NOVORAPID FLEX TOUCH Insulin Aspart 100IU / mL Solution for IV/SC Injection 3mL 5's
length of 8 mm. As a precautionary measure, always carry a spare insulin delivery device in case FlexPen is lost or damaged.
Preparing NovoRapid: Check the label to make sure that NovoRapid FlexPen contains the correct type of insulin. Pull off the pen cap. Disinfect the rubber membrane with a medicinal swab. Remove the protective tab from a new disposable needle. Screw the needle straight and tightly onto FlexPen. Pull off the big outer needle cap and keep it for later. Pull off the inner cap and dispose of it.
Always use a new needle for each injection to prevent contamination. Be careful not to bend or damage the needle before use. To reduce the risk of unexpected needle sticks, never put the inner needle cap back on when removing it from the needle.
Checking the Insulin Flow: Prior to each injection, small amounts of air may collect in the cartridge during normal use. To avoid injection of air and ensure proper dosing: Turn the dose selector to select 2 U. Hold FlexPen with the needle pointing upwards and tap the cartridge gently with a finger a few times to make any air bubbles collect at the top of the cartridge. Keeping the needle upwards, press the push-button all the way in. The dose selector returns to 0. A drop of insulin should appear at the needle tip. If not, change the needle and repeat the procedure no more than 6 times. If a drop of insulin still does not appear, the pen is defective and a new one must be used.
Selecting the Dose: Check that the dose selector is set at 0. Turn the dose selector to select the number of units needed to inject. The dose can be corrected either up or down by turning the dose selector in either direction until the correct dose lines up with the pointer. When turning the dose selector, be careful not to push the push-button as insulin will come out. A dose larger than the number of units left in the cartridge cannot be selected. Do not use the residual scale to measure the dose of insulin.
Making the Injection: Insert the needle into the skin. Use the injection technique shown by the doctor or nurse. Inject the dose by pressing the push-button all the way in until 0 lines up with the pointer. Be careful only to push the push-button when injecting. Turning the dose selector will not inject insulin. Keep the push-button fully depressed after the injection until the needle has been withdrawn from the skin. The needle must remain under the skin for at least 6 sec. This will ensure that the full dose has been injected. Lead the needle into the big outer needle cap without touching the big outer needle cap. When the needle is covered, carefully push the big outer needle cap completely on and then unscrew the needle.
Dispose of it carefully and put the pen cap back on.
Always remove the needle after each injection and store NovoRapid FlexPen without the needle attached. Otherwise, the liquid may leak out which can cause inaccurate dosing.
Caregivers should be most careful when handling used needles to avoid needle sticks.
Dispose of the used FlexPen carefully without the needle attached.
Do not share NovoRapid with anyone else.
Maintenance: NovoRapid FlexPen is designed to work accurately and safely. It must be handled with care. If it is dropped or crushed, there is a risk of damage and leakage of insulin. Clean the exterior part of NovoRapid FlexPen by wiping it with medicinal swab. Do not soak, wash or lubricate it as it may damage the pen. Do not refill the FlexPen.
Storage
Store in a refrigerator (2-8°C). Do not freeze.
Keep the cap on when NovoRapid FlexPen is not in use in order to protect from light. NovoRapid must be protected from excessive heat and light.
NovoRapid FlexPen in Use or Carried as a Spare: Do not refrigerate. Do not store above 30°C.
Shelf-Life: 30 months; 4 weeks (in-use).
Action
Pharmacotherapeutic Group: Insulins and analogues for injection, fast-acting. ATC Code: A10AB05.
Pharmacology: Pharmacodynamics: Mechanism of Action: NovoRapid produces a more rapid onset of action compared to soluble human insulin, together with a lower glucose concentration, as assessed within the first 4 hrs after a meal. It has a shorter duration of action compared to soluble human insulin after SC injection.
When NovoRapid is injected SC, the onset of action will occur within 10-20 min of injection. The maximum effect is exerted between 1 and 3 hrs after injection. The duration of action is 3-5 hrs.
