NovoRapid

Insulin aspart.

FlexPen: Clear, colourless, aqueous solution for injection in pre-filled pen.
1 ml of the solution contains 100 U of insulin aspart* (equivalent to 3.5 mg).
1 pre-filled pen contains 3 ml equivalent to 300 U.
Penfill: Clear, colourless, aqueous solution for injection in cartridge.
1 ml of the solution contains 100 U of insulin aspart* (equivalent to 3.5 mg).
1 cartridge contains 3 ml equivalent to 300 U.
*Insulin aspart is produced by recombinant DNA technology in Saccharomyces cerevisiae.
Excipients/Inactive Ingredients: Glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, hydrochloric acid/sodium hydroxide (for pH adjustment) and water for injections.

Pharmacotherapeutic group: Drugs used in diabetes. Insulins and analogues for injection, fast-acting. ATC code: A10AB05.
Pharmacology: Pharmacodynamics: Mechanism of action and pharmacodynamic effects: The blood glucose lowering effect of insulin aspart is due to the facilitated uptake of glucose following binding of insulin to receptors on muscle and fat cells and to the simultaneous inhibition of glucose output from the liver.
NovoRapid produces a more rapid onset of action compared to soluble human insulin, together with a lower glucose concentration, as assessed within the first four hours after a meal. NovoRapid has a shorter duration of action compared to soluble human insulin after subcutaneous injection.
When NovoRapid is injected subcutaneously, the onset of action will occur within 10 to 20 minutes of injection. The maximum effect is exerted between 1 and 3 hours after injection. The duration of action is 3 to 5 hours.
Clinical efficacy: Clinical trials in patients with type 1 diabetes have demonstrated a lower postprandial blood glucose with NovoRapid compared to soluble human insulin. In two long-term open label trials in patients with type 1 diabetes comprising 1,070 and 884 patients, respectively, NovoRapid reduced glycated haemoglobin by 0.12 [95% C.I. 0.03; 0.22] percentage points and by 0.15 [95% C.I. 0.05; 0.26] percentage points compared to human insulin; a difference of limited clinical significance.
Clinical trials in patients with type 1 diabetes have demonstrated a reduced risk of nocturnal hypoglycaemia with insulin aspart compared to soluble human insulin. The risk of daytime hypoglycaemia was not significantly increased.
Insulin aspart is equipotent to soluble human insulin on a molar basis.
Special populations: Elderly (≥65 years old): A randomised, double-blind cross-over PK/PD trial comparing insulin aspart with soluble human insulin was performed in elderly patients with type 2 diabetes (19 patients aged 65-83 years, mean age 70 years). The relative differences in the pharmacodynamic properties (GIR_max, AUC_{GIR, 0-120 min}) between insulin aspart and soluble human insulin in the elderly were similar to those seen in healthy subjects and younger patients with diabetes.
Paediatric population: A clinical trial comparing preprandial soluble human insulin with postprandial insulin aspart was performed in small children (20 patients aged 2 to less than 6 years, studied for 12 weeks, among those four were younger than 4 years old) and a single dose PK/PD trial was performed in children (6-12 years) and adolescents (13-17 years). The pharmacodynamic profile of insulin aspart in children was similar to that seen in adults.
The efficacy and safety of NovoRapid given as bolus insulin in combination with either insulin detemir or insulin degludec as basal insulin have been studied for up to 12 months in two randomised controlled clinical trials in adolescents and children aged 1 to less than 18 years (n=712). The trials included 167 children aged 1-5 years, 260 aged 6-11 and 285 aged 12-17. The observed improvements in HbA_1c and the safety profiles were comparable between all age groups.
Pregnancy: A clinical trial comparing safety and efficacy of insulin aspart vs. human insulin in the treatment of pregnant women with type 1 diabetes (322 exposed pregnancies (insulin aspart: 157; human insulin: 165)) did not indicate any adverse effect of insulin aspart on pregnancy or on the health of the foetus/newborn.
In addition, the data from a clinical trial including 27 women with gestational diabetes randomised to treatment with insulin aspart vs. human insulin (insulin aspart: 14; human insulin: 13) showed similar safety profiles between treatments.
Pharmacokinetics: Absorption, distribution and elimination: 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 subcutaneous 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 ± 256 pmol/l was reached 40 (interquartile range: 30-40) minutes after a subcutaneous dose of 0.15 U/kg bodyweight in type 1 diabetic patients. The insulin concentrations returned to baseline about 4 to 6 hours after dose. The absorption rate was somewhat slower in type 2 diabetic patients, resulting in a lower C_max (352 ± 240 pmol/l) and later t_max (60 (interquartile range: 50-90) minutes). 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 C_max for NovoRapid is larger.
Special populations: Elderly (≥65 years old): The relative differences in pharmacokinetic properties between insulin aspart and soluble human insulin in elderly patients (65-83 years, mean age 70 years) 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 patients, resulting in a later t_max (82 (interquartile range: 60-120) minutes), whereas C_max was similar to that observed in younger patients with type 2 diabetes and slightly lower than in patients with type 1 diabetes.
Hepatic impairment: A single dose pharmacokinetic study of insulin aspart was performed in 24 subjects with hepatic function ranging from normal to severely impaired. In patients with hepatic impairment, absorption rate was decreased and more variable, resulting in delayed t_max from about 50 min in subjects with normal hepatic function to about 85 min in patients with moderate and severe hepatic impairment. AUC, C_max and CL/F were similar in patients with reduced hepatic function compared with subjects with normal hepatic function.
Renal impairment: A single dose pharmacokinetic study of insulin aspart in 18 subjects with renal function ranging from normal to severely impaired was performed. No apparent effect of creatinine clearance values on AUC, C_max, CL/F and t_max of insulin aspart was found. Data were limited in patients with moderate and severe renal impairment. Patients with renal failure necessitating dialysis treatment were not investigated.
Paediatric population: The pharmacokinetic and pharmacodynamic properties of NovoRapid were investigated in children (6-12 years) and adolescents (13-17 years) with type 1 diabetes. Insulin aspart was rapidly absorbed in both age groups, with similar t_max as in adults. However, C_max differed between the age groups, stressing the importance of the individual titration of NovoRapid.
Toxicology: Preclinical safety data: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity or toxicity to reproduction and development.
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.

Treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.

Posology: The potency of insulin analogues, including insulin aspart, is expressed in units (U), whereas the potency of human insulin is expressed in international units.
NovoRapid dosing is individual and determined in accordance with the needs of the patient. It should normally be used in combination with intermediate-acting or long-acting insulin. Blood glucose monitoring and insulin dose adjustment are recommended to achieve optimal glycaemic control.
The individual insulin requirement in adults and children is usually between 0.5 and 1.0 U/kg/day. In a basal-bolus treatment regimen, 50-70% of this requirement may be provided by NovoRapid and the remainder by intermediate-acting or long-acting insulin. Adjustment of dosage may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness.
Special populations: Elderly (≥65 years old): NovoRapid can be used in elderly patients.
In elderly patients, glucose monitoring should be intensified and the insulin aspart dose adjusted on an individual basis.
Renal and hepatic impairment: Renal or hepatic impairment may reduce the patient's insulin requirements.
In patients with renal or hepatic impairment, glucose monitoring should be intensified and the insulin aspart dose adjusted on an individual basis.
Paediatric population: NovoRapid can be used in children and adolescents aged 1 year and above in preference to soluble human insulin when a rapid onset of action might be beneficial, for example, in the timing of the injections in relation to meals (see Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions). The safety and efficacy of NovoRapid in children below 1 year of age have not been established. No data are available.
Transfer from other insulin medicinal products: When transferring from other insulin medicinal products, adjustment of the NovoRapid dose and the dose of the basal insulin may be necessary. NovoRapid has a faster onset and a shorter duration of action than soluble human insulin. When injected subcutaneously into the abdominal wall, the onset of action will occur within 10-20 minutes of injection. The maximum effect is exerted between 1 and 3 hours after the injection. The duration of action is 3 to 5 hours. Close glucose monitoring is recommended during the transfer and in the initial weeks thereafter (see Precautions).
Method of administration: NovoRapid is a rapid-acting insulin analogue. NovoRapid is administered subcutaneously by injection in the abdominal wall, the thigh, the upper arm, the deltoid region or the gluteal region. Injection sites should always be rotated within the same region in order to reduce the risk of lipodystrophy and cutaneous amyloidosis (see Precautions and Adverse Reactions). Subcutaneous injection in the abdominal wall ensures a faster absorption than other injection sites. Compared to soluble human insulin the faster onset of action of NovoRapid is maintained regardless of the injection site. The duration of action will vary according to the dose, injection site, blood flow, temperature and level of physical activity. Due to the faster onset of action, NovoRapid should generally be given immediately before a meal. When necessary NovoRapid can be given soon after a meal.
NovoRapid FlexPen is a pre-filled pen designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm. FlexPen delivers 1-60 U in increments of 1 U.
NovoRapid FlexPen is colour-coded and accompanied by a package leaflet with detailed instructions for use to be followed.
NovoRapid Penfill is designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
Intravenous use: NovoRapid may be administered intravenously under medical supervision. For emergency use with FlexPen or Penfill, the NovoRapid must first be withdrawn into a syringe. Discard pen or cartridge after emergency use. NovoRapid has been used intravenously. No studies have been conducted in critically ill people with diabetes who are likely to require intravenous administration. There is no pharmacokinetic or pharmacodynamic advantage in using NovoRapid over soluble human insulin when these insulins are given intravenously.
For intravenous use, infusion systems with NovoRapid 100 U/ml at concentrations from 0.05 U/ml to 1.0 U/ml insulin aspart in the infusion fluids 0.9% sodium chloride, 5% dextrose or 10% dextrose including 40 mmol/l potassium chloride using polypropylene infusion bags, are stable at room temperature for 24 hours.
Although stable over time, a certain amount of insulin will be initially adsorbed to the infusion bag. Monitoring of blood glucose is necessary during insulin infusion.

