FrancophonIA/ELRC3.0 huggingface dataset:
English: Aerial baiting is not recommended in the vicinity of water (lakes, rivers, water reservoirs) neither in densely populated areas.
Croatian: Distribucija mamaca zrakom ne preporučuje se u blizini vode (jezera, rijeka, vodenih rezervoara) niti u blizini gusto naseljenih područja.
English: PACKAGE SIZE 1 x 800 units
Croatian: VELIČINA PAKOVANJA 1 x 800 jedinica
English: Rabitec is used for the induction of the protective immunity in foxes and raccoon dogs by the oral route characterised by the induction of rabies virus specific (neutralising) antibodies induced primarily by the G-protein (glycoprotein).
Croatian: Rabitec se koristi za indukciju zaštitne imunosti u lisica i kunopasa peroralnim putem, a karakterizira ga indukcija protutijela (neutralizirajućih) specifičnih za virus bjesnoće koje je primarno inducirao Gprotein (glikoprotein).
English: The baits are rectangular, brown coloured and have an intensive smell.
Croatian: Mamci su pravokutnog oblika, smećkaste boje i imaju intenzivan miris.
English: SPECIAL STORAGE CONDITIONS Store and transport frozen.
Croatian: Čuvati i prevoziti zamrznuto.
English: Vaccine baits are not suitable for vaccination of domestic animals.
Croatian: Mamci s cjepivom nisu prikladni za cijepljenje domaćih životinja.
English: Name and address of the manufacturer responsible for batch release IDT Biologika GmbH
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije u promet IDT Biologika GmbH
English: Vaccine baits are not intended for vaccination of domestic animals.
Croatian: Mamci cjepiva nisu namijenjeni za cijepljenje domaćih životinja.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box containing 800 baits (1 x 800 units, 4 x 200 units or 40 x 20 units)
Croatian: Kartonska kutija sadrži 800 mamaca (1 x 800 jedinica, 4 x 200 jedinica ili 40 x 20 jedinica)
English: The active ingredient is a quadruple highly attenuated genetically modified rabies virus construct, derived from the SAD B19 vaccine strain.
Croatian: Djelatna tvar je četverostruki, visoko atenuirani, genetski modificirani virus bjesnoće, dobiven iz soja cjepiva SAD B19.
English: EU/2/17/219/002
Croatian: EU/2/17/219/001 EU/2/17/219/002 EU/2/17/219/003
English: Baits are packed in plastic foil sleeves or bags in cardboard boxes of:
Croatian: Mamci su pakirani u navlake od plastične folije ili vrećice u kartonskim kutijama koje sadrže:
English: For the active immunization of foxes and raccoon dogs against rabies to prevent infection and mortality.
Croatian: Za aktivnu imunizaciju lisica i kunopasa protiv bjesnoće, za sprječavanje infekcije i mortaliteta.
English: Liquid vaccine contained in a polymer/aluminium blisters which are embedded in a bait matrix attractive for the target species.
Croatian: Tekuće cjepivo sadržano u polimernim/aluminijskim blisterima koji su uklopljeni u matricu mamca koja privlači ciljne vrste.
English: The thawed vaccine may be stored for up to 7 days at 2 °C - 8 °C before use; however baits for which the cooling chain was disrupted, because they were not stored in a refrigerator, should be destroyed.
Croatian: Otopljeno cjepivo može se čuvati tijekom 7 dana na temperaturi od 2 °C - 8 °C prije primjene; međutim mamce kod kojih je prekinut hladni lanac jer nisu bili pohranjeni u hladnjaku, treba uništiti.
English: 4.11 Withdrawal period (s)
Croatian: 4.11 Karencija(e)
English: The vaccine suspension is filled in polymer/aluminium blisters which are embedded in a bait matrix attractive for the target species.
Croatian: Suspenzija cjepiva je napunjena u polimerne/aluminijske blistere koji su uklopljeni u matricu mamca, koja privlači ciljne vrste.
