Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Levobupivacaine
Fresenius Kabi Deutschland GmbH
N01BB; N01BB10
Levobupivacaine
1.25 milligram(s)/millilitre
Solution for infusion
Product subject to prescription which may not be renewed (A)
Amides; levobupivacaine
Marketed
2014-10-24
- 1 - PACKAGE LEAFLET: INFORMATION FOR THE USER LEVOBUPIVACAINE 0.625 MG/ML SOLUTION FOR INFUSION LEVOBUPIVACAINE 1.25 MG/ML SOLUTION FOR INFUSION Levobupivacaine hydrochloride 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4. THE NAME OF YOUR MEDICINE IS LEVOBUPIVACAINE 0.625 MG/ML OR 1.25 MG/ML SOLUTION FOR INFUSION; IN THE REST OF THE LEAFLET IT WILL BE CALLED “LEVOBUPIVACAINE ” WHAT IS IN THIS LEAFLET : 1. What Levobupivacaine is and what it is used for 2. What you need to know before you are given Levobupivacaine 3. How you will be given Levobupivacaine 4. Possible side effects 5. How to store Levobupivacaine 6. Contents of the pack and other information 1. WHAT LEVOBUPIVACAINE IS AND WHAT IT IS USED FOR Levobupivacaine belongs to a group of medicines called local anaesthetics. This type of medicine is used to make an area of the body numb or free from pain. Levobupivacaine Solution for Infusion is FOR ADULT USE ONLY. Levobupivacaine is used for pain relief: after major surgery during childbirth 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN LEVOBUPIVACAINE DO NOT USE LEVOBUPIVACAINE: if you are allergic (hypersensitive) to levobupivacaine, to any similar local anaesthetics or to any of the other ingredients of this medicine (listed in section 6). if you have very low blood pressure. to numb an area by injecting Levobupivacaine into a vein. as a type of pain relief given by injection into the area around the neck of the womb (the cervix) during the early stage of labour (paracervical block). - 2 - WARNINGS AND PRECAUTIONS Talk to your doctor before you are given Levobupivacaine if you have any of the diseases or conditions below. You may need to be c Soma hati kamili
Health Products Regulatory Authority 18 May 2021 CRN00C8Y5 Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Levobupivacaine 1.25 mg/mL solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution contains 1.25 mg of levobupivacaine as levobupivacaine hydrochloride. Each bag of 100 ml contains 125 mg of levobupivacaine as levobupivacaine hydrochloride. Each bag of 200 ml contains 250 mg of levobupivacaine as levobupivacaine hydrochloride. Excipients with known effect: This medicinal product contains 3.6 mg sodium per ml, equivalent to 0.18% of the WHO recommended maximum daily intake of 2 g sodium for an adult. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion Clear colourless solution pH 4.0-6.0 Osmolarity: 271 – 332 mOsmol/l 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adults _Pain management_ Continuous epidural infusion, for the management of post operative pain and labour analgesia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Levobupivacaine should be administered only by, or under the supervision of, a clinician having the necessary training and experience. Posology Type of Block Concentration mg/ml Infusion Rate Per Hour ml mg _Continuous Infusion:_ Post operative pain management Lumbar epidural (analgesia in labour) 1.25 1.25 10-15 4-10 12.5-18.75 5–12.5 There is limited safety experience with levobupivacaine therapy for periods exceeding 24 hours. In order to minimise the risk for severe neurological complications, the patient and the duration of administration of levbupivacaine should be closely monitored (see Section 4.4). Health Products Regulatory Authority 18 May 2021 CRN00C8Y5 Page 2 of 9 Maximum dose The maximum dosage must be determined by evaluating the size and physical status of the patient. The maximum recommended dose during a 24 hour period is 400 mg. For post-operative pain management, the dose should not exceed 18.75 mg/hour, however the accumulated dose for a 24 hour period should not excee Soma hati kamili