FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, vaccination has been shown to reduce PCV2 nasal shedding, viral load in blood and lymphoid tissues, and duration of viraemia.
Croatian: Uz to se pokazalo da cijepljenje smanjuje otpuštanje PCV2 iz nosa, količinu virusa u krvi i limfnom tkivu i trajanje viremije.
English: This vaccine is designed to stimulate the development of an active immune response to porcine circovirus type 2.
Croatian: Ovo cjepivo je napravljeno da potakne razvoj aktivnog imuniteta na Cirkovirus svinja tip 2.
English: Ingelvac MycoFLEX may be not authorised in certain Member States.
Croatian: Ingelvac MycoFLEX ne mora biti odobren u određenim državama članicama.
English: Suspension for injection
Croatian: Suspenzija za injekcije
English: Interactions with other medicinal products and other forms of interaction Safety and efficacy data are available which demonstrate that this vaccine can be mixed with Boehringer Ingelheim's Ingelvac MycoFLEX and administered at one injection site.
Croatian: Interakcije s drugim medicinskim proizvodima i drugi oblici interakcija Podaci o neškodljivosti i djelotvornosti su dostupni i dokazuju da se ovo cjepivo može pomiješati s cjepivom Ingelvac MycoFLEX proizvođača Boehringer Ingelheim i primijeniti na isto injekcijsko mjesto.
English: METHOD AND ROUTE OF ADMINISTRATION
Croatian: NAČIN I PUT PRIMJENE
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Croatian: - rijetke (više od 1 ali manje od 10 životinja na 10.000 tretiranih životinja) - vrlo rijetke (manje od 1 životinje na 10.000 tretiranih životinja, uključujući izolirane slučajeve).
English: QUANTITY OF THE ACTIVE SUBSTANCE
Croatian: KOLIČINA DJELATNE TVARI
English: Ingelvac MycoFLEX may be not authorised to use in certain Member States.
Croatian: Ingelvac MycoFLEX ne mora biti odobren za primjenu u određenim državama članicama.
English: 10 ml (10 doses) 50 ml (50 doses)
Croatian: 10 ml (10 doza) 50 ml (50 doza)
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
Croatian: UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE C. IZVJEŠĆE O MRL
English: Withdrawal period: Zero days.
Croatian: Karencija: nula dana.
English: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein GERMANY
Croatian: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
English: A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case-by-case basis.
Croatian: Stoga se odluka o primjeni ovog cjepiva prije, odnosno poslije primjene bilo kojeg drugog veterinarsko medicinskog proizvoda, mora donositi od slučaja do slučaja.
English: To ensure correct mixing follow the steps as described below: Connect one end of the transfer needle to the vaccine bottle of Ingelvac MycoFLEX.
Croatian: Da bi se osiguralo ispravno miješanje cjepiva treba postupati po sljedećim „koracima“: Spojite jedan kraj igle za prijenos cjepiva s bočicom Ingelvac MycoFLEX.
English: Store and transport refrigerated.
Croatian: 11. POSEBNI UVIJETI ČUVANJA Čuvati i prevoziti rashlađeno.
English: For active immunisation of pigs from the age of 2 weeks against porcine circovirus type 2 (PCV2) to reduce mortality, clinical signs - including weight loss - and lesions in lymphoid tissues associated with PCV2 related disease (PCVD).
Croatian: Za aktivnu imunizaciju svinja starijih od 2 tjedna protiv svinjskog cirkovirusa tip 2 (PCV2) da bi se smanjili mortalitet, klinički znakovi - uključujući gubitak na tjelesnoj težini i lezije limfnog tkiva povezane s bolešću (PCVD) koju izaziva PCV2.
English: Avoid introduction of contamination during use.
Croatian: Tijekom primjene treba izbjeći kontaminaciju cjepiva.
