Physioneal 40 Glucose

Medicinal product

(Invented) name

Active substance (s)

Gliukozė/Natrio chloridas/Kalcio chloridas dihidratas/Magnio chloridas heksahidratas/Natrio-vandenilio karbonatas/Natrio (S)-laktatas

Strength

38,6 g/5,38 g/0,184 g/0,051 g/2,1 g/1,68 g/1000 ml

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

Vantive Belgium SRL, Belgija

Date of authorisation

2002-10-02

Date of renewal

2012-01-19

Documents

Stage

Perregistruotas

Controlled?

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1000 ml sumaišyto tirpalo yra	1000 ml
Gliukozė	38,6 g
Natrio chloridas	5,38 g
Kalcio chloridas dihidratas	0,184 g
Magnio chloridas heksahidratas	0,051 g
Natrio-vandenilio karbonatas	2,1 g
Natrio (S)-laktatas	1,68 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
5642	10869	1010869	maišelis	1500 ml N5	Receptinis	LT/1/02/2782/013	Netiekiama	-	-	No	-	-
50873	64763	1064763	maišelis	1500 ml N6	Receptinis	LT/1/02/2782/014	Netiekiama	-	-	No	-	-
5643	10870	1010870	maišelis	2000 ml N4	Receptinis	LT/1/02/2782/015	Netiekiama	-	-	No	-	-
50874	64764	1064764	maišelis	2000 ml N5	Receptinis	LT/1/02/2782/016	Tiekiama	-	-	No	-	-
5644	10871	1010871	maišelis	2500 ml N4	Receptinis	LT/1/02/2782/017	Netiekiama	-	-	No	-	-
50875	64765	1064765	maišelis	2500 ml N5	Receptinis	LT/1/02/2782/018	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2012-01-19	Perregistruotas
2002-10-02	Registruotas