English: The thawed vaccine bait may be stored for 7 days between 2 °C- 8 °C before use; however baits for which the cooling chain was disrupted, because they were not stored in a refrigerator, should be destroyed.
Croatian: Otopljeni mamac s cjepivom može se čuvati tijekom 7 dana na temperaturi od 2 °C - 8 °C prije primjene; međutim mamce kod kojih je prekinut hladni lanac jer nisu bili pohranjeni u hladnjaku, treba uništiti.
English: MINIMUM PARTICULARS TO APPEAR ON BAITS
Croatian: OSNOVNI PODACI KOJI SE MORAJU NALAZITI NA MAMCIMA
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Rabitec
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA
English: 40 x 20 units
Croatian: 40 x 20 jedinica
English: Oxytetracycline hydrochloride (may be added as biomarker if requested by authorities)
Croatian: Mamac: riblji obrok palmina mast kokosova mast parafin oksitetraciklin hidroklorid (može se dodati kao biomarker ako to traže nadležna tijela)
English: 1 x 800 units 4 x 200 units 40 x 20 units
Croatian: 1 x 800 jedinica 4 x 200 jedinica 40 x 20 jedinica
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) 1 dose (1.7 ml) embedded in bait contains:
Croatian: 1 doza (1.7 ml) uklopljena u mamac sadrži:
English: 4 x 200 units
Croatian: 4 x 200 jedinica
English: 1 x 800 units 4 x 200 units
Croatian: 1 x 800 jedinica 4 x 200 jedinica
English: METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Croatian: NAČIN I PUT(EVI) PRIMJENE Kroz usta.
English: PACKAGE LEAFLET Rabitec oral suspension, for foxes and raccoon dogs
Croatian: Rabitec peroralna suspenzija za lisice i kunopse
English: Attenuated live rabies vaccine virus, strain SPBN GASGAS 106.8 FFU*/dose - 108.1 FFU*/dose (* Focus Forming Units)
Croatian: atenuirani, živi virus bjesnoće, soj SPBN GASGAS FFU*/dose - 10
English: Foxes, raccoon dogs
Croatian: Lisice, kunopsi
English: Rabitec is a live modified rabies vaccine for oral administration to foxes and raccoon dogs.
Croatian: Rabitec je živo, modificirano cjepivo protiv bjesnoće za primjenu kroz usta za lisice i kunopse.
English: MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI BIOLOŠKI DJELATNE TVARI I PROIZVOĐAČ ODGOVORAN ZA
English: No adverse reactions have been observed.
Croatian: Nisu uočene nuspojave.
English: NAME OF THE MARKETING AUTHORISATION HOLDER IDT Biologika, Germany
Croatian: IDT Biologika, Njemačka
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Rabitec oral suspension for foxes and raccoon dogs
Croatian: UPUTA O VMP Rabitec peroralna suspenzija za lisice i kunopse
English: BATCH NUMBER Lot: {number}
Croatian: Lot: {broj}
English: Excipients:
Croatian: Adjuvansi:
English: Attenuated live rabies vaccine virus, strain SPBN GASGAS: 106.8 FFU* - 108.1 FFU* (* Focus Forming Units)
Croatian: Cjepivo s atenuiranim, živim virusom bjesnoće, soj SPBN GASGAS: 10
English: Bait:
Croatian: FFU*
English: ATCvet code:
Croatian: UPUTA O VMP
English: Oral use blister (PCTFE/PVC/alu) 28 capsules
Croatian: Blister (PCTFE/PVC/Al)
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size EU/1/08/443/001 Thalidomide Celgene 50 mg Capsule, hard
Croatian: EU/1/08/443/001 Thalidomide Celgene 50 mg Kapsula, tvrda Kroz usta
English: If you have just given birth you may be more at risk of certain conditions.
Croatian: Ako ste upravo rodili, možete imati povećan rizik za određena stanja.
English: - Stopping breast milk production for medical reasons only, and when you and your doctor have decided that it is necessary.
Croatian: - Zaustavljanje stvaranja majčinog mlijeka isključivo iz medicinskih razloga, i kad ste Vi i Vaš doktor odlučili da je to nužno.
English: Therefore, your doctor will need to check your blood pressure regularly during the first days of treatment.
Croatian: Stoga će Vaš liječnik trebati redovito provjeravati Vaš krvni tlak tijekom prvih dana liječenja.
English: Bromocriptine should not routinely be used to stop breast milk production.
Croatian: Bromokriptin se ne smije rutinski koristiti za zaustavljanje stvaranja majčinog mlijeka.
English: Package Leaflet 1.
Croatian: Uputa o lijeku 1.
English: Blood pressure should be carefully monitored, especially during the first days of therapy.
Croatian: Krvni tlak je potrebno pažljivo nadzirati, pogotovo tijekom prvih dana terapije.
English: Do not take bromocriptine if:
Croatian: Nemojte uzimati bromokriptin ako:
English: What bromocriptine is and what it is used for:
Croatian: Što je bromokriptin i za što se koristi:
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Croatian: Podatke o lijeku, ako je potrebno, može naknadno ažurirati nadležno tijelo zemlje članice, zajedno s referentnom zemljom članicom u skladu s procedurama iz Direktive 2001/83/EC, Glava III, poglavlje 4.
English: Bromocriptine may be used for:
Croatian: Bromokriptin se može koristiti za:
English: [The existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below]
Croatian: [Postojeće informacije o lijeku moraju biti izmijenjene (ubacivanjem, zamjenom ili brisanjem teksta, kako je prikladno) tako da odražavaju dogovoreni tekst koji je priložen niže]
English: These are very rare, but may include high blood pressure, heart attack, convulsion, stroke or mental problems.
Croatian: Takva stanja su vrlo rijetka, ali mogu uključivati povišen krvni tlak, srčani udar, konvulzije, moždani udar ili mentalne probleme.
English: What you need to know before you take bromocriptine [The wording below should be inserted in this section under the following headings for all products referred to in Annex I]
Croatian: Što morate znati prije nego uzmete bromokriptin [Dolje naveden tekst treba ubaciti u ovaj dio pod sljedeće naslove za sve lijekove navedene u Dodatku I]
English: Speak immediately to your doctor if you experience high blood pressure, chest pain or unusually severe or persistent headache (with or without vision problems).
Croatian: Odmah se obratite svom liječniku ako Vam se povisi krvni tlak, osjetite bol u prsima ili neobično tešku ili trajnu glavobolju (sa ili bez problema s vidom).
English: Prevention or suppression of post-partum physiological lactation only where medically indicated (such as in case of intrapartum loss, neonatal death, HIV infection of the mother…).
Croatian: Prevencija ili supresija poslijeporođajne fiziološke laktacije samo gdje je to medicinski indicirano (kao u slučaju gubitka ploda za vrijeme porođaja, smrti novorođenčeta, HIV infekcije majke…).
English: In some patients the development of seizures or stroke was preceded by severe headache and/or transient visual disturbances.
Croatian: U nekih je bolesnica razvoju napadaja ili moždanog udara prethodila teška glavobolja i/ili prolazne smetnje vida.
English: Annex III Amendments to relevant sections of the summary of product characteristics and package leaflet
Croatian: Dodatak III Izmjene relevantnih poglavlja sažetka opisa svojstava lijeka i uputa o lijeku
English: In rare cases serious adverse events, including hypertension, myocardial infarction, seizures, stroke, or psychiatric disorders have been reported in post-partum women treated with bromocriptine for the inhibition of lactation.
Croatian: U rijetkim slučajevima ozbiljni štetni događaji, uključujući hipertenziju, infarkt miokarda, napadaje, moždani udar ili psihijatrijske poremećaje prijavljeni su u žena poslije porođaja koje su liječene bromokriptinom radi sprječavanja laktacije.
English: It should also not be used to relieve symptoms of painful breast engorgement after giving birth if these can be adequately treated with non-medical means (such as firm breast support, ice application…) and/ or a painkiller.
