POTASSIUM CHLORIDE & SODIUM CHLORIDE 0.2/0.9 %w/v Solution for Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

POTASSIUM CHLORIDE, SODIUM CHLORIDE

Available from:

Maco Pharma (UK) Ltd

ATC code:

B05BB01

INN (International Name):

POTASSIUM CHLORIDE, SODIUM CHLORIDE

Dosage:

0.2/0.9 %w/v

Pharmaceutical form:

Solution for Infusion

Prescription type:

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

Therapeutic area:

Solutions affecting the electrolyte balance

Authorization status:

Authorised

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 VE

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Potassium Chloride 0.2%w/v Sodium Chloride 0.9%w/v Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Osmolality approx. 332 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 prophylactic and replacement therapy requiring the use of sodium chloride and potassium.
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:
1g KCl = 525 mg of K
+
or 13.4 mEq or 13.4 mmol of K
+
and Cl
-
1mmol K
+
= 39.1 mg K
+
GENERAL POSOLOGY
_- ADULTS:_
500ml to 3000ml/24h
- _BABIES AND CHILDREN:_
0 – 10kg body weight: 100ml /kg/24h
10 – 20kg body weight: 1000ml + (50ml/kg over 10 kg) / 24h
> 20kg body weight: 1500ml + (20ml/kg over 20 kg) / 24h
Active Component
Per 500 ml
Per 1000 ml
Potassium chloride
1.0 g
K
+,
13.5 mol
2.0 g
K
+,
27 mmol
Sodium chloride
4.5 g
Na
+
75 mmol
9.0 g
Na
+
150 mmol
Cl
-
88.5 mmol
Cl
-
177 mmol
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 26/01/2016_
_CRN 2166360_
_page number: 1_
_POSOLOGY FOR PREVENTION AND TREATMENT OF POTASSIUM DEPLETION_
Typical doses of potassium for the prevention of hypokalaemia and treatment of mild potassium deficie