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PRILOTEKAL

Active substance(s): PRILOCAINE HYDROCHLORIDE

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67801_03_Prilotekal_67801_03_ 25.04.12 09:12 Seite 1

PACKAGE LEAFLET: INFORMATION FOR THE USER

Prilotekal®
prilocaine hydrochloride
Read all of this leaflet carefully before you are given this medicine.
Keep this leaflet.You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Prilotekal is and what it is used for
2. Before Prilotekal is given
3. How Prilotekal is given
4. Possible side effects
5. How to store Prilotekal
6. Further information
1. What Prilotekal is and what it is used for
Prilotekal contains a medicine called prilocaine hydrochloride. This belongs
to a group of medicines called local anaesthetics. Prilotekal is used to anaesthetise (numb) specific parts of the body and prevent pain during surgery.
2. Before Prilotekal is given
Do not use Prilotekal if you:
– are allergic (hypersensitive) to prilocaine hydrochloride or any of the other
ingredients of Prilotekal (see Section 6: Further information),
– have problems with your heart,
– suffer from severe anaemia (a blood problem which means you have too
few red blood cells),
– suffer from shock,
– have a problem with blood pigment levels called ‘methaemoglobinaemia’.
You must not be given Prilotekal if any of the above apply to you. If you are
not sure, talk to your doctor before you are given Prilotekal.
Take special care with Prilotekal
and speak to your doctor before having Prilotekal if you:

prilocaine hydrochloride

67801 03



Prilotekal®
Prilotekal®
67801 03

prilocaine hydrochloride

SUMMARY OF PRODUCT CHARACTERISTICS

Prilotekal®
1. Name of the medicinal product
Prilotekal®
2. Qualitative and quantitative composition
1 ml of solution for injection contains 20 mg of prilocaine hydrochloride (equivalent to 2%)
1 ampoule with 5 ml solution, contains 100 mg of prilocaine hydrochloride
Excipients:
0.0086 mg sodium per 1 ml
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection. Clear, colourless solution.
4. Clinical Particulars
4.1 Therapeutic indications
– Spinal anaesthesia
4.2 Posology and method of administration
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)

2–3

40–60

Approx. 100–130

As a general guideline, the maximum recommended dose is 80 mg
of prilocaine hydrochloride (= 4 ml Prilotekal).
Paediatrics
Prilotekal must not be used in children and adolescents.
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.
In the case of compromised liver or kidney function a lower dosage
range is recommended.
Warnings for use
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.
Method of administration
Inject Prilotekal 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.
If the patient is in a seated position, the injected solution diffuses
mainly in a caudal direction (in the direction of the sacrum); if the
patient is lying down, the anaesthetic diffuses by gravity according to
the patient's position (Trendelenburg and anti-Trendelenburg ).
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 inject into infected areas!
4. Subarachnoid anaesthesia is contraindicated in patients taking
anticoagulants
By means of the excipient glucose, the density of Prilotekal is
1.026 g/g at 20°C, equivalent to 1.021 g/g at 37°C.

– have ever had a bad reaction to an anaesthetic in the past,
– have a skin infection at or near the proposed site of the injection,
– 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 (a rare disease of the blood pigment),
– fluid in your lungs,
– septicaemia (blood poisoning),
– have a heart condition,
– have any liver or kidney problems,
– suffer from neurological or neuromuscular disorders, such as multiple
scleroris.
If you are not sure if any of the above apply to you, talk to your doctor before
having Prilotekal.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
In particular, tell your doctor if you are taking any of the following medicines:
– other local anaesthetics,
– medicines to treat an uneven heartbeat (arrhythmia), such as amiodarone.
Pregnancy and breast-feeding
Before you are given Prilotekal, tell your doctor if you are pregnant, planning
to get pregnant, or if you are breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine if you
are pregnant or breast-feeding.
Prilotekal should not be administered for local or regional anaesthesia during
childbrith.
Driving and using machines
Prilotekal may make you feel sleepy and affect the speed of your reactions.
After you have been given Prilotekal, you should not drive or use tools or
machines until the next day.
Important information about some of the ingredients of Prilotekal
This medicinal product contains less than 1 mmol sodium (23 mg) per dose
(maximum dose equal to 4 ml of Prilotekal), so it is essentially “sodiumfree”.
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4.3 Contraindications
Prilotekal must not be used in patients with
– hypersensitivity to prilocaine hydrochloride, other amide-type local
anaesthetics or to any of the excipients,
– serious problems with cardiac conduction,
– severe anaemia,
– decompensated cardiac insufficiency,
– cardiogenic and hypovolemic shock,
– congenital or acquired methemoglobinemia.
It is also necessary to take into consideration general and specific
contraindications for the technique of subarachnoid anaesthesia.
4.4 Special warnings and precautions for use
Due to the glucose content Prilotekal is only to be used for spinal
anaesthesia. It is not recommended for the use in epidural anaesthesia.
Spinal anaesthesia must only be administered by (or under the
supervision of) specialist medical personnel with the necessary
knowledge and experience. The doctor in charge is responsible for
taking the measures needed to avoid an intravascular injection.
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. The risk of
methemoglobinemia must also be taken into consideration (see
section 4.8).
– Patients with advanced liver or kidney damage.
– Elderly patients and patients in reduced 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, Prilotekal should only be administered when there is a compelling indication for its use, as
Prilotekal may potentially precipitate porphyria. Appropriate precautions should be taken in all patients with porphyria.
Ensuring the presence of reliable venous access is recommended.
As with all local anaesthetics, a drop in arterial pressure may occur
and cardiac frequency may slow.
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 and patients in the final period of
pregnancy 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 and
paralysis. Occasionally these symptoms persist.
There is no evidence that neurological disorder, 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 than 1 mmol sodium (23 mg)
per dose (maximum dose equal to 4 ml of Prilotekal), i.e. essentially
“sodium-free”.
4.5 Interaction with other medicinal products and other forms
of interaction
Prilocaine may potentiate the formation of methemoglobin by medicinal products known to induce methemoglobin (e.g. sulfonamides,
antimalarials, sodium nitroprussiate and nitroglycerin).
In the event of the concomitant use of prilocaine and other local
anaesthetics or medicinal products with a chemical structure similar
to prilocaine, e.g. certain antiarrhythmics such as aprindine, lidocaine, mexiletine and tocainide, it is possible for undesirable effects
to be added. No studies have been performed on interactions
between prilocaine 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 Pregnancy and lactation
There are no adequate data from the use of prilocaine in pregnant
women. Prilocaine is able to cross the placenta. Cases of neonatal
methaemoglobinaemia requiring treatment have been reported
following paracervical block or pudendal anaesthesia with prilocaine
during obstetric use. Cases of foetal bradycardia with fatalities have
occurred with other local amide-type anaesthetics following paracervical block. Studies in animals have shown reproductive toxicity
(see section 5.3). Prilotekal may therefore only be administered in
cases where there is a compelling indication for its use. Use of
prilocaine for paracervical block or pudendal anaesthesia should be
avoided.
It is not known whether prilocaine passes into breast milk. If administration is required during lactation, breast-feeding can be resumed
approximately 24 hours after treatment.
4.7 Effects on ability to drive and use machines
In the case of using Prilotekal, the doctor is responsible for deciding
in each individual case if the patient can drive or use machines.
4.8 Undesirable effects
The frequency of onset of undesirable effects is classified as follows:
very common (≥1/10), common (≥1/100 to <1/10), uncommon
(≥1/1000 to <1/100), rare (≥1/10000 to <1/1000), very rare
(<1/10000).
The possible undesirable effects due to the use of Prilotekal are
generally similar to the undesirable effects of other local anaesthetics
for spinal anaesthesia from the amide 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).
Within each frequency grouping, undesirable effects are presented in
order of decreasing seriousness.

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3. How Prilotekal is given
This medicine will be given to you by your doctor who will decide what dose
is right for you. This will normally be between 2–4 ml (40–80 mg prilocaine
hydrochloride). This dose may be reduced if you are suffering from poor
health.
Prilotekal must not be used in children and adolescents.
Prilotekal is injected via the spinal route.
If you have any further questions on the use of this product, ask your doctor
or pharmacist.
4. Possible side effects
Like all medicines, Prilotekal can cause side effects, although not everybody
gets them.
All medicines can cause allergic reactions although serious allergic reactions are very rare. Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your
whole body) should be reported to a doctor immediately.
Rarely (affects less than 1 in 1,000 people) a high or total spinal block may
occur this may lead to heart and breathing difficulties, if you experience any
such difficulty inform your doctor immediately.
Prilotekal is unlikely to cause serious side effects unless it is accidentally
injected in the wrong way or used together with other local anaesthetics. If
you notice any of the following effects speak to your doctor immediately:
– numbness of the tongue, light-headedness, dizziness, shakiness and fits.
Other possible side effects:
Very common (affects more than 1 in 10 people)
– Low blood pressure. This might make you feel dizzy or light-headed.
– Feeling sick (nausea).
Common (affects less than 1 in 10 people)
– Being sick (vomiting).
– Feeling dizzy.
– Pins and needles.
Uncommon (affects less than 1 in 100 people)
– Itching.
– Numbness or tingling of the skin, or reduced sensitivity to touch.
– Back pain.
– Temporary muscle weakness.

