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

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Potassium chloride

Available from:

Noridem Enterprises Limited

ATC code:

B05XA; B05XA01

INN (International Name):

Potassium chloride

Dosage:

15 percent weight/volume

Pharmaceutical form:

Concentrate for solution for infusion

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Electrolyte solutions; potassium chloride

Authorization status:

Not marketed

Authorization date:

2008-11-14

Patient Information leaflet

PACKAGE LEAFLET
PATIENT INFORMATION LEAFLET
POTASSIUM CHLORIDE 15% W/V CONCENTRATE FOR SOLUTION FOR INFUSION
POTASSIUM CHLORIDE
PLEASE READ ALL OF THIS LEAFLET CAREFULLY. IT INCLUDES IMPORTANT
INFORMATION ON HOW YOU SHOULD TAKE THIS
MEDICINE CORRECTLY AND SAFELY.

Keep this leaflet. You may need to read it again.

If you are the parent of a child who is to be given this medicine,
read the leaflet replacing

‘you’ with ‘your child’ throughout.

This medicine is prescribed for you. Do not pass it on to others. It
may harm them, even if their
symptoms are the same as yours.

If any of the side effects get serious, or you notice any side effects
not listed in the leaflet, please tell
your doctor, nurse or pharmacist.

If you have any further questions, please ask your doctor, nurse or
pharmacist.
THE NAME OF YOUR MEDICINE IS POTASSIUM CHLORIDE 15% W/V CONCENTRATE
FOR SOLUTION FOR INFUSION.
_In the rest of this leaflet Potassium Chloride 15% w/v Concentrate
for Solution for Infusion is called _
_Potassium Chloride. _
IN THIS LEAFLET:
1.
What Potassium Chloride is and what it is used for
2.
Before you take Potassium Chloride
3.
How to take Potassium Chloride
4.
Possible side effects
5.
How to store Potassium Chloride
6.
Further information
1.
WHAT POTASSIUM CHLORIDE IS AND WHAT IT IS USED FOR
Potassium Chloride is a type of medicine called an electrolyte.
Electrolytes help keep the water levels in
different parts of your body in the right balance.
Potassium Chloride works by replacing a substance called potassium
that your body has lost.
Your body needs the right amount of potassium. Potassium helps your
muscles, heart and other organs to
work properly. Potassium also helps balance the water levels that
affect many electrical and chemical
processes in your body. Without the right amount of potassium your
heart may start to beat abnormally,
which could be life-threatening.
If you cannot take potassium by mouth, your doctor or nurse will give
you this medicine as a drip
(infusion).
2.
BEFORE YOU

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Potassium Chloride 15% w/v concentrate for solution for infusion.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Potassium Chloride 150mg/ml or 15% w/v (2mmol/ml).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
A clear colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The prevention and treatment of potassium deficiency when oral
replacement therapy is not feasible.
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 20 mmol per litre
and not more than 40 mmol per litre.
Infuse at a rate not exceeding 20 mmol 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 6 g (80 mmol) daily after dilution to a concentration of 20
mmol/litre and no greater than 40 mmol/litre.
Infants and children:
Up to 3 mmol per kg per day after dilution to a concentration of 20
mmol/litre.
For children weighing 25kg or over, refer to the adult dosage.
4.3 CONTRAINDICATIONS
Potassium chloride is contraindicated in patients with hyperkalaemia.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
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