FrancophonIA/ELRC3.0 huggingface dataset:
English: Denmark considered that Solamocta is essentially different from the reference product Amoxinsol 100% w/w Powder for Oral Solution and that these differences could be sufficient to require a formal bioequivalence study.
Croatian: Danska je smatrala da se Solamocta bitno razlikuje od referentnog VMP-a, praška za oralnu otopinu Amoxinsol 100 % masenog udjela, te da bi te razlike mogle biti dovoljne za zahtijevanje provedbe službenog ispitivanja bioekvivalencije.
English: The CVMP also recommended that the product information for Solamocta be amended.
Croatian: CVMP je također preporučio dopunu informacija o VMP-u za VMP Solamocta.
English: Solamocta contains 800 mg amoxicillin trihydrate (equivalent to 697 mg amoxicillin) as an active substance per gram product.
Croatian: Solamocta sadrži 800 mg djelatne tvari amoksicilin trihidrata (istovjetno 697 mg amoksicilina) po gramu VMP-a.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the marketing authorisation for Solamocta can be granted provided that the recommended revised instructions on product administration and prudent use warnings are added to the product information.
Croatian: Odbor za veterinarsko-medicinske proizvode (CVMP) pri Agenciji zaključio je da se odobrenje za stavljanje VMP-a Solamocta u promet može izdati pod uvjetom da se u informacije o VMP-u dodaju preporučene revidirane upute o primjeni VMP-a i upozorenja o opreznoj uporabi.
English: Thus the CVMP concluded that the concerns expressed by Denmark should not prevent the granting of marketing authorisations and recommended marketing authorisation be granted in the concerned Member States.
Croatian: Stoga je CVMP zaključio da zabrinutost koju je izrazila Danska ne treba biti razlog za sprečavanje izdavanja odobrenja za stavljanje VMP-a u promet te je preporučio izdavanje odobrenja za stavljanje VMP-a u promet u državama članicama sudionicima u postupku.
English: Eurovet Animal Health B.V. submitted a marketing authorisation application, under Article 13(3) of Directive 2001/82/EC (i.e. hybrid or mixed application), for Solamocta to the United Kingdom via the decentralised procedure referring to the reference product Amoxinsol 100% w/w Powder for Oral Solution authorised in the United Kingdom.
Croatian: Tvrtka Eurovet Animal Health B.V. podnijela je Ujedinjenoj Kraljevini zahtjev za izdavanje odobrenja za stavljanje VMP-a Solamocta u promet putem decentraliziranog postupka, u skladu s člankom 13. stavkom 3. Direktive 2001/82/EZ (tj. hibridna ili miješana primjena), pozivajući se na referentni VMP, prašak za oralnu otopinu Amoxinsol 100 % masenog udjela, koji je odobren u Ujedinjenoj Kraljevini.
English: The product is indicated for treatment of infections in chickens, turkeys and ducks caused by bacteria susceptible to amoxicillin.
Croatian: Taj je VMP indiciran za liječenje infekcija uzrokovanih bakterijama osjetljivima na amoksicilin u pilića, pura i pataka.
English: Veterinary Medicines Division
Croatian: EMA/90158/2016 Odjel za veterinarsko-medicinske proizvode
English: Questions and answers on Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys (amoxicillin trihydrate)
Croatian: Pitanja i odgovori u vezi s praškom Solamocta 697 mg/g za uporabu u pitkoj vodi za piliće, patke i pure (amoksicilin trihidrat)
English: What is Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys?
Croatian: Što je prašak Solamocta 697 mg/g za uporabu u pitkoj vodi za piliće, patke i pure?
English: Why was Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys reviewed?
Croatian: Zašto je provedeno ponovno ocjenjivanje praška Solamocta 697 mg/g za uporabu u pitkoj vodi za piliće, patke i pure?
English: It usually disappeared spontaneously within 1 week at most.
