FrancophonIA/ELRC3.0 huggingface dataset:
English: The PSUR submission schedule for Clopidogrel Teva Pharma film coated tablets should follow PSURs submission schedule for the reference medicinal product.
Croatian: Raspored predaje periodičkih izvješća o neškodljivosti lijeka za Klopidogrel Teva Pharma treba slijediti onaj za referentni lijek.
English: The number of patients experiencing the primary endpoint [cardiovascular (CV) death, myocardial infarction (MI), or stroke] was 582 (9.3%) in the clopidogrel-treated group and 719 (11.4%) in the placebo-treated group, a 20% relative risk reduction (95% CI of 10%-28%; p=0.00009) for the clopidogrel-treated group (17% relative risk reduction when patients were treated conservatively, 29% when they underwent percutaneous transluminal coronary angioplasty (PTCA) with or without stent and 10% when they underwent coronary artery bypass graft (CABG)).
Croatian: Broj bolesnika koji su doživjeli primarni ishod [kardiovaskularna smrt, infarkt miokarda ili moždani udar] bio je 582 (9,3%) u skupini koja je primala klopidogrel i 719 (11,4%) u skupini koja je primala placebo, uz 20%-tno smanjenje relativnog rizika (95% CI od 10% do 28%; p=0,00009) u skupini koja se liječila klopidogrelom (17% smanjenje relativnoga rizika u bolesnika koji su liječeni konzervativno, 29% u bolesnika podvrgnutih perkutanoj transluminalnoj koronarnoj angioplastici (PTCA) s ili bez ugradnje stenta i 10% za bolesnike kojima je obavljeno aortokoronarno premoštenje (CABG, engl. „Coronary Artery Bypass Graft“).
English: LIST OF EXCIPIENTS It also contains hydrogenated castor oil.
Croatian: Također sadrži hidrogenirano ricinusovo ulje.
English: - ST segment elevation acute myocardial infarction: clopidogrel should be given as a single daily dose of 75 mg initiated with a 300-mg loading dose in combination with ASA and with or without thrombolytics.
Croatian: Akutni infarkt miokarda s elevacijom ST-segmenta: liječenje klopidogrelom provodi se jednom dnevnom dozom od 75 mg, a započinje udarnom dozom od 300 mg u kombinaciji s ASK te s tromboliticima ili bez njih.
English: INFORMATION IN BRAILLE Clopidogrel Teva Pharma 75 mg
Croatian: Klopidogrel Teva Pharma 75 mg
English: Within less than 12 hours after regular scheduled time: patients should take the dose immediately and then take the next dose at the regular scheduled time.
Croatian: Propuštena doza: - Ako je prošlo manje od 12 sati od uobičajenog termina uzimanja lijeka: bolesnik treba odmah uzeti dozu, a sljedeću dozu treba uzeti prema uobičajenom rasporedu.
English: Furthermore, the pharmacodynamic activity of clopidogrel was not significantly influenced by the coadministration of phenobarbital or oestrogen.
Croatian: Nadalje, istodobna primjena fenobarbitala ili estrogena nije značajno utjecala istodobna primjena fenobarbitala ili estrogena.
English: Clopidogrel Teva Pharma 75 mg film-coated tablets Clopidogrel
Croatian: Klopidogrel Teva Pharma 75 mg filmom obložene tablete klopidogrel
English: Do not take Clopidogrel Teva Pharma
Croatian: Nemojte uzimati Klopidogrel Teva Pharma:
English: If you stop taking Clopidogrel Teva Pharma
Croatian: Ako prestanete uzimati Klopidogrel Teva Pharma:
English: How to take Clopidogrel Teva Pharma
Croatian: Kako uzimati Klopidogrel Teva Pharma
English: If you think any of these apply to you, or if you are in any doubt at all, consult your doctor before taking Clopidogrel Teva Pharma.
Croatian: Ako se bilo što od navedenog odnosi na Vas ili ako niste sigurni, obratite se svom liječniku prije uzimanja lijeka Klopidogrel Teva Pharma.
English: NAME OF THE MEDICINAL PRODUCT Clopidogrel Teva Pharma 75 mg film-coated tablets
Croatian: NAZIV LIJEKA Klopidogrel Teva Pharma 75 mg filmom obložene tablete
English: As a precaution, concomitant use of omeprazole or esomeprazole should be discouraged (see section 4.4).
Croatian: Stoga se zbog opreza ne preporučuje istodobna primjena s omeprazolom ili esomeprazolom (vidjeti dio 4.4).
English: If you forget to take Clopidogrel Teva Pharma
Croatian: Ako ste zaboravili uzeti Klopidogrel Teva Pharma:
English: Patients were required to have either ECG changes compatible with new ischaemia or elevated cardiac enzymes or troponin I or T to at least twice the upper limit of normal.
Croatian: Uključujući kriteriji bili su promjene u EKG-u povezane s novom ishemijom ili povećane vrijednosti srčanih enzima, ili troponin
English: How to store Clopidogrel Teva Pharma
Croatian: Kako čuvati Klopidogrel Teva Pharma
English: • if you have a risk of bleeding such as - a medical condition that puts you at risk of internal bleeding (such as a stomach ulcer) - a blood disorder that makes you prone to internal bleeding (bleeding inside any tissues, organs or joints of your body).
Croatian: • Ako postoji opasnost od krvarenja poput - medicinskih stanja kod kojih postoji opasnost od unutrašnjeg krvarenja (kao što je želučani čir), - poremećaja krvi zbog čega ste skloni unutrašnjim krvarenjima (krvarenje u tkivima, organima ili zglobovima), - nedavne teške ozljede, - nedavnog kirurškog zahvata (uključujući stomatološke zahvate), - planiranog kirurškog zahvata (uključujući stomatološke zahvate) u sljedećih sedam dana.
English: There was an excess of intracranial bleeding in the clopidogrel + ASA treatment group compared to the placebo + ASA group (1.4% versus 0.8%, respectively).
Croatian: U skupini klopidogrel + ASK zabilježen je veći broj intrakranijalnih krvarenja u odnosu na skupinu placebo + ASK (1,4% naspram 0,8%).
English: Tel: +44(0) 1977 628500
Croatian: United Kingdom Teva UK Limited Tel: +44(0) 1977 628500
English: In the intention to treat analysis, 939 events were observed in the clopidogrel group and 1,020 events with ASA (relative risk reduction (RRR) 8.7%, [95% CI: 0.2 to 16.4]; p=0.045), which corresponds, for every 1000 patients treated for 2 years, to 10 [CI: 0 to 20] additional patients being prevented from experiencing a new ischaemic event.
Croatian: U analizi ITT (engl. “intention to treat“) zabilježeno je 939 slučajeva u skupini koja je primala klopidogrel, a 1020 u skupini koja je primala ASK (realtivno smanjenje rizika, RRR - engl. relative risk reduction = 8,7% [95% CI: 0,2 do 16,4]; p=0,045), što odgovara broju od dodatnih 10 bolesnika kojima je spriječen novi ishemijski događaj na svakih 1000 bolesnika liječenih 2 godine [CI: 0 do 20]. Analiza ukupne smrtnosti, sekundarnog ishoda studije, nije pokazala značajnu razliku između klopidogrela (5,8%) i ASK (6,0%).
English: Warnings and precautions If any of the situations mentioned below apply to you, you should tell your doctor before taking Clopidogrel Teva Pharma:
Croatian: Ako se na Vas odnosi bilo koje od stanja navedenih u daljnjem tekstu, morate obavijestiti liječnika prije nego što uzmete Klopidogrel Teva Pharma:
English: As a precaution concomitant use of strong or moderate CYP2C19 inhibitors should be discouraged (see sections 4.4 and 5.2).
Croatian: Zbog opreza ne preporučuje se istodobna primjena klopidogrela i lijekova koji su jaki ili umjereni inhibitori CYP2C19 (vidjeti dio 4.4. i 5.2.).
English: However, patients entered into clinical trials with clopidogrel received a variety of concomitant medicinal products including diuretics, beta blockers, ACEI, calcium antagonists, cholesterol lowering agents, coronary vasodilators, antidiabetic agents
Croatian: Međutim, bolesnici koji su sudjelovali u kliničkim ispitivanjima s klopidogrelom istodobno su primali niz lijekova, među kojima su bili diuretici, beta blokatori, ACE inhibitori, antagonisti kalcija, lijekovi za snižavanje kolesterola, koronarni vazodilatatori, antidijabetici (uključujući inzulin), antiepileptici te antagonisti glikoproteina IIb/IIIa, i nisu primijećene klinički značajne štetne interakcije.
