Potassium Chloride 0.3% w/v and Sodium Chloride 0.18% w/v in Glucose 4% w/v Intravenous Infusion BP (Viaflo Container)

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Potassium chloride; Sodium chloride; Glucose monohydrate

Available from:

Baxter Holding B.V.

ATC code:

B05BB; B05BB02

INN (International Name):

Potassium chloride; Sodium chloride; Glucose monohydrate

Dosage:

0.3/0.18/4 percent weight/volume

Pharmaceutical form:

Solution for infusion

Therapeutic area:

Solutions affecting the electrolyte balance; electrolytes with carbohydrates

Authorization status:

Marketed

Authorization date:

2008-04-11

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
POTASSIUM CHLORIDE 0.3% W/V AND SODIUM CHLORIDE 0.18% W/V IN 4% W/V
GLUCOSE INTRAVENOUS
INFUSION BP (VIAFLO CONTAINER)
Active substances: potassium chloride, sodium chloride and glucose
monohydrate
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, Sodium Chloride
0.18% w/v and Glucose 4%
w/v, Solution for Infusion 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 enough potassium, sodium and chloride in your
blood. This can occur
when gastrointestinal (stomach) fluid is lost. This can happen if:
–
you have vomiting
–
you have diarrhoea
–
a wound is drained after surgery (by collecting body fluid in a bag)
–
you have gastric (stomach) suction to empty the stomach contents
–
part of your digestive system has been diverted so that food does not

Summary of Product characteristics

Health Products Regulatory Authority
10 August 2020
CRN008ZC3
Page 1 of 11
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: 362 mOsm/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 choice of the specific potassium chloride, sodium chloride, and
glucose concentration, dosage, volume, rate and duration
of
administration
depends
on
the
age,
weight
and
clinical
condition
of
the
patient
and
concomitant
therapy,
and
administration should be determined by a physician. For patients with
electrolyte and glucose abnormalities and for paediatric
patients, consult a physician experienced in intravenous fluid
therapy.
Fluid balance, serum glucose, serum sodium and other electrolytes
should be monitored before and during administration,
especially in patients with increased non-osmotic vasopressin release
(syndrome of inappropriate antidiuretic hormone
secretion, SIADH) and in patients co-medic