FrancophonIA/ELRC3.0 huggingface dataset:
English: After 30 minutes, if remnants from the Effentora tablet remain, they may be swallowed with a glass of water.
Croatian: Nakon 30 minuta preostali se dijelovi tablete, ako ih ima, mogu progutati s čašom vode.
English: • feeling nauseous, vomiting
Croatian: • mučnina, povraćanje
English: Tel.: (+ 36) 1 288 6400
Croatian: Teva Magyarország Zrt Tel.: (+ 36) 1 288 6400
English: Overdose (accidental ingestion) in the opioid-naive person For treatment of overdose (accidental ingestion) in the opioid-naive person, intravenous access should be obtained and naloxone or other opioid antagonists should be employed as clinically indicated.
Croatian: Predoziranje (slučajno gutanje) u osoba koje prethodno nikad nisu primile opioid Za liječenje predoziranja (slučajno gutanje) kod osoba koje nikad prije nisu primale opioide treba osigurati venski put te primijeniti nalokson ili drugi antagonist opioida kako je to klinički indicirano.
English: Excipient with known effect: Each tablet contains 20 mg of sodium.
Croatian: Pomoćna tvar s poznatim učinkom: jedna tableta sadrži 20 mg natrija.
English: Each tablet of Effentora 200 micrograms, Effentora 400 micrograms, Effentora 600 micrograms and Effentora 800 micrograms contains 20 mg of sodium.
Croatian: Jedna tableta Effentore 200 mikrograma, Effentore 400 mikrograma, Effentore 600 mikrograma i Effentore 800 mikrograma sadrži 20 mg natrija.
English: Patients should wait at least 4 hours before treating another BTP episode with Effentora during titration.
Croatian: Bolesnici trebaju čekati najmanje 4 sata prije liječenja druge epizode probijajuće boli Effentorom tijekom titracije.
English: • feeling anxious or confused, depression, insomnia
Croatian: • osjećaj tjeskobe ili smetenosti, depresija, nesanica • poremećeni okus, smanjena težina
English: • Instructions for use of fentanyl buccal tablet and how to place the tablet
Croatian: • Uputa za opću primjenu bukalnih tableta fentanila te kako ih stavljati u usta
English: • You experience symptoms such as difficulty in breathing or dizziness, swelling of the tongue, lip or throat while using Effentora.
Croatian: • ako za vrijeme uzimanja Effentore osjetite simptome kao što je otežano disanje ili omaglica, oticanje jezika, usana ili grla.
English: Bend 3.
Croatian: PRILOG III.
English: serotonin norepinephrine reuptake inhibitors [SNRIs], monoamine oxidase (MAO) inhibitors; see section 2 under “Do not use Effentora” and “Other medicines and Effentora”).
Croatian: • ako uzimate antidepresive ili antipsihotike (selektivne inhibitore ponovne pohrane serotonina, inhibitore ponovne pohrane serotonina i noradrenalina, inhibitore monoaminooksidaze (MAO), pogledajte dio 2, pod „Nemojte uzimati Effentoru“ i „Drugi lijekovi i Effentora“).
English: In addition, Effentora should be administered with caution to patients with hepatic or renal impairment.
Croatian: Effentoru treba primijeniti oprezno bolesnicima s oštećenjem jetre ili bubrega.
English: How to use Effentora
Croatian: Kako uzimati Effentoru
English: Mechanism of action and pharmacodynamic effects Fentanyl is an opioid analgesic, interacting predominantly with the opioid µ-receptor.
Croatian: Fentanil je opioidni analgetik koji pretežno stupa u interakcije s opioidnim µ-receptorom.
English: • Peel the blister backing to expose the tablet.
Croatian: • Odvojite poleđinu blistera kako biste otkrili tabletu.
English: • Summary of Product Characteristics (SmPC) and Package Leaflet
Croatian: • Sažetak opisa svojstava lijeka (SPC) i uputu o lijeku
English: • at the site of tablet application: pain, ulcer, irritation, bleeding, numbness, loss of sensation,
Croatian: • reakcije na mjestu primjene tablete: bol, ranica (ulcer), nadraženost, krvarenje, obamrlost, gubitak osjeta, crvenilo, oticanje tkiva ili mrlje
English: Fentanyl is metabolised mainly via the human cytochrome P450 3A4 isoenzyme system (CYP3A4), therefore potential interactions may occur when Effentora is given concurrently with agents that affect CYP3A4 activity.
Croatian: Fentanil se metabolizira uglavnom preko sustava izoenzima humanog citokroma P450 3A4 (CYP3A4)
English: The active substance of Effentora is fentanyl citrate.
Croatian: Djelatna tvar Effentore je fentanilcitrat.
English: Excipient with known effect: Each tablet contains 10 mg of sodium.
Croatian: Pomoćna tvar s poznatim učinkom: jedna tableta sadrži 10 mg natrija.
English: Dose titration
Croatian: Doziranje Titracija doze
English: You may experience withdrawal symptoms similar to the possible side effects of Effentora when discontinuing Effentora.
Croatian: Kad prestanete uzimati Effentoru, možete razviti simptome ustezanja koji su slični mogućim nuspojavama Effentore.
English: Effentora tablet once exposed to moisture utilises an effervescent reaction to deliver the active substance.
Croatian: Kad je tableta Effentore izložena vlazi, na temelju reakcije efervescencije oslobađa se djelatna tvar.
English: • muscle pain, back pain
Croatian: • bol u mišićima, bol u leđima
English: Effentora must not be prescribed in patients below 18 years of age
Croatian: Effentora se ne smije propisivati bolesnicima mlađima od 18 godina Edukacijski materijal za bolesnike sastojat će se od sljedeća tri dijela: 1.
English: OTFC (normalized to 400 mcg)
Croatian: 400 mikrograma EFFENTORA OTFC (normalizirano na 400 mikrograma)
English: Muscle twitching Muscular weakness
Croatian: slabost u mišićima
English: Tel: +353 (0) 51 321 740
Croatian: Teva Pharmaceuticals Ireland Tel: +353 (0) 51 321 740
English: Fentanyl passes into breast milk and may cause sedation and respiratory depression in the breast-fed child. Fentanyl should not be used by breastfeeding women and breastfeeding should not be restarted until at least 5 days after the last administration of fentanyl.
Croatian: Žene koje doje ne smiju koristiti fentanil te se dojenje ne smije nastaviti dok ne prođe barem 5 dana od zadnje primjene fentanila.
English: confusion, fear, seeing or hearing things that are not really there, sleep disturbance, nightmares)
Croatian: • delirij (simptomi mogu uključivati kombinaciju nemira, uznemirenosti, dezorijentacije, smetenosti, straha, pojave da vidite ili čujete nešto što zapravo ne postoji, poremećaja spavanja, noćnih mora)
English: Your doctor may change the treatment for your persistent pain; when your persistent pain is controlled, your doctor may need to change the dose of Effentora.
Croatian: Kad trajna bol bude pod kontrolom, liječnik Vam može promijeniti dozu Effentore.
English: Effentora buccal tablets are for oromucosal use.
Croatian: Bukalne tablete Effentora primjenjuju se na sluznicu usne šupljine.
English: • Remove the tablet from the blister unit and immediately place the entire tablet near a molar tooth between the gum and the cheek (as shown in the picture).
Croatian: • Izvadite tabletu iz reda blistera i odmah je cijelu stavite blizu kutnjaka, između obraza i desni
English: Blood and lymphatic system disorders
Croatian: Poremećaji krvi i limfnog sustava anemija, neutropenija trombocitopenija
English: Sodium starch glycolate type A Sodium hydrogen carbonate Sodium carbonate anhydrous Citric acid anhydrous Magnesium stearate
Croatian: 6.1 Popis pomoćnih tvari manitol natrijev škroboglikolat, vrsta A natrijev hidrogenkarbonat natrijev karbonat, bezvodni citratna kiselina, bezvodna magnezijev stearat
English: Patients should remove the tablet from the blister unit and immediately place the entire Effentora tablet in the buccal cavity (near a molar between the cheek and gum).
Croatian: Primjena tablete Bolesnik treba izvaditi tabletu iz odvojene jedinice blistera i odmah je cijelu staviti u bukalnu šupljinu
English: • malaise
Croatian: • malaksalost
English: The MAH shall ensure that, following discussions and agreement with the National Competent Authorities in each Member State where EFFENTORA is marketed all healthcare professionals who are expected to prescribe EFFENTORA are provided with an information pack containing the following items:
Croatian: Nositelj odobrenja osigurat će da, nakon rasprave i dogovora s nacionalnim nadležnim tijelom u pojedinoj zemlji članici u kojoj je
English: Nausea, vomiting, anorexia, fatigue, weakness, dizziness and low blood pressure Together these symptoms may be a sign of a potentially life-threatening condition called adrenal insufficiency.
