Description
Release form
Powder for solution for injection
packaging
1 bottle complete with solvent.
Pharmacological action
Rocefin is a long-acting, broad-spectrum, third-generation cephalosporin antibiotic for parenteral administration. The bactericidal activity of the drug is due to the suppression of the synthesis of cell membranes. Rocefin is highly resistant to the action of most beta-lactamases of gram-negative and gram-positive microorganisms.
Active against gram-positive aerobes: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus viridans, Streptococcus bovis gram-negative aerobes: Alomonpp. Aeromespp. Branhamella catarrhalis (forming and non-forming beta-lactamases), Citrobacter spp., Enterobacter spp. (some strains are resistant), Escherichia coli, Haemophilus ducreyi, Haemophilus influenzae (including penicillinase forming strains), Haemophilus parainfluenzae, Klebsiella spp. (including Klebsiella pneumoniae), Moraxella spp., Morganella morganii, Neisseria gonorrhoeae (including penicillinase forming strains), Neisseria meningitidis, Plesiomonas shigelloides, Proteus mirabilis, Proteus vulgaris, Providenciaella spp. (including Salmonella typhi), Serratia spp. (including Serratia marcescens), Shigella spp., Vibrio spp. (including Vibrio cholerae), Yersinia spp. (including Yersinia enterocolitica), individual strains of Pseudomonas aeruginosa are also sensitive to the preparation of anaerobes: Bacteroides spp. (including some strains of Bacteroides fragilis), Clostridium spp. (except Cl.difficile), Fusobacterium spp. (except Fusobacterium mortiferum and Fusobacterium varium), Peptococcus spp., Peptostreptococcus spp.
Staphylococcus spp. strains resistant to methicillin, Enterococcus strains, many Bacteroides spp. strains producing beta-lactamases are resistant to the drug.
Indications
Treatment of infectious diseases caused by microorganisms sensitive to the drug: – sepsis
– meningitis
– infectious diseases of the abdominal organs (peritonitis, infections of the biliary tract and gastrointestinal tract)
– infectious diseases of the bones, joints, skin, as well as wound infections
– infectious diseases in people with weakened immune systems
– infectious diseases of the upper and lower respiratory tract (including pneumonia)
– infectious diseases of the kidneys and urinary tract
– infectious diseases of the genital organs (including gonorrhea).
Prevention of postoperative infectious complications.
Contraindications
Hypersensitivity to cephalosporins and penicillins.
Pregnancy and lactation
The safety of the drug during pregnancy has not been established.
If necessary, the appointment of the drug during lactation should decide on the termination of breastfeeding. In low concentrations, ceftriaxone is excreted in breast milk.
In experimental studies, no embryotoxic, fetotoxic, teratogenic effects or other adverse factors on the fertility of males and females, the process of childbirth, perinatal and postnatal development of offspring were revealed. In primates, no embryotoxicity or teratogenicity was observed.
Special instructions
With simultaneous severe renal and hepatic insufficiency, the plasma concentration of the drug should be regularly determined.
In patients undergoing hemodialysis, it is necessary to monitor the concentration of the drug in blood plasma, because they may decrease the rate of its elimination.
With prolonged treatment with the drug, it is necessary to regularly monitor the picture of peripheral blood.
In rare cases, ultrasound of the gallbladder observes blackouts that disappear after discontinuation of the drug. Even if this phenomenon is accompanied by pain in the right hypochondrium, only symptomatic treatment is recommended.
After drinking alcohol after taking Rocefin, no effects similar to disulfiram (teturam) were observed.
Pediatric use
Rocefin should be used with caution in newborns with hyperbilirubinemia, especially premature babies.
Composition
1 vial contains:
Active substances: ceftriaxone disodium salt 596.5 mg, which corresponds to the content of ceftriaxone – 500 mg,
Solvent: water d / i – 5 ml.
Dosage and administration of
Adults and children over 12 years of age are prescribed 1-2 g of Rocefin 1 time / day. Depending on the clinical situation, the daily dose can be increased to 4 g.
Newborns (up to 2 weeks) are prescribed at a dose of 20-50 mg / kg body weight 1 time / day.
When calculating the dose, the degree of full-term baby is not taken into account.
Infants (from 3 weeks of age) and children under 12 years of age are prescribed 20-80 mg / kg of body weight 1 time / day.
Children with a body weight of over 50 kg are prescribed a dose for adults.
Duration of treatment is set individually. Usually, administration of the drug must be continued for another 48-72 hours after normalization of temperature.
With bacterial meningitis in infants and young children, treatment begins with a dose of 100 mg / kg body weight (but not more than 4 g) 1 time / day. When identifying the pathogen and its degree of sensitivity to the drug, the dose can be adjusted. The duration of treatment depends on the pathogen and can range from 4 days for Neisseria meningitidis, up to 7 days for sensitive strains of St. pneumoniae.
With gonorrhea, it is recommended to administer 250 mg IM once.
For the prevention of postoperative complications, it is recommended to administer 1-2 g of Rocefin once (depending on the degree of danger of infection) 30-90 minutes before the operation. For operations on the colon and rectum, additional administration of the drug from the group of 5-nitroimidazoles is recommended.
Side effects of the
From the digestive system: diarrhea, nausea, vomiting, stomatitis, glossitis rarely – increased transaminase activity, darkening on the echogram of the gallbladder.
From the hemopoietic system: eosinophilia, leukopenia, granulocytopenia, hemolytic anemia, thrombocytopenia.
From the side of the central nervous system: headache, dizziness.
Allergic reactions: rash, itching, dermatitis, urticaria, edema, exudative erythema multiforme rarely – anaphylactoid or anaphylactic reactions.
Local reactions: in rare cases, phlebitis. Intramuscular administration without lidocaine is painful.
Effects due to biological effects: superinfection (genital tract mycosis) is possible.
Other: oliguria, increased serum creatinine, fever, chills, bleeding disorder.
The frequency of all side effects does not exceed 2%.
Drug Interactions
Rocefin and aminoglycosides have a synergistic effect against many gram-negative bacteria.
With the simultaneous use of high doses of rocefin and loop diuretics, such as furosemide, renal dysfunction was not observed. There is no indication that rocefin increases the nephrotoxicity of aminoglycosides.
Probenecid has no effect on the excretion of rocefin.
Pharmaceutical Interaction.
Rocefin solution is incompatible with solutions containing other antibiotics (both in preparation and in administration)
Storage conditions
Keep out of the reach and sight of children at temperatures below 30 C
Freshly prepared rocefin solutions are physically and chemically stable for 6 hours at room temperature.
Active ingredient
Ceftriaxone
Dosage form
solution for injection and infusion Zee
Appointment
Pregnant II and III trimester by doctor’s appointment, Pregnant doctor’s appointment, Nursing mothers, Children by doctor’s appointment, Adults by doctor’s appointment
Indications
From osteomyelitis, From cholecystitis, From sinus infections, From infections, From infections, From infections, From gall, infections, From infections, From gall, infections pneumonia, From urinary tract infections, From intestinal infections, Bronchitis, From otitis media
Possible product names
ROCEFIN 1.0 N1 FLAC POR D / R-V / V / M
ROCEFIN 1.0 FLAC POR D / R-RA V / V + 10ML R-L
Rocefin for intravenous injection 1.0 g, bottle 1 pc.
Rocefin por d / r i / v 1g x 1
ROCEFIN POR. D / IN. I / O 1G FL. No. 1 WITH R-LEM (WATER D / IN.)
F. Hoffmann-La Roche L td, Switzerland
