FrancophonIA/ELRC3.0 huggingface dataset:
English: For practical information about using Kovaltry, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Kovaltry pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: This compared with an average of 6.9 bleeds per year before Kovaltry treatment.
Croatian: Izračunato je da je u prosjeku do pojave krvarenja tijekom liječenja lijekom Kovaltry došlo 3,8 puta godišnje (uglavnom u zglobovima), u usporedbi s prosječno 6,9 krvarenja godišnje prije liječenja lijekom Kovaltry.
English: For the full list of all side effects and restrictions with Kovaltry, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Kovaltry potražite u uputi o lijeku.
English: All of the tablets must be taken together at the same time every day, at least 1 hour before or 1 hour after food.
Croatian: Sve se tablete moraju uzeti zajedno i u isto vrijeme svakog dana, najmanje jedan sat prije ili jedan sat nakon obroka.
English: Further information on Tyverb can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Tyverb nalazi se na internetskim stranicama Agencije:ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Tyverb is used in the following ways:
Croatian: Tyverb se primjenjuje na sljedeće načine:
English: The studies also looked at how long the patients survived.
Croatian: Ispitivanja su također istražila koliko su dugo bolesnice preživjele.
English: This means that there was more evidence to come about the effectiveness of the medicine.
Croatian: To znači da su se očekivali dodatni podatci o djelotvornosti lijeka.
English: Tyverb was originally given ‘conditional approval'.
Croatian: Za lijek Tyverb prvotno je izdano „uvjetno odobrenje”.
English: This was switched to a full marketing authorisation on 17 February 2015.
Croatian: To je odobrenje pretvoreno u potpuno odobrenje za stavljanje u promet 17. veljače
English: What measures are being taken to ensure the safe and effective use of Tyverb?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Tyverb?
English: This combination is used in women who do not currently need to receive standard chemotherapy to treat their cancer.
Croatian: Ova se kombinacija koristi u žena koje trenutno ne trebaju primati standardnu kemoterapiju za liječenje raka.
English: Patients who stop taking Tyverb after developing severe liver problems should not start to take the medicine again.
Croatian: Bolesnici koji prestanu uzimati Tyverb nakon što se razviju teški problemi s jetrom ne smiju početi ponovno uzimati lijek.
English: What is Tyverb and what is it used for?
Croatian: Što je Tyverb i za što se koristi?
English: If patients start to take Tyverb again, they may need to use a lower dose.
Croatian: Ako bolesnici počnu ponovno uzimati Tyverb, možda će biti potrebna primjena manje doze.
English: About a quarter of breast cancers produce HER2.
Croatian: Otprilike četvrtina karcinoma dojke proizvodi HER2.
English: ‘Advanced' means that the cancer has started to spread and ‘metastatic' means that the cancer has already spread to other parts of the body;
Croatian: „Uznapredovao” znači da se rak počeo širiti, a „metastatski” znači da se rak već proširio na druge dijelove tijela;
English: The doctor may decide to interrupt or stop treatment in patients experiencing certain side effects, especially those affecting the heart, lungs or liver.
Croatian: Liječnik može odlučiti privremeno ili trajno prekinuti terapiju u bolesnika koji imaju određene nuspojave, posebice one koje zahvaćaju srce, pluća ili jetru.
English: The women had not received trastuzumab or an aromatase inhibitor before entering this study.
Croatian: Žene nisu primale trastuzumab ni inhibitor aromataze prije uključivanja u ispitivanje.
English: Tyverb is available as tablets (250 mg) and the recommended dose is 4 tablets a day when used with trastuzumab, 5 tablets a day when it is used with capecitabine, and 6 tablets a day when taken with an aromatase inhibitor.
Croatian: Lijek Tyverb dostupan je u obliku tableta (250 mg), a preporučena doza iznosi 4 tablete na dan ako se koristi s trastuzumabom, 5 tableta na dan ako se koristi s kapecitabinom, te 6 tableta na dan ako se uzima s inhibitorom aromataze.
English: In all the studies, the main measure of effectiveness was how long the patients lived without their disease getting worse, which was assessed in scans.
Croatian: Glavna mjera djelotvornosti u svim ispitivanjima bilo je vrijeme koje su bolesnice živjele bez pogoršanja bolesti, što se procjenjivalo snimkama.
English: What are the risks associated with Tyverb?
Croatian: Koji su rizici povezani s lijekom Tyverb?
English: Palmar-plantar erythrodysaesthesia (rash and numbness on the palms and soles) is also very common when Tyverb is taken with capecitabine.
Croatian: Palmarno-plantarna eritrodizestezija (osip i utrnuće dlanova i tabana) također je vrlo česta kada se Tyverb uzima s kapecitabinom.
