Potassium Chloride 0.3% w/v and 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:

B. Braun Melsungen AG

קוד ATC:

B05BB; B05BB02

INN (שם בינלאומי):

Potassium chloride; Glucose monohydrate

כמות:

0.3%w/v + 5.0 percent weight/volume

טופס פרצבטיות:

Solution for infusion

סוג מרשם:

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

איזור תרפויטי:

Solutions affecting the electrolyte balance; electrolytes with carbohydrates

מצב אישור:

Not marketed

תאריך אישור:

2012-07-27

עלון מידע

PACKAGE LEAFLET: INFORMATION FOR THE USER
POTASSIUM CHLORIDE 0.3% W/V AND GLUCOSE 5% W/V
SOLUTION FOR INFUSION
Potassium chloride and glucose
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 pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even
if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. 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 and Glucose 5% w/v is and what it
is used for
2. What you need to know before you use Potassium Chloride 0.3% w/v
and Glucose 5% w/v
3. How to use Potassium Chloride 0.3% w/v and Glucose 5% w/v
4. Possible side effects
5. How to store Potassium Chloride 0.3% w/v and Glucose 5% w/v
6. Contents of the pack and other information
1. WHAT POTASSIUM CHLORIDE 0.3% W/V AND GLUCOSE 5% W/V IS AND WHAT IT
IS USED FOR
This medicine contains a solution of potassium chloride and glucose.
It is administered to you through
a tube placed into a vein (intravenous drip).
You will receive it to maintain or restore your potassium levels and
to cover your basic energy
requirements.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE THIS MEDICINE
DO NOT USE POTASSIUM CHLORIDE 0.3% W/V AND GLUCOSE 5% W/V
• if you have too high levels of potassium or chloride in your blood
(hyperkalaemia or
hyperchloremia)
• if you have severe kidney disease
• if you have had a head injury (during the first 24 hours)
• if you have too much water in your body (hyperhydration)
• if you have too high blood sugar levels (hyperglycaemia)
• if you have recently suffered from a stroke
WARNINGS AND PRECAUTIONS
Patients who are acutely ill, with pain, postoperative stress,
infections, burns, nervous system, heart,
liver and kidney

מאפייני מוצר

Health≙Products≙Regulatory≙Authority
31≙January≙2019
CRN008L8F
Page≙1≙of≙11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Potassium≙Chloride≙0.3%≙w/v≙and≙Glucose≙5%≙w/v≙Solution≙for≙Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1000≙ml≙of≙solution≙for≙infusion≙contains:
Potassium≙chloride≙3.00g
Glucose≙(as≙Glucose≙monohydrate)≙50.00g
_Electrolyte concentrations:_
Potassium≙40≙mmol/l
Chloride≙40≙mmol/l
For≙the≙full≙list≙of≙excipients,≙see≙section≙6.1.
3 PHARMACEUTICAL FORM
Solution≙for≙infusion
Clear,≙colourless≙up≙to≙faintly≙straw-coloured≙aqueous≙solution
Energy≙835≙kJ/l≙
≙≙
200≙kcal/l
Theoretical≙osmolarity≙358≙mOsm/l
pH≙3.5≙–≙6.5
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Supply≙of≙potassium≙to≙correct≙or≙prevent≙potassium≙deficiency≙and≙supply≙of≙
glucose≙to≙cover≙basic≙energy≙requirements.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The≙dosage≙is≙dependent≙on≙age,≙weight≙and≙clinical≙condition≙of≙the≙patient,≙
especially≙those≙with≙renal≙or≙cardiac≙insufficiency.≙Fluid≙balance,≙serum≙glucose,≙
serum≙sodium≙and≙other≙electrolytes≙may≙need≙to≙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-medicated≙with≙vasopressin≙agonist≙drugs≙due≙to≙the≙risk≙of≙hyponatraemia.
Health≙Products≙Regulatory≙Authority
31≙January≙2019
CRN008L8F
Page≙2≙of≙11
Monitoring≙of≙serum≙sodium≙is≙particularly≙important≙for≙physiologically≙hypotonic≙
fluids.≙Potassium≙Chloride≙0.3≙%≙w/v≙and≙Glucose≙5%≙w/v≙Solution≙for≙Infusion≙may≙
become≙hypotonic≙after≙administration≙due≙to≙glucos