Potassium Chloride 0.15% w/v and Sodium Chloride 0.9% w/v Solution for Infusion

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Potassium chloride; Sodium chloride

Διαθέσιμο από:

B. Braun Melsungen AG

Φαρμακολογική κατηγορία (ATC):

B05BB; B05BB01

INN (Διεθνής Όνομα):

Potassium chloride; Sodium chloride

Δοσολογία:

0.15%w/ +0.9 percent weight/volume

Φαρμακοτεχνική μορφή:

Solution for infusion

Τρόπος διάθεσης:

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

Θεραπευτική περιοχή:

Solutions affecting the electrolyte balance; electrolytes

Καθεστώς αδειοδότησης:

Not marketed

Ημερομηνία της άδειας:

2012-08-24

Φύλλο οδηγιών χρήσης

PACKAGE LEAFLET: INFORMATION FOR THE USER
POTASSIUM CHLORIDE 0.3% W/V AND SODIUM CHLORIDE 0.9% W/V SOLUTION FOR
INFUSION
Potassium chloride and sodium chloride
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 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
chloride. 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
(hyperchloraemia) 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 medic

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
12 October 2018
CRN008HGJ
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Potassium Chloride 0.15% w/v and Sodium Chloride 0.9% w/v Solution for
Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Potassium Chloride 0.15% w/v and Sodium Chloride 0.9% w/v Solution for
Infusion
contains:
In 1 000 ml
Potassium chloride
1.50 g
Sodium chloride
9.00 g
_Electrolyte concentrations:_
Potassium
20 mmol/l
Sodium
154 mmol/l
Chloride
174 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.) 340 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
12 October 2018
CRN008HGJ
Page 2 of 10
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, oth