Potassium Chloride 0.3% w/v and Glucose 5% w/v Solution for Infusion - BP.

Country: Malta

Language: English

Source: Malta Medicines Authority

Available from:

Baxter Holding B.V. Kobaltweg 49, 3542CE Utrecht, Netherlands

ATC code:

B05BB02

INN (International Name):

GLUCOSE MONOHYDRATE 50.0 g/l POTASSIUM CHLORIDE 3.0 g/l

Pharmaceutical form:

SOLUTION FOR INFUSION

Composition:

GLUCOSE MONOHYDRATE 50.0 g/l POTASSIUM CHLORIDE 3.0 g/l

Prescription type:

POM

Therapeutic area:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Authorization status:

Authorised

Authorization date:

2024-02-14

Patient Information leaflet

PAGE 1 OF 10
PACKAGE LEAFLET: INFORMATION FOR THE USER
POTASSIUM CHLORIDE 0.3% W/V & GLUCOSE 5%W/V SOLUTION FOR INFUSION BP
Active substances: potassium chloride and glucose monohydrate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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.
WHAT IS IN THIS LEAFLET:
1.
What Potassium 0.3 & Glucose Infusion is and what it is used for
2.
What you need to know before you are given Potassium 0.3 & Glucose
Infusion
3.
How you will be given Potassium 0.3 & Glucose Infusion
4.
Possible side effects
5.
How to store Potassium 0.3 & Glucose Infusion
6.
Content of the pack and other information
1. WHAT POTASSIUM 0.3 & GLUCOSE INFUSION IS AND WHAT IT IS USED FOR
•
Potassium 0.3 & Glucose Infusion is a solution of potassium chloride
and glucose in water.
Potassium chloride is a chemical substance (often called a “salt”)
found in the blood.
Glucose is one of the body’s sources of energy. This solution for
infusion provides 200 kilocalories
per litre.
Potassium 0.3 & Glucose Infusion is used as a source of carbohydrate
(sugar) in the prevention and
treatment of:
•
a loss of potassium from the body (potassium depletion, e.g. after
treatment with certain
diuretics [water tablets])
•
a low level of potassium in the blood (hypokalaemia) in situations
that may cause potassium
chloride and water loss including:
-
when you cannot eat or drink, due to illness or after surgery
-
pronounced sweating due to high fever
-
extensive skin loss, as can occur in severe burns
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN POTASSIUM 0.3 & GLUCOSE
INFUSION
DO NOT RECEIVE POTASSIUM 0.3 & GLUCOSE INFUSION IF YOU ARE SUFFERING
FROM ANY OF THE FOLLOWING
CONDITIONS
•
higher levels of potassium in the blood than normal (hyperkalaemi

Summary of Product characteristics

PAGE 1 OF 16
1.1.
N
AME OF THE
M
EDICINAL
P
RODUCT
Potassium Chloride 0.3% w/v and Glucose 5% w/v Solution for Infusion -
BP.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Potassium Chloride : 3.0 g/L
Glucose (as monohydrate) : 50.0 g/L
mmol/l:
K
+
: 40
Cl
-
: 40
For the full list of excipients : see 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion.
Clear solution, free from visible particles.
Osmolarity: 358 mOsm/L
pH: 3.5 - 6.5
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prevention and treatment of potassium depletion and/or hypokalaemia in
cases where
supply of water and carbohydrates is required, due to restriction of
the intake of fluids
and electrolytes by normal routes.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION_. _
_ _
_ _
Posology
Adults, the Elderly and Children
The choice of specific potassium chloride and glucose concentration,
dosage, volume,
rate and duration of administration depends on the age, weight, and
clinical conditions of
the patient, concomitant therapy, and administration should be
determined by a physician.
For patients with electrolyte and glucose abnormalities and for
paediatric patients, consult
a physician experienced in intravenous fluid therapy.
Doses may be expressed in terms of mEq or mmol of potassium, mass of
potassium, or
mass of potassium salt:
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
+
_ _
_General posology _
The recommended dosage for the treatment of carbohydrates and fluid
depletion is
-
for adults : 500 ml to 3 Litres/24h
_ _
_ _
PAGE 2 OF 16
_Use in Paediatric Population: _
- 0-10 kg body weight : 100 ml/kg/24h
- 10-20 kg body weight : 1000 ml + (50 ml /kg over 10 kg) /24h
- > 20 kg body weight : 1500 ml + (20 ml/kg over 20 kg)/24h
The infusion rate should not exceed the patient’s glucose oxidation
capacities in order to
avoid hyperglycaemia. Therefore, the maximum dose ranges from
5mg/kg/min for adults
to 10-18 mg/kg/min for babies and children depending on the age and
the total body mass.
The infusion rate and v