FrancophonIA/ELRC3.0 huggingface dataset:
English: Foclivia should not be given to people who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, or to any substances found at trace levels in the vaccine, such as egg, chicken protein, kanamycin or neomycin (antibiotics), formaldehyde and cetyltrimethylammonium bromide (CTAB).
Croatian: Foclivia se ne smije davati bolesnicima koji su imali anafilaktičku reakciju (tešku alergijsku reakciju) na bilo koju komponentu cjepiva ili na bilo koju tvar koja je u tragovima nađena u cjepivu, poput jaja, pilećih proteina, kanamicina ili neomicina (antibiotika), formaldehida i cetiltrimetilamonijeva bromida (CTAB).
English: The most common side effects with Foclivia (which may affect up to 1 people in 10) are headache, sweating, arthralgia (joint pain), myalgia (muscle pain), reactions at the site of the injection (redness, swelling, hardening, bruising, pain), fever, feeling unwell, tiredness and shivering.
Croatian: Najčešće nuspojave lijeka Foclivia (koje se mogu javiti u najviše 1 na 10 osoba) bile su glavobolja, znojenje, artralgija (bol u zglobovima), mijalgija (bol u mišićima), reakcije na mjestu primjene injekcije (crvenilo, oticanje, otvrdnuće, nastanak modrica, bol), vrućica, loše osjećanje, umor i drhtavica.
English: Foclivia contains some parts of inactivated (killed) influenza (flu) virus.
Croatian: Lijek Foclivia sadrži određene dijelove inaktiviranog (umrtvljenog) virusa gripe.
English: The immune system will then be able to produce antibodies more quickly when it comes into contact with the virus again.
Croatian: Imunosni sustav može zatim brže stvarati protutijela pri ponovnom izlaganju virusu.
English: Foclivia received a marketing authorisation valid throughout the EU on 19 October 2009.
Croatian: Cjepivo Foclivia dobilo je odobrenje za stavljanje lijeka u promet koje je na snazi u EU-u od 19. listopada 2009.
English: Recommendations and precautions to be followed by healthcare professionals and their patients for the safe and effective use of Foclivia have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene cjepiva Foclivia nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Since Foclivia has been authorised under exceptional circumstances, the company that markets Foclivia will collect information on the safety and effectiveness of the final pandemic vaccine when it includes the flu strain responsible for a pandemic in the vaccine.
Croatian: Budući da je za cjepivo Foclivia izdano odobrenje u iznimnim okolnostima, tvrtka koja cjepivo stavlja u promet prikupit će informacije o sigurnosti i učinkovitosti završnog cjepiva protiv pandemije kada ono bude uključivalo soj gripe koji uzrokuje pandemiju u cjepivu.
English: Side effects reported with Foclivia are carefully evaluated and any necessary action taken to protect people who receive Foclivia.
Croatian: Nuspojave prijavljene za cjepivo Foclivia pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: During a pandemic, the virus strain in Foclivia will have to be replaced by the strain causing the pandemic before the vaccine can be used.
Croatian: Tijekom pandemije soj virusa u cjepivu Foclivia morat će se zamijeniti sojem koji uzrokuje pandemiju prije nego što se cjepivo bude moglo primjenjivati.
English: As for all medicines, data on the use of Foclivia are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni cjepiva Foclivia kontinuirano se prate.
English: Foclivia is given by injection into the upper arm muscle or the thigh in two doses, at least 3 weeks apart.
Croatian: Lijek Foclivia daje se injekcijom u mišić nadlatkice ili bedra u dvije doze, s razmakom od najmanje tri (3) tjedna.
English: The participants received two injections of Foclivia, containing either 7.5 or 15 micrograms of haemagglutinin (a protein found in flu viruses), 21 days apart.
Croatian: Sudionici su primili dvije injekcije cjepiva Foclivia, od kojih je svaka sadržavala 7,5 ili 15 mikrograma hemaglutinina (proteina koji se može naći u virusu gripe) u razmaku od 21 dan.
English: The European Medicines Agency decided that Foclivia's benefits are greater than its risk and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od cjepiva Foclivia nadmašuju s njim povezane rizike te da cjepivo može biti odobreno za primjenu u EU-u.
English: An overview of Foclivia and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Foclivia i zašto je odobren u EU-u
English: Why is Foclivia authorised in the EU?
Croatian: Zašto je lijek Foclivia odobren u EU-u?
English: What are the risks associated with Foclivia?
Croatian: Koji su rizici povezani s lijekom Foclivia?
