EPAR summary for the public
This document is a summary of the European Public Assessment Report (EPAR). It explains how the Committee for Medicinal products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
What is Monotard?
Monotard is an insulin suspension for injection. Monotard is supplied as 40 or 100 IU strengths in vials. Monotard contains the active ingredient insulin human (rDNA).
Monotard is used in patients with diabetes mellitus. Monotard can be used in type 1 diabetes, when the pancreas cannot produce insulin, and in type 2 diabetes, when the body is not able to use insulin
The medicine can only be obtained with a prescription.
How is Monotard used?
Monotard is given subcutaneously (under the skin) by injection, usually in the thigh. If convenient it may also be given in the abdominal wall (tummy), the buttocks or the deltoid region (shoulder). The patient's blood sugar should be tested regularly to find the lowest effective dose. In type 1 diabetes, the dosage varies between 0.5 and 1.0 IU/kg (0.7 and 1.0 IU/kg in children before puberty), in type 2 diabetes the dosage is 0.3 to 0.6 IU/kg. Monotard is a