FrancophonIA/ELRC3.0 huggingface dataset:
English: A transient increase in body temperature (up to 1.7 °C) is very common during the first 24 hours after vaccination.
Croatian: Vrlo čest je prolazni porast tjelesne temperature (do 1,7 ⁰C) u prvih 24 sata nakon vakcinacije, koji se spontano povlači unutar 48 sati bez liječenja.
English: Single intramuscular injection in the neck behind the ear of one dose (2 ml) to pigs from 21 days of age.
Croatian: Jedna intramuskularna injekcija u vrat svinje, iza uha u dozi od 2 ml prasadi starijoj od 21 dan.
English: Onset of immunity: from 3 weeks post-vaccination.
Croatian: Početak imunosti: 3 tjedna nakon vakcinacije.
English: Single intramuscular injection of one dose (2 ml).
Croatian: Jedna intramuskularna injekcija u dozi od 2 ml.
English: D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Croatian: OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE U PROMET
English: Major incompatibilities: Do not mix with any other veterinary medicinal product.
Croatian: Inkompatibilnosti:Ovaj proizvod se ne smije miješati s drugim veterinarsko-medicinskim proizvodima.
English: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Croatian: U slučaju da se nehotice samoinjiciranja, odmah potražite pomoć liječnika i pokažite mu uputu o VMP
English: It is intended to stimulate active immunity against PCV2 in piglets.
Croatian: Namijenjen za stimulaciju aktivne imunosti protiv PCV2 kod prasadi.
English: Pharmacotherapeutic group: Immunologicals for suidae, inactivated viral vaccine.
Croatian: Farmakoterapijska skupina: Imunološki proizvodi za svinje (Suidae), inaktivirano virusno cjepivo
English: Due to new field strains (PCV genotype), lack of expected efficacy (LEE) events should be submitted electronically on a yearly basis.
Croatian: Zbog novih terenskih sojeva (PCV genotip), nedostatak očekivane učinkovitosti (eng.
English: Cardboard box containing polyethylene bottles with a chlorobutyl elastomer closure and sealed with an aluminium cap.
Croatian: 6.5 Osobine i sastav unutarnjeg pakovanja Kartonska kutija sadrži polietilensku bočicu sa klorbutilnim elastomernim čepom i aluminijskom kapicom.
English: b) The disease to which the product is intended to confer immunity is largely absent from the territory in question.
Croatian: b) je bolest za koju je odnosni veterinarsko-medicinski proizvod namijenjen da pruži imunost, odsutna s tog područja.
English: A milky white to pink opaque liquid, free from visible particles
Croatian: Mliječno bijela do ružičasta neprozirna tekućina, bez vidljivih čestica
English: Pregnancy and lactation: Do not use during pregnancy and lactation.
Croatian: Ne primjenjivati tijekom graviditeta i laktacije.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV DJELATNE(IH) TVARI I DRUGIH SASTOJAKA
English: PACKAGE LEAFLET: Suvaxyn PCV suspension for injection for pigs
Croatian: UPUTA O VMP: Suvaxyn PCV suspenzija za injekciju za svinje
English: Name and address of the manufacturer of the biological active substance(s)
Croatian: Naziv i adresa proizvođača biološki djelatne tvari
English: Shake well before administration and intermittently during the process of vaccination.
Croatian: Dobro protresti prije uporabe te povremeno i za vrijeme vakcinacije.
English: Cardboard box of 10 bottles of 10 doses (20 ml), 50 doses (100 ml) or 125 doses (250 ml).
Croatian: Kartonska kutija s deset bočica od 10 doza (20 ml), 50 doza (100 ml) ili 125 doza (250 ml).
English: Administer one dose of 2 ml to piglets in the neck behind the ear.
Croatian: Vakcina se daje u dozi od 2 ml u vrat, iza uha prasadi.
English: Intramuscular use
Croatian: Intramuskularna primjena
English: Cardboard box of 1 bottle of 10 doses (20 ml), 50 doses (100 ml) or 125 doses (250 ml).
Croatian: Kartonska kutija s jednom bočicom od 10 doza (20 ml), 50 doza (100 ml) ili 125 doza (250 ml).
