FrancophonIA/ELRC3.0 huggingface dataset:
English: Velaglucerase alfa increases haemoglobin concentration and platelet counts and reduces liver and spleen volumes in patients with type 1 Gaucher disease.
Croatian: Velagluceraza alfa povećava koncentraciju hemoglobina i broj trombocita te smanjuje volumen jetre i slezene kod bolesnika s Gaucherovom bolešću tipa 1.
English: These treatment effects on haemoglobin, platelet count, organ volumes, bone mineral density and height were maintained through the end of the study.
Croatian: Ti su učinci liječenja na hemoglobin, broj trombocita, volumen organa, mineralnu gustoću kostiju i visinu održani do kraja liječenja.
English: The safety profile of VPRIV in clinical studies involving patients aged 65 years and above was similar to that observed in other adult patients.
Croatian: Profil sigurnosti VPRIV-a u kliničkim ispitivanjima koja su obuhvaćala bolesnike starosti 65 godina i više bio je sličan onome u drugih odraslih bolesnika.
English: Improvement from baseline in mean lumbar spine and femoral neck bone mineral density (BMD) Z-scores were observed at month 24 (0.4; 95% CI 0.1, 0.7) and month 33 (0.4; 95% CI 0.2, 0.6), respectively.
Croatian: Poboljšanja u odnosu na početnu vrijednost u srednjim Z-rezultatima mineralne gustoće kostiju (BMD, engl. bone mineral density) lumbalne kralježnice uočena su u 24. mjesecu (0,4; 95% CI 0,1; 0,7), odnosno vrata femura u 33. mjesecu (0,4; 95% CI 0,2; 0,6).
English: Paediatric subjects who switched from long-term imiglucerase to velaglucerase alfa in study 034 had greater mean height Z-scores at baseline and their mean height Z-scores remained stable over time.
Croatian: Pedijatrijski ispitanici koji su prešli s dugotrajnog liječenja imiglucerazom na velaglucerazu alfa u ispitivanju 034 imali su veći srednji Z-rezultat visine na početku ispitivanju i njihovi srednji Z-rezultati visine ostali su stabilni tijekom vremena.
English: Velaglucerase alfa 60 Units/kg given intravenously every other week demonstrated clinically meaningful increases from baseline in mean haemoglobin concentration (+2.4 g/dl) and platelet count (+50.9 x 10
Croatian: Velagluceraza alfa od 60 jedinica/kg dana intravenski svaki drugi tjedan pokazala je klinički značajan porast u odnosu na početnu vrijednost srednje vrijednosti koncentracije hemoglobina (+2,4 g/dl) i broja trombocita (+50,9 x 10
English: The data described below reflect exposure of 94 patients with type 1 Gaucher disease who received velaglucerase alfa at doses ranging from 15 to 60 Units/kg every other week in 5 clinical studies.
Croatian: Niže opisani podaci dobiveni su na temelju izloženosti 94 bolesnika s Gaucherovom bolešću tipa 1 velaglucerazi alfa u dozama u rasponu od 15 do 60 jedinica/kg svaki drugi tjedan u 5 kliničkih ispitivanja.
English: Due to the risk for hypersensitivity reactions including anaphylaxis appropriate medical support, including adequately trained personnel in emergency measures, should be readily available when velaglucerase alfa is administered.
Croatian: Zbog rizika od reakcija preosjetljivosti uključujući anafilaksiju, tijekom primjene velagluceraze alfa treba biti brzo dostupna odgovarajuća medicinska potpora, uključujući osoblje koje je primjereno uvježbano u primjeni hitnih mjera.
English: VPRIV has no or negligible influence on the ability to drive or use machines.
Croatian: VPRIV ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: These are called infusion related reactions and might appear as a hypersensitivity reaction with symptoms like nausea, rash, difficulty in breathing, back pain, chest discomfort (chest tightness), hives, joint pain or headache.
Croatian: Te se nuspojave nazivaju reakcije povezane s infuzijom, a mogu izgledati kao reakcije preosjetljivosti i imati simptome kao što su mučnina, osip, otežano disanje, bol u leđima, nelagoda u prsima (stezanje u prsima), koprivnjača, bol u zglobovima ili glavobolja.
English: Clinical studies have evaluated doses ranging from 15 to 60 Units/kg every other week.
