Pharmaceutical particulars : מידע רוקחי

6.      PHARMACEUTICAL PARTICULARS

6.1     List of excipients
None.

6.2     Incompatibilities

Not applicable.
6.3     Shelf life

The expiry date of the product is indicated on the packaging materials.

After the first opening of the bottle, the medicinal product must be used within 14 days and the bottle and its contents discarded, even if not empty.

6.4     Special precautions for storage

To be stored at no more than 25°C.
6.5     Nature and contents of container

Clear, Type III glass, bottle with a high density polyethylene (HDPE) child-resistant closure Each bottle contains 25 ml of liquid.

Pack size: 1 bottle and 1 reclosable bottle cap adapter per carton.

6.6     Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with national requirements.

One oral syringe should be used each day. The oral syringe should not be rinsed between daily doses as the introduction of water causes glycerol phenylbutyrate to degrade. The oral syringe should be discarded after the last dose of each day.


Chemical compatibility of glycerol phenylbutyrate with medical grade silicone nasogastric, gastrostomy, and nasojejunal tubes has been demonstrated. In vitro studies evaluating the percent recovery of total dose delivered with nasogastric or gastrostomy tubes demonstrated the percent of dose recovered was >99% for doses > 1 ml and 70% for a 0.5 ml dose. Therefore, it is recommended that nasogastric, nasojejunal or gastrostomy tubes only be used to administer doses > 1 ml. If there is a need to administer a dose of 0.5 ml or less with such nasogastric, gastrostomy or nasojejunal tubes, consideration should be given to the low drug recovery in dosing.

7. Manufacturer:

Immedica Pharma AB
Solnavagen 3H
113 63 Stockholm
Ravicti-SPC-0423-V1
Sweden