If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor.
5. How to store Prilotekal
Keep out of the reach and sight of children.
Do not use Prilotekal 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 store Prilotekal above 25°C. Do not refrigerate. Store in original pakkage in order to protect from light.
Your doctor or the hospital will normally store Prilotekal and they are responsible for the quality of the product when it has been opened if it is not used
immediately.
They are also responsible for disposing of any unused Prilotekal correctly.
6. Further Information
What Prilotekal contains
The active substance is prilocaine hydrochloride.
1 ml of solution for injection contains 20 mg of prilocaine hydrochloride
(equivalent to 2%).
1 ampoule with 5 ml solution, contains 100 mg of prilocaine hydrochloride.
The other ingredients are:
Glucose anhydrous
Sodium hydroxide 1N (for pH adjustment)
Water for injection
What Prilotekal looks like and contents of the pack
Solution for injection. Clear, colourless solution.
Prilotekal 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 leaflet was last revised in August 2010
The following information is intended for medical and healthcare professionals only:
The SPC is added at the end of the printed PL as a tear-off section.



Very common
Vascular disorders: hypotension
Gastrointestinal disorders: nausea
Common
Disorders of the nervous system: paresthesia, dizziness
Gastrointestinal disorders: vomiting
Uncommon
Disorders of the nervous system: signs and symptoms of CNS
toxicity (convulsions, circumoral paresthesia, feeling of numbness
affecting the tongue, hearing problems, visual problems, shaking,
tinnitus, speech problems, loss of consciousness)
Vascular disorders: bradycardia, hypertension
Rare
Blood and lymphatic system disorders: methemoglobinemia, cyanosis
Immune system disorders: allergic reactions, anaphylactic reactions/
anaphylactic shock
Disorders of the nervous system: neuropathy, lesions of peripheral
nerves, arachnoiditis
Eye disorders: diplopia
Cardiac disorders: cardiac arrest, arrhythmia
Respiratory disorders: respiratory depression
The signs of intoxication from local anaesthetics are similar for any
injected preparation, both in the way in which they manifest, and in
their treatment.
In spite of the demonstrated high clinical tolerability of Prilotekal,
undesirable toxic effects cannot be excluded in the presence of
plasma levels above a critical threshold. These undesirable effects
mainly manifest as symptoms affecting the central nervous and
cardiovascular system.
The most effective prophylactic measures are scrupulous compliance with the recommended posology for Prilotekal, with it being
essential for the doctor to check its action (visual and verbal contact
with the patient), as well as careful aspiration prior to injecting the
solution.
Mild undesirable effects (feeling dizzy or dazed) can be attributed to
moderate overdose and generally resolve rapidly after reducing the
dose or halting administration of Prilotekal.
Serious undesirable effects are attributable to significant overdose
and/or accidental injection of local anaesthetic into a blood vessel.
They manifest as symptoms affecting the central nervous system
(restlessness, speech problems, disorientation, dizziness, muscle
contractions, cramps, vomiting, loss of consciousness, respiratory
arrest and mydriasis) and the cardiocirculatory system (raised
arterial pressure and pulse frequency, arrhythmia, drop in arterial
pressure, asystole) following irritation and/or depression of the
cerebral cortex and the cerebral marrow (see section 4.9).
In addition, following inhibition or block of the cardiac conduction
system, cardiac frequency may slow down and myocardial depression may occur.
Any problems relating to metabolism (liver) or excretion (kidney) of
Prilotekal should also be considered as other possible causes of
undesirable effects.
4.9 Overdose
It is unlikely that Prilotekal, at the recommended posology, will
induce plasma levels capable of inducing systemic toxicity.
Acute systemic toxicity
Systemic undesirable effects, which may occur in the presence of
plasma levels of more than 5–10 micrograms of prilocaine/ml, are
iatrogenic, pharmacodynamic or pharmacokinetic origin and concern
the central nervous system and the cardiocirculatory system.
Iatrogenic undesirable effects occur due to:
– injection of an excessive quantity of solution
– accidental injection into a vessel
– incorrect patient position
– high spinal anaesthesia (marked drop in arterial pressure)
In the case of accidental intravenous administration, the toxic effect
occurs within 1–3 minutes. On the contrary, in the case of overdose
maximum plasma concentrations are only reached after 20–30 minutes, depending on the injection site, and the onset of signs of toxicity is delayed.
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 potentiates 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
anaesthetics 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 Prilotekal.
– Ensure an adequate supply of oxygen: keep the airways clear,
administer O2, artificial ventilation (intubation) if required.
In the event 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).
Methemoglobinemia
Methemoglobinemia may follow the administration of prilocaine.
Prilotekal is contraindicated for techniques of regional anaesthesia

