FrancophonIA/ELRC3.0 huggingface dataset:
English: Poly(0-2hydroxyethyl)starch 200 kDa mol.substitution 0,43-0,55, Sodium chloride
Croatian: D-34212 Melsungen poli(O-2 hidroksietil)škrob, 130 kDa mol.subst.
English: Hidroxietil amidon, Sodium chloride, Potassium chloride, Magnesium chloride hexahydrate, Calcium chloride dihydrate,Sodium acetate trihydrate, Malic acid
Croatian: Melsungen hidroksietilškrob, natrijev klorid, kalijev klorid, kalcijev klorid dihidrat, magnezijev klorid heksahidrat, natrijev acetat trihidrat, malatna kiselina
English: B. Braun Melsungen AG Carl-Braun Strasse 1 34212 Melsungen Germany
Croatian: Braun Melsungen AG Carl-Braun Strasse 1 34212 Melsungen Germany
English: Belgium Fresenius Kabi NV Molenberglei 7
Croatian: Molenberglei 7
English: 164 94 Kista Sweden hydroxyethyl starch,
Croatian: SE-751 74 Uppsala Sweden hidroksietilškrob, natrijev klorid, voda
English: D-34212 Melsungen
Croatian: Melsungen D-34212
English: Hydroxyethyl Starch, Sodium acetate trihydrate, Sodium chloride, Potassium chloride, Magnesium chloride hexahydrate,
Croatian: hidroksietilškrob, natrijev acetat trihidrat, natrijev klorid, kalijev klorid, magnezijev klorid heksahidrat,
English: B Braun Melsungen AG Carl-Braun-Strasse 1 Melsungen, D-34212 Germany
Croatian: Španjolska B. BRAUN MELSUNGEN AG Carl-Braun Strasse, 1 Melsungen D-34212
English: Hydroxyethyl Starch + Sodium Chloride + Potasium Chloride + Calcium Chloride Dihydrate + Magnesium Chloride Hexahydrate + Sodium Acetate Trihydrate
Croatian: Greece hidroksietilškrob + natrijev klorid + kalijev klorid + kalcijev klorid dihidrat + magnezijev klorid heksahidrat + natrijev acetat trihidrat
English: ul.Hrubieszowska 2 01-209 Warszawa, Poland
Croatian: Fresenius Kabi Polska Sp.zo.o. ul.Hrubieszowska 2 01-209 Warszawa, Poland poli(O-2 hidroksietil)škrob, natrijev klorid
English: Zona Industrial da Abrunheira - Edifício 10 - Sintra Business Park 2710-089 Sintra Portugal
Croatian: Zona Industrial da Abrunheira - Edifício 10 - Sintra Business Park 2710-089 Sintra Portugal natrijev acetat trihidrat + kalijev klorid + magnezijev klorid heksahidrat + hidroksietilškrob + kalcijev klorid dihidrat + natrijev klorid
English: Vitafusal 10 % 100g/l, 6 g/l, 0.4 g/l, 0.134 g/l, 0.2 g/l, 3.7 g/l
Croatian: Vitafusal 10 % 100g/l, 6 g/l, 0,4 g/l, 0,134 g/l, 0,2 g/l,
English: 3.7 mg/ml + 0.4mg/ml + 0.2mg/ml + 60mg/ml + 0.134mg/ml + 6mg/ml
Croatian: PlasmaVolume Redibag 3,7 mg/ml,0,4 mg/ml,0,2 mg/ml, 60 mg/ml, 0,134 mg/ml, 6 mg/ml
English: Vitafusal 6 % 60 g/l, 6 g/l, 0.4 g/l, 0.134 g/l, 0.2 g/l, 3.7 g/l
Croatian: Vitafusal 6 % 60 g/l, 6 g/l, 0,4 g/l, 0,134 g/l, 0,2 g/l,
English: INFOHES 60 g/L 60 g/l, 9 g/l
Croatian: Venofundin 6 g/100 ml 60 g/l, 9 g/l
English: Place du Marivel 5 92316 Sèvres Cedex France hydroxyethyl starch 200
Croatian: 5, place du Marivel 92316 Sèvres Cedex France hidroksietilškrob 200
English: hydroxyethyl starch, Sodium acetate trihydrate, Sodium chloride, Potassium chloride, Magnesium chloride hexahydrate
Croatian: hidroksietilškrob, natrijev acetat trihidrat, natrijev klorid, kalijev klorid, magnezijev klorid heksahidrat
