HUMULIN I 100 IU/ML Suspension for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

INSULIN HUMAN

Available from:

Eli Lilly and Company Limited

ATC code:

A10AC01

INN (International Name):

INSULIN HUMAN

Dosage:

100 IU/ML

Pharmaceutical form:

Suspension for Injection

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Insulin (human)

Authorization status:

Authorised

Authorization date:

1983-06-22

Patient Information leaflet

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. 
- 
Keep this leaflet. You may need to read it again. 
- 
If you have any further questions, ask your diabetes specialist nurse,
doctor or 
pharmacist. 
- 
This medicine has been prescribed for you. Do not pass it on to
others. It may 
harm them, even if their symptoms are the same as yours. 
- 
If any of the side effects gets serious, or if you notice any side
effects not listed 
in this leaflet, please tell your diabetes specialist nurse, doctor or
pharmacist. 

IN THIS LEAFLET:  
1. 
What Humulin I is and what it is used for 
2. 
Before you use Humulin I 
3. 
How to use Humulin I 
4. 
Possible side effects 
5. 
How to store Humulin I 
6. Further 
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 sulphate 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. 
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_). 
- 
are allergic (hypersensitive) to human insulin or any of the other
ingredients o

Summary of Product characteristics

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 human insulin (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
The dosage should be determined by the physician, according to the requirement of the patient.
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.
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.
Hypersensit