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Products
Finished Dosage Forms
Injectables & Parenterals
Large Volume Parenterals (LVP)/IV Infusions

Dotte

CT

Công ty Cổ phần Dược phẩm Thế Giới Mới

Marketing Authorization Holder · Finished Dosage FormsViet Nam

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Dotte

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Drug Marketing Authorization Number

Document No.: 690110767924

Issue Date: Aug 11, 2024

Expiry Date: Aug 11, 2029

Note: 593/QĐ-QLD | 121

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Dotte | Pharmacountry

Dosage Form: Emulsion intravenous infusion
Packaging: Bag 1440 mL comprising 3 compartment
Strength: Mỗi túi có thể tích 1440ml gồm 3 ngăn chứa: -Dung dịch Glucose 11%: 885ml -Dung dịch các Acid amin: 300ml -Nhũ tương chất béo 20% : 255ml Hàm lượng hoạt chất trong mỗi túi 1440ml: Anhydrous glucose 97g; Alanine 4,8g; Arginine 3,4g; Aspartic acid 1g
Standards: In-house standard
Shelf Life: 24 month

Finished Dosage Forms

Injectables & Parenterals

Large Volume Parenterals (LVP)/IV Infusions

Each bag with thể tích 1440 mL comprising 3 compartment containing: - solution Glucose 11 %: 885 mL - solution acid amin: 300 mL - emulsion substance béo 20 %: 255 mL Hàm lượng active ingredient clear each bag 1440 mL: Anhydrous glucose 97 g

Aspartic acid 1g

Phenylalanine 2,4g

Glutamic acid 1,7g

Isoleucine 1,7g

Lysine hydrochloride 3,4g

Methionine 1,7g

Tryptophan 0,57g

Tyrosine 0,069g

Sodium glycerophosphate (on anhydrous basis) 1,5g

Calcium chloride (on anhydrous basis) 0,22g

Potassium chloride 1,8g

Magnesium sulfate (on anhydrous basis) 0,48g

Sodium acetate (on anhydrous basis) 1,5g

Soybean oil 51g

-Dung dịch Glucose 11%: 885ml -Dung dịch các Acid amin: 300ml -Nhũ tương chất béo 20% : 255ml Hàm lượng hoạt chất trong mỗi túi 1440ml: Anhydrous glucose

Lysine hydrochloride

Sodium glycerophosphate (on anhydrous basis)

Calcium chloride (on anhydrous basis)

Potassium Chloride

Magnesium sulfate (on anhydrous basis)

Sodium acetate (on anhydrous basis)

L-Phenylalanine

Sichuan Kelun Pharmaceutical Co., Ltd