Levofloxacin 5mg/Ml Solution For Infusion
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Product + Component: |
Levofloxacina Hikma (bags) |
|
Identifier: | |
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Country: |
United Kingdom / Ireland |
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Dimensions: |
210 x 594 mm |
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Scale: |
1:1 |
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Circular for Corrections: |
07 |
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Date: |
17.07.2015 |
|
Colours: |
Black |
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Front/Reverse: |
Front |
|
Fonts: |
Frutiger |
79 mm
52,5 mm
1 mm9 mm 1 mm
|
Laetus |
Laetus | |
|
Barcode |
Barcode |
PACKAGE LEAFLET: INFORMATION FOR THE USER
Levofloxacin 5 mg/ml solution for infusion
Levofloxacin
/HIKMk
CT3
—1 QQ
594 mm
ln m
Read all of this leaflet carefully before you start taking 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.
- This medicine has been prescribed for you only. 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 gets serious, 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 given for
2. What you need to know before you take 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 became pregnant or think you may be pregnant
- You are breast-feeding
Do not take this medicine if any of the above applies to you. If you are not
sure, talk to your doctor, nurse or pharmacist before taking 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 corticosteroids, sometimes called steroids (see Other medicines and Levofloxacin solution for infusion)
- 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 solution for infusion).
- 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 taking Levofloxacin .
Other medicines and Levofloxacin solution for infusion
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Levofloxacin solution for infusion can affect the way some other medicines work. Also some medicines can affect the way Levofloxacin solution for infusion 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 solution for infusion:
• Corticosteroids, sometimes called steroids - used for inflammation. You may be more likely to have inflammation and/or breakage 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 and 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 erythromucin, 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 painkillers called 'opiates' in people taking Levofloxacin. If your doctor is due to take a urine test, tell them you are taking 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
Levofloxacin contains 8.1 mmol of sodium in 50 ml. This information should be taken into consideration in patients in a salt controlled diet.
Levofloxacin contains 16.2 mmol of sodium in 100 ml. This information should be taken into consideration by patients on a controlled diet.
3. 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 solution for infusion or have any questions about how much Levofloxacin solution for infusion 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 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 taking 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
x-------------------------------------------------------------------------------------------------------
The following information is intended for medical or healthcare professionals only:
Levofloxacin 5 mg/ml solution for infusion
Levofloxacin
Therapeutic indications
Levofloxacin solution for infusion is indicated in adults for the treatment of the following infections (see sections 4.4 and 5.1)
• Community-acquired pneumonia.
• Complicated skin and soft tissue infections.
For the above-mentioned infections Levofloxacin solution for infusion should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of these infections.
• Pyelonephritis and complicated urinary tract infections (see section 4.4)
• Chronic bacterial prostatitis
• Inhalation Anthrax: post-exposure prophylaxis and curative treatment (see section 4.4).
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Posology and method of administration
Levofloxacin solution for infusion is administered by slow intravenous infusion once or twice daily. The dosage depends on the type and severity of the infection and the susceptibility of the presumed causative pathogen. Treatment with Levofloxacin after initial use of the intravenous preparation may be completed with an appropriate oral presentation according to the SPC for the film-coated tablets and as considered appropriate for the individual patient. Given the bioequivalence of the parenteral and oral forms, the same dosage can be used.
Posology
The following dose recommendations can be given for Levofloxacin solution for infusion: Dosage in patients with normal renal function (creatinine clearance> 50 ml/min)
|
Indication |
Daily dose regimen (according to severity) |
Total duration of treatment (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 |
|
Chronic bacterial prostatitis. |
500mg once daily |
28 days |
|
Complicated skin and soft tissue infections |
500 mg once or twice daily |
7 - 14 days |
|
Inhalation anthrax |
500mg once daily |
8 weeks |
|
Product + Component: |
Levofloxacina Hikma (bags) |
|
Identifier: | |
|
Country: |
United Kingdom / Ireland |
|
Dimensions: |
210 x 594 mm |
|
Scale: |
1:1 |
|
Circular for Corrections: |
07 |
|
Date: |
17.07.2015 |
|
Colours: |
Black |
|
Front/Reverse: |
Reverse |
|
Fonts: |
Frutiger |
11 mm
594 mm
Levofloxacin Hikma 5 mg/ml I nfusionslosung Levofloxacin Hikma 5 mg/ml I nfusionslosung Levofloxacin 5 mg/ml solution for infusion Levofloxacina Hikma 5 mg/ml Soluzione per infusion Levofloxacin Hikma 5 mg/ml, oplossing voor infusie Levofloxacina Hikma 5 mg/ml Solupao para infusao Levofloxacin 5 mg/ml solution for infusion
last approved in 03/2015
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 to take 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 think you might have missed a dose inform your doctor or nurse.
If you stop having Levofloxacin solution for infusion
Your doctor or nurse will continue giving you Levofloxacin even you are feeling better. If the treatment 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 product, ask your doctor, nurse or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Levofloxacin can cause side effects, although not everybody gets them. These affects are normally mild to moderate and often disappear after a short time.
