Protaphane - human insulin
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 injections under the skin, usually in the thigh. If appropriate, injection into the abdominal wall (belly), gluteal region (buttocks) or deltoid region (shoulder) may be given. The patient's blood glucose level should be checked regularly 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 (with 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 analog identical to the insulin made by the pancreas. The active substance in Protaphane, human insulin (rDNA), is produced by a method known as 'recombinant DNA technique': Insulin is made by a yeast that has received a gene (DNA), which makes it possible the generation. Protaphane contains insulin mixed with another substance, protamine, in an "isophane" form that is absorbed much more slowly throughout the day. This gives Protaphane a longer lasting effect. The replacement insulin acts like naturally produced insulin. and helps glucose to enter cells from the blood.By controlling the level of glucose in the blood, the symptoms and complications of diabetes are reduced.
How has Protaphane been studied?
Protaphane has been studied in four major clinical trials involving a total of 557 people with type 1 diabetes (when the pancreas is unable to produce insulin [two studies involving 81 patients]) or in type 2 (when the body is unable to use insulin effectively [two studies involving 476 patients]). In the majority of patients, Protaphane was compared with other types of human insulin or analogues of the "insulin. 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 how well the blood glucose is controlled." Other studies involved 225 patients, in whom the medicine was administered via a syringe or 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 to a level similar 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 hypoglycaemia (low blood glucose).
For the full list of all side effects reported with Protaphane, see the package leaflet.
Protaphane must not be used in people who may be hypersensitive (allergic) to human insulin (rDNA) or other ingredients of the medicine. Protaphane doses must be adjusted when given with a number of other medicines that may have an effect on the blood glucose. The full list is available in the package leaflet.
Why has Protaphane been approved?
The Committee for Medicinal Products for Human Use (CHMP) considered that Protaphane's benefits for the treatment of diabetes are greater than its risks. The Committee therefore recommended the granting of a marketing authorization for Protaphane.
Learn more about Protaphane
On 7 October 2002, the European Commission granted Novo Nordisk A / S a "Marketing Authorization" for Protaphane, valid throughout the European Union.
The full text of the EPAR is available here.
Last update: 10 - 2007
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