Ulspira NITRIC OXIDE AIRGAS THERAPEUTICS, LLC FDA Approved No description available yet.
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Substance Nitric Oxide
Route
RESPIRATORY (INHALATION)
Applications
ANDA203144

Drug Facts

Composition & Profile

Quantities
362 liters 2138 liters

Identifiers & Packaging

Container Type UNKNOWN
UNII
31C4KY9ESH
Packaging

Ulspira TM (nitric oxide for inhalation) 800 PPM Rx Only CAUTION: HIGH PRESSURE GAS. CAN CAUSE RAPID SUFFOCATION WITHOUT WARNING. Use equipment rated for cylinder pressure. Store and use with adequate ventilation. Secure cylinder in use and storage. Close valve after each use and when empty. USE IN ACCORDANCE WITH APPROPRIATE SDS. WARNING: Administration of this gas mixture may be hazardous or contraindicated. For use only by or under the supervision of a licensed practitioner who is experienced in the use and administration of gas mixtures, and if familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and with the hazards, contraindications and side effects and the precautions to be taken. FIRST AID: IF INHALED, remove person to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical help. RETURN WITH 25 PSIG. TO BE REFILLED ONLY BY A PHARMACEUTICAL FACILITY AUTHORIZED BY AIRGAS THERAPEUTICS, LLC Manufactured Under Pharmaceutical Current Good Manufacturing Practices (cGMPs). DO NOT REMOVE THIS PRODUCT LABELS Store at 25 C (77 F) with excursions permitted between 15 - 30 C (59 – 86 F). Volume 362 Liters Airgas Therapeutics An Air Liquide company Manufactured by: AIRGAS THERAPEUTICS, LLC 6141 Easton Road Plumsteadville, PA 18949-0310 For Product Inquiry 1-833-ULSPIRA (857-7472) UN 1956 COMPRESSED GAS, N.O.S. (NITRIC OXIDE, NITROGEN) 2.2 Net Weight: 0.4 kg LOT: EXP: NDC 82605-005-02 Label No. ULSMD15 Rev. 00 800PPM MD15 nitric oxide one; Ulspira TM (nitric oxide for inhalation) 800 PPM Rx Only CAUTION: HIGH PRESSURE GAS. CAN CAUSE RAPID SUFFOCATION WITHOUT WARNING. Use equipment rated for cylinder pressure. Store and use with adequate ventilation. Secure cylinder in use and storage. Close valve after each use and when empty. USE IN ACCORDANCE WITH APPROPRIATE SDS. WARNING: Administration of this gas mixture may be hazardous or contraindicated. For use only by or under the supervision of a licensed practitioner who is experienced in the use and administration of gas mixtures, and is familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and with the hazards, contraindications, and side effects and the precautions to be taken. FIRST AID: IF INHALED, remove person to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical help. RETURN WITH 25 PSIG. TO BE REFILLED ONLY BY A PHARMACEUTICAL FACILITY AUTHORIZED BY AIRGAS THERAPEUTICS, LLC Manufactured Under Pharmaceutical Current Good Manufacturing Practices (cGmps). DO NOT REMOVE THIS PRODUCT LABEL Store at 25 C (77 F) with excursions permitted between 15 – 30 C (59 – 86 F). Volume 2138 Liters Airgas Therapeutics An Air Liquide company Manufactured by: AIRGAS THERAPEUTICS, LLC 6141 Easton Road Plumsteadville, PA 18949-0310 For Product Inquiry 1-833-ULSPIRA (857-7472) UN1956 COMPRESSED GAS, N.O.S. (NITRIC OXIDE, NITROGEN) 2.2 Net Weight: 2.5 kg LOT: EXP: NDC 82605-005-01 nitric oxide two

Package Descriptions
  • Ulspira TM (nitric oxide for inhalation) 800 PPM Rx Only CAUTION: HIGH PRESSURE GAS. CAN CAUSE RAPID SUFFOCATION WITHOUT WARNING. Use equipment rated for cylinder pressure. Store and use with adequate ventilation. Secure cylinder in use and storage. Close valve after each use and when empty. USE IN ACCORDANCE WITH APPROPRIATE SDS. WARNING: Administration of this gas mixture may be hazardous or contraindicated. For use only by or under the supervision of a licensed practitioner who is experienced in the use and administration of gas mixtures, and if familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and with the hazards, contraindications and side effects and the precautions to be taken. FIRST AID: IF INHALED, remove person to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical help. RETURN WITH 25 PSIG. TO BE REFILLED ONLY BY A PHARMACEUTICAL FACILITY AUTHORIZED BY AIRGAS THERAPEUTICS, LLC Manufactured Under Pharmaceutical Current Good Manufacturing Practices (cGMPs). DO NOT REMOVE THIS PRODUCT LABELS Store at 25 C (77 F) with excursions permitted between 15 - 30 C (59 – 86 F). Volume 362 Liters Airgas Therapeutics An Air Liquide company Manufactured by: AIRGAS THERAPEUTICS, LLC 6141 Easton Road Plumsteadville, PA 18949-0310 For Product Inquiry 1-833-ULSPIRA (857-7472) UN 1956 COMPRESSED GAS, N.O.S. (NITRIC OXIDE, NITROGEN) 2.2 Net Weight: 0.4 kg LOT: EXP: NDC 82605-005-02 Label No. ULSMD15 Rev. 00 800PPM MD15 nitric oxide one
  • Ulspira TM (nitric oxide for inhalation) 800 PPM Rx Only CAUTION: HIGH PRESSURE GAS. CAN CAUSE RAPID SUFFOCATION WITHOUT WARNING. Use equipment rated for cylinder pressure. Store and use with adequate ventilation. Secure cylinder in use and storage. Close valve after each use and when empty. USE IN ACCORDANCE WITH APPROPRIATE SDS. WARNING: Administration of this gas mixture may be hazardous or contraindicated. For use only by or under the supervision of a licensed practitioner who is experienced in the use and administration of gas mixtures, and is familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and with the hazards, contraindications, and side effects and the precautions to be taken. FIRST AID: IF INHALED, remove person to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical help. RETURN WITH 25 PSIG. TO BE REFILLED ONLY BY A PHARMACEUTICAL FACILITY AUTHORIZED BY AIRGAS THERAPEUTICS, LLC Manufactured Under Pharmaceutical Current Good Manufacturing Practices (cGmps). DO NOT REMOVE THIS PRODUCT LABEL Store at 25 C (77 F) with excursions permitted between 15 – 30 C (59 – 86 F). Volume 2138 Liters Airgas Therapeutics An Air Liquide company Manufactured by: AIRGAS THERAPEUTICS, LLC 6141 Easton Road Plumsteadville, PA 18949-0310 For Product Inquiry 1-833-ULSPIRA (857-7472) UN1956 COMPRESSED GAS, N.O.S. (NITRIC OXIDE, NITROGEN) 2.2 Net Weight: 2.5 kg LOT: EXP: NDC 82605-005-01 nitric oxide two

Overview

No description available yet.

Dosage & Administration

Not available

Warnings & Precautions
WARNING: Administration of this gas mixture may be hazardous or contraindicated. For use only by or under the supervision of a licensed practitioner who is experienced in the use and administration of gas mixtures, and if familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and with the hazards, contraindications and side effects and the precautions to be taken.

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