IMMUNE GLOBULIN INTRAVENOUS (HUMAN), 5% 5 G / 100 ML
IMMUNOGLOBULIN (HUMAN) : 5 G / 100 ML · DIN 02230919 · TALECRIS BIOTHERAPEUTICS INC
Health Canada status: CANCELLED POST MARKET
What is IMMUNE GLOBULIN INTRAVENOUS (HUMAN), 5%?
IMMUNE GLOBULIN INTRAVENOUS (HUMAN), 5% 5 G / 100 ML contains IMMUNOGLOBULIN (HUMAN) : 5 G / 100 ML. It is listed in the Health Canada Drug Product Database under DIN 02230919, held by TALECRIS BIOTHERAPEUTICS INC, supplied as SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as cancelled post market, status dated 03-Aug-2006. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.
What is IMMUNE GLOBULIN INTRAVENOUS (HUMAN), 5% used for?
Immune Globulin Intravenous (Human), 5% and Immune Globulin Intravenous (Human), 10% are effective in treating primary immunodeficiency states with severe impairment of antibody forming capacity, such as congenital agammaglobulinemias, common variable immunodeficiency, Wiskott-Aldrich syndrome, x-linked immunodeficiency with hyper IgM, and severe combined immunodeficiencies. They are particularly useful when high levels or rapid elevation of circulating antibodies are desired or when intramuscular injections are contraindicated. They are also used in clinical situations where a rapid rise in platelet count is needed for Idiopathic Thrombocytopenic Purpura (ITP) to control bleeding or for surgery. Immune Globulin Intravenous (Human), 5% and 10% can be considered for use in allogeneic bone marrow transplant (BMT) patients ≥ 20 years of age to decrease the risk of septicemia and other infections, interstitial pneumonia of infectious or idiopathic etiologies, and acute graft-versus-host disease (GVHD) in the first 100 days post transplant. Immune Globulin Intravenous (Human), 5% significantly decreases the frequency of serious and minor bacterial infections and hospitalization, and increases the time free of serious infection in children with clinical or immunologic evidence of HIV disease with CD4+ counts of ≥ 200 mm3.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
Product details and regulatory record
| DIN | 02230919 |
|---|---|
| Brand name | IMMUNE GLOBULIN INTRAVENOUS (HUMAN), 5% |
| Generic / active ingredient | IMMUNOGLOBULIN (HUMAN) : 5 G / 100 ML |
| Manufacturer | TALECRIS BIOTHERAPEUTICS INC |
| Strength | 5 G / 100 ML |
| Dosage form | SOLUTION |
| Route of administration | INTRAVENOUS |
| Schedule | Schedule D |
| ATC code | J06BA02 IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASC. ADM. |
| AHFS class | 80:04.00 |
| Biosimilar | No |
| Health Canada status | CANCELLED POST MARKET |
| Status date | 03-Aug-2006 |
| Original market date | 2000-07-31 00:00:00 |
How is it administered?
Administer intravenously. ITP: 400 mg/kg for 5 days or 1000 mg/kg for 1-2 days. BMT: 500 mg/kg. Pediatric HIV: 400 mg/kg every 28 days. Follow specific infusion rates.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
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How is it supplied?
5% (IN 10% MALTOSE) pH 4.25: 10, 20, 50, 100, 250 and 500 mL; 10% (IN 0.16-0.24 M GLYCINE) pH 4.25: 10, 25, 50, 100 and 200 mL
Contraindications
Known anaphylactic or severe systemic response to Immune Globulin (Human). Individuals with selective IgA deficiencies who have known antibody against IgA.
Warnings and precautions
Associated with renal dysfunction, acute renal failure, and death. Risk of infectious agents (human plasma product). Rare precipitous fall in blood pressure/anaphylaxis. Monitor vital signs.
What can be used instead?
Other Canadian products sharing ATC code J06BA02 IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASC. ADM.. 5 of 25 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.
| Product | Strength | Form | Manufacturer | Health Canada status | DIN |
|---|---|---|---|---|---|
| GAMMAGARD LIQUID | 10 % | SOLUTION | TAKEDA CANADA INC | MARKETED | DIN 02279444 |
| GAMMAGARD S/D | 5 G | SOLUTION ; POWDER FOR SOLUTION ; KIT | TAKEDA CANADA INC | MARKETED | DIN 02231470 |
| GAMUNEX | 10 G / 100 ML | SOLUTION | GRIFOLS THERAPEUTICS LLC | MARKETED | DIN 02247724 |
| IGIVNEX | 10 G / 100 ML | SOLUTION | GRIFOLS THERAPEUTICS LLC | MARKETED | DIN 02277921 |
| PRIVIGEN | 10 % | SOLUTION | CSL BEHRING CANADA INC | MARKETED | DIN 02304619 |
| FLEBOGAMMA 10% | 100 MG | SOLUTION | INSTITUTO GRIFOLS S.A. | APPROVED | DIN 02467526 |
| FLEBOGAMMA 5% | 50 MG | SOLUTION | INSTITUTO GRIFOLS S.A. | APPROVED | DIN 02467488 |
| GAMIMUNE N 10% (IV) | 100 MG | SOLUTION | TALECRIS BIOTHERAPEUTICS INC | CANCELLED POST MARKET | DIN 02229695 |
| GAMIMUNE N 5% (IV) | 50 MG | SOLUTION | TALECRIS BIOTHERAPEUTICS INC | CANCELLED POST MARKET | DIN 02178842 |
| GAMIMUNE N INJ 5% (IV) | 50 MG | LIQUID | CUTTER MED & BIOL, DIVISION OF MILES CANADA LTD. | CANCELLED POST MARKET | DIN 00559261 |
How can I get it?
Nexara Health supplies this product to licensed Canadian buyers — pharmacies, hospitals, clinics, licensed distributors, and clinical trial sponsors or their CROs. We confirm stock, pack size, expiry and pricing at the time of quotation. If the product is on backorder or in shortage, we identify equivalent alternatives and import options where permitted.
Ordering questions
Who can buy this from Nexara?
Licensed entities only. Nexara holds Health Canada establishment licence DEL 3-002896-A and ships only to a licensed address.
Is there a minimum order?
Yes, set per product line and per pack multiple rather than on the order total, so you are never asked to buy a part-pack. The minimum for this line is confirmed with your quote.
What is the lead time?
Confirmed per order at quotation, and it depends on current stock position and whether the product is in shortage.
Can Nexara supply this for a clinical trial?
Yes — comparator and background-therapy supply, including sourcing from other markets where a Canadian pack will not satisfy the protocol. Clinical trial supply.