Længerevarig brug af ACE- hæmmere under andet og tredje trimester medfører kendt human fosterforgiftning (nedsat nyrefunktion, oligohydramnion, forsinket forbening af kraniet) og neonatal forgiftning (nyresvigt, hypotension, hyperkaliæmi) (se 5. 3 ” Prækliniske sikkerhedsdata ”).
After assessment of the documentation provided by the MAH to substantiate scientifically the divergent information across member states and justify a proposed common wording and following an evaluation of the current EU-wide clinical practices relating to the use of COVERSYL, the most suitable harmonised Section 4.4 Special Warnings and Precautions for Use text was approved (See Annex III).