CHIROCAINE Solution for injection (2019)
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Περιεχόμενα
Name of the medicinal product
Chirocaine 5 mg/ml solution for injection/concentrate for solution for infusion.
Qualitative and quantitative composition
One ml contains 5 mg levobupivacaine as levobupivacaine hydrochloride. Each ampoule contains 50 mg in 10 ml. Excipients with known effect: 3.5 mg/ml of sodium per ampoule. For the full list of excipients, ...
Pharmaceutical form
Solution for injection/concentrate for solution for infusion. Clear colourless solution.
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: ...
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. ...
Contraindications
General contraindications related to regional anaesthesia, regardless of the local anaesthetic used, should be taken into account. Levobupivacaine solutions are contraindicated in patients with a known ...
Special warnings and precautions for use
All forms of local and regional anaesthesia with levobupivacaine should be performed in well-equipped facilities and administered by staff trained and experienced in the required anaesthetic techniques ...
Interaction with other medicinal products and other forms of interaction
In vitro studies indicate that the CYP3A4 isoform and CYP1A2 isoform mediate the metabolism of levobupivacaine. Although no clinical studies have been conducted, metabolism of levobupivacaine may be affected ...
Pregnancy and lactation
Pregnancy Levobupivacaine solutions are contraindicated for use in paracervical block in obstetrics. Based on experience with bupivacaine foetal bradycardia may occur following paracervical block (see ...
Effects on ability to drive and use machines
Levobupivacaine can have a major influence on the ability to drive, or use machines. Patients should be warned not to drive, or operate machinery until all the effects of the anaesthesia and the immediate ...
Undesirable effects
The adverse drug reactions for levobupivacaine are consistent with those known for its respective class of medicinal products. The most commonly reported adverse drug reactions are hypotension, nausea, ...
Overdose
Accidental intravascular injection of local anaesthetics may cause immediate toxic reactions. In the event of overdose, peak plasma concentrations may not be reached until 2 hours after administration ...
Pharmacodynamic properties
Pharmacotherapeutic group: Local anaesthetics, amide ATC Code: N01BB10 Levobupivacaine is a long acting local anaesthetic and analgesic. It blocks nerve conduction in sensory and motor nerves largely by ...
Pharmacokinetic properties
Absorption The plasma concentration of levobupivacaine following therapeutic administration depends on dose and, as absorption from the site of administration is affected by the vascularity of the tissue, ...
Preclinical safety data
In an embryo-foetal toxicity study in rats, an increased incidence of dilated renal pelvis, dilated ureters, olfactory ventricle dilatation and extra thoraco-lumbar ribs was observed at systemic exposure ...
List of excipients
Sodium chloride Sodium hydroxide Hydrochloric acid Water for injections
Incompatibilities
Levobupivacaine may precipitate if diluted with alkaline solutions and should not be diluted or co-administered with sodium bicarbonate injections. This medicinal product must not be mixed with other medicinal ...
Shelf life
Shelf life Shelf life as packaged for sale: 3 years. Shelf life after first opening: The product should be used immediately. Shelf life after dilution in sodium chloride solution 0.9%: Chemical and physical ...
Special precautions for storage
Polypropylene ampoules: polypropylene ampoules do not require any special storage conditions. For storage conditions of the reconstituted medicinal product, see section 6.3.
Nature and contents of container
Chirocaine is available in two presentations: 10 ml polypropylene ampoule in packs of 5, 10 & 20 10 ml polypropylene ampoule, in sterile blister packs of 5, 10 & 20 Not all pack sizes may be marketed. ...
Special precautions for disposal and other handling
For single use only. Discard any unused solution. The solution/dilution should be inspected visually prior to use. Only clear solutions without visible particles should be used. A sterile blister container ...
Marketing authorization holder
AbbVie Ltd., Maidenhead, SL6 4UB, UK
Marketing authorization number(s)
PL41042/0006
Date of first authorization / renewal of the authorization
Date of first authorisation: 06<sup>th</sup> January 2000 Date of last renewal: 18<sup>th</sup> December 2013
Date of revision of the text
14 June 2019
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