English: Veterinary medicinal product subject to prescription.
Croatian: Veterinarsko-medicinski proizvod se izdaje na veterinarski recept.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bottle label 50 and 125 doses
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKOVANJU Staklena bočica/etiketa 50 i 125 doza
English: The vaccine is to be administered aseptically.
Croatian: Treba provesti aseptičke mjere prilikom vakcinacije.
English: Store and transport refrigerated.
Croatian: 11. POSEBNI UVJETI ČUVANJA Čuvati i prevoziti na hladnom.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ BIOLOŠKI DJELATNE TVARI I PROIZVOĐAČ ODGOVORAN ZA
English: Adjuvants:
Croatian: Adjuvansi:
English: CLINICAL PARTICULARS 4.1 Target species
Croatian: 4.1 Ciljne vrste životinja
English: 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste material derived from the use of such products, if appropriate
Croatian: 6.6 Posebne mjere opreza prilikom odlaganja neupotrebljenog veterinarsko-medicinskog proizvoda ili otpadnih materijala dobivenih primjenom tih proizvoda
English: Exceptionally, a large proportion of animals may react in some specific herds after vaccination.
Croatian: U izuzetnim slučajevima, velika većina jedinki u specifičnim stadima može reagirati.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Boxes of 10 bottles of 10, 50 or 125 doses Boxes of 1 bottle of 10, 50 or 125 doses
Croatian: PODACI NA KOJI SE MORAJU NALAZITI VANJSKOM PAKOVANJU Kartonska kutija s jednom bočicom od 10, 50 ili 125 doza Kartonska kutija s deset bočica od 10, 50 ili 125 doza
English: Name and address of the manufacturer responsible for batch release
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije u promet
English: Box of 10 bottles of 10 doses Box of 10 bottles of 50 doses Box of 10 bottles of 125 doses
Croatian: Kartonska kutija s deset bočica od 10 doza Kartonska kutija s deset bočica od 50 doza Kartonska kutija s deset bočica od 125 doza
English: The vaccine strain is an inactivated recombinant Porcine Circovirus type 1 expressing the Porcine Circovirus type 2 ORF2 protein.
Croatian: Vakcinalni soj je inaktivirani rekombinirani cirkovirus svinja tip 1 s izraženim proteinom ORF2 cirkovirusa svinja tip 2.
English: Box of 1 bottle of 10 doses Box of 1 bottle of 50 doses Box of 1 bottle of 125 doses
Croatian: Kartonska kutija s jednom bočicom od 10 doza Kartonska kutija s jednom bočicom od 50 doza Kartonska kutija sa jednom bočicom od 125 doza
English: Inactivated recombinant Porcine Circovirus type 1 expressing the Porcine Circovirus type 2 ORF2 protein 1.6 ≤ RP ≤ 5.3
Croatian: Inaktivirani rekombinirani cirkovirus svinja tip 1 s izraženim proteinom ORF2 1,6 ≤ RP ≤ 5,3 cirkovirusa svinja tip 2
English: One injection from 21 days of age.
Croatian: Jedna aplikacija prasadi starijoj od 21 dan.
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: - Rijetke (više od 1 ali manje od 10 životinja na 10.000 tretiranih životinja).
English: No adverse reactions except those mentioned in section 6 were observed after the administration of a double dose of vaccine.
Croatian: Nakon primjene dvostruke doze cjepiva nisu uočene nuspojave osim onih spomenutih u odjeljku 6.
English: Active immunisation of pigs over the age of 3 weeks against Porcine Circovirus type 2 (PCV2) to reduce viral load in blood and lymphoid tissues, and the lesions in lymphoid tissues associated with PCV2 infection, as well as to reduce clinical signs - including loss of daily weight gain, and mortality associated with Post-Weaning Multisystemic Wasting Syndrome (PMWS).
