FrancophonIA/ELRC3.0 huggingface dataset:
English: This is a summary of the European public assessment report (EPAR) for Imrestor.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Imrestor.
English: The medicine can only be obtained with a prescription and is available as a solution for injection in pre-filled syringes.
Croatian: Lijek se izdaje samo na recept i dostupan je kao otopina za injekciju u napunjenim štrcaljkama.
English: Neutrophils are part of the immune system (the body's natural defences) and help to fight infection.
Croatian: Neutrofili su dio imunosnog sustava (prirodne obrane tijela) i pomažu u borbi protiv infekcije.
English: Gloves should be removed and hands and exposed skin washed after use.
Croatian: Nakon uporabe potrebno je skinuti rukavice te oprati ruke i izloženu kožu.
English: Other information about Imrestor
Croatian: Ostale informacije o VMP-u Imrestor
English: The withdrawal period for meat and milk from cows treated with Imrestor is ‘zero' days, which means there is no mandatory waiting time.
Croatian: Razdoblje karencije za meso i mlijeko krava liječenih VMP-om Imrestor iznosi „nula” dana, drugim riječima, nema obveznog perioda čekanja.
English: By giving Imrestor, the number of neutrophils in the blood is increased, which is an aid to reduce the risk of infections of the udder that might lead to mastitis.
Croatian: Davanjem Imrestora povećava se broj neutrofila u krvi, što pomaže u smanjenju rizika od infekcija vimena koje mogu rezultirati mastitisom.
English: It contains the active substance pegbovigrastim.
Croatian: Sadržava djelatnu tvar pegbovigrastim.
English: Headache and bone and muscle pain may occur.
Croatian: Mogu se javiti glavobolja te bol u kostima i mišićima.
English: In case of accidental self-injection, medical advice should be sought immediately and the package leaflet or label shown to the doctor.
Croatian: U slučaju nehotičnog samoinjektiranja potrebno je odmah potražiti liječnički savjet te pokazati uputu o proizvodu ili etiketu liječniku.
English: What are the risks associated with Imrestor?
Croatian: Koji su rizici povezani s VMP-om Imrestor?
English: The most common side effects with Imrestor (which may affect up to 1 in 100 cows) are non-typical anaphylactoid (allergic) reactions seen as swelling of mucous membranes (notably vulva and eyelid), skin reactions, increased respiration rate and salivation.
Croatian: Najčešće nuspojave VMP-a Imrestor (mogu se javiti u manje od jedne krave na 100 krava) jesu netipične anafilaktoidne (alergijske) reakcije koje se očituju kao oticanje sluznica (posebice vulve i očnog kapka), kožne reakcije, ubrzano disanje i povećano slinjenje.
English: Imrestor is a veterinary medicine used as an aid in a herd management programme, to reduce the risk of clinical mastitis (inflammation of the udder) in dairy cows and heifers (cows that have not produced a calf) during the 30 days following calving.
Croatian: Imrestor je veterinarsko-medicinski proizvod koji se koristi kao pomoć u programima upravljanja stadom za smanjenje rizika od kliničkog mastitisa (upala vimena) u krava muzara i junica (krave koje se još nisu otelile) tijekom 30 dana nakon teljenja.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Imrestor's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za veterinarsko-medicinske proizvode (CVMP) pri Agenciji odlučio je da koristi od VMP-a Imrestor nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za primjenu u Europskoj uniji.
English: The content of a single pre-filled syringe is given by injection under the skin (subcutaneously) to a dairy cow/heifer preferably 7 days before the anticipated date of calving.
Croatian: Sadržaj pojedine napunjene štrcaljke daje se ubrizgavanjem pod kožu (subkutano) krava muzara/junica, po mogućnosti sedam dana prije očekivanog dana teljenja.
English: How does Imrestor work?
Croatian: Kako djeluje Imrestor?
English: For the full list of all side effects reported with Imrestor, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Imrestor potražite u uputi o VMP-u.
