安命諾得輸注液10%

Land: Taiwan

Sprog: kinesisk

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

Indlægsseddel Indlægsseddel (PIL)
03-12-2021

Aktiv bestanddel:

ISOLEUCINE;;LEUCINE;;LYSINE ACETATE;;LYSINE MONOHYDRATE;;METHIONINE;;PHENYLALANINE;;THREONINE;;TRYPTOPHAN;;VALINE;;ARGININE;;HISTIDINE;;ALANINE;;GLYCINE (EQ TO AMINOACETIC ACID)(EQ TO GLYCOCOLL);;ASPARTIC ACID;;GLUTAMIC ACID;;PROLINE;;SERINE;;TYROSINE

Tilgængelig fra:

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-kode:

B05BA01

Lægemiddelform:

注射劑

Sammensætning:

ALANINE (4020100200) MG; ARGININE (4020100300) MG; ASPARTIC ACID (4020100400) MG; GLUTAMIC ACID (4020100700) MG; HISTIDINE (4020100900) MG; ISOLEUCINE (4020101000) MG; LEUCINE (4020101200) MG; LYSINE MONOHYDRATE (4020101304) (eq. to lysine 2.78mg)MG; LYSINE ACETATE (4020101320) (eq. to lysine 4.07mg)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

Enheder i pakken:

玻璃瓶裝

Klasse:

製 劑

Recept type:

限由醫師使用

Fremstillet af:

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

Terapeutisk område:

amino acids

Terapeutiske indikationer:

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。適用於成人、青少年和2歲以上兒童。

Produkt oversigt:

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

Autorisation dato:

2010-04-13

Indlægsseddel

                                1.
NAME OF THE MEDICINAL PRODUCT
Aminoplasmal Neo 10%
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 monohydrate
3.12 mg
0.78 g
1.56 g
3.12 g
(equivalent
to lysine)
(2.78 mg)
(0.70 g)
(1.39 g)
(2.78 g)
Lysine acetate
5.74 mg
1.44 g
2.87 g
5.74 g
(equivalent
to lysine)
(4.07 mg)
(1.02 g)
(2.04 g)
(4.07 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
Electrolyte concentrations
Acetate
28 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]
864
Acidity (titration to pH 7.4) [mmol NaOH/l]
approx. 20
pH
5.7 – 6.3
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Supply of amino acids for parenteral nutrition, when oral or enteral
nutri-
tion is impossible, insufficient or contraindicated. For adults,
adolescents
and children over 2 years of age.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dosage has to be adjusted according to the individual need of
amino
acids and fluid depending on the clinical condition of the patient
(nutri-
tional status due to underlying disease).
_Adults and adolescents from 14 to 17 years_
Daily dose:
1.0 – 2.0 g amino acids/kg body weight  10 – 20 ml/kg body
weight

                                
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