FrancophonIA/ELRC3.0 huggingface dataset:
English: Tell your doctor immediately if you experience any of the following side effects: - Adrenal insufficiency: fatigue, abdominal pain, nausea, vomiting, diarrhoea, confusion - Anaemia: cutaneous pallor, muscular fatigability, feeling breathless, vertigo especially when standing up - Liver damage: yellowing of the skin and eyes, itching, nausea, diarrhoea, fatigue, dark coloured urine - Neurological disorders: movement and coordination disorders, abnormal sensations like pins and needles, memory loss, concentration difficulty, difficulty to talk, vertigo
Croatian: Ako primjetite bilo koju od sljedećih nuspojava odmah obavijestite svog liječnika: - Zatajenje nadbubrežne žlijezde: umor, bol u trbuhu, mučnina, povraćanje, proljev, smetenost - Anemija: bljedoća kože, brzo umaranje mišića, osjećaj nedostatka zraka, vrtoglavica osobito pri ustajanju
English: Ovarian macrocysts
Croatian: Makrociste na jajnicima
English: OUTER CARTON BOTTLE LABEL
Croatian: KUTIJA NALJEPNICA NA BOČICI
English: Anaemia Thrombocytopenia
Croatian: Anemija Trombocitopenija
English: PHARMACEUTICAL FORM AND CONTENTS
Croatian: 4. FARMACEUTSKI OBLIK I SADRŽAJ Tableta.
English: There is no experience in the use of mitotane in patients with renal impairment, so data are insufficient to give a dose recommendation in this group.
Croatian: U bolesnika s oštećenjem bubrega nema iskustva s uporabom mitotana te su podaci nedovoljni za davanje preporuke o doziranju u ovoj skupini.
English: Caregivers should wear disposable gloves when handling the tablets.
Croatian: Kada rukuju tabletama, njegovatelji trebaju nositi rukavice za jednokratnu uporabu.
English: The use of mitotane in patients with severe hepatic impairment is not recommended.
Croatian: U bolesnika s teškim oštećenjem jetre uporaba mitotana se ne preporučuje.
English: Tell your doctor immediately if you have taken accidentally more Lysodren than you should or if a child has accidentally swallowed some.
Croatian: U slučaju da uzmete više Lysodrena nego što ste trebali ili ako dijete proguta lijek odmah obavijestite svog liječnika.
English: Because of an increased risk of acute adrenocortical insufficiency, patients should be instructed to contact their physician immediately if injury, infection, or any other concomitant illness occurs.
Croatian: Bolesnike treba savjetovati da kontaktiraju svog liječnika odmah nakon ozljede, infekcije ili pojave bilo koje druge prateće bolesti zbog povećanog rizika akutne insuficijencije kore nadbubrežne žlijezde.
English: 20 mg/l (see section 4.8).
Croatian: Dojenje (vidjeti dio 4.6)
English: - if you are being treated with medicines containing spironolactone (see "Other medicines and
Croatian: Ne smijete dojiti dok uzimate Lysodren. - ako se liječite lijekovima koji sadrže spironolakton (vidjeti dio
English: Behavioural and neurological assessments should be made at regular intervals, especially when mitotane plasma levels exceed
Croatian: Procjena ponašanja i neurološka procjena moraju biti učinjeni u redovitim razmacima, osobito ako razine mitotana u plazmi prelaze 20 mg/l (vidjeti dio 4.8).
English: Myasthenia
Croatian: Mijastenija
English: Hypertension Orthostatic hypotension Flushing
Croatian: Ortostatska hipotenzija Crvenilo uz osjećaj vrućine
English: Nausea
Croatian: Doziranje
English: Do not use after the expiry date which is stated on the carton and the bottle after EXP. Any unused product or waste material should be disposed of in accordance with local requirements for cytotoxic medicines.
Croatian: Neiskorišteni lijek ili otpadni materijal valja zbrinuti sukladno lokalnim propisima za odlaganje citotoksičnih lijekova.