English: For more information about treatment with Imrestor, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Dodatne informacije o terapiji VMP-om Imrestor vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u ili se trebaju obratiti svom veterinaru ili ljekarniku.
English: How is Imrestor used?
Croatian: Kako se Imrestor koristi?
English: What benefits of Imrestor have been shown in studies?
Croatian: Koje su koristi VMP-a Imrestor utvrđene u ispitivanjima?
English: Personal protective equipment consisting of gloves should be worn when handling broken or damaged syringes.
Croatian: Pri rukovanju s pokidanim ili oštećenim injekcijama potrebno je nositi osobnu zaštitnu opremu koja se sastoji od rukavica.
English: For practical information about using Imrestor, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Praktične informacije o primjeni VMP-a Imrestor vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti svo veterinaru ili ljekarniku.
English: The withdrawal period is the time required after administration of a medicine before an animal can be slaughtered and the meat used for human consumption.
Croatian: Razdoblje karencije je vrijeme koje treba proći nakon primjene VMP-a i prije klanja životinje te korištenja mesa za prehranu ljudi.
English: The European Commission granted a marketing authorisation valid throughout the EU for Imrestor on
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za VMP Imrestor na snazi u Europskoj uniji od 09/12/2015.
English: It works by preventing the release of the neurotransmitter noradrenaline from nerve cells in the body.
Croatian: Djeluje sprečavanjem otpuštanja neurotransmitera noradrenalina iz živčanih stanica u tijelu.
English: The duration and depth of sedation and analgesia relate to the dose that is used.
Croatian: Trajanje i dubina sedacije i analgezije ovisni su o dozi koja se primjenjuje.
English: • as premedication (treatment given before inducing general anaesthesia).
Croatian: • u slučaju premedikacije (postupak prije uvođenja opće anestezije).
English: In cats, it is given by intramuscular injection.
Croatian: U mačaka, primjenjuje se intramuskularnom injekcijom.
English: It explains how the Agency assessed this veterinary medicine to recommend its authorisation in the European Union (EU) and its conditions of use.
Croatian: Objašnjava kako je Agencija ocijenila ovaj VMP, kako bi preporučila njegovo odobrenje u Europskoj uniji (EU) i uvjete za njegovu primjenu.
English: Since noradrenaline is involved in maintaining alertness and arousal, reducing its release decreases the level of consciousness, including the sensation of pain.
Croatian: Budući da je noradrenalin uključen u održavanje budnosti i uzbuđenosti, smanjivanjem njegovog otpuštanja smanjuje se razina svijesti, uključujući i osjećaj boli.
English: A neurotransmitter is a substance that nerve cells use to communicate with neighbouring cells.
Croatian: Neurotransmiter je tvar koju živčane stanice upotrebljavaju za komunikaciju sa susjednim stanicama.
English: It is not intended to provide practical advice on how to use Sedadex.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju VMP-a Sedadex.
English: The company provided information on the quality and manufacture of Sedadex.
Croatian: Proizvođač je dostavio informacije o kvaliteti i proizvodnji VMP-a Sedadex.
English: This summary was last updated in June 2016.
Croatian: Sažetak je posljednji put ažuriran u 06.2016.
English: What are the benefits and risks of Sedadex?
Croatian: Koje su koristi i rizici VMP-a Sedadex?
English: Dexmedetomidine is closely related to another substance used to sedate animals, medetomidine, that has been used in veterinary medicine for many years.
Croatian: Deksmedetomidin je usko povezan s drugom tvari koja se primjenjuje u sedaciji životinja, medetomidinom, koji se dugi niz godina primjenjuje u veterinarskoj medicini.
English: Dexmedetomidine is an alpha2-adrenoceptor agonist.
Croatian: Deksmedetomidin je antagonist alfa2-adrenergičkih receptora.
English: The European Commission granted a marketing authorisation valid throughout the EU for Sedadex on 12 August 2016.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za VMP Sedadex na snazi u Europskoj uniji od 12. kolovoza 2016.
