ZINPLAVA Concentrate for solution for infusion Ref.[6508] Active ingredients: Bezlotoxumab

Source: European Medicines Agency (EU)  Revision Year: 2018  Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands

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.

Active Ingredient 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

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

Marketing authorization dates and numbers

EU/1/16/1156/001

Date of first authorisation: 18 January 2017

Drugs

Drug Countries
ZINPLAVA Austria, Estonia, Spain, Finland, France, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, United Kingdom, United States
 
Next: Usage >

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.

⇈