Sodium Chloride 0,9 %

This medicine contains sodium chloride at a concentration similar to the concentration of salts in your blood. It is used to replace fluids lost from your body such as when you are dehydrated or to prevent dehydration.

SODIUM CHLORIDE 0,9 % FRESENIUS should not be administered to you:

• if you are hypersensitive (allergic) to sodium chloride or any of the other ingredients of SODIUM CHLORIDE 0,9 % FRESENIUS (listed in section 6).

Warnings and precautions

Tell your doctor or healthcare provider before being given the injection if you have:

• heart disease or heart failure
• impaired kidney function
• acidification of the blood (acidosis)
• liver disease (e.g. cirrhosis)
• when there is a larger volume of blood in the blood vessels than there should be (hypervolaemia)
• high blood pressure (hypertension)
• pre-eclampsia (high blood pressure during pregnancy)
• fluid retention resulting in swelling of parts of the body, particularly your feet and ankles (peripheral oedema) or build-up of fluid in the lungs (pulmonary oedema).
• any other condition associated with sodium retention (when the body retains too much sodium), such as treatment with steroids (see also below “Other medicines and SODIUM CHLORIDE 0,9 % FRESENIUS ”)
• raised production of the hormone aldosterone (aldosteronism)
• if you have a condition that could cause high levels of vasopressin, a hormone regulating fluid in your body. You may have too much vasopressin in your body because, for example:

• you have had a sudden and serious illness
• you are in pain
• you have had surgery
• you have infections, burns or brain disease
• you have diseases linked to your heart, liver, kidneys or central nervous system
• because you are taking certain medicines (see also below “Other medicines and SODIUM CHLORIDE 0,9 % FRESENIUS ”)

This may increase the risk of low levels of sodium in your blood and can lead to headache, nausea, seizures, lethargy, coma, swelling of the brain and death. Brain swelling increases the risk of death and brain damage. People who are at higher risk of brain swelling are:

• children
• women (particularly if you are of a fertile age)
• people who have problems with their brain fluid levels, for example, because of meningitis, bleeding in the skull or a brain injury

Do not share medicines prescribed for you with any other person. You will not be expected to give yourself SODIUM CHLORIDE 0,9 % FRESENIUS. It will be given to you by intravenous injection, by a person who is qualified to do so. Your doctor will decide the correct dosage for you and how and when the injection will be given. Your doctor will tell you how long your treatment with SODIUM CHLORIDE 0,9 % FRESENIUS will last. If you have the impression that the effect of SODIUM CHLORIDE 0,9 % FRESENIUS is too strong or too weak, tell your doctor or pharmacist.

If you are given more SODIUM CHLORIDE 0,9 % FRESENIUS than you should

Since a healthcare provider will administer SODIUM CHLORIDE 0,9 % FRESENIUS, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage. If you think you have been given too much, and you start feeling thirsty, confused, weak, and drowsy or have a headache or fast heartbeat, you must tell the person giving you the injection.

SODIUM CHLORIDE 0,9 % FRESENIUS can have side effects. Not all side effects reported for SODIUM CHLORIDE 0,9 % FRESENIUS are included in this leaflet. Should your general health worsen or if you experience any untoward effects while using SODIUM CHLORIDE 0,9 % FRESENIUS, please consult your healthcare provider for advice. Tell your healthcare provider immediately if you start having fits or a headache, or start feeling nauseas, weak or confused.

Not known: frequency cannot be estimated from the available data

• tremor
• decreased blood pressure
• local pain or reaction (redness or swelling at the site of infusion)
• infection at the site of infusion
• itching (pruritus) at the site of infusion
• hives (urticaria), skin rash
• irritation and inflammation of the vein into which the solution is infused (phlebitis). This can cause redness, pain or burning and swelling along the path of the vein into which the solution is infused.
• the formation of a blood clot (venous thrombosis) at the site of infusion, which causes pain, swelling or redness in the area of the clot
• escape of the infusion solution into the tissues around the vein (extravasation). This can damage the tissues and cause scarring.
• an excess of fluid in the blood vessels (hypervolaemia)
• fever
• chills
• low levels of sodium in the blood that may be acquired during hospitalization (nosocomial hyponatraemia) and related neurological disorder (acute hyponatraemic encephalopathy). Hyponatraemia can lead to irreversible brain injury and death due to (cerebral oedema/swelling) (see also in the section 2 “Warning and precautions”)

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of SODIUM CHLORIDE 0,9 % FRESENIUS. Patients are asked to report any suspected adverse drug reactions to their healthcare provider or Holder of the Certificate of Registration at the following email address: [email protected] and to the relevant medicine’s regulatory authority in the country where the product is marketed.

Store all medicines out of reach of children. Store at or below 25 ºC. Do not use this medicine after the expiry date which is stated on the labels. The expiry date refers to the last day of that month. Do not use SODIUM CHLORIDE 0,9 % FRESENIUS if you notice that the solution appears cloudy or coloured, if you find particles in the solution or if the container is leaking. This medicine is for single use only. After use, container and any remaining contents have to be discarded. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).