Ceftriaxone 1 g
Ceftriaxone 1 g
WHAT ceftriaxone 1 g RV POWDER AND WHAT IT IS USED
The active substance of the medicinal product Ceftriaxone RV is Ceftriaxone sodium - a third generation cephalosporin antibiotic, bactericidal, characterized by a long biological half-life, increased resistance to most bacterial beta-lactamases and extended-spectrum high activity against Gram-negative bacteria.
Ceftriaxon RV is used for the treatment of severe infections such as:
Respiratory tract infections - acute and chronic bronchitis, bronchopneumonia, pulmonary abscess, infected bronchiectasis, postoperative pulmonary infections etc .;
abdominal infections - peritonitis, infections of the biliary tract and gastrointestinal tract - salmonellosis shigelosis;
infections of the kidneys and urinary tract;
Genital - chancroid, gonorrhea, syphilis;
infections of skin and skin structures, bones, joints, soft tissue, and infected wounds;
infections in patients with immunodeficiency.
perioperative prophylaxis in surgery.
2 BEFORE USING RV Ceftriaxone 1 g powder for solution for injection
Do not use RV Ceftriaxone 1 g, if you are allergic to ceftriaxone, cephalosporins or penicillins.
Take special care with Ceftriaxone RV if:
have had allergic reactions to other medications;
you are pregnant;
are dysfunctional kidneys and liver;
if you follow a diet with restriction of sodium to take into account the quantitative sodium content in the product (~ 70 mg / g).
Cefriaxone is contraindicated in infants requiring treatment with calcium products because of the risk of precipitation of the salts formed from ceftriaxone and calcium.
Administration of other drugs:
Please tell your doctor if you are taking or have recently taken any other medicines, such as:
medicines obtained without a prescription;
Pregnancy and lactation
Ask your doctor before taking any medicine. Application of Ceftriaxone RV in pregnant women (especially during the first three months) is not recommended unless absolutely necessary, although it is teratogenic and mutagenic.
RV ceftriaxone is excreted in low concentrations in breast milk, which requires caution in its application to nursing women.
Driving and using machines
Ceftriaxon RV did not affect the ability to drive and use machines.
3 HOW TO USE ceftriaxone RV
The medicinal product is administered only on prescription!
Ceftriaxone RV applies deep intramuscular, intravenous injection such as direct or infusion.
Adults and children over 12 years:
The usual dose for adults and children over 12 years is 1-2 g once or twice daily. In severe infections - 12 hours with a 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 intravenous injection of 1 g Ceftriaxone RV, between 0.5 to 2 hours before surgery.
Children under 12 years:
The usual dose for children under 12 years is 50-75 mg / kg body weight, administered once. In severe infections may be given up to 80 mg / kg body weight, the maximum daily dose should not exceed 2 g (does not apply to children with meningitis).
In premature and newborn - 20-50 mg / kg once daily.
In meningitis RV Ceftriaxone may be administered at a dose of 100 mg / kg once daily or in two equal doses every 12 hours. The maximum daily dose should not exceed 4 g.
In patients with impaired renal or hepatic function
It is not necessary to adjust the dose. Only in cases with advanced renal failure, creatinine clearance <10 ml / min, the dose should not exceed 2 g daily. In the case of the simultaneous presence of severe renal and liver function impairment, controlling the plasma concentration of Ceftriaxone at regular intervals.
The duration of treatment with Ceftriaxon RV depends on the course of the disease and usually lasts from 4 to 14 days and should last at least 2-3 days after the disappearance of clinical symptoms or following a negative microbiological examination. Treatment of infections caused by Streptococcus pyogenes, therapy should be continued for at least 10 days. Complicated infections 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.
Ceftriaxone is incompatible with calcium-containing solutions such as Hartmann and Ringer and not to be confused with them. Ceftriaxone should not be administered to patients simultaneously with calcium-containing solutions, even if the flow of various fluids.
In case of overdosage, drug concentration would not be reduced by hemodialysis or peritoneal dialysis. There is no specific antidote. Treatment should be symptomatic.
