Hartmann's Solution Compound Sodium Lactate Intravenous Infusion BP

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Sodium chloride; Calcium chloride dihydrate; Potassium chloride; Sodium lactate solution 60%

Available from:

Laboratoire AGUETTANT

ATC code:

B05BB; B05BB01

INN (International Name):

Sodium chloride; Calcium chloride dihydrate; Potassium chloride; Sodium lactate solution 60%

Pharmaceutical form:

Solution for infusion

Therapeutic area:

Solutions affecting the electrolyte balance; electrolytes

Authorization status:

Not marketed

Authorization date:

2007-05-18

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER HARTMANN’S SOLUTION
(Compound Sodium Lactate Intravenous Infusion B.P.)
SODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE DIHYDRATE,
SODIUM LACTATE 60%
READ ALL OF THIS LEAFLET CAREFULLY BEFORE BEING GIVEN 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 Hartmann’s solution
is and what it is used for
2.
What you need to know before you are given Hartmann’s solution
3.
How Hartmann’s solution is given
4.
Possible side effects
5.
How to store Hartmann’s solution
6.
Contents of the pack and other information
1. WHAT HARTMANN’S SOLUTION IS AND WHAT IT IS USED FOR
Hartmann’s solution
is a clear solution of sodium chloride, potassium chloride, calcium
chloride
dihydrate and sodium lactate 60% in water. The solution is stored in a
sealed plastic container.
Sodium, potassium, calcium and chloride ions are important for
maintaining the correct balance of fluid
in and around the body’s cells and tissues and are involved in nerve
signals and muscle contractions.
Hartmann’s solution may be given for a variety of reasons:
- to help restore fluid levels and the normal salt balance
- to correct for low blood pressure or decreased blood volume
- to treat metabolic acidosis, a condition where there is increased
acid in the body.
The solution may be given alone but may be given with other medicines
added.
You will be given Hartmann’s solution in hospital by a doctor or
nurse.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN HARTMANN’S SOLUTION
YOU MUST NOT BE GIVEN HARTMANN’S SOLUTION IF YOU HAVE:
•
increased levels of
SODIUM
,
POTASSIUM
,
CALCIUM
or
CHLORIDE
in the blood. These conditions can
be detected in blood tests
•
severe
KIDNEY DISEASE
and you are pass

Summary of Product characteristics

Health Products Regulatory Authority
17 July 2023
CRN00DKNQ
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Hartmann's Solution Compound Sodium Lactate Intravenous Infusion BP
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1000 ml contains:
​
Sodium Chloride
​
6.00 g
​
Potassium Chloride
​
​
0.40 g​
​
Calcium Chloride dihydrate
​
​
0.27 g
​
Sodium lactate 60%
​
​
5.16 g
ionic formula
Sodium (Na
+
)
131 mmol/l
Potassium (K
+
)
5 mmol/l
Calcium (Ca
++
)
2 mmol/l
Chloride (Cl
-
)
111 mmol/l
Bicarbonate (as Lactate)
29 mmol/l
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
Clear colourless solution.
Osmolarity: 278 mOsm/l (approx.)
pH: 5.0 – 7.0
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ringer Lactate solution is indicated for:
_-_ Restoration of extracellular fluid and electrolyte 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 hypovolemia 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
_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 litres / 24h
- for paediatric patients: 20 ml to 100 ml/kg/24 h.
Special clinical conditions, such as massive blood loss, burns,
surgical drains, diarrhea, require additional adjustments of the
necessary IV fluid volume.
Health Products Regulatory Authority
17 July 2023
CRN00DKNQ
Page 2 of 7
Fluid balance, serum electrolytes and acid-base balance may need to be
monitored before and during administration, with
particular attention to serum sodium in patients with increased
non-osmotic vasopressin re