VOLULYTE 6 % — DIN 02357291
HYDROXYETHYL STARCH 130/0.4 : 6 % · FRESENIUS KABI CANADA LTD · SOLUTION · wholesale supply in Canada
Health Canada status: MARKETED
What is VOLULYTE?
VOLULYTE 6 % contains HYDROXYETHYL STARCH 130/0.4 : 6 %. It is listed in the Health Canada Drug Product Database under DIN 02357291, held by FRESENIUS KABI CANADA LTD, supplied as SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as marketed, status dated 26-Nov-2015. 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 VOLULYTE used for?
Treatment of hypovolemia due to acute blood loss when crystalloids alone are not considered sufficient. Not a substitute for red blood cells or coagulation factors.
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 Hydroxyethylstarch 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.
3 holders have a Canadian DIN containing Hydroxyethylstarch, across 4 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 |
|---|---|---|---|---|
| FRESENIUS KABI CANADA LTD | 2 | 2 | VOLULYTE, VOLUVEN | Sourceable in Canada |
| BIOTIME INC | 1 | 0 | HEXTEND | No marketed DIN |
| BRISTOL-MYERS SQUIBB CANADA | 1 | 0 | PENTASPAN | 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 | 6 % |
|---|---|
| Dosage form | SOLUTION |
| Route | INTRAVENOUS |
| Pack configuration (monograph) | Polyolefin bag (freeflex) with overwrap: 250 mL (packs of 10, 20, 30, 35, 40) and 500 mL (packs of 10, 15, 20). |
| Storage | Store freeflex bags at 15 °C – 25 °C. Do not freeze. Use immediately after opening. |
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 | Hydroxyethylstarch |
|---|---|
| ATC code | B05AA07 |
| AHFS class | 28:08.04.92 |
| 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) | 02357291 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2357291 |
| Brand name | VOLULYTE |
| Generic / active ingredient | HYDROXYETHYL STARCH 130/0.4 : 6 % |
| Market authorization holder | FRESENIUS KABI CANADA LTD |
| Health Canada schedule | Prescription |
| ATC code | B05AA07 |
| ATC anatomical main group | B — Blood and blood-forming organs |
| ATC therapeutic subgroup | B05AA |
| Current status | MARKETED |
| Status date | 26-Nov-2015 |
| Original market date | 2011-06-10 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
Intravenous infusion only. Total volume and rate depend on clinical situation. Initial 10-20 mL infused slowly. Common usage up to 33 mL/kg/day.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Fluid overload, sepsis, renal impairment with oliguria/anuria, critical illness (ICU), severe liver disease, dialysis, severe electrolyte abnormalities, HES hypersensitivity, intracranial bleeding.
Warnings and precautions
Serious Risk: Increased mortality and renal replacement therapy in critically ill/sepsis patients. Monitor coagulation and renal function. Risk of anaphylaxis and pruritus.
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 4 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| VOLUVEN | 6 % | SOLUTION | FRESENIUS KABI CANADA LTD | MARKETED | 02278057 |
| HEXTEND | 6 G / 100 ML | SOLUTION | BIOTIME INC | CANCELLED POST MARKET | 02246024 |
| PENTASPAN | 10 G / 100 ML | SOLUTION | BRISTOL-MYERS SQUIBB CANADA | CANCELLED POST MARKET | 00887110 |
2 · Same class — other molecules in ATC B05AA
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Albumin | ALBUMIN (HUMAN) 25% SOLUTION · ALBUMIN (HUMAN) 25% SOLUTION USP · ALBUMIN (HUMAN) 5% SOLUTION · ALBUMIN (HUMAN) 5% SOLUTION, USP · +16 more | 20 | 5 | Yes |
| Dextran,Combinations | 10% DEXTRAN 40 IN 0.9% SODIUM CHLORIDE INJECTION · 10% DEXTRAN 40 IN 5% DEXTROSE INJECTION · 6% DEXTRAN 70 IN 0.9% SODIUM CHLORIDE INJECTION · DEXTRAN 6% IN 0.9% SODIUM CHLORIDE INJECTION · +10 more | 14 | 2 | Yes |
| Hydroxyethylstarch | HEXTEND · PENTASPAN · VOLULYTE · VOLUVEN | 4 | 2 | Yes |
| Other Plasma Protein Fractions | PLAS+SD · PLASMA PROTEIN FRACTION (HUMAN) PROTENATE | 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 B05A
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| B05AX | Blood Plasma | 1 | 1 |
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.