FrancophonIA/ELRC3.0 huggingface dataset:
English: • abdominal pain, abdominal discomfort, vomiting, nausea, constipation, diarrhoea, indigestion,
Croatian: • bol u trbuhu, nelagoda u trbuhu, povraćanje, mučnina, zatvor, proljev, poremećena probava,
English: Each INVEGA 12 mg prolonged-release tablet contains 12 mg of paliperidone.
Croatian: Jedna INVEGA tableta s produljenim oslobađanjem od 12 mg sadrži 12 mg paliperidona.
English: Each prolonged-release tablet contains 9 mg of paliperidone.
Croatian: Jedna tableta s produljenim oslobađanjem sadrži 9 mg paliperidona.
English: Polyethylene oxide 200K Sodium chloride Povidone (K29-32) Stearic acid
Croatian: Jezgra polietilenoksid 200K natrijev klorid povidon (K29-32) stearatna kiselina butilhidroksitoluen (E321) polietilenoksid 7000K
English: Each prolonged-release tablet contains 12 mg of paliperidone.
Croatian: Jedna tableta s produljenim oslobađanjem sadrži 12 mg paliperidona.
English: Each prolonged-release tablet contains 3 mg of paliperidone.
Croatian: Jedna tableta s produljenim oslobađanjem sadrži 3 mg paliperidona.
English: 30 prolonged-release tablets - EU/1/07/395/057 350 prolonged-release tablets - EU/1/07/395/058
Croatian: 30 tableta s produljenim oslobađanjem - EU/1/07/395/057 350 tableta s produljenim oslobađanjem - EU/1/07/395/058
English: Trilayer capsule-shaped white tablets of 11 mm in length and 5 mm in diameter printed with “PAL 3” Trilayer capsule-shaped beige tablets of 11 mm in length and 5 mm in diameter printed with “PAL 6” Trilayer capsule-shaped pink tablets of 11 mm in length and 5 mm in diameter printed with “PAL 9” Trilayer capsule-shaped yellow tablets of 11 mm in length and 5 mm in diameter printed with “PAL 12”
Croatian: Troslojne tablete roza boje oblika kapsule dužine 11 mm i promjera 5 mm s otisnutom oznakom „PAL 9”.
English: Each INVEGA 3 mg prolonged-release tablet contains 3 mg of paliperidone.
Croatian: Jedna INVEGA tableta s produljenim oslobađanjem od 3 mg sadrži 3 mg paliperidona.
English: d.o.o.
Croatian: oC.
English: Each prolonged-release tablet contains 6 mg of paliperidone.
Croatian: Jedna tableta s produljenim oslobađanjem sadrži 6 mg paliperidona.
English: Titanium dioxide (E171) Polyethylene glycol 400 Ferric oxide (yellow) (E172) Carnauba wax
Croatian: Ovojnica hipromeloza titanijev dioksid (E171) polietilenglikol 400 željezov oksid (žuti) (E172) karnauba vosak
English: 30 prolonged-release tablets - EU/1/07/395/061 350 prolonged-release tablets - EU/1/07/395/062
Croatian: 30 tableta s produljenim oslobađanjem - EU/1/07/395/061 350 tableta s produljenim oslobađanjem - EU/1/07/395/062
English: 3 mg tablets Contains lactose.
Croatian: 3 mg tablete
English: 30 prolonged-release tablets - EU/1/07/395/063 350 prolonged-release tablets - EU/1/07/395/064
Croatian: 30 tableta s produljenim oslobađanjem - EU/1/07/395/063 350 tableta s produljenim oslobađanjem - EU/1/07/395/064
English: Paliperidone
Croatian: BLISTER
English: Schizoaffective Disorder Studies: Primary Efficacy Parameter, PANSS Total Score Change from Baseline from Studies R076477-SCA-3001 and R076477-SCA-3002: Intent-to-Treat Analysis Set
Croatian: Promjena u ukupnom PANSS zbroju od osnovne početne vrijednosti, za klinička ispitivanja R076477-SCA-3001 i R076477-SCA-3002: tzv. analiza podataka bolesnika s namjerom liječenja (engl.