English: Vitakoll 10 % 100 g/l, 6 g/l, 0.4 g/l, 0.134 g/l, 0.2 g/l, 3.7 g/l
Croatian: Vitakoll 10 % 100 g/l, 6 g/l, 0,4 g/l, 0,134 g/l, 0,2 g/l,
English: Hydroxyethyl starch + Sodium chloride+Sodium acetate trihydrate+Potassium chloride+Magnesium chloride hexahydrate
Croatian: Greece hidroksietilškrob + natrijev klorid + natrijev acetat trihidrat + kalijev klorid + magnezijev klorid heksahidrat
English: Czech Republic hydroxyethyl starch, Sodium chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride hexahydrate, Sodium acetate trihydrate
Croatian: Czech Republic hidroksietilškrob 130 000, natrijev klorid, kalijev klorid, kalcijev klorid dihidrat, magnezijev klorid heksahidrat, natrijev acetat trihidrat
English: Place du Marivel 5 92316 Sèvres Cedex France hydroxyethyl starch 240
Croatian: 5, place du Marivel 92316 Sèvres Cedex France hidroksietilškrob 240
English: Poly(O-2-hydroxyethyl) starch (HES), Sodium acetate trihydrate, Sodium chloride, Potassium chloride, Magnesium chloride hexahydrate
Croatian: Poli(O-2hidroksietil)škrob, natrijev acetat trihidrat, natrijev klorid, kalijev klorid, magnezijev klorid heksahidrat
English: Poly-(o-2 hydroxyethyl)starch (M.W 200000) + Sodium Chloride
Croatian: poli(O-2 hidroksietil) škrob, 200 kDa mol.subst.
English: Hydroxyethyl starch, Sodium Chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride hexahydrate, Sodium acetate trihydrate
Croatian: HEShidroksietilškrob, natrijev klorid, kalijev klorid, kalcijev klorid dihidrat, magnezijev klorid heksahidrat, natrijev acetat trihidrat
English: Fresenius Kabi d.o.o.
Croatian: Fresenius Kabi d.o.o. Trg J.F.
English: 100 g/l 6,252 g/l 0,2984 g/l 0,3675 g/l
Croatian: 100 g/l 6,252 g/l 0,2984 g/l 0,3675 g/l 0,2033 g/l 3,266 g/l 0,6710 g/l
English: Magnesium chloride hexahydrate
Croatian: natrijev klorid, hidroksietilškrob
English: HES, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate, Sodium Acetate Trihydrate, Malic Acid
Croatian: 0,42, natrijev klorid, kalijev klorid, kalcijev klorid dihidrat, magnezijev klorid heksahidrat, natrijev acetat trihidrat, malatna kiselina
English: 100 g/l
Croatian: INFOHES 100 g/L
English: This overview was last updated in 11-2019.
Croatian: Pregled informacija posljednji je put ažuriran u 11. 2019.
English: Further information on Plegridy can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/plegridy.
Croatian: Više informacija o lijeku Plegridy dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/plegridy.
English: Treatment should start with a dose of 63 micrograms, followed by a dose of 94 micrograms after two weeks, and then 125 micrograms every two weeks thereafter.
Croatian: Liječenje treba započeti dozom od 63 mikrograma, nakon čega slijedi doza od 94 mikrograma nakon dva tjedna, a tek zatim 125 mikrograma svaka dva tjedna nakon toga.
English: Plegridy received a marketing authorisation valid throughout the EU on 18 July 2014.
Croatian: Lijek Plegridy dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 18. srpnja 2014.
English: What measures are being taken to ensure the safe and effective use of Plegridy?
