Compound Sodium Lactate Intravenous Infusion

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CALCIUM CHLORIDE, DIHYDRATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, SODIUM LACTATE

Available from:

Baxter Healthcare Limited

ATC code:

B05BB01

INN (International Name):

CALCIUM CHLORIDE, DIHYDRATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, SODIUM LACTATE

Pharmaceutical form:

SOLUTION FOR INFUSION

Composition:

CALCIUM CHLORIDE DIHYDRATE 0.27 gram(s)/litre ; POTASSIUM CHLORIDE 0.4 gram(s)/litre ; SODIUM CHLORIDE 6 gram(s)/litre ; SODIUM LACTATE 3.2 gram(s)/litre

Prescription type:

POM

Therapeutic area:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Authorization status:

Authorised

Authorization date:

2004-10-07

Patient Information leaflet

Page 1 of 12
PACKAGE LEAFLET: INFORMATION FOR THE USER
COMPOUND SODIUM LACTATE SOLUTION FOR INFUSION BP
Active substances: sodium chloride, potassium chloride, calcium
chloride dihydrate and sodium
lactate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or nurse.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Compound Sodium Lactate Infusion
is and what it is used for
2.
What you need to know before you are given Compound Sodium Lactate
Infusion
3.
How you will be given Compound Sodium Lactate Infusion
4.
Possible side effects
5.
How to store Compound Sodium Lactate Infusion
6.
Contents of the pack and other information
This medicine is called "Compound Sodium Lactate Solution for Infusion
BP”, but will be referred
to as "Compound Sodium Lactate Infusion” throughout the document.
1.
WHAT COMPOUND SODIUM LACTATE INFUSION IS AND WHAT IT IS USED
FOR
Compound Sodium Lactate Infusion is a solution of the following
substances in water:
-
sodium chloride
-
potassium chloride
-
calcium chloride dihydrate
-
sodium lactate.
Sodium, potassium, calcium, chloride and lactate are chemical
substances (electrolytes) found in the
blood.
Compound Sodium Lactate Infusion is used:
-
to treat a loss of body water and chemicals (e.g. by heavy sweating,
kidney disorders)
-
to treat you, if the volume of blood in your blood vessels is low
(hypovolaemia) or if you have
low blood pressure (hypotension)
-
in metabolic acidosis (when the blood becomes too acidic).
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN COMPOUND SODIUM
LACTATE INFUSION
YOU MUST NOT RECEIVE COMPOUND SODIUM LACTATE INFUSION IF YOU ARE
SUFFERING FROM ANY OF
THE FOLLOWING CONDITIONS
-
if you’re a newborn (less than 28 days old) receiving ceftriaxone
(an antibioti

Summary of Product characteristics

Page
1
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13
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:
6.00 g/l
Potassium Chloride:
0.40 g/l
Calcium Chloride dihydrate:
0.27 g/l
Sodium Lactate:
3.20 g/l
Na+
K+
Ca++
Cl-
C
3
H
5
O
3
-
(lactate)
mmol/l
131
5
2
111
29
mEq/l
131
5
4
111
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: _
Fluid balance, serum electrolytes and acid-base balance should be
monitored before and during
administration, with particular attention to serum sodium in patients
with increased non-osmotic
vasopressin release (syndrome of inappropriate antidiuretic hormone
secretion, SIADH) and in
patients co-medicated with vasopressin agonist drugs, due to the risk
of hospital acquired
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13
hyponatraemia (see sections 4.4, 4.5 and 4.8). Monitoring of serum
sodium is particularly important
for hypotonic fluids.
Compound Sodium Lactate solution has a tonicity of 278 mOsm/l
(approx.)
The infusion rate and volume depend on the age, weight, clinical
condition (e.g. burns, surgery,
head-injury, infections), and concomitant therapy should be determined
by the consulting physician
experienced in intravenous flu