involved [0.6%:two times the upper limit of normal) in aminotransferases (ALT or AST), up to 3.7 times the upper limit of normal, were noted in 3 of 27 (11.1%) subjects. Elevations were transient lasting three months or less. No subject developed any evidence of viral hepatitis or hepatitis seroconversion while being treated with ARALAST, including 13 evaluable subjects who were not vaccinated against hepatitis B. No clinically relevant alterations in blood pressure, heart rate, respiratory rate, or body temperature occurred during infusion of ARALAST. Mean hematology and laboratory parameters were little changed over the duration of the study, with individual variations not clinically meaningful. During the initial 10 weeks of the study, subjects were randomized to receive either ARALAST or a commercially available preparation of α 1 -PI (Prolastin ). The overall frequency, severity and symptomatology of adverse reactions were similar in both the ARALAST and Prolastin groups. There were two serious adverse events in the Prolastin group, both of which were considered to be possibly related to Prolastin . These included chest pain, dyspnea and bilateral pulmonary infiltrates in one individual that withdrew from the study prematurely following an unscheduled bronchoscopy to remove a foreign body and the other, a positive seroconversion to Parvovirus B-19. There were no serious adverse events or seroconversions reported for the ARALAST group during the 96 week study period. No subject developed an antibody to α 1 PI. Aralast NP Dosage and Administration Dose ranging studies using efficacy endpoints have not been performed. Chronic Augmentation Therapy FOR INTRAVENOUS USE ONLY. The recommended dosage of Aralast NP is 60 mg/kg body weight administered once weekly by intravenous infusion. Each vial of Aralast NP has the functional activity, as determined by inhibition of porcine pancreatic elastase, stated on the label. Administration of Aralast NP within three hours after reconstitution is recommended to avoid the potential ill effect of any inadvertent microbial contamination occurring during reconstitution. Discard any unused contents. Infusion Rate Aralast NP should be administered at a rate not exceeding 0.08 mL/kg body weight/minute. If adverse events occur, the rate should be reduced or the infusion interrupted until the symptoms subside. The infusion may then be resumed at a rate tolerated by the subject. RECONSTITUTION Use Aseptic Technique 1. Aralast NP and diluent should be at room temperature before reconstitution. 2. Remove caps from the diluent and product vials. 3. Swab the exposed stopper surfaces with alcohol. 4.Open the package of the BAXJECT II Hi-Flow device by peeling away the lid without touching the inside contents. (Fig. A). Do not remove the transfer system from the package. Do not touch the clear spike. 5. Turn the package over and insert the clear plastic spike through the diluent vial by pressing straight down (Fig B). 6. Grip the BAXJECT II Hi-Flow package at the edges and pull the package off the device (Fig. C). Do not remove the blue protective cap from the BAXJECT II Hi-Flow device. Do not touch the purple spike. 7. Turn the system over so that the diluent vial is on top. Press the purple spike of the BAXJECT II Hi-Flow device into the Aralast NP vial. The vacuum will draw the diluent into the Aralast NP vial. (Fig. D). 8. Let the vial stand until most of the contents is in solution, then GENTLY swirl until the powder is completely dissolved. Reconstitution requires no more than five minutes for a 0.5 gram vial and no more than 10 minutes for a 1.0 gram vial. 9. DO NOT SHAKE THE CONTENTS OF THE VIAL. DO NOT INVERT THE VIAL UNTIL READY TO WITHDRAW CONTENTS 10. Use within three hours of reconstitution. Fig A, Fig B, Fig C, Fig D For Intravenous Injection/Infusion After reconstituting the product as described under Reconstitution , inspect parenteral drug products visually for particulate matter and discoloration prior to administration. The reconstituted product should be a colorless or slightly yellowish to yellowish-green solution and be essentially free of visible particles. Remove the blue protective cap from the BAXJECT II Hi-Flow device. Connect the syringe to the BAXJECT II Hi-Flow device (DO NOT DRAW AIR INTO THE SYRINGE) (Fig. E). Invert the system (with the Aralast NP concentrate vial on top). Draw the dissolved product into the syringe by pulling the plunger back SLOWLY(Fig. F). Disconnect the syringe. Reconstituted product from several vials may be pooled into an empty, sterile IV solution container by using aseptic technique. Fig E, Fig F How is Aralast NP Supplied Aralast NP is supplied as a sterile, non-pyrogenic, lyophilized powder in single dose vials. The following product packages are available: Fill Size NDC 0.5 g 0944-2812-01 1 g 0944-2822-02 Aralast NP is packaged with a suitable volume of Sterile Water for Injection, USP diluent (25 mL/0.5 g vial; 50 mL/1 g vial), one BAXJECT II Hi-Flow Needleless Transfer Device and one package insert.. STORAGE Aralast NP should be stored at temperatures not to exceed 25 C (77 F). Do not freeze. Do not use after the expiration date printed on the label. Rx only REFERENCES Brantly M, Nukiwa T, Crystal RG. Molecular basis of alpha 1 antitrypsin deficiency. Am J Med 1988 (Suppl 6A);84:13 31. Data on file at Baxter Healthcare Corporation. Crystal RG, Brantly ML, Hubbard RC, Curiel DT, et al. The alpha1 antitrypsin gene and its mutations: Clinical consequences and strategies for therapy. Chest 1989;95:196 208. Crystal RG. α1 Antitrypsin deficiency: pathogenesis and treatment. Hospital Practice 1991;Feb.15:81 94. Hutchison DCS. Natural history of alpha 1 protease inhibitor deficiency. Am J Med 1988;84(Suppl 6A):3 12. Hubbard RC, Crystal RG. Alpha 1 antitrypsin augmentation therapy for alpha 1 antitrypsin deficiency. Am J Med 1988;84(Suppl 6A):52 62. Buist SA, Burrows B, Cohen A, et al. Guidelines for the approach to the patient with severe hereditary alpha 1 antitrypsin deficiency. Am Rev Respir Dis 1989;140:1494 1497. Gadek JE, Fells GA, Zimmerman RL, et al. Antielastases of the human alveolar structures: Implications for the protease-antiprotease theory of emphysema. J Clin Invest 1981;68:889-898. Stoller JK, Brantly M, Fleming LE, et al. Formation and current results of a patient-organized registry for α1 antitrypsin deficiency. Chest 2000; 118(3):843-848. McElvaney NG, Stoller JK, Buist AS, et al. Baseline characteristics of enrollees in the National Heart, Lung and Blood Institute Registry of α1-antitrypsin deficiency. Chest 1997;111:394-403. FDA/CBER Heterogeneity of Alpha-1-Proteinase Inhibitor Products 27 Mar 2006] FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Manufacturer Shire US, Inc. Drug Class Miscellaneous respiratory agents Related Drugs miscellaneous respiratory agents sodium chloride , Pulmozyme , nitric oxide , Prolastin , INOmax Alpha-1 Proteinase Inhibitor Deficiency Prolastin , Prolastin-C , Zemaira , Glassia , Aralast , alpha 1-proteinase inhibitor , More... Aralast NP Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! package
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