Croatian: Obično se spontano povukla najkasnije u roku od 1 tjedna.
English: Date of first authorisation: 03/05/2013 Date of last renewal: 20/03/2018
Croatian: Datum prvog odobrenja: 03/05/2013 Datum posljednjeg produljenja odobrenja: 20/03/2018
English: ATC-vet code: QL03AX90.
Croatian: ATC-vet kod:QL03AX90.
English: Store and transport refrigerated (2 °C-8 °C).
Croatian: Čuvati i prevoziti na hladnom (2 °C-8 °C).
English: This was demonstrated in a field trial over a period of 2 years.
Croatian: To je dokazano u ispitivanju koje je trajalo 2 godine.
English: Efficacy of the treatment has not been investigated beyond 2 years following treatment.
Croatian: Djelotvornost liječenja nije ispitana nakon 2 godine od liječenja.
English: After reconstitution, each dose of 1 ml contains:
Croatian: Nakon rekonstitucije jedna doza od 1 ml sadrži:
English: SPECIAL WARNING(S), IF NECESSARY
Croatian: POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO
English: Treatment course: 4 administrations at 1-week intervals (day 0, day 7, day 14, day 21) followed by 2 administrations at 2-week intervals (day 35, day 49).
Croatian: Tijek liječenja: 4 primjene u intervalima od 1 tjedna (0. dan, 7. dan, 14. dan, 21. dan) nakon kojih slijede 2 primjene u intervalima od 2 tjedna (35. dan, 49. dan).
English: 4.8 Interaction with other medicinal products and other forms of interaction
Croatian: 4.8 Interakcija s drugim medicinskim proizvodima i drugi oblici interakcija
English: Start the treatment course the day before radiation therapy, preferably within one month after surgical excision.
Croatian: Tijek liječenja započnite dan prije radioterapije, po mogućnosti unutar jednog mjeseca od kirurške ekscizije.
English: After two years of study follow-up, Oncept IL-2 treated cats showed a longer median time to relapse (above 730 days) compared to control cats (287 days).
Croatian: Nakon dvije godine praćenja mačke liječene Onceptom IL-2 pokazale su dulji medijan vremena do recidiva (oko 730 dana) u usporedbi s mačkama iz kontrolne skupine (287 dana).
English: If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon
Croatian: Ako zamijetite bilo koju nuspojavu, čak i one koje nisu navedene u ovoj uputi o VMP ili mislite da veterinarsko-medicinski proizvod ne djeluje, molimo obavijestite svog veterinara.
English: Pharmacotherapeutic group: Antineoplastic and immunomodulating agents, other immunostimulants.
Croatian: Farmakoterapijska grupa: antineoplastični i imunomodulatorni lijekovi, drugi imunostimulansi.
English: Moreover feline IL-2 has been shown to have very low biological activity on human leukocytes compared to human IL-2.
Croatian: Nadalje, mačji IL-2 ima vrlo nisko biološko djelovanje na ljudske leukocite u usporedbi s ljudskim IL-2.
English: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Croatian: U slučaju nehotičnog samoinjiciranja odmah potražite pomoć liječnika i pokažite mu uputu ili etiketu.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Croatian: Detaljne informacije o ovom veterinarsko-medicinskom proizvodu dostupne su na web-stranici Europske agencije za lijekove http://www.ema.europa.eu/.
English: EXP {month/year} Use immediately after reconstitution.
Croatian: EXP {mjesec/godina} Odmah primijeniti nakon rekonstitucije.
English: Lyophilisate: whitish homogeneous pellet.
Croatian: Liofilizat: bjelkasta homogena peleta.
English: Lyophilisate: 6 x 1 dose Solvent: 6 x 1 ml
Croatian: Liofilizat: 6 x 1 doza Otapalo: 6 x 1 ml
English: Efficacy has only been tested in conjunction with surgery and radiotherapy; therefore the treatment should be conducted according to treatment course described in section 4.9.
