Sundent Pharmaceutical Co., Ltd.  

Product Name: GMP Intralipid Injection 50g250ml, 50g500ml Model NO.: 50g250ml, 50g500ml Pharmaceutical Technology: Chemical Synthesis Type: Vitamin and Nutrition Shape: Liquid Suitable for: Elderly, Children, Adult Application: Internal Medicine Certification: GMP Standard: Cp OEM: Available Shelf Life: 3 Years Trademark: Sundent Transport Package: 1bottle/Box Specification: 50g250ml, 50g500ml Origin: China HS Code: 3004909099 Product Description Intralipid injection 250ml50g, 500ml50gIndicationsEnergy supplement medicine. This product is one of the components of intravenousnutrition, providing energy and essential fatty acids for the body, for supplemental energy and essential fatty acids for parenteral nutrition, prevention and treatment of essential fatty acid deficiency in the human body, but also unable to maintain and restore normal oral administration Patients with essential fatty acid levels provide essential fatty acids. 30% fat emulsion injection is more suitable for patients whose infusion volume is limited and whose energy demand is highly increased. Lecithin can assist in the treatment of atherosclerosis, fatty liver, and pediatric eczema, neurasthenia. As solubilizers, emulsifiers and antioxidants for oils and fats in pharmaceutical excipients.IngredientsActive ingredient: This product is acompound preparation, which is made from soybean oil for injection by emulsifying with lecithin by injection and adding glycerin for injection to make asterilized milky liquid.DosageAdults: Intravenous drip, the maximum recommended daily dose is 3g (triglyceride)/kg based on fat mass. This product can provide 70% of the total energy. The infusion time of 10%, 20% fat emulsion injection 500ml is not less than 5hours; the infusion time of 30% fat emulsion injection 250ml is not less than 4hours. Newborns and infants: 10%, 20% fat emulsion daily dose of 0.5 ~4g (triglyceride) /kg, infusion rate does not exceed 0.17g /(kg ·hours). The maximum daily usage should not exceed 4g/kg. only in close monitoring of serum triglycerides, liver function, oxygen saturation and other indicators of the infusion dose can be gradually increased to 4g/kg per day. Preterm infants and low-birth newborns are best given continuous 24-hour infusions, starting at adaily dose of 0.5 to 1g/kg and gradually increasing to 2g/kg daily thereafter. Essential fatty acid deficiency: For the prevention and treatment of essential fatty acid deficiency (EFAD), at least 4% to 8% of the energy in the non-protein calorie card should be provided by fat emulsion injection to provide adequate amounts of linoleic acid and flax acid. When EFAD is combined with stress, the amount of fat emulsion injection needed to treat EFAD should also increase accordingly. Usage: This product can be individually infused or used to formulate "all-in-one" nutrient mixture containing glucose, fat, amino acids, electrolytes, vitamins and trace elements. only if the compatibility can be guaranteed, can other drugs be added to this product. This product can also be injected into the body with glucose injection or amino acid injection via Y-tube. The law applies to both central and peripheral veins. Under aseptic conditions, the following drugs can be added to this product. 1. Vitalipatite (adult)/Vital Lipiti (children) 2. Hydrovitamin (For details on the preparation method, see the Hydrovitamin manual).Adverse reactionsCan cause increased body temperature, occasionally chills, chills, and nausea and vomiting. Other side effects are rare and include: 1. Immediate and early side effects: hypersensitivity reactions (anaphylaxis, rashes, urticaria), respiratory effects (such as shortness of breath), and circulatory effects (such as hypertension/hypotension). Hemolysis, reticulocytosis, abdominal pain, headache, tiredness, abnormal penile erection, etc. 2. Delayed side effects: long-term infusion of the product, the baby may have thrombocytopenia. In addition, even if you do not use this product for long-term intravenous nutrition, there will be transient liver function abnormalities. Even phlebitis, vascular pain, and bleeding tendency can occur. 3. When the patient's fat clearance capacity declines, fat overload syndrome may be caused despite normal infusion rate. Fat overload syndrome can occasionally occur in patients with renal dysfunction and infection. Fat overload syndrome manifests as hyperlipidemia, fever, fatty infiltration, organ dysfunction, etc. However, as long as the infusion is stopped, the above symptoms can be resolved.ContraindicationDisability in patients with shock and severe dyslipidemia (such as hyperlipidemia)PrecautionsThis product is used with caution in patients with impaired fat metabolism, such as liver and renal insufficiency, diabetic ketoacidosis, pancreatitis, hypothyroidism (accompanied by hyperlipidemia) and caution in sepsis patients. When these patients are infused with this product, serum triglyceride levels should be closely observed. Patients who have been continuously used for more than one week should be examined for their fat-soaking capacity. Allergic to soy protein allergy should be used with caution, allergy tests must be done before use. Newborns and immature children with hyperbilirubinemia or suspicious pulmonary hypertension should use this product with caution. In neonates, especially immature children, long-term use of this product must monitor platelet counts, liver function tests, and serum triglyceride concentrations. When blood is collected, if the product has not been completely removed from the blood stream, it will interfere with other laboratory tests (such as bilirubin, lactate dehydrogenase, oxygen saturation, hemoglobin, etc.). Most patients can be completely removed 5to 6hours after infusion of this product. Pregnant women: There have been reports that pregnant women using 10% and 20% fat emulsion injections are safe and successful. Theoretically, 30%, like 10% and 20% fat emulsion injections, can also be used in pregnant women, but evidence of animal reproduction studies is still lacking. Infants and children: For infants and children, the lack of 30% fat emulsion injections is not recommended for infants and children. Use this product more than one week must do fat clearance test. Specific operations are as follows: blood samples taken before infusion, centrifuged, if the plasma is milky, the original infusion plan should be delayed implementation (this method does not apply to patients with hyperlipidemia); when the patient's fat clearance capacity is found to be reduced, It is best to check serum triglycerides. For infants and children, the most reliable way to monitor fat profile is to measure serum triglyceride levels on aregular basis.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 CertificateFree sales certificateCertificate of Pharmaceutical ProductsManufacture LicenseCTD Dossier.