Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
Nitrous oxide
SOL S.p.A.
N01AX; N01AX13
Nitrous oxide
100 percent volume/volume
Medicinal gas, liquefied
Product subject to prescription which may not be renewed (A)
Other general anesthetics; nitrous oxide
Authorised
2016-07-08
Nitrous oxide Medicinal SOL 100 % v/v medicinal gas, liquefied PIL – Page 1of 10 November 2023 PACKAGE LEAFLET: INFORMATION FOR THE USER NITROUS OXIDE MEDICINAL SOL 100 % V/V MEDICINAL GAS, LIQUEFIED nitrous oxide 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, pharmacist or nurse. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Nitrous oxide Medicinal SOL is and what it is used for 2. What you need to know before you use Nitrous oxide Medicinal SOL 3. How to use Nitrous oxide Medicinal SOL 4. Possible side effects 5. How to store Nitrous oxide Medicinal SOL 6. Contents of the pack and other information 1. WHAT NITROUS OXIDE MEDICINAL SOL IS AND WHAT IT IS USED FOR Nitrous oxide Medicinal SOL is a colourless, sweet smelling inhalation gas (intended for breathing in). The active substance is nitrous oxide, otherwise known as “laughing gas”. It belongs to the group of general anaesthetics (narcotic agents). Nitrous oxide Medicinal SOL is used in adults and children from the age of 1 month: - In combination with oxygen (50% nitrous oxide and 50% oxygen) for relief of short-term, intermittent, mild to moderate pain. - In mixture with a minimum of 21% oxygen as a basic anaesthetic in combination with other anaesthetics. 2. WHAT YOU NEED TO NOW BEFORE YOU USE NITROUS OXIDE MEDICINAL SOL DO NOT USE NITROUS OXIDE MEDICINAL SOL if you have: - To inhale 100% medical oxygen regularly or constantly - Air trapped in a part of the body where it’s expansion may be dangerous, such as in collapsed lung (pneumothorax), in breathing difficulties such as emphysema or in decompression sickness (the bends) - Undergone a bypass surgery with or without heart lung machine - In patients with cardiac disease (i.e hea Đọc toàn bộ tài liệu
Health Products Regulatory Authority 28 September 2020 CRN008JWC Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nitrous oxide Medicinal SOL, 100 % v/v, medicinal gas, liquefied 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Nitrous oxide (N 2 O), 100% v/v 3 PHARMACEUTICAL FORM Medicinal gas, liquefied Colourless and odourless gas 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Nitrous oxide Medicinal SOL in equimolar concentration with oxygen (50% v/v nitrous oxide and 50% v/v oxygen) is indicated for the treatment of short-term pain conditions of mild to moderate intensity when rapid analgesic onset and offset effects are required, in adults and in children older than 1 month. Nitrous oxide Medicinal SOL is used as a basic anaesthetic in combination with inhalation anaesthetics or intravenous anaesthetics in adults and children from the age of 1 month. Medical oxygen is added at a concentration of at least 21% v/v. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Analgesia_ Administration of Nitrous oxide Medicinal SOL in an equimolar mixture with oxygen should commence shortly before the desired analgesic effect is required. The analgesic effect is seen after 4-5 breaths and reaches its maximum within 2-3 minutes. Administration of Nitrous oxide Medicinal SOL should continue throughout the painful procedure, or for as long as the analgesic effect is desired. Following discontinuation of the administration/inhalation, the effects wear off quickly within a few minutes. According to the individual pain relieving reaction in the patient, additional analgesics may be required. Nitrous oxide, as an analgesic, in an equimolar mixture with oxygen, may not be administered for longer than 1 hour continuously and should not be used for more than 15 consecutive days. _Anaesthesia_ Nitrous oxide acts as a basal anaesthetic to achieve anaesthesia. Nitrous oxide alone, with a maximum permitted concentration of 79 % v/v, cannot induce anaesthesia. In combination with other inhalation a Đọc toàn bộ tài liệu