Croatian: Djelotvornost je ispitana samo u kombinaciji s kirurškim zahvatom i radioterapijom; stoga je liječenje potrebno provesti u skladu s tijekom liječenja, opisanog u dijelu 4.9.
English: The virus expresses the IL-2 gene at the inoculation site, but does not replicate in the cat.
Croatian: Virus eksprimira gen IL-2 na mjestu inokulacije, ali se ne replicira u mački.
English: As safety and efficacy of repetition of the treatment to treat fibrosarcoma recurrence have not been investigated, repetition of the treatment should be considered by the veterinarian taking into account the benefit-risk balance.
Croatian: Budući da neškodljivost i djelotvornost ponovljene terapije za liječenje recidiva fibrosarkoma nisu ispitane, veterinar bi trebao razmotriti ponovljeno liječenje uzimajući u obzir odnos koristi i rizika.
English: Transient apathy and hyperthermia (above 39.5 °C) occurred commonly in field studies.
Croatian: Prolazna apatija i hipertermija (iznad 39,5 °C) zabilježena je često u terenskim ispitivanjima.
English: A moderate local reaction (pain on palpation, swelling, scratching) occurred very commonly in safety studies.
Croatian: Umjerena lokalna reakcija (bol na dodir, oticanje, grebanje) pojavljuje se vrlo često prema ispitivanjima sigurnosti.
English: Efficacy has not been tested in cats with metastasis or lymph node involvement.
Croatian: Djelotvornost nije ispitana u mačaka s metastazama i sa zahvaćenim limfnim čvorovima.
English: Shelf life after first opening the immediate packaging: use immediately after reconstitution.
Croatian: Rok valjanosti poslije prvog otvaranja unutarnjeg pakovanja: odmah primijeniti nakon rekonstitucije.
English: After reconstitution of the lyophilisate with the solvent, shake gently and administer five injections (each approximately 0.2 ml) around the tumour excision site: one injection at each corner and one injection at the centre of a 5 cm x 5 cm square centred on the middle of the surgical scar.
Croatian: Nakon rekonstitucije liofilizata s otapalom, lagano protresite te pet injiciranja (svako od oko 0,2 ml) primijenite oko mjesta ekscizije tumora: po jednu injekciju u svakom kutu i jednu injekciju u središtu kvadrata od 5 cm x 5 cm na sredini kirurškog ožiljka.
English: Use of the recommended mode of administration in 5 injection points is important for achieving efficacy of the product; injection in 1 point may lead to reduced efficacy (see section 4.9).
Croatian: Poštivanje preporučenog načina primjene na 5 injekcionih mjesta važno je za postizanje djelotvornosti proizvoda; primjena na samo 1 mjestu injiciranja može dovesti do smanjene djelotvornosti (vidi dio 4.9).
English: Specific mechanisms by which immunostimulation induces anti-tumoural activity are not known.
Croatian: Specifični mehanizmi putem kojih imunostimulacija inducira antitumorsko djelovanje nisu poznati.
English: Mild local and/or systemic adverse reactions related to the injection itself may be observed transitorily.
Croatian: Blage lokalne i/ili sustavne nuspojave u vezi sa samom injekcijom mogu se pojaviti, no one su kratkotrajne.
English: Do not mix with any other veterinary medicinal product, except the solvent supplied for use with the veterinary medicinal product.
Croatian: Ne miješati s bilo kojim drugim veterinarsko-medicinskim proizvodom, osim otapalom priloženim za primjenu s veterinarsko-medicinskim proizvodom.
English: Efficacy has only been tested in conjunction with surgery and radiotherapy; therefore the treatment should be conducted according to treatment course described in section “Dosage for each species, route and method of administration”.
Croatian: Djelotvornost je ispitana samo u kombinaciji s kirurškim zahvatom i radioterapijom; stoga je liječenje potrebno provesti u skladu s tijekom liječenja opisanog u dijelu „Doziranje za svaku vrstu životinja, put i način primjene“.
