BANZEL 400 MG
RUFINAMIDE : 400 MG · DIN 02369648 · EISAI LIMITED
Health Canada status: MARKETED
What is BANZEL?
BANZEL 400 MG contains RUFINAMIDE : 400 MG. It is listed in the Health Canada Drug Product Database under DIN 02369648, held by EISAI LIMITED, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 01-Sep-2011. 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 BANZEL used for?
Adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in children 4 years of age and older and in adults. Not indicated for other seizure types.
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 | 02369648 |
|---|---|
| Brand name | BANZEL |
| Generic / active ingredient | RUFINAMIDE : 400 MG |
| Manufacturer | EISAI LIMITED |
| Strength | 400 MG |
| Dosage form | TABLET |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | N03AF03 RUFINAMIDE |
| AHFS class | 28:12.92 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 01-Sep-2011 |
| Original market date | 2011-09-01 00:00:00 |
How is it administered?
Adjunctive treatment for LGS. Discontinue gradually (approx. 25% every two days). Target pediatric dose: 45 mg/kg/day. Adult doses up to 3200 mg/day. Administer with food.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Store at 15-30°C (implied by standard summary, though specific text snippet ends before storage section).
How is it supplied?
100 mg, 200 mg and 400 mg Tablets (specific bottle sizes not provided in text).
Contraindications
Patients with Familial Short QT syndrome, family history of short QT syndrome, or history of short QT interval. Hypersensitivity to rufinamide, triazole derivatives, or any excipients.
Warnings and precautions
QT shortening; Multi-organ hypersensitivity (DRESS); Suicidal ideation/behaviour; Status epilepticus; Somnolence/dizziness (caution driving); Withdrawal seizures if stopped abruptly.
What can be used instead?
Other Canadian products sharing ATC code N03AF03 RUFINAMIDE. 5 of 6 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 |
|---|---|---|---|---|---|
| AURO-RUFINAMIDE | 200 MG | TABLET | AURO PHARMA INC | MARKETED | DIN 02545985 |
| AURO-RUFINAMIDE | 400 MG | TABLET | AURO PHARMA INC | MARKETED | DIN 02545993 |
| BANZEL | 100 MG | TABLET | EISAI LIMITED | MARKETED | DIN 02369613 |
| BANZEL | 200 MG | TABLET | EISAI LIMITED | MARKETED | DIN 02369621 |
| BANZEL | 40 MG | SUSPENSION | EISAI LIMITED | CANCELLED PRE MARKET | DIN 02388685 |
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.