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AMPRES 10MG/ML SOLUTION FOR INJECTION

Active substance(s): CHLOROPROCAINE HYDROCHLORIDE

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10 mg/ml
solution for injection
chloroprocaine hydrochloride

67795 04

67795 04

Pediatric population
Ampres must not be used in children and adolescents (see section 5.1).

10 mg/ml
solution for injection
chloroprocaine hydrochloride

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Ampres 10 mg/ml solution for injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution for injection contains 10 mg of chloroprocaine
hydrochloride
1 ampoule with 5 ml solution, contains 50 mg of chloroprocaine
hydrochloride
Excipients with known effect:
1 ml of solution contains 2.8 mg sodium
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution.

The pH of the solution is comprised between 3.0 and 4.0.
The osmolality of the solution is comprised between 270 – 300 mOsm/kg.
4. CLINICAL PARTICULARS

4.1 Therapeutic indications
Spinal anaesthesia in adults where the planned surgical procedure should
not exceed 40 minutes.
4.2 Posology and method of administration

Posology
Posology must be established on an individual basis in accordance with
the characteristics of the specific case. When determining the dose, take
into consideration the patient’s physical condition and the concomitant
administration of other medicinal products.
The duration of action is dose-dependent.
The indications relating to recommended doses are valid in adults
of average height and weight (approximately 70 kg) for obtaining an
effective block with one single administration. There are wide individual
variations with regard to extent and duration of action. The experience
of the anaesthetist and knowledge of the patient’s general condition are
essential for establishing the dose.
With regard to posology the following guidelines are applied:
Posology Adults
Extension
of sensory
blockade
required T10

ml

mg

Average
duration of
action (minutes)

4
5

40
50

80
100

The maximum recommended dose is 50mg (=5ml) of chloroprocaine
hydrochloride.

Method of administration
For intrathecal use.
Precautions to be taken before administering the medicinal product.
The equipment, drugs and personnel capable of dealing with an
emergency, e.g. maintaining the patency of the airways and administering
oxygen, must be immediately available, since in rare cases severe
reactions, sometimes with a fatal outcome, have been reported after
using local anaesthetics, even in the absence of individual hypersensitivity
in the patient’s case history.
Inject Ampres via intrathecal route into the intervertebral space L2/L3,
L3/L4 and L4/L5.
Slowly inject the entire dose and check the patient’s vital functions
extremely carefully maintaining continuous verbal contact.
In general the following points should be taken into consideration:
1. Choose the lowest possible dose!
2. Administer the injection slowly, after having aspirated a minimum
quantity of CSF to confirm the correct position
3. Do not puncture the skin if there are signs of infection or inflammation
4. Spinal anaesthesia = intrathecal anaesthesia should not be performed
in patients taking anticoagulants or with congenital or acquired
bleeding disorder.
For single use. Any unused solution should be discarded.
The medicinal product has to be visually inspected prior to use. Only
clear solutions practically free from particles should be used. The intact
container must not be re-autoclaved.

4.3 Contraindications
• hypersensitivity to the active substance, medicinal products of the
PABA (para-aminobenzoic acid) ester group, other ester-type local
anaesthetics or to any of the excipients listed in section 6.1.
• general and specific contra-indications to spinal anaesthesia regardless
of the local anaesthetic used, should be taken into account (e.g.
decompensated cardiac insufficiency, hypovolemic shock….)
• intravenous regional anaesthesia (the anesthetic agent is introduced
into the limb and allowed to set in while tourniquets retain the agent
within the desired area)
• serious problems with cardiac conduction,
• severe anaemia,
It is also necessary to take into consideration general and specific
contraindications for the technique of spinal anaesthesia = intrathecal
anaesthesia.
4.4 Special warnings and precautions for use
Spinal anaesthesia must only be administered by anaesthetists with
the necessary knowledge and experience in the intrathecal anesthesia
domain. The doctor in charge is responsible for taking the measures
needed to avoid an intravascular injection and should be fully trained in
emergency medicine and resuscitation to be ready to prevent and treat
the side effects and complication of the procedure.
In addition, it is essential for the doctor to know how to recognize and
treat undesirable effects, systemic toxicity and other complications. If
signs of acute systemic toxicity or total spinal block are observed, the
injection of the local anaesthetic must be stopped immediately (see
section 4.9).
Some patients require special attention in order to reduce the risk
of serious undesirable effects, even when locoregional anaesthesia
constitutes the optimum choice for the surgical intervention:
• Patients with total or partial heart block, since local anaesthetics can
suppress myocardial conduction.
• Patients with high grade cardiac decompensation.
• Patients with advanced liver or kidney damage.
• Elderly patients and patients in poor general condition.
• Patients treated with class III antiarrhythmic agents (e.g. amiodarone).
These patients should be subjected to careful observation and ECG
monitoring, since cardiac effects may be added (see section 4.5).

• In patients with acute porphyria, Ampres should only be administered
when there is a compelling indication for its use, as Ampres may
potentially precipitate porphyria. Appropriate precautions should be
taken in all patients with porphyria.
• Since ester-type local anaesthetics are hydrolyzed by plasma
cholinesterase produced by the liver, chloroprocaine should be used
cautiously in patients with advanced hepatic disease.
• Patients with genetic deficiency of plasma cholinesterase

Ensuring the presence of reliable venous access is mandatory.
Hypotension and bradycardia are well known side effects of all local
anesthetics.
In high risk patients, the recommendation is to improve their general
condition prior to the intervention.
A rare, but serious, undesirable effect of spinal anaesthesia is high or total
spinal block, with consequent cardiovascular and respiratory depression.
Cardiovascular depression is induced by an extended block of the
sympathetic nervous system, which may induce severe hypotension
and bradycardia to the point of cardiac arrest. Respiratory depression
is induced by the block of the respiratory musculature and the diaphragm.
Especially in elderly patients there is an increased risk of high or total
spinal block: consequently it is advisable to reduce the anaesthetic dose.
Particularly in the case of elderly patients, an unexpected drop in arterial
pressure may occur as a complication of spinal anaesthesia.
Rarely, neurological damage may occur after spinal anaesthesia,
manifesting as paresthesia, loss of sensitivity, motor weakness, paralysis,
cauda equina syndrome and permanent neurological injury.
Occasionally these symptoms persist.
There is no suspicion that neurological disorders, such as multiple
sclerosis, hemiplegia, paraplegia or neuromuscular disorders may be
negatively influenced by spinal anaesthesia. Nevertheless, it should
be used with care. Careful evaluation of the risk-benefit ratio is
recommended prior to treatment.
This medicinal product contains less then 1 mmol sodium (23 mg) per
dose (maximum dose equal to 5 ml of Ampres), i.e. essentially “sodiumfree”.

4.5 Interaction with other medicinal products and other forms of
interaction
Concurrent administration of vasopressor drugs (e.g. for the treatment of
hypotension related to obstetric blocks) and ergot-type oxytocic drugs
may cause severe, persistent hypertension or cerebrovascular accidents.
The para-aminobenzoic acid metabolite of chloroprocaine inhibits the
action of sulfonamides. Therefore, chloroprocaine should not be used in
any condition in which a sulfonamide drug is being employed.

No studies have been performed on interactions between chloroprocaine
and class III antiarrhythmics (e.g. amiodarone), but care must also be
taken in this case (also see section 4.4).
The combination of various local anaesthetics induces additional effects
which affect the cardiovascular system and the CNS.
4.6 Fertility, pregnancy and lactation

Pregnancy
Animal studies are insufficient with respect to effects on pregnancy and
foetal development (see 5.3).

Therefore, Ampres is not recommended during pregnancy and in women
of childbearing potential not using contraception. The use of Ampres
in pregnancy should only be considered if the expected benefit to the
mother outweighs any potential risk to the foetus. This does not preclude
the use of Ampres at term for obstetrical anaesthesia.
Breastfeeding
It is not known whether chloroprocaine/metabolites are excreted in
human milk.
Fertility
No fertility studies the have been performed.

4.7 Effects on ability to drive and use machines
Ampres has major influence on the ability to drive and use machines.
The doctor is responsible for deciding in each individual case if the
patient can drive or use machines.

4.8 Undesirable effects
The possible undesirable effects due to the use of Ampres are generally
similar to the undesirable effects of other local anaesthetics for spinal



Special population
It is advisable to reduce the dose in patients in a compromised general
condition.
In addition, in patients with established concomitant disorders (e.g.
vascular occlusion, arteriosclerosis, diabetic polyneuropathy) a reduced
dose is indicated.