Croatian: Također se ne smije koristiti za olakšavanje simptoma bolne prepunjenosti dojki nakon porođaja ako se oni mogu primjereno liječiti nemedicinskim sredstvima (kao što su čvrsta potpora grudi, primjena leda…) i/ili lijekom protiv bolova.
English: Bromocriptine is contraindicated for use in the suppression of lactation or other non-life threatening indications in patients with a history of coronary artery disease or other severe cardiovascular conditions, or symptoms/history of severe psychiatric disorders.
Croatian: Korištenje bromokriptina je kontraindicirano za supresiju laktacije ili u drugim indikacijama koje nisu životno ugrožavajuće kod bolesnica s anamnezom bolesti koronarnih arterija ili drugih teških kardiovaskularnih stanja, ili simptomima/anamnezom teških psihijatrijskih poremećaja.
English: Bromocriptine is not recommended for the routine suppression of lactation or for the relief of symptoms of post-partum pain and engorgement which can be adequately treated with nonpharmacological intervention (such as firm breast support, ice application) and/or simple analgesics.
Croatian: Bromokriptin se ne preporučuje za rutinsku supresiju laktacije ili za olakšavanje simptoma poslijeporođajne boli i prepunjenosti dojki koji se mogu primjereno liječiti nefarmakološkom intervencijom (kao što su čvrsta potpora grudi, primjena leda) i/ili jednostavnim analgeticima.
English: Bromocriptine is contraindicated in patients with uncontrolled hypertension, hypertensive disorders of pregnancy (including eclampsia, pre-eclampsia or pregnancy-induced hypertension), hypertension post-partum and in the puerperium.
Croatian: Bromokriptin je kontraindiciran u bolesnica s nekontroliranom hipertenzijom, hipertenzivnim poremećajima u trudnoći (uključujući eklampsiju, preeklampsiju ili hipertenziju induciranu trudnoćom), hipertenzijom poslije porođaja i za vrijeme babinja.
English: This Summary of Product Characteristics, labelling and package leaflet is the outcome of the referral procedure.
Croatian: Opaska: Sažetak opisa svojstava lijeka, označavanje i uputa rezultat su arbitražnog postupka.
English: - You have high blood pressure, - You have ever had blood pressure problems during pregnancy or after giving birth, such as eclampsia, pre-eclampsia, pregnancy-induced high blood pressure, high blood pressure after giving birth.
Croatian: - imate povišen krvni tlak, - ste ikada imali probleme s krvnim tlakom za vrijeme trudnoće ili nakon porođaja, kao što su eklampsija, preeklampsija, povišen krvni tlak potaknut trudnoćom, povišen krvni tlak nakon porođaja - imate, ili ste ikad imali bolest srca ili druge teške bolesti krvnih žila - imate, ili ste ikad imali ozbiljnih problema s mentalnim zdravljem
English: [For products of 1 mg and 2.5 mg strengths only, this section should be amended as appropriate to reflect the wording below]
Croatian: [Samo za lijekove jačina 1 mg i 2,5 mg, ovo poglavlje treba popraviti na prikladan način tako da odražava tekst niže]
English: or unremitting headache (with or without visual disturbances), or evidence of central nervous system toxicity develop, the administration of bromocriptine should be discontinued and the patient should be evaluated promptly.
Croatian: Ako se razvije hipertenzija, sugestivna bol u prsnom košu, teška, progresivna ili perzistirajuća glavobolja (sa ili bez poremećaja vida) ili dokazi toksičnosti središnjeg živčanog sustava, potrebno je prekinuti primjenu bromokriptina i smjesta procijeniti stanje bolesnice.
