FrancophonIA/ELRC3.0 huggingface dataset:
English: 6.5 Nature and composition of immediate packaging The spot on pipette is composed of a bright yellow polypropylene shell, with a pale yellow aluminium foil back coated with a polyethylene terephthalate film.
Croatian: Spot-on pipeta sastoji se od svijetložute polipropilenske kapsule s blijedožutom aluminijskom folijom koja je obložena filmom od polietilen tereftalata.
English: One application is effective against ticks for 4 weeks.
Croatian: Jedna primjena djelotvorna je protiv krpelja tijekom 4 tjedna.
English: Prac-tic for very small dogs
Croatian: Prac-tic za vrlo male pse
English: Treatment and prevention of tick infestation (Ixodes ricinus, Ixodes scapularis, Dermacentor variabilis, Dermacentor reticulatus, Rhipicephalus sanguineus, Amblyomma americanum).
Croatian: Liječenje i prevencija infestacije krpeljima (Ixodes ricinus, Ixodes scapularis, Dermacentor variabilis, Dermacentor reticulatus, Rhipicephalus sanguineus, Amblyomma americanum).
English: Treatment and prevention of flea infestation (Ctenocephalides canis and C.
Croatian: Liječenje i prevencija infestacije buhama (Ctenocephalides canis i C. felis).
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Prac-tic 137.5 mg
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Prac-tic 137,5 mg
English: 26, Rue de la Chapelle 68330 Huningue
Croatian: 26, Rue de la Chapelle
English: Prac-tic for small dogs
Croatian: Prac-tic za male pse
English: TARGET SPECIES Dog (>11-22 kg)
Croatian: CILJNE VRSTE ŽIVOTINJA Pas (> 11 - 22 kg)
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Prac-tic spot-on for dogs
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Prac-tic spot-on otopina za pse
English: One application prevents flea infestation for 4 weeks.
Croatian: Jedna primjena sprječava infestaciju buhama tijekom četiri tjedna.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARDBOARD CARTON 137.5 mg
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU KARTONSKA KUTIJA (137,5 mg)
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Prac-tic 56.25 mg
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Prac-tic 56,25 mg
English: Spot-on use for external application to the skin.
Croatian: Spot-on uporaba za vanjsku primjenu na koži psa.
English: TARGET SPECIES Dog (2-4.5 kg)
Croatian: CILJNE VRSTE ŽIVOTINJA Pas (2 - 4,5 kg)
English: 4.5 Special precautions for use
Croatian: 6.4 Posebne mjere pri čuvanju
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Prac-tic 275 mg
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Prac-tic 275 mg
English: Prac-tic for medium dogs
Croatian: Prac-tic za pse srednje veličine
English: TARGET SPECIES Dog (>22-50 kg)
Croatian: CILJNE VRSTE ŽIVOTINJA Pas (> 22 - 50 kg)
English: TARGET SPECIES Dog (>4.5-11 kg)
Croatian: CILJNE VRSTE ŽIVOTINJA Pas (> 4,5 - 11 kg)
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Prac-tic 56.25 mg spot-on solution for very small dogs
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Prac-tic 56,25 mg spot-on otopina za vrlo male pse
English: - application site and skin reactions: pruritus (itchy skin), hair change, dermatitis (inflammation of the skin), erythema (redness of skin), alopecia (loss of hair), fur discoloration and greasy appearance of hair.
