Hemosol B0

Medicinal product

(Invented) name

Hemosol B0

Active substance (s)

Kalcio chloridas dihidratas/Magnio chloridas dihidratas/Pieno rūgštis+Natrio-vandenilio karbonatas/Natrio chloridas

Strength

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

2010-01-19

Date of renewal

2015-04-22

Documents

Stage

Perregistruotas

Controlled?

Controlled substance type

Legal basis

10a

Procedure number

SE/H/0171/001/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

1000 ml tirpalo mažajame skyriuje (A) yra	1000 ml
Kalcio chloridas dihidratas	5,145 g
Magnio chloridas dihidratas	2,033 g
Pieno rūgštis	5,4 g
1000 ml tirpalo didžiajame skyriuje (B) yra	1000 ml
Natrio-vandenilio karbonatas	3,09 g
Natrio chloridas	6,45 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
35894	38226	1038226	maišelis	5000 ml N2		Receptinis	LT/1/10/1838/001	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-04-22	Perregistruotas
2010-01-19	Registruotas