TOBRAMYCIN INHALATION SOLUTION USP 300 MG / 5 ML
TOBRAMYCIN (TOBRAMYCIN SULFATE) : 300 MG / 5 ML · DIN 02457563 · LABORATOIRE RIVA INC.
Health Canada status: APPROVED
What is TOBRAMYCIN INHALATION SOLUTION USP?
TOBRAMYCIN INHALATION SOLUTION USP 300 MG / 5 ML contains TOBRAMYCIN (TOBRAMYCIN SULFATE) : 300 MG / 5 ML. It is listed in the Health Canada Drug Product Database under DIN 02457563, held by LABORATOIRE RIVA INC., supplied as SOLUTION for INHALATION administration. Health Canada currently lists it as approved, status dated 19-Sep-2017. 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 TOBRAMYCIN INHALATION SOLUTION USP used for?
Management of cystic fibrosis patients (6 years and older) with chronic pulmonary Pseudomonas aeruginosa infections.
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 | 02457563 |
|---|---|
| Brand name | TOBRAMYCIN INHALATION SOLUTION USP |
| Generic / active ingredient | TOBRAMYCIN (TOBRAMYCIN SULFATE) : 300 MG / 5 ML |
| Manufacturer | LABORATOIRE RIVA INC. |
| Strength | 300 MG / 5 ML |
| Dosage form | SOLUTION |
| Route of administration | INHALATION |
| Schedule | Prescription |
| ATC code | J01GB01 TOBRAMYCIN |
| Biosimilar | No |
| Health Canada status | APPROVED |
| Status date | 19-Sep-2017 |
How is it administered?
300 mg (one ampoule) via nebulizer twice daily for 28 days, followed by 28 days off. Doses should be ~12 hours apart (min 6 hours). Not for SC, IV, or intrathecal use.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not explicitly detailed in provided text snippet (standard USP storage usually applies, but text cuts off before section 11 details).
How is it supplied?
Boxes of 56 single-use 5 mL ampoules (14 foil over-pouches containing 4 ampoules each).
Contraindications
Known hypersensitivity to any aminoglycoside or to any ingredient in the formulation.
Warnings and precautions
Risk of ototoxicity (hearing/vestibular), nephrotoxicity, and neuromuscular blockade. Bronchospasm may occur. Risk of ototoxicity may be increased in patients with certain mitochondrial DNA variants.
Is TOBRAMYCIN in shortage in Canada?
A Canadian shortage report is on file for this molecule: Resolved — reported by FRESENIUS KABI CANADA LTD, 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 J01GB01 TOBRAMYCIN. 9 of 23 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 |
|---|---|---|---|---|---|
| TEVA-TOBRAMYCIN | 60 MG | SOLUTION | TEVA CANADA LIMITED | MARKETED | DIN 02389622 |
| TOBI | 300 MG / 5 ML | SOLUTION | BGP PHARMA ULC | MARKETED | DIN 02239630 |
| TOBI PODHALER | 28 MG | CAPSULE | BGP PHARMA ULC | MARKETED | DIN 02365154 |
| TOBRAMYCIN FOR INJECTION | 1.2 G | POWDER FOR SOLUTION | FRESENIUS KABI CANADA LTD | MARKETED | DIN 00533688 |
| TOBRAMYCIN INJECTION | 40 MG | SOLUTION | FRESENIUS KABI CANADA LTD | MARKETED | DIN 02230640 |
| TOBRAMYCIN INJECTION USP | 10 MG | SOLUTION | SANDOZ CANADA INCORPORATED | MARKETED | DIN 02241209 |
| TOBRAMYCIN INJECTION USP | 40 MG | SOLUTION | STERIMAX INC | MARKETED | DIN 02502372 |
| TOBRAMYCIN INJECTION USP | 40 MG | SOLUTION | JAMP PHARMA CORPORATION | MARKETED | DIN 02533103 |
| TOBRAMYCIN INJECTION USP | 40 MG | SOLUTION | SANDOZ CANADA INCORPORATED | MARKETED | DIN 02241210 |
| AJ-TOBRAMYCIN | 40 MG | LIQUID | AGILA JAMP CANADA INC | CANCELLED PRE MARKET | DIN 02384930 |
Who else supplies TOBRAMYCIN worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. TOBRAMYCIN appears in 85 registered pack listings across 12 markets, published on 10 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.