Rehidrat Blackcurrant, Orange & Vanilla 14 g Powder.

Prevention and treatment of dehydration and electrolyte depletion associated with diarrhoea and gastro-enteritis.

Posology: Infants and children: During the rehydration phase of therapy, care should be taken to ensure an adequate intake of REHIDRAT to replace the loss of water and electrolytes (see recommended daily dose in Maintenance therapy section below).

Maintenance therapy: Patients should be observed carefully to confirm adequate maintenance of hydration. Frequent clinical observations should be made to ensure that adequate hydration is being maintained. The maximal dose of REHIDRAT should not be exceeded. If further fluid intake is required, water should be given freely.

Infants below 1 year of age: Infants below 1 year of age should be given u00bd to 1 cup (100 u2013 200 mL) of REHIDRAT for every bowel movement.

Children 1 to 5 years of age: Children 1 to 5 years of age should be given at least one cup (200 mL) for every bowel movement.

Older children and adults: Older children and adults should drink enough REHIDRAT to quench their thirst and replace the fluid lost in every stool. If fluid volumes and body mass can be measured, the following doses can be used instead of those above and a nasogastric tube can be used to administer REHIDRAT:

Maintenance of hydration in patients unable to take usual feeds/meals:

• Infants below 1 year of age: 120 mL /kg/day
• Children 1 - 2 years of age: 100 mL/kg/day
• Children 2 - 4 years of age: 85 mL/kg/day
• Children 4 - 10 years of age: 70 mL/kg/day
• Children over 10 years and adults: 2 to 3 litres/day

Rehydration in mild dehydration: 50 mL/kg body mass over the first 6 hours, followed by maintenance therapy.

Rehydration in moderate to severe dehydration: 100 mL/kg body mass over the first 6 hours, followed by maintenance therapy. Patients with moderate to severe dehydration are preferably rehydrated via the intravenous route with specially formulated intravenous dextrose-electrolyte solutions.

Ongoing losses: For every stool passed 10 to 20 mL/kg body mass should be given in addition to, and in between, normal feeds/meals.

Method of administration: The contents of one 14 g sachet should be dissolved in 250 mL of freshly boiled and cooled water. The solution must be freshly prepared every day. Discard unused solution after 24 hours. Oral rehydration solution should be administered using a method that the infant is familiar with e.g. baby bottle, cup or spoon. Breastfeeding mothers may choose any of the aforementioned methods to administer the solution to their infants. REHIDRAT should be given in addition to, and in between, normal feeds/meals in small, frequent and slowly administered amounts.

• Hypersensitivity to glucose, potassium chloride, sodium bicarbonate, sodium chloride, sucrose or to any of the inactive ingredients of REHIDRAT (see section 6.1).
• Patients with renal failure manifesting as oliguria or anuria, intestinal obstruction and paralytic ileus.
• Patients with severe diarrhoea where parenteral fluid therapy is required, such as severe dehydration or intractable vomiting, glucose-galactose malabsorption syndrome, and haemodynamic shock.

Contact a doctor, health professional, local clinic or hospital if:

• The infant cannot take fluid by mouth or is becoming weaker and dehydrated.
• Severe diarrhoea continues for 12 hours.

Care should be exercised when the formulation is given to patients with renal failure and diabetes insipidus. Potassium should be given with caution to patients with renal or adrenal insufficiency, acute dehydration, muscle cramps or heat cramps as well as patients receiving angiotensin-converting enzyme inhibitors, and other potassium containing or potassium-sparing diuretics. Sodium salts should be used with caution in patients with cardiac failure, hypertension, peripheral and pulmonary oedema, eclampsia/pre-eclampsia or aldosteronism. Sodium chloride solutions should not be used to induce emesis (see section 4.9).

Administration of oral sugar-electrolyte solutions to patients with sugar malabsorption may worsen the diarrhoea. Glucose intolerance may occur in some patients with diarrhoea. REHIDRAT should not be mixed or given with other oral electrolyte solutions. Salt or sugar should not be added to REHIDRAT. When REHIDRAT is used alone or as a supplement to parenteral fluid therapy, care must be taken not to exceed the total water and electrolyte requirements. Rapid intake of REHIDRAT may result in vomiting. REHIDRAT should be given in small and frequent amounts. Patients should stop use and consult a physician if symptoms persist or worsen, or if any new symptoms occur. REHIDRAT contains sugar (sucrose) and glucose. Patients with rare hereditary conditions such as fructose intolerance, glucose-galactose malabsorption or sucrase isomaltase insufficiency should not take REHIDRAT. REHIDRAT may have an effect on the glycaemic control of patients with diabetes mellitus.

None known.

There are no adequate and well controlled studies for the combination of glucose, potassium chloride, sodium bicarbonate, sodium chloride in pregnant or breastfeeding women. Safety during pregnancy and lactation has not been established.

The effect of REHIDRAT on the ability to drive a vehicle and use machines have not been studied. REHIDRAT is not expected to have any effect on the ability to drive a vehicle or operate machines.

No adverse events were identified for the combination of glucose, potassium chloride, sodium bicarbonate, sodium chloride and sucrose from the review of post marketing safety data. Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of REHIDRAT is important. It allows continued monitoring of the benefit/risk balance of REHIDRAT. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8. For further information, please contact the Johnson & Johnson call centre on 0860 410032 (landline).

No overdose-associated adverse events for glucose, potassium chloride, sodium bicarbonate, sodium chloride and sucrose have been reported in literature or post marketing safety data. The information presented below describes potential overdose symptoms where REHIDRAT is improperly formulated with water or ingested in large amounts without being diluted with water.

Glucose: Overdosage of glucose may cause nausea and vomiting.

Potassium chloride: Overdosage of potassium may cause hyperkalaemia with vomiting, paraesthesia of the extremities, cyanosis, poor peripheral pulses, listlessness, mental confusion, weakness/hypotonia, paralysis, unconsciousness, hypotension, abnormal electrocardiography findings and cardiac dysrhythmias, heart block and cardiac arrest.

Sodium bicarbonate: Overdosage of sodium bicarbonate may lead to hypokalaemia, hypernatremia, hypochloraemia and metabolic alkalosis. Symptoms include nausea and vomiting, abdominal pain, diarrhoea, abdominal bloating and gas, mood changes, tiredness/lethargy/drowsiness and weakness, dizziness, agitation, respiratory depression/hypoventilation and irregular heart beat/abnormal electrocardiographic changes. Muscle hypertonicity, twitching, and tetany may develop, especially in hypocalcaemic patients.

Sodium chloride: Overdosage of sodium may cause hypernatraemia, symptoms of which may include nausea, vomiting, diarrhoea, restlessness, or agitation, weakness, thirst, reduced salivation and lachrymation, swollen tongue, flushing of the skin, pyrexia, dizziness, headache, oliguria, hypotension or hypertension, tachycardia, drowsiness/lethargy, muscle twitching, delirium/altered mental status, seizures/convulsions, coma, and, hyperpnoea or tachypnoea and respiratory arrest. Sodium chloride solutions should not be used to induce emesis. Treatment is symptomatic and supportive.