Croatian: - reakcije na mjestu primjene i kožne reakcije: pruritus (svrbež), promjene na dlaci, dermatitis (upala kože), eritem (crvenilo kože), alopecija (gubitak dlake), promjena boje i masni izgled dlake; - neurološke reakcije: ataksija (manjak koordinacije) i konvulzije; - sustavne reakcije: letargija (omamljenost); - reakcije u probavnom sustavu: emeza (povraćanje) i proljev.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Prac-tic 137.5 mg spot-on solution for small dogs
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Prac-tic 137,5 mg spot-on otopina za male pse
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PIPETTE 137.5 mg
Croatian: OSNOVNI PODACI KOJI SE MORAJU NALAZITI NA BLISTERIMA ILI TRAKAMA PIPETA (137,5 mg)
English: Prac-tic for large dogs
Croatian: Prac-tic za velike pse
English: MARKETING AUTHORISATION HOLDER
Croatian: NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/066/001-012
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/06/066/001-012
English: Treatment and prevention of tick infestation (Ixodes ricinus, Rhipicephalus sanguineus, Ixodes scapularis, Dermacentor reticulatus, Dermacentor variabilis, Amblyomma americanum) in dogs.
Croatian: Liječenje i prevencija infestacije krpeljima (Ixodes ricinus, Rhipicephalus sanguineus, Ixodes scapularis, Dermacentor reticulatus, Dermacentor variabilis, Amblyomma americanum) u pasa.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARDBOARD CARTON 56.25 mg
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU KARTONSKA KUTIJA (56,25 mg)
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PIPETTE 56.25 mg
Croatian: OSNOVNI PODACI KOJI SE MORAJU NALAZITI NA BLISTERIMA ILI TRAKAMA PIPETA (56,25 mg)
English: ROUTE(S) OF ADMINISTRATION Spot-on
Croatian: PUT(EVI) PRIMJENE Spot-on.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Prac-tic 625 mg
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Prac-tic 625 mg
English: felis.
Croatian: Pas.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARDBOARD CARTON 275 mg
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU KARTONSKA KUTIJA (275 mg)
English: Only indicated for use in dogs.
Croatian: Informacije za sigurnost životinja: Indiciran samo za primjenu u pasa.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PIPETTE 275 mg
Croatian: OSNOVNI PODACI KOJI SE MORAJU NALAZITI NA BLISTERIMA ILI TRAKAMA PIPETA (275 mg)
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Prac-tic 275 mg spot-on solution for medium dogs
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Prac-tic 275 mg spot-on otopina za pse srednje veličine
English: Dog
Croatian: NUSPOJAVE
English: 4.9 Amounts to be administered and administration route Spot-on use for external application.
Croatian: 4.9 Količine koje se primjenjuju i put primjene
English: Special precautions for storage
Croatian: POSEBNI UVIJETI ČUVANJA
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
Croatian: POSEBNE MJERE OPREZA PRILIKOM ODLAGANJA NEUPOTREBLJENOG
English: NAME OF THE MARKETING AUTHORISATION HOLDER Elanco
Croatian: NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET Elanco GmbH
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Prac-tic 625 mg spot-on solution for large dogs
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Prac-tic 625 mg spot-on otopina za velike pse
English: Spot-on use for external application to the skin
Croatian: Spot-on otopina za vanjsku primjenu na koži.
English: PHARMACOLOGICAL PROPERTIES
Croatian: FARMACEUTSKI PODACI
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PIPETTE 625 mg
Croatian: OSNOVNI PODACI KOJI SE MORAJU NALAZITI NA BLISTERIMA ILI TRAKAMA PIPETA (625 mg)
English: AUTHORISATION
Croatian: PRIMJENE
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARDBOARD CARTON 625 mg
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU KARTONSKA KUTIJA (625 mg)
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product not subject to prescription
Croatian: UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE
English: PACKAGE LEAFLET: Prac-tic spot-on solution for dogs
Croatian: UPUTA O VMP: Prac-tic spot-on otopina za pse
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) 137.5 mg
Croatian: BLISTER (137,5 mg)
English: EU/2/06/066/011 (6 pipettes)
Croatian: EU/2/06/066/011 (6 pipeta)
English: MATERIALS, IF ANY
Croatian: SERIJE U PROMET, AKO JE RAZLIČITO
English: EU/2/06/066/012 (30 pipettes)
Croatian: EU/2/06/066/012 (30 pipeta)
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/066/010 (3 pipettes)
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/06/066/010 (3 pipete)
English: Dosage Table
Croatian: Tablica doziranja
English: EU/2/06/066/008 (6 pipettes)
Croatian: EU/2/06/066/008 (6 pipeta)
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/066/001 (3 pipettes)
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/06/066/001 (3 pipete)
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/066/007 (3 pipettes)
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/06/066/007 (3 pipete)
English: PHARMACEUTICAL FORM Spot-on solution for external application to the skin
Croatian: OBLIK Spot-on otopina za vanjsku primjenu na koži.