English: Immunotherapy to be used in addition to surgery and radiotherapy in cats with fibrosarcoma (2-5 cm diameter) without metastasis or lymph node involvement in order to reduce the risk of relapse and to increase the time to relapse (local recurrence or metastasis).
Croatian: Imunoterapija koja će se primjenjivati uz kirurški zahvat i radioterapiju u mačaka s fibrosarkomom (promjera 2-5 cm) bez metastaza ili zahvaćenosti limfnih čvorova kako bi se smanjio rizik od recidiva te povećalo vrijeme do recidiva (lokalni recidiv ili metastaze).
English: Oncept IL-2 injected into the tumour bed thus delivers in situ a low dose of feline interleukin-2, which stimulates antitumour immunity while avoiding toxicity associated with systemic treatment.
Croatian: Oncept IL-2 se injicira u ležište tumora, stoga oslobađa in situ nisku dozu mačjeg interleukina-2, koji stimulira antitumorski imunitet bez toksičnosti koja je povezana sa sustavnim liječenjem.
English: After reconstitution use immediately.
Croatian: Odmah primijeniti nakon rekonstitucije.
English: In a randomized clinical study, cats from different origins presenting a fibrosarcoma without metastasis or lymph node involvement were included in two groups, one receiving the reference treatment - surgery and radiotherapy - and the other receiving Oncept IL-2 in addition to surgery and radiotherapy.
Croatian: Mačke različitih podrijetla koje pokazuju fibrosarkom bez metastaza ili zahvaćenosti limfnih čvorova bile su uključene u dvije skupine randomiziranog kliničkog ispitivanja, od kojih je jedna primala referentno liječenje - kirurški zahvat i radioterapiju - a druga Oncept IL-2 uz kirurški zahvat i radioterapiju.
English: Use of the recommended mode of administration in 5 injection points is important for achieving efficacy of the product; injection in 1 point may lead to reduced efficacy (see section “Dosage for each species, route and method of administration”).
Croatian: Poštivanje preporučenog načina primjene na 5 injekcionih mjesta važno je za postizanje djelotvornosti proizvoda; primjena samo 1 injekcije može dovesti do smanjene djelotvornosti (vidi dio „Doziranje za svaku vrstu životinja, put i način primjene“).
English: Oncept IL-2 lyophilisate
Croatian: Oncept IL-2 liofilizat
English: Disodium phosphate dihydrate Potassium dihydrogen phosphate.
Croatian: Hidrolizat kolagena Hidrolizat kazeina Natrijev klorid Dinatrij-fosfat dihidrat Kalij-dihidrogenfosfat.
English: After the administration of an overdose (10 doses), transient moderate to marked hyperthermia, as well as local reactions (swelling, erythema or slight pain, and in some cases, heat at the injection site) may occur.
Croatian: Nakon predoziranja (primjene 10 doza) može se pojaviti prolazna umjerena do izrazita hipertemija, kao i lokalne reakcije (oticanje, eritem ili blaga bol te u nekim slučajevima toplina na mjestu injiciranja).
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Croatian: DOZIRANJE ZA SVAKU CILJNU VRSTU ŽIVOTINJA, PUT I NAČIN PRIMJENE
English: Solvent for Oncept IL-2
Croatian: Otapalo za Oncept IL-2
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
Croatian: 13. RIJEČI „SAMO ZA PRIMJENU NA ŽIVOTINJAMA“ I UVJETI ILI OGRANIČENJA
English: Oncept IL-2 treatment reduced the risk of relapse, from 6 months after the start of treatment, by approximately 56% after 1 year and 65% after 2 years.
Croatian: Liječenje Onceptom IL-2 smanjilo je rizik od recidiva, od 6 mjeseci nakon početka liječenja, za oko
English: Canarypox recombinants are known to be safe for humans.
