Potassium Chloride 15% w/v Concentrate for Solution for Infusion

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Potassium chloride

Предлага се от:

Mercury Pharmaceuticals (Ireland) Ltd

АТС код:

A12BA; A12BA01

INN (Международно Name):

Potassium chloride

дозиране:

15 percent weight/volume

Лекарствена форма:

Concentrate for solution for infusion

Вид предписание :

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

Терапевтична област:

Potassium; potassium chloride

Статус Оторизация:

Marketed

Дата Оторизация:

1988-11-18

Листовка

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
POTASSIUM CHLORIDE 15% W/V CONCENTRATE FOR SOLUTION FOR INFUSION
Potassium Chloride
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 or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
The name of your medicine is Potassium Chloride 15% w/v Concentrate
for Solution for Infusion,
it will be referred to as Potassium Chloride Concentrate throughout
the leaflet for ease here after
.
WHAT IS IN THIS LEAFLET:
1. What Potassium Chloride Concentrate is and what it is used for
2. What you need to know 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. Contents of the pack and other information
1. WHAT POTASSIUM CHLORIDE CONCENTRATE IS AND WHAT IT IS USED FOR
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. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN POTASSIUM CHLORIDE
CONCENTRATE
YOU SHOULD NOT BE GIVEN POTASSIUM CHLORIDE CONCENTRATE IF :
• you know that you are allergic to potassium chloride or any of the
other ingredients in this
medicine (listed in section 6)
• you have high levels of potassium in your blood (hyperkalaemia)-
your doctor will advice you.
Make sure your doctor knows if you suffer from the above.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR NURSE BEFORE YOU ARE GIVEN POTASSIUM CHLORIDE
CONCENTRATE IF YOU:
• have a kidney disorder or if your adrenal glands are not working
properly (your doctor will advise
you)
• h

Данни за продукта

Health Products Regulatory Authority
14 August 2020
CRN009RLP
Page 1 of 4
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
Each 10 ml of solution contains 1.5 g of Potassium Chloride.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion
Clear, colourless sterile solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For use in patientS requiring supplemental potassium therapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
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
100 mmol daily, it is rare that a larger amount is required
during potassium replacement therapy.
Method of administration
For intravenous administration, after dilution.
Before administering Potassium Chloride 15% w/v Concentrate for
Solution for Infusion:
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 20 mmol of potassium per
hour.
2. The ECG should be monitored continuously.
4.3 CONTRAINDICATIONS
1.
Hypersensitivity to the active substance(s) or to any of the
excipients listed in section 6.1
2.
Potassium Chloride Concentrate (15%) should never be used undiluted.
3.
Hyperkalaemia.
Health Products Regulatory Authority
14 August 2020
CRN009RLP
Page 2 of 4
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The diluted solution should always be given slowly as high blood
concentrations of potassium may cause serious cardiac
toxicity. Particular care is required when administering potassium to
pati