SODIUM CHLORIDE 0.9% - FRESENIUS

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

SODIUM CHLORIDE

Available from:

NEOPHARM (ISRAEL) 1996 LTD

ATC code:

B05XA03

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

SODIUM CHLORIDE 9 MG/ML

Administration route:

S.C, I.M, EXTERNAL, I.V

Prescription type:

Required

Manufactured by:

LABESFAL - LABORATORIOS ALMIRO S.A, FRESENIUS KABI GROUP, PORTUGAL

Therapeutic area:

SODIUM CHLORIDE

Therapeutic indications:

Short- term intravascular volume substitution. Hypotonic dehydration or isotonic dehydration. Vehicle solution for supplementary medication Flued and electrolyte replacement, hypochloremic alkalosis and chloride losses, externally for wound irrigation and moistening of wound tamponades dressing

Authorization date:

2021-02-28

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
SODIUM CHLORIDE 0.9% - FRESENIUS
Solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Sodium chloride 9 mg
Water for injection to 1 ml
Osmolarity 308 mOsmol/L.
3.
PHARMACEUTICAL FORM
Solution for injection
Clear and colourless solution
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Vehicle or diluent for parenteral administration of medicines for
intravenous route.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Intravenous route.
The amount to be used will depend on the concentration wanted for the
administration of the medicine to be dissolved.
4.3 CONTRAINDICATIONS
Due to the indications of the product, contraindications depend on the
medicine to be dissolved.
In general, the administration of this product is contra-indicated in
the
following situations:
•
Hypernatremia
•
Hypercholeremia
•
Hypertonia
•
Cardiac insufficiency
•
Oedematous states in patients with cardiac, hepatic or renal disorders
•
Severe hypertension
•
Metabolic acidosis
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Once the container is opened the solution should be used immediately.
Do not use the solution if it is not clear and without precipitates.
Before adding the medicine to the ampoule compatibility between the
substance to be administered and sodium chloride should be checked.
Newborns, whether premature or not, can present too high sodium
levels due to immaturity of renal function. Therefore, in newborns,
whether premature or not, repeated injections of sodium chloride can
only be administered after sodium levels in blood have been
determined.
Sodium chloride should be used with precaution in patients with
hypertension, cardiac failure, pulmonary or peripheral oedema, renal
impairment, pre-eclampsia, hyperaldosteronism, cirrhosis and other
disorders of liver, hypervolaemia, urinary tract obstruction,
hypoproteinemia and other sicknesses and treatments (eg.
corticosteroids) associated to sodium retention.
4.5 INTERACTION WIT