DEXTROSE 4.3 % AND 0.18 % SODIUM CHLORIDE VIOSER SOLUTION FOR INFUSION

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

DEXTROSE ANHYDROUS; SODIUM CHLORIDE

Available from:

ELDAN ELECTRONIC INSTRUMENTS CO LTD, ISRAEL

ATC code:

B05XA03

Pharmaceutical form:

SOLUTION FOR INFUSION

Composition:

DEXTROSE ANHYDROUS 4.3 %W/V; SODIUM CHLORIDE 0.18 %W/V

Administration route:

I.V

Prescription type:

Required

Manufactured by:

VIOSER S.A. PARENTERAL SOLUTIONS INDUSTRY, GREECE

Therapeutic area:

SODIUM CHLORIDE

Therapeutic indications:

DEXTROSE 4.3 % AND 0.18 % SODIUM CHLORIDE VIOSER solution is used in the following indications: Dehydration treatment due to a moderated loss of sodium and chloride (vomiting, diarrhoea, renal disorders, over use ofdiuretics) in cases where a source of energy is required (particularly starvation). Paediatric Population: This product should only be used in paediatric specialist settings (such as renal, hepatic and cardiac units, high dependency units and intensive care units) for intravenous fluid therapy requiring the use of 0.18% sodium chloride and4% glucose to maintain fluid and electrolyte balance.

Authorization date:

2022-12-18

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
DEXTROSE 4.3 % AND 0.18 % SODIUM CHLORIDE VIOSER, SOLUTION FOR
INFUSION
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1000ml solution contains:
Sodium Chloride: 1.8 g
Dextrose anhydrous: 43.0 g
Each ml contains 1.8 mg sodium chloride and 43 mg dextrose anhydrous.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
Clear and colorless aqueous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Dextrose 4.3 % and 0.18 % sodium chloride Vioser
solution is used in the following
indications:
Dehydration treatment due to a moderated loss of sodium and chloride
(vomiting,
diarrhoea, renal disorders, overuse of diuretics) in cases where a
source of energy is
required (particularly starvation).
Paediatric Population:
This product should only be used in paediatric specialist settings
(such as renal,
hepatic and cardiac units, high dependency units and intensive care
units) for
intravenous fluid therapy requiring the use of dextrose 4.3 % and 0.18
% sodium
chloride to maintain fluid and electrolyte balance.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The choice of the specific sodium chloride and dextrose (glucose)
concentration,
dosage, volume, rate and duration of administration depends on the
age, weight,
clinical condition of the patient and concomitant therapy. It should
be determined by a
physician. For patients with electrolyte and
glucose abnormalities and for paediatric
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
agonist drugs due
to the risk of hyponatraemia. Monitoring of serum sodium is
particularly important for
physiologically hypotonic fluids. Dextrose 4.3 % w/v and so