Moxifloxacin-Teva solution for infusion 400mg/250ml, 250 ml — Made in Czech Republic — Free Delivery

(Moxifloxacin-Teva )
Moxifloxacin-Teva solution for infusion 400mg/250ml, 250 ml — Made in Czech Republic — Free Delivery
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Description Moxifloxacin-Teva solution for infusion 400mg/250ml, 250 ml — Made in Czech Republic — Free Delivery

Pharmacological properties

Mechanism of action

Moxifloxacin inhibits type II bacterial topoisomerases (DNA gyrase and topoisomerase IV), which are required for replication, transcription and repair of bacterial DNA.

Pharmacokinetics / pharmacodynamics

The ability of fluoroquinolones to kill bacteria is directly related to their concentration. Pharmacodynamic studies of fluoroquinolones in animal models of infectious and inflammatory diseases and in humans indicate that the main determining factor of efficacy is the ratio between the area under the pharmacokinetic curve (AUC 24) and the MIC (MIC).

Mechanism of resistance

Resistance to fluoroquinolones can result from mutations in DNA gyrase and topoisomerase IV. Other mechanisms include overexpression of reflux pumps, impermeability, and protein-mediated protection of DNA gyrase. Cross-resistance is possible between moxifloxacin and other fluoroquinolones.

The mechanisms of resistance characteristic of other classes of antibacterial agents do not affect the antibacterial efficacy of moxifloxacin.

Indications

Community-acquired pneumonia.

Complicated infectious diseases of the skin and subcutaneous tissues.

Moxifloxacin should be prescribed only when other antibacterial preparationsthat are usually recommended for the initial treatment of these infections are impractical.

Attention should be paid to the official instructions for the proper use of antibacterial agents.

Structure

active substance: moxifloxacin;

1 bottle (250 ml) contains 400 mg of moxifloxacin in the form of anhydrous moxifloxacin hydrochloride;

excipients: propylene glycol, water for injection.

Contraindications

Hypersensitivity to moxifloxacin, other quinolone antibiotics or any of the excipients.

Children's age (up to 18 years old).

The period of pregnancy and lactation (see section "Application during pregnancy or lactation").

A history of tendon disease associated with the use of quinolones.

In the course of preclinical and clinical studies after the use of moxifloxacin, changes in the electrophysiology of the heart were found in the form of a prolongation of the QT interval. Therefore, moxifloxacin is contraindicated in patients with the following conditions:

  • congenital or acquired lengthening of the QT interval;
  • electrolyte imbalance, especially uncorrected hypo
  • kalemia
  • clinically significant bradycardia
  • clinically significant heart failure with a decrease in left ventricular ejection fraction;
  • a history of symptomatic arrhythmia.

Moxifloxacin should not be used concurrently with preparations that prolong the QT interval (see also the section "Interaction with other medicinal products and other forms of interaction").

Due to insufficient clinical experience of using the preparation, it is contraindicated in patients with impaired liver function (class C on the Child-Pugh scale) and an increase in the level of transaminases by five times or more.

Special security measures

One bottle of the preparation is intended solely for single use. Unused solution must be disposed of.

It was found that such solutions are compatible with moxifloxacin, solution for infusion 400 mg water for injection, sodium chloride solution 0.9%; 1 molar sodium chloride solution; glucose solution 5%, 10%, 40%; xylitol solution 20%; Ringer's solution; complex solutions of sodium lactate (Hartmann's solution, Ringer's lactate solution).

Moxifloxacin infusion solution should not be given with other preparations.

Do not use the preparation in the presence of visible solid impurities or if the solution is cloudy.

When stored in a cool place, a precipitate may form, which dissolves at room temperature. Therefore, it is not recommended to store the infusion solution at temperatures below 15 ° C.

Interaction with other medicinal products and other forms of interaction

Interaction with other medicinal products

The additive effect of moxifloxacin and other preparations that can cause prolongation of the QTc interval cannot be ruled out. This interaction can lead to an increased risk of developing ventricular arrhythmias, including "pirouette" of ventricular tachycardia (torsade de pointes). For this reason, the use of moxifloxacin in combination with any of the following preparations is contraindicated (see also section "Contraindications"):

  • antiarrhythmic preparations of the AI ​​class (eg quinidine, hydroquinidine, disopyramide)
  • class III antiarrhythmics (eg amiodarone, sotalol, dofetilide, ibutilide)
  • antipsychotic preparations (eg phenothiazines, pimozide, sertindole, haloperidol, sultopride)
  • tricyclic antidepressants;
  • some antimicrobials (saquinavir, sparfloxacin, IV erythromycin, pentamidine, antimalarial preparations such as halofantrine)
  • some antihistamines (terfenadine, astemizole, mizolastine)
  • others (cisapride, intravenous vincamine, bepridil, diphemanil).

