País: Reino Unido
Idioma: inglés
Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ropivacaine hydrochloride
Advanz Pharma
N01BB09
Ropivacaine hydrochloride
2mg/1ml
Infusion
Perineural; Epidural
No Controlled Drug Status
Valid as a prescribable product
BNF: 15020100; GTIN: 5099602996205
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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Ropivacaine is and what it is used for 2. Before you use Ropivacaine 3. How to use Ropivacaine 4. Possible side effects 5. How to store Ropivacaine 6. Further information This product will be referred to as Ropiv- acaine from here on. 1. WHAT ROPIVACAINE IS AND WHAT IT IS USED FOR Ropivacaine contains the active substance ropivacaine hydrochloride which is a type of medicine called local anaesthetic. Ropivacaine 2 mg/ml solution for infusion is used in adults and children of all ages for acute pain management. It numbs (anaes- thetises) parts of the body e.g. after surgery. 2. BEFORE YOU USE ROPIVACAINE YOU MUST NOT BE GIVEN ROPIVACAINE • if you are ALLERGIC (hypersensitive) TO ROP- IVACAINE HYDROCHLORIDE, other so called local anaesthetics of the amide type or any of the other ingredients of Ropiv- acaine, • if you have a DECREASE IN BLOOD VOLUME (hypovolaemia). This is measured by healthcare personnel. • for INFUSION INTO A BLOOD VESSEL to numb a specific area of your body, • for INFUSION INTO THE NECK OF THE WOMB to relieve pain during childbirth. TAKE SPECIAL CARE WITH ROPIVACAINE • In newborn children as they are more susceptible to Ropivacaine. • In children < 12 years as some injections of Ropivacaine in order to numb parts of the body are not established in younger children. Special care should be taken to AVOID ANY ADMINISTRATION of Ropivacaine DIRECTLY INTO A BLOOD VESSEL to prevent any immedi- ate toxic effects. Administration should not be performed in inflamed areas. Please tell your doctor Leer el documento completo
ROPIVACAINE 2 MG / ML SOLUTION FOR INFUSION Summary of Product Characteristics Updated 24-Sep-2014 | Concordia International - formerly AMCo 1. Name of the medicinal product Ropivacaine 2 mg / ml solution for infusion 2. Qualitative and quantitative composition Each ml solution for infusion contains 2 mg ropivacaine hydrochloride. Each 100 ml bag contains 200 mg ropivacaine hydrochloride. Each 200 ml bag contains 400 mg ropivacaine hydrochloride. Each 250 ml bag contains 500 mg ropivacaine hydrochloride. Excipient: Each 100 ml bag contains 14.7 mmol (or 339 mg) of sodium. Each 200 ml bag contains 29.5 mmol (or 678 mg) of sodium. Each 250 ml bag contains 36.8 mmol (or 847.5 mg) of sodium. For a full list of excipients, see section 6.1. 3. Pharmaceutical form Solution for infusion. Clear, colourless, sterile, isotonic, isobaric aqueous solution for infusion with a pH of 4.0 to 6.0. 4. Clinical particulars 4.1 Therapeutic indications Ropivacaine 2 mg/ml solution for infusion is indicated foracute pain management Iin adults and children above 12 years of age: - Continuous epidural infusion or intermittent bolus administration during postoperative or labour pain - Field blocks - Continuous peripheral nerve block via a continuous infusion or intermittent bolus injections, e.g. postoperative pain management In infants from 1 year and children up to and including 12 years for: - Single and continuous peripheral nerve block In neonates, infants and children up to and including 12 years for (per- and postoperative) - Caudal epidural block - Continuous epidural infusion 4.2 Posology and method of administration Ropivacaine should only be used by, or under the supervision, of clinicians experienced in regional anaesthesia. POSOLOGY _ADULTS AND CHILDREN ABOVE 12 YEARS OF AGE _ The following table is a guide to dosage for the more commonly used blocks. The smallest dose required to produce an effective block should be used. The clinician's experience and knowledge of the patient's physical status are of importance when decidin Leer el documento completo