10 mg/ml
solution for injection
chloroprocaine hydrochloride
PACKAGE LEAFLET: INFORMATION FOR THE USER
Ampres 10 mg/ml solution for injection
chloroprocaine hydrochloride
Read all of this leaflet carefully before you are given this
medicine because it contains important information for
you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
pharmacist.
• If you get any side effects, talk to your doctor, or
pharmacist. This includes any possible side effects not
listed in this leaflet.
What is in this leaflet
1.What Ampres is and what it is used for
2.What you need to know before you are given Ampres
3.How Ampres is used
4.Possible side effects
5.How to store Ampres
6.Contents of the pack and other information
1.What Ampres is and what it is used for
Ampres is a type of medicine called local anaesthetic,
belonging to the category of the esters, and is a solution for
injection. Ampres is used to anaesthetise (numb) specific
parts of the body and prevent pain during surgery.
Ampres is indicated in adults only.
2.What you need to know before you are given Ampres
Do not use Ampres:
• if you are allergic to chloroprocaine hydrochloride, other
ester-type local anaesthetics or any of the other ingredients
of this medicine (listed in section 6),
• if you have serious problems with cardiac conduction,
• if you suffer from severe anaemia,
It is also necessary to take into consideration general
and specific contraindications for the technique of spinal
anaesthesia = intrathecal anaesthesia (decompensated
cardiac insufficiency, hypovolemic shock).
Warnings and precautions
If you suffer of any of these, you should discuss it with your
doctor before being given this medicine.
• if you have ever had a bad reaction to an anaesthetic in the
past
• if you have signs of skin infection or inflammation at or near
the proposed site of the injection
• if you are suffering from any of the following:
-- diseases of the central nervous system such as
meningitis, polio and problems with your spinal cord due
to anaemia
-- a severe headache
-- brain, spine or any other tumours

-- tuberculosis of the spine
-- recent trauma to your spine
-- very low blood pressure or low blood volume
-- problems with clotting of your blood
-- acute porphyria
-- fluid in your lungs
-- septicaemia (blood poisoning)
• if you have a heart condition
• if you suffer from neurological disorder, such as multiple
scleroris, hemiplegia, paraplegia or neuromuscular
disorders
Other medicines and Ampres
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines. In particular if you
are taking any medicines for an irregular heartbeat (class III
antiarrhythmics agents) and for pain relief.
Ampres with food and drink
It is not recommended to assume any food or drink prior to
use Ampres.
Pregnancy, breast-feeding and fertility
If you are pregnant or you think you may be pregnant, you
have to inform your doctor. Ampres is not recommended for
local or regional anaesthesia during pregnancy and it should
be given in pregnancy only if absolutely necessary. This does
not preclude the use of Ampres during childbirth.
It is not known whether chloroprocaine passes into breast
milk. If you are breast-feeding you should inform your doctor
who will decide whether or not you should be given Ampres.
Driving and using machines
Ampres has a major influence on the ability to drive and use
machines.
Your doctor is responsible for deciding in each case if you
can drive or use machines.
Ampres contains sodium
This medicinal product contains less than 1 mmol sodium
(23 mg) per dose (maximum dose equal to 5 ml of Ampres
solution for injection), so it is essentially “sodium-free”.
3.How Ampres is used
Ampres is injected via intrathecal (spinal) route where the
planned surgical procedure should not exceed 40 minutes.
This medicine will be given to you by your doctor who will
decide what dose is right for you. This will normally be
between 4–5 ml (40–50 mg chloroprocaine hydrochloride).
For patients in a compromised general condition (e.g.
vascular occlusion, arteriosclerosis, diabetic polyneuropathy),
a reduced dose is indicated.
Use in children and adolescents
Ampres must not be used in children and adolescents.
Equipment, drugs and personnel capable of dealing
with an emergency, must be immediately available. Rare
cases of severe reactions have been reported after using
local anaesthetics, even in the absence of individual
hypersensitivity in the patient’s case history.
If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.
4.Possible side effects
Like all medicines, Ampres can cause side effects, although

