Aminosteril N-Hepa

Medicinal product

(Invented) name

Aminosteril N-Hepa

Active substance (s)

Izoleucinas/Leucinas/Lizinas/Metioninas/Cisteinas/Fenilalaninas/Treoninas/Triptofanas/Valinas/Argininas/Histidinas/Glicinas/Alaninas/Prolinas/Serinas/Acto rūgštis, ledinė

Strength

10,4 g/13,09 g/6,88 g/1,1 g/0,52 g/0,88 g/4,4 g/0,7 g/10,08 g/10,72 g/2,8 g/5,82 g/4,64 g/5,73 g/2,24 g/4,42 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 Kabi Deutschland GmbH, Vokietija

Date of authorisation

2005-09-28

Date of renewal

2009-12-23

Documents

0297_1_2 Pakuotės lapelis 201124.docx

0297_1_2 Aminosteril N_Hepa PL 201124.docx

Stage

Išregistruotas

Controlled?

Controlled substance type

Legal basis

8(3)

Procedure number

DE/H/0357/001/MR

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

1000 ml tirpalo yra	1000 ml
Izoleucinas	10,4 g
Leucinas	13,09 g
Lizinas	6,88 g
Metioninas	1,1 g
Cisteinas	0,52 g
Fenilalaninas	0,88 g
Treoninas	4,4 g
Triptofanas	0,7 g
Valinas	10,08 g
Argininas	10,72 g
Histidinas	2,8 g
Glicinas	5,82 g
Alaninas	4,64 g
Prolinas	5,73 g
Serinas	2,24 g
Acto rūgštis, ledinė	4,42 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
17589	21396	1021396	buteliukas	500 ml N1		Receptinis	LT/1/05/0297/001	Netiekiama	-	-	No	-	-
17590	21397	1021397	buteliukas	500 ml N10		Receptinis	LT/1/05/0297/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-07-07	Išregistruotas
2009-12-23	Perregistruotas
2005-09-28	Registruotas