Croatian: Za aktivnu imunizaciju svinja starijih od 3 tjedna života protiv cirkovirusa svinja tip 2 (PCV2) kako bi se smanjila viremija i količina virusa u limfoidnim tkivima te lezije u limfnim tkivima povezane sa
English: Inactivated recombinant Porcine Circovirus type 1 expressing the Porcine Circovirus type 2 ORF2 protein
Croatian: Inaktivirani rekombinirani cirkovirus svinja tip 1 s izraženim proteinom ORF2 cirkovirusa svinja tip 2
English: ANNEX II A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Croatian: UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE C. IZVJEŠĆE O MRL
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottle label 10 doses
Croatian: OSNOVNI PODACI KOJI SE MORAJU NALAZITI NA MALIM UNUTARNJIM PAKOVANJIMA
English: No adverse reactions except those mentioned in section 4.6 were observed after the administration of a double dose of vaccine.
Croatian: 4.10 Predoziranje (simptomi, hitni postupci, antidoti), ako je nužno Nikakve nuspojave osim onih opisanih u dijelu 4.6 nisu opažene nakon aplikacije dvostruke doze.
English: SPECIAL STORAGE PRECAUTIONS
Croatian: 11. POSEBNE MJERE PRI ČUVANJU
English: MARKETING AUTHORISATION NUMBERS
Croatian: 16. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET
English: Read the package leaflet before use.
Croatian: NAČIN I PUT(EVI) PRIMJENE Pročitati uputu o VMP prije primjene.
English: Ctra.
Croatian: NUSPOJAVE
English: Specific pharmacovigilance requirements:
Croatian: OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE U PROMET Specifični zahtjevi farmakovigilancije:
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Croatian: KARENCIJA(E) Karencija(e): nula dana
English: Outcome of a procedure under Article 13 of Regulation (EC) No 1234/2008
Croatian: Ishod postupka u skladu s člankom 13. Uredbe (EZ) br. 1234/2008
English: What is Cardioxane?
Croatian: Što je Cardioxane?
English: Its Committee for Medicinal Products for Human Use (CHMP) concluded that such a removal is acceptable.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je da je takvo uklanjanje prihvatljivo.
English: Cardioxane is authorised under a ‘mutual recognition' procedure1 based on an initial authorisation granted by France.
Croatian: Cardioxane je odobren u okviru postupka „međusobnog priznavanja”1 na temelju početnog odobrenja koje je izdala Francuska.
English: ANSM did not agree to the changes as requested by the company.
Croatian: ANSM nije odobrio izmjene u onom obliku u kojemu ih je zahtijevala tvrtka.
English: 1 A procedure through which an authorisation of a medicine in one European Union Member State is recognised by another Member State.
Croatian: Postupak kojim se odobrenje lijeka u jednoj državi članici Europske unije priznaje u drugoj državi članici.
English: Why was Cardioxane reviewed?
Croatian: Zašto je Cardioxane ponovno ocjenjivan?
English: Cardioxane is authorised in the Czech Republic, Germany, France, Italy, the Netherlands, Poland, Spain and the United Kingdom.
Croatian: Cardioxane je odobren u Češkoj, Njemačkoj, Francuskoj, Italiji, Nizozemskoj, Poljskoj, Španjolskoj i Ujedinjenoj Kraljevini.
English: The company wanted the changes to be recognised in Czech Republic, Germany, France, Italy, the Netherlands, Poland, Spain and the United Kingdom (the ‘concerned Member States').
Croatian: Tvrtka je željela da izmjene budu priznate u Češkoj, Njemačkoj, Francuskoj, Italiji, Nizozemskoj, Poljskoj, Španjolskoj i Ujedinjenoj Kraljevini („države članice sudionice u postupku”).
English: However, as there are a small number of patients under 18 years who require high doses of anthracyclines and who are therefore at greater risk of harmful effects on the heart, the Committee agreed that the contraindication should be lifted for this group.
Croatian: Međutim, budući da je broj bolesnika mlađih od 18 godina kojima su potrebne visoke doze antraciklina te kojima stoga prijeti veći rizik od štetnih utjecaja na srce malen, Odbor se složio da kontraindikaciju za tu skupinu treba ukinuti.
English: In 2015, Clinigen submitted an application to the French medicines regulator ANSM for changes to the terms of the marketing authorisation, including removal of the contraindication in children and adolescents.