Moxifloxacin should be used with caution in patients taking preparations that may lower potassium levels (eg, loop and thiazide diuretics, enemas and laxatives (in high doses), corticosteroids, amphotericin B), or preparations that are associated with clinically significant bradycardia.

After administration of the preparation, the use of activated carbon only slightly reduces systemic exposure.

After repeated use of moxifloxacin in healthy volunteers, an increase in C m ax of digoxin by about 30% was observed without affecting the AUC (area under the concentration-time curve) or trough concentrations. Therefore, there is no need for measures while taking digoxin.

It was reported that in diabetic patients, the simultaneous use of oral moxifloxacin and glibenclamide led to a decrease in the maximum concentration of glibenclamide by about 21%. The combination of glibenclamide with moxifloxacin can theoretically lead to minor short-term hyperglycemia. However, the observed changes in pharmacokinetics did not lead to changes in pharmacodynamic parameters (blood glucose, insulin levels). Thus, no clinically relevant interaction was found between moxifloxacin and glibenclamide.

Change in the value of the international normalized ratio (INR)

A large number of cases of increased activity of oral anticoagulants have been reported in patients treated with antimicrobial agents, especially fluoroquinolones, macrolides, tetracyclines, trimoxazole and some cephalosporins. Risk factors are infectious diseases and inflammation, age and general condition of the patient. In this regard, it is difficult to establish what exactly caused changes in INR: infection or treatment. As a precaution, the INR may be checked more frequently. If necessary, you should make an appropriate dose adjustment of the anticoagulant intake.

In clinical studies, the following substances have shown no clinically significant interaction with moxifloxacin: ranitidine, probenecid, oral contraceptives, calcium supplements, parenteral morphine, theophylline, cyclosporine or itraconazole.

In vitro studies using human cytochrome P450 enzymes have confirmed these results. Thus, metabolic interaction via cytochrome P450 enzymes is unlikely.

Food interactions

Moxifloxacin has no clinically significant interactions with food, including dairy products.

Application features

It is necessary to avoid the use of moxifloxacin in patients who in the past have had serious adverse reactions when using quinolones or fluoroquinolones (see section "Adverse Reactions"). Treatment of these patients with moxifloxacin should only be initiated in the absence of alternative treatment options and after a careful assessment of the benefit / risk ratio (see also section "Contraindications").

The benefits of moxifloxacin treatment, especially in the case of mild infections, need to be weighed against the information in this section.

Prolonged, disabling, and potentially irreversible serious adverse preparation reactions

In patients receiving quinolones and fluoroquinolones, regardless of their age and presence of risk factors, there were very rare cases of prolonged (within months or years), disabling and potentially irreversible serious adverse preparation reactions affecting various, sometimes multiple body systems ( musculoskeletal, nervous systems, psyche, sense organs). Moxifloxacin should be discontinued immediately after the first signs or symptoms of any serious adverse reaction appear, and patients should be advised to seek medical attention.

Prolongation of the QT interval with and clinical conditions in which it is possible to prolong the QT interval with

It was found that moxifloxacin in some patients leads to an extension of the QTc interval on the electrocardiogram. The degree of prolongation of the QT interval may increase with an increase in the concentration of the preparation  in the blood plasma during rapid intravenous infusion. Therefore, you should follow the recommendations for the duration of the infusion, which should be at least 60 minutes, but not exceed an intravenous dose of 400 mg once a day. For more details, see the sections "Contraindications" and "Interaction with other medicinal products and other types of interactions."

Moxifloxacin therapy is discontinued when symptoms appear during treatment that may be associated with cardiac arrhythmias, regardless of whether this is confirmed by ECG results.

Moxifloxacin should be used with caution in patients with conditions that contribute to the development of arrhythmias (for example, acute myocardial ischemia), since such patients have an increased risk of ventricular arrhythmias (including polymorphic ventricular tachycardia of the "pirouette" type) and cardiac arrest (see also sections "Contraindications" and “Interaction with other medicinal products and other forms of interaction”). It is necessary to use moxifloxacin with caution in patients who are using preparations that can reduce potassium levels (see also sections "Contraindications" and "Interaction with other preparations and other types of interactions").

