Potassium Chloride 0.15% w/v and Glucose 5% w/v Solution for Infusion - BP

Երկիր: Մալթա

Լեզու: անգլերեն

Աղբյուրը: Malta Medicines Authority

Հասանելի է:

Baxter Holding B.V. Kobaltweg 49, 3542CE Utrecht, Netherlands

ATC կոդը:

B05BB02

INN (Միջազգային անվանումը):

POTASSIUM CHLORIDE 1.5 g/l GLUCOSE MONOHYDRATE 50 g/l

Դեղագործական ձեւ:

SOLUTION FOR INFUSION

Կազմը:

POTASSIUM CHLORIDE 1.5 g/l GLUCOSE MONOHYDRATE 50 g/l

Ռեկվիզորի տեսակը:

POM

Թերապեւտիկ տարածք:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Լիազորման կարգավիճակը:

Authorised

Հաստատման ամսաթիվը:

2024-02-14

Տեղեկատվական թերթիկ

PAGE 1 OF 10
PACKAGE LEAFLET: INFORMATION FOR THE USER
Potassium Chloride 0.15% w/v & Glucose 5% w/v Solution for Infusion BP
Active substances: potassium 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.
WHAT IS IN THIS LEAFLET:
1.
What Potassium 0.15 & Glucose Infusion is and what it is used for
2.
What you need to know before you are given Potassium 0.15 & Glucose
Infusion
3.
How you will be given Potassium 0.15 & Glucose Infusion
4.
Possible side effects
5.
How to store Potassium 0.15 & Glucose Infusion
6.
Content of the pack and other information
1. WHAT POTASSIUM 0.15 & GLUCOSE INFUSION IS AND WHAT IT IS USED FOR
Potassium 0.15 & Glucose Infusion is a solution of potassium chloride
and glucose in water.
Potassium chloride is a chemical substance (often called a “salt”)
found in the blood. Glucose is one
of the body’s sources of energy. This solution for infusion provides
200 kilocalories per litre.
Potassium 0.15 & Glucose Infusion is used as a source of carbohydrate
(sugar) in the prevention and
treatment of:
•
a loss of potassium from the body (potassium depletion, e.g. after
treatment with certain
diuretics [water tablets])
•
a low level of potassium in the blood (hypokalaemia) in situations
that may cause potassium
chloride and water loss including:
-
when you cannot eat or drink, due to illness or after surgery
-
pronounced sweating due to high fever
-
extensive skin loss, as can occur in severe burns
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN POTASSIUM 0.15 & GLUCOSE
INFUSION
DO NOT RECEIVE POTASSIUM 0.15 & GLUCOSE INFUSION IF YOU ARE SUFFERING
FROM ANY OF THE
FOLLOWING CONDITIONS
•
higher levels of potassium in the blood than normal (hype

Ապրանքի հատկությունները

PAGE 1 OF 14
1.
NAME OF THE MEDICINAL PRODUCT
Potassium Chloride 0.15% w/v and Glucose 5% w/v Solution for Infusion
- BP
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Potassium Chloride : 1.5 g/L
Glucose (as monohydrate) : 50.0 g/L
mmol/l:
K
+
: 20
Cl
-
: 20
For the full list of excipients : see 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion.
Clear solution, free from visible particles
Osmolarity: 318 mOsm/L
pH: 3.5 - 6.5
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prevention and treatment of potassium depletion and/or hypokalaemia in
cases where supply of
water and carbohydrates is required due to restriction of the intake
of fluids and electrolytes by
normal routes.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Posology
_Adults, the Elderly and Children _
The choice of specific potassium chloride and glucose concentration,
dosage, volume, rate and
duration of administration depends on the age, weight, and clinical
conditions of the patient,
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.
Doses may be expressed in terms of mEq or mmol of potassium, mass of
potassium or mass of
potassium salt:
1g KCl = 525 mg of K
+
or 13.4 mEq or 13.4 mmol of K
+
and Cl
-
.
1 mmol K
+
= 39.1 mg K
+
_ _
_General posology _
The recommended dosage for the treatment of carbohydrates and fluid
depletion is :
-
for adults : 500 ml to 3 Litres/24h
_ _
_Use in Paediatric Population: _
- 0-10 kg body weight : 100 ml/kg/24h
- 10-20 kg body weight : 1000 ml + (50 ml /kg over 10 kg) /24h
PAGE 2 OF 14
- > 20 kg body weight : 1500 ml + (20 ml/kg over 20 kg)/24h
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 the age and the total
body mass.
The infusion rate and volume depends on