ZINPLAVA Concentrate for solution for infusion (2018)
Active ingredients: Bezlotoxumab
Product Name and Form
ZINPLAVA 25 mg/mL concentrate for solution for infusion.
Concentrate for solution for infusion.
Clear to moderately opalescent, colourless to pale yellow liquid.
Qualitative and Quantitative Composition
Each mL of concentrate contains 25 mg bezlotoxumab. One 40 mL vial contains 1,000 mg of bezlotoxumab.
Bezlotoxumab is a human monoclonal antibody produced in Chinese hamster ovary cells by recombinant DNA technology. It binds to C. difficile toxin B.
Excipient with known effect: Each mL of concentrate contains 0.2 mmol sodium, which is 4.57 mg sodium.
For the full list of excipients, see section 6.1.
Bezlotoxumab is a human monoclonal antitoxin antibody that binds with high affinity to C. difficile toxin B and neutralizes its activity. Bezlotoxumab prevents CDI recurrence by providing passive immunity against toxin produced by the outgrowth of persistent or newly-acquired C. difficile spores.
Citric acid monohydrate (E330)
Polysorbate 80 (E433)
Sodium citrate dihydrate (E331)
Water for injections
Sodium hydroxide (E524) (for pH adjustment)
Pack sizes and Marketing
Type I glass vial containing 40 mL solution, with a chlorobutyl stopper, and a flip-off cap seal.
Each carton contains one vial.
Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
Date of first authorisation: 18 January 2017