Monotard
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
15-02-2008
Charakterystyka produktu
(SPC)
15-02-2008
Sprawozdanie z oceny publicznego
(PAR)
15-02-2008
Składnik aktywny:
Insulin human
Dostępny od:
Novo Nordisk A/S
Kod ATC:
A10AC01
INN (International Nazwa):
insulin human (rDNA)
Grupa terapeutyczna:
Drugs used in diabetes
Dziedzina terapeutyczna:
Diabetes Mellitus
Wskazania:
Treatment of diabetes mellitus.
Status autoryzacji:
Withdrawn
Data autoryzacji:
2002-10-07
Ulotka dla pacjenta
Medicinal Product no longer authorised
30
B. PACKAGE LEAFLET
Medicinal Product no longer authorised
31
Monotard
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 further questions, please ask your doctor, diabetes nurse
or pharmacist. This medicine is
prescribed for you personally and you should not pass it on to others.
It may harm them, even if their
symptoms are the same as yours.
_ _
Monotard 40 IU/ml Suspension for injection in a vial
Suspension for injection in a vial. Insulin human, rDNA.
Monotard is a zinc suspension consisting of a mixture of amorphous and
crystalline particles
(ratio 3:7).
The active substance is insulin human made by recombinant
biotechnology.
1 ml contains 40 IU of insulin human. 1 vial contains 10 ml equivalent
to 400 IU.
Monotard also contains
zinc chloride, zinc acetate, sodium chloride, methyl parahydroxy
benzoate,
sodium actetate, sodium hydroxide, hydrochloric acid and water for
injections.
The suspension for injection comes as a white, cloudy aqueous
suspension in packs of 1 or 5 vials of
10 ml (not all packs may be marketed).
The marketing authorisation holder and manufacturer
is Novo Nordisk A/S, Novo Allé,
DK-2880 Bagsværd, Denmark.
1 What Monotard is
Monotard is human insulin to treat diabetes. It comes in a 10 ml vial
that you use to fill a syringe.
Monotard is a long-acting insulin. This means that it will start to
lower your blood sugar about 2 ½
hours after you take it, and the effect will last for approximately 24
hours. Monotard is often given in
combination with fast-acting insulins.
2 Before you use Monotard
Do not use Monotard_ _
►
If you feel a hypo coming on (a hypo is short for a hypoglycaemic
reaction and is symptoms of
low blood sugar). See 4 What to do in an emergency for more about
hypos
►
If you have ever had an allergic reaction to this insulin product or
any of the ingredients (see
box, below left). Some people are allergic to the ingredient methyl
parahydroxy benzo
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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
Monotard 40 IU/ml
Suspension for injection in a vial
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Insulin human, rDNA (produced by recombinant DNA technology in
_Saccharomyces cerevisiae_).
1 ml contains 40 IU of insulin human
1 vial contains 10 ml equivalent to 400 IU
One IU (International Unit) corresponds to 0.035 mg of anhydrous human
insulin.
Monotard is an insulin zinc suspension. The suspension consists of a
mixture of amorphous and
crystalline particles (ratio 3:7).
For excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Suspension for injection in a vial.
Monotard is a cloudy, white, aqueous suspension.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Treatment of diabetes mellitus.
4.2
Posology and method of administration
Monotard is a long-acting insulin.
Dosage
Dosage is individual and determined by the physician in accordance
with the needs of the patient.
The average range of total daily insulin requirement for maintenance
therapy in type 1 diabetic patients
lies between 0.5 and 1.0 IU/kg. In pre-pubertal children it usually
varies from 0.7 to 1.0 IU/kg. During
the period of partial remission, the insulin requirements can be much
lower, whereas in insulin resistant
states e.g. during puberty or due to obesity, the daily insulin
requirement may be substantially higher.
Initial dosages for type 2 diabetic patients are often lower, e.g. 0.3
to 0.6 IU/kg/day.
The physician determines whether one or several daily injections are
necessary. Monotard may be used
alone or mixed with fast-acting insulin. In intensive insulin therapy
the suspension may be used as
basal insulin (evening and/or morning injection) with fast-acting
insulin given at meals.
In patients with diabetes mellitus optimised glycaemic control delays
the onset and slows the
progression of late diabetic complications. Blood glucose monitoring
is therefore recommend
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