Humulin M3 KwikPen (mixture 3) 100 IU/ml Suspension for Injection

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Human insulin (recombinant dna origin)

Tillgänglig från:

Eli Lilly Nederland B.V.

ATC-kod:

A10AD; A10AD01

INN (International namn):

Human insulin (recombinant dna origin)

Dos:

100 international unit(s)/millilitre

Läkemedelsform:

Suspension for injection

Receptbelagda typ:

Product subject to prescription which may be renewed (B)

Terapiområde:

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

Bemyndigande status:

Marketed

Tillstånd datum:

2015-03-13

Bipacksedel

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
HUMULIN M3 IN PRE-FILLED PEN IS ONLY SUITABLE FOR INJECTING JUST UNDER
THE SKIN. SPEAK TO YOUR
DOCTOR IF YOU NEED TO INJECT YO

Produktens egenskaper

Health Products Regulatory Authority
09 November 2020
CRN009V6Z
Page 1 of 7
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 in pre-filled pen is only suitable for subcutaneous
injections. 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 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 con