FrancophonIA/ELRC3.0 huggingface dataset:
English: Porcine circovirus type 2 ORF2 subunit antigen: ≥ 4.5 log2 ELISA units.
Croatian: Cirkovirus svinja tip 2, subjedinični antigen ORF2 ≥ 4,5 log2 ELISA jed.*
English: To the physician:
Croatian: Za liječnika
English: Porcine circovirus type 2 ORF2 subunit antigen: at least 4.5 log2 ELISA units (as determined in the in vivo potency test in chickens)
Croatian: Cirkovirus svinja tip 2, subjedinični antigen ORF2 ≥ 4,5 log2 ELISA jed.* (kako je utvrđeno u in vivo testu kod pilića).
English: 22 weeks.
Croatian: Trajanje imuniteta: 22 tjedna.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
Croatian: KOLIČINA DJELATNE TVARI I DRUGIH TVARI
English: PACKAGE LEAFLET FOR: Porcilis PCV emulsion for injection for pigs
Croatian: UPUTA O VMP ZA: Porcilis PCV emulzija za injekciju za svinje
English: 6.1 List of excipients
Croatian: FARMACEUTSKE POJEDINOSTI 6.1 Popis pomoćnih tvari
English: PCV2 ORF2 subunit antigen: ≥ 4.5 log2 ELISA units.
Croatian: PCV2 ORF2 subjedinični antigen ≥ log2 ELISA jed.
English: Store in a refrigerator (2 °C - 8 °C).
Croatian: Čuvati u hladnjaku (2 - 8ºC) Čuvati od zamrzavanja.
English: Porcine circovirus type 2 ORF2 subunit antigen: at least 4.5 log2 ELISA units* * Antibody titre obtained according to the in vivo potency test in chickens.
Croatian: Cirkovirus svinja tip 2, subjedinični antigen ORF2 ≥ 4,5 log2 ELISA jed.* * titar protutijela utvrđen in vivo testom potencije na pilićima
English: Simethicon
Croatian: KARENCIJA
English: Duration of immunity:
Croatian: Početak imuniteta: 2 tjedna.
English: 4.5 Special precautions for use
Croatian: 4.5 Posebne mjere predostrožnosti prilikom primjene Posebne mjere predostrožnost prilikom primjene na životinjama
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis PCV emulsion for injection for pigs
Croatian: Porcilis PCV emulzija za injekciju za svinje
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE C. STATEMENT OF THE MRLs
Croatian: UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE
English: Excipients.
Croatian: NUSPOJAVE
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis PCV emulsion for injection
Croatian: Porcilis PCV emulzija za injekciju
English: Accidental injection/self-injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given.
Croatian: Slučajno injiciranje/samoinjiciranje može uzrokovati jaku bol i oteklinu, posebice ako je pripravak ubrizgan u zglob na prstu.
English: Even if small amounts have been injected, accidental injection with this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit.
Croatian: Čak i kod slučajnog ubrizgavanja malih količina ovaj proizvod može uzrokovati intenzivnu oteklinu koja može rezultirati npr. ishemičnom nekrozom, čak i gubitkom prsta, U takvim okolnostima ponekad treba brzo napraviti inciziju i isprati zahvaćeno mjesto, posebice ako je cjepivo injicirano u jagodicu prsta, zglob ili tetivu.
English: Use sterile syringes and needles.
Croatian: Izbjegavati višekratno izvlačenje sadržaja cjepiva iz bočice, te upotrebljavati sterilne igle i brizgaljke.
English: Light liquid paraffin
Croatian: Parafin, rijetko tekući
English: Special precautions for use in animals
Croatian: Posebno upozorenje za primjenu kod životinja:
English: Dl-α-tocopheryl acetate Light liquid paraffin Polysorbate 80
Croatian: D1-α-tokoferil acetat 25 mg Parafin, rijetko tekući 346 mg
English: Read the package leaflet before use
Croatian: Prije primjene pročitati uputu o VMP
English: Onset of immunity:
Croatian: Nekompatibilnost:
English: EMEA-number Invented Name Strength Pharmaceutical Form
Croatian: Jačina Farmaceutski oblik
English: Content Package size Withdrawal period
Croatian: Put primjene Pakovanje Sastav Veličina pakovanja
English: What is Nplate and what is it used for?