English: 100 ml (100 doses) 250 ml (250 doses)
Croatian: 100 ml (100 doza) 250 ml (250 doza)
English: INDICATIONS
Croatian: INDIKACIJE
English: - After the transfer of the full content of Ingelvac CircoFLEX, disconnect and discard transfer needle and empty vaccine bottle of Ingelvac CircoFLEX.
Croatian: - Nakon što se prenese cijeli sadržaj cjepiva Ingelvac CircoFLEX, odvoji se igla za prijenos i baci zajedno s praznom bočicom cjepiva Ingelvac CircoFLEX.
English: To ensure appropriate mixing of the vaccines, gently shake the vaccine bottle of Ingelvac MycoFLEX until the mixture is of uniform orange to reddish colour.
Croatian: Kako bi bili sigurni da su cjepiva odgovarajuće pomiješana bočicu od cjepiva Ingelvac MycoFLEX treba nježno protresti sve dok mješavina ne postane jednoliko narančasto crvenkasta.
English: Single intramuscular injection of one dose (1 ml), irrespective of body weight.
Croatian: Jednokratno se i.m. injicira jedna doza (1 ml), bez obzira na tjelesnu masu.
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed with Boehringer Ingelheim's Ingelvac MycoFLEX and administered at one injection site.
Croatian: Podaci o neškodljivosti i djelotvornosti su dostupni i dokazuju da se ovo cjepivo može pomiješati s cjepivom Ingelvac MycoFLEX proizvođača Boehringer Ingelheim i primijeniti na isto injekcijsko mjesto.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ BIOLOŠKI DJELATNE TVARI I PROIZVOĐAČ ODGOVORAN ZA
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Croatian: Sukladno članku 71. Direktive 2001/82/EZ i Europskog Parlamenta i Vijeća s izmjenama i dopunama, države članice, u skladu s nacionalnim zakonodavstvom mogu zabraniti proizvodnju, uvoz,
English: One dose (1 ml) contains: Porcine circovirus type 2 ORF2 protein Carbomer
Croatian: Jedna doza (1 ml) sadrži: Cirkovirus svinja tip 2, bjelančevina ORF2 Karbomer
English: MARKETING AUTHORISATION NUMBERS
Croatian: 16. BROJEVI ODOBRENJA ZA STAVLJANJE U PROMET
English: If needed, gently press the vaccine bottle of Ingelvac CircoFLEX to facilitate the transfer.
Croatian: Ako je potrebno, bočicu s cjepivom Ingelvac CircoFLEX lagano stisnite da se potakne (započne)
English: Pack sizes of 1 or 12 high density polyethylene bottles of 10 ml, 50 ml, 100 ml or 250 ml.
Croatian: Pakiranje sadržava 1 ili 12 bočica od polietilena visoke gustoće od 10 ml, 50 ml, 100 ml ili 250 ml.
English: Onset of immunity:
Croatian: Početak imunosti:
English: Any unused mixture or waste material should be disposed according with local requirements.
Croatian: Neiskorištenu vakcinalnu mješavinu i otpadne materijale treba zbrinuti u skladu sa lokalnim propisima.
English: Porcine circovirus type 2 ORF2 protein
Croatian: Cirkovirus svinja tip 2, bjelančevina ORF2
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE 10 ml; 50 ml, 100 ml, 250 ml cardboard box
Croatian: PODACI NA VANJSKOM PAKOVANJU 10 ml; 50 ml, 100 ml, 250 ml kartonska kutija
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Croatian: IME I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET I NOSITELJA ODOBRENJA ZA PROIZVODNJU ODGOVORNOG ZA PUŠTANJE
English: Pack sizes of 1 or 12 bottles of 10 ml (10 doses), 50 ml (50 doses), 100 ml (100 doses) or 250 ml (250 doses).
