Potassium Chloride 0.3%, Sodium Chloride 0.18 % and Glucose 4% Solution for Infusion BP

• 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.

Throughout this leaflet, Potassium Chloride 0.3% w/v, Sodium Chloride 0.18% w/v and Glucose 4% w/v, Solution for Infusion will be called Potassium chloride, Sodium chloride & Glucose Infusion

1. What Potassium chloride, Sodium chloride & Glucose Infusion is and what it is used for
2. What you need to know before you are given Potassium chloride, Sodium chloride & Glucose Infusion
3. How you will be given Potassium chloride, Sodium chloride & Glucose Infusion
4. Possible side effects
5. How to store Potassium chloride, Sodium chloride & Glucose Infusion
6. Content of the pack and other information

• higher levels of potassium in the blood than normal (hyperkalaemia)
• higher levels of chloride in the blood than normal (hyperchloraemia)
• 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
• Addison’s disease (poor function of the adrenal gland. The adrenal gland produces hormones that help to control the concentrations of the chemicals in the body).
• diabetes that is not adequately treated, allowing your blood sugar levels to rise above normal (uncompensated diabetes)
• states of glucose intolerance, for example:
  • metabolic stress (when the body’s metabolism does not function correctly, e.g. due to severe illness)
  • hyperosmolar coma (unconsciousness). This is a type of coma that can occur if you have diabetes and do not receive enough medicine.
• If you have higher amount of sugar in the blood than normal (hyperglycaemia)
• a higher amount of lactate in the blood than normal (hyperlactataemia)
• recent stroke
• head injury within the last 24 hours
• if you are allergic to potassium chloride, sodium chloride and glucose monohydrate or any other ingredients of this medicine (listed in Section 6).

Your doctor will take special care when giving you Potassium chloride, Sodium chloride & Glucose Infusion

Potassium chloride, Sodium chloride & Glucose Infusion is a hypertonic (concentrated) solution.

Once administered, the solution becomes hypotonic due to its low sodium content. Your doctor will take this into account when calculating how much to give you.

Please tell your doctor if you have or have had any of the following medical conditions:

• lower levels of sodium in the blood than normal (hyponatraemia)
  • Hyponatraemia can lead to headache, nausea, seizures, lethargy, coma, swelling of the brain (cerebral oedema) and death. Acute hyponatraemic encephalopathy is a serious complication.
  • Some patients are at higher risk for hyponatraemia. In general this applies to young people, old people, women and anyone with a condition such as low levels of oxygen in the blood (hypoxemia) or drinking a lot due to a dry mouth (psychogenic polydipsia). You may also be at a higher risk for hyponatraemia, if you have recently been operated on.
• any condition that causes you to have high blood potassium (hyperkalaemia) such as:
  • poor kidney function
  • adrenocortical insufficiency. This is a disease that affects the hormones that control the concentration of chemicals in the body.
  • acute dehydration (a rapid loss of water from the body, e.g. from vomiting or diarrhoea)
• extensive tissue damage (as can occur in severe burns)
• high blood pressure (hypertension)
• a build up of fluid under the skin (peripheral oedema), particularly around the ankles
• a build up of fluid in the lungs (pulmonary oedema)
• high blood pressure during pregnancy (pre-eclampsia)
• any condition associated with sodium retention (when the body has too much sodium), such as treatment with steroids (drugs that reduce inflammation) (See also below “Other medicines and Potassium chloride, Sodium chloride & Glucose Infusion”).
• diabetes, where insulin treatment may need to be changed because of the glucose (a type of sugar) in the solution
• allergy to corn (Potassium chloride, Sodium chloride & Glucose Infusion contains sugar derived from corn)
• 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 Potassium chloride, Sodium chloride & Glucose Infusion”).

This may increase the risk of low level 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

If you have any of these conditions, you will need additional tests to monitor your health. Your doctor will take blood and urine samples to monitor the amount of chemicals in your blood (your plasma electrolytes). You will also have a heart tracing (ECG).

You might have changes made to your other medicines.

Potassium chloride, Sodium chloride & Glucose Infusion should be given with special care in children.

Newborns, especially those born premature and with a low birth weight, are at increased risk of developing a too low or too high level of sugar in the blood (hypo or hyperglycaemia) due to infusion of glucose solutions. Low levels of sugar in the newborn can cause prolonged seizures, coma and brain damage. High level of sugar has been associated with bleeding into the brain, late onset bacterial and fungal infection, infection in the intestinal track (necrotizing enterocolitis), eye problems (retinopathy of prematurity), lung problems (bronchopulmonary dysplasia), prolonged length of hospital stay, and death.

