Lusduna

Country: European Union

Language: Slovenian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
22-01-2019
Summary of Product characteristics Summary of Product characteristics (SPC)
22-01-2019
Public Assessment Report Public Assessment Report (PAR)
22-01-2019

Active ingredient:

insulin glargin

Available from:

Merck Sharp & Dohme B.V.

ATC code:

A10AE04

INN (International Name):

insulin glargine

Therapeutic group:

Zdravila, ki se uporabljajo pri diabetesu

Therapeutic area:

Sladkorna bolezen

Therapeutic indications:

Zdravljenje diabetesa mellitusa pri odraslih, mladostnikih in otrocih, starih 2 leti in več.

Product summary:

Revision: 2

Authorization status:

Umaknjeno

Authorization date:

2017-01-03

Patient Information leaflet

                                20
Injekcijski peresnik zavrzite 28 dni po tem, ko ste ga vzeli iz
hladilnika.
9.
POSEBNA NAVODILA ZA SHRANJEVANJE
Pred uporabo
Shranjujte v hladilniku.
Ne zamrzujte in ne shranjujte v bližini zamrzovalnega razdelka ali
zamrzovalnega vložka.
Napolnjeni injekcijski peresnik shranjujte v zunanji ovojnini za
zagotovitev zaščite pred svetlobo.
Med uporabo
Shranjujte pri temperaturi do 30 °C.
Ne shranjujte v hladilniku in ne zamrzujte.
Po uporabi namestite pokrovček injekcijskega peresnika nazaj na
injekcijski peresnik za zagotovitev
zaščite pred svetlobo.
10.
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH
ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
11.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
Nizozemska
12.
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z
ZDRAVILOM
EU/1/16/1162/0011 napolnjen injekcijski peresnik s 3 ml
EU/1/16/1162/002 5 napolnjenih injekcijskih peresnikov s 3 ml
13.
ŠTEVILKA SERIJE
Lot
14.
NAČIN IZDAJANJA ZDRAVILA
15.
NAVODILA ZA UPORABO
16.
PODATKI V BRAILLOVI PISAVI
LUSDUNA
17.
EDINSTVENA OZNAKA – DVODIMENZIONALNA ČRTNA KODA
Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
Zdravilo nima več dovoljenja za promet
21
18.
EDINSTVENA OZNAKA – V BERLJIVI OBLIKI
PC:
SN:
NN:
Zdravilo nima več dovoljenja za promet
22
PODATKI NA ZUNANJI OVOJNINI
VMESNA ŠKATLA (BREZ MODREGA OKENCA) DEL MULTI PAKIRANJA – 5
PERESNIKOV
1.
IME ZDRAVILA
LUSDUNA 100 enot/ml raztopina za injiciranje v napolnjenem
injekcijskem peresniku
insulin glargin
2.
NAVEDBA ENE ALI VEČ UČINKOVIN
En mililiter vsebuje 100 enot (3,64 mg) insulina glargin.
3.
SEZNAM POMOŽNIH SNOVI
Pomožne snovi: cinkov klorid, metakrezol, glicerol, korovodikova
kislina in natrijev hidroksid (za
uravnavanje pH), voda za injekcije.
4.
FARMACEVTSKA OBLIKA IN VSEBINA
raztopina za injiciranje, Nexvue
5 napolnjenih injekcijskih peresnikov s 3 ml. Del multi pakiranja, ni
za posamično prodajo.
5.
POSTOPEK IN POT(I) UPORABE ZDRAVILA
                                
                                Read the complete document

Summary of Product characteristics

                                1
PRILOGA I
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
Zdravilo nima več dovoljenja za promet
2
Za to zdravilo se izvaja dodatno spremljanje varnosti. Tako bodo
hitreje na voljo nove informacije
o njegovi varnosti. Zdravstvene delavce naprošamo, da poročajo o
katerem koli domnevnem
neželenem učinku zdravila. Glejte poglavje 4.8, kako poročati o
neželenih učinkih.
1.
IME ZDRAVILA
LUSDUNA 100 enot/ml raztopina za injiciranje v napolnjenem
injekcijskem peresniku
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
En mililiter vsebuje 100 enot insulina glargin* (kar ustreza 3,64 mg).
En injekcijski peresnik vsebuje 3 ml raztopine za injiciranje, kar
ustreza 300 enotam.
*Insulin glargin je pridobljen s tehnologijo rekombinantne DNA iz
bakterij _Escherichia coli_.
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
3.
FARMACEVTSKA OBLIKA
raztopina za injiciranje (injekcija), Nexvue
bistra, brezbarvna raztopina
4.
KLINIČNI PODATKI
4.1
TERAPEVTSKE INDIKACIJE
Zdravljenje sladkorne bolezni pri odraslih, mladostnikih in otrocih,
starih 2 leti ali več.
4.2
ODMERJANJE IN NAČIN UPORABE
Odmerjanje
Zdravilo LUSDUNA vsebuje insulin glargin, insulinski analog, in ima
podaljšan čas delovanja.
Zdravilo LUSDUNA je treba aplicirati enkrat na dan kadar koli, vendar
vsak dan ob istem času.
Shemo odmerjanja (odmerek in čas uporabe) je treba prilagoditi
vsakemu bolniku posamezno. Pri
bolnikih s sladkorno boleznijo tipa 2 se zdravilo LUSDUNA lahko
uporablja skupaj s peroralnimi
antidiabetiki.
Jakost tega zdravila je navedena v enotah. Te enote veljajo izključno
za insulin glargin in niso enake
mednarodnim enotam (i.e.) ali enotam, ki se uporabljajo za izražanje
moči drugih insulinskih analogov
(glejte poglavje 5.1).
Posebne populacije
_Starejša populacija (≥ 65 let)_
Pri starejših bolnikih lahko napredujoče slabšanje delovanja ledvic
povzroči stalno zmanjševanje
potrebe po insulinu.
_Okvara ledvic_
Pri bolnikih z okvaro ledvic se potreba po insulinu lahko zmanjša
zaradi zmanjšane presnove insulina.
Zdravilo nima več dovoljenja
                                
                                Read the complete document

Similar products

Active ingredient insulin glargin

insulin glargin

ATC code A10AE04

A10AE04

Marketed by Merck Sharp & Dohme B.V.

Merck Sharp & Dohme B.V.

INN (International Name) insulin glargine

insulin glargine

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