Protaphane
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
27-10-2020
Fachinformation
(SPC)
27-10-2020
Öffentlichen Beurteilungsberichts
(PAR)
23-09-2014
Wirkstoff:
Insulin human
Verfügbar ab:
Novo Nordisk A/S
ATC-Code:
A10AC01
INN (Internationale Bezeichnung):
insulin human (rDNA)
Therapiegruppe:
Drugs used in diabetes
Therapiebereich:
Diabetes Mellitus
Anwendungsgebiete:
Treatment of diabetes mellitus.
Produktbesonderheiten:
Revision: 18
Berechtigungsstatus:
Authorised
Berechtigungsdatum:
2002-10-07
Gebrauchsinformation
43
B. PACKAGE LEAFLET
44
PACKAGE LEAFLET: INFORMATION FOR THE USER
PROTAPHANE 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 PROTAPHANE IS AND WHAT IT IS USED FOR
Protaphane is human insulin with a gradual onset and long duration of
action.
Protaphane 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 Protaphane helps to prevent complications
from your diabetes.
Protaphane will start to lower your blood sugar about 1½ hours after
you inject it, and the effect will
last for approximately 24 hours. Protaphane is often given in
combination with fast-acting insulin
preparations.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE PROTAPHANE
DO NOT USE PROTAPHANE
►
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
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Fachinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Protaphane 40 international units/ml suspension for injection in vial.
Protaphane 100 international units/ml suspension for injection in
vial.
Protaphane Penfill 100 international units/ml suspension for injection
in cartridge.
Protaphane InnoLet 100 international units/ml suspension for injection
in pre-filled pen.
Protaphane FlexPen 100 international units/ml suspension for injection
in pre-filled pen.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Protaphane vial (40 international units/ml)
1 vial contains 10 ml equivalent to 400 international units. 1 ml
suspension contains 40 international
units isophane (NPH) insulin human* (equivalent to 1.4 mg).
Protaphane vial (100 international units/ml)
1 vial contains 10 ml equivalent to 1,000 international units. 1 ml
suspension contains
100 international units isophane (NPH) insulin human* (equivalent to
3.5 mg).
Protaphane Penfill
1 cartridge contains 3 ml equivalent to 300 international units. 1 ml
suspension contains
100 international units isophane (NPH) insulin human* (equivalent to
3.5 mg).
Protaphane InnoLet/Protaphane FlexPen
1 pre-filled pen contains 3 ml equivalent to 300 international units.
1 ml suspension contains
100 international units isophane (NPH) insulin human* (equivalent to
3.5 mg).
*Human insulin is produced in
_Saccharomyces cerevisiae_
by recombinant DNA technology.
Excipient with known effect:
Protaphane contains less than 1 mmol sodium (23 mg) per dose, i.e.
Protaphane 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
Protaphane 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
Protaphane dosing is individual and determined in accordance with the
needs of the patient. The
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