Prismasol 4 mmol/l Kalio

Medicinal product

(Invented) name

Active substance (s)

Kalcio chloridas dihidratas/Magnio chloridas heksahidratas/Gliukozė/(S)-pieno rūgštis+Natrio chloridas/Kalio chloridas/Natrio-vandenilio karbonatas

Strength

5,145 g/2,033 g/22 g/5,4 g/1000 ml + 6,45 g/0,314 g/3,09 g/1000 ml

Pharmaceutical form

hemodializės ar hemofiltracijos tirpalas

Route (s) of administration

leisti į veną, hemodializei

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

B05ZB, Hemofiltrates

Marketing authorisation holder

Vantive Belgium SRL, Belgija

Date of authorisation

2009-10-20

Date of renewal

2013-01-14

Documents

Stage

Perregistruotas

Controlled?

Controlled substance type

Legal basis

10a

Procedure number

FR/H/0226/002/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

1000 ml elektrolitų tirpalo mažajame skyriuje (A) yra	1000 ml
Kalcio chloridas dihidratas	5,145 g
Magnio chloridas heksahidratas	2,033 g
Gliukozė	22 g
(S)-pieno rūgštis	5,4 g
1000 ml buferinio tirpalo didžiajame skyriuje (B) yra	1000 ml
Natrio chloridas	6,45 g
Kalio chloridas	0,314 g
Natrio-vandenilio karbonatas	3,09 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
33015	35395	1035395	maišelis	5000 ml N2		Receptinis	LT/1/09/1754/002	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2013-01-14	Perregistruotas
2009-10-20	Registruotas