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AMPRES 10MG/ML SOLUTION FOR INJECTION

Active substance(s): CHLOROPROCAINE HYDROCHLORIDE

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chloroprocaine hydrochloride

67795 02

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

4
5

40
50

Average duration of
action (minutes)
80
100

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

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 bradicardia are well known side effects of all local
anesthestics.
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
“sodium-free”.
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).
Ampres must not be administered during pregnancy and in women of
childbearing potential not using contraception.
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 anaesthesia from the ester group. The undesirable effects induced



67795 02

10 mg/ml
solution for injection

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

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 estertype 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 must not be administered for local or
regional anaesthesia 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 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:
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.
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.

Member State
Austria
Belgium

France
Germany
Ireland
Italy
Poland
Spain
United Kingdom

Product Name
Ampres 10mg/ml Injektionslösung
Ampres 10mg/ml Solution for injection Oplossing voor injectie – Solution injectable
- Injektionslösung
Clorotekal 10mg/ml solution pour injection
Ampres 10mg/ml Injektionslösung
Ampres 10mg/ml solution for injection
Clorotekal
Ampres
Ampres 10mg/ml solución inyectable
Ampres 10mg/ml solution for injection

This leaflet was last revised in 10/2012

101662/LF/1



5. How to store Ampres
Keep out of the reach and sight 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.
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.
6. Contents of the pack and other information
What Ampres contains
The active substance is chloroprocaine hydrochloride.
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
Mercury Pharmaceuticals Ltd
No.1 Croydon,
12-16 Addiscombe Road,
Croydon,
CR0 0XT, UK
This medicinal product is authorised in the Member States of
the EEA under the following names:

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.
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 1520 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 the first three subsets of the paediatric population and has deferred the obligation to submit the results
in adolescent 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
߬diethylaminoethanol 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, ߬diethylaminoethanol 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
18 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
Mercury Pharmaceuticals Ltd
No.1 Croydon
12-16 Addiscombe Road
Croydon,
CR0 0XT, UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 12762/0460
PA 899/38/1
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
19/03/2012
10 DATE OF REVISION OF THE TEXT
03/2012

101662/LF/1

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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