Medication info

Smofkabiven Injection

Prescription medicationSolution주사
Ingredient · strength
L-Alanine›14gL-Arginine›12gGlycine›11gL-Histidine›3gL-Isoleucine›5gL-Leucine›7.4gL-Lysine Acetate›9.3gL-Methionine›4.3gL-Phenylalanine›5.1gL-Proline›11.2gL-Serine›6.5gTaurine›1gL-Threonine›4.4gL-Tryptophan›2gL-Tyrosine›0.4gL-Valine›6.2gCalcium Chloride Hydrate›0.74gAnhydrous Sodium Glycerophosphate›4.18gMagnesium Sulfate Heptahydrate›2.47gPotassium Chloride›4.48gSodium Acetate Hydrate›5.62gZinc Sulfate Heptahydrate›0.023gGlucose Monohydrate›462gSoybean Oil›60gTriglycerides Medium-Chain›60gPurified Olive Oil›50gPurified Fish Oil (High Dose Omega-3 Fatty Acids)›30g
Manufacturer / importer
프레지니우스카비코리아(주)
Appearance
This product consists of a plastic container for infusion divided into three compartments, with an oxygen absorber placed in between them. Each inner bag contains an amino acid and electrolyte solution.
Packaging
986 mL/bag [(A solution 500 mL, B solution 298 mL, C solution 188 mL) x 4], 1477 mL/bag [(A solution 750 mL, B solution 446 mL, C solution 281 mL) x 4], 1970 mL/bag [(A solution 1000 mL, B solution 595 mL, C solution 375 mL) x 4]
Approval status
Active

MFDS item code 200811793 · Approved 2008.12.23 · Insurance code 650901580,650901590,650901600

Summary

Main use
Caloric and nutrient supply effect through intravenous nutrition
Who receives it
Adults · Children
Adult administration
The dosage and infusion rate are determined based on the patient's ability to eliminate fat, nitrogen and carbohydrate metabolism capabilities, and nutritional requirements. For adults and children aged 12 years and older: patients with normal nutritional status or mild metabolic stress: amino acid dosage of 0.6-0.9 g/kg/day (nitrogen of 0.10-0.15 g/kg), patients with moderate to severe metabolic stress: amino acid dosage of 0.9-1.6 g/kg/day (nitrogen of 0.15-0
Child administration
For children aged 2-11 years, the dosage should be regularly adjusted up to 35 mL/kg per day. The infusion rate should not exceed 2.4 mL/kg per hour, except in special circumstances.

Ingredients

Importer
프레지니우스카비코리아(주)

Efficacy & effects

Caloric and nutrient supply effect through intravenous nutrition

View approved original text

This medicine is used for children aged 2 years and older and adults who cannot obtain nutrition orally or through the gastrointestinal tract. It effectively improves the patient's nutritional status by supplying essential nutrients directly through venous infusion, including calories, amino acids, essential fatty acids, and omega-3 fatty acids. This helps support growth and recovery while preventing nutritional imbalances. It is mainly used when there is a need for long-term nutritional support.

How it is given

Adult administration

The dosage and infusion rate are determined based on the patient's ability to eliminate fat, nitrogen and carbohydrate metabolism capabilities, and nutritional requirements. For adults and children aged 12 years and older: patients with normal nutritional status or mild metabolic stress: amino acid dosage of 0.6-0.9 g/kg/day (nitrogen of 0.10-0.15 g/kg), patients with moderate to severe metabolic stress: amino acid dosage of 0.9-1.6 g/kg/day (nitrogen of 0.15-0

Child administration

For children aged 2-11 years, the dosage should be regularly adjusted up to 35 mL/kg per day. The infusion rate should not exceed 2.4 mL/kg per hour, except in special circumstances.

Precautions

This medication must be used strictly according to a physician's instructions and if symptoms of anaphylaxis such as fever, chills, rash, or dyspnea occur during use, administration should be stopped immediately. When used with intravenous calcium preparations, precipitation may occur, so do not use the same infusion equipment simultaneously; the infusion line should be thoroughly cleaned if necessary. Particular caution is required when administering to premature or underweight infants, and there have been reports of fatalities in cases with severe respiratory diseases, so it should be administered carefully. It should not be administered to patients with allergies to fish, eggs, soybeans, or peanuts, as well as those with severe hyperlipidemia, liver dysfunction, bleeding disorders, renal failure, acute shock, uncontrolled hyperglycemia, etc. Patients with renal failure, diabetes, or liver dysfunction should be administered cautiously, and during administration, blood triglyceride levels, electrolytes, blood glucose, and liver function should be periodically monitored to detect abnormalities at an early stage. This medication may cause side effects such as fat overload syndrome, amino acid overload, and hyperglycemia in cases of overdose, so the administration rate and dosage must be strictly managed. Additionally, this product contains soybean oil, fish oil, and egg yolk phospholipids, which may rarely cause allergic reactions, so caution is needed for patients with a history of allergies. Aseptic procedures are essential during administration to prevent infections, and before administration, the solution should be checked for homogeneity and transparency. Safety during pregnancy or breastfeeding has not been established, and it should only be administered if the benefits outweigh the risks. In cases of overdose, administration should be discontinued or the infusion rate slowed, and if necessary, treatments such as insulin administration or hemodialysis may be required.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, anaphylactic reactions, severe rash with high fever, blisters, skin peeling, pain in oral or eye mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme fatigue, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances

Mild side effects

Anorexia, nausea, vomiting, increased plasma liver enzyme levels, thrombophlebitis, hypotension, hypertension, slight increase in body temperature, chills, headache, dizziness, skin rash, flushing, warmth, coolness, cyanosis, pallor, pain (in the neck, back, bones, chest, lower back), hyperglycemia, nausea, sweating, constipation, diarrhea, abdominal pain, dyspepsia, generalized weakness, hypoglycemia, frequent urination, phlebitis, extravasation at the infusion site, heartburn, runny nose, cough

Not everyone experiences these, and they can vary from person to person.

Storage

This product should be stored in a sealed container and kept in a cool place, below 25 degrees Celsius. It is important not to freeze it, as freezing may alter the product's components.

Appearance and packaging

Appearance

This product consists of a plastic container for infusion divided into three compartments, with an oxygen absorber placed in between them. Each inner bag contains an amino acid and electrolyte solution.

Package unit

986 mL/bag [(A solution 500 mL, B solution 298 mL, C solution 188 mL) x 4], 1477 mL/bag [(A solution 750 mL, B solution 446 mL, C solution 281 mL) x 4], 1970 mL/bag [(A solution 1000 mL, B solution 595 mL, C solution 375 mL) x 4]

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.