Croatian: Clinigen je 2015. podnio zahtjev francuskom regulatornom tijelu za lijekove ANSM-u za izmjenu uvjeta odobrenja za stavljanje u promet, uključujući uklanjanje kontraindikacije za djecu i adolescente.
English: The company that markets the medicine is Clinigen Healthcare Limited.
Croatian: Lijek stavlja na tržište Clinigen Healthcare Limited.
English: The way in which dexrazoxane protects the heart is not entirely clear, but may be linked to the way the medicine attaches to charged iron particles that are involved in the processes that make anthracyclines harmful to the heart muscle.
Croatian: Način na koji deksrazoksan štiti srce nije potpuno jasan, ali može biti povezan s načinom na koji se lijek veže na nabijene čestice željeza koje su uključene u procese zbog kojih antraciklini štetno djeluju na srčani mišić.
English: Because of concerns that it might increase the risk of second cancers developing long after treatment, the CHMP reviewed the medicine2 in September 2011 and recommended on the basis of the evidence at that time that use of medicines containing dexrazoxane to protect the heart should be explicitly contraindicated in children and adolescents.
Croatian: Zbog zabrinutosti da bi mogao povećati rizik od razvoja drugih vrsta karcinoma dugo nakon liječenja, CHMP je ponovno ocijenio lijek2 u rujnu 2011. i na temelju tada postojećih dokaza preporučio je da se za primjenu lijekova koji sadržavaju deksrazoksan za zaštitu srca jasno trebaju navesti kontraindikacije kod djece i adolescenata.
English: Based on evaluation of the currently available data, and the scientific discussion within the Committee, the CHMP concluded that the benefits and risks of Cardioxane have not been established in children under the age of 18 years, in whom it is not licensed, particularly given that most young patients do not receive the high total doses of anthracyclines that can cause damage to the heart.
Croatian: Na temelju ocjene trenutačno dostupnih podataka i znanstvene rasprave u Odboru, CHMP je zaključio da koristi i rizici od lijeka Cardioxane nisu utvrđeni u djece mlađe od 18 godina, kod kojih njegova primjena nije odobrena, osobito uzimajući u obzir činjenicu da većina mlađih bolesnika ne dobiva visoke ukupne doze antraciklina koje mogu uzrokovati oštećenja srca.
English: Cardioxane is a medicine used in adults with breast cancer to prevent long-term harmful effects on the heart caused by treatment with the anthracycline cancer medicines doxorubicin and epirubicin.
Croatian: Cardioxane je lijek koji se primjenjuje u odraslih osoba oboljelih od raka dojke radi sprečavanja dugoročnih štetnih utjecaja na srce uzrokovanih doksorubicinom i epirubicinom, lijekovima za liječenje raka iz skupine antraciklina.
English: CHMP therefore concluded that the product information should state that the medicine is contraindicated in patients under 18 years old who are intended to receive a total cumulative dose of less than 300 mg of doxorubicin per m2 body surface or an equivalent dose of another anthracycline medicine.
Croatian: CHMP je stoga zaključio da se u informacijama o lijeku treba navesti da je lijek kontraindiciran za bolesnike mlađe od 18 godina koji trebaju primiti ukupnu kumulativnu dozu doksorubicina manju od 300 mg po m2 površine tijela ili istovjetnu dozu nekog drugog lijeka iz skupine antraciklina.
English: However ANSM and the concerned Member States were unable to reach agreement on whether the contraindication could be removed just for children and adolescents treated with high cumulative doses of anthracyclines, and, on 31 January 2017, France referred the matter to the CHMP for arbitration.
Croatian: Međutim, ANSM i države članice sudionice u postupku nisu se mogle složiti oko toga može li se ukloniti kontraindikacija samo za djecu i adolescente koji su liječeni velikim kumulativnim dozama antraciklina te je Francuska 31. siječnja 2017. predmet uputila na arbitražu CHMP-u.
English: The European Commission issued an EU-wide legally binding decision to implement the CHMP recommendations on Cardioxane on 19/07/2017.