English: Haemorrhagic cystitis Haematuria Proteinuria
Croatian: Hemoragijski cistitis Hematurija Proteinurija
English: Posology
Croatian: Pospanost
English: Epigastric discomfort
Croatian: Mučnina Nelagoda u epigastriju
English: If you get any side effects, talk to your doctor or pharmacist.
Croatian: Ako primjetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
English: Asthenia
Croatian: FARMACEUTSKI
English: What Lysodren looks like and contents of the pack
Croatian: Što Lysodren sadrži
English: EU (MA) number
Croatian: EU (MA)broj
English: (*) Antigen content (VP2 protein) by immune-assay
Croatian: (*) Sadržaj antigena (VP2 protein) pomoću imunoloških metoda
English: Invented name bottles
Croatian: EU (MA) broj Izmišljeni naziv
English: --1 BTV4 antigen ≥1.86 log10 pixels* (*) Antigen content (VP2 protein) by immune-assay
Croatian: --1 BTV1 antigen ≥1.9 log10 piksela* BTV8 antigen ≥ 2.12 log10 piksela* (*) Sadržaj antigena (VP2 protein) pomoću imunoloških metoda
English: BTV1 antigen ≥1.9 log10 pixels* BTV2 antigen ≥ 1.82 log10 pixels*
Croatian: --1 BTV1 antigen ≥1.9 log10 piksela BTV2 antigen ≥1.82 log10 piksela
English: BTV4 antigen ≥1.86 log10 pixels* BTV8 antigen ≥ 2.12 log10 pixels*
Croatian: --1 BTV4 antigen ≥1.86 log10 piksela*
English: BTV2 antigen ≥1.82 log10 pixels* BTV8 antigen ≥ 2.12 log10 pixels*
Croatian: --1 BTV2 antigen ≥1.82 log10 piksela
English: 5 December 2014
Croatian: 5. prosinca 2014.
English: Background information
Croatian: Osnovne informacije
English: Article 13 of Commission Regulation (EC) No. 1234/2008
Croatian: Članak 13. Uredbe Komisije (EZ) br. 1234/2008
English: The reference Member State (RMS) is France and 25 concerned Member States (CMS) are involved: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and the United Kingdom.
Croatian: Referentna država članica je Francuska, a postupkom je obuhvaćeno 25 država članica u postupku: Austrija, Belgija, Bugarska, Cipar, Češka, Danska, Estonija, Finska, Njemačka, Grčka, Mađarska, Irska, Italija, Latvija, Litva, Luksemburg, Nizozemska, Norveška, Poljska, Portugal, Rumunjska, Slovačka, Slovenija, Španjolska i Ujedinjena Kraljevina.
English: International non-proprietary name (INN): florfenicol, flunixin
Croatian: Međunarodno nezaštićeno ime (INN): florfenikol, fluniksin
English: Committee for medicinal products for veterinary use (CVMP)
Croatian: Odbor za veterinarsko-medicinske proizvode (CVMP)
English: A single subcutaneous injection of 40 mg florfenicol and 2.2 mg flunixin per kg body weight (2 mL/15 kg bw) is recommended.
Croatian: Preporučuje se jedna supkutana injekcija od 40 mg florfenikola i 2,2 mg fluniksina po kilogramu tjelesne težine (2 mL/15 kg tt).
English: The referral procedure started on 12 February 2014.
Croatian: Postupak upućivanja započet je 12. veljače 2014.
English: The opinion was converted into a Decision by the European Commission on 5 December 2014.
Croatian: Europska Komisija usvojila je konačno mišljenje u obliku Odluke dana 5. prosinca 2014.
English: Day 60 of the CMD(v) procedure was on 23 January 2014, and since the Member States concerned failed to reach an agreement, the procedure was referred to the CVMP.
Croatian: Šezdeseti dan postupka CMD(v)-a bio je 23. siječnja 2014., te budući da države članice nisu uspjele postići sporazum, postupak je upućen CVMP-u.
