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Potassium Chloride 15% W/V Concentrate For Solution For Infusion

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ARTWORK INFORMATION:


PRODUCT: LICENCE: ITEM/SIZE: ID CODE: VERSION:


Potassium Chloride 15% w/v Concentrate for sol. for infusion PL 17507/0026

Generic package leaflet / 210 mm (h) x 297 mm (w) [flat]

A1000070/1 1; 19/05/2015


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Black


4.7    Effects on ability to drive and use machines

None stated.

4.8    Undesirable effects Cardiovascular effects

Rapid infusion or injection can be toxic to the heart Cardiac arrhythmias can occur and even cardiac arrest

Other undesirable effects

Hyperkaiaemia can cause muscle weakness, mental confusion and, in extreme cases, chest pain and paralysis. Pain and phlebitis can occur during IV administration of solutions at concentrations in excess of about 30mmo! of potassium.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important It allows continued monitoring of the benefit/risk balance of the medicinal product Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme at: www. m h ra. gov. u k/ye 11 owca rd.

4.9    Overdose

Signs:

Signs of hyperkaiaemia include cardiac arrhythmias, chest pain, muscle weakness and paralysis.

Treatment:

In the event of hyperkaiaemia, ail potassium-containing medications and foods should be discontinued immediately. If the condition is serious, the first priority is to ensure stability of the cardiac rhythm. Continuous ECG monitoring is essential. Administration of calcium gluconate (but not to patients on digitalis) may be needed to reduce the cardiotoxic effects.

Intravenous glucose and insulin may be necessary to facilitate the transfer of potassium into the cells.

Severe and unresponsive hyperkaiaemia can be effectively treated with haemodialysis, peritoneal dialysis or the use of ion exchange resins.

5. PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Pharmacotherapeutic group: B05X A01

Potassium is the predominant cation within cells. It is involved in numerous ceiiuiar metabolic processes and is necessary for the conduction of nerve impulses in such tissues as the heart, brain and skeletal muscle.

In hypokaiaemia, prolongation of the QT interval and depression of the ST segment may be seen whereas hyperkaiaemia results in increased height of T-waves, lengthened PR interval, and even asystole or ventricular fibrillation.

5.2    Pharmacokinetic properties

Potassium is quickly transferred to the intracellular fluid by an active transport system which maintains high levels within cells. Extracellular fluid contains 4-5 mmol per litre while intracellular fluid contains 150 mmol per litre. Potassium is mainly excreted by the kidneys, although about 10% is excreted by the coionic mucosa.

5.3    Preclinical Safety Data

There is no additional information relevant to the prescriber.


6.    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Potassium hydroxide Hydrochloric acid Water for Injections

6.2    Incompatibilities

None known.

6.3    Shelf life

36 months

Discard any unused solution immediately after first use.

6.4    Special precautions for storage

No special precautions for storage

6.5    Nature and contents of container

10ml clear glass (Ph. Eur. Type I) ampoules containing 10ml concentrate for solution for injection.

Pack size: 10 or 20 ampoules per carton.

6.6    Instructions for use and handling

Potassium chloride concentrate must be diluted before use with sodium chloride intravenous infusion (0.9%w/v) or other suitable diluentto a concentration not more than 40mmol per litre.

It is important to mix thoroughly. If the solutions are not thoroughly mixed a concentrated layer of potassium chloride may form owing to differences in density.

Do not use unless solution is clear and practically free from particles.

7.    MARKETING AUTHORISATION HOLDER

Auden Mckenzie (Pharma Division) Ltd

Mckenzie House

Bury Street

Ruisiip

Middlesex

HA4 7TL

UK


8.    MARKETING AUTHORISATION NUMBER

PL 17507/0026

9.    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

10/02/2009


10. DATE OF REVISION OF THE TEXT

14/05/2015


Auden Mckenzie (Pharma Division) Ltd

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Auden Mckenzie

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PATIENT INFORMATION LEAFLET

Potassium Chloride 15% w/v Concentrate for solution for infusion

Potassium chloride 150mg/ml (1.5g inlOml total volume)

This leaflet contains important information about Potassium Chloride Injection.

Read all of this leaflet carefully before you start your treatment with this medicine.