English: • Sedadex can also be used in dogs to provide pain relief and deep sedation when carrying out medical procedures and minor surgery where it is used in combination with butorphanol (a sedative and analgesic).
Croatian: • Sedadex se također može koristiti u pasa za ublažavanje boli i duboku sedaciju kod provođenja medicinskih i manjih kirurških zahvata, kada se primjenjuje u kombinaciji s butorfanolom (sedativ i analgetik).
English: • when carrying out mildly to moderately painful procedures and examinations that require the animal to be restrained or sedated and made less sensitive to pain (analgesia) but are non-invasive (do not involve breaking the skin or a body cavity).
Croatian: • u slučaju provođenja blago do umjereno bolnih zahvata i pregleda koji zahtijevaju obuzdavanje ili sedaciju životinje i smanjenu osjetljivost na bol (analgeziju), ali su neinvazivni (ne uključuju probijanje kože niti tjelesne šupljine);
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that, in accordance with EU requirements, Sedadex has been shown to have comparable quality to Dexdomitor.
Croatian: Odbor za veterinarsko-medicinske proizvode (CVMP) pri Agenciji zaključio je kako je, u skladu sa zahtjevima EU-a, potvrđeno da Sedadex posjeduje usporedivu kvalitetu s VMP-om Dexdomitor.
English: In dogs, Sedadex is given by injection into a vein or a muscle.
Croatian: U pasa, Sedadex se ubrizgava se u venu ili mišić.
English: Sedadex dexmedetomidine
Croatian: Sedadex deksmedetomidin
English: What is Sedadex and what is it used for?
Croatian: Što je Sedadex i za što se koristi?
English: Sedadex is a medicine used to sedate (calm down) and relieve pain in dogs and cats:
Croatian: Sedadex je VMP koji se koristi za sedaciju (opuštanje) i ublažavanje boli u pasa i mačaka:
English: This is a summary of the European public assessment report (EPAR) for Sedadex.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) veterinarsko-medicinskog proizvoda (VMP) Sedadex.
English: This means that Sedadex is similar to a ‘reference medicine' already authorised in the EU called Dexdomitor.
Croatian: To znači da je Sedadex sličan „referentnom VMP-u” koji je već odobren u EU-u pod nazivom Dexdomitor.
English: The dose in each species depends on the body surface area in dogs (calculated using bodyweight) and bodyweight in cats, and on the use, type of injection and any other medicines that are being used.
Croatian: Doze se za pojedinu vrstu određuju prema površini tijela u pasa (izračunava se prema tjelesnoj težini) i tjelesnoj težini u mačaka, te prema primjeni, vrsti injekcije i drugim VMP-ovima koji se primjenjuju.
English: Therefore, the CVMP's view was that, as for Dexdomitor, the benefits outweigh the identified risks.
Croatian: Stoga je stav CVMP-a da u slučaju VMP-a Dexdomitor koristi nadmašuju utvrđene rizike.
English: Why is Sedadex approved?
Croatian: Zašto je Sedadex odobren?
English: No additional studies were needed as Sedadex is a generic medicine that is given by injection, is similar in composition to, and contains the same active substance as, the reference medicine, Dexdomitor.
Croatian: Nisu bila potrebna dodatna ispitivanja jer je Sedadex generički VMP koji se daje injekcijom, sličnog je sastava i sadrži istu djelatnu tvar kao i referentni VMP Dexdomitor.
English: Sedadex is available as a solution for injection and can only be obtained with a prescription.
Croatian: Sedadex je dostupan kao otopina za injekciju i izdaje se samo na veterinarski recept.
English: Because Sedadex is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je Sedadex generički VMP te je bioekvivalent referentnom VMP-u, smatra se da su njegove koristi i rizici isti kao i oni referentnog VMP-a.
English: Sedadex contains the active substance dexmedetomidine and is a ‘generic medicine'.
