IMMUNE GLOBULIN INTRAVENOUS (HUMAN), 10% 10 G / 100 ML
IMMUNOGLOBULIN (HUMAN) : 10 G / 100 ML · DIN 02230920 · TALECRIS BIOTHERAPEUTICS INC
Health Canada status: CANCELLED POST MARKET
What is IMMUNE GLOBULIN INTRAVENOUS (HUMAN), 10%?
IMMUNE GLOBULIN INTRAVENOUS (HUMAN), 10% 10 G / 100 ML contains IMMUNOGLOBULIN (HUMAN) : 10 G / 100 ML. It is listed in the Health Canada Drug Product Database under DIN 02230920, 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), 10% used for?
Immune Globulin Intravenous (Human), 5% and 10% are effective for treating primary immunodeficiency states with severe antibody-forming capacity impairment, such as congenital agammaglobulinemias, common variable immunodeficiency, Wiskott-Aldrich syndrome, x-linked immunodeficiency with hyper IgM, and severe combined immunodeficiencies. They are also useful when high levels or rapid elevation of circulating antibodies are desired or when intramuscular injections are contraindicated. For Idiopathic Thrombocytopenic Purpura (ITP), administration should be considered when a rapid rise in platelet count is needed to control bleeding or for pre-surgical preparation. Immune Globulin Intravenous (Human), 5% and 10% may also be considered for allogeneic bone marrow transplant (BMT) patients ≥ 20 years of age to reduce the risk of septicemia, other infections, interstitial pneumonia, 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, hospitalizations, 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 | 02230920 |
|---|---|
| Brand name | IMMUNE GLOBULIN INTRAVENOUS (HUMAN), 10% |
| Generic / active ingredient | IMMUNOGLOBULIN (HUMAN) : 10 G / 100 ML |
| Manufacturer | TALECRIS BIOTHERAPEUTICS INC |
| Strength | 10 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 this product identified?
Purchase orders, customs paperwork and tender documents each ask for a different identifier, and a DIN written without its leading zeros is the single most common reason an order line fails to match. Every form Nexara accepts for this product is listed here.
| DIN (8-digit, as used in Nexara ordering) | 02230920 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2230920 |
| Brand name | IMMUNE GLOBULIN INTRAVENOUS (HUMAN), 10% |
| Active ingredient / INN | IMMUNOGLOBULIN (HUMAN) : 10 G / 100 ML |
| ATC code | J06BA02 |
| ATC anatomical main group | J — Anti-infectives for systemic use |
| ATC therapeutic subgroup | J06 |
| AHFS class | 80:04.00 |
| Health Canada schedule | Schedule D |
| Biosimilar biologic | No |
| Market authorization holder | TALECRIS BIOTHERAPEUTICS INC |
How is it stored and handled?
null
How is it supplied?
10, 20, 50, 100, 250 and 500 mL (for 5%); 10, 25, 50, 100 and 200 mL (for 10%)
Which pack is which?
| Strength on the label | 10 G / 100 ML |
|---|---|
| Dosage form | SOLUTION |
| Route | INTRAVENOUS |
| Packaging as described in the monograph | 10, 20, 50, 100, 250 and 500 mL (for 5%); 10, 25, 50, 100 and 200 mL (for 10%) |
| Storage | null |
One DIN can cover more than one pack size, and the pack — not the DIN — is what gets priced, shipped and invoiced. Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation, because this listing covers more than one of them.
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 |
Can this still be bought in Canada?
No. This Drug Identification Number is cancelled post market in Health Canada's Drug Product Database, so the product is no longer authorized for sale in Canada and Nexara does not supply it. This page is kept as a regulatory record.
If you are looking for a current equivalent, the alternatives above list every product sharing this therapeutic class, with the marketed ones first. Ask us to source an alternative
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.