Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ropivacaine hydrochloride
Advanz Pharma
N01BB09
Ropivacaine hydrochloride
7.5mg/1ml
Solution for injection
Perineural; Epidural
No Controlled Drug Status
Valid as a prescribable product
BNF: 15020100; GTIN: 5099602996243
CHILDREN In children, the side effects are the same as in adults except for low blood pressure which hap- pens less often in children (affecting less than 1 in 10 children) and being sick which happens more often in children (affecting more than 1 in 10 children). If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. HOW TO STORE ROPIVACAINE Keep this medicine out of the reach and sight of children. Do not use Ropivacaine after the expiry date which is stated on the ampoule or carton box. The expiry date refers to the last day of that month. Do not freeze. Do not use Ropivacaine if you notice any precipitation in the solution for injection. Your doctor or the hospital will normally store Ropivacaine and they are responsible for the quality of the product when it has been opened if it is not used immediately. They are also re- sponsible for disposing of any unused Ropivacaine correctly. Medicines should not be disposed of via wastewater or household waste. Your doctor, nurse or pharmacist will dispose of medicines no longer required. These measures will help to protect the environment. 6. FURTHER INFORMATION WHAT ROPIVACAINE CONTAINS - The active substance is ropivacaine hydrochloride 7.5 mg/ml. Each 10 ml polypropylene ampoule contains 75 mg ropivacaine (as hydrochloride). Each 20 ml polypropylene ampoule contains 150 mg ropivacaine, (as hydrochloride). - The other ingredients are_ _sodium chloride, sodium hydroxide (for pH adjustment) and water for injections. WHAT ROPIVACAINE LOOKS LIKE AND CONTENTS OF THE PACK Ropivacaine solution for injection is a clear , colourless, sterile, isotonic, isobaric aqueous solu- tion for injection. Ropivacaine 7.5 mg/ml solution for injection is available in 10 ml and 20 ml transparent polypropylene ampoules. Pack sizes: 10 sterile ampoules in plastic overwrap MARKETING AUTHORISATION HOLDER AND MANUFACTURER Mercury Pharmaceuticals Ltd No. 1 Croydon, 12-16 Addiscombe Road, Croydon, CR0 0XT, Read the complete document
ROPIVACAINE 7.5 MG / ML SOLUTION FOR INJECTION Summary of Product Characteristics Updated 24-Sep-2014 | Concordia International - formerly AMCo 1. Name of the medicinal product Ropivacaine 7.5 mg / ml solution for injection 2. Qualitative and quantitative composition Ropivacaine 7.5 mg/ml: Each ml solution for injection contains 7.5 mg ropivacaine hydrochloride. Each 10 ml ampoule contains 75 mg ropivacaine hydrochloride. Each 20 ml ampoule contains 150 mg ropivacaine hydrochloride. Excipient: Ropivacaine 7.5 mg/ml: Each 10 ml ampoule contains 1.3 mmol (or 29.9 mg) of sodium. Each 20 ml ampoule contains 2.6 mmol (or 59.8 mg) of sodium. For a full list of excipients, see section 6.1 3. Pharmaceutical form Solution for injection Clear, colourless, sterile, isotonic, isobaric aqueous solution for injection with a pH of 4.0 to 6.0. 4. Clinical particulars 4.1 Therapeutic indications Ropivacaine 7.5 mg/ml solution for injection is indicated in adults and children above 12 years for: Surgical anaesthesia: - Epidural blocks for surgery, including Caesarean section - Major nerve blocks - Field blocks 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 deciding the dose. INDICATION CONCENTRATION MG/ML VOLUME ML DOSE MG ONSET MINUTES DURATION HOURS SURGICAL ANAESTHESIA LUMBAR EPIDURAL ADMINISTRATION Surgery 7.5 15-25 113-188 10-20 3-5 10.0 15-20 150-200 10-20 4-6 Caesarean section 7.5 15-20 113-150 1) 10-20 3-5 THORACIC EPIDURAL ADMINISTRATION To establish block for post- operative pain relief 7.5 5-15 (dependent on the level of injection) 38-113 10-20 -- MAJOR NERVE BLOCK* Brachial plexus block 7.5 30-40 225-300 2) 10-25 6-10 Read the complete document