ADDITRACE, CONCENTRATE FOR SOLUTION FOR INFUSION

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

FERRIC CHLORIDE HEXAHYDRATE ; ZINC CHLORIDE ; MANGANESE CHLORIDE TETRAHYDRATE ; CUPRIC CHLORIDE DIHYDRATE ; POTASSIUM IODIDE ; CHROMIUM TRICHLORIDE HEXAHYDRATE; SODIUM SELENITE ; SODIUM MOLYBDATE DIHYDRATE ; SODIUM FLUORIDE

Saadav alates:

Fresenius Kabi Limited

ATC kood:

B05XA31

INN (Rahvusvaheline Nimetus):

FERRIC CHLORIDE HEXAHYDRATE ; ZINC CHLORIDE ; MANGANESE CHLORIDE TETRAHYDRATE ; CUPRIC CHLORIDE DIHYDRATE ; POTASSIUM IODIDE ; CHROMIUM TRICHLORIDE HEXAHYDRATE; SODIUM SELENITE ; SODIUM MOLYBDATE DIHYDRATE ; SODIUM FLUORIDE

Annus:

10 Millilitre

Ravimvorm:

Concentrate for Soln for Inf

Retsepti tüüp:

Product subject to prescription which may not be renewed (A)

Terapeutiline ala:

electrolytes in combination with other drugs

Volitamisolek:

Marketed

Loa andmise kuupäev:

1988-05-16

Infovoldik

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, pharmacist or
nurse.
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Additrace
®
is and what it is used for
2.
What you need to know before you use Additrace
®
3.
How to use Additrace
®
4.
Possible side effects
5.
How to store Additrace
®
6.
Contents of the pack and other information
1.
WHAT ADDITRACE
® IS AND WHAT IT IS USED FOR
Additrace
®
provides trace elements into your blood stream when you cannot eat
normally.
Trace elements are tiny amounts of chemicals that your body needs to
work normally.
Additrace
®
is usually used as part of a balanced intravenous diet, together with
proteins, fat,
carbohydrates, salts and vitamins.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE ADDITRACE
®
DO NOT USE ADDITRACE
®
:
• if you are allergic to any of the ingredients of Additrace
®
mentioned in section 6.
IF YOU DEVELOP A RASH OR OTHER ALLERGIC REACTIONS (LIKE ITCHING,
SWOLLEN LIPS OR FACE OR SHORTNESS OF BREATH),
PLEASE INFORM YOUR DOCTOR.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before using Additrace
®
if you suffer from:
- impaired liver and/or kidney function
Your doctor may want to do regular blood tests to check your
condition.
Additrace
®
MUST BE DILUTED BEFORE USE. It will be added to another solution
before it is given to you. Your
doctor, pharmacist or nurse will make sure it is prepared correctly
before you receive Additrace
®
.
Additrace
®
should not be used if the solution is cloudy or contains particles.
The doctor, pharmacist or nurse
will check that the solution is particle free before it is
administered to you.
OTHER MEDICINES AND ADDITRACE
®
Talk to your doctor, pharmacist or nurse if you are taking,

Toote omadused

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Additrace, concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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
Each ampoule contains 10ml of concentrate.
Each 1 ml of concentrate contains:
Ferric chloride, 6H2O Ph. Eur.
540
microgram
Zinc chloride Ph. Eur
1.36
mg
Manganese chloride 4H
2
O USP
99.0
microgram
Copper chloride 2H
2
O USP
340
microgram
Chromic chloride 6H
2
O USP
5.33
microgram
Sodium selenite, 5H
2
O
10.5
microgram
Sodium molybdate, 2H
2
O Ph. Eur.
4.85
microgram
Sodium fluoride BP
210
microgram
Potassium iodide Ph. Eur
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.
H
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4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
A source of electrolytes and trace elements as an integral part of a
complete intravenous nutritional regimen, for adults and
children over 40 kg.
4.2 POSOLOGY AND MET