Croatian: Koje se mjere poduzimaju da bi se osigurala sigurna i učinkovita primjena lijeka Plegridy?
English: Plegridy must not be used in patients who have severe depression or have thoughts of suicide.
Croatian: Lijek Plegridy ne smiju uzimati bolesnici koji boluju od ozbiljne depresije ili pomišljaju na samoubojstvo.
English: The main measure of effectiveness was the number of relapses that patients experienced over one year but the study also looked at other measures including how fast the patients' disability progressed.
Croatian: Glavno je mjerilo učinkovitosti bio broj relapsa koje je bolesnik imao u godini dana, iako su se ispitivanjem uzela u obzir i druga mjerila, uključujući i kako je brzo invaliditet napredovao.
English: Other information about Plegridy
Croatian: Ostale informacije o lijeku Plegridy
English: The exact way that Plegridy works in MS is not yet known but it seems to calm down the immune system, and prevents relapses of MS.
Croatian: Još uvijek nije potpuno poznato na koji način lijek Plegridy kod MS-a djeluje, ali čini se da smiruje imunosni sustav i sprječava relapse MS-a.
English: Side effects reported with Plegridy are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Plegridy pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Plegridy is given by injection under the skin of the abdomen, the arm or the thigh.
Croatian: Lijek Plegridy primjenjuje se injekcijom pod kožu abdomena, ruke ili bedra.
English: Plegridy is available as a solution for injection in pre-filled pens or pre-filled syringes that contain 63, 94 or 125 micrograms peginterferon beta-1a.
Croatian: Lijek Plegridy dostupan je kao otopina za injekciju u napunjenim brizgalicama i štrcaljkama koje sadrže 63, 94 ili 125 mikrograma peginterferona beta-1a.
English: What is Plegridy and what is it used for?
Croatian: Što je Plegridy i za što se koristi?
English: This decreases the rate at which the medicine is removed from the body and allows it to be given less often.
Croatian: To smanjuje brzinu uklanjanja lijeka iz tijela i omogućava njegovu rjeđu primjenu.
English: Plegridy is a medicine used to treat multiple sclerosis (MS), a disease in which inflammation damages the protective insulation around nerves (demyelination) as well as the nerves themselves.
Croatian: Plegridy je lijek koji se koristi za liječenje multiple skleroze (MS), bolesti kod koje upala oštećuje zaštitnu izolacijsku ovojnicu živaca (demijelinizacija), kao i same živce.
English: The active substance in Plegridy is the protein interferon beta-1a, one of a group of interferons that can be naturally produced by the body to help it fight against viruses and other attacks.
Croatian: Djelatna tvar lijeka Plegridy je protein interferon beta-1a, jedan iz skupine interferona koji tijelo prirodno proizvodi kako bi se lakše borilo protiv virusa i drugih napada.
English: In MS, the immune system (the body's natural defences) malfunctions and attacks parts of the central nervous system (the brain, spinal cord and optic nerve [nerve that sends signals from the eye to the brain]), causing inflammation that damages the nerves and the insulation around them.
Croatian: Kod MS-a imunosni sustav (prirodna obrana tijela) ne funkcionira ispravno i napada dijelove središnjeg živčanog sustava (mozak, kralježničnu moždinu i optički živac [živac koji šalje signale iz oka u mozak]) uzrokujući upalu koja oštećuje živce i njihovu izolacijsku ovojnicu.
English: As for all medicines, data on the use of Plegridy are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Plegridy kontinuirano se prate.
English: Plegridy can only be obtained with a prescription and treatment should be started under the supervision of a doctor experienced in treating MS.
Croatian: Lijek Plegridy izdaje se samo na recept, a liječenje se mora započeti pod nadzorom liječnika s iskustvom u liječenju MS-a.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Plegridy 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 Plegridy nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: The European Medicines Agency decided that Plegridy's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Plegridy nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u EU-u.
English: The most common side effects with Plegridy (which may affect more than 1 in 10 people) are headache, muscle pain, joint pain, influenza (flu)-like symptoms, pyrexia (fever), chills, asthenia (weakness), and erythema (reddening of the skin), pain or pruritus (itching) at the injection site.
