Humulin S (Soluble), 100 IU/ml Solution for Injection in cartridge

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:

A10AB01

INN (International Name):

Human insulin (recombinant dna origin)

Dosage:

100 international unit(s)/millilitre

Pharmaceutical form:

Solution for injection in cartridge

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

insulin (human)

Authorization status:

Marketed

Authorization date:

2015-03-13

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
HUMULIN
® S (SOLUBLE) 100 IU/ML
SOLUTION FOR INJECTION IN CARTRIDGE
(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 S is and what it is used for
2. What you need to know before you use Humulin S
3. How to use Humulin S
4. Possible side effects
5. How to store Humulin S
6. Contents of the pack and other information
1. WHAT IS HUMULIN S AND WHAT IT IS USED FOR
Humulin S 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 S is used to control glucose in the long term. Humulin S is a
rapidly acting insulin preparation.
Your doctor may tell you to use Humulin S 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 cartridge so that you can easily tell the
difference.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE HUMULIN S
HUMULIN S IN CARTRIDGES IS ONLY SUITABLE FOR INJECTING JUST UNDER THE
SKIN USING A REUSABLE PEN.
SPEAK TO YOUR DOCTOR IF YOU NEED TO INJECT YOUR INSULIN BY ANOTHER
METHOD.
DO NOT USE HUMULIN S:
- IF YOU THINK HYPOGLYCAEMIA (LOW BLOOD SUGAR) IS STARTING.
Further in this leaflet it tells you how to
deal with mil

Summary of Product characteristics

Health Products Regulatory Authority
20 December 2023
CRN00DNTP
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Humulin S (Soluble), 100 IU/ml Solution for Injection in cartridge
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 100 IU insulin human (produced in _E. coli_ by
recombinant DNA technology).
One cartridge contains 3 ml equivalent to 300 IU of soluble insulin.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
A solution for injection in a cartridge.
Humulin S is a sterile, clear, colourless, aqueous solution of human
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 S in cartridges is only suitable for subcutaneous injections
from a reusable pen. If administration by syringe or
intravenous injection is necessary, a vial should be used.
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 formulation o