FrancophonIA/ELRC3.0 huggingface dataset:
English: Reversibility of the epithelial tympanic membrane blistering is also likely through epithelial migration, a natural self-cleaning and self-repair mechanism for the tympanic membrane and ear canal.
Croatian: Reverzibilnost nastanka mjehurića na timpaničkoj membrani se najvjerojatnije događa migracijom epitela, prirodnim mehanizmom samočišćenja i samopopravka timpaničke membrane i ušnog kanala.
English: Transient wetness of the inner and outer pinna can be observed.
Croatian: Moguće je uočiti prolaznu vlažnost unutarnje i vanjske uške.
English: Compatibility with ear cleaners, other than saline, has not been demonstrated.
Croatian: Kompatibilnost sa sredstvima za čišćenje ušiju, osim fiziološke otopine, nije dokazana.
English: 1 mg For the full list of excipients, see section 6.1.
Croatian: Potpuni popis pomoćnih tvari vidi u odjeljku 6.1.
English: Before the veterinary medicinal product is applied, the external auditory canal must be examined thoroughly to ensure that the ear drum is not perforated.
Croatian: Prije primjene veterinarsko-medicinskog proizvoda, vanjski slušni kanal treba temeljito pregledati kako biste se uvjerili da bubnjić uha nije perforiran.
English: The veterinary medicinal product may be irritating to eyes.
Croatian: Veterinarsko-medicinski proizvod može nadraživati oči.
English: 4.7 Use during pregnancy, lactation or lay
Croatian: 4.7 Primjena tijekom graviditeta i laktacije
English: Ear cleaning should not be repeated until 21 days after the second administration.
Croatian: Čišćenje ušiju ne treba ponavljati 21 dana nakon druge primjene.
English: Betamethasone acetate belongs to the diesters class of the glucocorticosteroids with a potent intrinsic glucocorticoid activity which relieves both inflammation and pruritus leading to an improvement of clinical signs observed in otitis externa.
Croatian: Betametazonacetat pripada diesterskoj klasi glukokortikoida s potentnom intrinzičnom aktivnosti glukokortikoida koja olakšava i upalu i pruritus, što uzrokuje poboljšanje kliničkih znakova uočenih kod vanjskog otitisa.
English: This product is a fixed combination of three active substances: antibiotic, antifungal and corticosteroid.
Croatian: Ovaj proizvod fiksna je kombinacija tri djelatne tvari: antibiotika, antifungika i kortikosteroida.
English: Appropriate measures (e.g. wearing safety glasses during administration, massaging the ear canal well after administration to ensure even distribution of product, restraining the dog after administration) are needed to avoid exposure to the eyes.
Croatian: Prikladne zaštitne mjere (nošenje zaštitnih naočala tijekom primjene, intenzivna masaža ušnog kanala nakon primjene kako bi se osigurala ujednačena distribucija veterinarsko-medicinskog proizvoda, ograničavanje kretanja psa nakon primjene) potrebne su kako bi se izbjeglo izlaganje očiju.
English: Deafness or impaired hearing, usually temporary, have been reported after use in very rare cases in dogs, mainly in elderly animals, in post authorisation experience.
Croatian: Vrlo rijetko prijavljeni su slučajevi gluhoće ili oštećenja sluha kod pasa, privremeno, uglavnom kod starijih životinja, na temelju iskustava nakon puštanja VMP-a u promet.
English: If accidental ocular exposure does occur, the eyes should be flushed thoroughly with water for 10 to 15 minutes.
Croatian: Ako slučajno dođe do doticaja s očima, oči treba obilno ispirati vodom 10 do 15 minuta.
English: In animals with a history of chronic or recurrent otitis externa, efficacy of the product may be affected if the underlying causes of the condition such as allergy or anatomical conformation of the ear are not addressed.
Croatian: U životinja s poviješću kronične ili ponavljajuće upale vanjskog uha učinkovitost proizvoda može biti smanjena ako se ne uklone uzroci u podlozi upale kao što su alergija ili anatomska građa uha.
