RINGER LACTATE SOLUTION FRESENIUS -FREEFLEX

Страна: Израиль

Язык: английский

Источник: Ministry of Health

Активный ингредиент:

CALCIUM CHLORIDE DIHYDRATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE

Доступна с:

NEOPHARM (ISRAEL) 1996 LTD

код АТС:

B05BB01

Фармацевтическая форма:

SOLUTION FOR INFUSION

состав:

SODIUM LACTATE 3.17 G / 1 L; CALCIUM CHLORIDE DIHYDRATE 0.27 G / 1 L; POTASSIUM CHLORIDE 0.4 G / 1 L; SODIUM CHLORIDE 6 G / 1 L

Администрация маршрут:

I.V

Тип рецепта:

Required

Производитель:

FRESENIUS KABI DEUCTSCHLAND GmbH,GERMANY

Терапевтические области:

ELECTROLYTES

Терапевтические показания :

Source of water and electrolytes. Regulation or maintenance of metabolic acidosis (except lactic acidosis).

Дата Авторизация:

2023-05-30

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCTS
RINGER LACTATE SOLUTION FRESENIUS - FREEFLEX
RINGER LACTATE SOLUTION FRESENIUS - KABIPAC
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium Chloride:
6.00 g/l
Sodium Lactate:
3.17 g/l
Potassium Chloride:
0.40 g/l
Calcium Chloride Dihydrate:
0.27 g/l
Na
+
131 mmol/l
K
+
5.36 mmol/l
Ca
+2
1.84 mmol/l
Cl
-
112 mmol/l
Lactate
-
28.3 mmol/l
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for I.V infusion.
Clear and colourless solution
Theoretical osmolarity: 278 mOsm/l
pH: 5.0
–
7.0
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
-
Source of water and electrolytes.
-
Regulation or maintenance of metabolic acidosis (except lactic
acidosis).
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults, the elderly and children: _
THE DOSAGE DEPENDS ON THE AGE, WEIGHT, CLINICAL AND BIOLOGICAL
(ACID-BASE BALANCE) CONDITIONS
OF THE PATIENT, AND CONCOMITANT THERAPY.
_Recommended dosage: _
The amount of Ringer Lactate solution Fresenius needed to restore
normal blood volume is 3 to
5 times the volume of lost blood.
The recommended dosage is:
-
for adults: 500 ml to 3 L/24h
-
for babies and children: 20 ml to 100 ml/kg/24 h
_Administration rate: _
The infusion rate is usually 40 ml/kg/24h in adults.
In pediatric patients the infusion rate is 5 ml/kg/h on average but
the value varies with age: 6-8
ml/kg/h for infants, 4-6 ml/kg/h for toddlers, and 2-4 ml/kg/h for
schoolchildren. In children with
burns, the dose is on average 3.4 ml/kg/percent burn at 24 h post-burn
and 6.3 ml/kg/percent
burn at 48 h. In severely head-injured children the dose is on average
2850 ml/m².
Infusion rate and total volume can be higher in surgery or in case of
need.
Note:
-
infants and toddlers: age ranges from about 28 days to 23 months (a
toddler is an infant who
can walk)
-
children and schoolchildren: age ranges from about 2 years to 11
years.
Administration:
The administration is performed by intravenous route using sterile and
non-pyrog