Država: Izrael
Jezik: engleski
Izvor: Ministry of Health
CALCIUM CHLORIDE DIHYDRATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
RAZ PHARMACEUTICS LTD, ISRAEL
B05BB01
SOLUTION FOR INFUSION
CALCIUM CHLORIDE DIHYDRATE 0.27 MG/ML; POTASSIUM CHLORIDE 0.4 MG/ML; SODIUM CHLORIDE 6 MG/ML; SODIUM LACTATE 3.2 MG/ML
I.V
Required
S.A.L.F. S.P.A. LABORATORIO FARMACOLOGICO, ITALY
ELECTROLYTES
Source of water and electrolytes. Regulation or maintenance of metabolic acidosis ( except lactic acidosis).
2020-02-23
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 Pročitajte cijeli dokument