English: Butylhydroxytoluene (E 321) Hypromellose
Croatian: Butilhidroksitoluen (E321) Hipromeloza
English: The decreased adrenal and thymus weights accompanied by atrophy of the adrenal cortex and lymphoid depletion of the thymus correlated with the decreased cortisol levels, and were consistent with the pharmacologic effects of betamethasone.
Croatian: Smanjena težina nadbubrežne žlijezde i timusa popraćena atrofijom kore nadbubrežne žlijezde i limfoidnim razaranjem timusa povezuje se sa smanjenim razinama kortizola i bila je u skladu s farmakološkim učincima betametazona.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only
Croatian: RIJEČI “SAMO ZA PRIMJENU NA ŽIVOTINJAMA”
English: Do not use in pregnant or breeding animals (see section 4.7).
Croatian: Ne primjenjivati na gravidnim ili rasplodnim životinjama (vidi u odjeljku 4.7).
English: Do not use in case of hypersensitivity to the active substances, to other corticosteroids, or to any of the excipients.
Croatian: Ne primjenjivati u slučaju preosjetljivosti na djelatne tvari, druge kortikosteroide ili na bilo koju od pomoćnih tvari.
English: Do not use during pregnancy and lactation (see section 4.3).
Croatian: Proizvod se ne smije koristiti tijekom graviditeta i laktacije (vidi odjeljak 4.3).
English: Betamethasone acetate:
Croatian: Betametazonacetat (betamethasoni acetas):
English: Do not use during pregnancy and lactation.
Croatian: Proizvod se ne smije koristiti tijekom graviditeta i laktacije.
English: Auricular use.
Croatian: Aurikularna primjena
English: Although a causal relationship with the veterinary medicinal product was not definitively established, owners should be recommended to monitor ocular signs (such as squinting, redness and discharge) in the hours and days following the product application, and to promptly consult a veterinarian in case such signs appear.
Croatian: Iako uzročna veza s veterinarsko-medicinskim proizvodom nije definitivno utvrđena, vlasnicima treba preporučiti neka prate simptome na očima (poput žmirkanja, crvenila ili iscjetka) nekoliko sati i dana nakon primjene veterinarsko-medicinskog proizvoda i odmah se posavjetuju s veterinarom u slučaju da se ovakvi simptomi pojave.
English: The veterinary medicinal product is a fixed combination of three active substances (corticosteroid, antifungal and antibiotic):
Croatian: Ovaj proizvod fiksna je kombinacija tri djelatne tvari (kortikosteroida, antifungika i antibiotika):
English: The safety of the veterinary medicinal product has not been established in pregnant and lactating bitches.
Croatian: Neškodljivost veterinarsko medicinskog proizvoda nije bila utvrđena kod gravidnih i kuja u laktaciji.
English: Prolonged and intensive use of topical corticosteroids preparation is known to trigger systemic effects, including suppression of adrenal function (see section Overdose).
Croatian: Poznato je da produljena i intenzivna uporaba topikalnih kortikosteroida uzrokuje sustavne učinke, uključujući i supresiju funkcije nadbubrežne žlijezde (vidjeti odjeljak Predoziranje).
English: C. STATEMENT OF THE MRLs Not applicable
Croatian: C. IZVJEŠĆE O MRL
English: In very rare cases, eye disorders such as keratoconjunctivitis sicca and corneal ulcers have been reported in treated dogs, in absence of eye contact with the product.
Croatian: U vrlo rijetkim slučajevima kod tretiranih su pasa prijavljeni slučajevi očnih smetnji poput keratokonjunktivitisa sicca i ulkusa rožnjače, iako nije bilo doticaja VMP-a s očima.
English: Single-use multi-layered aluminium and polyethylene tube with a polypropylene thermoplastic elastomer tip.
Croatian: 6.5 Osobine i sastav unutarnjeg pakovanja Višeslojna tuba za jednokratnu uporabu od aluminija i polietilena s vrhom od polipropilenskog termoplastičnog elastomera.
English: Use of the veterinary medicinal product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to florfenicol and fungi resistant to terbinafine and may decrease the effectiveness of treatment with other antibiotics and antifungal agents.
