Additrace Concentrate for solution for infusion

Country: Malta

Tungumál: enska

Heimild: Medicines Authority

Virkt innihaldsefni:

CHROMIC CHLORIDE, POTASSIUM IODIDE, COPPER CHLORIDE, FERRIC CHLORIDE, ZINC CHLORIDE, MANGANESE CHLORIDE, SODIUM FLUORIDE, SODIUM MOLYBDATE, SODIUM SELENITE

Fáanlegur frá:

Fresenius Kabi Limited Cestrian Court, Eastgate Way, Manor Park, Runcorn, Cheshire WA7 1NT, United Kingdom

ATC númer:

B05XA

INN (Alþjóðlegt nafn):

CHROMIC CHLORIDE 5.33 µg POTASSIUM IODIDE 16.6 µg COPPER CHLORIDE 340 µg FERRIC CHLORIDE 544 µg ZINC CHLORIDE 1.36 mg MANGANESE CHLORIDE 99 µg SODIUM FLUORIDE 210 µg SODIUM MOLYBDATE 4.85 µg SODIUM SELENITE 10.5 µg

Lyfjaform:

CONCENTRATE FOR SOLUTION FOR INFUSION

Samsetning:

CHROMIC CHLORIDE 5.33 µg POTASSIUM IODIDE 16.6 µg COPPER CHLORIDE 340 µg FERRIC CHLORIDE 544 µg ZINC CHLORIDE 1.36 mg MANGANESE CHLORIDE 99 µg SODIUM FLUORIDE 210 µg SODIUM MOLYBDATE 4.85 µg SODIUM SELENITE 10.5 µg

Gerð lyfseðils:

POM

Lækningarsvæði:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Leyfisstaða:

Withdrawn

Leyfisdagur:

2006-11-01

Upplýsingar fylgiseðill

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32
15801016D.indd   1
2012-03-14   10:13:02
6. CONTENTS OF THE PACK AND OTHER INFORMATION 
What Additrace
®
 infusions contain
Each vial contains 10ml of concentrate.
ACTIVE INGREDIENTS:
1 MILLILITRE OF ADDITRACE
®

CONTAINS:
EACH VIAL CONTAINS 10ML OF 
CONCENTRATE.
Ferric chloride, 6H
2
O
     540 microgram
20 micromol
Zinc chloride
     1.36  mg
100 micromol
Manganese chloride
     99.0 microgram
5 micromol
Copper chloride
     340 microgram
20 micromol
Chromic chloride
      5.33 microgram
0.2 micromol
Sodium selenite anhydrous
      6.9  microgram
0.4 micromol
Sodium molybdate, 2H
2
O
      4.85 microgram
0.2 micromol
Sodium fluoride
     210 microgram
50 micromol
Potassium iodide
     16.6 microgram
1 micromol
Note: Less than 1 mmol for potassium and sodium
Additrace
®
 also contains xylitol, hydrochloric acid, water for injections.
What Additrace® looks like and contents of the pack
Additrace
®
 is a clear, almost colourless solution of trace elements. 
Additrace is available in a clear glass ampoule or polypropylene
ampoule containing 10 ml of concentrate, 
in the following pack sizes:
•  glass ampoule, 10 x 10ml
•  polypropylene ampoule, 20 x 10 ml
Not all pack sizes may be marketed.
15801016D.indd   2
2012-03-14   10:13:02

Vara einkenni

 
Page 1 of 5 

SUMMARY OF PRODUCT CHARACTERISTICS 

1.

NAME OF THE MEDICINAL PRODUCT 

Additrace® Concentrate for solution for infusion 

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each vial contains 10ml of concentrate.   
Each 1 ml of concentrate contains: 

Ferric chloride, 6H2O  
540  
microgram 
Zinc chloride   

1.36    mg 
Manganese chloride    
99.0    microgram 
Copper chloride 

340  
microgram 
Chromic chloride 

 5.33   microgram 
Sodium selenite, 5H2O 
 10.5    microgram 
Sodium molybdate, 2H2O 
  4.85   microgram 
Sodium fluoride 

 210 
microgram 
Potassium iodide 

 16.6   microgram 

One 10ml ampoule of Additrace contains: 

Fe
3+

20 micromol 
Zn
2+

100 micromol 
Mn
2+

5 micromol 
Cu
2+

20 micromol 
Cr
3+

0.2 micromol 
Se
4+

0.4 micromol 
Mo
6+

0.2 micromol 
F
-

50 micromol 
I
-

1 micromol 

Less than 1 mmol of both potassium and sodium. 

For a full list of excipients, see section 6.1 

3.

PHARMACEUTICAL FORM 

Concentrate for solution for infusion. 

Sterile, clear, almost colourless solution for addition to amino acid solutions. 

• Osmolality: approx. 3100 mosm/kg water 
• pH: 2.3 – 2.8 

Page 2 of 5 

4. 
CLINICAL PARTICULARS 

4.1

      THERAPEUTIC INDICATIONS 

A source of electrolytes and trace elements as an integral part of complete intravenous 
regimen, for adults and children over 40kg. 

4.2

      POSOLOGY AND METHOD OF ADMINISTRATION 

_Route of administration:_ Intravenous infusion after dilution 
Additrace must not be given undiluted. 
For instructions on dilution of the medicinal product before administration, see section 6.6. 
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