NOVOMIX 70 Suspension for injection Ref.[50951] Active ingredients: Insulin aspart

Posology

The potency of insulin analogues, including insulin aspart, is expressed in units, whereas the potency of human insulin is expressed in international units.

NovoMix 70 dosing is individual and determined in accordance with the needs of the patient. Blood glucose monitoring and insulin dose adjustments are recommended to achieve optimal glycaemic control.

The individual insulin requirement is usually between 0.5 and 1.0 unit/kg/day. NovoMix 70 may fully or partially meet this requirement.

In patients with type 2 diabetes, NovoMix 70 can be given as monotherapy or in combination with metformin when the blood glucose is inadequately controlled with metformin alone.

Adjustment of dose may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness.

Special populations

In elderly patients (≥65 years old) and in patients with hepatic or renal impairment, glucose monitoring should be intensified and the insulin aspart dose adjusted on an individual basis.

Renal or hepatic impairment may reduce the patient’s insulin requirements.

Paediatric population

The safety and efficacy of NovoMix 70 in children below 18 years of age have not been established. No data are available.

Transfer from other insulin medicinal products

Transfer to NovoMix 70 from other insulin preparations may require adjustment of dose and timing of administration. Close glucose monitoring is recommended during the transfer and in the initial weeks thereafter (see section 4.4).

Method of administration

NovoMix 70 is a biphasic suspension of the insulin analogue, insulin aspart. The suspension contains rapid-acting and intermediate-acting insulin aspart in the ratio 70/30.

NovoMix 70 is for subcutaneous administration only.

NovoMix 70 is administered subcutaneously by injection in the thigh or in the abdominal wall. If convenient, the gluteal or deltoid region may be used. 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). The influence of different injection sites on the absorption of NovoMix 70 has not been investigated. The duration of action will vary according to the dose, injection site, blood flow, temperature and level of physical activity.

NovoMix 70 has a faster onset of action than biphasic human insulin and should generally be given immediately before a meal. When necessary, NovoMix 70 can be given soon after a meal.

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

NovoMix 70 Penfill

Administration with an insulin delivery system

NovoMix 70 Penfill is designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles. NovoMix 70 Penfill is only suitable for subcutaneous injections from a reusable pen. If administration by syringe is necessary, a vial should be used.

NovoMix 70 FlexPen

Administration with FlexPen

NovoMix 70 FlexPen is a pre-filled pen (colour-coded) designed to be used with NovoFine or NovoTwist needles. FlexPen delivers 1–60 units in increments of 1 unit. NovoMix 70 FlexPen is only suitable for subcutaneous injections. If administration by syringe is necessary, a vial should be used.

A specific overdose for insulin cannot be defined, however, hypoglycaemia may develop over sequential stages if too high doses relative to the patient’s requirement are 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: 2 years.

During use or when carried as a spare: The product can be stored for a maximum of 4 weeks.

Before opening: Store in a refrigerator (2°C–8°C). Keep away from the cooling element. Do not freeze.

NovoMix 70 Penfill:

During use or when carried as a spare: Store below 30°C. Do not refrigerate. Do not freeze. Keep the cartridge in the outer carton in order to protect it from light.

NovoMix 70 FlexPen:

During use or when carried as a spare: Store below 30°C. Do not refrigerate. Do not freeze. Keep the cap on FlexPen in order to protect it from light.

NovoMix 70 Penfill:

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

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

NovoMix 70 FlexPen:

3 ml suspension in cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene) contained 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 NovoMix 70 Penfill or NovoMix 70 FlexPen from the refrigerator, it is recommended to allow NovoMix 70 Penfill or NovoMix 70 FlexPen 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, cloudy and aqueous.

The necessity of resuspending the NovoMix 70 suspension immediately before use is to be stressed to the patient.

NovoMix 70 which has been frozen must not be used.

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

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

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

The cartridge must not be refilled.