Croatian: Uporaba veterinarsko-medicinskog proizvoda koja odstupa od uputa danih u uputi o VMP može povećati prevalenciju bakterija rezistentnih na florfenikol i gljivica rezistentnih na terbinafin te može smanjiti djelotvornost liječenja drugim antibioticima i antifungicima.
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Auricular use.
Croatian: DOZIRANJE ZA SVAKU CILJNU VRSTU ŽIVOTINJA, NAČIN I PUT(EVI)
English: Off-white to slightly yellow translucent gel.
Croatian: Bjeličasti do blago žuti, djelomično prozirni gel.
English: ROUTE(S) OF ADMINISTRATION Auricular use
Croatian: PUT(EVI) PRIMJENE Aurikularna primjena
English: Use of the veterinary medicinal product deviating from the instructions given in the package leaflet may increase the prevalence of bacteria resistant to florfenicol and fungi resistant to terbinafine, and may decrease the effectiveness of treatment with other antibiotics and antifungal agents.
Croatian: Uporaba veterinarsko-medicinskog proizvoda koja odstupa od uputa danih u sažetku opisa svojstava proizvoda može povećati prevalenciju bakterija rezistentnih na florfenikol i gljivica rezistentnih na terbinafin te može smanjiti učinkovitost liječenja drugim antibioticima i antifungicima.
English: Special warnings for each target species
Croatian: 4.4 Posebna upozorenja za svaku od ciljnih vrsta životinja
English: NAME OF THE VETERINARY MEDICINAL PRODUCT OSURNIA ear gel for dogs terbinafine/florfenicol/betamethasone acetate
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA OSURNIA gel za uho za pse terbinafin/florfenikol/betametazonacetat (terbinafinum/florfenicolum/betamethasoni acetas)
English: If symptoms develop, seek medical advice and show the package leaflet or the label to the physician.
Croatian: U slučaju razvoja simptoma, odmah potražite medicinsku pomoć i liječniku pokažite uputu o VMP-u ili etiketu.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT OSURNIA ear gel for dogs
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA OSURNIA gel za uho za pse
English: Fertility Do not use in breeding animals (see section 4.3).
Croatian: Ne primjenjivati na rasplodnim životinjama (vidi odjeljak 4.3).
English: Appropriate diagnosis should be used and therapy of causative conditions should be investigated before antimicrobial treatment is considered.
Croatian: Prije nego se razmotri primjena antimikrobne terapije, potrebno je koristiti odgovarajuću dijagnozu i ispitati mogućnosti terapije za uklanjanje uzročnih stanja.
English: Excipient: Butylhydroxytoluene (E321):
Croatian: Pomoćna tvar: Butilhidroksitoluen (E321)
English: Terbinafine:
Croatian: Terbinafin (terbinafinum):
English: Fertility: Do not use in breeding animals.
Croatian: Ne primjenjivati na rasplodnim životinjama.
English: In case of accidental ingestion by humans, seek medical advice immediately and show the package leaflet or the label to the physician.
Croatian: U slučaju da osoba nehotice proguta VMP, odmah potražite pomoć liječnika i pokažite mu uputu ili etiketu.
English: It is recommended to clean and dry the external ear canal before the first administration of the product.
Croatian: Prije prve primjene proizvoda preporučuje se očistiti i osušiti kanal vanjskog uha.
English: Propylene carbonate Glycerol formal
Croatian: Propilenkarbonat
English: PACKAGE LEAFLET: OSURNIA ear gel for dogs
Croatian: UPUTA O VMP: OSURNIA gel za uho za pse
English: OSURNIA ear gel for dogs is available in the following pack sizes: 1 cardboard box containing 2 tubes, 1 cardboard box containing 12 tubes 1 cardboard box containing 20 tubes 1 cardboard box containing 40 tubes Not all pack sizes may be marketed.
Croatian: OSURNIA gel za uho za pse dostupan je u sljedećim veličinama pakiranja: 1 kartonska kutija s 2 tube.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) One dose (1.2 g) contains 10 mg terbinafine, 10 mg florfenicol and 1 mg betamethasone acetate Excipient: 1 mg butylhydroxytoluene (E 321)
Croatian: SASTAV DJELATNE(IH) TVARI I DRUGIH SASTOJAKA Jedna doza (1,2 g) sadrži 10 mg terbinafina, 10 mg florfenikola i 1 mg betametazonacetata.
English: STATEMENT OF ACTIVE SUBSTANCES 1 dose: 10 mg terbinafine, 10 mg florfenicol, 1 mg betamethasone acetate
Croatian: SASTAV DJELATNIH TVARI 1 doza: 10 mg terbinafina, 10 mg florfenikola, 1 mg betametazonacetata
English: METHOD AND ROUTE(S) OF ADMINISTRATION Auricular use
Croatian: NAČIN I PUT(EVI) PRIMJENE
English: Marketing authorisation holder: Elanco GmbH, Heinz-Lohmann-Str. 4, 27472 Cuxhaven, Germany
Croatian: Nositelj odobrenja za stavljanje u promet: Elanco GmbH, Heinz-Lohmann-Str.
English: Argenta Dundee Limited, Kinnoull Road, Dunsinane Industrial Estate, Dundee
Croatian: Argenta Dundee Limited Kinnoull Road
English: 1 mg equivalent to Betamethasone base 0.9 mg
Croatian: 1 mg jednako bazi betametazona
English: Lecithin
Croatian: NUSPOJAVE
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) 10 mg terbinafine, 10 mg florfenicol, 1 mg betamethasone acetate
Croatian: 10 mg terbinafina, 10 mg florfenikola, 1 mg betametazon acetata
English: EXPIRY DATE EXP
Croatian: ROK VALJANOSTI EXP:
English: Prolonged or intensive use of the product may cause blistering of the tympanic membrane epithelium or mucosal ulceration in the lining of the middle ear cavity.
Croatian: Predoziranje (simptomi, hitni postupci, antidoti): Produljena ili intenzivna uporaba ovog proizvoda može uzrokovati stvaranje mjehurića na epitelu timpaničke membrane ili ulceraciju na sluznici šupljine srednjeg uha.
English: Prolonged and intensive use of topical corticosteroids preparation is known to trigger systemic effects, including suppression of adrenal function.
Croatian: Poznato je da produljena i intenzivna uporaba topikalnih kortikosteroida uzrokuje sustavne učinke,
English: Elanco GmbH Heinz-Lohmann-Str. 4 27472 Cuxhaven Germany
Croatian: 4, 27472 Cuxhaven, Njemačka
English: PHARMACEUTICAL FORM Ear gel.
Croatian: OBLIK Gel za uho.
English: Treatment of acute otitis externa and acute exacerbation of recurrent otitis externa associated with Staphylococcus pseudintermedius and Malassezia pachydermatis.
Croatian: Staphylococcus pseudintermedius i Malassezia pachydermatis.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT OSURNIA ear gel for dogs terbinafine, florfenicol, betamethasone acetate (EN or Latin)
Croatian: Terbinafinum, florfenicolum, betamethasoni acetas (Latin)
English: Treatment of acute otitis externa, and acute exacerbation of recurrent otitis externa associated with Staphylococcus pseudintermedius and Malassezia pachydermatis.
Croatian: Liječenje akutnog vanjskog otitisa i akutne egzacerbacije povratnog vanjskog otitisa povezanog s
English: PHARMACEUTICAL FORM Ear gel
Croatian: OBLIK Gel za uho
English: 4.9 Amounts to be administered and administration route
Croatian: 4.9 Količine koje se primjenjuju i put primjene Aurikularna primjena.
English: Active substances:
Croatian: KOLIČINA DJELATNE(IH) TVARI
English: Elanco France S.A.S.
Croatian: Heinz-Lohmann-Str.
