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Mixtard ® 30(insulinhuman,rDNA)willbe
discontinuedintheUKon31 st December2010.
Novo Nordisk appreciates that this decision will affect a number of healthcare
professionals and patients. We have developed a programme of support
services to provide assistance and resources to healthcare professionals to help
them ensure that all patients currently on Mixtard ® 30 are changed to another
appropriate treatment before 31st December 2010.
We are asking all healthcare professionals to identify their patients who are treated with Mixtard ® 30 as soon as
possible to discuss new insulin treatment options.
To support patients and healthcare professionals in this, Novo Nordisk will be providing the following:
• Dedicatedhelplineon08456005055
• PatientandprofessionalsupportmaterialthroughGPpractices,hospitalsandpharmacies
TodiscussthesupportservicesavailablefromNovoNordisktohelphealthcareprofessionalsmanage
theirMixtard ® 30patients,pleasecontactyourlocalNovoNordiskrepresentativeorcall08456005055
tofindoutmore,ortoarrangeavisitfromaNovoNordiskrepresentative.*
Mixtard ® 30 human insulin has been available in the UK for 25 years and has been declining in its use for the last
six years. 75% of all patients with diabetes who require insulin are now treated with modern insulin analogues. 1
Novo Nordisk is a leader in diabetes care and has been committed to improving the lives of people with diabetes for the
last 87 years through pioneering new and innovative treatments, services and devices. The decision to discontinue
Mixtard ® 30 has been taken in order to allow us to focus our resources on the future development of insulins.
*There is no obligation to grant a Novo Nordisk representative an interview in order to receive information about Novo Nordisk support services
www.novonordisk.co.uk
Prescribing Information
Mixtard ® 30, Mixtard ® 30 Penfill ® , Mixtard ® 30 InnoLet ® .
Insulin human, rDNA.
Presentation: Available in a strength of 100 iu/ml. 10ml vial;
3ml cartridge; 3ml InnoLet ® pre-filled multidose disposable pen,
delivers 1-50 units in increments of 1 unit. Mixtard ® 30 is a mixture
of soluble and isophane insulin in the ratio 30/70. Therapeutic
indications: The treatment of diabetes mellitus. Posology
and method of administration: Dosage is individual, given
by subcutaneous injection; Injection should be followed by a
meal or snack containing carbohydrates within 30 minutes of
administration; usually given once or twice daily. Resuspend before
use by gently agitating. Mixtard ® 30 must not be administered
intravenously or used in insulin infusion pumps. Mixtard ® 30
Penfill ® cartridges are designed to be used with Novo Nordisk
insulin delivery systems and NovoFine ® needles; instructions for
use are included with the devices and must be carefully followed.
Instructions for use of the InnoLet ® delivery device are given in the
package leaflet. NovoFine ® needles are designed to be used with
Novo Nordisk insulin delivery devices. Vials are for use with syringes
with corresponding unit scale. Penfill ® cartridges and InnoLet ®
devices are for single-patient use only. Contraindications:
Hypoglycaemia; hypersensitivity to the active substance or any of
the excipients. Special warnings and precautions for use: Use
of dosages which are inadequate, or discontinuation of treatment
may lead to hyperglycaemia and, especially in type 1 diabetes, to
ketoacidosis which is potentially lethal. Hypoglycaemia may occur
if the insulin dose is too high in relation to requirements. Reduction
of early warning symptoms for hypoglycaemia may be seen upon
tightening control and has been reported by a few patients on
transfer from animal to human insulin. Transfer to another type
or brand of insulin should be under medical supervision. Injection
site reactions, usually transitory, may occur; rotation of injection
sites within an area may help reduce or prevent these reactions.
Rarely injection site reaction may require discontinuation. Contains
metacresol which may cause allergic reactions. Pregnancy and
lactation: There are no restrictions on the treatment of diabetes
with insulin during pregnancy or lactation. Intensified control
during pregnancy is recommended. Insulin requirements usually
fall during the first trimester and increase during the second and
third trimesters. Insulin treatment of the nursing mother presents
no risk to the baby. Side effects: Hypoglycaemia. Oedema,
refraction anomalies and local hypersensitivity reactions may
occur at initiation of insulin therapy, but usually disappear during
continued treatment. Generalised hypersensitivity reactions
may occasionally occur and are potentially life-threatening.
Lipodystrophy may result from failure to rotate injection sites. Rapid
improvement in glycaemic control may be associated with acute
painful neuropathy (usually reversible) and worsening of diabetic
retinopathy. The Summary of Product Characteristics should be
consulted for a full list of side effects. PL Numbers: Mixtard ®
30 EU/1/02/231/003; Mixtard ® 30 Penfill ® EU/1/02/231/012;
Mixtard ® 30 InnoLet ® EU/1/02/231/031. Legal Category: POM.
Basic NHS Price: 1 x 10ml vial £7.48; 5 x 3ml Penfill ® cartridges
£19.08; 5 x 3ml InnoLet ® £20.40. Full prescribing information
can be obtained from: Novo Nordisk Limited, Broadfield
Park, Brighton Road, Crawley, West Sussex, RH11 9RT. Date
last revised: Mar 2010. Mixtard ® , Penfill ® and InnoLet ®
are registered trademarks owned by Novo Nordisk A/S.
Adverse events should be reported. Reporting
forms and information can be found at
www.yellowcard.gov.uk. Adverse events should
also be reported to Novo Nordisk Limited. (Telephone
Novo Nordisk Customer Care Centre 0845 6005055).
Calls may be monitored for training purposes.
References: 1. CSD Patient, Cegedim Strategic Data UK Ltd
UK/MX/0410/0009k Date of preparation: April 2010