GLUCOSE 20 %

Country: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Kauptu það núna

Vara einkenni Vara einkenni (SPC)
03-01-2023
Opinber matsskýrsla Opinber matsskýrsla (PAR)
03-01-2023

Virkt innihaldsefni:

GLUCOSE AS MONOHYDRATE

Fáanlegur frá:

LAPIDOT MEDICAL IMPORT AND MARKETING LTD

ATC númer:

B05CX01

Lyfjaform:

SOLUTION FOR INFUSION

Samsetning:

GLUCOSE AS MONOHYDRATE 20 %

Stjórnsýsluleið:

I.V

Gerð lyfseðils:

Required

Framleitt af:

B.BRAUN MELSUNGEN AG., GERMANY

Meðferðarhópur:

GLUCOSE

Lækningarsvæði:

GLUCOSE

Ábendingar:

High caloric carbohydrate infusion hypoglycaemia.

Leyfisdagur:

2022-10-31

Vara einkenni

                                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 
                                
                                Lestu allt skjalið
                                
                            

Leitaðu viðvaranir sem tengjast þessari vöru

Skoða skjalasögu