English: EU/2/06/066/009 (30 pipettes)
Croatian: EU/2/06/066/009 (30 pipeta)
English: EU/2/06/066/002 (6 pipettes)
Croatian: EU/2/06/066/002 (6 pipeta)
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/066/004 (3 pipettes)
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/06/066/004 (3 pipete)
English: EU/2/06/066/005 (6 pipettes)
Croatian: EU/2/06/066/005 (6 pipeta)
English: EU/2/06/066/003 (30 pipettes)
Croatian: EU/2/06/066/003 (30 pipeta)
English: EU/2/06/066/006 (30 pipettes)
Croatian: EU/2/06/066/006 (30 pipeta)
English: Unit dose Pyriprole
Croatian: Jedinična doza
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION For spot-on use for external application to the dog's skin.
Croatian: NAČIN I PUT(EVI) PRIMJENE Spot-on otopina za vanjsku primjenu na koži.
English: Do not give this medicine to children and adolescents below 18 years of age.
Croatian: Nemojte davati ovaj lijek djeci i adolescentima mlađima od 18 godina.
English: → Talk to your doctor immediately.
Croatian: Odmah se obratite se svom liječniku.
English: This study should be conducted according to an agreed protocol.
Croatian: To ispitivanje treba provesti u skladu s dogovorenim protokolom.
English: very rare (<1/10,000) and not known (cannot be estimated from the available data).
Croatian: vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: The trial was composed of three discrete periods:
Croatian: Ispitivanje se sastojalo od tri zasebna razdoblja:
English: The relevance of this effect for human pregnancy and lactation remains unknown.
Croatian: Važnost ovog učinka za ljudsku trudnoću i dojenje i dalje je nepoznata.
English: Results are similar to the adult population (≥18 to 65 years of age), however no definite conclusions can be drawn.
Croatian: Rezultati su slični onima u populaciji odraslih (≥18 do 65 godina), no ne mogu se donijeti konačni zaključci.
English: If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Croatian: Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svojem liječniku za savjet prije nego uzmete ovaj lijek.
English: Do not drive or use machines after you have been given Trogarzo if you do not feel well enough.
Croatian: Nemojte voziti ili upravljati strojevima nakon što ste dobili Trogarzo ako se ne osjećate dovoljno dobro.
English: Single use only.
Croatian: Samo za jednokratnu uporabu.
English: Typically, such reactions have been observed within the first few weeks or months of initiation of cART.
Croatian: Obično se takve reakcije primijete unutar prvih nekoliko tjedana ili mjeseci liječenja kART-om.
English: Trial TMB-301
Croatian: Ispitivanje TMB-301
English: Rashes were common.
Croatian: Osipi su bili česti.
English: If you are breast-feeding, or thinking about breast-feeding:
Croatian: Ako dojite ili razmišljate o dojenju:
English: Trial TNX-355.03
Croatian: Ispitivanje TNX-355.03
English: The bioavailability is 100% by definition.
Croatian: Prema definiciji, bioraspoloživost iznosi 100 %.
English: ATC code: J05AX23
Croatian: ATK oznaka: J05AX23
English: This is less likely if you receive Trogarzo regularly and without gaps in treatment.
