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:

Maco Pharma (UK) Ltd

ATC code:

B05BB01

INN (International Name):

SODIUM CHLORIDE ; CALCIUM CHLORIDE DIHYDRATE ; POTASSIUM CHLORIDE ; SODIUM LACTATE SOLUTION 60%

Dosage:

6/0.27/0.4 Grams

Pharmaceutical form:

Solution for Infusion

Prescription type:

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

Therapeutic area:

electrolytes

Authorization status:

Marketed

Authorization date:

2007-05-18

Patient Information leaflet

NTS085G-10/2016
GB
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%
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 passing little or no urine
• suffered HEART FAILURE
• increased BLOOD VOLUME or FLUID RETENTION (water intoxication, or
excess
water content in the body)
• severe METABOLIC ACIDOSIS or LACTIC ACIDOSIS, when you have
increased acid
in the body
• METABOLIC ALKALOSIS, when you have less acid in the body than
normal
• severe LIVER DISEASE or cannot breakdown LACTATE
• SWELLING caused by fluid retention
• heart disease which is being treated with the medicine digitalis
• a requirement to take ADDITIONAL MEDICINES which may lead to
increased
potassium levels in the body, such as diuretics (water pills)
WARNINGS AND PRECAUTIONS
Talk to your doctor

Summary of Product characteristics

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 :
ionic formula
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.
Sodium Chloride
6.00g
Sodium (Na
+
)
131 mmol/l
Potassium Chloride
0.40g
Potassium (K
+
)
5 mmol/l
Calcium Chloride dihydrate
0.27g
Calcium (Ca
++
)
2 mmol/l
Sodium lactate 60%
5.16g
Chloride (Cl
-
)
111 mmol/l
Bicarbonate (as Lactate)
29 mmol/l
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