LEVOFLOXACIN 5 MG/ML SOLUTION FOR INFUSION

Active substance: LEVOFLOXACIN HEMIHYDRATE

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Levofloxacin 5 mg/ml Solution for infusion
Version 5 (February 103)

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PACKAGE LEAFLET

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Package leaflet: Information for the user
Levofloxacin 5 mg/ml solution for infusion
Levofloxacin

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, nurse or pharmacist.

If you get any side effects talk to your doctor, nurse or pharmacist. This includes any possible side
effects not listed in this leaflet.
What is in this leaflet:
1.
What Levofloxacin solution for infusion is and what it is used for
2.
What you need to know before you are given Levofloxacin solution for infusion
3.
How Levofloxacin solution for infusion is given
4.
Possible side effects
5.
How to store Levofloxacin solution for infusion
6.
Contents of the pack and other information
1.

What Levofloxacin solution for infusion is and what it is used for

The name of your medicine is Levofloxacin solution for infusion. Levofloxacin solution for infusion
contains a medicine called levofloxacin. This belongs to a group of medicines called antibiotics.
Levofloxacin is a ‘quinolone’ antibiotic. It works by killing the bacteria that cause infections in your body.
Levofloxacin solution for infusion can be used to treat infections of the:

Lungs, in people with pneumonia

Urinary tract including your kidneys or bladder

Prostate gland, where you have a long lasting infection

Skin and underneath the skin, including muscles. This is sometimes called ‘soft tissue’
In some special situations, Levofloxacin solution for infusion may be used to lessen the chances of getting a
pulmonary disease named anthrax or worsening of the disease after you are exposed to the bacteria causing
anthrax.
2.

What you need to know before you are given Levofloxacin solution for infusion

Do not have this medicine and tell your doctor if:

You are allergic to levofloxacin, any other quinolone antibiotic such as moxifloxacin, ciprofloxacin
or ofloxacin or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic
reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or
tongue

You have ever had epilepsy

You have ever had a problem with your tendons such as tendonitis that was related to treatment with
a ‘quinolone antibiotic’. A tendon is the cord that joins your muscle to your skeleton

You are a child or a growing teenager

You are pregnant, might become pregnant or think you may be pregnant

You are breast-feeding.
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Do not have this medicine if any of the above applies to you. If you are not sure, talk to your doctor, nurse
or pharmacist before you are given Levofloxacin.
Warnings and precautions
Talk to your doctor, nurse or pharmacist before you have your medicine if:

You are 60 years of age or older

You are using coticosteroids, sometimes called steroids (see section ‘Other medicines and
Levofloxacin’)

You have ever had a fit (seizure).

You have had damage to your brain due to a stroke or other brain injury

You have kidney problems

You have something known as ‘glucose-6-phosphate dehydrogenase deficiency’. You are more
likely to have serious problems with your blood when taking this medicine

You have ever had mental health problems

You have ever had heart problems: caution should be taken when using this kind of medicine, if you
were born with or have family history of prolonged QT interval (seen on ECG, electrical recording
of the heart), have salt imbalance in the blood (especially low level of potassium or magnesium in
the blood), have a very slow heart rhythm (called ‘bradycardia’), have a weak heart (heart failure),
have a history of heart attack (myocardial infarction), you are female or elderly or you are taking
other medicines that result in abnormal ECG changes (see section ‘Other medicines and
Levofloxacin’)

You are diabetic

You have ever had liver problems

You have myasthenia gravis.
If you are not sure if any of the above applies to you talk to your doctor, nurse or pharmacist before being
given Levofloxacin.
Other medicines and Levofloxacin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
This is because Levofloxacin can affect the way some other medicines work. Also some medicines can
affect the way Levofloxacin work.
In particular, tell your doctor if you are taking any of the following medicines. This is because it can
increase the chance of you getting side effects, when taken with Levofloxacin:

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Corticosteroids, sometimes called steroids – used for inflammation. You may be more likely to
have inflammation and/or rupture of your tendons.
Warfarin – used to thin the blood. You may be more likely to have a bleed. Your doctor may need
to take regular blood tests to check how well your blood can clot.
Theophylline – used for breathing problems. You are more likely to have a fit (seizure) if taken
with Levofloxacin.
Non-steroidal anti-inflammatory drugs (NSAIDS) – used for pain and inflammation such as aspirin,
ibuprofen, fenbufen, ketoprofen, indomethacin. You are more likely to have a fit (seizure) if taken
with Levofloxacin.
Ciclosporin – used after organ transplants. You may be more likely to get the side effects of
ciclosporin.
Medicines known to affect the way your heart beats. This includes medicines used for abnormal
heart rhythm (antiarrhythmics such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide,
ibutilide and amiodarone), for depression (tricyclic antidepressants such as amitriptyline and
imipramine), for psychiatric disorders (antipsychotics), and for bacterial infections (‘macrolide’
antibiotics such as erythromycin, azithromycin and clarithromycin).
Probenecid – used for gout and cimetidine – used for ulcers and heartburn. Special care should be
taken when taking either of these medicines with Levofloxacin. If you have kidney problems, your
doctor may want to give you a lower dose.

Urine tests for opiates
Urine tests may show ‘false-positive’ results for strong pain killers called ‘opiates’ in people having
Levofloxacin. If your doctor has prescribed a urine test, tell your doctor you are having Levofloxacin.
Tuberculosis tests
This medicine may cause ‘false negative’ results for some tests used in laboratory to search for the bacteria
causing tuberculosis.

Pregnancy and breast-feeding
Do not have this medicine if:

You are pregnant, might become pregnant or think you may be pregnant

You are breast-feeding or planning to breast-feed.
Driving and using machines
You may get side effects after being given this medicine, including feeling dizzy, sleepy, a spinning feeling
(vertigo) or changes to your eyesight. Some of these side effects can affect you being able to concentrate and
your reaction speed. If this happens, do not drive or carry out any work that requires a high level of
attention.
Levofloxacin solution for infusion contains sodium
This medicine contains sodium chloride (salt). The product contains 3.546 mg of sodium per ml of infusion
(a total of 177.3 mg sodium in 50 ml and 354.6 mg sodium in 100 ml). To be taken into consideration by
patients on a controlled sodium diet.

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How Levofloxacin solution for infusion is given

How Levofloxacin solution for infusion is given

Levofloxacin solution for infusion is a medicine for use in hospitals

It will be given to you by a doctor or nurse as an injection. The injection will be into one of your
veins and be given over a period of time (this is called an intravenous infusion)

For 250 mg Levofloxacin solution for infusion, the infusion time should be 30 minutes or more

For 500 mg Levofloxacin solution for infusion, the infusion time should be 60 minutes or more

Your heart rate and blood pressure should be closely monitored. This is because an unusual fast
beating of the heart and a temporary lowering of blood pressure are possible side effects that have
been seen during the infusion of a similar antibiotic. If your blood pressure drops noticeably while
you are being given the infusion, it will be stopped straight away.
How much Levofloxacin solution for infusion is given
If you are not sure why you are being given Levofloxacin or have any questions about how much
Levofloxacin is being given to you, speak to your doctor, nurse or pharmacist.

Your doctor will decide on how much Levofloxacin you should have

The dose will depend on the type of infection you have and where the infection is in your body

The length of your treatment will depend on how serious your infection is
Adults and the Elderly

Pneumonia: 500 mg once or twice daily

Infection of urinary tract, including your kidneys or bladder: 500 mg once daily

Prostate gland infection: 500 mg once daily

Infection of skin and underneath the skin, including muscles: 500 mg once or twice daily
Adults and the elderly with kidney problems
Your doctor may need to give you a lower dose.
Children and Teenagers
This medicine must not be given to children or teenagers.
Protect your skin from sunlight
Keep out of direct sunlight while having this medicine and for 2 days after you stop having it. This is
because your skin will become much more sensitive to the sun and may burn, tingle or severely blister if you
do not take the following precautions:

