Rinoloxin solution for infusion 500 mg/100 ml PVC container 100 ml

Instructions Rinoloxin solution for infusion 500 mg/100 ml PVC container 100 ml

Composition

active ingredient: levofloxacin;

100 ml of solution contains levofloxacin hemihydrate equivalent to levofloxacin 500 mg; excipients: sodium chloride, disodium edetate, diluted hydrochloric acid, sodium hydroxide, water for injections.

Dosage form

Solution for infusion.

Main physicochemical properties: transparent solution from yellow to greenish-yellow color.

Pharmacotherapeutic group

Antibacterial agents of the quinolone group. Fluoroquinolones. ATX code J01M A12.

Pharmacological properties

Pharmacodynamics.

Levofloxacin is a synthetic antibacterial agent from the fluoroquinolone group, the S-enantiomer of the racemic mixture of ofloxacin.

Mechanism of action. As an antibacterial drug from the fluoroquinolone group, levofloxacin acts on the DNA-DNA gyrase complex and topoisomerase IV.

Pharmacokinetics/pharmacodynamics relationship. The degree of bactericidal activity of levofloxacin depends on the ratio of the maximum serum concentration (Cmax) or area under the pharmacokinetic curve (AUC) to the minimum inhibitory concentration (MIC).

Mechanism of resistance. The main mechanism of resistance is due to mutations in the gyr-A genes. In vitro, there is cross-resistance between levofloxacin and other fluoroquinolones. Due to the mechanism of action, there is usually no cross-resistance between levofloxacin and other classes of antibacterial agents.

Breakpoints. The European Committee on Antimicrobial Susceptibility Testing (EUCAST) recommended MIC breakpoints for levofloxacin that distinguish susceptible from intermediately susceptible (moderately resistant) organisms and intermediately susceptible from resistant organisms are listed in Table 1 for MIC testing (mg/L).

Clinical MIC breakpoints for levofloxacin.

Table 1

1 Only uncomplicated urinary tract infections.

2 Susceptibility can be determined based on ciprofloxacin susceptibility.

The prevalence of resistance may vary geographically and over time for individual species. It is advisable to obtain local information on resistance, particularly when treating severe infections. As necessary, specialist advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.

Usually sensitive species.

Aerobic Gram-positive bacteria:

Bacillus anthracis

Staphylococcus aureus methicillin-sensitive

Staphylococcus saprophyticus

Streptococci, group C and G

Streptococcus agalactiae

Streptococcus pneumoniae

Streptococcus pyogenes

Aerobic Gram-negative bacteria:

Eikenella corrodens

Haemophilus influenzae

Haemophilus parainfluenzae

Klebsiella oxytoca

Moraxella catarrhalis

Pasteurella multocida

Proteus vulgaris

Providencia rettgeri

Anaerobic bacteria:

Peptostreptococcus

Others:

Chlamydophila pneumoniae

Chlamydophila psittaci

Chlamydia trachomatis

Legionella pneumophila

Mycoplasma pneumoniae

Mycoplasma hominis

Ureaplasma urealyticum

Species that may acquire resistance

Aerobic Gram-positive bacteria:

Enterococcus faecalis

Staphylococcus aureus methicillin-resistant*

Coagulase-negative Staphylococcus spp

Aerobic Gram-negative bacteria:

Acinetobacter baumannii

Citrobacter freundii

Enterobacter aerogenes

Enterobacter cloacae

Escherichia coli

Klebsiella pneumoniae

Morganella morganii

Proteus mirabilis

Providencia stuartii

Pseudomonas aeruginosa

Serratia marcescens

Anaerobic bacteria:

Bacteroides fragilis

Naturally resistant strains

Aerobic Gram-positive bacteria:

Enterococcus faecium

*Methicillin-resistant S. aureus is likely to also be resistant to fluoroquinolones, including levofloxacin.

Pharmacokinetics.

Steady state is achieved within 48 hours with a dosage regimen of 500 mg once or twice daily.

Biotransformation. Levofloxacin is metabolized to a very small extent, the metabolites being desmethyl-levofloxacin and levofloxacin N-oxide. These metabolites account for less than 5% of the drug excreted in the urine. Levofloxacin is stereochemically stable and does not undergo inversion of the choral structure.

Elimination: After oral and intravenous administration, levofloxacin is eliminated from the blood plasma relatively slowly (half-life is 6–8 hours), usually excreted by the kidneys (more than 85% of the administered dose).

