Humulin I KwikPen (Isophane) 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 Nederland B.V.

ATC code:

A10AC; A10AC01

INN (International Name):

Human insulin (recombinant dna origin)

Dosage:

100 international unit(s)/millilitre

Pharmaceutical form:

Suspension for injection

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Insulins and analogues for injection, intermediate-acting; insulin (human)

Authorization status:

Marketed

Authorization date:

2015-03-13

Patient Information leaflet

1
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
HUMULIN I IN PRE-FILLED PEN IS ONLY SUITABLE FOR INJECTING JUST UNDER
THE SKIN. SPEAK TO YOUR
DOCTOR IF YOU NEED TO INJECT YOUR INSULIN BY ANOTHER METHOD.
DO NOT USE HUMULIN I KWIKPEN:
-
IF YOU THINK H

Summary of Product characteristics

Health Products Regulatory Authority
09 November 2020
CRN009V6Z
Page 1 of 7
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 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.
Each pack contains a patient information leaflet with instructions on
how to inject insulin.
4.3 CONTRAINDICATIONS
Hypoglycaemia.
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1, unless used as part of a desensitisation
programme.
Under no circumstances should any Humulin f