Potassium Chloride 0.15% w/v & Sodium Chloride 0.9% w/v Solution for Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Potassium chloride; Sodium chloride

Available from:

Fresenius Kabi Deutschland GmbH

ATC code:

B05BB; B05BB01

INN (International Name):

Potassium chloride; Sodium chloride

Dosage:

0.15% w/v + 0.9 percent weight/volume

Pharmaceutical form:

Solution for infusion

Therapeutic area:

Solutions affecting the electrolyte balance; electrolytes

Authorization status:

Marketed

Authorization date:

2014-11-03

Patient Information leaflet

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 CLORIDE:
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/hr, not exceeding 20 mmol/hr) and under
control of cardiac activity.
-
Since adequate urine flow must be ens

Summary of Product characteristics

Health Products Regulatory Authority
17 April 2019
CRN008S1T
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Potassium Chloride 0.15% w/v & Sodium Chloride 0.9% w/v Solution for
Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Potassium Chloride 1.50 g/l Sodium Chloride 9.00 g/l
Each ml contains 1.50 mg potassium chloride and 9.00 mg sodium
chloride.
Each 500 ml bottle contains 0.75 g potassium chloride and 4.5 g sodium
chloride.
Each 1000 ml bottle contains 1.50 g potassium chloride and 9.00 g
sodium chloride.
mmol/l: K
+
: 20Na
+
: 154 Cl
-
: 174
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion
Clear and colourless solution, free from visible particles
Osmolarity: 348 mOsm/l (approx.)
pH: 4.5 – 7.0
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Potassium Chloride 0.15% w/v & Sodium Chloride 0.9% w/v is indicated
for the prevention and treatment of potassium
depletion and/or hypokalaemia, in sodium chloride and water-losing
conditions.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Doses may be expressed in terms of mEq or mmol of each cation, mass of
each cation, or mass of each cation salt:
- for sodium
1 g NaCl = 394 mg of Na
+
or 17.1 mEq or 17.1 mmol of Na
+
and Cl
–
1 mmol Na
+
= 23 mg Na
+
- for potassium
1 g KCl = 525 mg of K
+
or 13.4 mEq or 13.4 mmol of K
+
and Cl
–
1 mmol K
+
= 39.1 mg K
+
The dosage of this solution depends on the age, weight, clinical and
biological (acid-base balance) conditions of the patient,
concomitant therapy and in particular the patient's hydration state.
_General posology _
The recommended dosage for treatment of isotonic fluid depletion
(extracellular dehydration) by means of any intravenous
solution is:
- for adults: 500 ml to 3 litres/24 h
- for babies and children: 20 to 100 ml per 24 h and per kg of body
weight, depending of the age and the total body mass.
Posology
- Adults, Older people and Adolescents:
Typical dose of potassium for the prevention of hypokalaemia may be up
to 50 mmol