TEVA-TOBRAMYCIN 60 MG
TOBRAMYCIN (TOBRAMYCIN SULFATE) : 60 MG · DIN 02389622 · TEVA CANADA LIMITED
Health Canada status: MARKETED
What is TEVA-TOBRAMYCIN?
TEVA-TOBRAMYCIN 60 MG contains TOBRAMYCIN (TOBRAMYCIN SULFATE) : 60 MG. It is listed in the Health Canada Drug Product Database under DIN 02389622, held by TEVA CANADA LIMITED, supplied as SOLUTION for INHALATION administration. Health Canada currently lists it as marketed, status dated 03-Feb-2016. 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 TEVA-TOBRAMYCIN used for?
Management of cystic fibrosis patients with chronic pulmonary Pseudomonas aeruginosa infections. (Limited to patients 6 years and older with FEV1 25-75% predicted).
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 | 02389622 |
|---|---|
| Brand name | TEVA-TOBRAMYCIN |
| Generic / active ingredient | TOBRAMYCIN (TOBRAMYCIN SULFATE) : 60 MG |
| Manufacturer | TEVA CANADA LIMITED |
| Strength | 60 MG |
| Dosage form | SOLUTION |
| Route of administration | INHALATION |
| Schedule | Prescription |
| ATC code | J01GB01 TOBRAMYCIN |
| AHFS class | 08:12.02 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 03-Feb-2016 |
| Original market date | 2016-02-03 00:00:00 |
How is it administered?
300 mg (one single-use ampoule) BID via PARI LC PLUS reusable nebulizer for 28 days, followed by 28 days off. Doses should be ~12 hours apart (minimum 6 hours). Not for IV/SC/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 (Section 11 referenced but content missing), though typically requires refrigeration and protection from light.
How is it supplied?
Boxes of 56 single-use 5 mL low-density polyethylene plastic ampoules (14 foil pouches, each containing 4 ampoules).
Contraindications
Known hypersensitivity to any aminoglycoside or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
Warnings and precautions
Caution in patients with renal, auditory, vestibular, or neuromuscular dysfunction. Risk of ototoxicity, nephrotoxicity, and bronchospasm. Risk of CDAD. Potential for fetal harm.
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 |
|---|---|---|---|---|---|
| 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 | SANDOZ CANADA INCORPORATED | MARKETED | DIN 02241210 |
| TOBRAMYCIN INJECTION USP | 40 MG | SOLUTION | JAMP PHARMA CORPORATION | MARKETED | DIN 02533103 |
| AJ-TOBRAMYCIN | 40 MG | LIQUID | AGILA JAMP CANADA INC | CANCELLED PRE MARKET | DIN 02384930 |
| JAMP-TOBRAMYCIN | 40 MG | SOLUTION | JAMP PHARMA CORPORATION | CANCELLED POST MARKET | DIN 02420287 |
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.