GAMIMUNE N 5% (IV) 50 MG
IMMUNOGLOBULIN (HUMAN) : 50 MG · DIN 02178842 · TALECRIS BIOTHERAPEUTICS INC
Health Canada status: CANCELLED POST MARKET
What is GAMIMUNE N 5% (IV)?
GAMIMUNE N 5% (IV) 50 MG contains IMMUNOGLOBULIN (HUMAN) : 50 MG. It is listed in the Health Canada Drug Product Database under DIN 02178842, 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 GAMIMUNE N 5% (IV) used for?
GAMIMUNE® N, 5% and 10% are effective in treating primary immunodeficiency states, including congenital agammaglobulinemias, common variable immunodeficiency, Wiskott-Aldrich syndrome, x-linked immunodeficiency with hyper IgM, and severe combined immunodeficiencies, especially when high or rapid antibody levels are needed or intramuscular injections are contraindicated. They are also considered for Idiopathic Thrombocytopenic Purpura (ITP) when a rapid rise in platelet count is required to control bleeding or before surgery. Additionally, GAMIMUNE® N, 5% can be used in allogeneic bone marrow transplant patients aged ≥20 years to reduce the risk of septicemia, infections, interstitial pneumonia, and acute graft-versus-host disease (GVHD) in the first 100 days post-transplant, and GAMIMUNE® N, 5% significantly decreases bacterial infections and hospitalization frequency in children with HIV disease and CD4+ counts ≥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 | 02178842 |
|---|---|
| Brand name | GAMIMUNE N 5% (IV) |
| Generic / active ingredient | IMMUNOGLOBULIN (HUMAN) : 50 MG |
| Manufacturer | TALECRIS BIOTHERAPEUTICS INC |
| Strength | 50 MG |
| 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 | 1997-01-17 00:00:00 |
How is it stored and handled?
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How is it supplied?
10, 20, 50, 100, 250 and 500 mL (5%) and 10, 25, 50, 100 and 200 mL (10%)
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 INJ 5% (IV) | 50 MG | LIQUID | CUTTER MED & BIOL, DIVISION OF MILES CANADA LTD. | CANCELLED POST MARKET | DIN 00559261 |
| GAMMAGARD S/D | 10 G | SOLUTION ; KIT ; POWDER FOR SOLUTION | TAKEDA CANADA INC | DORMANT | DIN 02231471 |
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.