Addamel N

Medicinal product

(Invented) name

Addamel N

Active substance (s)

Chromo chloridas heksahidratas/Vario chloridas dihidratas/Geležies chloridas heksahidratas/Mangano chloridas tetrahidratas/Kalio jodidas/Natrio fluoridas/Natrio molibdatas dihidratas/Natrio selenitas/Cinko chloridas

Strength

5,33 µg/0,34 mg/0,54 mg/99 µg/16,6 µg/0,21 mg/4,85 µg/6,9 µg/1,36 mg/ml

Pharmaceutical form

koncentratas infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

B05XA31, Electrolytes in combination with other drugs

Marketing authorisation holder

Fresenius Kabi AB, Švedija

Date of authorisation

2003-03-28

Date of renewal

2013-10-18

Documents

3391_01 Addamel_N_atn_t_12-09.doc

Stage

Išregistruotas

Controlled?

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml koncentrato yra	1 ml
Chromo chloridas heksahidratas	5,33 µg
Vario chloridas dihidratas	0,34 mg
Geležies chloridas heksahidratas	0,54 mg
Mangano chloridas tetrahidratas	99 µg
Kalio jodidas	16,6 µg
Natrio fluoridas	0,21 mg
Natrio molibdatas dihidratas	4,85 µg
Natrio selenitas	6,9 µg
Cinko chloridas	1,36 mg

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
5912	11090	1011090	ampulė	10 ml N20		Receptinis	LT/1/03/3391/001	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2017-10-05	Išregistruotas
2013-10-18	Perregistruotas
2003-03-28	Registruotas