Nephrotect

Medicinal product

(Invented) name

Nephrotect

Active substance (s)

Izoleucinas/Leucinas/Lizino acetatas/Metioninas/Fenilalaninas/Treoninas/Triptofanas/Valinas/Histidinas/Argininas/Alaninas/Acetilcisteinas/Glicinas/Prolinas/Serinas/Tirozinas/Gliciltirozino dihidratas

Strength

5,8 g/12,8 g/16,9 g/2 g/3,5 g/8,2 g/3 g/8,7 g/9,8 g/8,2 g/6,2 g/0,54 g/5,31 g/3 g/7,6 g/0,6 g/3,16 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

Fresenius AG, Vokietija

Date of authorisation

2004-04-13

Date of renewal

2012-05-21

Documents

0036_01-02 Nephrotect_atn-05-21.doc

Stage

Išregistruotas

Controlled?

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1000 ml tirpalo yra	1000 ml
Izoleucinas	5,8 g
Leucinas	12,8 g
Lizino acetatas	16,9 g
Metioninas	2 g
Fenilalaninas	3,5 g
Treoninas	8,2 g
Triptofanas	3 g
Valinas	8,7 g
Histidinas	9,8 g
Argininas	8,2 g
Alaninas	6,2 g
Acetilcisteinas	0,54 g
Glicinas	5,31 g
Prolinas	3 g
Serinas	7,6 g
Tirozinas	0,6 g
Gliciltirozino dihidratas	3,16 g

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
8215	12947	1012947	buteliukas	250 ml N10		Receptinis	LT/1/04/0036/001	Netiekiama	-	-	No	-	-
8216	12948	1012948	buteliukas	500 ml N10		Receptinis	LT/1/04/0036/002	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2017-03-31	Išregistruotas
2012-05-21	Perregistruotas
2004-04-13	Registruotas