Patient leaflet - Addaven concentrate for solution for infusion
1. What Addaven is and what it is used for
Addaven is a medicine that contains trace elements. Trace elements are tiny amounts of chemicals that your body needs to work normally. Addaven is given intravenously (into a vein) when you can not eat normally. This medicine 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 are given Addaven
You should not receive Addaven:
- if you are allergic to any of the ingredients of this medicine (listed in section 6). If you develop a rash or other allergic reactions (like itching, swollen lips or face, or shortness of breath), inform your doctor immediately.
Warnings and precautions
Talk to your doctor or nurse before you are given Addaven
Inform your doctor or nurse if you have problems with the way your liver and/or kidneys work.
Your doctor may want to do regular blood tests to check your condition.
Other medicines and Addaven.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine.
Driving and using machines
Addaven has no effect on driving or using machines.
3. How Addaven is given
This medicine will be administered to you by a healthcare professional. You will receive your medicine by infusion (IV drip), directly into a vein. Your doctor will decide on the correct dose for you to receive.
The recommended dose for adults is 10 millilitres (ml) each day. Addaven should be added to another solution before it is given to you. Your doctor or nurse will make sure it is prepared correctly before you receive Addaven.
Use in children and adolescents
Addaven is not recommended for use in children and adolescents weighing less than 40 kilograms.
If you receive too much Addaven
It is very unlikely that you will receive more medicine than you should as your doctor or nurse will monitor you during the treatment. However if you think that you have received too much Addaven, inform your doctor or nurse immediately.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
There are no known undesirable effects reported with the use of Addaven.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. The includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or serach for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
01-58-01-xxx VOO1
5. How to store Addaven
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and vial label. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Your doctor and hospital pharmacist are responsible for the correct storage, use and disposal of Addaven infusion.
After dilution: The addition of Addaven should be performed immediately before the start of the infusion and should be used within 24 hours. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the healthcare professional and would normally not be longer than 24 hours at 2-8°C, unless mixing has taken place in controlled and validated aseptic conditions.
Any solution remaining after treatment should be thrown away via approved hospital procedures.
6. Contents of the pack and other information
What Addaven infusion contains
The active substances in one ampoule (10 ml) are:
Chromic chloride hexahydrate 53.3 micrograms Copper chloride dihydrate 1.02 milligrams Ferric chloride hexahydrate 5.40 milligrams Manganese chloride tetrahydrate 198 micrograms Potassium iodide 166 micrograms Sodium fluoride 2.10 milligrams Sodium molybdate dihydrate 48.5 micrograms Sodium selenite 173 micrograms Zinc chloride 10.5 milligrams
The active ingredients in 10 ml of Addaven correspond to: Cr 0.2 μmol 10 μg Cu 6 μmol 380 μg Fe 20 μmol 1.1 mg Mn 1 μmol 55 μg I 1 μmol 130 μg F 50 μmol 950 μg Mo 0.2 μmol 19 μg (as Mo6+) Se 1 μmol 79 μg (as Se4+) Zn 77 μmol 5 mg
The content of sodium and potassium in 10 ml corresponds to: Sodium 1.2 mg 52 μmol Potassium 39 μg 1 μmol
- The other ingredients are: xylitol, hydrochloric acid, water for injections.
What Addaven looks like and contents of the pack
Addaven is a clear, almost colourless solution of trace elements.
Addaven is available in a polypropylene ampoule containing 10 ml of concentrate, in the following pack size: 20 x 10 ml
Marketing Authorisation Holder
Fresenius Kabi Limited
Cestrian Court, Eastgate Way,
Manor Park, Runcorn,
Cheshire, WA7 1NT
UK
Manufacturer
Fresenius Kabi Norge AS
NO-1753 Halden
Norway