Potassium Chloride 0.3% w/v and Sodium Chloride 0.9% w/v Solution for Infusion

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Potassium chloride; Sodium chloride

Dostupné z:

B. Braun Melsungen AG

ATC kód:

B05BB; B05BB01

INN (Medzinárodný Name):

Potassium chloride; Sodium chloride

Dávkovanie:

0.3%w/ + 0.9 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

Stav Autorizácia:

Not marketed

Dátum Autorizácia:

2012-08-24

Príbalový leták

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273/436492/0417
WHAT IS IN THIS LEAFLET:
1. What Potassium Chloride 0.3% w/v and Sodium Chloride 0.9% 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 Sodium Chloride 0.9% w/v
3. How
to
use
Potassium
Chloride
0.3%
w/v
and
Sodium
Chloride
0.9% w/v
4. Possible side effects
5. How to store Potassium Chloride 0.3% w/v and Sodium Chloride
0.9% w/v
6. Contents of the pack and other information
1. WHAT
POTASSIUM
CHLORIDE
0.3%
W/V
AND
SODIUM
CHLORIDE 0.9% W/V IS AND WHAT IT IS USED FOR
This medicine contains a solution of potassium chloride and sodium
chlo-
ride. It is administered given to you through a tube placed into a
vein
(intravenous drip).
You will receive it to maintain or restore your potassium, sodium,
chloride
and fluid levels when the levels are low.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE THIS MEDICINE
DO NOT USE POTASSIUM CHLORIDE 0.3% W/V AND SODIUM CHLORIDE
0.9% W/V
• if you have high levels of potassium (hyperkalaemia) or chloride
(hyper-
chloraemia) or too high levels of sodium (severe hypernatraemia) in
your
blood
• if you have serious kidney disease
• if you have too much water in your body (hyperhydration)
WARNINGS AND PRECAUTIONS
Talk to your doctor before you are given Potassium Chloride 0.3% w/v
and
Sodium Chloride 0.9% w/v
Before or when giving you this medicine, your doctor will pay special
attention to the following:
• High levels of sodium in your blood (hypernatraemia)
• Swelling of the lower limbs (oedematous states) or water on your
lungs
(pulmonary oedema):
If you have one of these conditions, you will be given large amounts
of
this medicine only carefully.
• Kidney and liver function:
You will receive this medicine as a slow intravenous drip after your
doc-
tor has made sure that your kidneys and liver are working properly. If
they
don’t do so, your potassium blood levels and your heart will be
monitored
while you receive this medicin

Súhrn charakteristických

Health Products Regulatory Authority
22 October 2018
CRN008HGK
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Potassium Chloride 0.3% w/v and Sodium Chloride 0.9% w/v Solution for
Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Potassium Chloride 0.3% w/v and Sodium Chloride 0.9% w/v Solution for
Infusion
contains:
in 1 000 ml
Potassium chloride 3.00 g
Sodium chloride 9.00 g
_Electrolyte concentrations:_
Potassium 40 mmol/l
Sodium 154 mmol/l
Chloride 194 mmol/l
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion
A clear colourless aqueous solution
Theoretical osmolarity (approx.) 380 mOsmol/l
pH (approx.) 4.5 – 7.0
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Correction or maintenance of potassium, sodium, chloride and fluid
balance,
depending upon the clinical condition of the patient.
The solution is particularly indicated in the treatment of
hypokalaemia, hypotonic
and isotonic dehydration, and hypochloraemic alkalosis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The dosage is dependent on age, weight and clinical condition of the
patient,
especially those with renal or cardiac insufficiency. Dosage and rate
of infusion
should be determined by ECG and serum electrolyte monitoring.
Health Products Regulatory Authority
22 October 2018
CRN008HGK
Page 2 of 11
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
and in
maintenance may be calculated according to the following formula:
mmol K+required = (body weight [kg] × 0.2)* × 2 × (serum-K+target**
–
serum-K+actual [mmol/l])
*Term represents the extracellular fluid volume
** should be 4.5 mmol/l
The maximum recommended dose of potassium is 2 – 3 mmol/kg b.w./24
h.
Fluids
Generally, not more than 40 ml fluid/kg b.w./day should be supplied.
In cases where
more potassium is needed, other