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

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Potassium chloride

Disponible depuis:

Fresenius Kabi Deutschland GmbH

Code ATC:

B05XA; B05XA01

DCI (Dénomination commune internationale):

Potassium chloride

Dosage:

15 percent weight/volume

forme pharmaceutique:

Concentrate for solution for infusion

Domaine thérapeutique:

Electrolyte solutions; potassium chloride

Statut de autorisation:

Not marketed

Date de l'autorisation:

2010-07-16

Notice patient

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Potassium Chloride is and what it is used for
2.
What you need to know before you use Potassium Chloride
3.
How to use Potassium Chloride
4.
Possible side effects
5.
How to store Potassium Chloride
6.
Contents of the pack and other information
1. WHAT POTASSIUM CHLORIDE IS AND WHAT IT IS USED FOR
This product belongs to the group “Additives for intravenous
solutions’: Electrolytic solutions” and it
is dispensed under medical prescription.
Potassium Chloride is indicated for the treatment of potassium
deficiency in patients for whom dietary
measures or oral medication are inadequate.
You must talk to a doctor if you do not feel better or if you feel
worse.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE POTASSIUM CHLORIDE
DO NOT USE POTASSIUM CHLORIDE:
You must not be given Potassium Chloride if you suffer from excess of
potassium in the blood
(hyperkalaemia).
WARNINGS AND PRECAUTIONS
Talk to your doctor before using Potassium Chloride.
Potassium Chloride will be given by or under the direct supervision of
your physician, who will take
care for the following:
-
Direct injection of potassium chloride concentrates without
appropriate dilution may cause instant
death.
-
The administration should be slow (usually 10 mmol/h, not exceeding 20
mmol/h) and under
control of cardiac activity.
-
Since adequate urine flow must be ensured

Résumé des caractéristiques du produit

Health Products Regulatory Authority
17 April 2019
CRN008S1W
Page 1 of 7
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 1 ml of solution contains 150 mg of potassium chloride (15 % w/v)
equivalent to 2 mmol potassium ions.
Each 5 ml of solution contain 750 mg of potassium chloride (15 % w/v)
equivalent to 10 mmol potassium ions.
Each 10 ml of solution contain 1500 mg of potassium chloride (15 %
w/v) equivalent to 20 mmol potassium ions.
Each 20 ml of solution contain 3000 mg of potassium chloride (15 %
w/v) equivalent to 40 mmol potassium ions.
Ionic content: Cl
–
2000 mEq/l or 2000 mmol/l
K
+
2000 mEq/l or 2000 mmol/l
Theoretical osmolarity: 4000 mosm/l
pH-value: 4.5 – 7.0
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion. A clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Potassium Chloride 15% w/v is indicated for the treatment of potassium
deficiency in patients for whom dietary measures or
oral medication are inadequate.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
INTRAVENOUS ADMINISTRATION ONLY AFTER DILUTION
Posology
_Paediatric population_
The safety and efficacy of potassium chloride for paediatric patients
has not been fully established.
Currently available data are described in section 5.1.
_Adults_
Normal dose for adults:
Administer intravenously only after dilution in a suitable solution,
up to a maximum concentration of 3 g/l of potassium
chloride (or 40 mEq of potassium). For therapy of severe hypokalaemia
or diabetic ketoacidosis higher concentrations may be
necessary; in this case, the infusion should be into a high blood flow
vein and continuous ECG monitoring is advisable.
1 g of potassium chloride corresponds to 13.4 mEq or 524 mg of
potassium.
Dose is dependent on results of serum electrolyte levels and
acid-base-state. The potassium deficit is to be calculated via the
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