Addaven Concentrate for Solution for infusion, Trace Element Solution
1. What Addaven Is And What It Is Used For
Addaven is a medicine that contains trace elements. Trace elements are small substances you normally get in you through food that the body needs to function normally. Addaven is given intravenously (as a drip into a vein) when you cannot eat normally. This medicine is usually used as part of a balanced intravenous diet, along with protein, fat, carbohydrates, salts, and vitamins.
Addaven may also be approved for treating other diseases not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have further questions, and always follow their instructions.
2. What You Need To Know Before You Are Given Addaven
Stop Using Addaven:
- If you are allergic to any of the ingredients of this medicine (listed in section 6). Tell your doctor immediately if you get a rash or other allergic reactions (such as itching, swollen lips or face, or shortness of breath).
- If your bile secretion is blocked.
- If you have Wilson’s disease (a genetic disease in which copper is stored in the body) or hemochromatosis (storing iron in the body).
Addaven should not be given to children weighing less than 15 kg.
Warnings And Cautions
Talk to a doctor if you have problems with your liver and kidney function.
Your doctor may want to take regular blood tests to check your condition. If you are taking iron supplements simultaneously with an infusion, your doctor will check that iron is not accumulating in your body. Iron and iodine can rarely cause allergic reactions when given as a drip. Tell your doctor or nurse if you get an allergic reaction when you receive Addaven.
Other Medicines And Addaven
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy And Breastfeeding
Addaven can be used during pregnancy and lactation.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
Driving And Using Machines
Addaven has no effect on driving ability and the use of machines.
You are responsible for assessing whether you can drive a motor vehicle or perform work requiring sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
3. How To Take Addaven
Addaven uses
- This medicine will be given to you by a healthcare professional.
- You will receive your medicine as an infusion (drip) directly into a vein.
- Your doctor will decide what dose you will receive.
- The recommended dose for adults is 10 milliliters (ml) daily. You may be given a lower dose if you have liver or kidney problems.
- Addaven medicine should be mixed with another solution before giving it to you. Your doctor or nurse will ensure it is mixed properly before receiving Addaven.
Use For Children
The recommended dose for children weighing more than 15 kg is 0.1 ml per kg body weight and day.
If You Take More Addaven Than You Should
It is very unlikely that you will receive more medicines than you should because your doctor or nurse will monitor your treatment. If you have received too much Addaven, tell your doctor or nurse immediately.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible Addaven Side Effects
No side effects have been reported with this medicine medicine as recommended. If you get any side effects, talk to your doctor or nurse.
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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How To Store Addaven
- Keep this medicine out of sight and reach of children.
- Do not use this medicine after the expiry date stated on the carton and ampoule label. The expiration date is the last day of the specified month.
- This medicine does not require any special storage instructions.
- Your doctor and pharmacy staff at the hospital are responsible for the proper storage, use, and destruction of Addaven infusion fluid.
- After dilution: This medicine should be added immediately before infusion, and the infusion solution should be used within 24 hours. If not used immediately, in-use storage times and conditions before use are the user’s responsibility. They would normally not be longer than 24 hours at 2-8 ° C unless mixing has been performed under controlled and validated aseptic conditions.
- Any unused product or waste material should be disposed of in accordance with local requirements.
6. Contents Of The Packaging And Other Information
Content Declaration
| The active substances (trace elements) in an ampoule (10 ml) are: | |
| Chromium chloride hexahydrate | 53.3 micrograms |
| Copper chloride dihydrate | 1.02 mg |
| Iron (III) chloride hexahydrate | 5.40 mg |
| Manganese chloride tetrahydrate | 198 micrograms |
| Potassium iodide | 166 micrograms |
| Sodium fluoride | 2.10 mg |
| Sodium molybdate dihydrate | 48.5 micrograms |
| Sodium selenite anhydrous | 173 micrograms |
| Zinc chloride | 10.5 mg |
| The other ingredients are arP xylitol, hydrochloric acid, and water for injections. | |
| This product contains 0.052 mmol sodium (1.2 mg) per dose (10 ml). |
What The Medicine Looks Like And The Contents Of The Pack
- Addaven is a clear, almost colorless solution of trace elements.
- Addaven is supplied in a polypropylene ampoule containing 10 ml of concentrate in the following pack size: 20 x 10 ml.
Marketing Authorization Holder and Manufacturer
| Marketing Authorisation Holder | Manufacturer |
|---|---|
| Fresenius Kabi AB | Fresenius Kabi Norge AS |
| 751 74 Uppsala | Halden, Norway |