FrancophonIA/ELRC3.0 huggingface dataset:
English: Oral emulsion Pigs
Croatian: Oralno emulsion Svinje
English: Consequently the use of altrenogest in mares is not considered to pose a risk to the environment when used as specified in the SPCs given the minimal environmental exposure associated with this use, and the environmental risk assessment presented below is based on the use of altrenogest in gilts.
Croatian: Posljedično, smatra se da uporaba altrenogesta u kobila ne predstavlja rizik za okoliš kada se primjenjuje u skladu s uputama sadržanima u sažetku opisa svojstava lijeka s obzirom na minimalnu izloženost okoliša povezanu s takvom uporabom, stoga se procjena rizika za okoliš u nastavku temelji na uporabi altrenogesta u nazimica.
English: REGUMATE SOLUTION HUILEUSE A 4 POUR MILLE
Croatian: A 4 POUR MILLE
English: REGUMATE PORCINO EMULSION ORAL
Croatian: REGUMATE PORCINO EMULSION ORALNO
English: The DT50 values for soils 1, 2, 3 and 4 are 23.7, 5.3, 2.0, and
Croatian: Vrijednosti DT50 za tla 1, 2, 3 i 4 redom iznose 23,7, 5,3, 2,0, i 4,6 dana, na temelju čega se dobiva srednja geometrijska vrijednost DT50 od 5,8 dana.
English: Risk mitigation measures are recommended in the product information for veterinary medicinal products containing altrenogest to be administered orally to pigs to lower the risk to the environment and to make the user aware that altrenogest may be hazardous for fish and other aquatic organisms.
Croatian: Preporučuje se da se mjere za smanjivanje rizika uključe u informacije o proizvodu za veterinarsko-medicinske proizvode koji sadržavaju altrenogest za oralnu primjenu u svinja radi smanjivanja rizika za okoliš te kako bi se korisnika obavijestilo da bi altrenogest mogao biti opasan za ribe i ostale vodene organizme.
English: Romania Intervet International B.V Wim de Korverstr.35
Croatian: Rumunjska Intervet International B.V Wim de Korverstr.35
English: Risks to the environment
Croatian: Rizici za okoliš
English: The MAHs used this latter value (69% metabolism) for the PECsoil refinement.
Croatian: Nositelji odobrenja za stavljanje lijeka u promet upotrijebili su tu vrijednost (metabolizam od 69 %) za dobivanje preciznih podataka o predviđenoj koncentraciji u okolišu za tlo (PECtlo).
English: Poland Ceva Animal Health Polska Sp. z o.o.
Croatian: Ceva Animal Health Polska Sp. z o.o. Okrzei 1A Str.
English: Grounds for amendment of the summary of product characteristics, labelling and package leaflets
Croatian: Razlozi za izmjenu sažetka opisa svojstava lijeka, označivanja i uputa o lijeku
English: {Invented name} should not enter water courses as this may be dangerous for fish and other aquatic organisms.
Croatian: {Izmišljeni naziv} ne treba odlagati u otvorene vode jer to može biti opasno za ribe i druge vodene organizme.
English: Industrial El Montalvo
Croatian: Industrial El
English: АЛТРЕЗИН 4 мг/мл разтвор за перорално приложение/ ALTRESYN 4 mg/ml oral solution
Croatian: АЛТРЕЗИН 4 мг/мл разтвор за перорално приложение/ ALTRESYN 4 mg/ml Oralna otopina
English: A PNEC (Predicted No Effect Concentration) of <0.4 ng altrenogest/l was used for the risk assessment.
Croatian: Za procjenu rizika upotrijebljen je PNEC (predviđena koncentracija bez učinka) u iznosu od 0,4 ng altrenogesta po litri.
English: Intervet International Wim de Korverstraat 35 P.O.
Croatian: Intervet International Wim de Korverstraat 35 P.O. Box 31
English: Consequently, a PNEC of below
Croatian: Posljedično tome utvrđen je PNEC ispod 40 pg/l.
English: Amendments in the relevant sections of the summary of product characteristics, labelling and package leaflet
Croatian: Izmjene i dopune u odnosnim dijelovima sažetka opisa svojstava, označavanju i uputama
English: For the Phase I the PECsoil initial for gilts, sows and mares was established using the daily doses and the default values from the CVMP guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL 38 (EMEA/CVMP/418282/2005Rev.1).
