SODIUM CHLORIDE 0.33% AND GLUCOSE 5% BAXTER

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

GLUCOSE MONOHYDRATE; SODIUM CHLORIDE

Available from:

BAXTER HEALTHCARE DISTRIBUTION LTD., ISRAEL

ATC code:

B05BB02

Pharmaceutical form:

SOLUTION FOR INFUSION

Composition:

GLUCOSE MONOHYDRATE 5.5 %W/V; SODIUM CHLORIDE 0.33 %W/V

Administration route:

I.V

Prescription type:

Required

Manufactured by:

BIEFFE MEDITAL S.A., SPAIN

Therapeutic area:

ELECTROLYTES WITH CARBOHYDRATES

Therapeutic indications:

A source of water, electrolytes and calories

Authorization date:

2023-02-19

Patient Information leaflet

1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Sodium chloride 0.33% and Glucose 5% Baxter.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Glucose (as monohydrate)
50 g/L
Sodium chloride
3.3 g/L
Each mL contains 50 mg glucose (as monohydrate) and 3.3 mg sodium
chloride.
mmol/L:
Na
+
: 56
Cl
-
: 56
390 mOsm/L (approx.)
pH: 3.5-6.5
Nutritional value: approximately 840 KJ/L (200 Kcal/L).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for infusion.
Clear solution.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
A SOURCE OF WATER, ELECTROLYTES AND CALORIES.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The choice of the specific sodium chloride and glucose concentration,
dosage, volume, duration
and rate of administration depend on the age, weight, clinical
condition of the patient and
concomitant therapy. These should be determined by a physician. For
patients with electrolyte
and glucose abnormalities and for pediatric patients, consult a
physician experienced in
intravenous fluid therapy.
Fluid balance, serum glucose, serum sodium and other electrolytes
should be monitored before
and during administration, especially in patients with increased
non-osmotic vasopressin release
(syndrome of inappropriate antidiuretic hormone secretion, SIADH) and
in patients co-medicated
with vasopressin agonists due to the risk of hyponatremia.
Monitoring of serum sodium is particularly important when
administering physiologically hypotonic
solutions. Sodium chloride 0.33% and Glucose 5% Baxter may become
extremely hypotonic after
administration due to glucose metabolization in the body (see sections
4.4, 4.5 and 4.8).
2 of 13
Rapid correction of hyponatremia and hypernatremia is potentially
dangerous (risk of serious
neurologic complications). Electrolyte supplementation may be
indicated according to the clinical
needs of the patient.
_Adults, older patients and adolescents (age 12 years and over): _
_ _
The recommended dosage is: 500 mL to 3 liters every 24 hours

Summary of Product characteristics

1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Sodium chloride 0.33% and Glucose 5% Baxter.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Glucose (as monohydrate)
50 g/L
Sodium chloride
3.3 g/L
Each mL contains 50 mg glucose (as monohydrate) and 3.3 mg sodium
chloride.
mmol/L:
Na
+
: 56
Cl
-
: 56
390 mOsm/L (approx.)
pH: 3.5-6.5
Nutritional value: approximately 840 KJ/L (200 Kcal/L).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for infusion.
Clear solution.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
A source of water, electrolytes and calories.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The choice of the specific sodium chloride and glucose concentration,
dosage, volume, duration
and rate of administration depend on the age, weight, clinical
condition of the patient and
concomitant therapy. These should be determined by a physician. For
patients with electrolyte
and glucose abnormalities and for pediatric patients, consult a
physician experienced in
intravenous fluid therapy.
Fluid balance, serum glucose, serum sodium and other electrolytes
should be monitored before
and during administration, especially in patients with increased
non-osmotic vasopressin release
(syndrome of inappropriate antidiuretic hormone secretion, SIADH) and
in patients co-medicated
with vasopressin agonists due to the risk of hyponatremia.
Monitoring of serum sodium is particularly important when
administering physiologically hypotonic
solutions. Sodium chloride 0.33% and Glucose 5% Baxter may become
extremely hypotonic after
administration due to glucose metabolization in the body (see sections
4.4, 4.5 and 4.8).
2 of 13
Rapid correction of hyponatremia and hypernatremia is potentially
dangerous (risk of serious
neurologic complications). Electrolyte supplementation may be
indicated according to the clinical
needs of the patient.
_Adults, older patients and adolescents (age 12 years and over): _
_ _
The recommended dosage is: 500 mL to 3 liters every 24 hours