Potassium chloride 15% (potassium 20mmol/10ml) solution for infusion 10ml ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Potassium chloride

Available from:

potassium 20mmol/10ml) solution for infusion 10ml ampoules (Advanz Pharma

ATC code:

B05XA01

INN (International Name):

Potassium chloride

Dosage:

150mg/1ml

Pharmaceutical form:

Solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 09020201; GTIN: 5099602334229

Patient Information leaflet

READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START USING THIS MEDICINE.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or
pharmacist.
If any of the side effects becomes serious, or if you
notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
The name of your medicine is Potassium Chloride
15% w/v Concentrate for Solution for Infusion but will
be referred to as ‘Potassium chloride concentrate’
throughout the remainder of this leaflet.
In this leaflet:
1. What Potassium chloride concentrate is and what it
is used for
2. Before you are given Potassium chloride concentrate
3. How you are given Potassium chloride concentrate
4. Possible side effects
5. How to store Potassium chloride concentrate
6. Further information
1. WHAT POTASSIUM CHLORIDE CONCENTRATE
AND WHAT IT IS USED FOR
Potassium chloride concentrate belongs to a group of
medicines called electrolyte replacement solutions.
Electrolytes are a group of chemicals and salts that are
in the body fluids.
Potassium chloride concentrate is used in patients
needing additional amounts of potassium.
2. BEFORE YOU ARE GIVEN POTASSIUM
CHLORIDE CONCENTRATE
YOU SHOULD NOT BE GIVEN POTASSIUM CHLORIDE
CONCENTRATE IF :
• you have hyperkalaemia (high levels of potassium in
your blood - your doctor will advise you)
• you suffer from impaired kidney function (you may
produce 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.
TAKE SPECIAL CARE WITH POTASSIUM CHLORIDE
CONCENTRATE 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 situ

Summary of Product characteristics

OBJECT 1
POTASSIUM CHLORIDE CONCENTRATE BP, 15% W/V,
1.5G IN 10ML
Summary of Product Characteristics Updated 12-Jul-2013 | Concordia
International - formerly AMCo
1. Name of the medicinal product
Potassium Chloride 15% w/v Concentrate for Solution for Infusion.
2. Qualitative and quantitative composition
Each 10ml contains 15% w/v (1.5g) Potassium Chloride BP.
3. Pharmaceutical form
Concentrate for Solution for Infusion
Clear, colorless, sterile, aqueous solution for infusion.
4. Clinical particulars
4.1 Therapeutic indications
For use in patients requiring supplemental potassium therapy.
4.2 Posology and method of administration
Route of administration: Intravenous, after dilution.
Before administering Sterile Potassium Chloride Concentrate:
1.) This solution must be diluted with not less than 50 times its
volume of sodium chloride solution or
other suitable diluent.
2.) The solution should be carefully mixed with the infusion fluid.
During administration:
1.) The diluted injection should be administered by slow intravenous
infusion at a maximal rate of
20mmol of potassium per hour.
2.) The ECG should be monitored continuously.
The goal of potassium replacement therapy is to elevate the plasma
concentration of the ion to within the
normal range.
Dose per hour: The maximal rate of intravenous infusion is
20mmol/hour.
Dose per day: Since the normal dietary intake of potassium is 50 to
100mmol daily, it is rare that a larger
amount is required during potassium replacement therapy.
4.3 Contraindications
1.) Sterile Potassium Chloride Concentrate should never be used
undiluted.
2.) Hyperkalaemia (plasma-potassium concentration above 5 mmol/litre).
3.) Hyperchloraemia,
4.) Impaired renal function with oliguria, anuria or azotaemia
5.) Addison's disease,
6.) Acute dehydration
7.) Heat cramps.
4.4 Special warnings and precautions for use
Administration – see also section 4.2
– Only use with specialist advice
– ECG should be used throughout and monitored continuously
– High concentrations of potassium cause serious c