Prospect: information for the user
Levofloxacino Aurovitas 5 mg/ml solution for infusion EFG
Read this prospect carefully before starting to use this medicine, because it contains important information for you.
-Keep this prospect, as you may need to read it again.
-If you have any doubts, consult your pharmacist or nurse.
-If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.
1.What is Levofloxacino Aurovitas solution for infusion and what it is used for
2.What you need to know before starting to use Levofloxacino Aurovitas solution for infusion
3.How to use Levofloxacino Aurovitas solution for infusion
4.Possible adverse effects
5.Storage of Levofloxacino Aurovitas solution for infusion
6.Contents of the package and additional information
The name of this medication isLevofloxacino Aurovitassolution for perfusion.Levofloxacino Aurovitassolution for perfusion contains an active ingredient called levofloxacino, which belongs to a group of medications known as antibiotics. Levofloxacino is a type of antibiotic called a quinolone and works by eliminating the bacteria that cause infections in your body.
Antibiotics are used to treat bacterial infections and do not work for viral infections such as the flu or a cold.
It is essential that you follow the instructions regarding the dose, administration interval, and treatment duration indicated by your doctor.
Do not store or reuse this medication. If you have any leftover antibiotic after treatment, return it to the pharmacy for proper disposal. Do not dispose of medications through the drain or in the trash.
Levofloxacino solution for perfusion can be used to treat infections in:
•the lungs, in patients with pneumonia.
•the urinary tract, including the kidneys or bladder.
•the prostate, when the infection is persistent.
•the skin and under the skin, including muscles. This is sometimes referred to as "soft tissues."
In some special situations,levofloxacinosolution for perfusion may be used to reduce the likelihood of acquiring a lung infection called anthrax or a worsening of the disease after exposure to the anthrax-causing bacteria.
Do not use Levofloxacino Aurovitas solution for infusion
•If you are allergic to levofloxacino, to other antibiotics of the quinolone type such as moxifloxacino, ciprofloxacino, or ofloxacino, or to any of the other components of this medication (listed in section 6).
•The signs of an allergic reaction include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
•If you have ever had epilepsy.
•If you have ever had problems with your tendons, such as tendinitis, that were related to taking medications of the quinolone type. The tendon is the tissue that connects your muscle to your skeleton.
•If you are a child or adolescent in a growth period.
•If you are pregnant, may become pregnant, or think you may be pregnant.
•If you are breastfeeding.
Do not use this medication if any of the above cases apply to you. If in doubt, consult your doctor, nurse, or pharmacist before using levofloxacino solution for infusion.
Warnings and precautions
Consult your doctor, pharmacist, or nurse before using Levofloxacino Aurovitas solution for infusion if:
•You have ever developed a severe skin rash or peeling of the skin, blisters, and/or mouth sores after taking levofloxacino.
•You are 60 years of age or older.
•You are taking corticosteroids, sometimes called steroids (see section “Other medications and Levofloxacino Aurovitas solution for infusion”).
•You have received a transplant.
•You have ever had a seizure (convulsion).
•You have had brain damage due to a stroke or other brain injury.
•You have kidney problems.
•You have what is known as “glucose-6-phosphate dehydrogenase deficiency”, as you may be prone to having serious blood problems when taking this medication.
•You have ever had mental problems.
•You have ever had heart problems: you should be cautious when using this type of medication, if you were born with, or have a family history of, prolonged QT interval (seen on an electrocardiogram (ECG), a graphical representation of the heart's electrical activity), have an imbalance of salts in your blood (especially low levels of potassium or magnesium in your blood), have a slow heart rate (called “bradycardia”), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), if you are a woman or an older person, or are taking other medications that may cause abnormal changes in the ECG (see section “Other medications and Levofloxacino Aurovitas solution for infusion”).
•You are diabetic.
•You have ever had liver problems.
•You have myasthenia gravis.
•You have peripheral neuropathy (nerve damage).
•You have been diagnosed with an aneurysm of a large blood vessel (aortic aneurysm or aneurysm of a large peripheral vessel).