Make sure you use high factor sun cream

Always wear a hat and clothes which cover your arms and legs

Avoid sun beds
If you have more Levofloxacin solution for infusion than you should
It is unlikely that your doctor or nurse will give you too much medicine. Your doctor and nurse will monitor
your progress, and check the medicine you are given. Always ask if you are not sure why you are getting a
dose of medicine.
Having too much Levofloxacin may cause the following effects to happen: convulsive fits (seizures), feeling
confused, dizzy, less conscious, having tremor and heart problems – leading to uneven heart beats as well as
feeling sick (nausea).
If you miss a dose of Levofloxacin solution for infusion
Your doctor or nurse will have instructions on when to give you this medicine. It is unlikely that you will
not be given the medicine as it has been prescribed. However, if you do think you may have missed a dose,
tell your doctor or nurse.
If you stop having Levofloxacin solution for infusion
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Your doctor or nurse will continue giving you Levofloxacin, even if you feel better. If it is stopped too soon,
your condition may get worse or the bacteria may become resistant to the medicine. After a few days
treatment with the solution for infusion, your doctor may decide to switch you to the tablet form of this
medicine to complete your course of treatment.
If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.
4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. These effects are
normally mild or moderate and often disappear after a short time.
Stop having Levofloxacin and tell a doctor or nurse straight away if you notice the following side
effect:
Very rare (may affect up to 1 in 10,000 people)

You have an allergic reaction. The signs may include: a rash, swallowing or breathing problems,
swelling of your lips, face, throat or tongue.
Stop having Levofloxacin and tell a doctor or nurse straight away if you notice any of the following
serious side effects – you may need urgent medical treatment:
Rare (may affect up to 1 in 1,000 people)

Watery diarrhoea which may have blood in it, possibly with stomach cramps and a high
temperature. These could be signs of a severe bowel problem

Pain and inflammation in your tendons or ligaments which could lead to rupture. The Achilles
tendon is affected most often

Fits (convulsions)
Very rare (may affect up to 1 in 10,000 people)

Burning, tingling, pain or numbness. These may be signs of something called ‘neuropathy’
Other:

Severe skin rashes which may include blistering or peeling of the skin around your lips, eyes,
mouth, nose and genitals.

Loss of appetite, skin and eyes becoming yellow in colour, dark-coloured urine, itching, or tender
stomach (abdomen). These may be signs of liver problems which may include a fatal failure of the
liver
If your eyesight becomes impaired or if you have any other eye disturbances whilst taking Levofloxacin,
consult an eye specialist immediately.
Tell your doctor if any of the following side effects gets serious or lasts longer than a few days:
Common (may affect up to 1 in 10 people)

Sleeping problems

Headache, feeling dizzy

Feeling sick (nausea, vomiting) and diarrhoea

Increase in the level of some liver enzymes in your blood

Reactions at the site of infusion

Inflammation of a vein
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Uncommon (may affect up to 1 in 100 people)

Changes in the number of other bacteria or fungi, infection by fungi named Candida, which may
need to be treated

Changes in the number of white blood cells shown up in the results of some blood tests (leukopenia,
eosinophilia)

Feeling stressed (anxiety), feeling confused, feeling nervous, feeling sleepy, trembling, a spinning
feeling (vertigo)

Shortness of breath (dyspnoea)

Changes in the way things taste, loss of appetite, stomach upset or indigestion (dyspepsia), pain in
your stomach area, feeling bloated (flatulence) or constipation

Itching and skin rash, severe itching or hives (urticaria), sweating too much (hyperhidrosis)

Joint pain or muscle pain

Blood tests may show unusual results due to liver (bilirubin increased) or kidney (creatinine
increased) problems

General weakness
Rare (may affect up to 1 in 1,000 people)

Bruising and bleeding easily due to a lowering in the number of blood platelets (thrombocytopenia)

Low number of white blood cells (neutropenia)

Exaggerated immune response (hypersensitivity)

Lowering of your blood sugar levels (hypoglycaemia). This is important for people that have
diabetes

Seeing or hearing things that are not there (hallucinations, paranoia), change in your opinion and
thoughts (psychotic reactions) with a risk of having suicidal thoughts or actions

