SODIUM CHLORIDE 0.45 % AND GLUCOSE 5.0 % SOUTION FOR INFUSION BAXTER

Χώρα: Ισραήλ

Γλώσσα: Αγγλικά

Πηγή: Ministry of Health

Δραστική ουσία:

GLUCOSE AS MONOHYDRATE; SODIUM CHLORIDE

Διαθέσιμο από:

TEVA ISRAEL LTD

Φαρμακολογική κατηγορία (ATC):

B05BB02

Φαρμακοτεχνική μορφή:

SOLUTION FOR INFUSION

Σύνθεση:

GLUCOSE AS MONOHYDRATE 5 %W/V; SODIUM CHLORIDE 0.45 %W/V

Οδός χορήγησης:

I.V

Τρόπος διάθεσης:

Required

Κατασκευάζεται από:

BAXTER HEALTHCARE LTD. U.K.

Θεραπευτική περιοχή:

ELECTROLYTES WITH CARBOHYDRATES

Θεραπευτικές ενδείξεις:

Sodium Chloride 0.45 % And Glucose 5 % Soution For Infusion Baxter is indicated to provide electrolytes and calories and as a source of water for hydration

Ημερομηνία της άδειας:

2020-04-02

Αρχείο Π.Χ.Π.

SA-30-02-449
1.
NAME OF THE MEDICINAL PRODUCT
Sodium Chloride 0.45 % and Glucose 5.0 % Solution for
Infusion Baxter
2.
QUALITATIVE AND QUANTITATIVE
COMPOSITION
Sodium Chloride:
4.5 g/l (0.45 % w/v)
Glucose (as monohydrate):
50.00 g/l (5.0 % w/v)
Each ml contains 50 mg glucose (as monohydrate) and
4.5 mg sodium chloride.
mmol/l:
Na+: 77
Cl-:77
mEq/l:
Na+: 77
Cl-:77
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 432 mOsm/l (approx)
pH: 3.5 to 6.5
4.
CLINICAL PARTICULARS
4.1 Therapeutic indications
Sodium Chloride 0.45 % And Glucose 5 % Solution for
Infusion Baxter is indicated to provide electrolytes and
calories and as a source of water for hydration.
4.2 Posology and method of administration
As directed by a physician. Dosage is dependent upon
the age, weight, and clinical condition of the patient as
well as laboratory determinations.
The dosage and constant infusion rate of intravenous
Sodium Chloride 0.45 % and Glucose 5.0 % Solution
for Infusion Baxter must be selected with caution in
pediatric patients, particularly neonates and low weight
infants, because of the increased risk of hyperglycemia/
hypoglycemia.
The infusion rate and volume depend on the age,
weight, clinical and metabolic conditions of the patient,
concomitant therapy and should be determined by the
consulting physician experienced in pediatric intravenous
fluid therapy.
Precautions to be taken before manipulating or
administering the product
Parenteral drug products should be inspected visually
for particulate matter and discoloration prior to
administration whenever solution and container permit.
Do not administer unless solution is clear, and seal is
intact.
Administer immediately following the insertion of
infusion set. Do not remove unit from overwrap until
ready for use. The inner bag maintains the sterility of the
product.
All injections in plastic containers are intended for
i