Sodium chloride 0.45% Glucose 5% infusion 500ml Viaflex bags

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

Wirkstoff:

Glucose anhydrous; Sodium chloride

Verfügbar ab:

Baxter Healthcare Ltd

INN (Internationale Bezeichnung):

Glucose anhydrous; Sodium chloride

Dosierung:

50mg/1ml ; 4.5mg/1ml

Darreichungsform:

Infusion

Verabreichungsweg:

Intravenous

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Valid as a prescribable product

Produktbesonderheiten:

BNF:

Fachinformation

OBJECT 1
SODIUM CHLORIDE 0.45 % W/V AND GLUCOSE 5.0 %
W/V SOLUTION FOR INFUSION BP
Summary of Product Characteristics Updated 14-Jul-2016 | Baxter
Healthcare Ltd
1. Name of the medicinal product
Sodium Chloride 0.45 % w/v and Glucose 5.0 % w/v Solution for Infusion
BP
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 % w/v and Glucose 5.0 % w/v solution is indicated
for:
- Treatment of dehydration or hypovolaemia in cases where supply of
water, sodium chloride and
carbohydrates is required due to restriction of the intake of fluids
and electrolytes by normal routes.
4.2 Posology and method of administration
The choice of the specific sodium chloride and glucose concentration,
dosage, volume, rate and duration
of administration depends on the age, weight, clinical condition of
the patient and concomitant therapy. It
should be determined by a physician. For patients with electrolyte and
glucose abnormalities and for
paediatric patients, consult a physician experienced in intravenous
fluid therapy. Rapid correction of
hyponatraemia and hypernatraemia is potentially dangerous (risk of
serious neurologic complications).
_ADULTS, OLDER PATIENTS AND ADOLESCENTS (AGE 12 YEARS AND OVER):_
The recommended dosage is 500 ml to 3 L/24h
Administration rate
The infusion rate is usually 40 ml/kg/24h and should not exceed the
patient's glucose oxidation capacities
in order to avoid hyperglycaemia. Therefore the maximum acute
administration rate is 5 mg/kg/min.
_PAEDIATRIC POPULATION_
The dosage varies with weight:
•