HUMULIN M 100 IU/ML Suspension for Injection

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

HUMAN INSULIN (RECOMBINANT DNA ORIGIN)

Disponível em:

Eli Lilly and Company Limited

Código ATC:

A10AD01

DCI (Denominação Comum Internacional):

HUMAN INSULIN (RECOMBINANT DNA ORIGIN)

Dosagem:

100 IU/ML

Forma farmacêutica:

Suspension for Injection

Via de administração:

Subcutaneous administration

Unidades em pacote:

Pack size 1 or 2

Tipo de prescrição:

Product subject to prescription which may be renewed (B)

Fabricado por:

Lilly Pharma Fertigung und Distribution Gmbh

Grupo terapêutico:

Humulin M3

Área terapêutica:

Insulins and analogues for injection, intermediate- or long-acting combined with fast-acting

Indicações terapêuticas:

For the treatment of patients with diabetes mellitus who require insulin for the maintenance of glucose homeostasis.

Status de autorização:

Authorised

Data de autorização:

2015-03-13

Folheto informativo - Bula

PACKAGE LEAFLET: INFORMATION FOR THE USER
HUMULIN M3 (MIXTURE 3) 100 IU/ML SUSPENSION FOR INJECTION IN VIAL
(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 vial so
that you can easily tell
the difference.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE HUMULIN M3
DO NOT USE HUMULIN M3:
-
IF YOU THINK HYPOGLYCAEMIA (LOW BLOOD SUGAR) IS STARTING. Further in
this leaflet it
tells you how to deal with mild hypoglycaemia (_see A in Section 4_).
-
If you are allergic to human insulin

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Humulin M3 (Mixture 3) 100 IU/ml Suspension for Injection in vial
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 100 IU insulin human (produced in_ E. coli_ by
recombinant DNA technology).
One vial contains 10 ml equivalent to 1000 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 vial.
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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