RINGER LACTATE (HARTMANNS SOLUTION) 500 Millilitre Solution for Infusion

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

SODIUM CHLORIDE POTASSIUM CHLORIDE CALCIUM CHLORIDE DIHYDRATE LACTIC ACID SODIUM HYDROXIDE

Tillgänglig från:

Bieffe Medital SpA

INN (International namn):

SODIUM CHLORIDE POTASSIUM CHLORIDE CALCIUM CHLORIDE DIHYDRATE LACTIC ACID SODIUM HYDROXIDE

Dos:

500 Millilitre

Läkemedelsform:

Solution for Infusion

Bemyndigande status:

Withdrawn

Tillstånd datum:

2007-02-06

Produktens egenskaper

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Compound Sodium Lactate (Hartmann’s Solution) Solution
for Intravenous Infusion (500 ml)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Solution for infusion.
Colourless, clear solution.
4 CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS
-
Electrolyte replenisher.
-
Maintenance or replacement of deficits in extracellular fluid. 
-
Hypervolaemia.
-
Acid-base balance regulation.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
Intravenous infusion according to the clinical situation and
the intake output balance. 500ml to 3000 ml per 24 hours.
4.3 CONTRAINDICATIONS
-
Cardiac insufficiency.
-
Hypovolaemia, hypernatraemia, hyperkalaemia and hypercalcemia.
-
Oedema and cirrhotic ascites.
-
Lactic acidosis, alkalosis.
1000 ml of solution contains:
Active Ingredients:
mmol
Sodium Chloride Ph. Eur.
6.00 g
Sodium
131
Potassium Chloride Ph. Eur.
0.40 g
Potassium
5
Calcium Chloride Ph. Eur.
0.27 g
Calcium
2
Lactic Acid Ph. Eur.
2.60 g*
Chloride 
111
Sodium Hydroxide Dihydrate Ph. Eur.
1.17 g*
Lactate
29
*Such quantities correspond to Anhydrous Sodium Lactate 3.25 g
derived from Sodium Lactate 60%
Total osmolarity
279.56
mOsm/1
For excipients, see 6.1
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Issued 25/10/2005_
_CRN 2016094_
_page number: 1_
4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Prior to use, check the condition of the bag. Do not use damaged
bags.
-
Verify that the solution is clear and
free of visible particles.
-
Check flow regulation.
Prior to administration the solution should be warmed to
approximately body temperature and after removal of the 
overwrap the bag should be squeezed to check for leaks.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION 
In prepa