Croatian: Klinička ispitivanja ocijenila su doze u rasponu od 15 do 60 jedinica/kg svaki drugi tjedan.
English: Prior to dilution, visually inspect the solution in the vials; the solution should be clear to slightly opalescent and colourless; do not use if the solution is discoloured, or if foreign particulate matter is present.
Croatian: Prije razrjeđivanja, vizualno pregledajte otopinu u bočicama; otopina treba biti bistra do lagano opalescentna i bezbojna; nemojte koristiti ako je otopina promijenila boju ili ako su prisutne vidljive čestice.
English: Discard any unused solution.
Croatian: Neiskorištenu otopinu odbacite.
English: Study in patients switching from imiglucerase treatment to VPRIV Study 034 was a 12-month, open-label safety study in 40 patients aged 2 years and older who had been receiving treatment with imiglucerase at doses ranging from 15 to 60 Units/kg for a minimum of 30 consecutive months.
Croatian: Ispitivanje na bolesnicima koji su prešli s liječenja imiglucerazom na VPRIV Ispitivanje 034 bilo je 12-mjesečno, otvoreno ispitivanje sigurnosti na 40 bolesnika u dobi od 2 godine i starijim koji su primali terapiju imiglucerazom u dozama u rasponu od 15 do 60 jedinica/kg kroz najmanje 30 mjeseci zaredom.
English: Extractable volume
Croatian: Volumen koji se može izvući
English: Prior to further dilution, the solution in the vials should be visually inspected; the solution should be clear to slightly opalescent and colourless; the solution should not be used if it is discoloured or if foreign particulate matter is present.
Croatian: Prije dodatnog razrjeđivanja, potrebno je vizualno pregledati otopinu u bočicama; otopina treba biti bistra do lagano opalescentna i bezbojna; otopina se ne smije koristiti ako je promijenila boju ili ako su prisutne vidljive čestice.
English: Clinically meaningful improvements from baseline were observed in haemoglobin concentration and platelet counts as early as 3 months and in liver and spleen volumes at both 6 months and 9 months following the initiation of treatment with velaglucerase alfa.
Croatian: Klinički značajno poboljšanje u odnosu na početno stanje bilo je zabilježeno u koncentraciji hemoglobina i broju trombocita već nakon 3 mjeseca, a u volumenu jetre i slezene nakon 6 i 9 mjeseci od početka liječenja velaglucerazom alfa.
English: Other medicines and VPRIV
Croatian: Drugi lijekovi i VPRIV
English: Studies in treatment naïve patients
Croatian: Ispitivanja na prethodno neliječenim bolesnicima
English: Patients transferring from a dose of <15 Units/kg imiglucerase were administered 15 Units/kg of velaglucerase alfa.
Croatian: Bolesnici koji su prešli s doze od <15 jedinica/kg imigluceraze primili su 15 jedinica/kg velagluceraze alfa.
English: No patients were classified at a more severe WHO classification of bone density compared to baseline.
Croatian: Nijedan od bolesnika nije bio klasificiran po strožoj klasifikaciji SZO za gustoću kostiju u usporedbi s početnim vrijednostima.
English: • Annex: Package Leaflet, Infusion diary, Patient Reconstitution Guide, Emergency plan.
Croatian: • prilog: uputa o lijeku, dnevnik infuzija, upute za pripremu lijeka namijenjene bolesniku, plan postupanja u hitnim situacijama.
English: Deposits in the bone marrow and splenic sequestration lead to clinically significant anaemia and thrombocytopenia.
Croatian: Nakupine u koštanoj srži te sekvestracija u slezeni dovode do klinički značajne anemije i trombocitopenije.
English: Patients transferring from imiglucerase were administered velaglucerase alfa infusions every other week at the same number of units as imiglucerase within the range of 15 to 60 Units/kg.
Croatian: Bolesnici koji su prešli s imigluceraze primili su infuzije velagluceraze alfa svakog drugog tjedna s istim brojem jedinica kao i imigluceraze u rasponu od 15 do 60 jedinica/kg.
English: VPRIV contains a substance called velaglucerase alfa which is designed to replace the missing or defective enzyme, glucocerebrosidase, in patients with Gaucher disease.
Croatian: VPRIV sadrži tvar koja se naziva velagluceraza alfa koja je namijenjena zamjeni glukocerebrozidaze, enzima koji nedostaje ili je oštećen, kod bolesnika s Gaucherovom bolešću.