•You have had a previous episode of aortic dissection (tear in the wall of the aorta).
•You have been diagnosed with heart valve insufficiency (regurgitation of heart valves).
•You have a family history of aortic aneurysm or aortic dissection, congenital heart valve disease, or other risk factors or predisposing conditions (e.g., connective tissue disorders such as Marfan syndrome or Ehlers-Danlos syndrome, Turner syndrome, or Sjögren's syndrome (an autoimmune inflammatory disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension, or atherosclerosis, or rheumatoid arthritis (a joint disease) or endocarditis (a heart infection)).
Quinolone antibiotics can cause an increase in your blood sugar levels above normal levels (hyperglycemia), or a decrease in your blood sugar levels below normal levels, which in severe cases can cause a loss of consciousness (hypoglycemic coma) (see section 4). This is important for people with diabetes. If you have diabetes, your blood sugar levels should be carefully controlled.
Severe skin reactions
Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with the use of levofloxacino.
-SJS/TEN may initially appear on the trunk as red, ring-shaped spots or circular patches often with blisters in the center. They may also appear as ulcers in the mouth, throat, nose, genitals, and eyes (red, swollen eyes). These severe skin eruptions often come before fever and/or flu-like symptoms. The eruptions may progress to widespread peeling of the skin and potentially life-threatening or fatal complications.
-DRESS initially presents with flu-like symptoms and a rash on the face, followed by a more widespread rash with elevated body temperature, elevated liver enzymes observed in blood tests, and an increase in a type of white blood cell (eosinophilia) and swollen lymph nodes.
If you develop a severe skin eruption or any of these skin symptoms, stop using levofloxacino and contact your doctor or seek immediate medical attention.
Before starting to use this medication
You should not take fluoroquinolone or quinolone antibiotics, including levofloxacino, if you have had a severe reaction to a quinolone or fluoroquinolone in the past. If this is the case, you should inform your doctor as soon as possible.
Consult your doctor, nurse, or pharmacist during treatment with your medication:
•If you experience severe, sudden pain in the abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm, go to an emergency department immediately. You may be at increased risk if you are receiving systemic corticosteroid treatment.
•If you start experiencing sudden onset of shortness of breath, especially when lying down, or if you notice swelling in your ankles, feet, or abdomen, or if you experience palpitations (sensation of rapid or irregular heartbeat), you should inform your doctor immediately.
•If you experience nausea, general discomfort, have intense or persistent pain, or worsening pain in the stomach area or vomit - consult a doctor immediately, as this could be a sign of acute pancreatitis.
Consult an ophthalmologist immediately if you experience any vision changes orhaveany eye problems.
During treatment with this medication
In rare cases, you may experience pain and swelling in your joints and inflammation or tendon rupture. The risk is higher if you are an older person (over 60 years), have received an organ transplant, have kidney problems, or are taking corticosteroids. Tendon inflammation and rupture can occur within the first 48 hours of treatment and even several months after stopping levofloxacino treatment. At the first sign of tendon pain or inflammation (e.g., in your ankle, wrist, elbow, shoulder, or knee), stop taking levofloxacino, contact your doctor, and keep the affected area at rest. Avoid any unnecessary exercise, as this may increase the risk of tendon rupture.
In rare cases, you may experience symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness, and/or weakness, especially in your feet and legs or hands and arms. If this happens, stop taking levofloxacino and inform your doctor immediately to prevent the development of a potentially irreversible condition.
Severe, long-lasting, and potentially irreversible adverse effects
Fluoroquinolone or quinolone antibiotics, including levofloxacino, have been associated with rare but severe adverse effects, some of which have been long-lasting (persistent for months or years), incapacitating, or potentially irreversible. This includes tendon pain, muscle pain, and joint pain in the upper and lower extremities, difficulty walking, abnormal sensations such as pins and needles, numbness, tingling, or burning (paresthesia), sensory disorders such as decreased vision, taste, smell, and hearing, depression, decreased memory, intense fatigue, and severe sleep disorders.
