Trade name of the drug: CEPRAZONE -C Active ingredients (INN): cefoperazone, sulbactam Dosage form: powder for the preparation of an injectable solution for intramuscular and intravenous administration Composition: 1 bottle in grams contains: active substances: cefoperazone sodium salt (equivalent to cefoperazone) – 1.0 g; sulbactam sodium salt (equivalent to sulbactam) – 0.5 g. Description: White or almost white powder. Very hygroscopic. Pharmacotherapeutic group: Antibiotic (gr. cephalosporins). ATX Code: J01DD62
Pharmacological properties Generation III cephalosporin in combination with a beta-lactamase inhibitor. Cefoperazone sodium is a semi-synthetic cephalosporin broad-spectrum antibiotic intended only for parenteral use. It acts on sensitive microorganisms during their active reproduction by inhibiting the biosynthesis of the mucopeptide of the cell wall. Sulbactam is a stable irreversible inhibitor of various beta-lactamases secreted by microorganisms resistant to beta-lactam antibiotics. Sulbactam expands the spectrum of activity of the drug against resistant strains, without changing the activity (against sensitive strains, binding to some penicillin-binding proteins of bacteria) shows synergism when used simultaneously with beta-lactam antibiotics. Sulbactam has no clinically significant antibacterial activity of its own (with the exception of Neisseriaceae and Acinetobacter). CEPRAZONE-C is active against all microorganisms sensitive to cefoperazone. In addition, it has synergism (a decrease in BMD when using CEPRAZONE-C up to 4 times compared to those when using both components separately) against various microorganisms, primarily the following: Haemophilusinfluenzae, Bacteroidesspp., Staphylococcusspp., Acinetobactercalcoaceticus, Enterobacteraerogenes, Escherichiacoli, Proteusmirabilis, Klebsiellapneumoniae, Morganellamorganii, Citrobacterfreundii, Enterobactercloacae, Citrobacterdiversus. CEPRAZONE-C is active in vitro against a wide range of clinically significant microorganisms. Gram-positive microorganisms: Staphylococcus Aureus, producing and not producing penicillinase, Staphylococcusepidermidis, Streptococcuspneumoniae, Streptococcuspyogenes (beta-hemolytic streptococcus group A), Streptococcus Galactiae (beta-hemolytic streptococcus group B), most other strains of beta- hemolytic streptococci, many strains of Streptococcusfaecalis (enterococcus). Gram-negative microorganisms: Escherichiacoli, rpbsiellaspp., Enterobacterspp., Citrobacterspp., Haemophilusinfluenzae, Proteusmirabilis, Proteusvulgaris, Morganellamorganii (old name Proteusmorganii), Providenciarettgeri (old name Proteusrettgeri), Providenciaspecies, Serratia spp. ( including S. marcescens), Salmonella and Shigellaspp., Pseudomonasaeruginosa and some other Pseudomonasspp., Acinetobactercalcoaceticus, Neisseriagonorrhoeae, Neisseriameningitidis, Bordetellapertussis, Yersiniaenterocolitica. Anaerobic microorganisms: Gram-negative bacilli (including Bacteroidesfragilis, other Bacteroides spp. and Fusobacterium spp.). Gram-positive and gram-negative cocci (including Peptococcus, Peptostreptococcus and Veillonellaspecies). Gram-positive papillae (including Clostridium, Eubacterium and Lactobacillus spp.). Pharmacokinetics Both sulbactam and cefoperazone are well distributed in various tissues and body fluids, including bile, gallbladder, skin, appendix, fallopian tubes, ovaries, uterus. There is no data on the presence of any pharmacokinetic interaction between sulbactam and cefoperazone with the administration of CEPRAZONE -C. A certain portion of the dose of sulbactam and cefoperazone is excreted by the kidneys. The rest of cefoperazone is excreted mainly with bile.
Indications for use Infectious and inflammatory diseases caused by microorganisms sensitive to the drug: - upper and lower respiratory tract infections; - infections of the upper and lower urinary tract; - intraabdominal infections (including peritonitis, cholecystitis, cholangitis); - septicemia; - meningitis; - skin and soft tissue infections; - infections of bones and joints; - inflammatory diseases of the pelvic organs; - endometritis; - gonorrhea. Given the wide spectrum of action of CEPRAZONE-C, monotherapy with this drug is effective for most infections. However, if necessary, CEPRAZONE-C can be used in combination with other antibiotics (with simultaneous use of aminoglycosides, kidney function should be monitored).
