SODIUM CHLORIDE 0.9% IMUNA

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

SODIUM CHLORIDE

Available from:

A.L. MEDI-MARKET LTD.

ATC code:

B05CB01

Pharmaceutical form:

SOLUTION FOR INFUSION

Composition:

SODIUM CHLORIDE 9 MG/ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

IMUNA PHARM A.S, SLOVAK REPUBLIC

Therapeutic area:

SODIUM CHLORIDE

Therapeutic indications:

Short- term intravascular volume substitution. Hypotonic dehydration or isotonic dehydration. Vehicle solution for supplementary medication.Fluid and electrolyte replacement, hypochloremic alkalosis and chloride losses.

Authorization date:

2021-06-20

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Sodium chloride 0.9% Imuna
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1000 mL solution for infusion contain:
Sodium chloride
9.0 g
_Electrolytes_
Sodium
154 mmol/L
Chloride
154 mmol/L
For the full list of excipients, see section 6.1.
2.
PHARMACEUTICAL FORM
Solution for infusion
Clear, colourless, solution free of mechanical impurities
Theoretical osmolarity 308 mOsm/L
Titration acidity (pH 7.4) < 0.3 mmol/L
pH 4.5 – 7.0
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Short- term intravascular volume substitution.
Hypotonic dehydration or isotonic dehydration.
Vehicle solution for supplementary medication.
Fluid and electrolyte replacement, hypochloremic alkalosis and
chloride losses.
4.2 Posology and method of administration
Dosage
The dosage guideline for adults:
Average dose: 1000 ml per day.
Flow rate: Up to 180 drops/min, corresponding to 550 ml/h.
Maximum recommended dosage: 40 ml per KG body weight and per day, not
more
than 2000 ml per day.
Dosage is dependent upon the age, weight and clinical condition of the
patient as
well as laboratory determination.
Route of administration
I.V.
4.3 Contraindications
Sodium chloride 0.9 % Imuna may not be used in the event of
-
hyperhydration
-
severe hypernatraemia.
-
severe hyperchloraemia
4.4 Special warnings and precautions for use
Sodium chloride 0.9 % Imuna should be used with caution only in
- hypokalaemia
- hypernatraemia
- hyperchloraemia
- Conditions requiring a restricted intake of sodium, such as heart
failure, generalised
oedema, pulmonary oedema, hypertension, eclampsia and severe renal
failure.
In order to prevent osmotic demyelination syndrome from developing,
serum sodium
concentrations should not exceed 9 mmol/L/day. As a general
recommendation, a
rate of correction of 4 to 6 mmol/L/day is considered appropriate in
the majority of
cases, depending on the patient's conditions and associated risk
factors.
Clinical monitoring should include checks of the serum ionogram, water
bala