TERCEF 1 g. 5 vials
1 g, 5 vials per carton.
TERCEF 1 g.
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
The active substance is ceftriaxone Tertsef - a third generation cephalosporin antibiotic, bactericidal, characterized by an increased resistance against most of the enzymes of the bacterial cells, which destroy antibiotics, broad spectrum and high activity particularly against Gram-negative bacteria.
Ceftriaxone destroy 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 shigelosis;
• infections of the kidneys and urinary tract (when 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 (in surgery, which is considered to have primary infection or are expected to occur).
INFORMATION REQUIRED BEFORE USE
Known hypersensitivity to cephalosporin and penicillin antibiotics.
SPECIAL PRECAUTIONS FOR USE
Tertsef be used in known sensitivity of the pathogen measured by microbiological methods.
Before any new course of treatment, the patient should be carefully examined to determine 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 a form of allergy.
In the absence of an allergic history is made scarification (scratching with) 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 scarification sample. Samples were read after 30 minutes. In the case of severe acute hypersensitivity reactions require application of 0,5 -1 mg epinephrine subcutaneously, intravenous infusion of corticosteroid preparations antihistamine (parenteral) novphylline and selective beta-mimetic 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 the presence of underlying renal disease, it should not exceed 2 g, except under strict control of serum concentrations. May develop 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 may change Tertsef normal intestinal flora and 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 be managed with treatment interruption and medium and heavy - with the use of more fluids, electrolytes, proteins, and the 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®mozhe be prescribed in combination with aminoglycoside antibiotics.
Prolonged use of Tertsef may result in the overgrowth of fungi ilidrugi microorganisms. 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 patients receiving verapamil long time.
With prolonged use of Tertsef "Blood counts should be monitored periodically.
During treatment possible false positive reactions for glucose in the urine, so it is recommended that the determination be made at least 4 hours after administration of the product or by glucose oxidase method. It is a false positive test of Coombs. Not recommended Tertsef be used for prophylaxis in neurosurgery. To take into account the quantitative sodium content in the product (~ 70 mg / g) in patients on diets restricting sodium.
Intramuscular injections of Tertsef 'without lidocaine painful. When using solvent lidocaine must make sample hypersensitivity to it.
It is unacceptable lidocaine solutions Tertsef Tax and administered intravenously!
It is always recommended since prick intramuscular injection to withdraw the plunger (no blood appears) to ensure that the needle is not affected blood vessel. It is recommended to use freshly prepared solutions.
DRUG INTERACTIONS AND OTHER
The 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 to carry out 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 suppressing the synthesis of vitamin K.
ADMINISTRATION DURING PREGNANCY AND BREAST-FEEDING
Although not teratogenic and mutagenic effect is 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 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!
Tertsef applies deep intramuscular or intravenous injection as, 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 to 2 hours prior to surgery. -
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 - 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 be administered at least two days after the disappearance of symptoms of the 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 impairment and liver function is necessary to control the plasma concentration of ceftriaxone at specified intervals.
The duration of treatment depends on Tertsef course of "'illness usually lasts 4 to 14 days. It should last at least 2-3 days after disappearance of symptoms of the disease - the temperature falls 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.
In dialysis patients do not need additional dose after dialysable. In such patients require monitoring of plasma concentrations of antibiotic and dose adjustment. Preparation of 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 of 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 administered in more dilute solutions. The application takes place deep in the gluteus. It is recommended that in one place can be administered not more than lg Tertsef. Prepared with lidocaine solutions for intramuscular use Tertsef 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 of ceftriaxone). The injection time is 2-5 minutes.
For short intravenous infusion lg and 2g Tercef® dissolve both direct intravenous injection and diluted to concentrations of 100 mg / ml Ceftriaxone respectively in 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 laevulose. The infusion time is 15-30 minutes.
No reports of overdose Tertsef.
Tertsef generally well tolerated. Sometimes it 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 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 a characteristic light yellow to amber color, depending on concentration, which is not related to the activity, efficiency and affordability and 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