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ALFENTANIL 5 MG/ML SOLUTION FOR INJECTION

Active substance(s): ALFENTANIL HYDROCHLORIDE / ALFENTANIL HYDROCHLORIDE / ALFENTANIL HYDROCHLORIDE

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PACKAGE LEAFLET

Patient Information Leaflet

ALFENTANIL 5mg/ml,
Solution for Injection

Please read all of this leaflet carefully before taking your medicine.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as
yours.

• If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or
pharmacist.

In this leaflet:
1. What is ALFENTANIL and what is it used for?
2. Before you are given ALFENTANIL
3. How you will be given ALFENTANIL
4. Possible side effects
5. Storing ALFENTANIL
6. Further information

1. What is ALFENTANIL and what is it used for?
What is ALFENTANIL?
ALFENTANIL 5 mg/ml, Solution for Injection is a potent and short­acting painkiller. It belongs to a group of medicines known as opioid
analgesics which relieve or prevent pain.
What is ALFENTANIL used for?
ALFENTANIL is used to control pain and breathing when using an artificial breathing machine in intensive care.
ALFENTANIL 5 mg/ml, Solution for Injection will be diluted and given as an infusion (a ‘drip’) into a vein.

2. Before you are given ALFENTANIL
Always inform your doctor if you are pregnant, think you might be pregnant or are trying to become pregnant.
Always tell your doctor about any medicines (either prescribed by a doctor or that you have bought) which you have taken recently or are
taking now.
Do not use ALFENTANIL:

if you are taking, or have recently been taking (within the last two weeks), any of the antidepressant medicines known as
monoamine oxidase inhibitors (MAOIs), including moclobemide.

if you think that you may have had an allergic or any other type of reaction to ALFENTANIL or a similar medicine in the past. An
allergic reaction may be recognized as a rash, itching, swollen face or lips, or shortness of breath.

if you are pregnant or think that you are pregnant.
If any of the above applies to you, tell the doctor.
Warnings
Medicines like ALFENTANIL 5 mg/ml, Solution for Injection may cause a drop in blood pressure and breathing rate. These effects are usually
short‐lived. It may also cause the heart to beat more slowly.
Particular care has to be taken following treatment with other medicines which have similar effects. Blood pressure and heart rate are
therefore monitored during administration of ALFENTANIL and any unwanted effects of this nature can be reversed with other medicines.
Rarely, the rhythm of the heart may be altered and this will be treated if it occurs.
The doctor who will be giving ALFENTANIL 5 mg/ml, Solution for Injection will be aware of the possibility of all these unwanted effects and
will take steps to avoid them.

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Special Precautions
Your doctor will take special precautions when giving you ALFENTANIL if any of the points listed below applies to you:



The dose of ALFENTANIL 5 mg/ml, Solution for Injection is normally reduced in elderly patients, and those with some thyroid
problems or liver disease.
Your dose will be carefully monitored if you have a history of lung disease, alcoholism, kidney problems or if you have been on
long term opioid therapy.



ALFENTANIL can make the muscles stiff. Your doctor will take measures to avoid this happening.



As with all strong opioid painkillers, good pain relief is accompanied by a lowering of the breathing rate. This may last into the
recovery period or occur again during this time. This effect may be increased if you have recently used similar medicines for pain
relief. Your breathing will therefore be carefully monitored until it returns to normal.

