BLEOMYCIN Powder for solution for injection (2018)
Active ingredients: Bleomycin
Product Name and Form
Bleomycin 15000 IU Powder for solution for injection/infusion.
Powder for solution for injection/infusion.
White to light yellowish freeze dried substance.
pH: Between 4.5 to 6.0
Osmlolarity: 260 to 340 mOsm/ltr
Qualitative and Quantitative Composition
Each vial contains 15000 intenational units (I.U) of bleomycin (as bleomycin sulphate).
Excipient with known effect: Each vial contains <1 mmol sodium.
For the full list of excipients, see section 6.1.
Bleomycin is a mixture of basic, water-soluble glycopeptide-antibiotics with cytotoxic activity. Bleomycin acts by interacting with both single and double-stranded DNA (deoxyribonucleic acid) leading to both single and double-strand scission, which leads in turn to inhibition of cell division, inhibition of growth and inhibition of DNA synthesis. Bleomycin can also influence RNA (ribonucleic acid) and protein biosynthesis to a lesser extent.
Sodium hydroxide (for pH adjustment)
Hydrochloric acid (for pH adjustment)
Pack sizes and Marketing
6 ml Type I tubular clear glass vial, closed with bromobutyl rubber stopper and sealed with a flip-off aluminium seal.
Availbale in pack of 1vial. 10 and 100 vials.
Not all pack sizes may be marketed.
Accord Healthcare Limited, Sage House, 319, Pinner Road, North Harrow, Middlesex HA1 4HF, United Kingdom
Date of first authorisation: 08th July 2016