English: 4.3 Contraindications [This section should be amended as appropriate to reflect the wording below for all products referred in Annex I]
Croatian: [Ovo poglavlje treba popraviti na prikladan način tako da odražava tekst niže za sve lijekove navedene u Dodatku I]
English: [B. For product of higher strengths (5 mg and 10 mg) the indication related to inhibition of lactation in post-partum, including the examples of mastitis and painful breast engorgement, should be removed and the complete SmPC should be revised to remove wording related to the deleted indication]
Croatian: Za lijekove većih jačina (5 mg i 10 mg) indikacija vezana uz sprječavanje laktacije poslije porođaja, uključujući slučajeve mastitisa i bolne prepunjenosti dojki, treba biti uklonjena i cijeli SPC treba biti revidiran da bi se uklonio tekst vezan uz izbrisanu indikaciju]
English: [A. For products of 1 mg and 2.5 mg strengths, the current indication related to lactation inhibition in post-partum, including the examples of mastitis and painful breast engorgement, should be deleted and the below wording should be included in its place]
Croatian: Za lijekove jačina 1 mg i 2,5 mg, trenutna indikacija vezana uz sprječavanje laktacije poslije porođaja, uključujući slučajeve mastitisa i bolne prepunjenosti dojki, treba biti izbrisana i niže priloženi tekst treba uključiti na njeno mjesto]
English: 4.4 Special warnings and precautions for use [For products of 1 mg and 2.5 mg strengths only, this section should be amended as appropriate to reflect the wording below]
Croatian: [Samo za lijekove jačina 1 mg i 2,5 mg, ovo ovo poglavlje treba popraviti na prikladan način tako da odražava tekst niže]
English: A total of 104 subjects were enrolled.
Croatian: U ispitivanje su bila uključena ukupno 104 ispitanika.
English: 1 December 2018
Croatian: 1. prosinca 2018.
English: 30 January 2019
Croatian: 30. siječnja 2019.
English: The levels of magnesium in these cases are not considered to represent clinically relevant hypermagnesemia.
Croatian: Smatra se da razine magnezija u tim slučajevima ne predstavljaju klinički značajnu hipermagnezemiju.
English: Overall, data suggest that neonates can tolerate during a short time a relatively wide range of serum magnesium concentrations without increased risk of adverse outcomes.
Croatian: Cjelokupno, podaci upućuju na to da novorođenčad može tijekom kratkog vremenskog perioda podnijeti relativno širok raspon koncentracija magnezija u serumu bez povećanja rizika od štetnih ishoda.
English: Therefore, in view of available data regarding the PASS final study report, the PRAC considered that changes to the conditions of the marketing authorisation were warranted.
Croatian: Zato, s obzirom na dostupne podatke završnog izvješća PASS-a, PRAC smatra da su izmjene uvjeta odobrenja za stavljanje lijeka u promet opravdane.
English: The marketing authorisation holder(s) shall remove the following condition(s) (new text underlined and in bold, deleted text strike through)
Croatian: Nositelj(i) odobrenja za stavljanje lijeka u promet uklonit će sljedeći(e) uvjet(e) (novi tekst je podcrtan i podebljan, obrisani tekst je precrtan)
English: The MAH should conduct a prospective non-interventional post-authorisation safety study to further evaluate magnesium levels observed in term newborn infants and children up to two years of age treated with Numeta G16%E in routine clinical practice.
Croatian: Nositelj odobrenja treba provesti prospektivno neintervencijsko ispitivanje sigurnosti primjene lijeka nakon stavljanja u promet radi dodatne analize razina magnezija zabilježenih u novorođenčadi rođene u terminu i djece u dobi do dvije godine koja su liječena Numetom G16%E u rutinskoj kliničkoj praksi.
English: October 2018 CMDh meeting
Croatian: Sastanak CMDh-a u listopadu 2018.
English: Hypermagnesaemia was reported in 4 cases, 3 of which were mild and one moderate in severity.
Croatian: U 4 slučaja prijavljena je hipermagnezemija, od čega su u pogledu težine 3 bila blaga a jedan umjereno težak.
English: No pattern of accumulation or continued increase in serum magnesium levels that would raise any safety concern was observed.
Croatian: Nije zabilježen obrazac nakupljanja ili kontinuiranog povećanja razina magnezija u serumu koji bi izazvao zabrinutost po pitanju sigurnosti lijeka.
