POTASSIUM CHLORIDE AND SODIUM CHLORIDE

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

POTASSIUM CHLORIDE ; SODIUM CHLORIDE

Tilgjengelig fra:

Maco Pharma (UK) Ltd

ATC-kode:

B05BB01

INN (International Name):

POTASSIUM CHLORIDE ; SODIUM CHLORIDE

Dosering :

0.3 0.9 %w/v

Legemiddelform:

Solution for Infusion

Resept typen:

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

Terapeutisk område:

electrolytes

Autorisasjon status:

Marketed

Autorisasjon dato:

2002-12-17

Informasjon til brukeren

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.

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Potassium Chloride 0.3% w/v Sodium Chloride 0.9% w/v Solution for
Infusion.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Osmolality approx. 360 mOsmol/kg water.
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Solution for
infusion
Sterile endotoxin-free solution, colourless to faintly straw coloured
without visible particles.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For fluid replacement, and provision of potassium, sodium and chloride
electrolytes in the prevention and treatment of
hypokalaemia and potassium depletion.
Medium for intravenous administration of medicinal products known to
be compatible.
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 and sodium chloride 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 age, body
weight, complementary treatment and clinical and
biochemical status. Rapid infusion may be harmful. The rate of
administration should not exceed 30mmol of potassium
per hour. Typically 500ml is infused slowly over 2 to 3 hours, but the
dose and rate of administration are subject to
clinical and laboratory assessment in each case. A recommended maximum
dose is 2 – 3 mmol potassium per kg body
weight in 24 hours.
Fluid balance, serum electrolytes and acid-base balance may need to be
monitored before and during administration,
with particular attention to serum sodium in patients with increased
non-osmotic vasopressin release (syndrome of
inappropriate antidiuretic hormone secretion, SIADH) and in patients
co-medicated with vasopressin agonist drugs, due
to the risk of hospital acquired hyponatraemia (see sections 4.4, 4.5
and 4.8).
Monitoring of serum sodium is particularly important for hypotonic
fluids.
Potass