Ringers Solution for Infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed 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 to store Ringer’s Solution for Infusion
6. Contents of the pack and other information

• Preterm newborn infants and term newborn infants (≤28 days of age): Your child must not receive a certain antibiotic called ceftriaxone as a drip into a vein at the same time with this medicine
• when there is too much fluid in the spaces around the cells of the body (extracellular hyperhydration)
• when there is a larger volume of blood in the blood vessels than there should be (hypervolaemia)
• severe kidney failure (when your kidneys do not work well and you require dialysis)
• uncompensated heart failure. This is heart failure that is not adequately treated and causes symptoms such as:
  • shortness of breath
  • swelling of the ankles
• when there is too much fluid in the body caused by too many salts in the blood (hypertonic dehydration)
• higher levels of potassium in the blood than normal (hyperkalaemia)
• higher levels of sodium in the blood than normal (hypernatraemia)
• higher levels of calcium in the blood than normal (hypercalcaemia)
• higher levels of chloride in the blood than normal (hyperchloraemia)
• severe high blood pressure (hypertension)
• build up of fluid under the skin, affecting all parts of the body (general oedema)
• liver disease that causes fluid to build up within the abdomen (ascitic cirrhosis)
• if you are taking cardiac glycosides (cardiotonics) used to treat heart failure, such as digitalis or digoxin. (see also “Other Medicines and Ringer’s Solution for Infusion”)

Talk to your doctor or nurse if you have or have had any of the following medical conditions:

• respiratory failure (lung disease) (special monitoring may be required in the above conditions)
• any type of heart disease or impaired heart function
• impaired kidney function
• high blood pressure (hypertension)
• build up of fluid under the skin, 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 (see also below “Other medicines and Ringer’s Solution for Infusion”).
• if you have problems with the fluid levels in your brain (for example, because of meningitis, bleeding in the skull or brain injury)
• if you have a condition that could cause high level of vasopressin, a hormone regulating fluid in your body, such as
  • a sudden and serious illness or injury
  • you have had surgery
  • brain disease
  • you are taking certain medicines

These conditions may increase the risk of low levels of sodium in your blood, which can lead to headache, nausea, seizures, lethargy, coma and swelling in the brain.

People who are at higher risk of brain swelling are:

• children
• women (particularyly if you are of a fertile age)

• if you have a condition where the glands in the body are not making enough of some hormones (adrenocortical insufficiency)
• a loss of water from the body (acute dehydration, e.g. from vomiting or diarrhoea)
• extensive tissue damage (can occur in severe burns)
• diseases associated with high levels of vitamin D (e.g. sarcoidosis, a disease affecting the skin and internal organs)
• diseases associated with kidney stones
• ceftriaxone, an antibiotic, must not be mixed with or given at the same time as any solutions with calcium in, when given to you through the vein. This medicine contains calcium. If you are older than 28 days, you may be given ceftriaxone and a solution with calcium, one after the other, as long as your doctor takes action to avoid medicines reacting with each other. If you or your child suffer from low blood volume your doctor will avoid giving you or your child calcium and ceftriaxone sequentially heart failure.

When you are given this infusion, your doctor 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 (your plasma electrolytes)

Although Ringer’s Solution for Infusion contains potassium and calcium, it does not contain enough to:

• maintain levels of these chemicals
• treat very low blood plasma levels of potassium (severe potassium deficiency) or calcium (severe calcium deficiency).

Once your dehydration has been treated using Ringer’s Solution for Infusion, your doctor will give you a different infusion to provide you with enough potassium and calcium. Your doctor will take into account if you are receiving parenteral nutrition (nutrition given by infusion into a vein). If you are given Ringer’s Solution for Infusion for a long time, you will be given an extra source of nutrients.

Calcium chloride can be harmful if injected into the body tissues. Therefore, the Ringer’s Solution for Infusion must not be given by injecting it into a muscle (intramuscular injection). Also, your doctor will make every effort to avoid the escape of the solution into the tissues surrounding the vein.

Ringer’s Solution for Infusion must not be given through the same needle as a blood transfusion. This can damage the red blood cells or cause them to clump together.

Tell your doctor or nurse if you are taking or have recently taken any other medicines.

