Plasmalyte

Medicinal product

(Invented) name

Plasmalyte

Active substance (s)

Natrio chloridas/Kalio chloridas/Magnio chloridas heksahidratas/Natrio acetatas trihidratas/Natrio gliukonatas

Strength

5,26 g/0,37 g/0,3 g/3,68 g/5,02 g/1000 ml

Pharmaceutical form

infuzinis tirpalas

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

B05BB01, Electrolytes

Marketing authorisation holder

UAB Baxter Lithuania, Lietuva

Date of authorisation

2006-06-30

Date of renewal

2010-04-16

Documents

Stage

Perregistruotas

Controlled?

Controlled substance type

Legal basis

10(1)

Procedure number

IE/H/0803/001

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

1000 ml tirpalo yra	1000 ml
Natrio chloridas	5,26 g
Kalio chloridas	0,37 g
Magnio chloridas heksahidratas	0,3 g
Natrio acetatas trihidratas	3,68 g
Natrio gliukonatas	5,02 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
15650	19784	1019784	maišelis	500 ml N20	Receptinis	LT/1/06/0532/005	Netiekiama	-	-	No	-	-
15651	19785	1019785	maišelis	1000 ml N10	Receptinis	LT/1/06/0532/006	Netiekiama	-	-	No	-	-
111886	98001	1098001	maišelis	1000 ml N12	Receptinis	LT/1/06/0532/007	Netiekiama	-	-	No	-	-
112416	98531	1098531	maišelis	500 ml N1	Receptinis	LT/1/06/0532/008	Netiekiama	-	-	No	-	-
112417	98532	1098532	maišelis	1000 ml N1	Receptinis	LT/1/06/0532/009	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2010-04-16	Perregistruotas
2006-06-30	Registruotas