a. Summary of the safety profileAdverse reactions observed in patients using NovoMix are mainly due to the pharmacological effect of insulin aspart.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, please see section c below.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.
b. Tabulated list of adverse reactionsThe adverse reactions listed below 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 section c.
|Immune system disorders ||Uncommon Urticaria, rash, eruptions
|Very rare Anaphylactic reactions*
|Metabolism and nutrition disorders
||Very common Hypoglycaemia*
|Nervous system disorders
||Rare Peripheral neuropathy (painful neuropathy)
||Uncommon Refraction disorders
|Uncommon Diabetic retinopathy
|Skin and subcutaneous tissue disorders||Uncommon Lipodystrophy*
|General disorders and administration site conditions||Uncommon Oedema
|Uncommon Injection site reactions
c. Description of selected adverse reactionsAnaphylactic 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 concentrating, 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.Lipodystrophy:Lipodystrophy (including lipohypertrophy, lipoatrophy) may occur at the injection site. Continuous rotation of the injection site within the particular area reduces the risk of developing these reactions.
d. Paediatric populationBased 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.
e. Other special populationsBased on post-marketing sources and clinical trials, the frequency, type and severity of adverse reactions observed in older patients and in patients with renal or hepatic impairment do not indicate any differences to the broader experience in the general population.
f. Reporting of suspected adverse reactionsReporting 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 via:
IrelandPharmacovigilance Section Irish Medicines Board Kevin O'Malley House Earlsfort Centre Earlsfort Terrace IRL - Dublin 2Tel: +353 1 6764971Fax: +353 1 67625177836Website: www.imb.iee-mail: firstname.lastname@example.org
MaltaADR ReportingThe Medicines Authority Post-Licensing Directorate203 Level 3, Rue D'ArgensGŻR-1368 GżiraWebsite: www.medicinesauthority.gov.mte-mail: email@example.com
United KingdomYellow Card SchemeWebsite: www.mhra.gov.uk/yellowcard