If you experience any of these adverse effects after taking levofloxacino, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue or discontinue treatment, considering also the use of an antibiotic from a different class.
If you are unsure whether any of the above cases apply to you, inform your doctor, nurse, or pharmacist before they administer this medication.
Other medications and Levofloxacino Aurovitas solution for infusion
Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This is because levofloxacino may affect the way some medications work, and some medications may have an effect on levofloxacino.
Particularly, inform your doctor if you are taking any of the following medications, as it increases the likelihood of experiencing adverse effects when taking them with levofloxacino solution for infusion:
•Corticosteroids, sometimes called steroids - used for inflammation. You may be more likely to experience inflammation and/or tendon rupture.
•Warfarin - used to make your blood thinner. You may be more likely to experience bleeding. Your doctor may need to perform regular blood tests to check if your blood clots properly.
•Theophylline - used for respiratory problems. You may be more likely to experience a seizure (convulsion) if you take it with levofloxacino.
•Nonsteroidal anti-inflammatory drugs (NSAIDs) - used for pain and inflammation such as aspirin, ibuprofen, phenbufen, ketoprofen, and indomethacin. You may be more likely to experience a seizure (convulsion) if you take them with levofloxacino.
•Ciclosporin - used after organ transplants. You may be more likely to experience the adverse effects of ciclosporin.
•Medications with known effects on your heart rhythm. This includes medications 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). Your doctor may need to give you a lower dose if you have kidney problems.
•Cimetidine (used for ulcers and heartburn). Your doctor may need to give you a lower dose if you have kidney problems.
Inform your doctor if any of the above cases apply to you.
Determination of opiates in urine
Urine tests may show “false positive” results for the presence of strong painkillers called “opioids” in patients taking levofloxacino. Inform your doctor that you are taking levofloxacino if they have prescribed a urine test.
Tuberculosis test
This medication may cause a “false negative” result in some laboratory tests used to search for the bacteria that causes tuberculosis.
Pregnancy and breastfeeding
Do not use this medication if:
-you are pregnant, may become pregnant, or think you may be pregnant.
-you are breastfeeding or plan to be.
Driving and operating machinery
You may experience some adverse effects, including dizziness, drowsiness, balance disturbances (vertigo), or visual disturbances. Some of these adverse effects may affect your ability to concentrate or decrease your reaction time. If this happens, do not drive or perform any work that requires a high level of attention.
Levofloxacino Aurovitas solution for infusion contains sodium
Patients with low-sodium diets should note that this medication contains 177 mg (7.7 mmol) of sodium per 50 ml dose and 354 mg (15.4 mmol) of sodium per 100 ml dose.
How to use Levofloxacino Aurovitas solution for infusion
•Levofloxacino solution for infusion is a medication for hospital use.
•It will be administered by a doctor or nurse through an injection. The injection will be administered in one of your veins and for a period of time (this is called intravenous infusion).
•For 250 mg of levofloxacino solution for infusion, the infusion time will be 30 minutes or more.
•For 500 mg of levofloxacino solution for infusion, the infusion time will be 60 minutes or more.
•Your heart rate and blood pressure will be monitored frequently. This is because an abnormal rapid heartbeat and a temporary decrease in blood pressure are possible side effects that have been seen during the infusion of a similar antibiotic. If your blood pressure drops significantly while you are receiving the infusion, it will be stopped immediately.
How much Levofloxacino Aurovitas solution for infusion is administered
If you are unsure why you are being administered levofloxacino or have any questions about how much levofloxacino you are being administered, consult your doctor, nurse, or pharmacist.
•Your doctor will decide how much levofloxacino you should be administered.
•The dose will depend on the type of infection you have and where it is located in your body.
•The duration of treatment will depend on the severity of your infection.
Adults and elderly patients
•Pneumonia: 500 mg once or twice a day.
•Urinary tract infection, including kidneys or bladder: 500 mg once a day.
•Prostate infection: 500 mg once a day.
•Skin and subcutaneous tissue infection, including muscles: 500 mg once or twice a day.
Adults and elderly patients with kidney problems
Your doctor may administer a lower dose.
