GLUCOSE 50 % BAXTER

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

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Last ned Preparatomtale (SPC)
11-05-2023

Aktiv ingrediens:

GLUCOSE AS MONOHYDRATE

Tilgjengelig fra:

BAXTER HEALTHCARE DISTRIBUTION LTD., ISRAEL

ATC-kode:

B05CX01

Legemiddelform:

SOLUTION FOR INFUSION

Sammensetning:

GLUCOSE AS MONOHYDRATE 500 G / 1 L

Administreringsrute:

I.V

Resept typen:

Required

Produsert av:

BAXTER HEALTHCARE LTD. U.K.

Terapeutisk område:

GLUCOSE

Indikasjoner:

High caloric carbohydrate infusion, hypoglycaemia

Autorisasjon dato:

2023-01-29

Preparatomtale

                                SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Glucose 50% Baxter
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
100 mL concentrate for solution for infusion
Contain Glucose monohydrate
55.0 g
(Equivalent to 50.0 g anhydrous glucose)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion
Clear, colourless or not more than faintly yellow solution.
Energy: 835 kJ/100 mL
≙
200 kcal/100 mL
Theoretical osmolarity:
2,770 mOsm/L
Titratable acidity (pH 7.4): < 1.5 mmol/L
pH:
3.2-5.5
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. Up to 14 ml/kg body weight/day.
Flow rate:
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 ac cordingly.
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 cen- tral 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
●
Hypokalaemia
●
Acidosis
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Glucose 50% Baxter is a hypertonic solution. In the body, however,
glucose-containing
fluids can become extremely hypotonic due to rapid glucose
metabolisation.
Depending on the tonicity of the solution, the volume and the rate of
infusion and dependin
                                
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