Basic Info.
Model NO.
250ml: Soya Oil25g&Medium chain triglyceride25g
Function
Specialist Drugs, Anesthetic and Adjuvant
Grade Standard
Medicine Grade
Application
Internal Medicine
Usage Mode
for External Use
Suitable for
Elderly, Children, Adult
Pharmaceutical Technology
Chemical Synthesis
Trademark
medium and long chain fat emulsion inject
Specification
250ml: Soya Oil25g&Medium chain triglyceride25g
Origin
Qingyuan, Guangdong, China
Product Description
his information is only for medical or pharmacy professionals to read. Medium and Long Chain Fat Emulsion Injection (C8-24Ve)
Warning: Deaths in preterm infants have been reported in literature. Autopsy findings included intravascular fat accumulation in the lungs. Preterm and low birth weight infants have poor clearance of intravenous lipid emulsion and increased free fatty acid plasma levels following lipid emulsion infusion.[Drug Name]
Generic name: Medium and Long Chain Fat Emulsion Injection (C8-24Ve)
[Ingredients]
This product is a combination drug, which is composed of the followings:
Each 100ml of lipid emulsion contains:
Soybean Oil (for injection) 100.0g
Medium-Chain Triglycerides 100.0 g
Egg Yolk Phospholipid 12.0g
Glycerin (for injection) 25.0g
Other excipients: Sodium Oleate, Vitamin E, Sodium Hydroxide, Water for injection.
The content of essential fatty acids: |
Linoleic Acid | 48.0-58.0 g/L |
α-Linolenic Acid | 5.0-11.0 g/L |
Caloric Value | 8095 KJ/L |
Osmolality | 340-420 mOsmol/kg |
pH | 6.5-8.5 |
[Description]This product is a white lipid emulsion[Indications]This product is intended as a source of calories and essential fatty acids for parenteral nutrition.[Strength]250ml: 25g soybean oil and 25g medium-chain triglycerides [Dosage and Administration]This product is one of compositions for intravenous nutrition, which is for intravenous infusion only through a peripheral or central line. This product can be infused concurrently with dextrose and amino acids through a peripheral or central line by means of Y-connector located near the infusion site. Therefore, these three solutions can be mixed quickly before entering into the vein, the flow rate of each solution can be controlled separately by infusion pump. The fat emulsion should be warmed to room temperature before infusing.The maximum daily intake dosage should gradually achieve as per increment method while monitoring tolerance dosage closely.As per energy requirements:Adult and school-age child1-2g /kg (body weight)/day of fat Equivalent to 5-10ml/kg(body weight)/day of this productInfant2-3g /kg (body weight)/day of fat, maximum dose: 4g/kg/dayEquivalent to 10-15ml/kg (body weight) /day of this product, maximum dose: 20ml/kg/dayEspecially, Preterm and undernutrition infants completely have no ability to eliminate triglycerides and lipid. Therefore, it is necessary to adhere to recommended doses while monitoring the serum triglycerides, so as to avoid hyperlipemia. Infant and school-age child5-15ml/kg (body weight)/day of this productInfusion/drop rateIn principle, slowly and evenly infuse fat emulsion as soon as possible, especially within the first 15 mins, the infusion rate should not exceed 0.05-0.1 g/kg (body weight)/ hour of fat, equivalent to 0.25-.05ml/kg/hour of this productMaximum infusion rate:0.15 g/kg (body weight)/ hour of fat, equivalent to 0.75ml/kg(body weight)/hour of this productMaximum drop rate:0.25drops/kg(body weight)/minIn patients with 70kg bodyweight, the infusion rate is equivalent to about 50ml/hour, the drop rate is equivalent to 18drops/min at most. In patients or children requiring the nutrition reduce, the drop rate should be reduced as per the body weight.Adjust the infusion rate by taking into account the planned daily dose, which should be infused within 24hrs, at least within 16hrsThe means of intravenous infusion should be adopted. The fat emulsion is suitable for peripheral intravenous infusion, and is solely infused through peripheral vine within the range of complete parenteral nutrition.Use the filter by taking into account fat permeability.It is necessary to turn down air valve when infusing by means of flexible bag.Y-connector or bypass-connector should be located nearby the patient when the fat emulsion is concurrently infused with amino acid solution and carbohydrate solution. It is necessary to ensure that the infused solution obtained by mixing with this product is compatible through the final position.In the range of complete parenteral nutrition, the duration of infusion is 1-2 weeks. The duration of infusion can be appropriately prolonged under suitable monitoring if the indicator requiring parenteral nutrition with fat emulsion still exists.Or follow doctor's advice.Adverse