacturer: REMEDYREPACK INC.

Presentation: TABLET

Strength: 2.5; .025 mg/1; mg/1

Pack Size:

Fluoxetine Hydrochloride (Fluoxetine)

Fluoxetine Hydrochloride (Fluoxetine)

Manufacturer: REMEDYREPACK INC.

Presentation: CAPSULE

Strength: 40 mg/1

Pack Size:

Metoprolol Succinate (Metoprolol Succinate)

Metoprolol Succinate (Metoprolol Succinate)

Manufacturer: REMEDYREPACK INC.

Presentation: TABLET, EXTENDED RELEASE

Strength: 25 mg/1

Pack Size:

Losartan Potassium (Losartan Potassium)

Losartan Potassium (Losartan Potassium)

Manufacturer: REMEDYREPACK INC.

Presentation: TABLET, FILM COATED

Strength: 25 mg/1

Pack Size:

Browse Our Services And Processes

Comparator Sourcing for Clinical Trials

Comparator Sourcing for Clinical Trials

GNH India brings over 10 years of experience in Comparator

Read More

Name Patient Supply

Name Patient Supply

Today, the exact cause for many rare diseases remains unknown

Read More

Validated Cold Chain Shipment

Validated Cold Chain Shipment

With shifting of pharma industry from synthetic molecules to biologic

Read More

Clinical Trials Supply

Clinical Trials Supply

STOP SOURCING..... START SMART SOURCING...... COME STRAIGHT TO THE SOURCE

Read More

Pharmaceutical Contract Manufacturing

Pharmaceutical Contract Manufacturing

GNH Provides Contract Manufacturing services for: Generic Medicines with following

Read More

Pricing

Pricing

PRICING POLICY Terms of sales are typically prepaid, unless otherwise

Read More

Disclaimer

Please see the Legal Notice for detailed terms and disclaimers. The Legal Notice governs the use of this Website and by accessing and using this Website you agree to be bound by and accept the Legal Notice.

Browse from other international pharmaceuticals

General

64020 Products

GNH India Brings to over 64036 Product SKUs from India all at 1 place with easy access and global deliveries.

US NDC

71245 Products

GNH India Brings to over 71252 Product SKUs from India all at 1 place with easy access and global deliveries.

Canadian DIN

51046 Products

GNH India Brings to over 51047 Product SKUs from India all at 1 place with easy access and global deliveries.

Swiss Drugs

150 Products

GNH India Brings to over 150 Product SKUs from India all at 1 place with easy access and global deliveries.

NZ Drugs

13296 Products

GNH Brings to over 13298 Product SKUs from India all at 1 place with easy access and global deliveries.

FAQ

Check out our delivery process

Can’t find what
you’re looking for?

Contact US
Get Price

Are you an existing customer or a vendor of GNH India? Log in here to

View your Transaction
COMPANY
SERVICES
QUICK LINKS
CONTACT US
Registered Office Address:

Unit # G- 14, 15, 16, 17, Ground Floor, Prabhadevi Industrial Estate, Enterprises Industrial Premises, 408, Veer Sawarkar Road, Prabhadevi,
Mumbai 400025 India

US Office Address:

GNH Pharmaceuticals USA LLC,
Suite E # 499, 1235 EAST BLVD,
Charlotte, NC, 28203, U.S.A
TEL: +1 704 557 0412

Pharmexcil
DB
FIEO-2016
SiteLock

Copyright © 2024 GNHIndia .com. All Rights Reserved. Please read Legal Notice for further details.

Disclaimer: Product names, logos, brands and other trademarks featured or referred to are the property of their respective trademark holders.