3.3 mmol / mL concentrate for infusion solution
1. What Addex-THAM is and what it is used for
Addex-THAM is a concentrated solution that, after dilution, is given by healthcare professionals as a drip into a blood vessel ( intravenous infusion ). It is a buffering solution that counteracts acidification in the body, which can occur in cases of shock, poisoning, cardiac arrest, or diabetic coma ( acute metabolic acidosis ) and in asthma attacks ( acute respiratory acidosis ) that can not be quickly stopped with artificial respiration alone.
The active substances contained in Addex-THAM may also be approved for the treatment of other diseases not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
2. What you need to know before you are given Addex-THAM
You should not be given Addex-THAM
- if you are allergic to trometamol or any of the other ingredients of this medicine (listed in section 6),
- if you have severe renal impairment,
- if you have chronic acidification in the body ( respiratory or metabolic acidosis ).
Warnings and cautions
Talk to your doctor or nurse before giving Addex-THAM if you have:
- renal impairment
Other medicines and Addex-THAM
Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
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
Addex-THAM has no known effects on the ability to drive or use machines.
How to take Addex-THAM
Your doctor will decide on a dose based on your condition and the underlying cause. You will be given this medicine by a healthcare professional, as a drip into a blood vessel ( intravenous infusion ). Samples may be taken to check the treatment.
If you have any further questions on the use of this product, ask your doctor or nurse.
4. Possible side effects
When recommended dosing instructions have been followed, no side effects of Addex-THAM have been reported.
5. How to store Addex-THAM
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 label after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Any remaining infusion solution should be discarded.
6. Contents of the packaging and other information
- The active substance is trometamol.
- The other ingredients are hydrochloric acid and water for injections.
What the medicine looks like and the contents of the pack
Addex-THAM is a concentrate for solution for infusion sold in vials packaged in a 10 × 50 ml carton.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Fresenius Kabi AB
751 74 Uppsala
Apoteket Produktion & Laboratorier AB
906 21 Umeå