English: In patients who switched from imiglucerase to velaglucerase alfa, haemoglobin concentrations and platelet counts were sustained at therapeutic levels through 12 months of treatment.
Croatian: Kod bolesnika koji su prešli s imigluceraze na velaglucerazu alfa, održani su koncentracija hemoglobina i broj trombocita na terapijskoj razini kroz 12 mjeseci liječenja.
English: The total volume required is diluted in 100 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion.
Croatian: Ukupni potrebni volumen razrjeđuje se u 100 ml 0,9%-tne (9 mg/ml) otopine natrijeva klorida za infuziju.
English: Powder for solution for infusion 25 vials
Croatian: Prašak za otopinu za infuziju 25 bočica
English: Adverse drug reactions derived from post-marketing reports other than interventional clinical trials are printed in italics.
Croatian: Nuspojave koje potječu iz prijava nakon stavljanja lijeka u promet, a ne iz intervencijskih kliničkih ispitivanja, otisnute su u kurzivu.
English: VPRIV is supplied in a vial as a packed powder which is mixed with sterile water and further diluted in sodium chloride 9 mg/ml (0.9%) solution prior to intravenous infusion.
Croatian: VPRIV se nalazi u bočici kao upakirani prašak koji se prije intravenske infuzije otapa u sterilnoj vodi i dalje razrjeđuje u otopini natrijeva klorida od 9 mg/ml (0,9%).
English: Vascular disorders hypertension, hypotension, flushing
Croatian: Krvožilni poremećaji hipertenzija, hipotenzija, crvenilo uz osjećaj vrućine
English: The calculated volume of medicinal product is withdrawn from the appropriate number of vials and the total volume required is diluted in 100 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion.
Croatian: Izračunati volumen lijeka izvlači se iz odgovarajućeg broja bočica te se ukupni potrebni volumen razrjeđuje u 100 ml 0,9%-tne (9 mg/ml) otopine natrijeva klorida za infuziju.
English: Each vial is reconstituted using sterile water for injections:
Croatian: Svaka se bočica priprema za primjenu sa sterilnom vodom za injekcije: Veličina bočice
English: In this small, exploratory study, the non-neurological efficacy findings and the safety profile of intravenous velaglucerase alfa in type 3 Gaucher patients were consistent with those observed in patients with type 1 Gaucher disease.
Croatian: Podaci o djelotvornosti izvan neuroloških manifestacija i sigurnosni profil intravenski primijenjene velagluceraze alfa u bolesnika s Gaucherovom bolešću tipa 3 dobiveni u tom malom eksplorativnom ispitivanju podudarali su se s onima opaženima u bolesnika s Gaucherovom bolešću tipa 1.
English: All patients received at least 2 years of ERT and were followed for a mean of 4.5 years (min. 2.3 years, max 5.8 years).
Croatian: Svi su bolesnici primali najmanje 2 godine enzimsko nadomjesno liječenje i bili su praćeni prosječno 4,5 godina (min.
English: Description of selected adverse reactions Vomiting
Croatian: Opis odabranih nuspojava
English: VPRIV 400 Units powder for solution for infusion velaglucerase alfa
Croatian: VPRIV 400 jedinica prašak za otopinu za infuziju velagluceraza alfa
English: VIAL - 400 UNITS
Croatian: BOČICA - 400 JEDINICA
English: It is for single-use only and is administered through a 0.22 µm filter.
Croatian: Isključivo je za jednokratnu primjenu te se primjenjuje kroz filtar od 0,22 µm.
English: - Apart from symptoms of hypersensitivity reactions infusion-related reactions might show as dizziness, high blood pressure, tiredness, fever, itching, or blurry vision.
Croatian: - Osim simptoma reakcija preosjetljivosti, reakcije povezane s infuzijom mogu se očitovati kao omaglica, visok krvni tlak, umor, vrućica, svrbež ili zamagljen vid.
English: In this study, haemoglobin concentration, platelet count, liver volume and spleen volume were assessed in treatment-naïve patients after 24 months of treatment.
Croatian: U tom ispitivanju procijenjene su koncentracija hemoglobina, broj trombocita, volumen jetre i slezene nakon 24 mjeseca liječenja u bolesnika koji nisu prethodno bili liječeni.
