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:

1998-09-18

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
HUMULIN
®
 M3 (MIXTURE 3) KWIKPEN™
100 IU/ML SUSPENSION FOR INJECTION 
(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 KwikPen is and what it is used for
2. Before you use Humulin M3 KwikPen
3. How to use Humulin M3 KwikPen
4. Possible side effects
5. How to store Humulin M3 KwikPen
6. Further information
1. WHAT HUMULIN M3 KWIKPEN IS AND WHAT IT IS USED FOR
Humulin M3 KwikPen is a pre-filled pen containing 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 KwikPen 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 pen so that 
you can easily tell the difference.
2. BEFORE YOU USE HUMULIN M3 KWIKPEN
DO NOT USE HUMULIN M3 KWIKPEN IF YOU:
-  THINK HYPOGLYCAEMIA (LOW BLOOD SUGAR) IS STARTING. Further in

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Humulin M3 KwikPen (Mixture 3) 100 IU/ml suspension for injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 100 IU human insulin (produced in E. coli by recombinant DNA technology).
One pre-filled pen contains 3 ml equivalent to 300 IU of biphasic isophane insulin – 30 % soluble insulin / 70 % isophan
insulin.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
A suspension for injection in a pre-filled pen.
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