English: On 24 January 2014, the reference Member State, France, notified the European Medicines Agency that the CMD(v) had failed to reach an agreement and referred the matter to the CVMP pursuant to Article 13(2) of Commission Regulation (EC) No. 1234/2008.
Croatian: Dana 24. siječnja 2014, referentna država članica, Francuska, obavijestila je Europsku agenciju za lijekove da CMD(v) nije postigao sporazum i uputila je pitanje CVMP-u u skladu s člankom 13. stavkom 2. Uredbe komisije (EZ) br. 1234/2008.
English: It is indicated for the treatment of respiratory infections caused by Mannheimia haemolytica, Pasteurella multocida and Histophilus somni associated with pyrexia.
Croatian: Indiciran je za liječenje infekcija dišnih putova uzrokovanih bakterijama Mannheimia haemolytica, Pasteurella multocida i Histophilus somni povezanima s pireksijom.
English: The marketing authorisation holder Intervet International BV submitted an application for a type II variation to add Mycoplasma bovis as a target pathogen.
Croatian: Nositelj odobrenja za stavljanje VMP-a u promet, Intervet International BV, dostavio je zahtjev za izmjenu tipa II kako bi se dodao Mycoplasma bovis kao ciljni patogen.
English: The CVMP concluded that the clinical benefit of Resflor in the treatment of respiratory infections associated with M. bovis has been demonstrated and no specific risk of antimicrobial resistance has been identified with the use of this product.
Croatian: CVMP je zaključio da su dokazane kliničke koristi lijeka Resflor u liječenju respiratornih infekcija povezanih s M. bovis te da nisu identificirani specifični rizici antimikrobne rezistencije s primjenom ovog proizvoda.
English: Based on the evaluation of the available data the CVMP adopted by majority, on 7 October 2014, an opinion recommending the granting of the variation of the marketing authorisations for Resflor solution injectable and its associated names.
Croatian: Na temelju ocjene dostupnih podataka CVMP je 7. listopada 2014. većinom usvojio mišljenje kojim se preporuča odobrenje izmjene odobrenja za stavljanje lijeka u promet Resflor injektibilnu otopinu i povezane nazive.
English: Written explanations were provided by the marketing authorisation holder on 12 May 2014 and 19 June 2014.
Croatian: Nositelji odobrenja za stavljanje VMP-a u promet dostavili su pisana pojašnjenja dana 12. svibnja 2014. i 19. lipnja 2014.
English: Resflor is a solution for injection for use in cattle containing florfenicol and flunixin as active ingredients.
Croatian: Resflor je otopina za injekciju za primjenu u goveda, koja sadrži fluorfenikol i fluniksin kao djelatne tvari.
English: Opinion following an Article 13
Croatian: Mišljenje nakon provođenja postupka upućivanja u skladu s člankom 13.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics and package leaflet in Annex III.
Croatian: Znanstveni zaključci navedeni su u Prilogu II. zajedno s dopunama u sažetcima opisa svojstava proizvoda, etiketama i uputama o lijeku u Prilogu III.
English: Potential serious risks to animal health were identified during the decentralised procedure by Denmark and Germany regarding the demonstration of efficacy in the clinical trials and the justification of the recommended treatment dose of Resflor in the treatment of respiratory infections caused by Mycoplasma bovis, which may be associated with an increased risk of development of antimicrobial resistance.
Croatian: Postupak izmjene (FR/V/0167/01/II/017) započet je 28. siječnja 2013. Danska i Njemačka identificirale su tijekom decentraliziranog postupka potencijalne ozbiljne rizike za zdravlje životinja vezane uz demonstraciju djelotvornosti u kliničkim ispitivanjima i opravdanja preporučene terapijske doze lijeka Resflor u liječenju respiratornih infekcija uzrokovanih bakterijom Mycoplasma bovis, što se može povezati s povećanim rizikom od razvoja rezistencije na antimikrobik.
English: Oral explanations were given on 10 September 2014.
Croatian: Usmena pojašnjenja iznijeta su 10. rujna 2014.