Feeling depressed, mental problems, feeling restless (agitation), abnormal dreams or nightmares

Tingly feeling in your hands and feet (paraesthesia)

Problems with your hearing (tinnitus) or eyesight (blurred vision)

Unusual fast beating of your heart (tachycardia) or low blood pressure (hypotension)

Muscle weakness. This is important in people with myasthenia gravis (a rare disease of the nervous
system)

Changes in the way your kidney works and occasional kidney failure which may be due to an
allergic kidney reaction called interstitial nephritis

Fever.
Other side effects include:

Lowering in red blood cells (anemia): this can make the skin pale or yellow due to damage of the
red blood cells; lowering in the number of all types of blood cells (pancytopenia)

Fever, sore throat and a general feeling of being unwell that does not go away. This may be due to a
lowering in the number of white blood cells (agranulocytosis)

Loss of circulation (anaphylactic like shock)

Increase of your blood sugar levels (hyperglycaemia) or lowering of your blood sugar levels leading
to coma (hypoglycaemic coma). This is important for people that have diabetes

Changes in the way things smell, loss of smell or taste (parosmia, anosmia, ageusia)

Problems moving and walking (dyskinesia, extrapyramidal disorders)

Temporary loss of consciousness or posture (syncope)

Temporary loss of vision

Impairment or loss of hearing

Abnormal fast heart rhythm, life-threatening irregular heart rhythm including cardiac arrest,
alteration of the heart rhythm (called ‘prolongation of QT interval’, seen on ECG, electrical activity
of the heart)

Difficulty breathing or wheezing (bronchospasm)

Allergic lung reactions
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Pancreatitis
Inflammation of the liver (hepatitis)
Increased sensitivity of your skin to sun and ultraviolet light (photosensitivity)
Inflammation of the vessels that carry blood around your body due to an allergic reaction (vasculitis)
Inflammation of the tissue inside the mouth (stomatitis)
Muscle rupture and muscle destruction (rhabdomyolysis)
Joint redness and swelling (arthritis)
Pain, including pain in the back, chest and extremities
Attacks of porphyria in people who already have porphyria (a very rare metabolic disease)
Persistent headache with or without blurred vision (benign intracranial hypertension).

If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects
not listed in this leaflet.

5.

How to store Levofloxacin solution for infusion

Keep out of the sight and reach of children.
Keep the infusion bag in the outer foil pouch until ready to use, in order to protect from light. Do not use the
product after 2 days of removing the infusion bag from the outer packaging.
Do not use this medicine after the expiry date that is stated on the outer packaging. The expiry date refers to
the last day of that month.
The solution for infusion should be used immediately.
Do not use this medicine if you notice that the solution is not clear, greenish-yellow solution and/or has
particles in it.
Do not throw away any medicines via wastewater or household waste. Ask your nurse or pharmacist how to
throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Levofloxacin 5 mg/ml solution for infusion contains:
 The active ingredient is levofloxacin (as levofloxacin hemihydrate) Each ml of infusion contains 5 mg
of Levofloxacin.
Each 50 ml bag of Solution for Infusion contains 250 mg of levofloxacin.
Each 100 ml bag of Solution for Infusion contains 500 mg of levofloxacin.
 The other ingredients are sodium chloride, hydrochloric acid and water for injections.
What Levofloxacin 5 mg/ml solution for infusion look(s) like and contents of the pack:
Levofloxacin 5 mg/ml solution for infusion is a clear greenish-yellow solution. The solution is supplied in
an infusion bag with either one or two infusion ports closed with rubber stoppers and snap caps. The bag has
an aluminium foil over-pouch with clear window. Each bag contains either 50 ml or 100 ml solution.
The 50 ml bags are available in packs of 1, 5 and 10 bags.
The 100 ml bags are available in packs of 1, 5, 10 and 20 bags.
Not all pack sizes may be marketed.

