Pharmaceutical particulars : מידע רוקחי

6      PHARMACEUTICAL PARTICULARS

6.1    List of excipients
Sorbitol Liquid (non-crystallising)
Glycerol
Citric acid monohydrate
Sodium Citrate
Sodium methyl parahydroxybenzoate (E219)
Sodium propyl parahydroxybenzoate (E217)

Strawberry flavour:
Flavouring substance
Maltodextrin (maize)
Acacia (E414)
Triacetin (E1518)

6.2    Incompatibilities
Not applicable.


6.3    Shelf life
The expiry date of the product is indicated on the packaging materials 
Once opened, the product may be stored for up to 28 days at a maximum of 25°C.

6.4    Special precautions for storage
Store below 25°C.
Do not freeze.
Store in the original bottle. Keep bottle in the original carton in order to protect from light.
For storage conditions after first opening of the medicinal product, see section 6.3.
6.5     Nature and contents of container

Rybrila oral solution is supplied in a 150 ml amber type III glass bottle with a tamper evident, child resistant cap.

Each bottle is provided in a cardboard carton along with a 15 ml syringe with graduations and a syringe adaptor to allow the correct dose to be measured.


6.6     Special precautions for disposal
Instructions for use
Insert the syringe adaptor into the neck of the bottle. Insert the end of the oral syringe into the syringe adaptor and ensure it is secure. Turn the bottle upside down. Gently pull down the plunger to the correct level (see Table 1 for the correct dose). Turn the bottle upright. Remove the oral syringe. Place the oral syringe inside the child's mouth and press the plunger slowly to gently release the medicinal product.

If the Rybrila Oral Solution is given through a feeding tube, flush the tube with 20 ml of water after administering the medicinal product.
No special requirements for disposal.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.