Insuman
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
12-07-2023
Charakterystyka produktu
(SPC)
12-07-2023
Sprawozdanie z oceny publicznego
(PAR)
26-11-2013
Składnik aktywny:
Insulin human
Dostępny od:
Sanofi-aventis Deutschland GmbH
Kod ATC:
A10AB01, A10AC01
INN (International Nazwa):
insulin human
Grupa terapeutyczna:
Drugs used in diabetes
Dziedzina terapeutyczna:
Diabetes Mellitus
Wskazania:
Diabetes mellitus where treatment with insulin is required. Insuman Rapid is also suitable for the treatment of hyperglycaemic coma and ketoacidosis, as well as for achieving pre-, intra- and postoperative stabilisation in patients with diabetes mellitus.
Podsumowanie produktu:
Revision: 33
Status autoryzacji:
Authorised
Data autoryzacji:
1997-02-21
Ulotka dla pacjenta
205
B.
PACKAGE LEAFLET
206
PACKAGE LEAFLET: INFORMATION FOR THE USER
INSUMAN RAPID 100 IU/ML SOLUTION FOR INJECTION IN A 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 Insuman Rapid is and what it is used for
2.
What you need to know before you use Insuman Rapid
3.
How to use Insuman Rapid
4.
Possible side effects
5.
How to store Insuman Rapid
6.
Contents of the pack and other information
1.
WHAT INSUMAN RAPID IS AND WHAT IT IS USED FOR
Insuman Rapid contains the active substance insulin human which is
made by a biotechnology process
and is identical with the body's own insulin.
Insuman Rapid is an insulin solution with a rapid onset and short
duration of action.
Insuman Rapid 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. Insuman Rapid may also be used
for treating hyperglycaemic coma
(coma caused by too much blood sugar) and ketoacidosis (build-up of
acid in the blood because the
body is breaking down fat instead of sugar) as well as for controlling
blood sugar before, during and
after surgery.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE INSUMAN RAPID
DO NOT USE INSUMAN RAPID
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 Rapid.
Follow closely the instruct
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Insuman Rapid 40 IU/ml solution for injection in a vial
Insuman Rapid 100 IU/ml solution for injection in a vial
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Insuman Rapid 40 IU/ml in a vial
Each ml contains 40 IU insulin human (equivalent to 1.4 mg).
Each vial contains 10 ml of solution for injection, equivalent to 400
IU insulin.
Insuman Rapid 100 IU/ml in a vial
Each ml contains 100 IU insulin human (equivalent to 3.5 mg).
Each vial contains 5 ml of solution for injection, equivalent to 500
IU insulin, or 10 ml of solution for
injection, equivalent to 1000 IU insulin.
One IU (International Unit) corresponds to 0.035 mg of anhydrous human
insulin
*
.
Insuman Rapid 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. Insuman
Rapid is also suitable for the
treatment of hyperglycaemic coma and ketoacidosis, as well as for
achieving pre-, intra- and
post-operative stabilisation in patients with diabetes mellitus.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The desired blood glucose levels, the insulin preparations to be used
and the insulin dose regimen
(doses and timings) must be determined individually and adjusted to
suit the patient’s diet, physical
activity and life-style.
_Daily doses and timing of administration _
There are no fixed rules for insulin dose regimen. However, the
average insulin requirement is often
0.5 to 1.0 IU per kg body weight per day. The basal metabolic
requirement is 40% to 60% of the total
daily requirement. Insuman Rapid is injected subcutaneously 15 to 20
minutes before a meal.
In the treatment of severe hyperglycaemia or ketoacidosis in
particular, insulin administration is part of
a com
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