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

Maa: Israel

Kieli: englanti

Lähde: Ministry of Health

Aktiivinen ainesosa:

GLUCOSE AS MONOHYDRATE; SODIUM CHLORIDE

Saatavilla:

TEVA ISRAEL LTD

ATC-koodi:

B05BB02

Lääkemuoto:

SOLUTION FOR INFUSION

Koostumus:

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

Antoreitti:

I.V

Prescription tyyppi:

Required

Valmistaja:

BAXTER HEALTHCARE LTD. U.K.

Terapeuttinen alue:

ELECTROLYTES WITH CARBOHYDRATES

Käyttöaiheet:

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

Valtuutus päivämäärä:

2020-03-24

Valmisteyhteenveto

Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
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.
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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 insu