Croatian: Sedadex sadrži djelatnu tvar deksmedetomidin te je „generički VMP”.
English: The Committee recommended that Sedadex be approved for use in the EU.
Croatian: Odbor je preporučio izdavanje odobrenja za stavljanje u promet VMP-a Sedadex u EU-u.
English: Other information about Sedadex?
Croatian: Ostale informacije o VMP-u Sedadex
English: The full EPAR for Sedadex can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za VMP Sedadex nalazi se na internetskim stranicama Agencije: http://www.ema.europa.eu/docs/hr_HR/document_library/Medicine_QA/2009/11/WC500012382.pdf.
English: For practical information about using Sedadex, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Praktične informacije o primjeni VMP-a Sedadex vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti svojem veterinaru ili ljekarniku.
English: How does Sedadex work?
Croatian: Kako djeluje Sedadex?
English: Safety information has been included in the summary of product characteristics and the package leaflet for Sedadex, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Croatian: U sažetku opisa svojstava VMP-a kao i u uputi o VMP-u Sedadex nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se veterinari te vlasnici životinja ili uzgajivači trebaju pridržavati.
English: How is Sedadex used?
Croatian: Kako se Sedadex koristi?
English: For more information about treatment with Sedadex, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Više informacija o terapiji VMP-om Sedadex vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno obratiti se odabranom veterinaru ili ljekarniku.
English: How has Sedadex been studied?
Croatian: Kako je Sedadex ispitivan?
English: The precautions are the same as for the reference medicine since Sedadex is a generic medicine.
Croatian: Budući da je Sedadex generički VMP, mjere opreza iste su kao i kod referentnog VMP-a.
English: How much and how often to take?
Croatian: Koja količina i koliko često uzeti?
English: • any issue you had
Croatian: • sve probleme koje ste možda imali
English: • Upright and stable during use,
Croatian: • uspravan i stabilan tijekom upotrebe,
English: 2 April 2019
Croatian: 02. travnja 2019.
English: You will hear a loud click, which means the injection has started.
Croatian: Čuti ćete glasan klik, što znači da je injektiranje započelo.
English: concentrations were dose proportional.
Croatian: koncentracije su bile proporcionalne dozi.
English: CI 95% for HR
Croatian: 95% CI za HR
English: Not known (frequency cannot be estimated from available data)
Croatian: Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka)
English: 6.6 The needle is now covered and is safe.
Croatian: Igla je sada prekrivena i sigurna.
English: 1.2 You will also need (Figure A):
Croatian: Također će vam biti potrebni (slika A):
English: Open here
Croatian: Ovdje otvoriti
English: • Hold the syringe like a pencil.
Croatian: • Držite štrcaljku kao olovku.
English: Clinical response (CR- 100)
Croatian: Klinički odgovor (CR-100)
English: • Properly labeled to warn of hazardous waste inside the container.
Croatian: • pravilno obilježen da bi upozorio na opasan otpad u spremniku.
English: Note: With experience, you will find the angle (between 45° an 90°) that is most comfortable for you and the child.
Croatian: Napomena: Kad steknete iskustvo, pronaći ćete kut (između 45° i 90°) koji je najugodniji za Vas i Vaše dijete.
English: Maintenance dose starting at week 4
Croatian: Doza održavanja počevši od 4. tjedna
English: Median time to failure (months)
Croatian: Medijan vremena do neuspjeha (mjeseci)
English: confidence interval)
Croatian: interval pouzdanosti)
English: If you still see air gaps or bubbles at the tip of the syringe, repeat this step until air gaps or bubbles are gone.
Croatian: Ako još uvijek vidite zračne prostore ili mjehuriće na vrhu štrcaljke, ponavljajte ovaj korak dok zračni prostori ili mjehurići ne nestanu.
English: Injecting cold medicine may be painful.
Croatian: Injiciranje hladnog lijeka može biti bolno.