English: Study 039 was a 9-month, randomized, double-blind, non-inferiority, active-comparator (imiglucerase) controlled, parallel-group efficacy study in 34 patients aged 2 years and older who were naïve to ERT (defined as having not been treated with ERT for at least 12 months prior to study entry).
Croatian: Ispitivanje 039 bilo je 9-mjesečno, randomizirano, dvostruko slijepo, neinferiornog dizajna, aktivnokontrolirano (imiglucerazom) ispitivanje djelotvornosti na paralelnim skupinama od 34 bolesnika u dobi od 2 godine i starijim koji nisu bili liječeni enzimskom nadomjesnom terapijom (definirano kao neuzimanje enzimske nadomjesne terapije barem 12 mjeseci prije uključenja u ispitivanje).
English: Meaningful increases from baseline were observed in the 45 Units/kg dose group in haemoglobin concentration (+2.4 g/dl) and platelet count (+40.9 x 10
Croatian: Značajan porast od početne vrijednosti bio je primijećen u skupini koja je primala dozu od 45 jedinica/kg u koncentraciji hemoglobina (+2,4 g/dl) i broju trombocita (+40,9 x 10
English: OUTER CARTON - 400 UNITS (25 vial pack)
Croatian: VANJSKO PAKIRANJE - 400 JEDINICA (pakiranje s 25 bočica)
English: Haemoglobin concentration (g/dL) Platelet count (x 10
Croatian: Koncentracija hemoglobina (g/dl) Broj trombocita (x 109/l)
English: VPRIV is a powder for solution for infusion.
Croatian: VPRIV je prašak za otopinu za infuziju.
English: For intravenous infusion use only.
Croatian: Samo za primjenu u obliku intravenske infuzije.
English: VPRIV 400 Units powder for solution for infusion
Croatian: VPRIV 400 jedinica prašak za otopinu za infuziju
English: Patients were randomized to receive velaglucerase alfa at a dose of either 45 Units/kg (N=13) or 60 Units/kg (N=12) every other week.
Croatian: Bolesnici su bili randomizirani na primanje velagluceraze alfa u dozi od 45 jedinica/kg (N=13) ili 60 jedinica/kg (N=12) svaki drugi tjedan.
English: VPRIV is for single-use only and is administered through a 0.22 µm filter.
Croatian: VPRIV je isključivo za jednokratnu primjenu i primjenjuje se kroz filtar od 0,22 µm.
English: Patients received either 60 Units/kg of velaglucerase alfa (N=17) or 60 Units/kg of imiglucerase (N=17) every other week.
Croatian: Bolesnici su primili ili velaglucerazu alfa od 60 jedinica/kg (N=17) ili imiglucerazu od 60 jedinica/kg (N=17) svaki drugi tjedan.
English: One vial contains 400 Units of velaglucerase alfa.
Croatian: Jedna bočica sadržava 400 jedinica velagluceraze alfa.
English: Gastrointestinal disorders abdominal pain/abdominal pain upper,
Croatian: Poremećaji probavnog sustava bol u abdomenu/ bol u gornjem dijelu abdomena mučnina povraćanje
English: One vial contains 400 Units* of velaglucerase alfa**.
Croatian: Jedna bočica sadržava 400 jedinica* velagluceraze alfa**.
English: OUTER CARTON - 400 UNITS (5 vial pack)
Croatian: VANJSKO PAKIRANJE - 400 JEDINICA (pakiranje s 5 bočica)
English: Sodium citrate dihydrate
Croatian: saharoza natrijev citrat dihidrat citratna kiselina hidrat polisorbat 20
English: Apart from symptoms associated with hypersensitivity reactions IRRs might show as fatigue, dizziness, pyrexia, blood pressure increase, pruritus, or vision blurred.
Croatian: Osim simptoma povezanih s reakcijama preosjetljivosti, reakcije povezane s infuzijom mogu se očitovati kao umor, omaglica, pireksija, povišenje krvnog tlaka, pruritus ili zamagljen vid.
English: Powder for solution for infusion 5 vials
Croatian: Prašak za otopinu za infuziju 5 bočica
English: Study 025 was a 9 month, open-label study in 12 adult (≥18 years) patients who were naïve to ERT (defined as having not been treated with ERT for at least 12 months prior to study entry).