The mean apparent total clearance of levofloxacin after a single 500 mg dose was 175 ± 29.2 mL/min. There is no significant difference in the pharmacokinetics of levofloxacin after intravenous and oral administration, indicating that these routes (oral and intravenous) are interchangeable.

Linearity. Levofloxacin exhibits linear pharmacokinetics over the dose range of 50–1000 mg. Patients with renal impairment. The pharmacokinetics of levofloxacin are affected by renal impairment. Renal excretion and clearance are reduced with decreased renal function, and half-lives are prolonged, as shown in Table 2.

Table 2

Elderly patients: There are no significant differences in the pharmacokinetics of levofloxacin between young and elderly patients, except for differences related to creatinine clearance.

Gender differences: A separate analysis of male and female patients demonstrated slight gender differences in the pharmacokinetics of levofloxacin. There is no evidence that these gender differences are clinically relevant.

Indication

Rinoloxin, solution for infusion, is indicated for the treatment of the following infectious diseases in adults:

— community-acquired pneumonia*;

— acute pyelonephritis and complicated urinary tract infections;

— complicated skin and soft tissue infections*;

— chronic bacterial prostatitis;

— pulmonary form of anthrax: post-exposure prophylaxis and radical treatment.

*For the above infectious diseases, levofloxacin should be prescribed only in cases of insufficient effectiveness of other antibacterial drugs, which are mainly used for the initial treatment of these infections.

Official recommendations on the appropriate use of antibacterial agents should be considered.

Contraindication

Hypersensitivity to levofloxacin, other fluoroquinolones or to any component of the drug. Epilepsy. Adverse reactions from the tendons after previous use of quinolones. Pregnancy or breastfeeding. Children's age (up to 18 years).

Interaction with other medicinal products and other types of interactions

Effects of other drugs on levofloxacin.

Theophylline, fenbufen, or similar nonsteroidal anti-inflammatory drugs (NSAIDs).

No pharmacokinetic interaction of levofloxacin with theophylline has been observed. However, a significant decrease in the seizure threshold may occur when quinolones are administered concomitantly with theophylline and nonsteroidal anti-inflammatory drugs and other agents that lower the seizure threshold. Levofloxacin concentrations in the presence of fenbufen were approximately 13% higher than when levofloxacin was administered alone.

Probenecid and cimetidine.

Probenecid and cimetidine have a statistically significant effect on the elimination of levofloxacin. The renal clearance of levofloxacin is reduced by 24% in the presence of cimetidine and by 34% in the presence of probenecid. This is because both drugs are capable of blocking the tubular secretion of levofloxacin. However, at the doses tested in the study, it is unlikely that the statistically significant kinetic differences are of clinical relevance. Caution should be exercised when levofloxacin is co-administered with drugs that affect tubular secretion, such as probenecid and cimetidine, especially in patients with renal impairment.

Other information.

The following drugs have no clinically significant effect on the pharmacokinetics of levofloxacin when used concomitantly: calcium carbonate, digoxin, glibenclamide, ranitidine.

The effect of levofloxacin on other drugs.

Cyclosporine.

The half-life of cyclosporine increases by 33% when co-administered with levofloxacin.

Vitamin K antagonists.

When used concomitantly with vitamin K antagonists (e.g. warfarin), increases in coagulation tests (prothrombin time/international normalized ratio) and/or bleeding, which may be severe, have been reported. Therefore, coagulation parameters should be monitored in patients receiving concomitant vitamin K antagonists (see section 4.4).

Drugs that prolong the QT interval.

Levofloxacin, like other fluoroquinolones, should be used with caution in patients receiving medicinal products known to prolong the QT interval (e.g. class IA and III antiarrhythmics, tricyclic antidepressants, macrolides and antipsychotics) (see section "Special warnings and precautions for use. QT interval prolongation").

Levofloxacin does not affect the pharmacokinetics of theophylline, which is predominantly metabolized by CYP1A2, therefore it can be assumed that levofloxacin is not a CYP1A2 inhibitor.

Glucocorticoids.

Concomitant use with glucocorticoids increases the risk of tendon rupture.

Other.

No clinically significant effect on the pharmacokinetics of levofloxacin was observed when it was used together with the following drugs: calcium carbonate, digoxin, glibenclamide, ranitidine. The use of levofloxacin simultaneously with alcohol is not recommended.

Application features

The drug should be avoided in patients who have had serious adverse reactions to quinolones or fluoroquinolones in the past (see section 4.8). Levofloxacin should only be initiated in these patients if no alternative treatment options are available and after a careful benefit/risk assessment (see also section 4.8).