Caution should be exercised when prescribing moxifloxacin in patients receiving medications associated with clinically significant bradycardia (see also section "Contraindications").

In women and elderly patients, there may be a greater sensitivity to the action of preparations that prolong the QT interval with, such as moxifloxacin, therefore, such patients require special attention.

Aneurysm and aortic dissection

Epidemiological studies indicate an increased risk of aneurysm and aortic dissection following fluoroquinolones, especially in old age.

Therefore, fluoroquinolones should be used only after careful assessment of the benefit-risk ratio and after considering other possible treatment options in patients with a family history of aneurysm, or in patients already diagnosed with aneurysm and / or aortic dissection, or in the presence of other risk factors or conditions contributing to development of aneurysm and / or aortic dissection (for example, Marfan syndrome, Ehlers-Danlos vascular syndrome, Takayasu arteritis, giant cell arteritis, Behcet's disease, arterial hypertension, atherosclerosis diagnosed).

In the event of sudden abdominal, chest, or back pain, patients should seek immediate medical attention at the emergency room.

Hypersensitivity / allergic reactions

Cases of hypersensitivity and allergic reactions have been reported after the first use of fluoroquinolones, including moxifloxacin. Anaphylactic reactions can take the form of life-threatening shock even after the first use of the preparation. In such cases, it is necessary to discontinue the use of moxifloxacin and initiate appropriate treatment (for example, shock therapy).

Severe liver dysfunction

When using moxifloxacin, cases of fulminant hepatitis have been reported, which can lead to the development of liver failure, incl. with a lethal outcome (see the section "Adverse reactions"). If symptoms of fulminant hepatitis, such as asthenia, develop rapidly and are accompanied by jaundice, dark urine, bleeding tendencies, or hepatic encephalopathy, patients are advised to consult a doctor before starting treatment.

If signs of liver dysfunction appear, a liver function test should be performed.

Severe bullous skin reactions

When using moxifloxacin, cases of bullous skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis have been reported (see section "Adverse Reactions"). In the event of reactions on the skin and / or mucous membranes, patients are advised to consult a doctor immediately before continuing treatment.

Patients prone to developing seizures

Quinolones are known to cause seizures. They should be used with caution in patients who have disorders of the central nervous system or other risk factors that can provoke the onset of seizures or lower the seizure threshold. If seizures occur, it is necessary to stop using moxifloxacin and take appropriate measures.

Peripheral neuropathy

Cases of sensory or sensorimotor polyneuropathy have been reported in patients treated with quinolones and fluoroquinolones, including moxifloxacin, resulting in paresthesia, hypesthesia, dysesthesia, or weakness. Patients taking moxifloxacin are advised to inform their doctor if they develop symptoms of neuropathy, such as pain, burning, tingling, numbness or weakness, before continuing treatment (see Adverse Reactions section).

From the psyche

Mental reactions can occur even after the first use of fluoroquinolones, including moxifloxacin. In rare cases, depression or mental reactions progressed to the development of suicidal thoughts and such manifestations of self-aggression as attempted suicide (see section "Adverse reactions"). If a patient develops such reactions, treatment with moxifloxacin should be discontinued and appropriate measures taken. Care must be taken when prescribing moxifloxacin to patients who have had or are currently suffering from mental illness.

Diarrhea associated with antibiotic use, including colitis

Cases of antibiotic-associated diarrhea (AAD) and antibiotic-associated colitis (AAA), including pseudomembranous and Clostridium difficile-associated diarrhea have been observed in connection with the use of broad-spectrum antibiotics, including moxifloxacin. These symptoms can range from mild diarrhea to fatal colitis. Therefore, it is important to consider the likelihood of such a diagnosis in patients who develop severe diarrhea during or after the use of moxifloxacin. For suspected or confirmed AAD or AAC, treatment with antimicrobial agents, including moxifloxacin, should be discontinued and appropriate therapeutic interventions initiated immediately. In addition, appropriate measures must be taken to control the infection in order to reduce the risk of transmission. Preparations that suppress motility are contraindicated in patients who develop severe diarrhea.

Patients with severe myasthenia gravis

Moxifloxacin should be used with caution in patients with severe myasthenia gravis (Myasthenia gravis), as its symptoms may worsen.

