Sodium lactate compound infusion 1litre Viaflo bags

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sodium chloride; Potassium chloride; Calcium chloride; Sodium lactate

Available from:

Baxter Healthcare Ltd

INN (International Name):

Sodium chloride; Potassium chloride; Calcium chloride; Sodium lactate

Dosage:

6mg/1ml ; 400microgram/1ml ; 270microgram/1ml ; 3.17mg/1ml

Pharmaceutical form:

Infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 09020201

Summary of Product characteristics

OBJECT 1
COMPOUND SODIUM LACTATE SOLUTION FOR INFUSION
BP
Summary of Product Characteristics Updated 11-May-2017 | Baxter
Healthcare Ltd
1. Name of the medicinal product
Compound Sodium Lactate Solution for Infusion BP
(Synonyms: - Ringer Lactate Solution for Infusion
- Hartmann's Solution for Infusion)
2. Qualitative and quantitative composition
Sodium Chloride:
Potassium Chloride:
Calcium Chloride dihydrate:
Sodium Lactate:
6.00 g/l
0.40 g/l
0.27 g/l
3.20 g/l
mmol/l
mEq/l
Na+
131
131
K+
5
5
Ca++
2
4
Cl-
111
111
C
3
H
5
O
3
-
(lactate)
29
29
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Solution for infusion.
Clear solution, free from visible particles.
278 mOsm/l (approx.)
pH: 5.0 – 7.0
4. Clinical particulars
4.1 Therapeutic indications
Compound Sodium Lactate solution is used in the following indications:
- Restoration of extracellular fluid and electrolytes balances or
replacement of extracellular fluid loss
where isotonic concentrations of electrolytes are sufficient
- Short term volume replacement (alone or in association with colloid)
in case of hypovolaemia or
hypotension.
- Regulation or maintenance of metabolic acidosis balance and/or
treatment of mild to moderate
metabolic acidosis (except lactic acidosis)
4.2 Posology and method of administration
Posology
_Adults, the Elderly and Children: _
Dosage, rate, and duration of administration are to be individualized
and depend upon the indication for
use, the patient's age, weight, clinical condition, and concomitant
treatment, and on the patient's clinical
and laboratory response to treatment.
_Recommended dosage:_
The amount of Compound Sodium Lactate solution 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 infants, toddlers and children : 20 ml to 100 ml/kg/24 h
_Administration rate:_
The infusion rate is usually 40 mL/kg/24h in adults.
_Use in paediatric patients_
The safety and efficacy of Compound Sodium Lactate solution in
ch