NovoMix 30

NovoMix 30 Adverse Reactions

insulin aspart + insulin aspart protamine


Novo Nordisk


Zuellig Pharma
Full Prescribing Info
Adverse Reactions
Adverse drug reactions observed in patients using NovoMix 30 are mainly dose-dependent and due to the pharmacologic effect of insulin. As for other insulin products, hypoglycaemia, in general is the most frequently adverse reaction. It may occur if the insulin dose is too high in relation to the insulin requirement and therefore require special attention during dose intensification. Severe hypoglycaemia 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 during marketed use the frequency varies with patient population and dose regimens, therefore, no specific frequency can be presented.
During clinical trials, the overall rates of hypoglycaemia did not differ between patients treated with insulin aspart compared to human insulin.
Frequencies of adverse drug reactions from clinical trials, which by an overall judgement are considered related to insulin aspart are listed as follows: The frequencies are defined as: Uncommon (>1/1000, <1/100) and rare (>1/10,000, <1/1000). Isolated spontaneous cases are presented as very rare defined as (<1/10,000) including isolated reports. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Immune System Disorders: Uncommon: Urticaria, rash, eruptions. Very Rare: Anaphylactic reactions. Symptoms of generalised hypersensitivity may include generalised skin rash, itching, sweating, gastrointestinal upset, angioneurotic oedema, difficulties in breathing, palpitation and reduction in blood pressure. Generalised hypersensitivity reactions are potentially life-threatening.
Nervous System Disorders: Rare: Peripheral neuropathy. Fast improvement in blood glucose control may be associated with a condition termed acute painful neuropathy, which is usually reversible.
Eye Disorders: Uncommon: Refraction disorder. Refraction anomalies may occur upon initiation of insulin therapy. These symptoms are usually of transitory nature. Uncommon: Diabetic retinopathy. Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy. However, intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with worsening of diabetic retinopathy.
Skin and Subcutaneous Tissue Disorders: Uncommon: Lipodystrophy. Lipodystrophy may occur at the injection site as a consequence of failure to rotate injection sites within an area. Uncommon: Local hypersensitivity. Local hypersensitivity reactions (redness, swelling and itching at the injection site) may occur during treatment with insulin. These reactions are usually transitory and they normally disappear during continued treatment.
General Disorders and Administration Site Conditions: Uncommon: Oedema. Oedema may occur upon initiation of insulin therapy. These symptoms are usually of transitory nature. Oedema and weight increase may occur when NovoMix 30 is used in combination with oral antidiabetic drugs.
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