Taking other medicines
Always tell your doctor if you are taking any other medicines because taking some medicines together can be harmful. Remember that the
doctor at the hospital may not have been informed if you have recently begun a course of treatment for another illness.
Some medicines may affect the length of time it takes for the effects of ALFENTANIL to wear off:

cimetidine, a medicine for ulcers, stomach‐ache and heartburn

erythromycin, an antibiotic

diltiazem, a medicine used for a certain type of heart disorder.
Some medicines will have some of the same effects as ALFENTANIL. When one or more of these medicines is used at the same time as
ALFENTANIL, the effects of either may be increased.

beta‐blockers (used to treat high blood pressure and disorders of heart rhythm)

anaesthetic agents

drugs which depress the central nervous system (such as tranquillisers and sleeping pills)

benzodiazepines e.g. clobazam, clonazepam (used to treat epilepsy)

barbiturates e.g. phenobarbitone

other strong opioid painkillers.
It may also be necessary to adjust the dose of ALFENTANIL 5 mg/ml, Solution for Injection if you are taking the following:

certain medicines for fungal infections, e.g. fluconazole, ketoconazole and itraconazole;

certain medicines called antiviral protease inhibitors, e.g. ritonavir.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking this medicine.
Pregnancy and breast feeding
If you are pregnant, or think you may be, you should inform your doctor. He/she will decide whether or not you should be given
ALFENTANIL.
ALFENTANIL may get into breast milk. It is therefore recommended that you should not breast feed for 24 hours after treatment.
Driving and using machines
You should not drive or operate machinery for 24 hours after being given ALFENTANIL as you may be less alert than usual.

3. How you will be given ALFENTANIL
Your doctor will decide how much ALFENTANIL 5 mg/ml, Solution for Injection you need. This will depend, for example, on the type of
surgery, your body weight, age and general health.
ALFENTANIL 5 mg/ml, Solution for Injection should be mixed with sodium chloride injection, dextrose injection or compound sodium lactate
injection (Hartmann’s solution). These dilutions should be used within 24 hours of preparation.
The usual recommended dosage is as follows:
Adults:
Your initial dose will be 2 mg per hour. Sometimes a higher initial dose (for example 5 mg) is given over a period of 10 minutes to achieve
more rapid control.
Adolescents and young adults will be given higher than the average adult dose.
Elderly:
The above amounts of ALFENTANIL 5 mg/ml, Solution for Injection will be reduced.
Patients with liver problems and hypothyroidism (underactive thyroid) will also need their dose of ALFENTANIL to be reduced from the
normal adult dosage.

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Children:
ALFENTANIL 5 mg/ml, Solution for Injection is not usually used to treat children in intensive care.
The usual maximum treatment time with ALFENTANIL infusions is 4 days.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, using Alfentanil can cause side-effects, although not everybody gets them.

To give you an idea of how many patients might get side effects, they have been listed as very common, common, uncommon, rare and very
rare. These mean the following:
Very common
Common
Uncommon
Rare
Very rare

More than 1 in 10 people.
up to 1 in 10 people.
up to 1 in 100 people.
up to 1 in 1,000 people.
fewer than 1 in 10,000 people.

These are the side effects we know about for ALFENTANIL 5 mg/ml, Solution for Injection:




Very common: Feeling or being sick.

Common: Low blood pressure (hypotension); high blood pressure (hypertension), muscle stiffness, twitching, dizziness, slow or
fast heart beat, feeling sleepy, stopping breathing temporarily, lowered breathing rate.

Uncommon: Pain at the site of the injection, shivering, allergic reaction (such as dif�iculty in breathing, skin rash or itching, or
swollen face), headache, irregular heart beat, feeling disorientated, agitation, feeling ‘high’ (euphoria), cough, continued lowered
breathing rate, tightness of the throat, hiccup, itching of the skin, sweating, blurred or ‘double’ vision.

If you think your medicine has affected you in any other way, you should tell the doctor.
See also Section 2, Before you are given ALFENTANIL 5 mg/ml, Solution for Injection, above.

5. Storing ALFENTANIL
Keep out of the reach and sight of children.

You must not be given ALFENTANIL 5 mg/ml, Solution for Injection after the expiry date (month and year) printed after “EXP” on the carton.
The expiry date refers to the last day of that month.
Dilutions made with ALFENTANIL 5 mg/ml, Solution for Injection must be used within 24 hours of preparation.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.

