RINGERS SOLUTION - patient leaflet, side effects, dosage

Patient leaflet - RINGERS SOLUTION

Ringer’s Solution for Infusion

Sodium chloride, potassium chloride, calcium chloride dihydrate

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Ringer’s Solution for Infusion is and what it is used for
2. What you need to know before you are given Ringer’s Solution for Infusion
3. How you will be given Ringer’s Solution for Infusion
4. Possible side effects
5. How Ringer’s Solution for Infusion is stored
6. Contents of the pack and other information

1. what ringer’s solution for infusion is and what it is used for

Ringer’s Solution for Infusion is a clear solution of sodium chloride, potassium chloride and calcium chloride in water.

Ringer’s Solution for Infusion is given by intravenous infusion (into a veinl to patients suffering from water loss (dehydration) and low sodium or low potassium levels.

2. what you need to know before you are given ringer’s solution for infusion

You should not receive Ringer’s Solution for Infusion if you have:

a known allergy (hypersensitivity) to sodium chloride, potassium chloride, calcium chloride dihydrate or any of the other ingredients of Ringer’s Solution for Infusion (listed in section 6l
very high sodium or potassium levels
kidney or heart disorders
too much fluid in the spaces around the cells of the body (hyperhydration)
uncompensated heart failure (heart failure that is not adequately treated and causes symptoms such as shortness of breath and swelling of the ankles)

Your doctor will check for these.

Warnings and precautions

Talk to your doctor or nurse before being given Ringer’s Solution for Infusion if you have, or have had, any of the following medical conditions:

heart failure, heart disease or reduced heart function
reduced kidney function
high blood pressure (hypertension)
build-up of fluid in the tissues, particularly around the ankles (peripheral oedema)
build-up of fluid in the lungs (pulmonary oedema)
high blood pressure during pregnancy (pre-eclampsia)
a disease that causes high levels of a hormone called aldosterone (aldosteronism)
any other condition associated with sodium retention (when the body retains too much sodium), such as treatment with steroids
a loss of water from the body (acute dehydration, e.g. from vomiting or diarrhoeal

Tell your doctor if you:

suffer from acute illness, pain, post-operative stress, infections, burns, or disease of the central nervous system.
have any type of liver disease.
have been treated with a medicine increasing the effect of vasopressin (a hormone regulating the body’s water retention) because this may increase the risk of hospital-acquired low sodium levels in the blood (hyponatraemia)
heat cramp
have sickle cell disease ( a condition affecting the red blood cells)
have excess fluids build up around the brain (cerebral oedema)
have meningitis (swelling of the protective membranes covering brain and spinal cord)
have any brain injury.

When you are given this infusion, your doctor or nurse will take blood and urine samples and monitor:

the amount of fluid in your body
your vital signs
the amount of chemicals such as sodium, potassium, calcium and chlorides in your blood (plasma electrolytes)

Your doctor or nurse will ensure the solution is clear and free from particles before use.

Other medicines and Ringer’s Solution for Infusion

Tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

It is particularly important that you inform your doctor or nurse if you are taking any of the following medicines because they can cause the body to accumulate sodium and water, leading to tissue swelling (oedema) and high blood pressure (hypertension):

digitalis preparations used to treat heart failure, as they must not be used with Ringer’s Solution for Infusion. The effects of these drugs can be increased by calcium. This can lead to life-threatening changes to the heart rhythm
corticosteroids (anti-inflammatory medicines)
carbenoxolone (an anti-inflammatory medicine used to treat stomach ulcers)

The following medicines can increase the concentration of potassium in the blood. This effect can be life-threatening. A rise in the blood potassium levels is more likely to occur if you have kidney disease.

potassium-sparing diuretics (certain water tablets, e.g. amiloride, spironolactone, triamterenel. (Note that these medicines may be included in combination medicinal products)
angiotensin converting enzyme (ACEl inhibitors (used to treat high blood pressure)
angiotensin II receptor agonists (used to treat high blood pressure)
tacrolimus (used to prevent rejection of a transplant and to treat some skin diseases)
cyclosporin (used to prevent rejection of a transplant)
suxamethonium

Other medicines that can affect or be affected by Ringer’s Solution for

Infusion include:

thiazide diuretics such as hydrochlorothiazide or chlorthalidone
vitamin D
Medicines leading to an increased vasopressin effect e.g.:
Medicines stimulating vasopressin release (e.g. chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine, ifosfamide,antipsychotics, narcotics)
Medicines potentiating vasopressin action (e.g. non-steroidal anti-inflammatory drugs, chlorpropamide, cyclophophamide) _____
Medicines acting as vasopressin, so called vasopressin analogues e.g.: ------

Desmopressin, oxytocin, vasopressin, terlipressin

other medicinal products increasing the risk of hyponatraemia including diuretics in general and antiepiliptics e.g. oxcarbazepine

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Ringer’s Solution should be given with special caution for pregnant women during labour, if given in combination with oxytocin this may cause low sodium concentration in the blood.

