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ZINPLAVA Concentrate for solution for infusion (2018)

Active ingredients: Bezlotoxumab

Product Name and Form

ZINPLAVA 25 mg/mL concentrate for solution for infusion.

Pharmaceutical form

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.

Chemical substance
Description
Bezlotoxumab

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.

List of excipients

Citric acid monohydrate (E330)
Diethylenetriaminepentaacetic acid
Polysorbate 80 (E433)
Sodium chloride
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.

Marketing authorization holder
Authorization dates

Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands

Date of first authorisation: 18 January 2017

Marketing authorization number:

EU/1/16/1156/001