Actraphane

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

Insulin human

MAH:

Novo Nordisk A/S

ATC_code:

A10AD01

INN:

insulin human (rDNA)

therapeutic_group:

Drugs used in diabetes

therapeutic_area:

Diabetes Mellitus

therapeutic_indication:

Treatment of diabetes mellitus.

leaflet_short:

Revision: 19

authorization_status:

Authorised

authorization_date:

2002-10-07

PIL

53
B. PACKAGE LEAFLET
54
PACKAGE LEAFLET: INFORMATION FOR THE USER
ACTRAPHANE 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 ACTRAPHANE IS AND WHAT IT IS USED FOR
Actraphane is human insulin with both a fast-acting and a long-acting
effect.
Actraphane 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 Actraphane helps to prevent complications
from your diabetes.
Actraphane 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 ACTRAPHANE
DO NOT USE ACTRAPHANE
►
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 Actraphane. Talk to your doctor,
pharmacist

SPC

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Actraphane 30 40 international units/ml suspension for injection in
vial.
Actraphane 30 100 international units/ml suspension for injection in
vial.
Actraphane 30 Penfill 100 international units/ml suspension for
injection in cartridge.
Actraphane 30 InnoLet 100 international units/ml suspension for
injection in pre-filled pen.
Actraphane 30 FlexPen 100 international units/ml suspension for
injection in pre-filled pen.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Actraphane 30 vial (40 intern
ational 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).
Actraphane 30 vial (100 inter
national 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).
Actraphane 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).
Actraphane 30 InnoLet/Actrap
hane 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:
Actraphane 30 contains less than 1 mmol sodium (23 mg) per dose, i.e.
Actraphane 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
Actraphane is indicated for treatment of diabetes mellitus.
3
4.2
PO