9 mg / ml solution for injection
sodium chloride
What Sodium Chloride Noridem is and what it is used for
Sodium chloride Noridem belongs to a group of medicines called electrolytes. It is a sterile, physiological saline solution that is used in several different treatments.
Sodium chloride Noridem is mainly used to dissolve or dilute other medicines, which are to be given as an injection or infusion (drip) into veins, muscles, or tissues.
Sodium chloride Noridem can also be used in preparation for surgery and various medical treatments, such as:
– flushing of catheters (injection needles for the administration of drugs into veins)
for initial administration via intravenous tubes to check that no air remains in the tubes, e.g. in hemodialysis (treatment to purify the blood in kidney disease)
during blood transfusions, as initial and final administration, so as not to damage the blood cells.
Sodium chloride Noridem is also used as an additive to other medicines, such as for infusion (drip) of eg sugar solutions. Sodium chloride Noridem is then used to regulate the body’s electrolyte and
fluid balance.
What you need to know before you use Sodium Chloride Noridem
The doctor or healthcare professional who gives you this medicine may ask some questions. They need the following information before receiving this medicine for the first time.
Do not use Sodium Chloride Noridem
– if you have hypernatremia (the sodium content of your body is too high)
– if you have hyperchloremia (your chloride content is too high)
Take special care with Sodium Chloride Noridem
Tell your doctor or healthcare professional before starting treatment:
– if you have heart problems
– if you have problems with blood pressure –
if you have kidney problems
– if you have problems with sodium levels in your blood.
Read the package leaflets of your other medicines carefully, as Sodium Chloride Noridem is sometimes added to other medicines for solution or dilution.
Other medicines and Sodium Chloride Noridem
Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. You must tell your doctor if you are taking any of the following medicines: corticosteroids such as cortisone, hydrocortisone, prednisone, prednisolone, betamethasone.
Pregnancy, breastfeeding and fertility
There are no known risks with the use of Sodium Chloride Noridem during pregnancy or breastfeeding.
Because Sodium Chloride Noridem is sometimes given with other medicines, you must tell your doctor:
• if you are pregnant or think you may be pregnant
• if you are breastfeeding.
Your doctor will tell you if you are going to use this medicine.
How to use Sodium Chloride Noridem
This medicine is usually given by a doctor or healthcare professional, who adjusts the dosage according to the area of use.
Your doctor will decide on the amount ( dose one) of the medicine and for how long you need to take it.
Dosage one of Sodium Chloride Noridem depends on what it is to be used for, e.g. to dissolve or dilute another drug or as a solution for rinsing.
If you use more Sodium Chloride Noridem than you should
This medicine is usually given by a doctor or healthcare professional. If you think you have been given too much medicine, tell your doctor or healthcare professional immediately.
Because this medicine is supplied in small volumes (maximum 20 milliliters per container), it is unlikely that you will get too much.
Because Sodium Chloride Noridem is sometimes given with other medicines, you should read all the package leaflets for your medicines carefully.
If you forget to use Sodium Chloride Noridem
This medicine is usually given by a doctor or healthcare professional. If you think you have missed a dose, tell your doctor or healthcare professional.
If you have any further questions on the use of this product, ask your doctor, healthcare professional, or pharmacist.
The known side effects of Sodium Chloride Noridem when used to dissolve and dilute other medicines or when used as a rinsing solution are too high sodium and chloride levels in the blood.
Keep in mind that you may also get side effects from the other medicines when Sodium Chloride Noridem is used as a solvent or diluent. Be sure to read all the package leaflets for your medicines.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, healthcare professional, or pharmacist.
Possible side effects
The known side effects of Sodium Chloride Noridem when used to dissolve and dilute other medicines or when used as a rinsing solution are too high sodium and chloride levels in the blood.
Keep in mind that you may also get side effects from the other medicines when Sodium Chloride Noridem is used as a solvent or diluent. Be sure to read all the package leaflets for your medicines.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, healthcare professional, or pharmacist.
By reporting side effects, you can help increase the safety of medicines.
How to store Sodium Chloride Noridem
Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. and on the label on ampoule one after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Use only if it is a clear and colorless liquid. Do not use immediately after opening. Unused solutions should be discarded.
Leftover medicine should be given to your doctor, healthcare professional, or pharmacist. These
measures are to protect the environment.
Contents of the pack and other information
Content declaration
The active substance is sodium chloride, 9 mg/ml.
The other ingredients are water for injections.
What the medicine looks like and contents of the pack
Sodium chloride Noridem is a clear and colorless liquid.
Each plastic ampoule contains 5 ml (milliliters), 10 ml or 20 ml of the medicine.
Pack sizes: 20 and 50 ampoules containing 5 ml, 20, 50, and 100 ampoules containing
10 ml and 20 ampoules containing 20 ml.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
No ride Enterprises Ltd., Evagorou & Markariou, Mitsi Building 3, Suite. 115, 10 65 Nicosia Cyprus
Manufacturer:
Demo SA, 21 km National Road Athens-Lamia, 14568 Athens, Greece
Local Representative:
Frostpharma AB
Berga Backe 2
182 53 Danderyd
This medicine is authorized in the European Economic Area under the names:
Denmark: Sodium chloride “Noridem”, solvent for parenteral
use / solution for injection 9mg / mL
Germany: Sodium chloride Noridem 0.9% Solution for injection
Ireland: Sodium Chloride 0.9% (w / v) Injection BP
Norway : Sodium chloride Noridem 9mg / mL solution for injection “Noridem”
Portugal: Cloreto de sodio Noridem, 9mg / mL, Injectable solution
Sweden: Sodium chloride Noridem 9mg / mL solution for injection
Spain: Cloruro de sodio Serraclinics 9 mg / ml (0.9% ), injectable solution
United Kingdom: Sodium Chloride 0.9% (w / v)Injection BP
Austria: Sodium Chloride Noridem 0.9% Solution for injection or Solvent for
Parenteralia
Greece: Sodium Chloride Noridem 0.9% Solution for injection or Solvent for
Parenteral
Netherlands: Sodium Chloride Noridem 0.9%, solution for injection and solvent
for 9 ml