安命諾補樂含電解質注射液-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)
31-05-2020
公众评估报告 公众评估报告 (PAR)
31-05-2020

有效成分:

L-ISOLEUCINE;;L-LEUCINE;;LYSINE L- (HCL);;L-METHIONINE;;L-PHENYLALANINE;;L-THREONINE;;L-TRYPTOPHAN;;L-VALINE;;L-ARGININE;;L-HISTIDINE;;GLYCINE (EQ TO AMINOACETIC ACID)(EQ TO GLYCOCOLL);;L-ALANINE;;L-PROLINE;;L-ASPARTIC ACID;;ASPARAGINE L- MONOHYDRATE (EQ TO ASPARAGINE H2O L- );;ACETYLCYSTEINE;;L-CYSTEINE;;GLUTAMIC ACID L-;;L-ORNITHINE HCL;;L-SERINE;;TYROSINE L-(N-ACETYL);;L-TYROSINE;;SODIUM ACETATE TRIHYDRATE (EQ TO SODIUM ACETATE 3H2O );;POTASSIUM ACETATE;;MAGNESIUM ACETATE TETRAHYDRATE;;SODIUM PHOSPHATE MONOBASIC (EQ TO MONOSODIUM PHOSPHATE)(EQ TO SODIUM DIHYDROGEN PHOSPHATE);;MALIC ACID L-;;SODIUM HYDROXIDE;;EDETATE DISODIUM DIHYDRATE (EQ TO DISODIUM EDETATE DIHYDRATE)

可用日期:

臺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:

B05BA01

药物剂型:

注射劑

组成:

POTASSIUM ACETATE (4008000100) 2.45GM; SODIUM ACETATE TRIHYDRATE (EQ TO SODIUM ACETATE 3H2O ) (4008000670) 3.95GM; MAGNESIUM ACETATE TETRAHYDRATE (4012001450) 0.56GM; L-ALANINE (4020100202) 13.70GM; L-ARGININE (4020100302) 9.20GM; L-ASPARTIC ACID (4020100402) 1.30GM; ASPARAGINE L- MONOHYDRATE (EQ TO ASPARAGINE H2O L- ) (4020100472) (3.72G) 3.27GM; L-CYSTEINE (4020100502) 0.50GM; GLUTAMIC ACID L- (4020100702) 4.60GM; L-HISTIDINE (4020100902) 5.20GM; L-ISOLEUCINE (4020101002) 5.10GM; L-LEUCINE (4020101202) 8.90GM; L-METHIONINE (4020101502) 3.80GM; L-ORNITHINE HCL (4020101612) (3.20G) 2.5GM; L-PHENYLALANINE (4020101702) 5.10GM; L-PROLINE (4020101802) 8.90GM; L-SERINE (4020101902) 2.40GM; L-THREONINE (4020102002) 4.10GM; L-TRYPTOPHAN (4020102102) 1.80GM; L-TYROSINE (4020102202) 0.30GM; L-VALINE (4020102302) 4.80GM; GLYCINE (EQ TO AMINOACETIC ACID)(EQ TO GLYCOCOLL) (4020102400) 7.90GM; LYSINE L- (HCL) (4020191312) (7.00G) 5.6GM; TYROSINE L-(N-ACETYL) (4020192212) (1.23G) 1.00GM; ACETYLCYSTEINE (4800000100) 0.68GM; SODIUM PHOSPHATE MONOBASIC (EQ TO MONOSODIUM PHOSPHATE)(EQ TO SODIUM DIHYDROGEN PHOSPHATE) (5612002610) 1.40GM; EDETATE DISODIUM DIHYDRATE (EQ TO DISODIUM EDETATE DIHYDRATE) (6400000315) 0.050GM; MALIC ACID L- (9600017802) 1.01GM; SODIUM HYDROXIDE (9600028200) 0.20GM

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-STRASSE 1, 34212 MELSUNGEN, GERMANY DE

治疗领域:

amino acids

疗效迹象:

不能攝取適當食物之患者之補助治療劑、蛋白質之消化吸收機能或合成利用障礙、嚴重創傷火傷骨折時蛋白質之補給、蛋白質攝取減少之營養失調症

產品總結:

註銷日期: 2016/09/08; 註銷理由: 自請註銷; 有效日期: 2020/05/08; 英文品名: AMINOPLASMAL-10% E

授权状态:

已註銷

授权日期:

2015-05-08

资料单张

                                [成分]
每1000 ml中含
主成分:
Isoleucine
5.10 g
Leucine
8.90 g
Lysine Hydrochloride
7.00 g
(equivalent to Lysine 5.60 g)
Methionine
3.80 g
Phenylalanine
5.10 g
Threonine
4.10 g
Tryptophan
1.80 g
Valine
4.80 g
Arginine
9.20 g
Histidine
5.20 g
Glycine
7.90 g
Alanine
13.70 g
Proline
8.90 g
Aspoartic Acid
1.30 g
Asparagine Monohydrate
3.72 g
(equivalent to Asparagine 3.27 g)
Acetylcysteine
0.68 g
(equivalent to Cysteine 0.50 g)
Glutamic Acid
4.60 g
Ornithine Hydrochloride
3.20 g
(equivalent to Ornithine 2.51 g)
Serine
2.40 g
Tyrosine
0.30 g
Acetyltyrosine
1.23 g
(equivalent to Tyrosine 1.00 g)
Sodium Acetate Trihydrate
3.95 g
Potassium Acetate
2.45 g
Magnesium Acetate Tetrahydrate
0.56 g
Sodium Dihydrogen Phosphate Dihydrate
1.40 g
Sodium Hydroxide
0.20 g
Malic Acid
1.01 g
_Electrolyte concentrations_
Sodium
43
mmol/l
Potassium
25
mmol/l
Magnesium
2.6 mmol/l
Acetate
59
mmol/l
Chloride
57
mmol/l
Dihydrogen phosphate
9.0 mmol/l
L-Malate
7.5 mmol/l
Total amino acids
100
g/l
Total nitrogen
16.0
g/l
Caloric value:
1675 kJ/l = 400 kcal/l
Theoretical osmolarity
1030
mOsm/l
Titration acidity (to pH 7.4) approx.
22
mmol/l
pH
5.0 – 7.5
賦形劑:
Disodium Edetate、Water for Injections
[劑型]
靜脈輸注液。
[藥物治療]
提供多種胺基酸之輸注液。
[適應症]
不能攝取適當食物之患者之輔助治療劑,蛋白質之消化吸收
機能或合成利用障礙,嚴重創傷火傷骨折時蛋白質之補給,
蛋白質攝取減少之營養失調症。
[禁忌]
– 有致命性之體循環不穩定者,如休克。
– 細胞性低血氧症或酸中毒者。
– 急性肺水腫。
– 已知對任一種 Aminoplasmal - 10 % E 的成分過敏者。
本溶液不適用於新生兒或2歲以下嬰兒使用,因本劑之營養
成分不適用於特殊的小兒需求。
[注意事項]
下列患者需就其功效及前在危險加以評估後,才可使用。
– 先天性胺基酸代謝障礙者。
– 水分過多者。
– 高血鉀症。
– 低血鈉症。
肝、腎、腎上腺、心、肺
                                
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