Children and adolescents
This medication should not be administered to children or adolescents.
Protect your skin from the sun
Do not expose your skin directly to the sun (even on cloudy days) while you are receiving this medication and for two days after stopping it, as your skin will become much more sensitive to the sun and may burn, itch, or even blister if you do not take the following precautions:
•Make sure to use high-protection sunscreens.
•Always wear a hat and clothing that covers your arms and legs.
•Avoid ultraviolet A (UVA) lamps.
If you use more Levofloxacino Aurovitas solution for infusion than you should
It is unlikely that your doctor or nurse will administer more medication than you need. Your doctor and nurse will monitor your progress and control the medication that has been administered to you. Always ask if you are unsure why you are receiving this medication.
If you are administered more levofloxacino than you need, the following side effects may appear: seizures (convulsions), confusion, dizziness, decreased consciousness, tremors, heart rhythm disturbances that may cause irregular heartbeats, as well as discomfort (nausea).
If you forget to use Levofloxacino Aurovitas solution for infusion
Your doctor or nurse will have instructions on when to give you this medication. It is unlikely that you will not receive the medication as prescribed. However, if you think you have forgotten a dose, inform your doctor or nurse.
If you interrupt the treatment with Levofloxacino Aurovitas solution for infusion
Your doctor or nurse will continue to administer levofloxacino to you, even if you feel better. If treatment is interrupted too soon, the infection may recur, you may worsen, or the bacteria may become resistant to the medication. After a few days of treatment with the solution for infusion, your doctor may decide to switch you to the tablet form of this medication to complete the treatment.
If you have any other questions about the use of this medication, ask your doctor, nurse, or pharmacist.
Like all medicines, this medicine can cause side effects, although not everyone will experience them. Usually, they are mild to moderate and tend to disappear over time.
Stop taking levofloxacin and contact a doctor or nurse immediately if you notice any of the following side effects:
Very rare(may affect up to 1 in 10,000 people)
•If you have an allergic reaction. Symptoms may include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
Stop taking levofloxacin and contact a doctor or nurse immediately if you notice any of the following serious side effects, as you may need urgent medical treatment:
Rare(may affect up to 1 in 1,000 people)
•Generalized rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and other organs of the body involved (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See also section 2.
•Syndrome associated with alterations in water elimination and low sodium levels (SIADH).
•Watery diarrhea that may contain blood, possibly with stomach cramps and fever. These may be signs of a serious intestinal problem.
•Pain and inflammation in tendons or ligaments, which may lead to rupture. The Achilles tendon is most commonly affected.
•Seizures (convulsions).
•Seeing or hearing things that are not real (hallucinations, paranoia).
•Depression, mental disorders, feeling restless (agitation), abnormal dreams or nightmares.
•Low blood sugar levels (hypoglycemia) or low blood sugar levels that may lead to coma (hypoglycemic coma). This is particularly important for diabetic patients.
Very rare(may affect up to 1 in 10,000 people)
•Burning, tingling, pain, or numbness. These may be signs of what is called "neuropathy".
Frequency not known(cannot be estimated from available data)
•Severe skin eruptions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the trunk as red macules in the shape of a target or circular patches often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers, and may be preceded by symptoms similar to the flu. See also section 2.
•Loss of appetite, yellow skin and eyes, dark urine, itching or stomach pain. These may be signs of liver problems that may include fulminant liver failure.
•Changes in opinion and thought (psychotic reactions) with a risk of having suicidal thoughts or actions.
•Nausea, general discomfort, stomach discomfort, or vomiting. These may be signs of acute pancreatitis. See section 2.
Consult a specialist eye doctor immediately if your vision worsens or you experience any other eye problems while taking levofloxacin.
The administration of antibiotics containing quinolones and fluoroquinolones has been associated with very rare cases of long-lasting or permanent adverse reactions (even months or years) or permanent reactions, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pinpricks, numbness, tingling, burning, or pain (neuropathy), depression, fatigue, sleep disorders, memory loss, and hearing, vision, taste, and smell loss, in some cases regardless of the presence of pre-existing risk factors.
