Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
Oxygen
SOL S.p.A.
V03AN; V03AN01
Oxygen
21.75 percent volume/volume
Medicinal gas, compressed
Product subject to prescription which may not be renewed (A)
Medical gases; oxygen
Authorised
2016-05-20
1/6 PACKAGE LEAFLET: INFORMATION FOR THE USER MEDICINAL AIR SYNTHETIC SOL 21.75% V/V MEDICINAL GAS, COMPRESSED Oxygen READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Medicinal air synthetic SOL is and what it is used for 2. What you need to know before you use Medicinal air synthetic SOL 3. How to use Medicinal air synthetic SOL 4. Possible side effects 5. How to store Medicinal air synthetic SOL 6. Contents of the pack and other information 1. WHAT MEDICINAL AIR SYNTHETIC SOL IS AND WHAT IT IS USED FOR Medicinal air synthetic SOL is an inhalation gas and belongs to the group of medicinal gases. This medicine is used to prevent oxygen deficiency where treatment with atmospheric air is indicated. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE MEDICINAL AIR SYNTHETIC SOL DO NOT USE MEDICINAL AIR SYNTHETIC SOL There are no known situations in which this medicine cannot be used. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using this medicine. Before treatment with medicinal air, ensure that it is administered at atmospheric pressure. The administration of pressurised medicinal air may cause decompression sickness and oxygen toxicity. Decompression sickness is a disease that occurs during the transition from high pressure to normal pressure and causes headache, nausea, and confusion, and sometimes paralysis and un-consciousness (and even death). If medicinal air is mixed with other inhalational gases, there should be sufficient oxygen (at least 21% v/v) in this gas mixture. Lesen Sie das vollständige Dokument
Health Products Regulatory Authority 20 November 2019 CRN008PP9 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Medicinal air synthetic SOL 21.75% v/v medicinal gas, compressed 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Oxygen 21.75% v/v. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Medicinal gas, compressed Medicinal Air Synthetic is a colourless, odourless and tasteless gas. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevention of hypoxia where treatment with atmospheric air is indicated. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The flow rate and duration of administration should be determined based on the cause of the hypoxia. Method of administration A physician, experienced in intensive care or pneumology, should see to the administration of medicinal air as inlet gas for respirators used in respiratory support. For long-term administration, humidification is advised. Medicinal air is administered via inhaled air, preferably by means of dedicated equipment (for example, a nasal cannula, facial mask, facial tent, an oxygen tent over a crib, or flow to tracheotomy). Such devices must be used according to the instructions of the manufacturer. Through this equipment, medicinal air is administered along with inhaled air. Upon exhaling, the exhaled gas leaves the patient together with any surplus air and mixes with the ambient air (“non-rebreathing” system). If the patient is not able to breathe independently, artificial breathing support can be provided. General Connections for tubes, valves, etc., must be clean and dry. If needed, clean them according to the instructions of the supplier. Do not use solvents. Do not use oil or grease on the cylinder valve or the related equipment. 4.3 CONTRAINDICATIONS There are no absolute contraindications. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Medicinal air may only be administered to patients under atmospheric pressure or at pressure levels that are slightly positive, when ventilators are u Lesen Sie das vollständige Dokument