| Product Information |
|
| Registration Number |
DRP-14444
|
| Generic Name |
42% Glucose + 20% Lipids Emulsion + 10% Amino
Acids with Electrolytes.
|
| Brand Name |
Omapone Central
|
| Dosage Strength |
Solution A (10% Amino Acids with Electrolytes):
Each 100 mL contains:
L-Alanine 1.40 g
L-Arginine 1.20 g
Glycine 1.10 g
L-Histidine 300 mcg
L-Isoleucine 500 mcg
L-Leucine 740 mcg
L-Lysine acetate (as L-Lysine 930 mcg) 660 mcg
L-Methionine 430 mcg
L-Phenylalanine 510 mcg
L-Proline 1.12 g
L-Serine 650 mcg
Glacial acetic acid q.s.
Water for Injection q.s.
Taurine 100 mcg
L-Threonine 440 mcg
L-Tryptophan 200 mcg
L-Tyrosine 40 mcg
L-Valine 620 mcg
Calcium chloride dihydrate (as Calcium as calcium chloride dehydrate 74 mcg) 56 mcg
Sodium glycerophosphate (anhydrous) 418 mg
Magnesium sulfate (as magnesium sulfate hepathydrate 247 mcg) 120 mcg
Potassium chloride 448 mcg
Sodium acetate (as sodium acetate trihydrate 526 mcg) 340 mcg
Zinc (as zinc sulfate heptahydrate 2.3 mcg) 0.5 mcg
Solution B (42% Glucose):
Each 100 mL contains:
Glucose monohydrate (as Glucose 46.2g) 42 g
Hydrochloric acid q.s
Water for injection q.s
Emulsion C (20% Lipids Emulsion)
Each 100 mL contains:
Soybean oil, refined 6 g
Medium-chain triglycerides 6 g
Olive oil, refined 5 g
Fish oil, rich in omega 3 acids 3 g
Egg lecithin 1.2 g
Sodium oleate 30 mcg
dl-a-tocopherol 19.4 mg
Glycerol 2.5 g
Sodium hydroxide q.s.
Water for injection q.s.
|
| Dosage Form |
Emulsion for I.V. Infusion
|
| Classification |
Prescription (Rx) Drug
|
| Pharmacologic Category |
Parenteral Nutrition
|
| Packaging |
Clear and Transparent Non-PVC Bag connected with PP (Polypropylene) Closed Cap and Isoprene Rubber Flip- off Port Enclosed in Polyethylene Terephthalate (PET), silicon-oxide PET (SiOxPET), Ethylene Vinyl Alcohol Copolymer (EVOH), Nylon, Retort Cast PP Overwrap Pouch x 986 mL (Box of 4's), 1.477 L (Box of 4's)
|
| Manufacturer |
Hk Inno.N Corporation.
|
| Country of Origin |
Korea
|
| Trader |
N/A
|
| Importer |
Unilab, Inc.
|
| Distributor |
Unilab, Inc.
|
| Application Type |
Initial (Re-application)
|
| Issuance Date |
05 September 2023
|
| Expiry Date |
05 September 2028
|