Croatian: Najčešće nuspojave lijeka Plegridy (koje se mogu javiti u više od 1 na 10 osoba) jesu glavobolja, bol u mišićima, bol u zglobovima, simptomi slični influenci (gripi), pireksija (vrućica), zimica, astenija (slabost), eritem (crvenilo kože), bol ili pruritus (svrbež) na mjestu injiciranja.
English: Plegridy continued to produce benefit in the second year of treatment.
Croatian: Koristi od lijeka Plegridy bile su prisutne i tijekom druge godine liječenja.
English: It is used specifically in adults with a type of MS known as relapsing-remitting MS, where the patient has flareups of symptoms (relapses) between periods of recovery (remissions).
Croatian: Koristi se osobito u odraslih osoba s vrstom MS-a koji se naziva relapsno-remitirajuća multipla skleroza kod koje bolesnik između razdoblja oporavka (remisija) ima izbijanja simptoma (relapse).
English: What are the risks associated with Plegridy?
Croatian: Koji su rizici povezani s lijekom Plegridy?
English: Why is Plegridy authorised in the EU?
Croatian: Zašto je lijek Plegridy odobren u EU-u?
English: An overview of Plegridy and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Plegridy i zašto je odobren u EU-u
English: The Agency considered that Plegridy given every two weeks has been shown to produce about a 30% reduction in the number of relapses in patients with relapsing-remitting MS compared with placebo, which is comparable to the effect of other MS medicines containing nonpegylated interferon beta, and is considered clinically relevant.
Croatian: Agencija smatra da se uzimanjem lijeka Plegridy svaka dva tjedna broj relapsa u bolesnika s relapsno-remitirajućom multiplom sklerozom smanjio za oko 30 % u usporedbi s onima koji su uzimali placebo, što je usporedivo s učinkom drugih lijekova protiv MS-a koji sadrže nepegiliran interferon beta i što se smatra klinički relevantnim.
English: When Plegridy was given every four weeks its beneficial effect was smaller, and it was not possible to identify a group of patients in whom this less frequent dosing was considered appropriate.
Croatian: Kada se lijek Plegridy davao svaka četiri tjedna njegov je koristan učinak bio manji te nije bilo moguće identificirati skupinu bolesnika za koju se smatralo da je rjeđa primjena lijeka bila primjerena.
English: For more information about using Plegridy, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Plegridy pročitajte uputu o lijeku odnosno obratite se liječniku ili ljekarniku.
English: During the first year, patients were given Plegridy every two or four weeks, or placebo (a dummy treatment); during the second year, all patients were given Plegridy every two or four weeks.
Croatian: Tijekom prve godine bolesnici su primali lijek Plegridy ili placebo (prividno liječenje) svaka dva ili četiri tjedna, dok su tijekom druge godine svi bolesnici primali lijek Plegridy svaka dva ili četiri tjedna.
English: During the first year, patients treated with Plegridy every two or four weeks experienced fewer relapses on average than patients on placebo: 0.26 and 0.29 relapses versus 0.40, respectively.
Croatian: Bolesnici koji su tijekom prve godine primali lijek Plegridy svakih dva ili četiri tjedna imali su u prosjeku manje relapsa od bolesnika koji su uzimali placebo: 0,26 i 0,29 relapsa u odnosu na 0,4 relapsa kod obje skupine.
English: Patients can inject Plegridy themselves, provided that they have been trained.
Croatian: Bolesnici si mogu sami ubrizgavati lijek Plegridy uz uvjet da su za to osposobljeni.
English: With regards to the safety profile, the most common side effects observed during treatment with Plegridy are considered to be manageable and generally consistent with those seen with non-pegylated interferon products.
Croatian: S obzirom na sigurnosni profil najčešće nuspojave koje su uočene tijekom terapije lijekom Plegridy smatraju se rješivima i općenito u skladu s onima zabilježenima kod proizvoda s nepegiliranim interferonima.
