Sodium Chloride 5 % Solution

SODIUM CHLORIDE 5 % FRESENIUS is a hypertonic solution that is used for severe sodium deficits.

SODIUM CHLORIDE 5 % FRESENIUS should not be given:

• to you if you are hypersensitive (allergic) to SODIUM CHLORIDE 5 % FRESENIUS
• to babies, young children and the elderly if undiluted.

Warnings and precautions

Tell your doctor or health care provider before being given the injection:

Special care should be taken with SODIUM CHLORIDE 5 % FRESENIUS:

• if SODIUM CHLORIDE 5 % FRESENIUS is given to children, as they may have impaired ability to regulate fluids and electrolytes
• if SODIUM CHLORIDE 5 % FRESENIUS is given to the elderly, as they may have decreased liver, kidney or heart function, have other diseases or be on other medicines
• if you have primary or secondary hyperaldosteronism, a condition where your body creates too much of the hormone aldosterone, resulting in too much sodium and fluid in the blood
• if you have high blood pressure or congestive heart failure (inability of the heart to supply sufficient blood flow)
• if you are pregnant and have high blood pressure
• if you have liver disease or liver damage
• if you have severely impaired kidney function or kidney damage
• if you have a condition that causes water retention (swelling) or water on the lungs
• if you are taking medicines that may increase the risk of sodium and fluid retention, such as corticosteroids or corticotrophin.

You will not be expected to give yourself SODIUM CHLORIDE 5 % FRESENIUS. It will be given to you by a person who is qualified to do so.

Dose: SODIUM CHLORIDE 5 % FRESENIUS will be slowly infused (dripped) into a vein. Your doctor will determine your dose, the rate at which the medicine is dripped into your veins and for how long this should continue. You will be carefully monitored and your dose adjusted according to the results of your blood tests.

Your health care provider will always inspect containers for intactness of seals and the solutions for injection for discolouration or presence of any visible particulate matter. The solution will not be used if it is not clear, if it has visible particles, or if the seals of the bag are not intact.

If you receive more SODIUM CHLORIDE 5 % FRESENIUS than you should Since a healthcare provider will administer SODIUM CHLORIDE 5 % FRESENIUS, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

SODIUM CHLORIDE 5 % FRESENIUS can have side effects. Not all side effects reported for SODIUM CHLORIDE 5 % FRESENIUS are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving SODIUM CHLORIDE 5 % FRESENIUS, please consult your doctor, pharmacist or other healthcare provider for advice.

If any of the following happens, stop receiving SODIUM CHLORIDE 5 % FRESENIUS and tell your doctor immediately:

• Hypersensitivity reactions such as a fast heartbeat, chest pain, difficulty in breathing and flushing.
• Convulsions from too much salt in the blood.
• Too high salt concentration in the blood from unsuitable intravenous use of SODIUM CHLORIDE 5 % FRESENIUS. This may lead to a serious side effect where the brain loses water, resulting in sleepiness, confusion, convulsions, coma, respiratory failure and death. These are all very serious side effects. If you have them, you may have had a serious reaction to SODIUM CHLORIDE 5 % FRESENIUS. You may need urgent medical attention or further hospitalisation.

Tell your doctor immediately if you notice any of the following:

• Thirst.
• Less saliva and tear formation.
• Fever.
• Sweating.
• Abnormal rapid beating of the heart.
• High blood pressure or low blood pressure.
• Headache.
• Dizziness.
• Restlessness, irritability.
• Weakness.
• Muscular twitching and rigidity (stiffness and resistance to movement).

These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following:

• Hives, rash and itching.
• Shaking or quivering.
• Chills.
• Too much fluid on the lungs.
• Abnormal electrolyte levels in the body.
• Injection site reactions such as infection, irritation, redness, hives and a burning sensation.
• Vein irritation.
• Vein inflammation with clot formation.
• Swelling.

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

Reporting of side effects: Healthcare providers are asked to report any suspected adverse drug reactions to the 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. If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects via the Adverse Drug Reaction Reporting Form, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of SODIUM CHLORIDE 5 % FRESENIUS.

Store at or below 25 ºC. Use immediately after the bag is opened. Discard any unused portion. Store all medicines out of reach of children.