Insuman Infusat 100unitsml solution for injection 3.15ml cartridges

البلد: المملكة المتحدة

اللغة: الإنجليزية

المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)

العنصر النشط:

Insulin human

متاح من:

Sanofi

INN (الاسم الدولي):

Insulin human

جرعة:

100unit/1ml

الشكل الصيدلاني:

Solution for injection

طريقة التعاطي:

Subcutaneous

الفئة:

No Controlled Drug Status

نوع الوصفة الطبية :

Valid as a prescribable product

ملخص المنتج:

BNF:

نشرة المعلومات

541551
541551
SAP-NR. (DMC): 541551
SCHRIFTGRÖSSE: 9 PUNKT
DRUCKFARBEN: PANTONE REFLEX BLUE
FORMAT 420 X 296 MM
ERSTELLT AM: 04. MAI 2018 / VERSION: 3 / MAC
541551
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.
Special patient groups
If you have liver or kidneys problems or if you
are elderly, speak to your doctor as you may
need a lower dose.
Travel
Before travelling, consult your doctor. You may
need to talk about
– the availability of your insulin in the country
you are visiting,
– supplies of insulin, injection syringes etc.,
– correct storage of your insulin while travelling,
– whom to contact in the event of technical
problems with your pump,
– timing of meals and insulin administration
while travelling,
– the possible effects of changing to different
time zones,
– possible new health risks in the countries to
be visited,
– what you should do in emergency situations
when you feel unwell or become ill.
Illnesses and injuries.
In the following situations, the management of
your diabetes may require a lot of care:
– If you are ill or have a major injury then your
blood sugar level may increase (hyperglycaemia).
– If you are not eating enough, your blood sugar
level may become too low (hypoglycaemia).
In most cases you will need a doctor. MAKE
SURE THAT YOU CONTACT A DOCTOR EARLY.
If you have type 1 diabetes (insulin dependent
diabetes mellitus), do not stop your insulin and
continue to get enough carbohydrates. Always
tell people who are caring for you or treating
you tha

خصائص المنتج

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