GLUCONA (Glucose & Sodium Clorid)

COMPOSITION

Active ingredient:

Sodium chloride 0.9% w/v

Glucose (as glucose monohydrate) 5% w/v

Excipients: Water for injection.

Mmol/l: Na+: 154 Cl-:154

Meq/l: Na+: 154 Cl-:154

Nutritional value: approximately 840 kJ/l (or 200 kcal/l)

PHARMACEUTICAL FORM

Solution for infusion

A clear, colourless or faintly straw-coloured solution, no strange particles, packed in colourless plastic bottle, sealed with plastic cap with 2 rubber discs inside.

pH: 3,5 – 6,5

Osmolarity: 585 mOsmol/L

THERAPEUTIC INDICATIONS

Treatment of sodium depletion, extracellular dehydration or hypovolaemia in cases where supply of water and carbohydrates is required due to restriction of the intake of fluids and electrolytes by normal routes.

CONTRAINDICATIONS

The solution is contraindicated in patients presenting with:

• Known hypersensitivity to the product

• Extracellular hyperhydration or hypervolaemia

• Fluid and sodium retention

• Severe renal insufficiency (with oliguria/anuria)

• Uncompensated cardiac failure

• Hypernatraemia or hyperchloraemia

• General oedema and ascitic cirrhosis

• Clinically significant hyperglycaemia.

The solution is also contraindicated in case of uncompensated diabetes, other known glucose intolerances (such as metabolic stress situations), hyperosmolar coma or hyperlactataemia

STORAGE CONDITIONS, EXPIRATION DATE, QUALITY STANDARDS

Storage conditions: Store in a cool, dry place at a temperature not exceeding 30°C, protect from light.

Expiration date: 36 months from manufacturing date.

Packaging specifications:

Bottle of 250 mL; Bottle of 500 mL
Carton of 24 bottles x 250 mL; Carton of 30 bottles x 250 mL; Carton of 48 bottles x 250 mL
Carton of 12 bottles x 500 mL; Carton of 24 bottles x 500 mL; Carton of 30 bottles x 500 mL

MANUFACTURING FACILITY

NANOGEN LAM DONG PHARMACEUTICAL MANUFACTURING CO., LTD.

BII-11-KCN; BII-12-KCN; BII-13-KCN; BII-14-KCN at Phu Hoi Industrial Zone, Phu Hoi Commune, Duc Trong District, Lam Dong Province, Vietnam

GLUCONA (Glucose & Sodium Clorid)