oreFIASP® FlexTouch® without a needle attached.
Thisprevents contamination and/or infection, or leakage ofinsulin, and will ensure accurate dosing. Always use anew needle for each injection to prevent contamination.
The storage conditions for vials and FIASP® FlexTouch® pens aresummarized in Table 9:
Table 9. Storage Conditions for Vial, FIASP® FlexTouch,
and PenFill® Cartridges
FIASP®
presentation Not in-use (unopened) In-use (opened)
Room
Temperature
(below 30°C)
Refrigerated
(2°C to 8°C)
Room
Temperature
(below 30°C)
Refrigerated
(2°C to 8°C)
10 mL vial 28 days Until expiration
date 28 days 28 days
3 mL FIASP®
FlexTouch® 28 days Until expiration
date 28 days 28 days
3 mL PenFill®
cartridges 28 days Until expiration
date 28 days Do not
refrigerate
Storage of FIASP® in Intravenous Infusion Fluids:
Infusion bags prepared as indicated under Dosage and Administration
(2.2) are stable at room temperature for 24 hours.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-Approved Patient Labeling(Patient Information and Instructions for Use).Never Share a FIASP® FlexTouch® Pen Device, PenFill® Cartridgeor PenFill® Cartridge Device Between PatientsAdvise patients that they should never share a FIASP® FlexTouch®pen device, PenFill® cartridge or PenFill® cartridge devices withanother person, even if the needle is changed, because doing socarries a risk for transmission of blood-borne pathogens. Advisepatients using FIASP® vials not to share needles or syringeswith another person. Sharing poses a risk for transmission ofblood-borne pathogens [see Warnings and Precautions (5.1)].
Hypoglycemia
Inform patients that hypoglycemia is the most common adversereaction with insulin. Instruct patients on self-managementprocedures including glucose monitoring, proper injectiontechnique, and management of hypoglycemia and hyperglycemia,especially at initiation of FIASP® therapy. Instruct patients onhandling of special situations such as intercurrent conditions(illness, stress, or emotional disturbances), an inadequate orskipped insulin dose, inadvertent administration of an increased
insulin dose, inadequate food intake, and skipped meals. Instructpatients on the management of hypoglycemia [see Warnings andPrecautions (5.3)].
Inform patients that their ability to concentrate and react may beimpaired as a result of hypoglycemia. Advise patients who havefrequent hypoglycemia or reduced or absent warning signs of hypoglycemiato use caution when driving or operating machinery.
Hypersensitivity Reactions
Advise patients that hypersensitivity reactions have occurred withFIASP®. Inform patients on the symptoms of hypersensitivityreactions [see Warnings and Precautions (5.6)].
Hypoglycemia due to Medication Errors
Instruct patients to always check the insulin label before eachinjection to avoid mix-ups between insulin products.
Women of Reproductive Potential
Advise patients to inform their health care professional if they arepregnant or are contemplating pregnancy.
Administration
FIASP® must only be used if the solution is clear and colorless withno particles visible. Patients must be advised that FIASP® must NOT be diluted or mixed with any other insulin or solution [see Dosageand Admi |
