GLUCOSE 5 % INTRAVENOUS INFUSION BP

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

GLUCOSE MONOHYDRATE

Available from:

TEVA MEDICAL MARKETING LTD.

ATC code:

B05CX01

Pharmaceutical form:

SOLUTION FOR INFUSION

Composition:

GLUCOSE MONOHYDRATE 5.5 %W/V

Administration route:

I.V

Prescription type:

Required

Manufactured by:

BAXTER HEALTHCARE LTD.UK

Therapeutic group:

GLUCOSE

Therapeutic area:

GLUCOSE

Therapeutic indications:

For the treatment of carbohydrate and fluid depletion. Glucose 5 % is also used as a vehicle and diluent for compatible medicinal products for parenteral administration.

Authorization date:

2014-03-31

Patient Information leaflet

לע העדוה לע העדוה לע העדוה
( הרמחה
( הרמחה
( הרמחה עדימ עדימ עדימ
ל ןולעב )תוחיטב
ל ןולעב )תוחיטב
ל ןולעב )תוחיטב
אפור
אפור
אפור
ןכדועמ(
ןכדועמ(
ןכדועמ(
.102.50
.102.50
.102.50
)
)
) ךיראת
.102.30
תילגנאב רישכת םש
םושירה רפסמו
GLUCOSE 5% INTRAVENOUS INFUSION BP (VIAFLO®)
140 24 30797 00 ; 140 24 30797 01; 134 06 31397 00
םושירה לעב םש
TEVA MEDICAL (MARKETING) LTD., HAORGIM ST 8, ASHDOD 77100
ה טורפל דעוימ הז ספוט
דבלב תורמחה
!
תושקובמה תורמחהה
ןולעב קרפ
יחכונ טסקט
שדח טסקט
PHARMACEUTICAL
FORM
Solution for infusion.
Clear solution, free from visible particles
Solution for infusion.
Clear solution, free from visible particles.
Osmolarity : 278 mOsm/l (approx.)
pH : 3.5 – 6.5
I
NDICATION
POSOLOGY,
DOSAGE &
ADMINISTRATION
When additive is used, verify isotonicity prior to
parenteral
administration.
Thorough
and
careful
aseptic
mixing
of
any
additive
is
mandatory.
Solutions
containing
additives
should
be
used
immediately and not stored.
Glucose 5% intravenous infusion is an isosmotic solution.
Please see section 3 for the information about the osmolarity
of the solution.
_Precautions to be taken before handling or administering the _
_medicinal product _
Parenteral drug products should be inspected visually for
particulate matter and discoloration prior to administration,
whenever solution and container permit.
Electrolyte supplementation may be indicated according to
the clinical needs of the patient.
When introducing additives, the final osmolarity of solutions
need
to
be
checked.
Administration
of
hyperosmolar
solutions
may
cause
venous
irritation
and
phlebitis.
Thorough
and
careful
aseptic
mixing
of
any
additive
is
mandatory. Solutions containing additives should be used
immediately and not stored.
Please see section 4.4 for the risk of air embolism
.
CONTRA-
INDICATIONS
Hypersensitivity to the

Summary of Product characteristics

GLUCOSE 5% IV Infusion BP Notification 06.2022 N.A
1
GLUCOSE 5% INTRAVENOUS INFUSION BP
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Glucose 5% Intravenous Infusion BP
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Glucose (as monohydrate): 50.0 g/l
Each ml contains 50 mg glucose (as monohydrate)
Approximately 840 kJ/l (or 200 kcal/l)
For the full list of excipients: see 6.1
3.
PHARMACEUTICAL FORM
Solution for infusion.
Clear solution, free from visible particles.
Osmolarity : 278 mOsm/l (approx.)
pH : 3.5 – 6.5
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Glucose 5% is indicated for the treatment of carbohydrate and fluid
depletion.
Glucose 5% is also used as a vehicle and diluent for compatible
medicinal products for parenteral
administration.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults, the Elderly and Children : _
The concentration and dosage of Glucose 5% Intravenous Infusion is
determined by several factors
including the age, weight, and clinical condition of the patient.
Serum-glucose concentrations may
need to be carefully monitored.
The recommended dosage for treatment of carbohydrate and fluid
depletion is:
- for adults : 500 ml to 3 litres/24h
- for babies and children :
- 0-10 kg body weight:
100 ml/kg/24 h.
- 10-20 kg body weight:
1000 ml + 50 ml/kg over 10 kg/24 h.
- > 20 kg body weight :
1500 ml + 20 ml/kg over 20 kg/24 h.
_ _
The infusion rate depends on the patient's clinical condition.
Infusion rate should not exceed the patient’s glucose oxidation
capacities in order to avoid
hyperglycaemia. Therefore, the maximum dose ranges from 5mg/kg/min for
adults to 10-18
mg/kg/min for babies and children depending on the age and the total
body mass.
GLUCOSE 5% IV Infusion BP Notification 06.2022 N.A
2
The recommended dosage when used as a vehicle or diluent ranges from
50 to 250 ml per dose of
medicinal product to be administered.
When Glucose 5% is used as a diluent for injectable preparations of
other drugs, the dosage and the
infusion rate will be princi