Country: Malta
Language: English
Source: Medicines Authority
ROPIVACAINE HYDROCHLORIDE
Fresenius Kabi Italia S.r.l Via Camagre 41, 37063 Isola della Scala (Vr) , Italy
N01BB09
ROPIVACAINE HYDROCHLORIDE 7.5 mg/ml
SOLUTION FOR INJECTION
ROPIVACAINE HYDROCHLORIDE 7.5 mg/ml
POM
ANESTHETICS
Licence number in the source country: NOT APPLICAPABLE
Authorised
2021-12-22
PL112303101,4,5,6,8,9PL112303101,4,5,6,8,9 1 PACKAGE LEAFLET: INFORMATION FOR THE USER Ropivacaine Kabi 2 mg/ml solution for injection Ropivacaine Kabi 7.5 mg/ml solution for injection Ropivacaine Kabi 10 mg/ml solution for injection Ropivacaine hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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, nurse or any other healthcare professional. - If you get any side effects, talk to your doctor, nurse or any other healthcare professional. This includes any possible side effects not listed in this leaflet. See section 4. The full names of the medicines covered by this leaflet are: Ropivacaine Kabi 2 mg/ml solution for injection Ropivacaine Kabi 7.5 mg/ml solution for injection Ropivacaine Kabi 10 mg/ml solution for injection In this leaflet they are jointly referred to as Ropivacaine Kabi. WHAT IS IN THIS LEAFLET 1. What Ropivacaine Kabi is and what it is used for 2. What you need to know before you are given Ropivacaine Kabi 3. How to use Ropivacaine Kabi 4. Possible side effects 5. How to store Ropivacaine Kabi 6. Contents of the pack and other information 1. WHAT ROPIVACAINE KABI IS AND WHAT IT IS USED FOR • Ropivacaine Kabi contains a medicine called ropivacaine hydrochloride. • It belongs to a group of medicines called local anaesthetics. Ropivacaine Kabi 2 mg/ml solution for injection is used in adults and children of all ages for acute pain management. It numbs (anaesthetises) parts of the body e.g. after surgery. Ropivacaine Kabi 7.5 mg/ml solution for injection is used in adults and children above 12 years 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, including having a baby by Caesarean section. - Relieve pain during childbirth, after surgery, or after an accident. Ropivacaine Kabi 10 mg/ml solution for i Read the complete document
SPC112303101,4,5,6,8,9 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Ropivacaine Kabi 2 mg/ml solution for injection Ropivacaine Kabi 7.5 mg/ml solution for injection Ropivacaine Kabi 10 mg/ml solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _Ropivacaine Kabi 2 mg/ml: _ Each ml solution for injection contains 2 mg ropivacaine hydrochloride. Each 10 ml ampoule contains 20 mg ropivacaine hydrochloride. Each 20 ml ampoule contains 40 mg ropivacaine hydrochloride. _Ropivacaine Kabi 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. _Ropivacaine Kabi 10 mg/ml: _ Each ml solution for injection contains 10 mg ropivacaine hydrochloride. Each 10 ml ampoule contains 100 mg ropivacaine hydrochloride. Each 20 ml ampoule contains 200 mg ropivacaine hydrochloride. Excipient with known effect: _Ropivacaine Kabi 2 mg/ml: _ Each 10 ml ampoule contains 1.48 mmol (or 34 mg) of sodium. Each 20 ml ampoule contains 2.96 mmol (or 68 mg) of sodium. _Ropivacaine Kabi 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. _Ropivacaine Kabi 10 mg/ml: _ Each 10 ml ampoule contains 1.2 mmol (or 28 mg) of sodium. Each 20 ml ampoule contains 2.4 mmol (or 56 mg) of sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear, colourless solution with a pH of 4.0 to 6.0 and an osmolality between 255 and 305 mOsmol/kg. SPC112303101,4,5,6,8,9 2 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ropivacaine Kabi 2 mg/ml solution for injection is indicated for acute pain management: • In adults and adolescents above 12 years of age for - Continuous epidural infusion or intermittent bolus administration during postoperative or labour pain - Field blocks - Continuous peripheral nerve block via a continuous infusion or inter Read the complete document