Humulin M3 KwikPen (mixture 3) 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:

PCO Manufacturing Ltd.

ATC code:

A10AD; A10AD01

INN (International Name):

Human insulin (recombinant dna origin)

Pharmaceutical form:

Suspension for injection

Therapeutic area:

Insulins and analogues for injection, intermediate- or long-acting combined with fast-acting; insulin (human)

Authorization date:

2023-05-19

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
HUMULIN
® M3 KWIKPEN
® (MIXTURE 3) 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
HUMULIN M3 IN PRE-FILLED PEN IS ONLY SUITABLE FOR INJECTING JUST UNDER
THE SKIN. SPEAK TO
YOUR DOCTOR IF YOU NEED TO INJECT YOU

Summary of Product characteristics

Health Products Regulatory Authority
22 May 2023
CRN00DGMV
Page 1 of 3
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 the full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
A suspension for injection in a pre-filled pen.
_Product imported from Czech Republic:_
Humulin M3 is a sterile suspension of human insulin in the proportion
of 30 % soluble insulin to 70 % isophane insulin.
4 CLINICAL PARTICULARS
As per PA2276/006/002
5 PHARMACOLOGICAL PROPERTIES
As per PA2276/006/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
m-cresol
glycerol
phenol
protamine sulfate
dibasic sodium phosphate
zinc oxide
water for injections.
The following may be used to adjust pH; hydrochloric acid and/or
sodium hydroxide.
6.2 INCOMPATIBILITIES
Humulin preparations should not be mixed with insulins produced by
other manufacturers or with animal insulin preparations.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the container and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
_Unused pre-filled pens_
Health Products Regulatory Authority
22 May 2023
CRN00DGMV
Page 2 of 3
Store in a refrigerator (2° C – 8° C). Do not freeze. Do not
expose to excessive heat or direct sunlight.
_After first use_
Store below 30° C. Do not refrigerate. The pre-filled pen should not
be stored with the needle attached.
6.5 NATURE AND CONTENTS OF CONTAINER
3 ml suspension in a cartridge (type I glass) with a plunger head at
the bottom (rubber) and disc seal at the top (rubber) in a
pre-filled pen. Pack size of 5.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
Do not reuse needles. Dispose o