Humulin I (Isophane) 100 IU/ml Suspension for Injection in vial

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) 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 I is and what it is used for
2.
What you need to know before you use Humulin I
3.
How to use Humulin I
4.
Possible side effects
5.
How to store Humulin I
6.
Contents of the pack and other information
1.
WHAT HUMULIN I IS AND WHAT IT IS USED FOR
Humulin I 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 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 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 vial so
that you can easily tell
the difference.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE HUMULIN I
DO NOT USE HUMULIN I:
-
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 or any of the other ingredients
of this medicine
(listed in section 6

Summary of Product characteristics

Health Products Regulatory Authority
09 November 2020
CRN009V6Z
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Humulin I (Isophane) 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 isophane insulin.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
A suspension for injection in a vial.
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 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.
Humulin I (Isophane) may be administered in combination with Humulin S
(Soluble). (See Instructions for use and handling for
Mixing of Insulins).
Each pack contains a patient information leaflet with instructions on
how to inject insulin.
4.3 CONTRAINDICATIONS
Hypoglycaemia.
Hype