Phoxilium

Medicinal product

(Invented) name

Phoxilium

Active substance (s)

Kalcio chloridas dihidratas/Magnio chloridas heksahidratas+Natrio chloridas/Natrio-vandenilio karbonatas/Kalio chloridas/Dinatrio fosfatas dihidratas

Strength

3,68 g/2,44 g/1000 ml + 6,44 g/2,92 g/0,314 g/0,225 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

2009-07-27

Date of renewal

2014-04-28

Documents

Stage

Perregistruotas

Controlled?

Controlled substance type

Legal basis

10a

Procedure number

NL/H/1147/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1000 ml tirpalo prieš paruošimą mažajame skyriuje (A) yra	1000 ml
Kalcio chloridas dihidratas	3,68 g
Magnio chloridas heksahidratas	2,44 g
1000 ml tirpalo prieš paruošimą didžiajame skyriuje (B) yra	1000 ml
Natrio chloridas	6,44 g
Natrio-vandenilio karbonatas	2,92 g
Kalio chloridas	0,314 g
Dinatrio fosfatas dihidratas	0,225 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
27426	29981	1029981	maišelis	5000 ml N2		Receptinis	LT/1/09/1653/001	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-04-28	Perregistruotas
2009-07-27	Registruotas