Prolonged, disabling and potentially irreversible serious adverse reactions.

In very rare cases, patients treated with quinolones and fluoroquinolones, regardless of age or risk factors, have experienced prolonged (months or years), disabling and potentially irreversible serious adverse reactions affecting various body systems, and sometimes several systems at once (musculoskeletal, nervous, mental and sensory). The drug should be discontinued immediately at the first signs or symptoms of any serious adverse reaction and a doctor should be consulted. Methicillin-resistant S. Aureus.

Methicillin-resistant S. Aureus (MRSA) has a very high probability of being co-resistant to fluoroquinolones, including levofloxacin. Therefore, levofloxacin is not recommended for the treatment of infections known or suspected to be caused by MRSA, unless laboratory tests have confirmed that the pathogen is susceptible to levofloxacin.

Fluoroquinolone resistance in E. coli (the most common cause of urinary tract infections) varies between countries. The local prevalence of E. coli resistance to fluoroquinolones should be taken into account when prescribing fluoroquinolones.

Infusion duration.

The recommended infusion duration should be at least 30 minutes for 250 mg or 60 minutes for 500 mg of levofloxacin solution for infusion. Tachycardia and a transient decrease in blood pressure are known to occur during ofloxacin infusion. Rarely, a severe decrease in blood pressure may result in cardiovascular failure. If a marked decrease in blood pressure occurs during the infusion of levofloxacin (the L-isomer of ofloxacin), the drug should be discontinued immediately.

Tendinitis and tendon rupture.

Tendinitis and tendon rupture (particularly of the Achilles tendon), sometimes bilateral, may occur within the first 48 hours of starting treatment with quinolones or fluoroquinolones, and have also been reported several months after discontinuation of the drug. The risk of tendonitis and tendon rupture is increased in elderly patients, patients with impaired renal function, patients who have undergone solid organ transplantation, patients receiving daily doses of 1000 mg levofloxacin, and patients receiving concomitant corticosteroid therapy. Therefore, concomitant use of corticosteroids should be avoided. At the first signs of tendinitis (e.g. painful swelling, inflammation), levofloxacin should be discontinued immediately and alternative treatment options should be considered. Affected limbs should be treated appropriately (e.g. immobilization). Corticosteroids are not recommended if there are signs of tendinopathy.

Diseases caused by Clostridium difficile.

Diarrhoea, particularly severe, persistent and/or bloody, occurring during or after treatment with levofloxacin (including within a few weeks of treatment), may be a symptom of Clostridium difficile-associated disease. The most severe form of this disease is pseudomembranous colitis (see section 4.8). The severity of Clostridium difficile-associated disease ranges from mild to life-threatening, with pseudomembranous colitis being the most severe form (see section 4.8). It is therefore important to consider this diagnosis in patients who develop severe diarrhoea during or after treatment with levofloxacin. If Clostridium difficile-associated disease is suspected, levofloxacin should be discontinued immediately and appropriate treatment should be initiated as soon as possible. Medicinal products that inhibit intestinal motility are contraindicated in this case.

Patients with a tendency to seizures.

Patients with glucose-6-phosphate dehydrogenase deficiency.

Patients with latent or overt glucose-6-phosphate dehydrogenase deficiency may be predisposed to hemolytic reactions when treated with quinolone antibiotics. Therefore, if levofloxacin is used, these patients should be monitored for possible hemolysis.

Patients with renal failure.

Since levofloxacin is excreted mainly by the kidneys, dose adjustment is required for patients with impaired renal function (renal failure) (see section "Method of administration and dosage").

Hypersensitivity reactions.

Levofloxacin can cause serious, potentially fatal hypersensitivity reactions (e.g. angioedema to anaphylactic shock), in some cases after the first dose of the drug. If hypersensitivity reactions occur, levofloxacin should be discontinued, a doctor should be consulted and appropriate treatment should be initiated.

Severe skin reactions.

Severe cutaneous adverse reactions, including toxic epidermal necrolysis (also known as Lyell's syndrome), Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), which can be life-threatening or fatal, have been reported with levofloxacin (see section 4.8).

Patients should be warned about the signs and symptoms of serious skin reactions that may occur after use of the medicinal product and should be monitored closely. If signs and symptoms suggestive of these reactions appear, levofloxacin should be discontinued immediately and alternative treatment should be considered.

If a patient develops a serious reaction such as toxic epidermal necrolysis, Stevens-Johnson syndrome or DRESS syndrome while taking levofloxacin, levofloxacin treatment should never be resumed in that patient.

