PATENT BLUE SODIUM INJECTION 50 MG / 2 ML — DIN 00405396
PATENT BLUE SODIUM : 50 MG / 2 ML · GUERBET · SOLUTION · wholesale supply in Canada
Health Canada status: MARKETED
What is PATENT BLUE SODIUM INJECTION?
PATENT BLUE SODIUM INJECTION 50 MG / 2 ML contains PATENT BLUE SODIUM : 50 MG / 2 ML. It is listed in the Health Canada Drug Product Database under DIN 00405396, held by GUERBET, supplied as SOLUTION for SUBCUTANEOUS ; INTRAVENOUS administration. Health Canada currently lists it as marketed, status dated 18-Mar-2014. 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 PATENT BLUE SODIUM INJECTION used for?
Marking lymphatic vessels, arterial territories, and sentinel lymph node prior to biopsy in patients with operable breast cancer and clinically negative lymph nodes.
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 Other Diagnostic Agents 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.
24 holders have a Canadian DIN containing Other Diagnostic Agents, across 50 DINs, of which 9 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 |
|---|---|---|---|---|
| METHAPHARM INC | 8 | 3 | PROVOCHOLINE, PROVOCHOLINE INHALATION SOLUTION, STERILE PROVOCHOLINE SOLUTION 16, STERILE PROVOCHOLINE SOLUTION PLUS | Sourceable in Canada |
| OMEGA LABORATORIES LIMITED | 4 | 1 | METHACHOLINE OMEGA, SOLUTION SALINE STERILE AUX PHOSPHATES | Sourceable in Canada |
| ALCON CANADA INC | 2 | 1 | FLUORESCITE, FLUORESCITE INJ 25% | Sourceable in Canada |
| ALK-ABELLO INC | 1 | 1 | PRE-PEN | Sourceable in Canada |
| GUERBET | 1 | 1 | PATENT BLUE SODIUM INJECTION | Sourceable in Canada |
| PHARMAXIS EUROPE LIMITED | 1 | 1 | ARIDOL | Sourceable in Canada |
| PHOTOCURE ASA | 1 | 1 | CYSVIEW | Sourceable in Canada |
| MATHESON GAS PRODUCTS CANADA INC. | 6 | 0 | LUNG DIFFUSION TEST MIXTURE | No marketed DIN |
| PANDA PHARMACEUTICALS INC. | 5 | 0 | METHACHOLINE CHLORIDE, USP | No marketed DIN |
| TYCO HEALTHCARE | 3 | 0 | LYMPHAZURIN 1%, PERCHLORACAP CAPSULE 200MG, SCHILLINGS TEST KIT CO57 CAP | No marketed DIN |
| ODAN LABORATORIES LTD | 2 | 0 | ODAN-FLUORESCEIN | No marketed DIN |
| PHARMA STULLN INC. | 2 | 0 | FLUORESCEIN | 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 | 50 MG / 2 ML |
|---|---|
| Dosage form | SOLUTION |
| Route | SUBCUTANEOUS ; INTRAVENOUS |
| Pack configuration (monograph) | Box containing 5 x 2 mL ampoules. |
| Storage | Not specified in the provided text. |
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.
Substance and classification
| Active substance | Other Diagnostic Agents |
|---|---|
| ATC code | V04CX |
| AHFS class | 36:89.00* ; See footnote |
| 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) | 00405396 |
|---|---|
| DIN (unpadded, as printed on some documents) | 405396 |
| Brand name | PATENT BLUE SODIUM INJECTION |
| Generic / active ingredient | PATENT BLUE SODIUM : 50 MG / 2 ML |
| Market authorization holder | GUERBET |
| Health Canada schedule | Ethical |
| ATC code | V04CX |
| ATC anatomical main group | V — Various |
| ATC therapeutic subgroup | V04CX |
| Current status | MARKETED |
| Status date | 18-Mar-2014 |
| Original market date | 1979-12-31 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
Subcutaneous or intravascular: 1 to 10 mL. For sentinel lymph node: injected subcutaneously around the tumour or nipple. For arterial territories: 40 mL of 2.5% solution in a 140 mL mixture.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Hypersensitivity to Patent Blue Na, any of the excipients, or triphenylmethane dyes.
Warnings and precautions
Risk of life-threatening anaphylactic shock. Resuscitation equipment must be available. Monitor patient for at least 30 minutes post-injection. Skin may turn bluish for 24-48 hours.
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
9 of 50 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| ARIDOL | 20 MG | POWDER ; KIT | PHARMAXIS EUROPE LIMITED | MARKETED | 02489562 |
| CYSVIEW | 100 MG | KIT ; POWDER FOR SOLUTION | PHOTOCURE ASA | MARKETED | 02436639 |
| FLUORESCITE | 10 % | SOLUTION | ALCON CANADA INC | MARKETED | 00505005 |
| METHACHOLINE OMEGA | 1600 MG | POWDER FOR SOLUTION | OMEGA LABORATORIES LIMITED | MARKETED | 02263912 |
| PRE-PEN | 0.000060 M | SOLUTION | ALK-ABELLO INC | MARKETED | 00328693 |
| PROVOCHOLINE | 1280 MG | POWDER FOR SOLUTION | METHAPHARM INC | MARKETED | 02243834 |
| PROVOCHOLINE | 1600 MG | POWDER FOR SOLUTION | METHAPHARM INC | MARKETED | 02288826 |
| PROVOCHOLINE | 100 MG | POWDER FOR SOLUTION | METHAPHARM INC | MARKETED | 02239656 |
| DENTI-CARE DISCLOSING SOLUTION | 2 % | LIQUID | AMD MEDICOM INC | CANCELLED POST MARKET | 02239704 |
| ENLON 10MG/ML | 10 MG | LIQUID | BAXTER CORPORATION | CANCELLED POST MARKET | 02188848 |
2 · Same class — other molecules in ATC V04CX
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Other Diagnostic Agents | ARIDOL · CYSVIEW · DENTI-CARE DISCLOSING SOLUTION · ENLON 10MG/ML · +29 more | 50 | 9 | Yes |
| Indocyanine Green | INDOCYANINE GREEN FOR INJECTION KIT · INDOCYANINE GREEN FOR INJECTION, USP · SPY AGENT GREEN · SPY AGENT GREEN KIT FOR ADVANCED IMAGING MODALITY (AIM) AND PINPOINT · +3 more | 9 | 7 | 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 V04C
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| V04CL | Tests For Allergic Diseases | 10 | 8 |
| V04CC | Sincalide | 3 | 2 |
| V04CD | Tests For Pituitary Function | 1 | 1 |
| V04CF | Tuberculin | 5 | 1 |
| V04CG | Histamine · Methylthionine · Pentagastrin | 5 | 1 |
| V04C | Other Diagnostic Agents | 1 | 0 |
| V04CM | Gonadorelin | 5 | 0 |
| V04CA | Glucose | 6 | 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.