Episalvan

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
15-07-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
15-07-2022
Public Assessment Report Public Assessment Report (PAR)
15-07-2022

Active ingredient:

Betulae cortex

Available from:

Amryt AG

ATC code:

D03AX13

INN (International Name):

birch bark extract

Therapeutic group:

Pripravci za liječenje rana i ulkusa

Therapeutic area:

Wounds and Injuries; Wound Healing

Therapeutic indications:

Liječenje rana djelomične debljine kod odraslih osoba. Pogledajte odjeljke 4. 4 i 5. 1 u Informacije o proizvodu s obzirom na vrstu rana koje se proučavaju.

Product summary:

Revision: 7

Authorization status:

povučen

Authorization date:

2016-01-14

Patient Information leaflet

                                B.
UPUTA O LIJEKU
15
Lijek koji više nije odobren
UPUTA O LIJEKU: INFORMACIJE ZA BOLESNIKA
EPISALVAN GEL
ekstrakt brezove kore
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 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
medicinsku sestru. To uključuje i svaku moguću nuspojavu koja nije
navedena u
ovoj uputi. Pogledajte dio 4.
ŠTO SE NALAZI U OVOJ UPUTI:
1.
Što je Episalvan i za što se koristi
2.
Što morate znati prije nego počnete primjenjivati Episalvan
3.
Kako primjenjivati Episalvan
4.
Moguće nuspojave
5.
Kako čuvati Episalvan
6.
Sadržaj pakiranja i druge informacije
1.
ŠTO JE EPISALVAN I ZA ŠTO SE KORISTI
Episalvan gel je biljni lijek koji sadrži suhi ekstrakt iz brezove
kore.
Primjenjuje se u odraslih za liječenje rana na koži, koje su nastale
primjerice zbog
opeklina 2.a stupnja ili kirurške transplantacije kožnog presatka.
Ne postoje iskustva
primjene lijeka Episalvan u liječenju kroničnih rana, npr.
dijabetičkog stopala ili
venskih vrijedova nogu.
2.
ŠTO MORATE ZNATI PRIJE NEGO POČNETE PRIMJENJIVATI EPISALVAN
_ _
NEMOJTE PRIMJENJIVATI EPISALVAN
-
ako ste alergični na brezovu koru ili neki drugi sastojak ovog lijeka
(naveden u
dijelu 6.).
UPOZORENJA I MJERE OPREZA
Obratite se svom liječniku ili medicinskoj sestri prije nego
primijenite Episalvan.
Episalvan ne sadrži polen breze, pa ga mogu upotrebljavati osobe
alergične na polen
breze.
Infekcija rane predstavlja ozbiljnu komplikaciju koja se može
pojaviti tijekom postupka
cijeljenja.
Mogući su znakovi infekcije rane ako iz nje počne istjecati žuta
ili zelenkasta tekućina
(gnoj) ili ako koža oko rane postane crvena, topla, otečena ili
pojačano bol
                                
                                Read the complete document

Summary of Product characteristics

                                PRILOG I.
SAŽETAK OPISA SVOJSTAVA LIJEKA
1
Lijek koji više nije odobren
1.
NAZIV LIJEKA
Episalvan gel
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
1 g gela sadrži: 100 mg ekstrakta (kao suhi ekstrakt, rafiniran) iz
brezove kore iz
_Betula _
_pendula_
Roth,
_Betula pubescens_
Ehrh., kao i hibrida obiju vrsta (istovjetno 0,5 - 1,0 g
brezove kore), što odgovara 72-88 mg betulina.
Otapalo za ekstrakciju: n-heptan
Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
3.
FARMACEUTSKI OBLIK
Gel.
Bezbojan do blago žućkast, opalescentan.
4.
KLINIČKI PODACI
4.1
TERAPIJSKE INDIKACIJE
Liječenje rana koje zahvaćaju djelomičnu debljinu kože u odraslih.
Vidjeti dijelove 4.4 i
5.1 za vrstu ispitivanih rana.
4.2
DOZIRANJE I NAČIN PRIMJENE
Doziranje
Gel je potrebno nanijeti na površinu rane u sloju od oko 1 mm i
prekriti sterilnom
kompresom. Gel je potrebno ponovno nanijeti pri svakoj promjeni
komprese, sve dok
rana ne zacijeli, tijekom razdoblja od maksimalno 4 tjedna (vidjeti
dio 4.4 „Veličina
rane“ i „Trajanje uporabe“).
Posebne populacije
_Oštećenje funkcije bubrega ili jetre _
Nisu provedena službena ispitivanja s lijekom Episalvan u bolesnika s
oštećenjem
funkcije bubrega ili jetre. Nisu predviđena prilagodba doze ili
posebna razmatranja za
bolesnike s oštećenjem funkcije bubrega ili jetre, vidjeti dio 5.2.
_Starije osobe _
Nije potrebna prilagodba doze.
_Pedijatrijska populacija _
Sigurnost i djelotvornost lijeka Episalvan u djece i adolescenata u
dobi do 18 godina
nisu još ustanovljene. Nema dostupnih podataka.
Način primjene
Za primjenu na koži.
Svježe rane trebaju prestati krvariti prije nanošenja lijeka
Episalvan. Ako je potrebno,
rane (slučajne rane) treba očistiti u skladu sa standardnim
postupkom, uporabom npr.
antiseptičke otopine za rane, prije nanošenja lijeka Episalvan.
2
Lijek koji više nije odobren
Episalvan je namijenjen samo za jednokratnu uporabu.
4.3
KONTRAINDIKACIJE
Preosjetljivost na djelatnu tvar ili pomoćnu tvar navedenu u dijelu
6.1.
4.4
POSEBNA UPOZORENJA I MJERE OPREZ
                                
                                Read the complete document

Similar products

Active ingredient Betulae cortex

Betulae cortex

ATC code D03AX13

D03AX13

Marketed by Amryt AG

Amryt AG

INN (International Name) birch bark extract

birch bark extract

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Patient Information leaflet Patient Information leaflet Bulgarian 15-07-2022
Summary of Product characteristics Summary of Product characteristics Bulgarian 15-07-2022
Public Assessment Report Public Assessment Report Bulgarian 15-07-2022
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Public Assessment Report Public Assessment Report Spanish 15-07-2022
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