English: Warning: Gloves do not replace the need for washing hands.
Croatian: Upozorenje: Rukavice ne zamjenjuju potrebu pranja ruku.
English: No effects on the breastfed newborns/infants are anticipated.
Croatian: Ne očekuju se učinci na dojenu novorođenčad/dojenčad.
English: After Use
Croatian: Poslije uporabe
English: • severe allergic reaction with shock;
Croatian: • teška alergijska reakcija uz šok,
English: Slowly release your thumb up.
Croatian: Polako otpustite pritisak palcem.
English: Other opportunistic infections
Croatian: Druge oportunističke infekcije
English: Available data suggest that adalimumab does not worsen or cause strictures.
Croatian: Dostupni podaci pokazuju da adalimumab ne uzrokuje i ne pogoršava strikture.
English: Succursale de Corsier-sur-Vevey Chemin du Fenil Zone Industrielle B 1804 Corsier-sur-Vevey Switzerland
Croatian: Succursale de Corsier-sur-Vevey Chemin du Fenil Zone Industrielle B 1804 Corsier-sur-Vevey Švicarska
English: Check components to make sure that the packaging and the content are not damaged.
Croatian: Provjerite komponente kako biste bili sigurni da njihovo pakiranje ili sadržaj nisu oštećeni,,
English: • the date
Croatian: • datum
English: • place two fingers on the label area
Croatian: • stavite dva prsta na označeni dio
English: Among those, 109 subjects (63.7%) were reported to be in remission at 10 years.
Croatian: Za 109 od tih ispitanika (63,7%) prijavljeno je da su bili u remisiji nakon 10 godina.
English: Clinical studies in patients suffering hidradenitis suppurativa in this section are merely included for public health reasons.
Croatian: Kliničke studije u bolesnika koji boluju od gnojnog hidradenitisa su uključene u ovaj dio samo iz razloga javnog zdravlja.
English: Then release the pinched skin.
Croatian: Zatim otpustite kožni nabor.
English: It can now be thrown away in the sharps container.
Croatian: Sada se može baciti u spremnik za oštre predmete.
English: 1.3 Open the kit and take out all components and put them on a clean, dry, flat surface.
Croatian: 1.3 Otvorite set i izvadite sve komponente te ih stavite na čistu, suhu i ravnu površinu.
English: 1.1 Prepare a clean flat surface, such as a table or countertop, in a well-lit area.
Croatian: 1.1 Pripremite čistu ravnu površinu, poput stola ili radne ploče, na dobro osvijetljenu području.
English: • You did not inject the full dose or
Croatian: • niste injicirali punu dozu ili
English: Tuberculosis (TB)
Croatian: Tuberkoloza (TBC)
English: If you do not have a sharps disposal container, you may use a household container that is:
Croatian: Ako nemate spremnik za odlaganje oštrih predmeta, možete koristiti kućni spremnik koji je:
English: Detailed instructions on how to inject Kromeya are provided in section 7 ‘Instructions for use'.
Croatian: Detaljne informacije o injektiranju lijeka Kromeya su dane u dijelu 7 „Upute za uporabu“.
English: However, please note that Kromeya is neither intended nor authorized for treatment of hidradenitis suppurativa.
Croatian: Međutim važno je da znate da Kromeya nije namijenjena niti odobrena za liječenje gnojnog hidradenitisa.
English: - This medicine has been prescribed for your child only.
Croatian: Ovaj je lijek propisan samo Vašem djetetu.
English: Injecting cold medicine can be painful (Figure E).
Croatian: Injiciranje hladnog lijeka može biti bolno (slika E).
English: TIME (MONTHS)
Croatian: VRIJEME (MJESECI)
English: Your child may first be given other medicines.
Croatian: Moguće je da će Vašem djetetu prvo biti propisani drugi lijekovi.
English: Use a new pre-filled syringe instead.
Croatian: Umjesto toga primijenite novu napunjenu štrcaljku.