Change in blood glucose levels.

With the use of all quinolones, cases of changes in blood glucose levels have been reported, including cases of both hypoglycemia and hyperglycemia, usually in patients with diabetes mellitus receiving concomitant therapy with an oral hypoglycemic agent (e.g. glibenclamide) or insulin. Cases of hypoglycemic coma have been reported. In patients with diabetes mellitus, careful monitoring of blood glucose levels is recommended (see section "Adverse reactions").

Prevention of photosensitization.

Photosensitivity has been reported with levofloxacin (see section 4.8). To prevent photosensitivity, it is recommended that patients avoid unnecessary exposure to strong sunlight or artificial UV sources (e.g. UV lamps, tanning beds) during treatment and for 48 hours after stopping levofloxacin.

Patients receiving vitamin K antagonists.

Due to the possible increase in blood coagulation parameters (prothrombin time/international normalized ratio) and/or an increase in the frequency of hemorrhagic complications in patients receiving levofloxacin in combination with a vitamin K antagonist (e.g. warfarin), blood coagulation parameters should be monitored during concomitant use of these agents (see section "Interaction with other medicinal products and other forms of interaction"). Psychotic reactions.

Psychotic reactions have been reported in patients taking quinolones, including levofloxacin. Very rarely, these have progressed to suicidal ideation and self-harm, sometimes after only a single dose of levofloxacin (see section 4.8). If a patient develops these reactions, levofloxacin should be discontinued and appropriate measures should be taken. Levofloxacin should be used with caution in patients with psychotic disorders or a history of psychiatric illness. QT prolongation.

Fluoroquinolones, including levofloxacin, should be used with caution in patients with risk factors for QT prolongation, such as:

- congenital or acquired long QT syndrome;

- simultaneous use of drugs that have the ability to prolong the QT interval (such as class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotic drugs);

- electrolyte imbalance (e.g. hypokalemia, hypomagnesemia);

Aortic aneurysm and dissection and valvular regurgitation/insufficiency. Epidemiological studies have shown an increased risk of aortic aneurysm and dissection, particularly in the elderly, and of aortic and mitral valve regurgitation following the use of fluoroquinolones. Cases of aortic aneurysm and dissection, sometimes complicated by rupture (including fatal cases), and regurgitation/insufficiency of any of the valvular heart valves have been reported in patients treated with fluoroquinolones (see section 4.8). Therefore, fluoroquinolones should only be used after a careful benefit-risk assessment and after consideration of other therapeutic options in patients with a family history of aneurysm or congenital valvular heart disease, in patients with a known diagnosis of aortic aneurysm and/or dissection, or with valvular heart disease, or in the presence of other risk factors, such as:

· risk factors for both aortic aneurysm and dissection and heart valve regurgitation/insufficiency: connective tissue disorders such as Marfan syndrome or Ehlers-Danlos syndrome, Turner syndrome, Behçet's disease, hypertension, rheumatoid arthritis;

· risk factors for aortic aneurysm and dissection: vascular disorders such as Takayasu arteritis or giant cell arteritis, or atherosclerosis, or Sjögren's syndrome;

· risk factors for regurgitation/heart valve insufficiency: infective endocarditis.

The risk of aortic aneurysm and dissection and rupture is increased in patients receiving concomitant systemic corticosteroids.

Patients should seek immediate medical attention in the emergency department if they experience sudden abdominal, chest, or back pain.

Patients should be advised to seek immediate medical attention if they experience acute shortness of breath, new onset palpitations, or develop abdominal or lower extremity edema. Peripheral neuropathy.

Cases of sensory or sensorimotor polyneuropathy resulting in paresthesia, hypoesthesia, dysesthesia or weakness have been reported in patients treated with quinolones and fluoroquinolones. If symptoms of neuropathy such as pain, burning, tingling, numbness or weakness occur, patients taking the drug should inform their doctor to prevent the development of a potentially irreversible condition (see section "Adverse reactions").

Hepatobiliary disorders.

Cases of hepatic necrosis up to and including fatal hepatic failure have been reported with levofloxacin, predominantly in patients with severe underlying diseases such as sepsis (see section 4.8). Patients should be advised to discontinue treatment and seek medical advice if signs and symptoms of liver disease such as anorexia, jaundice, dark urine, pruritus or abdominal pain occur.

Exacerbation of myasthenia gravis.

