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DECAN CONCENTRATE FOR SOLUTION FOR INFUSION

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Concentrate for solution for infusion

Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or nursing staff.
- 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.

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

1. WHAT DECAN IS AND WHAT IT IS USED FOR
Decan is a concentrate for solution for infusion.
It contains 10 essential trace elements (iron, copper, manganese, zinc, fluorine, cobalt,
iodine, selenium, chromium, molybdenum).
These trace elements are considered as essential because the body cannot synthesize
them but needs them in very small quantities in order to function properly.
Decan is used to provide trace elements in adults needing intravenous feeding.

2. BEFORE YOU USE DECAN
Do not use Decan and tell your doctor if:
- you are allergic (hypersensitive) to any of the ingredients of Decan (See section 6 of this
leaflet).
- your body weight is less than 40 kg.
- you have abnormally high level of any of the constituents of the product in your blood.
(If you have any doubt, ask your doctor).
- you have a pronounced cholestasis (yellowing of the skin or whites of the eyes caused by
liver or blood problem).
- you have an excess of copper (Wilson´s disease) or iron in the body (hemochromatosis).
Decan must not be used in children

Take special care with Decan and tell your doctor if:
- you have kidney problems,
- you have liver problems as mild cholestasis (impaired liver function with a yellowing of
the skin or whites of eyes),
- you receive repeated blood transfusions.
Blood level of trace elements should be monitored regularly during the treatment.
your doctor will adapt the dosage of Decan.

Taking other medicines
Please tell your doctor if you are taking or have recently taken other medicines, including
medicines obtained without a prescription.

Pregnancy and Breastfeeding
You should tell your doctor or nurse in advance, as for any medicine:
l If you are pregnant or think that you may be pregnant,
l Or if you are breastfeeding.
Decan should not be used during pregnancy and lactation unless the doctor considers it is
absolutely necessary.

Important information about some of the ingredients of Decan
This product contains 0.078 mmol of Sodium (1.796 mg) per dose, i.e. essentially
"sodium free".

The following information is intended for medical
and healthcare professional only

Decan

Concentrate for solution for infusion

Qualitative and Quantitative Composition
Composition per 1000 ml DECAN
Ferrous gluconate
Copper gluconate
Manganese gluconate
Zinc gluconate
Sodium fluoride
Cobalt II gluconate
Sodium iodide
Sodium selenite
Ammonium molybdate
Chromic chloride
Density
Osmolality
Osmolarity
Content per bottle of 40 ml
Iron (Fe)
Copper (Cu)
Manganese (Mn)
Zinc (Zn)
Fluorine (F)
Cobalt (Co)
Iodine (I)
Selenium (Se)
Molybdenum (Mo)
Chromium (Cr)

199.9 mg
85
mg
40.5 mg
1742
mg
80
mg
0.280 mg
0.045 mg
3.83 mg
1.08 mg
1.14 mg
1.00
19
mOsmol/kg water
17.6 mOsmol/liter
1.00 mg
0.48 mg
0.20 mg
10.00 mg
1.45 mg
1.47 microg
1.52 microg
0.070 mg
0.025 mg
0.015 mg

List of excipients: Glucono delta lactone and Water for Injections

Description of solution
Clear, limpid and slightly yellow solution.

Posology and method of administration
For adults only.
The recommended daily dose in patients with basal to moderately increased requirements is one vial (40 ml) of Decan.
In cases of significantly increased trace element requirements (such as extensive burns,
severe hypercatabolic major trauma patients) 2 vials (80 ml) of Decan may be given per
day, and monitoring of serum trace elements values is recommended.
Decan is not intended to be administered in its current presentation.
Decan can also be included as such in parenteral nutrition admixtures. In this case,
special attention must be paid to the compatibility of both products.

Pharmaceutical Particulars
Incompatibilities
Decan must not be used as a vehicle for other drugs.
Decan, as with other trace element solutions, cannot be added directly to inorganic
phosphate (additive) solutions.
Degradation of ascorbic acid in parenteral nutrition admixtures is accelerated by trace
elements.
This medicinal product must not be mixed with other medicinal products other than those
mentioned in "instructions for use and handling, and disposal".
Shelf-life
2 years.
After dilution, chemical and physical in-use stability has been demonstrated for 24 h at 25°C.
From a microbiological point of view, the product should be used immediately after
dilution or addition. If not used immediately, in-use storage times and conditions
prior to use are the responsibility of the user and would normally not be longer than
24 h at 5°C unless dilution or addition has taken place in controlled and validated aseptic
conditions.