Croatian: U pogledu faze I početna predviđena koncentracija u okolišu za tlo (PECtlo ) za nazimice, krmače i kobile utvrđena je primjenom dnevnih doza i zadanih vrijednosti iz smjernica CVMP-a o procjeni utjecaja na okoliš za veterinarsko-medicinske proizvode kao potpora smjernicama VICH-a GL6 i GL38 (EMEA/CVMP/418282/2005-Rev.1).
English: REGUMATE PORCINO SOLUCION ORAL
Croatian: REGUMATE PORCINO SOLUCION ORALNO
English: • the CVMP considered that veterinary medicinal products containing altrenogest are essential in modern pig production since the oestrus synchronisation of gilts is a tool facilitating strict batch farrowing with obvious benefits for the management and hygiene in these farms, and consequently the health of the animals;
Croatian: • CVMP je smatrao da su veterinarsko-medicinski proizvodi koji sadržavaju altrenogest važni za suvremeni uzgoj svinja jer je sinkronizacija estrusa u nazimica alat koji olakšava strogo kontrolirano prasenje, s očitim koristima za upravljanje i čistoću na takvim farmama te posljedično za zdravlje tih životinja;
English: According to the CVMP guideline on environmental impact assessment for veterinary medicinal products in support of VICH GL6 and GL381 when “adverse environmental effects are anticipated from the use of products, further assessment of possible exposure of the environment can be performed, even if straightforward application of the Phase I guidance would indicate exemption from further testing.” This provision implies that some products, which do not meet the trigger value for entering a Phase II environmental risk assessment (ERA), may however require further assessment to address specifically the concerns related to their activity and use.
Croatian: U skladu sa smjernicama CVMP-a o procjeni utjecaja na okoliš za veterinarsko-medicinske proizvode kao potpora smjernicama VICH-a GL6 i GL381 kada se „od uporabe proizvoda očekuju štetni utjecaji na okoliš, može se provesti dodatno vrednovanje mogućeg izlaganja okoliša, čak i u slučajevima kada bi jednostavna primjena smjernica iz faze
English: Regumate Equinos, 2,2 mg/ml solução oral para cavalos
Croatian: Regumate Equinos, 2,2 mg/ml solução Oralno para cavalos
English: SPC section 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products.
Croatian: Posebne mjere za zbrinjavanje neiskorištenih veterinarsko-medicinskih proizvoda ili otpadnih materijala dobivenih uporabom tih proizvoda.
English: Folliplan 4mg/ml soluzione orale per suini
Croatian: Folliplan 4mg/ml soluzione Oralnoe per suini
English: However, veterinary medicinal products containing altrenogest are essential in modern pig production since the synchronisation of gilts is a tool facilitating strict batch farrowing, with obvious benefits for the management and hygiene in these farms, and consequently the health of the animals.
Croatian: Međutim, veterinarsko-medicinski proizvodi koji sadržavaju altrenogest važni su za suvremeni uzgoj svinja jer je sinkronizacija nazimica alat koji olakšava strogo kontrolirano prasenje, s očitim koristima za upravljanje i čistoću na takvim farmama te stoga i za zdravlje tih životinja.
English: Veterinary medicinal products containing altrenogest are essential in modern pig production, as the synchronisation of gilts is a tool facilitating strict batch farrowing, with obvious benefits for the management and hygiene in these farms, and consequently the health of the animals.
Croatian: Veterinarsko-medicinski proizvodi koji sadržavaju altrenogest važni su za suvremeni uzgoj svinja jer je sinkronizacija nazimica alat koji olakšava strogo kontrolirano prasenje, s očitim koristima za upravljanje i čistoću na takvim farmama te stoga i za zdravlje tih životinja.
English: Intervet Nederland BV Wim de Korverstraat 35 5831 AN Boxmeer The Netherlands
Croatian: Wim de Korverstraat 35 5831 AN Boxmeer The Netherlands
English: 1a
Croatian: Feldstr. 1a
English: The MAHs proposes the following risk mitigation measure: “When spreading manure from treated animals, the minimum distance to surface water as defined in the national or local regulations has to be strictly respected, because the manure may contain altrenogest which could cause adverse effects in the aquatic environment”.
