Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
Naloxone hydrochloride dihydrate
Emergent Operations Ireland Limited
V03AB; V03AB15
Naloxone hydrochloride dihydrate
1.8 milligram(s)
Nasal spray, solution in single-dose container
Product subject to prescription which may not be renewed (A)
Antidotes; naloxone
Not marketed
2018-03-23
Revision: 02 1 October 2020 PACKAGE LEAFLET: INFORMATION FOR THE USER NARCAN 1.8 MG NASAL SPRAY, SOLUTION IN SINGLE DOSE CONTAINER. NARCAN 3.6 MG NASAL SPRAY, SOLUTION IN SINGLE DOSE CONTAINER. naloxone 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 nurse. - If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet (See section 4). WHAT IS IN THIS LEAFLET 1. What Narcan is and what it is used for 2. What you need to know before you are given Narcan 3. How Narcan is to be given 4. Possible side effects 5. How to store Narcan 6. Contents of the pack and other information 1. WHAT NARCAN IS AND WHAT IT IS USED FOR This medicine contains the active substance naloxone. Narcan temporarily reverses the effects of opioids such as heroin, methadone, fentanyl, oxycodone, buprenorphine and morphine. Narcan is a nasal spray used for the emergency treatment of opioid overdose or possible opioid overdose in adults. SIGNS AND SYMPTOMS OF AN OPIOID OVERDOSE includes: breathing problems extreme sleepiness extremely small pupils in the eye not responding to a loud noise or touch IF YOU ARE AT RISK OF AN OPIOID OVERDOSE YOU SHOULD ALWAYS CARRY NARCAN WITH YOU. Narcan works for a short time only to reverse the effects of opioids while you wait for emergency medical attention. It is not a substitute for emergency medical care. Narcan is intended for use by appropriately trained individuals. Always tell your friends and family that you carry Narcan with you. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN NARCAN YOU SHOULD NOT BE GIVEN NARCAN - if you are allergic to naloxone or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS _ _ Narcan will be supplied to you only after you or the person who will be giving the medicine to you have been t Baca dokumen lengkap
Health Products Regulatory Authority 23 March 2021 CRN00C3YS Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Narcan 1.8 mg Nasal Spray, solution in a single dose container 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 0.1 mL dose contains naloxone hydrochloride dihydrate equivalent to 1.8 mg naloxone. _Excipient with known effect_ Benzalkonium chloride 0.01 mg per dose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Nasal Spray, solution in single dose container. A clear or colourless or slightly yellow, buffered solution intended for nasal administration 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Narcan is intended for emergency reversal of respiratory and/or central nervous system depression induced by or suspected to be induced by opioids (natural or synthetic), in healthcare settings and in non-medical settings by appropriately trained individuals. Narcan is indicated for use in adults only. Narcan is not a substitute for emergency medical care. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Narcan may be made available once the prescriber has assessed the suitability and competence of an individual to administer naloxone in the appropriate circumstances. Narcan may need to be used in a non-medical setting. Therefore, the prescriber as per local clinical guidance should take appropriate steps to ensure that the patient thoroughly understands the indications and use of Narcan. The choice of a 1.8 mg or 3.6 mg dose depends on the specific particulars of each case and the following factors should be taken into account: the type and amount of opioid which has been taken, patient co-morbidities and concomitant drug or alcohol usage. In opioid-dependent patients expected to be at risk of severe opioid withdrawal, Narcan 1.8 mg should be administered. Subjects believed to have taken high potency opioids such as fentanyl should be administered the 3.6 mg dose, as they may require larger doses of Narcan in order to achieve a response. In cases where Baca dokumen lengkap