Ringer – Lactate Solution

Ringer - Lactate Solution Fresenius is a solution of the following substances in water: calcium, chloride, lactate, potassium and sodium. It is used to treat a loss of body water (dehydration), which occurs after burns, trauma, severe diarrhoea or an operation. It is also used to treat loss of blood volumes, which occurs after bleeding (haemorrhage).

Do not receive Ringer - Lactate Solution Fresenius:

• if you are hypersensitive (allergic) to calcium, chloride, lactate, potassium, sodium or any of the other ingredients of Ringer - Lactate Solution Fresenius (listed in section 6)
• if you have kidney failure (when your kidneys do not work well), or you produce abnormally small amounts of urine (oliguria) or if your kidneys are not producing any urine (anuria)
• if you suffer from a medical condition characterised by major shock and renal failure after a crushing injury to skeletal muscle (crush syndrome)
• if you experience a life-threatening reaction after receiving a blood transfusion (severe haemolytic reactions)
• if you have a condition in which your adrenal glands do not produce adequate amounts of steroid hormones, primarily cortisol (adrenocortical insufficiency)
• if you have higher levels of potassium in the blood than normal (hyperkalaemia)
• if you have a low urine output after an operation (oliguria)
• if you have higher levels of sodium in your blood than normal (hypernatraemia)
• if there is too much water (extracellular hyperhydration) or blood (hypervolaemia) in your body than there should be
• if you have heart failure
• if you have higher levels of calcium in your blood than normal (hypercalcaemia)
• if you have a condition called metabolic alkalosis, which occurs when your blood becomes overly alkaline
• if you have a liver disease that causes fluid to build up within your stomach area (ascitic cirrhosis)
• if you have abnormally high levels of acid, caused by your metabolism in your blood (severe metabolic acidosis)
• if you have an impairment to metabolise lactate, connected with high levels of lactate in your blood (hyperlactataemia)
• if you are taking medicine used to treat heart failure, such as digoxin (see Other medicines and Ringer - Lactate Solution Fresenius)

Preterm newborn infants and full term newborn infants (≤ 28 days of age): Your child must not receive ceftriaxone (an antibiotic) as a drip into a vein at the same time with Ringer - Lactate Solution Fresenius.

Ringer - Lactate Solution Fresenius is administered into the vein. You will not be expected to give yourself Ringer - Lactate Solution Fresenius. It will be given to you by a person who is qualified to do so. Your doctor will determine your dose, the rate at which Ringer - Lactate Solution Fresenius is dripped into your veins and for how long this should continue. The dose will depend on your age, body mass, medical condition and the laboratory results. If you have an impression that the effect of Ringer - Lactate Solution Fresenius is too strong or too weak, talk to your doctor or pharmacist. Your doctor will monitor the calcium, chloride, lactate, potassium and sodium in your blood before you are being treated and during treatment with Ringer - Lactate Solution Fresenius, especially if you are on medicines as mentioned (see Other medicines and Ringer - Lactate Solution Fresenius).

If you receive more Ringer - Lactate Solution Fresenius than you should Since a health care provider will administer Ringer - Lactate Solution Fresenius, he/she will control the dosage. However, in the event of overdosage your doctor will manage the symptoms of overdosage.

If you miss a dose of Ringer - Lactate Solution Fresenius Since a health care provider will administer Ringer - Lactate Solution Fresenius, it is unlikely that a dose will be missed.

Ringer - Lactate Solution Fresenius can have side effects. Not all side effects reported for Ringer - Lactate Solution Fresenius are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving Ringer - Lactate Solution Fresenius, please consult your doctor, pharmacist or other health care provider for advice. If any of the following happens, stop receiving Ringer - Lactate Solution Fresenius and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Sweating of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing.
• Rash or itching.
• Fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to Ringer - Lactate Solution Fresenius.

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

• Decreased ability to think, headaches, nausea and poor balance. These symptoms could be an indication of low sodium levels in your blood (hyponatraemia).
• Neurological symptoms typically occur with very low levels of plasma sodium. When sodium levels in the blood become very low, water enters the brain cells and causes them to swell. This results in increased pressure in the skull and causes hyponatraemic encephalopathy and is a medical emergency.

These are all serious side effects. You may need urgent medical attention. 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 via the 6.04 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 Ringer - Lactate Solution Fresenius. Health care 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 medicines regulatory authority in the country where the product is marketed.

• Store at or below 25 °C. Protect from light.

• Discard after single use.

• Discard any unused portion.

• Do not reconnect partially used bags.

• STORE ALL MEDICINES OUT OF REACH OF CHILDREN.

• Return all unused medicine to your pharmacist.

• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).