Levemir
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
13-07-2021
Valmisteyhteenveto
(SPC)
13-07-2021
Julkisesta arviointikertomuksesta
(PAR)
05-10-2015
Aktiivinen ainesosa:
Insulin detemir
Saatavilla:
Novo Nordisk A/S
ATC-koodi:
A10AE05
INN (Kansainvälinen yleisnimi):
insulin detemir
Terapeuttinen ryhmä:
Drugs used in diabetes
Terapeuttinen alue:
Diabetes Mellitus
Käyttöaiheet:
Treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.
Tuoteyhteenveto:
Revision: 29
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2004-06-01
Pakkausseloste
40
B. PACKAGE LEAFLET
41
PACKAGE LEAFLET: INFORMATION FOR THE USER
LEVEMIR 100 UNITS/ML SOLUTION FOR INJECTION IN CARTRIDGE
insulin detemir
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 Levemir is and what it is used for
2.
What you need to know before you use Levemir
3.
How to use Levemir
4.
Possible side effects
5.
How to store Levemir
6.
Contents of the pack and other information
1.
WHAT LEVEMIR IS AND WHAT IT IS USED FOR
Levemir is a modern insulin (insulin analogue) with a long-acting
effect. Modern insulin products are
improved versions of human insulin.
Levemir is used to reduce the high blood sugar level in adults,
adolescents and children aged 1 year
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.
Levemir can be used with meal-related rapid acting insulin medicines.
In treatment of type 2 diabetes mellitus, Levemir may also be used in
combination with tablets for
diabetes and/or with injectable anti-diabetic products, other than
insulin.
Levemir has a long and steady blood-sugar-lowering action within 3 to
4 hours after injection.
Levemir provides up to 24 hours of basal insulin coverage.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE LEVEMIR
DO NOT USE LEVEMIR
►
If you are allergic to insulin detemir or any of the other ingredients
in this medicine, see section
6, Contents of the pack and other information.
►
If you suspect hypoglycaemia (low blood sugar) is
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Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Levemir Penfill 100 units/ml solution for injection in cartridge.
Levemir FlexPen 100 units/ml solution for injection in pre-filled pen.
Levemir InnoLet 100 units/ml solution for injection in pre-filled pen.
Levemir
_ _
FlexTouch 100 units/ml solution for injection in pre-filled pen.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Levemir Penfill
1 ml of the solution contains 100 units insulin detemir* (equivalent
to 14.2 mg). 1 cartridge contains
3 ml equivalent to 300 units.
Levemir FlexPen/Levemir InnoLet/Levemir FlexTouch
1 ml of the solution contains 100 units insulin detemir* (equivalent
to 14.2 mg). 1 pre-filled pen
contains 3 ml equivalent to 300 units.
*Insulin detemir is produced in
_Saccharomyces cerevisiae_
by recombinant DNA technology.
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
Levemir is indicated for treatment of diabetes mellitus in adults,
adolescents and children aged 1 year
and above.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The potency of insulin analogues, including insulin detemir, is
expressed in units, whereas the potency
of human insulin is expressed in international units. 1 unit insulin
detemir corresponds to
1 international unit of human insulin.
Levemir can be used alone as the basal insulin or in combination with
bolus insulin. It can also be used
in combination with oral antidiabetic medicinal products and/or GLP-1
receptor agonists.
When Levemir is used in combination with oral antidiabetic medicinal
products or when added to
GLP-1 receptor agonists it is recommended to use Levemir once daily,
initially at a dose of 0.1–
0.2 units/kg or of 10 units
IN ADULT PATIENTS
. The dose of Levemir should be titrated based on the
individual patient’s needs.
When a GLP-1 receptor agonist is added to Levemir, it is recommended
to reduce the dose of Levemi
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