Croatian: Što je Nplate i za što se koristi?
English: It is given once a week as an injection under the skin.
Croatian: Primjenjuje se jedanput tjedno kao potkožna injekcija.
English: What measures are being taken to ensure the safe and effective use of Nplate?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Nplate?
English: This summary was last updated in 12-2017.
Croatian: Pregled informacija posljednji je put ažuriran u 12. 2017.
English: Why is Nplate approved?
Croatian: Zašto je lijek Nplate odobren?
English: The company that markets Nplate will provide doctors a ‘dosing calculator' to help them calculate the sometimes very small volumes of Nplate that need to be injected.
Croatian: Tvrtka koja stavlja na tržište lijek Nplate dostavit će liječnicima „kalkulator za doziranje” kako bi im pomogao pri izračunu katkad vrlo malih volumena lijeka Nplate koje je potrebno ubrizgati.
English: Other information about Nplate
Croatian: Ostale informacije o lijeku Nplate
English: The European Commission granted a marketing authorisation valid throughout the European Union for Nplate on 4 February 2009.
Croatian: Europska komisija izdala je odobrenje za stavljanje lijeka Nplate u promet koje je na snazi na prostoru Europske unije od 4. veljače 2009.
English: This is a summary of the European public assessment report (EPAR) for Nplate.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Nplate.
English: What are the risks associated with Nplate?
Croatian: Koji su rizici povezani s lijekom Nplate?
English: It is not intended to provide practical advice on how to use Nplate.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Nplate.
English: The improvement in platelet count was long-lasting and clinically relevant in both groups, although the treatment only manages symptoms and is not a cure.
Croatian: Povećanje broja trombocita pokazalo se dugotrajnim i klinički relevantnim u objema skupinama, iako se terapijom samo kontroliraju simptomi, a ne može se izliječiti bolest.
English: Because the number of patients with ITP is low, the disease is considered ‘rare', and Nplate was designated an ‘orphan medicine' (a medicine used in rare diseases) on 27 May 2005.
Croatian: Budući da je broj bolesnika s ITP-om nizak, dotična se bolest smatra „rijetkom” te je Nplate dobio status „lijeka za rijetku bolest” od 27. svibnja 2005.
English: The full EPAR for Nplate can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Nplate nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Adults whose platelet levels are stable may inject the medicine themselves after they have been properly trained.
Croatian: Odrasle osobe čije su koncentracije trombocita stabilne mogu sami ubrizgati lijek nakon što prođu odgovarajuću obuku.
English: The European Medicines Agency decided that Nplate's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Nplate nadmašuju s njim povezane rizike te je preporučila izdavanje odobrenja za stavljanje lijeka u promet.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Nplate can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Croatian: Sažetak mišljenja Odbora za lijekove za rijetke bolesti o lijeku Nplate možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Treatment should be stopped if the platelet count does not rise enough to reduce the risk of bleeding after 4 weeks of treatment with the maximum dose of Nplate.
Croatian: Liječenje je potrebno prekinuti ako se broj trombocita ne poveća dovoljno da bi se smanjio rizik od krvarenja nakon četiri tjedna terapije maksimalnom dozom lijeka Nplate.
English: Patients were treated for 24 weeks and the main measure of effectiveness was the increase in platelet count above a threshold of 50 million platelets per millilitre of blood during at least 6 of the last 8 weeks of treatment.
Croatian: Bolesnici su liječeni 24 tjedna, a glavno mjerilo djelotvornosti bio je porast broja trombocita iznad praga od 50 milijuna trombocita po mililitru krvi tijekom najmanje šest od posljednjih osam tjedana liječenja.
English: Doctors can also receive a home administration training pack, which includes materials on training patients who will inject themselves with Nplate, and materials for patients on how to prepare the medicine for injection.
Croatian: Liječnici također trebaju dobiti komplet za obuku za kućno ubrizgavanje, koji uključuje materijale o obuci bolesnika koji će si sami ubrizgavati Nplate, kao i materijale za bolesnike o tome kako pripremiti lijek za ubrizgavanje.
English: Nplate must not be used in people who are hypersensitive (allergic) to romiplostim, any of the other ingredients, or proteins produced by Escherichia coli (a bacterium).