Croatian: Ispitivanje 025 bilo je devetomjesečno, otvoreno ispitivanje na 12 odraslih bolesnika (≥18 godina) koji nisu bili liječeni enzimskom nadomjesnom terapijom (što je bilo definirano tako da nisu bili liječeni enzimskom nadomjesnom terapijom barem 12 mjeseci prije ulaska u ispitivanje).
English: Close monitoring of the pregnancy and clinical manifestations of Gaucher disease is necessary for the individualisation of therapy.
Croatian: Da bi terapija bila prilagođena pojedinoj bolesnici, potrebno je pažljivo pratiti trudnoću i kliničke manifestacije Gaucherove bolesti.
English: • Annex: SmPC; Healthcare Professional Reconstitution Guide, Infusion diary
Croatian: • prilog: sažetak opisa svojstava lijeka; upute za pripremu lijeka namijenjene zdravstvenim radnicima, dnevnik infuzija.
English: See section 5.1 for further information.
Croatian: Dodatne informacije potražite u dijelu 5.1.
English: The most frequently reported symptoms of hypersensitivity include nausea, rash, dyspnoea, back pain, chest discomfort (including chest tightness), urticaria, arthralgia, and headache.
Croatian: Najčešće zabilježeni simptomi preosjetljivosti uključuju mučninu, osip, dispneju, bol u leđima, nelagodu u prsištu (uključujući stezanje u prsištu), urtikariju, artralgiju i glavobolju.
English: After reconstitution, one ml of the solution contains 100 Units of velaglucerase alfa.
Croatian: Nakon rekonstitucije, jedan ml otopine sadržava 100 jedinica velagluceraze alfa.
English: Prepare VPRIV as follows:
Croatian: Pripremite VPRIV na sljedeći način:
English: VPRIV is a long-term enzyme replacement therapy (ERT) for patients with type 1 Gaucher disease.
Croatian: VPRIV je dugoročna nadomjesna enzimska terapija za bolesnike s Gaucherovom bolešću tipa 1.
English: Similar results were seen in treatment-naïve patients who received 9 months of imiglucerase followed by velaglucerase alfa for 15 months.
Croatian: Slični rezultati primijećeni su u bolesnika koji nisu prethodno bili liječeni, a koji su dobivali imiglucerazu tijekom 9 mjeseci, a nakon toga velaglucerazu alfa tijekom 15 mjeseci.
English: Study 032 was a 12-month, randomized, double-blind, parallel-group efficacy study in 25 patients aged 2 years and older who were naïve to ERT (defined as having not been treated with ERT for at least 30 months prior to study entry).
Croatian: Ispitivanje 032 bilo je 12-mjesečno, randomizirano, dvostruko slijepo, ispitivanje djelotvornosti s paralelnim skupinama od 25 bolesnika u dobi od 2 godine i starijim koji nisu bili liječeni enzimskom nadomjesnom terapijom (definirano kao neuzimanje enzimske nadomjesne terapije barem 30 mjeseci prije uključenja u ispitivanje).
English: There are no data from studies in breast-feeding women.
Croatian: Za dojilje ne postoje podaci iz ispitivanja.
English: The mean absolute increase from baseline in haemoglobin concentrations was 1.624 g/dl (±0.223 SE) following 9 months of treatment with velaglucerase alfa.
Croatian: Srednja vrijednost apsolutnog porasta u odnosu na početnu vrijednost koncentracije hemoglobina nakon 9 mjeseci liječenja velaglucerazom alfa bila je 1,624 g/dl (±0,223 SE).
English: VPRIV contains sodium
Croatian: VPRIV sadržava natrij
English: How to store VPRIV
Croatian: Kako primjenjivati VPRIV
English: Musculoskeletal and connective tissue disorders bone pain, arthralgia, back pain
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva bol u kostima, bol u zglobovima, bol u leđima
English: OUTER CARTON - 400 UNITS (single vial pack)
Croatian: VANJSKO PAKIRANJE - 400 JEDINICA (pakiranje s jednom bočicom)
English: In this study, BMD was assessed using dual x-ray absorptiometry of the lumbar spine and femoral neck.
Croatian: U tom je ispitivanju BMD procijenjen primjenom denzitometrije kostiju lumbalne kralježnice i vrata bedrene kosti.
English: • Patient evaluation and selection;
Croatian: • procjena i odabir bolesnika;
English: Posology The recommended dose is 60 Units/kg administered every other week.
Croatian: Doziranje Preporučena doza je 60 jedinica/kg primijenjena svaki drugi tjedan.