English: This study demonstrated the efficacy of INVEGA of the medium dose group in adolescent subjects with schizophrenia.
Croatian: U adolescentskih ispitanika sa shizofrenijom ispitivanje je pokazalo djelotvornost lijeka INVEGA u skupini koja je primala srednju dozu lijeka.
English: Schizophrenia Studies: Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Total Score - Change From Baseline to End Point - LOCF for Studies R076477-SCH-303, R076477-SCH-304, and R076477-SCH-305: Intent-to-Treat Analysis Set
Croatian: Ukupan rezultatpromjena od početne do završne vrijednosti - LOCF za klinička ispitivanja R076477-SCH-303, R076477SCH-304 i R076477-SCH-305: prema tzv. Intent-to-Treat Analysis
English: 30 prolonged-release tablets - EU/1/07/395/059 350 prolonged-release tablets - EU/1/07/395/060
Croatian: 30 tableta s produljenim oslobađanjem - EU/1/07/395/059 350 tableta s produljenim oslobađanjem - EU/1/07/395/060
English: Change in PANSS Score 26 week endpoint Mean baseline (SD) Mean change (SD) P-value (vs aripiprazole) Diff. of LS Means (SE) Responder Analysis 26 week endpoint Responder, n (%) Non-responder, n (%) P value (vs aripiprazole)
Croatian: Promjena PANSS rezultata Ishod nakon 26 tjedana Srednja početna vrijednost (SD) Srednja vrijednost promjene (SD)
English: Mean baseline (SD) Mean change (SD) P-value (vs, Placebo) Diff. of LS Means (SE)
Croatian: P-vrijednost (vs aripiprazol) Razlika LS srednjih vrijednosti (SE)
English: 14 prolonged-release tablets - EU/1/07/395/074 - CLEAR 28 prolonged-release tablets - EU/1/07/395/016 - CLEAR 30 prolonged-release tablets - EU/1/07/395/017 - CLEAR 49 prolonged-release tablets - EU/1/07/395/018 - CLEAR 56 prolonged-release tablets - EU/1/07/395/019 - CLEAR 98 prolonged-release tablets - EU/1/07/395/020 - CLEAR
Croatian: 14 tableta s produljenim oslobađanjem - EU/1/07/395/074 - PROZIRNI 28 tableta s produljenim oslobađanjem - EU/1/07/395/016 - PROZIRNI 30 tableta s produljenim oslobađanjem - EU/1/07/395/017 - PROZIRNI 49 tableta s produljenim oslobađanjem - EU/1/07/395/018 - PROZIRNI 56 tableta s produljenim oslobađanjem - EU/1/07/395/019 - PROZIRNI 98 tableta s produljenim oslobađanjem - EU/1/07/395/020 - PROZIRNI
English: LOCF endpoint change from baseline
Croatian: Promjena LOCF ishoda u odnosu na početnu vrijednost
English: 14 prolonged-release tablets - EU/1/07/395/070 28 prolonged-release tablets - EU/1/07/395/045 49 prolonged-release tablets - EU/1/07/395/046 56 prolonged-release tablets - EU/1/07/395/047 98 prolonged-release tablets - EU/1/07/395/048
Croatian: 14 tableta s produljenim oslobađanjem - EU/1/07/395/070 28 tableta s produljenim oslobađanjem - EU/1/07/395/045 49 tableta s produljenim oslobađanjem - EU/1/07/395/046 56 tableta s produljenim oslobađanjem - EU/1/07/395/047 98 tableta s produljenim oslobađanjem - EU/1/07/395/048
English: Each prolonged-release tablet contains 3 mg paliperidone Each prolonged-release tablet contains 6 mg paliperidone Each prolonged-release tablet contains 9 mg paliperidone Each prolonged-release tablet contains 12 mg paliperidone
Croatian: INVEGA 3 mg tablete s produljenim oslobađanjem INVEGA 6 mg tablete s produljenim oslobađanjem INVEGA 9 mg tablete s produljenim oslobađanjem INVEGA 12 mg tablete s produljenim oslobađanjem paliperidon
