FrancophonIA/ELRC3.0 huggingface dataset:
English: 100 ml (50 doses) 240 ml (120 doses)
Croatian: 100 ml (50 doza) 240 ml (120 doza)
English: Cardboard box with 1 bottle of 120 doses (240 ml).
Croatian: Kartonska kutija s 1 bočicom od 120 doza (240 ml).
English: A local reaction at the injection site may occur very commonly after vaccination.
Croatian: Vrlo često nakon cijepljenja na mjestu primjene može se pojaviti lokalna reakcija.
English: Full stability data for three batches of monovalent BTV-4 vaccine within 39 months of the granting of the Marketing Authorisation shall be provided.
Croatian: OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE U PROMET U roku 39 mjeseci nakon izdavanja odobrenja, treba dostaviti podatke kompletnih ispitivanja stabilnosti, tri serije monovalentnog BTV-4 cjepiva.
English: Cardboard box with 1 bottle of 50 doses (100 ml).
Croatian: Kartonska kutija s 1 bočicom od 50 doza (100 ml).
English: Pharmacotherapeutic group: Immunologicals for Bovidae, inactivated viral vaccines for cattle.
Croatian: Farmakoterapijska grupa: imunolobiolški proizvod za goveda, inaktivirana virusna cjepiva za goveda ATCvet kod: QI02AA.
English: Potassium dihydrogen phosphate Disodium phosphate dihydrate Sodium chloride
Croatian: Aluminijev hidroksid Quil-A (ekstrakt saponina Quillaja saponaria) tiomersal kalijev klorid kalijev dihidrogenfosfat dinatrijev fosfat dihidrat natrijev klorid voda za injekcije
English: Zulvac BTV suspension for injection for sheep and cattle
Croatian: Zulvac BTV suspenzija za injekciju za ovce i goveda
English: A transient increase in rectal temperature, not exceeding 2.7 °C, was commonly observed during the 48 hours following vaccination in field safety studies.
Croatian: Čest je prolazni porast rektalne temperature, ne veći od 2,7 ° C, tijekom 48 sati nakon cijepljenja u terenskim ispitivanjima neškodljivosti.
English: Quil-A (Quillaja saponaria saponin extract)
Croatian: Quil-A (ekstrakt saponina Quillaja saponaria)
English: Onset of immunity: 21 days after completion of the primary vaccination scheme.
Croatian: Početak imunosti: 21 dan nakon dovršetka sheme primarnog cijepljenja.
English: Each dose of 2 ml of vaccine contains:
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna doza od 2 ml cjepiva sadrži:
English: Shelf life after first opening the immediate packaging: use immediately.
Croatian: Rok valjanosti poslije prvog otvaranja unutarnjeg pakovanja: upotrijebiti odmah nakon otvaranja bočice.
English: **Relative potency by a mice potency test compared to a reference vaccine efficacious in sheep.
Croatian: ** Relativna potentnost s potentnosti u miševa u usporedbi s referentnim cjepivom učinkovitim kod ovaca.
English: 20 ml (10 doses) 100 ml (50 doses) 240 ml (120 doses)
Croatian: VELIČINA PAKOVANJA 20 ml (10 doza) 100 ml (50 doza) 240 ml (120 doza)
English: EU/2/17/207/001 (20 ml) BTV 1 EU/2/17/207/002 (100 ml) BTV 1 EU/2/17/207/003 (240 ml) BTV 1 EU/2/17/207/007 (20 ml) BTV 8 EU/2/17/207/008 (100 ml) BTV 8
Croatian: EU/2/17/207/001 (20 ml) BTV 1 EU/2/17/207/002 (100 ml) BTV 1 EU/2/17/207/003 (240 ml) BTV 1 EU/2/17/207/007 (20 ml) BTV 8 EU/2/17/207/008 (100 ml) BTV 8 EU/2/17/207/009 (240 ml) BTV 8
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box 1 x 20 ml, 1 x 100 ml and 1 x 240 ml (BTV-4 for sheep)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU Kartonska kutija 1 x 20 ml, 1 x 100 ml i 1 x 240 ml (BTV-4 za ovce)
English: Local reactions of < 2 cm diameter were very commonly observed while reactions of up to 5 cm diameter were commonly observed after administration of a single dose in field safety studies.
