Ultratard
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
15-02-2008
Fachinformation
(SPC)
15-02-2008
Öffentlichen Beurteilungsberichts
(PAR)
15-02-2008
Wirkstoff:
Insulin human
Verfügbar ab:
Novo Nordisk A/S
ATC-Code:
A10AE01
INN (Internationale Bezeichnung):
insulin human (rDNA)
Therapiegruppe:
Drugs used in diabetes
Therapiebereich:
Diabetes Mellitus
Anwendungsgebiete:
Treatment of diabetes mellitus.
Berechtigungsstatus:
Withdrawn
Berechtigungsdatum:
2002-10-07
Gebrauchsinformation
Medicinal Product no longer authorised
30
B. PACKAGE LEAFLET
Medicinal Product no longer authorised
31
Ultratard
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.
_ _
Ultratard 40 IU/ml Suspension for injection in a vial
Suspension for injection in a vial. Insulin human, rDNA.
Ultratard is a zinc suspension consisting of crystalline particles.
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.
Ultratard also contains zinc chloride, sodium chloride, methyl
parahydroxy benzoate, sodium
actetate, sodium hydroxide, hydrochloric acid and water for
injections.
The suspension for injection comes as a white, cloudy 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 Ultratard is
Ultratard is human insulin to treat diabetes. It comes in a 10 ml vial
that you use to fill a syringe.
Ultratard is a very long-acting insulin. This means that it will start
to lower your blood sugar about 4
hours after you take it, and the effect will last for approximately 28
hours. Ultratard is often given in
combination with fast-acting insulins.
2 Before you use Ultratard
Do not use Ultratard_ _
►
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 benzoate. Look
out for the signs of allergy in 5 Possi
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Fachinformation
Medicinal Product no longer authorised
1
_ _
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal Product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Ultratard 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.
Ultratard is an insulin zinc suspension. The suspension consists of
crystalline particles.
For excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Suspension for injection in a vial.
Ultratard is a cloudy, white, aqueous suspension.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Treatment of diabetes mellitus.
4.2
Posology and method of administration
Ultratard 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 0.7to 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. Ultratard 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 recommended.
Dosage adjustment
Conco
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