Mixtard

Land: Europese Unie

Taal: Engels

Bron: EMA (European Medicines Agency)

Werkstoffen:

Insulin human

Beschikbaar vanaf:

Novo Nordisk A/S

ATC-code:

A10AD01

INN (Algemene Internationale Benaming):

insulin human (rDNA)

Therapeutische categorie:

Drugs used in diabetes

Therapeutisch gebied:

Diabetes Mellitus

therapeutische indicaties:

Treatment of diabetes mellitus.

Product samenvatting:

Revision: 19

Autorisatie-status:

Authorised

Autorisatie datum:

2002-10-07

Bijsluiter

53
B. PACKAGE LEAFLET
54
PACKAGE LEAFLET: INFORMATION FOR THE USER
MIXTARD 30 40 IU/ML (INTERNATIONAL UNITS/ML) SUSPENSION 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 MIXTARD IS AND WHAT IT IS USED FOR
Mixtard is human insulin with both a fast-acting and a long-acting
effect.
Mixtard 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 Mixtard helps to prevent complications
from your diabetes.
Mixtard will start to lower your blood sugar about 30 minutes after
you inject it, and the effect will last
for approximately 24 hours.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE MIXTARD
DO NOT USE MIXTARD
►
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 resuspended insulin does not appear uniformly white and cloudy.
If any of these apply, do not use Mixtard. Talk to your doctor,
pharmacist or nurse for advice.
BEFORE

Productkenmerken

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Mixtard 30 40 international units/ml suspension for injection in vial.
Mixtard 30 100 international units/ml suspension for injection in
vial.
Mixtard 30 Penfill 100 international units/ml suspension for injection
in cartridge.
Mixtard 30 InnoLet 100 international units/ml suspension for injection
in pre-filled pen.
Mixtard 30 FlexPen 100 international units/ml suspension for injection
in pre-filled pen.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Mixtard 30 vial (40 international units/ml)
1 vial contains 10 ml equivalent to 400 international units. 1 ml
suspension contains 40 international
units soluble insulin human*/isophane (NPH) insulin human* in the
ratio 30/70 (equivalent to 1.4 mg).
Mixtard 30 vial (100 international units/ml)
1 vial contains 10 ml equivalent to 1,000 international units. 1 ml
suspension contains
100 international units soluble insulin human*/isophane (NPH) insulin
human* in the ratio 30/70
(equivalent to 3.5 mg).
Mixtard 30 Penfill
1 cartridge contains 3 ml equivalent to 300 international units. 1 ml
suspension contains
100 international units soluble insulin human*/isophane (NPH) insulin
human* in the ratio 30/70
(equivalent to 3.5 mg).
Mixtard 30 InnoLet/Mixtard 30 FlexPen
1 pre-filled pen contains 3 ml equivalent to 300 international units.
1 ml suspension contains
100 international units soluble insulin human*/isophane (NPH) insulin
human* in the ratio 30/70
(equivalent to 3.5 mg).
*Human insulin is produced in _Saccharomyces cerevisiae_ by
recombinant DNA technology.
Excipient with known effect:
Mixtard 30 contains less than 1 mmol sodium (23 mg) per dose, i.e.
Mixtard 30 is essentially ‘sodium-
free’.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
The suspension is cloudy, white and aqueous.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Mixtard is indicated for treatment of diabetes mellitus.
3
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOL