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Direct Healthcare Professional Communication (DHPC) on Isozid 0.5 N powder for solution for infusion: visual particles, use of a particle filter

Active substance: isoniazid

Esteve Pharmaceuticals GmbH has issued a warning about visible particles in batch 286490A of the medicinal product Isozid 0.5 N powder for solution for infusion after reconstitution. Users are advised to visually inspect the reconstituted infusion solution prior to use, as described in the Summary of
Product Characteristics (SmPC), and to use only clear solutions without visible particles. In addition, an infusion device with an integrated particle filter with a pore size ≤ 15 μm must be used for administration.

 

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