POTASSIUM CHLORIDE 0.15 % WV AND SODIUM CHLORIDE 0.9% WV

Страна: Ізраїль

мова: англійська

Джерело: Ministry of Health

Активний інгредієнт:

POTASSIUM CHLORIDE; SODIUM CHLORIDE

Доступна з:

LAPIDOT MEDICAL IMPORT AND MARKETING LTD

Код атс:

A12BA51

Фармацевтична форма:

SOLUTION FOR INFUSION

Склад:

POTASSIUM CHLORIDE 1.5 MG / 1 ML; SODIUM CHLORIDE 9 MG / 1 ML

Адміністрація маршрут:

I.V

Тип рецепту:

Required

Виробник:

B.BRAUN MELSUNGEN AG, GERMANY

Терапевтична области:

POTASSIUM CHLORIDE, COMBINATIONS

Терапевтичні свідчення:

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.

Дата Авторизація:

2017-05-08

Характеристики продукта

This leaflet format has been determined by the Ministry of Health and
the content thereof has been checked
and approved on April 2017
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:
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.
Adequate urine flow must be ensured.
_Adults: _
The following recommendations are general guidelines on potassium.
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 strengths should be considered as well.
_Paediatric population _
The