English: • swollen face, hands, feet;
Croatian: • otečeno lice, šake ili stopala,
English: Do not try to reinsert it and use a new kit.
Croatian: Ne pokušavajte ga ponovno umetnuti, već upotrijebite novi set.
English: HR of adalimumab vs placebo from proportional hazards regression with treatment as factor.
Croatian: HR za adalimumab naspram placeba iz regresije proporcionalnih hazarda, uz liječenje kao faktor.
English: The liquid should be clear and colorless.
Croatian: Tekućina treba biti bistra i bezbojna.
English: • A sharps container (see section 7.2).
Croatian: • spremnik za oštre predmete (vidjeti dio 7.2).
English: Concomitant stable doses of aminosalicylates, corticosteroids, and/or immunomodulatory agents were permitted and 80% of patients continued to receive at least one of these medications.
Croatian: Istodobne stabilne doze aminosalicilata, kortikosteroida i/ili imunomodulatora bile su dozvoljene te je 80% bolesnika nastavilo uzimati barem jedan od ovih lijekova.
English: Other medicines and Kromeya
Croatian: Drugi lijekovi i Kromeya
English: Warning: Call your healthcare professional or pharmacist if:
Croatian: Upozorenje: Nazovite svog liječnika ili ljekarnika ako:
English: Reports included cases of pulmonary and extra-pulmonary (i.e. disseminated) tuberculosis.
Croatian: Prijave su obuhvaćale slučajeve pulmonalne i ekstrapulmonalne (tj. diseminirane) tuberkuloze.
English: PROBABILITY OF FAILING TREATMENT
Croatian: VJEROJATNOST NEUSPJEHA LIJEČENJA
English: Always take the outer carton of the medicine with you, even if it is empty.
Croatian: Vanjsko pakiranje lijeka uvijek ponesite sa sobom, čak i ako je prazno.
English: What Kromeya is and what it is used for
Croatian: Što je Kromeya i za što se koristi
English: Sodium hydroxide (for pH adjustment) Water for injections
Croatian: natrijev hidroksid (za podešavanje pH) voda za injekcije
English: The primary efficacy endpoint in both studies was ´time to treatment failure´.
Croatian: Primarna mjera ishoda za djelotvornost u oba ispitivanja bilo je 'vrijeme do neuspjeha liječenja'.
English: Patients who experience insufficient response may benefit from an increase in dosage:
Croatian: Bolesnici u kojih se ne postigne zadovoljavajući odgovor mogli bi imati koristi od povećanja doziranja:
English: Double-blind response at week 12
Croatian: Dvostruko slijepo Odgovor u 12. tjednu
English: • When the syringe plunger has moved to the bottom and has stopped moving, continue holding it for 5 seconds.
Croatian: • Kada se klip štrcaljke spustio skroz dolje i prestao se micati, nastavite držati tako brizgalicu još 5 sekundi.
English: Non-clinical data reveal no special hazard for humans based on studies of single dose toxicity, repeated dose toxicity and genotoxicity.
Croatian: Neklinički podaci ne upućuju na poseban rizik za ljude na temelju ispitivanja toksičnosti pojedinačne doze, toksičnosti ponovljenih doza i genotoksičnosti.
English: Table 23 Maintenance regimen
Croatian: Tablica 23 Režim održavanja
English: 61352 Bad Homburg v.d.Höhe Germany
Croatian: 61352 Bad Homburg v.d.Höhe
English: Table 17 Maintenance regimen
Croatian: Tablica 17 Režim održavanja
English: You and your doctor should pay special attention to signs of infection while you are being treated with Kromeya.
Croatian: I Vi i Vaš liječnik morate obratite posebnu pažnju na znakove infekcije dok se liječite lijekom Kromeya.
English: Step 2 Wash your hands
Croatian: 2. korak Operite ruke
English: Double-blind response at week 68
Croatian: Dvostruko slijepo Odgovor u 68. tjednu