6. Further Information

What ALFENTANIL contains:
The name of your medicine is ALFENTANIL 5 mg/ml, Solution for Injection and its active ingredient is ALFENTANIL. Each millilitre contains
5 milligrams of ALFENTANIL (as the hydrochloride).
The solution for injection also contains sodium chloride, water for injections, sodium hydroxide and hydrochloric acid.
This medicinal product contains less than 1 mmol sodium (23 mg) per 5 mg dose, i.e. essentially 'sodium-free'.

What ALFENTANIL looks like and contents of the pack:
It is a solution for injection which comes in 1 millilitre (ml) clear glass ampoules. It is a clear colourless solution.
ALFENTANIL 5 mg/ml, Solution for Injection is supplied in packs of 10 x 1 ml ampoules.
Marketing authorisation holder:
Auden Mckenzie (Pharma Division) Ltd.
Mckenzie House
Bury Street
Ruislip
Middlesex
HA4 7TL
UK

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Manufacturer:
SNS Pharmaceuticals Ltd
30 Stadium Business Centre
North End Road
Middlesex
HA9 0HT
UK

This lea�let was last approved in February 2010.

For information in large print, on tape, on CD or in Braille, phone 01895 627 420.
ALFENTANIL Intensive Care 5mg/ml, Solution for Injection
PL 17507/0037

Auden Mckenzie

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(Please detach prior to giving the leaflet to the patient)

Information for the Healthcare Professional

ALFENTANIL 5mg/ml,
Solution for Injection

1. NAME OF THE MEDICINAL PRODUCT
Alfentanil 5 mg/ml, Solution for Injection

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of Alfentanil solution for injection contains 5 mg alfentanil (as hydrochloride) per ml.
For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM
Solution for injection.
A clear colourless solution.

4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Alfentanil is a potent opioid analgesic with a very rapid onset of action. It is indicated for analgesia and suppression of respiratory activity in
mechanically ventilated patients on intensive care and to provide analgesic cover for painful manoeuvres. It will aid compliance with
mechanical ventilation, and tolerance of the endotracheal tube. Intravenous bolus doses of Alfentanil 5 mg/ml (0.5 mg/ml) may be used to
provide additional pain relief during brief painful procedures such as physiotherapy, endotracheal suction, etc. Despite being mechanically
ventilated, patients may be awake in the presence of adequate analgesia.
At the proposed doses, Alfentanil has no sedative activity. Therefore supplementation with an appropriate hypnotic or sedative agent is
recommended. Admixture is not advisable due to the need to individually titrate both agents.
Alfentanil given by infusion should only be given in areas where facilities are available to deal with respiratory depression and where
continuous monitoring is performed. Alfentanil should only be prescribed by physicians familiar with the use of potent opioids when given
by continuous IV infusion.

4.2 Posology and method of administration
For intravenous infusions.
Dosage
Alfentanil 5 mg/ml should be diluted with sodium chloride intravenous infusion BP, glucose intravenous infusion BP, or compound sodium
lactate intravenous infusion BP (Hartmann's solution). Such dilutions are compatible with plastic bags and giving sets. These dilutions
should be used within 24 hours of preparation.
Once the patient has been intubated, mechanical ventilation can be initiated using the following dosage regimen:
The recommended initial infusion rate for mechanically ventilated adult patients is 2 mg per hour (equivalent to 0.4 ml per hour of undiluted
Alfentanil 5 mg/ml). For a 70 kg patient, this corresponds to approximately 30 micrograms per kilogram per hour.
More rapid control may initially be gained by using a loading dose. For example, a dose of 5 mg may be given in divided doses over a period
of 10 minutes, during which time careful monitoring of blood pressure and heart rate should be performed. If hypotension or bradycardia
occurs, the rate of administration should be reduced accordingly and other appropriate measures instituted.

