Potassium Chloride 0.3% w/v and Glucose 5% w/v 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.

1. What Potassium 0.3 & Glucose Infusion is and what it is used for
2. What you need to know before you are given Potassium 0.3 & Glucose Infusion
3. How you will be given Potassium 0.3 & Glucose Infusion
4. Possible side effects
5. How to store Potassium 0.3 & 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.
  • a higher amount of sugar in the blood than normal (hyperglycaemia)
  • a higher amount of lactate in the blood than normal (hyperlactataemia)
  • if you are allergic to potassium chloride and glucose monohydrate or any other ingredients of this medicine (listed in Section 6).

Potassium 0.3 & Glucose Infusion is a hypertonic (concentrated) solution. Your doctor will take this into account when calculating how much solution to give you.

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

• heart failure
• respiratory failure (lung disease)
• any type of heart disease or poor heart function
• poor kidney function (special monitoring may be required in the above conditions)
• adrenocortical insufficiency (this disease of the adrenal gland affects hormones that control the concentration of chemicals in the body).
• a loss of water from the body (acute dehydration, e.g. from vomiting or diarrhoea)
• extensive tissue damage (as can occur in severe burns)
• head injury within the past 24 hours
• a high pressure within the skull (intracranial hypertension)
• if you have recently had a stroke
• allergy to corn (Potassium 0.3 & Glucose Infusion contains sugar derived from corn, see section 4)
• 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 0.3 & 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

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

• the amount of fluid in your body
• the amount of sugar (glucose)
• your vital signs
• the amount of chemicals such as sodium and potassium in your blood (your plasma electrolytes)
• the blood concentration of a substance called creatinine (your plasma creatinine)
• the blood concentration of a substance called urea (your BUN levels)
• the acidity of your blood and urine (your acid-base balance)
• your heart tracing (ECG)

Your doctor will take into account if you are receiving parenteral nutrition (nutrition given by infusion into a vein). During long term treatment with Potassium 0.3 & Glucose Infusion you may need to be given extra nutrition

As Potassium 0.3 & Glucose Infusion contains sugar (glucose), it can cause a high level of sugar in the blood (hyperglycaemia). If this occurs, your doctor may:

• adjust the speed of infusion
• give you insulin to reduce the blood sugar levels

This is particularly important if you are diabetic.

Potassium 0.3 & Glucose Infusion should be given with special care in children.

In newborns, especially born premature and with low birth weight are at increased risk of developing a too low or too high level of sugar in the blood (hypo or hyperglycemia) due to infusion of glucose solutions.

Low level 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), affects eyes (retinopathy of prematurity), lungs problems (bronchopulmonary dysplasia), prolonged length of hospital stay, and death.

Pediatric patients should be closely monitored. In cases where normal regulation of the water content of the blood is disturbed due to increased secretion of Antidiuretic Hormone (ADH), the infusion of fluids with a low concentration of sodium chloride (hypotonic fluids) may result in a low level of sodium in the blood (hyponatraemia). This can lead to headache, nausea, seizures, lethargy, coma, swelling of the brain (cerebral oedema) and death; therefore these symptoms (acute symptomatic hyponatraemic encephalopathy) are considered a medical emergency.

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

It is particularly important that you inform your doctor if you are taking medicines that increase the concentration of potassium in the blood, such as:

• potassium-sparing diuretics (certain water tablets, e.g. amiloride, spironolactone, triamterene)
• angiotensin converting enzyme (ACE) inhibitors (used to treat high blood pressure)
• angiotensin II receptor antagonists (used to treat high blood pressure)
• cyclosporin (used to prevent rejection of a transplant)
• tacrolimus (used to prevent rejection of a transplant and to treat some skin diseases)
• medicines that contain potassium (e.g. potassium supplements, salt substitutes containing potassium)

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).

Potassium & Glucose Infusion must not be added or given through the same needle with citrate anticoagulated/preserved blood. This can damage the red blood cells or cause them to clump together.

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.

Changes in the potassium levels in your blood can affect how well your heart and your unborn baby’s heart work. Your doctor will therefore carefully monitor the levels of the chemicals in your blood.

Potassium 0.3 & Glucose Infusion can be given during pregnancy. The amount you are given must be carefully controlled by your doctor.

However, 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.

Potassium 0.3 & Glucose Infusion does not affect your ability to drive or use machines.

If you are given too much Potassium 0.3 & Glucose Infusion (over-infusion), this may lead to the following symptoms:

• 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
• 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 Potassium 0.3 & Glucose 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.

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

Ireland

Malta

United Kingdom

The active substances are:

• potassium chloride: 3 g per litre.
• glucose (as monohydrate): 50 g per litre.

The other ingredients are

• hydrochloric acid, concentrated
• water for injections

Potassium 0.3 & 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 overpouch

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

Marketing Authorisation Holder:

United Kingdom

Ireland and Malta

Manufacturers for Great Britain:

Manufacturers for Ireland: