FrancophonIA/ELRC3.0 huggingface dataset:
English: The withdrawal period for meat from pigs treated with Baycox Iron is 53 days.
Croatian: Razdoblje karencije za meso svinja liječenih VMP-om Baycox Iron iznosi 53 dana.
English: Further information on Baycox Iron can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/baycox-iron.
Croatian: Više informacija o VMP-u Baycox Iron nalazi se na internetskim stranicama Agencijeema.europa.eu/medicines/veterinary/EPAR/baycox-iron.:
English: Baycox Iron must not be given to piglets suspected to have insufficient levels of vitamin E or selenium.
Croatian: Baycox Iron se ne smije davati prasadi za koju se sumnja da ima nedovoljne razine vitamina E ili selena.
English: Baycox Iron may be harmful for the unborn child.
Croatian: VMP Baycox Iron može biti štetan za nerođenu djecu.
English: Following injection into the muscle, gleptoferron is absorbed and broken down to release iron for use and/or storage depending on the need for iron in suckling piglets.
Croatian: Nakon injekcije u mišić gleptoferon se apsorbira i razgrađuje te otpušta željezo za uporabu i/ili skladištenje, ovisno o potrebi prasadi za željezom.
English: Baycox Iron (toltrazuril/gleptoferron) EMA/207583/2019
Croatian: Baycox Iron (toltrazuril/gleptoferon) EMA/207583/2019
English: People who are hypersensitive (allergic) to iron compounds or toltrazuril should avoid contact with Baycox Iron.
Croatian: Osobe koje su preosjetljive (alergične) na spojeve sa željezom ili na toltrazuril trebaju izbjegavati kontakt s VMP-om Baycox Iron.
English: Baycox Iron is a veterinary medicine.
Croatian: Baycox Iron je veterinarsko-medicinski proizvod.
English: Iron is an essential nutrient needed to make haemoglobin to transport oxygen in the blood, as well as certain key enzymes, and without additional iron, piglets raised under intensive farming conditions will develop anaemia within 10 days after birth.
Croatian: Željezo je ključna hranjiva tvar za proizvodnju hemoglobina koji prenosi kisik u krvi, kao i određenih ključnih enzima, te će se bez dodatnog željeza u prasadi u uvjetima intenzivnog uzgoja razviti anemija u roku od 10 dana od njihova rođenja.
English: In a field study performed in 3 EU countries and involving 968 piglets on farms with a history of coccidiosis, a single intramuscular injection of Baycox Iron given at 3 days of age was effective in preventing iron deficiency anaemia, and reducing oocyst excretion and diarrhoea associated with coccidiosis caused by the coccidia parasite Cystoisospora suis, in comparison with giving iron only (as gleptoferron) at 3 days of age.
Croatian: U terenskom ispitivanju provedenom u trima državama EU-a, koje je obuhvatilo 968 praščića na gospodarstvima na kojima je prethodno bila zabilježena kokcidioza, jednokratna injekcija VMP-a Baycox Iron u mišić, ubrizgana kad su praščići bili stari 3 dana, bila je učinkovita u sprječavanju anemije uzrokovane manjkom željeza, u smanjenju izlučivanja oocista i proljeva povezanog s kokcidiozom koju uzrokuje parazit kokcidioze Cystoisospora suis, u usporebi s primjenom samo željeza (u obliku gleptoferona) u dobi od 3 dana starosti.
English: Pregnant women and women intending to conceive should avoid contact with the medicine, especially accidental self-injection.
Croatian: Trudnice i žene koje namjeravaju zatrudnjeti trebaju izbjegavati kontakt s ovim VMP-om, te je potreban oprez kako bi se izbjeglo nehotično samoinjiciranje.
English: Coccidiosis is a disease of the gut which results in reduced growth due to diarrhoea.
Croatian: Kokcidioza je bolest crijeva koja uzrokuje slabiji rast zbog proljeva.
