HUMULIN S 100 IU/ML Solution for Injection

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

INSULIN HUMAN

थमां उपलब्ध:

Eli Lilly and Company Limited

ए.टी.सी कोड:

A10AB01

INN (इंटरनेशनल नाम):

INSULIN HUMAN

डोज़:

100 IU/ML

फार्मास्यूटिकल फॉर्म:

Solution for Injection

प्रिस्क्रिप्शन प्रकार:

Product subject to prescription which may be renewed (B)

चिकित्सीय क्षेत्र:

Insulins and analogues for injection, fast-acting

प्राधिकरण का दर्जा:

Authorised

प्राधिकरण की तारीख:

1996-04-30

सूचना पत्रक

PA010FSAA00
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.
-  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 S is and what it is used for
2.  Before you use Humulin S
3.  How to use Humulin S
4.  Possible side effects
5.  How to store Humulin S
6.  Further information
1. WHAT HUMULIN S IS 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. BEFORE YOU USE HUMULIN S
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 
mild hypoglycaemia (_see A in Section 4_).
-  are allergic (hypersensitive) to human insulin or any of the
other ingredients of Humulin S (_see S

उत्पाद विशेषताएं

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 human insulin (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
The dosage should be determined by the physician, according to the requirement of the patient.
Humulin S should be given by subcutaneous injection but may, although not recommended, also be given by
intramuscular injection. It may also 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.
Each pack contains a patient information leaflet with instructions on how to inject insulin.
4.3 CONTRAINDICATIONS
Hypoglycaemia.
Hypersensitivity to Humulin or to the formulation excipients, unless used as part of a desensitisation programme.
Under no circumstances should any Humulin formulation other than Humulin S (Soluble) be given intrave