1. what potassium chloride solution for infusion is and what it is used for

Potassium Chloride Solution for Infusion belongs to a group of medicines called electrolyte replacement solutions.

Electrolytes are a group of chemicals and salts that are in the body fluids, they help to keep the water levels in different parts of your body in the right balance. Potassium Chloride Solution for Infusion is used in patients needing additional amounts of potassium. Potassium helps your muscles, heart and other organs to work properly. Without the right amount of potassium your heart may start to beat abnormally, which could be life-threatening.

2. what you need to know before you are given potassium chloride solution for infusion

You should not be given Potassium Chloride Solution for Infusion if:

! You are allergic to potassium chloride or any of the other ingredients of this medicine (listed in section 6)

! You have hyperkalaemia (high levels of potassium in your blood – your doctor will advise you)

! You suffer from impaired kidney function (you may product little or no urine)

! You suffer from Addison's disease (a hormonal disorder where you may feel weak, lose weight and have a darkened skin)

! You are very dehydrated

! You suffer from heat cramps

! You suffer from hyperchloraemia (electrolyte disturbance in which there is an abnormally elevated level of the chloride ion in the blood.

Make sure your doctor knows if you suffer from the above.

nogen Healthcare

Warnings and precautions

Talk to your doctor or nurse before being given this medicine if you:

! Have heart disease

! Have had a recent severe injury involving a large area of skin such as a burn.

Make sure your doctor is aware of these situations if it is not already obvious.

Other medicines and Potassium Chloride Solution for Infusion

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

In particular, tell your doctor or nurse if you are taking any of the following:

! Diuretics (“water tablets”) such as amiloride, spironolactone and triamterene

! ACE inhibitors such as lisinopril, captopril, enalapril (these may make the amount of potassium in your blood too high)

! Angiotensin II receptor antagonists such as losartan, valsartan, candesartan and aliskiren used to treat high blood pressure (these may make the amount of potassium in your blood too high)

! Ciclosporin, tacrolimus (used to suppress the immune system following transplants)

! Glucose infusions (used in patients who have low levels of sugar in their blood or are dehydrated)

! Corticosteroids such as cortisone, hydrocortisone, prednisone, prednisolone, betamethasone (may make the infusion not work properly)

! Digoxin (may give you more side effects)

! Quinidine (may make your heart start to beat abnormally)

! Any other medicines which contain potassium, including potassium supplements

! Heparin used to help thin the blood

! Suxamethonium used to help relax muscles.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before being given this medicine. Your doctor may decide it is in your best interest to take this medicine.

Driving and using machines

Potassium Chloride Solution for Infusion should not interfere with your ability to drive or use machines, but consult your doctor first.

• 3. How you are given Potassium Chloride Solution for Infusion

Potassium Chloride Solution for Infusion will be given to you by a doctor or nurse. It will be slowly dripped through a needle into a vein (your doctor or nurse may call this an IV or intravenous infusion). This product is only for use via a central venous route. The process may take an hour or more depending on your dose. Your doctor will decide on the best dose for you.

Your doctor will monitor your heart while you receive your medicine. Your doctor will also test your blood and check how much urine you produce.

Adults and the elderly

The usual dose is up to 80mmol per day.

Use in children

The usual dose is up to 3mmol per kg of bodyweight per day. For children weighing 25kg or over, refer to the adult dosage.

If you are given more Potassium Chloride Solution for Infusion than you should

As Potassium Chloride Solution for Infusion is administered by a healthcare professional it is unlikely that you will be given too much. If you think you have been given too much medicine, tell your doctor. The likely signs of an overdose are the occurrence of side-effects as listed in section 4.

In this event, you will be treated in the hospital and you will be given the necessary treatment.

If you miss a dose of Potassium Chloride Solution for Infusion

This is unlikely as the infusion is given by a healthcare professional, but if you are concerned about missing a dose talk to your doctor.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The most likely side effects are:

! Tingling or other odd sensations

! Muscle weakness or loss of movements

! Faintness or irregular heart beats, or heart attack

! Hyperkalaemia (too much potassium in the blood which would be identified by a blood test)

! Hypotension (low blood pressure causing dizziness on standing)

! Pain at the site of injection

! Inflammation of the vein into which the solution is injected ! Feeling sick or being sick

! Oesophageal ulcers (a type of ulcer that develops in the food pipe, between the throat and the stomach)

! Small intestine ulcers.

The frequency at which these side effects may occur is not known (frequency cannot be estimated from the available data).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist 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 to store potassium chloride solution for infusion

These instructions apply mainly to the healthcare professional administering the infusion.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is printed on the reverse of the bag and on the carton. The expiry date refers to the last day of that month.

Store the unopened bags in their overwrap. Protect from light and store below 25°C. Do not freeze.

Store in a separate location away from other IV infusion bags.

Do not use if the overwrap or infusion bag is damaged or if the solution is cloudy or has particles in.