Croatian: Vrlo često se javljaju lokalne reakcije promjera < 2 cm vrlo, dok su reakcije promjera do 5 cm često javljaju nakon davanja jedne doze u terenskim ispitivanjima neškodljivosti.
English: Administer one dose of 2 ml according to the following vaccination scheme: 1st injection: from 12 weeks of age.
Croatian: Primijeniti jednu dozu od 2 ml prema sljedećoj shemi cijepljenja: 1. injekcija: od 12 tjedana starosti.
English: Administer one dose of 2 ml according to the following vaccination scheme: 1st injection: from 6 weeks of age.
Croatian: Primijeniti jednu dozu od 2 ml prema sljedećoj shemi cijepljenja: 1. injekcija: od 6 tjedana starosti.
English: Administer one dose of 2 ml according to the following vaccination scheme: - 1st injection: from 6 weeks of age.
Croatian: Primijeniti jednu dozu od 2 ml prema sljedećoj shemi cijepljenja: - 1. injekcija: od 6 tjedana starosti.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box 1 x 20 ml, 1 x 100 ml and 1 x 240 ml (BTV-1 for sheep and cattle; BTV-8 for sheep and cattle)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU Kartonska kutija 1 x 20 ml, 1 x 100 ml i 1 x 240 ml (BTV-1 za ovce i goveda, BTV-8, za ovce i goveda)
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bottle of 100 ml and 240 ml (BTV-4 for sheep)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKOVANJU Etiketa na bočici od 100 ml i 240 ml (BTV-4 za ovce)
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bottle of 100 ml and 240 ml (BTV-1 for sheep and cattle; BTV-8 for sheep and cattle)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKOVANJU Etiketa na bočici od 100 ml i 240 ml (BTV-1 za ovce i goveda; BTV-8 za ovce i goveda)
English: One of the following inactivated bluetongue virus strains: Inactivated bluetongue virus, serotype 1, strain BTV-1/ALG2006/01 E1
Croatian: Inaktivirani virus bolesti plavog jezika, serotip 1, soj BTV-1/ALG2006/01 E1 RP* ≥ 1 Inaktivirani virus bolesti plavog jezika, serotip 8, soj BTV-8/BEL2006/02 RP* ≥ 1 Inaktivirani virus bolesti plavog jezika, serotip 4, soj SPA-1/2004
English: Al3+ (as hydroxide), Quil-A (Quillaja saponaria saponin extract), thiomersal.
Croatian: Aluminijev hidroksid, Quil-A (ekstrakt saponina Quillaja saponaria), tiomersal.
English: Active immunisation of sheep from 6 weeks of age for the reduction* of viraemia caused by bluetongue virus, serotype 4.
Croatian: Aktivna imunizacija ovaca od 6 tjedana života, za smanjenje* viremije koju uzrokuje virus bolesti plavog jezika, serotip 4.
English: Inactivated BTV, serotype 1 Inactivated BTV, serotype 8
Croatian: Inaktivirani virus bolesti plavog jezika, serotip 1 Inaktivirani virus bolesti plavog jezika, serotip 8
English: For protection against serotype 1, administer one dose of 2 ml, every 12 months.
Croatian: Za zaštitu od serotipa 1 primijeniti jednu dozu od 2 ml, svakih 12 mjeseci.
English: EU/2/17/207/002 (100 ml) BTV 1 EU/2/17/207/003 (240 ml) BTV 1 EU/2/17/207/008 (100 ml) BTV 8
Croatian: EU/2/17/207/002 (100 ml) BTV 1 EU/2/17/207/003 (240 ml) BTV 1 EU/2/17/207/008 (100 ml) BTV 8 EU/2/17/207/009 (240 ml) BTV 8
English: For protection against serotype 1 or serotype 8, administer one dose of 2 ml, every 12 months.
Croatian: Za zaštitu od serotipa 1 ili serotipa 8 primijeniti jednu dozu od 2 ml, svakih 12 mjeseci.
English: For protection against serotype 8, administer two doses of 2 ml three weeks apart, every 12 months.
Croatian: Za zaštitu od serotipa 8 primijeniti dvije doze od 2 ml, s međusobnim razmaku od tri tjedna, svakih 12
English: Bluetongue virus, serotype 8: 25 days after completion of the primary vaccination scheme.
Croatian: Virus bolesti plavog jezika, serotip 8: 25 dana nakon dovršetka sheme primarnog cijepljenja.
English: For protection against serotype 4, administer two doses of 2 ml three weeks apart, every 12 months.
Croatian: Za zaštitu od serotipa 4 primijeniti dvije doze od 2 ml, s međusobnim razmakom od tri tjedna, svakih
English: Bluetongue virus, serotype 8: 12 months after completion of the primary vaccination scheme.
Croatian: Virus bolesti plavog jezika, serotip 8: 12 mjeseci nakon dovršetka sheme primarne vakcinacije.
English: Inactivated BTV, serotype 1
Croatian: Inaktivirani virus bolesti plavog jezika, serotip 1
English: Inactivated BTV, serotype 4
Croatian: Inaktivirani virus bolesti plavog jezika, serotip 4
English: Manufacturer responsible for batch release:
Croatian: UPUTA O VMP:
English: Active immunisation of sheep from 6 weeks of age for the prevention* of viraemia caused by bluetongue virus, serotype 1 or serotype 8.
Croatian: Aktivna imunizacija ovaca od 6 tjedana života, za prevenciju* viremije koju uzrokuje virus bolesti plavog jezika, serotip 1 ili serotip 8.
English: EU/2/17/207/001-009
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/17/207/001-009
English: Inactivated BTV, serotype 8
Croatian: Inaktivirani virus bolesti plavog jezika, serotip 8
English: STATEMENT OF ACTIVE SUBSTANCES
Croatian: NAVOĐENJE DJELATNE TVARI
English: Cattle: Active immunisation of cattle from 12 weeks of age for the prevention** of viraemia caused by bluetongue virus, serotype 1 or serotype 8.
Croatian: Aktivna imunizacija goveda starijih od 12 tjedana života, za prevenciju ** viremije uzrokovane virusom bolesti plavog jezika, serotipom 1 ili serotipom 8.
English: *Below the level of detection of < 3.9 log10 genome copies/ml by the validated RT-qPCR method, indicating no presence of viral genome.
Croatian: * Ispod razine detekcije od < 3.9 log10 kopija genoma/ml prema validiranoj metodi RT-qPCR, što ukazuje na odsustvo virusnog genoma.
English: Revaccination
Croatian: Ponovno cijepljenje
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Croatian: NAČIN I PUT(EVI) PRIMJENE Subkutana primjena.
English: *Relative potency by a mice potency test compared to a reference vaccine efficacious in sheep and cattle.
Croatian: RP** ≥ 0,8 * Relativna potentnost utvrđena u ispitivanju potentnosti na miševima u usporedbi s referentnim cjepivom koje se pokazalo djelotvornim kod ovaca i goveda.
English: Bluetongue virus, serotype 1: 15 days after completion of the primary vaccination scheme.
Croatian: Početak imunosti: Virus bolesti plavog jezika, serotip 1: 15 dana nakon dovršetka sheme primarnog cijepljenja.
English: EU/2/17/207/005 (100 ml) BTV 4 EU/2/17/207/006 (240 ml) BTV 4
Croatian: EU/2/17/207/005 (100 ml) BTV 4
English: **Below the level of detection of < 3.4 log10 genome copies/ml by a validated RT-qPCR method, indicating no presence of viral genome.
Croatian: ** Ispod razine detekcije od <3,4 log10 kopija genoma / ml prema validiranoj metodi RT-qPCR, što ukazuje na odsustvo virusnog genoma.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottle of 20 ml (BTV-1 for sheep and cattle; BTV-8 for sheep and cattle)
Croatian: Etiketa na bočici od 20 ml (BTV-1 za ovce i goveda; BTV-8 za ovce i goveda) NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA
English: Bluetongue virus, serotype 1: 12 months after completion of the primary vaccination scheme.
Croatian: Trajanje imunosti: Virus bolesti plavog jezika, serotip 1: 12 mjesec nakon dovršetka sheme primarnog cijepljenja.