Tendonitis and tendon rupture

Tendinitis and tendon rupture (especially but not limited to the Achilles tendon), sometimes bilateral, can occur within 48 hours of treatment with quinolones and fluoroquinolones. It was also reported about such cases, observed several months after the termination of treatment. The risk of tendonitis and tendon rupture is increased in elderly patients, patients with impaired renal function, patients after parenchymal organ transplantation, and patients receiving concomitant treatment with corticosteroids. Therefore, concomitant corticosteroid therapy should be avoided.

When the first symptoms of tendonitis appear (eg, excruciating edema, inflammation), treatment with moxifloxacin should be discontinued and alternative treatment should be considered. Provide appropriate treatment for the affected limb (s) (eg, immobilization). Do not use corticosteroids if signs of tendinopathy appear.

Patients with impaired renal function

Elderly patients with renal impairment should be used with caution in moxifloxacin if they are unable to maintain adequate fluid volume in the body, since dehydration increases the risk of renal failure.

On the part of the organs of vision

In case of visual impairment or any effect on the organs of vision, you should immediately seek the advice of an ophthalmologist (see Sections "Ability to influence the reaction rate when driving or driving other mechanisms", "Adverse reactions").

Dysglycemia

As with all fluoroquinolones, abnormal blood glucose levels have been reported during treatment with moxifloxacin, both in the form of hypoglycemia and in the form of hyperglycemia. Dysglycemia developed mainly in elderly patients with diabetes who received oral hypoglycemic agents (for example, sulfonylurea) or insulin simultaneously with treatment with moxifloxacin. Patients with diabetes mellitus are advised to carefully monitor their blood glucose levels (see Section "Adverse Reactions").

Prevention of photosensitivity reactions

With the use of quinolones, photosensitization was recorded in patients. According to research data, with the use of moxifloxacin, the risk of induction of photosensitization reactions was low. However, patients need to avoid exposure to prolonged and / or intense sunlight or ultraviolet radiation during treatment with moxifloxacin.

Patients with glucose-6-phosphate dehydrogenase deficiency

Patients with insufficient activity of glucose-6-phosphate dehydrogenase, as well as patients with a family history of this pathology, are prone to the development of hemolytic reactions during treatment with quinolones. Thus, moxifloxacin should be used with caution in this category of patients.

Inflammation of tissues in the periarterial zone

Moxifloxacin, solution for infusion, is for intravenous use only. Intra-arterial injection should be avoided, since in preclinical studies in the case of this route of administration, tissue inflammation in the periarterial zone was observed.

Patients with specific complicated infections of the skin and subcutaneous tissue

The clinical efficacy of moxifloxacin in the treatment of severe infections associated with burns, fasciitis and infected "diabetic foot" accompanied by osteomyelitis has not been established.

Impact on biological tests

Moxifloxacin may interfere with the test for Mycobacterium spp. by suppressing mycobacterial growth, which, in turn, can lead to false negative results in patients taking moxifloxacin.

Patients with methicilin-resistant Staphylococcus aureus (MRSA) infections

Moxifloxacin is not recommended for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) infections. If MRSA infection is suspected or confirmed, treatment with an appropriate antibacterial preparation should be initiated (see Pharmacological section).

Application during pregnancy or lactation.

Pregnancy

The safety of using moxifloxacin during pregnancy in humans has not been studied. The results of animal studies indicate reproductive toxicity (see section "Pharmacological properties"). The potential risk to humans has not been established. Given the experimentally established risk of harmful effects of fluoroquinolones on cartilage, which carry the main load, in immature animals and taking into account the development of reversible joint lesions in children treated with certain fluoroquinolones, moxifloxacin should not be prescribed to pregnant women (see section "Contraindications").

Lactation

There is no data on the use of the preparation during lactation in women. The results of preclinical studies indicate that a small amount of moxifloxacin passes into breast milk. Due to the lack of data on the effect on infants who are breastfed, and given the experimental risk of harmful effects of fluoroquinolone on the cartilage of immature animals carrying the main load, breastfeeding is contraindicated in treatment with moxifloxacin (see section "Contraindications").

Fertility

Animal studies have not shown any effect on fertility (see section "Pharmacological properties").

The ability to influence the reaction rate when driving vehicles or other mechanisms.

The study of the effect of moxifloxacin on the ability to drive vehicles and work with mechanisms has not been conducted. However, fluoroquinolones, including moxifloxacin, can affect the reaction rate when driving or operating other mechanisms, causing reactions from the central nervous system (for example, dizziness, acute temporary loss of vision) or acute and short-term loss of consciousness (fainting) (see section " adverse reactions "). Patients are advised to check their reaction to moxifloxacin before driving or operating machinery.

Method of administration and dosage

Dosage

The recommended dosing regimen is 400 mg of moxifloxacin as an infusion once a day.

Initial intravenous therapy can be continued with oral 400 mg moxifloxacin tablets when clinically indicated.

In the course of the studies, most patients switched to the oral route of using moxifloxacin for 4 days (community-acquired pneumonia) or 6 days (complicated infectious diseases of the skin and subcutaneous tissues). The recommended total duration of intravenous and oral treatment is 7-14 days for community-acquired pneumonia and 7-21 days for complicated infectious diseases of the skin and subcutaneous tissues.

Mode of application

The preparation is administered intravenously as a continuous infusion with a duration of at least 60 minutes (see also the section "Peculiarities of use").

If indicated, the infusion solution can be administered through a T-shaped catheter along with compatible infusion solutions (see the "Special Precautions" section).

Impaired kidney / liver function

Patients with mild to severe renal impairment and patients on chronic dialysis, such as those undergoing hemodialysis and long-term ambulatory peritoneal dialysis, do not require dose adjustment (see the Pharmacological Properties section for more details).

There is no sufficient information regarding patients with impaired liver function (see Section "Contraindications").

Other special patient groups

Elderly patients and patients with low body weight do not need dose adjustment.

Children

Due to the negative effect on the cartilage of young animals (see section "Pharmacological properties"), the use of moxifloxacin in children (under the age of 18) is contraindicated (see "Contraindications").

The efficacy and safety of using moxifloxacin in children and adolescents has not been established (see "Contraindications").

Overdose

Special measures after accidental overdose are not recommended. In case of overdose, symptomatic treatment is performed. Because QT may be prolonged, ECG monitoring is required. Concomitant use of activated charcoal with a dose of moxifloxacin 400 mg administered orally or intravenously can reduce the systemic bioavailability of the preparation by more than 80% or 20%, respectively. Taking activated charcoal at the initial stage of absorption can be an effective prevention of excessive increase in systemic exposure to moxifloxacin in case of overdose after oral administration of the preparation.

Side effects

Below are the adverse reactions that were observed during clinical trials and in the post-registration period in the case of using moxifloxacin at a dose of 400 mg per day (only intravenous therapy, stepwise [intravenous / oral] and oral).

All adverse reactions, with the exception of nausea and diarrhea, were observed with a frequency of less than 3%.

Infections and infestations: Superinfections associated with resistant bacteria or fungi, such as oral and vaginal candidiasis.

From the circulatory and lymphatic systems: anemia, leukopenia, neutropenia, thrombocytopenia, thrombocythemia, eosinophilia, increased prothrombin time / increased INR, increased prothrombin / decreased INR, agranulocytosis.

From the immune system: allergic reactions, anaphylactic / anaphylactoid reactions, including rare cases of shock (potentially life-threatening), allergic edema / angioedema, including laryngeal edema (potentially life-threatening) (see section "Peculiarities of use").

Metabolic and nutritional disorders: hyperlipidemia, hyperglycemia, hyperuricemia, hypoglycemia.

Mental disorders * anxiety reactions, increased psychomotor activity / agitation, mood lability, depression (in rare cases with possible self-aggression such as suicidal ideas / thoughts or suicidal attempts), hallucinations, depersonalization, psychotic reactions (with possible self-aggression such as suicidal ideation / thoughts or attempted suicide) (see section "Peculiarities of use").

From the nervous system * headache, dizziness, paresthesia / dysesthesia, taste disturbance (including ageusia in rare cases), confusion and disorientation, sleep disturbance (mainly insomnia), tremor, vertigo, drowsiness, hyperesthesia, hypoesthesia, impaired sense of smell (including loss of smell), pathological dreams, impaired coordination (including gait disorder due to dizziness or vertigo), seizures (including "grand mal" seizures) (see section "Peculiarities of use"), impaired attention, speech disorders, amnesia, peripheral neuropathy and polyneuropathy.

From the side of the visual organs * visual impairment, including diplopia and blurred vision (especially during reactions from the central nervous system), transient loss of vision (especially during reactions from the central nervous system).

