Cefazolin powder for solution for injection 1000mg vial 1 piece ind.upak.

Description

Composition
Active substance:
1 vial contains: cefazolin sodium (calculated as cefazolin) – 0.5 g or 1 g
Product form:
powder for solution for intravenous and intramuscular administration of 0.5 g 1 g 0.5 g and 1 g of active substance in a colorless glass bottle with capacity of 10 ml or 20 ml or dark glass bottle with capacity of 10 ml or 20 ml. 1, 5 and 10 vials with instructions for use placed in a pile of cardboard. 50 vials of 5 the instructions for use are placed in a box made of cardboard for hospitals.
Contraindications
Hypersensitivity to cephalosporin antibiotics and other beta-lactam antibiotics, neonates (up to 1 month), pregnancy, lactation.
Dosage
1 g
Indications
Infectious-inflammatory diseases caused by susceptible to malaria infections: bacterial infection of the upper and lower respiratory tract infections, upper respiratory tract (including otitis media), urinary and biliary tract, pelvic organs, skin and soft tissues, bones and joints ( including osteomyelitis); endocarditis, septicemia, peritonitis, mastitis; wound, burn and post-operative infections; syphilis, gonorrhea.
Prevention of surgical infections in pre- and postoperative period.
Interaction with other drugs
Not recommended simultaneous reception with anticoagulants and diuretics. With simultaneous application of cefazolin and “loop diuretics” derives its blockade tubular secretion. Aminoglycosides increases the risk of kidney damage. Pharmaceutically compatible with aminoglycosides (mutual inactivation). Drugs that block tubular secretion, increase the concentration in the blood slows down and increases the risk of toxic reactions.
pharmachologic effect
Pharmacological group:
Cephalosporin antibiotic.
Pharmacodynamics:
I generation cephalosporin antibiotic for parenteral administration. Bactericidal effect, disrupting the synthesis of cell walls of microorganisms. It has a wide spectrum of action, is active against Gram-positive (Staphylococcus spp., Staphylococcus aureus (not producing and penicillinase), Streptococcus pneumoniae, Corynebacterium diphtheriae, Bacillus anthracis) and gram (Neisseria meningitidis, Neisseria gonorrhoeae, Shigella spp., Salmonella spp., Escherichia coli, Klebsiella spp., Treponema spp., Leptospira spp.) microorganisms. It is active against Haemophilus influenzae, some strains of Enterobacter spp. and Enterococcus spp .. Ineffective against Pseudomonas aeruginosa, indolpolozhitelnyh strains of Proteus spp., Mycobacterium tuberculosis, Serratia spp., anaerobes, methicillin-resistant strains of Staphylococcus spp.
Pharmacokinetics:
The time to reach maximum concentration (TCmax) when administered intramuscularly at a dose of 0.5 and 1 g, respectively, – 2, and 1 hour; maximum concentration (Cmax) – 38 and 64 ug / ml; after intravenous administration TCmax – at the end of infusion, after intravenous administration of 1 g of Cmax – 180 ug / ml. Penetrates into the joints, heart and vascular tissue in the abdominal cavity, kidneys and urinary tract, placenta, middle ear, respiratory tract, skin and soft tissue. In small amounts excreted in breast milk. The concentration in the tissue of the gallbladder and bile is significantly higher than in serum. When obstruction of the gallbladder bile concentration in less than in plasma. The volume of distribution – 0.12 L / kg. Relationship to plasma proteins – 85%. The half-life (T1 / 2) when administered intramuscularly – 1.8 hours after intravenous injection – 2 hours If the kidney function T1 / 2 – 20-40 hours is derived primarily by the kidneys in unchanged form.. For the first 6 hr – 60-90 %, after 24 hours – 70-95%. After intramuscular administration at doses of 0.5 and 1 g of Cmax in the urine of 1 mg / ml and 4 mg / ml, respectively.
Pregnancy and breast-feeding
Contraindicated.
