Actrapid

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

human insulin

Διαθέσιμο από:

Novo Nordisk A/S

Φαρμακολογική κατηγορία (ATC):

A10AB01

INN (Διεθνής Όνομα):

human insulin (rDNA)

Θεραπευτική ομάδα:

Drugs used in diabetes

Θεραπευτική περιοχή:

Diabetes Mellitus

Θεραπευτικές ενδείξεις:

Treatment of diabetes mellitus.

Περίληψη προϊόντος:

Revision: 17

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2002-10-07

Φύλλο οδηγιών χρήσης

43
B. PACKAGE LEAFLET
44
PACKAGE LEAFLET: INFORMATION FOR THE USER
ACTRAPID 40 IU/ML (INTERNATIONAL UNITS/ML) SOLUTION FOR INJECTION IN
VIAL
human insulin
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.
1.
WHAT ACTRAPID IS AND WHAT IT IS USED FOR
Actrapid is human insulin with a fast-acting effect.
Actrapid is used to reduce the high blood sugar level in patients with
diabetes mellitus (diabetes).
Diabetes is a disease where your body does not produce enough insulin
to control the level of your
blood sugar. Treatment with Actrapid helps to prevent complications
from your diabetes.
Actrapid will start to lower your blood sugar about half an hour after
you inject it, and the effect will
last for approximately 8 hours. Actrapid is often given in combination
with intermediate-acting or
long-acting insulin preparations.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ACTRAPID
DO NOT USE ACTRAPID
►
If you are allergic
to human insulin or any of the other ingredients in this medicine, see
section
6.
►
If you
suspect hypoglycaemia (low blood sugar) is starting, see Summary of
serious and very
common side effects in section 4.
►
In insulin infusion pumps.
►
If the protective cap is loose or missing. Each vial has a protective,
tamper-proof plastic cap. If
it is not in perfect condition when you get the vial, return the vial
to your supplier.
►
If it has not been stored correctly or if it has been frozen, see
section 5.
►
If the insulin does not appear clear and colourless.
If any of these apply, do not use Actr

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Actrapid 40 international units/ml solution for injection in vial.
Actrapid 100 international units/ml solution for injection in vial.
Actrapid Penfill 100 international units/ml solution for injection in
cartridge.
Actrapid InnoLet 100 international units/ml solution for injection in
pre-filled pen.
Actrapid FlexPen 100 international units/ml solution for injection in
pre-filled pen.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Actrapid vial (40 international units/ml)
1 vial contains 10 ml equivalent to 400 international units. 1 ml
solution contains 40 international units
insulin human* (equivalent to 1.4 mg).
Actrapid vial (100 international units/ml)
1 vial contains 10 ml equivalent to 1,000 international units. 1 ml
solution contains 100 international
units insulin human* (equivalent to 3.5 mg).
Actrapid Penfill
1 cartridge contains 3 ml equivalent to 300 international units. 1 ml
solution contains 100 international
units insulin human* (equivalent to 3.5 mg).
Actrapid InnoLet/Actrapid FlexPen
1 pre-filled pen contains 3 ml equivalent to 300 international units.
1 ml solution contains
100 international units insulin human* (equivalent to 3.5 mg).
*Human insulin is produced in
_Saccharomyces cerevisiae_
by recombinant DNA technology.
Excipient with known effect:
Actrapid contains less than 1 mmol sodium (23 mg) per dose, i.e.
Actrapid is essentially ‘sodium-
free’.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
The solution is clear, colourless and aqueous.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Actrapid is indicated for treatment of diabetes mellitus.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The potency of human insulin is expressed in international units.
3
Actrapid dosing is individual and determined in accordance with the
needs of the patient. It can be
used alone or in combination with intermediate-acting or long-acting
insulin before a meal or a