TERCEF 2 g. 5 vials
The active substance in TERCEF ceftriaxone is - Bactericidal third generation cephalosporin antibiotic, characterized by increased resistance to most enzymes of bacterial cells that destroy antibiotics, broad spectrum and high activity particularly against Gram-negative microorganisms such as bakterii.Tseftriakson destroys inhibits the synthesis on their cell membrane.
TERCEF is used to treat serious infections caused by susceptible microorganisms such as ceftriaxone:
• Respiratory tract infections - acute and chronic bronchitis,
• ear-nose-throat infections
• meningitis (inflammation of the brain canister);
• abdominal infections - peritonitis, infection of the biliary tract. and digestive tract - salmonellosis, shigellosis;
• infections of the kidney and urinary tract (where aminoglycosides are unsuitable);
• Genital - soft chancre (chancroid), gonorrhea, syphilis (primary, secondary, latent);
• septicemia (bacterial infection of the blood);
• Lyme disease;
• infections of skin and skin structures, bones, joints, soft tissue, infected wounds;
• infections in patients with immune deficiency.
Prophylactic surgery (in surgery, which is considered to have primary infection or expect any).
NECESSARY INFORMATION BEFORE USE
Known hypersensitivity to cephalosporin and penicillin antibiotics.
SPECIAL PRECAUTIONS FOR USE
TERCEF apply to the proven sensitivity of the pathogen determined by microbiological metodi.Predi each new course of treatment the patient should be carefully questioned to ascertain whether he had previous hypersensitivity reactions to cephalosporins, penicillins, or other lekarstva.Preporachva be caution and medical supervision after the first injection in patients allergic to penicillin, penicillamine and grizeofulfin (cross-allergy) and patients with some form of alergiya.Pri lack of an allergic history is made scarification (with scratch) skin sample solution product. If there is evidence of allergy in the past as a home is performed Skin patch (skin) test and if it is negative proceed to scarification sample. Samples were counted after 30 minutes. In case of onset of severe acute hypersensitivity reactions require application of 0,5 -1 mg adrenalin s.c., intravenous infusion of corticosteroid preparations antihistamine (parenteral), novphylline and selective beta-mimetic in bronhospazamq, oxygen ventilation and if necessary , intubation.
In patients with renal insufficiency not require a change in the usual dose. It is recommended that regular monitoring of serum concentrations of the product and where there is evidence of accumulation dose should be reduced saotvetno.Pri patients with impaired hepatic function is not necessary to reduce the dose, but the presence of underlying renal disease it should not exceed 2 g except under strict monitoring of serum concentrations. It can be observed prolongation of the prothrombin time, so it is necessary to control it, especially in patients with impaired production and low stores of vitamin K in chronic liver disease and malnutrition. If necessary, can be given vitamin K (10 mg weekly) .TERCEF should be prescribed with caution in patients with gastrointestinal diseases in history, particularly colitis. Like all antibacterial agents and TERCEF can change the normal intestinal flora to develop severe disease (pseudomembranous colitis). Caution should be exercised in patients who develop diarrhea after administration. Upon diagnosis pseudomembranous colitis should take appropriate therapeutic measures. Mild cases are handled with treatment interruption and medium and heavy - with the application of more fluids, electrolytes, protein supplement and oral antibacterial agents against Clostridium difficile.Lechenieto with TERCEF should be discontinued in patients developing symptoms gallbladder disease (jaundice and biliary colic) .For patients with granulocytopenia (low white blood cells), TERCEF mozhe be administered in combination with aminoglycoside antibiotitsi.Prodalzhitelnata Tertsef® use may result in overgrowth fungus ilidrugi microorganisms. In case of secondary infection during treatment should take appropriate merki.Poradi high plasma protein binding, Tertsef® should be used with caution in newborns with hyperbilirubinemia and in patients receiving long term treatment during verapamil.Pri Tertsef of "blood counts should be monitored during treatment periodichno.Po possible false positive reaction for glucose in the urine, so it is recommended that the determination be carried out at least 4 hours after administration of the product or by glucose oxidase method. It false positive test of Coombs. not recommended TERCEF be used for prophylaxis in neurosurgery. to take into account the quantitative sodium content in the product (~ 70 mg / g) in patients on diets with restriction of sodium.
Intramuscular injections of Tertsef 'without lidocaine painful. When using solvent lidocaine must make a sample of hypersensitivity to nego.Nedopustimo is lidocaine solutions Tertsef® da- administered intravenously! It is always recommended after pricking at intramuscular injections to pull the plunger of the syringe (not to be displayed blood) to ensure that the needle has not affected blood vessel. It is recommended to use freshly prepared solutions.
DRUG AND OTHER INTERACTIONS
Was observed additive and synergic effect between ceftriaxone and aminoglycoside antibiotics against Gram negative microorganisms including Pseudomonas aeruginosa and Streptococcus faecalis. In cases where Tertsef® used with aminoglgokozidi, it is imperative intramuscular administration of antibiotics to be carried out in different places and not be mixed in the same syringe for injection or infusion solutions, as are inactivated. The product is compatible with vankomitsin.Ednovremennoto administration of oral anticoagulants (products reduce blood clotting) may lead to increased effects of past due suppressing the synthesis of vitamin K.
