Actrapid

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

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Active ingredient:

humanog inzulina

Available from:

Novo Nordisk A/S

ATC code:

A10AB01

INN (International Name):

human insulin (rDNA)

Therapeutic group:

Lijekovi koji se koriste u dijabetesu

Therapeutic area:

Šećerna bolest

Therapeutic indications:

Liječenje dijabetes melitusa.

Product summary:

Revision: 17

Authorization status:

odobren

Authorization date:

2002-10-07

Patient Information leaflet

                                44
B. UPUTA O LIJEKU
45
UPUTA O LIJEKU: INFORMACIJE ZA KORISNIKA
ACTRAPID 40 IU/ML (INTERNACIONALNIH JEDINICA/ML) OTOPINA ZA INJEKCIJU
U BOČICI
humani inzulin
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 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, ljekarnika ili medicinsku
sestru. To uključuje i svaku moguću nuspojavu koja nije navedena u
ovoj uputi. Pogledajte
dio 4.
1.
ŠTO JE ACTRAPID I ZA ŠTO SE KORISTI
Actrapid je humani inzulin brzog djelovanja.
Actrapid se koristi za snižavanje visoke razine šećera u krvi u
bolesnika s dijabetesom (šećernom
bolešću). Šećerna bolest je vrsta bolesti u kojoj tijelo ne stvara
dovoljno inzulina za kontrolu razine
šećera u krvi. Liječenje lijekom Actrapid pomaže spriječiti
komplikacije šećerne bolesti.
Actrapid će početi snižavati razinu šećera u krvi oko pola sata
nakon što ga injicirate, a učinak će
trajati približno 8 sati. Actrapid se često daje u kombinaciji sa
srednjedugodjelujućim ili
dugodjelujućim inzulinskim pripravcima.
2.
ŠTO MORATE ZNATI PRIJE NEGO POČNETE PRIMJENJIVATI ACTRAPID
NEMOJTE PRIMJENJIVATI ACTRAPID
►
ako ste alergični na humani inzulin ili neki drugi sastojak ovog
lijeka, vidjeti dio 6.
►
ako sumnjate da počinje hipoglikemija (niska razina šećera u krvi),
vidjeti Sažetak ozbiljnih i
vrlo čestih nuspojava u dijelu 4.
►
u inzulinskim infuzijskim pumpama.
►
ako zaštitni zatvarač ne stoji čvrsto ili nedostaje. Svaka bočica
ima zaštitni plastični zatvarač s
evidencijom otvaranja. Ako on nije u besprijekornom stanju kad
dobijete bočicu, vratite bočicu
u ljekarnu.
►
ako nije ispravno čuvan ili ako je bio z
                                
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Summary of Product characteristics

                                1
PRILOG I.
SAŽETAK OPISA SVOJSTAVA LIJEKA
2
1.
NAZIV LIJEKA
Actrapid 40 internacionalnih jedinica/ml otopina za injekciju u
bočici.
Actrapid 100 internacionalnih jedinica/ml otopina za injekciju u
bočici.
Actrapid Penfill 100 internacionalnih jedinica/ml otopina za injekciju
u ulošku.
Actrapid InnoLet 100 internacionalnih jedinica/ml otopina za injekciju
u napunjenoj brizgalici.
Actrapid FlexPen 100 internacionalnih jedinica/ml otopina za injekciju
u napunjenoj brizgalici.
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
_ _
Actrapid bočica (40 internacionalnih jedinica/ml)
1 bočica sadrži 10 ml što odgovara 400 internacionalnih jedinica. 1
ml otopine sadrži
40 internacionalnih jedinica humanog inzulina* (što odgovara 1,4 mg).
Actrapid bočica (100 internacionalnih jedinica/ml)
1 bočica sadrži 10 ml što odgovara 1000 internacionalnih jedinica.
1 ml otopine sadrži
100 internacionalnih jedinica humanog inzulina* (što odgovara 3,5
mg).
Actrapid Penfill
1 uložak sadrži 3 ml što odgovara 300 internacionalnih jedinica. 1
ml otopine sadrži
100 internacionalnih jedinica humanog inzulina* (što odgovara 3,5
mg).
Actrapid InnoLet/Actrapid FlexPen
1 napunjena brizgalica sadrži 3 ml što odgovara 300 internacionalnih
jedinica. 1 ml otopine sadrži
100 internacionalnih jedinica humanog inzulina* (što odgovara 3,5
mg).
*Humani inzulin proizveden je u
_Saccharomyces cerevisiae_
tehnologijom rekombinantne DNK.
Pomoćna tvar s poznatim učinkom:
Actrapid sadrži manje od 1 mmol (23 mg) natrija po dozi tj. Actrapid
sadrži zanemarive količine
natrija.
Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
3.
FARMACEUTSKI OBLIK
Otopina za injekciju.
Otopina je bistra, bezbojna i vodena.
4.
KLINIČKI PODACI
4.1
TERAPIJSKE INDIKACIJE
Actrapid je indiciran za liječenje šećerne bolesti.
4.2
DOZIRANJE I NAČIN PRIMJENE
DOZIRANJE
Jakost humanog inzulina izražava se u internacionalnim jedinicama.
3
Doziranje lijeka Actrapid individualno je i određuje se u skladu s
potrebama bolesnika. Može se
primjenjivati sam ili u kombin
                                
