Država: Velika Britanija
Jezik: angleščina
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Bupivacaine hydrochloride
0.125%) infusion bags (Sandoz Ltd
N01BB01
Bupivacaine hydrochloride
1.25mg/1ml
Infusion
Epidural
No Controlled Drug Status
Valid as a prescribable product
BNF: 15020100; GTIN: 5099602903142 05021691001560
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. The name of your medicine is Bupivacaine Hydrochloride 0.1% w/v Solution for Infusion, Bupivacaine Hydrochloride 0.125% w/v Solution for Infusion. It will be referred to as Bupivacaine Hydrochloride Infusion Solution for ease hereafter. In this leaflet: 1. What Bupivacaine Hydrochloride Infusion Solution is and what it is used for 2. Before you are given Bupivacaine Hydrochloride Infusion Solution 3. How Bupivacaine Hydrochloride Infusion Solution is given to you 4. Possible side effects 5. How to store Bupivacaine Hydrochloride Infusion Solution 6. Further information 1. WHAT BUPIVACAINE HYDROCHLORIDE INFUSION SOLUTION IS AND WHAT IT IS USED FOR Bupivacaine belongs to a group of medicines called amide-type anaesthetics. Bupivacaine Hydrochloride solution for infusion is used to numb (anaesthetise) parts of the body. It is used to stop pain happening or to provide pain relief. It can be used to: • Numb parts of the body during surgery in adults and children above 12 years • Relieve pain in adults, infants and children above 1 year of age. Bupivacaine Hydrochloride Infusion Solution may be used to prevent or give prolonged relief of pain when it is injected around the spinal cord, e.g. as an epidural in labour or after a surgical operation. 2. BEFORE YOU ARE GIVEN BUPIVACAINE HYDROCHLORIDE INFUSION SOLUTION YOU SHOULD NOT BE GIVEN THIS MEDICINE IF: • you know you are allergic to bupivacaine or to any other amide-type of local anaesthetic, or to any of the other ingredients (see Section 6 of this leaflet) • you are to be injected in a vein of the Preberite celoten dokument
OBJECT 1 BUPIVACAINE HYDROCHLORIDE 0.125%W/V SOLUTION FOR INFUSION Summary of Product Characteristics Updated 13-Nov-2014 | Concordia International - formerly AMCo 1. Name of the medicinal product Bupivacaine Hydrochloride 0.125%w/v Solution for Infusion 2. Qualitative and quantitative composition Each 100ml contains anhydrous bupivacaine hydrochloride 0.125g equivalent to 0.1319g of bupivacaine hydrochloride. For excipients, see 6.1. 3. Pharmaceutical form Solution for Infusion 4. Clinical particulars 4.1 Therapeutic indications Bupivacaine Hydrochloride Infusion Solution 0.125% w/v may be used: 1) for continuous infusion lumbar epidural analgesia to relieve pain during labour. 2) for continuous infusion epidural analgesia to control postoperative pain. 3) Surgical anaesthesia in adults and children above 12 years of age. 4) Acute pain management in adults, infants and children above 1 year of age. 4.2 Posology and method of administration Route of Administration: Epidural infusion. Bupivacaine Hydrochloride Infusion Solution should only be used by, or under the supervision of, clinicians experienced in regional anaesthesia. Every precaution should be taken to avoid accidental intravascular administration; careful aspiration is essential. Prior to commencing a continuous epidural infusion, satisfactory epidural block should be established with test and loading doses of local anaesthetic. A test dose containing adrenaline is recommended, since an intravascular injection of an adrenaline-containing solution may be recognised by an increase in heart rate. A test dose of 7.5mg of bupivacaine 0.25% (3ml) or 10mg of bupivacaine 0.5% (2ml) containing adrenaline may be used. Verbal contact with the patient and repeated measurements of heart rate (ECG) should be maintained following the test dose. Aspiration should be repeated prior to administration of the loading dose and before starting the infusion. Epidural block can usually be established with test and loading doses (total volume 8 12ml of bupivacaine 0.25%) and Preberite celoten dokument