Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
ZINPLAVA 25 mg/mL concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
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Concentrate for solution for infusion. Clear to moderately opalescent, colourless to pale yellow liquid. |
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) |
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
EU/1/16/1156/001
Date of first authorisation: 18 January 2017
| Drug | Countries | |
|---|---|---|
| ZINPLAVA | Austria, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, Poland, United Kingdom, United States |
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