NovoMix
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
29-08-2023
Fachinformation
(SPC)
29-08-2023
Öffentlichen Beurteilungsberichts
(PAR)
16-08-2019
Wirkstoff:
insulin aspart
Verfügbar ab:
Novo Nordisk A/S
ATC-Code:
A10AD05
INN (Internationale Bezeichnung):
insulin aspart
Therapiegruppe:
Drugs used in diabetes
Therapiebereich:
Diabetes Mellitus
Anwendungsgebiete:
Treatment of diabetes mellitus.
Produktbesonderheiten:
Revision: 29
Berechtigungsstatus:
Authorised
Berechtigungsdatum:
2000-08-01
Gebrauchsinformation
43
B. PACKAGE LEAFLET
VV-LAB-103275
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0
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44
PACKAGE LEAFLET: INFORMATION FOR THE USER
NOVOMIX 30 PENFILL 100 UNITS/ML SUSPENSION FOR INJECTION IN A
CARTRIDGE
30% soluble insulin aspart and 70% insulin aspart crystallised with
protamine
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, nurse or
pharmacist.
•
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, nurse or pharmacist.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What NovoMix 30 is and what it is used for
2.
What you need to know before you use NovoMix 30
3.
How to use NovoMix 30
4.
Possible side effects
5.
How to store NovoMix 30
6.
Contents of the pack and other information
1.
WHAT NOVOMIX 30 IS AND WHAT IT IS USED FOR
NovoMix 30 is a modern insulin (insulin analogue) with both a
rapid-acting and an intermediate-acting
effect, in the ratio 30/70. Modern insulin products are improved
versions of human insulin.
NovoMix 30 is used to reduce the high blood sugar level in adults,
adolescents and children aged
10 years and above with diabetes mellitus (diabetes). Diabetes is a
disease where your body does not
produce enough insulin to control the level of your blood sugar.
NovoMix 30 will start to lower your blood sugar 10–20 minutes after
you inject it, the maximum
effect occurs between 1 and 4 hours after the injection, and the
effect lasts for up to 24 hours.
In treatment of type 2 diabetes mellitus, NovoMix 30 may be used in
combination with tablets for
diabetes and/or with injectable antidiabetic products.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE NOVOMIX 30
DO NOT USE NOVOMIX 30
►
If you are allergic to insulin aspart or any of the other ingredients
in t
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Fachinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
VV-LAB-103275
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1.
NAME OF THE MEDICINAL PRODUCT
NovoMix 30 Penfill 100 units/ml suspension for injection in cartridge
NovoMix 30 FlexPen 100 units/ml suspension for injection in pre-filled
pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
NovoMix 30 Penfill
1 ml of the suspension contains 100 units soluble insulin
aspart*/protamine-crystallised insulin aspart*
in the ratio 30/70 (equivalent to 3.5 mg). 1 cartridge contains 3 ml
equivalent to 300 units.
NovoMix 30 FlexPen
1 ml of the suspension contains 100 units soluble insulin
aspart*/protamine-crystallised insulin aspart*
in the ratio 30/70 (equivalent to 3.5 mg). 1 pre-filled pen contains 3
ml equivalent to 300 units.
*Insulin aspart is produced in
_Saccharomyces cerevisiae_
by recombinant DNA technology.
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
NovoMix 30 is indicated for treatment of diabetes mellitus in adults,
adolescents and children aged
10 years and above.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The potency of insulin analogues, including insulin aspart, is
expressed in units, whereas the potency
of human insulin is expressed in international units.
NovoMix 30 dosing is individual and determined in accordance with the
needs of the patient. Blood
glucose monitoring and insulin dose adjustments are recommended to
achieve optimal glycaemic
control.
_ _
In patients with type 2 diabetes, NovoMix 30 can be given as
monotherapy. NovoMix 30 can also be
given in combination with oral antidiabetic medicinal products and/or
GLP-1 receptor agonists. For
patients with type 2 diabetes, the recommended starting dose of
NovoMix 30 is 6 units at breakfast and
6 units at dinner (evening meal). NovoMix 30 can also be initiated
once daily with 12 units at dinner
(evening meal). When using NovoMix 30 once daily, it is generally
recommended to move to twice
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