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

Country: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

Human insulin (recombinant dna origin)

থেকে পাওয়া:

Eli Lilly Nederland B.V.

এটিসি কোড:

A10AC; A10AC01

INN (International Name):

Human insulin (recombinant dna origin)

ডোজ:

100 international unit(s)/millilitre

ফার্মাসিউটিকাল ফর্ম:

Suspension for injection in cartridge

প্রেসক্রিপশন টাইপ:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Insulins and analogues for injection, intermediate-acting; insulin (human)

অনুমোদন অবস্থা:

Marketed

অনুমোদন তারিখ:

2015-03-13

তথ্য লিফলেট

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
HUMULIN
® I (ISOPHANE) 100 IU/ML SUSPENSION 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 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 cartridge so that you
can easily tell the difference.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE HUMULIN I
HUMULIN I 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 I:
-
IF YOU THINK HYPOGLYCAEMIA (LOW BLOOD SUGAR) IS STARTING.
Further in this leaflet

পণ্য বৈশিষ্ট্য

Health Products Regulatory Authority
09 November 2020
CRN009V6Z
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Humulin I (Isophane) 100 IU/ml Suspension 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 isophane insulin.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
A suspension for injection in a cartridge.
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 in cartridges is only suitable for subcutaneous injections
from a reusable pen. 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.
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 an