Croatian: Nositelji odobrenja za stavljanje lijeka u promet predlažu sljedeću mjeru za smanjivanje rizika: „Pri rasprostiranju gnojiva od liječenih životinja potrebno je poštovati najmanju udaljenost od površinske vode kako je definirana u skladu s nacionalnim ili lokalnim propisima jer bi gnojivo moglo sadržavati altrenogest koji bi mogao prouzročiti štetne učinke na vodeni okoliš.”
English: Regumate Porcine, 0.4% w/v Oral Solution
Croatian: Regumate Porcine, 0.4% w/v Oralna otopina
English: When spreading manure from treated animals, the minimum distance to surface water as defined in the national or local regulations has to be strictly respected, because the manure may contain altrenogest which could cause adverse effects in the aquatic environment.
Croatian: Pri rasprostiranju gnojiva od liječenih životinja potrebno je poštovati najmanju udaljenost od površinske vode kako je definirana u skladu s nacionalnim ili lokalnim propisima jer bi gnojivo moglo sadržavati altrenogest koji bi mogao prouzročiti štetne učinke na vodeni okoliš.
English: ВИРБАГЕСТ 4 мг/мл перорален разтвор за прасета/ VIRBAGEST 4 mg/ml oral solution for pigs
Croatian: ВИРБАГЕСТ 4 мг/мл перорален разтвор за прасета/ VIRBAGEST 4 mg/ml Oralna otopina for Svinje
English: MATERIALS, IF ANY {Invented name} should not enter water courses as this may be dangerous for fish and other aquatic organisms.
Croatian: ILI OTPADNIH MATERIJALA, AKO IH IMA {Izmišljeni naziv} ne treba odlagati u otvorene vode jer to može biti opasno za ribe i druge vodene organizme.
English: ALTRESYN 4 mg/ml peroralna raztopina
Croatian: ALTRESYN 4 mg/ml perOralnona raztopina
English: Oral solution Horses
Croatian: Oralna otopina Konji
English: 0.4% w/v Oral suspension Pigs
Croatian: 0.4% w/v Oralna suspenzija
English: 1ère Avenue 2065 m - LID Carros Cedex
Croatian: 2065 m - LID Carros Cedex
English: Hungary aniMedica GmgH, Im Südfeld 9
Croatian: Mađarska aniMedica GmgH, Im Südfeld 9
English: Bulgaria Virbac S.A. 1ère avenue
Croatian: Bugarska Virbac S.A. 1ère avenue
English: Spain aniMedica GmbH Im Sudfeld
Croatian: Španjolska aniMedica GmbH Im Sudfeld
English: 1107 Budapest
Croatian: Mađarska Ceva-Phylaxia Zrt. 1107 Budapest
English: United Kingdom aniMedica GmbH Im Sudfeld
Croatian: Velika Britanija aniMedica GmbH Im Sudfeld
English: The PECgroundwater (Phase IIA STEP 1) was calculated using the recommended stepwise approach described in the CVMP guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL 38 (EMEA/CVMP/418282/2005-Rev.1), STEP 1 to STEP 3.
Croatian: Predviđena koncentracija u okolišu za površinsku vodu (PECpodzemnavoda) (faza IIA, korak 1) izračunana je primjenom preporučenog postupnog pristupa koji je opisan u smjernicama CVMP-a o procjeni utjecaja na okoliš za veterinarsko-medicinske proizvode kao potpora smjernicama VICH-a GL6 i GL38 (EMEA/CVMP/418282/2005-Rev.1), od koraka 1 do koraka 3. Korak 1. rezultirao je time da je predviđena koncentracija u okolišu za površinsku vodu (PECpodzemnavoda) bila ispod granične vrijednosti (0,1 µg/l), predvidjevši da bi rizik za površinske vode u načelu mogao biti isključen.
English: REGUMATE EQUINO 2,2 mg/ml SOLUCION ORAL PARA CABALLOS
Croatian: REGUMATE EQUINO 2,2 mg/ml SOLUCION ORALNO PARA CABALLOS
English: ALTRESYN 4 mg/ml solução oral
Croatian: ALTRESYN 4 mg/ml solução Oralno
English: SUIFERTIL 4 MG/ML SOLUCION ORAL PARA CERDOS
Croatian: SUIFERTIL 4 MG/ML SOLUCION ORALNO PARA CERDOS
English: Belgium Virbac S.A. 1ère avenue
Croatian: Španjolska Virbac S.A. 1ère Avenue
English: Poland Intervet International B.V. Wim de Körverstraat B.V.
Croatian: Wim de Körverstraat B.V.
English: Other precautions regarding impact on the environment When spreading manure from treated animals, the minimum distance to surface water as defined in the national or local regulations has to be strictly respected, because the manure may contain altrenogest which could cause adverse effects in the aquatic environment.
Croatian: Kod rasprostiranja gnojiva od tretiranih životinja treba se striktno pridržavati minimalne udaljenosti od površinskih voda, prema definiciji u državnim i lokalnim propisima, jer gnojivo može sadržavati altrenogest koji može uzrokovati neželjene učinke u vodenom okolišu.
English: Virbagest 4 mg/ml solução oral para suínos
Croatian: Virbagest 4 mg/ml solução Oralno para suínos
English: VIRBAGEST 4 mg/ml SOLUCION ORAL PARA CERDOS
Croatian: VIRBAGEST 4 mg/ml SOLUCION ORALNO PARA CERDOS
English: 0.4% w/w Oral solution Pigs
Croatian: 0.4% w/w Oralna otopina Svinje
English: Romania aniMedica GmbH Im Südfeld 9
Croatian: Rumunjska aniMedica GmbH Im Südfeld 9
English: The Netherlands aniMedica GmbH Im Südfeld 9
Croatian: Nizozemska aniMedica GmbH Im Südfeld 9
English: Maximum PECsurfacewater concentrations were calculated using FOCUS STEP 4 modelling for all representative scenarios for different buffer zone (1 m, 3 m, 5 m, 10 m (Directive 91/676/EEC) These buffer zones are minimum distances to surface water which must be maintained when manure (or organic fertilizer) is spread onto cropland for the protection of waters against pollution caused by nitrates from agricultural sources which is implemented in national law in the EU Member States.
Croatian: Maksimalne koncentracije PECpovršinskavoda izračunane su primjenom modeliranja iz koraka 4 FOCUS-a za sve reprezentativne scenarije te za različitu zonu ograničenja (1 m, 3 m, 5 m i 10 m (Direktiva 91/676/EEZ)).
English: 0.4% w/v Oral solution Pigs
Croatian: 0.4% w/v Oralna otopina Svinje
English: Hungary Intervet International B.V. Wim de Körverstraat 35
Croatian: Nizozemska Intervet Nederland BV Wim de Korverstraat 35
English: France aniMedica GmbH Im Südfeld 9
Croatian: Francuska aniMedica GmbH Im Südfeld 9
English: Hungary Virbac 1ère avenue 2065 m - LID 06516 Carros Cedex France
Croatian: Mađarska Virbac 1ère avenue 2065 m - LID 06516 Carros Cedex France
English: Romania Virbac SA 1ère Avenue 2065 m - LID 06516 Carros Cedex France
Croatian: Rumunjska Virbac SA 1ère Avenue 2065 m - LID 06516 Carros Cedex France
English: Germany Virbac 1ère Avenue 2065 m - LID 06516 Carros Cedex France
Croatian: Njemačka Virbac 1ère Avenue 2065 m - LID 06516 Carros Cedex France
English: Poland AniMedica GmbH Im Südfeld 9
Croatian: AniMedica GmbH Im Südfeld 9
English: R1 (middle European land) and R3 (middle European Mediterranean) (but not R2) are also considered
Croatian: Međutim, kad je riječ o izračunima graničnih zona koje predstavljaju scenarij najviše razine izloženosti, preporučuje se cijeli reprezentativni scenarij R. Scenariji R1 (srednjoeuropsko kopno) i R3 (srednjoeuropsko Sredozemlje) (ali ne i R2) također se smatraju važnima za zimske žitarice, kako je predloženo u izvješću FOCUS-SW za površinske vode, stoga ih je također potrebno izračunati.
English: SPC section 4.5 Special precautions for use.
Croatian: 4.5 Posebne mjere opreza prilikom primjene Druge mjere opreza vezane uz utjecaj na okoliš
English: Postbox 66,
Croatian: Dio SPC-a 6.6.
English: Belgium Ceva Santé Animale N.V. Metrologielaan 6
Croatian: Nizozemska Ceva Santé Animale B.V.
English: EU/1/07/416/002 Ecalta
Croatian: EU/1/07/416/002 Ecalta 100 mg Prašak za koncentrat za otopinu za infuziju
English: MA (EU) number Name Strength Pharmaceutical Form
Croatian: Ime Doza Farmaceutski oblik Put primjene Unutarnje pakovanje
English: EU Number
Croatian: MA (EU) broj
English: Intravenous use vial (glass)
Croatian: u venu bočica (staklena)
English: Powder for concentrate for solution for infusion
Croatian: 29 mg Prašak za koncentrat za otopinu za infuziju.
