Aminoplasmal B.Braun 10%

Medicinal product

(Invented) name

Active substance (s)

Izoleucinas/Leucinas/Lizino acetatas/Metioninas/Fenilalaninas/Lizinas, monohidratas/Treoninas/Triptofanas/Valinas/Argininas/Histidinas/Alaninas/Glicinas/Asparto rūgštis/Glutamo rūgštis/Prolinas/Serinas/Tirozinas

Strength

5 g/8,9 g/5,74 g/4,4 g/4,7 g/3,12 g/4,2 g/1,6 g/6,2 g/11,5 g/3 g/10,5 g/12 g/5,6 g/7,2 g/5,5 g/2,3 g/0,4 g/1000 ml

Pharmaceutical form

infuzinis tirpalas

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

B05BA01, Amino acids

Marketing authorisation holder

B.Braun Melsungen AG, Vokietija

Date of authorisation

2005-11-04

Date of renewal

2019-04-30

Documents

0326_1_3 Pakuotės lapelis 210217.docx

0326_1_3 Aminoplasmal B_Braun 10proc inf PCS PL 210217.docx

Stage

Perregistruotas

Controlled?

Controlled substance type

Legal basis

10a

Procedure number

DE/H/0543/001/MR

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

1000 ml tirpalo yra	1000 ml
Izoleucinas	5 g
Leucinas	8,9 g
Lizino acetatas	5,74 g
Metioninas	4,4 g
Fenilalaninas	4,7 g
Lizinas, monohidratas	3,12 g
Treoninas	4,2 g
Triptofanas	1,6 g
Valinas	6,2 g
Argininas	11,5 g
Histidinas	3 g
Alaninas	10,5 g
Glicinas	12 g
Asparto rūgštis	5,6 g
Glutamo rūgštis	7,2 g
Prolinas	5,5 g
Serinas	2,3 g
Tirozinas	0,4 g

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
15102	19308	1019308	buteliukas	250 ml N10	Receptinis	LT/1/05/0326/001	Netiekiama	-	-	No	-	-
15103	19309	1019309	buteliukas	500 ml N10	Receptinis	LT/1/05/0326/002	Tiekiama	-	-	No	-	-	Download
15104	19310	1019310	buteliukas	1000 ml N6	Receptinis	LT/1/05/0326/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-04-30	Perregistruotas
2005-11-04	Registruotas