Medium and Long Chain Fat Emulsion Injection (C8-24 Ve)

• Function: Specialist Drugs, Anesthetic and Adjuvant
• Certification: GMP
• Grade Standard: Medicine Grade
• Type: Biological Products
• State: Liquid
• Volatile: Volatile
• Model NO.: 250ml: Soya Oil25g&Medium chain triglyceride25g
• Application: Internal Medicine
• Usage Mode: for External Use
• Suitable for: Elderly, Children, Adult
• Pharmaceutical Technology: Chemical Synthesis
• Transport Package: Carton
• Specification: 250ml: Soya Oil25g&Medium chain triglyceride25g
• Trademark: medium and long chain fat emulsion inject
• Origin: Qingyuan, Guangdong, China
• HS Code: 3004909099

Product Description

his information is only for medical or pharmacy professionals to read.                                

Medium and Long Chain Fat Emulsion Injection (C_8-24Ve)

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 (C_8-24Ve)

[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 child
1-2g /kg (body weight)/day of fat 
Equivalent to 5-10ml/kg(body weight)/day of this product
Infant
2-3g /kg (body weight)/day of fat, maximum dose: 4g/kg/day
Equivalent to 10-15ml/kg (body weight) /day of this product, maximum dose: 20ml/kg/day
Especially, 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 child
5-15ml/kg (body weight)/day of this product
Infusion/drop rate
In 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 product
Maximum infusion rate:
0.15 g/kg (body weight)/ hour of fat, equivalent to 0.75ml/kg(body weight)/hour of this product
Maximum drop rate:
0.25drops/kg(body weight)/min
In 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 16hrs
The 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 products
Hypersensitivity 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 acidosis
The 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]
Heparin
If 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 Derivatives
The 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]
Symptom
In the event of overdose, hyperlipidaemia, metabolic acidosis and fat overload syndrome may result (See adverse reactions)
Therapy
In 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