POTASSIUM CHLORIDE & SODIUM CHLORIDE

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

POTASSIUM CHLORIDE; SODIUM CHLORIDE

Beschikbaar vanaf:

Maco Pharma (UK) Ltd

ATC-code:

B05BB01

INN (Algemene Internationale Benaming):

POTASSIUM CHLORIDE; SODIUM CHLORIDE

Dosering:

0.15/0.9 %w/v

farmaceutische vorm:

Solution for Infusion

Prescription-type:

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

Therapeutisch gebied:

electrolytes

Autorisatie-status:

Marketed

Autorisatie datum:

2005-12-02

Bijsluiter

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.

Productkenmerken

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
Osmolality approx. 322 mOsm/kg H2O.
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:
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 500ml
Per 1000ml
Potassium chloride
0.75 g
K
+
10 mmol
1.5g
K
+
20 mmol
Sodium chloride
4.5 g
Na
+
75 mmol
9.0 g
Na
+
150 mmol
Cl
-
85mmol
Cl
-
170 mmol
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