Fresenius Kabi

Concentrate for solution for infusion 3.3 mmol / ml 
(clear, colorless liquid)

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or nurse.
  • If you get any side effects, talk to your doctor or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Addex-THAM is and what it is used for 
2. What you need to know before you are given Addex-THAM 
3. How to give Addex-THAM 
4. Possible side effects 
5. How Addex-THAM to be stored 
6. Contents of the packaging and other information 

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

Content declaration

  • 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

Manufacturer

Apoteket Produktion & Laboratorier AB

Formvägen 5B

906 21 Umeå

Muhammad Nadeem

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