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Common name
NovoRapid FlexPen (Insulin Aspart [rDNA origin] injection)
Description
NovoRapid is a clear, colourless solution for subcutaneous injection. NovoRapid FlexPen is a 3mL prefilled glass cartridge contained in a dial-a-dose insulin pen. NovoRapid contains insulin aspart (rys) 100 units per mL (100 U/mL) as the active ingredient. The abbreviation rys indicates the method of genetic engineering used to manufacture the insulin aspart.
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Active Ingredients:
Insulin Aspart [rDNA origin] injection
Therapeutic actions:
Pharmacotherapeutic group: insulins and analogues, fast-acting. ATC code A10A B05. The blood glucose lowering effect of insulin occurs when the molecules facilitate the uptake of glucose by binding to insulin receptors on muscle and fat cells - and simultaneously inhibit the output of glucose 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 1020 minutes of injection.
The maximum effect is exerted between 1 and 3 hours after injection.
The duration of action is 3 to 5 hours. In NovoRapid substitution of the 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: 3040) 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 Cmax (352±240 pmol/l) and later tmax (60 (interquartile range: 5090) 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 Cmax for NovoRapid is larger.
What is it used for?:
(Indications:)
The insulin aspart, or NovoRapid, in NovoRapid FlexPen is a rapid-acting insulin used to treat diabetes mellitus. Diabetes mellitus is a condition where your pancreas does not produce enough insulin to control your blood sugar (glucose) level. Extra insulin is therefore needed.
NovoRapid lowers your blood sugar level after injection. When injected under your skin, NovoRapid has a faster onset of action than soluble human insulin. It takes effect within 10 to 20 minutes. As with all insulins, the duration of action will vary according to the dose, injection site, blood flow, temperature and level of physical activity.
Usually, the maximum effect will occur between 1-3 hours after injection and the effect may last for up to 5 hours. Due to its shorter duration of action, NovoRapid has a lower risk of causing nocturnal hypoglycaemic episodes. FlexPen is a pre-filled dial-a-dose insulin pen able to deliver from 1 to 60 units of NovoRapid in increments of 1 unit.
Contraindications and cautions:
Before you start to use it Tell your doctor if you:
are pregnant or planning to become pregnant
are breast-feeding or planning to breast-feed
plan to have surgery
think you may have allergies to insulin aspart or any of the ingredients T
ell your doctor if you have or have had any medical conditions, especially the following:
kidney problems
liver problems
gastrointestinal problems
Side effects:
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects. Hypoglycaemia NovoRapid may cause hypoglycaemia.
Allergy Some people may notice redness, swelling and itching at the site of injection (local allergy). Usually these symptoms disappear within a few weeks during continued use. If the symptoms do not disappear, spread to other parts of your body or if you suddenly feel sick (i.e. sweating, vomiting, breathing difficulties, rapid heart beat, feeling dizzy), you should contact your doctor immediately.
You may have a general allergic reaction which is rare but could be serious. Other When you first start your insulin treatment you may get visual problems or swollen hands and feet. If you inject too often in the same site, this may result in skin changes (called lipodystrophy).
To avoid this, you should change your injection site regularly as shown to you by your doctor or diabetes educator. Tell your doctor or pharmacist as soon as possible if you notice any side effects or do not feel well while you are using NovoRapid FlexPen.
Interactions:
Your dose of insulin may need to change if you take other medicines.
Tell your doctor if you are currently taking any medicines, especially the following:
oral hypoglycaemic agents - used for the treatment of noninsulin dependent diabetes (type 2 diabetes)
monoamine oxidase inhibitors (MAOI) - used for the treatment of depression
alpha-blocking agents - used for the treatment of high blood pressure and to relieve difficulty in passing urine caused by an enlarged prostate
non-selective beta-blocking agents - used for the treatment of certain heart conditions and high blood pressure
angiotensin converting enzyme (ACE) inhibitors - used for the treatment of certain heart conditions, high blood pressure or elevated protein/albumin in the urine
salicylates e.g. aspirin - used to relieve pain and lower fever
anabolic steroids used to promote growth
glucocorticoids (except when applied locally) used to treat inflammatory conditions
oral contraceptives (the pill) - used for birth control
thiazides, frusemide or ethacrynic acid - used for the treatment of high blood pressure or fluid retention (oedema)
thyroid hormones - used for the treatment of malfunction of the thyroid gland
sympathomimetics - used for the treatment of asthma
sulphonamides used to treat bacterial infections
Or other specific medicines including:
danazol - used to treat certain female conditions
oxymetholone used to treat certain blood disorders
octreotide - used to treat gastrointestinal endocrine tumours
diazoxide - used for the treatment of high blood pressure
nicotinic acid - used for the treatment of high cholesterol levels in the blood
asparaginase - used to treat leukaemia and lymph gland tumours
quinine used for the prevention of malaria and the relief of muscle cramps
quinidine used for the control of heart problems
growth hormone used to treat persons with growth hormone deficiency
Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.
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