Croatian: To je manje vjerojatno ako Trogarzo primate redovito i bez prekida u liječenju.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Croatian: Zbog nedostatka ispitivanja kompatibilnosti, ovaj lijek ne smije se miješati s drugim lijekovima, osim onih navedenih u dijelu 6.6.
English: • It is very important that you are given Trogarzo every 2 weeks as instructed by your doctor.
Croatian: • Vrlo je važno da primate lijek Trogarzo svaka dva tjedna, prema uputama liječnika.
English: Patients in all three arms also received an OBR.
Croatian: Bolesnici u svim trima skupinama također su primili OBR.
English: Your immune system might get stronger and begin to fight infections that have been hidden in your body for a long time (this is called ‘immune reconstitution inflammatory syndrome').
Croatian: Vaš imunosni sustav može ojačati i početi se boriti protiv infekcija koje su dugo vremena bile prikrivene u Vašem tijelu (to se naziva „upalni sindrom imunosne rekonstitucije”).
English: Trogarzo is used in combination with other medicines.
Croatian: Trogarzo se primjenjuje u kombinaciji s drugim lijekovima.
English: Resistance With INSTI resistance Without INSTI resistance OSS
Croatian: S rezistencijom na INSTI Bez rezistencije na INSTI OSS
English: Do not change the schedule of your Trogarzo infusions or any of your other antiretroviral medicines without talking to your doctor first.
Croatian: • Nemojte mijenjati raspored Vaših infuzija lijeka Trogarzo ili bilo kojeg drugog antiretrovirusnog lijeka bez prethodnog razgovora sa svojim liječnikom.
English: This will reduce the amount of virus in your body, and keeps it at a low level.
Croatian: Na taj se način smanjuje količina virusa u Vašem tijelu i održava na niskoj razini.
English: Talk to your doctor or nurse about how to avoid infecting other people.
Croatian: Razgovarajte sa svojim liječnikom ili medicinskom sestrom o tome kako izbjeći prenošenje infekcije na druge osobe.
English: If you are not sure, talk to your doctor or nurse before being given Trogarzo.
Croatian: Ako niste sigurni, obratite se liječniku ili medicinskoj sestri prije nego primite Trogarzo.
English: Date of first authorisation: {DD month YYYY}
Croatian: Datum prvog odobrenja: {DD mjesec GGGG}
English: Ibalizumab is active against HIV-1 group M isolates (subtypes A, B, C, D, E, or O).
Croatian: Ibalizumab djeluje protiv izolata HIV-1 skupine M (podtipovi A, B, C, D, E ili O).
English: The elimination is nonlinear and concentration-dependent.
Croatian: Eliminacija je nelinearna i ovisi o koncentraciji.
English: Injury, poisoning and procedural complications contusion
Croatian: Ozljede, trovanja i proceduralne komplikacije kontuzija
English: Your doctor or nurse will monitor you during the Trogarzo infusion and for a period of time after your infusion.
Croatian: Vaš liječnik ili medicinska sestra nadzirat će Vas tijekom infuzije lijeka Trogarzo i neko vrijeme nakon infuzije.
English: This is a type of protein called a ‘monoclonal antibody' that can attach to a specific target in the body.
Croatian: To je vrsta proteina zvana „monoklonsko antitijelo”, a može se vezati za određenu ciljnu tvar u tijelu.
English: Allergic reaction (hypersensivity).
Croatian: • Alergijska reakcija (preosjetljivost).
English: 4 vials (5.32 mL)
Croatian: 4 bočice (5,32 ml)
English: Standard supportive measures should be applied as required, including monitoring of vital signs as well as observation of the clinical status of the patient.
Croatian: Prema potrebi treba primijeniti standardne potporne mjere, uključujući praćenje vitalnih znakova kao i promatranje kliničkog statusa bolesnika.
English: End of control period End of functional monotherapy period
Croatian: Kraj kontrolnog razdoblja Kraj razdoblja funkcionalne monoterapije
English: Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama nedostatna su u pogledu reproduktivne toksičnosti (vidjeti dio 5.3).
English: Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti, nuspojave su prikazane redoslijedom prema sve manjoj ozbiljnosti.
English: The body weight range was very narrow in the population PK model, and the impact of body weight may not be precisely estimated.
Croatian: Raspon tjelesne težine bio je vrlo uzak u populacijskom farmakokinetičkom modelu i moguće je da utjecaj tjelesne težine nije precizno procijenjen.
English: Prophylactic medication is not warranted prior to each infusion.
Croatian: Nije potrebna primjena profilaktičkih lijekova prije svake infuzije.
English: The safety and efficacy of ibalizumab in children under the age of 18 years have not yet been established.
Croatian: Sigurnost i djelotvornost ibalizumaba u djece mlađe od 18 godina nisu još ustanovljene.
English: It is recommended that women of childbearing potential use an effective method of contraception during treatment.
Croatian: Ženama u reproduktivnoj dobi preporučuje se da tijekom liječenja koriste učinkovitu metodu kontracepcije.
English: Look out for new signs of infection after receiving Trogarzo; these can be different from person to person depending on the type of infection that was hidden and might include fever, headache, difficulty breathing, stomach ache, coughing and swollen glands (lumps and bumps on your body, neck, armpit or groin).
Croatian: Pripazite na nove znakove infekcije nakon što ste primili Trogarzo; one se mogu razlikovati od osobe do osobe, ovisno o vrsti infekcije koja je bila skrivena i mogu uključivati vrućicu, glavobolju, otežano disanje, bolove u trbuhu, kašljanje i natečene žlijezde (kvržice i izbočine na Vašem tijelu, vratu, pazuhu ili preponama).
English: If you could get pregnant while taking Trogarzo, you need to use a reliable method of barrier contraception (for example, a condom) with other methods of contraception including oral contraceptive (the pill) or other hormonal contraceptives (for example, implants or injections), to prevent pregnancy.
Croatian: Ako biste mogli zatrudnjeti dok primate lijek Trogarzo, morate primjenjivati pouzdanu metodu barijerne kontracepcije (na primjer kondom) uz druge metode kontracepcije, uključujući oralne kontraceptive (pilula) ili druge hormonske kontraceptive (na primjer implantate ili injekcije) da biste spriječili trudnoću.
English: If you stop and there is a gap in your treatment, the level of HIV virus in your blood may begin to rise.
Croatian: Ako prestanete i tako dođe do prekida u Vašem liječenju, razina virusa HIV-a u Vašoj krvi može početi rasti.
English: 10 vials (13.3 mL)
Croatian: 10 bočica (13,3 ml)
English: This helps your body to increase the CD4 cell count in your blood.
Croatian: To pomaže Vašem tijelu da poveća broj CD4 stanica u krvi.
English: • If you miss an appointment, ask your doctor straight away when to schedule your next dose.
Croatian: • Ako propustite infuziju, odmah upitajte liječnika kada možete dogovoriti primjenu sljedeće doze.
English: HIV-RNA (copies/mL)
Croatian: HIV-RNK (kopija/ml)
English: Toxicity to reproduction and development
Croatian: Reproduktivna i razvojna toksičnost
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU-a (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: Human immunoglobulin (IgG) is known to cross the placental barrier.
Croatian: Poznato je da ljudski imunoglobulin (IgG) prelazi placentnu barijeru.
English: Maintenance dose of 800 mg
Croatian: Doza održavanja od 800 mg
English: The results suggest that ibalizumab concentration decreases as body weight increases.
Croatian: Rezultati ukazuju na to da se koncentracija ibalizumaba smanjuje kako se tjelesna težina povećava.
English: Trogarzo can cause serious side effects that you need to tell your doctor or nurse about straight away.
