POTASSIUM CHLORIDE, SODIUM CHLORIDE & GLUCOSE
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
30-05-2014
Summary of Product characteristics
(SPC)
06-06-2018
Active ingredient:
POTASSIUM CHLORIDE; SODIUM CHLORIDE; GLUCOSE MONOHYDRATE
Available from:
Maco Pharma (UK) Ltd
ATC code:
B05BB02
INN (International Name):
POTASSIUM CHLORIDE; SODIUM CHLORIDE; GLUCOSE MONOHYDRATE
Dosage:
0.15 0.18 4 %w/v
Pharmaceutical form:
Solution for Infusion
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
electrolytes with carbohydrates
Authorization status:
Marketed
Authorization date:
2005-12-02
Patient Information leaflet
WHAT IS IN THIS LEAFLET
1. What Potassium Chloride 0.3%w/v Sodium Chloride 0.9%w/v Solution
for Infusion is and what it is used for
2. What you need to know before you are given Potassium Chloride
0.3%w/v Sodium Chloride 0.9%w/v Solution for Infusion
3. How Potassium Chloride 0.3%w/v Sodium Chloride 0.9%w/v Solution for
Infusion is given
4. Possible side effects
5. How to store Potassium Chloride 0.3%w/v Sodium Chloride 0.9%w/v
Solution for Infusion
6. Contents of the pack and other information
1. WHAT POTASSIUM CHLORIDE 0.3%W/V
SODIUM CHLORIDE 0.9%W/V SOLUTION
FOR INFUSION IS AND WHAT IT IS USED
FOR
Potassium Chloride 0.3%w/v Sodium Chloride
0.9%w/v Solution for Infusion is a clear
colourless to faintly straw-coloured solution of
potassium chloride and sodium chloride 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.
The solution is given to help restore the normal
salt balance and to add water to tissues which are
dehydrated.
The solution may be given alone but may be
given with other medicines added.
You will be given Potassium Chloride 0.3%w/v
Sodium Chloride 0.9%w/v Solution for Infusion
in hospital by a doctor or nurse.
2. WHAT YOU NEED TO KNOW BEFORE
YOU ARE GIVEN POTASSIUM CHLORIDE
0.3%W/V SODIUM CHLORIDE 0.9%W/V
SOLUTION FOR INFUSION
YOU MUST NOT BE GIVEN this solution if you
have:
• an ALLERGY to potassium chloride or sodium
chloride or any of the other ingredients
• increased levels of POTASSIUM or SODIUM in the
blood, or an increased blood volume
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse if you:
• have HEART FAILURE, KIDNEY or ADRENOCORTICAL
PROBLEMS, HIGH BLOOD PRESSURE, LIVER DISEASE, or
OEDEMA (swelling)
• are DEHYDRATED which may cause thirst, dry
mouth, dark urine, irregular heartbeat, tiredness
• have PRE-ECLAMPSIA of pregnancy
• have severe TISSUE DESTRUCTION such as occurs
after burns
• are VERY YOUNG or ELDERLY.
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Summary of Product characteristics
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
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.
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
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
-
25mmol
Cl
-
50 mmol
Glucose monohydrate
Equivalent to 20 g anhydrous
glucose 111 mmol
Equivalent to 40 g anhydrous
glucose 222 mmol
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