ROPIVACAINE Solution for infusion (2019)
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Περιεχόμενα
Name of the medicinal product
Ropivacaine 2 mg/ml solution for infusion.
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 ...
Pharmaceutical form
Solution for infusion. Clear, colourless, sterile, isotonic, isobaric aqueous solution for infusion with a pH of 4.0 to 6.0.
Therapeutic indications
Ropivacaine 2 mg/ml solution for infusion is indicated for acute pain management. <u>In adults and children above 12 years of age:</u> Continuous epidural infusion or intermittent bolus administration ...
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 ...
Contraindications
Hypersensitivity to the active substance, to other local anaesthetics of the amide type, or to any of the excipients listed in section 6.1. General contraindications related to epidural anesthesia, regardless ...
Special warnings and precautions for use
Regional anaesthetic procedures should always be performed in a properly equipped and staffed area. Equipment and medicinal products necessary for monitoring and emergency resuscitation should be immediately ...
Interaction with other medicinal products and other forms of interaction
Ropivacaine hydrochloride should be used with caution in patients receiving other local anaesthetics or agents structurally related to amide-type local anaesthetics, e.g. certain antiarrhythmics, such ...
Fertility, pregnancy and lactation
Fertility There are no data available concerning the fertility. Pregnancy Apart from epidural administration for obstetrical use, there are no adequate data on the use of ropivacaine hydrochloride in human ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. Depending on the dose, local anaesthetics may have a minor influence on mental function and coordination even in ...
Undesirable effects
The adverse reaction profile for Ropivacaine is similar to those for other long acting local anaesthetics of the amide type. Adverse drug reactions should be distinguished from the physiological effects ...
Overdose
Symptoms of overdose Accidental intravascular injections of local anaesthetics may cause immediate (within seconds to a few minutes) systemic toxic reactions. In the event of overdose, peak plasma concentrations ...
Pharmacodynamic properties
Pharmacotherapeutic group: Anaesthetics, local, Amides ATC code: N01BB09 Ropivacaine hydrochloride is a long-acting amide-type local anaesthetic with both anaesthetic and analgesic effects. At high doses ...
Pharmacokinetic properties
Absorption and distribution Ropivacaine hydrochloride has a chiral centre and is available as the pure S-(-)-enantiomer. It is highly lipid-soluble. All metabolites have a local anaesthetic effect but ...
Preclinical safety data
Based on conventional studies of safety pharmacology, single and repeated dose toxicity, reproduction toxicity, mutagenic potential and local toxicity, no hazards for humans were identified other than ...
List of excipients
Sodium chloride Sodium hydroxide (for pH adjustment) Water for injections
Incompatibilities
Compatibilities with other solutions than those mentioned in section 6.6 have not been investigated. In alkaline solutions precipitation may occur as ropivacaine hydrochloride shows poor solubility at ...
Shelf life
<u>Shelf-life before opening:</u> 3 years. <u>Shelf-life after opening:</u> From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and ...
Special precautions for storage
Do not freeze. For storage conditions after opening the medicinal product, see section 6.3.
Nature and contents of container
Ropivacaine 2 mg/ml solution for infusion. Polypropylene bags: 10 100ml, 20 100ml, 5 200 ml, 10 200ml, 20 200ml, 5 250 ml, 10 250ml, 20 250ml, 5 500 ml Not all pack sizes may be marketed.
Special precautions for disposal and other handling
Handling Ropivacaine products are preservative free and are intended for single use only. Discard any unused solution. The medicinal product should be visually inspected prior to use. The solution should ...
Marketing authorization holder
Sintetica Limited, 30<sup>th</sup> Floor, 40 Bank Street, Canary Wharf, London, E14 5NR, United Kingdom
Marketing authorization number(s)
PL 46926/0009
Date of first authorization / renewal of the authorization
12/05/2016
Date of revision of the text
28/02/2019
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