TERTSEF. 1gr. 5 flacons
Ceftriaxone destroys microorganisms by inhibiting the synthesis of cell membranes.
TERTSEF. 1gr. 5 flacons
The active substance is ceftriaxone Tertsef - a third generation cephalosporin antibiotic, bactericidal , characterized by an increased resistance against most of the bacterial cells enzymes that destroy antibiotics , broad spectrum , highly active, especially against Gram- negative bacteria .
Ceftriaxone destroys microorganisms by inhibiting the synthesis of cell membranes .
Tertsef 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 , infections 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 immunodeficiency .
Prophylactic surgery ( surgical interventions , which are considered to have primary infection or are expected to occur ) .
INFORMATION NECESSARY BEFORE USE
Known hypersensitivity to penicillin and cephalosporin antibiotics.
SPECIAL PRECAUTIONS FOR USE
Tertsef is used in known sensitivity of the pathogen , determined by microbiological methods .
Before any new course of treatment, the patient should be carefully questioned about whether he had previous hypersensitivity reactions to cephalosporins , penicillins, or other drugs.
Caution is advised and medical surveillance after the first injection in patients hypersensitive to penicillin, penicillamine and grizeofulfin ( cross-allergy ) and in patients with some form of allergy.
If there is no history of allergy is made skarifikatsionna ( with scratches ) skin sample with a solution of the product. If there is evidence of allergy in the past as a start is performed epicutaneous ( skin ) test and if it is negative proceed to skarifikatsionna sample. Samples were read after 30 minutes. In case of onset of severe acute hypersensitivity require application of 0,5 -1 mg adrenalin s.c. , infusion of glucocorticoids , antihistamines ( parenteral ) novphylline and selective beta- adrenergic agents in bronhospazamq oxygen ventilation and, if necessary , intubation .
In patients with renal impairment do not require a change in the usual dose. Periodic monitoring of serum concentrations of the product and where there is evidence of accumulation dose should be reduced accordingly .
In patients with impaired liver function is not necessary to reduce the dose, but in the presence of underlying renal disease , it should not exceed 2 g, except under strict control of serum concentrations. Can be observed prolongation of prothrombin time , so it is necessary to control it , especially in patients with impaired production and low vitamin K stores in chronic liver disease and malnutrition. If necessary, it can be administered vitamin K ( 10 mg weekly ) .
Tertsef should be prescribed with caution in patients with gastrointestinal diseases in history , particularly colitis. Like all antibacterial agents and Tertsef may alter the normal intestinal flora and to develop severe disease ( pseudomembranous colitis) . Caution should be exercised in patients with diarrhea occurring after administration . In the diagnosis of pseudomembranous colitis should take appropriate therapeutic measures . Mild cases are handled with discontinuation of treatment, and the average and worst - with the application of more fluids , electrolytes, proteins and addition of oral antibacterial agents against Clostridium difficile.
Tertsef therapy should be discontinued in patients who develop symptoms of gallbladder disease ( jaundice and biliary colic ) .
In patients with granulocytopenia ( low white blood cells) , Tertsef can be administered in combination with aminoglycoside antibiotics.
Prolonged use of Tertsef may result in the overgrowth of microorganisms ilidrugi fungi . In the presence of secondary infection during treatment must take appropriate measures.
Due to the high plasma protein binding , Tertsef should be used with caution in neonates with hyperbilirubinemia and in patients receiving verapamil long time .
With prolonged use of Tertsef " blood counts should be monitored periodically.
During treatment possible false positive reaction for glucose in the urine, so it is recommended determination be made at least 4 hours after administration of the product or by glucose oxidase method. Possible false positive test of Coombs. Not recommended Tertsef be used for prophylaxis in neurosurgery . To take account of the quantity of sodium content of the product ( ~ 70 mg / g) in patients on diets with sodium restriction .
Intramuscular injections of Tertsef ' without lidocaine painful . When using solvent lidocaine must make sample hypersensitivity to it.
It is unacceptable lidocaine solutions to Tertsef - administered intravenously !
It is always recommended after pricking intramuscular injections to pull the plunger (no blood appears ) to ensure that the needle does not hit a blood vessel. It is recommended to use freshly prepared solutions .
Was observed additive and synergistic effect between ceftriaxone and aminoglycoside antibiotics against gram -negative microorganisms including Pseudomonas aeruginosa and Streptococcus faecalis. In cases where Tertsef used with aminoglgokozidi is imperative that intramuscular administration of antibiotics can be made in different places and not be mixed in the same syringe for injection or infusion solutions , as inactivated . The product is compatible with vancomycin.
