Humulin M3 100units/ml suspension for injection 10ml vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Insulin soluble human; Insulin isophane human

Available from:

Eli Lilly and Company Ltd

ATC code:

A10AD01

INN (International Name):

Insulin soluble human; Insulin isophane human

Dosage:

30unit/1ml ; 70unit/1ml

Pharmaceutical form:

Suspension for injection

Administration route:

Subcutaneous

Class:

No Controlled Drug Status

Prescription type:

Caution - AMP level prescribing advised

Product summary:

BNF: 06010102; GTIN: 5014602100131

Patient Information leaflet

1
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

Summary of Product characteristics

OBJECT 1
HUMULIN M3 (MIXTURE 3) 100IU/ML SUSPENSION
FOR INJECTION IN VIAL
Summary of Product Characteristics Updated 29-Apr-2018 | Eli Lilly and
Company Limited
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 con