English: Local reactions of up to 5 cm diameter were very commonly observed and reactions > 5 cm diameter were commonly observed after repeated administration of a single dose in field safety studies.
Croatian: Kod terenskih ispitivanja neškodljivosti nakon višekratne primjene jedne doze vrlo često se javljaju lokalne reakcije promjera do 5 cm, a često se javljaju reakcije promjera > 5 cm.
English: Intramuscular use.
Croatian: Goveda: Intramuskularna primjena
English: Name and address of the manufacturer responsible for batch release
Croatian: PROIZVOĐAČ BIOLOŠKI DJELATNE TVARI I PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE U PROMET
English: The tablets are given once a day.
Croatian: Tablete se daju jedanput na dan.
English: Symptoms are expected to improve within 1 to 2 weeks.
Croatian: Poboljšanje simptoma očekuje se u roku od 1 do 2 tjedna.
English: This summary was last updated in August 2016.
Croatian: Sažetak je posljednji put ažuriran u kolovozu 2016.
English: In case there is no improvement within 4 weeks, the veterinarian should re-evaluate treatment.
Croatian: Ako se u roku od 4 tjedna ne primijeti poboljšanje, veterinar bi trebao ponovno procijeniti terapiju.
English: Reconcile fluoxetine
Croatian: Reconcile fluoksetin
English: What is Reconcile and what is it used for?
Croatian: Što je Reconcile i za što se koristi?
English: Fluoxetine is an antidepressant.
Croatian: Fluoksetin je antidepresiv.
English: Reconcile is available as tablets (8, 16, 32 and 64 mg) and can only be obtained with a prescription.
Croatian: VMP Reconcile dostupan je u tabletama (8, 16, 32 i 64 mg), a izdaje se samo na recept.
English: The main measure of effectiveness was the change in each of the nine different behaviours recognised as characteristic indicators of separation anxiety in dogs.
Croatian: Glavna mjera djelotvornosti bila je promjena u svakom od devet različitih oblika ponašanja koji su prepoznati kao karakteristični pokazatelji straha od odvajanja u pasa.
English: The study showed that Reconcile was as effective as clomipramine.
Croatian: Ispitivanje je pokazalo da je Reconcile bio jednako djelotvoran kao klomipramin.
English: The European Commission granted a marketing authorisation valid throughout the EU for Reconcile on 8 July 2008.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za VMP Reconcile na snazi u Europskoj uniji od 8. srpnja 2008.
English: Fluoxetine works by increasing the levels of the neurotransmitter serotonin in the central nervous system.
Croatian: Fluoksetin djeluje tako da povećava razine neurotransmitera serotonina u središnjem živčanom sustavu.
English: The full EPAR for Reconcile can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za VMP Reconcile nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: The tablet strength should be chosen according to the dog's weight.
Croatian: Jačinu tablete treba odrediti ovisno o tjelesnoj težini psa.
English: Why is Reconcile approved?
Croatian: Zašto je Reconcile odobren?
English: Since low levels of serotonin can be linked to depression and anxiety, increasing them can help dogs feel calmer so improving the behaviour in dogs with separation-related problems.
Croatian: Budući da niske razine serotonina mogu biti povezane s depresijom i anksioznosti, povećanjem njihove razine psi se osjećaju mirnije i stoga se poboljšava ponašanje pasa koji imaju probleme povezane s odvajanjem.
English: After 8 weeks of treatment, two separation anxiety behaviours were significantly improved in the Reconcile group (inappropriate defecation and destructive behaviour).
Croatian: Nakon osam tjedana liječenja dva su oblika ponašanja povezana sa strahom od odvajanja znatno poboljšana u skupini koja je primala Reconcile (neprikladno obavljanje nužde i destruktivno ponašanje).
English: Reconcile must not be given to dogs weighing less than 4 kg or to dogs with epilepsy or a history of fits.
Croatian: Reconcile se ne smije davati psima čija je tjelesna težina manja od 4 kg ili psima s epilepsijom ili epizodama napadaja.
English: Such problems may include destruction of property, excessive barking or howling and inappropriate defecation and urination in the home.
