ZEMAIRA®

ZEMAIRA is indicated for chronic augmentation and maintenance therapy for adults with alpha1-proteinase inhibitor (A1-PI) deficiency and emphysema. The effect of augmentation therapy with ZEMAIRA or any A1-PI product on pulmonary exacerbations and progression of emphysema in A1-PI deficiency has not been demonstrated in randomized, controlled clinical studies.

ZEMAIRA is not indicated for lung disease patients in whom severe A1-PI deficiency has not been established.

History of anaphylaxis or severe systemic reactions to ZEMAIRA or A1 -PI protein .

Immunoglobulin A (IgA)-deficient patients with antibodies against IgA, due to the risk of severe hypersensitivity.

The recommended weekly dose of ZEMAIRA is 60 mg/kg body weight.

Do not mix ZEMAIRA with other medicinal products; administer ZEMAIRA through a separate dedicated infusion line.
  
Perform a visual inspection of the reconstituted solution. The solution should be clear, colorless to slightly yellow, and free from visible particles.
  
Administer at room temperature within 3 hours after reconstitution. • Filter the reconstituted solution during administration. To ensure proper filtration of ZEMAIRA, use an intravenous administration set with a suitable 5 micron infusion filter (not supplied). 
  
Administer ZEMAIRA intravenously at a rate of approximately 0.08 mL/kg/min as determined by the response and comfort of the patient. The recommended dosage of 60 mg/kg body weight will take approximately 15 minutes to infuse. 
  
Monitor closely the infusion rate and the patient’s clinical state, including vital signs, throughout the infusion. Slow or stop the infusion if adverse reactions occur. If symptoms subside promptly, the infusion may be resumed at a lower rate that is comfortable for the patient.
   
ZEMAIRA is for single use only. Following administration, discard any unused solution and all administration equipment in an appropriate manner as per local requirements