English: A flu pandemic occurs when a new type (strain) of flu virus can spread easily from person to person because people have no immunity (protection) against it. A pandemic can affect most countries and regions around the world.
Croatian: Pandemija gripe događa se kada nastane novi tip (soj) virusa gripe koji se može lako širiti s osobe na osobu jer ljudi nisu razvili imunitet (zaštitu) na nju.
English: What information is still awaited for Foclivia?
Croatian: Koje se još informacije očekuju o cjepivu Foclivia?
English: How does Foclivia work?
Croatian: Kako djeluje Foclivia?
English: Foclivia is a ‘pandemic preparedness' vaccine.
Croatian: Foclivia je cjepivo spremno protiv pandemijske gripe.
English: What benefits of Foclivia have been shown in studies?
Croatian: Koje su koristi od lijeka Foclivia utvrđene u ispitivanjima?
English: For the full list of all side effects of Foclivia, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Foclivia potražite u uputi o lijeku.
English: How is Foclivia used?
Croatian: Kako se Foclivia primjenjuje?
English: Foclivia contains some parts the H5N1 virus.The virus has been first inactivated so that it does not cause disease.
Croatian: Lijek Foclivia sadrži neke dijelove virusa H5N1.
English: 20 vials
Croatian: 20 bočica
English: Intramuscular use vial (glass) 0.5 ml
Croatian: Bočica (staklo) 5 ml
English: Whole virion influenza vaccine, inactivated containing antigen of pandemic strain*: A/California/7/2009 (H1N1)v 7.5 micrograms** per 0.5 ml dose * propagated in Vero cells (continuous cell line of mammalian origin) ** expressed in micrograms haemagglutinin.
Croatian: 7,5 mikrograma/0,5 ml Otopina za injekciju Primjena u mišić
English: EU Number
Croatian: Broj EU odobrenja (Zaštićeno) ime
English: Suspension for injection
Croatian: Put primjene Unutarnje pakovanje
English: Invented name Strength Pharmaceutical Form
Croatian: Lijek koji više nije odobren
English: These circumstances should be taken into account when choosing an appropriate needle length.
Croatian: Ove okolnosti treba uzeti u obzir prilikom odabira odgovarajuće dužine igle.
English: Aggressive and sexual (mounting) behaviours are also reduced.
Croatian: Agresivno i seksualno ponašanje (opasivanje) također se reducira.
English: An increasing proportion will return to normal function after this time.
Croatian: Nakon tog razdoblja rastući udio vratit će se na normalnu funkciju.
English: Only healthy animals should be immunised.
Croatian: Smiju se imunizirati samo zdrave životinje.
English: Date of last renewal: 10/04/2014
Croatian: Datum posljednjeg produljenja odobrenja: 10/04/2014
English: The general health of the animals was not affected.
Croatian: Opće zdravstveno stanje životinja nije bilo ugroženo.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 11/05/ 2009
Croatian: Datum prvog odobrenja: 11/05/2009
English: In case of suspected misdosing, the animal should be revaccinated immediately.
Croatian: U slučaju sumnje na pogrešno doziranje, životinju odmah treba ponovo cijepiti.
English: Advice to the physician:
Croatian: Savjet liječniku:
English: In a small number of animals death occurred following the reaction, however most animals recovered without treatment and did not appear to react to subsequent vaccinations.
Croatian: U malog broja životinja nakon reakcija uslijedila je smrt, međutim, većina životinja oporavila se bez liječenja i čini se da se nakon sljedećih cijepljenja nisu javljale reakcije.
English: A gradual resolution of the local reactions occurs, but in 20-30% of the animals these may persist for more than 42 days.
Croatian: Lokalne reakcije povlače se postupno, ali u 2030% životinja te reakcije mogu potrajati dulje od 42 dana.
English: After first broaching with a sterile needle, the container should be returned to the refrigerator.
Croatian: Nakon prvog bušenja sterilnom iglom spremnik treba vratiti u hladnjak.
English: Administer by subcutaneous injection in the neck, immediately behind the ear, using a safety vaccinator.
Croatian: Primijeniti subkutanom injekcijom u vrat, neposredno iza uha, sigurnosnim vakcinatorom.
English: Advice to the user in the event of accidental self-injection:
Croatian: Savjet korisniku u slučaju nehotičnog samoinjiciranja:
English: The conjugate is adjuvanted to increase the level and duration of effect.
Croatian: Konjugatu je dodan adjuvans da bi se povećala razina i trajanje učinka.
English: Shelf life after first opening: 28 days at 2-8 °C.
