TRACUTIL CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance: ZINC CHLORIDE

View full screen / Print PDF » Download PDF ⇩

Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER
B. Braun Melsungen AG · 34209 Melsungen, Germany

Tracutil

Concentrate for Solution for Infusion
Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

Dosage

1. What Tracutil is and what it is used for
2. Before you use Tracutil
3. How to use Tracutil
4. Possible side effects
5. How to store Tracutil
6. Further information

Your doctor will decide on the dose that is right for you.
For normal requirements you will receive 1 ampoule Tracutil per day and for
moderately increased requirements up to 2 ampoules.
If the requirement is much greater (e.g. after serious injuries, burns or major
surgery) higher doses may also be needed.
If you have a liver or kidney disease your dose may be reduced where this is
appropriate.

1. WHAT TRACUTIL IS AND WHAT IT IS USED FOR
Tracutil is a solution that contains substances required in small quantities
(trace elements) as part of a nutritional feeding regimen. You are given this
product by a vein drip (infusion) because you are unable to eat adequately
or cannot be fed in a different way.

2. BEFORE YOU USE TRACUTIL
Do not use Tracutil,
• If you are hypersensitive (allergic) to any of the ingredients of Tracutil
• f you have cholestasis (a condition where bile from the liver does not
I
flow to the gut)
• If some liver function tests (liver enzymes) have higher than normal values
• f you have Wilson’s disease (a condition in which copper is not eliminated
I
properly from the body)
• f you have certain types of iron storage disorders (haemosiderosis,
I
haemochromatosis)
Tracutil should not be administered to newborn babies, infants and children.

Take special care with Tracutil:
• If you have liver problems
• If you have kidney problems
• If you have an overactive thyroid gland
• If you are hypersensitive to iodide
Various laboratory tests will be performed to make sure that none of the
elements that Tracutil contains causes excessive accumulation in the body.

If you receive more Tracutil than you should
An overdose is very unlikely as the amount of trace elements contained
in Tracutil is far below values that could cause symptoms of intoxication.
If an overdose is suspected administration of Tracutil should be discontinued.
An overdose can be confirmed by appropriate laboratory tests.
If you have any further questions on the use of this product, ask your doctor
or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines Tracutil can cause side effects, although not everybody
gets them.

If you notice any of the following side effects please tell your
doctor without delay:
Allergic reactions (frequency not known)

There have been isolated reports of allergic (anaphylactic) reactions to iron
given intravenously, which under certain circumstances may be serious.
Iodide may trigger allergic reactions.
If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE TRACUTIL

Keep out of reach and sight of children.
Do not use the Tracutil after the expiry date which is stated on the ampoule
Please tell your doctor or pharmacist if you are taking or using or have and carton after “EXP”. The expiry date refers to the last day of the month.
recently taken any other medicines, including medicines obtained without This medicinal product does not require any special storage conditions.
a prescription.
In particular, please tell your doctor if you are taking or using other
medicines containing iodide at the same time, e.g. disinfectants containing
iodide.

Using Tracutil with other medicines

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
There is no adequate data available on safety of use during pregnancy or
while breast-feeding. Your doctor will therefore weigh up very carefully
whether this medicine is appropriate for you.

Driving and using machines
Tracutil has no effect on the ability to drive and use machines.

3. HOW TO USE TRACUTIL
This medicine will be given to you by a medical or healthcare professional.

Method of administration
You will be given Tracutil in the form of an infusion (venous drip) after it has
been diluted in a suitable carrier solution.

12610276_GIF_Tracutil_GB_293__L03.indd 1

09.02.11 14:41

6. FURTHER INFORMATION

Marketing Authorisation Holder and Manufacturer

B. Braun Melsungen AG
Carl-Braun-Straße 1
34212 Melsungen
• The active substances are salts of trace elements:
Germany
1 ampoule with 10 ml concentrate for solution for infusion contains:
Ferrous (II) chloride tetrahydrate 
6.958 mg Postal address
34209 Melsungen
( 35 micromols or 2.0 mg iron)
Zinc chloride 
6.815 mg Germany
( 50 micromols or 3.3 mg zinc)
Tel.: +49 5661-71-0
Manganese (II) chloride tetrahydrate 
1.979 mg Fax: +49 5661-71-4567
( 10 micromols or 550 micrograms manganese)
Copper(II) chloride dihydrate 
2.046 mg This medicinal product is authorised in the Member States of
the EEA under the following names:
( 12 micromols or 760 micrograms copper)
Chromium(III) chloride hexahydrate 
0.053 mg Belgium:
Tracutil
( 0.2 micromol or 10 micrograms chromium)
Denmark:
Nutritrace
Sodium selenite pentahydrate 
0.0789 mg Finland:
Nutritrace
( 0.3 micromol or 24 micrograms selenium)
France:
Tracutil
Sodium molybdate dihydrate 
0.0242 mg Great Britain: Tracutil
( 0.1 micromol or 10 micrograms molybdenum)
Ireland:
Tracutil
Potassium iodide 
0.166 mg Italy:
Olitrace
( 1.0 micromol or 127 micrograms iodide)
Luxembourg: Tracutil
Sodium fluoride 
1.260 mg Netherlands: Nutritrace
( 30 micromols or 570 micrograms fluoride)
Austria:
Tracutil
Spain:
OligoPlus
• The other ingredients are:
hydrochloric acid and water for injections
This leaflet was last approved in

What Tracutil contains

What Tracutil looks like and contents of the pack

03/2010

Tracutil is a concentrate for solution for infusion, i.e. it is administered as an
infusion after being diluted in a carrier solution.
It is a clear, colourless, aqueous solution.
Tracutil is supplied in 10 ml glass ampoules.
Tracutil is available in packs containing 5 or 50 glass ampoules.

The following information is intended for medical or healthcare A compatibility test must be performed before it is added to other infusion
solutions.
professionals only:

Injection into the infusion solution should be performed immediately prior
to use and this should be done under aseptic conditions.
Trace elements can cause loss of vitamin C in infusion solutions. This should Infusion of the ready-to-use mixture should be carried over not less than
be taken into account in admixtures of vitamin preparations.
6 hours and should be completed within 24 hours.
This medicinal product should not be added to alkaline solutions with a high It is used for as long as parenteral nutrition is needed.
buffer capacity such as sodium bicarbonate solution.
Note:
Do not add to fat emulsions.
In cases of diarrhoea increased intestinal loss of zinc may occur and in this
Admixtures with infusion solutions other than those given in the dosage event serum concentrations must be monitored.
instructions as well as adding other medicines should be avoided until the
An individual trace element deficiency should if possible be selectively
compatibility has been tested.
corrected.

Incompatibilities

Method and duration of administration

Tracutil is a concentrate for solution for infusion. It may only be infused
after dilution in at least 250 ml of a compatible infusion solution. Suitable
carrier solutions include for example
- glucose solutions (glucose 5 % or 10 %)
- electrolyte solutions (e.g. sodium chloride 0.9 %, Ringer’s solution)

12610276_GIF_Tracutil_GB_293__L03.indd 2

09.02.11 14:41

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web5)