Croatian: Europska komisija objavila je 19/07/2017 odluku o primjeni preporuka CHMP-a o lijeku Cardioxane koja je zakonski obvezujuća na području cijelog EU-a.
English: On 18 May 2017, the European Medicines Agency completed an arbitration procedure for Cardioxane (dexrazoxane powder for solution for injection).
Croatian: Europska agencija za lijekove završila je postupak arbitraže za lijek Cardioxane (deksrazoksan u prahu za otopinu za injekciju).
English: The Agency had been asked to arbitrate on the removal of the contraindication for children and adolescents treated with high cumulative doses of cancer medicines called anthracyclines.
Croatian: Od Agencije je zatraženo da odluči o uklanjanju kontraindikacije za djecu i adolescente liječene visokim kumulativnim dozama lijekova za liječenje raka koji se nazivaju antraciklini.
English: The grounds for the referral were the concerns of the UK that removing the contraindication in patients less than 18 years old receiving a high cumulative dose of anthracyclines was not justified given the remaining uncertainties regarding the safety and effectiveness of Cardioxane in this population, particularly given the previous decision of the CHMP regarding dexrazoxane medicines.
Croatian: Razlog za pokretanje arbitraže bila je zabrinutost Ujedinjene Kraljevine da uklanjanje kontraindikacije za bolesnike mlađe od 18 godina liječene visokom kumulativnom dozom antraciklina nije opravdano jer postoje dodatne nejasnoće u pogledu sigurnosti i djelotvornosti lijeka Cardioxane za ovu populaciju, osobito uzimajući u obzir prethodnu odluku CHMP-a koja se odnosi na lijekove koji sadržavaju deksrazoksan.
English: The contraindication should however remain in children and adolescents who are given lower cumulative doses of anthracyclines.
Croatian: No kontraindikacija i dalje treba vrijediti za djecu i adolescente kojima se daju manje kumulativne doze antraciklina.
English: It contains the active substance dexrazoxane.
Croatian: Sadržava djelatnu tvar deksrazoksan.
English: Metamizole-containing medicines are available in Austria, Belgium, Bulgaria, Croatia, Czech Republic, Finland, Germany, Hungary, Italy, Latvia, Lithuania, Luxembourg, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia and Spain.
Croatian: Lijekovi koji sadržavaju metamizol dostupni su u Austriji, Belgiji, Bugarskoj, Češkoj, Finskoj, Hrvatskoj, Italiji, Latviji, Litvi, Luksemburgu, Mađarskoj, Nizozemskoj, Njemačkoj, Poljskoj, Portugalu, Rumunjskoj, Slovačkoj, Sloveniji i Španjolskoj.
English: They are marketed under a variety of names including Algifen, Algifen Neo, Algi-Mabo, Algoblock, Algocalmin, Algopyrin, Algozone, Alindor, Alkagin, Alvotor, Amizolmet, Analgin, Benalgin, Benlek, Berlosin, Buscapina Compositum, Dialgin, Dolocalma, Flamborin, Freshalgin, Gardan, Generalgin, Hexalgin, Litalgin, Locamin, Metagelan, Metalgial, Metamilan, Metamistad, Metapyrin, Metarapid, Nevralgin, Nodoryl, Nolotil, Novalgin, Novalgina, Novalgine, Novaminsulfon, Novocalmin, Panalgorin, Parakofdal, Piafen, Piralgin, Proalgin, Pyralgin, Pyralgina, Quarelin, Scopolan Compositum, Spasmalgon, Spasmoblok, Tempalgin and Tempimet.
Croatian: Stavljaju se na promet pod različitim nazivima, uključujući Algifen, Algifen Neo, Algi-Mabo, Algoblock, Algocalmin, Algopyrin, Algozone, Alindor, Alkagin, Alvotor, Amizolmet, Analgin, Benalgin, Benlek, Berlosin, Buscapina Compositum, Dialgin, Dolocalma, Flamborin, Freshalgin, Gardan, Generalgin, Hexalgin, Litalgin, Locamin, Metagelan, Metalgial, Metamilan, Metamistad, Metapyrin, Metarapid, Nevralgin, Nodoryl, Nolotil, Novalgin, Novalgina, Novalgine, Novaminsulfon, Novocalmin, Panalgorin, Parakofdal, Piafen, Piralgin, Proalgin, Pyralgin, Pyralgina, Quarelin, Scopolan Compositum, Spasmalgon, Spasmoblok, Tempalgin i Tempimet.