Croatian: Nplate se ne smije primjenjivati u osoba koje su preosjetljive (alergične) na romiplostim, bilo koji drugi sastojak ili na bjelančevine koje proizvodi Escherichia coli (bakterija).
English: Nplate can only be obtained with a prescription and treatment with it should be supervised by a doctor who has experience in treating blood disorders.
Croatian: Nplate se izdaje samo na liječnički recept, a liječenje mora nadzirati liječnik s iskustvom u liječenju poremećaja krvi.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nplate have also 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 Nplate također se nalaze u sažetku opisa svojstava i u uputi o lijeku.
English: Nplate is a powder that is made up into a solution for injection.
Croatian: Nplate je prašak od kojeg se radi otopina za injekciju.
English: A platelet count below 30 million per millilitre puts patients at risk of bleeding while the normal count is 150 to 400 million per millilitre.
Croatian: Bolesnici s brojem trombocita ispod 30 milijuna po mililitru izloženi su riziku od krvarenja, a normalan broj iznosi između 150 i 400 milijuna trombocita po mililitru.
English: Long-term studies involving over 1,000 patients, some treated for longer than 5 years, confirmed that Nplate remained effective both in patients whose spleen had been removed and those who had their spleen.
Croatian: Dugoročna ispitivanja koja su obuhvatila više od 1000 bolesnika, od kojih su neki liječeni dulje od pet godina, potvrdila su da je Nplate zadržao djelotvornost u bolesnika kojima je odstranjena slezena kao i u bolesnika sa slezenom.
English: Nplate is used in patients from 1 year of age with long-term immune thrombocytopenic purpura (ITP), a disease in which the patient's immune system destroys platelets (components in the blood that help it to clot).
Croatian: Nplate se primjenjuje u bolesnika starijih od jedne godine s kroničnom imunom trombocitopeničnom purpurom (ITP-om), bolesti kod koje imunosni sustav bolesnika uništava trombocite (tjelešca u krvi koje potiču grušanje).
English: The first study involved 63 patients whose disease was not controlled despite removal of their spleen.
Croatian: Prvo ispitivanje obuhvatilo je 63 bolesnika čija bolest nije bila pod kontrolom unatoč tome što im je odstranjena slezena.
English: The most common side effects in children include infections of the nose and throat, runny nose, cough, fever, mouth and throat pain, abdominal (belly) pain, diarrhoea, rash and bruising.
Croatian: Najčešće nuspojave u djece uključuju infekcije nosa i grla, hunjavicu, kašalj, vrućicu, bol u ustima i grlu, abdominalnu bol (bol u trbuhu), proljev, osip i pojavu modrica.
English: What benefits of Nplate have been shown in studies?
Croatian: Koje su koristi lijeka Nplate utvrđene u ispitivanjima?
English: The most common side effects with Nplate in adults (seen in more than 1 patient in 10) include headache, infections of the nose and throat and allergic (hypersensitivity) reactions such as rash, itching and rapid swelling under the skin.
Croatian: Najčešće nuspojave lijeka Nplate (zabilježene u više od 1 na 10 bolesnika) uključuju glavobolju, infekcije nosa i grla, te alergijske reakcije (preosjetljivost) kao što su osip, svrbež i brzo oticanje tkiva ispod kože.
English: All studies compared Nplate with placebo (a dummy treatment).
Croatian: Nplate je u svim ispitivanjima uspoređen s placebom (prividno liječenje).
English: The starting dose depends on the patient's weight, and is then adjusted to maintain platelet counts at the target levels.
Croatian: Početna doza ovisi o tjelesnoj težini bolesnika te se zatim prilagođava kako bi se broj trombocita zadržao na željenoj razini.
English: Patients with ITP have low platelet counts and are at risk of bleeding.
Croatian: Bolesnici s ITP-om imaju mali broj trombocita i izloženi su riziku od krvarenja.
English: The study in children involved 62 patients aged 1 to less than 18 years whose ITP had been treated previously (including some whose spleen had been removed).
Croatian: Ispitivanje na djeci obuhvatilo je 62 bolesnika u dobi od 1 do manje od 18 godina koji su prethodno liječeni od ITP-a (uključujući neke bolesnike kojima je odstranjena slezena).
English: Therefore, in patients with intact spleens, the possibility of removing the spleen should be evaluated periodically.
