SODIUM CHLORIDE

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

SODIUM CHLORIDE

Available from:

Bieffe Medital SpA

Dosage:

0.9 %w/v

Pharmaceutical form:

Solution for Infusion

Authorization date:

1996-06-10

Summary of Product characteristics

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sodium Chloride Solution for Infusion 0.9% w/v
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1000ml of solution contains:
Sodium Chloride
9.00g
EQUIVALENT TO:
Sodium
approximately
150mmol/l
Chloride
approximately
150mmol/l
For full list of excipients, see section 6.1.
Osmolarity: 308 mOsm/L Isotonic
3 PHARMACEUTICAL FORM
Solution for Infusion.
Clear, colourless, sterile, non-pyrogenic solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Electrolyte replacement
o
Maintenance or replacement of deficits of extracellular fluid(Osmolarity – 308 mOsm/L)
o
Vehicle for drug admixtures
o
Hypovolemia
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adult: intravenous infusion, according to the clinical situation and intake-output balance (500 to 3000 ml/24h).
4.3 CONTRAINDICATIONS
o
Hypervolemia and hypernatremia
o
Cardiac insufficiency
o
Oedema and cirrhotic ascitis
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 10/01/2008_
_CRN 2045051_
_page number: 1_
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Sodium Chloride must be used cautiously in patients with renal impairment or insufficiency.
Use an aseptic method to set up infusion (disinfection of stopper and injection site, use a new sterile infusion set).
Check flow regulation.
Use only if solution is clear and free from particles.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
Preparing drug admixture, take care of pH value (acid) and of sodium and chloride ions.
Classical examples of chemical incompatibilities: hydrocortisone, tetracyclines, cephalothin, and amphotericin.
Before mixing, check compatibility.
Before administration, check limpidity and colour of solutions.
Solutions