Additrace Concentrate for solution for infusion
국가: 몰타
언어: 영어
출처: Medicines Authority
환자 정보 전단 유효 성분:
CHROMIC CHLORIDE, POTASSIUM IODIDE, COPPER CHLORIDE, FERRIC CHLORIDE, ZINC CHLORIDE, MANGANESE CHLORIDE, SODIUM FLUORIDE, SODIUM MOLYBDATE, SODIUM SELENITE
제공처:
Fresenius Kabi Limited Cestrian Court, Eastgate Way, Manor Park, Runcorn, Cheshire WA7 1NT, United Kingdom
ATC 코드:
B05XA
INN (International Name):
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
약제 형태:
CONCENTRATE FOR SOLUTION FOR INFUSION
구성:
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
처방전 유형:
POM
치료 영역:
BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
승인 상태:
Withdrawn
승인 날짜:
2006-11-01
환자 정보 전단
32
32
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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.
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제품 특성 요약
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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