Croatian: Stoga je u bolesnika sa slezenom potrebno povremeno procijeniti mogućnost odstranjivanja slezene.
English: By mimicking the action of thrombopoietin, romiplostim stimulates the production of platelets, thereby increasing blood platelet counts and reducing the risk of bleeding.
Croatian: Oponašajući djelovanje trombopoetina, romiplostim stimulira stvaranje trombocita povećavajući time broj trombocita u krvi i smanjujući rizik od krvarenja.
English: Romiplostim has been designed to attach to and stimulate the same targets (receptors) as thrombopoietin.
Croatian: Romiplostim je namijenjen vezivanju na iste tvari(receptore) kao i trombopoetin te ih stimulira.
English: Nplate is used when treatment with medicines such as corticosteroids or immunoglobulins has not worked.
Croatian: Nplate se primjenjuje u bolesnika u kojih ne djeluje terapija lijekovima poput kortikosterioda ili imunoglobulina.
English: Nplate contains the active substance romiplostim.
Croatian: Nplate sadrži djelatnu tvar romiplostim.
English: For practical information about using Nplate, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Nplate bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: Two main studies in adults and a third one in children found Nplate effective for the treatment of longstanding ITP.
Croatian: U dvama glavnim ispitivanjima na odraslim osobama te u trećem ispitivanju na djeci utvrđena je djelotvornost lijeka Nplate u liječenju kroničnog ITP-a.
English: The spleen, an organ behind the stomach, is involved in the removal of platelets from the blood.
Croatian: Slezena je organ iza želuca koji je uključen u proces uklanjanja trombocita iz krvi.
English: The second study involved 62 patients whose ITP had been treated previously (but who did not have their spleen removed).
Croatian: Drugo ispitivanje obuhvatilo je 62 bolesnika koji su prethodno liječeni od ITP-a (ali im nije odstranjena slezena).
English: Nplate can be used in patients whose spleen has been removed to control the disease and in those who still have a spleen.
Croatian: Nplate se može primjenjivati u bolesnika kojima je odstranjena slezena radi kontroliranja bolesti, kao i u bolesnika kojima slezena nije odstranjena.
English: For more information about treatment with Nplate, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Nplate pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se liječniku ili ljekarniku.
English: The Agency noted that Nplate was effective in patients who had had their spleen removed, as well as in patients who had not had their spleen removed.
Croatian: Agencija je uočila je da je lijek Nplate djelotvoran u bolesnika kojima je odstranjena slezena, kao i u bolesnika kojima slezena nije odstranjena.
English: How is Nplate used?
Croatian: Kako se Nplate koristi?
English: The active substance in Nplate, romiplostim, stimulates the production of platelets.
Croatian: Djelatna tvar lijeka Nplate, romiplostim, stimulira stvaranje trombocita.
English: In the body, a hormone called ‘thrombopoietin' normally stimulates the production of platelets in the bone marrow.
Croatian: Uobičajeno je da hormon naziva "trombopoetin" u tijelu stimulira stvaranje trombocita u leđnoj moždini.
English: Platelet count rose above the threshold in 61% of patients who received Nplate (25 out of 41) compared with 5% receiving placebo (1 out of 21).
Croatian: Broj trombocita premašio je prag u 61 % bolesnika koji su primali Nplate (25 od 41), u usporedbi s 5 % u bolesnika koji su primali placebo (1 od 21).
English: Platelet count rose above the threshold in 38% of patients who received Nplate (16 out of 42) compared with none of the 21 patients receiving placebo.
Croatian: Broj trombocita premašio je prag u 38 % bolesnika koji su primali Nplate (16 od 42), u usporedbi s nijednim od 21 bolesnika koji su primali placebo.
English: Platelet count rose above the threshold in 52% of patients who received Nplate (22 out of 42) compared with 10% receiving placebo (2 out of
Croatian: Broj trombocita premašio je prag u 52% bolesnika koji su primali Nplate (22 od 42), u usporedbi s 10% u bolesnika koji su primali placebo (2 od 20).
English: For the full list of side effects reported with Nplate, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Nplate potražite u uputi o lijeku.
English: What is Tegsedi and what is it used for?
Croatian: Što je Tegsedi i za što se koristi?