English: The ACTIVE-W study demonstrated that anticoagulant treatment with vitamin K antagonists was more effective than with clopidogrel and ASA.
Croatian: Studija ACTIVE-W pokazala je da je antikoagulantna terapija antagonistima vitamina
English: • Tablet coating: Polyvinyl alcohol, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), talc and macrogol 3000.
Croatian: Pomoćne tvari su(vidjeti dio 2. "Klopidogrel Teva Pharma sadrži hidrogenirano ricinusovo ulje"): Jezgra tablete: mikrokristalična celuloza, koloidni, bezvodni silicijev dioksid, krospovidon (tip A), makrogol 6000, hidrogenirano ricinusovo ulje Ovojnica tablete: Poli(vinilni alkohol), titanijev dioksid (E171), crveni željezov oksid (E172), žuti željezov oksid (E172), talk i makrogol 3000.
English: Clopidogrel has no or negligible influence on the ability to drive and use machines.
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Klopidogrel ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Fertility Clopidogrel was not shown to alter fertility in animal studies.
Croatian: U ispitivanjima na životinjama klopidogrel nije utjecao na plodnost.
English: In CLARITY, there was an overall increase in bleeding in the clopidogrel plus ASA group vs. the placebo plus ASA group.
Croatian: U studiji CLARITY uočeno je ukupno povećanje krvarenja u grupi koja je primala klopidogrel uz ASK u odnosu na skupinu koja je uzimala placebo uz ASK.
English: /AG Tel/Tél: +32 3 820 73 73
Croatian: Teva Pharma Belgium N.V./S.A. /AG Tel/Tél: +32 3 820 73 73
English: For minor cuts and injuries e.g., cutting yourself, shaving, this is usually of no concern.
Croatian: Ne trebate biti zabrinuti zbog manjih posjekotina ili ozljeda, primjerice porezotina nastalih tijekom brijanja.
English: In patients with atrial fibrillation, clopidogrel should be given as a single daily dose of 75 mg. ASA (75-100 mg daily) should be initiated and continued in combination with clopidogrel (see section 5.1).
Croatian: Primjenu ASK (75-100 mg na dan) treba započeti i nastaviti je davati u kombinaciji s klopidogrelom (vidjeti dio
English: You should not breast-feed while taking this medicine.
Croatian: Ovaj se lijek ne bi trebao primjenjivati tijekom dojenja.
English: Batch
Croatian: Čet
English: - signs of liver problems such as yellowing of the skin and/or the eyes (jaundice), whether or not associated with bleeding which appears under the skin as red pinpoint dots and/or confusion (see section 2 ‘Warnings and precautions').
Croatian: Odmah se obratite svom liječniku ako primijetite: - vrućicu, znakove infekcije ili teškog umora; ti simptomi mogu biti posljedica rijetkog smanjenja broja nekih krvnih stanica; - znakove oštećenja funkcije jetre kao što su žuta boja kože ili očiju (žutica), bez obzira na to jesu li povezani s krvarenjem koje se pojavljuje kao crvene točkice ispod kože i/ili zbunjenošću (vidjeti dio 2 "Upozorenja i mjere opreza"); - oticanje u ustima ili kožne poremećaje kao što su osip i svrbež te mjehurići na koži; ovi simptomi mogu biti znakovi alergijske reakcije.
English: Fri
Croatian: TVARI
English: EU/1/09/561/009 Cartons of 100 film-coated tablets in OPA/Al/PVC - Al blisters
Croatian: EU/1/09/561/001 Kutije sa 7 filmom obloženih tableta u OPA/Al/PVC - Al blisterima EU/1/09/561/002 Kutije sa 14 filmom obloženih tableta u OPA/Al/PVC - Al blisterima EU/1/09/561/003 Kutije sa 28 filmom obloženih tableta u OPA/Al/PVC - Al blisterima EU/1/09/561/004 Kutije sa 30 filmom obloženih tableta u OPA/Al/PVC - Al blisterima
English: What Clopidogrel Teva Pharma contains
Croatian: Klopidogrel Teva Pharma.
