Insuman Infusat 100unitsml solution for injection 10ml vials

Quốc gia: Vương quốc Anh

Ngôn ngữ: Tiếng Anh

Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)

Thành phần hoạt chất:

Insulin human

Sẵn có từ:

Sanofi

Mã ATC:

A10AB01

INN (Tên quốc tế):

Insulin human

Liều dùng:

100unit/1ml

Dạng dược phẩm:

Solution for injection

Tuyến hành chính:

Subcutaneous

Lớp học:

No Controlled Drug Status

Loại thuốc theo toa:

Valid as a prescribable product

Tóm tắt sản phẩm:

BNF:

Tờ rơi thông tin

READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU STAR 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 inclu-
des any possible side effects not listed in
this leaflet. See section 4.
535502
535502
SAP-NR. (DMC): 535502
CODE: 1385
SCHRIFTGRÖSSE: 9 PUNKT
DRUCKFARBEN: PANTONE REFLEX BLUE
FORMAT 420 X 296 MM
ERSTELLT AM: 17. NOVEMBER 2016 / VERSION: 1 / MAC
535502
WHAT IS IN THIS LEAFLET
1. What Insuman Infusat is and what it is used
for
2. What you need to know before you use
Insuman Infusat
3. How to use Insuman Infusat
4. Possible side effects
5. How to store Insuman Infusat
6. Contents of the pack and other information
1. WHAT INSUMAN INFUSAT IS AND
WHAT IT IS USED FOR
Insuman Infusat contains the active substance
insulin human which is made by a biotechno-
logy process and is identical with the body’s
own insulin.
Insuman Infusat is an insulin preparation with
a rapid onset and short duration of action.
Insuman Infusat must only be used in insulin
pumps suitable for this insulin.
Insuman Infusat is used to reduce high blood
sugar in patients with diabetes mellitus who
need treatment with insulin. Diabetes mellitus
is a disease where your body does not produce
enough insulin to control the level of blood
sugar.
2. WHAT YOU NEED TO KNOW
BEFORE YOU USE INSUMAN INFUSAT
DO NOT USE INSUMAN INFUSAT
If you are allergic to insulin or any of the other
ingredients of this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before
using Insuman Infusat.
Follow closely the instructions for dose, moni-
toring (blood and urine tests), diet and physical
activity (physical work and exercise) as

Đặc tính sản phẩm

OBJECT 1
INSUMAN INFUSAT 100 IU/ML SOLUTION FOR INJECTION
IN A VIAL
Summary of Product Characteristics Updated 16-May-2018 | SANOFI
1. Name of the medicinal product
Insuman Infusat 100 IU/ml solution for injection in a vial
Insuman Infusat 100 IU/ml solution for injection in a cartridge
2. Qualitative and quantitative composition
Insuman Infusat 100 IU/ml in a vial
Each ml contains 100 IU insulin human (equivalent to 3.5 mg).
Each vial contains 10 ml of solution for injection, equivalent to 1000
IU insulin.
Insuman Infusat 100 IU/ml in a cartridge
Each ml contains 100 IU insulin human (equivalent to 3.5 mg).
Each cartridge contains 3.15 ml of solution for injection, equivalent
to 315 IU insulin.
One IU (International Unit) corresponds to 0.035 mg of anhydrous human
insulin
*
.
Insuman Infusat is a neutral insulin solution (regular insulin).
*
Human insulin is produced by recombinant DNA technology in
_Escherichia coli_.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection .
Clear, colourless solution.
4. Clinical particulars
4.1 Therapeutic indications
Diabetes mellitus where treatment with insulin is required.
4.2 Posology and method of administration
Posology
Insuman Infusat has been specially designed for use in external
portable insulin pumps. It is specially
stabilised to minimise loss of efficacy which may result from
mechanical and thermal stress in such
pumps. Insuman Infusat is therefore also suitable for continuous
insulin infusion with other, conventional
injection syringe pumps.
The desired blood glucose levels and the insulin dose regimen must be
determined individually and
adjusted to suit the patient's diet, physical activity and life-style.
_Daily doses and timing of administration _
When used in external portable insulin pumps, part of the daily
insulin dose is infused continuously
("basal rate"), and the rest is administered in the form of bolus
injections before meals. Refer to the
operating instructions for detailed information about the infusion
pump