POTASSIUM CHLORIDE & GLUCOSE

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Cumpara asta acum

Descarcare Prospect (PIL)
30-05-2014

Ingredient activ:

POTASSIUM CHLORATE ; GLUCOSE MONOHYDRATE

Disponibil de la:

Maco Pharma (UK) Ltd

Codul ATC:

B05BB02

INN (nume internaţional):

POTASSIUM CHLORATE ; GLUCOSE MONOHYDRATE

Dozare:

0.3/5 %w/v

Forma farmaceutică:

Solution for Infusion

Tip de prescriptie medicala:

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

Zonă Terapeutică:

electrolytes with carbohydrates

Statutul autorizaţiei:

Marketed

Data de autorizare:

2005-12-02

Prospect

                                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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Caracteristicilor produsului

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Potassium Chloride 0.3%w/v Glucose 5%w/v Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Osmolality approx. 370 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 prevention and treatment of potassium depletion and/or
hypokalaemia in cases where supply of water and
carbohydrates is required due to restriction of intake of fluids and
electrolytes by normal routes.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For intravenous infusion under medical supervision.
Single use only.
The pathophysiological response to dehydration, to electrolyte loss
and to potassium chloride and glucose infusion will
vary with the age of the patient being treated and this should be
taken into account during rehydration therapy.
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:_
Active Component
Per 500ml
Per 1000ml
Potassium chloride
1.5g
K+
20 mmol
Cl¯
20 mmol
3.0g
K+
40 mmol
Cl¯
40 mmol
Glucose monohydrate
equivalent to 25.0g
anhydrous glucose
139 mmol
equivalent to 50.0g
anhydrous glucose
278 mmol
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