Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Capsule content
Maize starch
Magnesium stearate
Silica, colloidal anhydrous
Water

Capsule shell
Gelatin
Titanium dioxide
Quinoline yellow
Erythrosine
6.2   Incompatibilities

Not applicable.

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

6.4   Special precautions for storage

Do not store above 25˚C
6.5   Nature and contents of container

Capsules are packed in polyvinyl chloride (PVC) blisters sealed with aluminium foil and packed in cardboard boxes.
Pack size: 100 hard capsules

6.6   Special precautions for disposal and other handling

Patients who are unable to swallow capsules
For children (1 year to 11 years), adolescents (12 years to 18 years) and adults who cannot swallow capsules and/or need to take a dose below 250 mg, the capsule may be opened, the contents of added to 25 mL of sodium bicarbonate solution 8.4% (1 mmol/mL) and mixed to produce a suspension containing chenodeoxycholic acid 10 mg/mL.

For infants (1 month to 11 months) the capsule may be opened, the contents added to 50 mL of sodium bicarbonate solution 8.4% (1 mmol/mL) and mixed to produce a suspension containing chenodeoxycholic acid 5 mg/mL.

The active substance itself will be dissolved in the sodium bicarbonate solution and it appears as a suspension because not all components of the capsule contents will be dissolved. The suspension is formed quite easily and is ready when there are no visible lumps or powder left.

The suspension produced contains 22.9 mg of sodium per mL, which needs to be taken into consideration by patients on a controlled sodium diet.

It is recommended that this suspension is prepared at the pharmacy and instructions given to the parent on how to administer the suspension.

The suspension should be stored in a glass bottle. Do not refrigerate or freeze. The suspension is stable for up to 7 days at ambient temperature and humidity.

The pharmacy should provide oral dose syringes of appropriate volume and grading for administering the suspension. The correct volumes should preferably be marked on the oral syringe.

The physician should provide information on the dose to be received according to the weight of the child. The dose range in paediatric patients (1 month to 18 years) is 5-15 mg/kg per day (see section 4.2).

Disposal
Any unused product or waste material should be disposed of in accordance with national requirements.