KINOX Inhalation gas (2016)

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

KINOX Nitric oxide for inhalation 100 ppm, 800 ppm.

Indications and clinical use

KINOX (nitric oxide), in conjunction with ventilatory support and other appropriate agents, is indicated for the treatment of term and late pre-term (≥34 weeks) neonates with hypoxic respiratory failure ...

Contraindications

In patients with the rare cardiovascular defect in which the systemic oxygenation is wholly dependent on extra-pulmonary right-to-left shunting, the use of nitric oxide has the potential to decrease right-to-left ...

Warnings and precautions

WARNINGS Left to Right Shunting Treatment with nitric oxide might aggravate cardiac insufficiency in a situation with left-to-right shunting. This is due to unwanted pulmonary vasodilation caused by inhaled ...

Adverse reactions

The NINOS and CINRGI studies were not powered to detect statistically significant differences with regards to adverse events between the placebo and inhaled nitric oxide treatment groups. In the NINOS ...

Dosage and administration

Dosage The minimum effective dose for the indication has not been optimally identified in randomized clinical trials. The initial dose of nitric oxide should be as low as possible and in no cases higher ...

Overdosage

Overdosage with nitric oxide will be manifest by elevations in methemoglobin and NO2. Elevated NO2 may cause acute lung injury. Elevations in methemoglobinemia reduce the oxygen delivery capacity of the ...

Action and clinical pharmacology

Nitric oxide is a compound produced by many cells of the body. It relaxes vascular smooth muscle by binding to the heme moiety of cytosolic guanylate cyclase, activating guanylate cyclase and increasing ...

Storage and stability

The shelf life of KINOX is 24 months. Store cylinders between 15-30ºC (59-86ºF). All regulations concerning handling of pressure vessels must be followed. Protect the cylinders from shocks, falls, oxidizing ...

Special handling instructions

Used KINOX cylinders are returned to VitalAire Canada Inc. Occupational Exposure The upper limit of exposure (mean exposure) to nitric oxide for personnel defined by workers legislation is 25 ppm for 8 ...

Dosage forms, composition and packaging

Availability of Dosage Forms KINOX (nitric oxide) for inhalation is supplied in aluminum cylinders as a compressed gas under high pressure (2000 pounds per square inch gauge [psig]) and is available in ...

Pharmaceutical information

Drug Substance: Nitric oxide Proper name: Nitric oxide Chemical name: Nitric oxide, nitrogen II oxide Structural formula: NO Chemical structure: ·N=O: Molecular mass: 30.01 grams Physical form: gas

Detailed pharmacology

Human Pharmacokinetics The safety of short-term inhalation of nitric oxide (NO) (40 ppm for 2 hours) in 12 healthy volunteers demonstrated no notable effects on systolic and diastolic blood pressures, ...

Toxicology

The preclinical safety profile of nitric oxide was assessed in rats in repeat dose inhalation studies up to 2 years in duration. Age-specific nitric oxide-induced toxicity has not been determined, as juvenile ...

Marketing authorization holder

Manufactured by: Airgas USA LLC, 6141 Easton Road, Plumsteadville, PA 18949-0310, USA Importer: VitalAire Canada Inc., 8 Bram Court, Brampton, ON, L6W 3R6

Submission control number

198879

Date of approval

January 21, 2016

Date of revision

December 1, 2016

References

Clark R.H., Huckaby J.L., Kueser T.J., et al., Low-dose nitric oxide therapy for persistent pulmonary hypertension: 1-year follow-up. Journal of Perinatology 2003;23:300-303. Young J.D., Sear J.W., Valvini ...

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