English: No potential risk factors for notable increase in serum magnesium were identified.
Croatian: Nisu utvrđeni potencijalni čimbenici rizika za primjetan porast razine magnezija u serumu.
English: The CMDh reaches the position that the marketing authorisation(s) of the products concerned by this PASS final report should be varied.
Croatian: Stajalište je CMDh-a da je potrebna izmjena odobrenja za stavljanje lijeka u promet za lijek(ove) obuhvaćen(e) ovim završnim izvješćem PASS-a.
English: The MAH should submit the protocol for the above mentioned study.
Croatian: Nositelj odobrenja treba predati protokol gore navedenog ispitivanja. (Prilog V. stajališta CMDh-a).
English: The descriptive study final report submitted by the MAH complies with their obligation to conduct a prospective non-interventional post-authorisation safety study to further evaluate magnesium levels observed in term newborn infants and children up to two years of age treated in routine clinical practice as imposed during the Article 107i procedure EMEA/H/A-107i/1373 for alanine, arginine, aspartic acid, cysteine, glucose, glutamic acid, glycine, histidine, isoleucine, leucine, lysine monohydrate, methionine, ornithine hydrochloride, phenylalanine, proline, serine, taurine, threonine, tryptophan, tyrosine, valine, calcium chloride, magnesium acetate, potassium acetate, sodium chloride, sodium glycerophosphate, refined soybean oil, refined olive oil containing products.
Croatian: Završno izvješće opisnog ispitivanja koje je predao nositelj odobrenja u skladu je s njegovom obvezom provođenja prospektivnog neintervencijskog ispitivanja sigurnosti primjene lijeka nakon stavljanja u promet radi dodatne analize razina magnezija zabilježenih u novorođenčadi rođene u terminu i djece u dobi do dvije godine koja su liječena prema rutinskoj kliničkoj praksi, što je zatraženo tijekom postupka EMEA/H/A-107i/1373, provedenog po članku 107.i, za lijekove koji sadrže alanin, arginin, aspartatnu kiselinu, cistein, glukozu, glutamatnu kiselinu, glicin, histidin, izoleucin, leucin, lizin hidrat, metionin, ornitinklorid, fenilalanin, prolin, serin, taurin, treonin, triptofan, tirozin, valin, kalcijev klorid, magnezijev acetat, kalijev acetat, natrijev klorid, natrijev glicerofosfat, rafinirano sojino ulje i rafinirano maslinovo ulje.
English: On the basis of the scientific conclusions for the results of the study for the medicinal product(s) containing the active substance Alanine, arginine, aspartic acid, cysteine, glucose, glutamic acid, glycine, histidine, isoleucine, leucine, lysine monohydrate, methionine, ornithine hydrochloride, phenylalanine, proline, serine, taurine, threonine, tryptophan, tyrosine, valine, calcium chloride, magnesium acetate, potassium acetate, sodium chloride, sodium glycerophosphate, refined soybean oil, refined olive oil and concerned by the PASS final report , the CMDh is of the opinion that the benefitrisk balance of the medicinal product(s) mentioned above is unchanged subject to the proposed changes to the product information.
Croatian: Na temelju znanstvenih zaključaka o rezultatima ispitivanja za lijek(ove) koji sadrži(e) djelatne tvari alanin, arginin, aspartatnu kiselinu, cistein, glukozu, glutamatnu kiselinu, glicin, histidin, izoleucin, leucin, lizin hidrat, metionin, ornitinklorid, fenilalanin, prolin, serin, taurin, treonin, triptofan, tirozin, valin, kalcijev klorid, magnezijev acetat, kalijev acetat, natrijev klorid, natrijev glicerofosfat, rafinirano sojino ulje i rafinirano maslinovo ulje, a koje su obuhvaćene završnim izvješćem PASS-a, CMDh smatra da je omjer koristi i rizika gore navedenog(ih) lijeka(ova) nepromijenjen, uz predložene izmjene informacija o lijeku.