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HUMULIN I Suspension for injection in a vial (2019)

Active ingredients: Insulin (human)

Product Name and Form

Humulin I (Isophane) 100 IU/ml suspension for injection in vial.

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.

Qualitative and Quantitative Composition

1 ml contains 100 IU insulin human (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.

Chemical substance
Description

The blood glucose lowering effect of insulin is due to the facilitated uptake of glucose following binding of insulin to receptors on muscle and fat cells and to the simultaneous inhibition of glucose output from the liver.

List of excipients

m-cresol
Glycerol
Phenol
Protamine sulfate
Dibasic sodium phosphate 7H2O
Zinc oxide
Water for injections

The following may be used to adjust pH; hydrochloric acid and/or sodium hydroxide.

Pack sizes and Marketing

10 ml of suspension in a vial (type I glass) with a stopper (rubber) sealed with a seal (aluminium) combined with a flip top (plastic). Pack size 1 or 2 or 5 (5 × 1). Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

Eli Lilly and Company Limited, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL

30 July 2019

Marketing authorization number:

PL 00006/0666