English: Package size
Croatian: Put primjene Unutarnje pakiranje Veličina pakiranja
English: Oral use Oral use Oral use Oral use blister (OPA/alu/PVC/alu) blister (OPA/alu/PVC/alu) blister (OPA/alu/PVC/alu) blister (OPA/alu/PVC/alu)
Croatian: Blister (OPA/al/PVC/al) Blister (OPA/al/PVC/al) Blister (OPA/al/PVC/al) Blister (OPA/al/PVC/al)
English: EU/1/18/1291/005 EU/1/18/1291/006
Croatian: EU/1/18/1291/003 EU/1/18/1291/004 EU/1/18/1291/005 EU/1/18/1291/006
English: 84 tablets 10 tablets 30 tablets 100 tablets
Croatian: 84 tableta 10 tableta 30 tableta 100 tableta
English: Strength Pharmaceutical Form Route of Administration
Croatian: Farmaceutski oblik Put primjene Unutarnje pakiranje
English: The median time to event was nine days.
Croatian: Medijan vremena do nastupa događaja bio je devet dana.
English: ≥ 8 hours
Croatian: ≥ 8 sati
English: < 8 hours or unknown
Croatian: < 8 sati ili nepoznato
English: Pontevedra 36410
Croatian: Porrino Pontevedra 36410
English: Please note this medicine is mainly used in emergency situations, and the doctor will have decided that you needed it.
Croatian: Imajte na umu da se ovaj lijek uglavnom koristi u hitnim slučajevima i liječnik će odlučiti je li Vam potreban.
English: Tell your doctor if you are taking, have recently taken, or might take, any other medicines.
Croatian: Obavijestite svog liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: Frequency in healthy volunteers
Croatian: Učestalost u zdravih dobrovoljaca
English: Tell your doctor if you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby.
Croatian: Recite liječniku ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete.
English: ATC code: V03AB38
Croatian: ATK oznaka: V03AB38
English: This medicine will be stored in the hospital, and these instructions are intended for hospital staff only.
Croatian: Ovaj će se lijek čuvati u bolnici i ove su upute namijenjene samo bolničkom osoblju.
English: • Calculated number of vials as given in table 1.
Croatian: • Izračunati broj bočica kako je navedeno u tablici 1.
English: The dissolution time for each vial is approximately three to five minutes.
Croatian: Vrijeme otapanja kod svake bočice iznosi otprilike 3 do 5 minuta.
English: Read all of this leaflet carefully, because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego primite ovaj lijek jer sadrži Vama važne podatke.
English: Before starting reconstitution, you will need the following:
Croatian: Prije početka rekonstitucije potrebno je sljedeće:
English: Validation has not been successful, yet.
Croatian: Njihovo vrednovanje još nije uspješno provedeno.
English: Reduction in anti-FXa activity
Croatian: Smanjenje anti-FXa aktivnosti
English: Your doctor or nurse will work out the dose of this medicine that you need.
Croatian: Liječnik ili medicinska sestra izračunat će dozu lijeka koja Vam je potrebna.
English: The elimination halflife ranges from four to seven hours.
Croatian: Poluvrijeme eliminacije kreće se u rasponu od 4 do 7 sati.
English: Haemostatic efficacy was good or excellent in 81.9% of 249 patients.
Croatian: Hemostatski učinak bio je dobar ili odličan u 81,9% od 249 bolesnika.
English: It is unlikely that Ondexxya will influence the effect of other medicines or that other medicines will influence Ondexxya.
Croatian: Nije vjerojatno da će Ondexxya utjecati na učinak drugih lijekova ili da će drugi lijekovi utjecati na Ondexxyu.
English: These elevations were maintained between several hours to a few days following administration, but no thrombotic events were reported.
Croatian: Ovo je povišenje održano u trajanju od nekoliko sati do nekoliko dana nakon primjene, ali nisu zabilježeni trombotički događaji.
English: Submission by 30 September
Croatian: Podnošenje do 30. rujna
English: Distribution The Vd for andexanet alfa is 5.3 ± 2.6 L, approximately equivalent to the blood volume.
