Levemir

Country: European Union

Language: Slovenian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
13-07-2021
Summary of Product characteristics Summary of Product characteristics (SPC)
13-07-2021
Public Assessment Report Public Assessment Report (PAR)
05-10-2015

Active ingredient:

Insulin detemir

Available from:

Novo Nordisk A/S

ATC code:

A10AE05

INN (International Name):

insulin detemir

Therapeutic group:

Zdravila, ki se uporabljajo pri diabetesu

Therapeutic area:

Sladkorna bolezen

Therapeutic indications:

Zdravljenje diabetesa mellitusa pri odraslih, mladostnikih in otrocih, starih 1 leto in več.

Product summary:

Revision: 29

Authorization status:

Pooblaščeni

Authorization date:

2004-06-01

Patient Information leaflet

                                23
9.
POSEBNA NAVODILA ZA SHRANJEVANJE
Pred odprtjem: shranjujte v hladilniku (2 °C - 8 °C).
Med uporabo: ne shranjujte v hladilniku. Shranjujte pri temperaturi do
30 °C.
Ne zamrzujte.
Vložek shranjujte v zunanji ovojnini za zagotovitev zaščite pred
svetlobo.
10.
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH
ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
Iglo po vsakem injiciranju zavrzite.
11.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsvaerd
Danska
12.
ŠTEVILKE DOVOLJENJ ZA PROMET
EU/1/04/278/001 1 vložek s 3 ml
EU/1/04/278/002 5 vložkov s 3 ml
EU/1/04/278/003 10 vložkov s 3 ml
13.
ŠTEVILKA SERIJE
Lot:
14.
NAČIN IZDAJANJA ZDRAVILA
Predpisovanje in izdaja zdravila je le na recept.
15.
NAVODILA ZA UPORABO
16.
PODATKI V BRAILLOVI PISAVI
Levemir Penfill
17.
EDINSTVENA OZNAKA – DVODIMENZIONALNA ČRTNA KODA_ _
Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
18.
EDINSTVENA OZNAKA – V BERLJIVI OBLIKI_ _
24
PC
SN
NN
25
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
OVOJNINAH
NALEPKA (VLOŽEK PENFILL)
1.
IME ZDRAVILA IN POT UPORABE
Levemir 100 enot/ml
raztopina za injiciranje
insulin detemir
za s.c. uporabo
2.
POSTOPEK UPORABE
Penfill
3.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
EXP
4.
ŠTEVILKA SERIJE
Lot
5.
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
3 ml
6.
DRUGI PODATKI
Novo Nordisk A/S
26
PODATKI NA ZUNANJI OVOJNINI
ŠKATLA (NAPOLNJEN INJEKCIJSKI PERESNIK FLEXPEN)
1.
IME ZDRAVILA
Levemir 100 enot/ml
raztopina za injiciranje v napolnjenem injekcijskem peresniku
insulin detemir
2.
NAVEDBA ENE ALI VEČ UČINKOVIN
1 napolnjen injekcijski peresnik s 3 ml vsebuje 300 enot. 1 ml
raztopine vsebuje 100 enot insulina
detemir (kar ustreza 14,2 mg),
3.
SEZNAM POMOŽNIH SNOVI
glicerol, fenol, metakrezol, cinkov acetat, natrijev hidrogenfosfat
dihidrat, natrijev klorid,
klorovodikovo kislino/natrijev hidroksid za uravnavanje pH in vodo za
injekcije.
4.
FARMACEVTSKA OBLIKA IN VSEBINA
raztopina za inji
                                