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The dose to produce the desired effects should then be individually determined and reassessed regularly to ensure that the optimum dose is
being used.
In clinical trials, patient requirements have generally been met with doses of 0.5 to 10 mg alfentanil per hour.
Additional bolus doses of 0.5‐1.0 mg alfentanil may be given to provide analgesia during short painful procedures.
The elderly and those patients with liver impairment and hypothyroidism will require lower doses. Obese patients may require a dose based
on their lean body mass.
Adolescents and young adults will require higher than average doses. There is little experience of use of alfentanil to treat children in
intensive care.
The maximum recommended duration of treatment with alfentanil infusions is 4 days.
Present data suggest that clearance of alfentanil is unaltered in renal failure. However there is an increased free fraction and hence dosage
requirements may be less than in the patient with normal renal function.

4.3 Contraindications
Known intolerance of alfentanil or other morphinomimetics. Pregnancy, and concurrent administration with monoamine oxidase inhibitors.

4.4 Special warnings and special precautions for use
Warnings:
Following administration of Alfentanil, a fall in blood pressure may occur. The magnitude of this effect may be exaggerated in the
hypovolaemic patient or in the presence of concomitant sedative medication. Appropriate measures to maintain a stable arterial pressure
should be taken.
Like other opioids, alfentanil may cause bradycardia, an effect which may be marked and rapid in onset but which can be antagonised by
atropine.
Particular care must be taken following treatment with drugs which may depress the heart or increase vagal tone, such as anaesthetic agents
or beta‐blockers since they may predispose to bradycardia or hypotension. Heart rate and blood pressure should therefore be monitored
carefully. If hypotension or bradycardia occurs, the rate of administration of alfentanil should be reduced and other appropriate measures
instituted. Asystole following bradycardia has been reported on very rare occasions in non‐atropinised patients. Therefore it is advisable to
be prepared to administer an anticholinergic drug.
Care must be taken if the patient has received monoamine oxidase inhibitors within the previous 2 weeks.
Significant respiratory depression and loss of consciousness will occur following administration of alfentanil in doses in excess of 1 mg and is
dose‐related. If necessary for assessment purposes, naloxone or other specific antagonists may be administered to reverse the opioid
respiratory depression and other pharmacological effects of alfentanil. More than one dose of naloxone may be required in view of its short
half life.
Muscle rigidity (morphine‐like effect) may occur, in which case neuromuscular blocking drugs may be helpful.
Precautions:
It is wise to reduce the dosage in the elderly and debilitated patient. In hypothyroidism, pulmonary disease, decreased respiratory reserve,
alcoholism and liver or renal impairment the dosage should be titrated with care and prolonged monitoring may be required.
Patients on chronic opioid therapy or with a history of opioid abuse may require higher doses.
Non‐epileptic (myo)clonic movements can occur.
As with all potent opioids, profound analgesia is accompanied by marked respiratory depression, which may persist into or recur in the early
post infusion period. Care should therefore be taken throughout the weaning period and adequate spontaneous respiration should be
established and maintained in the absence of stimulation or ventilatory support. Following cessation of the infusion, the patient should be
closely observed for at least 6 hours. Prior use of opioid medication may enhance or prolong the respiratory depressant effects of alfentanil.
The use of rapid bolus injections of opioids should be avoided in patients with compromised intracerebral compliance; in such patients a
transient decrease in the mean arterial pressure has occasionally been accompanied by a transient reduction of the cerebral perfusion
pressure.
This medicinal product contains less than 1 mmol sodium (23 mg) per 5 mg dose, i.e. essentially 'sodium‐free'.

