Country: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
Insulin human
Eli Lilly Nederland B.V.
A10AC; A10AC01
Insulin human
100 international unit(s)/millilitre
Suspension for injection
Insulins and analogues for injection, intermediate-acting; insulin (human)
Not marketed
1983-06-22
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Humulin I (Isophane) 100 IU/ml Suspension for Injection in vial. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains 100 IU human insulin (produced in_ E. coli_ by recombinant DNA technology). One vial contains 10 ml equivalent to 1000 IU of isophane insulin. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM A suspension for injection in a vial. Humulin I is a sterile suspension of a white, crystalline precipitate of isophane human insulin in an isotonic phosphate buffer. 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 I 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 should not be massaged. Patients must be educated to use proper injection techniques. Humulin I (Isophane) may be administered in combination with Humulin S (Soluble). (See Instructions for use and handling for Mixing of Insulins). Each pack contains a patient information leaflet with instructions on how to inject insulin. 4.3 CONTRAINDICATIONS Hypoglycaemia. Hypersensitivity to Humulin or to the formulation excipients, unless used as part of a desensitisation programme. Under no circumstances should any Humulin formulation other than Humulin S (Soluble) be given intravenously. H E A L T H P R O D U C T S R E G সম্পূর্ণ নথি পড়ুন