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

国: マルタ

言語: 英語

ソース: Malta Medicines Authority

有効成分:

INSULIN HUMAN (RDNA)

から入手可能:

Eli Lilly & Co. Limited

ATCコード:

A10AC01

INN（国際名）:

INSULIN HUMAN (RDNA)

医薬品形態:

SUSPENSION FOR INJECTION

構図:

INSULIN HUMAN (RDNA) 100 IU

処方タイプ:

POM

治療領域:

DRUGS USED IN DIABETES

認証ステータス:

Authorised

情報リーフレット

Page 1 of 7
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
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_).
-
If you are allergic to human insulin or any of the other ingredients
of this medicine (lis

製品の特徴

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 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.
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 (Soluble) be
given intravenously.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FO