Croatian: Rekombinanti virusi boginja kanarinaca nisu škodljivi za ljude.
English: The vaccine strain vCP1338 is a recombinant canarypox virus expressing feline interleukin-2 (IL-2).
Croatian: Cjepni soj vCP1338 rekombinantni je virus boginja kanarinaca koji se eksprimira u mačjem interleukinu-2 (IL-2).
English: Cardboard box containing 6 vials of 1 dose of lyophilisate and 6 vials of 1 ml of solvent.
Croatian: Kartonska kutija sadrži 6 bočica s po 1 dozom liofilizata i 6 bočica od 1 ml otapala.
English: Oncept IL-2 lyophilisate and solvent for suspension for injection for cats
Croatian: Oncept IL-2 liofilizat i otapalo za suspenziju za injekciju za mačke
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ ODGOVORAN
English: SC Read the package leaflet before use.
Croatian: NAČIN I PUT(EVI) PRIMJENE Pročitati uputu o VMP prije primjene.
English: Oncept IL-2 treatment reduced the risk of relapse, from 6 months after the start of treatment, by approximately 56% after 1 year and 65% after 2 years, compared to the control group.
Croatian: 56% nakon 1 godine i za 65% nakon 2 godine u usporedbi s kontroliranom skupinom.
English: SPECIAL STORAGE PRECAUTIONS
Croatian: 12. POSEBNA UPOZORENJA
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
Croatian: PROIZVOĐAČI BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ
English: Manufacturer responsible for batch release: MERIAL
Croatian: Proizvođač odgovoran za puštanje serije u promet:
English: Laboratoire Porte des Alpes Rue de l'Aviation
Croatian: Laboratoire Porte des Alpes Rue de l'Aviation 69800 Saint Priest Francuska
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box of 6 vials of lyophilisate and 6 vials of solvent
Croatian: Kartonska kutija sa 6 bočica liofilizata i 6 bočica otapala
English: Feline interleukin-2 recombinant canarypox virus (vCP1338) ....................................... ≥ 106.0 EAID*50 *ELISA infectious dose 50%.
Croatian: ≥ 106,0 EAID*50 *ELISA infektivna doza 50%.
English: Feline interleukin-2 recombinant canarypox virus (vCP1338) ........................................ ≥ 106.0 EAID50
Croatian: Mačji interleukin-2 rekombinantni virus boginja kanarinaca (vCP1338) .........................
English: After the administration of an overdose (10 doses), transient moderate to marked hyperthermia, as well as local reactions (swelling, redness or slight pain, and in some cases, heat at the injection site) may occur.
Croatian: kao i lokalne reakcije (oticanje, crvenilo ili blaga bol te u nekim slučajevima toplina na mjestu injiciranja).
English: Lyophilisate and solvent for suspension for injection
Croatian: Liofilizat i otapalo za suspenziju za injekciju namijenjeni mačkama
English: However, the low number of patients involved and other serious shortcomings in the design of the studies prevented any firm conclusions being drawn.
Croatian: Međutim, zbog malog broja uključenih bolesnika i drugih ozbiljnih nedostataka u vezi s dizajnom ispitivanja nije bilo moguće doći do pouzdanih zaključaka.
English: A doctor or a qualified healthcare practitioner should be consulted if the symptoms last for more than 2 weeks or worsen during the use of the medicine.
Croatian: Potrebno je obratiti se liječniku ili kvalificiranom zdravstvenom radniku ako simptomi traju dulje od dva tjedna ili se pogoršaju tijekom primjene lijeka.
English: Passion flower EMA/275240/2014
Croatian: Pasiflorova zelen EMA/275240/2014
English: Passion flower medicines should only be used in adults and adolescents over the age of 12 years.
Croatian: Lijekovi koji sadrže pasiflorovu zelen smiju se koristiti samo u odraslih osoba i adolescenata starijih od 12 godina.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20 September 2016 EMA/275240/2014
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● Ujedinjena Kraljevina
English: Passion flower preparations may also be found in combination with other herbal substances in some herbal medicines.
