Each litre of solution contains the following electrolytes:
PHARMACOLOGICAL CLASSIFICATION A. 24 Mineral substitutes. Electrolytes.
PHARMACOLOGICAL ACTION HYDROL is a palatable glucose-electrolyte mixture which, when mixed with water as directed, supplements electrolytes and fluids.
INDICATIONS Treatment of electrolyte and fluid depletion associated with diarrhoea.
CONTRA-INDICATIONS In patients with impaired renal function. In severe diarrhoea and dehydration requiring parenteral fluid therapy. In patients with the glucose-galactose syndrome.
DOSAGE AND DIRECTIONS FOR USE Dissolve one sachet in a litre of previously boiled and cooled water. (Do not boil the solution after adding the electrolyte mixture).
Administer the solution in frequent small volumes to compensate for fluid and electrolyte imbalance. Your doctor's advice may be required.
It is recommended to use a feeding bottle for infants and a cup and spoon for small children.
In children with acute diarrhoea this solution must be used as indicated by thirst. The oral solution should be freshly prepared daily. Discard unused solution after 24 hours. If patients are unable to drink the oral fluid as recommended due to tiredness or drowsiness, HYDROL can be administered by continuous nasogastric infusion.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS Glucose malabsorption may occur in a small percentage of patients with acute diarrhoea. Administration of fluids to such cases may worsen the diarrhoea and dehydration.
HYDROL should not be mixed with or given with fruit juices or milk or other electrolyte-containing solutions.
HYDROL should be used as recommended in order to avoid complications with excessive electrolyte ingestion. Excess fluid intake may also cause puffy eyelids. In which case oral therapy should be stopped until this disappears. Sodium salt should be used with caution in patients with cardiac failure, hypertension, impaired renal function, oedema and in toxaemia of pregnancy.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT Overdosage of glucose may cause nausea and vomiting.
Overdosage of potassium chloride may cause hyperkalaemia, with symptoms such as abnormal sensations in the limbs, listlessness, mental confusion, weakness, paralysis, hypotension and cardiac arrhythmias.
Sodium overdosage may cause hypernatremia with symptoms such as restlessness, weakness, thirst, reduced salivation, swollen tongue, flushing of the skin, fever, dizziness, headache, oliguria, hypotension, tachycardia and gasping breathing.
Treatment is symptomatic.
IDENTIFICATION White to off-white free flowing powder. When reconstituted, an opaque milk flavoured solution.
PRESENTATION Cartons containing 10 or more sachets, each filled with 24,69 g powder.
STORAGE INSTRUCTIONS Store below 25°C. KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBER W/24/97
NAME AND BUSINESS ADDRESS OF THE APPLICANT JANSSEN - CILAG logo