Compound Sodium Lactate Solution for Infusion BP

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Sodium chloride; Potassium chloride; Calcium chloride dihydrate; Sodium lactate

Available from:

Baxter Healthcare Limited

ATC code:

B05BB; B05BB01

INN (International Name):

Sodium chloride; Potassium chloride; Calcium chloride dihydrate; Sodium lactate

Dosage:

0 percent volume/volume

Pharmaceutical form:

Solution for infusion

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Solutions affecting the electrolyte balance; electrolytes

Authorization status:

Marketed

Authorization date:

2003-04-17

Patient Information leaflet

EUROPEAN LABELLING CENTRE
ARTWORK APPROVAL
1st DRAFT
DATE 22 April 2015
RA TO APPROVE LAYOUT
AND FORMAT
PLANT APPROVAL
HALLE ONLY
Country
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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 antibiotic).
�

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Compound Sodium Lactate Solution for Infusion BP.
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 a 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 (Ringer Lactate solution) is used in
the following indications:
o
Restoration of extracellular fluid and electrolytes balances or
replacement of extracellular fluid loss where
isotonic concentrations of electrolytes are sufficient
o
Short term volume replacement (alone or in association with colloid)
in case of hypovolaemia or hypotension.
o
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 (Ringer 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
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