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

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 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 KwikPen is and what it is used for
2.
What you need to know 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.
Contents of the pack and other 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.
WHAT YOU NEED TO KNOW BEFORE YOU USE HUMULIN M3 KWIKPEN
DO NOT USE HUMULIN M3 KWIKPEN:
-
IF YOU THINK HYPOGLYCAEMIA (LOW BLOOD SUGAR) IS STARTING. Further in
this leaflet it tells you

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 insulin human (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 %
isophane 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
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 mix insulin preparations. A patient's
treatment regimen should be based on their individual
metabolic requirements.
Each pack contains a patient information leaflet with instructions on
how to inject insulin.
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