Humulin M3 KwikPen 100units/ml suspension for injection 3ml pre-filled pens

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv bestanddel:

Insulin soluble human; Insulin isophane human

Tilgængelig fra:

Eli Lilly and Company Ltd

ATC-kode:

A10AD01

INN (International Name):

Insulin soluble human; Insulin isophane human

Dosering:

30unit/1ml ; 70unit/1ml

Lægemiddelform:

Suspension for injection

Indgivelsesvej:

Intramuscular; Subcutaneous

Klasse:

No Controlled Drug Status

Recept type:

Caution - AMP level prescribing advised

Produkt oversigt:

BNF: 06010102; GTIN: 5014602101503

Indlægsseddel

1
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
DO NOT USE HUMULIN M3 KWIKPEN:
-
IF YOU THINK HYPOGLYCAEMIA (LOW BLOOD SUGAR) IS STARTING.
Further in this leaflet it tells y

Produktets egenskaber

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