English: Opinion following an Article 13 referral for Resflor solution injectable and associated names
Croatian: Mišljenje nakon provođenja postupka upućivanja u skladu s člankom 13. za Resflor injektibilnu otopinu i povezane nazive
English: The Committee appointed C. Ibrahim as rapporteur and M. Holzhauser-Alberti as co-rapporteur.
Croatian: Holzhausera-Albertia kao pomoćnog izvjestitelja.
English: referral for Resflor solution injectable and associated names
Croatian: 1 za Resflor injektibilnu otopinu i povezane nazive
English: On day 90, these issues remained unsolved and therefore a referral under Article 13(1) of Commission Regulation (EC) No. 1234/2008 to the Coordination group for Mutual recognition and Decentralised procedures (veterinary) (CMD(v)) was started on 25 November 2013.
Croatian: Koordinacijska skupina za međusobno priznavanje i decentralizirani postupak za veterinarsko-medicinske proizvode (CMD(v)) započela postupak upućivanja u skladu s člankom 13. stavkom 1. Uredbe Komisije (EZ) br. 1234/2008
English: It is used to treat the following conditions:
Croatian: Koristi se za liječenje sljedećih stanja:
English: IN addition, no infections occurred during the study period.
Croatian: Nadalje, nije zabilježena nijedna infekcija tijekom ispitivanja.
English: Further information on Hizentracan be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Više informacija o lijeku Hizentra možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Normal immunoglobulin has been used as a medicine since the 1980s.
Croatian: Normalni imunoglobulin koristi se kao lijek od 1980-tih.
English: This overview was last updated in 03-2018.
Croatian: Sažetak je posljednji put ažuriran u 03. 2018.
English: It can also help to control the immune system when it is working abnormally such as in CIDP.
Croatian: Može pomoći i u kontroli imunosnog sustava kada funkcionira nenormalno, na primjer u CIDP-u.
English: Other information about Hizentra
Croatian: Ostale informacije o lijeku Hizentra
English: It contains mainly immunoglobulin G (IgG), which is composed of a range of antibodies involved in fighting organisms that can cause infection.
Croatian: Sadrži uglavnom imunoglobulin G (IgG) koji se sastoji od niza antitijela uključenih u borbu protiv organizama koji mogu prouzročiti infekciju.
English: As human normal immunoglobulin has been used to treat these diseases for many years, in accordance with current guidelines, two small studies were needed to establish the effectiveness and safety of Hizentra in patients.
Croatian: Budući da se normalni ljudski imunoglobulin odavno koristi za liječenje ovih bolesti, u skladu s postojećim smjernicama bilo je potrebno provesti dva mala ispitivanja kako bi se utvrdila djelotvornost i sigurnost lijeka Hizentra u bolesnika.
English: What measures are being taken to ensure the safe and effective use of Hizentra?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Hizentra?
English: It is given by subcutaneous infusion (very slow injection under the skin) through a device that controls the speed of infusion.
Croatian: Primjenjuje se potkožnom infuzijom (vrlo sporo ubrizgavanje pod kožu) putem uređaja koji upravlja brzinom infuzije.
English: It may be given at home, while the side effects are manageable.
Croatian: Može se primjenjivati kod kuće, a nuspojave je moguće kontrolirati.
English: The dose may need to be adjusted depending on how well the medicine is working.
Croatian: Dozu možda treba prilagoditi ovisno o tome funkcionira li lijek i u kojoj mjeri.
English: • chronic inflammatory demyelinating polyneuropathy (CIDP).
Croatian: • kronična upalna demijelinizirajuća polineuropatija (CIDP).
English: The most common side effects with Hizentra (which may affect more than 1 in 10 people) are headache, rash, muscle and joint pain (including muscle spasm and weakness), reactions around the injection area (swelling, soreness, redness, pitting, warmth, itching, bruising and rash) and flu-like illness.
