Abbreviated prescribing information
- NovoRapid® (insulin aspart)
NovoRapid® 10ml
NovoRapid® Penfill® 3ml
NovoRapid® NovoLet® 3ml
NovoRapid® FlexPen®
All presentations contain insulin aspart 100 units/ml.
Indication
Treatment of diabetes mellitus
Dosage
Individual by subcutaneous injection. If necessary, NovoRapid® may also be administered intravenously which should be carried out by health care professionals. NovoRapid® has a faster onset and shorter duration of action than soluble human insulin and should generally be given immediately before a meal. When necessary, NovoRapid® can be given soon after a meal. No studies in children under the age of 6 years. Only use in children in preference to soluble insulin when a fast onset of action might be beneficial.
Contraindications
Hypoglycaemia, hypersensitivity
Warnings and precautions for use
Patients whose blood glucose control is greatly improved may experience a change in their usual warning symptoms of hypoglycaemia. If hypoglycaemia occurs, it may occur earlier after an injection compared with soluble human insulin. The fast onset of action should be considered in patients where a delayed absorption of food might be expected. Transferring to a new type or brand of insulin should be done under strict medical supervision. Patients taking NovoRapid® may require an increased number of daily injections or a change in dosage. Too much insulin, omission of a meal or strenuous exercise may lead to hypoglycaemia. Hypoglycaemia may constitute a risk when driving or operating machinery. Too little insulin may lead to hyperglycaemia and ketoacidosis.
Pregnancy and lactation
Limited clinical experience in pregnancy. No restrictions on use during lactation.
Undesirable effects
Hypoglycaemia; oedema and refraction anomalies on instituting therapy; local hypersensitivity; generalised hypersensitivity reactions are rare but potentially life-threatening; lipodystrophy.
PL numbers
NovoRapid® 10ml, EU/1/99/119/001
NovoRapid® Penfill® 3ml, EU/1/99/119/003
NovoRapid® NovoLet® 3ml, EU/1/99/119/005
NovoRapid® FlexPen®, EU/1/99/119/009
Legal category
POM
PL holder
Novo Nordisk A/S Novo Allé DK-2880 Bagsvaerd Denmark
Date of preparation
May 2003