English: EU/1/14/987/001 Holoclar cells/cm²
Croatian: EU/1/14/987/001 Holoclar stanica/cm2
English: 1 implant
Croatian: 1 implantat
English: Living tissue equivalent
Croatian: Ekvivalent živoga tkiva
English: Screw cap container (stainless steel)
Croatian: Spremnik s navojnim zatvaračem (nehrđajući čelik)
English: Moreover, the intended use does not require medical supervision.
Croatian: Nadalje, predviđena uporaba ne zahtijeva medicinski nadzor.
English: Juglans regia L., folium
Croatian: Juglans regia L., list
English: Walnut leaf preparations should only be used in adults, and should not be used for longer than one week.
Croatian: Pripravci orahovog lista trebaju se koristiti samo u odraslih osoba i ne smiju se koristiti dulje od tjedan dana.
English: This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
Croatian: To znači da, iako nema dovoljno dokaza dostupnih iz kliničkih ispitivanja, djelotvornost ovih biljnih lijekova je vjerodostojna i postoji dokaz da se sigurno koriste na ovaj način barem 30 godina (uključujući barem 15 godina na području EU-a).
English: If symptoms persist, a doctor should be consulted.
Croatian: Ako se simptomi nastave, potrebno je potražiti liječnički savjet.
English: EMA/HMPC/432131/2013
Croatian: Orahov list EMA/HMPC/432131/2013
English: In its assessment the HMPC considered the potential effects of juglone (a toxic component of walnut tree) but noted that it is only present in traces (very small amounts) in dry walnut leaf and therefore does not pose a risk to human health.
Croatian: U svojoj ocjeni HMPC je razmotrio moguće djelovanje juglona (toksične komponente orahova stabla), no zaključio je da je ova tvar prisutna samo u tragovima (vrlo malim količinama) u suhom orahovom listu te stoga ne predstavlja rizik za ljudsko zdravlje.
English: Walnut leaf medicines must not be applied on open wounds and large skin injuries.
Croatian: Orahov list ne smije se primjenjivati na otvorene rane i velike ozljede lože.
English: In its assessment the HMPC took into account the well documented and very longstanding use of walnut leaf for these indications.
Croatian: U svojoj ocjeni HMPC je uzeo u obzir dobro dokumentiranu i dugotrajnu primjenu orahovog lista za te indikacije.
English: This summary is not intended to provide practical advice on how to use medicines containing walnut leaf.
Croatian: Svrha ovog sažetka nije pružanje praktičnih savjeta o načinu uporabe lijekova koji sadrže orahov list.
English: For detailed information on the studies assessed by the HMPC, see the HMPC assessment report.
Croatian: Za podrobnije informacije o studijama koje je HPMC ocijenio pogledajte izvješće HMPC-a o ocjeni.
English: The HMPC concluded that, on the basis of its long-standing use, walnut leaf can be used for the relief of minor inflammatory conditions of the skin and to reduce excessive sweating of the hands and feet.
Croatian: HMPC je zaključio da se, na temelju dugotrajne uporabe, orahov list može koristiti za ublažavanje manjih upalnih stanja kože i smanjenje prekomjernog znojenja ruku i nogu.
English: Information on the use and licensing of walnut leaf medicines in EU Member States should be obtained from the relevant national authorities.
Croatian: Informacije o uporabi i odobrenju lijekova koji sadrže orahov list u državama članicama EU-a treba zatražiti od nadležnih nacionalnih tijela.
English: The HMPC conclusions on the use of walnut leaf medicines for minor inflammatory skin conditions and excessive sweating are based on their ‘traditional use'.
Croatian: Zaključci HMPC-a o primjeni lijekova koji sadrže orahov list za manja upalna stanja kože i prekomjerno znojenje temelje se na njihovoj „tradicionalnoj uporabi".
English: Any applications for the licensing of medicines containing walnut leaf have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Croatian: Svi zahtjevi za odobrenje lijekova koji sadrže orahov list moraju se podnijeti nacionalnim tijelima nadležnim za lijekove, koja ocjenjuju zahtjev za biljni lijek i uzimaju u obzir znanstvene zaključke HMPC-a.
