ADDAMEL N FOR INFUSION

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

CHROMIC CHLORIDE.6H2O; COPPER CHLORIDE.2H2O; FERRIC CHLORIDE.6H2O; MANGANESE CHLORIDE.4H2O; POTASSIUM IODIDE; SODIUM FLUORIDE; SODIUM MOLYBDATE.2H2O; SODIUM SELENITE ANHYDROUS; ZINC CHLORIDE

Available from:

FRESENIUS KABI (SINGAPORE) PTE LTD

ATC code:

B05XA31

Dosage:

5.33 mcg/ml

Pharmaceutical form:

INJECTION

Composition:

CHROMIC CHLORIDE.6H2O 5.33 mcg/ml; COPPER CHLORIDE.2H2O 0.34 mg/ml; FERRIC CHLORIDE.6H2O 0.54 mg/ml; MANGANESE CHLORIDE.4H2O 99 mcg/ml; POTASSIUM IODIDE 16.6 mcg/ml; SODIUM FLUORIDE 0.21 mg/ml; SODIUM MOLYBDATE.2H2O 4.85 mcg/ml; SODIUM SELENITE ANHYDROUS 6.9 mcg/ml; ZINC CHLORIDE 1.36 mg/ml

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

FRESENIUS KABI NORGE AS

Authorization status:

ACTIVE

Authorization date:

1992-01-31

Patient Information leaflet

COMPOSITION:
1 ml contains: 
Chromic chloride 6H
2
O  
5.33 µg
Copper Chloride 2H
2
O  
0.34 mg
Ferric chloride 6H
2
O  
0.54 mg
Manganese chloride 4H
2
O  
99.0 µg
Sodium molybdate 2H
2
O  
4.85 µg
Sodium selenite anhydrous  
6.90 µg
Zinc chloride  
1.36 mg
Potassium iodide  
16.6 µg
Sodium fluoride  
0.21 mg
 Xylitol  
300 mg
Hydrochloric acid 
to pH 2.5
Water for injections  
to 1 ml 
01-58-01-001H
   
TM
PROPERTIES:
Addamel  N  is  an  almost  colourless  solution  containing  trace  elements  for  addition  to 
infusion fluids.
The active ingredients in 1 ml of Addamel N correspond to: Cr
3+
 0.02 µmol, Cu
2+ 
2 µmol, 
Fe
3+
 2 µmol, Mn
2+
 0.5 µmol, MoO
4

2-
 0.02 µmol, SeO
3
2-
 0.04 µmol, Zn
2+
 10 µmol, F
-
 5 µmol, 
I
-
 0.1 µmol.
The contents of one ampoule will meet the daily requirements of Cr, Cu, Fe, Mn, Mo, Se, 
Zn, F and I in adults with basal to moderately increased requirements.
_The osmolality is around 3100 mosm/kg water. pH 2.5._
INDICATIONS:
Addamel N is indicated as a supplement in intravenous nutrition of adults to meet the 
requirements of trace elements.
CONTRAINDICATIONS:
Total biliary obstruction. 
PRECAUTIONS:
Addamel N should be used with caution in patients with impaired biliary and/or renal 
function when the excretion of trace elements may be significantly
decreased.
Addamel  N  should  also  be  used  with  caution  in  patients  with  biochemical  or  clinical 
evidence of liver dysfunction (especially cholestasis). If treatment is continued for more 
than 4 weeks checking of manganese levels is required.
PREGNANCY:
Animal  reproduction  studies  of  clinical  investigation  during  pregnancy  have  not  been 
carried out with Addamel N. However, the requirements of trace elements in a pregnant 
woman are the same or even slig

Summary of Product characteristics

COMPOSITION:
1 ml contains:
Chromic chloride 6H
2
O
5.33 µg
Copper Chloride 2H
2
O
0.34 mg
Ferric chloride 6H
2
O
0.54 mg
Manganese chloride 4H
2
O
99.0 µg
Sodium molybdate 2H
2
O
4.85 µg
Sodium selenite anhydrous
6.90 µg
Zinc chloride
1.36 mg
Potassium iodide
16.6 µg
Sodium fluoride
0.21 mg
Xylitol
300 mg
Hydrochloric acid
to pH 2.5
Water for injections
to 1 ml
01-58-01-001H
 
TM
PROPERTIES:
Addamel N is an almost colourless solution containing trace elements
for addition to
infusion fluids.
The active ingredients in 1 ml of Addamel N correspond to: Cr
3+
0.02 µmol, Cu
2+
2 µmol,
Fe
3+
2 µmol, Mn
2+
0.5 µmol, MoO
4
2-
0.02 µmol, SeO
3
2-
0.04 µmol, Zn
2+
10 µmol, F
-
5 µmol,
I
-
0.1 µmol.
The contents of one ampoule will meet the daily requirements of Cr,
Cu, Fe, Mn, Mo, Se,
Zn, F and I in adults with basal to moderately increased requirements.
_The osmolality is around 3100 mosm/kg water. pH 2.5._
INDICATIONS:
Addamel N is indicated as a supplement in intravenous nutrition of
adults to meet the
requirements of trace elements.
CONTRAINDICATIONS:
Total biliary obstruction.
PRECAUTIONS:
Addamel N should be used with caution in patients with impaired
biliary and/or renal
function when the excretion of trace elements may be significantly
decreased.
Addamel N should also be used with caution in patients with
biochemical or clinical
evidence of liver dysfunction (especially cholestasis). If treatment
is continued for more
than 4 weeks checking of manganese levels is required.
PREGNANCY:
Animal reproduction studies of clinical investigation during pregnancy
have not been
carried out with Addamel N. However, the requirements of trace
elements in a pregnant
woman are the same or even slightly increased compared to nonpregnant
females. No
adverse events are expected when Addamel N is administered during
pregnancy.
174
MASTER ARTWORK/LABEL SPECIFICATION
Halden article number:
LYA 1941
Label spec. number:
01-58-01-001H
Pharma code/Code lines:
174
Colour coding:
Black
Size:
270 x 128 mm