NAGLAZYME 1 MG
GALSULFASE : 1 MG · DIN 02412683 · BIOMARIN PHARMACEUTICAL INC.
Health Canada status: MARKETED
What is NAGLAZYME?
NAGLAZYME 1 MG contains GALSULFASE : 1 MG. It is listed in the Health Canada Drug Product Database under DIN 02412683, held by BIOMARIN PHARMACEUTICAL INC., supplied as SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as marketed, status dated 01-Jan-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 NAGLAZYME used for?
Long-term enzyme replacement therapy in patients with a confirmed diagnosis of Mucopolysaccharidosis VI (MPS VI; N-acetylgalactosamine 4-sulfatase deficiency; Maroteaux-Lamy syndrome).
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 | 02412683 |
|---|---|
| Brand name | NAGLAZYME |
| Generic / active ingredient | GALSULFASE : 1 MG |
| Manufacturer | BIOMARIN PHARMACEUTICAL INC. |
| Strength | 1 MG |
| Dosage form | SOLUTION |
| Route of administration | INTRAVENOUS |
| Schedule | Schedule D |
| ATC code | A16AB08 GALSUFASE |
| AHFS class | 44:00.00 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 01-Jan-2014 |
| Original market date | 2014-01-01 00:00:00 |
How is it administered?
1 mg/kg body weight administered once weekly as an intravenous infusion over no less than 4 hours. Pretreatment with antihistamines (with/without antipyretics) is recommended 30-60 minutes prior.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Store refrigerated at 2°C to 8°C. Do not freeze or shake. Protect from light. Diluted solution stable for 48 hours refrigerated.
How is it supplied?
5 mL glass vials. Each vial provides 5 mg of galsulfase.
Contraindications
Hypersensitivity to this drug or to any ingredient in the formulation or component of the container.
Warnings and precautions
Risk of spinal cord compression; acute cardiorespiratory failure (fluid overload); anaphylaxis and severe allergic reactions; infusion reactions; sleep apnea; immune-mediated reactions.
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.