POTASSIUM CHLORIDE 14.9 %

Country: Իսրայել

language: անգլերեն

source: Ministry of Health

active_ingredient:

POTASSIUM CHLORIDE

MAH:

LAPIDOT MEDICAL IMPORT AND MARKETING LTD

ATC_code:

A12BA01

pharmaceutical_form:

CONCENTRATE FOR SOLUTION FOR INFUSION

composition:

POTASSIUM CHLORIDE 14.9 G / 100 ML

administration_route:

I.V

prescription_type:

Required

manufactured_by:

B.BRAUN MELSUNGEN AG, GERMANY

therapeutic_group:

POTASSIUM CHLORIDE

therapeutic_area:

POTASSIUM CHLORIDE

therapeutic_indication:

Treatment of potassium deficiency states when oral replacement is not feasable.

authorization_date:

2015-02-28

SPC

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Potassium Chloride 14.9 %
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL of concentrate contains 0.149 g potassium chloride
corresponding to 2 mmol K
+
and 2 mmol Cl
–
1 ampoule (= 10 mL ampoule) contains 1.49 g potassium chloride
corresponding to 20 mmol K
+
and 20 mmol Cl
–
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion
Clear, colourless solution
Theoretical osmolarity
3 995 mOsm/L
pH
4.5-7.5
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
States of potassium deficiency when oral replacement is not feasible.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Individualize dosage. Guide dosage and rate of infusion by ECG and
serum electrolyte determinations.
The potassium deficit is calculated according to the following
formula:
mmol potassium = kg body weight x 0.2 x 2 x [4.5
–
current
serum potassium (mmol/l)]. (Body weight x 0.2 represents the
extracellular fluid volume.)
_Maximum daily dose _
Not more than 2
–
3 mmol/kg body weight/day.
_Maximum infusion rate _
Up to 20 mmol potassium per hour in adults (corresponding to 0.3 mmol
potassium/kg body
weight/hour).
_Children_
IV infusion up to 3 mEq/kg/day. Adjust volume of administered fluids
to body size.
METHOD OF ADMINISTRATION
Intravenously use. Use only diluted as an additive to infusion
solutions. The potassium concentration in
the infusion solution must not exceed 40 mmol/l. Suitable vehicle
solutions are e.g. 5% or 10% glucose
solutions, isotonic sodium chloride solution, Compound Sodium Lactate
solution, or complete
electrolyte solutions.
Do not infuse rapidly. Adjust rate of administration according to
tolerance. Use of the largest peripheral
vein and a small bore needle is recommended.
In addition to ECG effects, vein irritation may result when a
potassium concentration greater than 40
mEq/l is infused.
Concentrated potassium solutions are for IV admixtures only; do not
use undiluted. Direct injection
may b