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requiring continuous administration. The doses used in subarachnoid
anaesthesia do not induce blood levels capable of inducing
methemoglobinemia, which occurs if the quantity of prilocaine hydrochloride administered is equal to or higher than 600 mg.
There is a metabolite of prilocaine, o-toluidine, which can induce
methemoglobin formation. In general, methemoglobin formation is
clinically negligible, except in cases of extremely severe anaemia
and high grade cardiac decompensation.
Patients with severe anaemia may develop hypoxia. It is important to
exclude other serious causes of cyanosis, e.g. acute hypoxia and/or
cardiac insufficiency.
Treatment of methemoglobinemia
Proven methemoglobinemia resolves 15 minutes after the i.v. injection of 2–4 mg/kg body weight of toluidine blue.
Additional information:
Even low concentrations of methemoglobin can alter measurements
of pulsoxymetria.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: anaesthetics, local; amides
ATC code: N01BB04
Prilocaine is an amide-type local anaesthetic. Prilocaine inhibits the
function of the excitable structures (e.g. all types of nerve fibres
[sensory, motor, autonomous nerve fibres]). It inhibits the excitability
of sensory pain receptors and the conductivity of the sensory nerve
fibres, at local level and in a reversible way, reducing the perception
of pain and, subsequently, that of cold, heat, touch and pressure.
Prilocaine reduces membrane permeability to sodium. This reduces
the excitability of the nerve fibres in accordance with its concentration, through reducing the sudden peak sodium permeability, needed
to form the potential for action. The effect depends on the pH of the
substance and the pH of the environment. The local anaesthetic
effect is due to the protonated form. In inflamed tissues, the effect of
the local anaesthetics is lower because of the lower pH of the
environment.
5.2 Pharmacokinetic properties
The plasma concentration should be negligible for intrathecal use.
The terminal elimination half-life of prilocaine is 1.6 hours.
The plasma protein bond is approximately 55%.
The bioavailability of prilocaine at the application site is 100%.
5.3 Preclinical safety data
The therapeutic dose used locally in humans is close to the dose
which is toxic in animals after intravenous administration. In animals,
signs of acute toxicity are reduced activity, convulsions, dyspnea,
cyanosis and death on account of cardiac insufficiency.
The subcutaneous injection of 3 ml/kg of body weight of prilocaine
hydrochloride induced reversible local necrosis in the rat. At the
same posology no damaging effects were observed in the monkey.
The administration of 60 mg/kg body weight of prilocaine for 5 days a
week for 7 weeks induced slight weight loss in the rat.
In mutagenesis tests, prilocaine did not demonstrate any mutagenic
effects. The indices for a potential mutagen are based on knowledge
relating to the metabolite o-toluidine, which caused genetic damage
and cell proliferation (chromosome mutations, aneuploidy, DNA
repair, cell conversion) in various tests in vitro.
In carcinogenicity studies performed in the rat and the mouse with
high doses of the metabolite o-toluidine, an increase in the frequency of tumours of the spleen and the bladder were observed.
Neither of the results seem significant for humans in the case of the
therapeutic short-term use of prilocaine; nevertheless, for safety
reasons avoiding the administration of high doses over prolonged
periods is recommended.
Prilocaine has no effect on the fertility of male and female rats.
However, the postnatal survival of the offspring of treated females
was reduced. In one study on embryotoxicity in the rat lethal effects
on the foetus were observed, and dose-dependent hydronephrosis
occurred in the foetuses.
6. Pharmaceutical Particulars
6.1 List of excipients
Glucose anhydrous
Sodium hydroxide 1N (for pH adjustment)
Water for injection
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years
The medicinal product has to be used immediately after first
opening.
6.4 Special precautions for storage
Do not store above 25°C.
Do not refrigerate.
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
5 ml ampoules of solution for injection are exclusively single-use.
Any remaining product must be disposed of.
Do not resterilize.
The medicinal product has to be visually inspected prior to use. Only
clear solutions practically free from particles should be used.
7. Marketing authorization holder
Mercury Pharmaceuticals Ltd
No. 1 Croydon,
12-16 Addiscombe Road,
Croydon,
CR0 0XT, UK
8. Marketing authorisation number
PL 12762/0447
9. Date of first authorisation / Renewal of the authorisation
29/09/2009
10. Date of revision of the text
November 2009

101661/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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