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Prolastin-c Generic Name & Formulations
Legal Class
Rx
General Description
Alpha1-proteinase inhibitor (human) 1000mg/vial; lyophilized pwd for IV infusion after reconstitution; preservative-free.
How Supplied
Single-use vial—1 (w. diluent + needles)
Manufacturer
Prolastin-c Indications
Indications
For chronic augmentation and maintenance therapy in adults with clinical evidence of emphysema due to severe alpha1-proteinase inhibitor deficiency.
Prolastin-c Dosage and Administration
Adult
Give by IV infusion at a rate of 0.08mL/kg/min. 60mg/kg once weekly.
Children
Not established.
Prolastin-c Contraindications
Contraindications
IgA deficient patients with antibodies against IgA.
Prolastin-c Boxed Warnings
Not Applicable
Prolastin-c Warnings/Precautions
Warnings/Precautions
Contains human plasma; monitor for possible infection transmission (eg, viruses, Creutzfeldt-Jakob disease agent). Pregnancy (Cat.C). Nursing mothers.
Prolastin-c Pharmacokinetics
See Literature
Prolastin-c Interactions
Not Applicable
Prolastin-c Adverse Reactions
Adverse Reactions
Upper respiratory tract infection, UTI, nausea, pain, chills, cough, dizziness, dyspnea, headache, hot flush, oral candidiasis; rash, hypersensitivity reactions (discontinue if occur).
Prolastin-c Clinical Trials
See Literature
Prolastin-c Note
Not Applicable
Prolastin-c Patient Counseling
See Literature