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Documents in other languages

Patient Information leaflet Patient Information leaflet Bulgarian 21-10-2020
Summary of Product characteristics Summary of Product characteristics Bulgarian 21-10-2020
Public Assessment Report Public Assessment Report Bulgarian 28-08-2013
Patient Information leaflet Patient Information leaflet Spanish 21-10-2020
Public Assessment Report Public Assessment Report Spanish 28-08-2013
Patient Information leaflet Patient Information leaflet Czech 21-10-2020
Public Assessment Report Public Assessment Report Czech 28-08-2013
Patient Information leaflet Patient Information leaflet Danish 21-10-2020
Public Assessment Report Public Assessment Report Danish 28-08-2013
Patient Information leaflet Patient Information leaflet German 21-10-2020
Public Assessment Report Public Assessment Report German 28-08-2013
Patient Information leaflet Patient Information leaflet Estonian 21-10-2020
Public Assessment Report Public Assessment Report Estonian 28-08-2013
Patient Information leaflet Patient Information leaflet Greek 21-10-2020
Public Assessment Report Public Assessment Report Greek 28-08-2013
Patient Information leaflet Patient Information leaflet English 21-10-2020
Public Assessment Report Public Assessment Report English 28-08-2013
Patient Information leaflet Patient Information leaflet French 21-10-2020
Public Assessment Report Public Assessment Report French 28-08-2013
Patient Information leaflet Patient Information leaflet Italian 21-10-2020
Public Assessment Report Public Assessment Report Italian 28-08-2013
Patient Information leaflet Patient Information leaflet Latvian 21-10-2020
Public Assessment Report Public Assessment Report Latvian 28-08-2013
Patient Information leaflet Patient Information leaflet Lithuanian 21-10-2020
Summary of Product characteristics Summary of Product characteristics Lithuanian 21-10-2020
Public Assessment Report Public Assessment Report Lithuanian 28-08-2013
Patient Information leaflet Patient Information leaflet Hungarian 21-10-2020
Summary of Product characteristics Summary of Product characteristics Hungarian 21-10-2020
Public Assessment Report Public Assessment Report Hungarian 28-08-2013
Patient Information leaflet Patient Information leaflet Maltese 21-10-2020
Public Assessment Report Public Assessment Report Maltese 28-08-2013
Patient Information leaflet Patient Information leaflet Dutch 21-10-2020
Public Assessment Report Public Assessment Report Dutch 28-08-2013
Patient Information leaflet Patient Information leaflet Polish 21-10-2020
Public Assessment Report Public Assessment Report Polish 28-08-2013
Patient Information leaflet Patient Information leaflet Portuguese 21-10-2020
Summary of Product characteristics Summary of Product characteristics Portuguese 21-10-2020
Public Assessment Report Public Assessment Report Portuguese 28-08-2013
Patient Information leaflet Patient Information leaflet Romanian 21-10-2020
Public Assessment Report Public Assessment Report Romanian 28-08-2013
Patient Information leaflet Patient Information leaflet Slovak 21-10-2020
Public Assessment Report Public Assessment Report Slovak 28-08-2013
Patient Information leaflet Patient Information leaflet Slovenian 21-10-2020
Summary of Product characteristics Summary of Product characteristics Slovenian 21-10-2020
Public Assessment Report Public Assessment Report Slovenian 28-08-2013
Patient Information leaflet Patient Information leaflet Finnish 21-10-2020
Public Assessment Report Public Assessment Report Finnish 28-08-2013
Patient Information leaflet Patient Information leaflet Swedish 21-10-2020
Public Assessment Report Public Assessment Report Swedish 28-08-2013
Patient Information leaflet Patient Information leaflet Norwegian 21-10-2020
Summary of Product characteristics Summary of Product characteristics Norwegian 21-10-2020
Patient Information leaflet Patient Information leaflet Icelandic 21-10-2020
Summary of Product characteristics Summary of Product characteristics Icelandic 21-10-2020

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