Potassium Chloride 0.3%w/v Sodium Chloride 0.18%w/v Glucose 4%w/v Solution for Infusion

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Potassium chloride; Sodium chloride; Glucose monohydrate

Dostupné z:

Carelide

ATC kód:

B05BB; B05BB02

INN (Medzinárodný Name):

Potassium chloride; Sodium chloride; Glucose monohydrate

Dávkovanie:

0.3/0.18/4 percent weight/volume

Forma lieku:

Solution for infusion

Terapeutické oblasti:

Solutions affecting the electrolyte balance; electrolytes with carbohydrates

Stav Autorizácia:

Not marketed

Dátum Autorizácia:

2005-12-02

Príbalový leták

NTS125A-01/2019
PACKAGE LEAFLET: INFORMATION FOR THE USER POTASSIUM CHLORIDE 0.3%
W
/
V SODIUM CHLORIDE 0.18%
W
/
V GLUCOSE
4%
W
/
V SOLUTION FOR INFUSION
POTASSIUM CHLORIDE, SODIUM CHLORIDE AND GLUCOSE ANHYDROUS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE BEING 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.
See section 4.
WHAT IS IN THIS LEAFLET
1.
What Potassium Chloride 0.3%w/v Sodium Chloride 0.18%w/v
Glucose 4%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 0.18%w/v
Glucose 4%w/v
Solution
for Infusion
3.
How Potassium Chloride 0.3%w/v Sodium Chloride 0.18%w/v
Glucose 4%w/v
Solution
for Infusion is given
4.
Possible side effects
5.
How to store Potassium Chloride 0.3%w/v Sodium Chloride 0.18%w/v
Glucose 4%w/v
Solution
for Infusion
6.
Contents of the pack and other information
1.
WHAT POTASSIUM CHLORIDE 0.3%
W
/
V SODIUM CHLORIDE 0.18%
W
/
V
GLUCOSE 4%
W
/
V SOLUTION FOR INFUSION IS AND WHAT IT IS USED FOR
Potassium Chloride 0.3%w/v Sodium Chloride 0.18%w/v Glucose 4%w/v
Solution for Infusion
is a clear colourless to faintly straw-coloured solution of potassium
chloride, sodium chloride
and glucose 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, and are involved in
nerve signals and muscle
contractions. Glucose is a simple sugar which provides a source of
energy. The solution is given
to help restore the normal salt balance, to add water to tissues which
are dehydrated and to
provide energy.
The solution may be given alone but may be given with other medicines
added.
You will be given Potassium Chlor

Súhrn charakteristických

Health Products Regulatory Authority
26 May 2020
CRN009801
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Potassium Chloride 0.3%w/v Sodium Chloride 0.18%w/v Glucose 4%w/v
Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Component
Potassium chloride
Sodium chloride
Glucose monohydrate
Per 500 ml
Per 1000 ml
1.5 g
K
+
20 mmol
3.0 g
K
+
40 mmol
0.9 g
Na
+
15 mmol
1.8 g
Na
+
30 mmol
Cl
-
35 mmol
Cl
-
70 mmol
equivalent to 20 g anhydrous glucose 111 mmol
Equivalent to 40 g anhydrous glucose 222 mmol
Osmolality approx. 366 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 correction and maintenance of fluid, potassium, sodium and
chloride ion balance and as a source of energy, where oral
administration is not feasible.
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
Health Products Regulatory Authority
26 May 2020
CRN009801
Page 2 of 7
The infusion rate should not exceed the patient’s glucose oxidation
capacities in order to avoid hyperglycaemia. Therefore the
maximum dose ranges from 5mg/kg/min for adults to 10-18 mg/kg/min for
babies and children depending on age and total
body mass.
_POSOLOGY FOR PREV