Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
Tramadol hydrochloride
Grunenthal Pharma Ltd
N02AX; N02AX02
Tramadol hydrochloride
100mg/2ml milligram(s)/millilitre
Solution for injection
Product subject to prescription which may be renewed (B)
Other opioids; tramadol
Not marketed
1993-04-16
m1-3-1-leaflet-1189-1-4-v11-tracked (00000002) Details: Type IAin – updates following PSUSA Mar 2018 Page 1 1 PACKAGE LEAFLET: INFORMATION FOR THE USER ZYDOL 100 MG / 2 ML SOLUTION FOR INJECTION Tramadol hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 (section 4). IN THIS LEAFLET: 1. What ZYDOL is and what it is used for 2. What you need to know before you receive ZYDOL 3. How to use ZYDOL 4. Possible side effects 5. How to store ZYDOL 6. Contents of the pack and other information 1. WHAT ZYDOL IS AND WHAT IT IS USED FOR The full name of your medicine is ‘ZYDOL 100 mg / 2 ml solution for injection’. It is referred to as ‘ZYDOL’ in the rest of this leaflet. Tramadol - the active substance in ZYDOL - is a painkiller belonging to the class of opioids that acts on the central nervous system. It relieves pain by acting on specific nerve cells of the spinal cord and brain. ZYDOL is used for the treatment of moderate to severe pain. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZYDOL DO NOT RECEIVE ZYDOL - if you are allergic to tramadol or any of the other ingredients of this medicine (listed in section 6); - in acute poisoning with alcohol, sleeping pills, pain relievers or other psychotropic medicines (medicines that affect mood and emotions) - if you are also taking MAO inhibitors (certain medicines used for treatment of depression) or have taken them in the last 14 days before treatment with ZYDOL (see "Other medicines and ZYDOL") - if you are an epileptic and your fits are not adequately controlled by treatment - as a substit Baca dokumen lengkapnya
Health Products Regulatory Authority 04 March 2020 CRN009DR0 Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT ZYDOL 100 mg / 2 ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ZYDOL 100 mg / 2 ml Solution for injection ampoule contains 100 mg tramadol hydrochloride in 2 ml solution, i.e. 50 mg tramadol hydrochloride per ml. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection or infusion. Clear colourless, aqueous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of moderate to severe pain. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The dose should be adjusted to the intensity of the pain and the sensitivity of the individual patient. The lowest effective dose for analgesia should generally be selected. The total daily dose of 400 mg tramadol hydrochloride should not be exceeded, except in special clinical circumstances. Unless otherwise prescribed, ZYDOL should be administered as follows: Adults and adolescents above the age of 12 years The usual dosage is 50 or 100 mg 4-6 hourly (see section 5.1). Intravenous injections must be given slowly over 2-3 minutes. For post-operative pain, administer an initial bolus of 100 mg. During the 60 minutes following the initial bolus, further doses of 50mg may be given every 10-20 minutes, up to a total dose of 250mg including the initial bolus. Subsequent doses should be 50mg-100mg 4-6 hourly up to a total daily dose of 400mg. Children above the age of 1 year The recommended single dose of tramadol hydrochloride is 1 mg/kg to 2 mg/kg body weight. The total daily dose of 8 mg tramadol hydrochloride per kg body weight or 400 mg tramadol hydrochloride, whichever is lower, should not be exceeded per day. On account of their high dosage strengths, capsules, prolonged release tablets and dispersible tablets are not intended for children below the age of 12 years. Older patients A dose adjustment is not usually necessary in patients up to 75 years without clinicall Baca dokumen lengkapnya