Stop having Levofloxacin solution for infusion and tell a doctor or nurse straight away if you notice the following side effects:
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 solution for infusion 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 solution for infusion, 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 the vein
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 1000 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
• 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 reach and sight of children.
Keep the bag in the outer package in order to protect from light.
Store below 25°C.
Do not use Levofloxacin after the expiry date, which is stated on the outer package and bag after EXP. The expiry date refers to the last day of the month.
Do not use Levofloxacin if the solution is not clear, if the solution is not green to yellow and/or if it is not free from particles.
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 protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Levofloxacin Solution for infusion contains
- The active substance is levofloxacin.
- Each ml of solution for infusion contains 5 mg of levofloxacin (as hemihydrate)
- The other ingredients are: sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment) and water for injections.
What Levofloxacin Solution for infusion looks like and contents of the pack Plastic bags:
Polypropylene bag containing 50 ml of solution for infusion with a twist-off -port:
Packs: 1 bag of 50 ml
Polypropylene bag containing 100 ml of solution for infusion with a twist-off -port:
Packs: 1 bag of 100 ml
Marketing Authorisation Holder and Manufacturer
Hikma Farmaceutica (Portugal), S.A.
Estrada do Rio da Mo, n° 8, 8A - 8B Fervenpa
2705 - 906 Terrugem SNT Portugal
Tel: +351 21 960 84 10 Fax: +351 21 961 51 02 e-mail: geral@hikma.pt
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria:
Germany:
Ireland:
Italy:
Netherlands:
Portugal:
United Kingdom:
This leaflet was
PIN400-HUK/1
X
Special populations
Impaired renal function (creatinine clearance <50 ml/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/mi (including haemodialysis and CAPD) 1 |
then: 125 mg/48 h |
then: 125 mg/24 h |
then: 125 mg/24 h |
xNo additional doses are required after haemodialysis or continuous ambulatory peritoneal dialysis (CAPD).
Impaired liver function
No adjustment of dosage 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 dosage is required in the elderly, other than that imposed by consideration of renal function (See section 4.4 “Tendinitis and tendon rupture" and QT interval prolongation).
Paediatric population
Levofloxacin is contraindicated in children and growing adolescents (see section 4.3).
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 (see section 4.4).
List of excipients
Sodium chloride
Sodium hydroxide (for pH adjustment)
Hydrochloric acid (for pH adjustment)
Water for injections.
Incompatibilities
Levofloxacin should not be mixed with heparin or alkaline solutions (e.g. sodium hydrogen carbonate).
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Special precautions for storage
Keep the bag in the outer package in order to protect from light.
Store below 25°C Inspect visually prior to use.
Only clear solutions without particles should be used.
|
Product + Component: |
Levofloxacina Hikma (vials) |
|
Identifier: | |
|
Country: |
United Kingdom / Ireland |
|
Dimensions: |
210 x 594 mm |
|
Scale: |
1:1 |
|
Circular for Corrections: |
06 |
|
Date: |
17.07.2015 |
|
Colours: |
Black |
|
Front/Reverse: |
Front |
|
Fonts: |
Frutiger |
79 mm
52,5 mm
1 mm9 mm 1 mm
H-H
E T E
CT) 1
E
Laetus Laetus
Barcode Barcode
PACKAGE LEAFLET: INFORMATION FOR THE USER
Levofloxacin 5 mg/ml solution for infusion
Levofloxacin
CD
594 mm
LT)
m
Read all of this leaflet carefully before you start taking 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.
- This medicine has been prescribed for you only. 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 gets serious, 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 given for
2. What you need to know before you take 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 section6)
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 became pregnant or think you may be pregnant
- You are breast-feeding
Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor, nurse or pharmacist before taking Levofloxacin.
CO 0
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 corticosteroids, sometimes called steroids (see “Other medicines and Levofloxacin solution for infusion" )
- 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 solution for infusion).
- You are diabetic
- You have ever had liver problems
- You have myasthenia gravis
If you are not sure, talk to your doctor, nurse or pharmacist before taking Levofloxacin.
Other medicines and Levofloxacin solution for infusion
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Levofloxacin solution for infusion can affect the way some other medicines work. Also some medicines can affect the way Levofloxacin solution for infusion 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 solution for infusion:
• Corticosteroids, sometimes called steroids - used for inflammation. You may be more likely to have inflammation and/or breakage 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 and 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 painkillers called 'opiates' in people taking Levofloxacin. If your doctor is due to take a urine test, tell them you are taking 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
Levofloxacin contains 16.2 mmol of sodium in 100 ml. This information should be taken into consideration by patients on a controlled diet.
3. 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 solution for infusion or have any questions about how much Levofloxacin solution for infusion 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 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 taking 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
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The following information is intended for medical or healthcare professionals only:
Levofloxacin 5mg/ml solution for infusion
Levofloxacin
Therapeutic indications
Levofloxacin solution for infusion is indicated in adults for the treatment of the following infections (see sections 4.4 and 5.1)
• Community-acquired pneumonia.
• Complicated skin and soft tissue infections.
For the above-mentioned infections Levofloxacin solution for infusion should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of these infections.