Croatian: Pakiranje sadržava 1 ili 12 bočica od 10 ml (10 doza), 50 ml (50 doza), 100 ml (100 doza) ili 250 ml
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 10 ml, 50 ml bottle
Croatian: OSNOVNI DJELOVI NAPISANI NA MALIM JEDINICAMA UNUTARNJIH PAKOVANJA 10 ml, 50 ml bočica
English: Active substance:
Croatian: Početakimunosti:
English: Vaccination devices should be used in accordance with the device instructions provided by the manufacturer.
Croatian: Pribor za cijepljenje treba koristiti u skladu s uputama proizvođača.
English: - Transfer the Ingelvac CircoFLEX vaccine into the vaccine bottle of Ingelvac MycoFLEX.
Croatian: - Prebacite cjepivo Ingelvac CircoFLEX u bočicu s cjepivom Ingelvac MycoFLEX.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Croatian: 15. IME I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET
English: - Connect the opposite end of the transfer needle to the vaccine bottle of Ingelvac CircoFLEX.
Croatian: - Spojite suprotni kraj igle za prijenos cjepiva s bočicom Ingelvac CircoFLEX.
English: Administer one single injection dose (2 ml) of the mixture intramuscularly per pig, irrespective of body weight.
Croatian: Jedna doza (2 ml) mješavine cjepiva aplicira se jednokratno i.m. svinjama, neovisno o tjelesnoj masi.
English: Porcine circovirus type 2 ORF2 protein: RP* 1.0-3.75 * Relative potency (ELISA test) by comparison with a reference vaccine.
Croatian: RP* 1,0-3,75 * Relativna potencija (ELISA test) u usporedbi s referentnim cjepivom.
English: Special precautions for use in animals Not applicable.
Croatian: Posebne mjere opreza prilikom primjene na životinjama
English: A mild and transient hyperthermia very commonly occurs on the day of vaccination.
Croatian: Na dan cijepljenja vrlo se često javlja blaga i prolazna hipertermija.
English: SPECIAL WARNINGS
Croatian: 12. POSEBNA UPOZORENJA
English: U.S.A.
Croatian: i.m.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE 100 ml, 250 ml bottle
Croatian: PODACI NA UNUTARNJEM PAKOVANJU 100 ml, 250 ml bočica
English: Overdose (symptoms, emergency procedures, antidotes) Following the administration of a 4-fold overdose of vaccine no adverse reactions other than those described under section “Adverse reactions” have been observed.
Croatian: Nakon predoziranja četverostrukom dozom cjepiva nisu primijećene druge nuspojave osim onih opisanih u dijelu Nuspojave.
English: IM
Croatian: A.
English: WITHDRAWAL PERIOD
Croatian: ROK VALJANOSTI
English: ROUTE OF ADMINISTRATION
Croatian: PUT PRIMJENE
English: Veterinary medicinal product subject to prescription.
Croatian: VMP se izdaje na veterinarski recept.
English: 2621 North Belt Highway,
Croatian: Boehringer Ingelheim Animal Health USA Inc. 2621 North Belt Highway, St. Joseph, Missouri, 64506-2002 SAD
English: ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
Croatian: I SAŽETAK OPISA SVOJSTAVA
English: Avoid multiple broaching.
Croatian: Mora se izbjeći višekratno probadanje čepa na bočici.
English: (An 8-point improvement is considered clinically significant in this scale, which ranges from 0 to 100).
Croatian: (Poboljšanje od 8 bodova smatra se statistički značajnim na ovoj ljestvici, koja se kreće od 0 do 100).
English: Fampyra fampridine
Croatian: Fampyra fampridin
English: The full EPAR for Fampyra can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Fampyra nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: After two to four weeks, patients are evaluated and those who have not shown an improvement should stop treatment.
Croatian: Nakon dva do četiri tjedna bolesnike se ocjenjuje i oni kod kojih nije zabilježeno poboljšanje trebali bi prestati s liječenjem.
English: As the company has supplied the additional information necessary, the authorisation has been switched from conditional to full approval.
Croatian: Budući da je tvrtka dostavila dodatne potrebne informacije, uvjetno odobrenje pretvoreno je u potpuno odobrenje.
English: This was switched to a full marketing authorisation on 22 May 2017.
Croatian: To je odobrenje pretvoreno u potpuno odobrenje za stavljanje u promet 22. svibnja 2017.
English: Fampyra is available as 10 mg tablets taken without food twice a day, 12 hours apart.
Croatian: Lijek Fampyra dostupan je u obliku tableta od 10 mg koje se uzimaju bez hrane dva puta na dan s razmakom od 12 sati.
English: The patients were treated for 9 or 14 weeks, with their waking speed measured along a 25 feet (7.5 metres) footpath.
Croatian: Bolesnici su dobivali lijek 9 ili 14 tjedana, a njihova brzina hodanja mjerila se na udaljenosti od 25 stopa (7,5 metara).
English: What is Fampyra and what is it used for?
Croatian: Što je Fampyra i za što se koristi?
English: The side effects seen with Fampyra are mostly neurological (relating to the brain or nerves) and include seizures (fits), insomnia (difficulty sleeping), anxiety, problems with balance, dizziness, paraesthesia (unusual sensations like pins and needles), tremor, headache and asthenia (weakness).
Croatian: Nuspojave zabilježene pri primjeni lijeka Fampyra uglavnom su neurološke (povezane s mozgom ili živcima) i uključuju napadaje (grčeve), nesanicu (problemi sa spavanjem), anksioznost, probleme s ravnotežom, vrtoglavicu, paresteziju (neobični osjećaji poput trnaca i probadanja), tremor, glavobolju i asteniju (slabost).
English: Fampyra must not be used with other medicines that contain fampridine or medicines known as ‘inhibitors of organic cation transporter 2' such as cimetidine.
Croatian: Fampyra se ne smije primjenjivati s ostalim lijekovima koji sadržavaju fampridin ili s lijekovima koji se nazivaju „inhibitorima transportera organskih kationa 2”, kao što je cimetidin.
English: What measures are being taken to ensure the safe and effective use of Fampyra?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Fampyra?
English: Other information about Fampyra
Croatian: Ostale informacije o lijeku Fampyra
English: The European Commission granted a conditional marketing authorisation valid throughout the European Union for Fampyra on 20 July 2011.
Croatian: Europska komisija izdala je uvjetno odobrenje za stavljanje u promet lijeka Fampyra koje je bilo na snazi u Europskoj uniji od 20. srpnja 2011.
English: Fampyra was originally given ‘conditional approval' because there was more evidence to come about the medicine.
Croatian: Za lijek Fampyra prvotno je izdano „uvjetno odobrenje” jer su se očekivali dodatni podatci o lijeku.
English: With regard to the medicine's safety, serious side effects with Fampyra are rare.
Croatian: Kada je riječ o sigurnosti lijeka, ozbiljne nuspojave lijeka Fampyra rijetke su.
English: This is a summary of the European public assessment report (EPAR) for Fampyra.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Fampyra.
English: Treatment should also be stopped if a patient's walking ability worsens or if the patient does not report any benefit.
Croatian: S liječenjem bi trebalo prestati i ako se sposobnost hodanja bolesnika pogorša ili ako bolesnik ne primijeti nikakve koristi.
English: The most common side effect reported in clinical studies, affecting around 12% of the patients, is urinary tract infection.
Croatian: Najčešća nuspojava zabilježena u kliničkim ispitivanjima, koja se javlja u oko 12 % bolesnika, jest infekcija mokraćnog sustava.
English: What are the risks associated with Fampyra?
Croatian: Koji su rizici povezani s lijekom Fampyra?
English: It must not be used in patients who have seizures or have ever had seizures or in patients with kidney problems.
Croatian: Ne smije se primjenjivati u bolesnika koji imaju napadaje ili koji su ih nekada imali ili u bolesnika koji imaju probleme s bubrezima.
