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Product Name: Diclofenac Sodium Injection Model NO.: 75mg3ml Drug Ad Approval No.: Available Drug Reg./Approval No.: Available Pharmaceutical Technology: Chemical Synthesis Type: Organic Chemicals Shape: Liquid for Injection State: Liquid Suitable for: Elderly, Children, Adult Usage Mode: For external use Application: Internal Medicine Quality Standard: Cp Certification: GMP Shelf Life: 3years OEM: Available Trademark: Sundent Transport Package: 10ampoules/Box Specification: 3ml Origin: China HS Code: 3004909099 Product Description Diclofenac Sodium InjectionIndicationIt is used to relieve joint swelling and pain symptoms in various acute arthritis cases such as rheumatoid arthritis, osteoarthritis, spondyloarthropathies, gouty arthritis, and rheumatoid arthritis. 2. Relieve all kinds of soft tissue rheumatic pain during acute attack, such as shoulder pain, tenosynovitis, bursitis, myalgia and so on. 3. Acute mild to moderate pain such as post-operative, post-traumatic, post-exercise and post-exercise traumatic pain, primary dysmenorrhea, toothache, and headache. 4. It has antipyretic effects on fever in adults and children.Usage andDosageDeep intramuscular injection. One75mg (one), 2or 3times aday.Contraindications1. Patients with an allergic or asthmatic history of aspirin or other non-steroidal anti-inflammatory drugs are prohibited.2. Pregnant and lactating women are disabled.Pharmacology and toxicology1. PharmacologyDiclofenac sodium is anon-steroidal anti-inflammatory analgesic derived from phenylacetic acid. Its mechanism of action is inhibition of cyclooxygenase activity, thereby blocking the conversion of arachidonic acid to prostaglandin. At the same time, it can also promote the combination of arachidonic acid and triglycerides, reduce the concentration of free arachidonic acid in cells, and indirectly inhibit the synthesis of leukotrienes.Diclofenac sodium is apotent non-steroidal anti-inflammatory drug. It has astronger inhibitory effect on prostaglandin synthesis than aspirin and indomethacin.2. ToxicologyDiclofenac sodium was given to rats daily at 2mg/kg. No long-term observations revealed an increase in the incidence of tumors. In atwo-year study of mice, 2mg/kg of drug was administered daily, and no tumor proneness was observed. Various mutation studies have not found diclofenac-induced gene mutations. The rats were treated with 4mg/kg daily, and no infertility occurred in males and females.Acute toxicity test results: The oral LD50 of rats is 150 mg/kg; the oral LD50 of mice is 390 mg/kg.Shelf Life36 monthsStorageSeal storage. The formulated liquid is for single use only and must not be frozen or refrigerated.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.Technical Supportregulatory documentsYesGMP Certificate /CE CertificateYesFree sales certificateYesCertificate of Pharmaceutical ProductsYesManufacture LicenseYesCTD DossierYes
