Insulin lispro Sanofi

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

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Active ingredient:

inzulin lispro

Available from:

Sanofi Winthrop Industrie

ATC code:

A10AB04

INN (International Name):

insulin lispro

Therapeutic group:

Lijekovi koji se koriste u dijabetesu

Therapeutic area:

Šećerna bolest

Therapeutic indications:

Za liječenje odraslih i djece s dijabetesom koji zahtijevaju inzulin za održavanje normalne homeostaze glukoze. Inzulin lispro Sanofi je također indiciran za početnu stabilizaciju šećerne bolesti.

Product summary:

Revision: 9

Authorization status:

odobren

Authorization date:

2017-07-19

Patient Information leaflet

                                21
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU
KUTIJA (BOČICA OD 10 ML)
1.
NAZIV LIJEKA
Insulin lispro Sanofi 100 jedinica/ml otopina za injekciju u bočici
inzulin lispro
2.
NAVOĐENJE DJELATNE(IH) TVARI
Jedan ml otopine sadrži 100 jedinica inzulina lispro (što odgovara
3,5 mg).
Jedna bočica sadrži 10 ml, što odgovara 1000 jedinica inzulina
lispro.
3.
POPIS POMOĆNIH TVARI
Pomoćne tvari: metakrezol, glicerol, cinkov oksid, natrijev
hidrogenfosfat heptahidrat, kloridna
kiselina i natrijev hidroksid (za podešavanje pH), voda za injekcije.
Za više informacija pročitajte
uputu o lijeku.
4.
FARMACEUTSKI OBLIK I SADRŽAJ
Otopina za injekciju
1 x 10 ml
5 x 10 ml
5.
NAČIN I PUT(EVI) PRIMJENE LIJEKA
Prije uporabe pročitajte uputu o lijeku.
Supkutano i intravenski
6.
POSEBNO UPOZORENJE O ČUVANJU LIJEKA IZVAN POGLEDA I DOHVATA
DJECE
Čuvati izvan pogleda i dohvata djece.
7.
DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO
8.
ROK VALJANOSTI
EXP
22
9.
POSEBNE MJERE ČUVANJA
Prije prve uporabe:
Čuvati u hladnjaku.
Ne zamrzavati.
Bočicu čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
Nakon prve uporabe:
Čuvati na temperaturi ispod 30°C.
Ne odlagati u hladnjak.
Bočicu čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
Baciti nakon 4 tjedna.
10.
POSEBNE MJERE ZA ZBRINJAVANJE NEISKORIŠTENOG LIJEKA ILI OTPADNIH
MATERIJALA KOJI POTJEČU OD LIJEKA, AKO JE POTREBNO
11.
NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
Sanofi Winthrop Industrie
82 avenue Raspail
94250 Gentilly
Francuska
12.
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
EU/1/17/1203/007 1 bočica
EU/1/17/1203/008 5 bočica
13.
BROJ SERIJE
Lot
14.
NAČIN IZDAVANJA LIJEKA
15.
UPUTE ZA UPORABU
16.
PODACI NA BRAILLEOVOM PISMU
Insulin lispro Sanofi 100
17.
JEDINSTVENI IDENTIFIKATOR – 2D BARKOD
Sadrži 2D barkod s jedinstvenim identifikatorom.
23
18.
JEDINSTVENI IDENTIFIKATOR – PODACI ČITLJIVI LJUDSKIM OKOM
PC
SN
NN
24
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE
NALJEPNICA (BOČICA OD 1
                                
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Summary of Product characteristics

                                1
PRILOG I.
SAŽETAK OPISA SVOJSTAVA LIJEKA
2
1.
NAZIV LIJEKA
Insulin lispro Sanofi 100 jedinica/ml otopina za injekciju u bočici
Insulin lispro Sanofi 100 jedinica/ml otopina za injekciju u ulošku
Insulin lispro Sanofi 100 jedinica/ml otopina za injekciju u
napunjenoj brizgalici
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Jedan ml otopine sadrži 100 jedinica (što odgovara 3,5 mg) inzulina
lispro*.
Insulin lispro Sanofi 100 jedinica/ml otopina za injekciju u bočici
Jedna bočica sadrži 10 ml, što odgovara 1000 jedinica inzulina
lispro.
Insulin lispro Sanofi 100 jedinica/ml otopina za injekciju u ulošku
Jedan uložak sadrži 3 ml, što odgovara 300 jedinica inzulina
lispro.
Insulin lispro Sanofi 100 jedinica/ml otopina za injekciju u
napunjenoj brizgalici
Jedna napunjena brizgalica sadrži 3 ml, što odgovara 300 jedinica
inzulina lispro.
Jedna napunjena brizgalica može isporučiti dozu od 1-80 jedinica u
koracima od 1 jedinice.
*proizveden tehnologijom rekombinantne DNA na _E. coli_.
Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
3.
FARMACEUTSKI OBLIK
Insulin lispro Sanofi 100 jedinica/ml otopina za injekciju u bočici i
u ulošku
Otopina za injekciju (injekcija).
Insulin lispro Sanofi 100 jedinica/ml otopina za injekciju u
napunjenoj brizgalici
Otopina za injekciju (injekcija) u napunjenoj brizgalici (SoloStar).
Bistra, bezbojna, vodena otopina.
4.
KLINIČKI PODACI
4.1
TERAPIJSKE INDIKACIJE
Liječenje odraslih osoba i djece sa šećernom bolešću kojima je za
održavanje normalne homeostaze
glukoze potreban inzulin. Insulin lispro Sanofi indiciran je i za
početnu stabilizaciju šećerne bolesti.
4.2
DOZIRANJE I NAČIN PRIMJENE
Doziranje
Dozu mora odrediti liječnik sukladno potrebama bolesnika.
Inzulin lispro može se primijeniti neposredno prije obroka. Kada je
potrebno, inzulin lispro može se
dati neposredno nakon obroka.
Nakon supkutane primjene učinak inzulina lispro nastupa vrlo brzo i
traje kraće (2 - 5 sati) nego
učinak običnog inzulina. Taj brz nastup djelovanja omogućuje da se
injekcija
                                