• Pyelonephritis and complicated urinary tract infections (see section 4.4)
• Chronic bacterial prostatitis
• Inhalation Anthrax: post-exposure prophylaxis and curative treatment (see section 4.4).
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Posology and method of administration
Levofloxacin solution for infusion is administered by slow intravenous infusion once or twice daily. The dosage depends on the type and severity of the infection and the susceptibility of the presumed causative pathogen. Treatment with Levofloxacin after initial use of the intravenous preparation may be completed with an appropriate oral presentation according to the SPC for the film-coated tablets and as considered appropriate for the individual patient. Given the bioequivalence of the parenteral and oral forms, the same dosage can be used.
Posology
The following dose recommendations can be given for Levofloxacin solution for infusion:
Dosage in patients with normal renal function (creatinine clearance> 50 ml/min)
|
Indication |
Daily dose regimen (accordina to severity) |
Total duration of treatment (accordina 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 |
|
Chronic bacterial prostatitis. |
500mg once daily |
28 days |
|
Complicated skin and soft tissue infections |
500 mg once or twice daily |
7 - 14 days |
|
Inhalation anthrax |
500mg once daily |
8 weeks |
|
Product + Component: |
Levofloxacina Hikma (vials) |
|
Identifier: | |
|
Country: |
United Kingdom / Ireland |
|
Dimensions: |
210 x 594 mm |
|
Scale: |
1:1 |
|
Circular for Corrections: |
06 |
|
Date: |
17.07.2015 |
|
Colours: |
Black |
|
Front/Reverse: |
Reverse |
|
Fonts: |
Frutiger |
11 mm
594 mm
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 to take 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 think you might have missed a dose inform your doctor or nurse.
If you stop having Levofloxacin solution for infusion
Your doctor or nurse will continue giving you Levofloxacin even you are feeling better. If the treatment 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 product, ask your doctor, nurseor pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Levofloxacin can cause side effects, although not everybody gets them. These affects are normally mild to moderate and often disappear after a short time.
Stop having Levofloxacin solution for infusion and tell a doctor or nurse straight away if you notice the following side effects:
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 solution for infusion 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 solution for infusion, 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 the vein
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 1000 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
• 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 reach and sight of children.
Keep the vials in the outer package in order to protect from light.
Store below 25°C
Once the infusion vial has been opened (rubber stopper perforated) the solution should be used immediately (within 3 hours) in order to prevent any bacterial contamination.
Do not use Levofloxacin after the expiry date, which is stated on the outer package and vial after EXP. The expiry date refers to the last day of the month.
Do not use Levofloxacin if the solution is not clear, if the solution is not green to yellow and/or if it is not free from particles.
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 protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Levofloxacin Solution for infusion contains
- The active substance is levofloxacin.
- Each ml of solution for infusion contains 5 mg of levofloxacin (as hemihydrate)
- The other ingredients are: sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment) and water for injections.
What Levofloxacin Solution for infusion looks like and contents of the pack Glass vials:
Type I, clear glass, fitted with an Ommiflex rubber stopper and aluminium flip-off caps.
Packs: 1 or 5 vials
Marketing Authorisation Holder and Manufacturer
Hikma Farmaceutica (Portugal), S.A.
Estrada do Rio da Mo, n° 8, 8A - 8B Fervenpa
2705 - 906 Terrugem SNT Portugal
Tel: +351 21 960 84 10 Fax: +351 21 961 51 02 e-mail: geral@hikma.pt
This medicinal product is authorised in the Member States of the EEA under the following names
Austria: Levofloxacin Hikma 5 mg/ml I nfusionslosung
Germany: Levofloxacin Hikma 5 mg/ml I nfusionslosung
Ireland: Levofloxacin 5 mg/ml solution for infusion
Italy: Levofloxacina Hikma 5 mg/ml Soluzione per infusion
Netherlands: Levofloxacin Hikma 5 mg/ml oplossing voor infusie
Portugal: Levofloxacina Hikma 5 mg/ml Solupao para infusao
United Kingdom: Levofloxacin 5 mg/ml solution for infusion
This leaflet was last approved in 03/2015
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Special populations
Impaired renal function (creatinine clearance <50 ml/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/mi (including haemodialysis and CAPD) 1 |
then: 125 mg/48 h |
then: 125 mg/24 h |
then: 125 mg/24 h |
LNo additional doses are required after haemodialysis or continuous ambulatory peritoneal dialysis (CAPD).
Impaired liver function
No adjustment of dosage 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 dosage is required in the elderly, other than that imposed by consideration of renal function (See section 4.4 “Tendinitis and tendon rupture" and QT interval prolongation).
Paediatric population
Levofloxacin is contraindicated in children and growing adolescents (see section 4.3).
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 (see section 4.4).
List of excipients
Sodium chloride
Sodium hydroxide (for pH adjustment)
Hydrochloric acid (for pH adjustment)
Water for injections.
Incompatibilities
Levofloxacin should not be mixed with heparin or alkaline solutions (e.g. sodium hydrogen carbonate).
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Special precautions for storage
Keep the vials in the outer package in order to protect from light.
Store below 25°C.
Inspect visually prior to use.
Only clear solutions without particles should be used.