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SPC, UK: CHIROCAINE Solution for injection (2019)

Αναφορές

Βιβλιογραφική αναφορά

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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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