reactions of similar productsHypersensitivity reactions (allergic shock), anaphylactoid reaction, hypersensitivity, epileptic seizure, phlebophlogosis, angiodynia, bleeding tendency [Contraindications]This product is contraindicated in patients who have:- known hypersensitivity to any ingredient of this product- known hypersensitivity to egg or soybean proteins or soybean product or peanut product- severe hyperlipidaemia- severe cruor disorder- severe hypohepatia- intrahepatic cholestasis- severe renal failure and not received replacement therapy- acute thromboembolic events- fat embolism- aggravated bleeding tendency- metabolic acidosisThe common contraindications of parenteral nutrition include the followings:- Unstable loop state with death threat (prostration or shock)- Unstable metabolism (e.g. severe post-traumatic syndrome, severe sepsis, unexplained coma)- Acute myocardial infarction or cerebral stroke- Un-correct body fluid or electrolyte balance disturbance, e.g. hypokalemia, hypotonic dehydration (refer to precautions)- Decompensated cardiac insufficiency- Acute lung edema[Drug interactions]HeparinIf administering heparin as per clinical dose, the lipoprotein lipase may momently release to loop system. Firstly, it may lead to rapidly decompose fat in the plasma, then the clearance rate of triglyceride momently reduces.Coumarin DerivativesThe soybean oil has a natural ingredient-vitamin K1, the content of which is low in this product. It is predicted that there is no apparently impact on coagulation process of patients receiving coumarin derivatives. Nevertheless, the coagulation situation of patients receiving coumarin derivatives should be also monitored.The product can't be used as carrier solutions of electrolyte concentrate or other drug, this emulsion must not mix with other infusion solution under no test since the emulsion stability can't sufficiently be ensured. The regimen of drug combination can also be used in parenteral nutrition only if it is ensured that the drugs are compatible and pass the test.Avoid mixing this product with infusion or injection containing alcohol [Overdosage]SymptomIn the event of overdose, hyperlipidaemia, metabolic acidosis and fat overload syndrome may result (See adverse reactions)TherapyIn the event of overdose, immediately stop the infusion. Other therapy measurements are taken according to detailed symptoms and severity.Restart the infusion after symptom decreases, it is recommended to gradually add infusion rate and frequently monitor . [Storage]Store below 25ºC, do not freeze[Package]Three layer co-extrusion infusion bag with outer barrier bag: 10 bags/carton, 20 bags/carton, 36 bags/carton[Expiry date]: 18months[Standard No.] YBH15102020 (issued by NMPA)[Registration No.]: H20213040 (issued by NMPA)[MAH]
Name: Guangdong Jiabo Pharmaceutical Co., Ltd.
Address: Bio-Pharmaceutical Park, High &New Technology industries development Zone, Qingyuan City, Guangdong Province, China
Post Code: 511517
[Manufacturer]
Name: Guangdong Jiabo Pharmaceutical Co., Ltd.
Address: Bio-Pharmaceutical Park, High &New Technology industries development Zone, Qingyuan City, Guangdong Province, China
Address:
Bio-Pharmaceutical Park, High&New Technology Industries Development Zone, Qingyuan, Guangdong, China
Business Type:
Manufacturer/Factory, Trading Company
Business Range:
Health & Medicine
Company Introduction:
Guangdong Jiabo Pharmaceutical Co. Ltd, which was established in 2003, is a new high-tech enterprise integrating drug research and development, manufacturing and sales.
Holding the company spirit of "Harmony, Preciseness, Progress, Innovation", Jiabo has developed into an innovative and high-tech pharmaceutical enterprise that focusing on perioperative field and special injection over the past 17 years.
Relying on the R&D center, Jiabo has actively conducted external cooperation, building up technological platform such as the production, study and research base of sun yat-sen university, the technology research center of intravenous fat emulsion engineering of Guangdong Province, and the post-doctoral innovation and practice base of Guangdong Province.
Jiabo has the production line of small volume injection, large volume injection and soft bag line. The main product of the company, Propofol Medium and Long Chain Fat Emulsion Injection, is a new and high-tech product in Guangdong Province and has won the honor of the China Patent Excellence Award and the third prize of the Guangdong Science Award. In addition, Jiabo is the national quality standard drafting company for propofol emulsion injection.
Our products are distributed throughout the country with the annual sales volume increasing year by year.