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Zemaira Generic Name & Formulations
Legal Class
Rx
General Description
Alpha1-proteinase inhibitor (human) 1000mg, 4000mg, 5000mg; per vial; lyophilized pwd for IV infusion after reconstitution; preservative-free.
How Supplied
Single-use vial—1 (w. diluent + filter transfer set)
Manufacturer
Zemaira Indications
Indications
For chronic augmentation and maintenance therapy in adults with alpha1-proteinase inhibitor (A1-PI) deficiency and clinical evidence of emphysema.
Zemaira Dosage and Administration
Adult
Give by IV infusion at a rate of 0.08mL/kg/min. 60mg/kg once weekly. Monitor infusion rates and clinical state closely during infusion. Reduce rate or discontinue if adverse reactions occur; resume at lower rate if subside.
Children
Not established.
Zemaira Contraindications
Contraindications
History of anaphylaxis or severe systemic response to A1-PI products. IgA deficiencies with known antibodies against IgA.
Zemaira Boxed Warnings
Not Applicable
Zemaira Warnings/Precautions
Warnings/Precautions
Not for lung disease where severe A1-PI deficiency has not been established. Monitor for hypersensitivity reactions; discontinue immediately if anaphylaxis or severe reactions occur. Have epinephrine and other supportive therapy readily available. Contains human plasma; monitor for possible infection transmission (eg, viruses, Creutzfeldt-Jakob disease). Pregnancy. Nursing mothers.
Zemaira Pharmacokinetics
See Literature
Zemaira Interactions
Not Applicable
Zemaira Adverse Reactions
Adverse Reactions
Headache, sinusitis, upper respiratory infection, bronchitis, asthenia, cough increased, fever, inj site hemorrhage, rhinitis, sore throat, vasodilation; hypersensitivity reactions.
Zemaira Clinical Trials
See Literature
Zemaira Note
Not Applicable
Zemaira Patient Counseling
See Literature