If you have any further questions on the use of Ceftriaxone RV, ask your doctor.
4 POSSIBLE SIDE EFFECTS
As with all medications, Ceftriaxone RV can have side effects, although not everyone gets them.
Ceftriaxon RV usually well tolerated.
The most frequently reported adverse events of ceftriaxone are diarrhea, nausea and vomiting. Other reported adverse events include hypersensitivity reactions such as skin allergic reactions and anaphylactic reactions, secondary infections with yeast, fungi or resistant organisms, and changes in the blood picture.
Infections and infestations:
Rare (> 0.01% - <0.1%): mycosis of the genital tract;
Possible superinfections in various places in yeast, fungi or other resistant organisms.
Blood and lymphatic system disorders:
Rare (> 0.01% - ^ 0.1%): neutropenia, leukopenia, eosinophilia, thrombocytopenia, anemia (including hemolytic anemia), slightly increased prothrombin time;
Very rare (<0.01%), including isolated reports: positive test Coombs, coagulation disorders, agranulocytosis (<500 / m), mainly after 10 days of treatment and after a total dose of 20 g ceftriaxone and more.
Immune system disorders:
Rare (> 0.01% - <0.1%): anaphylaxis (eg. Bronchospasm) and anaphylactoid reactions (see section 4.4).
Nervous System Disorders
Rare (> 0.01% - <0.1%): headache, dizziness.
Common (> 1% - <10%): loose stools or diarrhea, nausea, vomiting;
Rare (> 0.01% - <0.1%): stomatitis, glossitis. These side effects are usually mild and often resolved during treatment or after discontinuation of therapy;
Very rare (<0.01%), including isolated reports: pseudomembranous colitis (mainly caused by Clostridium difficile), pancreatitis (possibly caused by obstruction of the bile ducts).
Rare (> 0.01% - <0.1%): increased serum liver enzymes (AST, ALT, alkaline phosphatase);
There was precipitation of ceftriaxone calcium salt in the gallbladder (see section 4.4), especially in patients treated with doses higher than the recommended standard dose. In rare cases, the precipitation is accompanied by symptoms such as pain. In these cases, symptomatic treatment is recommended. You might consider also discontinuation of ceftriaxone.
Skin and subcutaneous tissue disorders:
Uncommon (> 0.1% - <1%): allergic skin reactions such as maculopapular rash or exanthema, urticaria, dermatitis, pruritus, edema;
Very rare (<0.01%), including isolated reports: Erythema multiforme, syndrome Stevens-Johnson, syndrome Lyell / toxic epidermal necrolysis.
Renal and urinary disorders:
Rare (> 0.01% - <0.1%): increased serum creatinine, oliguria, glycosuria, hematuria;
Very rare (<0.01%), including isolated reports: precipitation in the kidney, mainly in children older than 3 years who were treated with high daily doses (80 mg / kg per day or more) or total dose exceeds 10 g, and other risk factors such as dehydration or immobilization. Precipitation in the kidney is reversible upon discontinuation of ceftriaxone. In this regard reported anuria and renal impairment.
General disorders and administration site conditions:
Rare (> 0.01% - <0.1%): phlebitis and pain at the injection site after intravenous administration. These can be minimized by slow injection over at least 2-4 minutes.
Intramuscular injection without lidocaine is painful.
If any of the side effects gets serious, or if you notice other effects not listed in this leaflet, please tell your doctor.
5 HOW TO STORE ceftriaxone RV
Keep out of reach of children.
At temperatures below 25 ° C!
Store in the original package!
It is desirable to apply the solutions immediately after preparation.
Ceftriaxone solutions RV remain stable for 24 hours under refrigeration (2 ° -8 ° C).
6 FURTHER INFORMATION
What does Ceftriaxone RV
The active substance is: Ceftriaxone sodium.
Ceftriaxone RV looks like and contents of pack
Medicinal product Ceftriaxone RV is a white crystalline powder in a glass vial sealed with a rubber stopper sealed with aluminum cap and plastic protective cap. Each vial is placed in a cardboard box with a package leaflet.