HUMULIN M 100 IU/ML Suspension for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

INSULIN HUMAN

Available from:

Eli Lilly and Company Limited

ATC code:

A10AD01

INN (International Name):

INSULIN HUMAN

Dosage:

100 IU/ML

Pharmaceutical form:

Suspension for Injection

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

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

Authorization status:

Authorised

Authorization date:

1993-02-23

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER 

HUMULIN M3 (MIXTURE 3) 100 IU/ML SUSPENSION FOR INJECTION IN VIAL 
(INSULIN, HUMAN) 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. 
- 
Keep this leaflet. You may need to read it again. 
- 
If you have any further questions, ask your diabetes specialist
nurse, doctor or 
pharmacist. 
- 
This medicine has been prescribed for you. Do not pass it on to
others. It may harm 
them, even if their symptoms are the same as yours. 
- 
If any of the side effects gets serious, or if you notice any side
effects not listed in this 
leaflet, please tell your diabetes specialist nurse, doctor or
pharmacist. 

IN THIS LEAFLET:  
1. 
What Humulin M3 is and what it is used for 
2. 
Before you use Humulin M3 
3. 
How to use Humulin M3 
4. 
Possible side effects 
5. 
How to store Humulin M3 
6. Further 
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 sulphate 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 vial so
that you can easily tell 
the difference. 

2. 
BEFORE YOU USE HUMULIN M3 

DO NOT USE HUMULIN M3 IF YOU: 
- 
THINK HYPOGLYCAEMIA (LOW BLOOD SUGAR) IS STARTING. Further in this
leaflet it tells you 
how to deal with mild hypoglycaemia (_see A in Section 4_). 
- 

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 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 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 vial.
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 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 i