English: The review of metamizole was initiated on 31 May 2018 at the request of Poland, under Article 31 of Directive 2001/83/EC.
Croatian: Pregled metamizola pokrenut je 31. svibnja 2018. na zahtjev Poljske, u skladu s člankom 31. Direktive 2001/83/EZ.
English: A summary of the recommended changes will be published on the EMA website.
Croatian: Sažetak preporučenih izmjena bit će objavljen na internetskim stranicama EMA-e.
English: • Patients who have any concerns about their medication should consult their doctor or pharmacist.
Croatian: • Bolesnici koji imaju bilo kakvih pitanja o svojim lijekovima trebaju se obratiti svojem liječniku ili ljekarniku.
English: E M A /191666/2019
Croatian: EMA/191666/2019
English: Treatment should start at the lowest recommended dose and only be increased if needed.
Croatian: Liječenje treba započeti s najnižom preporučenom dozom, a ona se može povećati samo ako je to potrebno.
English: The review has been carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which has adopted the Agency's opinion.
Croatian: Pregled je proveo Odbor za lijekove za humanu uporabu (CHMP), koji je nadležan za pitanja koja se odnose na lijekove za humanu uporabu te koji je usvojio mišljenje Agencije.
English: EMA's recommendations include setting a maximum single dose by mouth of 1,000 mg, taken up to 4 times daily (a maximum daily dose of 4,000 mg), in patients from 15 years of age.
Croatian: Preporuke EMA-e uključuju određivanje najveće dopuštene pojedinačne doze koja se uzima na usta od 1 000 mg do 4 puta dnevno (najveća dopuštena dnevna doza iznosi 4 000 mg) u bolesnika starijih od 15 godina.
English: • Updated summaries of product characteristics (information for healthcare professionals) and package leaflets for patients which contain the new recommendations will be available nationally following the final legal decision issued by the European Commission.
Croatian: • Ažurirani sažetci opisa svojstava lijeka (informacije za zdravstvene radnike) i upute o lijeku za bolesnike koji sadržavaju nove preporuke bit će dostupni na nacionalnoj razini nakon konačne pravne odluke koju je donijela Europska komisija.
English: Although metamizole has been on the market for nearly a century, evidence of its effects in pregnancy and breastfeeding is scarce.
Croatian: Iako je metamizol prisutan na tržištu već gotovo stoljeće, dokazi o njegovu utjecaju na trudnoću i dojenje oskudni su.
English: The Agency reviewed the available information on the way the medicine is distributed in the body, how it works and the limited data on its effects on the unborn child or breast-fed infant.
Croatian: Agencija je pregledala dostupne informacije o načinu na koji se lijek raspoređuje u tijelu, o njegovu djelovanju te ograničene podatke o njegovu utjecaju na nerođeno dijete ili na dojene bebe.
English: Metamizole (also known as dipyrone) is an analgesic medicine (painkiller) that can also relieve fever and muscle spasm.
Croatian: Metamizol (poznat i kao dipiron) je analgetik koji se može upotrebljavati i za ublažavanje vrućice i grčeva u mišićima.
English: The review was carried out by EMA's human medicines committee (CHMP) at the request of Poland, which was concerned by the substantial differences in the recommendations on the use of metamizole in different EU countries, given that it is known the medicine may occasionally cause severe side effects, such as effects on the blood.
Croatian: Pregled je proveo EMA-in Odbor za lijekove za humanu uporabu (CHMP) na zahtjev Poljske koja je izrazila zabrinutost zbog znatnih razlika u preporukama za primjenu metamizola u različitim državama EU-a, s obzirom na činjenicu da je poznato da taj lijek može ponekad uzrokovati ozbiljne nuspojave kao što je djelovanje na krv.