Product Name: GMP Cefalexin Capsule 125mg, 250mg, 500mg Model NO.: 125mg, 250mg, 500mg Pharmaceutical Technology: Chemical Synthesis Type: Antibiotic Shape: Capsules Suitable for: Children, Adult Application: Internal Medicine Certification: GMP Standard: Cp, USP OEM: Available Shelf Life: 3 Years Trademark: Sundent Transport Package: 10capsules/Blister Specification: 125mg, 250mg, 500mg Origin: China HS Code: 3004909099 Product Description DescriptionCefalexin capsule 125mg, 250mg, 500mgIngredientsThis product is mainly composed of cephalexin.Chemical name: (6R,7R)-3-methyl-7-[(R)-2-amino-2-phenylacetylamino]-8-oxo-5-thia-1-azabicyclo[4.2. 0] Oct-2-ene-2-carboxylic acid-hydrate.Molecular formula: C16H17N3O4S·H2OMolecular weight: 365.41CharacterThis product is acapsule.IndicationsApplicable to sensitive bacteria caused by acute tonsillitis, angina, otitis media, sinusitis, bronchitis, pneumonia and other respiratory infections, urinary tract infections and skin and soft tissue infections. This product is an oral preparation and should not be used for severe infections.SpecificationCalculate 0.25g by C16H17N3O4SDosageAdult dose: Oral. Usually 250 ~500mg, 4times aday, the highest dose of 4g aday. Patients with impaired renal function should be given reduced doses based on the degree of impaired renal function. Simple cystitis, skin and soft tissue infections, and streptococcal angina patients 500 mg every 12 hours.Child dose: Oral. Daily weight 25 ~50mg/kg, 4times aday. Skin and soft tissue infections and streptococcal angina patients take oral administration of 12.5 to 50 mg/kg every 12 hours.Adverse reactions1. Nausea, vomiting, diarrhea and abdominal discomfort are more common.2. Allergic reactions such as skin rashes and drug fever can cause anaphylactic shock.3. Dizziness, diplopia, tinnitus, convulsions and other nervous system reactions.4. Even transient kidney damage may occur during the application of this product.5. Occasionally, patients have elevated serum aminotransferases and positive Coombs tests. Rare hemolytic anemia, neutropenia and pseudomembranous colitis have also been reported.ContraindicationsAllergic to cephalosporins and penicillin anaphylactic shock or immediate reaction history were banned.Precautions1. Before applying this product, patients must be asked in detail about the cephalosporins, penicillins and other drugs allergic history, history of penicillin drugs allergic shock can not be applied to this product, other patients must pay attention to cephalosporins and the application of this product The chance of cross-allergic reactions in penicillins is about 5% to 7%, which should be used with caution under close observation. In the event of an allergic reaction, the drug is discontinued immediately. If anaphylactic shock occurs, it must be rescued on the spot, including maintaining airway patency, oxygen intake, and the use of adrenaline and glucocorticoids.2. Patients with ahistory of gastrointestinal disease, especially those with ulcerative colitis, localized colitis, or antibiotic-associated colitis (with cephalosporin rarely producing pseudomembranous colitis), and those with impaired renal function should use this product with caution.3. Disturbance to Diagnosis: Direct Coombs test positive reaction and urine sugar false positive reaction (copper sulphate method) may occur when this product is used; Alkaline phosphatase, serum alanine aminotransferase and aspartate aminotransferase in afew patients Enzymes can increase.4. When daily oral doses exceed 4g (anhydrous cephalexin), cephalosporin drugs for injection should be considered.5. Cephalexin is mainly excreted by the kidneys, and patients with impaired renal function must reduce the amount of this product.StorageShade, seal, save in acool place (shading not exceeding 20°C).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.
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