English: Skin and subcutaneous tissue disorders pruritus, rash urticaria, alopecia, eczema, acne angioedema, drug eruption c, hyperkeratosis, dry skin, erythema, skin discolouration, seborrhoeic dermatitis, dandruff
Croatian: Poremećaji kože i potkožnog tkiva pruritus, osip urtikarija, alopecija, ekcem, akne angioedem, osip prouzročen lijekom c,
English: 14 prolonged-release tablets - EU/1/07/395/071 - CLEAR 28 prolonged-release tablets - EU/1/07/395/011 - CLEAR 30 prolonged-release tablets - EU/1/07/395/012 - CLEAR 49 prolonged-release tablets - EU/1/07/395/013 - CLEAR 56 prolonged-release tablets - EU/1/07/395/014 - CLEAR 98 prolonged-release tablets - EU/1/07/395/015 - CLEAR
Croatian: 14 tableta s produljenim oslobađanjem - EU/1/07/395/071 - PROZIRNI 28 tableta s produljenim oslobađanjem - EU/1/07/395/011 - PROZIRNI 30 tableta s produljenim oslobađanjem - EU/1/07/395/012 - PROZIRNI 49 tableta s produljenim oslobađanjem - EU/1/07/395/013 - PROZIRNI 56 tableta s produljenim oslobađanjem - EU/1/07/395/014 - PROZIRNI 98 tableta s produljenim oslobađanjem - EU/1/07/395/015 - PROZIRNI
English: Withdrawal of INVEGA may be needed.
Croatian: Možda će biti potrebno prekinuti uzimati lijek INVEGA.
English: 14 prolonged-release tablets - EU/1/07/395/067 28 prolonged-release tablets - EU/1/07/395/041 49 prolonged-release tablets - EU/1/07/395/042 56 prolonged-release tablets - EU/1/07/395/043 98 prolonged-release tablets - EU/1/07/395/044
Croatian: 14 tableta s produljenim oslobađanjem - EU/1/07/395/067 28 tableta s produljenim oslobađanjem - EU/1/07/395/041 49 tableta s produljenim oslobađanjem - EU/1/07/395/042 56 tableta s produljenim oslobađanjem - EU/1/07/395/043 98 tableta s produljenim oslobađanjem - EU/1/07/395/044
English: 14 prolonged-release tablets - EU/1/07/395/075 - WHITE 28 prolonged-release tablets - EU/1/07/395/036 - WHITE 30 prolonged-release tablets - EU/1/07/395/037 - WHITE 49 prolonged-release tablets - EU/1/07/395/038 - WHITE 56 prolonged-release tablets - EU/1/07/395/039 - WHITE 98 prolonged-release tablets - EU/1/07/395/040 - WHITE
Croatian: 14 tableta s produljenim oslobađanjem - EU/1/07/395/075 - BIJELI 28 tableta s produljenim oslobađanjem - EU/1/07/395/036 - BIJELI 30 tableta s produljenim oslobađanjem - EU/1/07/395/037 - BIJELI 49 tableta s produljenim oslobađanjem - EU/1/07/395/038 - BIJELI 56 tableta s produljenim oslobađanjem - EU/1/07/395/039 - BIJELI 98 tableta s produljenim oslobađanjem - EU/1/07/395/040 - BIJELI
English: 14 prolonged-release tablets - EU/1/07/395/069 - WHITE 28 prolonged-release tablets - EU/1/07/395/026 - WHITE 30 prolonged-release tablets - EU/1/07/395/027 - WHITE 49 prolonged-release tablets - EU/1/07/395/028 - WHITE 56 prolonged-release tablets - EU/1/07/395/029 - WHITE
Croatian: 14 tableta s produljenim oslobađanjem - EU/1/07/395/069 - BIJELI 28 tableta s produljenim oslobađanjem - EU/1/07/395/026 - BIJELI 30 tableta s produljenim oslobađanjem - EU/1/07/395/027 - BIJELI 49 tableta s produljenim oslobađanjem - EU/1/07/395/028 - BIJELI
