what is NOVORAPID FLEXPEN 100 U ml Insulin?
NOVORAPID FLEXPEN 100 U ml Insulin is an insulin analogue quick action.
Dosage of NOVORAPID FLEXPEN 100 U ml Insulin is individual and is determined by the patient’s needs. Generally, NovoRapid is used in combination with a long-acting insulin or intermediate, administered at least once per day. Glycemic control and adjustment of the insulin dosage are recommended to achieve optimal glycemic control.
The individual insulin requirement in adults and in children is usually between 0.5 and 1.0 U / kg / day. When administered in a basal-bolus regimen of 50 to 70% of these needs can be provided by NovoRapid and the remainder by insulin prolonged or intermediate action. Adjustment of dosage may also be necessary if patients change physical activity, diet or during concomitant illness.
As with all insulins, it is necessary to intensify glycemic control and dose adjustments of insulin aspart individually in elderly patients and patients with renal or hepatic impairment.
Use in children
No studies have been conducted in children under 2 years. NovoRapid may be used in these patients only under careful medical supervision.
In children, NOVORAPID FLEXPEN 100 U ml Insulin may be preferred to soluble human insulin in cases where a rapid onset of action can be useful for example, to plan the injections in relation to meals (see section Pharmacodynamics and Pharmacokinetics)
Transfer from other insulins
NOVORAPID FLEXPEN 100 U ml Insulin has a faster onset of action and a shorter duration of action than soluble human insulin. In case of subcutaneous injection in the abdominal wall, the onset of action within 10-20 minutes after injection. The maximum effect is exerted between 1 to 3 hours after injection. Its duration of action is 3 to 5 hours.
Because of its faster onset of action, NOVORAPID FLEXPEN 100 U ml Insulin should generally be given immediately before a meal. If necessary, NovoRapid can be given soon after a meal. Whatever the injection site, the onset of action more rapid than that of human insulin. A dose adjustment of NovoRapid and basal insulin may be necessary when transferring from other insulin.
Administration with FlexPen:
NovoRapid FlexPen is a pre-filled pen designed to be used with NovoFine or NovoTwist needles.
FlexPen delivers 1-60 units in increments of 1 unit.
NovoRapid FlexPen is color coded and accompanied by a package leaflet with instructions must be followed.
NovoRapid is administered subcutaneously by injection in the abdominal wall, thigh, upper arm, the deltoid region or the fessière.Une rotation of injection sites area should always be done within the same region. As with all insulins, the absorption is faster if the injection is done subcutaneously in the abdominal wall rather than another injection site. The duration of action varies according to the dose, injection site, blood flow, temperature and intensity of physical activity.
Perfusion continuous subcutaneous insulin (CSII):
NovoRapid can be administered by infusion continuous subcutaneous insulin (CSII) using an insulin infusion pump. CSII should be administered in the abdominal wall. Infusion sites should be rotated.
When used with an insulin infusion pump, NOVORAPID FLEXPEN 100 U ml Insulin should not be mixed with any other insulin.
Patients treated with CSII will receive detailed instructions on the use of the pump and use the correct reservoir and tubing for the pump (see Special precautions for disposal and handling). The infusion set (tubing and cannula) should be replaced according to the instructions in the attached information sheet with the infusion set.
Administering NovoRapid by CSII must have an alternative insulin available in case of pump failure.
If necessary, NOVORAPID FLEXPEN 100 U ml Insulin may also be administered by intravenous injection by healthcare professionals.
Intravenous infusion systems with NovoRapid 100 U / ml insulin aspart concentrations from 0.05 U / mL to 1.0 U / ml in sodium chloride infusion fluids 0.9 percent to 5 or 10 percent glucose 40 mmol / l potassium chloride are stable at room temperature for 24 hours in polypropylene infusion bags.
Although stable over time, a certain amount of insulin will be initially adsorbed from the start to the infusion bag. Blood glucose should be monitored during insulin infusion.
Hypersensitivity to the active substance or to any of the excipients
Adverse effects NOVORAPID FLEXPEN 100 U ml Insulin
Adverse events observed in patients using NOVORAPID FLEXPEN 100 U ml Insulin are generally dose-dependent and due to the pharmacologic effect of insulin.
Hypoglycemia is a side effect that frequently occurs. This occurs when the insulin dose is too high in relation to the insulin requirement. Severe hypoglycemia may lead to unconsciousness and / or convulsions and may result in temporary or permanent impairment of brain function or even death.
In clinical trials and post marketing, the frequency of hypoglycaemia varied with patient population and dose used, that is why it is not possible to evaluate it. In clinical trials, the overall rates of hypoglycaemia did not differ between patients treated with insulin aspart and those treated with human insulin.
Adverse reactions listed below are classified according to frequency and system organ classification. Frequency categories are defined using the following convention: very common (≥ 1/10); Common (≥ 1/100 to <1/10); uncommon (≥ 1/1 000 to ≤ 1/100); rare (≥ 1/10 to 000 1/1 ≤ 000); very rare (≤ 1/10 000), undetermined (can not be estimated from the available data).
Rare – Peripheral neuropathy
A rapid improvement in glycemic control may be associated with a condition termed “acute painful neuropathy”, which is usually reversible.
Uncommon – Refraction disorders
Of refractive errors can occur at the start of insulin therapy. These symptoms are usually transient.
Uncommon – Diabetic retinopathy
The long-term glycemic control decreases the risk of progression of diabetic retinopathy. However, intensification of insulin therapy with abrupt improvement in glycemic control may be associated with temporary worsening of diabetic retinopathy.
Skin and subcutaneous tissue
Uncommon – Lipodystrophy
The appearance of lipodystrophy at the injection site as the rotate injection sites within a region is not respected.
Uncommon – Local hypersensitivity
Local hypersensitivity reactions (pain, redness, hives, inflammation, swelling and itching at the injection site) may occur during treatment with insulin. These reactions are usually transitory and disappear during continued treatment.
General disorders and administration site
Uncommon – Oedema
Swelling may occur upon initiation of insulin therapy. These symptoms are usually transient.
Immune system disorders
Uncommon – Urticaria, rash, eruptions
Very rare – Anaphylactic reactions
Symptoms of generalized hypersensitivity may include generalized skin rash, itching, sweating, gastrointestinal upset, angioneurotic edema, difficulty breathing, palpitations and decreased blood pressure. Generalised hypersensitivity reactions may be life threatening.