Gelofusine

Medicinal product

(Invented) name

Gelofusine

Active substance (s)

Želatinos polisukcinatas/Natrio chloridas/Natrio hidroksidas

Strength

40 g/7,01 g/1,36 g/1000 ml

Pharmaceutical form

infuzinis tirpalas

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

B05AA06, Gelatin agents

Marketing authorisation holder

B.Braun Melsungen AG, Vokietija

Date of authorisation

1997-04-09

Date of renewal

2013-04-11

Documents

3264_1 Gelofusine inf PZ PL keit.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1000 ml infuzinio tirpalo yra	1000 ml
Želatinos polisukcinatas	40 g
Natrio chloridas	7,01 g
Natrio hidroksidas	1,36 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
5153	10449	1010449	buteliukas	500 ml N10 (Ecoflac)		Receptinis	LT/1/97/3264/001	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2018-12-05	Išregistruotas
2013-04-11	Perregistruotas
1997-04-09	Registruotas