Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients
Mannitol
Microcrystalline cellulose and carmellose sodium
Sodium benzoate
Hypromellose 5cP
Citric acid, anhydrous
Xanthan gum
Flavour sweet and creamy: flavouring substances, maltodextrin (maize), propylene glycol (E 1520) and acacia gum (E 414)
Sucralose

6.2   Incompatibilities

Not applicable.
6.3   Shelf life

The expiry date of the product is indicated on the packaging materials.
After reconstitution the suspension is stable for 14 days at room temperature.

6.4   Special precautions for storage
Do not store above 30 °C.
Do not freeze.
Store the prepared suspension upright.

6.5     Nature and contents of container

Xarelto 1 mg/mL granules for oral suspension is packed in a folding box containing:
•     For children weighing less than 4 kg: -     2.625 g granules, corresponding to 51.7 mg rivaroxaban, in 1 brown glass bottle 100 mL, closed with a child resistant screw cap
-     2 blue syringes 1 mL with 0.1 mL marked graduations
-     1 adapter for bottles and blue syringes
-     1 water syringe 50 mL with 1 mL marked graduations
 or
•     For children weighing 4 kg and more:
-     5.25 g granules, corresponding to 103.4 mg rivaroxaban, in 1 brown glass bottle 250 mL, closed with a child resistant screw cap
-     2 blue syringes 5 mL with 0.2 mL marked graduations
-     2 blue syringes 10 mL with 0.5 mL marked graduations
-     1 adapter for bottles and blue syringes
-     1 water syringe 100 mL with 2 mL marked graduations

Not all pack sizes may be marketed.

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



Suspension
Before administration the granules must be suspended into a homogenous suspension with non- carbonated water giving a final concentration of 1 mg per mL.
The amount of water to be used is:
-      50 mL for the 100 mL bottle containing 2.625 g granules
-      100 mL for the 250 mL bottle containing 5.25 g granules
The bottle has to be shaken after reconstitution for 60 seconds and before each dose for 10 seconds.
After reconstitution the medicinal product is a white to off-white suspension.
For dose administration after reconstitution, the blue syringes (1 mL, 5 mL or 10 mL) are provided (see section 4.2, Table 1).
Complete details on preparation and administration of the oral suspension can be found in the Instructions for Use that is provided with the medicinal product.
The suspension may be given through a nasogastric or gastric feeding tube. Gastric placement of the tube should be confirmed before administering Xarelto. Since rivaroxaban absorption is dependent on the site of active substance release, administration of rivaroxaban distal to the stomach should be avoided, as this can result in reduced absorption and thereby, reduced active substance exposure. After the administration, the feeding tube should be flushed with water. This should then be immediately followed by nasogastric or gastric feeding.