Croatian: Rok valjanosti poslije prvog otvaranja: 28 dana na 2-8 °C.
English: In case of skin contact, wash immediately with soap and water.
Croatian: U slučaju kontakta s kožom odmah isprati sapunom i vodom.
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Croatian: Pomoćne tvari (uključujući adjuvanse) navedene u dijelu 6.1 SPC su ili dozvoljene tvari za koje je u tablici 1, Dodatka Uredbe Komisije (EU) br. 37/2010 navedeno da određivanje MRL nije nužno, ili se smatra da se na njih ne primjenjuju odredbe Uredbe (EK) br. 470/2009 kada se primjenjuju u tim veterinarsko medicinskim proizvodima.
English: The active substance, being a principle of biological origin intended to produce active immunity, is not within the scope of Regulation (EC) No 470/2009.
Croatian: Djelatna tvar koja se sastoje od tvari biološkog podrijetla, namijenjene za stvaranje aktivne imunosti na koje se ne primjenjuju odredbe Uredbe (EK) br. 470/2009.
English: Avoid introduction of contamination.
Croatian: Izbjegavajte uvođenje onečišćenja.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Croatian: Detaljne informacije o ovom veterinarsko-medicinskom proizvodu su dostupne na web stranici Europske agencije za lijekove (EMA) (http://www.ema.europa.eu/).
English: The needle should be directed perpendicular to the skin surface.
Croatian: Iglu treba usmjeriti okomito na površinu kože.
English: Avoid injecting pigs that are wet and dirty.
Croatian: Izbjegavajte cijepljenje mokrih i prljavih svinja.
English: This reflects the time needed for clearance of boar taint compounds already present at the time of vaccination as well as the variability of response between individual animals.
Croatian: To odražava vrijeme potrebno za oslobađanje od spojeva spolnog mirisa prisutnih u vrijeme cijepljenja, kao i varijabilnost reakcije među pojedinačnim životinjama.
English: The recommended time for slaughter is 4 to 6 weeks after the final injection.
Croatian: Preporučeno vrijeme za klanje je 4 do 6 tjedana nakon posljednje injekcije.
English: Once broached, the container should be returned to the refrigerator and then can be broached once more during the next 28 days, then discarded immediately after use.
Croatian: Jednom kada se probuši, spremnik treba vratiti u hladnjak, nakon toga može se probušiti još jedanput tijekom sljedećih 28 dana, a zatim se mora baciti neposredno nakon primjene.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE
Croatian: 13. RIJEČI „SAMO ZA PRIMJENU NA ŽIVOTINJAMA“ I UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE, AKO JE PRIMJENJIVO
English: Seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you.
Croatian: Potražite hitnu medicinsku pomoć čak ako je injicirana vrlo mala količina i ponesite uputu o VMP sa sobom.
English: Accidental self-injection may produce similar effects in people to those seen in pigs.
Croatian: Nehotično samoinjiciranje u ljudi može izazvati učinak sličan onome u svinja.
English: Accidental injection/self-injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given.
Croatian: Nehotična injekcija/samoinjiciranje može prouzročiti jaku bol i oticanje, naročito ako se injicira u zglob prsta, a u rijetkim slučajevima može rezultirati gubitkom zahvaćenog prsta ukoliko nije pružena hitna medicinska pomoć.
English: This leads to reduced production and concentration of testosterone and other testicular steroids, including androstenone, one of the main substances responsible for boar taint.
Croatian: To uzrokuje smanjenu proizvodnju i koncentraciju testosterona i ostalih steroida testisa, uključujući androstenon, jednu od glavnih tvari odgovornih za neugodan spolni miris nerasta.
English: In the event of accidental self-injection, wash the injury thoroughly with clean running water.
Croatian: U slučaju nehotičnog samoinjiciranja temeljito isperite ozljedu čistom tekućom vodom.
English: As a guide, use a short needle to give 12 to 15 mm penetration.
Croatian: Naputak, koristiti kratku iglu koja omogućuje penetraciju od 12 do 15 mm.
English: If self-injection with Improvac is suspected, reproductive physiology should be monitored by assay of testosterone or oestrogen levels (as appropriate).
Croatian: Ako se sumnja u samoinjiciranje Improvaca, potrebno je pratiti reproduktivnu fiziologiju mjerenjem razina testosterona ili estrogena (ovisno o spolu).
English: As skatole levels are not fully dependent on sexual status, both dietary and hygiene management procedures to reduce skatole levels are also important.
Croatian: Budući da razine skatola ne ovise u potpunosti o spolnom statusu, za njihovu su redukciju također važni postupci upravljanja prehranom i higijenom.
