GMP Intravenous Fat Emulsion, Intralipid Injection Infusion

• Application: Internal Medicine
• Usage Mode: Infusion
• Suitable for: Elderly, Children, Adult
• State: Liquid
• Shape: Injection
• Type: Biological Products
• Model NO.: injection
• Pharmaceutical Technology: Natural Product Extraction
• Name: Fat Emulsion
• Use: Infusion
• Transport Package: Bag
• Trademark: DMSCARE
• Origin: China
• Production Capacity: 500000box

Product Description

Product Description

Intralipid injection 250ml 50g, 500ml 50g
Indications
Energy supplement medicine. This product is one of the components of intravenous 
nutrition, 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.
Ingredients
Active ingredient: This product is a compound preparation, which is made from soybean oil for injection by emulsifying with lecithin by injection and adding glycerin for injection to make a sterilized milky liquid.
Dosage
Adults: 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 5 hours; the infusion time of 30% fat emulsion injection 250ml is not less than 4 hours. 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 a daily dose of 0.5 to 1 g/kg and gradually increasing to 2 g/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 reactions
Can 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.
Contraindication 
Disability in patients with shock and severe dyslipidemia (such as hyperlipidemia)
Precautions
This 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 5 to 6 hours 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 a regular basis.

The regulatory documents we can provided:
GMP Certificate / CE Certificate,Free sales certificate,Certificate of Pharmaceutical Products,Manufacture License,CTD Dossier.