A specific overdose for insulin cannot be defined, however, hypoglycaemia may develop over sequential stages if too high doses relative to the patient's requirements are administered: Mild hypoglycaemic episodes can be treated by oral administration of glucose or sugary products. It is therefore recommended that the diabetic patient always carries sugar-containing products.
Severe hypoglycaemic episodes, where the patient has become unconscious, can be treated with glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a trained person, or with glucose given intravenously by physicians or other healthcare staff. Glucose must be given intravenously, if the patient does not respond to glucagon within 10 to 15 minutes.
Upon regaining consciousness, administration of oral carbohydrate is recommended for the patient in order to prevent a relapse.

Hypersensitivity to the active substance or any of the excipients.

Before travelling between different time zones, the patient must be advised since this may mean that the patient has to take the insulin and meals at different times.
Hyperglycaemia: Inadequate dosing or discontinuation of treatment, especially in type 1 diabetes, may lead to hyperglycaemia and diabetic ketoacidosis.
Usually the first symptoms of hyperglycaemia develop gradually over a period of hours or days. They include thirst, increased frequency of urination, nausea, vomiting, drowsiness, flushed dry skin, dry mouth, loss of appetite as well as acetone odour of breath. In type 1 diabetes, untreated hyperglycaemic events eventually lead to diabetic ketoacidosis, which is potentially lethal.
Hypoglycaemia: Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycaemia.
Especially in children, care should be taken to match insulin doses (especially in basal-bolus regimens) with food intake, physical activities and current blood glucose level in order to minimise the risk of hypoglycaemia.
Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement. In case of hypoglycaemia or if hypoglycaemia is suspected NovoRapid must not be injected. After stabilisation of patient's blood glucose adjustment of the dose should be considered (see Adverse Reactions and Overdosage).
Patients whose blood glucose control is greatly improved, e.g. by intensified insulin therapy, may experience a change in their usual warning symptoms of hypoglycaemia, and should be advised accordingly. Usual warning symptoms may disappear in patients with longstanding diabetes.
A consequence of the pharmacodynamics of rapid-acting insulin analogues is that if hypoglycaemia occurs, it may occur earlier after an injection when compared to soluble human insulin.
Since NovoRapid should be administered in immediate relation to a meal, the rapid onset of action should be considered in patients with concomitant diseases or treatment where a delayed absorption of food might be expected.
Concomitant illness, especially infections and feverish conditions, usually increases the patient's insulin requirements. Concomitant diseases of the kidney, liver or affecting the adrenal, pituitary or thyroid gland can require changes in the insulin dose.
When patients are transferred between different types of insulin medicinal products, the early warning symptoms of hypoglycaemia may change or become less pronounced than those experienced with their previous insulin.
Transfer from other insulin medicinal products: Transferring a patient to another type or brand of insulin should be done under strict medical supervision. Changes in strength, brand (manufacturer), type, origin (animal, human insulin or human insulin analogue) and/or method of manufacture (recombinant DNA versus animal source insulin) may result in the need for a change in dose. Patients transferred to NovoRapid from another type of insulin may require an increased number of daily injections or a change in dose from that used with their usual insulin medicinal products. If an adjustment is needed, it may occur with the first dose or during the first few weeks or months.
Injection site reactions: As with any insulin therapy, injection site reactions may occur and include pain, redness, hives, inflammation, bruising, swelling and itching. Continuous rotation of the injection site within a given area reduces the risk of developing these reactions. Reactions usually resolve in a few days to a few weeks. On rare occasions, injection site reactions may require discontinuation of NovoRapid.
Skin and subcutaneous tissue disorders: Patients must be instructed to perform continuous rotation of the injection site to reduce the risk of developing lipodystrophy and cutaneous amyloidosis. There is a potential risk of delayed insulin absorption and worsened glycaemic control following insulin injections at sites with these reactions. A sudden change in the injection site to an unaffected area has been reported to result in hypoglycaemia. Blood glucose monitoring is recommended after the change in the injection site from an affected to an unaffected area, and dose adjustment of antidiabetic medications may be considered.
Combination of NovoRapid with pioglitazone: Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin, especially in patients with risk factors for development of cardiac heart failure. This should be kept in mind if treatment with the combination of pioglitazone and NovoRapid is considered. If the combination is used, patients should be observed for signs and symptoms of heart failure, weight gain and oedema. Pioglitazone should be discontinued if any deterioration in cardiac symptoms occurs.
Avoidance of accidental mix-ups/medication errors: Patients must be instructed to always check the insulin label before each injection to avoid accidental mix-ups between NovoRapid and other insulin products.
Insulin antibodies: Insulin administration may cause insulin antibodies to form. In rare cases, the presence of such insulin antibodies may necessitate adjustment of the insulin dose in order to correct a tendency to hyper- or hypoglycaemia.
Traceability: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Effects on ability to drive and use machines: The patient's ability to concentrate and react may be impaired as a result of hypoglycaemia. This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or operating machinery).
Patients should be advised to take precautions to avoid hypoglycaemia while driving. This is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycaemia or have frequent episodes of hypoglycaemia. The advisability of driving should be considered in these circumstances.