Co-administration of oral anticoagulants (products reduce blood clotting ) may lead to increased effects of past due inhibits the synthesis of vitamin K.
Use in Pregnancy and lactation
Although not teratogenic and mutagenic effects not recommended to Tertsef in pregnant women ( especially during the first three months) unless absolutely necessary.
Tertsef is excreted in low concentrations in breast milk , which requires caution in its application to nursing women .
EFFECTS ON THE ABILITY TO DRIVE AND USE MACHINES
Tertsef does not affect the ability to drive and use machines.
INFORMATION FOR PROPER USE
DOSAGE AND ADMINISTRATION
The product is applied with a prescription !
Tertsef is deep intramuscular or intravenous injection as a direct or infusion. Adults and children over 12 years
The usual dose is 1-2 g per day , singly ( or in two equal doses twice ) and for 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.
Prophylaxis in surgical interventions recommended single iv injection of 1 g Tertsef 0,5 - 2 hours before the operation. -
Children under 12 years
The usual dose is 50-75 mg / kg once daily. The maximum daily dose should not exceed 2 g.
In premature and newborn babies - 20-50 mg / kg once daily. In meningitis Tertsef ® can be administered at a dose of 100 mg / kg, daily, or once in two equal doses 12 hours. The maximum daily dose should not exceed 4 g. The usual duration of treatment is 7-14 days. Tertsef should be administered at least two days after the disappearance of the symptoms of infection. In complicated infections may extend the duration of therapy.
In patients with impaired renal or hepatic function is not necessary to adjust the dose. Only in cases with advanced renal failure with creatinine clearance <10 ml / min, the dose should not exceed 2 g daily. In cases of simultaneous presence of severe renal or hepatic impairment, functional control of the plasma concentration of ceftriaxone over certain intervals.
The duration of treatment depends on Tertsef course of " ' the disease and usually lasts from 4 to 14 days. Should be continued for at least 2-3 days after the disappearance of disease symptoms - drop in temperature or negative microbiological examination . Treatment of infections caused by Streptococcus pyogenes , therapy should be continued for at least 10 days. Complicated infections may require prolonged therapy.
Dialysis patients do not need additional dose after dialysable. In such patients require monitoring of plasma concentrations of the antibiotic and dosage adjustment . Method of preparation of the suspension
For intramuscular injection, lg and 2g Tertsef were dissolved in 3,6 ml , and thereafter 7,2 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 of water for injection is painful. If necessary, may be administered in more dilute solutions . The application takes place deep in the gluteus . It is recommended that in one place to be administered no more than lg Tertsef ®. Prepared with lidocaine solutions Tertsef for intramuscular administration is not given 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 ) . Injection time is 2-5 minutes.
For short intravenous infusion lg and 2g Tercef were dissolved 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 , 5 % dextrose solution , 10 % glucose solution , a 5% solution of levulose . The infusion time is 15-30 minutes.
No reports of overdose Tertsef .
Usually Tertsef is well tolerated . Sometimes it can be observed :
• allergic skin rashes and fever (fever ), rarely anaphylactic shock ;
• gastrointestinal disorders - nausea , vomiting , diarrhea, initial symptoms of pseudomembranous colitis;
• reversible hematologic effects - eosinophilia, thrombocytosis , leukopenia , rarely anemia , haemolytic anemia , decrease in white blood cells and platelets ;
• changes in some laboratory blood tests , prothrombin time , transient elevations of serum transaminases ;
• - fungal superinfections or other causes;
• jaundice and biliary colic , hyperbilirubinemia ;
• rarely observed ultrasound identified sediment in the gallbladder , which, whether or not accompanied by clinical symptoms are reversible after discontinuation of the application ;
• central nervous system - in the case of high doses of beta- lactam antibiotics , especially in patients with renal failure may occur headache and dizziness ;
• changes in the intestinal flora due to the high degree of biliary excretion of ceftriaxone ;
• there was an 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 having 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 at refrigerated (2-8 ° C ) .
It is desirable solutions to inlay immediately after preparation .
Three (3 ) years from date of manufacture
Drug per vial: Ceftriaxone sodium eq. 1 g Ceftriaxone
PHARMACEUTICAL FORM AND CONTENTS
Tercef powder for injection in colorless glass vials of 30 ml in
1 g, 5 vials per carton