English: A third study in 633 patients measured improvements in walking ability over 24 weeks using a rating scale known as the multiple sclerosis walking scale (MSWS), where patients rated how well they were able to do various activities such as walking, running or climbing stairs.
Croatian: U trećem ispitivanju koje je obuhvatilo 633 bolesnika mjerilo se poboljšanje sposobnosti hodanja u razdoblju od 24 tjedna uporabom ljestvice koja se naziva ljestvica hodanja kod multiple skleroze, kojom bolesnici ocjenjuju koliko dobro mogu obavljati različite aktivnosti, poput hodanja, trčanja ili penjanja po stepenicama.
English: Fampyra is a medicine used to improve walking ability in adults with multiple sclerosis (MS) who have a walking disability.
Croatian: Fampyra je lijek koji se koristi za poboljšanje sposobnosti hodanja u odraslih osoba s multiplom sklerozom (MS) koje ne mogu hodati.
English: This summary was last updated in 07-2017
Croatian: Ovaj sažetak posljednji je put ažuriran u srpnju 2017.
English: It is not intended to provide practical advice on how to use Fampyra.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Fampyra.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Fampyra 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 lijeka Fampyra nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: The active substance in Fampyra, fampridine, is a potassium channel blocker.
Croatian: Djelatna tvar lijeka Fampyra, fampridin, blokator je kalijevog kanala.
English: Two main studies in 540 patients with multiple sclerosis showed that Fampyra was more effective than placebo (a dummy treatment) at improving walking speed.
Croatian: U dvama glavnim ispitivanjima u kojima je sudjelovalo 540 bolesnika s multiplom sklerozom dokazano je da je lijek Fampyra djelotvorniji od placeba (prividno liječenje) u pogledu poboljšanja brzine hodanja.
English: The European Medicines Agency therefore concluded that the benefits of Fampyra outweigh its risks for patients with a walking disability and recommended that it be given marketing authorisation.
Croatian: Europska agencija za lijekove stoga je zaključila da koristi lijeka Fampyra nadmašuju s njim povezane rizike za bolesnike koji ne mogu hodati te je preporučila davanje odobrenja za stavljanje lijeka u promet.
English: Why is Fampyra approved?
Croatian: Zašto je lijek Fampyra odobren?
English: What benefits of Fampyra have been shown in studies?
Croatian: Koje su koristi lijeka Fampyra dokazane u ispitivanjima?
English: For more information about treatment with Fampyra, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Fampyra pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: This is believed to have the effect of allowing the electrical impulse to continue travelling along the nerves to stimulate the muscles, making it easier to walk.
Croatian: Vjeruje se da se time omogućava električnim impulsima da nastave svoj put živcima kako bi potaknuli rad mišića, što olakšava hodanje.
English: The studies with Fampyra showed that the medicine is likely to benefit approximately one third of patients with MS who have a walking disability, and that patients benefiting from the treatment can be identified at an early stage allowing treatment to be stopped in other patients.
Croatian: Ispitivanjima lijeka Fampyra dokazano je da lijek može biti koristan otprilike jednoj trećini bolesnika s multiplom sklerozom koji ne mogu hodati i da se bolesnici koji imaju koristi od liječenja mogu utvrditi u ranom stadiju, što omogućava da se prestane s liječenjem ostalih bolesnika.
English: It acts on damaged nerves, where it prevents charged potassium particles from leaving the nerve cells.
Croatian: Djeluje na oštećene živce te sprečava nabijene čestice kalija da napuste živčane stanice.
English: For the body's muscles to contract, electrical impulses are transmitted along the nerves to the muscles.
Croatian: Za stezanje tjelesnih mišića električni impulsi prenose se živcima do mišića.
English: It contains the active substance fampridine.
Croatian: Lijek sadržava djelatnu tvar fampridin.