English: Plegridy contains the active substance peginterferon beta-1a.
Croatian: Plegridy sadrži djelatnu tvar peginterferon beta-1a.
English: this interferon has been ‘pegylated' (attached to a chemical called polyethylene glycol).
Croatian: U lijeku Plegridy taj je interferon „pegiliran” (konjugiran s kemijskom tvari koja se naziva polietilenglikol).
English: How does Plegridy work?
Croatian: Kako djeluje Plegridy?
English: What benefits of Plegridy have been shown in studies?
Croatian: Koje su koristi od lijeka Plegridy utvrđene u ispitivanjima?
English: The progression of disability was reduced in patients given Plegridy every two weeks but less clearly so in those given the medicine every four weeks.
Croatian: Progresija onesposobljenosti bila je manja je u bolesnika koji su primali lijek Plegridy svaka dva tjedna, što je kod bolesnika koji su lijek primali svaka četiri tjedna bilo manje vidljivo.
English: Also, the Agency considered Plegridy to be of greater benefit to patients when given every two weeks as compared to less frequent injections tested in the study.
Croatian: Agencija također smatra da je lijek Plegridy od velike koristi za bolesnike kada se daje svaka dva tjedna u usporedbi s njegovom rjeđom primjenom kako se provjeravalo u ispitivanju.
English: How is Plegridy used?
Croatian: Kako se Plegridy primjenjuje?
English: This study was extended for two further years to investigate the long-term safety and efficacy of Plegridy, and available data from the extension phase at the time of approval were consistent with the results of the main study.
Croatian: Ispitivanje je produženo na dvije dodatne godine kako bi se ispitala dugoročna sigurnost i djelotvornost lijeka Plegridy.
English: For the full list of side effects and restrictions with Plegridy, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Plegridy potražite u uputi o lijeku.
English: Plegridy has been shown to reduce the rate of relapses in patients with relapsing-remitting MS in a main study which lasted two years and involved 1,516 patients.
Croatian: U glavnom ispitivanju koje je trajalo dvije godine i obuhvaćalo 1 516 bolesnika utvrđeno je da se lijekom Plegridy smanjuje stopa relapsa u bolesnika s relapsno-remitirajućom multiplom sklerozom.
English: ATCvet code: QI01AD07.
Croatian: ATC vet kod : QI01AD07
English: However, the chance of a hazard occurring has been estimated very low.
Croatian: Međutim, procijenjeno je da je mogućnost pojave opasnosti vrlo mala.
English: EXP Once reconstituted use within 2 hours.
Croatian: EXP Jednom rekonstituirano upotrijebiti unutar 2 sata.
English: Date of first authorisation: 04/09/2014.
Croatian: Datum prvog odobrenja: 04/09/2014.
English: 4) Offer to birds immediately.
Croatian: 4) Odmah primijenite na pticama.
English: Date of last renewal: 13/06/2019.
Croatian: Datum zadnjeg produljenja: 13/06/2019.
English: These measures should help to protect the environment.
Croatian: Ove mjere bi trebale pomoći u zaštiti okoliša.
English: After reconstitution the suspension looks clear.
Croatian: Nakon rekonstitucije suspenzija izgleda bistro.
English: Overdose (symptoms, emergency procedures, antidotes):
Croatian: Predoziranje (simptomi, hitni postupci, antidoti)::
English: Live IBV, D388
Croatian: Živi IBV, D388
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 stranici Europske Agencije za lijekove (http://www.ema.europa.eu/)
English: Interaction with other medicinal products and other forms of interaction:
Croatian: Interakcije s drugim medicinskim proizvodima i drugi oblici interakcija:
English: Duration of immunity: 8 weeks.
Croatian: Trajanje imunosti: 8 tjedana.
English: a) the administration of the product to animals will interfere with the implementation of a national programme for the diagnosis, control or eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
Croatian: a) će primjena veterinarsko-medicinskog proizvoda na životinjama interferirati s provedbom nacionalnog programa otkrivanja, kontrole ili iskorjenjivanja bolesti životinja ili će prouzročiti poteškoće u certificiranju odsutnosti zaraze u živim životinjama ili hrani ili drugim proizvodima dobivenim od tretiranih životinja.