English: 14 prolonged-release tablets - EU/1/07/395/066 - WHITE 28 prolonged-release tablets - EU/1/07/395/021 - WHITE 30 prolonged-release tablets - EU/1/07/395/022 - WHITE 49 prolonged-release tablets - EU/1/07/395/023 - WHITE 56 prolonged-release tablets - EU/1/07/395/024 - WHITE 98 prolonged-release tablets - EU/1/07/395/025 - WHITE
Croatian: 14 tableta s produljenim oslobađanjem - EU/1/07/395/066 - BIJELI 28 tableta s produljenim oslobađanjem - EU/1/07/395/021 - BIJELI 30 tableta s produljenim oslobađanjem - EU/1/07/395/022 - BIJELI 49 tableta s produljenim oslobađanjem - EU/1/07/395/023 - BIJELI 56 tableta s produljenim oslobađanjem - EU/1/07/395/024 - BIJELI 98 tableta s produljenim oslobađanjem - EU/1/07/395/025 - BIJELI
English: Titanium dioxide (E171) Polyethylene glycol 400 Ferric oxide (yellow) (E172)
Croatian: Ovojnica hipromeloza titanijev dioksid (E171) polietilenglikol 400 željezov oksid (žuti) (E172) željezov oksid (crveni) (E172) karnauba vosak
English: 14 prolonged-release tablets - EU/1/07/395/065 - CLEAR 28 prolonged-release tablets - EU/1/07/395/001 - CLEAR 30 prolonged-release tablets - EU/1/07/395/002 - CLEAR 49 prolonged-release tablets - EU/1/07/395/003 - CLEAR 56 prolonged-release tablets - EU/1/07/395/004 - CLEAR 98 prolonged-release tablets - EU/1/07/395/005 - CLEAR
Croatian: 14 tableta s produljenim oslobađanjem - EU/1/07/395/065 - PROZIRNI 28 tableta s produljenim oslobađanjem - EU/1/07/395/001 - PROZIRNI 30 tableta s produljenim oslobađanjem - EU/1/07/395/002 - PROZIRNI 49 tableta s produljenim oslobađanjem s - EU/1/07/395/003 - PROZIRNI 56 tableta s produljenim oslobađanjem - EU/1/07/395/004 - PROZIRNI 98 tableta s produljenim oslobađanjem - EU/1/07/395/005 - PROZIRNI
English: 14 prolonged-release tablets - EU/1/07/395/072 - WHITE 28 prolonged-release tablets - EU/1/07/395/031 - WHITE 30 prolonged-release tablets - EU/1/07/395/032 - WHITE 49 prolonged-release tablets - EU/1/07/395/033 - WHITE 56 prolonged-release tablets - EU/1/07/395/034 - WHITE 98 prolonged-release tablets - EU/1/07/395/035 - WHITE
Croatian: 14 tableta s produljenim oslobađanjem - EU/1/07/395/072 - BIJELI 28 tableta s produljenim oslobađanjem - EU/1/07/395/031 - BIJELI 30 tableta s produljenim oslobađanjem - EU/1/07/395/032 - BIJELI 49 tableta s produljenim oslobađanjem - EU/1/07/395/033 - BIJELI 56 tableta s produljenim oslobađanjem - EU/1/07/395/034 - BIJELI 98 tableta s produljenim oslobađanjem - EU/1/07/395/035 - BIJELI
English: 14 prolonged-release tablets - EU/1/07/395/076 28 prolonged-release tablets - EU/1/07/395/053 49 prolonged-release tablets - EU/1/07/395/054 56 prolonged-release tablets - EU/1/07/395/055 98 prolonged-release tablets - EU/1/07/395/056
Croatian: 14 tableta s produljenim oslobađanjem - EU/1/07/395/076 28 tableta s produljenim oslobađanjem - EU/1/07/395/053 49 tableta s produljenim oslobađanjem - EU/1/07/395/054 56 tableta s produljenim oslobađanjem - EU/1/07/395/055 98 tableta s produljenim oslobađanjem - EU/1/07/395/056
English: General disorders pyrexia, asthenia, fatigue face oedema, oedema e, chills, body temperature increased, gait abnormal, thirst, chest pain, chest discomfort, malaise hypothermia c, body temperature decreased c, drug withdrawal syndrome induration
Croatian: zimica, povišena tjelesna temperatura, nenormalan hod, žeđ, bol u prsima, nelagoda u prsima, opća slabost hipotermija c, snižena tjelesna temperatura c,