Pregnancy: NovoRapid (insulin aspart) can be used in pregnancy. Data from two randomised controlled clinical trials (322 and 27 exposed pregnancies) do not indicate any adverse effect of insulin aspart on pregnancy or on the health of the foetus/newborn when compared to human insulin (see Pharmacology: Pharmacodynamics under Actions).
Intensified blood glucose control and monitoring of pregnant women with diabetes (type 1 diabetes, type 2 diabetes or gestational diabetes) are recommended throughout pregnancy and when contemplating pregnancy. Insulin requirements usually fall in the first trimester and increase subsequently during the second and third trimesters. After delivery, insulin requirements normally return rapidly to pre-pregnancy values.
Breast-feeding: There are no restrictions on treatment with NovoRapid during breast-feeding. Insulin treatment of the nursing mother presents no risk to the baby. However, the NovoRapid dose may need to be adjusted.
Fertility: Animal reproduction studies have not revealed any differences between insulin aspart and human insulin regarding fertility.

Summary of the safety profile: Adverse reactions observed in patients using NovoRapid are mainly due to the pharmacologic effect of insulin.
The most frequently reported adverse reaction during treatment is hypoglycaemia. The frequencies of hypoglycaemia vary with patient population, dose regimens and level of glycaemic control, see Description of selected adverse reactions as follows.
At the beginning of the insulin treatment, refraction anomalies, oedema and injection site reactions (pain, redness, hives, inflammation, bruising, swelling and itching at the injection site) may occur. These reactions are usually of transitory nature. Fast improvement in blood glucose control may be associated with acute painful neuropathy, which is usually reversible. Intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy, while long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
Tabulated list of adverse reactions: Adverse reactions listed as follows are based on clinical trial data and classified according to MedDRA frequency and System Organ Class. Frequency categories are defined according to the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data). (See table.)