ADMINISTRATION DURING PREGNANCY AND BREAST-FEEDING
Although no teratogenic and mutagenic effect is not recommended to Tertsef® in pregnant women (especially in the first three months) unless it is absolutely nalozhitelno.TERCEF is excreted in low concentrations in breast milk, which requires caution implementation of lactating women.
EFFECTS ON THE ABILITY TO DRIVE AND USE MACHINES
TERCEF not affect the ability to drive and use machines.
INFORMATION FOR PROPER USE
DOSAGE AND METHOD OF ADMINISTRATION
The product is applied with a prescription! TERCEF apply deep intramuscularly or intravenously as direct injection or infusion. Adults and children over 12 godiniObichaynata dosage is 1-2 g a day, once (or in two equal doses twice), and in life-threatening infections - 12 hours. The maximum daily dose should not exceed 4 g.
For the treatment of uncomplicated gonococcal infections recommended single intramuscular injection of 250 mg.Za prophylaxis in surgical interventions recommended single i.v. injection of 1 g Tertsef® 0.5 to 2 hours before surgery. -Children Under 12 godiniObichaynata dose is 50-75 mg / kg once daily. The maximum daily dose should not exceed 2 g.Pri premature and newborn babies - 20-50 mg / kg once daily. In meningitis Tertsef® may be administered at a dose of 100 mg / kg, per day, once or in two equal doses every 12 hours. The maximum daily dose should not exceed 4 g. The usual duration of treatment is 7-14 days. Tertsef® should apply at least two days after the disappearance of the symptoms of infection. In complicated infections it is possible to extend the duration of terapiyata.Pri patients with impaired renal or hepatic function does not need dose adjustment. Only in cases of advanced renal insufficiency with creatinine clearance <10 ml / min, the dose should not exceed 2 g daily. In the cases of simultaneous presence of severe kidney and liver function impairment is required controlling the plasma concentration of ceftriaxone over certain intervali.Prodalzhitelnostta treatment Tertsef® depends on the flow of '' disease and usually lasts from 4 to 14 days. It should be continued at least 2-3 days after the disappearance of symptoms of the disease - the temperature falls or negative microbiological testing. treatment of infections caused by Streptococcus pyogenes therapy should last at least 10 days. Complicated infections may require prolonged therapy. in dialysis patients do not need an extra dose after dialysable. in such patients require monitoring of plasma concentrations of the antibiotic and dosage adjustment. preparation of suspensiyataZa intramuscular injection lg and 2g TERCEF dissolve in 3,6 ml and 7 respectively , 2 ml of 1% solution of lidocaine (concentration 250 mg / ml ceftriaxone). It is necessary to test the sensitivity of the patient prior to lidocaine. Intramuscular injection of solutions with water for injection is painful. If necessary, can be applied and in dilute solutions. The application takes place deep in the gluteus. It is recommended that a place be given no more than lg Tertsef®. Formulated with lidocaine solutions Tertsef® for intramuscular injection is not administered intravenously!
For direct intravenous injection of 1 g and 2g Tercef® were dissolved respectively in 9,6 ml and 19,2 ml of sterile double distilled water (concentration 100 mg / ml ceftriaxone). The injection time is 2-5 minuti.Za short intravenous infusion lg and 2g TERCEF dissolve both for direct intravenous injection and diluted to concentrations of 100 mg / ml Ceftriaxone respectively into 50 ml and 100 ml of solvent. Suitable solvents for intravenous infusion include water for injection, 0.9% sodium chloride solution, 5% dextrose solution, 10% glucose solution, a 5% solution of laevulose. The infusion time is 15-30 minutes.
No reports of overdose TERCEF
TERCEF generally well tolerated. Sometimes they can be observed:
• allergic skin rashes and fever (chills); rarely anaphylactic shock;
• Gastrointestinal disorders - nausea, vomiting, diarrhea, initial symptoms of pseudomembranous colitis;
• reversible hematologic effects - eosinophilia, thrombocytosis, leukopenia, rarely anemia, hemolytic anemia, decrease in white blood cells and platelets;
• changes in some laboratory pokazateli- prothrombin time, transient increase in serum transaminases;
• superinfections-fungal or other causes;
• jaundice and biliary colic, hyperbilirubinemia;
• rarely observed ultrasound identified sediment in the gallbladder that whether or not accompanied by clinical symptoms are reversible after discontinuation of the application;
• CNS - when high doses of beta-lactam antibiotics, especially in patients with renal insufficiency may occur headache and dizziness;
• changes in the intestinal flora due to the high degree of biliary excretion of ceftriaxone;
• observed was impairment of renal function during treatment with beta-lactam antibiotics, especially when co-administered with aminoglycosides or potent diuretics;
• Other - reduced urine, pain at the injection site, phlebitis.
At temperatures below 25 ° C Store in the original package! Solutions of Tertsef® have a characteristic light yellow to amber color, depending on concentration, which is not related to the activity, efficacy and tolerability, and they remain stable for 24 hours under refrigeration (2-8 ° C) is .Zhelatelno solutions to lined immediately after preparation.
Three (3) years from date of manufacture