|Patients hypersensitive to Insuman Comb 25 for whom no better tolerated preparation is available must only continue treatment under close medical supervision and where necessary in conjunction with anti-allergic treatment.In patients with an allergy to animal insulin intradermal skin testing is recommended prior to a transfer to Insuman Comb 25, since they may experience immunological cross-reactions.In case of insufficient glucose control or a tendency to hyper- or hypoglycaemic episodes, the patient's adherence to the prescribed treatment regimen, injection sites and proper injection technique and all other relevant factors must be reviewed before dose adjustment is considered.|
Transfer to Insuman Comb 25Transferring a patient to another type or brand of insulin should be done under strict medical supervision. Changes in strength, brand (manufacturer), type (regular, NPH, lente, long-acting, etc.), origin (animal, human, human insulin analogue) and/or method of manufacture may result in the need for a change in dose.The need to adjust (e.g. reduce) the dose may become evident immediately after transfer. Alternatively, it may emerge gradually over a period of several weeks.Following transfer from an animal insulin to human insulin, dose regimen reduction may be required in particular in patients who- were previously already controlled on rather low blood glucose levels,- have a tendency to hypoglycaemia,- previously required high insulin doses due to the presence of insulin antibodies.Close metabolic monitoring is recommended during the transition and in the initial weeks thereafter. In patients who require high insulin doses because of the presence of insulin antibodies, transfer under medical supervision in a hospital or similar setting must be considered.HypoglycaemiaHypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement.Particular caution should be exercised, and intensified blood glucose monitoring is advisable in patients in whom hypoglycaemic episodes might be of particular clinical relevance, such as in patients with significant stenoses of the coronary arteries or of the blood vessels supplying the brain (risk of cardiac or cerebral complications of hypoglycaemia) as well as in patients with proliferative retinopathy, particularly if not treated with photocoagulation (risk of transient amaurosis following hypoglycaemia).Patients should be aware of circumstances where warning symptoms of hypoglycaemia are diminished. The warning symptoms of hypoglycaemia may be changed, be less pronounced or be absent in certain risk groups. These include patients:- in whom glycaemic control is markedly improved,- in whom hypoglycaemia develops gradually,- who are elderly,- after transfer from animal insulin to human insulin,- in whom an autonomic neuropathy is present,- with a long history of diabetes,- suffering from a psychiatric illness,- receiving concurrent treatment with certain other medicinal products (see section 4.5).Such situations may result in severe hypoglycaemia (and possibly loss of consciousness) prior to the patient's awareness of hypoglycaemia.If normal or decreased values for glycated haemoglobin are noted, the possibility of recurrent, unrecognised (especially nocturnal) episodes of hypoglycaemia must be considered.Adherence of the patient to the dose regimen and dietary regimen, correct insulin administration and awareness of hypoglycaemia symptoms are essential to reduce the risk of hypoglycaemia. Factors increasing the susceptibility to hypoglycaemia require particularly close monitoring and may necessitate dose adjustment. These include:- change in the injection area,- improved insulin sensitivity (e.g. by removal of stress factors),- unaccustomed, increased or prolonged physical activity,- intercurrent illness (e.g. vomiting, diarrhoea),- inadequate food intake,- missed meals,- alcohol consumption,- certain uncompensated endocrine disorders (e.g. in hypothyroidism and in anterior pituitary or adrenocortical insufficiency),- concomitant treatment with certain other medicinal products.
Intercurrent illnessIntercurrent illness requires intensified metabolic monitoring. In many cases, urine tests for ketones are indicated, and often it is necessary to adjust the insulin dose. The insulin requirement is often increased. Patients with type 1 diabetes must continue to consume at least a small amount of carbohydrates on a regular basis, even if they are able to eat only little or no food, or are vomiting etc. and they must never omit insulin entirely.
Handling of the penBefore using SoloStar, the Instructions for Use included in the Package Leaflet must be read carefully. SoloStar has to be used as recommended in these Instructions for Use (see section 6.6).
Medication errorsMedication errors have been reported in which other Insuman formulations or other insulins have been accidentally administered. Insulin label must always be checked before each injection to avoid medication errors between insulin human and other insulins.
Combination of Insuman with pioglitazoneCases of cardiac failure have been reported when pioglitazone was used in combination with insulin, especially in patients with risk factors for development of cardiac heart failure. This should be kept in mind if treatment with the combination of pioglitazone and Insuman is considered. If the combination is used, patients should be observed for signs and symptoms of heart failure, weight gain and oedema. Pioglitazone should be discontinued if any deterioration in cardiac symptoms occurs.