Episalvan

Country: European Union

Language: Slovenian

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:

Priprave za zdravljenje ran in razjed

Therapeutic area:

Wounds and Injuries; Wound Healing

Therapeutic indications:

Zdravljenje delnih ran z debelino pri odraslih. Glej poglavja 4. 4 in 5. 1 v podatkih o izdelku glede na vrsto preučenih ran.

Product summary:

Revision: 7

Authorization status:

Umaknjeno

Authorization date:

2016-01-14

Patient Information leaflet

                                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
Amryt GmbH
Streiflingsweg 11
75223 Niefern-Öschelbronn
Nemčija
12.
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z
ZDRAVILOM
EU/1/15/1069/001
13.
ŠTEVILKA SERIJE
_ _
Številka serije
14.
NAČIN IZDAJANJA ZDRAVILA
_ _
Predpisovanje in izdaja zdravila je le na recept.
15.
NAVODILA ZA UPORABO
16.
PODATKI V BRAILLOVI PISAVI
Episalvan gel
17.
EDINSTVENA OZNAKA – DVODIMENZIONALNA ČRTNA KODA
Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
18.
EDINSTVENA OZNAKA – V BERLJIVI OBLIKI
PC
SN
NN
14
Zdravilo nima več dovoljenja za promet
B.
NAVODILO ZA UPORABO
15
Zdravilo nima več dovoljenja za promet
NAVODILO ZA UPORABO
EPISALVAN GEL
ekstrakt skorje breze
PRED ZAČETKOM UPORABE ZDRAVILA NATANČNO PREBERITE NAVODILO, KER
VSEBUJE ZA VAS
POMEMBNE PODATKE!
-
Navodilo shranite. Morda ga boste želeli ponovno prebrati.
-
Če imate dodatna vprašanja, se posvetujte z zdravnikom ali
medicinsko sestro.
-
Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
Njim bi
lahko celo škodovalo, čeprav imajo znake bolezni, podobne vašim.
-
Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom
ali medicinsko
sestro. Posvetujte se tudi, če opazite katere koli neželene učinke,
ki niso navedeni
v tem navodilu. Glejte poglavje 4.
KAJ VSEBUJE NAVODILO
1.
Kaj je zdravilo Episalvan in za kaj ga uporabljamo
2.
Kaj morate vedeti, preden boste uporabili zdravilo Episalvan
3.
Kako uporabljati zdravilo Episalvan
4.
Možni neželeni učinki
5.
Shranjevanje zdravila Episalvan
6.
Vsebina pakiranja in dodatne informacije
1.
KAJ JE ZDRAVILO EPISALVAN IN ZA KAJ GA UPORABLJAMO
Episalvan gel je zdravilo rastlinskega izvora, ki vsebuje suh ekstrakt
skorje breze.
Uporablja se pri odraslih za zdravljenje kožnih ran, ki so na primer
posledica opeklin
stopnje 2a ali kirurške odstranitve kože za presaditev. Za uporabo
zdravila Epi
                                
                                Read the complete document

Summary of Product characteristics

                                PRILOGA I
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
1
Zdravilo nima več dovoljenja za promet
1.
IME ZDRAVILA
Episalvan gel
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
1 g gela vsebuje: 100 mg prečiščenega suhega ekstrakta skorje breze
vrst
_Betula _
_pendula_
Roth in
_Betula pubescens_
Ehrh. ter tudi hibridov obeh vrst (enakovrednega
0,5–1,0 g skorje breze), kar ustreza 72-88 mg betulina.
Ekstrakcijsko topilo: n-heptan
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
3.
FARMACEVTSKA OBLIKA
gel
brezbarven do rahlo rumenkast, opalescenten
4.
KLINIČNI PODATKI
4.1
TERAPEVTSKE INDIKACIJE
Za zdravljenje ran delne debeline kože pri odraslih. Za vrste
preiskovanih ran glejte
poglavji 4.4 in 5.1.
4.2
ODMERJANJE IN NAČIN UPORABE
Odmerjanje
Gel je treba nanesti na površino rane v debelini približno 1 mm in
rano pokriti s
sterilnim povojem. Gel je treba ponovno nanesti pri vsakem previjanju
rane, dokler ni
rana zaceljena, do 4 tedne (za »velikost rane« in »trajanje
zdravljenja« glejte
poglavje 4.4).
Posebne skupine bolnikov
_Okvara ledvic ali jeter _
Pri bolnikih z okvaro ledvic ali jeter niso izvedli nobene uradne
študije z zdravilom
Episalvan. Pri bolnikih z okvaro ledvic ali jeter ni treba prilagajati
odmerka ali biti
posebno pozoren (glejte poglavje 5.2).
_Starejše osebe _
Prilagajanje odmerka ni potrebno.
_Pediatrična populacija _
Varnost in učinkovitost zdravila Episalvan pri otrocih in
mladostnikih, starih do 18 let,
še nista bili dokazani. Podatki niso na voljo.
Način uporabe
Za dermalno uporabo.
2
Zdravilo nima več dovoljenja za promet
Pred uporabo zdravila Episalvan morajo sveže rane doseči popolno
hemostazo. Po
potrebi je treba rane (rane zaradi nezgod) pred nanosom zdravila
Episalvan očistiti po
standardnem postopku, tj. z uporabo antiseptične raztopine za rane.
Zdravilo Episalvan je samo za enkratno uporabo.
4.3
KONTRAINDIKACIJE
Preobčutljivost na učinkovino ali katero koli pomožno snov,
navedeno v poglavju 6.1.
4.4
POSEBNA OPOZORILA IN PREVIDNOSTNI UKREPI
Okužbe ran
Episalvan gel je st
                                
                                Read the complete document

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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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Episalvan