Croatian: slabost, omaglica i nizak krvni tlak - ovi simptomi zajedno mogu biti znak stanja kod kojeg nadbubrežne žlijezde ne proizvode dovoljno hormona, a koje se zove adrenalna insuficijencija i može biti opasno za život.
English: It is very important that you use Effentora exactly as the doctor tells you The initial dose is 100 micrograms.
Croatian: Vrlo je važno da koristite Effentoru točno onako kako Vam je to odredio liječnik.
English: • drug dependence (addiction)
Croatian: • ovisnost o lijeku
English: Sedative medicines such as benzodiazepines or related drugs The concomitant use of opioids with sedative medicines such as benzodiazepines or related drugs increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect.
Croatian: Istodobna primjena opioida sa sedativima poput benzodiazepina ili sličnih lijekova povećava rizik od sedacije, respiratorne depresije, kome i smrti zbog aditivnih učinaka na depresiju SŽS-a.
English: Discontinuation of therapy
Croatian: Prekid liječenja
English: • If a single 200 micrograms tablet of Effentora (or two 100 micrograms tablets) is not considered to be efficacious the patient can be instructed to use two 200 micrograms tablets (or four 100 micrograms tablets) to treat the next episode of BTP.
Croatian: 100 mikrograma), bolesniku se može savjetovati da za sljedeću epizodu probijajuće boli uzme dvije tablete od 200 mikrograma (ili četiri tablete od 100 mikrograma).
English: Tel: +421257267911
Croatian: TEVA Pharmaceuticals Slovakia s.r.o. Tel: +421257267911
English: Visual disturbance Ocular hyperaemia Blurred vision Visual acuity reduced
Croatian: Poremećaji oka smetnje vida, okularna hiperemija, zamagljen vid, smanjena oštrina vida abnormalni osjet u oku, fotopsija
English: • delirium (symptoms may include a combination of agitation, restlessness, disorientation,
Croatian: Serotoninski sindrom može uključivati promjene mentalnog statusa (npr. agitaciju, halucinacije,
English: Hypersensitivity reactions have been reported in post-marketing experience, including rash, erythema, lip and face swelling, and urticaria (see section 4.4).
Croatian: eritem, oticanje usana i lica i urtikariju (vidjeti dio 4.4).
English: Iatrogenic addiction following therapeutic use of opioids is known to occur.
Croatian: Poznato je da se nakon terapijske primjene opioida zna pojaviti jatrogena ovisnost.
English: The concomitant use of partial opioid agonists/antagonists (e.g. buprenorphine, nalbuphine, pentazocine) is not recommended.
Croatian: Parcijalni opioidni agonisti/antagonisti Istodobna primjena parcijalnih opioidnih agonista/antagonista (primjerice, buprenorfina, nalbufina,
English: Serotonin syndrome may include mental-status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular abnormalities (e.g., hyperreflexia, incoordination, rigidity), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea).
Croatian: neuromuskularne poremećaje (npr. hiperrefleksiju, nekoordiniranost, rigidnost) i/ili gastrointestinalne simptome (npr. mučninu, povraćanje, proljev).
English: Musculoskel etal and connective tissue disorders
Croatian: Poremećaji mišićno koštanog sustava i vezivnog tkiva mialgija,
English: • Certain type of strong pain killers, calledpartial agonist/antagonists e.g. buprenorphine, nalbuphine and pentazocine (medicines for treatment of pain).
Croatian: buprenorfin, nalbufin i pentazocin (lijekovi protiv bolova).
English: • Patients without maintenance opioid therapy as there is an increased risk of respiratory depression.
Croatian: • Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1. • Bolesnici koji se ne nalaze na terapiji održavanja opioidima jer postoji povećan rizik od respiratorne depresije.
English: Very common: may affect more than 1 in 10 people
Croatian: Vrlo često: mogu se javiti u više od 1 na 10 osoba • omaglica, glavobolja
English: Effentora 400 micrograms buccal tablets EU/1/08/441/005-006
Croatian: Effentora 400 mikrograma bukalne tablete EU/1/08/441/005-006
English: • itching, excessive sweating, rash
Croatian: • svrbež, prekomjerno znojenje, osip • nedostatak zraka, grlobolja
English: Application site reactions including bleeding, pain, ulcer, irritation, paraesthesia, anaesthesia, erythema, oedema, swelling and vesicles
Croatian: Opći poremećaji i reakcije na mjestu primjene reakcije na mjestu primjene uključujući krvarenje, bol, ulceracije, iritacije, paresteziju, anesteziju, eritem, edem, oticanje i vezikule periferni edem, umor, astenija, sindrom ustezanja lijeka*, zimica malaksalost, tromost, nelagoda u prsima,
English: • cold sweat, swollen face, generalised itching, hair loss, muscle twitching, muscular weakness,
Croatian: • hladan znoj, natečeno lice, opći svrbež, gubitak kose, trzanje mišića, slabost u mišićima, osjećaj slabosti, nelagoda u prsima, žeđ, osjećaj hladnoće, osjećaj vrućine, teškoće u mokrenju
English: Controlled sodium diet
Croatian: Dijeta s ograničenim unosom natrija
English: Fentanyl should be used with caution in patients with previous or pre-existing bradyarrythmias.
Croatian: U bolesnika s prijašnjim ili postojećim bradiaritmijama treba ga koristiti s oprezom.
English: feeling unwell, chest discomfort, thirst, feeling cold, feeling hot, difficulty passing urine
Croatian: loše osjećanje, osjećaj treme, žeđ, osjećaj hladnoće, osjećaj vrućine pireksija, sindrom ustezanja u novorođenče ta (vidjeti dio 4.6)
English: Effentora 200 micrograms buccal tablets EU/1/08/441/003-004
Croatian: Effentora 200 mikrograma bukalne tablete EU/1/08/441/003-004
English: • sleepiness, sedation, excessive tiredness, weakness, migraine, numbness, swelling of arms or legs,
Croatian: • pospanost, sedacija, prekomjerni umor, slabost, migrena, utrnulost, oticanje ruku i nogu, sindrom ustezanja lijeka (može se očitovati nastankom sljedećih nuspojava: mučnina, povraćanje, proljev,
English: Platelet count decreased Heart rate increased Haematocrit decreased Haemoglobin decreased
Croatian: povećan broj srčanih otkucaja, snižen hematokrit, snižen hemoglobin
English: Co-administration of fentanyl with a serotoninergic agent, such as a Selective Serotonin Re-uptake Inhibitor (SSRI) or a Serotonin Norepinephrine Re-uptake Inhibitor (SNRI) or a Monoamine Oxidase Inhibitor (MAOI), may increase the risk of serotonin syndrome, a potentially life-threatening condition.
Croatian: Serotoninergički lijekovi Istodobna primjena fentanila sa serotoninergičkim lijekom kao što je selektivni inhibitor ponovne pohrane serotonina (SSRI) ili selektivni inhibitor ponovne pohrane serotonina i noradrenalina (SNRI)
English: Wait at least 4 hours before treating another episode of breakthrough pain with Effentora.
Croatian: Tijekom titracije bolesnici trebaju pričekati najmanje 4 sata prije liječenja druge epizode probijajuće boli Effentorom.
English: Effentora 800 micrograms buccal tablets EU/1/08/441/009-010
Croatian: Effentora 800 mikrograma bukalne tablete EU/1/08/441/009-010
English: Effentora 600 micrograms buccal tablets EU/1/08/441/007-008
Croatian: Effentora 600 mikrograma bukalne tablete EU/1/08/441/007-008
English: Effentora 800 micrograms buccal tablets
Croatian: Effentora 800 mikrograma bukalne tablete
English: Patients should wait at least 4 hours before treating another BTP episode with Effentora during maintenance therapy.
Croatian: Tijekom terapije održavanja bolesnici trebaju pričekati najmanje 4 sata prije liječenja druge epizode probijajuće boli Effentorom.
English: Effentora 100 micrograms buccal tablets EU/1/08/441/001-002
Croatian: Effentora 100 mikrograma bukalne tablete EU/1/08/441/001-002
English: • You may feel a gentle bubbling sensation between your cheek and gum as the tablet dissolves.
Croatian: • Kako se tableta bude otapala možda ćete osjetiti blago stvaranje mjehurića između obraza i desni.
English: Cognitive disorder Motor dysfunction
Croatian: poremećaj ravnoteže, dizartrija kognitivni poremećaj, motorička disfunkcija gubitak svijesti*, konvulzije
English: Effentora 200 micrograms buccal tablets
Croatian: Effentora 200 mikrograma bukalne tablete
English: Renal and urinary disorders
Croatian: Poremećaji bubrega i mokraćnog sustava urinarna retencija
English: Effentora 600 micrograms buccal tablets
Croatian: Effentora 600 mikrograma bukalne tablete
English: The concomitant use of Effentora with strong CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, and nelfinavir) or moderate CYP3A4 inhibitors (e.g.,
Croatian: Istodobna primjena Effentore s jakim inhibitorima CYP3A4 (primjerice, s ritonavirom, ketokonazolom, itrakonazolom, troleandomicinom, klaritromicinom i nelfinavirom) ili umjerenim inibitorima CYP3A4 (primjerice, s amprenavirom, aprepitantom, dilitiazemom, eritromicinom, flukonazolom, fosamprenavirom, sokom od grejpfruta i verapamilom) može uzrokovati porast plazmatskih koncentracija fentanila što potencijalno uzrokuje ozbiljne nuspojave, uključujući smrtonosnu respiratornu depresiju.
English: Effentora 400 micrograms buccal tablets
Croatian: Effentora 400 mikrograma bukalne tablete
English: • drug abuse
Croatian: • zlouporaba lijeka
English: Convulsion
Croatian: Dojenje
English: Each buccal tablet contains 800 micrograms fentanyl (as citrate)
Croatian: Jedna bukalna tableta sadrži 800 mikrograma fentanila (u obliku fentanilcitrata).
English: Onychorrhexis
Croatian: • grlobolja
English: Effentora 100 micrograms buccal tablets
Croatian: Effentora 100 mikrograma bukalne tablete
English: • 800 micrograms fentanyl (as citrate)
Croatian: • 800 mikrograma fentanila (u obliku fentanilcitrata)
English: Effentora 100 micrograms buccal tablets Fentanyl
Croatian: Effentora 100 mikrograma bukalne tablete fentanil
English: • 200 micrograms fentanyl (as citrate)
Croatian: • 200 mikrograma fentanila (u obliku fentanilcitrata)
English: Effentora 600 micrograms buccal tablets Fentanyl
Croatian: Effentora 600 mikrograma bukalne tablete fentanil
English: Flat-faced, white, round bevelled-edge tablet, embossed on one side with a “C” and on the other side with “8”.
Croatian: Plosnata, bijela, okrugla tableta ukošenih rubova, s oznakom „C“ na jednoj strani te s „8“ na drugoj strani.
English: Each buccal tablet contains 200 micrograms fentanyl (as citrate)
Croatian: Jedna bukalna tableta sadrži 200 mikrograma fentanila (u obliku fentanilcitrata).
English: • 400 micrograms fentanyl (as citrate)
Croatian: • 400 mikrograma fentanila (u obliku fentanilcitrata)
English: Effentora 200 micrograms buccal tablets Fentanyl
Croatian: Effentora 200 mikrograma bukalne tablete fentanil
English: stomach pain, uncomfortable stomach, indigestion, toothache, oral thrush
Croatian: Poremećaji uha i labirinta vrtoglavica, tinitus, nelagoda u ušima
English: Each buccal tablet contains 600 micrograms fentanyl (as citrate)
Croatian: Jedna bukalna tableta sadrži 600 mikrograma fentanila (u obliku fentanilcitrata).
English: • 600 micrograms fentanyl (as citrate)
Croatian: • 600 mikrograma fentanila (u obliku fentanilcitrata)
English: Partial opioid agonists/antagonists
Croatian: • Određenu vrstu jakih lijekova protiv bolova koji se zovu djelomični agonisti/antagonisti, npr.
English: Each buccal tablet contains 400 micrograms fentanyl (as citrate)
Croatian: Jedna bukalna tableta sadrži 400 mikrograma fentanila (u obliku fentanilcitrata).
English: Each buccal tablet contains 100 micrograms fentanyl (as citrate)
Croatian: Jedna bukalna tableta sadrži 100 mikrograma fentanila (u obliku fentanilcitrata).
