POTASSIUM CHLORIDE AND SODIUM CHLORIDE IN GLUCOSE

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

POTASSIUM CHLORIDE ; SODIUM CHLORIDE ; GLUCOSE MONOHYDRATE

Available from:

Baxter Healthcare Limited

ATC code:

B05BB02

INN (International Name):

POTASSIUM CHLORIDE ; SODIUM CHLORIDE ; GLUCOSE MONOHYDRATE

Dosage:

0.3/0.18/4 %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:

2008-04-11

Patient Information leaflet

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DATE 05 September 2013
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1a
PACKAGE LEAFLET: INFORMATION FOR THE USER
Active substances: potassium chloride, sodium chloride and glucose
monohydrate
b
Read all of this leaflet carefully before you
are given this medicine because it contains
important information for you
•
Keep this leaflet. You may need to read it
again.
•
If you have any further questions, ask your
doctor or nurse.
•
If you get any side effects, talk to your doctor
or nurse. This includes any possible side
effects not listed in this leaflet.
Throughout this leaflet, Potassium Chloride 0.3% w/v
and Sodium Chloride 0.18% w/v in Glucose 4% w/v
Intravenous Infusion BP will be called Potassium
chloride, Sodium chloride & Glucose Infusion
What is in this leaflet:
1.
What Potassium chloride, Sodium chloride &
Glucose Infusion is and what it is used for
2.
What you need to know before you are
given Potassium chloride, Sodium chloride &
Glucose Infusion
3.
How you will be given Potassium chloride,
Sodium chloride & Glucose Infusion
4.
Possible side effects
5.
How to store Potassium chloride, Sodium
chloride & Glucose Infusion
6.
Content of the pack and other information
1. What Potassium chloride,
Sodium chloride & Glucose
Infusion is and what it is
used for
Potassium chloride, Sodium chloride & Glucose
Infusion is a solution of potassium chloride,
sodium chloride and glucose monohydrate in
water. Potassium chloride and sodium chloride are
chemicals (often called “salts”) found in the blood.
It is used to prevent and treat the following
conditions:
•
if you do not have enoug

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Potassium Chloride 0.3% w/v and Sodium Chloride 0.18% w/v in Glucose
4% w/v Intravenous Infusion BP (Viaflo
Container)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Substances:
Potassium Chloride
0.30 % w/v
Sodium Chloride
0.18 % w/v
Glucose Monohydrate 4.4 % w/v
_(equivalent to anhydrous glucose 4.0%w/v)_
Equivalent to:
mmol/L
Potassium
40
Sodium
30
Chloride
70
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
Clear, colourless solution, free from visible particles.
pH: 3.5 – 5.5
Osmolarity: 362mOsm/l
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prevention and treatment of potassium, sodium and chloride depletion
due to a loss of gastrointestinal fluid (vomiting,
diarrhoea, surgical drainage, gastric suction, small intestinal bypass
procedure, or small bowel fistula), a chronic abuse
of laxative, malabsorption syndromes, mucus secreting villous adenoma
of the small intestine, or renal salt-losing
conditions (renal disorders, overuse of diuretics), particularly in
cases (e.g. starvation) where a source of energy is
required.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults, the Elderly and Children_
The dosage depends on the age, weight, clinical and biological
conditions of the patient and concomitant therapy.
Typical doses of potassium for the prevention of hypokalaemia may be
up to 50 mmol daily and similar doses may be
adequate in mild potassium deficiency. In severe acute hypokalaemia,
up to 20 mmol of potassium in 500 ml over 2 to
3 hours under ECG control. Patients with renal impairment should
receive lower doses.
The maximum recommended dose of potassium is 2 to 3 mmol/kg/24h. The
rate should not exceed 10 to 40 mmol/h to
avoid hyperkalaemia. For peripheral infusions, potassium concentration
should be less than 60 mmol/l to avoid pain.
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