Croatian: Trogarzo može uzrokovati ozbiljne nuspojave o kojima morate odmah obavijestiti svog liječnika ili medicinsku sestru.
English: Patients experiencing these symptoms should be advised to use caution when driving or using machines until symptoms abate.
Croatian: Bolesnicima s tim simptomima treba savjetovati oprez pri vožnji ili radu sa strojevima dok se simptomi ne smire.
English: Demonstrating drug susceptibility by both genotypic and phenotypic testing was required, when testing by both methods was technically feasible.
Croatian: Bilo je potrebno dokazati osjetljivost na lijek genotipskim i fenotipskim testiranjem, kada je testiranje objema metodama bilo tehnički izvedivo.
English: This behaviour is characteristic of saturable (capacity-limited) elimination kinetics.
Croatian: Takvo ponašanje karakteristično je za kinetiku eliminacije koja podliježe zasićenju (ograničenog kapaciteta).
English: While effective viral suppression with antiretroviral therapy has been proven to substantially reduce the risk of sexual transmission, a residual risk cannot be excluded.
Croatian: Iako je dokazano da djelotvorna virusna supresija antiretrovirusnom terapijom značajno smanjuje rizik od prijenosa spolnim putem, rezidualni rizik ne može se isključiti.
English: It is also active against HIV-1 resistant to currently approved antiretroviral medicinal products and exhibits antiretroviral activity against R5-tropic, X4-tropic, and dual-tropic HIV-1.
Croatian: Također djeluje protiv virusa HIV-1 otpornog na trenutačno odobrene antiretrovirusne lijekove i pokazuje antiretrovirusnu aktivnost protiv R5-tropnih, X4-tropnih i dvostruko tropnih virusa HIV-1.
English: The following information is intended for healthcare professionals only:
Croatian: Sljedeće informacije namijenjene su samo zdravstvenim radnicima: Način primjene
English: Patients in Arm A and B arm who experienced virologic failure had the option of switching to a new OBR.
Croatian: Bolesnici u skupinama A i B koji su doživjeli virološki neuspjeh imali su mogućnost prelaska na novi OBR.
English: The volume of distribution of ibalizumab is approximately 4.8 L, which is comparable with vascular space, based on the performed population pharmacokinetics analysis.
Croatian: Volumen distribucije ibalizumaba je približno 4,8 l, što je usporedivo s krvožilnim prostorom, na temelju provedene populacijske farmakokinetičke analize.
English: Subjects must have been treated with antiretrovirals for at least 6 months and be failing or had recently failed therapy (i.e., in the last 8 weeks).
Croatian: Ispitanici su prethodno morali biti liječeni antiretrovirusnim lijekovima najmanje šest mjeseci bez uspjeha ili imati terapijski neuspjeh koji je nedavno utvrđen (tj. u posljednjih osam tjedana).
English: Laboratory abnormalities
Croatian: Laboratorijske abnormalnosti
English: The use of an investigational drug as a component of the optimized background regimen was allowed.
Croatian: Dopuštena je primjena ispitivanog lijeka kao komponente optimiziranog osnovnog režima.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1359/001
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/1/19/1359/001
English: Pharmacotherapeutic group: Antivirals for systemic use, other antivirals.
Croatian: Farmakoterapijska skupina: Antivirotici za sistemsku primjenu, ostali antivirotici.
English: However, the effect is unlikely to impact virologic outcome and does not warrant a dose adjustment.
Croatian: Međutim, malo je vjerojatno da će učinak utjecati na virološki ishod te nije razlog za prilagodbu doze.
English: Your doctor has prescribed Trogarzo to help control your HIV infection.
Croatian: Vaš liječnik Vam je propisao lijek Trogarzo kako bi Vam pomogao u kontroli infekcije virusom
English: Non-clinical data reveal no special hazard for humans based on conventional studies of in vitro and in vivo safety assessments.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih in vitro i in vivo ispitivanja za procjenu sigurnosti.