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Documents in other languages

Patient Information leaflet Patient Information leaflet Bulgarian 07-07-2023
Summary of Product characteristics Summary of Product characteristics Bulgarian 07-07-2023
Public Assessment Report Public Assessment Report Bulgarian 22-09-2017
Patient Information leaflet Patient Information leaflet Spanish 07-07-2023
Public Assessment Report Public Assessment Report Spanish 22-09-2017
Patient Information leaflet Patient Information leaflet Czech 07-07-2023
Public Assessment Report Public Assessment Report Czech 22-09-2017
Patient Information leaflet Patient Information leaflet Danish 07-07-2023
Public Assessment Report Public Assessment Report Danish 22-09-2017
Patient Information leaflet Patient Information leaflet German 07-07-2023
Public Assessment Report Public Assessment Report German 22-09-2017
Patient Information leaflet Patient Information leaflet Estonian 07-07-2023
Public Assessment Report Public Assessment Report Estonian 22-09-2017
Patient Information leaflet Patient Information leaflet Greek 07-07-2023
Public Assessment Report Public Assessment Report Greek 22-09-2017
Patient Information leaflet Patient Information leaflet English 07-07-2023
Public Assessment Report Public Assessment Report English 22-09-2017
Patient Information leaflet Patient Information leaflet French 07-07-2023
Public Assessment Report Public Assessment Report French 22-09-2017
Patient Information leaflet Patient Information leaflet Italian 07-07-2023
Public Assessment Report Public Assessment Report Italian 22-09-2017
Patient Information leaflet Patient Information leaflet Latvian 07-07-2023
Public Assessment Report Public Assessment Report Latvian 22-09-2017
Patient Information leaflet Patient Information leaflet Lithuanian 07-07-2023
Summary of Product characteristics Summary of Product characteristics Lithuanian 07-07-2023
Public Assessment Report Public Assessment Report Lithuanian 22-09-2017
Patient Information leaflet Patient Information leaflet Hungarian 07-07-2023
Summary of Product characteristics Summary of Product characteristics Hungarian 07-07-2023
Public Assessment Report Public Assessment Report Hungarian 22-09-2017
Patient Information leaflet Patient Information leaflet Maltese 07-07-2023
Public Assessment Report Public Assessment Report Maltese 22-09-2017
Patient Information leaflet Patient Information leaflet Dutch 07-07-2023
Public Assessment Report Public Assessment Report Dutch 22-09-2017
Patient Information leaflet Patient Information leaflet Polish 07-07-2023
Public Assessment Report Public Assessment Report Polish 22-09-2017
Patient Information leaflet Patient Information leaflet Portuguese 07-07-2023
Summary of Product characteristics Summary of Product characteristics Portuguese 07-07-2023
Public Assessment Report Public Assessment Report Portuguese 22-09-2017
Patient Information leaflet Patient Information leaflet Romanian 07-07-2023
Public Assessment Report Public Assessment Report Romanian 22-09-2017
Patient Information leaflet Patient Information leaflet Slovak 07-07-2023
Public Assessment Report Public Assessment Report Slovak 22-09-2017
Patient Information leaflet Patient Information leaflet Slovenian 07-07-2023
Summary of Product characteristics Summary of Product characteristics Slovenian 07-07-2023
Public Assessment Report Public Assessment Report Slovenian 22-09-2017
Patient Information leaflet Patient Information leaflet Finnish 07-07-2023
Public Assessment Report Public Assessment Report Finnish 22-09-2017
Patient Information leaflet Patient Information leaflet Swedish 07-07-2023
Public Assessment Report Public Assessment Report Swedish 22-09-2017
Patient Information leaflet Patient Information leaflet Norwegian 07-07-2023
Summary of Product characteristics Summary of Product characteristics Norwegian 07-07-2023
Patient Information leaflet Patient Information leaflet Icelandic 07-07-2023
Summary of Product characteristics Summary of Product characteristics Icelandic 07-07-2023

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