VOLULYTE 6 %
HYDROXYETHYL STARCH 130/0.4 : 6 % · DIN 02357291 · FRESENIUS KABI CANADA LTD
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.
Product details and regulatory record
| DIN | 02357291 |
|---|---|
| Brand name | VOLULYTE |
| Generic / active ingredient | HYDROXYETHYL STARCH 130/0.4 : 6 % |
| Manufacturer | FRESENIUS KABI CANADA LTD |
| Strength | 6 % |
| Dosage form | SOLUTION |
| Route of administration | INTRAVENOUS |
| Schedule | Prescription |
| ATC code | B05AA07 HYDROXYETHYLSTARCH |
| AHFS class | 28:08.04.92 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 26-Nov-2015 |
| Original market date | 2011-06-10 00:00:00 |
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.
How is it stored and handled?
Store freeflex bags at 15 °C – 25 °C. Do not freeze. Use immediately after opening.
How is it supplied?
Polyolefin bag (freeflex) with overwrap: 250 mL (packs of 10, 20, 30, 35, 40) and 500 mL (packs of 10, 15, 20).
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?
Other Canadian products sharing ATC code B05AA07 HYDROXYETHYLSTARCH. 2 of 4 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 |
|---|---|---|---|---|---|
| VOLUVEN | 6 % | SOLUTION | FRESENIUS KABI CANADA LTD | MARKETED | DIN 02278057 |
| HEXTEND | 6 G / 100 ML | SOLUTION | BIOTIME INC | CANCELLED POST MARKET | DIN 02246024 |
| PENTASPAN | 10 G / 100 ML | SOLUTION | BRISTOL-MYERS SQUIBB CANADA | CANCELLED POST MARKET | DIN 00887110 |
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.