Croatian: Pripravci pasiflorove zeleni mogu postojati također i u kombinaciji s drugim biljnim tvarima u nekim biljnim lijekovima.
English: Further information on the HMPC assessment of passion flower 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: Daljnje informacije o HMPC-ovoj ocjeni lijekova koji sadrže pasiflorovu zelen, uključujući pojedinosti zaključaka Povjerenstva, mogu se pronaći pod karticom „All documents” na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Any applications for the licensing of medicines containing passion flower 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 pasiflorovu zelen moraju se podnijeti nacionalnim tijelima nadležnima za lijekove, koja ocjenjuju zahtjev za biljni lijek i uzimaju u obzir znanstvene zaključke HMPC-a.
English: Further information on the risks associated with these passion flower 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 o rizicima povezanim s ovim lijekovima koji sadrže pasiflorovu zelen, uključujući odgovarajuće mjere opreza za njihovu sigurnu primjenu, možete pronaći u monografiji pod karticom „All documents” na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: This summary is not intended to provide practical advice on how to use medicines containing passion flower.
Croatian: Svrha ovog sažetka nije davati praktične savjete o načinu primjene lijekova koji sadrže pasiflorovu zelen.
English: What is passion flower?
Croatian: Što je pasiflorova zelen?
English: Herbal medicines containing these passion flower preparations are usually available as herbal teas to be drunk or as solid or liquid forms to be taken by mouth.
Croatian: Biljni lijekovi koji sadrže te pripravke pasiflorove zeleni najčešće su dostupni kao biljni čaj koji se pije ili u krutom ili tekućem obliku za uzimanje kroz usta.
English: Passion flower
Croatian: Pasiflorova zelen
English: Information on the use and licensing of passion flower medicines in EU Member States should be obtained from the relevant national authorities.
Croatian: Informacije o primjeni i davanju odobrenja za lijekove koji sadrže pasiflorovu zelen u državama članicama EU-a mogu se dobiti od nadležnih nacionalnih tijela.
English: The HMPC conclusions on the use of these passion flower medicines for mild symptoms of mental stress and to aid sleep are based on their ‘traditional use' in these conditions.
Croatian: Zaključci HMPC-a o primjeni ovih lijekova koji sadrže pasiflorovu zelen za blage simptome mentalnog stresa i za poboljšanje spavanja temelje se na njihovoj „tradicionalnoj primjeni” kod tih stanja.
English: The HMPC concluded that, on the basis of its long-standing use, these passion flower preparations can be used for the relief of mild symptoms of mental stress and to aid sleep.
Croatian: Na temelju dugotrajne primjene, HMPC je zaključio da se ovi pripravci pasiflorove zeleni mogu koristiti za ublažavanje blagih simptoma mentalnog stresa i za poboljšanje spavanja.
English: Other information about passion flower medicines
Croatian: Ostale informacije o lijekovima koji sadrže pasiflorovu zelen
English: What are the risks associated with passion flower medicines?
Croatian: Koji su rizici povezani s lijekovima koji sadrže pasiflorovu zelen?
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing passion flower.
Croatian: Države članice EU-a uzimaju u obzir zaključke HMPC-a prilikom ocjene zahtjeva za davanje odobrenja za biljne lijekove koji sadrže pasiflorovu zelen.
English: For more information about treatment with passion flower medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Croatian: Za više informacija o liječenju lijekovima koji sadrže pasiflorovu zelen pročitajte uputu o lijeku priloženu uz lijek, odnosno obratite se svom liječniku ili ljekarniku.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of passion flower.
Croatian: Ovaj dokument predstavlja sažetak znanstvenih zaključaka Povjerenstva za biljne lijekove (HMPC) u pogledu medicinske primjene pasiflorove zeleni.