English: • 100 micrograms fentanyl (as citrate)
Croatian: • 100 mikrograma fentanila (u obliku fentanilcitrata)
English: Effentora 800 micrograms buccal tablets Fentanyl
Croatian: Effentora 800 mikrograma bukalne tablete fentanil
English: Flat-faced, white, round bevelled-edge tablet, embossed on one side with a “C” and on the other side with “6”.
Croatian: Plosnata, bijela, okrugla tableta ukošenih rubova, s oznakom „C“ na jednoj strani te s „6“ na drugoj strani.
English: • constipation, inflammation of the mouth, dry mouth, diarrhoea, heartburn, loss of appetite,
Croatian: Poremećaji živčanog sustava omaglica, glavobolja disgeuzija, somnolencija, letargija, tremor, sedacija, hipoestezija, migrena smanjena razina svijesti,
English: Constipation Stomatitis Dry mouth Diarrhoea Abdominal pain Gastrooesophageal reflux disease Stomach discomfort Dyspepsia Toothache
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja dispneja, faringolaringeal na bol respiratorna depresija, sindrom apneje u snu respiratorni arest*
English: Peripheral oedema Fatigue Asthenia Drug withdrawal syndrome* Chills
Croatian: Infekcije i infestacije oralna kandidijaza faringitis oralne pustule
English: Flat-faced, white, round bevelled-edge tablet, embossed on one side with a “C” and on the other side with “1”.
Croatian: Plosnata, bijela, okrugla tableta ukošenih rubova, s oznakom „C“ na jednoj strani te s „1“ na drugoj strani.
English: Flat-faced, white, round bevelled-edge tablet, embossed on one side with a “C” and on the other side with “2”.
Croatian: Plosnata, bijela, okrugla tableta ukošenih rubova, s oznakom „C“ na jednoj strani te s „2“ na drugoj strani.
English: • inflammation of the oesophagus, paralysis of the gut, gall bladder disorder
Croatian: • upala jednjaka, paraliza crijeva, poremećaji žučnog mjehura
English: Effentora 400 micrograms buccal tablets Fentanyl
Croatian: Effentora 400 mikrograma bukalne tablete fentanil
English: You should discontinue Effentora when you no longer have any breakthrough pain.
Croatian: Ako više nemate probijajuće bolove, trebate prekinuti liječenje Effentorom.
English: Flat-faced, white, round bevelled-edge tablet, embossed on one side with a “C” and on the other side with “4”.
Croatian: Plosnata, bijela, okrugla tableta ukošenih rubova, s oznakom „C“ na jednoj strani te s „4“ na drugoj strani.
English: Effentora should be discontinued immediately if the patient no longer experiences breakthrough pain episodes.
Croatian: Ako bolesnik više nema epizode probijajućeg bola, primjenu Effentore treba odmah prekinuti.
English: Place in buccal cavity.
Croatian: Stavite u usnu šupljinu.
English: Hypotension Hypertension
Croatian: Apsolutna bioraspoloživost
English: At the request of the European Medicines Agency;
Croatian: Na zahtjev Europske agencije za lijekove;
English: Your doctor will advise you what to do.
Croatian: Liječnik će Vam savjetovati što učiniti.
English: Your doctor will advise you about using a reliable contraceptive.
Croatian: Liječnik će Vam dati savjet o korištenju pouzdane kontracepcije.
English: PML often leads to severe disability or death.
Croatian: PML često vodi do teške invalidnosti ili smrti.
English: No pattern was identified in the causes of death.
Croatian: Nije se utvrdio nikakav obrazac u uzrocima smrti.
English: Date of latest renewal: 18 February 2016
Croatian: Datum posljednje obnove odobrenja: 18.veljače 2016.
English: Day 5, Day 14 and Day 28
Croatian: 5. dan, 14. dan i 28. dan
English: You might get symptoms that you might not be aware of yourself.
Croatian: Možete dobiti simptome kojih sami ne morate biti svjesni.
English: The clinical relevance of such antibodies is unclear.
Croatian: Klinička važnost takvih protutijela nije jasna.
English: Ciclosporin Belatacept LI
Croatian: Ciklosporin Belatacept LI
English: For a list of symptoms please see section 4, “Possible side effects”.
Croatian: Za popis simptoma, molimo vidjeti dio 4: "Moguće nuspojave".
English: Dublin 15 - Ireland
Croatian: Dublin 15 - Irska
English: EBV is the virus that causes glandular fever.
Croatian: EBV je virus koji uzrokuje žljezdanu groznicu.