English: Infected piglets shed disease spores (oocysts) in their faeces that can spread the infection.
Croatian: U stolici zaražene prasadi nalaze se spore bolesti (oociste) koje mogu širiti bolest.
English: Other information about Baycox Iron
Croatian: Ostale informacije o VMP-u Baycox Iron
English: The European Medicines Agency decided that Baycox Iron'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 Baycox Iron nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: What is Baycox Iron and what is it used for?
Croatian: Što je Baycox Iron i za što se koristi?
English: Baycox Iron is available as an injection and can only be obtained with a prescription.
Croatian: Baycox Iron je dostupan kao injekcija i izdaje se samo na veterinarski recept.
English: Baycox Iron (toltrazuril/gleptoferron)
Croatian: Baycox Iron (toltrazuril/gleptoferon)
English: The most common side effects with Baycox Iron (which may affect up to 1 in 10 piglets) are short-lived tissue discolouration and slight swelling at the injection site.
Croatian: Najčešće nuspojave VMP-a Baycox Iron (koje se mogu javiti u do 1 na 10 praščića) jesu kratkotrajna promjena boje tkiva i blaga oteklina na mjestu primjene injekcije.
English: It is used in young piglets on farms which have been affected in the past by the parasitic infection coccidiosis to prevent diarrhoea caused by a new coccidiosis infection.
Croatian: Primjenjuje se u mlade prasadi na gospodarstvima na kojima je prethodno bila zabilježena parazitska infekcija kokcidioza za sprječavanje proljeva uzrokovanog ponovnom kokcidiozom.
English: Baycox Iron is also used to reduce spread of the infection through passage of oocysts in faeces, and at the same time to prevent iron deficiency anaemia due to the limited iron reserves of new-born piglets, low iron content of milk and high growth rate of suckling piglets.
Croatian: Baycox Iron se primjenjuje i za ograničavanje širenja infekcije izlučivanjem oocista u stolici te istovremeno za sprječavanje anemije uzrokovane manjkom željeza zbog ograničenih zaliha željeza u novorođene prasadi, niskog udjela željeza u mlijeku i visoke stope rasta prasadi.
English: Baycox Iron received a marketing authorisation valid throughout the EU on 20 May 2019.
Croatian: Za VMP Baycox Iron izdano je odobrenje za stavljanje u promet koje je na snazi u EU-u od 20. svibnja
English: Why is Baycox Iron authorised in the EU?
Croatian: Zašto je Baycox Iron odobren u EU-u?
English: An overview of Baycox Iron and why it is authorised in the EU
Croatian: Pregled informacija o VMP-u Baycox Iron i zašto je odobren u EU-u
English: For more information about using Baycox Iron, see the package leaflet or contact your veterinarian or pharmacist.
Croatian: Za dodatne informacije o primjeni VMP-a Baycox Iron pogledajte uputu o VMP-u odnosno obratite se veterinaru ili ljekarniku.
English: What are the risks associated with Baycox Iron?
Croatian: Koji su rizici povezani s VMP-om Baycox Iron?
English: Baycox Iron contains the active substances toltrazuril and gleptoferron (an iron-containing compound).
Croatian: Baycox Iron sadrži djelatne tvari toltrazuril i gleptoferon (spoj koji sadrži željezo).
English: How does Baycox Iron work?
Croatian: Kako djeluje Baycox Iron?
English: How is Baycox Iron used?
Croatian: Kako se Baycox Iron koristi?
English: The other active substance in Baycox Iron, gleptoferron, is an iron-containing compound.
Croatian: Druga djelatna tvar VMP-a Baycox Iron, gleptoferon, spoj je koji sadrži željezo.
English: For the full list of side effects and restrictions of Baycox Iron, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja pri primjeni VMP-a Baycox Iron potražite u uputi o VMP-u.
English: What benefits of Baycox Iron have been shown in studies?
Croatian: Koje su koristi od VMP-a Baycox Iron utvrđene u ispitivanjima?
English: Applicant company name, address
Croatian: Podnositelj zahtjeva, naziv tvrtke, adresa
English: (Invented) Name Strength
Croatian: (Novoizumljeno) ime
English: Mentocaína Spray 8.75 mg/dose Oromucosal spray, solution
Croatian: Mentocaína Spray 8.75 mg/dose Sprej za usnu sluznicu, otopina
English: Flurbiprofen Sejmet 8.75 mg/dose Oromucosal spray, solution
Croatian: Flurbiprofen Sejmet 8.75 mg/dose Sprej za usnu sluznicu, otopina
English: The third study involved 59 children aged 2 to 12 years.
Croatian: Trećim ispitivanjem bilo je obuhvaćeno 59 djece u dobi između 2 i 12 godina.
English: Further information on Vihuma can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Vihuma.
Croatian: Više informacija o lijeku Vihuma nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/Vihuma.
English: Vihuma can be used for short-term or long-term treatment.
Croatian: Vihuma se može primjenjivati za kratkoročno ili dugoročno liječenje.
English: This medicine is the same as Nuwiq, which is already authorised in the EU.
Croatian: Ovaj lijek isti je kao lijek Nuwiq, koji je već odobren u EU-u.
English: The main measure of effectiveness was based on patients' assessment of how well treatment worked.
Croatian: Glavno mjerilo učinkovitosti temeljilo se na procjeni bolesnika o uspješnosti liječenja.
English: Vihuma received a marketing authorisation valid throughout the EU on 13 February 2017.
Croatian: Lijek Vihuma dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 13. veljače 2017.
English: What measures are being taken to ensure the safe and effective use of Vihuma?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Vihuma?
English: Vihuma (simoctocog alfa)
Croatian: Vihuma (simoktokog alfa)
English: The company that makes Nuwiq has agreed that its scientific data can be used for Vihuma (‘informed consent').
Croatian: Tvrtka koja proizvodi Nuwiq pristala je da se njezini znanstveni podatci koriste za lijek Vihuma (tzv. „informirani pristanak”).
English: What is Vihuma and what is it used for?
Croatian: Što je Vihuma i za što se primjenjuje?
English: A total of 986 bleeding episodes were recorded, most of which resolved with one injection of Vihuma.
Croatian: Zabilježeno je ukupno 986 epizoda krvarenja, a većina njih zaustavljena je jednom injekcijom lijeka Vihuma.
English: What are the risks associated with Vihuma?
Croatian: Koji su rizici povezani s lijekom Vihuma?
English: Other information about Vihuma
Croatian: Ostale informacije o lijeku Vihuma
English: Treatment with Vihuma was rated ‘excellent' or ‘good' for 94% of bleeding episodes.
Croatian: Terapija lijekom Vihuma ocijenjena je kao „izvrsna” ili „dobra” u 94 % epizoda krvarenja.
English: It contains the active substance simoctocog alfa (human coagulation factor VIII).
Croatian: Sadržava djelatnu tvar simoktokog alfa (ljudski koagulacijski faktor VIII).
English: Side effects reported with Vihuma are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Vihuma pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Why is Vihuma authorised in the EU?
Croatian: Zašto je lijek Vihuma odobren u EU-u?
English: Vihuma can only be obtained with a prescription, and treatment should be supervised by a doctor experienced in the treatment of haemophilia.
Croatian: Vihuma se izdaje samo na liječnički recept, a liječenje treba nadzirati liječnik s iskustvom u liječenju hemofilije.
English: The dose and duration of treatment depend on whether Vihuma is used to treat or prevent bleeding, or during surgery, as well as on the patient's factor VIII levels, the seriousness of the haemophilia, the extent and location of the bleeding and the patient's condition and weight.
Croatian: Doza i trajanje liječenja ovise o tome primjenjuje li se Vihuma za liječenje ili sprječavanje krvarenja ili tijekom kirurškog zahvata, kao i o razinama faktora VIII u bolesnika, o stupnju hemofilije, jačini i mjestu krvarenja te o stanju i težini bolesnika.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vihuma 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 Vihuma nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: An overview of Vihuma and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Vihuma i zašto je odobren u EU-u
English: The European Medicines Agency decided that Vihuma'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 Vihuma nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: As for all medicines, data on the use of Vihuma are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Vihuma kontinuirano se prate.
English: Vihuma was effective at preventing and treating bleeding episodes in three main studies involving 113 patients with haemophilia A.
Croatian: Lijek Vihuma pokazao se učinkovitim u sprječavanju i liječenju epizoda krvarenja u trima glavnim ispitivanjima u kojima je sudjelovalo 113 bolesnika s hemofilijom A.
English: When Vihuma was used for treatment, bleeding episodes resolved in 81% of cases following 1 or 2 injections.
Croatian: Kada se lijek Vihuma primjenjivao za liječenje, epizode krvarenja prestale su u 81 % slučajeva nakon jedne ili dviju injekcija.
English: Patients with haemophilia A lack factor VIII, and this causes blood clotting problems leading to events such as bleeding in the joints, muscles or internal organs.
Croatian: Bolesnicima s hemofilijom A nedostaje faktor VIII, što uzrokuje probleme sa zgrušavanjem krvi koji dovode do krvarenja u zglobovima, mišićima ili unutarnjim organima.
English: Some patients treated with factor VIII medicines may develop inhibitors (antibodies) against factor VIII, which may stop the medicine from working and controlling bleeding.
Croatian: U nekih bolesnika koji se liječe lijekovima koji sadrže faktor VIII mogu se razviti inhibitori (protutijela) faktora VIII, što može zaustaviti djelovanje lijeka i kontrolu krvarenja.
English: Vihuma is a medicine used for the treatment and prevention of bleeding in patients of all ages with haemophilia A (an inherited bleeding disorder caused by lack of factor VIII).
Croatian: Vihuma je lijek koji se primjenjuje za liječenje i sprječavanje krvarenja u bolesnika svih dobnih skupina s hemofilijom A (nasljednim poremećajem krvarenja prouzročenim nedostatkom faktora VIII).
English: Patients or their carers may be able to inject Vihuma themselves at home once they have been trained.
Croatian: Nakon obuke bolesnici ili njihovi njegovatelji mogu samostalno ubrizgavati lijek Vihuma kod kuće.
English: When used to prevent bleeding, an average of 0.19 bleeding episode per month was recorded for each patient.
Croatian: Kada se lijek primjenjivao za sprječavanje krvarenja, za svakog bolesnika zabilježeno je prosječno 0,19 epizoda krvarenja mjesečno.
English: The Agency concluded that Vihuma was effective at treating and preventing bleeding in patients with haemophilia A and it has an acceptable safety profile.
Croatian: Agencija je zaključila da je lijek Vihuma učinkovit u liječenju i sprječavanju krvarenja u bolesnika s hemofilijom A i da ima prihvatljiv sigurnosni profil.
English: Hypersensitivity (allergic) reactions have been reported with factor VIII medicines and they may be severe in some cases.
Croatian: Pri primjeni lijekova koji sadrže faktor VIII zabilježene su reakcije preosjetljivosti (alergijske reakcije) koje u nekim slučajevima mogu biti ozbiljne.
English: When used for treating bleeding episodes, Vihuma was mainly rated ‘excellent' or ‘good' at treating major bleeding episodes and most bleeding episodes resolved following one or more injections of Vihuma.
Croatian: U primjeni za liječenje epizoda krvarenja lijek Vihuma uglavnom je ocijenjen kao „izvrstan” ili „dobar” u liječenju velikih epizoda krvarenja, a većina epizoda krvarenja zaustavljena je nakon jedne injekcije lijeka Vihuma ili više njih.
English: For more information about using Vihuma, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Vihuma pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: The active substance in Vihuma, simoctocog alfa (human coagulation factor VIII), is a substance that helps the blood to clot.
Croatian: Djelatna tvar u lijeku Vihuma, simoktokog alfa (ljudski koagulacijski faktor VIII), pomaže u zgrušavanju krvi.
English: When Vihuma was used to prevent bleeding, an average of 0.34 bleeding episode per month was recorded for each child.
Croatian: Kada se lijek Vihuma primjenjivao radi sprječavanja krvarenja, za svako dijete zabilježene su prosječno 0,34 epizode krvarenja mjesečno.
English: In the 5 surgeries during the study, Vihuma was rated excellent in preventing bleeding episodes for 4 surgeries and as moderate to prevent bleeding during one surgical intervention.
Croatian: U pet kirurških zahvata obavljenih tijekom ispitivanja lijek Vihuma ocijenjen je kao izvrstan u sprječavanju epizoda krvarenja u četiri kirurška zahvata i kao umjereno učinkovit u sprječavanju krvarenja tijekom jedne kirurške intervencije.
English: The first study involved 22 patients aged 12 years and above, who were given Vihuma for the treatment of bleeding episodes or to prevent bleeding during surgery.
Croatian: U prvom ispitivanju sudjelovalo je 22 bolesnika u dobi od 12 i više godina, koji su primali lijek Vihuma za liječenje epizoda krvarenja ili za sprječavanje krvarenja tijekom kirurškog zahvata.
English: Vihuma corrects the factor VIII deficiency by replacing the missing factor VIII, giving temporary control of the bleeding disorder.
Croatian: Lijekom Vihuma rješava se nedostatak faktora VIII time što se njime nadomješćuje faktor VIII i tako omogućuje privremena kontrola poremećaja krvarenja.
English: How does Vihuma work?
Croatian: Kako djeluje Vihuma?
English: Vihuma is available as a powder and solvent to mix together to make a solution that is injected into a vein.
Croatian: Lijek Vihuma dostupan je u obliku praška i otapala koji se miješaju da bi se pripremila otopina za injekciju u venu.
English: What benefits of Vihuma have been shown in studies?
Croatian: Koje su koristi od lijeka Vihuma utvrđene u ispitivanjima?
English: For the full list of side effects and restrictions of Vihuma, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja vezanih uz primjenu lijeka Vihuma potražite u uputi o lijeku.
English: The second study involved 32 patients aged 12 years and above who were given Vihuma to prevent and treat bleeding events as well as to prevent bleeding during surgery.
Croatian: U drugom ispitivanju sudjelovalo je 32 bolesnika u dobi od 12 i više godina koji su primali lijek Vihuma radi sprječavanja i liječenja krvarenja kao i za sprječavanje krvarenja tijekom kirurškog zahvata.
English: In the 2 surgeries during the study, Vihuma was rated excellent in preventing bleeding episodes.
Croatian: U dva kirurška zahvata obavljena tijekom ispitivanja lijek Vihuma ocijenjen je kao izvrstan u sprječavanju epizoda krvarenja.
English: How is Vihuma used?
Croatian: Kako se Vihuma primjenjuje?
English: ATCvet code QI07AB01.
Croatian: ATCvet kod: QI07AB01.
English: 0.1 mg Colourless suspension.
Croatian: 0.1 mg Bezbojna suspenzija.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 03/07/2015
Croatian: Datum prvog odobrenja:03/07/2015
English: Do not mix with any other veterinary medicinal products except those mentioned in section 4.8.
Croatian: Ne miješati s bilo kojim drugim veterinarsko-medicinskim proizvodima osim onih navedenih u odjeljku 4.8.
English: (*) In case of high level of maternally derived antibodies, first vaccination is recommended at 9 weeks of age.
