Sundent Pharmaceutical Co., Ltd.  

Product Name: Cefuroxime for Injection 0.75g, 1.5g Model NO.: 0.75g, 1.5g Pharmaceutical Technology: Chemical Synthesis Type: Antibiotic Shape: Powder State: Powder Suitable for: Adult Application: Internal Medicine Certification: GMP OEM: Available Shelf Life: 3 Years Trademark: Sundent Transport Package: 10vials/Box, 300vials/Carton Specification: 0.75g, 1.5g Origin: China HS Code: 3004909099 Product Description Cefuroxime for InjectionIngredientsThis product is mainly composed of cefuroxime sodium.Chemical name: (6R ,7R)-7-[2-furyl(methoxyimino)acetylamino]3-carbamoyloxymethyl-8-oxo-5-thia-1-azabicyclo [4.2.0] Oct-2-en-2-methyl sodium salt.Molecular formula: C16H15N4NaO8SMolecular weight: 446.37AppearanceThis product is white to light yellow powder or crystalline powder.IndicationsThis product can be used for the following infections caused by cefuroxime sensitive bacteria:1. Respiratory tract infection: Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant bacteria), Klebsiella spp., Staphylococcus aureus (producing strains of penicillinase-producing bacteria and non-penicillinase-producing bacteria), and pus Respiratory infections caused by Streptococcus and E. coli, such as acute and chronic bronchitis, bronchiectasis, bacterial pneumonia, lung abscess, and postoperative lung infections.2, ENT infections: otitis media, sinusitis, tonsillitis, pharyngitis.3, urinary tract infections: E. coli and Klebsiella bacteria caused by urinary tract infections, such as acute and chronic pyelonephritis, cystitis and asymptomatic bacteriuria.4. Skin and soft tissue infections: caused by Staphylococcus aureus (producing strains of penicillinase-producing and non-penicillinase-producing bacteria), Streptococcus pyogenes, Escherichia coli, Klebsiella, and Enterobacter bacteria Skin and soft tissue infections such as cellulitis, erysipelas, peritonitis, and wound infections.5. Septicemia: Staphylococcus aureus (producing strains of ampicillin and non-penicillinase-producing bacteria), Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae (including ampicillin resistant strains) and Klebsiella species Septicemia caused by bacteria.6. Meningitis: caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant bacteria), Neisseria meningitidis, and Staphylococcus aureus (producing enzymes of penicillinase and non-penicillinase-producing bacteria) Meningitis.7, gonorrhea: Neisseria gonorrhoeae (penicillin enzyme-producing bacteria and non-penicillin enzyme-producing bacteria) caused by simple (without complications) and complications of gonorrhea, especially for those who are not suitable for penicillin treatment.8. Bone and Joint Infections: Bone and joint infections caused by Staphylococcus aureus (protease produced by penicillinase and non-penicillinase-producing bacteria).This product can still be used to prevent the growth of sensitive pathogens before surgery or surgery, and reduce the infection caused by contamination during and after surgery. Such as abdominal pelvic and orthopedic surgery, heart, lungs, esophagus and vascular surgery, total joint replacement surgery to prevent infection.DosageThis product can be injected deep muscles, but also intravenous injection or infusion.For intramuscular administration, the product is dissolved in 1.0 ml of sterile water for injection or 0.75 gin 3ml of sterile water for injection, and the product is slowly shaken to obtain asuspension for deep muscle injection. Before intramuscular injection, blood must be drawn back before injection.Intravenous injection: 0.25g is dissolved with at least 2.0ml of sterile water for injection, 0.75g is dissolved with at least 6.0ml of sterile water for injection, 1.5g is dissolved with at least 15ml of sterile water for injection, shaken and then intravenously injected slowly, and intravenous can also be added. Infusion tube infusion.Intravenous infusion: 1.5g of cefuroxime can be added to at least 50ml of commonly used intravenous injections, and can not be used in combination with aminoglycoside antibiotics.This product is commonly used in adults for each 0.75g, every 8hours of administration, treatment for 5-10 days, for life-threatening serious infections or infection caused by rare strains, can be increased to 1.5g each time, daily 3Times; if necessary, the interval can be increased to once every 6hours, the total daily amount of 3-6g. For bacterial meningitis, the dose should not exceed 3.0 gevery 8hours. For simple gonorrhea, asingle dose of 1.5g should be injected intramuscularly on both hips.Prevention of surgical infections: 1.5-1.5 hours before surgery intravenously 1.5g of this product, if the operation is too long, then every 8hours intravenously or intramuscular injection of 0.75g dose. In the case of thoracic surgery, intravenous injection of 1.5 gshould be performed with the introduction of anesthetic; once every 12 hours, the total dose should be 6g.For children more than 3months old, 50-100 mg per kilogram of body weight will be given in 3-4 doses. For severe infections, use no less than 0.1 g/kg of body weight per day but not exceed the maximum dose used by adults. Bone and joint infections, 0.15g per kilogram body weight per day (not to exceed the maximum dose used by adults), divided into three doses. Meningitis patients daily 0.2-0.24g per kilogram of body weight, 3-4 doses.In patients with renal insufficiency, the usage and dosage should be adjusted according to the degree of renal impairment. The recommended adjustment method is shown in the following table.Children with renal insufficiency should also be adjusted with reference to the following table.Creatinine clearance (ml/min) Dose Interval>20 0.75-1.5g every 8h10-20 0.75g every 12h<10 0.75g per 24hFor patients undergoing dialysis, asingle dose of 0.75g should be given at the end of dialysis.Adverse reactionsThis product is well tolerated and common adverse reactions are as follows:1, local reactions: such as muscle injection site pain, thrombophlebitis.2, gastrointestinal reactions: such as diarrhea, nausea, pseudomembranous colitis and so on.3, allergic reactions: common rash, itching, urticaria and so on. Occasional allergy, drug fever, erythema multiforme, interstitial nephritis, toxic exfoliative dermatitis, and Stevens Johnson syndrome.4, blood: visible hemoglobin and hematocrit reduction, transient eosinophilia, transient neutropenia and leukopenia, and occasionally thrombocytopenia.5, liver function: visible ALT, AST, alkaline phosphatase, lactate dehydrogenase and serum bilirubin transient increase.6, other: still see vomiting, abdominal pain, conjunctivitis, vaginitis (including vaginal candidiasis), abnormal liver function (including cholestasis), aplastic anemia, hemolytic anemia, bleeding, triggering epilepsy, prothrombin time Prolonged, various types of cytopenia, agranulocytosis and so on.ContraindicationsThis product is banned for cephalosporins or cephamycin drug allergies.Precautions1, this product and penicillin cross-allergic reaction. For those who are allergic to penicillin drugs, use this product with caution. Penicillin anaphylactic shock, should not choose this product.2, when using this product, should pay attention to monitor renal function, especially for patients receiving high-dose severe illness.3, renal insufficiency should reduce the daily dose. Patients who are treated with acombination of potent diuretics or aminoglycoside antibiotics should pay special attention because there have been reports of renal impairment caused by combination therapy. For these patients, renal function monitoring is best.4, this product can cause pseudomembranous colitis, patients with ahistory of gastrointestinal disease, especially ulcerative colitis, localized colitis or antibiotic-associated colitis, should be vigilant.After the diagnosis of pseudomembranous colitis is established, appropriate treatment should be given. Mild patients can be stopped, moderate and severe should be given liquids, electrolytes, protein supplements, and need to use antibiotics for Clostridium effective antibiotics.5. It has been reported that minor children have mild to moderate hearing impairments when using this product.6, compatibility and stability:Intramuscular injection: When formulated with sterile water for injection, the suspension of the product can be kept at room temperature for 24 hours and refrigerator at 5°C for 48 hours to maintain the activity. After this period, any unused solution should be discarded.Intravenous injection: When formulated with sterile water for injection, 750 mg, 1.5 gof the prepared solution is allowed to stand at room temperature for 24 hours, and the refrigerator is stored at 5° C. for 48 hours to maintain the activity.This product can maintain compatibility with the following solutions at room temperature within 24 hours: heparin (10-50u/ml), potassium chloride (10-40mEq/l), 0.9% sodium chloride. This product is 750mg and 1.5g, with 50ml or 100ml 5% glucose injection, 0.9% sodium chloride injection, 0.45% sodium chloride injection diluted, can be stored at room temperature for 24 hours, refrigerator storage for 7days.Interference to diagnosis: This product can interfere with the direct Coombs test results, there is apositive reaction, this phenomenon will interfere with the blood cross-fitting; will appear when the urine sugar is tested on the Benedict test or the Felling's test or Clintest tabets test paper Afalse positive reaction, but no false positives when tested by the enzyme method. In the case of blood sugar, false negative results may occur with the method of ferricyanide, and cefuroxime sodium does not interfere with the determination of urine and blood inosine by the alkaline picric acid method.StorageShading, sealed, kept in acool (no more than 20°C) dry placeProductphotoOur factoryThis product is produced in our GMP factory, all our facility has past China GMP, and also officially certificated by more than ten countries'MOH.Our ServiceWe can specially develop the products per customers' specification.We can offer OEM service with customers' private brands and labels.We can offer excellent after-sale service and professional technical support.Our Quality control systemIn manufacturing, quality is what sustains our life. Starting from the material selection, there are many factors that contribute to the quality control process. Our manufacturing facility isGMPcertified. Quality Control (QC) and monitoring procedures are built into every aspect of our work.Our Quality Control System is outlined below:Initial inspection (such as raw material, excipients, package materials, etc.)In-process inspection (make sure that each testing items should be qualified )Final inspection before shipment of each order.Provide temperature control recorder when it is necessary for special market before loading.Our Registration Team and technical supportWe have experienced team to provide qualified and professional registration documents for most of countries. Up to present, we have registered more than hundred products and exported to more than 20 countries. Especially including those in Asia, Africa, South America, Middle east area and East Europe.We can provide regulatory documentsGMP Certificate /CE CertificateFree sales certificateCertificate of Pharmaceutical ProductsManufacture LicenseCTD Dossier.