Croatian: Distribucija Vd za andeksanet alfa je 5,3 ± 2,6 l, otprilike jednak volumenu krvi.
English: Among the healthy subjects studied, women experienced more adverse reactions (mainly infusion-related reactions) than men.
Croatian: Među ispitivanima zdravim ispitanicima, žene su imale više nuspojava (uglavnom reakcije povezane s infuzijom) nego muškarci.
English: Of 352 enrolled patients, 249 (70.7%) were included in the efficacy-analysis.
Croatian: Od 352 bolesnika uključena u ispitivanje, 249 (70,7%) je bilo uključeno u analizu djelotvornosti.
English: Based on its mechanism of action and on the characteristics of proteins, no carcinogenic or genotoxic effects are anticipated.
Croatian: Na temelju mehanizma djelovanja i karakteristika proteina ne očekuju se kancerogeni ili genotoksični učinci.
English: Pharmacotherapeutic group: All other therapeutic products, antidotes.
Croatian: Farmakoterapijska skupina: Ostali terapijski pripravci, antidoti.
English: Your doctor or nurse will give you this medicine by injection or infusion into a vein.
Croatian: Liječnik ili medicinska sestra dat će Vam lijek u venu u obliku injekcije ili infuzije.
English: There is no information on the use of Ondexxya in children and adolescents.
Croatian: Nema podataka o primjeni Ondexxye u djece i adolescenata.
English: In case of mild or moderate infusion reactions, careful observation may be sufficient.
Croatian: U slučaju blage ili umjerene infuzijske reakcije, pažljivo nadziranje bolesnika može biti dovoljno.
English: In an updated interim analysis, data of 352 patients were evaluated.
Croatian: U ažuriranoj interim analizi podataka obrađena su 352 bolesnika.
English: Approximately half of the patients were male, and the mean age was 77.4 years.
Croatian: Otprilike polovica bolesnika bili su muškog spola i srednje vrijednosti dobi od 77,4 godine.
English: These antibodies were generally low titre, and no clinical consequences were observed.
Croatian: Njihov je titar općenito bio nizak i nisu primijećene nikakve kliničke posljedice.
English: Use aseptic technique during the reconstitution procedure.
Croatian: Koristite aseptičnu tehniku tijekom postupka rekonstiitucije.
English: Detailed instructions for your doctor or nurse on how to give Ondexxya are given at the end of this package leaflet (see ‘Handling instructions').
Croatian: Detaljne upute za liječnika ili medicinsku sestru kako primjenjivati Ondexxyu nalaze se na kraju ove upute o lijeku (pogledati „Upute za rukovanje“).
English: Each vial is reconstituted according to the following instructions:
Croatian: Svaka se bočica rekonstituira prema sljedećim uputama:
English: 8 mg/min for 120 minutes (960 mg)
Croatian: 8 mg/min tijekom 120 minuta (960 mg)
English: The updated interim analysis demonstrated that the change in anti-FXa activity (surrogate) was not predictive for achievement of hemostatic efficacy in the overall patient population.
Croatian: Ažurirana interim analiza pokazala je da promjena u aktivnosti anti-FXa (surogata) nije bila prediktivna za postizanje hemostatske djelotvornosti u sveukupnoj populaciji bolesnika.
English: The clinical relevance of this interaction in terms of maintenance of thrombin generation and the potential for a prothrombotic effect has not been fully elucidated.
Croatian: Kliničko značenje ove interakcije u smislu održavanja stvaranja trombina i mogućeg protrombotičkog učinka nije u potpunosti razjašnjeno.
English: Elderly patients (aged 65 years and over): No dose adjustment is required in elderly patients (see section 5.2).
Croatian: Bolesnici starije životne dobi (65 godina ili stariji): Prilagođavanje doze u bolesnika starije životne dobi nije potrebno (vidjeti dio 5.2).
English: Store in a refrigerator (2°C to 8°C).
Croatian: Čuvati u hladnjaku (2 °C - 8 °C).
English: Duration of this effect in bleeding patients is not known.
Croatian: Trajanje ovog učinka u bolesnika koji krvare nije poznato.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology and repeated dose toxicity studies up to two weeks in rats and monkeys.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije i ispitivanja toksičnosti ponovljenih doza do dva tjedna, provedenih na štakorima i majmunima.
English: • Calculated number of vials (see section 4.2).
Croatian: • Izračunati broj potrebnih bočica (vidjeti dio 4.2).