Generic name: .ALPHA.1-PROTEINASE INHIBITOR HUMAN 1g in 50mL
Dosage form: injection, solution
Medically reviewed by Drugs.com. Last updated on Jan 30, 2019.
For intravenous use only.
- Administer 60 mg/kg body weight of GLASSIA once weekly by intravenous infusion.
- Dose ranging studies using efficacy endpoints have not been performed.
- The carton and label on each vial of GLASSIA show the actual amount of functionally active Alpha1-PI in milligrams.
- Use aseptic technique.
- Allow the product to reach room temperature prior to infusing and administer within three hours of entering the vials.
- Inspect the vial of GLASSIA. The solution should be clear and colorless to yellow-green and may contain a few protein particles. Do not use if the product is cloudy.
- The product is suitable for infusion directly from the vial or pooled into a sterile container for intravenous infusion.
- For pooling the product, use a vented spike (not supplied) to withdraw the solution from the vial and then use the supplied 5 micron filter needle to transfer the solution into the intravenous infusion container. NOTE: Do not use the 5 micron filter needle to withdraw GLASSIA from the vial.
For intravenous infusion only.
GLASSIA should be administered by a healthcare professional or self-administered by the patient/caregiver after appropriate training. For self-administration, provide the patient/caregiver with detailed instructions and adequate training for infusion in the home or other appropriate setting [see Patient Counseling Information (17)].
- Use aseptic technique.
- Inspect parenteral products visually for particulate matter and discoloration prior to administration whenever solution and container permit.
- Administer GLASSIA alone. Do not mix with other agents or diluting solutions.
- When infusing directly from the vials, use a vented spike (not supplied). If the contents of vials have been pooled to a sterile intravenous container, use an appropriate intravenous administration set.
- Always use a 5 micron in-line filter (not supplied) during infusion.
- Administer GLASSIA within three hours of entering the vials to avoid the potential ill effect of any inadvertent microbial contamination.
- Administer GLASSIA at room temperature through an appropriate intravenous administration set at a rate not to exceed 0.2 mL/kg body weight per minute, and as determined by the response and comfort of the patient. The recommended dosage of 60 mg/kg at a rate of 0.2 mL/kg/min will take approximately 15 minutes to infuse.
- Monitor the infusion rate closely during administration and observe the patient for signs of infusion related reactions. If infusion related adverse reactions occur, reduce the rate or interrupt the infusion as appropriate until the symptoms subside. Resume the infusion at a rate tolerated by the patient, except in the case of severe reaction [see Warnings and Precautions (5.1)].
- Following administration, discard all open vials, unused solution and administration equipment.
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