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

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Potassium chloride; Sodium chloride

Available from:

Fresenius Kabi Limited

ATC code:

B05BB; B05BB01

INN (International Name):

Potassium chloride; Sodium chloride

Dosage:

0.15% w/v + 0.9% w/v percent weight/volume

Pharmaceutical form:

Solution for infusion

Prescription type:

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

Therapeutic area:

Solutions affecting the electrolyte balance; electrolytes

Authorization status:

Not marketed

Authorization date:

2014-11-03

Patient Information leaflet

CORES:
COLOURS
CÓDIGO:
_CODE_
VERSÃO:
_VERSION_
FICHA TÉCNICA:
_TECHNICAL SHEET_
DESIGNAÇÃO:
_NAME_
PROVA:
_PROOF_
ELABORADO POR:
_MADE BY_
DATA:
_DATE_
ESCALA:
_SCALE_
Anexo 6.00 do PT.G.087
This medicinal product is authorised in the Member States of
the EEA under the following names:
THIS LEAFLET WAS LAST REVISED IN 07/2014
9
10
from visible particles. It is available in 500 ml and 1000 ml
polyethylene bottles (KabiPac) closed with a polyolefin cap
containing a polyisoprene rubber stopper. It is supplied in
packs of 10 bottles.
Not all pack sizes may be marketed.
MARKETING AUTHORISATION HOLDER AND MANUFACTURER
MARKETING AUTHORISATION HOLDER
Fresenius Kabi Limited,
Cestrian Court, Eastgate Way,
Manor Park, Runcorn,
Cheshire, WA7 1NT, UK
MANUFACTURER
Fresenius Kabi Deutschland GmbH
Freseniusstraße 1, D-61169 Friedberg, Germany
POTASSIUM CHLORIDE 0.15% W/V &
SODIUM CHLORIDE 0.9% W/V SOLUTION FOR INFUSION
0xxxxx1/00 V001
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 & Sodium Chloride
0.9% 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 & Sodium Chloride 0.9% w/v
3. How Potassium Chloride 0.15% w/v & Sodium Chloride
0.9% w/v is given
4. Possible side effects
5. How to store Potassium Chloride 0.15% w/v & Sodium
Chloride 0.9% w/v
6. Contents of the pack and other information
1. WHAT POTASSIUM CHLORIDE 0.15% W/V & SODIUM
CHLORIDE 0.9% W/V IS AND WHAT IT IS USED FOR
Potassium Chloride 0.15% w/v & Sodium Chloride 0.9% w/v
is a solution of potassium chloride and sodium chloride in
water. Potassium chloride and sodium chloride are chemicals
(often called ‘salts’) th

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Potassium Chloride 0.15% w/v & Sodium Chloride 0.9% w/v Solution for
Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Potassium Chloride 1.50 g/l
Sodium Chloride 9.00 g/l
Each ml contains 1.50 mg potassium chloride and 9.00 mg sodium
chloride.
Each 500 ml bottle contains 0.75 g potassium chloride and 4.5 g sodium
chloride.
Each 1000 ml bottle contains 1.50 g potassium chloride and 9.00 g
sodium chloride.
mmol/l:
K
+
: 20 Na
+
: 154
Cl
-
: 174
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion
Clear and colourless solution, free from visible particles
Osmolarity: 348 mOsm/l (approx.)
pH: 4.5 – 7.0
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Potassium Chloride 0.15% w/v & Sodium Chloride 0.9% w/v is indicated
for the prevention and treatment of
potassium depletion and/or hypokalaemia, in sodium chloride and
water-losing conditions.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Doses may be expressed in terms of mEq or mmol of each cation, mass of
each cation, or mass of each cation salt:
-
for sodium
1 g NaCl = 394 mg of Na
+
or 17.1 mEq or 17.1 mmol of Na
+
and Cl
–
1 mmol Na
+
= 23 mg Na
+
-
for potassium
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 treatment of isotonic fluid depletion
(extracellular dehydration) by means of any
intravenous solution is:
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
__