Fluoroquinolones, including levofloxacin, have neuromuscular blocking effects and may exacerbate muscle weakness in patients with myasthenia gravis. In the post-marketing period, serious adverse reactions, including fatalities and conditions requiring respiratory support, have been associated with the use of fluoroquinolones in patients with myasthenia gravis. Levofloxacin is not recommended for use in patients with a history of myasthenia gravis. Visual impairment.

If any visual disturbances or adverse reactions from the visual organs occur while taking levofloxacin, you should immediately consult an ophthalmologist (see sections “Adverse reactions” and “Ability to affect the speed of reactions when driving vehicles or using other mechanisms”).

Superinfection.

The use of levofloxacin, especially long-term, may lead to overgrowth of microorganisms insensitive (resistant) to the drug. If superinfection develops during therapy, appropriate measures should be taken.

Acute pancreatitis.

Acute pancreatitis may occur in patients taking levofloxacin. Patients should be informed of the characteristic symptoms of acute pancreatitis. Patients who experience nausea, malaise, abdominal discomfort, acute abdominal pain or vomiting should seek immediate medical attention. If acute pancreatitis is suspected, levofloxacin should be discontinued and if confirmed, levofloxacin should not be restarted. Caution should be exercised when used in patients with a history of pancreatitis.

Impact on laboratory test results.

In patients treated with levofloxacin, the determination of opiates in urine may give a false-positive result. It may be necessary to confirm positive results for opiates obtained in a screening test using more specific methods. Levofloxacin may inhibit the growth of Mycobacterium tuberculosis and therefore lead to false-negative results in the bacteriological diagnosis of tuberculosis. Important information about excipients.

The medicine contains sodium - caution should be exercised when used in patients on a sodium-restricted diet.

Use during pregnancy or breastfeeding

Pregnancy. There are limited data on the use of levofloxacin in pregnant women. Animal studies do not indicate direct or indirect reproductive toxicity. However, in the absence of human data and in the presence of experimental data indicating a risk of cartilage damage in the developing fetus due to fluoroquinolones, the drug is contraindicated in pregnancy (see section "Contraindications").

Breastfeeding. Levofloxacin is contraindicated in women who are breastfeeding. There is insufficient information on the excretion of levofloxacin in breast milk. However, other fluoroquinolones are excreted in human milk. In the absence of data on the use of levofloxacin in humans and in the presence of experimental data indicating a risk of damage to cartilage in the growing organism due to the action of fluoroquinolones, levofloxacin is contraindicated in women who are breastfeeding (see section "Contraindications").

Fertility: Levofloxacin does not impair fertility or reproductive function in animals.

Ability to influence reaction speed when driving vehicles or other mechanisms

Some adverse reactions (e.g. dizziness/vertigo, drowsiness, visual disturbances) may impair the patient's ability to concentrate and react, and thus pose an increased risk in situations where these qualities are of particular importance (e.g. when driving or operating machinery).

Method of administration and doses

Levofloxacin solution should be administered by slow intravenous infusion 1–2 times daily. The dose depends on the type and severity of the infection and the sensitivity of the pathogen. Usually, after a few days of treatment, if the patient's condition permits, it is possible to transfer him from the initial intravenous administration to oral administration (levofloxacin tablets 250 mg or 500 mg). The duration of treatment depends on the course of the disease.

The recommended dosage of levofloxacin is listed below.

Table 3

Dosage for patients with normal renal function (creatinine clearance > 50 mL/min)

* Depending on the patient's clinical condition, a switch from initial intravenous to oral administration at the same dosage may be possible after a few days (usually 2–4 days).

Table 4

Dosage for adult patients with renal impairment with creatinine clearance < 50 mL/min

1 No additional doses are required after hemodialysis or chronic ambulatory peritoneal dialysis (CHAPD).

Dosage for patients with impaired liver function.

No dose adjustment is required, as levofloxacin is metabolized to a minor extent in the liver and excreted mainly by the kidneys.

Dosage for elderly patients.

If renal function is not impaired, there is no need for dose adjustment (see section "Special instructions": "Tendinitis and tendon rupture", "QT interval prolongation"). Levofloxacin is administered intravenously slowly by drip infusion. The duration of administration should be at least 30 minutes for a dose of 250 mg or at least 60 minutes for a dose of 500 mg. Depending on the patient's condition, a switch from intravenous administration to oral administration of levofloxacin at the same dosage may be possible after a few days.

The duration of treatment depends on the course of the disease. As with other antibacterial agents, it is recommended to continue treatment with the drug for at least 48–72 hours after normalization of body temperature or confirmed destruction of pathogens by microbiological tests.