English: 1) Reconstitute the lyophilisate using water of good quality (e.g. free from chlorine and/or disinfectants).
Croatian: 1) Rekonstituirajte liofilizat koristeći vodu dobre kvalitete (npr. bez klora i/ili dezinficijensa).
English: Ensure that the nasal drop is inhaled before freeing the bird.
Croatian: Osigurajte da se nazalna kapljica udahne prije puštanja ptice.
English: Pol. Ind. El Montalvo I, Parcela 38, Carbajosa de la Sagrada, Salamanca, 37008,
Croatian: Parcela 38, Carbajosa de la Sagrada, Salamanca, 37008,
English: Each dose of reconstituted vaccine contains:
Croatian: Svaka doza rekonstituiranog cjepiva sadrži: Djelatna tvar:
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/EV i Europskog Parlamenta i Vijeća koja je dopunjena, države članice zabranjuju ili mogu zabraniti uvoz, prodaju, opskrbu i/ili primjenu veterinarsko-medicinskog proizvoda na cijelom teritoriju ili na jednom njegovom dijelu ako je utvrđeno da:
English: 50% egg infective dose.
Croatian: 50% infektivna doza za jaja
English: Simultaneous use of both vaccines increases the risk of recombination of viruses and potential emergence of new variants.
Croatian: Istodobna primjena oba cjepiva povećava rizik rekombinacije virusa i potencijalnog stvaranja novih virusnih sojeva.
English: Wash and disinfect hands and equipment after vaccination to avoid the spread of the virus.
Croatian: Nakon cijepljenja, operite i dezinficirajte ruke i opremu zbog izbjegavanja širenja virusa.
English: 3) One drop containing one dose should be applied into one nostril or one eye.
Croatian: 3) Jedna kap koja sadrži jednu dozu mora se primijeniti u jednu nosnicu ili jedno oko.
English: Do not use the product if the contents are brownish and stick to the container as this indicates that the integrity of the container has been breached.
Croatian: Ne upotrebljavajte proizvod ako je sadržaj smećkast i zalijepljen za spremnik jer to ukazuje da je cjelovitost spremnika narušena.
English: All containers used for reconstitution should be clean and free from any traces of detergent or disinfectant.
Croatian: Svi spremnici upotrijebljeni za rekonstituciju moraju biti čisti i bez tragova deterdženta ili dezinficijensa.
English: If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Croatian: Ako zamijetite bilo koju nuspojavu, čak i one koje nisu navedene u ovoj uputi o VMP ili mislite da veterinarsko-medicinski proizvod ne djeluje, molimo obavijestite svog veterinara
English: EID50/dose
Croatian: EID50/doza
English: During this time, the contact of immunosuppressed and unvaccinated chickens with vaccinated chickens should be avoided.
Croatian: Tijekom tog vremena kontakt imunosupresivnih i necijepljenih pilića sa cijepljenim bi trebalo izbjegavati.
English: When spray devices are used it is advisable to consult the technical staff of the distributors before using this technique.
Croatian: Kada se koriste uređaji za raspršivanje, prije upotrebe ove tehnike preporučuje se posavjetovati s tehničkim osobljem distributera.
English: All chickens on the site should be vaccinated at the same time.
Croatian: Istovremeno treba cijepiti sve piliće na istom području.
English: Sodium hydroxide or hydrochloric acid (for pH adjustment) Water for injections
Croatian: Natrijev hidroksid ili klorovodična kiselina (za prilagodbu pH) Voda za injekcije
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 navedene u dijelu 6.1 SPC su ili dozvoljene tvari za koje je u tablici 1, Dodatka Uredbe Komisije (EU) br. 37/2010 naznačeno da određivanje MRL nije nužno, ili se smatra da se na njih ne primjenjuju odredbe Uredbe (EK) br. 470/2009 kada se primjenjuju u tom veterinarsko-medicinskim proizvodu.