Country: Ástralía
Tungumál: enska
Heimild: Department of Health (Therapeutic Goods Administration)
nitric oxide, Quantity: 0.0004 mol
Air Liquide Healthcare Pty Ltd
Nitric oxide
Gas, medicinal
Excipient Ingredients: nitrogen
Inhalation
20L, 11L, 5L
(S4) Prescription Only Medicine
VasoKINOX is indicated in conjunction with ventilator support and other appropriate active substances to selectively decrease pulmonary arterial pressure in patients with perioperative pulmonary hypertension in conjunction with heart surgery
Visual Identification: Colourless gas; Container Type: Gas Cylinder; Container Material: Al; Container Life Time: 3 Years; Container Temperature: No Temperature on label; Container Closure: Restricted flow insert
Licence status A
2017-01-16
1 CONSUMER MEDICINE INFORMATION VASOKINOX VasoKINOX Consumer Medicine Information / Version: proposed March 2018 CONSUMER MEDICINE INFORMATION VASOKINOX® 450PPM (nitric oxide for inhalation), medicinal gas compressed WHAT IS IN THIS LEAFLET? This leaflet answers some common questions about VasoKINOX It does not contain all the available information. It does not take the place of talking to your specialist, doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed up the risks of using VasoKINOX against the benefits it is expected to have for you or your child. IF YOU HAVE ANY QUESTIONS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT DOSAGE FORM DOES VASOKINOX COME IN? VasoKINOX is a medicinal product that is in the form of a gas and is packaged in gas cylinders in a concentration of 450 parts per million (ppm). WHAT DOES VASOKINOX CONTAIN? The active substance is nitric oxide, its dosage is 450 ppm mole/mole. The other ingredient is nitrogen. Nitrogen is a major component of the air we breathe. WHAT IS VASOKINOX USED FOR? VasoKINOX is a gas mixture, composed of nitric oxide and nitrogen, used to treat acute pulmonary hypertension (increase in blood pressure in the pulmonary circulation), which can occur during heart surgery. VasoKINOX is a ‘PRESCRIPTION ONLY MEDICINE’. It is to be given only to the person for whom it has been prescribed. HOW VASOKINOX WORKS? VasoKINOX can improve the flow of blood through the lungs by relaxing the cells in the blood vessels and allowing the blood vessels to widen. This may help to decrease the blood pressure and increase the amount of oxygen that reaches the blood. WHEN VASOKINOX SHOULD NOT BE USED DO NOT USE VASOKINOX IF: • YOU ARE ALLERGIC TO NITRIC OXIDE OR NITROGEN • in newborns who have the following heart defects: - RIGHT-TO-LEFT SHUNT - MALIGNANT LEFT-RIGHT ARTERIAL CANAL VASOKINOX SHOULD NOT BE USED IN PREMATURE INFANTS BORN BEFORE 34 WEEKS FROM CONCEPTION. Tell your d Lestu allt skjalið
PRODUCT INFORMATION VASOKINOX VasoKINOX –AUST R 235184 1 /14 AUSTRALIAN PRODUCT INFORMATION – VASOKINOX (NITRIC OXIDE) 445 PPM MEDICINAL GAS 1. NAME OF THE MEDICINE VasoKINOX® 450ppm (nitric oxide for inhalation), medicinal gas compressed 2. QUALITATIVE AND QUANTITATIVE COMPOSITION VasoKINOX is a colourless and odourless medicinal gas. Nitric oxide (NO), the active ingredient of VasoKINOX, is a pulmonary vasodilator. VasoKINOX is supplied in aluminium alloy gas cylinders (of 5L or 11L or 20L capacity) with a NO concentration of 450ppm mol/mol (NO 0.450 ml in Nitrogen (N 2 ) 999.55 ml). 3. PHARMACEUTICAL FORM A 5-litre cylinder filled to 200 bar (20,000 kPa) supplies 0.94m 3 of gas at a pressure of 1 bar (101.3kPa) at 15°C A 11-litre cylinder filled to 200 bar (20,000 kPa) supplies 2.1m 3 of gas at a pressure of 1 bar (101.3kPa) at 15°C A 20-litre cylinder filled to 200 bar (20,000 kPa) supplies 3.8m 3 of gas at a pressure of 1 bar (101.3kPa) at 15°C. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS VasoKINOX is indicated in conjunction with ventilator support and other appropriate active substances to selectively decrease pulmonary arterial pressure in patients with perioperative pulmonary hypertension in conjunction with heart surgery 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE Prescription of NO should be supervised by a physician experienced in cardiothoracic anaesthesia & intensive care. Prescription should be limited to those cardio-thoracic units that have received adequate training in the use of a NO delivery system. VasoKINOX should only be delivered according to an anaesthetist’s or intensive care physician’s prescription. VasoKINOX should be used only after respiratory support has been optimised, according to the current clinical practices. Inhaled NO is usually given in addition to other standard treatment regimes in the peri- operative setting, including inotropic and vasoactive medicinal products. VasoKINOX should be administered under close monitoring of haemodynamics and oxygena Lestu allt skjalið