BACLOFEN INJECTION 10 MG / 20 ML
BACLOFEN : 10 MG / 20 ML · DIN 02413639 · STERIMAX INC
Health Canada status: MARKETED
What is BACLOFEN INJECTION?
BACLOFEN INJECTION 10 MG / 20 ML contains BACLOFEN : 10 MG / 20 ML. It is listed in the Health Canada Drug Product Database under DIN 02413639, held by STERIMAX INC, supplied as SOLUTION for INTRATHECAL administration. Health Canada currently lists it as marketed, status dated 11-Jan-2018. 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 BACLOFEN INJECTION used for?
Management of severe spasticity due to spinal cord injury or multiple sclerosis unresponsive to oral baclofen or with unacceptable side effects. Alternative to neurosurgical procedures.
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 | 02413639 |
|---|---|
| Brand name | BACLOFEN INJECTION |
| Generic / active ingredient | BACLOFEN : 10 MG / 20 ML |
| Manufacturer | STERIMAX INC |
| Strength | 10 MG / 20 ML |
| Dosage form | SOLUTION |
| Route of administration | INTRATHECAL |
| Schedule | Prescription |
| ATC code | M03BX01 BACLOFEN |
| AHFS class | 12:20.12 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 11-Jan-2018 |
| Original market date | 2014-06-06 00:00:00 |
How is it administered?
Initial screening with 25-50 mcg bolus. Maintenance via implanted pump ranges from 10-1200 mcg/day (typically 300-800 mcg/day). Titrate slowly by 10-30% increments.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not explicitly detailed in provided text (standard section 11 mentioned in TOC but content not in snippet).
How is it supplied?
0.05 mg/mL and 2 mg/mL: cartons of 5 ampoules. 0.5 mg/mL: cartons of 1 ampoule.
Contraindications
Known or suspected hypersensitivity to baclofen or any excipients. Not for intravenous, intramuscular, subcutaneous, or epidural routes.
Warnings and precautions
Abrupt discontinuation can cause high fever, altered mental status, rebound spasticity, rhabdomyolysis, and death. Risk of inflammatory mass at catheter tip. Requires specialized training.
Is BACLOFEN in shortage in Canada?
A Canadian shortage report is on file for this molecule: Discontinued — reported by AVIR PHARMA INC., last seen 04 Sep 2026. A shortage on one presentation does not always affect every DIN of the molecule — the alternatives below list what else is marketed in Canada. Nexara can confirm current availability and identify substitutions or import options where permitted.
What can be used instead?
Other Canadian products sharing ATC code M03BX01 BACLOFEN. 23 of 59 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 |
|---|---|---|---|---|---|
| APO-BACLOFEN | 10 MG | TABLET | APOTEX INC | MARKETED | DIN 02139332 |
| APO-BACLOFEN | 20 MG | TABLET | APOTEX INC | MARKETED | DIN 02139391 |
| BACLOFEN | 10 MG | TABLET | SIVEM PHARMACEUTICALS ULC | MARKETED | DIN 02544660 |
| BACLOFEN | 10 MG | TABLET | SANIS HEALTH INC | MARKETED | DIN 02287021 |
| BACLOFEN | 20 MG | TABLET | SANIS HEALTH INC | MARKETED | DIN 02287048 |
| BACLOFEN | 20 MG | TABLET | SIVEM PHARMACEUTICALS ULC | MARKETED | DIN 02544679 |
| BACLOFEN INJECTION | 0.05 MG / 1 ML | SOLUTION | STERIMAX INC | MARKETED | DIN 02413620 |
| BACLOFEN INJECTION | 10 MG / 5 ML | SOLUTION | STERIMAX INC | MARKETED | DIN 02413647 |
| BACLOFEN INJECTION | 2 MG | SOLUTION | HIKMA CANADA LIMITED | MARKETED | DIN 02457075 |
| BACLOFEN INJECTION USP | 2 MG | SOLUTION | JAMP PHARMA CORPORATION | MARKETED | DIN 02553341 |
Who else supplies BACLOFEN worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. BACLOFEN appears in 174 registered pack listings across 12 markets, published on 9 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.
Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.
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.