For single use only, discard any unused solution.

6. contents of the pack and other information

What Potassium Chloride Solution for Infusion contains

The active substance is potassium chloride. The other ingredients are water for injection and potassium hydroxide.

The medicine contains 29.8mg per ml of potassium chloride. Each ml of this medicine contains 0.4mmol of potassium and 0.4mmol of chloride.

What Potassium Chloride Solution for Infusion looks like and contents of the pack

1. what potassium chloride solution for infusion is and what it is used for

Potassium Chloride Solution for Infusion belongs to a group of medicines called electrolyte replacement solutions.

Electrolytes are a group of chemicals and salts that are in the body fluids, they help to keep the water levels in different parts of your body in the right balance. Potassium Chloride Solution for Infusion is used in patients needing additional amounts of potassium. Potassium helps your muscles, heart and other organs to work properly. Without the right amount of potassium your heart may start to beat abnormally, which could be life-threatening.

2. what you need to know before you are given potassium chloride solution for infusion

You should not be given Potassium Chloride Solution for Infusion if:

! You are allergic to potassium chloride or any of the other ingredients of this medicine (listed in section 6)

! You have hyperkalaemia (high levels of potassium in your blood – your doctor will advise you)

! You suffer from impaired kidney function (you may product little or no urine)

! You suffer from Addison's disease (a hormonal disorder where you may feel weak, lose weight and have a darkened skin)

! You are very dehydrated

! You suffer from heat cramps

! You suffer from hyperchloraemia (electrolyte disturbance in which there is an abnormally elevated level of the chloride ion in the blood.

Make sure your doctor knows if you suffer from the above.

nogen Healthcare

Warnings and precautions

Talk to your doctor or nurse before being given this medicine if you:

! Have heart disease

! Have had a recent severe injury involving a large area of skin such as a burn.

Make sure your doctor is aware of these situations if it is not already obvious.

Other medicines and Potassium Chloride Solution for Infusion

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

In particular, tell your doctor or nurse if you are taking any of the following:

! Diuretics (“water tablets”) such as amiloride, spironolactone and triamterene

! ACE inhibitors such as lisinopril, captopril, enalapril (these may make the amount of potassium in your blood too high)

! Angiotensin II receptor antagonists such as losartan, valsartan, candesartan and aliskiren used to treat high blood pressure (these may make the amount of potassium in your blood too high)

! Ciclosporin, tacrolimus (used to suppress the immune system following transplants)

! Glucose infusions (used in patients who have low levels of sugar in their blood or are dehydrated)

! Corticosteroids such as cortisone, hydrocortisone, prednisone, prednisolone, betamethasone (may make the infusion not work properly)

! Digoxin (may give you more side effects)

! Quinidine (may make your heart start to beat abnormally)

! Any other medicines which contain potassium, including potassium supplements

! Heparin used to help thin the blood

! Suxamethonium used to help relax muscles.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before being given this medicine. Your doctor may decide it is in your best interest to take this medicine.

Driving and using machines

Potassium Chloride Solution for Infusion should not interfere with your ability to drive or use machines, but consult your doctor first.

• 3. How you are given Potassium Chloride Solution for Infusion

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The most likely side effects are:

! Tingling or other odd sensations

! Muscle weakness or loss of movements

! Faintness or irregular heart beats, or heart attack

! Hyperkalaemia (too much potassium in the blood which would be identified by a blood test)

! Hypotension (low blood pressure causing dizziness on standing)

! Pain at the site of injection

! Inflammation of the vein into which the solution is injected ! Feeling sick or being sick

! Oesophageal ulcers (a type of ulcer that develops in the food pipe, between the throat and the stomach)

! Small intestine ulcers.

The frequency at which these side effects may occur is not known (frequency cannot be estimated from the available data).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist 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 to store potassium chloride solution for infusion

These instructions apply mainly to the healthcare professional administering the infusion.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is printed on the reverse of the bag and on the carton. The expiry date refers to the last day of that month.

Store the unopened bags in their overwrap. Protect from light and store below 25°C. Do not freeze.

Store in a separate location away from other IV infusion bags.

Do not use if the overwrap or infusion bag is damaged or if the solution is cloudy or has particles in.

For single use only, discard any unused solution.

6. contents of the pack and other information

What Potassium Chloride Solution for Infusion contains

The active substance is potassium chloride. The other ingredients are water for injection and potassium hydroxide.

The medicine contains 29.8mg per ml of potassium chloride. Each ml of this medicine contains 0.4mmol of potassium and 0.4mmol of chloride.

What Potassium Chloride Solution for Infusion looks like and contents of the pack

Potassium Chloride Solution for Infusion is a clear, colourless, sterile solution which is ready to use, supplied in a polyolefin/styrene infusion bag which is sealed in an overwrap.

The solution is supplied in infusion bags filled with 50ml or 100ml. Each fill weight is supplied in cartons of 20 bags.

