Citanest Plain

New Zealand - English - Medsafe (Medicines Safety Authority)

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Active ingredient:
Prilocaine hydrochloride 2%; Prilocaine hydrochloride 20 mg/mL
Available from:
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
INN (International Name):
Prilocaine hydrochloride 2%
Dosage:
2 %
Pharmaceutical form:
Solution for injection
Composition:
Active: Prilocaine hydrochloride 2% Excipient: Sodium chloride Sodium hydroxide Water for injection Active: Prilocaine hydrochloride 20 mg/mL Excipient: Hydrochloric acid as 2M solution for pH adjustment (pH 5-7) Methyl hydroxybenzoate Sodium chloride Sodium hydroxide as 2M solution for pH adjustment (pH 5-7) Water for injection
Units in package:
Polyamp, 10x5ml Duofit., 50 mL
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Siegfried Evionnaz SA
Product summary:
Package - Contents - Shelf Life: Polyamp, 5ml Duofit. - 10 dose units - 24 months from date of manufacture stored at or below 25°C
Authorization number:
TT50-1043/1b
Authorization date:
1969-12-31

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Data Sheet

NEW ZEALAND DATA SHEET

1. PRODUCT NAME

ITANEST

solution for injection

Prilocaine hydrochloride 0.5%, 2.0%

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Citanest contains 5mg or 20mg of prilocaine hydrochloride per 1mL

For full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

Citanest solution for injection is a sterile, isotonic aqueous solution. The pH of the

solution is 5.0-7.0. The single dose vials and Polyamps® are free from preservatives

and are intended for single use only.

4. CLINICAL PARTICULARS

4.1

Therapeutic Indications

Citanest solutions are indicated for the production of local or regional anaesthesia by

the following techniques:

local infiltration

minor and major nerve blocks

epidural block

arthroscopy

intravenous regional anaesthesia.

4.2

Dose and method of administration

Care should be taken to prevent toxic reactions by avoiding intravascular injection.

Careful aspiration before and during the injection is recommended. When a large

dose is to be injected, e.g. in epidural block, a test dose of 3-5 mL of prilocaine

containing adrenaline is recommended. An accidental intravascular injection may be

recognised by a temporary increase in heart rate. The main dose should be injected

slowly, at a rate of 100-200 mg/min, or in incremental doses, while keeping in

constant verbal contact with the patient. If toxic symptoms occur, the injection

should be stopped immediately.

In general, surgical anaesthesia (e.g. epidural administration) requires the use of the

higher concentrations and doses. When a less intense block is required, the use of

a lower concentration is indicated. The volume of local anaesthetic used will affect

the extent of spread of anaesthesia.

more

prolonged

effect,

indwelling

catheter,

through

which

local

anaesthetic may be injected, can be used. This technique is common in epidural

anaesthesia and may also be used in brachial plexus anaesthesia and interpleural

analgesia.

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The following table is a guide to dosage for the more commonly used techniques in

the average adult. The figures reflect the expected average dose range needed.

Standard

textbooks

should

consulted

factors

affecting

specific

block

techniques and for individual patient requirements.

The clinician´s experience and knowledge of the patient´s physical status are of

importance in calculating the required dose. The lowest dose required for adequate

anaesthesia should be used (see Special warnings and precautions for use).

Individual variations in onset and duration occur.

Table 1 - Dosage Recommendations.

Type of block

Conc.

Dose

Indication

mg/mL

%

mL

mg

Lumbar epidural

a)

15-25

300-500

Surgical operations and

pain relief

Surgical operations

Thoracic epidural

a)

10-15

10-30

200-300

100-300

Surgical operations

Caudal epidural

20-30

15-25

200-300

300-500

Surgical operations and

pain relief

Surgical operations

IV Regional (Bier´s block)

Upper limb

b)

Lower limb

b)

i). thigh tourniquet

ii). calf tourniquet

Surgical operations

- " -

- " –

Intra-articular block

c)

Arthroscopy and surgical

operations

- " -

Field block (eg minor nerve

blocks and infiltration

Local infiltration

Surgical operations

- " -

Digital block

10-50

Surgical operations

Intercostal (per nerve)

20-50

Surgical operations.

Postoperative pain and

fractured ribs

Paravertebral

3-5 mL

30-50 mg

Surgical operations

Retrobulbar

Peribulbar

10-15

100-150

Ocular surgery

- " -

Major Nerve Block

Brachial plexus:

Axillary

Supraclavicular, interscalene and

subclavian perivascular

40-50

30-40

400-500

300-400

Surgical operations

Sciatic

15-20

300-400

Surgical operations

3 in 1 (Femoral, obturator and

laternal cutaneous)

30-40

300-400

Surgical operations

a) Dose includes test dose

b) Do not deflate tourniquet within 20 min of injection

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c) There have been post marketing reports of chondrolysis in patients receiving post-operative intra-articular

continuous infusion of local anaesthetics. C

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is not approved for this indication (Also see Special warnings

and precautions for use).

= up to

NR = not recommended

PAEDIATRICS

The doses in Table 2 should be regarded as guidelines for use in paediatrics.

Individual variations occur. In children with a high body weight a gradual reduction of

the dosage is often necessary and should be based on the ideal body weight.

Standard

textbooks

should

consulted

factors

affecting

specific

block

techniques and for individual patient requirements.

Table 2 - Dosage Recommendations in Children.

Type of block

Conc.

Dose

Indication

mg/mL

%

mL

mg

Caudal epidural

(children above the age of 6 months)

0.5 mL/kg

5 mg/kg

Surgical operations

Consider both age and weight for calculation of dosages.

Prilocaine for injection is not recommended in children under 6 months of age or for

use in paracervical (PCB) block and pudendal block in the obstetric patient. There is

an increased risk of methaemoglobin formation in children and in the neonate after

delivery.

GERIATRICS

A reduction in dosage may be necessary for elderly patients, especially those with

compromised cardiovascular and/ or hepatic function.

In epidural anaesthesia a smaller dose may provide adequate anaesthesia.

WITH IMPAIRED HEPATIC FUNCTION

Although prilocaine is partly metabolised by the liver, dosage reduction is probably

not warranted. However, caution should be exercised with repeated doses.

WITH IMPAIRED RENAL FUNCTION

Impairment of renal function is unlikely to affect prilocaine clearance in the short-term

(24 hours). However toxicity due to accumulation may develop with prolonged or

repeated administration.

4.3

Contraindications

Prilocaine solutions are contraindicated in patients with known hypersensitivity to

local anaesthetics of the amide type or any of the excipients.

Prilocaine solutions are contraindicated in patients with congenital or idiopathic

methaemoglobinaemia.

4.4

Special warnings and precautions for use

Regional anaesthetic procedures should always be performed in a properly equipped

staffed

area.

Equipment

medication

necessary

monitoring

emergency resuscitation should be immediately available. When performing major

blocks or using large doses, an IV cannula should be inserted before the local

anaesthetic is injected. Clinicians should have received adequate and appropriate

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training in the procedure to be performed and should be familiar with the diagnosis

treatment

side

effects,

systemic

toxicity

other

complications

(see

Overdose).

Although regional anaesthesia is frequently the optimal anaesthetic technique, some

patients require special attention to reduce the risk of dangerous side effects:

The elderly and patients in poor general condition.

Patients

with

partial

complete

heart

block

fact

that

local

anaesthetics may depress myocardial conduction.

Patients with advanced liver disease or severe renal dysfunction.

In patients with severe anaemia or cardiac insufficiency the risk of developing

methaemoglobinaemia should be considered (see Undesirable effects).

Patients treated with anti-arrhythmic drugs class III (e.g. amiodarone) should be

under close surveillance and ECG monitoring considered, since cardiac effects

may be additive (see Interaction with other medicines and other forms of

interaction).

Patients with acute porphyria. Prilocaine is possibly porphyrinogenic and should

only be prescribed to patients with acute porphyria when no safer alternative is

available. Appropriate precautions should be taken in the case of vulnerable

patients.

Patients with severe bradycardia, cardiac conduction disturbances or severe

digitalis intoxication.

Prilocaine is not recommended for use in children below the age of 6 months.

Prilocaine is not recommended for use in obstetric patients under paracervical block

(PCB) or pudendal block due to the risk of methaemoglobinaemia (see Fertility,

pregnancy and lactation, and Undesirable effects).

Certain local anaesthetic procedures may be associated with serious adverse

reactions, regardless of the local anaesthetic used, for example

Central nerve blocks may cause cardiovascular depression, especially in the

presence of hypovolaemia. Epidural anaesthesia should be used with caution in

patients with impaired cardiovascular function.

Retrobulbar injections may (very occasionally) reach the cranial subarachnoid

space,

causing

temporary

blindness,

cardiovascular

collapse,

apnoea,

convulsions etc. These must be diagnosed and treated promptly.

Retro-

peri-bulbar

injections

local

anaesthetics

carry

risk

persistent ocular muscle dysfunction. The primary causes include trauma and/or

local toxic effects on muscles and/or nerves. The severity of such tissue

reactions is related to the degree of trauma, the concentration of the local

anaesthetic and the duration of exposure of the tissue to the local anaesthetic.

For this reason, as with all local anaesthetics, the lowest effective concentration

and dose of local anaesthetic should be used. Vasoconstrictors and other

additives

aggravate

tissue

reactions,

should

used

only

when

indicated.

Injections in the head and neck regions may be made inadvertently into an

artery, causing cerebral symptoms even at low doses.

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Paracervical block can sometimes cause foetal bradycardia/tachycardia, and

careful monitoring of the foetal heart rate is necessary.

Patients with pre-existing abnormal neurological conditions.

There have been post-marketing reports of chondrolysis in patients receiving

postoperative

intra-articular

continuous

infusion

local

anaesthetics.

majority of reported cases of chondrolysis have involved the shoulder joint. Due

multiple

contributing

factors

inconsistency

scientific

literature

regarding mechanism of action, causality has not been established. Intra-

articular continuous infusion is not an approved indication for C

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Epidural anaesthesia may lead to hypotension and bradycardia. This risk of such

effects can be reduced, e.g., by injecting vasopressor. Hypotension should be

treated promptly with an intravenous sympathomimetic repeated as necessary.

4.5

Interaction with other medicines and other forms of interaction

Prilocaine should be used with caution in patients receiving other local anaesthetics

or agents structurally related to amide-type local anaesthetics e.g. certain anti-

arrhythmic drugs such as lignocaine, mexiletine and tocainide, since the toxic effects

could be additive. Specific interaction studies with prilocaine and anti-arrhythmic

drugs class III (e.g. amiodarone) have not been performed, but caution is advised

(see Special warnings and precautions for use).

Prilocaine in high doses may cause an increase in the methaemoglobin level,

particularly

conjunction

with

other

methaemoglobin-inducing

drugs

e.g.

sulphonamides, antimalarials and certain nitric compounds.

4.6

Fertility, pregnancy and lactation

Although prilocaine is indicated for anaesthesia in obstetrics there is no information

on use of prilocaine in early pregnancy. Therefore, with the exception of its use in

obstetrics, prilocaine should not be used in pregnant women, or those likely to

become pregnant, unless the expected benefit outweighs any potential risk.

When used for obstetric anaesthesia in doses over 600 mg, clinically apparent

maternal

foetal

methaemoglobinaemia

develop,

caused

prilocaine

metabolites.

Neonatal methaemoglobinaemia has been reported after paracervical block (PCB) or

pudendal block in the obstetric patient.

Foetal adverse effects due to local anaesthetics, such as foetal bradycardia, seem to

be most apparent in paracervical block anaesthesia. Such effects may be due to

high concentrations of anaesthetic reaching the foetus.

It is not known to what degree prilocaine is excreted in breast milk. However, the

amounts of prilocaine reaching the infant can be assumed to be very small.

4.7

Effects on ability to drive and use machines

Besides the direct anaesthetic effect, local anaesthetics may have a very mild effect

on mental function and co-ordination even in the absence of overt CNS toxicity, and

may temporarily impair locomotion and alertness.

4.8

Undesirable effects

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GENERAL

The adverse reaction profile for C

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is similar to those of other amide local

anaesthetics. Adverse reactions caused by the drug per se are difficult to distinguish

from the physiological effects of the nerve block (e.g. decrease in blood pressure,

bradycardia), events caused directly (e.g. nerve trauma) or indirectly (e.g. epidural

abscess) by the needle puncture.

Table 3 Table of Adverse Drug Reactions (ADR)

Frequency Classification

Adverse Drug Reaction

Very Common: >1/10

Vascular disorders: hypotension *

Gastrointestinal disorders: nausea *

Common

>1/100 <1/10)

Gastrointestinal disorders: vomiting *

Nervous system disorders: paraesthesia, dizziness

Uncommon

(>1/1,000 <1/100)

Cardiac disorders: bradycardia

Nervous system disorders: signs and symptoms of CNS

toxicity (convulsions, paraesthesia circumoral, numbness

of the tongue, hyperacusis, visual disturbances, tremor,

tinnitus, dysarthria, loss of consciousness)

Vascular disorders: hypertension

Rare (<1/1,000)

Cardiac disorders: cardiac arrest, cardiac arrhythmias

Immune system disorders: allergic reactions, anaphylactic

reaction

Respiratory disorders: respiratory depression

Nervous system disorders: neuropathy, peripheral nerve

injury, arachnoiditis

Blood and lymphatic system disorders:

methaemoglobinaemia (See OVERDOSE) and cyanosis.

Eye disorders: diplopia

*ADRs occur more frequently after epidural blocks.

ACUTE SYSTEMIC TOXICITY

Systemic toxic reactions primarily involve the central nervous system (CNS) and the

cardiovascular

system

(CVS).

Such

reactions

caused

high

blood

concentrations

local

anaesthetic,

which

occur

(accidental)

intravascular

injection,

overdose

exceptionally

rapid

absorption

from

highly

vascularised

areas

(see

Special

warnings

and

precautions

for

use).

reactions are similar for all amide local anaesthetics, while cardiac reactions are

more dependent on the drug, both quantitatively and qualitatively.

Central nervous system toxicity is a graded response with symptoms and signs of

escalating severity. The first symptoms are circumoral paraesthesia, numbness of

tongue,

lightheadedness,

hyperacusis,

tinnitus

visual

disturbances.

Dysarthria, muscular twitching or tremors are more serious and precede the onset of

generalized convulsions. These signs must not be mistaken for neurotic behaviour.

Unconsciousness and grand mal convulsions may follow which may last from a few

seconds

several

minutes.

Hypoxia

hypercarbia

occur

rapidly

following

convulsions due to the increased muscular activity, together with the interference

with respiration and possible loss of functional airways. In severe cases apnoea may

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occur. Acidosis, hyperkalaemia, hypocalcaemia and hypoxia increase and extend

the toxic effects of local anaesthetics.

Recovery is due to redistribution of the local anaesthetic drug from the central

nervous system and subsequent metabolism and excretion. Recovery may be rapid

unless large amounts of the drug have been injected.

Cardiovascular system toxicity may be seen in severe cases and is generally

preceded by signs of toxicity in the central nervous system. In patients under heavy

sedation or receiving a general anaesthetic, prodromal CNS symptoms may be

absent. Hypotension, bradycardia, arrhythmia and even cardiac arrest may occur as

a result of high systemic concentrations of local anaesthetics, but in rare cases

cardiac arrest has occurred without prodromal CNS effects.

In children, early signs of local anaesthetic toxicity may be difficult to detect in cases

where the block is given during general anaesthesia.

TREATMENT OF ACUTE TOXICITY

If signs of acute systemic toxicity appear, injections of the local anaesthetic should

be stopped immediately and CNS symptoms (convulsion, CNS depression) must

promptly

treated

with

appropriate

airway/respiratory

support

administration of anticonvulsant medicines.

If circulatory arrest should occur, immediate cardiopulmonary resuscitation should be

instituted. Optimal oxygenation and ventilation and circulatory support as well as

treatment of acidosis are of vital importance.

cardiovascular

depression

occurs

(hypotension,

bradycardia),

appropriate

treatment with intravenous fluids, vasopressor, chronotropic and or inotropic agents

should be considered. Children should be given doses commensurate with age and

weight.

METHAEMOGLOBINAEMIA

Methaemoglobinaemia

occur

after

administration

prilocaine.

repeated administration of prilocaine, even in relatively small doses, can lead to

clinically

overt

methaemoglobinaemia

(cyanosis).

Prilocaine

therefore

recommended for continuous techniques of regional anaesthesia.