English: In the second study the results were similar, with 43% of patients in the Fampyra group surpassing their previous best speed on three out of four occasions, compared with 9% in the placebo group.
Croatian: U drugom ispitivanju zabilježeni su slični rezultati: 43 % bolesnika u skupini koja je uzimala lijek Fampyra nadmašilo je svoju prethodnu najveću brzinu u tri od četiri mjerenja, u usporedbi s 9 % bolesnika u skupini koja je uzimala placebo.
English: In MS, this transmission of electrical impulses is impaired when the protective sheaths around the nerves become damaged, which can lead to muscle weakness, muscle stiffness and difficulty walking.
Croatian: Kod multiple skleroze prijenos električnih impulsa oslabljen je jer su zaštitne ovojnice oko živaca oštećene, što može dovesti do slabosti mišića, ukočeosti mišića i teškoća u hodanju.
English: For practical information about using Fampyra, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Fampyra bolesnici trebaju pročitati u uputi o lijeku, odnosno trebaju se obratiti svojem liječniku ili ljekarniku.
English: How does Fampyra work?
Croatian: Kako djeluje Fampyra?
English: MS is a disease of the nerves, in which inflammation destroys the protective sheath around the nerves.
Croatian: Multipla skleroza bolest je živaca kod koje upala uništava zaštitnu ovojnicu oko živaca.
English: In one of the studies 35% of patients taking Fampyra had higher walking speed on at least three out of four occasions than their quickest speed before treatment compared with 8% of patients taking placebo .
Croatian: U jednom ispitivanju u 35 % pacijenata koji su uzimali lijek Fampyra zabilježena je veća brzina hodanja u najmanje tri od četiri mjerenja u usporedbi s njihovom najvećom brzinom prije liječenja, dok je kod bolesnika koji su uzimali placebo takvo povećanje zabilježeno kod 8 % bolesnika.
English: The medicine can only be obtained with a prescription, and should be prescribed by a doctor experienced in treating MS. For further information, see the package leaflet.
Croatian: Lijek se izdaje samo na liječnički recept, a treba ga propisati liječnik s iskustvom u liječenju multiple skleroze.
English: In this study, 43% of patients taking Fampyra had at least an 8-point improvement in their MSWS score compared with 34% of those on placebo.
Croatian: U tom je ispitivanju u 43 % bolesnika koji su uzimali lijek Fampyra zabilježeno poboljšanje rezultata na ljestvici od najmanje 8 bodova u usporedbi s 34 % bolesnika koji su uzimali placebo.
English: For the full list of all side effects reported with Fampyra, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Fampyra potražite u uputi o lijeku.
English: How is Fampyra used?
Croatian: Kako se lijek Fampyra koristi?
English: (*) equivalent to titre prior to inactivation (log10)
Croatian: (*) jednako titru prije inaktivacije (log10)
English: Suspension for injection.
Croatian: Injekcijska suspenzija.
English: Sheep and cattle
Croatian: Ovce i goveda
English: Bluetongue Virus Serotype 1 antigen ≥ 8.1 CCID50*
Croatian: Virusni antigen protiv bolesti plavog jezika serotip 1 ≥ 8,1 CCID50*
English: Invented Name
Croatian: Izmišljeni naziv
English: Subcutaneous Type I glass bottle with butyl elastomere closure
Croatian: Supkutano Staklena bočica (staklo tip I) s čepom iz butilnog elastomera.
English: Packaging Content Package size Withdrawal period
Croatian: Sadržaj Veličina pakovanja
English: EU Number
Croatian: Broj
English: Route of administration
Croatian: Način primjene
English: Note:
Croatian: Napomena:
English: This product information is the outcome of the referral procedure to which this Commission decision relates.
Croatian: Ove informacije o lijeku rezultat su postupka upućivanja Komisiji na koji se odnosi ova odluka Komisije.
English: Product information
Croatian: Informacije o lijeku