English: Bleeding time prolonged, neutrophil count decreased, platelet count decreased * Information related to clopidogrel with frequency “not known”.
Croatian: Pretrage produljeno vrijeme krvarenja, smanjen broj neutrofila, smanjen broj trombocita
English: Teva Pharma Belgium N.V./S.A.
Croatian: Pharmachemie B.V.
English: The other ingredients are (see section 2 ‘Clopidogrel Teva Pharma contains hydrogenated castor oil'):
Croatian: Klopidogrel Teva Pharma sadrži hidrogenirano ricinusovo ulje
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription.
Croatian: DODATAK II A. PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE LIJEKA U PROMET B. UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU C. OSTALI UVJETI I ZAHTJEVI ZA STAVLJANJE LIJEKA U PROMET D. UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU LIJEKA
English: Pregnancy and breast-feeding It is preferable not to take this medicine during pregnancy.
Croatian: Ne preporučuje se uzimanje lijeka Klopidogrel Teva Pharma za vrijeme trudnoće.
English: - First data-lock point is 30 days later.
Croatian: - Prvo zaključavanje baze je 30 dana kasnije.
English: A-2304 Orth/Donau Austria
Croatian: A-2304 Orth/Donau Austrija
English: CZ-281 63 Kostelec nad Cernymi lesy Czech Republic
Croatian: CZ-281 63 Kostelec nad Cernymi lesy
English: The following information is intended for health care professionals only:
Croatian: Sljedeće informacije namijenjene su samo zdravstvenim djelatnicima:
English: - Reporting to be monthly for the first 6 months.
Croatian: - Izvještavanje će biti mjesečno prvih 6 mjeseci.
English: The Western Blot technique disproves the results.
Croatian: Western Blot tehnika pobija rezultate.
English: The following age groups will be used: < 2 years, 2-8 years, ≥ 9 years.
Croatian: Koristit će se sljedeće dobne skupine: < 2 godine, 2-8 godina, ≥ 9 godina.
English: AESIs will be defined as follows:
Croatian: AESI-i će biti definirani kako slijedi:
English: System Organ Class (SOC)
Croatian: Klasa organskog sustava (SOC)
English: An updated RMP should be submitted:
Croatian: Nadopunjen RMP treba biti dostavljen:
English: • if you have a severe infection with a high temperature (over 38°C).
Croatian: • ako imate tešku infekciju s visokom temperaturom (iznad 38 °C).
English: All control animals succumbed to the infection.
Croatian: Sve su kontrolne životinje podlegle infekciji.
English: Read all of this leaflet carefully, before you are vaccinated because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego što primite cjepivo jer sadrži Vama važne podatke.
English: Pandemic flu is a type of influenza that occurs every few decades and which spreads rapidly to affect most countries and regions around the world.
Croatian: Pandemijska gripa je vrsta influence koja se javlja svakih nekoliko desetljeća i koja svojim brzim širenjem zahvaća većinu država i regija diljem svijeta.
English: Adults, older people and special risk groups
Croatian: Odrasli, starije osobe i posebne rizične skupine
English: Based on the assumption that product name will not be provided in a significant proportion of cases.
Croatian: Na temelju pretpostavke da naziv lijeka neće biti poznat u znatnom broju slučajeva.
English: The vaccine works by helping the body to produce its own protection (antibodies) against the disease.
Croatian: Cjepivo djeluje na način da pomaže tijelu da proizvede vlastitu zaštitu (protutijela) protiv bolesti.
English: Such reactions have happened both in people who have allergies and in those who do not;
Croatian: Takve su se reakcije pojavile i u osoba koje imaju alergije i u onih koje ih nemaju;
English: narrow SMQ “Demyelination” (as GBS is also included in this SMQ, there will be an overlap in the number of cases for these two categories).
Croatian: suženi SMQ “Demijelinizacija” (budući da je GBS također uključen u ovaj SMQ, ovaj SMQ doći će do preklapanja broja slučajeva u ove dvije kategorije).
English: DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 October 2009
Croatian: Datum prvog odobrenja: 16. listopada 2009.
English: - “Cumulatively” means since the use of the vaccine; events not reported during the period of interest should not be presented in the tables.
