The need to supplement the instructions for the use of medicinal products with the following information is revealed:
1. In the section "Pharmacological properties" of the subsection "Pharmacokinetics", information on the cumulation of polymyxin B should be presented in the following edition: "When re-administered, cumulates".
2. The "Indications for Use" presented in the following wording: "Severe infections caused by susceptible to polymyxin B Gram-negative organisms with multiple resistance to other antibiotics: sepsis, meningitis (intrathecal injected), pneumonia, wound infection generalized".
3. Section "Side effect" present in the following wording: "The nervous system: dizziness, ataxia, impaired consciousness, drowsiness, paresthesia, neuromuscular blockade.From the urinary system: albuminuria, cylindruria, azotemia, proteinuria, renal tubular necrosis. On the part of the respiratory system: paralysis of respiratory muscles, apnea. From the digestive system: pain in the epigastric region, nausea, decreased appetite; pseudomembranous colitis. From the sense organs; impaired vision. Allergic reactions: skin rash, itching, eosinophilia. Local reactions: phlebitis, periphlebitis, thrombophlebitis, tenderness in the place of intramuscular injection. Other: superinfection, candidiasis, with intrathecal injection - meningeal symptoms (facial flushing, headache, fever, stiff neck, increased number of cells and protein in cerebrospinal fluid). "
4. The section "Overdose" should be presented in the following edition: "Symptoms: paralysis of respiratory muscles, neurotoxicity, nephrotoxicity Treatment: supportive and symptomatic therapy".
5. In the section "Special instructions" the information on pseudomembranous colitis should be presented in the following edition: "Pseudomembranous colitis caused by Clostridium difficile can appear both against a background of prolonged use,and within 2-3 weeks after discontinuation of treatment; is manifested by diarrhea, leukocytosis, fever, abdominal pain (sometimes accompanied by discharge with mucous masses of blood and mucus). If these phenomena occur in mild cases, it is sufficient to cancel the treatment and apply ion-exchange resins (colestramine, colestipol), in severe cases, compensation for loss of fluid, electrolytes and protein, the appointment of vancomycin or metronidazole. Do not use drugs that inhibit the intestinal motility. "
6. The section "Influence on the ability to drive vehicles and mechanisms" should be presented in the following edition: "During the period of drug treatment, care should be taken when carrying out potentially dangerous activities requiring increased concentration of attention and speed of psychomotor reactions (vehicle management, work with moving mechanisms , work of the dispatcher, the operator) ".