Croatian: Ti problemi mogu uključivati uništavanje imovine, pretjerano lajanje ili zavijanje te neprikladno obavljanje nužde i mokrenje u kući.
English: It must also not be used in dogs which are hypersensitive (allergic) to the active substance, any other ingredients or medicines in the same class as fluoxetine (serotonin-reuptake inhibitors).
Croatian: Također se ne smije davati psima koji su preosjetljivi (alergični) na djelatnu tvar, bilo koje druge sastojke ili lijekove iz istog razreda kao fluoksetin (inhibitori serotonina).
English: Reconcile should only be given in combination with behavioural therapy.
Croatian: Reconcile se smije primjenjivati samo u kombinaciji s bihevioralnom terapijom.
English: It is not intended to provide practical advice on how to use Reconcile.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni VMP Reconcile.
English: What are the risks associated with Reconcile?
Croatian: Koji su rizici povezani s VMP-om Reconcile?
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Reconcile'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 Reconcile nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: This is a summary of the European public assessment report (EPAR) for Reconcile.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o veterinarsko-medicinskom proizvodu Reconcile.
English: Other common side effects with Reconcile (which may affect up to 1 in 10 dogs) are urinary problems (inflammation of the bladder, lack of control in passing urine, inability to completely empty the bladder, and pain and difficulty in passing urine), and lack of coordination and disorientation.
Croatian: Ostale česte nuspojave povezane s VMP-om Reconcile (koje se mogu pojaviti u do 1 na 10 pasa) jesu problemi s mokrenjem (upala mjehura, manjak kontrole pri mokrenju, nemogućnost potpunog pražnjenja mjehura, te bolovi i teškoće pri mokrenju) te slaba koordinacija i dezorijentiranost.
English: The most common side effects with Reconcile (which may affect more than 1 in 10 dogs) are loss of appetite and lethargy (lack of energy).
Croatian: Najčešće nuspojave VMP-a Reconcile (koje se mogu javiti u više od 1 na 10 pasa) jesu gubitak teka i letargija (manjak energije).
English: Reconcile is a veterinary medicine used as an aid to treat dogs with behavioural problems caused by separation from their owners or homes or from other dogs (separation anxiety).
Croatian: Reconcile je veterinarsko-medicinski proizvod koji se upotrebljava kao pomoć u liječenju poremećaja ponašanja u pasa koji nastaju zbog odvajanja od njihovih vlasnika, napuštanja njihovih domova ili odvajanja od drugih pasa (strah od odvajanja).
English: If the product is accidentally swallowed by a person, the advice of a doctor should be sought immediately.
Croatian: U slučaju da se VMP nehotice proguta, treba odmah potražiti pomoć liječnika.
English: All dogs received behavioural therapy and were treated either with Reconcile or with clomipramine (another medicine used to treat dogs with separation-related disorders).
Croatian: Svi su psi primali bihevioralnu terapiju te su primali Reconcile ili klomipramin (drugi lijek koji se upotrebljava za liječenje pasa s poremećajima povezanima s odvajanjem).
English: A field study was conducted in a large number of dogs that were treated for separation anxiety in two European countries.
Croatian: U dvije europske države provedeno je terensko ispitivanje na velikom broju pasa koji su liječeni od straha od odvajanja.
English: For the full list of all side effects and restrictions reported with Reconcile, see the package leaflet.
Croatian: Potpuni popis svih nuspojava i ograničenja prijavljenih prilikom primjene VMP-a Reconcile potražite u uputi o VMP-u.
English: It contains the active substance fluoxetine.
Croatian: Sadrži djelatnu tvar fluoksetin.
English: How does Reconcile work?
Croatian: Kako djeluje Reconcile?
English: For practical information about using Reconcile, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Praktične informacije o primjeni VMP-a Reconcile vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti svojem veterinaru ili ljekarniku.
English: For more information about treatment with Reconcile, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Dodatne informacije o terapiji VMP-om Reconcile vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti svojem veterinaru ili ljekarniku.
English: What benefits of Reconcile have been shown in studies?
Croatian: Koje su koristi VMP-a Reconcile utvrđene u ispitivanjima?