Cases of increased size and weakening or tearing of the aortic wall (aneurysms and dissections) that could lead to rupture and be fatal, and heart valve insufficiency in patients who have received fluoroquinolones have been reported. See also section 2.
Inform your doctor if any of the following side effects worsen or last more than a few days:
Common(may affect up to 1 in 10 people)
•Sleep problems.
•Headache, dizziness.
•Discomfort (nausea, vomiting) and diarrhea.
•Increased levels of certain liver enzymes in the blood.
•Reactions at the infusion site.
•Vein inflammation.
Uncommon(may affect up to 1 in 100 people)
•Changes in the number of other bacteria or fungi, fungal infection by Candida, which may require treatment.
•Changes in the number of white blood cells in blood test results (leucopenia, eosinophilia).
•Stress (anxiety), confusion, nervousness, drowsiness, tremors, feeling of dizziness (vertigo).
•Difficulty breathing (dyspnea).
•Changes in taste, loss of appetite, stomach disorders or indigestion (dyspepsia), stomach pain, feeling bloated (flatulence) or constipation.
•Itching and rash on the skin, intense itching or hives (urticaria), excessive sweating (hyperhidrosis).
•Joint pain or muscle pain.
•Abnormal values in blood test results due to liver problems (elevated bilirubin) or kidney problems (elevated creatinine).
•Generalized weakness.
Rare(may affect up to 1 in 1,000 people)
•Appearance of bruises and bleeding easily due to a decrease in the number of platelets in the blood (thrombocytopenia).
•Decrease in the number of white blood cells in the blood (neutropenia).
•Exaggerated immune response (hypersensitivity).
•Sensation of tingling in hands and feet (paresthesias).
•Ear or vision disorders (tinnitus, blurred vision).
•Abnormally fast heart rate (tachycardia) or low blood pressure (hypotension).
•Muscle weakness. This is particularly important in people with myasthenia gravis (rare nervous system disease).
•Changes in kidney function and, sometimes, kidney insufficiency, which may be a consequence of an allergic reaction in the kidneys called interstitial nephritis.
•Fever.
•Clearly defined red patches with or without blisters, which develop a few hours after levofloxacino administration and heal with residual post-inflammatory hyperpigmentation; usually, they repeat in the same skin or mucous membrane site after subsequent exposure to levofloxacino.
•Memory loss.
Frequency not known(cannot be estimated from available data)
•Decrease in red blood cells in the blood (anemia): this may cause the skin to become pale or yellowish due to damage to red blood cells; decrease in the number of all types of blood cells (pancytopenia).
•Fever, sore throat, and persistent general discomfort. This may be due to a decrease in the number of white blood cells (agranulocytosis).
•Circulatory collapse (anaphylactic shock).
•Increased blood sugar levels (hyperglycemia). This is particularly important in diabetic patients.
•Changes in sense of smell, loss of sense of smell or taste (parosmia, anosmia, ageusia).
•Movement and gait disorders (dyskinesia, extrapyramidal disorders).
•Temporary loss of consciousness or posture (syncope).
•Temporary loss of vision, eye inflammation.
•Ear problems or hearing loss.
•Abnormally fast heart rate, irregular heart rhythm with life-threatening risk including heart stoppage, alteration of heart rhythm (denominated "prolongation of the QT interval", observed in the ECG, graphical representation of heart electrical activity).
•Difficulty breathing or wheezing (bronchospasm).
•Respiratory allergic reactions.
•Pancreatitis (inflammation of the pancreas).
•Heptatitis (inflammation of the liver).
•Increased skin sensitivity to the sun and ultraviolet light (photosensitivity).
•Vasculitis (inflammation of blood vessels due to an allergic reaction).
•Stomatitis (inflammation of the mucous membrane inside the mouth).
•Muscle rupture and muscle destruction (rhabdomyolysis).
•Red and swollen joints (arthritis).
•Pain, including back, chest, and limb pain.
•Porphyria crisis in patients with porphyria (rare metabolic disease).