English: 14 prolonged-release tablets - EU/1/07/395/068 - CLEAR 28 prolonged-release tablets - EU/1/07/395/006 - CLEAR 30 prolonged-release tablets - EU/1/07/395/007 - CLEAR 49 prolonged-release tablets - EU/1/07/395/008 - CLEAR 56 prolonged-release tablets - EU/1/07/395/009 - CLEAR 98 prolonged-release tablets - EU/1/07/395/010 - CLEAR
Croatian: 14 tableta s produljenim oslobađanjem - EU/1/07/395/068 - PROZIRNI 28 tableta s produljenim oslobađanjem - EU/1/07/395/006 - PROZIRNI 30 tableta s produljenim oslobađanjem - EU/1/07/395/007 - PROZIRNI 49 tableta s produljenim oslobađanjem - EU/1/07/395/008 - PROZIRNI 56 tableta s produljenim oslobađanjem - EU/1/07/395/009 - PROZIRNI 98 tableta s produljenim oslobađanjem - EU/1/07/395/010 - PROZIRNI
English: Butyl hydroxytoluene (E321) Polyethylene oxide 7000K Ferric oxide (red) (E172) Iron oxide (black) (E172) Hydroxyethyl cellulose Polyethylene glycol 3350 Cellulose acetate
Croatian: Jezgra polietilenoksid 200K natrijev klorid povidon (K29-32) stearatna kiselina butilhidroksitoluen (E321) polietilenoksid 7000K željezov oksid (crveni) (E172) željezov oksid (crni) (E172) hidroksietilceluloza polietilenglikol 3350 celulozaacetat
English: 14 prolonged-release tablets - EU/1/07/395/073 28 prolonged-release tablets - EU/1/07/395/049 49 prolonged-release tablets - EU/1/07/395/050 56 prolonged-release tablets - EU/1/07/395/051 98 prolonged-release tablets - EU/1/07/395/052
Croatian: 14 tableta s produljenim oslobađanjem - EU/1/07/395/073 28 tableta s produljenim oslobađanjem - EU/1/07/395/049 49 tableta s produljenim oslobađanjem - EU/1/07/395/050 56 tableta s produljenim oslobađanjem - EU/1/07/395/051 98 tableta s produljenim oslobađanjem - EU/1/07/395/052
English: Butyl hydroxytoluene (E321) Ferric Oxide (Yellow) (E172) (3, 12 mg tablet only) Polyethylene Oxide 7000K Ferric Oxide (Red) (E172)
Croatian: Jezgra obložene tablete: polietilenoksid 200K natrijev klorid povidon (K29-32) stearatna kiselina butilhidroksitoluen (E321) željezov oksid (žuti) (E172) (samo tablete od 3 i 12 mg) polietilenoksid 7000K željezov oksid (crveni) (E172) hidroksietilceluloza polietilenglikol 3350 celulozaacetat željezov oksid (crni) (E172) (samo tablete od 9 mg)
English: tremor tardive dyskinesia,
Croatian: • nevoljno drhtanje
English: Class effects
Croatian: Promjena PANSS rezultata
English: Butyl hydroxytoluene (E321) Polyethylene oxide 7000K Ferric oxide (red) (E172) Ferric oxide (yellow) (E172) Hydroxyethyl cellulose Polyethylene glycol 3350 Cellulose acetate
Croatian: Jezgra polietilenoksid 200K natrijev klorid povidon (K29-32) stearatna kiselina butilhidroksitoluen (E321) polietilenoksid 7000K željezov oksid (crveni) (E172) željezov oksid (žuti) (E172) hidroksietilceluloza polietilenglikol 3350 celulozaacetat
English: 98 prolonged-release tablets - EU/1/07/395/030 - WHITE
Croatian: 56 tableta s produljenim oslobađanjem - EU/1/07/395/029 - BIJELI 98 tableta s produljenim oslobađanjem - EU/1/07/395/030 - BIJELI
English: Renal impairment
Croatian: Placebo INVEGA
English: MARKETING AUTHORISATION NUMBER(S)
Croatian: Srednja početna vrijednost (SD)
English: Janssen-Cilag Polska Sp. z o.o.