Conditions of supply of pharmacies
On prescription.
side effects
Allergic reactions: pyrexia, rash, hives, itchy skin, bronchospasm, eosinophilia, angioedema, arthralgia, anaphylactic shock, erythema multiforme (including Stevens-Johnson syndrome).
From the nervous system: convulsions.
From the urinary system: patients with renal diseases in the treatment of high doses (6 g) – renal dysfunction (in these cases, reduce the dose and the treatment is carried out under the control of the dynamics in the blood concentration of urea nitrogen and creatinine).
From the digestive system: nausea, vomiting, diarrhea, abdominal pain, pseudomembranous enterocolitis, rarely – cholestatic jaundice, hepatitis.
From the side of hematopoiesis: leukopenia, neutropenia, thrombocytopenia, thrombocytosis, haemolytic anemia.
Prolonged treatment – dysbacteriosis superinfection caused by antibiotic-resistant strains, candidiasis (including oral candidiasis).
Laboratory findings: Positive Coombs’ test, increased activity of “liver” transaminases, hypercreatininemia, increased prothrombin time.
Local reactions: Intramuscular – pain (injection site) when administered intravenously – phlebitis.
special instructions
Patients who had a history of allergic reactions to penicillins, carbapenems, may be sensitive to cephalosporin antibiotics. During treatment with cefazolin is possible to obtain positive direct and indirect Coombs test, as well as false-positive reaction on urine glucose. In appointing the drug may increase gastrointestinal tract, particularly colitis.
Storage conditions
In a dry, dark place at a temperature not higher than 25 C. Keep out of reach of children.
Dosing and Administration
Intravenously (bolus or infusion), intramuscular. The average daily dose for adults – 1 -4 g; frequency of administration – 2-4 times a day. The maximum daily dose – 6 g (in rare cases – 12 g). The average duration of treatment is 7-10 days.
For prevention of postoperative infections – i.v., 1 g for 0.5-1 h before the operation, 0.5 g of 1 – during surgery and at 0.5-1 g – every 8 hours during the first day after surgery.
Patients with impaired renal function required dosing regime change according to the values ​​of creatinine clearance (CC): QA 55 ml / min or more or in a plasma creatinine concentration of 1.5 mg% or less of the total dose may be administered; with CC 54-35 ml / min or plasma creatinine concentration 3-1,6% mg can be administered a full dose, but the interval between injections to be increased to 8 hours; with CC 34-11 ml / min or plasma creatinine concentration 4,5-3,1 mg% – 1/2 dose at intervals of 12 hours; with CC 10 mL / min and less than or plasma creatinine concentration 4.6 mg% or more -. 1/2 the usual dose every 18-24 hours All recommended dose is administered after the initial dose of 0.5 g
Children 1 month and older – 25-50 mg / kg / day; in severe infections the dose may be increased to 100 mg / kg / day. Multiplicity of introduction – 3-4 times a day.
In children with renal impairment correction mode is performed depending on the values ​​of CC: CC at 70-40 ml / min – 60% of the average daily dose is administered and every 12 hours; with CC 40-20 ml / min – 25% of the average daily dose iytervalom 12 hours; with CC 5-20 ml / min -. 10% of the average daily doses every 24 hours, all the recommended dose is administered after the initial dose.
For intramuscular administration of 0.5 g of product was dissolved in 3.2 ml of sodium chloride 0.9% solution of procaine 0.25- 0.5%, or water for injection 1 g – in 4-5 ml of sodium chloride 0.9 %, 0.25-0.5% solution of procaine, or water for injection. The resulting solution was injected deep into the muscle.
For intravenous single bolus dose of 10 ml diluted in sodium chloride 0.9% and injected slowly, over 3-5 minutes. For intravenous drip preparation (0.5 g, 1 g) was diluted in 100-250 ml of sodium chloride 0.9% or 5% dextrose and is administered for 20 30 minutes (introduction rate of 60-80 drops per minute 1 ). During breeding vials must be shaken vigorously until completely dissolved.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist