Potassium Chloride 0.15%w/v Sodium Chloride 0.18%w/v Glucose 4%w/v Solution for Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Potassium chloride; Glucose monohydrate; Sodium chloride

Available from:

MACO PHARMA

ATC code:

B05BB; B05BB02

INN (International Name):

Potassium chloride; Glucose monohydrate; Sodium chloride

Dosage:

0.15 0.18 4 percent weight/volume

Pharmaceutical form:

Solution for infusion

Prescription type:

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

Therapeutic area:

Solutions affecting the electrolyte balance; electrolytes with carbohydrates

Authorization status:

Marketed

Authorization date:

2005-12-02

Patient Information leaflet

NTS124A-01/2019
PACKAGE LEAFLET: INFORMATION FOR THE USER POTASSIUM CHLORIDE 0.15%
W
/
V SODIUM CHLORIDE 0.18%
W
/
V GLUCOSE
4%
W
/
V SOLUTION FOR INFUSION
POTASSIUM CHLORIDE, SODIUM CHLORIDE AND GLUCOSE ANHYDROUS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE BEING 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. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Potassium Chloride 0.15%w/v Sodium Chloride 0.18%w/v
Glucose 4%w/v
Solution
for Infusion
is and what it is used for
2.
What you need to know before you are given Potassium Chloride 0.15%w/v
Sodium
Chloride 0.18%w/v
Glucose 4%w/v
Solution
for Infusion
3.
How Potassium Chloride 0.15%w/v Sodium Chloride 0.18%w/v
Glucose 4%w/v
Solution
for Infusion is given
4.
Possible side effects
5.
How to store Potassium Chloride 0.15%w/v Sodium Chloride 0.18%w/v
Glucose
4%w/v
Solution
for Infusion
6.
Contents of the pack and other information
1.
WHAT POTASSIUM CHLORIDE 0.15%
W
/
V SODIUM CHLORIDE 0.18%
W
/
V
GLUCOSE 4%
W
/
V SOLUTION FOR INFUSION IS AND WHAT IT IS USED FOR
Potassium Chloride 0.15%w/v Sodium Chloride 0.18%w/v Glucose 4%w/v
Solution for
Infusion is a clear colourless to faintly straw-coloured solution of
potassium chloride, sodium
chloride and glucose in water. The solution is stored in a sealed
flexible plastic bag.
Potassium, sodium and chloride ions are important for maintaining the
correct balance of fluid
in and around the body’s cells and tissues, and are involved in
nerve signals and muscle
contractions. Glucose is a simple sugar which provides a source of
energy. The solution is given
to help restore the normal salt balance, to add water to tissues which
are dehydrated and to
provide energy.
The solution may be given alone but may be given with other medicines
added.
You will be given Potassiu

Summary of Product characteristics

Health Products Regulatory Authority
16 January 2019
CRN008TZW
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Potassium Chloride 0.15%w/v Sodium Chloride 0.18%w/v Glucose 4%w/v
Solution
for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Component
Per 500 ml
Per 1000 ml
Potassium chloride
0.75 g
K+ 10 mmol
1.5 g
K+ 20 mmol
Sodium chloride
0.9 g
Na+ 15 mmol
1.8 g
Na+ 30 mmol
Cl- 25 mmol
Cl- 50 mmol
Glucose monohydrate
Equivalent to 20 g anhydrous
glucose
111 mmol
Equivalent to 40 g anhydrous
glucose
222 mmol
Osmolality approx. 330 mOsm/kg H
2
O.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion (Intravenous Infusion)
Colourless to faintly straw-coloured solution without visible
particles in bags,
individually overwrapped.
pH 3.5 - 6.5.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For correction and maintenance of fluid, potassium, sodium and
chloride ion balance
and as a source of energy, where oral administration is not feasible.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For intravenous infusion under medical supervision.
The volume of solution needed to replenish deficits varies with
hydration state, age,
body weight, complementary treatment and clinical and biochemical
status.
Health Products Regulatory Authority
16 January 2019
CRN008TZW
Page 2 of 10
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
+
POSOLOGY
_- ADULTS:_
500ml to 3000ml/24h
_ _
_- PAEDIATRIC POPULATION:_
0 – 10kg body weight: 100ml/kg/24h
10 – 20kg body weight: 1000ml + (50ml/kg over 10kg)/24h
> 20kg body weight: 1500ml + (20ml/kg over 20kg)/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
age and total body mass.
_POSOLOGY