Isophane (NPH) insulin

INDICATION (§4.1, verbatim and complete): 'Insulatard is indicated for treatment of diabetes mellitus.' That matches this page's identity — an intermediate-acting basal human insulin given subcutaneously in diabetes — so the posology below is this page's own indication, not a neighbouring one. SOURCE PRODUCT: the UK SPC fetched is Insulatard 100 international units/ml suspension for injection in vial, the first brand listed on this page; the figures are that product's and are not automatically transferable to any other isophane brand (Humulin I and Insuman Basal have their own SPCs, which were not fetched). ⚠️ SCOPE OF THE 0.3–1.0 FIGURE — READ IT AS THE LABEL WRITES IT: §4.2 states 'The individual insulin requirement is usually between 0.3 and 1.0 international unit/kg/day' in the same paragraph as 'Insulatard may be used alone or mixed with fast-acting insulin' and 'In intensive insulin therapy the suspension may be used as basal insulin (evening and/or morning injection) with fast-acting insulin given at meals'. It is therefore the TOTAL daily insulin requirement, not a dose of isophane to be added on top of mealtime insulin; the dose field says so explicitly. Read the other way, the top of the range would be 70 units of NPH for a 70 kg adult in addition to prandial insulin, and §4.8 records that severe hypoglycaemia 'may result in temporary or permanent impairment of brain function or even death'. NO MAXIMUM DOSE is stated anywhere in this SPC, so maxDose is deliberately omitted rather than invented — 1.0 international unit/kg/day is the top of a usual-requirement range, not a ceiling. VERBATIM §4.2 (opening): 'The potency of human insulin is expressed in international units. Insulatard dosing is individual and determined in accordance with the needs of the patient. The physician determines whether one or several daily injections are necessary… Blood glucose monitoring is recommended to achieve optimal glycaemic control… Adjustment of dose may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness.' ELDERLY (≥65 years): 'Insulatard can be used in elderly patients. In elderly patients, glucose monitoring should be intensified and the insulin dose adjusted on an individual basis.' TRANSFER FROM OTHER INSULINS: 'When transferring from other intermediate or long-acting insulin medicinal products, adjustment of the Insulatard dose and timing of administration may be necessary. Close glucose monitoring is recommended during the transfer and in the initial weeks thereafter.' PAEDIATRIC: §4.2 says only 'Insulatard can be used in children and adolescents' — it gives NO paediatric number, so no paediatric dose is published here and paedDose is null; children's insulin dosing must come from a children's formulary and the diabetes team. ADMINISTRATION DETAIL: 'Subcutaneous injection into the thigh results in a slower and less variable absorption compared to the other injection sites. The duration of action will vary according to the dose, injection site, blood flow, temperature and level of physical activity.' Some sections of the product information we used were incomplete — check the full SPC.