Nutrineal PD4 Clear-Flex

Medicinal product

(Invented) name

Active substance (s)

Alaninas/Argininas/Glicinas/Histidinas/Izoleucinas/Leucinas/Lizino hidrochloridas/Metioninas/Fenilalaninas/Prolinas/Serinas/Treoninas/Triptofanas/Tirozinas/Valinas/Natrio chloridas/Kalcio chloridas dihidratas/Magnio chloridas heksahidratas/Natrio (S)-laktatas

Strength

951 mg/1071 mg/510 mg/714 mg/850 mg/1020 mg/955 mg/850 mg/570 mg/595 mg/510 mg/646 mg/270 mg/300 mg/1393 mg/5380 mg/184 mg/51 mg/4480 mg/l

Pharmaceutical form

pilvaplėvės ertmės dializės tirpalas

Route (s) of administration

leisti į pilvaplėvės ertmę

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

B05DB, Hypertonic solutions

Marketing authorisation holder

UAB Baxter Lithuania, Lietuva

Date of authorisation

2015-02-25

Date of renewal

Documents

3686_3_4 Nutrineal PD4 Clear_Flex RPP 160408.docx

Stage

Išregistruotas

Controlled?

Controlled substance type

Legal basis

10a

Procedure number

DK/H/0258/001/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

1 tirpalo litre yra	1 l
Alaninas	951 mg
Argininas	1071 mg
Glicinas	510 mg
Histidinas	714 mg
Izoleucinas	850 mg
Leucinas	1020 mg
Lizino hidrochloridas	955 mg
Metioninas	850 mg
Fenilalaninas	570 mg
Prolinas	595 mg
Serinas	510 mg
Treoninas	646 mg
Triptofanas	270 mg
Tirozinas	300 mg
Valinas	1393 mg
Natrio chloridas	5380 mg
Kalcio chloridas dihidratas	184 mg
Magnio chloridas heksahidratas	51 mg
Natrio (S)-laktatas	4480 mg

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
61433	75752	1075752	maišelis	2500 ml, viengubas N3		Receptinis	LT/1/15/3686/003	Netiekiama	-	-	No	-	-
61434	75753	1075753	maišelis	2500 ml, viengubas N4		Receptinis	LT/1/15/3686/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-07-07	Išregistruotas
2015-02-25	Registruotas