SODIUM CHLORIDE 0.9 % AND GLUCOSE 5 % SOLUTION FOR INFUSION BAXTER

País: Israel

Idioma: anglès

Font: Ministry of Health

ingredients actius:

GLUCOSE AS MONOHYDRATE; SODIUM CHLORIDE

Disponible des:

TEVA ISRAEL LTD

Codi ATC:

B05BB02

formulario farmacéutico:

SOLUTION FOR INFUSION

Composición:

GLUCOSE AS MONOHYDRATE 5 %W/V; SODIUM CHLORIDE 0.9 %W/V

Vía de administración:

I.V

tipo de receta:

Required

Fabricat per:

BIEFFE MEDITAL S.A., SPAIN

Área terapéutica:

ELECTROLYTES WITH CARBOHYDRATES

indicaciones terapéuticas:

Sodium Chloride 0.9 % And Glucose 5 % Solution For Infusion Baxter is indicated as a source of water, electrolytes and/or calories.

Data d'autorització:

2020-03-24

Fitxa tècnica

1.
NAME OF THE MEDICINAL PRODUCT
Sodium chloride 0.9% and Glucose 5%
Solution for infusion Baxter
2.
QUALITATIVE AND QUANTITATIVE
COMPOSITION
Sodium Chloride:
9.0 g/l (0.9% w/v)
Glucose (as monohydrate):
50.0 g/l (5.0% w/v)
Each ml contains 50 mg glucose (as monohydrate) and
9.0 mg sodium chloride.
Mmol/l:
Na
+
: 154
Cl
-
:154
Meq/l:
Na
+
: 154
Cl
-
:154
Nutritional value: approximately 840 kJ/l (or 200 kcal/l)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion.
Clear solution, free from visible particles.
Osmolarity: 585 mosm/l (approx)
pH: 3.5 to 6.5
4.
CLINICAL PARTICULARS
4.1. Therapeutic indications
Sodium Chloride 0.9 % And Glucose 5 % Solution
For Infusion Baxter is indicated as a source of water,
electrolytes and/or calories.
4.2. Posology and method of administration
_Adults_
The dose is adjusted according to individual
requirements of fluid, electrolyte and energy. Thus the
patient`s age, weight, clinical and biological (acid-base
balance) conditions and concomitant therapy should be
taken into account.
Maximum daily dose
40 ml/kg body weight (BW) per day, corresponding to
2 g glucose/kg BW per day and 6 mmol of sodium /kg BW
per day.
Maximum Infusion rate:
5 ml/kg BW per hour, corresponding to 0.25 g glucose/kg
BW per hour. Partial coverage of energy requirements,
i. e. substitution of the obligatory daily glucose
requirements, is only possible with the maximum dose
stated above.
_Pediatric patients_
The dose is adjusted according to the individual
requirements of fluid, electrolytes and energy. Thus the
patients age, weight, clinical and biological (acid-base
balance) conditions and concomitant therapy should be
taken into account.
When administering this solution the total daily fluid and
glucose requirements should be taken into account.
_Elderly patients_
Basically the same dosage as for adults applies, but
caution should be exercised in patients suffering from
further diseases like cardiac insufficiency or renal
insufficiency that may frequently be assoc