1.    Keep this leaflet. You may need to read it again.

2.    If you have further questions, please askyour doctor.

3.    If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.

In this leaflet

1.    What is Potassium Chloride Injection and what is it for

2.    Before you are given Potassium Chloride Injection

3.    How Potassium Chloride Injection is used

4.    Possible side effects

5.    How Potassium Chloride Injection is stored

6.    Further information

1. What is Potassium Chloride Injection and what is it for

Potassium chloride occurs naturally in your body.

Potassium chloride injection is used to treat low levels of potassium in the blood, if this cannot be achieved when given by mouth or in the diet.

2. Before you are given Potassium Chloride Injection

Potassium Chloride Injection should not be used if:

•    the potassium levels in your blood are too high (hyperkalaemia)

•    you have severe kidney disease.

Always tell your doctor or nurse about any of these before having your injection.

Take special care with Potassium Chloride:

•    if your kidneys are not working properly

•    if you have Addison's disease (a disease characterised by a reduced secretion of hormones from a gland situated near the kidneys)

•    if you have heart disease

•    if you are very dehydrated

•    if you suffer from heat cramps

•    if you have had severe burns or tissue damage

•    if you are taking particular medicines used to reduce fluid retention called potassium-sparing diuretics.

•    if you are receiving glucose infusions as glucose lowers potassium levels

•    if you are elderly

•    if you have or have previously had stomach ulcers. Taking other medicines

Tell your doctor if you are taking or have recently taken any medicines including medicines obtained without a prescription. Potassium Chloride can nterfere with the action of some other drugs and some drugs can have an effect on Potassium Chloride.

The following drugs can cause some problems when

taken together with Potassium Chloride Injection:

•    ACE inhibitors (such as captopril and ramipril) which are used to treat heart problems high blood pressure (hypertension), diabetic neuropathy (decrease in blood flow to fingers and toes due to diabetes)

•    Digoxin for heart problems

•    Quinidine for muscle cramps or heart problems

•    certain medicines used to treat high blood pressure such as losartan, valsartan, candesartan and irbesartan

•    ciclosporin or tacrolimus used to suppress your system

•    medicines used to reduce fluid retention called diuretics

•    potassium containing products

•    Steroids such as hydrocortisone and Betamethasone.

Pregnancy and Breast-feeding

•    Always tell your doctor if you are pregnant, think you might be pregnant or are trying to become pregnant. The effects of Potassium Chloride injection on the baby are not known.

•    Potassium is likely to be excreted in milk; it is sensible to stop breast-feeding duringtreatment.

Driving and using machines

•    Potassium chloride treatment will not affect your ability to drive or use machines.

3. How Potassium Chloride Injection is used

The concentrate must be diluted before use with saline or other suitable diluent. After dilution, potassium chloride will be given to you by slow infusion (over 2-3 hours) into a vein. The nurse or doctor will first check that the diluted solution is clear.

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You will be given the following doses:

Adults and the elderly

Up to 6g (80mmol) daily.

Infants and children

Up to 3mmol per kg bodyweight daily.

Some monitoring may be required such as your heart rhythm.

If more Potassium Chloride is used than should be:

Tell the doctor or nurse immediately if you feel any muscle weakness, confusion, changes in your heart rate and even chest pain, so that he/she can give appropriate treatment.

If you have already left the medical premises, contact your nearest hospital, doctor or nurse.

If you miss a dose of Potassium Chloride:

It is unlikely that you will miss a dose as your doctor or nurse will be giving it to you. However, it is important not to have a double dose if you have missed one. Ask your doctor or nurse when you should have the next dose.

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


4. Possible side effects


Like all medicines, Potassium Chloride can cause side effects although not everyone gets them.

Side effects occur if it is given too quickly or too much is given. The most serious side effect is a change in your heart rate.

Other side effects from having too much potassium in your blood are muscle weakness, confusion and even chest pain and paralysis.

Pain and phlebitis (inflammation of the wall of a vein) can sometimes occur during infusion of high concentrations of potassium.

Reporting of side effects:

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (Website: www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.


A1000070_1 V1 Potassium Cl Inj PlL.indd 2


5. How Potassium Chloride Injection is stored


■    Keep out of the reach and sight of children.

■    Do not use Potassium Chloride Injection after the expiry date which is stated on the ampoule and carton after Exp:. The expiry date refers to the last day of that month.

■    Medicines should not be disposed via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.


6. Further information


Potassium Chloride Injection is a sterile solution for injection containing potassium chloride. It also contains water and may contain a small amount of hydrochloric acid and/or potassium hydroxide.

