ACTRAPHANE 30 Suspension for injection Ref.[49806] Active ingredients: Insulin (human)

Posology

The potency of human insulin is expressed in international units.

Actraphane dosing is individual and determined in accordance with the needs of the patient. Premixed insulin medicinal products are usually given once or twice daily when a rapid initial effect together with a more prolonged effect is desired. Blood glucose monitoring is recommended to achieve optimal glycaemic control.

The individual insulin requirement is usually between 0.3 and 1.0 international unit/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)

Actraphane 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

Actraphane 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 Actraphane dose and timing of administration may be necessary.

Close glucose monitoring is recommended during the transfer and in the initial weeks thereafter (see section 4.4).

Method of administration

Actraphane is a dual-acting human insulin. It is a biphasic formulation containing both fast-acting and long-acting insulin.

Actraphane 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 sections 4.4 and 4.8). 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 abdominal wall ensures a faster 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.

An injection should be followed within 30 minutes by a meal or snack containing carbohydrates.

Insulin suspensions are not to be used in insulin infusion pumps.

For detailed user instructions, please refer to the package leaflet.

Actraphane 30 vial (40 international units/ml)/Actraphane 30 vial (100 international units/ml)

Administration with a syringe

Actraphane vials are for use with insulin syringes with a corresponding unit scale.

Actraphane 30 Penfill

Administration with an insulin delivery system

Actraphane Penfill is designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles. Actraphane Penfill is only suitable for subcutaneous injections from a reusable pen. If administration by syringe is necessary, a vial should be used.

Actraphane 30 InnoLet

Administration with InnoLet

Actraphane InnoLet is a pre-filled pen designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm. InnoLet delivers 1-50 units in increments of 1 unit. Actraphane InnoLet is only suitable for subcutaneous injections. If administration by syringe is necessary, a vial should be used.

Actraphane 30 FlexPen

Administration with FlexPen

Actraphane FlexPen is a pre-filled pen designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm. FlexPen delivers 1-60 units in increments of 1 unit. Actraphane FlexPen is only suitable for subcutaneous injections. If administration by syringe is necessary, a vial should be used.

A specific overdose of insulin cannot be defined, however, hypoglycaemia may develop over sequential stages if too high a dose relative to the patient’s requirement is administered:

• Mild hypoglycaemic episodes can be treated by oral administration of glucose or sugary products. It is therefore recommended that the diabetic patient always carries sugar-containing products.
• Severe hypoglycaemic episodes, where the patient has become unconscious, can be treated with glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a trained person, or with glucose given intravenously by a healthcare professional. Glucose must be given intravenously, if the patient does not respond to glucagon within 10 to 15 minutes. Upon regaining consciousness, administration of oral carbohydrates is recommended for the patient in order to prevent a relapse.

Before opening: 30 months.

Actraphane 30 vial (40 international units/ml)/Actraphane 30 vial (100 international units/ml):

During use or when carried as a spare: The product can be stored for a maximum of 6 weeks. Store below 25°C.

Actraphane 30 Penfill/Actraphane 30 InnoLet/Actraphane 30 FlexPen:

During use or when carried as a spare: The product can be stored for a maximum of 6 weeks. Store below 30°C.

Before opening: Store in a refrigerator (2°C–8°C). Do not freeze.

Actraphane 30 vial (40 international units/ml)/Actraphane 30 vial (100 international units/ml):

During use or when carried as a spare: Store below 25°C. Do not refrigerate or freeze.

Keep the vial in the outer carton in order to protect from light.

Actraphane 30 Penfill:

During use or when carried as a spare: Store below 30°C. Do not refrigerate or freeze.

Keep the cartridge in the outer carton in order to protect from light.

Actraphane 30 InnoLet/Actraphane 30 FlexPen:

During use or when carried as a spare: Store below 30°C. Do not refrigerate or freeze.

Keep the pen cap on the pen in order to protect from light.

Actraphane 30 vial (40 international units/ml)/Actraphane 30 vial (100 international units/ml):

Vial (type 1 glass) closed with a disc (bromobutyl/polyisoprene rubber) and a protective tamper-proof plastic cap containing 10 ml of suspension.

Pack sizes of 1 and 5 vials of 10 ml or a multipack of 5 packs of 1 × 10 ml vial. Not all pack sizes may be marketed.

Actraphane 30 Penfill:

Cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene) containing 3 ml of suspension. The cartridge contains a glass ball to facilitate resuspension.

Pack sizes of 1, 5 and 10 cartridges. Not all pack sizes may be marketed.

Actraphane 30 InnoLet/Actraphane 30 FlexPen:

Cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene) containing 3 ml of suspension in a pre-filled multidose disposable pen made of polypropylene. The cartridge contains a glass ball to facilitate resuspension.

Pack sizes of 1, 5 and 10 pre-filled pens. Not all pack sizes may be marketed.

After removing Actraphane vial, cartridge or pre-filled pen from the refrigerator, it is recommended to allow the Actraphane vial, cartridge or pre-filled pen to reach room temperature before resuspending the insulin as instructed for first time use.

Do not use this medicinal product if you notice that the resuspended liquid is not uniformly white and cloudy.

Actraphane which has been frozen must not be used.

The patient should be advised to discard the needle and syringe after each injection.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Needles, syringes, cartridges and pre-filled pens must not be shared.

The cartridge must not be refilled.