HUMULIN I KWIKPEN 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:

Eli Lilly and Company Limited

ATC code:

A10AC01

INN (International Name):

HUMAN INSULIN (RECOMBINANT DNA ORIGIN)

Dosage:

100 IU/ML

Pharmaceutical form:

Suspension for Injection

Administration route:

Subcutaneous administration

Units in package:

Pack size of 5

Prescription type:

Product subject to prescription which may be renewed (B)

Manufactured by:

Lilly France

Therapeutic group:

Humulin I

Therapeutic area:

Insulin (human)

Therapeutic indications:

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

Authorization status:

Authorised

Authorization date:

2015-03-13

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
HUMULIN
®
I (ISOPHANE) 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 I KwikPen is and what it is used for
2.
What you need to know before you use Humulin I KwikPen
3.
How to use Humulin I KwikPen
4.
Possible side effects
5.
How to store Humulin I KwikPen
6.
Contents of the pack and other information
1.
WHAT HUMULIN I KWIKPEN IS AND WHAT IT IS USED FOR
Humulin I 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 I is used to control
glucose in the long term. Its action
is prolonged by the inclusion of protamine sulfate in the suspension.
Your doctor may tell you to use Humulin I KwikPen as well as a
fast-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 I KWIKPEN
DO NOT USE HUMULIN I KWIKPEN:
-
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 all

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Humulin I KwikPen (Isophane) 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 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 I is a sterile suspension of a white, crystalline precipitate
of isophane human insulin in an isotonic phosphate
buffer.
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 I 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.
Each pack contains a patient information leaflet with instructions on
how to inject insulin.
4.3 CONTRAINDICATIONS
Hypoglycaemia.
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