Microsoft word - novorapid pi v25 mar 2012.doc

PRESCRIBING INFORMATION
within an area may help reduce or prevent these reactions. Rarely injection site reactions may require discontinuation NovoRapid®
of NovoRapid®. Hypoglycaemia may constitute a risk when driving or operating machinery. NovoRapid® must not be mixed with other medicinal products except for NPH (Neutral Protamine Hagedorn) insulin and some infusion fluids. Cases of cardiac failure were reported when pioglitazone was used in combination with insulin, especially in patients with risk factors for development of cardiac heart failure. If the combination of pioglitazone All presentations contain insulin aspart 100 U/ml and NovoRapid® is used, patients should be observed for signs and symptoms of heart failure, weight gain and All available in a strength of 100 U/ml; each device oedema. Pioglitazone should be discontinued if any contains 3 ml. NovoRapid® FlexPen® and NovoRapid® deterioration in cardiac symptoms occurs.
FlexTouch® are disposable pre-filled pens able to deliver 1-60 units and 1-80 units respectively, in increments of Fertility, pregnancy and lactation: NovoRapid® can
1 unit. NovoRapid® FlexPen®, NovoRapid® FlexTouch® be used in pregnancy. No restrictions on use during Indication: Treatment of diabetes mellitus in adults and
Undesirable effects: Very common (≥1/10); common
adolescents and children aged 2 to 17 years. (≥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), Posology
administration:
not known (cannot be estimated from the available subcutaneous injection. It should normally be used in data). Common: Hypoglycaemia; Uncommon: Refraction combination with intermediate or long-acting insulin anomalies on instituting therapy, diabetic retinopathy given at least once a day. NovoRapid® has a faster onset with intensification may result in temporary worsening, and a shorter duration of action than soluble human lipodystrophy, oedema and urticaria, rash and eruptions, insulin and should generally be given immediately before local hypersensitivity reactions which are usually a meal. When necessary NovoRapid® can be given soon transient and disappear during continued treatment; after a meal. Blood glucose monitoring and dose Rare: Peripheral neuropathy – acute painful neuropathy, adjustments are recommended to achieve optimal usually reversible, may occur with rapid improvement in glycaemic control. In elderly patients, patients with renal glycaemic control; Very rare: Anaphylactic reactions - or hepatic impairment, glucose monitoring should be Generalised hypersensitivity reactions are potentially life- intensified and insulin aspart dosage adjusted on an threatening. The Summary of Product Characteristics individual basis. No studies in children under the age of 2 should be consulted for a full list of side effects. years; should only be used in this age group under careful medical supervision. Can be used in children in MA numbers:
preference to soluble insulin when a fast onset of action might be beneficial. Transfer from other insulin products, may require adjustment of the NovoRapid® or basal
dose. May also be used in a suitable pump system for continuous subcutaneous insulin infusion. If necessary may be administered intravenously by healthcare Legal category: POM.
professional. Penfill® designed to be used with Novo Basic NHS price:
Nordisk insulin delivery systems. Penfill® and FlexPen® are designed to be used with NovoFine® and NovoTwist® Contraindications: Hypersensitivity to active substance
Full prescribing information can be obtained from:
Novo Nordisk Limited, Broadfield Park, Brighton Road, Special warnings and precautions for use:
Inadequate dosing or discontinuation of treatment may Date created/last revised: March 2012
lead to hyperglycaemia and diabetic ketoacidosis, which is potentially lethal. Travelling between time zones may Adverse events should be reported. Reporting
require change in the applied insulin regimen. Omission forms and information can be found at
of a meal, unplanned strenuous physical exercise or too www.mhra.gov.uk/yellowcard
high a dose in relation to insulin requirements may lead to Adverse events should also be reported to Novo
hypoglycaemia. Patients whose blood glucose control is Nordisk Limited (Telephone Novo Nordisk
greatly improved may experience a change in their usual Customer Care Centre 0845 6005055). Calls
warning symptoms of hypoglycaemia. Usual warning may be monitored for training purposes.
symptoms may disappear in patients with longstanding diabetes. If hypoglycaemia occurs, it may occur earlier NovoRapid®, Penfill®, FlexPen®, FlexTouch®,
after an injection compared with soluble human insulin. NovoTwist®, NovoFine® and the Apis Bull Logo® are
Changes in early warning symptoms of hypoglycaemia trademarks owned by Novo Nordisk A/S.
may occur on transfer between different types of insulin products. The fast onset of action should be considered in patients where a delayed absorption of food might be expected. Transferring to another type or brand of insulin should be done under strict medical supervision. Patients transferred to NovoRapid® from another type of insulin may require an increased number of daily injections or a change in dosage. Injection site reactions, usually transitory, may occur; rotation of injection sites

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