Humulin M3 (Mixture 3) 100 IU/ml Suspension for Injection in cartridge

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Insulin human

Tilgængelig fra:

Eli Lilly Nederland B.V.

ATC-kode:

A10AD; A10AD01

INN (International Name):

Insulin human

Dosering:

100 international unit(s)/millilitre

Lægemiddelform:

Suspension for injection

Recept type:

Product subject to prescription which may be renewed (B)

Terapeutisk område:

Insulins and analogues for injection, intermediate- or long-acting combined with fast-acting; insulin (human)

Autorisation status:

Not marketed

Autorisation dato:

1996-04-30

Produktets egenskaber

Health Products Regulatory Authority
23 October 2018
CRN008KDH
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Humulin M3 (Mixture 3) 100 IU/ml Suspension for Injection in
cartridge.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 100 IU human insulin (produced in _E. coli_ by
recombinant DNA
technology).
One cartridge 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 cartridge.
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 8
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 instructio