Children are at higher risk for having or developing a too low sodium concentration in their blood (hyponatraemia). Hyponatraemia can lead to headache, nausea, seizures, lethargy, coma, swelling of the brain (cerebral oedema) and death. Acute hyponatraemic encephalopathy is a serious complication, especially in children.

Your doctor knows this and will closely monitor the amount of chemicals such as sodium and chloride in your child’s blood (plasma electrolytes)

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

Other medicines that can affect or be affected by Potassium chloride, Sodium chloride & Glucose Infusion include:

• lithium (used to treat psychiatric illnesses)
• potassium-sparing diuretics (some water tablets, e.g. amiloride, spironolactone, triamterene)
• medicines that contain potassium (e.g. potassium supplements, salt substitutes containing potassium and some types of penicillin)
• medications that increase the risk of hyponatremia or sodium and fluid retentionangiotensin converting enzyme (ACE) inhibitors (used to treat high blood pressure)
• cyclosporin (used to prevent rejection of a transplant)
• corticosteroids (anti-inflammatory medicines)

Some medicines act on the hormone vasopressin. These may include:

• anti-diabetic medication (chlorpropamide)
• cholesterol medicine (clofibrate)
• some cancer drugs (vincristine, ifosfamide, cyclophosphamide)
• selective serotonin reuptake inhibitors (used to treat depression)
• antipsychotics or opioids for severe pain relief
• medicines for pain and/or inflammation (also known as NSAIDs)
• medicines that imitate or strengthen the effects of vasopressin such as desmopressin (used to treat increased thirst and urination), terlipressin (used to treat bleeding of the gullet) and oxytocin (used to induce labour)
• anti-epileptic medication (carbamazepine and oxcarbazepine)
• diuretics (water tablets).

If you need a blood transfusion at the same time as your infusion, you will be given the blood into another vein.

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

Ask your doctor or nurse for advice before taking this medicine.

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.

There is a small possibility that if you are given Potassium chloride, Sodium chloride & Glucose Infusion during labour, glucose could affect the unborn baby by causing:

• hyperglycaemia (high blood sugar, which causes severe thirst, dry mouth and frequent urination)
• hyperinsulinaemia (high levels of insulin, the hormone that regulates blood sugar. Blood glucose (sugar) levels can become too low.)
• acidosis (an imbalance in blood chemistry) that can lead to low blood sugar and jaundice (yellow colour of the skin or whites of the eyes)

However, the relationship between glucose infusion and these effects has not been proven.

If another medicine is to be added to your solution for infusion during pregnancy or breast-feeding you should:

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

The infusion does not affect your ability to drive or use machines.

If you are given too much Potassium chloride, Sodium chloride & Glucose Infusion (over-infusion), this may lead to the following symptoms:

• high levels of sugar in the blood (hyperglycaemia), which causes severe thirst, dry mouth and frequent urination)
• low levels of sodium in the blood (hyponatraemia). Hyponatraemia can lead to headache, nausea, seizures, lethargy, coma, swelling of the brain (cerebral oedema) and death
• fluid collection under the skin (peripheral oedema), particularly around the ankles
• high levels of potassium (hyperkalaemia), Symptoms includes:
  • pins and needles (paraesthesia) in the arms and legs
  • respiratory paralysis (inability to breathe)
  • gastrointestinal symptoms (painful obstruction of intestine., nausea, vomiting, abdominal pain)
  • hypotension (low blood pressure)
  • muscle weakness
  • an inability to move your muscles (paralysis)
  • irregular heartbeat (cardiac arrhythmia)
  • heart block (a very slow heartbeat)
  • cardiac arrest (the heart stops beating; a life-threatening condition)

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 the Potassium chloride, Sodium chloride & Glucose Infusion and you receive more than you should, the added medicine may also cause side effects. 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.

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 methods 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: website: www.mhra.gov.uk/yellowcard

The active substances are potassium chloride (3.0 g per litre), sodium chloride (1.8 g per litre) and glucose (40 g per litre, equivalent to 44 g glucose as monohydrate).

The only other ingredient is water for injection

Potassium chloride, Sodium chloride & Glucose Infusion, is a clear solution, free from visible particles. It is supplied in polyolefin/polyamide plastic bags (VIAFLO). Each bag is wrapped in a sealed, protective, outer plastic bag.

The bag sizes are:

• 500 ml
• 1000 ml

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

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

Not all pack sizes may be marketed

Send all enquires to this address

Potassium chloride, Sodium chloride & Glucose Infusion can be made at any of these addresses: