Sundent Pharmaceutical Co., Ltd.  

Product Name: GMP Cefepime Hydrochloride for Injection Model NO.: 0.5g, 1g, 2g Pharmaceutical Technology: Chemical Synthesis Type: Antibiotic Shape: Powder Suitable for: Elderly, Children, Adult Application: Internal Medicine Certification: GMP Standard: Cp OEM: Available Shelf Life: 3 Years Trademark: Sundent Transport Package: 10vials/Box, 300vials/Carton Specification: 0.5g, 1g, 2g Origin: China HS Code: 3004909099 Product Description DescriptionCefepime hydrochloride for injection 0.5g,1g,2gIndicationsThis product is used to treat moderate and severe infections caused by sensitive bacteria in adults and children aged 2months to 16 years, including lower respiratory infections (pneumonia and bronchitis), simple lower urinary tract infections and complicated urinary tract infections (including pyelonephritis). ), Non-complicated skin and skin soft tissue infections, complex intraperitoneal infections (including peritonitis and biliary tract infections), obstetrics and gynecology infections, sepsis, and neutropenic fever patients with experiential treatment. Can also be used for children with bacterial cerebrospinal meningitis.Bacterial infection and susceptibility testing should be performed when bacterial infection is suspected, but because cefepime is abroad-spectrum fungicide of gram-positive and gram-negative bacteria, cefepime can be started before susceptibility testing results are revealed. Monotherapy. For anaerobic mixed infections, it is recommended to use other anti-anaerobic drugs such as metronidazole for initial treatment. once the bacterial culture and drug susceptibility test results are revealed, the treatment plan should be adjusted in time.UsageThis product can be used for intravenous drip or deep intramuscular injection.Adults and children over the age of 16 or children weighing more than 40 kg can be 1-2 grams each time depending on the condition.once every 12 hours, intravenous drip, course of 7-10 days; mild to moderate urinary tract infection, 0.5-1 geach time, intravenous drip or deep intramuscular injection, course of treatment 7-10 days; severe urinary tract infection, each time 2g, once every 12 hours, intravenous drip, course of treatment for 10 days; for serious infection and life-threatening, 2g per 2hours of intravenous infusion; for the treatment of neutropenia with fever, 2times each Intravenous infusion every 8hours, 7-10 days of treatment or reduction in neutropenia. If the fever is relieved but the neutrophils are still at abnormally low levels, it is necessary to re-evaluate the need for continued use of antibiotics.For children aged 2months to 12 years, the maximum dose should not exceed the adult dose (ie 2grams per dose). Adult doses for children weighing more than 40 kg can be used. Usually 40 mg per kg body weight, intravenous infusion every 12 hours, treatment for 7-14 days; for children with bacterial cerebrospinal meningitis, 50 mg per kg of body weight, once every 8hours, intravenous drip. The usual dose for experiential treatment of neutropenia and fever in children is 50 mg/kg body weight once every 12 hours (neutropenia with fever treatment is every 8hours), and the course of treatment is the same as adults.Children under 2months have limited treatment experience. Adose of 50 mg/kg body weight can be used. However, data from children older than 2months showed that 30 mg/kg is sufficient for children 1to 2months of age once every 8or 12 hours. Use this product should be cautious for children under 2months of age.Children have limited experience with deep intramuscular injections.For liver insufficiency, there is no need to adjust the dose of this product.Adverse reactionsThis product is usually well tolerated, adverse reactions are mild and short-lived, termination of treatment is rare. Common adverse reactions associated with this product are mainly diarrhea, rashes and local injection reactions such as phlebitis, pain and inflammation at the injection site. Other adverse reactions included nausea, vomiting, allergies, itching, fever, paresthesias, and headaches. Patients with renal insufficiency who do not respond to cefepime dose adjustments can cause encephalopathy, muscle spasm, and epilepsy. If treatment-related epilepsy occurs, medication should be discontinued and, if necessary, anticonvulsant therapy should be performed. This product for the treatment of children with meningitis, occasional convulsions, drowsiness, nervousness and headache, mainly caused by meningitis, no significant relationship with this product.Occasionally enteritis (including pseudomembranous colitis) and oral candidiasis were reported.Abnormalities in laboratory tests associated with this product are mostly transient and can be restored by discontinuation of the drug, including elevated or reduced serum phosphorus, elevated aminotransferases (ALT and AST), eosinophilia, partial prothrombin time, and coagulation Prolonged zymogen time. Alkaline phosphatase, blood urea nitrogen, creatinine, serum potassium, and total bilirubin increased, blood calcium decreased, and hematocrit decreased. Similar to other cephalosporin antibiotics, there are reports of leukopenia, neutropenia, and thrombocytopenia.Cephalosporins can also cause Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrosis, renal dysfunction, toxic nephropathy, aplastic anemia, hemolytic anemia, hemorrhage, liver dysfunction (cholestasis) and blood cells cut back.ContraindicationThis product is contraindicated in patients with immediate allergic reactions to cefepime or L-arginine, cephalosporins, penicillins or other beta-lactam antibiotics.Precautions Before using this product, it should be determined whether the patient has ahistory of cefepime, other cephalosporins, penicillin or other beta-lactam antibiotics. Patients should be cautious about any history of allergies, especially drug allergies.Broad-spectrum antibacterial drugs can induce pseudomembranous colitis. The possibility of pseudomembranous colitis should be considered when the patient develops diarrhea during treatment with this product. For mild cases of enteritis, only drugs can be stopped; moderate and severe cases require special treatment. Patients with gastrointestinal disorders, especially enteritis, should be careful about cefepime.Like other cephalosporin antibiotics, cefepime may cause adecrease in prothrombin activity. Patients with risk factors for decreased prothrombin activity, such as liver and renal insufficiency, malnutrition, and prolonged antimicrobial therapy should monitor prothrombin time and give exogenous vitamin Kif necessary.This product contains arginine at adose of 33 times the maximum recommended dose will cause glucose metabolism disorder and transient potassium elevation. The effect of arginine at lower doses is not yet clear.For patients with renal insufficiency (creatinine elimination rate ≤60 ml/min), the dosage of this product or the administration interval should be adjusted according to renal function.When the product is combined with aminoglycosides or potent diuretics, clinical observations should be strengthened and renal function should be monitored to avoid initiating the nephrotoxic or ototoxic effects of aminoglycosides.Dosing for pregnant and lactating womenAlthough animal reproductive toxicity tests and teratogenic tests have shown that cefepime is not teratogenic and embryotoxic, there are no sufficient and well-controlled clinical data on the use of this product in pregnant women and women during childbirth. Therefore, this product should be used with caution for pregnant women.Cefepime is minimally excreted in human milk (concentration approximately 0.5 &g; g/ml). Cefepime should be used with caution in lactating women.StorageShading, closed, preserved in adry and cool place.ProductphotoOur 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 Certificate/Free sales certificateCertificate of Pharmaceutical ProductsManufacture LicenseCTD Dossier.