Very common: may affect more than 1 in 10 people
Lowered blood pressure, feeling sick (nausea)
Common: may affect up to 1 in 10 people
Anxiety, restlessness, paresthesia, dizziness, vomiting.
Uncommon: may affect up to 1 in 100 people
Drop in arterial blood pressure (with high doses), slow
heart beat, shaking, convulsions, numbness of the tongue,
hearing problems, visual problems, speech problems, loss of
consciousness.
Rare: may affect up to 1 in 1,000 people
Allergic reactions such as itching, erythema (redness of skin),
edema (swelling), sneezing, vomiting, dizziness, excessive
sweating, elevated temperature, anaphylactic reactions.
Neuropathy, drowsiness, merging into unconsciousness and
respiratory arrest, spinal block (including total spinal block),
lowered blood pressure consequently to spinal block, loss of
bladder and bowels control, loss of perineal sensation and
sexual function, arachnoiditis, persistent motor, sensory and/
or autonomic (sphincter control) deficit of some lower spinal
segments with slow recovery (several months), cauda equina
syndrome and permanent neurological injury.
Diplopia, irregular heartbeat.
Depression of myocardium, cardiac arrest (the risk is
increased by high doses or unintended intravascular
injection).
Respiratory depression.

1 ml of solution for injection contains 10 mg of
chloroprocaine hydrochloride.
1 ampoule with 5 ml solution, contains 50 mg of
chloroprocaine hydrochloride.
The other ingredients are hydrochloric acid 1N (for pH
adjustment), sodium chloride, water for injection.
What Ampres looks like and contents of the pack
This medicinal product is presented as a solution for
injection. The solution is a clear, colourless solution.
It comes in Type I clear colourless glass ampoules.
Box of 10 ampoules each containing 5 ml of solution for
injection
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sintetica Limited,
30th Floor,
40 Bank Street,
Canary Wharf,
London,
E14 5NR,
United Kingdom
Manufacturer
Sirton Pharmaceuticals S.P.A.
Piazza XX Settembre 2
22079 Villa Guardia
Italy
This medicinal product is authorised in the Member
States of the EEA under the following names:
Member State

Product Name

Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card
Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.

Belgium

Ampres 10mg/ml Solution for injection Oplossing voor injectie – Solution
injectable - Injektionslösung

5.How to store Ampres
Keep out of the sight and reach of children.
Do not use Ampres after the expiry date which is stated on
the ampoules and the outer carton. The expiry date refers to
the last day of that month.
Do not refrigerate or freeze. Please do not store above 25°C.
Store in original package in order to protect from light.
Use immediately after first opening. For single use only.
Ampres should not be administred if noticed that the solution
is not clear and free from particles.
Any unused medicinal product or waste material should be
disposed of in accordance with local requirements. As it is
limited to hospital use the waste drug elimination is carried
out directly by the hospital. These measures will help to
protect the environment.

Spain

6.Contents of the pack and other information
What Ampres contains
The active substance is chloroprocaine hydrochloride.

Austria

France

Germany
Ireland
Italy

Poland

Ampres 10mg/ml Injektionslösung

Clorotekal 10mg/ml solution pour injection
Ampres 10mg/ml Injektionslösung

Ampres 10mg/ml solution for injection
Decelex
Ampres

Ampres 10mg/ml solución inyectable

United Kingdom Ampres 10mg/ml solution for injection
This leaflet was last revised in 03/2017
---------------------------------------------------------------------The following information is intended for medical or
healthcare professionals only:
The SmPC is added at the end of the printed PL as a tear-off
section.



not everybody gets them.
You may feel sick, have lowered blood pressure or a slow
heart beat. Other possible effects are headache after surgery,
vomiting and difficulty in passing urine.
These are the possible side effects:

anaesthesia from the ester group. The undesirable effects induced by
the medicinal product are difficult to distinguish from the physiological
effects of the nerve block (e.g. reduction in arterial pressure, bradycardia,
temporary urine retention), from direct effects (e.g. spinal hematoma) or
the indirect effects (e.g. meningitis) of the injection or from the effects due
to the loss of cerebrospinal liquid (e.g. post-spinal headache).
The frequency of undesirable effects listed below is defined using the
following convention:
Very common (≥1/10), Common (≥1/100 to <1/10),
Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000),
Very rare (<1/10,000), Not known (cannot be estimated from the available
data).

