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

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

INSULIN HUMAN, RDNA

Available from:

Eli Lilly Nederland B.V Papendorpseweg 83, 3528 BJ, Utrecht, NL-3991, Netherlands

ATC code:

A10AB01

INN (International Name):

INSULIN HUMAN (RDNA) 100 IU

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

INSULIN HUMAN (RDNA) 100 IU

Prescription type:

POM

Therapeutic area:

DRUGS USED IN DIABETES

Authorization status:

Authorised

Authorization date:

2005-09-26

Patient Information leaflet

1
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

Summary of Product characteristics

1
HUMULIN
® S CARTRIDGE
MALTA
(insulin human)
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).
2
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 other than
Humulin S (