Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
Insulin human
Eli Lilly Nederland B.V.
A10AD; A10AD01
Insulin human
100 international unit(s)/millilitre
Suspension for injection
Product subject to prescription which may be renewed (B)
Insulins and analogues for injection, intermediate- or long-acting combined with fast-acting; insulin (human)
Not marketed
1998-09-18
Health Products Regulatory Authority 23 October 2018 CRN008KDH Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Humulin M3 KwikPen(Mixture 3) 100 IU/ml suspension for injection. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains 100 IU human insulin (produced in E. coli by recombinant DNA technology). One pre-filled pen contains 3 ml equivalent to 300 IU of biphasic isophane insulin – 30 % soluble insulin / 70 % isophane insulin. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM A suspension for injection in a pre-filled pen. Humulin M3 is a sterile suspension of human insulin in the proportion of 30 % soluble insulin to 70 % isophane insulin. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of patients with diabetes mellitus who require insulin for the maintenance of glucose homeostasis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The dosage should be determined by the physician, according to the requirement of the patient. Humulin M3 should be given by subcutaneous injection but may, although not recommended, also be given by intramuscular injection. This formulation should not be administered intravenously. Subcutaneous administration should be in the upper arms, thighs, buttocks or abdomen. Use of injection sites should be rotated so that the same site is not used more than approximately once a month. Care should be taken when injecting any Humulin insulin preparations to ensure that a blood vessel has not been entered. After any insulin injection, the injection site Health Products Regulatory Authority 23 October 2018 CRN008KDH Page 2 of 9 should not be massaged. Patients must be educated to use proper injection techniques. Humulin Mixture formulation is a ready-made defined mixture of soluble and isophane insulin designed to avoid the need for the patient to mix insulin preparations. A patient's treatment regimen should be based on their individual metabolic requirements. Each pack contains a patient information leaflet with instruc Διαβάστε το πλήρες έγγραφο