Rocefin powder intramuscular 1000mg №1 + solvent 3,5ml

antibiotic, cephalosporin.

Crystalline powder of white or white with a yellowish-orange shade of color.

Active ingredient and dosage form

Powder for preparation of solution for intramuscular administration:
1 bottle contains Ceftriaxone 250, 500 mg or 1 g;
1, 5 or 50 fl. in a package complete with a solvent (1 ampoule with 2 ml or 3.5 ml of 1% solution of lidocaine).

Powder for preparation of solution for intravenous jet administration:
1 bottle contains Ceftriaxone 250, 500 mg or 1 g;
1, 5 or 50 fl. in a package complete with a solvent (1 ampoule with 5 or 10 ml of water for injection).

Powder for solution for intramuscular, intravenous injection or infusion:
1 bottle contains Ceftriaxone 1 g
50, 100 or 143 fl. packaged.

Powder for solution for intravenous drip:
1 bottle contains ceftriaxone 2 g
1, 5 or 50 fl. packaged.

All dosage forms of Rocefin contain about 83 mg (3.6 mmol) of sodium per 1 g of ceftriaxone.

Powder for preparation of a solution for in / m in. - П №013244 / 01-2001;
Powder for preparation of a solution for in / in in. - П №013244 / 02-2001;
Powder for the preparation of p-ra for injection 1 g - P №013244 / 04-2001;
Powder for preparation of a solution for infusions 2g - P No. 0133244 / 03-2001.

Mechanism of action

A long-acting cephalosporin antibiotic of the III generation of a broad spectrum of activity 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 most beta-lactamase 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: Aeromonas spp., Alcaligenes spp., Branhamella catarrhalis (forming and non-forming beta-lactamase), Citrobacter spp., Enterobacter spp. (some strains are resistant), Escherichia coli, Haemophilus ducreyi, Haemophilus influenzae (including strains forming penicillinase), Haemophilus parainfluenzae, Klebsiella spp. (including Klebsiella pneumoniae), Moraxella spp., Morganella morganii, Neisseria gonorrhoeae (including strains that form penicillinase), Neisseria meningitidis, Plesiomonas shigelloides, Proteus mirabilis, Proteus mirabilis, Proteus mirabilis, Proteus mirabilis, Proteus mirabilis, Proteus mirabilis, Proteus mirabilis, Proteus mirabilis, Proteus mirabilis, Proteus mirabilis, Proteus mirabilis, Proteus mirabilis, Proteus mirabilis, Proteus mirabilis, Proteus mirabilis, Proteus mirabilis, Proteus mirabilis, Proteus mirabilis, Proteus mirabilus (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 susceptible to the drug; 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.
To the action of the drug are resistant strains of Staphylococcus spp., showing resistance to methicillin, strains of Enterococcus, many strains of Bacteroides spp., producing beta-lactamase.

Treatment of infectious diseases caused by microorganisms sensitive to the drug:
- sepsis;
- meningitis;
- infectious diseases of the abdominal cavity organs (peritonitis, infections of the gall tract and the gastrointestinal tract);
- infectious diseases of bones, joints, soft tissues, skin, and also wound infections;
- infectious diseases in persons with weakened immunity;
- 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.

Adults and children over 12 years old appoint 1-2 g of Rocefina 1 time / day. Depending on the clinical situation, the daily dose can be increased to 4 g.
Newborn (up to 2 weeks) prescribed in a dose of 20-50 mg / kg of body weight 1 time / day.
When calculating the dose, the degree of the child's term is not taken into account.
Infants (from 3 weeks of age) and children under the age of 12 years appoint 20-80 mg / kg body weight 1 time / day.
Children weighing over 50 kg prescribe a dose for adults.

The duration of treatment is set individually. As a rule, the introduction of the drug should be continued for another 48-72 hours after the temperature normalizes.

With bacterial meningitis 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 the degree of its sensitivity to the drug dose can be adjusted. The duration of treatment depends on the pathogen and can be from 4 days for Neisseria meningitidisup to 7 days for sensitive strains St. pneumoniae.

With gonorrhea It is recommended to inject 250 mg intramuscularly once.

For the prevention of postoperative complications It is recommended to administer once to 1-2 grams of Rocefin (depending on the degree of danger of infection) 30-90 minutes before the operation.In operations on the colon and rectum, additional administration of a drug from the group of 5-nitroimidazoles is recommended.

dose adjustment is required only when the CC values ​​are below 10 ml / min. In this case, the daily dose should not exceed 2 g.

Use only freshly prepared solutions.
For intramuscular administration, 250 mg or 500 mg of the drug is dissolved in 2 ml, and 1 g in 3.5 ml of 1% Lidocaine solution. It is recommended to introduce no more than 1 g of the drug in one buttock.
For intravenous injection, 250 mg or 500 mg of Rocefin is dissolved in 5 ml, and 1 g in 10 ml of water for injection. The drug is introduced into / in slowly over 2-4 minutes.
For i / v infusion, dissolve 2 g of the drug Rocefin in 40 ml of a solution that does not contain Calcium ions. The following base solutions are commonly used: saline; 5% or 10% glucose solution; 5% levulose solution; 0.45% sodium chloride solution + 2.5% glucose solution.
In / in doses of 50 mg / kg body weight and more should be administered drip for at least 30 minutes.

Adverse reactions

Gastrointestinal: diarrhea, nausea, vomiting, stomatitis, glossitis; rarely, an increase in transaminase activity, a darkening on the echogram of the gallbladder.
Hemic and lymphatic: eosinophilia, leukopenia, granulocytopenia, hemolytic anemia, thrombocytopenia.
From the side of the central nervous system: headache, dizziness.
Allergic reactions: rash, itching, dermatitis, urticaria, edema, exudative polyformal erythema; rarely, anaphylactoid or Anaphylactic reactions.
Local reactions: in rare cases - phlebitis. V / m administration without lidocaine is painful.
Effects due to biological effects: possible development of superinfection (mycosis of the genital tract).
Other: oliguria, increased serum creatinine, fever, chills, bleeding disorders.
The frequency of all side effects does not exceed 2%.

Hypersensitivity to cephalosporins and penicillins.

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 were identified on the fecundity of males and females, the process of childbirth, perinatal and postnatal development of offspring. No signs of embryotoxicity or teratogenicity were observed in primates.

With simultaneous severe renal and hepatic insufficiency, it is necessary to regularly determine the concentration of the drug in the blood plasma.
In patients on hemodialysis, it is necessary to monitor the drug concentration in the blood plasma, because they may decrease its rate of excretion.
With long-term drug treatment is necessary to regularly monitor the picture of peripheral blood.
In rare cases with ultrasound of the gallbladder, there are 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 following the administration of Rocefin, no effects similar to those of disulfiram (teturam) were observed.
Use in pediatrics
Newborn babies with hyperbilirubinemia, especially premature, Rocefin should be administered with caution.

Currently, no cases of drug overdose have been reported for Rocefin.
Treatment: symptomatic.

Rocefin and aminoglycosides have synergistic effects against many gram-negative bacteria.
With the simultaneous use of high doses of Rocefin and "loop" diuretics, for example, Furosemide , renal impairment was not observed. There is no indication that Rocefin increases aminoglycoside nephrotoxicity.
Probenecid has no effect on Rocefin elimination.
Pharmaceutical interaction.
Rocefin solution is incompatible with solutions containing other antibiotics (both during preparation and when administered).

Keep out of reach of children at temperature up to 30 С
Rocephine’s freshly prepared solutions are physically and chemically stable for 6 hours at room temperature.

- 3 years.
Pharmacy sales terms
The drug is available on prescription.