The conversion of haemoglobin to methaemoglobin is caused by the prilocaine

metabolite, orthotoluidine, which has a long half-life and tends to accumulate, and in

turn, is converted to 4- and 6-hydroxytoluidine. Methaemoglobin has risen to

clinically significant levels in patients receiving high doses of prilocaine. Cyanosis

occurs when the methaemoglobin concentration in the blood reaches 1-2 g/100 mL

(6-12% of the normal haemoglobin concentration). Methaemoglobin oxidises only

slowly back to haemoglobin, although this process can be greatly accelerated by the

intravenous injection of methylene blue (see below).

The reduction in oxygen-carrying capacity due to the administration of prilocaine in

normal

patients

marginal;

hence,

methaemoglobinaemia

usually

symptomless. However, in severely anaemic patients it may cause hypoxaemia. It

is important to rule out other more serious causes of cyanosis such as acute

hypoxaemia and/or heart failure.

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neonates

small

infants

there

increased

risk

development

methaemoglobinaemia (see Dose and method of administration, and Special

warnings and precautions for use).

Note: Even low concentrations of methaemoglobin may interfere with pulse oximetry

readings, indicating a false low oxygen saturation.

TREATMENT OF METHAEMOGLOBINAEMIA

clinical

methaemoglobinaemia

occurs,

rapidly

treated

single

intravenous injection of a 1% methylene blue solution, 1 mg/kg body weight, over a

5-minute period. Cyanosis will disappear in about 15 minutes. This dose should not

be repeated as methylene blue in high concentrations acts as a haemoglobin

oxidant.

Reporting

suspected

adverse

reactions

after

authorisation

medicine

important. It allows continued monitoring of the benefit/risk balance of the medicine.

Healthcare professionals are asked to report any suspected adverse reactions

https://nzphvc.otago.ac.nz/reporting/

4.9

Overdose

Accidental intravascular injections of local anaesthetics may cause immediate (within

seconds to a few minutes) systemic toxic reactions. In the event of overdose,

systemic toxicity appears later (15-60 minutes after injection) due to the slower

increase in local anaesthetic blood concentration (see Undesirable effects).

For advice on the management of overdose please contact the National Poisons

Centre on 0800 POISON (0800 764766).

5. PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Prilocaine hydrochloride is a local anaesthetic of the amide type. It is similar to

lignocaine in having a rapid onset and a medium duration of action. The 2% solution

will last 1½-2 h when given epidurally, and up to 4 hours with peripheral nerve

blocks. When used in concentrations of 1% there is less effect on motor nerve fibres

and the duration of action is shorter. The peak plasma concentrations of prilocaine

are lower than those associated with the same dose of lignocaine and it is also more

quickly eliminated. Prilocaine has a lower acute toxicity than lignocaine.

Onset and duration of the local anaesthetic effect of prilocaine depend on the dose

site

administration.

However,

propensity

causing

methaemoglobinaemia makes it unsatisfactory for continuous techniques.

Prilocaine, like other local anaesthetics, causes a reversible blockade of impulse

propagation along nerve fibres by preventing the inward movement of sodium ions

through the cell membrane of nerve fibres. The sodium channels of the nerve

membrane are considered a receptor for local anaesthetic molecules.

Local anaesthetics may have similar effects on other excitable membranes e.g.

brain and myocardium. If excessive amounts of local anaesthetic reach the systemic

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circulation, symptoms and signs of toxicity may appear, emanating mainly from the

central nervous and cardiovascular systems.

Central

nervous

system

toxicity

occurs

lower

plasma

concentrations

(see

Undesirable effects) and usually precedes the cardiovascular effects. Direct effects

of local anaesthetics on the heart include slow conduction, negative inotropism and

eventual cardiac arrest.

Indirect cardiovascular effects (hypotension, bradycardia) may occur after epidural

administration depending on the extent of the concomitant sympathetic block.

5.2

Pharmacokinetic properties

Prilocaine has a pKa of 7.89 and an N-heptane/pH 7.4 buffer partition coefficient of

0.9. Prilocaine has an octanol:water partition ratio of 25 at pH 7.4, and is 40%

protein bound (mainly to alpha-1-acid glycoprotein) in plasma.

