Fresenius Kabi

Concentrate for solution for infusion 4 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.

This leaflet contains information about: 
1. What Addex-Sodium Chloride is and what it is used for 
2. What you need to know before you are given Addex-Sodium Chloride 
3. How to take Addex-Sodium Chloride 
4. Possible side effects 
5. How to Addex-Sodium Chloride to be stored 
6. Contents of the packaging and other information 

1. What Addex-Sodium Chloride is and what it is used for

Addex-Sodium chloride is a concentrated sodium chloride solution which, after dilution, is given by healthcare professionals as a drip into a blood vessel ( intravenous infusion ). It belongs to a group of medicines called electrolyte solutions that are used for electrolyte deficiency (salt deficiency). Addex-Sodium chloride is used for sodium deficiency and ongoing sodium losses, e.g. in the case of liquid drip or when you get nutrition only via a drip.

Sodium chloride contained in Addex-Sodium chloride may also be approved for the treatment of other conditions 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 you are given Addex-Sodium Chloride

Warnings and cautions

Talk to your doctor or nurse before giving Addex-Sodium Chloride if you have:

  • renal impairment
  • fluid retention in the body ( edema )
  • heart failure
  • high blood pressure

Other medicines and Addex-Sodium chloride

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.

How to take Addex Sodium Chloride

You will receive this medicine by a drip into a blood vessel ( intravenous infusion ). The infusion rate and the amount of solution you receive depend on your needs and the condition being treated. 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

When recommended dosing instructions have been followed, no side effects of Addex-Sodium Chloride have been reported.

5. How to store Addex-Sodium Chloride

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. date. The expiration date is the last day of the specified month.

6. Contents of the packaging and other information

Content declaration

  • The active substance is sodium chloride 4 mmol/ml.
  • The other ingredients are hydrochloric acid and water for injections.

What the medicine looks like and the contents of the pack

Addex-Sodium is contained in the cartridge you or vials polypropylene.

Pack size: ampoule 20 x 20 ml, vial 10 x 20 ml.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Fresenius Kabi AB

751 74 Uppsala

Manufacturer

Fresenius Kabi Norge AS

NO-1788 Halden

Norway

Muhammad Nadeem

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