DIGIFAB 40 MG — DIN 02361043
DIGOXIN IMMUNE FAB (OVINE) : 40 MG · BTG INTERNATIONAL INC · POWDER FOR SOLUTION · wholesale supply in Canada
Health Canada status: MARKETED
What is DIGIFAB?
DIGIFAB 40 MG contains DIGOXIN IMMUNE FAB (OVINE) : 40 MG. It is listed in the Health Canada Drug Product Database under DIN 02361043, held by BTG INTERNATIONAL INC, supplied as POWDER FOR SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as marketed, status dated 04-Nov-2011. 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 DIGIFAB used for?
Treatment of life-threatening or potentially life-threatening digoxin toxicity or overdose. Also used for life-threatening digitoxin overdose.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
Is there a generic Digitalis Antitoxin in Canada, and who makes it?
Every market authorization holder with a Canadian DIN for this molecule, and how many of their listings Health Canada currently shows as marketed.
2 holders have a Canadian DIN containing Digitalis Antitoxin, across 2 DINs, of which 1 are currently marketed. Marketed count is the number that matters: an approval that is not marketed cannot be bought.
| Market authorization holder | DINs | Marketed | Brand names | Position |
|---|---|---|---|---|
| BTG INTERNATIONAL INC | 1 | 1 | DIGIFAB | Sourceable in Canada |
| GLAXOSMITHKLINE INC | 1 | 0 | DIGIBIND | No marketed DIN |
Health Canada’s Drug Product Database does not flag which listing is the originator and which are subsequent-entry products, so Nexara does not label them here. Interchangeability is determined provincially, not federally — confirm for your province before a formulary switch. Nexara can confirm which of these is actually obtainable, and on what lead time, per order.
How is it supplied and stored?
Pack configuration, storage class and the handling constraints that drive cold-chain planning. One DIN can cover more than one pack size, and the pack — not the DIN — is what gets priced, shipped and invoiced.
| Strength on the label | 40 MG |
|---|---|
| Dosage form | POWDER FOR SOLUTION |
| Route | INTRAVENOUS |
| Pack configuration (monograph) | 40 mg/vial. Reconstitute with 4 mL Sterile Water for Injection. |
| Storage | Store at 2 - 8°C. Reconstituted product should be used promptly or stored at 2 - 8°C for up to 4 hours. |
| Shipping class | Cold chain — validated shipper with temperature monitoring |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Cold chain. This product is stored refrigerated. Nexara ships it on a validated cold chain with temperature monitoring; a delivery address that cannot receive and store it at 2–8 °C on arrival must be flagged before the order is placed.
Substance and classification
| Active substance | Digitalis Antitoxin |
|---|---|
| ATC code | V03AB24 |
| AHFS class | 91:00.00 |
| Biosimilar biologic | No |
Health Canada record and identifiers
The regulatory facts straight from the Drug Product Database, plus every identifier form Nexara accepts on a purchase order. A DIN written without its leading zeros is the commonest reason an order line fails to match.
| DIN (8-digit, as used in ordering) | 02361043 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2361043 |
| Brand name | DIGIFAB |
| Generic / active ingredient | DIGOXIN IMMUNE FAB (OVINE) : 40 MG |
| Market authorization holder | BTG INTERNATIONAL INC |
| Health Canada schedule | Schedule D |
| ATC code | V03AB24 |
| ATC anatomical main group | V — Various |
| ATC therapeutic subgroup | V03AB |
| Current status | MARKETED |
| Status date | 04-Nov-2011 |
| Original market date | 2011-11-04 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
Administer by IV infusion over 30 minutes (bolus if cardiac arrest is imminent). Dosage varies based on amount of digoxin/digitoxin to be neutralized; average dose is 4 vials.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
There are no known contraindications.
Warnings and precautions
Risk of anaphylactic/allergic reactions (especially if allergic to sheep protein or papain). Monitor for rapid drop in serum potassium and withdrawal of inotropic action of digoxin.
What can be used instead?
Alternatives on every axis a buyer actually considers — the same molecule in another presentation, the same class, an adjacent class, or a fixed-dose combination. Every row is led by the marketed DIN count, because that is what can be bought this week.
1 · Same molecule, other Canadian presentations
1 of 2 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| DIGIBIND | 38 MG | POWDER FOR SOLUTION | GLAXOSMITHKLINE INC | CANCELLED POST MARKET | 02146967 |
2 · Same class — other molecules in ATC V03AB
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Naloxone | INJECTABLE NALOXONE HYDROCHLORIDE · KLOXXADO · NALOXONE HCL INJECTION - 0.4MG/ML USP · NALOXONE HCL INJECTION - 1MG/ML USP · +11 more | 26 | 12 | Yes |
| Sugammadex | BRIDION · PMS-SUGAMMADEX · SUGAMMADEX · SUGAMMADEX INJECTION · +1 more | 14 | 4 | Yes |
| Thiosulphate | SEACALPHYX · SODIUM THIOSULFATE INJ 25% USP · SODIUM THIOSULFATE INJECTION USP | 4 | 3 | Yes |
| Methylthioninium Chloride | METHYLENE BLEU LIQ 2% · METHYLENE BLUE INJ 1% · METHYLENE BLUE INJ 1% USP · METHYLENE BLUE INJ 10MG/ML USP · +3 more | 11 | 2 | Yes |
| Flumazenil | ANEXATE INJ 0.1MG/ML · FLUMAZENIL INJECTION · FLUMAZENIL INJECTION SDZ · FLUMAZENIL INJECTION, USP · +1 more | 6 | 2 | Yes |
| Protamine | PROTAMINE SULFATE INJ 10MG/ML USP · PROTAMINE SULFATE INJECTION USP · PROTAMINE SULFATE INJECTION, USP | 4 | 2 | Yes |
| Fomepizole | ANTIZOL · FOMEPIZOLE FOR INJECTION | 2 | 2 | Yes |
| Hydroxocobalamin | CYANOKIT | 2 | 1 | Yes |
| Digitalis Antitoxin | DIGIBIND · DIGIFAB | 2 | 1 | Yes |
| Idarucizimab | PRAXBIND | 1 | 1 | Yes |
A molecule with zero marketed DINs cannot be sourced domestically, however many approvals it holds — if one of these sits on a formulary or in an older protocol, that is the line to check.
3 · Adjacent classes in ATC V03A
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| V03AC | Deferasirox · Deferiprone · Deferoxamine | 57 | 44 |
| V03AN | Carbon Dioxide · Combination · Helium · Medical Air · Medical Gases · +2 more | 112 | 43 |
| V03AE | Calcium Acetate · Drugs For Treatment Of Hyperkalemia And Hyperphosphatemia · Lanthanum Carbonate · Patiromer Calcium · Polystyrene Sulphonate · +3 more | 40 | 19 |
| V03AF | Amifostine · Calcium Folinate · Dexrazoxane · Mesna · Palifermin · +1 more | 34 | 16 |
| V03AH | Diazoxide | 2 | 1 |
| V03AX | Cobicistat · Difelikefalin · Other Therapeutic Products | 8 | 1 |
| V03AZ | Ethanol | 1 | 0 |
Not clinical advice. These tables describe what can be supplied in Canada, not what should be prescribed. Substitution within or across classes is a prescriber and pharmacist decision, and interchangeability is determined provincially.
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. Patients and unlicensed buyers are routed to a partner pharmacy.
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.
Why is there no price on this page?
Nexara quotes a delivered Canadian price per order, against a verified licence. Foreign list prices are published on incompatible bases and are not a guide to what any buyer can obtain here, so this page shows which markets list the molecule and on what basis, and nothing more.
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.