HUMULIN M 100 IU/ML Suspension for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

HUMAN INSULIN (RECOMBINANT DNA ORIGIN)

Available from:

Eli Lilly and Company Limited

ATC code:

A10AD01

INN (International Name):

HUMAN INSULIN (RECOMBINANT DNA ORIGIN)

Dosage:

100 IU/ML

Pharmaceutical form:

Suspension for Injection

Administration route:

Subcutaneous administration

Units in package:

Pack size of 5

Prescription type:

Product subject to prescription which may be renewed (B)

Manufactured by:

Lilly France

Therapeutic group:

Humulin M3

Therapeutic area:

Insulins and analogues for injection, intermediate- or long-acting combined with fast-acting

Therapeutic indications:

For the treatment of patients with diabetes mellitus who require insulin for the maintenance of glucose homeostasis

Authorization status:

Authorised

Authorization date:

2015-03-13

Patient Information leaflet

 
1 

PACKAGE LEAFLET: INFORMATION FOR THE USER 

HUMULIN M3 (MIXTURE 3) 100 IU/ML
SUSPENSION FOR INJECTION IN CARTRIDGE 

(Insulin human) 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT 
CONTAINS IMPORTANT INFORMATION FOR YOU. 
- 
Keep this leaflet. You may need to read it again. 
- 
If you have any further questions, ask your doctor,
pharmacist or nurse. 
- 
This medicine has been prescribed for you only. Do not pass it on
to others. It 
may harm them, even if their signs of illness are the same
as yours. 
- 
If  you get any side effects, talk to your doctor,
 pharmacist or nurse.  This 
includes any possible side effects not listed in this leaflet.
 See section 4. 

WHAT IS IN THIS LEAFLET:  
1. 
What Humulin M3 is and what it is used for 
2. 
What you need to know before you use Humulin M3 
3. 
How to use Humulin M3 
4. 
Possible side effects 
5. 
How to store Humulin M3 
6. 
Contents of the pack and other information 

1. 
WHAT HUMULIN M3 IS AND WHAT IT IS USED FOR 

Humulin M3 contains the active substance human insulin, which is
used to treat 
diabetes. You get diabetes if your pancreas does not make enough
insulin to control 
the level of glucose in your blood (blood sugar). Humulin M3 is
used to control 
glucose in the long term. It is a premixed suspension of rapid
and long acting insulin. 
Its action is prolonged by the inclusion of protamine sulfate in
the suspension.  

Your doctor may tell you to use Humulin M3 as well as
a longer-acting insulin. Each 
kind of insulin comes with its own patient information leaflet to
tell you about it. Do 
not change your insulin unless your doctor tells you to.
Be very careful if you do 
change insulin. Each type of insulin has a different colour and
symbol on the pack and 
the cartridge so that you can easily tell the difference. 

2.

Summary of Product characteristics

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 insulin human (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
Posology
The dosage should be determined by the physician, according to the requirement of the patient.
_Paediatric population_
No data are available.
Method of administration
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 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