BRINEURA 150 MG / 5 ML
CERLIPONASE ALFA : 150 MG / 5 ML · DIN 02484013 · BIOMARIN INTERNATIONAL LIMITED
Health Canada status: MARKETED
What is BRINEURA?
BRINEURA 150 MG / 5 ML contains CERLIPONASE ALFA : 150 MG / 5 ML. It is listed in the Health Canada Drug Product Database under DIN 02484013, held by BIOMARIN INTERNATIONAL LIMITED, supplied as SOLUTION for INTRACEREBROVENTRICULAR administration. Health Canada currently lists it as marketed, status dated 18-Mar-2019. 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 BRINEURA used for?
Treatment of neuronal ceroid lipofuscinosis type 2 (CLN2) disease, also known as tripeptidyl peptidase 1 (TPP1) deficiency.
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 | 02484013 |
|---|---|
| Brand name | BRINEURA |
| Generic / active ingredient | CERLIPONASE ALFA : 150 MG / 5 ML |
| Manufacturer | BIOMARIN INTERNATIONAL LIMITED |
| Strength | 150 MG / 5 ML |
| Dosage form | SOLUTION |
| Route of administration | INTRACEREBROVENTRICULAR |
| Schedule | Schedule D |
| ATC code | A16AB17 CERLIPONASE ALFA |
| AHFS class | 44:00.00 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 18-Mar-2019 |
| Original market date | 2019-03-18 00:00:00 |
How is it administered?
Administered once every other week by intracerebroventricular infusion at 2.5 mL/hour. Pre-treatment with antihistamines (with/without antipyretics or corticosteroids) is recommended.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Thaw vials at room temperature for approximately 60 minutes. Do not refreeze. (Note: Specific long-term storage temperature not in provided text snippet).
How is it supplied?
Each package contains 2 vials of BRINEURA (150 mg/5 mL) and 1 vial of Flushing Solution (5 mL).
Contraindications
CLN2 patients with ventriculo-peritoneal shunts; acute intracerebroventricular access device complications; severe hypersensitivity to drug or ingredients.
Warnings and precautions
Risk of device-related infections, meningitis, and acute systemic hypersensitivity reactions (including anaphylaxis). Monitor vital signs and ECG. Use aseptic technique.
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.