Pharmaceutical particulars : מידע רוקחי

6.      PHARMACEUTICAL PARTICULARS
6.1     List of excipients
-     Purified water
-     Hydroxypropylbetadex
-     Sucralose
-     Sodium citrate
-     Sodium benzoate
-     Strawberry flavour
-     Citric acid

6.2     Incompatibilities

Not applicable.
6.3     Shelf life

The expiry date of the product is indicated on the packaging materials.
After first opening: 10 days.
Store in a refrigerator (2 °C - 8 °C).

6.4     Special precautions for storage
Store in a refrigerator (2 °C - 8 °C).
Do not freeze.

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

6.5     Nature and contents of container
Amber glass (type III) bottle with a child-resistant polypropylene (PP) screw cap.

Each carton contains two bottles containing 50 mL oral solution each.


6.6   Special precautions for disposal and other handling

Instructions for use:
Oral syringe
-     Use a suitable oral syringe with CE marking and bottle adapter (28 mm diameter) if applicable.
-          For volumes less than 1 mL use a 1 mL oral syringe with 0.1 mL graduation.
-          For volumes of 1 mL and higher use a 5 mL oral syringe with 0.2 mL graduation.
-     Open the bottle: press the bottle cap and turn it counter clockwise.
-     Insert the bottle adapter into the bottle neck and ensure it is well fixed.
-     Take the oral syringe and ensure that the plunger is fully depressed. Put the oral syringe in the adapter opening. Turn the bottle upside down.
-     Fill the oral syringe with small amount of solution by pulling the plunger down, then push the plunger upwards to remove any bubbles.
-     Pull the plunger down to the graduation mark equal to the quantity in mL as prescribed.
-     Turn the bottle the right way up and remove the oral syringe from the bottle adapter.
-     Slowly depress the plunger, directing the liquid towards the inside cheek to allow for natural swallowing.
-     Close the bottle with the original bottle cap (leaving the adapter in place).

Nasogastric feeding tube
-    Use a suitable nasogastric feeding tube. The outer diameter of the nasogastric feeding tube should be selected based on the patient characteristics. Typical tube diameter, tube lengths and derived prime volumes are presented in Table 8.
-    The feeding should be stopped and the tube flushed with at least 10 mL water. NOTE: See exceptions regarding neonates and patients with fluid restrictions in the sub-point directly below.
-    A suitable syringe should be used to administer VITRAKVI to the nasogastric feeding tube.
The tube should be flushed again with at least 10 mL water to ensure VITRAKVI is delivered and to clear the tube.
Neonates and children with fluid restrictions may require minimal flushing volume of 0.5 to 1 mL or flushing with air to deliver VITRAKVI.
-    Restart the feeding.

Table 8: Recommended tube dimensions per age group
Patient     Tube diameter for Tube diameter for                 Tube length          Tube prime standard feeds    high density feeds                 (cm)              volume (mL) Neonate          4-5 FR                6 FR                        40-50               0.25-0.5 Children           6 FR                8 FR                        50-80                0.7-1.4 Adult              8 FR               10 FR                       80-120                1.4-4.2 
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.


7.    MARKETING AUTHORISATION HOLDER
Bayer Israel Ltd., 36 Hacharash St., Hod Hasharon