País: Regne Unit
Idioma: anglès
Font: MHRA (Medicines & Healthcare Products Regulatory Agency)
Levobupivacaine hydrochloride
AbbVie Ltd
N01BB10
Levobupivacaine hydrochloride
2.5mg/1ml
Solution for injection
Intrathecal; Epidural
No Controlled Drug Status
Valid as a prescribable product
BNF: 15020100; GTIN: 5013158770744
PACKAGE LEAFLET: INFORMATION FOR THE USER CHIROCAINE 2.5 MG/ML AND 5.0 MG/ML SOLUTION FOR INJECTION/CONCENTRATE FOR SOLUTION FOR INFUSION LEVOBUPIVACAINE 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, please 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. WHAT IS IN THIS LEAFLET 1. What Chirocaine is and what it is used for 2. What you need to know before you are given Chirocaine 3. How you will be given Chirocaine 4. Possible side effects 5. How to store Chirocaine 6. Contents of the pack and other information 1. WHAT CHIROCAINE IS AND WHAT IT IS USED FOR Chirocaine 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. ADULTS: Chirocaine is used as a local anaesthetic to numb parts of the body before major surgery (for example as an epidural for caesarean section) and minor surgery (such as on the eye and mouth). IT IS ALSO USED FOR PAIN RELIEF: • after major surgery • during childbirth CHILDREN: Chirocaine can also be used with children to numb parts of the body before surgery and for pain relief after minor surgery, such as the repair of a groin hernia. Chirocaine has not been tested in children less than 6 months of age. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CHIROCAINE_ _ DO NOT TAKE CHIROCAINE: • 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 • 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) • to numb an area by injecting Chirocaine into a vein WARNINGS AND PR Llegiu el document complet
OBJECT 1 CHIROCAINE 2.5MG/ML SOLUTION FOR INJECTION/CONCENTRATE FOR SOLUTION FOR INFUSION Summary of Product Characteristics Updated 07-Aug-2015 | AbbVie Limited 1. Name of the medicinal product Chirocaine 2.5 mg/ml solution for injection/concentrate for solution for infusion. 2. Qualitative and quantitative composition One ml contains 2.5 mg levobupivacaine as levobupivacaine hydrochloride. Each ampoule contains 25 mg in 10 ml. Excipients with known effect: 3.6 mg/ml of sodium per ampoule. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Solution for injection/concentrate for solution for infusion. Clear colourless solution. 4. Clinical particulars 4.1 Therapeutic indications Adults _Surgical anaesthesia_ - Major, e.g. epidural (including for caesarean section), intrathecal, peripheral nerve block. - Minor, e.g. local infiltration, peribulbar block in ophthalmic surgery. _Pain management_ - Continuous epidural infusion, single or multiple bolus epidural administration for the management of pain especially post-operative pain or labour analgesia. Paediatric population Analgesia (ilioinguinal/iliohypogastric blocks). No data are available in paediatric population < 6 months of age. 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. The table below is a guide to dosage for the more commonly used blocks. For analgesia (e.g. epidural administration for pain management), the lower concentrations and doses are recommended. Where profound or prolonged anaesthesia is required with dense motor block (e.g. epidural or peribulbar block), the higher concentrations may be used. Careful aspiration before and during injection is recommended to prevent intravascular injection. 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 administrat Llegiu el document complet