ULSPIRA gas

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

NITRIC OXIDE (UNII: 31C4KY9ESH) (NITRIC OXIDE - UNII:31C4KY9ESH)

Tilgjengelig fra:

Airgas Therapeutics, LLC

Administreringsrute:

RESPIRATORY (INHALATION)

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

ULSPIRA™ is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents. ULSPIRA is contraindicated in neonates dependent on right-to-left shunting of blood. 8.4 Pediatric Use The safety and efficacy of nitric oxide for inhalation has been demonstrated in term and near- term neonates with hypoxic respiratory failure associated with evidence of pulmonary hypertension [see Clinical Studies (14.1)]. Additional studies conducted in premature neonates for the prevention of bronchopulmonary dysplasia have not demonstrated substantial evidence of efficacy [see Clinical Studies (14.3)]. No information about its effectiveness in other age populations is available. 8.5 Geriatric Use Nitric oxide is not indicated for use in the adult population.

Produkt oppsummering:

Size D Portable aluminum cylinders containing 362 liters at STP of nitric oxide gas in 800 ppm concentration in nitrogen (delivered volume 350 liters) (NDC 82605-006-02) Size 88 Aluminum cylinders containing 2138 liters at STP of nitric oxide gas in 800 ppm concentration in nitrogen (delivered volume 2083 liters) (NDC 82605-006-01) Distributed by Airgas Therapeutics LLC Radnor, PA 19087 USA AirGas Therapeutics an Air Liquide company © 2023 Airgas ULSPI 01

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

ULSPIRA- ULSPIRA GAS
AIRGAS THERAPEUTICS, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ULSPIRA™ SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ULSPIRA.
ULSPIRA™ (NITRIC OXIDE) GAS, FOR INHALATION INITIAL U.S. APPROVAL:
1999
INDICATIONS AND USAGE
ULSPIRA is a vasodilator indicated to improve oxygenation and reduce
the need for extracorporeal
membrane oxygenation in term and near- term (>34 weeks gestation)
neonates with hypoxic respiratory
failure associated with clinical or echocardiographic evidence of
pulmonary hypertension in conjunction
with ventilatory support and other appropriate agents. (1)
DOSAGE AND ADMINISTRATION
The recommended dose is 20 ppm, maintained for up to 14 days or until
the underlying oxygen
desaturation has resolved (2.1). (2)
Doses greater than 20 ppm are not recommended (2.1, 5.2) (2)
Administration: (2)
Avoid abrupt discontinuation (2.2, 5.1).
DOSAGE FORMS AND STRENGTHS
ULSPIRA (nitric oxide) is a gas available in a 800 ppm concentration
(3). (3)
CONTRAINDICATIONS
Neonates dependent on right-to-left shunting of blood (4). (4)
WARNINGS AND PRECAUTIONS
Rebound: Abrupt discontinuation of ULSPIRA may lead to worsening
oxygenation and increasing pulmonary
artery pressure (5.1). (5)
Methemoglobinemia: Methemoglobin increases with the dose of nitric
oxide; following discontinuation or
reduction of nitric oxide, methemoglobin levels return to baseline
over a period of hours (5.2). (5)
Elevated NO
Levels: Monitor NO
levels (5.3). (5)
Heart Failure: In patients with pre-existing left ventricular
dysfunction, ULSPIRA may increase pulmonary
capillary wedge pressure leading to pulmonary edema (5.4). (5)
ADVERSE REACTIONS
The most common adverse reaction is hypotension. (6). (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT AIRGAS THERAPEUTICS AT
1-833-ULSPIRA
(857-7472) AND HTTP://WWW.ULSPIRA.COM/ OR FDA AT 1-800-FDA-1088 OR
WWW.FDA.GOV/MEDWATCH. (6)
DRUG INTERACTIONS
Ni