Active substance(s): CHROMIC CHLORIDE / COPPER CHLORIDE / FERRIC CHLORIDE HEXAHYDRATE / MANGANESE CHLORIDE / POTASSIUM IODIDE / SODIUM FLUORIDE / SODIUM MOLYBDATE DIHYDRATE / SODIUM SELENITE ANHYDROUS / ZINC CHLORIDE
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.
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Concentrate for Solution for Infusion
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Additrace if you suffer from:
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.
- 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.
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
Other medicines and Additrace
Talk to your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
1. What Additrace is and what it is used for
3.HOW TO USE ADDITRACE
Additrace is usually used as part of a balanced intravenous diet, together with proteins, fat,
The recommended dose of Additrace for adults is 10 millilitres each day when added to Vamin 9 Glucose, Vamin 14,
Vamin 14 Electrolyte-Free, Vamin 18 Electrolyte-Free, and Glucose 5%-50%.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask you doctor or
pharmacist for advice before taking this medicine.
Driving and using machines
Additrace has no effect on the ability to drive and use machines.
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.
You will receive your medicine by infusion (IV drip).
Your doctor or pharmacist will decide on the correct dose for you to receive.
carbohydrates, salts and vitamins.
It is very unlikely that you will receive more infusion than you should as your doctor or nurse will monitor you during the
treatment. However if you think that you have received too much Additrace, inform your doctor or nurse immediately.
If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.
4. POSSIBLE SIDE EFFECTS
Although no known undesirable effects have been reported with the use of Additrace, like all medicines, this medicine
can cause side effects.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly via the national reporting schemes listed below. By reporting
side effects you can help provide more information on the safety of this medicine.
For UK - you can report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard
For Ireland – you can also report side effects directly via:
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
For Malta - Healthcare professionals are asked to report any suspected adverse reactions to The Medicines Authority
at the following contact details;
The Medicines Authority
203 Level 3, Rue D’Argens
Use in children and adolescents
Additrace is not recommended for use in children weighing less than 40 kilograms.
If you received more Additrace than you should
MASTER ARTWORK/LABEL SPECIFICATION
Halden article number:
Label spec. number:
Pharma code/Code lines:
Prepared by: Sven-Erik Arneberg
405 x 128 mm folded to 135 x 64 mm
5. HOW TO STORE ADDITRACE
6. CONTENTS OF THE PACK AND OTHER INFORMATION
Your doctor, pharmacist and nurse are responsible for the correct storage, use and disposal of Additrace.
Each ampoule contains 10ml of concentrate.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and ampoule label. The expiry date refers to the
last day of that month.
Store below 25ºC. Do not freeze.
Keep the ampoules in the outer carton in order to protect from light.
Do not use this medicine if it is cloudy or contains particles.
The addition of Additrace should be performed immediately before the start of infusion and should be used within
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 hours at 2-8ºC, unless mixing has taken place in controlled and validated
Any unused solution should be discarded. Do not throw away any medicines via wastewater. Ask your pharmacist
how to throw away medicines that you no longer use. These measure will help protect the environment.
Marketing Authorisation Holder and Manufacturer:
What Additrace contains
1 millilitre of Additrace
Marketing authorisation holder
Each ampoule contains 10ml
Ferric chloride, 6H20
Manganese chloride 4H20
Chromic chloride 6H20
Sodium selenite anhydrous
Copper chloride 2H20
Fresenius Kabi Limited
Sodium molybdate, 2H20
Fresenius Kabi Norge AS
This leaflet was last revised in January 2016
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.
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.