What is Protaphane?
Protaphane includes a series of injectable insulin suspensions. Protaphane is available in vials, cartridges (Penfill) or pre-filled pens (InnoLet, NovoLet and FlexPen). The active substance in Protophane is human insulin (rDNA).
What is Protaphane used for?
Protaphane is indicated in patients with diabetes.
The medicine can only be obtained with a prescription.
How is Protaphane used?
Protaphane is given as a subcutaneous injection, usually in the thigh. If appropriate, it is possible to inject into the abdominal wall (belly), in the gluteal region (buttocks) or deltoid (shoulder). It is advisable to regularly check the glucose level in the patient's blood to find the lowest effective dose. Protaphane is a long-acting insulin. It can be given once or twice a day, alone or in combination with fast-acting insulin (at meals), as directed by your doctor.
How does Protaphane work?
Diabetes is a disease in which the body does not produce enough insulin to control blood glucose. Protaphane is an insulin analogue identical to the insulin produced by the pancreas. The active ingredient in Protaphane, human insulin (DNAr), is produced by a method known as "recombinant DNA technique": Insulin is produced by a yeast into which a gene (DNA) has been placed that makes it possible the generation. Protaphane contains insulin mixed with another substance, protamine, in an "isophane" form that is absorbed much more slowly during the day. This gives Protaphane a longer lasting effect. Replacement insulin acts like naturally produced insulin and helps glucose penetrate cells from the blood. By controlling the level of glucose in the blood, the symptoms and complications of diabetes are reduced.
What studies have been carried out on Protaphane?
Protaphane has been studied in four major clinical trials involving a total of 557 people with type 1 diabetes (ie when the pancreas is unable to produce insulin [two studies involving 81 patients]) or type 2 (when the body is unable to use insulin effectively [two studies involving 476 patients]). In most patients, Protaphane was compared with other types of human insulin or insulin analogues. These studies measured the concentration of fasting glucose in the blood or a substance in the blood called glycosylated hemoglobin (HbA1c) which gives an indication of the efficacy of blood glucose control. Other studies have been conducted on 225 patients, in whom the medicine was administered via a syringe or a pre-filled pen (InnoLet, NovoPen or FlexPen).
What benefit has Protaphane shown during the studies?
Protaphane caused a decrease in the level of HbA1c, indicating that blood sugar levels were controlled at a similar level to that found with other human insulins. Protaphane has been shown to be effective in both forms of diabetes (type 1 and type 2 diabetes), regardless of the mode of administration (injection or pens).
What is the risk associated with Protaphane?
Like all insulins, Protaphane can cause hypoglycemia (reduced blood glucose).
For the full list of all side effects reported with Protaphane, see the Package Leaflet.
Protaphane should not be used in people who may be hypersensitive (allergic) to human insulin (rDNA) or other ingredients in the medicine. Protaphane doses must be adjusted when given with a certain number of other medicines that may have an effect on blood glucose. The complete list is available in the package leaflet.
Why has Protaphane been approved?
The Committee for Medicinal Products for Human Use (CHMP) considered that the benefits of Protaphane for the treatment of diabetes outweigh the risks. The Committee therefore recommended the granting of the marketing authorization for Protaphane.
More information on Protaphane
On 7 October 2002, the European Commission issued a marketing authorization for Protaphane, valid throughout the European Union, to Novo Nordisk A / S.
The full text of the EPAR is available here.
Last update: 10 - 2007