English: VPRIV is indicated for long-term enzyme replacement therapy (ERT) in patients with type 1 Gaucher disease.
Croatian: VPRIV je indiciran za dugotrajno enzimsko nadomjesno liječenje bolesnika s Gaucherovom bolešću tipa 1.
English: If anaphylactic or other acute reactions occur, immediately discontinue the infusion and initiate appropriate medical treatment.
Croatian: Ako nastupi anafilaktička ili druga akutna reakcija, infuzija se mora odmah prekinuti i uvesti odgovarajuće medicinsko liječenje (pogledajte dio 4.4).
English: Respiratory, thoracic and mediastinal disorders dyspnea
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja dispneja
English: Appropriate medical support, including adequately trained personnel in emergency measures, should be readily available when velaglucerase alfa is administered.
Croatian: Tijekom primjene velagluceraze alfa treba biti brzo dostupna odgovarajuća medicinska potpora, uključujući osoblje koje je primjereno uvježbano u primjeni hitnih mjera.
English: In this one event, the antibodies were determined to be neutralising in an in vitro assay.
Croatian: U ovom jednom slučaju, pomoću in vitro analize utvrđena su neutralizirajuća protutijela.
English: Table 1: Adverse reactions reported with VPRIV observed in patients with type 1 Gaucher disease Italic text denotes post-marketing event.
Croatian: Tablica 1: Nuspojave zabilježene kod primjene VPRIV-a u bolesnika s Gaucherovom bolešću tipa 1.
English: After reconstitution, one ml of solution contains 100 Units of velaglucerase alfa
Croatian: Nakon pripreme, jedan ml otopine sadržava 100 jedinica velagluceraze alfa.
English: Fifty-four patients were naïve to ERT and 40 patients switched from imiglucerase to VPRIV.
Croatian: Pedeset četiri bolesnika nisu bila liječena enzimskom nadomjesnom terapijom,
English: Dose
Croatian: Nuspojava
English: Infusion-related reaction, asthenia/fatigue, pyrexia/body temperature increased
Croatian: Opći poremećaji i reakcije na mjestu primjene reakcija povezana s infuzijom, astenija/umor, vrućica/povišena tjelesna temperatura nelagoda u prsištu
English: nausea vomiting
Croatian: Povraćanje
English: No dosing adjustment is recommended in patients with renal or hepatic impairment based on current knowledge of the pharmacokinetics and pharmacodynamics of velaglucerase alfa.
Croatian: Na temelju trenutnih saznanja o farmakokinetici i farmakodinamici velagluceraze alfa nije potrebna prilagodba doze kod bolesnika s oštećenjem funkcije bubrega ili jetre.
English: Renal or hepatic impairment
Croatian: Poremećaj funkcije bubrega ili jetre
English: Conditions to the marketing authorisations for Numeta G16%E and associated names
Croatian: Uvjeti odobrenja za stavljanje lijeka u promet
English: Date
Croatian: Prilog V.
English: It is available as an emulsion for injection.
Croatian: Dostupan je kao emulzija za injekciju.
English: In the future, if the animals are exposed to West Nile virus the immune system will be able to respond more quickly.
Croatian: U buduće, ako životinje budu izložene virusu Zapadnog Nila, imunosni sustav može brže odgovoriti.
English: In very rare cases a higher temperature may occur for up to 2 days.
Croatian: U rijetkim slučajevima može doći do prolazne povišene tjelesne temperature u trajanju od najviše dva dana.
English: The vaccine also contains an ‘adjuvant' to enhance the immune response.
Croatian: Cjepivo također sadrži „adjuvans” kako bi se pojačao imunosni odgovor.
English: The first is given from six month of age and the second is given three to five weeks later.
Croatian: Prva se injekcija primjenjuje nakon 6 mjeseci starosti, a druga injekcija tri do pet tjedana kasnije.
English: Equip WNV is a vaccine that contains inactivated (killed) West Nile virus.
Croatian: Equip WNV je cjepivo koje sadrži inaktivirani (ubijeni) virus Zapadnog Nila.
English: The withdrawal period for Equip WNV is zero days.
Croatian: Razdoblje karencije za Equip WNV iznosi nula dana.
English: The vaccine is initially given as two injections into the muscles in the neck.
Croatian: Cjepivo se primarno primjenjuje u dvije injekcije u područje mišića vrata.