Potassium Chloride 0.15% w/v and Glucose 5% w/v solution for infusion

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Potassium chloride; Glucose monohydrate

Dostupné z:

B. Braun Melsungen AG

ATC kód:

B05BB; B05BB02

INN (Medzinárodný Name):

Potassium chloride; Glucose monohydrate

Dávkovanie:

0.15%w/v +5.0 percent weight/volume

Forma lieku:

Solution for infusion

Typ predpisu:

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

Terapeutické oblasti:

Solutions affecting the electrolyte balance; electrolytes with carbohydrates

Stav Autorizácia:

Not marketed

Dátum Autorizácia:

2012-07-27

Príbalový leták

PACKAGE LEAFLET: INFORMATION FOR THE USER
POTASSIUM CHLORIDE 0.15% 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 0.15% 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 0.15% w/v
and Glucose 5% w/v
3. How to use Potassium Chloride 0.15% w/v and Glucose 5% w/v
4. Possible side effects
5. How to store Potassium Chloride 0.15% w/v and Glucose 5% w/v
6. Contents of the pack and other information
1. WHAT POTASSIUM CHLORIDE 0.15% 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 0.15% 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

Súhrn charakteristických

Health Products Regulatory Authority
19 September 2019
CRN008L8D
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Potassium Chloride 0.15% w/v and Glucose 5% w/v solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1000 ml of solution for infusion contains:
Potassium chloride 1.50g
Glucose (as glucose monohydrate) 50.00g
_Electrolyte concentrations:_
Potassium 20 mmol/l
Chloride 20 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
​
318 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.
Monitoring of serum sodium is particularly important for
physiologically hypotonic fluids. Potassium Chloride 0.15 % w/v and
Glucose 5% w/v Solution for Infusion may become hypotonic after
administration due to glucose metabolisation in the body
(see sections 4.4, 4.5 and 4.8).
Dosage and rate of infusion should be determined by ECG and serum
electrolyte monitoring.
Adequate urine flow must be ensured.
_Adults:_
The following recommendations are general guidelines on potassium,
however prescribing should follow local guidelines.
Potassium
The amount required for correction of moderate potassium deficiency
andin maintenance may be calculat