English: Other information about Reconcile?
Croatian: Ostale informacije o VMP-u Reconcile
English: How is Reconcile used?
Croatian: Kako se Reconcile koristi?
English: The main measure of effectiveness was based on improvements in any of these four symptoms during the first 24 weeks of treatment.
Croatian: Glavna mjera djelotvornosti temeljila se na poboljšanju bilo kojeg od tih četiriju simptoma tijekom prva 24 tjedna liječenja.
English: It was to be available as tablets.
Croatian: Trebao je biti dostupan u tabletama.
English: Outcome of re-examination
Croatian: Ishod preispitivanja
English: The company requested a re-examination of the initial opinion.
Croatian: Tvrtka je zatražila preispitivanja prvotnog mišljenja.
English: 15 September 2017 EMA/599464/2017 EMEA/H/C/004159
Croatian: EMA/599464/2017 EMEA/H/C/004159
English: What is Masipro?
Croatian: Što je Masipro?
English: The CHMP refusal was confirmed after re-examination.
Croatian: Odbijanje CHMP-a potvrđeno je nakon ponovnog pregleda.
English: What were the CHMP's main concerns that led to the refusal?
Croatian: Koji su bili glavni razlozi za zabrinutost CHMP-a koji su doveli do odbijanja zahtjeva?
English: How does Masipro work?
Croatian: Kako djeluje Masipro?
English: In addition, major changes were made to the study design while the study was ongoing, which made the results difficult to interpret.
Croatian: Osim toga, izvedba ispitivanja znatno je promijenjena za vrijeme trajanja ispitivanja, što je otežalo tumačenje rezultata.
English: Refusal of the marketing authorisation for Masipro (masitinib) EMA/599464/2017
Croatian: Odbijanje odobrenja Zajednice za stavljanje u promet lijeka Masipro (masitinib) EMA/599464/2017
English: What consequences does this refusal have for patients in clinical trials or compassionate use programmes?
Croatian: Koje posljedice ima ovo odbijanje zahtjeva za bolesnike u kliničkim ispitivanjima ili u programima milosrdnog davanja lijekova?
English: After considering the grounds for this request, the CHMP re-examined the opinion, and confirmed the refusal of the marketing authorisation on 14 September 2017.
Croatian: Nakon razmatranja razloga za ovaj zahtjev CHMP je preispitao prvotno mišljenje i potvrdio odbijanje izdavanja odobrenja za stavljanje lijeka u promet dana 14. rujna 2017.
English: The CHMP was concerned about the reliability of the study results because a routine GCP (good clinical practice) inspection at the study sites revealed serious failings in the way the study had been conducted.
Croatian: CHMP je izrazio zabrinutost u pogledu pouzdanosti rezultata ispitivanja jer je rutinska inspekcija dobre kliničke prakse na lokacijama ispitivanja otkrila ozbiljne nedostatke u načinu provedbe ispitivanja.
English: By blocking these enzymes, Masipro is thought to help slow down the growth of the mast cells.
Croatian: Smatra se da blokiranjem tih enzima lijek Masipro pomaže pri usporavanju rasta mastocita.
English: Finally, data on the safety of the medicine were limited and there were concerns regarding the medicine's side effects, including neutropenia (low levels of white blood cells) and harmful effects on the skin and liver, which were of relevance particularly because the medicine was to be used long term.
Croatian: Naposljetku, podaci o sigurnosti lijeka bili su ograničeni te su postojali razlozi za zabrinutost u pogledu nuspojava lijeka, uključujući neutropeniju (niske razine bijelih krvnih stanica) i štetne učinke na kožu i jetru, koji su bili osobito važni jer je lijek bio namijenjen za dugotrajnu primjenu.
English: Refusal of the marketing authorisation for Masipro (masitinib)
Croatian: Odbijanje odobrenja Zajednice za stavljanje u promet lijeka Masipro (masitinib)
English: The company that applied for authorisation is AB Science.
Croatian: Zahtjev za izdavanje odobrenja podnijela je tvrtka AB Science.
English: In the study, Masipro was compared with placebo (a dummy treatment).
Croatian: U ispitivanju je Masipro uspoređen s placebom (prividno liječenje).