English: Further information on Tegsedi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Tegsedi možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What measures are being taken to ensure the safe and effective use of Tegsedi?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Tegsedi?
English: The first injection should be given under the supervision of a qualified healthcare professional, and patients or carers can give the subsequent injections after receiving appropriate training.
Croatian: Prvu injekciju treba dati pod nadzorom osposobljenog zdravstvenog radnika, a sljedeće injekcije mogu davati bolesnici ili njegovatelji nakon što prođu odgovarajuću obuku.
English: Further information on the orphan designation can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Croatian: Više informacija o statusu lijeka za liječenje rijetkih bolesti možete naći ovdje: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Why is Tegsedi authorised in the EU?
Croatian: Zašto je lijek Tegsedi odobren u EU-u?
English: In light of the unmet medical need, the safety profile of Tegsedi was considered acceptable and the risks to be manageable with specific monitoring, dose reduction and stopping rules.
Croatian: Uzimajući u obzir i neudovoljenu medicinsku potrebu, sigurnosni profil lijeka Tegsedi smatra se prihvatljivim, a rizicima se može upravljati uz poseban nadzor, smanjenje doza i pravila za prekid liječenja.
English: The medicine is available as a solution for injection under the skin in pre-filled syringes (284 mg).
Croatian: Lijek je dostupan u obliku otopine koja se ubrizgava pod kožu, u napunjenim štrcaljkama (284 mg).
English: Side effects reported with Tegsedi are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Tegsedi pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: The recommended dose is one injection once a week, given under the skin in the belly, upper thigh or upper arm.
Croatian: Preporučena doza je jedna injekcija jedanput tjedno koja se daje pod kožu abdomena, natkoljenice ili nadlaktice.
English: The main measures of effectiveness were the changes in the patients' nerve damage and quality of life, as measured using standard scales called ‘mNIS+7' and ‘Norfolk QoL-DN' respectively.
Croatian: Glavna mjerila djelotvornosti bila su promjene u oštećenju živaca i u kvaliteti života bolesnika, mjerene s pomoću standardnih ljestvica naziva „mNIS+7”, odnosno „Norfolk QoL-DN”.
English: Tegsedi is used in adult patients in the first two stages of the nerve damage (stage 1, when the patient is able to walk unaided, and stage 2, when the patient can still walk but needs help).
Croatian: Lijek Tegsedi primjenjuje se u odraslih bolesnika u prvim dvama stadijima oštećenja živaca (1. stadij, kada bolesnik može hodati bez pomoći i 2. stadij, kada bolesnik može hodati, ali mu je potrebna pomoć).
English: An overview of Tegsedi and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Tegsedi i zašto je odobren u EU-u
English: What are the risks associated with Tegsedi?
Croatian: Koji su rizici povezani s lijekom Tegsedi?
English: For more information about using Tegsedi, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Tegsedi pogledajte uputu o lijeku ili se obratite liječniku ili ljekarniku.
English: The most common side effects with Tegsedi (which may affect more than 1 in 10 people) are reactions at the site of injection, nausea (feeling sick), low level of red blood cells, headache, fever, peripheral oedema (swelling, especially of the ankles and feet), chills, vomiting and low blood platelet counts which can lead to bleeding and bruising.
Croatian: Najčešće nuspojave lijeka Tegsedi (koje se mogu javiti u više od 1 na 10 osoba) su reakcije na mjestu injekcije, mučnina (osjećaj slabosti), niska razina crvenih krvnih stanica, glavobolja, vrućica, periferni edem (oticanje, osobito zglobova i stopala), zimica, povraćanje i nizak broj trombocita u krvi koji može dovesti do krvarenja i pojave modrica.
English: How does Tegsedi work?
Croatian: Kako djeluje Tegsedi?
English: This reduces production of transthyretin, thereby reducing the formation of amyloids and relieving the symptoms of hATTR amyloidosis.
Croatian: To dovodi do smanjenog stvaranja transtiretina, čime se smanjuje nastajanje amiloida i ublažavaju simptomi nasljedne transtiretinske amiloidoze.
English: The European Medicines Agency therefore decided that Tegsedi's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove stoga je zaključila da koristi od lijeka Tegsedi nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tegsedi have also 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 Tegsedi nalaze se također u sažetku opisa svojstava lijeka i u uputi o lijeku.