Click on icon to see table/diagram/image

Description of selected adverse reactions: Anaphylactic reactions: The occurrence of generalised hypersensitivity reactions (including generalised skin rash, itching, sweating, gastrointestinal upset, angioneurotic oedema, difficulties in breathing, palpitation and reduction in blood pressure) is very rare but can potentially be life-threatening.
Hypoglycaemia: The most frequently reported adverse reaction is hypoglycaemia. It may occur if the insulin dose is too high in relation to the insulin requirement. Severe hypoglycaemia may lead to unconsciousness and/or convulsions and may result in temporary or permanent impairment of brain function or even death. The symptoms of hypoglycaemia usually occur suddenly. They may include cold sweats, cool pale skin, fatigue, nervousness or tremor, anxiousness, unusual tiredness or weakness, confusion, difficulty in concentration, drowsiness, excessive hunger, vision changes, headache, nausea and palpitation.
In clinical trials, the frequency of hypoglycaemia varied with patient population, dose regimens and level of glycaemic control. During clinical trials the overall rates of hypoglycaemia did not differ between patients treated with insulin aspart compared to human insulin.
Skin and subcutaneous tissue disorders: Lipodystrophy (including lipohypertrophy, lipoatrophy) and cutaneous amyloidosis may occur at the injection site and delay local insulin absorption. Continuous rotation of the injection site within the given injection area may help to reduce or prevent these reactions (see Precautions).
Paediatric population: Based on post-marketing sources and clinical trials, the frequency, type and severity of adverse reactions observed in the paediatric population do not indicate any differences to the broader experience in the general population.
Other special populations: Based on post-marketing sources and clinical trials, the frequency, type and severity of adverse reactions observed in the elderly patients and in patients with renal or hepatic impairment do not indicate any differences to the broader experience in the general population.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.

A number of medicinal products are known to interact with the glucose metabolism.
The following substances may reduce the patient's insulin requirements: Oral antidiabetic medicinal products, monoamine oxidase inhibitors (MAOIs), beta-blockers, angiotensin converting enzyme (ACE) inhibitors, salicylates, anabolic steroids and sulfonamides.
The following substances may increase the patient's insulin requirements: Oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics, growth hormone and danazol.
Beta-blocking agents may mask the symptoms of hypoglycaemia.
Octreotide/lanreotide may either increase or decrease the insulin requirements.
Alcohol may intensify or reduce the hypoglycaemic effect of insulin.

Special precautions for disposal and other handling: Needles and NovoRapid FlexPen or Penfill must not be shared. The cartridge must not be refilled.
NovoRapid must not be used if it does not appear clear and colourless or if it has been frozen.
The patient should be advised to discard the needle after each injection.
In case of emergency in current NovoRapid users (hospitalisation or insulin pen malfunction), NovoRapid can be withdrawn with an U100 insulin syringe from the FlexPen or cartridge.
Incompatibilities: Substances added to NovoRapid may cause degradation of insulin aspart.
This product must not be diluted or mixed with other products, except infusion fluids as described in Posology under Dosage & Administration.

Before opening: Store in a refrigerator (2°-8°C). Keep away from the cooling element.
During use or when carried as a spare: Store below 30°C. Use within 4 weeks.
Do not freeze.
Keep the pen cap on NovoRapid FlexPen or cartridge in the outer carton in order to protect from light.
NovoRapid must be protected from excessive heat and light.
FlexPen: Can be stored in a refrigerator (2°C-8°C).
Penfill: Do not refrigerate.

