MT-Gwardamangia: medicinal products for the respiratory system
Summary
Supply of C1 esterase inhibitor injections.
C1 esterase inhibitor 500 to 1 000U (1U is equivalent to the C1 esterase
inhibitor activity in 1mL of fresh citrated.
Plasma of healthy donors) with a total protein of 65 mg to 1 200 mg powder
for reconstitution for injection/infusion.
For IV use in 10mL to 20mL vials.
Label: pertinent storage conditions should be clearly indicated on the
label of the outer pack. All ampoules should be labelled accordingly.
The batch / lot number and expiry date must be printed on each individual
ampoule / vial.
CPV: 33670000.
