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

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

INSULIN HUMAN, RDNA

Available from:

Eli Lilly Nederland B.V Papendorpseweg 83, 3528 BJ, Utrecht, NL-3991, Netherlands

ATC code:

A10AD01

INN (International Name):

INSULIN HUMAN (RDNA) 100 IU

Pharmaceutical form:

SUSPENSION FOR INJECTION

Composition:

INSULIN HUMAN (RDNA) 100 IU

Prescription type:

POM

Therapeutic area:

DRUGS USED IN DIABETES

Authorization status:

Authorised

Authorization date:

2005-09-26

Patient Information leaflet

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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.
WHAT YOU NEED TO KNOW BEFORE YOU USE HUMULIN M3
HUMULIN M3 IN CARTRIDGES IS ONLY SUITABLE FOR INJECTING JUST UNDER THE
SKIN USING A
REUSABLE PEN. SPEAK TO YOUR DOCTOR IF YOU NEED TO INJECT YOUR INSULIN
BY ANOTHER
METHOD.
DO NOT USE HUMULIN M3:

Summary of Product characteristics

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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 in cartridges is only suitable for subcutaneous injections
from a reusable pen.
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 in order to reduce the risk of lipodystrophy and
cutaneous amyloidosis (see
section 4.4 and 4.8).
Care should be taken when injecting any Humulin insulin preparations
to ensure that a
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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 inje