Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Mannitol, L-Histidine, Dibasic sodium phosphate heptahydrate, Monobasic sodium phosphate monohydrate.

6.2   Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3   Shelf life

The expiry date of the product is indicated on the packaging materials.
After reconstitution, the solution should be used immediately.


6.4   Special precautions for storage
Store refrigerated at 2°C to 8°C. Do not freeze.
The product may be stored for up to 3 months below 25°C.

For storage conditions after reconstitution of the medicinal product, see section 6.3.

6.5     Nature and contents of container
GATTEX (teduglutide) is supplied in a sterile, single-use 3 ml glass vial with rubber stopper (bromobutyl) containing 5 mg of teduglutide as a white, lyophilized powder to be reconstituted with 0.5 mL Sterile Water for Injection.

Each package contains a 1,5,6,10,30 or 60 vials.
Not all pack sizes may be marketed.

6.6   Special precautions for disposal and other handling
Determination of the number of vials needed for administration of one dose must be based on the individual patient’s weight and the recommended dose of 0.05 mg/kg/day. The physician should at each visit weigh the patient, determine the daily dose to be administered until next visit and inform the patient accordingly.

Tables with the injection volumes based on the recommended dose per body weight for both adults and paediatric patients are provided in section 4.2.

Syringe with the diluent Water for Injection must be assembled with aplunger and a reconstitution needle.

The powder in the vial must then be dissolved by adding all the solvent from the pre-filled syringe.

The vial should not be shaken, but can be rolled between the palms and gently turned upside-down once. Once a clear colourless solution is formed in the vial, the solution should be sucked up into a 1 ml injection syringe (or 0.5 ml or smaller injection syringe for paediatric use) with scale intervals of 0.02 ml or smaller (not included in the pack).

If two vials are needed, the procedure for the second vial must be repeated and the additional solution sucked up into the injection syringe containing the solution from the first vial. Any volume exceeding the prescribed dose in ml must be expelled and discarded.

The solution must be injected subcutaneously into a cleaned area on the abdomen, or if this is not possible, on the thigh (see section 4.2 Method of administration) using a thin needle for subcutaneous injection.

Detailed instructions on the preparation and injection of Gattex are provided in the package leaflet.

The solution must not be used if it is cloudy or contains particulate matter.
For single use only.

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

All needles and syringes should be disposed of in a sharps disposal container.