English: This effect is apparent within one week of treatment but it may take up to 3 weeks for any existing concentrations of boar taint compounds to be reduced to insignificant levels.
Croatian: Taj učinak postaje očit unutar jednog tjedna od primjene terapije, ali može proći do tri tjedna da bi se postojeće koncentracije spojeva neugodnog mirisa u nerasta smanjile na beznačajne razine.
English: Depending on the type of safety vaccinator, pressure may also be put on the skin and push the needle a few millimetres deeper into the tissue.
Croatian: Ovisno o modelu sigurnosnog vakcinatora biti će potrebno primijeniti dodatni pritisak na kožu kako bi igla prodrla nekoliko milimetara dublje u tkivo.
English: The patient should be advised not to administer Improvac and/or any other product with similar action in the future.
Croatian: Pacijentu treba savjetovati da ubuduće više ne primjenjuje Improvac i/ili bilo koji proizvod sa sličnim djelovanjem.
English: Accidental vaccination of male breeding stock may affect subsequent fertility.
Croatian: Slučajno cijepljenje rasplodnih mužjaka kasnije može utjecati na plodnost.
English: Do not administer the veterinary medicinal product in the future.
Croatian: Ubuduće ne primjenjujte veterinarsko-medicinski proizvod.
English: This directly controls the production of androstenone and, by removing the inhibitory effect of testicular steroids on hepatic metabolism, indirectly reduces levels of skatole.
Croatian: To izravno kontrolira androstenon, te uklanjanjem inhibicijskog učinka steroida testisa na jetreni metabolizam, neizravno snižava razine skatola.
English: The risk of a physiological effect is greater after a second or subsequent accidental injection than after a first injection.
Croatian: Rizik od fizioloških učinaka veći je nakon drugog ili sljedećih slučajnih injiciranja nego nakon prvog.
English: Boars given an initial dose of Improvac are immunologically primed but retain their full testicular function until they receive the second dose, which induces a strong immune response to GnRF and causes temporary immunological suppression of testicular function.
Croatian: Nerasti koji su primili početnu dozu Improvaca imunološki su senzibilizirani, ali zadržavaju potpunu funkciju testisa dok ne prime drugu dozu koja inducira snažnu imunu reakciju na GnRF i uzrokuje privremenu imunološku supresiju funkcije testisa.
English: These may include a temporary reduction in sexual hormones and reproductive functions in both men and women and an adverse effect on pregnancy.
Croatian: Ti učinci mogu uključivati privremenu redukciju spolnih hormona i reproduktivnih funkcija i u muškaraca i u žena te neželjene učinke na trudnoću.
English: In case of eye contact, rinse immediately with copious amounts of water.
Croatian: U slučaju kontakta s očima odmah isprati obilnim količinama vode.
English: The risk of these effects occurring is greater after a second or subsequent accidental injection than after a first injection.
Croatian: Rizik od pojave tih učinaka veći je nakon drugog ili sljedećih slučajnih injiciranja nego nakon prvog.
English: 601 W. Cornhusker Highway Lincoln, NE 68521
Croatian: 601 W. Cornhusker Highway,
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Croatian: Svi neupotrebljeni veterinarsko-medicinski proizvodi ili otpadni materijali dobiveni primjenom takvih veterinarsko-medicinskih proizvoda moraju se odlagati u skladu s lokalnim propisima.
English: Reduction of androstenone and skatole levels has been demonstrated from 4 to 6 weeks post second vaccination.
Croatian: Redukcija razina androstenona i skatola dokazana je četiri do šest tjedana nakon drugog cijepljenja.
English: The container can be broached once more only during the next 28 days, then discarded immediately after use.
Croatian: Spremnik se može probušiti još samo jedanput tijekom sljedećih 28 dana, a zatim se mora baciti neposredno nakon primjene.
English: In very rare cases anaphylactoid type reactions (dyspnoea, collapse, cyanosis and hypersalivation associated with or without muscle twitching or emesis) have been observed within a few minutes after the first vaccination with a duration of up to 30 minutes.
Croatian: U vrlo rijetkim slučajevima nekoliko minuta nakon prvog cijepljenja uočene su reakcije anafilaktoidnog tipa (dispneja, kolaps, cijanoza i hipersalivacija povezani s mišićnim trzajima ili povraćanjem ili bez njih) u trajanju od najviše 30 minuta.
English: Reduction of aggressive and sexual (mounting) behaviours can be expected from 1 to 2 weeks post second vaccination.