The product is available in 10ml ampoules (150mg/ml potassium chloride) in packs of 10 or 20 ampoules.

The Marketing Authorisation for Potassium Chloride Injection is held by Auden Mckenzie (Pharma Division) Ltd., Mckenzie House, Bury Street, Ruislip, Middlesex, HA4 7TL, UK.

Potassium Chloride Injection is manufactured by SNS Pharmaceuticals Ltd., Mckenzie House,

Bury Street, Ruislip, Middlesex, HA4 7TL, UK.


This leaflet was updated in May 2015


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Auden Mckenzie


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Information for the Healthcare Professional

(Please detach prior to giving the leaflet to the patient)

Potassium Chloride 15% w/v Concentrate for solution for infusion

Potassium chloride 150mg/ml (1.5g in10ml total volume)


1. NAME OF THE MEDICINAL PRODUCT

Potassium Chloride 15% w/v, Concentrate for solution for nfusion.

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

Potassium chloride 150mg/ml (1.5g/10ml total volume)

For excipients, see Section 6.1.

3.    PHARMACEUTICAL FORM

Concentrate for solution for infusion (Colourless solution)

4.    CLINICAL PARTICULARS

4.1    Therapeutic indications

Electrolyte imbalance.

4.2    Posology and method of administration

Method of administration: Slow intravenous infusion.

Dilute with a suitable infusion fluid and mix well before use to produce a potassium concentration of 20mmol per litre and not more than 40mmol per litre. Infuse at a rate not exceeding 20mmol potassium per hour. In the treatment of severe hypokalaemia or diabetic ketoacidosis, the higher concentration and a higher infusion rate may be required. In this case, the infusion should be into a high blood flow vein and continuous ECG monitoring is advisable.

Adults and the elderly:

Up to 6g (80mmol) daily after dilution to a concentration of 20mmol/litre and no greater than 40mmol/litre.

Infants and children:

Up to 3mmol per kg per day after dilution to a concentration of 20mmol/litre.

4.3    Contraindications

Do not use:-

1)    In patients with hyperkalaemia

2)    In patients with severe renal impairment (plasma potassium concentrations above 5mmol/litre).

4.4    Special warnings and precautions for use

This product must be diluted with sodium chloride ntravenous infusion BP (0.9% w/v) or other suitable diluent to a concentration not more than 40mmol per litre, thoroughly mixed and given by slow intravenous infusion under ECG control, ensuring adequate urine flow and with careful monitoring of electrolytes.

Initial potassium replacement therapy should not involve glucose infusions, because glucose may cause a further decrease in the plasma-potassium concentration.

Repeated measurements of plasma-potassium concentration are necessary to determine whether further infusions are required and to avoid the development of hyperkalaemia.


Patients with mild to moderate renal impairment and adrenal insufficiency should be closely monitored. Considerable care should also be taken with patients having cardiac disease, acute dehydration, heat cramps, extensive tissue destruction eg severe burns and those receiving potassium-sparing diuretics. Care should be taken with elderly patients since renal function may be impaired.

4.5    Interaction with other medicinal products and other forms of interaction

ACE inhibitors

Concurrent treatment may cause severe hyperkalaemia.

Angiotensin-ii Receptor Antagonists There is an increased risk of hyperkalaemia.

Ciclosporin

There is an increased risk of hyperkalaemia. Potassium-sparing Diuretics

There is a risk of hyperkalaemia but occasionally this combination may prove useful if the hypokalaemia is very severe.

Tacrolimus

There is an increased risk of hyperkalaemia.

Other Forms of interaction

Blood transfusions can contain significant serum potassium levels.

If exchange resins or sodium cycles are administered with potassium supplements, serum potassium levels are reduced by sodium replacement of the potassium.

Hyperkalaemia can result from the use of thiazide diuretics and potassium containing medicaments.

Hyperkalaemia can be very dangerous in digitalised patients and careful monitoring of serum potassium levels is very important.

Potassium can enhance the antiarrhythmic effect of quinidine

Concurrent use of adrenocorticoids, glucocorticoids and mineralocorticoids may all decrease the effects of potassium supplements.

4.6    Pregnancy and lactation

There are no adequate data from the use of potassium chloride in pregnant women. Animal data are insufficient with respect to effects on pregnancy and embryonal/foetal development.

Caution should be exercised when prescribing to pregnant women.

Potassium salts are likely to be excreted in milk. It would be prudent to cease breast-feeding during infusion.


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