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BLEOMYCIN Powder for solution for injection (2018)

Active ingredients: Bleomycin

Product Name and Form

Bleomycin 15000 IU Powder for solution for injection/infusion.

Pharmaceutical form

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.

Chemical substance
Description
Bleomycin

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.

List of excipients

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.

Marketing authorization holder
Authorization dates

Accord Healthcare Limited, Sage House, 319, Pinner Road, North Harrow, Middlesex HA1 4HF, United Kingdom

Date of first authorisation: 08th July 2016

Marketing authorization number:

PL 20075/0440