Velosulin
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
17-04-2009
Charakterystyka produktu
(SPC)
17-04-2009
Sprawozdanie z oceny publicznego
(PAR)
15-07-2008
Składnik aktywny:
Insulin human
Dostępny od:
Novo Nordisk A/S
Kod ATC:
A10AB01
INN (International Nazwa):
insulin human (rDNA)
Grupa terapeutyczna:
Drugs used in diabetes
Dziedzina terapeutyczna:
Diabetes Mellitus
Wskazania:
Treatment of diabetes mellitus.
Podsumowanie produktu:
Revision: 5
Status autoryzacji:
Withdrawn
Data autoryzacji:
2002-10-07
Ulotka dla pacjenta
Medicinal product no longer authorised
22
B. PACKAGE LEAFLET
Medicinal product no longer authorised
23
PACKAGE LEAFLET: INFORMATION FOR THE USER
VELOSULIN 100 IU/ML SOLUTION FOR INJECTION IN A VIAL
Insulin human (rDNA)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING YOUR
INSULIN.
–
Keep this leaflet. You may need to read it again.
–
If you have any further questions, ask your doctor, diabetes nurse or
your pharmacist.
–
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours.
–
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor, diabetes nurse or your pharmacist.
1.
WHAT VELOSULIN IS AND WHAT IT IS USED FOR
VELOSULIN IS HUMAN INSULIN TO TREAT DIABETES. Velosulin is a
fast-acting insulin. This means that it
will start to lower your blood sugar about half an hour after you take
it.
2.
BEFORE YOU USE VELOSULIN
DO NOT USE VELOSULIN
IF YOU ARE ALLERGIC (HYPERSENSITIVE) to this insulin product,
metacresol or any of the other
ingredients (see_ 7 Further information)_. Look out for the signs of
allergy in _5 Possible side _
_effects_
IF YOU FEEL A HYPO coming on (a hypo is short for a hypoglycaemic
reaction and is a symptom
of low blood sugar). See _4 What to do in an emergency_ for more about
hypos.
TAKE SPECIAL CARE WITH VELOSULIN
IF YOU HAVE TROUBLE with your kidneys or liver, or with your adrenal,
pituitary or thyroid glands
IF YOU ARE DRINKING ALCOHOL: watch for signs of a hypo and never drink
alcohol on an empty
stomach
IF YOU ARE EXERCISING more than usual or if you want to change your
usual diet
IF YOU ARE ILL: carry on taking your insulin
IF YOU ARE GOING ABROAD: travelling over time zones may affect your
insulin needs and the
timing of your injections.
USING OTHER MEDICINES
Many medicines affect the way glucose works in your body and they may
influence your insulin dose.
Listed below are the most common medicines which may affect your
insuli
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Charakterystyka produktu
Medicinal product no longer authorised
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Velosulin 100 IU/ml solution for injection or infusion in a vial.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Insulin human, rDNA (produced by recombinant DNA technology in
_Saccharomyces cerevisiae_).
1 ml contains 100 IU of insulin human.
1 vial contains 10 ml equivalent to 1000 IU.
One IU (International Unit) corresponds to 0.035 mg of anhydrous human
insulin.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection or infusion in a vial.
Clear, colourless, aqueous solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of diabetes mellitus.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
This phosphate-buffered soluble insulin is intended for continuous
subcutaneous insulin infusion
(CSII) in external insulin infusion pumps.
Velosulin is a fast-acting insulin and may be used in combination with
certain long-acting insulin
products. For incompatibilities see section 6.2.
Dosage
Dosage is individual and determined by the physician in accordance
with the needs of the patient.
Usually, 40-60% of the total daily dose is given as a continuous basal
rate and the remaining 40-60%
as boluses divided between the three main meals.
In general, when patients are transferred from injection to infusion
therapy, it may be advisable to
reduce the dosage by initiating the patient at 90% of the previous
total daily dosage, with 40% as
basal rate and 50% as boluses divided between the three main meals.
Dosage is individual and determined in accordance with the needs of
the patient. The individual
insulin requirement is usually between 0.3 and 1.0 IU/kg/day. The
daily insulin requirement may be
higher in patients with insulin resistance (e.g. during puberty or due
to obesity) and lower in patients
with residual, endogenous insulin production.
In patients with diabetes mellitus optimised glycaemic control delays
the onset of
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