•Persistent headache with or without blurred vision (benign intracranial hypertension).
•Loss of consciousness due to severe decrease in blood sugar levels (hypoglycemic coma). See section 2.
Reporting of adverse reactions
If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date that appears on the box and the vial after CAD. The expiration date is the last day of the month indicated.
Keep the vial in the outer packaging to protect it from light. During infusion, no protection from light is required.
Once the vial for infusion (piercing of the rubber stopper) has been opened, the solution must be used immediately (within 3 hours) to prevent microbiological contamination.
Do not use this medication if you observe that the solution is not transparent, has a yellowish green color, and/or has particles.
Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.
Composition of Levofloxacino Aurovitas infusion solution
-The active ingredient is levofloxacino. Each ml of infusion solution contains 5 mg of levofloxacino (as hemihydrate).
Cada vial of 50 ml of infusion solution contains 250 mg of levofloxacino (as hemihydrate).
Cada vial of 100 ml of infusion solution contains 500 mg of levofloxacino (as hemihydrate).
-The other components are: sodium chloride, sodium hydroxide, hydrochloric acid, and water for injection preparations.
Appearance of the product and contents of the package
Levofloxacino Aurovitas infusion solution is a transparent yellowish-green solution, without particles, with a pH of 4.2 to 5.5.
50 ml glass type I transparent vial with a grey bromobutyl rubber stopper and an aluminium cap with a polypropylene disc. Each vial contains 50 ml of solution.
100 ml glass type I transparent vial with a grey bromobutyl rubber stopper and an aluminium cap with a polypropylene disc. Each vial contains 100 ml of solution.
Packaging sizes:
50 ml: 1, 5 and 10 vials.
100 ml: 1, 5, 10 and 20 vials.
Only some packaging sizes may be commercially available.
Marketing authorization holder and manufacturer responsible
Marketing authorization holder
Eugia Pharma (Malta) Limited
Vault 14, Level 2, Valletta Waterfront
Floriana, FRN 1914
Malta
Manufacturer responsible
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
For more information about this medicine, please contact the local representative of the marketing authorization holder:
Aurovitas Spain, S.A.U.
Avda. de Burgos, 16-D
28036 Madrid
Spain
This medicine is authorized in the member states of the European Economic Area with the following names:
Bélgica: | Levofloxacin Eugia 5 mg/ml oplossing voor infusie/solution pour perfusion/infusionslösung |
España: | Levofloxacino Aurovitas 5 mg/ml solución para perfusión EFG |
Italia: | Levofloxacina Aurobindo Italia |
Portugal: | Levofloxacina Aurovitas |
Last review date of this leaflet: December 2023
For detailed information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).
This information is intended solely for healthcare professionals:
This product should be used immediately (within 3 hours) after piercing the rubber stopper to prevent microbiological contamination. Keep the vial in the outer packaging to protect it from light. During infusion, no protection from light is required.
The solution should be visually inspected before use. Only use if the solution is transparent, yellowish-green in color, and free of particles.
Administration
Levofloxacino Aurovitas infusion solution is only indicated for intravenous slow infusion; it is administered once or twice a day. The infusion time should be at least 30 minutes for 250 mg of levofloxacino infusion solution or 60 minutes for 500 mg of levofloxacino infusion solution. During the infusion time, the patient should be monitored for any signs of severe tachycardia (rapid heartbeat) and transient hypotension. In rare cases, circulatory problems may occur due to severe hypotension.
Mixing with other infusion solutions
Levofloxacino Aurovitas 5 mg/ml infusion solution is physically compatible and chemically stable at controlled room temperature (15-25°C) for up to 8 hours when mixed with the following infusion solutions within the concentration range of 0.5 mg/ml to 2 mg/ml.
•Sodium chloride 0.9% solution.
•Glucose injection 5%.
•Glucose 2.5% in Ringer's solution.
•Nutrient parenteral solutions (amino acids, glucose, electrolytes).
Incompatibilities
This product should not be mixed with:
•Heparin.
•Alkaline solutions (e.g., sodium bicarbonate).
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