Gastrolyte Electrolyte Hydration

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Citric acid 0.384 g; Glucose 1.62 g; Potassium chloride 0.186 g; Sodium bicarbonate 0.336 g; Sodium chloride 0.117 g

Available from:

sanofi-aventis new zealand limited

INN (International Name):

Citric acid 0.384 g

Pharmaceutical form:

Effervescent tablet

Composition:

Active: Citric acid 0.384 g Glucose 1.62 g Potassium chloride 0.186 g Sodium bicarbonate 0.336 g Sodium chloride 0.117 g Excipient: Raspberry flavour permaseal PHS131990 Saccharin sodium

Units in package:

Tube, plastic, white polypropylene, 20 tablets

Class:

General sale

Prescription type:

General sale

Manufactured by:

SA Citrique Belge NV

Product summary:

Package - Contents - Shelf Life: Tube, plastic, white polypropylene - 20 tablets - 36 months from date of manufacture stored at or below 25°C 24 hours reconstituted 1 hours reconstituted (not refrigerated)

Authorization date:

2010-10-26

Summary of Product characteristics

New Zealand Data Sheet
26 July 2017
Gastrolyte Electrolyte Hydration
gastrolyte-eh-ccsiv1-dsv8-26jul17
Page 1 of 7 DATA SHEET
1
PRODUCT NAME
Gastrolyte Electrolyte Hydration
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sachet, each 5.1g sachet contains: Sodium chloride 470mg, potassium
chloride 300mg, sodium
acid citrate 530mg, glucose 3.56g.
Tablet, each tablet contains: Sodium chloride 117mg, potassium
chloride 186mg, citric acid
384mg, sodium bicarbonate 336mg, glucose 1.62g.
For full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Powder for oral solution
Effervescent Tablet
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral correction of fluid and electrolyte loss in infants, children and
adults. The product has been
formulated to treat fluid and electrolyte loss associated with acute
dehydration in infantile
diarrhoea, but is also appropriate for the treatment of older children
and adults.
Gastrolyte Electrolyte Hydration is also indicated for the correction
of dehydration due to
traveller’s gastroenteritis and vigorous and prolonged exercise.
4.2
DOSE AND METHOD OF ADMINISTRATION
For oral administration only.
Reconstitution: The powder contents of one sachet or two effervescent
tablets should be made up
to 200ml with fresh drinking water. (For infants, the water should be
freshly boiled and cooled
before mixing with Gastrolyte Electrolyte Hydration). An infant's
feeding bottle is a convenient
measure of this volume. The solution should be made up immediately
prior to feeding and any
solution remaining an hour after reconstitution should be discarded.
However, the solution may be
used for up to 24 hours if stored in a refrigerator immediately after
reconstitution. The
reconstituted solution must not be boiled.
New Zealand Data Sheet
26 July 2017
Gastrolyte Electrolyte Hydration
gastrolyte-eh-ccsiv1-dsv8-26jul17
Page 2 of 7
Dosage: The volume of reconstituted Gastrolyte Electrolyte Hydration
needed per day should be
determined by the physician, taking into account the weight of the
patient an