PETERKAÏEN 1% m/v INJECTION 10 mL; PETERKAÏEN 1% m/v INJECTION 20 mL; PETERKAÏEN 1% m/v INJECTION 25 mL; PETERKAÏEN 2% m/v INJECTION 10 mL; PETERKAÏEN 2% m/v INJECTION 20 mL; PETERKAÏEN 2% m/v INJECTION 25 mL

INDICATIONS CONTRA-INDICATIONS DOSAGE SIDE-EFFECTS PREGNANCY OVERDOSE IDENTIFICATION PATIENT INFORMATION

PETERKAÏEN 1% m/v INJECTION 10 mL
PETERKAÏEN 1% m/v INJECTION 20 mL
PETERKAÏEN 1% m/v INJECTION 25 mL
PETERKAÏEN 2% m/v INJECTION 10 mL
PETERKAÏEN 2% m/v INJECTION 20 mL
PETERKAÏEN 2% m/v INJECTION 25 mL

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

PETERKAÏEN 1% m/v INJECTION 10 mL
PETERKAÏEN 1% m/v INJECTION 20 mL
PETERKAÏEN 1% m/v INJECTION 25 mL
PETERKAÏEN 2% m/v INJECTION 10 mL
PETERKAÏEN 2% m/v INJECTION 20 mL
PETERKAÏEN 2% m/v INJECTION 25 mL

COMPOSITION:
Contains lignocaine hydrochloride monohydrate 10 mg/mL (1% )
Contains lignocaine hydrochloride monohydrate 20 mg/mL (2% )
Preservative:
Methylhydroxybenzoate 0,1% m/v

PHARMACOLOGICAL CLASSIFICATION:
A 4 - Local anaesthetic.

PHARMACOLOGICAL ACTION:
Lignocaine has local anaesthetic action (it blocks conduction of nerve impulses by decreasing or preventing the large transient increase in permeability of the cell membrane to sodium ions) with a rapid onset and intermediate duration of action when injected.

INDICATIONS:
Lignocaine is used as a local anaesthetic in infiltration field block, nerve block and spinal anaesthesia. As a local anaesthetic it has an action of intermediate duration which can be increased by adding adrenaline.

CONTRA-INDICATIONS:
Contra-indicated in patients that are hypersensitive to local anaesthetics. Lignocaine hydrochloride should not be given to patients with hypovolaemia, heartblock or other conduction disturbances, bradycardia, cardiac decompensation or hypotension unrelated to treatable tachyarrhythmias, myasthenia gravis.

WARNING
Should not be given intravenously.

DOSAGE AND DIRECTIONS FOR USE:
As local anaesthetic the dose is dependent of the area to be anaesthetized and it is given subcutaneously or intramuscularly:

1.	Infiltration anaesthesia - a 0,5 to 1,0% solution is used.
2.	Field block anaesthesia - as for infiltration anaesthesia.
3.	Nerve block anaesthesia - depending upon which nerves or plexuses, the type of fibres - a 1 to 2% solution is used.
4.	Spinal anaesthesia - 0,5 to 5% solution; 100 mg when high thoracic anaesthesia is sought.
5.	Epidural anaesthesia - determined by the segmental level of anaesthesia required. The volume of anaesthetic required is determined by which nerve fibres are to be blocked, what level of anaesthesia is required and whether adrenaline is used. The addition of adrenaline 1:200 000 is often used to increase the duration of anaesthesia.

The maximum 24 hour dose is 300 mg of lignocaine.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Caution should be exercised in the presence of hepatic insufficiency, other cardiac conditions, epilepsy, myasthenia gravis and impaired respiratory function. The plasma half-life of lignocaine hydrochloride may be prolonged in conditions which reduce hepatic blood flow such as cardiac and circulatory failure. The main systemic toxic effect is stimulation of the central nervous system manifested by yawning, restlessness excitement, nervousness, dizziness, blurred vision, nausea, vomiting, muscle twitching and convulsions.
Excitation of the central nervous system may be transient, and followed by depression, with drowsiness, respiratory failure and coma. There is simultaneous depression of the cardiovascular system, with pallor, sweating and hypotension.
Arrhythmias, bradycardia and cardiac arrest may be precipitated. Allergic reactions of an anaphylactic nature may occur. Drowsiness, lassitude and amnesia have been reported with therapeutic doses of lignocaine hydrochloride.
Numbness of the tongue and perioral region is an early sign of systemic toxicity.
Methaemoglobinaemia has been reported. Foetal intoxication has occurred following the use of lignocaine hydrochloride in labour. Doses should be reduced in elderly and debilitated patients and in children. The local anaesthetic effect of Peterkaïen may be reduced if the injection is administered into an inflamed area with a low tissue pH.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See symptoms mentioned under Side-effects and special precautions.
Treatment is symptomatic and supportive.

IDENTIFICATION:
A clear solution in clear vials.

PRESENTATION:
Ten vials of 10, 20 or 25 mL containing 1% or 2% solution.

STORAGE INSTRUCTIONS:
Store below 25°C.
KEEP OUT OF REACH OF CHILDREN

REFERENCE NUMBER:
10 mL vial (1%) G2781 (Act 101/1965)
20 mL vial (1%) G2781 (Act 101/1965)
25 mL vial (1%) G2781 (Act 101/1965)
10 mL vial (2%) G2782 (Act 101/1965)
20 mL vial (2%) G2782 (Act 101/1965)
25 mL vial (2%) G2782 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF APPLICANT:
Intramed (Pty) Ltd
6 Gibaud Road
Port Elizabeth
6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:

September 1988	12-311/10-94
	KOHLER C&P P.E.