Each 50ml bag contains 20mmol of potassium chloride.

Each 100ml bag contains 40mmol of potassium chloride.

Marketing Authorisation Holder

Ennogen Healthcare Ltd

Unit G4 Riverside Industrial Estate

Riverside Way

Dartford

DA1 5BS

UK.

Manufacturer

SALF S.p.A Laboratorio Farmacologico

Via Marconi 2,

24069 Cenate Sotto

(Bergamo)

Italy

This leaflet was last revised in October 2020.

ENV02

The following information is for healthcare professionals only:

Please detach before handing above section to the patient.

Potassium Chloride 0.4mmol/ml Solution for Infusion.

To be administered only via the central venous route

Instructions for administration

Potassium Chloride 0.4mmol/ml solution for infusion should be administered as a slow intravenous infusion only at a rate not exceeding 20 mmol potassium per hour using an infusion pump. It should be administered only via a central venous route.

Dosage

Dosage depends on the serum ionogram value and the acid-base state. A potassium deficiency is calculated according to the formula:

MMOL Potassium = KG BW x 0.2 × 2 x (4.5 -actual serum potassium (MMOL)). (The extracellular volume is calculated from the body weight in KG x 0.2). It is recommended not to exceed 2–3 MMOL potassium per kg body weight in 24 hours.

Adults (including the elderly): Up to 6g (80 mmol) daily.

Paediatric population:

Up to 3mmol per kg per day. Children over 25kg refer to the adult dose.

Infusions should be administered slowly over at least 2–3 hours.

Monitoring

This product must be given by slow intravenous infusion, with continuous ECG monitoring, ensuring adequate urine flow and with careful monitoring of electrolytes.

Plasma potassium concentration must be measured at regular intervals to avoid the development of hyperkalaemia, especially in patients with renal impairment.

Read all of this leaflet carefully before you start using 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 nurse.

! If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Potassium Chloride Solution for Infusion is and what it is used for

• 2. What you need to know before you are given Potassium Chloride Solution for Infusion

• 3. How you are given Potassium Chloride Solution for Infusion

• 4. Possible side effects

• 5. How to store Potassium Chloride Solution for Infusion

• 6. Contents of the pack and other information

1. what potassium chloride solution for infusion is and what it is used for

Potassium Chloride Solution for Infusion belongs to a group of medicines called electrolyte replacement solutions.

Electrolytes are a group of chemicals and salts that are in the body fluids, they help to keep the water levels in different parts of your body in the right balance. Potassium Chloride Solution for Infusion is used in patients needing additional amounts of potassium. Potassium helps your muscles, heart and other organs to work properly. Without the right amount of potassium your heart may start to beat abnormally, which could be life-threatening.

2. what you need to know before you are given potassium chloride solution for infusion

You should not be given Potassium Chloride Solution for Infusion if:

! You are allergic to potassium chloride or any of the other ingredients of this medicine (listed in section 6)

! You have hyperkalaemia (high levels of potassium in your blood – your doctor will advise you)

! You suffer from impaired kidney function (you may product little or no urine)

! You suffer from Addison's disease (a hormonal disorder where you may feel weak, lose weight and have a darkened skin)

! You are very dehydrated

! You suffer from heat cramps

! You suffer from hyperchloraemia (electrolyte disturbance in which there is an abnormally elevated level of the chloride ion in the blood.

Make sure your doctor knows if you suffer from the above.

nogen Healthcare

Warnings and precautions

Talk to your doctor or nurse before being given this medicine if you:

! Have heart disease

! Have had a recent severe injury involving a large area of skin such as a burn.

Make sure your doctor is aware of these situations if it is not already obvious.

Other medicines and Potassium Chloride Solution for Infusion

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

In particular, tell your doctor or nurse if you are taking any of the following:

! Diuretics (“water tablets”) such as amiloride, spironolactone and triamterene

! ACE inhibitors such as lisinopril, captopril, enalapril (these may make the amount of potassium in your blood too high)

! Angiotensin II receptor antagonists such as losartan, valsartan, candesartan and aliskiren used to treat high blood pressure (these may make the amount of potassium in your blood too high)

! Ciclosporin, tacrolimus (used to suppress the immune system following transplants)

! Glucose infusions (used in patients who have low levels of sugar in their blood or are dehydrated)

! Corticosteroids such as cortisone, hydrocortisone, prednisone, prednisolone, betamethasone (may make the infusion not work properly)

! Digoxin (may give you more side effects)

! Quinidine (may make your heart start to beat abnormally)

! Any other medicines which contain potassium, including potassium supplements

! Heparin used to help thin the blood

! Suxamethonium used to help relax muscles.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before being given this medicine. Your doctor may decide it is in your best interest to take this medicine.

Driving and using machines

Potassium Chloride Solution for Infusion should not interfere with your ability to drive or use machines, but consult your doctor first.

• 3. How you are given Potassium Chloride Solution for Infusion