FrancophonIA/ELRC3.0 huggingface dataset:
English: Transfusion reactione a See section c (Description of selected adverse reactions) b There have been reports of GvHD and fatalities in patients after allogeneic bone marrow transplantation (see section c) c Includes bone pain, back pain, arthralgia, myalgia, pain in extremity, musculoskeletal pain, musculoskeletal chest pain, neck pain d Cases were observed in the post-marketing setting in patients undergoing bone marrow transplant or
Croatian: Uključuje bol u kostima, bol u leđima, artralgiju, mialgiju, bol u ekstremitetima, bol u mišićima i kostima, bol u mišićima i kostima prsnog koša, bol u vratu d Slučajevi su uočeni nakon stavljanja lijeka u promet u bolesnika koji se podvrgavaju transplantaciji koštane srži ili mobilizaciji progenitorskih stanica periferne krvi e Štetni događaji s većom incidencijom u bolesnika liječenih filgrastimom nego u onih koji su primali placebo, te povezani s posljedicama podležeće zloćudne bolesti ili citotoksične kemoterapije c.
English: Filgrastim for PBPC mobilisation after myelosuppressive chemotherapy: Filgrastim should be given by subcutaneous injection.
Croatian: Filgrastim za mobilizaciju progenitorskih stanica periferne krvi nakon mijelosupresijske kemoterapije:
English: Fluid volume disturbances
Croatian: (pirofosfatna hondrokalcinoza) Poremećaji volumena tekućine
English: Sickle cell crisis, in some cases fatal, have been reported with the use of filgrastim in patients with sickle cell trait or sickle cell disease.
Croatian: Pri primjeni filgrastima u bolesnika s nasljednim obilježjem srpastih stanica ili bolešću srpastih stanica zabilježena je kriza srpastih stanica, u nekim slučajevima sa smrtnim ishodom.
English: ● Periodic Safety Update Reports
Croatian: Sažetak sigurnosnog profila
English: Geriatric Use
Croatian: FARMAKOLOŠKA SVOJSTVA
English: Prior to allogeneic PBPC transplantation, use of filgrastim for the mobilisation of PBPC in normal donors allows a collection of ≥ 4 x 10
Croatian: Primjenom filgrastima u zdravih davatelja u svrhu mobilizacije progenitorskih stanica periferne krvi prije alogenog presađivanja tih stanica, u većine se davatelja dvjema leukaferezama prikupi  4 x 106 CD34+ stanica po kg tjelesne težine davatelja.
English: 700 mg Film-coated tablets
Croatian: 700mg Filmom obložena tableta
English: 50 mg/ml Oral suspension
Croatian: 50mg/mL
English: 1 bottle + 10 ml dosing syringe
Croatian: + dozirna štrcaljka od 10 ml
English: Invented name Strength Pharmaceutical form Route of administration Packaging Content
Croatian: (Zaštićeno) ime Doza Farmaceutski oblik
English: Bottle (HDPE) 225 ml
Croatian: 225 ml
English: Bottle (HDPE)
Croatian: 1 bočica
English: --1 Influenza A/eq/Ohio/03 [H3N8] recombinant canarypox virus (vCP2242) ≥ 5.3 log10 FAID50*/ml Influenza A/eq/Richmond/1/07 [H3N8] recombinant canarypox virus (vCP3011) ≥ 5.3 log10 FAID50*/ml * vCP content checked by global FAID50 (fluorescent assay infectious dose 50%) and qPCR ratio between vCP.
Croatian: --1 Virus influence konja A/eq/Ohio/03 [H3N8] rekombiniran s virusom boginja kanarinca (vCP2242) ≥ 5.3 log10 FAID50 */ml Virus influence konja A/eq/Richmond/1/07 [H3N8] rekombiniran s virusom boginja kanarinca ( vCP3011) ≥ 5.3 log10 FAID50*/ml
English: 10 vials Zero days
Croatian: 10 bočica Nula dana
English: Target Species
Croatian: Ciljne vrste životinja
English: Packaging Content Package Size
Croatian: Veličina pakovanja
English: Withdrawal period
Croatian: Broj odobrenja
English: Horses Intramuscular use Vial (glass) 1 ml
Croatian: Bočica (staklena)
English: Route of administration
Croatian: Put primjene Pakovanje Sastav
English: Neutropenia lasted 1 day on average with both medicines.
Croatian: Neutropenija je u prosjeku trajala jedan dan uz oba lijeka.
English: Further information on Fulphila can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/fulphila.
Croatian: Više informacija o lijeku Fulphila nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/fulphila.
English: Filgrastim has been available in other medicines in the European Union (EU) for a number of years.
Croatian: Filgrastim je godinama dostupan u drugim lijekovima u Europskoj uniji (EU).
English: Patients can inject themselves if they have been trained appropriately.
Croatian: Bolesnici si mogu sami ubrizgati lijek ako prođu odgovarajuću obuku.
English: Pain in muscles is also common.
Croatian: Bol u mišićima također je čest.
English: The most common side effect with Fulphila (which may affect more than 1 in 10 people) is pain in the bones.
Croatian: Najčešća nuspojava lijeka Fulphila (koja se može javiti u više od 1 na 10 osoba) jest bol u kostima.
English: It is given specifically to reduce the duration of neutropenia and prevent febrile neutropenia (when neutropenia is accompanied by fever).
Croatian: Posebno se daje za skraćivanje trajanja neutropenije i sprečavanje febrilne neutropenije (kad je neutropenija popraćena vrućicom).
English: This slows down the removal of filgrastim from the body, allowing the medicine to be given less often.
Croatian: Time se usporava uklanjanje filgrastima iz tijela, zbog čega se lijek može davati rjeđe.
English: This means that Fulphila is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Croatian: Drugim riječima, lijek Fulphila vrlo je sličan drugom biološkom lijeku („referentnom lijeku”) koji je već odobren u EU-u.
English: Fulphila is given as a single dose of 6 mg injected under the skin at least 24 hours after the end of each cycle of chemotherapy (treatment with cancer medicines).
Croatian: Lijek Fulphila se daje kao jedna doza od 6 mg koja se ubrizgava pod kožu najmanje 24 sata nakon završetka svakog ciklusa kemoterapije (terapije lijekovima protiv raka).
English: Side effects reported with Fulphila are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Fulphila pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: What measures are being taken to ensure the safe and effective use of Fulphila?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Fulphila?
English: What is Fulphila and what is it used for?
Croatian: Što je Fulphila i za što se primjenjuje?
English: Fulphila can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the treatment of cancer or blood disorders.
Croatian: Lijek Fulphila izdaje se samo na recept, a terapiju mora započeti i nadzirati liječnik s iskustvom u liječenju raka ili poremećaja krvi.
English: For more information about using Fulphila, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Fulphila pogledajte uputu o lijeku ili se obratite liječniku ili ljekarniku.
English: Fulphila is a ‘biosimilar medicine'.
Croatian: Lijek Fulphila je „biosličan lijek”.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Fulphila has a highly similar structure, purity and biological activity to Neulasta and is distributed in the body in the same way.
Croatian: Europska agencija za lijekove zaključila je da, u skladu sa zahtjevima EU-a za bioslične lijekove, lijek Fulphila ima vrlo sličnu strukturu, čistoću i biološku aktivnost kao i lijek Neulasta te se u tijelu raspoređuje na isti način.
English: Other information about Fulphila
Croatian: Ostale informacije o lijeku Fulphila
English: Because Fulphila is a biosimilar medicine, the studies on effectiveness and safety of pegfilgrastim carried out with Neulasta do not all need to be repeated for Fulphila.
Croatian: Budući da je lijek Fulphila biosličan lijek, ispitivanja učinkovitosti i sigurnosti primjene pegfilgrastima provedena za lijek Neulasta nije potrebno ponavljati za lijek Fulphila.
English: An overview of Fulphila and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Fulphila i zašto je odobren u EU-u
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Fulphila have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Fulphila nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: What are the risks associated with Fulphila?
Croatian: Koji su rizici povezani s lijekom Fulphila?
English: Why is Fulphila authorised in the EU?
Croatian: Zašto je lijek Fulphila odobren u EU-u?
English: The safety of Fulphila has been evaluated, and on the basis of all the studies carried out the side effects of the medicine are considered to be comparable to those of the reference medicine Neulasta.
Croatian: Ocijenjena je sigurnost primjene lijeka Fulphila i na temelju svih provedenih ispitivanja nuspojave lijeka smatraju se usporedivima s onima za referentni lijek Neulasta.
English: Therefore, the Agency's view was that, as for Neulasta, the benefit of Fulphila outweighs the identified risk and it can be authorised for use in the EU.
Croatian: Stoga je stav Agencije da korist od lijeka Fulphila, kao i od lijeka Neulasta, nadmašuje identificirani rizik te da lijek može biti odobren za primjenu u EU-u.
English: Fulphila is not intended for use in patients with the blood cancer chronic myeloid leukaemia or with myelodysplastic syndromes (conditions in which large numbers of abnormal blood cells are produced, which can develop into leukaemia).
Croatian: Lijek Fulphila nije namijenjen za primjenu u bolesnika s rakom krvi, kroničnom mijeloičnom leukemijom i mijelodisplastičnim sindromima (stanjima kod kojih se stvara velik broj abnormalnih krvnih stanica, koja se mogu razviti u leukemiju).
English: As for all medicines, data on the use of Fulphila are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Fulphila kontinuirano se prate.
English: The active substance in Fulphila, pegfilgrastim, is a form of filgrastim, which is very similar to a human protein called granulocyte-colony-stimulating factor (G-CSF).
Croatian: Djelatna tvar u lijeku Fulphila, pegfilgrastim, oblik je filgrastima, koji je vrlo sličan ljudskoj bjelančevini naziva faktor stimulacije rasta kolonije granulocita (G-CSF).
English: The reference medicine for Fulphila is Neulasta.
Croatian: Referentni lijek za lijek Fulphila je Neulasta.
English: How does Fulphila work?
Croatian: Kako djeluje Fulphila?
English: It is available as a prefilled syringe containing a solution for injection under the skin.
Croatian: Lijek je dostupan u obliku napunjene štrcaljke koja sadrži otopinu za potkožnu injekciju.
English: Filgrastim works by encouraging the bone marrow to produce more white blood cells, increasing white blood cell counts and so treating neutropenia.
Croatian: Filgrastim stimulira koštanu srž na stvaranje više bijelih krvnih stanica, što dovodi do povećanja broja bijelih krvnih stanica i liječenja neutropenije.
English: All these data were considered sufficient to conclude that Fulphila will behave in the same way as Neulasta in terms of effectiveness and safety in its authorised uses.
Croatian: Svi ti podatci smatraju se dovoljnima za donošenje zaključka da će lijek Fulphila za odobrene indikacije djelovati na isti način kao lijek Neulasta u pogledu učinkovitosti i sigurnosti primjene.
English: In addition, a study involving 194 patients who had chemotherapy before or after surgery for breast cancer showed that Fulphila was as effective as Neulasta in reducing the duration of neutropenia.
Croatian: Nadalje, ispitivanjem koje je obuhvatilo 194 bolesnica koje su prošle kemoterapiju nakon operativnog zahvata zbog raka dojke pokazalo se da je lijek Fulphila jednako učinkovit kao i lijek Neulasta u skraćivanju trajanja neutropenije.
English: Fulphila is a medicine used in cancer patients to help with neutropenia (low levels of neutrophils, a type of white blood cell), which is a common side effect of cancer treatment and can leave patients vulnerable to infections.
Croatian: Fulphila je lijek koji se primjenjuje u bolesnika s rakom radi ublaživanja neutropenije (niskih razina neutrofila, vrste bijelih krvnih stanica), koja je česta nuspojava liječenja raka i koja može dovesti do osjetljivosti bolesnika na infekcije.
English: Laboratory studies comparing Fulphila with Neulasta have shown that the active substance in Fulphila is highly similar to that in Neulasta in terms of structure, purity and biological activity.
Croatian: Laboratorijska ispitivanja u kojima je uspoređivan lijek Fulphila s lijekom Neulasta pokazala su da je djelatna tvar u lijeku Fulphila vrlo slična djelatnoj tvari u lijeku Neulasta u pogledu strukture, čistoće i biološke aktivnosti.
English: In addition, studies in breast cancer patients undergoing chemotherapy have shown that the effectiveness of Fulphila is equivalent to that of Neulasta in reducing the duration of neutropenia.
Croatian: Nadalje, u ispitivanjima provedenim na bolesnicama s rakom dojke koje prolaze kemoterapiju pokazalo se da je učinkovitost lijeka Fulphila jednaka učinkovitosti lijeka Neulasta u skraćivanju trajanja neutropenije.
English: In Fulphila, filgrastim has been ‘pegylated' (attached to a chemical called polyethylene glycol).
Croatian: U lijeku Fulphila filgrastim je „pegiliran” (konjugiran s kemijskom tvari koja se naziva polietilenglikol).
English: Studies have also shown that giving Fulphila produces similar levels of the active substance in the body to giving Neulasta.
Croatian: Ispitivanjima se također pokazalo da se primjenom lijeka Fulphila proizvodi slična razina djelatne tvari u tijelu kao i primjenom lijeka Neulasta.
English: What benefits of Fulphila have been shown in studies?
Croatian: Koje su koristi od lijeka Fulphila utvrđene u ispitivanjima?
English: How is Fulphila used?
Croatian: Kako se lijek Fulphila koristi?
English: For the full list of side effects and restrictions with Fulphila, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja pri primjeni lijeka Fulphila potražite u uputi o lijeku.
English: EU number
Croatian: Broj EU odobrenja
English: Invented name Strength Pharmaceutical form Route of administration Packaging
Croatian: Farmaceutsk i oblik
English: 1 cartridge
Croatian: 3 uloška
English: Doctors may consider stopping treatment if patients do not benefit after 12 weeks.
Croatian: Liječnici bi trebali razmisliti o prestanku liječenja ako nema koristi za bolesnike nakon 12 tjedana.
English: These enzymes are needed for the production of serotonin.
Croatian: Ti su enzimi potrebni za proizvodnju serotonina.
English: It is available as tablets containing 250 mg of telotristat and the recommended dose is one tablet three times a day.
Croatian: Dostupan je u obliku tableta koje sadrže 250 mg telotristata, a preporučena doza je jedna tableta tri puta na dan.
English: The European Medicines Agency therefore decided that Xermelo's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Stoga je Europska agencija za lijekove zaključila da koristi od lijeka Xermelo nadmašuju s njim povezane rizike i preporučila davanje odobrenja za njegovu primjenu u EU-u.
English: The effects of Xermelo were seen from about 3 weeks after starting treatment.
Croatian: Učinci lijeka Xermelo mogli su se vidjeti već nakon 3 tjedna od početka liječenja.
English: The most common side effects with Xermelo (which may affect more than 1 in 10 people) are abdominal (belly) pain, increases in the liver enzyme gamma-glutamyl transferase, and tiredness, and are usually mild or moderate.
Croatian: Najčešće nuspojave lijeka Xermelo (koje se mogu javiti u više od 1 od 10 osoba) jesu bol u abdomenu (trbuhu), povećanje broja enzima gama-glutamil transferaze u jetri i umor, a obično su blage ili umjerene.
English: This is a summary of the European public assessment report (EPAR) for Xermelo.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Xermelo.
English: What measures are being taken to ensure the safe and effective use of Xermelo?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Xermelo?
English: What is Xermelo and what is it used for?
Croatian: Što je Xermelo i za što se koristi?
English: Doses may need to be reduced in patients with mildly or moderately reduced liver function.
Croatian: Možda će biti potrebno smanjiti doze u bolesnika s blago ili umjereno smanjenom funkcijom jetre.
English: Other information about Xermelo
Croatian: Ostale informacije o lijeku Xermelo
English: The commonest side effect severe enough to cause treatment to be stopped is abdominal pain.
Croatian: Najčešća nuspojava koja može biti dovoljno jaka da se zbog nje prekine liječenje jest bol u abdomenu.
English: Although small, this reduction was considered significant given that patients view the frequency of bowel movements as a symptom with an important impact on their quality of life.
Croatian: Iako je to smanjenje maleno, smatra se značajnim jer bolesnici smatraju učestalost pražnjenja crijeva simptomom koji ima znatan utjecaj na kvalitetu njihova života.
English: Because the number of patients with carcinoid syndrome is low, the disease is considered ‘rare', and Xermelo was designated an ‘orphan medicine' (a medicine used in rare diseases) on 8 October 2009.
Croatian: Budući da je broj bolesnika s karcinoidnim sindromom nizak, ta se bolest smatra „rijetkom” te se lijek Xermelo označava kao „lijek za rijetku bolest” od 8. listopada 2009.
English: The full EPAR for Xermelo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Xermelo nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Carcinoid syndrome occurs when certain tumours produce and release too much of a substance called serotonin into the blood.
Croatian: Karcionidni sindrom javlja se kada određeni tumori proizvode i oslobađaju prevelike količine tvari naziva serotonin u krv.
English: Xermelo was compared with placebo (a dummy treatment) and the main measure of effectiveness was the change in average number of daily bowel movements over the 12 weeks of the study.
Croatian: Lijek Xermelo uspoređen je s placebom (prividno liječenje), a osnovna mjera djelotvornosti bila je promjena prosječnog broja pražnjenja crijeva u danu tijekom 12 tjedana ispitivanja.
English: It is not intended to provide practical advice on how to use Xermelo.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Xermelo.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Xermelo have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Xermelo nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Xermelo 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 Xermelo možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The side effects that were seen, which mainly affected the gut, did not raise major concerns and were considered mild and manageable.
Croatian: Zabilježene nuspojave, koje se uglavnom javljaju u crijevima, nisu pretjerani razlog za zabrinutost te se smatraju blagima i lako ih se može kontrolirati.
English: The excess serotonin can cause severe diarrhoea as well as other symptoms such as flushing of the face and cramps.
Croatian: Višak serotonina može uzrokovati težak proljev te ostale simptome kao što su crvenilo lica i grčevi.
English: What are the risks associated with Xermelo?
Croatian: Koji su rizici povezani s lijekom Xermelo?
English: Why is Xermelo approved?
Croatian: Zašto je lijek Xermelo odobren?
English: Xermelo is a medicine used to treat adults with severe diarrhoea associated with a condition called carcinoid syndrome.
Croatian: Xermelo je lijek koji se koristi za liječenje odraslih osoba koje boluju od teškog proljeva povezanog sa stanjem koje se naziva karcinoidni sindrom.
English: Xermelo is used together with other medicines, called somatostatin analogues, when those medicines are not sufficient on their own to control the diarrhoea.
Croatian: Xermelo se primjenjuje zajedno s ostalim lijekovima koji se nazivaju analozi somatostatina u slučajevima kada ti lijekovi sami nisu dovoljni za kontroliranje proljeva.
English: By blocking the enzymes, telotristat reduces the production of serotonin in patients with carcinoid syndrome, and so relieves the symptoms of the condition.
Croatian: Inhibiranjem tih enzima telotristat smanjuje proizvodnju serotonina u bolesnika s karcinoidnim sindromom te tako ublažava simptome bolesti.
English: At the start, patients given Xermelo had an average of 6.1 bowel movements per day, and this went down over the 12 weeks to an average of 4.7 per day, a reduction of 1.4 movements.
Croatian: Na početku ispitivanja bolesnici koji su uzimali lijek Xermelo u prosjeku su praznili crijeva 6,1 put na dan, dok se nakon 12 tjedana taj broj u prosjeku smanjio na 4,7 puta na dan, što predstavlja smanjenje od 1,4 pražnjenja.
English: For more information about treatment with Xermelo, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Xermelo pročitajte u uputi o lijeku (također dio EPAR-a) odnosno obratite se svojem liječniku ili ljekarniku.
English: The active substance in Xermelo, telotristat, blocks the action of enzymes called L-tryptophan hydroxylases.
Croatian: Djelatna tvar u lijeku Xermelo, telotristat, inhibira djelovanje enzima naziva L-triptofan hidroksilaza.
English: The benefits of adding Xermelo to treatment have been shown in one main study involving 135 patients with carcinoid syndrome whose diarrhoea had not been fully controlled with somatostatin analogues alone.
Croatian: Koristi od dodavanja lijeka Xermelo u terapiju utvrđene su u jednom glavnom ispitivanju koje je obuhvatilo 135 bolesnika s karcinoidnim sindromom kod kojih se proljev nije mogao u potpunosti kontrolirati samo analozima somatostatina.
English: Xermelo can only be obtained with a prescription.
Croatian: Lijek Xermelo izdaje se samo na liječnički recept.
English: Xermelo has been shown to produce a reduction in the number of bowel movements suffered by patients with carcinoid syndrome not fully controlled with other medicines.
Croatian: Pokazalo se da lijek Xermelo dovodi do smanjenja broja pražnjenja crijeva u bolesnika koji boluju od karcinoidnog sindroma koji se ne može u potpunosti kontrolirati drugim lijekovima.
English: Patients taking placebo were having an average of 5.2 bowel movements daily at the start, which fell to an average of 4.6 movements daily, a fall of 0.6 movements.
Croatian: Bolesnici koji su uzimali placebo praznili su crijeva u prosjeku 5,2 puta na dan na početku, dok se na kraju ispitivanja taj broj u prosjeku smanjio na 4,6 pražnjenja, odnosno 0,6 pražnjenja manje.
English: For practical information about using Xermelo, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Xermelo bolesnici trebaju pročitati u uputi o lijeku, odnosno trebaju se obratiti svojem liječniku ili ljekarniku.
English: How does Xermelo work?
Croatian: Kako djeluje Xermelo?
English: What benefits of Xermelo have been shown in studies?
Croatian: Koje su koristi od lijeka Xermelo utvrđene u ispitivanjima?
English: For the full list of all side effects and restrictions with Xermelo, see the package leaflet.
Croatian: Potpuni popis svih nuspojava i ograničenja pri primjeni lijeka Xermelo potražite u uputi o lijeku.