Croatian: - “Kumulativno” znači od uporabe cjepiva; događaji koji nisu prijavljeni tijekom razdoblja od interesa ne unose se u tablice.
English: 60 years and above
Croatian: 60 godina i više
English: This means that for scientific reasons, it has been impossible to get complete information on this medicine.
Croatian: To znači da zbog znanstvenih razloga nije bilo moguće doći do potpunih informacija o ovom lijeku.
English: The following principles should be followed when compiling the data:
Croatian: Prilikom sakupljanja podataka potrebno je slijediti sljedeća načela:
English: • If the pandemic situation allows, immunisation shall be postponed in patients with severe febrile illness or acute infection.
Croatian: • Ako to pandemijska situacija dopušta, imunizaciju treba odgoditi u pacijenata s teškom febrilnom bolešću ili akutnom infekcijom.
English: - A line listing of fatal cases will be provided in an Annex.
Croatian: - Popis smrtnih slučajeva bit će naveden u Dodatku.
English: • pain in arms and or legs (in the majority of cases reported as pain in the vaccination arm)
Croatian: • bol u rukama i/ili nogama (u većini slučajeva prijavljeno kao bol u ruci u koju se cijepilo)
English: Moreover, a 6-monthly cycle may be too long to allow assessment of the safety of a vaccine for which high levels of exposure are expected within a short period of time.
Croatian: Štoviše, 6-mjesečni ciklus može biti predug za procjenu sigurnosti cjepiva za kojeg se očekuju u kratkom vremenskom periodu visoke razine izlaganja.
English: This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:
Croatian: Budući da je ovo odobrenje u iznimnim okolnostima, a temeljem članka 14.(8) Uredbe (EZ) br. 726/2004 nositelj odobrenja će, unutar navedenog vremenskog okvira, provoditi sljedeće mjere:
English: A short summary should be provided in which validated signals and areas of concern are highlighted, taking into account information arising from the prospective cohort study described in 4.5.
Croatian: Potrebno je pripremiti kratak sažetak u kojemu su naglašeni potvrđeni signali i područja od posebne važnosti, uzimajući u obzir informacije koje proizlaze iz prospektivnog kohortnog ispitivanja opisanog u dijelu 4.5.
English: Adults and children from 6 months onwards: One dose of 0.5 ml at an elected date.
Croatian: Odrasli i djeca starija od 6 mjeseci: Jedna doza od 0,5 ml na odabrani datum.
English: • if you have a poor immune response (for example because of immunosuppressive therapy, e.g. corticosteroid treatments or chemotherapy for cancer);
Croatian: • ako imate loš imunološki odgovor (na primjer zbog imunosupresijske terapije kao što su liječenje kortikosteroidima ili kemoterapija zbog raka);
English: Those which have not yet been entered should be reported in the following S-PSUR.
Croatian: Oni koji još nisu uneseni trebaju biti navedeni u sljedećem S-PSUR-u.
English: Day 180
Croatian: 180. dan
English: The symptoms (signs) of pandemic flu are similar to those of an ‘ordinary' flu but are usually more severe.
Croatian: Simptomi (znakovi) pandemijske gripe slični su onima 'obične' gripe, no uglavnom su teži.
English: The frequency cannot be estimated from the available data.
Croatian: Učestalost se ne može procijeniti iz dostupnih podataka.
English: Outside of the pandemic period, the normal PSUR periodicity and format will be maintained, with a specific review of AESI.
Croatian: Izvan razdoblja pandemije bit će zadržana uobičajena periodičnost i format PSUR-a, uz specifičan pregled AESI-a.
English: - All non-medically confirmed events are those that have been entered into the database by the data-lock point.
Croatian: Svi medicinski nepotvrđeni događaji su oni koji su uneseni u bazu podataka do zaključavanja baze.
English: - The clock should start from the first Monday after shipment of the first batch of vaccine.
Croatian: - Vrijeme počinje teći od prvog ponedjeljka nakon otpreme prve serije cjepiva.
English: In the event of multiple signals, signal work-up may be prioritised and appropriate timelines for submission of a full signal evaluation report should be provided.
Croatian: U slučaju pojave više signala, obrada signala može dobiti prioritet te je potrebno osigurati odgovarajuće vremenske rokove za predaju potpunih izvješća o procjeni signala.