Croatian: U slučaju visoke razine maternalno dobivenih antitijela, prvo cijepljenje se preporučuje u dobi od 9 tjedana.
English: Shelf life of the veterinary medicinal product as packaged for sale: 21 months.
Croatian: Rok valjanosti veterinarsko-medicinskog proizvoda kad je zapakiran za prodaju: -21 mjesec.
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 nuspojave, čak i one koje nisu opisane u uputi o VMP ili mislite da proizvod nije djelotvoran, molimo javite veterinaru.
English: VIRBAC Ltd, Woolpit Business Park, Windmill Avenue, Woolpit,
Croatian: VIRBAC Ltd, Woolpit Business Park, Windmill Avenue, Woolpit, Bury St.
English: Potassium chloride Disodium phosphate dihydrate Potassium dihydrogen phosphate Water for injections
Croatian: Natrijev klorid Kalijev klorid Dinatrij fosfat dihidrat Kalij dihidrogenfosfat Voda za injekcije
English: Pharmacotherapeutic group: Immunologicals for Canidae, inactivated bacterial vaccine.
Croatian: Farmakoterapijska grupa: imunološki pripravak za Canidae, inaktivirano bakterijsko cjepivo.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
Croatian: RIJEČI “SAMO ZA PRIMJENU NA ŽIVOTINJAMA” I UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE, ako je primjenjivo
English: Basic vaccination: The first vaccination can be administered from 6 to 9(*) weeks of age and the second vaccination from 10 to 13 weeks of age.
Croatian: Osnovno cijepljenje: prvo cijepljenje u dobi 6 do 9(*) tjedana, a drugo cijepljenje u dobi od 10 do 13 tjedana starosti.
English: 10x 1 ml (1 dose) 50x 1 ml (1 dose) 1x 10 ml (10 doses)
Croatian: 10 x 1 ml (1 doza) 50 x 1 ml (1 doza) 1 x 10 ml (10 doza)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL
Croatian: OSNOVNI PODACI NAPISANI NA MALIM JEDINICAMA UNUTARNJIH PAKOVANJA NALJEPNICA
English: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Croatian: Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer Nizozemska
English: MARKETING AUTHORISATION NUMBER(S) EU/2/15/183/001 - 10 vials (1 ml) EU/2/15/183/002 - 50 vials (1 ml) EU/2/15/183/003 - 1 vial (10 ml)
Croatian: EU/2/15/183/001 - 10 bočica (1 ml) EU/2/15/183/002 - 50 bočica (10ml) EU/2/15/183/003 - 1 bočica (10 ml)
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label.
Croatian: Ne koristiti veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na etiketi.
English: België/Belgique/Belgien: VIRBAC,
Croatian: België/Belgique/Belgien:
English: VIRBAC ESPAÑA S.A., Angel Guimerá 179-181, ES-8950 Esplugues de Llobregat, infocliente@virbac.es
Croatian: VIRBAC ESPAÑA S.A., Angel Guimerá 179-181, ES-8950 Esplugues de Llobregat,
English: Revaccination: Dogs should be re-vaccinated annually with one dose (1 ml) of vaccine.
Croatian: Revakcinacija: pse treba nadocijepiti svake godine s jednom dozom (1 ml) cjepiva. (*)
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - 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: Učestalost nuspojava je određena prema slijedećim pravilima: - vrlo česte (više od 1 na 10 tretiranih životinja pokazuju nuspojave) - česte (više od jedne ali manje od 10 životinja od 100 tretiranih životinja) - manje česte (više od 1 ali manje od 10 životinja na 1000 tretiranih životinja) - 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: Type I glass vial of 1 ml (1 dose) or 10 ml (10 doses) closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap.
Croatian: Staklena bočica tipa I, od 1 ml (1 doza) ili 10 ml (10 doza) začepljena s halogenbutil gumenim čepom i zapečaćena s označenom aluminijskom kapicom.