Driving and using machines

Ringer’s Solution for Infusion has no effect on driving or using machines.

3. how you will be given ringer’s solutionfor infusionringer’s solution for infusion will be given to you by a doctor or nurse.

You will receive your medicine by infusion (an injection into a vein).

Dosage

The amount and rate at which the infusion is given depends on your requirements. Your doctor will decide on the correct dose for you to receive.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

If you receive more Ringer’s Solution for Infusion than you should

It is very unlikely that you will receive more solution than you should as this medicine will be given to you by a doctor or nurse and you will be closely monitored during treatment. If you are given too much Ringer’s Solution for Infusion or you are given your infusion too quickly, this may lead to the following symptoms:

water and/or sodium overload with build-up of liquid in the tissues (oedema) causing swelling, swelling of the legs or ankles
pain that gets worse when you stand and subsides when you raise your legs
cramping, aching, throbbing, or a feeling of heaviness in your legs
itchy or weak legs
thickening of the skin on your legs or ankles
skin changing colour, especially around the ankles
leg ulcers or varicose veins
shortness of breath, rapid or irregular breathing
dizziness
fatigue or weakness
headache
neck pain or stiffness
nausea or vomiting
decreased appetite
constipation
stomach pain
excessive thirst (polydipsia) or a dry mouth
chalky taste in the mouth
producing more urine than normal (polyuria) or dark, concentrated urine
kidney disease due to build-up of calcium in the kidneys (nephrocalcinosis) or kidney stones
vision loss or changes
memory loss
mental disturbances such as confusion, irritability or depression
difficulty speaking or inability to think normally
seizures
loss of consciousness
inability to walk or inability to move (paralysis)
an irregular heartbeat (cardiac arrhythmia)
cardiac arrest (the heart stops beating; if the infusion is given too quickly)
acidification of the blood (acidosis) leading to tiredness, confusion, lethargy and increased breathing rate

Dosage System

Fluid balance, glucose and salts along with other electrolytes found within your blood may need to be monitored before and during administration, especially if you are at risk of high blood pressure or kidney problems.

Monitoring of your salt levels is important for this type of infusion solution (hypotonic fluid), as it may become very hypotonic after administration due to glucose utilisation in the body.

If you develop any of these symptoms you must inform your doctor immediately. Your infusion will be stopped and you will be given treatment depending on the symptoms.

4. possible side effects

Like all medicines, Ringer’s Solution for Infusion can cause side effects, although not everybody gets them.

If you have a side effect that is not mentioned in this leaflet or if any side effect gets serious, please tell your doctor or pharmacist

Possible side effects are listed below:

Very common: may affect more than 1 in 10 people

too much fluid in the spaces around the cells of the body (hyperhydration) and
heart failure in patients with cardiac disorder or pulmonary oedema

Not known: frequency cannot be estimated from the available data

oedema due to water/sodium overload

The following side effects have been reported if the solution is given too quickly:

heart attack
blood circulation problems
thrombosis (the formation of a clot) may occur in the vein where the infusion is given.

Reactions due to the administration technique:

fever
infection at the site of the infusion
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
escape of the infusion solution into the tissues around the vein (extravasation). This can damage the tissues and cause scarring.

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW RINGER’S SOLUTION FOR INFUSION IS STORED

6. contents of the pack and other information

What Ringer’s Solution for Infusion contains

Ringer’s Solution for Infusion contains 0.86% sodium chloride, 0.03% potassium chloride and 0.033% calcium chloride dihydrate in water.

The solution also contains small amounts of hydrochloric acid and sodium hydroxide.

What Ringer’s Solution for Infusion looks like and contents of the pack Ringer’s Solution for Infusion is a clear liquid in a sealed plastic container known as Polyfusor® or Kabipac®. The solutions are available in 500 ml and 1000 ml volumes.

All pack sizes may not be marketed.

Marketing Authorisation Holder

Fresenius Kabi Limited

Cestrian Court, Eastgate Way,

Manor Park, Runcorn, Cheshire, WA7 1NT. UK.

Manufacturer

Terumo BCT Limited,

Old Belfast Road, Millbrook, Larne, Co Antrim, BT40 2SH, UK.

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Fresenius Kabi Limited

Cestrian Court, Eastgate Way,

Manor Park, Runcorn,

Cheshire, WA7 1NT

UK.

+44 (0) 1928 533 533

This leaflet was last revised in December 2019.

Uk FRESENIUS

111 KABI V004/TM/PFKP