101453 - 10/2010

Decan

"

PACKAGE LEAFLET :
INFORMATION FOR THE USER

Nature and content of container
Glass bottle of 50 ml (colourless/transparent glass type II) filled with 40 ml.
Package size:
40 ml x 1 unit
40 ml x 25 units
Instructions for use and handling, and disposal (if appropriate)
This product contains 0.078 mmol of sodium (1.796 mg) per dose, i.e. essentially
"sodium free".
Before use check that the solution is homogeneous and that the bottle is not damaged
and is free of particles. Decan is not intended to be administered in its current presentation.
Decan must be diluted or admixed with gentle agitation during preparation under strict
aseptic conditions, before infusion.
Decan must be diluted with respect to the final appropriate osmolarity. For example:
l 40 ml of Decan can be diluted in at least 250 ml of Sodium Chloride 0.9% solution for infusion,
l 40 ml of Decan can be diluted in at least 500 ml of Glucose 5% to 70% solutions for infusion.
In case of dilution of Decan in Glucose solutions above 20%, the dilution must not be
administered alone with regard to the final osmolarity.
The reconstituted solution for infusion has to be visually inspected prior to use. Only clear
solution without particles should be used.
Do not store partly used containers and discard all equipment after use.
The compatibility with solutions administered simultaneously via a common inlet cannula
must be ensured.

"

Special precautions for storage
Do not store above 25°C, do not freeze.
Keep the container in the outer carton in order to protect from light.

3. HOW DECAN IS GIVEN
Decan is intended for adult patients only.
Decan will be given to you intravenously (into a vein). For any additional information how
to use this product, ask your doctor.

Dosage
Your doctor will determine the right dosage for you.
The recommended daily dose is one vial (40 ml) of Decan. Your doctor can give you up
to 2 vials per day.
Decan will be diluted before use.

If you take more Decan than you should
The quantity of trace elements in Decan is well below known toxic levels. Therefore,
overdose is highly unlikely. Your doctor will stop your treatment with Decan and do
the necessary laboratory tests in the case of suspected overdose.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Decan can cause side effects, although not everybody gets them.
Tell your doctor if you notice any of the following:
Frequency not known (cannot be estimated from the available data) : Pain at the
application site.
If any of the side effects gets serious or if you notice any side effects not listed in this
leaflet, please tell your doctor

5. HOW TO STORE DECAN
Keep out of reach and sight of children.
Do not use Decan after the expiry date, which is stated on the bottle after EXP. The expiry
date refers to the last day of that month.
Do not store above 25°C. Do not freeze. Keep the container in the outer carton in order
to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help to
protect the environment.

6. FURTHER INFORMATION
What Decan contains
The active substances are:
For 40 ml Decan
Iron (Fe)
Copper (Cu)
Manganese (Mn)
Zinc (Zn)
Fluorine (F)
Cobalt (Co)
Iodine (I)
Selenium (Se)
Molybdenum (Mo)
Chromium (Cr)

1.00
0.48
0.20
10.00
1.45
1.47
1.52
0.070
0.025
0.015

mg
mg
mg
mg
mg
microg
microg
mg
mg
mg

(as Ferrous Gluconate)
(as Copper Gluconate)
(as Manganese Gluconate)
(as Zinc Gluconate)
(as Sodium Fluoride)
(as Cobalt Gluconate)
(as Sodium Iodide)
(as Sodium Selenite)
(as Ammonium Molybdate)
(as Chromic Chloride)

The other ingredients are Glucono delta lactone and Water for Injections.

What Decan looks like and contents of the pack
Decan is clear, limpid and slightly yellow solution.
Decan is packaged in a transparent glass bottle containing 40 ml of solution.
If the integrity of the bottle is damaged, or if the product looks different than a clear, limpid
and slightly yellow solution, do not use the product.
Pack sizes
40 ml x 1 unit
40 ml x 25 units
Not all pack sizes may be marketed.

Marketing Authorisation Holder
For any information about Decan please contact the Marketing Authorisation Holder:
Baxter Healthcare Limited
Caxton Way, Thetford, Norfolk, IP24 3SE, UK

Manufacturer
Laboratoire Aguettant – 1 rue Alexander Fleming – 69007 Lyon, France

This medicinal product is authorised in the Member States of the EEA under the
following names:
Greece: Deskan
Italy, Poland: Decaven
Austria, Denmark, Spain, Finland, France, Luxembourg, The Netherlands, Portugal,
Sweden, Republic of Ireland and United Kingdom: Decan.

This leaflet was revised in 02/2011.

+ Expand Transcript

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.

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