Croatian: Janssen-Cilag SpA Via C.
English: Bucureşti-Ploieşti Nr. 1A, Clădirea C1, Etaj 3, Sector 1, Bucureşti Romania
Croatian: Bucureşti-Ploieşti Nr. 1A, Clădirea C1, Etaj 3, Sector 1, Bucureşti Rumunjska
English: 00-867 Warszawa Poland
Croatian: 00-867 Warszawa Poljska
English: Heinzelova 62a 10 000 Zagreb Croatia
Croatian: Heinzelova 62a 10 000 Zagreb Hrvatska
English: 85540 Haar
Croatian: 85540 Haar Njemačka
English: Red Oak North South County Business Park Leopardstown
Croatian: Red Oak North South County Business Park
English: MSD Polska Sp. z o.o.
Croatian: MSD Polska Sp. z o.o. ul.
English: Annex I List of the names, pharmaceutical form, strength of the medicinal products, route of administration, Marketing Authorisation Holders in the Member States
Croatian: Popis naziva, farmaceutskog oblika, jačine lijeka, puta primjene, nositelj(a) odobrenja u državama članicama
English: Edifício Vasco da Gama 2770-192 Paço de Arcos Portugal
Croatian: Quinta da Fonte, 19 Edifício Vasco da Gama 2770-192 Paço de Arcos Portugal
English: Malesci Istituto Farmacobiologico S.p.A Via Lungo l'Ema 7 Bagno a Ripoli (FI) Italy
Croatian: Malesci Istituto Farmacobiologico S.p.A Via Lungo l'Ema 7 Bagno a Ripoli (FI) Italija
English: C/ Josefa Valcárcel, 38 28027 Madrid Spain
Croatian: C/ Josefa Valcárcel, 38 28027 Madrid Španjolska
English: 0.05% w/w Mometasone furoate (monohydrate) calculated on the anhydrous basis
Croatian: 0,05% w/w mometazonfuroat (hidrat) izračunat na temelju bezvodnog oblika
English: Via Vitorchiano 151 00189 Roma Italy
Croatian: MSD Italia S.r.l. Via Vitorchiano 151 00189 Roma Italija
English: Nasonex aquosumNasenspray
Croatian: Nasonex aquosum - Nasenspray
English: MSD Pharma Hungary Kft. H-1095 Budapest Lechner Ödön fasor 8.
Croatian: H-1095 Budapest Lechner Ödön fasor 8.
English: Belgium MSD Belgium BVBA/SPRL Clos du Lynx 5
Croatian: MSD Belgium BVBA/SPRL Clos du Lynx 5
English: Luxembourg MSD Belgium BVBA/SPRL Clos du Lynx 5
Croatian: Luksemburg MSD Belgium BVBA/SPRL Clos du Lynx 5
English: 2031 BN Haarlem P.O.
Croatian: 2031 BN Haarlem P.O. Box 581
English: 174 56 Alimos Greece
Croatian: Ag. Dimitriou 63 174 56 Alimos Grčka
English: 34 avenue Léonard de Vinci 92400 Courbevoie France
Croatian: 92400 Courbevoie Francuska
English: Germany MSD SHARP & DOHME GMBH
Croatian: MSD SHARP & DOHME GMBH
English: Denmark Merck Sharp & Dohme BV Waarderweg 39
Croatian: Merck Sharp & Dohme BV Waarderweg 39
English: Dublin 18
Croatian: Leopardstown Dublin 18
English: Šmartinska cesta 140 1000 Ljubljana Slovenia
Croatian: Merck Sharp & Dohme, inovativna zdravila d.o.o. Šmartinska cesta 140 1000 Ljubljana Slovenija
English: Merck Sharp & Dohme B.V.
Croatian: Merck Sharp & Dohme S.A.
English: The full EPAR for Xiapex can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Xiapex nalazi se na internetskim stranicama Agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Xiapex on 28 February 2011.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Xiapex na snazi u Europskoj uniji od 28. veljače 2011.
