PROLASTIN-C 1000 MG
ALPHA1-PROTEINASE INHIBITOR (HUMAN) : 1000 MG · DIN 02204606 · GRIFOLS THERAPEUTICS LLC
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.
Product details and regulatory record
| DIN | 02204606 |
|---|---|
| Brand name | PROLASTIN-C |
| Generic / active ingredient | ALPHA1-PROTEINASE INHIBITOR (HUMAN) : 1000 MG |
| Manufacturer | GRIFOLS THERAPEUTICS LLC |
| Strength | 1000 MG |
| Dosage form | POWDER FOR SOLUTION |
| Route of administration | INTRAVENOUS |
| Schedule | Schedule D |
| ATC code | B02AB02 ALFA1 ANTITRYPSIN |
| AHFS class | 44:00.00 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 04-Feb-2012 |
| Original market date | 1996-11-11 00:00:00 |
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.
How is it stored and handled?
Do not refrigerate after reconstitution. Administer within 3 hours after reconstitution. (General storage of lyophilized powder not explicitly detailed in provided text snippet).
How is it supplied?
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.
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?
Other Canadian products sharing ATC code B02AB02 ALFA1 ANTITRYPSIN. 2 of 10 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 |
|---|---|---|---|---|---|
| GLASSIA | 1000 MG / 50 ML | SOLUTION | TAKEDA CANADA INC | MARKETED | DIN 02522438 |
| ALPHA1-PROTEINASE INHIBITOR (HUMAN) | 1 G | POWDER FOR SOLUTION | GRIFOLS THERAPEUTICS LLC | CANCELLED PRE MARKET | DIN 02223651 |
| ALPHA1-PROTEINASE INHIBITOR (HUMAN) | 500 MG | POWDER FOR SOLUTION | GRIFOLS THERAPEUTICS LLC | CANCELLED PRE MARKET | DIN 02223643 |
| PROLASTIN INJ 25.0MG/ML | 25 MG | POWDER FOR SOLUTION | CUTTER BIOLOGICAL, DIVISION OF MILES LAB INC. | CANCELLED POST MARKET | DIN 00803529 |
| PROLASTIN-C LIQUID | 1000 MG / 20 ML | SOLUTION | GRIFOLS THERAPEUTICS LLC | APPROVED | DIN 02488787 |
| PRONEXTICA LIQUID | 1000 MG / 20 ML | SOLUTION | GRIFOLS THERAPEUTICS LLC | APPROVED | DIN 02543028 |
| ZEMAIRA | 1000 MG | POWDER FOR SOLUTION ; KIT | CSL BEHRING CANADA INC | APPROVED | DIN 02457911 |
| ZEMAIRA | 4000 MG | KIT ; POWDER FOR SOLUTION | CSL BEHRING CANADA INC | APPROVED | DIN 02494760 |
| ZEMAIRA | 5000 MG | POWDER FOR SOLUTION ; KIT | CSL BEHRING CANADA INC | APPROVED | DIN 02494779 |
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.