2 mmol / ml concentrate for solution for infusion ,
potassium hydroxide and dipotassium phosphate trihydrate
1. What Addex-Potassium is and what it is used for
Addex- Potassium is a concentrate for infusion fluid given by healthcare professionals as a drip into a blood vessel ( intravenous infusion ). It belongs to a group of medicines called electrolyte solutions used in electrolyte deficiency. Addex- Potassium is used for potassium deficiency and ongoing potassium losses, e.g. then you get fluid or nutrition through the drip.
Potassium hydroxide and dipotassium phosphate trihydrate contained in Addex- Potassium may also be approved for the treatment of other diseases not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
2. What you need to know before using Addex-Potassium
You should not be given Addex-Potassium
- if you are allergic to potassium hydroxide or dipotassium phosphate trihydrate or any of the other ingredients of this medicine (listed in section 6).
- if you have high levels of potassium in your blood, e.g. in case of renal impairment, shock condition, or dehydration. The medical staff checks this.
Warnings and cautions
The drug must be diluted before use.
Addex- Potassium should be used with caution
- impaired renal function ;
- abnormally low urine production,
The medical staff checks this.
Addex- Potassium increases the osmolality (number of dissolved molecules ) in the infusion solution and may increase the risk of thrombophlebitis ( inflammation of a superficial blood vessel). Talk to your doctor or nurse if you experience redness and pain near the place where you received the drip.
Talk to your doctor or nurse before giving Addex- Potassium .
Other medicines and Addex-Potassium
Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding, and fertility
No known risks at recommended doses.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before taking this medicine.
Driving and using machines
No known effects.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or 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.
How to take Addex-Potassium
You will usually receive this medicine in a hospital by a drip into a blood vessel ( intravenous infusion ) after diluting the solution. The infusion rate and the amount of solution you receive depend on your needs, the disease being treated, and the maximum daily dose. Your doctor will decide what is the right dose for you.
If you have any further questions on the use of this product, ask your doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
When given dosing instructions, no side effects of Addex- Potassium have been reported.
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 Addex-Kalium
The medical staff is responsible for the storage of Addex- Potassium and any waste. No special storage instructions. Keep out of sight and reach of children.
6. Contents of the packaging and other information
- The active substances are potassium hydroxide and dipotassium phosphate trihydrate.
- The other ingredients are concentrated acetic acid and water for injections.
What the medicine looks like and the contents of the pack
Addex- Potassium is a sterile, clear solution. It is delivered in ampoules or plastic vials.
Pack size: ampoule 20 x 10 ml, vial 10 x 10 ml.
Marketing Authorization Holder and Manufacturer
Holder of a marketing authorization
Fresenius Kabi AB
SE-751 74 Uppsala
Fresenius Kabi Norge AS