English: Dupuytren's contracture is a condition where one or more fingers are bent forwards toward the palm and cannot be fully straightened.
Croatian: Dupuytrenova kontraktura je stanje u kojem se jedan ili dva prsta savijaju prema naprijed u dlanu i ne mogu se u potpunosti izravnati.
English: Xiapex collagenase clostridium histolyticum
Croatian: Xiapex kolagenaza clostridium histolyticum
English: The most common side effects seen with Xiapex were local injection site reactions such as swelling, bruising, bleeding and pain.
Croatian: Najčešće nuspojave zabilježene s lijekom Xiapex bile su lokalne reakcije na mjestu injekcije poput oticanja, modrica, krvarenja i boli.
English: These reactions were mostly mild to moderate in severity and generally subsided within one to two weeks.
Croatian: Te su reakcije najčešće blago do umjereno ozbiljne i obično se smanjuju u roku jednog do dva tjedana.
English: Up to 2 cords or 2 affected joints in the same hand can be treated at a time.
Croatian: Do dvije niti ili dva zahvaćena zgloba na istoj ruci može se liječiti odjednom.
English: Patients should subsequently continue modeling procedures daily at home as instructed for the rest of the cycle.
Croatian: Bolesnici trebaju zatim nastaviti s dnevnom primjenom postupka modeliranja kod kuće prema uputi za ostatak ciklusa.
English: Among patients who completed the first study, 64% (130 out of 203) of those receiving Xiapex could straighten their fingers to an angle of 5 degrees or less compared with 7% (7 out of 103) of patients receiving placebo.
Croatian: Od bolesnika koji su završili prvo ispitivanje, 64% (130 od 203) od onih koji su primili lijek Xiapex moglo je izravnati prste do kuta od 5 stupnjeva ili manje u usporedbi sa 7% (7 od 103) bolesnika koji su primili placebo.
English: This is a summary of the European public assessment report (EPAR) for Xiapex.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Xiapex.
English: Injection site reactions were very common, occurring in the vast majority of patients.
Croatian: Reakcije na mjestu injekcije su vrlo uobičajene i javljaju se kod većine bolesnika.
English: Xiapex contains a mixture of two ‘collagenases', enzymes that break up collagen.
Croatian: Xiapex sadrži mješavinu dvije "kolagenaze", enzima koji razgrađuju kolagen.
English: The company must carry out an educational programme for doctors on the correct use and the potential side effects associated with the medicine.
Croatian: Tvrtka mora provesti obrazovni program za liječnike o ispravnom korištenju i mogućim nuspojavama lijeka.
English: What measures are being taken to ensure the safe and effective use of Xiapex?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Xiapex?
English: Around 24 hours after the injection, the finger can then be straightened by the doctor, by performing a ‘finger extension procedure' whereby it is stretched out for around 10 to 20 seconds to help disrupt the cord.
Croatian: Otprilike 24 sata nakon injekcije liječnik može izravnati prst izvodeći "zahvat istezanja prsta" pri čemu se isteže otprilike 10 do 20 sekundi kako bi se lakše prekinulo nit.
English: The patients were treated with three injections and their hands were examined three months after the last injection to see how much the finger joints could be straightened out.
Croatian: Bolesnici su liječeni s tri injekcije, a njihovi dlanovi pregledani su tri mjeseca nakon posljednje injekcije kako bi se utvrdilo u kojoj se mjeri izravnao zglob prsta.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Xiapex.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Xiapex.
English: In each cycle, the dose of Xiapex is injected into the plaque causing the deformity followed by a second injection given 1 to 3 days after the first.
Croatian: U svakom ciklusu doza lijeka Xiapex ubrizgava se u plak čime uzrokuje deformiranost, nakon čega slijedi druga injekcija koja se primjenjuje 1 do 3 mjeseca nakon prve.
English: If injection and finger extension have not brought about a satisfactory response, the procedure may be repeated at monthly intervals up to a maximum of 3 injections per cord.
Croatian: Ako se nije postigao zadovoljavajući odgovor injekcijom i postupkom ekstenzije prsta, postupak se može ponoviti u mjesečnim intervalima do 3 puta po niti.