Humulin S 100units/ml solution for injection 10ml vials

国: イギリス

言語: 英語

ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)

有効成分:

Insulin soluble human

から入手可能:

Eli Lilly and Company Ltd

ATCコード:

A10AB01

INN（国際名）:

Insulin soluble human

投薬量:

100unit/1ml

医薬品形態:

Solution for injection

投与経路:

Intravenous; Subcutaneous

クラス:

No Controlled Drug Status

処方タイプ:

Caution - AMP level prescribing advised

製品概要:

BNF: 06010101; GTIN: 5014602100087

情報リーフレット

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
HUMULIN
® S (SOLUBLE) 100 IU/ML SOLUTION FOR INJECTION IN VIAL
(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 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 vial so
that you can easily tell
the difference.
2.
WHAT YOU NEED TO KNOW 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_
).
-
If you are allergic to human insulin or any of the other ingredients
of this medicine
(listed in section 6).
WARNINGS AND PRECAUTIONS
T

製品の特徴

OBJECT 1
HUMULIN S (SOLUBLE) 100IU/ML SOLUTION FOR
INJECTION IN VIAL
Summary of Product Characteristics Updated 29-Apr-2018 | Eli Lilly and
Company Limited
1. Name of the medicinal product
Humulin
®
S (Soluble) 100 IU/ml solution for injection in vial
2. Qualitative and quantitative composition
1 ml contains 100 IU insulin human (produced in _E.coli _by
recombinant DNA technology).
One vial contains 10 ml equivalent to 1000 IU of soluble insulin.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
A solution for injection in a vial.
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 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.
Humulin I (Isophane) may be administered in combination with Humulin S
(Soluble) (See Instructions
for use and handling - for Mixing of Insulins).
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 dese