PROLASTIN-C 1000 MG — DIN 02204606
ALPHA1-PROTEINASE INHIBITOR (HUMAN) : 1000 MG · GRIFOLS THERAPEUTICS LLC · POWDER FOR SOLUTION · wholesale supply in Canada
Health Canada status: MARKETED
What is PROLASTIN-C?
PROLASTIN-C 1000 MG contains ALPHA1-PROTEINASE INHIBITOR (HUMAN) : 1000 MG. It is listed in the Health Canada Drug Product Database under DIN 02204606, held by GRIFOLS THERAPEUTICS LLC, supplied as POWDER FOR SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as marketed, status dated 04-Feb-2012. 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 PROLASTIN-C used for?
Chronic replacement therapy for congenital alpha1-proteinase inhibitor deficiency (genotypes PiZZ, PiZ(null), Pi(null)(null), PiSZ) with clinically demonstrable emphysema in adults.
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 Alfa1 Antitrypsin 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.
4 holders have a Canadian DIN containing Alfa1 Antitrypsin, across 10 DINs, of which 2 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 |
|---|---|---|---|---|
| GRIFOLS THERAPEUTICS LLC | 5 | 1 | ALPHA1-PROTEINASE INHIBITOR (HUMAN), PROLASTIN-C, PROLASTIN-C LIQUID, PRONEXTICA LIQUID | Sourceable in Canada |
| TAKEDA CANADA INC | 1 | 1 | GLASSIA | Sourceable in Canada |
| CSL BEHRING CANADA INC | 3 | 0 | ZEMAIRA | No marketed DIN |
| CUTTER BIOLOGICAL, DIVISION OF MILES LAB INC. | 1 | 0 | PROLASTIN INJ 25.0MG/ML | 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 | 1000 MG |
|---|---|
| Dosage form | POWDER FOR SOLUTION |
| Route | INTRAVENOUS |
| Pack configuration (monograph) | Single use vials containing 1000 mg functional activity. Provided with 20 mL Sterile Water for Injection, a double-ended transfer needle, and a filter needle. |
| Storage | Do not refrigerate after reconstitution. Administer within 3 hours after reconstitution. (General storage of lyophilized powder not explicitly detailed in provided text snippet). |
| 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 | Alfa1 Antitrypsin |
|---|---|
| ATC code | B02AB02 |
| AHFS class | 44:00.00 |
| 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) | 02204606 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2204606 |
| Brand name | PROLASTIN-C |
| Generic / active ingredient | ALPHA1-PROTEINASE INHIBITOR (HUMAN) : 1000 MG |
| Market authorization holder | GRIFOLS THERAPEUTICS LLC |
| Health Canada schedule | Schedule D |
| ATC code | B02AB02 |
| ATC anatomical main group | B — Blood and blood-forming organs |
| ATC therapeutic subgroup | B02AB |
| Current status | MARKETED |
| Status date | 04-Feb-2012 |
| Original market date | 1996-11-11 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
60 mg/kg body weight administered once weekly by intravenous infusion. Infusion rate: 0.08 mL/kg/min or greater. Recommended dose takes approximately 15 minutes to infuse.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Hypersensitivity to the product; selective IgA deficiency; history of anaphylaxis or severe systemic reaction to alpha1-proteinase inhibitor products.
Warnings and precautions
Risk of infectious agent transmission (human plasma-derived); risk of circulatory overload; hypersensitivity/anaphylaxis risk; contains trace IgA; not for PiMZ or PiMS phenotypes.
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
2 of 10 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| GLASSIA | 1000 MG / 50 ML | SOLUTION | TAKEDA CANADA INC | MARKETED | 02522438 |
| ALPHA1-PROTEINASE INHIBITOR (HUMAN) | 500 MG | POWDER FOR SOLUTION | GRIFOLS THERAPEUTICS LLC | CANCELLED PRE MARKET | 02223643 |
| ALPHA1-PROTEINASE INHIBITOR (HUMAN) | 1 G | POWDER FOR SOLUTION | GRIFOLS THERAPEUTICS LLC | CANCELLED PRE MARKET | 02223651 |
| PROLASTIN INJ 25.0MG/ML | 25 MG | POWDER FOR SOLUTION | CUTTER BIOLOGICAL, DIVISION OF MILES LAB INC. | CANCELLED POST MARKET | 00803529 |
| PROLASTIN-C LIQUID | 1000 MG / 20 ML | SOLUTION | GRIFOLS THERAPEUTICS LLC | APPROVED | 02488787 |
| PRONEXTICA LIQUID | 1000 MG / 20 ML | SOLUTION | GRIFOLS THERAPEUTICS LLC | APPROVED | 02543028 |
| ZEMAIRA | 4000 MG | KIT ; POWDER FOR SOLUTION | CSL BEHRING CANADA INC | APPROVED | 02494760 |
| ZEMAIRA | 5000 MG | POWDER FOR SOLUTION ; KIT | CSL BEHRING CANADA INC | APPROVED | 02494779 |
| ZEMAIRA | 1000 MG | POWDER FOR SOLUTION ; KIT | CSL BEHRING CANADA INC | APPROVED | 02457911 |
2 · Same class — other molecules in ATC B02AB
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Alfa1 Antitrypsin | ALPHA1-PROTEINASE INHIBITOR (HUMAN) · GLASSIA · PROLASTIN INJ 25.0MG/ML · PROLASTIN-C · +3 more | 10 | 2 | Yes |
| Aprotinin | TRASYLOL · TRASYLOL INJ 10000 KIU/ML | 2 | 0 | Not in Canada |
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 B02A
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| B02AA | Aminocaproic Acid · Tranexamic Acid | 29 | 12 |
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.