English: Further information on the HMPC assessment of walnut leaf medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Croatian: Dodatne informacije o HMPC-ovoj procjeni lijekova koji sadrže orahov list, uključujući pojedinosti zaključaka Odbora, nalaze se u rubrici „All documents” na internetskoj stranici Agencije: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: The HMPC also noted studies in laboratory tests, which showed that walnut leaf has antimicrobial effects.
Croatian: HMPC također je razmotrio ispitivanja u laboratorijskim testovima kojima je utvrđeno da orahov list ima antimikrobno djelovanje.
English: Further information on the risks associated with walnut leaf medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Croatian: Više informacija o rizicima povezanim s lijekovima koji sadrže orahov list, uključujući odgovarajuće mjere opreza za sigurnu uporabu, nalazi se u dokumentu u rubrici „All documents” na internetskoj stranici Agencije: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: What is walnut leaf?
Croatian: Što je orahov list?
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of walnut leaf.
Croatian: Ovaj dokument predstavlja sažetak znanstvenih zaključaka Odbora za biljne lijekove (HMPC) u pogledu medicinske uporabe orahovog lista.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing walnut leaf.
Croatian: Države članice EU-a uzimaju u obzir zaključke HMPC-a prilikom ocjenjivanja zahtjeva za odobrenje biljnih lijekova koji sadrže orahov list.
English: What are the risks associated with walnut leaf medicines?
Croatian: Koji su rizici povezani s lijekovima koji sadrže orahov list?
English: Other information about walnut leaf medicines
Croatian: Ostale informacije o lijekovima koji sadrže orahov list
English: Walnut leaf is the common name for the whole leaf of the tree Juglans regia L. The leaf is gathered from wild or cultivated trees.
Croatian: Orahov list uobičajeni je naziv za cijeli list stabla Juglans regia L.
English: Herbal medicines containing walnut leaf are usually available as comminuted herbal material to be boiled in water to make a ‘decoction' which is applied to the skin.
Croatian: Biljni lijekovi koji sadrže orahov list najčešće su dostupni kao usitnjeni biljni materijal za kuhanje u vodi kako bi se dobio dekokt za primjenu na koži.
English: Walnut leaf preparations are obtained by comminuting (reducing into tiny pieces) the dried leaves.
Croatian: Pripravci orahovog lista dobivaju se drobljenjem (usitnjavanjem) osušenog lišća.
English: Walnut leaf can also be found in combination with other herbal substances in some herbal medicines.
Croatian: Orahov list dostupan je i u kombinaciji s drugim biljnim tvarima u nekim biljnim pripravcima.
English: What evidence supports the use of walnut leaf medicines?
Croatian: Koji dokazi potkrjepljuju uporabu lijekova koji sadrže orahov list?
English: For more information about treatment with walnut leaf medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekovima koji sadrže orahov list pročitajte u uputi o lijeku priloženoj uz lijek, odnosno obratite se svom liječniku ili ljekarniku.
English: For practical information about using walnut leaf medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Croatian: Za praktične informacije o uporabi lijekova koji sadrže orahov list bolesnici moraju pročitati uputu o lijeku priloženu uz lijek, odnosno obratiti se svom liječniku ili ljekarniku.
English: How are walnut leaf medicines approved in the EU?
Croatian: Kako se u EU-u odobravaju lijekovi koji sadrže orahov list?
English: Detailed instruction on how to use walnut leaf medicines and who can use them can be found in the package leaflet that comes with the medicine.
Croatian: Za podrobnije informacije o načinu uporabe lijekova koji sadrže orahov list kao i o tome tko ih smije koristiti pogledajte uputu o lijeku priloženu uz lijek.
English: Walnut leaf
Croatian: Orahov list
English: Committee on Herbal Medicinal Products (HMPC)
Croatian: EMA/HMPC/432131/2013 Odbor za biljne lijekove (HMPC)
English: ATCvet code: QI09AA03.
Croatian: ATCvet kod: QI09AA03.
English: Protect from light.
Croatian: Zaštiti od svjetla .
English: Date of first authorisation: 17/05/2017
Croatian: Datum prvog odobrenja: 17/05/2017