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Marketing Authorisation Holder and Manufacturer

This medicinal product is authorised in the Member States of the EEA under the following names:

This leaflet does not contain all the information about your medicine. If you have any questions or are not
sure about anything, ask your doctor or pharmacist.
This leaflet was last revised in:

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The following information is intended for healthcare professionals only:
Incompatibilities
Levofloxacin solution for infusion should not be mixed with heparin or alkaline solutions (e.g. sodium
hydrogen carbonate).
This medicinal product must not be mixed with other medicinal products except those mentioned in the
following section.
Mixture with other solutions for infusion:
Levofloxacin solution for infusion is compatible with the following solutions for infusion:
0.9% sodium chloride solution.
5% dextrose injection.
2.5% dextrose in Ringer solution.
Combination solutions for parenteral nutrition (amino acids, carbohydrates, electrolytes).
Storage information
See section 5 'How to store Levofloxacin'.
After first opening:
From a microbiological point of view, unless the method of opening precludes the risk of microbial
contamination, the product should be used immediately. If not used immediately, in-use storage times and
conditions are the responsibility of the user.
Special precautions for disposal and other handling
Levofloxacin solution for infusion should be used immediately (within 3 hours) after perforation of the
rubber stopper in order to prevent any bacterial contamination. No protection from light is necessary during
infusion. If not used immediately, in-use storage times and conditions are the responsibility of the user.
This medicinal product is for single use only.
The solution should be visually inspected prior to use. It must only be used if the solution is clear, greenishyellow solution, practically free from particles.
As for all medicines any unused medicinal product should be disposed of accordingly and in compliance
with local environmental regulations.
Posology
The following dose recommendations can be given for Levofloxacin:
Dosage in patients with normal renal function (creatinine clearance > 50 ml/min)
Indication

Daily dose regimen
(according to severity)

Total duration of treatment1
(according to severity)

Community-acquired pneumonia 500 mg once or twice daily

7-14 days

Pyelonephritis

500 mg once daily

7-10 days

Complicated urinary tract
infections

500 mg once daily

7-14 days
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Chronic bacterial prostatitis.

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500 mg once daily

28 days

Complicated skin and soft tissue 500 mg once or twice daily
infections

7-14 days

Inhalation anthrax

8 weeks

500 mg once daily

1

Treatment duration includes intravenous plus oral treatment. The time to switch from intravenous to oral
treatment depends on the clinical situation but is normally 2 to 4 days.
Special populations
Impaired renal function (creatinine clearance

50ml/min)

Dose regimen
250 mg/24 h

500 mg/24 h

500 mg/12 h

Creatinine
clearance

first dose: 250 mg

first dose: 500 mg

first dose: 500 mg

50 - 20 ml/min

then: 125 mg/24 h

then: 250 mg/24 h

then: 250 mg/12 h

19-10 ml/min

then: 125 mg/48 h

then: 125 mg/24 h

then: 125 mg/12 h

< 10 ml/min

then: 125 mg/48 h

then: 125 mg/24 h

then: 125 mg/24 h

(including
haemodialysis and
CAPD) 1
1

No additional doses are required after haemodialysis or continuous ambulatory peritoneal dialysis (CAPD).

Impaired liver function
No adjustment of dose is required since levofloxacin is not metabolised to any relevant extent by the liver
and is mainly excreted by the kidneys.
Elderly Population
No adjustment of dose is required in the elderly, other than that imposed by consideration of renal function
(See section 2 ‘What you need to know before you are given Levofloxacin solution for infusion’).
Paediatric Population
Levofloxacin is contraindicated in children or growing adolescents.
Method of administration
Levofloxacin solution for infusion is only intended for slow intravenous infusion; it is administered once or
twice daily. The infusion time must be at least 30 minutes for 250 mg or 60 minutes for 500 mg
Levofloxacin solution for infusion.

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THIS IS A REPRESENTATION OF AN ELECTRONIC RECORD THAT WAS SIGNED ELECTRONICALLY AND THIS
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE

Teva Pharmaceuticals Europe B.V
1.3.1 Levofloxacin Solution for Infusion 5mgml-pil-common-clean

APPROVALS
Signed by
Preetham Fernandes

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Meaning of Signature
Regulatory Affairs Approval

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Server Date
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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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