Method of application.

The medicinal product should be used immediately (within 3 hours) after perforation of the rubber stopper to prevent bacterial contamination. No protection from light is required during infusion. The medicinal product is for single use only. The solution should be inspected before use. Only clear solutions free from particles should be used.

Mixing with other infusion solutions.

0.9% sodium chloride solution, 5% glucose solution for injection, 2.5% glucose in Ringer's solution, multicomponent solutions for parenteral nutrition (amino acids, carbohydrates, electrolytes). See also section "Incompatibilities".

Any unused medicinal product should be disposed of in accordance with local requirements.

Children.

The drug is contraindicated for use in children (under 18 years of age), as damage to articular cartilage cannot be ruled out.

Overdose

Symptoms: The most important expected symptoms of levofloxacin overdose are related to the central nervous system: confusion, dizziness, impaired consciousness and seizures, tremor, prolongation of the QT interval. Central nervous system (CNS) effects, including confusion, seizures, hallucinations and tremor, have been observed in the post-marketing period with levofloxacin.

Treatment: Symptomatic and supportive. ECG monitoring should be considered as QT prolongation may occur. Levofloxacin is not removed by haemodialysis, peritoneal dialysis or continuous ambulatory peritoneal dialysis (CAPD); there is no specific antidote.

Adverse reactions

Adverse reactions are listed below by system organ class and frequency: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1000, < 1/100), rare (≥ 1/10000, < 1/1000), frequency unknown (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Table 5

Organ systems	Often	Infrequently	Rarely	Frequency unknown
Infections and infestations	-	Fungal infections, including infections caused by fungi of the genus Candida. Resistance of pathogenic microorganisms	-	-
From the circulatory and lymphatic systems	-	Leukopenia. Eosinophilia	Thrombocytopenia. Neutropenia.	Pancytopenia. Agranulocytosis. Hemolytic anemia
On the part of the immune system	-	-	Angioedema. Hypersensitivity (see section "Special warnings and precautions for use")	Anaphylactic shock 1. Anaphylactoid shock 1
Gastrointestinal and metabolic disorders	-	Anorexia	Hypoglycemia, especially in patients with diabetes	Hyperglycemia. Hypoglycemic coma
From the psyche*	Insomnia	Anxiety. Confusion. Nervousness.	Psychotic reactions (including hallucinations, paranoia). Depression. Agitation. Nightmares. Abnormal dreams. Delirium	Psychotic disorders with behavior threatening to the patient, including suicidal thoughts or suicide attempts (see section "Special warnings and precautions for use")
Nervous system*	Headache. Dizziness.	Drowsiness. Tremor. Dysgeusia.	Convulsions; paresthesia	Peripheral sensory neuropathy (see section "Special warnings and precautions for use"). Peripheral sensorimotor neuropathy (see section "Special warnings and precautions for use"). Parosmia, including anosmia. Dyskinesia. Extrapyramidal disorders. Ageusia. Syncope. Benign intracranial hypertension
From the side of the organs of vision*	-	-	Visual disturbances such as blurred vision (see section "Special warnings and precautions for use")	Transient vision loss, uveitis (see section "Special warnings and precautions for use")
From the side of the organs of hearing and vestibular apparatus*	-	Vertigo	Tinnitus	Hearing loss. Hearing impairment
Cardiac system**	-	-	Tachycardia. Feeling of heart palpitations	Ventricular tachycardia, which may lead to cardiac arrest. Ventricular arrhythmia and torsades de pointes (predominantly in patients with risk factors for QT prolongation), QT prolongation Specifications Characteristics Active ingredient Levofloxacin Adults Can Country of manufacture Ukraine Diabetics Can Dosage 5 mg/ml Drivers With caution For allergies With caution For children It is impossible. Form Infusions Method of application Injections Nursing It is impossible. Pregnant It is impossible. Producer Pharmatrade DP Quantity per package 100 ml Trade name Rinoloxin Vacation conditions By prescription Reviews There are no reviews for this product. + Add review Write a review Rinoloxin solution for infusion 500 mg/100 ml PVC container 100 ml My mark: Continue There are no reviews for this product, be the first to leave your review. Answers & questions Add your question and we will answer as soon as possible. + Ask a question Ask a question Add your question and we will answer as soon as possible. * Your question Continue No questions about this product, be the first and ask your question. You are watched new Hit Peony tincture bottle 110 ml In stock 0 62.22 грн. Add to Cart 407.45 грн. Add to Cart