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Forsteo Summary of Product Characteristics (SmPC)
When travelling, the travel (cool) bag and gel packs (supplied with the starter kit) can be used to protect Forsteo for up to 36 hours total travel time.
storage instructions for Forsteo are as follows (Summary of Product
in a refrigerator (2°C-8°C) at all times. The pen should be
returned to the refrigerator immediately after use. Do not freeze.
when travelling, the travel (cool) bag and gel packs can be used.
Forsteo can be kept out of the fridge for a maximum of 36 hours up to
25°C during its 28 day in use period (Data on file).
available regarding travel with Forsteo:
Forsteo travel (cool) bag is intended only for occasional use when
travelling. Do not store the travel bag itself in the freezer or
refrigerator. Do not store the travel bag in a car boot (Data on
is recommended that the gel packs be frozen solid before using the
travel bag. If the gel packs cannot be frozen solid, they should be
refrigerated. The frozen gel packs, when properly placed in the
travel bag, are insulated from the Forsteo Pen and do not make
direct contact with the pen to ensure that the medicine does not
freeze (0°C or 32°F) (Data on file).
gel packs consist of a water-soluble starch or cellulose in a
plastic pouch. All Koolit refrigerants are made of high quality,
non-toxic materials but are not intended for human consumption.
Users who notice leaking, or puffing of the bag should dispose and
request new refrigerant packs.
Disposal: These water-based Koolit refrigerants are suitable for
disposal in normal waste streams. To recycle, simply cut open a
thawed gel pack and dispose of its liquid content in the normal
waste stream. The pouch may be recycled in centers that accept
hours is the total travel time allowed per device as long as the
provided travel bag is used for travelling with the Forsteo pen and
the temperature that the pen is exposed to during travel does not
exceed 25°C or 77°F (room temperature) (Data on file).
ensure the cool bag remains at the correct temperature for 36 hours
the gel packs must be replaced every 11 hours (Data on file).
Forsteo Pen should be returned to the refrigerator as soon as
possible when arriving at the travel destination (Data on file).
little advanced planning is needed when travelling by air.
doctor’s letter/prescription label may be required to verify
the Forsteo pen belongs to the patient. Check the requirements
with the airline.
Forsteo Travel Bag should be brought onto the aeroplane as a
carry-on. The temperature in the checked luggage area is not
always controlled and may become too hot or too cold.
Forsteo pen can be passed through a standard airport security
scanner when travelling by air. Lilly have completed a study that
showed that Forsteo is not altered by x-ray radiation found in
airport scanners. Multiple passes through scanners required by the
connecting and return flights of typical airline travel should not
damage the Forsteo pen (Data on file).
on file, Eli Lilly and Company and/or one of its subsidiaries.