Immune system disorders
Rare: allergic reactions as a result of sensitivity to the local anaesthetic,
characterized by signs such as urticaria, pruritus, erythema, angioneurotic
edema with possible airway obstruction (including laryngeal edema),
tachycardia, sneezing, nausea, vomiting, dizziness, syncope, excessive
sweating, elevated temperature, and possibly, anaphylactoid type
symptomatology (including severe hypotension).
Nervous system disorders
Common: anxiety, restlessness, paresthesia, dizziness.
Uncommon: signs and symptoms of CNS toxicity (backache, headache,
tremors possibly proceeding to convulsions, convulsions, circumoral
paresthesia, feeling of numbness affecting the tongue, hearing problems,
visual problems, blurred vision, shaking, tinnitus, speech problems, loss
of consciousness).
Rare: neuropathy, drowsiness merging into unconsciousness and
respiratory arrest, spinal block of varying magnitude (including total spinal
block), hypotension secondary to spinal block, loss of bladder and bowel
control, and loss of perineal sensation and sexual function, arachnoiditis,
persistent motor, sensory and/or autonomic (sphincter control) deficit of
some lower spinal segments with slow recovery (several months), cauda
equina syndrome and permanent neurological injury.
Eye disorders
Rare: diplopia

Cardiac disorders
Rare: arrhythmia, depression of the myocardium, cardiac arrest (the risk is
increased by high doses or unintended intravascular injection).
Vascular disorders
Very common: hypotension.
Uncommon: bradycardia, hypertension, hypotension raised by high
doses.
Respiratory, thoracic and mediastinal disorders
Rare: respiratory depression
Gastrointestinal disorders
Very common: nausea
Common: vomiting.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the
medicinal product is important. It allows continued monitoring of the
benefit/risk balance of the medicinal product. Healthcare professionals
are asked to report any suspected adverse reactions via the Yellow Card
Scheme website: www.mhra.gov.uk/yellowcard.
4.9 Overdose
It is unlikely that Ampres, at the recommended posology by intrathecal
administration, will induce plasma levels capable of inducing systemic
toxicity.

Acute systemic toxicity
Systemic undesirable effects are of methodological (due to use),
pharmacodynamic or pharmacokinetic origin and concern the central
nervous system and the cardiocirculatory system.
Iatrogenic undesirable effects occur:
• after injecting an excessive quantity of solution
• from accidental injection into a vessel
• from incorrect patient position
• from high spinal anaesthesia (marked drop in arterial pressure)
In the case of accidental intravenous administration, the toxic effect
occurs within 1 minute. In mice, the intravenous LD50 of chloroprocaine
HCl is 97 mg/kg

Signs of overdose can be classified into two different sets of symptoms
which differ in terms of quality and intensity:

a) Symptoms affecting the central nervous system
Generally, the first symptoms are paresthesia in the mouth area, feeling
of numbness of the tongue, feeling dazed, problems with hearing and
tinnitus. Visual problems and muscle contractions are more severe and
precede a generalized convulsion. These signs must not be erroneously
mistaken for neurotic behaviour. Subsequently loss of consciousness and
tonic-clonic seizure may occur, generally lasting between a few seconds
and a few minutes. The convulsions are immediately followed by hypoxia
and increased levels of carbon dioxide in the blood (hypercapnia),
attributable to increased muscular activity associated with respiratory
problems. In serious cases respiratory arrest may occur. Acidosis and/or
hypoxia potentiate the toxic effects of local anaesthetics.
The reduction or improvement of symptoms affecting the central nervous
system can be attributed to the redistribution of local anaesthetic outside
the CNS, with its consequent metabolism and excretion. Regression may
be rapid, unless enormous quantities have been used.
b) Cardiovascular symptoms
In serious cases cardiovascular toxicity may occur. Hypotension,
bradycardia, arrhythmia and also cardiac arrest may occur in the
presence of a high systemic concentration of local anaesthetics.
The first signs of toxic symptoms affecting the central nervous system
generally precede toxic cardiovascular effects. This statement does not
apply if the patient is under general anaesthesia or heavily sedated with
medicinal products such as benzodiazepine or barbiturates.

Treatment of acute systemic toxicity
The following measures must be taken immediately:
• Stop administration of Ampres.
• Ensure an adequate supply of oxygen: keep the airways clear,
administer O2, artificial ventilation (intubation) if required.
• In case of cardiovascular depression circulation must be stabilized.
If convulsions occur and do not resolve spontaneously after
15-20 seconds, the administration of an intravenous anticonvulsant is
recommended.
Analeptics with a central action are contraindicated in the case of
intoxication caused by local anaesthetics!
In the event of serious complications, when treating the patient it is
advisable to obtain the assistance of a doctor specializing in emergency
medicine and resuscitation (e.g. anaesthetist).
In patients with genetic deficiency of plasma cholinesterase an
intravenous lipid solution could be administered.
5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties
Pharmacotherapeutic group: anaesthetics, local; esters of aminobenzoic
acid
ATC code: N01BA04
Chloroprocaine, is an ester-type local anaesthetic. Chloroprocaine, blocks
the generation and the conduction of nerve impulses, presumably by
increasing the threshold for electrical excitation in the nerve, by slowing
the propagation of the nerve impulse and by reducing the rate of rise of
the action potential.
The onset of action for spinal administration is very rapid
(9.6 min ± 7.3 min at 40 mg dose; 7.9 min ± 6.0 min at 50 mg dose) and
the duration of anaesthesia may be up to 100 minutes.

Paediatric population
The European Medicines Agency has waived the obligation to submit the
results of studies with Ampres in all subsets of the paediatric population
as per Paediatric Investigation Plan (PIP) decision.
5.2 Pharmacokinetic properties

Absorption and Distribution
The plasma concentration should be negligible for intrathecal use.

Biotransformation
Chloroprocaine is rapidly metabolized in plasma by hydrolysis of the ester
linkage by pseudocholinesterase. This process could be decelerated in
case of pseudocholinesterase deficiency.
The hydrolysis of chloroprocaine results in the production of
ßdiethylaminoethanol and 2-chloro-4-aminobenzoic acid.
The in vitro plasma half-life of chloroprocaine in adults is 21 ± 2 seconds

for males and 25 ± 1 seconds for females. The in vitro plasma half-life
in neonates is 43 ± 2 seconds. In women, plasma half-lives in vivo of
3.1 ±1.6 minutes was measured.
Elimination
The metabolites, ßdiethylaminoethanol and 2-chloro-4-aminobenzoic
acid, are excreted by the kidney into the urine.

Pharmacokinetic in spine
Elimination of chloroprocaine from the CSF is entirely by diffusion and
vascular absorption, either in neural tissues in the intrathecal space or
by crossing the dura along the concentration gradient between CSF and
the epidural space. Consequently, chloroprocaine is subject to vascular
absorption. The predominant factors determining the rate of absorption
are local blood flow and competing binding to local tissues, but not
enzymatic hydrolysis in the CSF. In patients with cholinesterase deficiency
it is reasonable to expect very low peak plasma levels of chloroprocaine
after intrathecal injection. Clearance of chloroprocaine from CSF by
diffusion across the dura into the epidural space and subsequent
systemic absorption may not be impaired to a clinically significant degree.
5.3 Preclinical safety data
Effects in non-clinical studies were observed only at exposures
considered sufficiently in excess of the maximum human exposure
indicating little relevance to clinical use.
No studies in animals to evaluate carcinogenic potential and reproductive
and developmental toxicity have been conducted with chloroprocaine.
In vitro genotoxicity studies didn’t provide evidence for 2-chloroprocaine
to have a relevant mutagenic or clastogenic potential.
6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Hydrochloric acid 1N (for pH adjustment)
Sodium chloride,
Water for injection

6.2 Incompatibilities
In the absence of compatibility studies, this medicinal product must not
be mixed with other medicinal products.
6.3 Shelf life
24 months.
The medicinal product has to be used immediately after first opening.
6.4 Special precautions for storage
Do not refrigerate or freeze. Please do not store above 25°C. Store in
original package in order to protect from light.
6.5 Nature and contents of container
Type I clear colourless glass ampoule.
Box of 10 ampoules each containing 5 ml of solution for injection.

6.6 Special precautions for disposal
Any unused medicinal product or waste material should be disposed of in
accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
Sintetica Limited
30th Floor
40 Bank Street
Canary Wharf
London
E14 5NR
United Kingdom
8. MARKETING AUTHORISATION NUMBER(S)
PL 46926/0001
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
Date of first authorisation: 19/04/2012
Date of latest renewal: 09/03/2017
10. DATE OF REVISION OF THE TEXT
09/03/2017

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