It is particularly important that you inform your doctor if you are taking:

• ceftriaxone (an antibiotic), when given intravenously (see Warnings and precautions)
• cardiac glycosides (cardiotonics) such as digitalis or digoxin, used to treat heart failure as they must not be used with Ringer’s Solution for Infusion (see also section “Do not receive Ringer’s Solution for Infusion if you are suffering from…”). The effects of these drugs can be increased by calcium. This can lead to life threatening changes to the heart rhythm

The following medicines can cause the body to store up sodium and water, leading to tissue swelling and high blood pressure:

• 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, triamterene)
  (Note that these medicines may be included in combination medicinal products)
• angiotensin converting enzyme (ACE) inhibitors (used to treat high blood pressure)
• angiotensin II receptor antagonists (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)

Some medicines can increase the risk of side effects due to low levels of sodium in blood. These medicines may include:

• water tablets (diuretics)
• medicines for pain and /or inflammation (also known as NSAIDs)
• antipsychotics
• medicines used to treat depression (selective serotonin reuptake inhibitors)
• medicines that produce morphine-like effects (opioids)
• certain medicines used to treat epilepsy (antiepileptics)
• hormone called oxytocin (causes uterus to contract)
• certain medicines used to treat cancer (chemotherapy).
• cholestrol medicine
• anti-diabetic medicine

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

• thiazide diuretics such as hydrochlorothiazide or chlortalidone
• vitamin D

You should ask your doctor about what you can eat or drink.

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

Ringer’s Solution for Infusion can be used safely during pregnancy or breast-feeding as long as the electrolyte and fluid balance is controlled and monitored by your doctor. Your doctor will take special caution if you are taking oxytocin during labour.

Calcium can reach your unborn baby through the placenta and, after birth, through the breast milk. Your doctor will monitor the levels of chemicals in your blood and the amount of fluid in your body.

However, if another medicine is to be added to your solution for infusion during pregnancy particularly during labour or breast-feeding you should:

• consult your doctor
• read the Package Leaflet of the medicine that is to be added.

Ringer’s Solution for Infusion does not affect your ability to drive or use machines.

If you are given too much Ringer’s Solution for Infusion (over-infusion), or you are given your infusion too quickly, this may lead to the following symptoms:

• water and/or sodium (salt) overload with build up of liquid in the tissues (oedema) causing swelling
• pins and needles in the arms and legs (paresthesia)
• muscle weakness
• an inability to move (paralysis)
• an irregular heartbeat (cardiac arrhythmias)
• heart block (a very slow heartbeat)
• cardiac arrest (the heart stops beating; a life-threatening situation)
• confusion
• a decreased appetite (anorexia)
• feeling sick (nausea)
• vomiting
• constipation
• abdominal pain
• mental disturbances such as irritability or depression
• drinking lots of water (polydipsia)
• producing more urine than normal (polyuria)
• kidney disease due to build up of calcium in the kidneys (nephrocalcinosis)
• kidney stones
• coma (unconsciousness)
• chalky taste
• redness (hot flushes)
• dilatation of the blood vessels in the skin (peripheral vasodilatation)
• acidification of the blood (acidosis) leading to tiredness, confusion, lethargy and increased breathing rate

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.

If a medicine has been added to your Ringer’s Solution for Infusion before over-infusion occurs, that medicine may also cause symptoms. You should read the Package Leaflet of the added medicine for a list of possible symptoms.

Your doctor will decide when to stop giving you this infusion.

• reactions due to the administration technique:
  • fever (febrile response)
  • infection at the site of infusion
  • local pain or reaction (redness or swelling at the site of 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.
  • 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.
• low levels of sodium in the blood (hyponatraemia)
• swelling of the brain which may cause brain injury (cerebral-oedema)

If a medicine has been added to the solution for infusion, the added medicine may also cause side effects. These side effects will depend on the medicine that has been added. You should read the Package Leaflet of the added medicine for a list of possible symptoms.

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

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed below. By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom:

Via the Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard

Ireland:

Malta:

The active substances are:

• sodium chloride: 8.60 g per litre
• potassium chloride: 0.30 g per litre
• calcium chloride dihydrate: 0.33 g per litre

The other ingredients are:

• water for injections
• sodium hydroxide

Ringer’s Solution for Infusion is a clear solution, free from visible particles.

It is supplied in a polyolefin/polyamide plastic bags (Viaflo). Each bag is wrapped in a sealed, protective, outer plastic overpouch.

The bag sizes are:

• 500 ml
• 1000 ml

The bags are supplied in cartons. Each carton contains one of the following quantities:

• 1 bag of 500 ml
• 1 bag of 1000 ml
• 20 bags of 500 ml
• 10 or 12 bags of 1000 ml
• 10 bags of 1000 ml

Not all pack sizes may be marketed

Marketing Authorisation Holder:

United Kingdom:

Republic of Ireland and Malta:

Manufacturers for Great Britain:

Manufacturers for Ireland and Malta: