Lantus

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
10-07-2023
Summary of Product characteristics Summary of Product characteristics (SPC)
10-07-2023

Active ingredient:

inzulin glargin

Available from:

sanofi-aventis Deutschland GmbH

ATC code:

A10AE04

INN (International Name):

insulin glargine

Therapeutic group:

Lijekovi koji se koriste u dijabetesu

Therapeutic area:

Šećerna bolest

Therapeutic indications:

Liječenje dijabetes melitusa kod odraslih, adolescenata i djece u dobi od dvije i više godina.

Product summary:

Revision: 40

Authorization status:

odobren

Authorization date:

2000-06-09

Patient Information leaflet

                                37
B. UPUTA O LIJEKU
38
Uputa o lijeku: Informacija za korisnika
Lantus 100 jedinica/ml otopina za injekciju u bočici
inzulin glargin
Pažljivo pročitajte cijelu uputu prije nego počnete primjenjivati
ovaj lijek jer sadrži Vama
važne podatke.
-
Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati.
-
Ako imate dodatnih pitanja, obratite se svom liječniku, ljekarniku
ili medicinskoj sestri.
-
Ovaj je lijek propisan samo Vama. Nemojte ga davati drugima. Može im
naškoditi, čak i ako su
njihovi znakovi bolesti jednaki Vašima.
-
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti
liječnika ili ljekarnika. To
uključuje i svaku moguću nuspojavu koja nije navedena u ovoj uputi.
Pogledajte dio 4.
Što se nalazi u ovoj uputi:
1.
Što je Lantus i za što se koristi
2.
Što morate znati prije nego počnete primjenjivati Lantus
3.
Kako primjenjivati Lantus
4.
Moguće nuspojave
5.
Kako čuvati Lantus
6.
Sadržaj pakiranja i druge informacije
1.
Što je Lantus i za što se koristi
Lantus sadrži inzulin glargin. To je modificirani inzulin, vrlo
sličan ljudskom inzulinu.
Lantus se koristi za liječenje šećerne bolesti u odraslih,
adolescenata i djece u dobi od 2 i više godina.
Šećerna bolest je vrsta bolesti u kojoj tijelo ne stvara dovoljno
inzulina za kontrolu razine šećera u
krvi. Inzulin glargin ima dugotrajan i ravnomjeran učinak snižavanja
razine šećera u krvi.
2.
Što morate znati prije nego počnete primjenjivati Lantus
Nemojte primjenjivati Lantus:

Ako ste alergični na inzulin glargin ili neki drugi sastojak ovog
lijeka (naveden u dijelu 6.).
Upozorenja i mjere opreza
Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije
nego primijenite Lantus.
Pažljivo slijedite upute o doziranju, kontroli (pretrage krvi i
mokraće), prehrani i tjelesnoj aktivnosti
(fizički rad i tjelovježba) o kojima ste razgovarali sa svojim
liječnikom.
Ako Vam je šećer u krvi prenizak (hipoglikemija), slijedite upute za
slučaj hipoglikemije (vidjeti
uokvireni tekst na kraju ov
                                
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Summary of Product characteristics

                                1
PRILOG I.
SAŽETAK OPISA SVOJSTAVA LIJEKA
2
1.
NAZIV LIJEKA
Lantus 100 jedinica/ml otopina za injekciju u bočici
Lantus 100 jedinica/ml otopina za injekciju u ulošku
Lantus SoloStar 100 jedinica/ml otopina za injekciju u napunjenoj
brizgalici
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Jedan ml sadrži 100 jedinica inzulina glargina
*
(što odgovara 3,64 mg).
Lantus 100 jedinica/ml otopina za injekciju u bočici
Jedna bočica sadrži 5 ml otopine za injekciju, što odgovara 500
jedinica, odnosno 10 ml otopine za
injekciju, što odgovara 1000 jedinica.
Lantus 100 jedinica/ml otopina za injekciju u ulošku, Lantus SoloStar
100 jedinica/ml otopina za
injekciju u napunjenoj brizgalici
Jedan uložak ili jedna napunjena brizgalica sadrže 3 ml otopine za
injekciju, što odgovara
300 jedinica.
*
Inzulin glargin proizveden je tehnologijom rekombinantne DNK na
bakteriji Escherichia coli.
Za cjeloviti popis pomoćnih tvari, vidjeti dio 6.1.
3.
FARMACEUTSKI OBLIK
Otopina za injekciju.
Bistra, bezbojna otopina.
4.
KLINIČKI PODACI
4.1
Terapijske indikacije
Liječenje šećerne bolesti u odraslih, adolescenata i djece u dobi
od 2 ili više godina.
4.2
Doziranje i način primjene
Doziranje
Lantus sadrži inzulin glargin, koji je inzulinski analog s
produljenim djelovanjem.
Lantus se primjenjuje jedanput na dan, u bilo koje vrijeme, ali svaki
dan u isto doba dana.
Režim doziranja (dozu i vrijeme primjene) potrebno je prilagoditi
pojedinom bolesniku. U bolesnika
sa šećernom bolešću tipa 2, Lantus se može primjenjivati zajedno
s oralnim antidijabeticima. Jačina
ovoga lijeka izražena je u jedinicama. Ove se jedinice odnose
isključivo na Lantus te nisu istovjetne
internacionalnim jedinicama (IU) ili jedinicama koje se koriste za
izražavanje jačine drugih
inzulinskih analoga (vidjeti dio 5.1).
Posebne populacije
Stariji bolesnici (≥ 65 godina)
U starijih osoba progresivno pogoršanje bubrežne funkcije može
dovesti do postupnog i ravnomjernog
smanjenja potrebe za inzulinom.
3
Oštećenje funkcije bubrega
U bolesnika s o
                                
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Similar products

Active ingredient inzulin glargin

inzulin glargin

ATC code A10AE04

A10AE04

Marketed by sanofi-aventis Deutschland GmbH

sanofi-aventis Deutschland GmbH

INN (International Name) insulin glargine

insulin glargine

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Patient Information leaflet Patient Information leaflet Bulgarian 10-07-2023
Summary of Product characteristics Summary of Product characteristics Bulgarian 10-07-2023
Public Assessment Report Public Assessment Report Bulgarian 14-08-2012
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Public Assessment Report Public Assessment Report Spanish 14-08-2012
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Public Assessment Report Public Assessment Report Czech 14-08-2012
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Public Assessment Report Public Assessment Report Danish 14-08-2012
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Public Assessment Report Public Assessment Report German 14-08-2012
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Public Assessment Report Public Assessment Report Greek 14-08-2012
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Public Assessment Report Public Assessment Report English 14-08-2012
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