Instructions on how to use NovoRapid solution for injection in FlexPen: Read the following instructions carefully before using your FlexPen. If you do not follow the instructions carefully, you may get too little or too much insulin, which can lead to too high or too low blood sugar level.
Your FlexPen is a pre-filled dial-a-dose insulin pen. You can select doses from 1 to 60 units in increments of 1 unit. FlexPen is designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm. As a precautionary measure, always carry a spare insulin delivery device in case your FlexPen is lost or damaged.
Caring for your pen: Your FlexPen must be handled with care.
If it is dropped, damaged or crushed, there is a risk of insulin leakage. This may cause inaccurate dosing, which can lead to too high or too low blood sugar level.
You can clean the exterior of your FlexPen by wiping it with a medicinal swab. Do not soak it, wash or lubricate it as it may damage the pen.
Do not refill your FlexPen. Once empty, it must be disposed of.
Preparing your NovoRapid FlexPen: Check the name and coloured label of your pen to make sure that it contains the correct type of insulin. This is especially important if you take more than one type of insulin. If you take the wrong type of insulin, your blood sugar level may get too high or too low.
Pull off the pen cap.
Remove the paper tab from a new disposable needle. Screw the needle straight and tightly onto your FlexPen.
Pull off the big outer needle cap and keep it for later.
Pull off the inner needle cap and dispose of it. Never try to put the inner needle cap back on the needle. You may stick yourself with the needle.
Always use a new needle for each injection. This reduces the risk of contamination, infection, leakage of insulin, blocked needles and inaccurate dosing.
Be careful not to bend or damage the needle before use.
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 units.
Hold your FlexPen with the needle pointing upwards and tap the cartridge gently with your 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 you must use a new one.
Always make sure that a drop appears at the needle tip before you inject. This makes sure that the insulin flows. If no drop appears, you will not inject any insulin, even though the dose selector may move. This may indicate a blocked or damaged needle.
Always check the flow before you inject. If you do not check the flow, you may get too little insulin or no insulin at all. This may lead to too high blood sugar level.
Selecting your dose: Check that the dose selector is set at 0.
Turn the dose selector to select the number of units you need 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. You cannot select a dose larger than the number of units left in the cartridge.
Always use the dose selector and the pointer to see how many units you have selected before injecting the insulin.
Do not count the pen clicks. If you select and inject the wrong dose, your blood sugar level may get too high or too low. Do not use the residual scale, it only shows approximately how much insulin is left in your pen.
Further important information: Caregivers must be very careful when handling used needles - to reduce the risk of needle sticks and cross-infection.
Dispose of your used FlexPen carefully without the needle attached.
Never share your pen or your needles with other people. It might lead to cross-infection.
Never share your pen with other people. Your medicine might be harmful to their health.
Always keep your pen and needles out of sight and reach of others, especially children.
Making the injection: Insert the needle into your skin. Use the injection technique shown by your 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 and let the needle remain under the skin for at least 6 seconds. This will make sure you get the full dose. Withdraw the needle from the skin, then release the pressure on the push-button. Always make sure that the dose selector returns to 0 after the injection. If the dose selector stops before it returns to 0, the full dose has not been delivered, which may result in too high blood sugar level .
Lead the needle into the big outer needle cap without touching it. 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 your FlexPen without the needle attached. This reduces the risk of contamination, infection, leakage of insulin, blocked needles and inaccurate dosing.
NovoRapid solution for injection in cartridge: Penfill: Instructions for Use for the Patient: Do not use NovoRapid: If you are allergic (hypersensitive) to insulin aspart or any of the other ingredients in NovoRapid.
If you suspect hypoglycaemia (low blood sugar) is starting.
If the cartridge or the device containing the cartridge is dropped, damaged or crushed.
If it has not been stored correctly or if it has been frozen.
If the insulin does not appear clear and colourless.
Before using NovoRapid: Check the label to make sure it is the right type of insulin.
Always check the cartridge, including the rubber stopper. Do not use it if any damage is seen or if there is a gap between the rubber stopper and the white label band. Take it back to your supplier. See your delivery system manual for further instructions.
Always use a new needle for each injection to prevent contamination.
Needles and NovoRapid Penfill must not be shared.
Method of administration: NovoRapid is for injection under the skin (subcutaneously). NovoRapid may also be given directly into a vein (intravenously) by healthcare professionals. Never inject your insulin directly into a muscle (intramuscular).
Always vary the sites you inject within the same region to reduce the risk of developing lumps or skin pitting. The best places to give yourself an injection are: the front of your waist (abdomen); the upper arm or the front of your thighs. The insulin will work more quickly if injected into the waist. You should measure your blood sugar regularly.
How to inject this insulin: Inject the insulin under the skin. Use the injection technique advised by your doctor or nurse and as described in your delivery system manual.
Keep the needle under your skin for at least 6 seconds. Keep the push-button fully depressed until the needle has been withdrawn. This will ensure correct delivery and limit possible flow of blood into the needle or insulin reservoir.
After each injection be sure to remove and discard the needle and store NovoRapid without the needle attached. Otherwise the liquid may leak out which can cause inaccurate dosing.
Do not refill the cartridge.
NovoRapid Penfill is designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
If you are treated with NovoRapid Penfill and another insulin Penfill cartridge, you should use two insulin delivery systems, one for each type of insulin.
As a precautionary measure, always carry a spare insulin delivery system in case your Penfill is lost or damaged.

Insulin Preparations

A10AB05 - insulin aspart ; Belongs to the class of fast-acting insulins and analogues. Used in the treatment of diabetes.

P₁