Croatian: Najčešće nuspojave nakon primjene lijeka Hizentra (mogu se pojaviti u više od 1 u 10 osoba) su glavobolja, osip, bolovi u zglobovima i mišićima (uključujući mišićne grčeve i slabost), reakcije oko područja ubrizgavanja (oticanje, bol, crvenilo, stvaranje rupa na koži, toplina, svrbež, modrice i osip) i bolest slična gripi.
English: The patients received Hizentra for 28 weeks and the lowest IgG levels during treatment with Hizentra (average level of 8.1 g per litre) were comparable to those seen during previous immunoglobulin treatment.
Croatian: Bolesnici su primali lijek Hizentra tijekom 28 tjedana, a najniže razine IgG-a tijekom liječenja lijekom Hizentra (prosječna razina od 8,1 g po litri) bile su usporedive s razinama koje su zabilježene tijekom prethodnog liječenja imunoglobulinom.
English: What is Hizentra and what is it used for?
Croatian: Što je Hizentra i za što se koristi?
English: Hizentra is available as a solution for injection.
Croatian: Lijek Hizentra dostupan je kao otopina za injekciju.
English: Rarely patients may have a sudden drop in blood pressure or an anaphylactic shock (sudden, severe allergic reaction).
Croatian: Rijetko može doći do iznenadnog pada krvnog tlaka ili anafilaktičkog šoka (iznenadna, teška alergijska reakcija) u bolesnika.
English: Hizentra received a marketing authorisation valid throughout the EU on 14 April 2011.
Croatian: Lijek Hizentra dobio je odobrenje za stavljanje lijeka u promet koje je na snazi u Europskoj uniji od 14. travnja 2011.
English: Hizentra can only be obtained with a prescription and treatment should be started by a doctor or nurse who is experienced in the treatment of patients with weakened immune systems or CIDP.
Croatian: Izdaje se samo na liječnički recept, a liječenje mora započeti liječnik ili bolničarka s iskustvom u liječenju osoba oboljelih od oslabljenog imunosnog sustava ili CIDP-a.
English: Side effects reported with Hizentra are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Hizentra pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Hizentra is used in patients whose blood does not contain enough antibodies (proteins that help the body to fight infections and other diseases), also known as immunoglobulins.
Croatian: Hizentra se koristi u bolesnika čija krv ne sadrži dovoljno antitijela (bjelančevine koje pomažu tijelu da se bori protiv infekcija i drugih bolesti) poznatih i kao imunoglobulini.
English: For patients on placebo, the disease came back in about 63% of patients, for patients on Hizentra, the disease came back in 33 and 39% of patients; depending on the dose used.
Croatian: U bolesnika koji su primali placebo bolest se vratila u približno 63 % slučajeva, a u bolesnika koji su primali lijek Hizentra bolest se vratila u 33 odnosno 39 % slučajeva, ovisno o primijenjenoj dozi.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Hizentra 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 Hizentra nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: Why is Hizentra authorised in the EU?
Croatian: Zašto je lijek Hizentra odobren u EU-u?
English: • primary immunodeficiency syndromes (PID, when people are born with an inability to produce enough antibodies);
Croatian: • sindromi primarne imunodeficijencije (PID, urođena nesposobnost proizvodnje dovoljno antitijela);
English: It is given in the abdomen (belly), thigh, upper arm or hip.
Croatian: Primjenjuje se u abdomen (trbuh), bedro, nadlakticu ili kuk.
English: As for all medicines, data on the use of Hizentra is continuously monitored.
Croatian: Kao za sve lijekove, podatci o primjeni lijeka Hizentra kontinuirano se prate.
English: An overview of Hizentra and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Hizentra i zašto je odobren u EU-u
English: What are the risks associated with Hizentra?
Croatian: Koji su rizici povezani s lijekom Hizentra?
English: Hizentra was shown to prevent serious bacterial infections in PID patients and reduce the chance of CIDP coming back.
Croatian: Dokazano je da lijek Hizentra sprječava teške bakterijske infekcije u bolesnika s PID-om i smanjuje vjerojatnost za vraćanje CIDP-a.