Method of administration and dosage In adults, CEPRAZONE-C is recommended to be used in the following daily doses:
In severe or refractory infections, the daily dose of CEPRAZONE-C can be increased to 8 g with a 1:1 component ratio (i.e. 4 g of cefoperazone). Patients receiving CEPRAZONE-C in a 1:1 ratio may require additional administration of cefoperazone. The dose should be divided into equal parts and administered every 12 hours. The recommended maximum daily dose of sulbactam is 4 g. In children, CEPRAZONE-C is recommended to be used in the following daily doses:
The ratio of CEPRAZONE To Cefoperazone Sulbactam 1 cefoperazone / sulbactam (mg/kg/day) (mg/kg/day) (mg/kg/day) 1:2 60 to 120 20 to 40 40 to 80
In case of serious or refractory infections, doses can be increased to 160 mg / kg / day with a component ratio of 1:1. The daily dose is divided into 2-4 equal parts. For newborns during the first week of life , the drug should be administered every 12 hours. The maximum daily dose of sulbactam in children should not exceed 80 mg / kg / day. In patients with severe renal insufficiency (CC less than 3 ml / min), the dose of CEPRAZONE-C is changed to compensate for the decrease in clearance of sulbactam. In patients with CC (creatinine clearance) of 15-30 ml /min, the maximum dose of sulbactam is 1 g every 12 hours (the maximum daily dose of sulbactam is 2 g), and in patients with CC <15 ml/ min, the maximum dose of sulbactam is 500 mg every 12 hours (the maximum daily dose of sulbactam is 1 g). In severe infections, additional administration of cefoperazone may be required. Since the pharmacokinetics of sulbactam changes significantly during hemodialysis, and the half-life of cefoperazone from blood plasma decreases somewhat, the administration of CEPRAZONE-C should be planned after dialysis. Rules for the preparation and application of a solution for intravenous administration, for repeated infusions, the contents of each vial of CEPRAZONE-C are dissolved in an adequate volume of 5% dextrose solution, 0.9% sodium chloride solution and / or sterile water for injection, and then diluted to 20 ml with the same solvent. The infusion is carried out for 15-20 minutes . To prepare a solution for intravenous infusion, a Ringer's lactated solution can be used, however, it cannot be used for initial dissolution.The vial should be removed from the vial as specified in the document, and stored for a minimum of 3 minutes. Rules for preparation of the plant:
Total Equivalent Dose Volume Maximum Final dose (d) cefoperazone+sulbactam (d) solvent (ML) concentration (mg / mL) 1.5 1,0+0,5 3.2 250+125
CEPRAZONE-with water-soluble inyectium, 5% growth dextrose, physiological growth and 5% growth dextrose in physiological growth in concentrations from 10 mg/mL cefoperazone and 10 mg/mL sulbactam to 250 mg/mL and 250 mg/mL respectively. In divorces, lactrovannous Ringer Ringer Ringer ready in 2 apostilles: start with a large sterile water supply of inyectium, then end with a obtained raster dilute lactrovannous ringer to a concentration of 5 mg/ml (2 ml start with 50 ml start with a lactovannous Ringer ringer or 4 ml) 100 ml of lactated Ringer grower). In divorces, lidocainoma in the growing pestilence is followed by a huge sterile water drop inectium. Rastvor, soderjashti cefoperazone in concentrations of 250 mg/mL or Bole, ready in 2 ambigtap: start large sterile water with inyectium, and then dilute 2% lidocaine growth, thatB.get rastvor, soderjashti up to 250 mg/mL cefoperazone 250 mg/mL sulbactam for example in 0.5% grow lidocaine hydrochloride.
Further actions Co-storon. piscivarative system........... Allergic reactions: removed maculo-papulesnaya with Apostille, krapivnitsa, risk ich voznnovenia in extravehicular disease with allergic reactions (especially of penicillin in anamnese). Anaphylactoid penile reactions (including shock), Stevens-Johnson syndrome Co-storon the organism in celoma: golovnaya Boly, lichoradka, pain at inovets, oznob. Co-storon. labn. extravehicular indicator: transitioning to Urgench. function indicator baked-Apostille, alt, STF, bilirubin. Serdeciosudistoy system urgand: arterial hypotension, vasculitis. Co-storon. system. Local area reactions: inogda then B / M inactivation observed transient pain. In C / C VVEDENIA CEPRAZONE-C (as well as other cephalosporin and penicillin) with the help of the catheter, phlebitis may develop in place of infusions. Dermatological reactions: Sud. Co storon. mochev. repeatable system...........
Contraindications More amenable sensitivities to cephalosporinam and others. With ostrogothiness change in berementi, in the period of rudimentary tuber, in the case of baking and more frequent shortcomings.
Pharmacovigilance interactions Pharmaceutical interaction Ceprazone-C and aminoglycoside are not followed in a single syringe or in a B / C infusion system. If combined therapy with CEPRAZONE-C and aminoglycosides is performed, then two drugs are administered by successive infusions using separate secondary catheters, and the primary catheter is washed with an adequate solution between doses of drugs. Interval between VVEDENEM CEPRAZONE-C and aminoglycoside over the course of the day. Big lacturevaniaexample ristor Ringeraexploitation of primordial growth pestilence does not follow, teach asbaexamplea incongruentyexamplea mixtures. One of the shuttlecocks can get putem two-to-two-to-two-to-one preparations for growth-first-to-start growth in water and water, and then to divorce lactrovannn-to-grow-to-grow-in ringer. 2% growth of lidocaine hydrochloride will not be affected by the first growth of the blister. In addition, you can get a couple of days ' worth of plant preparation - first of all, you can grow in water and water, and then you can divorce 2% of the plant from lidocaine hydrochloride.