On the part of the hearing organs and the vestibular apparatus * ringing in the ears, hearing impairment including deafness (usually reverse).

From the side of the cardiovascular system: prolongation of the QT interval in patients with hypokalemia, prolongation of the QT interval, increased heart rate, tachycardia, atrial fibrillation, angina pectoris, ventricular tachyarrhythmias, syncope (that is, acute and short-term loss of consciousness), nonspecific arrhythmias, "pirouetric arrhythmias "Ventricular tachycardia (torsade de pointes) (see section" Peculiarities of use "), cardiac arrest, vasodilation, arterial hypertension, arterial hypotension, vasculitis.

From the respiratory system, chest and mediastinal organs: shortness of breath (including asthmatic condition).

From the digestive tract: nausea, vomiting, abdominal pain, diarrhea, decreased appetite and decreased food intake, constipation, dyspepsia, flatulence, gastritis, increased amylase levels, dysphagia, stomatitis, antibiotic-associated colitis (including pseudomembranous colitis, in rare cases associated with life-threatening complications) (see section "Peculiarities of use").

Hepatobiliary system: increased transaminase levels, abnormal liver function (including increased LDH (lactate dehydrogenase)), increased bilirubin levels, increased GGTP (gamma-glutamyl transpeptidase), increased blood alkaline phosphatase levels, jaundice, hepatitis (mainly cholestatic), potentially fulminant hepatitis can lead to the development of life-threatening liver failure (including death).

Skin and subcutaneous tissue disorders: itching, rash, urticaria, dry skin, bullous skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis (potentially life-threatening).

On the part of the musculoskeletal system * arthralgia, myalgia, tendonitis (see section "Peculiarities of use"), muscle twitching, cramps, muscle weakness, tendon rupture, arthritis, muscle stiffness, exacerbation of symptoms of myasthenia gravis (see section "Peculiarities of use" ).

From the side of the kidneys and urinary tract: dehydration, impaired renal function (including an increase in urea nitrogen and blood plasma creatinine), renal failure (see section "Peculiarities of use").

General disorders and condition of the injection site * reactions at the infusion site, (thrombosis) phlebitis at the infusion site, general weakness (mainly asthenia or fatigue), edema, sensation of pain (including pain in the lower back, chest, limb pain, soreness in the area small pelvis), hyperhidrosis.

* With the use of quinolones and fluoroquinolones, very rare cases of prolonged (over months or years), disabling and potentially irreversible serious adverse preparation  reactions have been reported, sometimes affecting several body systems and sensory organs (including reactions such as tendonitis, tendon rupture, arthralgia, pain in the extremities, gait disturbance, neuropathies associated with paresthesia, depression, fatigue, memory impairments, sleep disorders and impaired hearing, vision, taste and smell) in some cases, regardless of the presence of risk factors (see section "Peculiarities of use" ).

The incidence of the following effects is higher when using the intravenous route of administration of the preparation  with or without subsequent oral therapy: increased levels of gamma-glutamyl transferase, ventricular tachyarrhythmia, hypotension, edema, antibiotic-associated colitis (including pseudomembranous colitis, in rare cases associated with life-threatening complications , see the section "Peculiarities of use"), convulsive seizures (including "grand mal" seizures) (see the section "Peculiarities of use"), hallucinations, impaired renal function (including increased levels of blood urea nitrogen and creatinine), renal failure (see the section "Peculiarities of application").

In rare cases, after treatment with other fluoroquinolones, adverse reactions have been reported that could possibly also be observed with moxifloxacin: hypernatremia, hypercalcemia, hemolytic anemia, rhabdomyolysis, photosensitization (see section "Peculiarities of use").

Reporting suspected adverse reactions

Reporting suspected adverse reactions after preparation registration is important. They allow continuous monitoring of the balance of benefits and risks of using a preparation. Health care professionals should report any suspected adverse reactions.

Shelf life

5 years.

Storage conditions

The preparation does not require special storage conditions. Keep out of the reach of children.

Incompatibility

Moxifloxacin infusion solution should not be administered simultaneously with solutions incompatible with it, which include: sodium chloride solution 10%; sodium chloride solution 20%; sodium bicarbonate solution 4.2%; sodium bicarbonate solution 8.4%.

This medicinal product should not be mixed with medications other than those listed in the "Special Safety Precautions" section.

Tags: Moxifloxacin

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