This product is used to replace fluids, minerals and carbohydrates (e.g., sodium, potassium and dextrose) lost due to diarrhea and vomiting. It helps prevent or treat the loss of too much body water (dehydration). Having the right amount of fluids and minerals is important for the normal functioning of the body.

The basic unit of dosage is 240ml of water.
Babylyte should be offered frequently depending on the degree of dehydration, response to therapy and amount that can be tolerated.
Children under 2 years of age – before use consult your doctor first.
Children over 2 years of age – offer Babylyte every 3 or 4 hours.

1 to 2 liters (from 4 to 8 bottles) should be taken each day while diarrhea continues.
If diarrhea continues for more than 24 hours or there is vomiting or fever other measures must be taken on consideration.

If there is no improvement within 24-48 hours the physician should be consulted.
For infants under 12 months use only on medical advice.
If nausea and vomiting are present with the diarrhea, small but frequent amounts of Babylyte should be drunk at first.
For use in the elderly no specific precautions are necessary. However, care should be taken when administering glucose-electrolyte solutions in cases of severe renal or hepatic impairment or other conditions where the normal electrolyte balance may be distributed.
Medical supervision is necessary in patients with renal disease, including anuria and prolonged oliguria.
This product contains dextrose. Patients with rare-glucose-galactose malabsorption should not take this medicine.

None.

Babylyte is not contra-indicated in pregnancy or lactation.

None.

To report any side effect(s):

Saudi Arabia:
The National Pharmacovigilance and Drug Safety Centre (NPC) Fax: +966-11-205-7662
Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.
Toll free phone: 8002490000
E-mail: npc.drug@sfda.gov.sa
Website: www.sfda.gov.sa/npc
Other GCC States:
Please contact the relevant competent authority.

In the event of significant overdose, serum electrolytes should be evaluated as soon as possible, appropriate steps taken to correct any abnormalities and levels monitored until return to normal levels is established. This is particularly important in the very young and in cases of severe hepatic or renal failure.

Babylyte is an oral rehydration therapy. The combination of electrolytes stimulates water and electrolyte absorption from the gastro-intestinal tract and therefore prevents dehydration in diarrhea.

Sodium and glucose are actively transported via the membrane into the enterocytes. Sodium is then extruded into the intercellular spaces and the resulting osmotic gradient causes water and electrolytes to be drawn from the gut and then into the circulation.

None.

Water for injections

Not applicable.

Store at a temperature not exceeding 30°C

240 ml glass bottles with plastic cap.

Before administration, the product should be visually inspected for any particulate matter and discoloration. For single use only. Any unused solution should be discarded.
Use only if the solution is clear, without visible particles and if the container is undamaged.
Discard any unused portion.