Specificservice instructions In the hospital, I was getting beta-lactam in the antibiotics, in T.H. cephalosporin fluconazole, described aposematic cases developed seryesn extravehicular reactionservicationsfor anaphylactic sensitivities (anaphylactic), Kotor Urga inogda brought to death. The risk of developing such reactions in the patient in the patient in the patient in the patient in the patient in the patient in the patient in the patient in the patient in the patient in the patient in the patient in the patient in the patient observed reactions in the patient in the patient in the patient in the patient in the patient in the patient in the patient in the patient in the patient in the patient in the patient in the patient in the patient in the patient in the patient in the patient in the patient. In cases of allergic reactions, it is necessary to cancel the preparation and appoint adequate therapy. In sereznabh anaphylactic reaction and needed an urgent injection of adrenaline. According to the indications, appoint oxygen, V/V to give steroid, and make sure that you are able to obtain a passageway, including intubation. In the case of polar obstructions, you can use the dosage regimen of the preparation. In patients with impaired functions baked and soputative disorders more necessary monitoring of the specific concentrations of cefoperazone and correlation ego dosage in case of need. Regular monitoring of the specific concentrations of cefoperazone in such cases is not conductive, The Morning Dose is not lower than the 2G. In the treatment of cefoperazome, as well as other antibiotics, in rare cases I developed vitamin K deficiency. The cause of ego, probably, is the supply of normal microflora. K grouppe risk may be taken away from patients receiving plohoe feeding, patients with malabsorption (e.g., cystic fibrosis) and patients with severe drinking conditions. In such cases, and in such cases in the hospital, the patients receiving anticoagulant Apostille, you need to control the prothrombin time and, if available, prescribe Vitamin K. In the treatment of CEPRAZONE-C (as well as other antibiotics), you can observe the selectsextact. The patient needs to be closely monitored during treatment. In the treatment of CEPRAZONE-with periodic monitoring of indicators of functions in the internal organ, including CEPR, CEPR and system of treatment. In the use of long-term cephoperazone treatments and for up to 5 days thereafter, the ego in the B. U. B. recorded the reactions characterized by high tides, sweating, naked pain and tachycardia. Similar reactions have been observed with the use of some other cephalosporins, therefore, patients should be warned about the possibility of ih occurrence when drinking alcoholic beverages against the background of treatment with CEPRAZONE-C. In the case of the patient, the patient must be given proper nutrition (vnutri or parenteral), after which avoid the usual rastorov, soderingsdings2. In the case of large amounts in the deck of the Benedicta or felling of the modified preparation, you can observe a positive reaction of glucose in Moche. Cefoperazone is not found in any bilirubin in white plasma. Growth in Pediatrics In the course of the treatment of the drug in the child, the periodic monitoring of the indicators of the functions of the skin, the baked, the system of the blood, especially in the new-born, the premature, the old, and the young. Change in bremenization and lactation period Sulbactam and cefoperazone penetrate the cherry placenta. Adequate and strictly controllable evaluative safety of ZEPRAZONE-with no conduction in the case of no conduction, in the case of no conduction, in the case of no need. Sulbactam and cefoperazone in extravasation are separated with tuber-worm molocom in the eyes of the non-sick. Hotya Oba component plocho penetrates into the tuberous Moloco, they do not change, after which they will be exposed to the severity of the changes of CEPRAZONE-C in the lactation period (tuberous injection). Influence of the ability to drive a car and complex paragliding mechanisms Let's take a moment to communicate.
Peredosis Human toxicity of cefoperazone sodium and sulbactama sodium is limited. Symptom Apostille: in peredozirovka you can wait for the appearance undesirable. It is necessary to study the fact that in the high concentration of beta-lactam, the antibiotic in the cerebrospinal fluid can cause neurological disorders, including hemorrhoids. Treatment: how cefoperazone, TAC and sulbactam can be used in hemodialysis, in a method of treatments, you can contribute to the preparation in the organism in the case of peredositions in the hospital, with impaired functions.
Shape in aposematic 1.5 g of the drug in glass vials, hermetically sealed with rubber stoppers, compressed with aluminum caps with the control of the first hiding (flip-off). On a vial, you can use the pen to self-destruct. An Odin vial containing instructions for medical treatment is placed in korobu on the card. Feeding conditions Eat in dry and protected from the world, at a temperature of 250c. Eat in an uncomplicated place.
Shelf life 3 years. Do not change the date of the date.
Terms of leave from pharmacy Recipe.
Manufacturer HARASHA PHARMA PVT. LTD. India. DG-II/159 A, Vikaspuri, D-Block, New Delhi, India
Owner registration certificates HARASHA PHARMA PVT. LTD., India
Name and address organizations making claims (proposals) for quality medicinal products of territories Republic of Uzbekistan «FUTURE-WORLD GROUP» Republic of Uzbekistan, Tashkent, Chilanzarsky r-n, str. Sanyat 13A. Tel.:+99891 134 94 14 E-mail: info.fwg@yandex.com
