Potassium Chloride 0.15% w/v & Glucose 5% w/v Solution for Infusion

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Potassium chloride; Glucose monohydrate

זמין מ:

Fresenius Kabi Limited

קוד ATC:

B05BB; B05BB02

INN (שם בינלאומי):

Potassium chloride; Glucose monohydrate

כמות:

0.15 + 5 percent weight/volume

טופס פרצבטיות:

Solution for infusion

מסלול נתינה (של תרופות):

intravenous route

יחידות באריזה:

500 ml and 1000 ml

סוג מרשם:

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

קבוצה תרפויטית:

Blood substitutes and perfusion solutions; electrolytes with carbohydrates

איזור תרפויטי:

Solutions affecting the electrolyte balance; electrolytes with carbohydrates

סממני תרפויטית:

Prevention and treatment of potassium depletion and/or hypokalaemia in cases where supply of water and carbohydrates is required due to either restriction of the intake of fluids and electrolytes or depletion by normal routes

מצב אישור:

Not marketed

תאריך אישור:

2015-09-11

עלון מידע

2146969.PA0566_071_002.2de58705-8abd-4e8e-a243-80853e5d7ea1_12_.palen-KCl
0.15_Glucose5-dec2014-clean.150422.doc
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
POTASSIUM CHLORIDE 0.15% W/V & GLUCOSE 5% W/V SOLUTION FOR INFUSION
potassium chloride, glucose (as monohydrate)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 0.15% w/v & Glucose 5% w/v is and what it is
used for
2.
What you need to know before you are given Potassium Chloride 0.15%
w/v & Glucose 5% w/v
3.
How Potassium Chloride 0.15% w/v & Glucose 5% w/v is given
4.
Possible side effects
5.
How to store Potassium Chloride 0.15% w/v & Glucose 5% w/v
6.
Contents of the pack and other information
1.
WHAT POTASSIUM CHLORIDE 0.15% W/V & GLUCOSE 5% W/V IS AND WHAT IT IS
USED FOR
Potassium Chloride 0.15% w/v & Glucose 5% w/v is a solution of
potassium chloride and glucose in water.
Potassium chloride is a chemical substance (often called a ‘salt’)
that occurs naturally in the blood. Glucose is
one of the body’s sources of energy. This solution provides 200
kilocalories per litre.
This medicine is used as a source of carbohydrates (sugar) in the
prevention and treatment of:

loss of potassium from the body (e.g. after treatment with certain
diuretics [water tablets])

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
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN POTASSIUM CHLORIDE 0.15%
W/V & GLUCOSE 5% W/V
_ _
YOU WILL NOT BE GIVEN POTASSIUM CHLORIDE 0.15% W/V & GLUCOSE 5% W/V

if the level of p

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Potassium Chloride 0.15% w/v & Glucose 5% w/v Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 1.50 mg Potassium Chloride and 50.0 mg Glucose
Each 500 ml bottle contains 0.75 g Potassium Chloride and 25 g Glucose
Each 1000 ml bottle contains 1.50 g Potassium Chloride and 50 g
Glucose
mmol/l:
K
+
: 20 Cl
-
: 20
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion
Clear solution, free from visible particles.
pH
3.5 – 6.0
Osmolarity
318 mOsm/l
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 either restriction of the intake of
fluids and electrolytes or depletion by normal routes.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
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
+
.
The dosage of this solution depends on the age, weight, clinical and
biological (acid-base balance) conditions of the
patient, concomitant therapy and in particular the patient’s
hydration state.
_General posology_
The recommended dosage for the treatment of carbohydrates and fluid
depletion is
- for adults: 500 ml to 3 litres/24 h
- for babies and children:
0 - 10 kg body weight: 100 ml/kg/24 h
10 - 20 kg body weight: 1000 ml + (50 ml/kg over 10 kg) /24 h
> 20 kg body weight: 1500 ml + (20 ml/kg over 20 kg)/24 h
The infusion rate should not exceed the patient’s glucose oxidation
capacities in order to avoid hyperglycaemia.
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