Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
THIOPENTAL SODIUM
Archimedes Pharma UK Limited
N01AF03
THIOPENTAL SODIUM
500 Milligram
Pdr for Soln for Injection
Product subject to prescription which may not be renewed (A)
Barbiturates, plain
Authorised
1997-06-09
PACKAGE LEAFLET: INFORMATION FOR THE USER THIOPENTAL SODIUM 500 MG POWDER FOR SOLUTION FOR INJECTION READ ALL OF THIS LEAFLET CAREFULLY BEFORE RECEIVING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. – Please keep this leaflet. You may need to read it again. – If you have any further questions, ask the doctor or nurse. – If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET: 1. What Thiopental injection is and what it is used for 2. What you need to know before Thiopental injection is given 3. How Thiopental injection is given 4. Possible side effects 5. How to store Thiopental injection 6. Contents of the pack and other information 1. WHAT THIOPENTAL INJECTION IS AND WHAT IT IS USED FOR Thiopental injection contains the active ingredient thiopental sodium which is also known as thiopentone sodium. It is an anaesthetic agent, which may be given: • as a general anaesthetic or to make you sleepy before using another anaesthetic agent • before using agents to prevent pain or to relax muscles • to control fits • to reduce intracranial pressure. This injection is usually given to you by a doctor directly into a vein. 2. WHAT YOU NEED TO KNOW BEFORE THIOPENTAL INJECTION IS GIVEN YOU MUST NOT BE GIVEN THIOPENTAL INJECTION IF YOU: • are ALLERGIC to thiopental sodium or have had reactions to thiopental or to other barbiturates (such as some anaesthetics) • have any RESPIRATORY ABNORMALITIES (including difficulty in breathing), such as an obstruction in your lungs or in the tubes leading to them • have ACUTE ASTHMA (short term asthma) • are in SEVERE SHOCK • have MYOTONIC DYSTROPHY - a muscular disease • have the condition known as PORPHYRIA - a metabolic disorder. If any of these apply to you, tell the doctor or nurse, they will usually decide to use another medicine instead. TAKE SPECIAL CARE WITH THIOPENTAL INJECTION Tell your doctor before you are given thiopental if you have any Olvassa el a teljes dokumentumot
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Thiopental Sodium 500 mg Powder for Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 500 mg thiopental sodium (as thiopental sodium and sodium carbonate). Contains 53.5mg sodium per vial For full list of excipients see section 6.1 3 PHARMACEUTICAL FORM Powder for solution for injection (Powder for Injection) Yellow-white freeze dried powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Thiopental sodium is given intravenously to induce short duration general anaesthesia. It is also indicated as an induction agent, and for the control of convulsive disorders. It may be used rectally to produce basal anaesthesia. Thiopental sodium may be used to reduce the intracranial pressure in patients with increased intracranial pressure, if controlled ventilation is provided. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Thiopental sodium is administered normally as a 2.5% w/v (500mg in 20ml) solution. On occasions it may be administered as a 5% solution (500mg in 10ml). A test dose of 25mg to 75mg can precede the main administration. Use in anaesthesia Normal dosage for the induction of anaesthesia is 100mg to 150mg injected over 10 to 15 seconds. If necessary a repeat dose of 100mg to 150mg may be given after one minute. No fixed dosage recommendations for the intravenous injection can be given, since the dosage will need to be carefully adjusted according to the patient’s response. Factors such as age, sex, weight of the patient should be taken into consideration. Thiopental sodium reaches effective concentrations in the brain within 30 seconds and anaesthesia is normally produced within one minute of an intravenous dose. _Adult_ 100 mg to 150 mg intravenously over 10 to 15 seconds, normally as a 2.5% w/v solution. A repeat dose of 100 mg to 150 mg may be given after one minute. The intravenous injection should be given slowly and the amounts given titrated against the patient’s response to minimise the ris Olvassa el a teljes dokumentumot