RINGER LACTATE S.A.L.F

Pajjiż: Iżrael

Lingwa: Ingliż

Sors: Ministry of Health

Ingredjent attiv:

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

Disponibbli minn:

RAZ PHARMACEUTICS LTD, ISRAEL

Kodiċi ATC:

B05BB01

Għamla farmaċewtika:

SOLUTION FOR INFUSION

Kompożizzjoni:

CALCIUM CHLORIDE DIHYDRATE 0.27 MG/ML; POTASSIUM CHLORIDE 0.4 MG/ML; SODIUM CHLORIDE 6 MG/ML; SODIUM LACTATE 3.2 MG/ML

Rotta amministrattiva:

I.V

Tip ta 'preskrizzjoni:

Required

Manifatturat minn:

S.A.L.F. S.P.A. LABORATORIO FARMACOLOGICO, ITALY

Żona terapewtika:

ELECTROLYTES

Indikazzjonijiet terapewtiċi:

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

Data ta 'l-awtorizzazzjoni:

2020-02-23

Karatteristiċi tal-prodott

SUMMARY OF PRODUCT CHARACTERISTICS
RINGER LACTATE S.A.L.F
1.
NAME OF THE MEDICINAL PRODUCT
RINGER LACTATE S.A.L.F
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml contain:
Sodium Chloride:
6.00 mg
Potassium Chloride:
0.4 mg
Calcium Chloride dihydrate:
0.27 mg
Sodium Lactate :
3.2 mg
Na+
K+
Ca++
Cl-
C
3
H
5
O
3
-
(lactate)
mEq/l
132
5
4
112
29
For the full list of excipients, see section 6.1
.
3.
PHARMACEUTICAL FORM
Solution for infusion.
Clear and colorless solution.
280 mOsm/l (approx.)
.
pH: 5.5 – 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 S.A.L.F 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 3Liters /24h
.
-
For babies and children: 20 ml to 100 mL / kg / 24h
.
_Administration rate:_
The infusion rate is usually 40 mL/kg/24h in adults.
In Pediatric patients, the infusion rate is 5 ml/kg/h in 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 school children: age ranges from about 2 years to 11
years
.
Administration:
The administration is performed by intravenous route using sterile and
non-pyrogenic equipment.
4.3.
CONTRAINDICATIONS
As for other calcium-contain