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Tobramycin sulfate

Tobramycin sulfate is the sulfate salt of tobramycin, an aminoglycoside antibiotic active against Gram-negative bacteria including most Enterobacteriaceae, Pseudomonas aeruginosa and a few Gram-positive bacteria such as Staphylococcus aureus.

Indication: Used in the treatment of septicemia (bloodstream infection), infections of the skin, bone, lower respiratory tract, central nervous system, intra-abdominal and complicated recurrent urinary tract infections.

 

Application: Administered systemically by intramuscular injections or intravenous infusions. Can be mixed with bone cement.

Product grades

Sterile, non-micronized Non-sterile, non-micronized

Compliance

USP

Manufacturing site

Xellia Pharmaceuticals ApS, Copenhagen, Denmark

Release site

Xellia Pharmaceuticals ApS, Copenhagen, Denmark

Site registered

EU GMP issued by Danish Medicines Agency

US FDA

Other health authorities

Regulatory documentation

EU Drug Master File (DMF)

US Drug Master File (DMF)

Letter of Access (LoA)

Packaging sizes

Sterile, non-micronized

Non-sterile, non-micronized

2.15 kg

2.15 kg

Packaging material

Sterile, non-micronized

Non-sterile, non-micronized

Primary: Aluminum containers with PE insert and polypropylene lid

Secondary: Polystyrene

Primary: Aluminum containers with PE insert and polypropylene lid

Secondary: Polystyrene

Shelf life

3 years

Storage conditions

Below 25°C (77°F)