GLUCOSE 50 %

Country: Israel

Bahasa: Inggeris

Sumber: Ministry of Health

Beli sekarang

Ciri produk Ciri produk (SPC)
20-10-2021
Laporan Penilaian Awam Laporan Penilaian Awam (PAR)
20-10-2021

Bahan aktif:

GLUCOSE AS MONOHYDRATE

Boleh didapati daripada:

LAPIDOT MEDICAL IMPORT AND MARKETING LTD

Kod ATC:

B05CX01

Borang farmaseutikal:

CONCENTRATE FOR SOLUTION FOR INFUSION

Komposisi:

GLUCOSE AS MONOHYDRATE 50 %

Laluan pentadbiran:

I.V

Jenis preskripsi:

Required

Dikeluarkan oleh:

B.BRAUN MELSUNGEN AG., GERMANY

Kumpulan terapeutik:

GLUCOSE

Kawasan terapeutik:

GLUCOSE

Tanda-tanda terapeutik:

High caloric carbohydrate infusion hypoglycaemia.

Tarikh kebenaran:

2020-09-30

Ciri produk

                                SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Glucose 20%
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1000 ml of solution for infusion contains:
Glucose monohydrate
220.0g
(equivalent to anhydrous glucose)
(200.0g)
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for infusion
Clear, colourless or slightly yellowish aqueous solution.
Caloric value
3350 kJ/l

800 kcal/l
Theoretical osmolarity
1110 mOsm/l
Titration acidity (to pH 7.4)
< 1 mmol/l
pH
3.5 - 5.5
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
High caloric carbohydrate infusion
•
Hypoglycemia
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
DOSAGE
_Adults: _
The dosage depends on age, weight and clinical condition of the
patient.
Glucose 20 %: Up to 35 ml/kg body weight/day
Glucose 50 %: Up to 14 ml/kg body weight/day
_Flow rate: _
Glucose 20 %: Up to 2.5 ml/kg bw/h or (for 70 kg patient) up to 58
drops/min = 175 ml/h
Glucose 50 %: Up to 1.0 ml/kg bw/h or (for 70 kg patient) up to 23
drops/min = 70 ml/h.
For patients in a markedly depleted nutritional state, the above
drop/flow rates have to be reduced
accordingly.
_Insulin induced hypoglycemia:_
Determine blood glucose before injecting dextrose.
_Children: _
According to individual requirements.
ROUTE OF ADMINISTRATION
I.V. via a central venous catheter.
For total parenteral nutrition Glucose Injection is administered
by slow intravenous infusion (a)
after admixture
with amino acid solutions via an indwelling catheter
with the tip positioned in a
large central vein, preferably
the superior vena cava, or (b) after dilution with sterile
water for
injection. Dosage should be adjusted to meet
individual patient requirements.
4.3
CONTRAINDICATIONS
–
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
–
Hyperglycaemia, not responding to insulin doses of up to 6 units
insulin/hour
–
Delirium tremens if such patients are already dehydrated
–
Acute states of shock or collapse
–
Metabolic acidosis
–
Since 
                                
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