Protaphane/Protaphane Penfill Dosage/Direction for Use

The potency of human insulin is expressed in IU.
Protaphane dosing is individual and determined in accordance with the needs of the patient. The physician determines whether one or several daily injections are necessary.
Protaphane may be used alone or mixed with fast-acting insulin. In intensive insulin therapy the suspension may be used as basal insulin (evening and/or morning injection) with fast-acting insulin given at meals. Blood glucose monitoring is recommended to achieve optimal glycaemic control.
The individual insulin requirement is usually between 0.3 and 1.0 IU/kg/day. Adjustment of dose may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness.
Special populations: Elderly (≥ 65 years old): Protaphane can be used in elderly patients.
In elderly patients, glucose monitoring should be intensified and the insulin dose adjusted on an individual basis.
Renal and hepatic impairment: Renal or hepatic impairment may reduce the patient's insulin requirements.
In patients with renal or hepatic impairment, glucose monitoring should be intensified and the human insulin dose adjusted on an individual basis.
Paediatric population: Protaphane can be used in children and adolescents.
Transfer from other insulin medicinal products: When transferring from other intermediate or long-acting insulin medicinal products, adjustment of the Protaphane dose and timing of administration may be necessary.
Close glucose monitoring is recommended during the transfer and in the initial weeks thereafter (see Precautions).
Method of administration: Protaphane is a human insulin with gradual onset and long duration of action.
Protaphane is administered subcutaneously by injection in the thigh, the abdominal wall, the gluteal region or the deltoid region. Injection sites should always be rotated within the same region in order to reduce the risk of lipodystrophy and cutaneous amyloidosis (see Precautions and Adverse Reactions). Insulin suspensions are never to be administered intravenously. Injection into a lifted skin fold minimises the risk of unintended intramuscular injection.
The needle should be kept under the skin for at least 6 seconds to make sure the entire dose is injected. 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.
Insulin suspensions are not to be used in insulin infusion pumps.
Protaphane vials are for use with insulin syringes with a corresponding unit scale.
Protaphane Penfill is designed to be used with Novo Nordisk delivery systems and NovoFine or NovoTwist needles.
Protaphane/Protaphane Penfill is accompanied by a package leaflet with detailed instructions for use to be followed.