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4.5 Interaction with other medicinal products and other forms of Interaction
Alfentanil is metabolised mainly via the human cytochrome P450 3A4 enzyme. Available human pharmacokinetic data indicate that the
metabolism of alfentanil may be inhibited by fluconazole, erythromycin, diltiazem and cimetidine (known cytochrome P450 3A4 enzyme
inhibitors). In vitro data suggest that other potent cytochrome P450 3A4 enzyme inhibitors (e.g. ketoconazole, itraconazole, ritonavir) may
also inhibit the metabolism of alfentanil. This could increase the risk of prolonged or delayed respiratory depression. The concomitant use of
such drugs requires special patient care and observation; in particular, it may be necessary to lower the dose of Alfentanil.
Treatment with drugs which may depress the heart or increase vagal tone, such as beta‐blockers and anaesthetic agents, may predispose to
bradycardia or hypotension. Bradycardia and possibly asystole can occur when Alfentanil 5 mg/ml is combined with non‐vagolytic muscle
relaxants.
Prior use of opioid premedication, barbiturates, benzodiazepines, neuroleptics, halogenic gases and other non‐selective CNS depressants
may enhance or prolong the respiratory depressant effects of alfentanil.
If other narcotic or CNS depressant drugs are used concurrently with alfentanil, the effects of the drugs can be expected to be additive. When
patients have received such drugs, the dose of alfentanil required will be less than usual. Likewise, following the administration of alfentanil,
the dose of other CNS‐depressant drugs should be reduced.

4.6 Pregnancy and lactation
Animal studies are insufficient with respect to effects on pregnancy. Although no teratogenic or acute embryotoxic effects have been
observed in animal experiments, the potential risk for humans is unknown.
Alfentanil should not be used in pregnancy unless clearly necessary. I.V. administration during childbirth (including Caesarean section) is
not recommended, because alfentanil crosses the placenta and because the foetal respiratory centre is particularly sensitive to opiates. If,
however, alfentanil is administered, an antidote should always be at hand for the child.
Alfentanil may appear in breast milk. It is therefore recommended that breast feeding is not initiated within 24 hours of treatment.

4.7 Effects on ability to drive and use machines
Where early discharge is envisaged, patients should be advised not to drive or operate machinery for the 24 hours following administration.

4.8 Undesirable effects
The most frequently reported ADRs (incidence 10%) are: nausea and vomiting. Undesirable effects listed below in Table 1 have been
reported in a clinical trial and/or from spontaneous reports from post‐marketing experience. The following terms and frequencies are
applied: very common ( 1/10), common ( 1/100 to < 1/10), uncommon ( 1/1000 to < 1/100), rare ( 1/10,000 to < 1/1000), very
rare (< 1/10,000), and not known (frequency cannot be estimated from the available data). Adverse drug reactions from spontaneous
reports during worldwide postmarketing experience with Alfentanil that met threshold criteria are included. Unlike for clinical trials, precise
frequencies cannot be provided for spontaneous reports. The frequency for these reports is therefore classified as 'not known'.

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Table 1 Adverse drug reactions reported in clinical trials and/or postmarketing
Body System/Organ Class
Frequency Category

Clinical trials

Spontaneous Reportsa

Immune system disorders
Uncommon

Allergic reactions (such as anaphylaxis, bronchospasm,
urticaria)

Psychiatric Disorders
Common

Somnolence

Uncommon

Disorientation, Agitation, Euphoria

Nervous system disorders
Common

Muscle rigidity (may also involve thoracic muscles)
Myoclonic movements, Dizziness

Uncommon

Headache

Not known

Loss of consciousness (Postoperative period), Convulsion

Eye disorders
Uncommon

Blurred/double vision

Not known

Miosis

Cardiac disorders
Common

Bradycardia, Tachycardia

Uncommon

Arrhythmia

Not known

Cardiac arrest

Vascular Disorders
Common

Hypotension, Hypertension

Respiratory, thoracic, and mediastinal disorders
Common

Apnoea, Respiratory depression

Uncommon

Cough, Recurrence of respiratory depression,
Laryngospasm, Hiccup

Not known

Respiratory arrest (including fatal outcome)

Gastrointestinal disorders
Very common

Nausea, Vomiting

Skin and subcutaneous tissue disorders
Uncommon

Pruritis, Sweating

General disorders and administration site
conditions
Uncommon

Injection site pain, Shivering

Not known
a: Listed are only those adverse drug reactions that were not identified in clinical trials

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4.9 Overdose
The manifestations of alfentanil overdose are generally an extension of its pharmacological action, which include the following:‐
Action:
Bradycardia:

Anticholinergics such as atropine or glycopyrrolate;

Hypoventilation or apnoea:

O2 administration, assisted or controlled respiration and an opioid antagonist may be
required;

Muscle rigidity:

Intravenous neuromuscular blocking agent may be given.

