국가: 스웨덴
언어: 스웨덴어
출처: Läkemedelsverket (Medical Products Agency)
bupivakainhydroklorid, vattenfri
Baxter Holding B.V.
N01BB01
bupivacaine hydrochloride, anhydrous
2,5 mg/ml
Injektionsvätska, lösning
bupivakainhydroklorid, vattenfri 2,5 mg Aktiv substans
Receptbelagt
Förpacknings: Injektionsflaska, 5 x 10 ml; Injektionsflaska, 10 x 10 ml; Injektionsflaska, 10 x 20 ml; Injektionsflaska, 5 x 20 ml; Injektionsflaska, 1 x 20 ml
Godkänd
2015-10-09
PACKAGE LEAFLET: INFORMATION FOR THE USER BUPIVACAINE BAXTER 2.5 MG/ML SOLUTION FOR INJECTION BUPIVACAINE BAXTER 5 MG/ML SOLUTION FOR INJECTION Bupivacaine 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, 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 Bupivacaine Baxter is and what it is used for 2. What you need to know before you use Bupivacaine Baxter 3. How to use Bupivacaine Baxter 4. Possible side effects 5. How to store Bupivacaine Baxter 6. Contents of the pack and other information 1. WHAT BUPIVACAINE BAXTER IS AND WHAT IT IS USED FOR Bupivacaine Baxter is a local anaesthetic. It belongs to a group of medicines called amide-type local anaesthetics. It works by blocking the transmission of pain signals through nerves in or near the spinal cord. It is used to numb or make parts of the body free from pain. Bupivacaine Baxter can be used to: • numb parts of the body during surgery in adults and adolescents above 12 years • relieve of acute pain in adults, infants and children above 1 year of age It is used for example in surgical operations and as relief of pain after an operation. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE BUPIVACAINE BAXTER YOU SHOULD NOT BE GIVEN BUPIVACAINE BAXTER: • if you are allergic to bupivacaine hydrochloride or local anaesthetics of the amide type or to any of the other ingredients of this medicine (listed in section 6). • to numb an area by injecting Bupivacine Baxter into a vein • to produce epidural anaesthesia in case you have: - very low blood pressure or low blood volume - a disease in the central nervous system, e.g. meningitis, polio, tumours, increased pressure or bleedings into your brain - a disease in the backbon 전체 문서 읽기
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Bupivacaine Baxter 2.5 mg/ml solution for injection Bupivacaine Baxter 5 mg/ml solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 2.5 mg or 5 mg of bupivacaine hydrochloride. Excipients with known effect: Each ml of the solution contains 3.15 mg of sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear, colourless aqueous solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Surgical anaesthesia in adults and adolescents above 12 years of age • Acute pain management in adults, infants and children above 1 year of age Infiltration anesthesia when prolonged duration of action is required, e.g. for post-operative pain. Conduction anesthesia with prolonged duration or epidural anesthesia in cases where addition of epinephrine is contraindicated and severe muscle relaxation is not desirable. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Bupivacaine Baxter should only be used by physicians experienced in regional anaesthesia or under his or hers supervision. The lowest dosage needed to provide effective anaesthesia should be administered. In order to avoid intravascular injection, aspiration should be repeated prior to and during administration of the main dose, which should be injected slowly or in divided doses, at a rate of 25-50 mg/min, while closely observing the patient's vital functions and maintaining verbal contact. When an epidural dose is to be injected, a preceding test dose of 3-5 ml bupivacaine containing adrenaline (epinephrine) is recommended. An inadvertent intravascular injection may be recognised by a temporary increase in heart rate and an accidental intrathecal injection by signs of a spinal block. If toxic symptoms occur, the injection should be stopped immediately. The dosage varies and depends upon the area to be anaesthetised, the vascularity of the tissues, the number of neuronal segments to be blocked, individual tole 전체 문서 읽기