安命諾得含電解質輸注液10%

国家: 台湾

语言: 中文

来源: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

资料单张 资料单张 (PIL)
03-12-2021
公众评估报告 公众评估报告 (PAR)
10-06-2020

有效成分:

ISOLEUCINE;;LEUCINE;;LYSINE HCL;;METHIONINE;;PHENYLALANINE;;THREONINE;;TRYPTOPHAN;;VALINE;;ARGININE;;HISTIDINE;;ALANINE;;GLYCINE (EQ TO AMINOACETIC ACID)(EQ TO GLYCOCOLL);;ASPARTIC ACID;;GLUTAMIC ACID;;PROLINE;;SERINE;;TYROSINE;;SODIUM ACETATE TRIHYDRATE (EQ TO SODIUM ACETATE 3H2O );;SODIUM HYDROXIDE;;POTASSIUM ACETATE;;MAGNESIUM CHLORIDE HEXAHYDRATE (EQ TO MAGNESIUM CHLORIDE 6H2O);;SODIUM PHOSPHATE DIBASIC DODECAHYDRATE (EQ TO DISODIUM PHOSPHATE DODECAHYDRATE)

可用日期:

台灣柏朗股份有限公司 台北市松山區健康路152號9樓 (23525106)

ATC代码:

B05BA10

药物剂型:

注射劑

组成:

POTASSIUM ACETATE (4008000100) MG; SODIUM ACETATE TRIHYDRATE (EQ TO SODIUM ACETATE 3H2O ) (4008000670) MG; MAGNESIUM CHLORIDE HEXAHYDRATE (EQ TO MAGNESIUM CHLORIDE 6H2O) (4012001550) MG; ALANINE (4020100200) MG; ARGININE (4020100300) MG; ASPARTIC ACID (4020100400) MG; GLUTAMIC ACID (4020100700) MG; HISTIDINE (4020100900) MG; ISOLEUCINE (4020101000) MG; LEUCINE (4020101200) MG; LYSINE HCL (4020101310) (eq. to lysine 6.85mg)MG; METHIONINE (4020101500) MG; PHENYLALANINE (4020101700) MG; PROLINE (4020101800) MG; SERINE (4020101900) MG; THREONINE (4020102000) MG; TRYPTOPHAN (4020102100) MG; TYROSINE (4020102200) MG; VALINE (4020102300) MG; GLYCINE (EQ TO AMINOACETIC ACID)(EQ TO GLYCOCOLL) (4020102400) MG; SODIUM PHOSPHATE DIBASIC DODECAHYDRATE (EQ TO DISODIUM PHOSPHATE DODECAHYDRATE) (5612002607) MG; SODIUM HYDROXIDE (9600028200) MG

每包单位数:

玻璃瓶裝

类:

製 劑

处方类型:

限由醫師使用

厂商:

B. BRAUN MELSUNGEN AG CARL-BRAUN-STRABE 1, 34212 MELSUNGEN, GERMANY DE

治疗领域:

combinations

疗效迹象:

無法經口服攝取食物或腸道吸收營養、功能不全或有禁忌症時,作為靜脈營養治療提供胺基酸和限量的電解質之補充。適用於成人、青少年和2歲以上兒童。

產品總結:

有效日期: 2025/04/13; 英文品名: Aminoplasmal Neo 10% E

授权日期:

2010-04-13

资料单张

                                1.
NAME OF THE MEDICINAL PRODUCT
Aminoplasmal Neo 10% E
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The solution for infusion contains:
per 1 ml
per 250 ml
per 500 ml
per 1000 ml
Isoleucine
5.00 mg
1.25 g
2.50 g
5.00 g
Leucine
8.90 mg
2.23 g
4.45 g
8.90 g
Lysine hydrochloride
8.56 mg
2.14 g
4.28 g
8.56 g
(equivalent to lysine)
(6.85 mg)
(1.71 g)
(3.43 g)
(6.85 g)
Methionine
4.40 mg
1.10 g
2.20 g
4.40 g
Phenylalanine
4.70 mg
1.18 g
2.35 g
4.70 g
Threonine
4.20 mg
1.05 g
2.10 g
4.20 g
Tryptophan
1.60 mg
0.40 g
0.80 g
1.60 g
Valine
6.20 mg
1.55 g
3.10 g
6.20 g
Arginine
11.50 mg
2.88 g
5.75 g
11.50 g
Histidine
3.00 mg
0.75 g
1.50 g
3.00 g
Alanine
10.50 mg
2.63 g
5.25 g
10.50 g
Glycine
12.00 mg
3.00 g
6.00 g
12.00 g
Aspartic acid
5.60 mg
1.40 g
2.80 g
5.60 g
Glutamic acid
7.20 mg
1.80 g
3.60 g
7.20 g
Proline
5.50 mg
1.38 g
2.75 g
5.50 g
Serine
2.30 mg
0.58 g
1.15 g
2.30 g
Tyrosine
0.40 mg
0.10 g
0.20 g
0.40 g
Sodium acetate
trihydrate
2.858 mg
0.715 g
1.429 g
2.858 g
Potassium acetate
2.453 mg
0.613 g
1.227 g
2.453 g
Sodium hydroxide
0.360 mg
0.090 g
0.180 g
0.360 g
Magnesium chloride
hexahydrate
0.508 mg
0.127 g
0.254 g
0.508 g
Disodium phosphate
dodecahydrate
3.581 mg
0.895 g
1.791 g
3.581 g
_Electrolyte concentrations_
Sodium
50 mmol/l
Potassium
25 mmol/l
Magnesium
2.5 mmol/l
Acetate
46 mmol/l
Chloride
52 mmol/l
Phosphate
10 mmol/l
Citrate
1.0 – 2.0 mmol/l
Total amino acids
100 g/l
Total nitrogen
15.8 g/l
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion.
Clear, colourless up to faintly straw-coloured aqueous solution.
Energy [kJ/l (kcal/l)]
1675 (400)
Theoretical osmolarity [mOsm/l]
1021
Acidity (titration to pH 7.4) [mmol NaOH/l]
approx. 26
pH
5.7 – 6.3
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Supply of amino acids and a limited amount of electrolytes for paren-
teral nutrition, when oral or enteral nutrition is impossible,
insufficient or
contraindicated. For adults, adolescents and children over 2 years of
age.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
                                
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