If hypotension is severe or persists, the possibility of hypovolaemia should be considered and controlled with appropriate parenteral fluid
administration.
The suggested treatments given above do not preclude the use of other clinically indicated counter measures.
Body temperature and adequate fluid intake should be maintained and the patient observed for 24 hours.
A specific narcotic antagonist (eg naloxone) should be available to treat respiratory depression.

5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
In man, alfentanil at therapeutic doses has no detrimental effects on myocardial performance. The cardiovascular stability is remarkable
both in healthy and poor‐risk patients. The only changes seen in blood pressure and heart rate were transient, slight decreases occurring
immediately after induction. The incidence and degree of respiratory depression is less and of shorter duration after alfentanil than with
fentanyl. Like other narcotic analgesics, alfentanil increases the amplitude of the EEG and reduces its frequency. Alfentanil reduces
intraocular pressure by about 45%. It blocks increases in plasma cortisol and in plasma antidiuretic and growth hormones throughout
surgery, and prevents increases in plasma catecholamines up to, but not during or after, cardiopulmonary bypass in patients undergoing
open heart surgery.

5.2 Pharmacokinetic properties
After bolus injections ranging from 2.4 to 125 µg/kg, plasma levels in man decay triexponentially with a terminal half life of approx. 90
minutes. Total distribution volume varies from 0.4 to 1.0 l/kg, indicating a limited distribution of alfentanil to the tissues. Plasma clearance,
varying from 3.3 to 8.3 ml/kg/min represents approximately one third of liver plasma flow indicating that elimination of alfentanil is not
flow dependent. Since only 0.4% of the dose is excreted with the urine as unchanged drug, elimination of alfentanil occurs mainly by
metabolism.
These main parameters in patients undergoing surgery are similar to those in healthy volunteers. Only when the drug was given as the sole
anaesthetic in a continuous high infusion over about 5 hours was the clearance of alfentanil reduced resulting in a plasma half‐life of about
200 minutes, the distribution volume not being markedly changed.
Plasma protein binding of alfentanil is 92%, mainly due to a strong binding to the 'acute phase' α1‐acid‐glycoprotein. It is not bound to the
blood cells. Pharmacokinetics were comparable in rats, dogs and man. In children, alfentanil has been shown to have a much shorter half‐life
than adults, whereas the elderly show a longer half‐life for alfentanil, after IV bolus doses.

5.3 Preclinical safety data
Preclinical effects observed were only at exposures considered sufficiently in excess of the maximum human exposure indicating little
relevance to clinical use.

6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium chloride
Water for injections
Hydrochloric acid*
Sodium hydroxide*
* for occasional pH adjustment only

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6.2 Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3 Shelf life
24 months (unopened).
24 hours (dilutions).

6.4 Special precautions for storage
This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container
Type I Ph Eur clear glass ampoules containing 1 ml.
10 ampoules per carton.

6.6 Special precautions for disposal and other handling
If desired, Alfentanil Solution for Injection can be mixed with sodium chloride injection BP, dextrose injection BP or compound sodium
lactate injection BP (Hartmann's solution). Such dilutions are compatible with plastic bags and giving sets. These dilutions should be used
within 24 hours of preparation.

7. MARKETING AUTHORISATION HOLDER
Auden McKenzie (Pharma Division) Ltd
Mckenzie House
Bury Street
Ruislip
Middlesex
HA4 7TL

8. MARKETING AUTHORISATION NUMBER(S)
PL 17507/0037

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

10. DATE OF REVISION OF THE TEXT
Legal category POM

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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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