English: The European Medicines Agency decided that Hizentra'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 lijeka Hizentra nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: Hizentra (human normal immunoglobulin)
Croatian: Hizentra (normalni ljudski imunoglobulin)
English: For more information about using Hizentra, see the package leaflet or contact a doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Hizentra pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: Patients (or their carers) may inject Hizentra at home once they have been trained.
Croatian: Nakon odgovarajuće obuke, bolesnici (ili njihovi njegovatelji) mogu primjenjivati lijek Hizentra kod kuće.
English: Hizentra must not be used in patients with hyperprolinaemia (a genetic disorder causing hgh levels of the amino acid proline in the blood).
Croatian: Lijek Hizentra ne smije se primjenjivati u bolesnika s hiperprolinemijom (genetski poremećaj koji uzrokuje visoke razine aminokiseline prolina u krvi).
English: In this rare disease, the immune system (the body's defence system) works abnormally and destroys the protective covering over the nerves.
Croatian: Imunosni sustav (tjelesni obrambeni sustav) zaražen ovom rijetkom bolešću nenormalno funkcionira i uništava zaštitni sloj živaca.
English: The dose and how often Hizentra infusion is given depend on the disease being treated.
Croatian: Doziranje i učestalost infuzija lijeka Hizentra ovisi o bolesti koja se liječi.
English: The active substance in Hizentra, human normal immunoglobulin, is a highly purified protein extracted from donated human blood.
Croatian: Djelatna tvar u lijeku Hizentra, normalni ljudski imunoglobulin, iznimno je pročišćena bjelančevina dobivena iz donirane ljudske krvi.
English: In the first study, Hizentra was investigated in 51 PID patients who had already received human immunoglobulin into a vein for at least six months.
Croatian: U prvom ispitivanju lijek Hizentra ispitan je na 51 bolesniku koji boluju od PID-a i koji su već primali ljudski imunoglobulin venskim putem najmanje šest mjeseci.
English: • low levels of antibodies in the blood in patients before or after allogeneic haematopoietic stem cell transplantation (a procedure where the patient's bone marrow is cleared of cells and replaced by stem cells from a donor);
Croatian: • niske razine antitijela u krvi u bolesnika prije ili poslije transplantacije alogenih krvotvornih matičnih stanica (postupak u kojem se stanice iz koštane srži bolesnika uklanjaju i zamjenjuju matičnim stanicama donora);
English: How is Hizentra used?
Croatian: Kako se Hizentra koristi?
English: • low levels of antibodies in the blood in patients with chronic lymphocytic leukaemia (a cancer of a type of white blood cell) or myeloma (a cancer of another type of white blood cell) and who have frequent infections;
Croatian: • niske razine antitijela u krvi u bolesnika s kroničnom limfocitnom leukemijom (rak tipa bijelih krvnih stanica) ili mijelomom (rak druge vrste bijelih krvnih stanica, plazma stanica) i čestim infekcijama;
English: Hizentra contains the active substance human normal immunoglobulin.
Croatian: Hizentra sadržava djelatnu tvar ljudski normalni imunoglobulin.
English: Hizentra works by restoring abnormally low IgG levels to their normal range in the patient's blood.
Croatian: Lijek Hizentra djeluje tako da omogućuje da abnormalno niske razine IgG-a u krvi bolesnika opet postanu normalne.
English: What benefits of Hizentra have been shown in studies?
Croatian: Koje su koristi lijeka Hizentra utvrđene u ispitivanjima?
English: It must not be injected into a blood vessel.
Croatian: Hizentra se ne smije primjenjivati unutar krvnih žila.
English: How does Hizentra work?
Croatian: Kako djeluje Hizentra?
English: In the second study Hizentra was studied in 172 patients with CIDP who had previously received human immunoglobulin treatment by injection into a vein.
Croatian: U drugom ispitivanju lijek Hizentra ispitan je na 172 bolesnika s CIPD-om koji su već primali ljudski imunoglobulin venskim putem.