Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Potassium citrate monohydrate
Citric acid monohydrate
Hydroxyethylcellulose
(Monosodium phosphate (E 339); Disodium phosphate (E 339)- pH stabilizers) Sodium methyl para-hydroxybenzoate (E 219)
Sucralose (E 955)
Cherry flavouring powder:
Dextrose (maize)
Gum Arabic/ Acacia E414
Ethyl benzoate
Sulfur dioxide (E 220)
Natural flavouring preparations
Natural flavouring substances
Flavouring substances
Maltodextrin (maize)

Sodium ethyl para-hydroxybenzoate (E 215)
Potassium citrate (E 332)
Citric acid monohydrate (E 330)
Water for injections

6.2    Incompatibilities
Not applicable.

6.3    Shelf life

The expiry date of the product is indicated on the packaging materials 
Shelf life after first opening

This medicinal product should be used within 3 months of first opening the bottle.
6.4    Special precautions for storage

This medicinal product does not require any special storage conditions. Do not refrigerate or freeze.

6.5    Nature and contents of container
Fintepla is presented in a white High Density Polyethylene (HDPE) bottle with a child-resistant, tamper-evident cap packaged in a carton, a Low Density Polyethylene (LDPE) press-in bottle adaptor, and Polypropylene (PP)/HDPE oral syringes. The oral syringe included in the pack should be used to administer the prescribed dose.

Presentations:

Bottle containing 60 mL oral solution, a bottle adaptor, two 3 mL oral syringes with 0.1 mL graduations, and two 6 mL syringes with 0.2 mL graduations.
Bottle containing 120 mL oral solution, a bottle adaptor, two 3 mL oral syringes with 0.1 mL graduations, and two 6 mL syringes with 0.2 mL graduations.
Bottle containing 250 mL oral solution, a bottle adaptor, two 3 mL oral syringes with 0.1 mL graduations, and two 6 mL syringes with 0.2 mL graduations.
Bottle containing 360 mL oral solution, a bottle adaptor, two 3 mL oral syringes with 0.1 mL graduations, and two 6 mL syringes with 0.2 mL 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.

Inserting the bottle adaptor:

When the bottle is first opened the bottle adaptor must be pushed into the bottle.
Wash and dry hands.
Remove the bottle adaptor packaging.
Place the bottle on a flat, firm surface.
Open the bottle.
Hold the bottle firmly.
Align the bottle adaptor with the open top of the bottle.
Push the bottle adaptor into the bottle using the palm of the hand.
The bottle adaptor should be flush with the top of the bottle.
The bottle adaptor should not be removed after each use.
The bottle cap can be screwed onto the bottle with the bottle adaptor in place.
Cleaning the syringe:

Separate the plunger from the syringe to rinse each part.
Rinse the oral syringe with clean water and allow it to air dry after each use.
Rinse the inside of the syringe and the plunger.
The syringe and plunger can be cleaned in a dishwasher.
Clean water can be pulled into the syringe with the plunger and pushed out several times to clean the syringe.
The syringe and plunger must be completely dry before the next use.

Feeding tubes

Fintepla oral solution is compatible with most enteral feeding tubes.
To flush the feeding tube, fill the syringe used for dosing with water and flush the tube. Do this 3 times.