                                Read the complete document

Summary of Product characteristics

                                1
PRILOGA I
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
2
1.
IME ZDRAVILA
Levemir Penfill 100 enot/ml raztopina za injiciranje v vložku
Levemir FlexPen 100 enot/ml raztopina za injiciranje v napolnjenem
injekcijskem peresniku
Levemir InnoLet 100 enot/ml raztopina za injiciranje v napolnjenem
injekcijskem peresniku
Levemir FlexTouch 100 enot/ml raztopina za injiciranje v napolnjenem
injekcijskem peresniku
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
_ _
Levemir Penfill
1 ml raztopine vsebuje 100 enot insulina detemir* (kar ustreza 14,2
mg). 1 vložek vsebuje 3 ml, kar
ustreza 300 enotam.
Levemir FlexPen/Levemir InnoLet/Levemir FlexTouch
1 ml raztopine vsebuje 100 enot insulina detemir* (kar ustreza 14,2
mg). 1 napolnjen injekcijski
peresnik vsebuje 3 ml, kar ustreza 300 enotam.
* Insulin detemir je pridobljen iz
_Saccharomyces cerevisiae _
s tehnologijo rekombinantne DNA.
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
3.
FARMACEVTSKA OBLIKA
raztopina za injiciranje
Raztopina je bistra, brezbarvna in vodna.
4.
KLINIČNI PODATKI
4.1
TERAPEVTSKE INDIKACIJE
Zdravilo Levemir je namenjeno zdravljenju sladkorne bolezni pri
odraslih, mladostnikih in otrocih,
starih 1 leto in več.
4.2
ODMERJANJE IN NAČIN UPORABE
ODMERJANJE
Moč insulinskih analogov, tudi insulina detemir, izražamo v enotah,
moč humanega insulina pa v
mednarodnih enotah. Ena enota insulina detemir ustreza eni mednarodni
enoti humanega insulina.
Zdravilo Levemir je mogoče uporabljati sàmo, kot bazalni insulin,
ali v kombinaciji z bolusnim
insulinom. Uporabljati ga je mogoče tudi v kombinaciji s peroralnimi
antidiabetiki in/ali agonisti
receptorjev GLP-1.
Če se zdravilo Levemir uporablja v kombinaciji s peroralnimi
antidiabetiki ali se ga doda k zdravljenju
z agonistom receptorjev GLP-1, je zdravilo Levemir priporočljivo
uporabljati enkrat na dan, uvodoma
z odmerkom 0,1-0,2 enoti/kg ali z odmerkom 10 enot
PRI ODRASLIH BOLNIKIH
. Odmerek zdravila
Levemir je treba titrirati glede na potrebe posameznega bolnika.
Če se agonist receptorjev GLP-1 doda k zdrav
                                
                                Read the complete document

Similar products

Active ingredient Insulin detemir

Insulin detemir

ATC code A10AE05

A10AE05

Marketed by Novo Nordisk A/S

Novo Nordisk A/S

INN (International Name) insulin detemir

insulin detemir

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Patient Information leaflet Patient Information leaflet Bulgarian 13-07-2021
Summary of Product characteristics Summary of Product characteristics Bulgarian 13-07-2021
Public Assessment Report Public Assessment Report Bulgarian 05-10-2015
Patient Information leaflet Patient Information leaflet Spanish 13-07-2021
Summary of Product characteristics Summary of Product characteristics Spanish 13-07-2021
Public Assessment Report Public Assessment Report Spanish 05-10-2015
Patient Information leaflet Patient Information leaflet Czech 13-07-2021
Summary of Product characteristics Summary of Product characteristics Czech 13-07-2021
Public Assessment Report Public Assessment Report Czech 05-10-2015
Patient Information leaflet Patient Information leaflet Danish 13-07-2021
Summary of Product characteristics Summary of Product characteristics Danish 13-07-2021
Public Assessment Report Public Assessment Report Danish 05-10-2015
Patient Information leaflet Patient Information leaflet German 13-07-2021
Summary of Product characteristics Summary of Product characteristics German 13-07-2021
Public Assessment Report Public Assessment Report German 05-10-2015
Patient Information leaflet Patient Information leaflet Estonian 13-07-2021
Summary of Product characteristics Summary of Product characteristics Estonian 13-07-2021
Public Assessment Report Public Assessment Report Estonian 05-10-2015
Patient Information leaflet Patient Information leaflet Greek 13-07-2021
Summary of Product characteristics Summary of Product characteristics Greek 13-07-2021
Public Assessment Report Public Assessment Report Greek 05-10-2015
Patient Information leaflet Patient Information leaflet English 13-07-2021
Summary of Product characteristics Summary of Product characteristics English 13-07-2021
Public Assessment Report Public Assessment Report English 05-10-2015
Patient Information leaflet Patient Information leaflet French 13-07-2021
Summary of Product characteristics Summary of Product characteristics French 13-07-2021
Public Assessment Report Public Assessment Report French 05-10-2015
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Public Assessment Report Public Assessment Report Italian 05-10-2015
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Public Assessment Report Public Assessment Report Hungarian 05-10-2015
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Public Assessment Report Public Assessment Report Romanian 05-10-2015
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Public Assessment Report Public Assessment Report Slovak 05-10-2015
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Public Assessment Report Public Assessment Report Finnish 05-10-2015
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Patient Information leaflet Patient Information leaflet Croatian 13-07-2021
Summary of Product characteristics Summary of Product characteristics Croatian 13-07-2021
Public Assessment Report Public Assessment Report Croatian 05-10-2015

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