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Product Information
Registration Number DR-XY40842
Generic Name Glucose + Amino Acids + Electrolytes + Lipid
Brand Name Smofkabiven Peripheral
Dosage Strength Formulation: Glicose 13%: Each mL contains: Glucose monohydrate-143mg Corresponding to glucose, anhydrous-130mg Lipid Emulsion 20% Each ml contains: Soya-bean oil, refined-60mg Triglycerides, medium chain-60mg Olive oil, refined-50mg Fish oil, rich in omega 3-acids-30mg Amino Acid solution 10% with electrolytes: Each ml contains. L-Alanine-14mg L-Arginine-12mg L-Proline-11.2mg Glycine (Amino acetic acid)-11mg L-Lysine acetate-9.3mg Corresponding to L-Lysine-6.6mg L-Leucine-7.4mg L-Serine-6.5mg L-Valine-6.2mg Sodium acetate trihydrate-5.62mg Corresponding to sodium acetate anhydrous-3.4mg L-Phenylalanine Potassium chloride-4.48mg L-Threonine-4.4mg L-Methionine-4.3mg Sodium glycerophosphate, anhydrous-4.18mg L-Histidine-3mg Magnesium sulfate heptahydrate-2.47mg corresponding to magnesium sulfate, anhydrous-1.2mg L-Tryptophan-2mg L-Taurine-1mg Calcium chlonde dehydrate-740mg corresponding to calçium chloride, anhydrous-560mg L-Tyrosine-400mg Zinc sulfate heptahydrate-23mg corresponding to zinc sulfate, anhydrous-12.9mg Electrolytes-5.1 mg Acetate-66 mmol/L Sodium-25 mmol/L Chloride-22 mmol/L Potassium-19 mmol/L Phosphate-8.2 mmoVL Magnesium-3.2 mmoll Sulfate-3.2 mmol/L Calcium-1.6 mmol/L Zinc-20 umol/L Osmolarity approx. 950 mosmol/kg water Osmolarity approx. 850 mosmol/L pH (after mixing) approx...5.6
Dosage Form Emulsion For IV Infusion
Classification Prescription Drug (RX)
Pharmacologic Category Parenteral Nutrition
Packaging Biofine three-chamber bag (1206 mL in box of 4's); 1448 mL in box of 4's; 1904 mL in box of 4's) Biofine th Biofine three-chamber bag (1206 mL in box of 1's); 1448 mL in box of 1's; 1904 mL in box of 1's)
Manufacturer Fresenius Kabi AB
Country of Origin Sweden
Trader N/A
Importer Fresenius Kabi AB
Distributor N/A
Application Type Automatic Renewal (Reconstruction)
Issuance Date 31 July 2024
Expiry Date 06 April 2026