The peak plasma concentration after prilocaine administration depends on the dose,

the route of administration, vascularity of the injection site and the concomitant

administration of vasoconstrictor agents. A linear relationship exists between the

amount of prilocaine administered and the resultant peak plasma concentration in

the dose range 200-600 mg.

The highest plasma concentrations will occur after intercostal nerve block, followed

in order of decreasing concentration by injection into the lumbar epidural space,

major nerve blocks such as brachial plexus and subcutaneous tissue.

The higher concentrations following intercostal administration may be related to the

multiple injections required for this technique, whereby the solution is exposed to a

greater vascular area, which results in a greater rate of absorption. On the other

hand, the large amount of adipose tissue in the lumbar epidural space will tend to

retard vascular absorption.

Prilocaine has a mean total plasma clearance of 2.37 L/min, a large apparent

distribution volume of between 190 L and 260 L, and the terminal half-life of

prilocaine is 1.6 h.

Only a small proportion of prilocaine (less than 5%) is excreted unchanged in the

urine. In vitro and animal studies have shown metabolism of prilocaine by lung and

kidney tissues.

In the liver, prilocaine is primarly metabolized by amide hydrolysis to ortho-toluidine

and N-propylamine. Ortho-toluidine is subsequentially hydroxylated to 2-amino-3-

hydroxytoluene and 2-amino-5-hydroxytoluene, metabolites which are believed to be

responsible for the occurrence of methaemoglobinaemia.

It is uncertain to what extent disease states like severe liver cirrhosis and congestive

heart failure influence the disposition of prilocaine.

Prilocaine readily passes the placenta and free plasma concentrations are similar in

both foetus and mother. In the presence of foetal acidosis, they may be slightly

higher in the foetus, due to ion trapping. Information concerning the elimination half-

life of prilocaine in neonates is not available.

5.3

Preclincial safety data

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In animal studies, the symptoms and signs of toxicity noted after high doses of

prilocaine are the results of the effects on the central nervous and cardiovascular

systems. A mild methaemoglobinaemia was seen in a single study in rats, after

repeated dosing. This is also occasionally seen in the therapeutic situation as a

result of prilocaine overdose or off-label use. No drug related adverse effects were

seen in reproduction toxicity studies, neither did prilocaine show mutagenic potential

in either in vitro or in vivo mutagenicity tests. Cancer studies have not been

performed with prilocaine, due to the area and duration of therapeutic use for this

drug.

Prilocaine

show

mutagenic

potential

either

vitro

vivo

mutagenicity tests. Cancer studies have not been performed with prilocaine due to

the indication and duration of therapeutic use of this medicine.

A metabolite of prilocaine, ortho-toluidine, showed evidence of mutagenic activity.

The metabolite ortho-toluidine has been shown to have carcinogenicity potential in

preclinical toxicological studies evaluating chronic exposure. Risk assessments

comparing

calculated

maximum

human

exposure

from

intermittent

prilocaine, with the exposure used in preclinical studies, indicate a wide margin of

safety for clinical use.

6. PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Sodium chloride

Sodium hydroxide (for pH adjustment)

Water for injection

6.2

Incompatibilities

solubility

prilocaine

limited

>7.0.

This

must

taken

into

consideration when alkaline solutions, i.e. carbonates are added since precipitation

might occur.

6.3

Shelf life

Single Dose Vials

36 months

Plastic ampoules (Polyamp®)

24 months

6.4

Special precautions for storage

Store below 25

C. Do not freeze.

6.5

Nature and contents of container

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0.5% 5 x 50 mL Single Dose Vials

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2.0% 10 x 5 mL Polyamp® Duofit®

7. MEDICINE SCHEDULE

Prescription Medicine

8. SPONSOR

Pharmacy Retailing (NZ) Limited

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Trading as Healthcare Logistics

58 Richard Pearse Drive

Airport Oaks

Auckland

New Zealand

Telephone: (09) 918 5100

Email: aspen@aspenpharma.co.nz

9. DATE OF FIRST APPROVAL

31 December 1969

10.

DATE OF REVISION OF THE TEXT

10 November 2017

SUMMARY TABLE OF CHANGES

Section changed

Summary of new information

Management

hypotension

bradycardia

related to epidural anaesthesia is updated.

© This data sheet is copyrighted to AstraZeneca Limited and may be reproduced but not

altered in any way.

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