Adults: Clinical trials in patients with type 1 diabetes have demonstrated a lower postprandial blood glucose with NovoRapid compared to soluble human insulin. In 2 long-term, open-label trials in patients with type 1 diabetes comprising 1,070 patients and 884 patients, respectively, NovoRapid reduced glycosylated hemoglobin by 0.12 percentage points and by 0.15 percentage points compared to soluble human insulin, a difference of doubtful clinical significance.
Elderly: In a pharmacokinetic/pharmacodynamic (PK/PD) trial the relative differences in the PD properties between insulin aspart and soluble human insulin in the elderly patients with type 2 diabetes were similar to those seen in healthy subjects and younger patients with diabetes.
Children and Adolescents: When given to children, NovoRapid showed similar long-term glucose control compared to soluble human insulin.
In clinical trials for children and adolescents 2-17 years, the pharmacodynamic profile of insulin aspart in children was similar to that seen in adults.
Clinical trials in patients with type 1 diabetes have demonstrated a reduced risk of nocturnal hypoglycemia with insulin aspart compared to soluble human insulin. The risk of daytime hypoglycemia was not significantly increased.
Pregnancy: A clinical trial comparing safety and efficacy of insulin aspart versus soluble human insulin in the treatment of pregnant women with type 1 diabetes (322 exposed pregnancies) did not indicate any adverse effect of insulin aspart on pregnancy or on the health of the fetus/newborn.
In addition, the data from a clinical trial including 27 women with gestational diabetes randomized to treatment with insulin aspart versus soluble human insulin showed similar safety profiles between treatments as well as a significant improvement in postprandial glucose control in the insulin aspart-treated group.
Pharmacokinetics: In NovoRapid, substitution of amino acid proline with aspartic acid at position B28 reduces the tendency to form hexamers as observed with soluble human insulin. NovoRapid is therefore more rapidly absorbed from the SC layer compared to soluble human insulin.
The time to maximum concentration is, on average, half of that for soluble human insulin. A mean maximum plasma concentration of 492 pmol/L was reached 40 min after an SC dose of 0.15 U/kg in type 1 diabetic patients. The insulin concentrations returned to baseline about 4-6 hrs after dose. The absorption rate was somewhat slower in type 2 diabetic patients, resulting in a lower Cmax (352±240 pmol/L) and later tmax (60 min). The intra-individual variability in time to maximum concentration is significantly less for NovoRapid than for soluble human insulin, whereas the intra-individual variability in Cmax for NovoRapid is larger.
Children and Adolescents: The pharmacokinetic and pharmacodynamic properties of NovoRapid were investigated in children and adolescents with type 1 diabetes. Insulin aspart was rapidly absorbed in both age groups with similar tmax as in adults. However, Cmax differed between the age groups, stressing the importance of the individual titration of NovoRapid.
Elderly: The relative differences in pharmacokinetic properties between insulin aspart and soluble human insulin in elderly patients with type 2 diabetes were similar to those observed in healthy subjects and in younger patients with diabetes. A decreased absorption rate was observed in elderly subjects, resulting in a later tmax (82 min), whereas Cmax was similar to that observed in younger subjects with type 2 diabetes and slightly lower than in subjects with type 1 diabetes.
Hepatic Impairment: In subjects with hepatic impairment, tmax was delayed to about 85 min (50 min in subjects with normal hepatic function) while AUC, Cmax and CL/F were similar.
Renal Impairment: A single dose pharmacokinetic study of insulin aspart in 18 subjects with normal to severely impaired renal function was performed. No apparent effect of creatinine clearance values on AUC, Cmax, CL/F and tmax of insulin aspart was found. Data were limited in subjects with moderate and severe renal impairment.
Subjects with renal failure necessitating dialysis treatment were not investigated.
Toxicology: Preclinical Safety Data: Nonclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated-dose toxicity, genotoxicity and toxicity to reproduction.
In in vitro tests, including binding to insulin and IGF-1 receptor sites and effects on cell growth, insulin aspart behaved in a manner that closely resembled human insulin. Studies also demonstrate that the dissociation of binding to the insulin receptor of insulin aspart is equivalent to human insulin.
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Features
- Insulin Aspart