Zolev LEVOFLOXACINUM solution for infusion 500mg /100ml, 150ml vial №1

Zolev LEVOFLOXACINUM solution for infusion 500mg /100ml, 150ml vial №1

Product Code: 4256
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Composition active ingredient: levofloxacin; 100 ml solution contains levofloxacin hemihydrate equivalent to levofloxacin 500 mg auxiliary substances: anhydrous glucose, sodium edetate, hydrochloric acid divorced, sodium hydroxide, water for injections. Dosage form Solution for infusion. Pharmacological group Antibacterial agents of the quinolone group. Fluoroquinolones. PBX code A01M A12. Indications Bacterial inflammatory processes in adults caused by bacteria sensitive to levofloxacin pneumonia, complicated urinary tract infections (including pyelonephritis), infections of skin and soft tissue, chronic bacterial prostatitis. Contraindications Hypersensitivity to levofloxacin, other quinolones or to any component of the drug epilepsy complaints about adverse reactions from tendons after preliminary use of quinolones. Pregnancy and breast-feeding. Childhood. Method of application and doses The product should be used immediately after perforation of the rubber stopper (within 3 hours) in order to prevent any bacterial contamination. Protection from light during infusion is not needed. Taking into account the biological equivalence of oral and parenteral forms of levofloxacin, the same dosage is possible. Dosage depends on the type and severity of infection. Table 1. Dose for the treatment of adults with normal renal function, in which creatinine clearance 50 ml/min pokazyvaetsya doshkolyata introductions per day community-acquired pneumonii500 Mg1 - 2 times Complicated infections of the urinary tract, including пиелонефрит250 mg *1 time Chronic bacterial простатит500 mg **1 time Infections of the skin and soft tissues 500 Mg1 - 2 times * It should be considered the feasibility of increasing the dose in cases of severe infection (this reference applies only to solutions for infusion). ** In accordance with the patient's condition, in a few days it is possible to switch from the initial administration of levofloxacin to oral administration with the same dosage. Since levofloxacin is excreted mainly by the kidneys, the dose should be reduced for patients with impaired renal function. Table 2. Dosage for adult patients with impaired renal function who have creatinine clearance less than 50 ml/min CC dosing Regimen (depending on the severity of infection and nosological form) 50-20 ml/мин250 mg/24 часа500 mg/24 mg часа500/12:00 the first dose-250 mg subsequent - 125 mg/24 hours the first dose - 500 mg subsequent-250 mg/ 24 hour first dose - 500 mg subsequent-250 mg/ 12:00. 19-10 ml/min first dose - 250 mg subsequent-125 mg/ 48 hours first dose - 500 mg subsequent-125 mg/ 24 hour first dose - 500 mg subsequent-125 mg/ 12:00. One ) the first dose - 250 mg subsequent-125 mg/ 48 hours first dose - 500 mg the following -125 mg/ 24 hour first dose - 500 mg subsequent-125 mg/ 24 hours 1 After hemodialysis or chronic ambulatory peritoneal dialysis (GAPD) additional doses are not required. Dosing for patients with impaired liver function. Dose correction is not required, since levofloxacin is slightly metabolized in the liver. Dosing for elderly patients. If kidney function is not impaired, there is no need for dose adjustment. The drug is administered slowly intravenously by drip infusion. The duration of administration of one bottle of the drug (100 ml intravenous solution with 500 mg levofloxacin) should be at least 60 minutes. In accordance with the patient's condition, in a few days it is possible to switch from intravenous administration to oral administration with the same dosage. 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 the normalization of body temperature or confirmed by microbiological tests of destruction of pathogens. Adverse reaction The frequency is determined on the basis of the following symbol: very often (? 1/10), often (? 1/100,<1/10), infrequently (? 1/1000, ? 1/100), rarely (? 1/10 000, ? 1/1000), very rarely (? 1/10 000), the frequency is unknown (cannot be estimated from the available data). Infections and invasions: rare - fungal infections (and proliferation of other resistant microorganisms). From the blood and lymphatic systems: infrequently-leukopenia, eosinophilia; rarely-thrombocytopenia, neutropenia; very rarely - agranulocytosis frequency unknown - pancytopenia, hemolytic anemia. From the immune system: very rarely - anaphylactic shock (see section "Peculiarities of application"). Anaphylactic and anaphylactoid reactions may sometimes occur even after the first dose, frequency unknown - increased sensitivity (hypersensitivity) (see section "Peculiarities of use"). Metabolic disorders: uncommon - anorexia; very rarely - hypoglycemia, especially in patients with diabetes mellitus (see section "Peculiarities of use"). Psychiatric disorders: rarely - insomnia, nervousness; rarely psychotic disorders, depression, confusion, anxiety, agitation, anxiety very rare psychotic reactions with self-destructive behavior, including suicidal thought or action (see section "Peculiarities of use"), hallucinations. From the nervous system: rare - dizziness, headache, somnolence rare convulsion, tremor, paraesthesia very rare sensory or sensorimotor peripheral neuropathy, dysgeusia (subjective taste disorder), including ageusia (loss of taste), parosmia (impaired olfaction), including anosmia (lack of smell). From the body of the vision: rarely - visual impairment. Organs of hearing: infrequent - vertigo; very rarely - hearing disorders frequency unknown is ringing in the ears. From the cardiovascular system: rarely-tachycardia, arterial hypotension, the frequency is unknown-lengthening THE Qt interval on the ECG (see" Features of application "(lengthening the QT interval) and"Overdose"). The respiratory system: rare - bronchospasm, dyspnoea very rare pneumonitis allergic. From the digestive tract: often - diarrhea, nausea, rarely - vomiting, abdominal pain, dyspepsia, flatulence, constipation; rarely diarrhoea haemorrhagic, in very rare cases may be indicative of enterocolitis, including pseudomembranous colitis. The liver and biliary tract: often - increased activity of liver enzymes (ALT/AST, alkaline phosphatase, GGT) rarely - increase of blood bilirubin very rare - hepatitis frequency unknown - reported cases of jaundice and severe liver injury, including cases of acute liver failure, primarily in patients with severe underlying diseases (see section "Peculiarities of use"). The skin and subcutaneous tissue: often - rash, pruritus rare urticaria very rare angioneurotic edema, increased sensitivity to sun and ultraviolet radiation; the frequency is unknown toxic epidermal necrolysis (Lyell's syndrome), Stevens-Johnson syndrome, exudative erythema multiforme, hyperhidrosis. Sometimes there may be skin-mucous reactions even after taking the first dose. From the musculoskeletal system: rarely-tendon lesions (see section" Peculiarities of application"), including their inflammation (tendinitis) (for example, Achilles tendon), arthralgia, myalgia very rarely - rupture of tendons (see section"Peculiarities of application"). This undesirable side effect can occur within 48 hours from the beginning of treatment and affect the Achilles tendon of both legs. Possible muscle weakness, which may be of particular importance for patients with severe myasthenia gravis; frequency unknown - muscle damage (rhabdomyolysis). From the urinary system: rarely - increased creatinine in blood serum; very rare - acute renal failure (e.g. due to interstitial nephritis). General disorders and conditions at the site of administration: infrequently - asthenia very rarely - pyrexia; frequency unknown - pain (including pain in the back, chest and limbs). Among other undesirable side effects associated with taking fluoroquinolones, such as: extrapyramidal symptoms and other disorders of coordination of movements, hypersensitivity vasculitis, attacks of porphyria in patients with porphyria. Overdose Symptoms: dizziness, disturba

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