English: Therefore, 6-monthly or annual PSURs falling within the pandemic period will be replaced by monthly “simplified PSURs” (S-PSUR) accompanied by a summary of vaccine distribution.
Croatian: Dakle, 6-mjesečni ili godišnji PSUR-ovi za vrijeme razdoblja pandemije bit će zamijenjeni mjesečnim “pojednostavljenim PSUR-ovima” (S-PSUR) koje prati sažetak distribucije cjepiva.
English: 12 Month Booster
Croatian: 12-mjesečni booster
English: However, in a pandemic situation, it may be appropriate to give the vaccine, provided that facilities for resuscitation are immediately available in case of need.
Croatian: Međutim, u pandemijskoj će situaciji možda biti potrebno dati cjepivo pod uvjetom da je resuscitacija, u slučaju potrebe, odmah dostupna.
English: The report should include the following Tables of aggregate data (using the pre-defined templates attached in Annex 2).
Croatian: To izvješće treba sadržavati sljedeće tablice zbirnih podataka (korištenjem gotovih predložaka priloženih u Dodatku 2).
English: During a pandemic situation, the resources must be concentrated on a timely and effective monitoring of the safety profile of the influenza vaccines used during the pandemic.
Croatian: Tijekom pandemijske situacije resursi se moraju usmjeriti na pravovremeno i učinkovito praćenje sigurnosnog profila cjepiva protiv influence korištenih tijekom pandemije.
English: • if you have a bleeding problem or bruise easily.
Croatian: • ako imate problema s krvarenjem ili lako dobijete modrice.
English: Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
Croatian: Znakovi alergijske reakcije mogu uključivati osip na koži koji svrbi, nedostatak zraka i oticanje lica ili jezika.
English: During the pandemic, the applicant will conduct a prospective cohort study as identified in the Pharmacovigilance plan.
Croatian: Tijekom pandemije podnositelj će provesti prospektivno kohortno ispitivanje navedeno u Farmakovigilancijskom planu.
English: 6 - 35 months
Croatian: 6 - 35 mjeseci
English: After first opening, the medicinal product should be used immediately.
Croatian: Nakon prvog otvaranja, lijek je potrebno odmah primijeniti.
English: • crying
Croatian: • plač
English: In accordance with Article 114 Directive 2001/83/EC as amended, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Croatian: Sukladno članku 114 Direktive 2001/83/EZ te njegovim izmjenama i dopunama, službeno puštanje serije lijeka u promet preuzet će državni laboratoriji ili laboratorij određen za tu svrhu.
English: When it has been agreed by the CHMP that the S-PSUR is no longer necessary, a full PSUR covering the period since the data lock point of the last routine PSUR will be submitted within a time frame to be agreed with the Rapporteur.
Croatian: Kada se CHMP složi da S-PSUR nije više potreban, potpuni PSUR koji obuhvaća razdoblje od zaključavanja baze zadnjeg rutinskog PSUR-a bit će predan unutar roka koji će se dogovoriti s izvjestiteljem.
English: The most frequently occurring side effect was injection site pain, which was usually mild.
Croatian: Najčešća nuspojava bila je bol na mjestu injiciranja, koja je obično blaga.
English: Uncommon: generalised skin reactions
Croatian: Manje često: generalizirane kožne reakcije
English: This section describes the clinical experience with the mock-up vaccine following a two-dose administration.
Croatian: Ovaj dio opisuje kliničko iskustvo s mock-up cjepivom nakon primjene dvije doze.
English: INFECTIONS AND INFESTATIONS
Croatian: INFEKCIJE I INFESTACIJE
English: The transient false positive reactions could be due to the IgM response by the vaccine.
Croatian: Moguće je da su prolazne lažno pozitivne reakcije uzrokovane IgM odgovorom na cjepivo.
English: Post-marketing surveillance
Croatian: Postmarketinško praćenje
English: These antigens can be considered as ‘novel' antigens and simulate a situation where the target population for vaccination is immunologically naïve.
Croatian: Ti se antigeni mogu smatrati ‘novim' antigenima i simuliraju situaciju u kojoj je ciljna populacija za cijepljenje imunološki naivna.