Croatian: Redukcija agresivnog i seksualnog ponašanja (opasivanja) može se očekivati jedan do dva tjedna nakon drugog cijepljenja.
English: Moreover, fully immunised boars develop metabolic characteristics typical of surgically castrated animals, including reduced concentrations of skatole, another key contributor to boar taint.
Croatian: Osim toga, potpuno imunizirani nerasti razviju metaboličke karakteristike tipične za kirurški kastrirane životinje, uključujući reducirane koncentracije skatola, drugog glavnog uzročnika neugodnog spolnog mirisa nerasta.
English: The onset of immunity (induction of anti-GnRF antibodies) can be expected within 1 week post second vaccination.
Croatian: Početak imuniteta (indukcija protutijela koja djeluju protiv GnRF-a) može se očekivati unutar jednog tjedna nakon drugog cijepljenja.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One dose (2 ml) contains:
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna doza (2 ml) sadrži:
English: To avoid intramuscular deposition and lesions, it is recommended to use a shorter needle to give 5 mm to 9 mm penetration in undersized pigs and pigs younger than 16 weeks of age.
Croatian: Kako bi se izbjeglo intramuskularno taloženje i lezije preporuča se upotreba kraće igle koja omogućava penetraciju od 5 mm do 9 mm kod manjih svinja i onih mlađih od 16 tjedana starosti.
English: (a synthetic peptide analogue of GnRF conjugated to diphtheria toxoid) Adjuvant:
Croatian: (sintetički analog peptida GnRF-a konjugiranog u difterijski toksoid) Adjuvans:
English: Male pigs (from 8 weeks of age).
Croatian: Mužjaci svinja (od 8 tjedana starosti).
English: The patient should be advised not to administer Improvac and/or any other veterinary medicinal products with similar action in the future.
Croatian: Pacijentu treba savjetovati da ubuduće više ne primjenjuje Improvac i/ili bilo koji veterinarsko-medicinski proizvod sa sličnim djelovanjem.
English: Accidental self-injection could temporarily affect reproductive physiology of both men and women and may adversely affect pregnancy.
Croatian: Nehotično samoinjiciranje može privremeno utjecati na reproduktivnu fiziologiju i u muškaraca i u žena i može imati neželjene učinke na trudnoću.
English: Clinically meaningful suppression of gonadal function should be managed with supportive endocrine replacement therapy until normal function returns.
Croatian: Klinički značajnu supresiju funkcije spolnih žlijezda treba tretirati pomoćnom nadomjesnom hormonskom terapijom do povratka normalne funkcije.
English: Improvac has been shown to be safe in male pigs from 8 weeks of age onwards.
Croatian: Improvac se pokazao neškodljiv u mužjaka svinje od 8 tjedana starosti nadalje.
English: If pigs cannot be slaughtered within this recommended period the available trial data support that pigs may still be sent for slaughter up to 10 weeks after the final injection with minimal risk of boar taint.
Croatian: Ako klanje unutar tog preporučenog razdoblja nije moguće, dostupni pokusni podaci potvrđuju da se svinje još uvijek mogu slati na klanje do deset tjedana nakon posljednje injekcije uz minimalni rizik od neugodnog mirisa.
English: The effects of immunisation derive from the reduction in testicular function resulting from reduced GnRF activity.
Croatian: Učinci imunizacije proizlaze iz redukcije funkcije testisa zbog smanjenog djelovanja GnRF-a.
English: CONTRAINDICATIONS Do not use in female pigs.
Croatian: KONTRAINDIKACIJE Ne primjenjivati na ženkama svinja.
English: A transient increase in body temperature of 0.2 to 1.7°C was observed during the 24 hours after administration, returning to normal after two days.
Croatian: Prolazno povišenje tjelesne temperature od 0,2 do 1,7 °C uočeno je u razdoblju od 24 sata nakon primjene, a nakon dva dana temperatura se vratila na normalne vrijednosti.
English: Administration of a double dose of Improvac (4 ml) to 8 week old piglets very commonly resulted in palpable injection site reactions.
Croatian: Primjena dvostruke doze Improvaca (4 ml) na praščićima starim 8 tjedana često je uzrokovala opipljive reakcije na mjestu injiciranja.
English: A reduction of typical male behaviour such as mounting and aggressiveness when mixed with non-penmates can be expected after the second vaccination.
Croatian: Redukcija tipičnog mužjačkog ponašanja kao što su opasivanje i agresivnost u kontaktu sa životinjama s kojima nerasti ne dijele nastambu može se očekivati nakon drugog cijepljenja.