English: Other information about Tyverb
Croatian: Ostale informacije o lijeku Tyverb
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tyverb have also been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Tyverb također se nalaze u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Why is Tyverb authorised in the EU?
Croatian: Zašto je lijek Tyverb odobren u EU-u?
English: Tyverb received a conditional marketing authorisation valid throughout the EU on 10 June 2008.
Croatian: Lijek Tyverb dobio je uvjetno odobrenje za stavljanje lijeka u promet koje je na snazi u Europskoj uniji 10. lipnja 2008.
English: As for all medicines, data on the use of Tyverb are continuously monitored.
Croatian: Kao za sve lijekove, podatci o primjeni lijeka Tyverb kontinuirano se prate.
English: The active substance in Tyverb, lapatinib, belongs to a group of medicines called protein kinase inhibitors.
Croatian: Djelatna tvar u lijeku Tyverb, lapatinib, pripada skupini lijekova poznatih pod nazivom inhibitori protein-kinaze.
English: Side effects reported with Tyverb are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Tyverb pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: This means that the cancer produces a specific protein called HER2 (also known as ErbB2) in large quantities on the surface of the cancer cells.
Croatian: To znači da rak proizvodi velike količine specifičnog proteina naziva HER2 (također poznat pod nazivom ErbB2) na površini stanica raka.
English: An overview of Tyverb and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Tyverb i zašto je odobren u EU-u
English: 219 of the women had cancer that was producing large quantities of HER2.
Croatian: Od tih žena, 219 ih je imalo rak s proizvodnjom velikih količina proteina HER2.
English: The European Medicines Agency decided that Tyverb's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Tyverb nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: Tyverb contains the active substance lapatinib.
Croatian: Tyverb sadržava djelatnu tvar lapatinib.
English: Tyverb in combination with another cancer medicine was shown to be more effective than the comparator treatment in three main studies involving women with breast cancer.
Croatian: Lijek Tyverb u kombinaciji s drugim lijekom protiv raka pokazao se djelotvornijim od usporednog liječenja u trima glavnim ispitivanjima kojima su bile obuhvaćene žene s rakom dojke.
English: It involved 408 women with advanced or metastatic disease that was producing large quantities of HER2 who had already been treated with anthracyclines, taxanes and trastuzumab but whose disease had got worse or come back.
Croatian: Obuhvatilo je 408 žena s uznapredovalom ili metastatskom bolesti koja je proizvodila velike količine proteina HER2, a koje su već bile liječene antraciklinima, taksanima i trastuzumabom, no čija se bolest pogoršala ili se vratila.
English: For more information about using Tyverb, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Tyverb pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: The most common side effects with Tyverb (which may affect more than 1 in 4 patients) are rash and side effects affecting the stomach and gut (such as diarrhoea, nausea (feeling sick) and vomiting).
Croatian: Najčešće su nuspojave lijeka Tyverb (koje se mogu javiti u više od 1 na 4 osobe) osip i nuspojave koje zahvaćaju želudac i crijeva (kao što su proljev, mučnina i povraćanje).
English: By blocking HER2 receptors, Tyverb helps to control growth of the cancer.
Croatian: Inhibirajući te HER2 receptore lijek Tyverb pomaže pri kontroli rasta raka.
English: The third study compared Tyverb with placebo (a dummy treatment), both of which were taken together with letrozole (an aromatase inhibitor).
Croatian: Tijekom trećeg ispitivanja lijek Tyverb uspoređen je s placebom (prividnim liječenjem), pri čemu su oba lijeka uzimana zajedno s letrozolom (inhibitorom aromataze).
English: It involved 1,286 women who had been through the menopause with metastatic breast cancer that was sensitive to hormones.
Croatian: Obuhvatilo je 1 286 žena u postmenopauzi s metastatskim rakom dojke osjetljivim na hormone.
English: HER2 is a receptor for a substance called epidermal growth factor which stimulates the cancer cells to grow uncontrollably.
Croatian: HER2 je receptor tvari naziva faktor epidermalnog rasta koji potiče stanice raka na nekontroliranu diobu.
English: Tyverb can only be obtained with a prescription and should only be started by a doctor who has experience in giving cancer medicines.
Croatian: Tyverb se izdaje samo na liječnički recept, a terapiju lijekom mora započeti liječnik koji ima iskustva s primjenom lijekova protiv raka.
English: It involved 296 women with metastatic disease that was producing large quantities of HER2 and got worse despite treatment with trastuzumab and other cancer medicines (including anthracyclines and taxanes).
Croatian: Obuhvatilo je 296 žena s metastatskom bolesti koja je proizvodila velike količine proteina HER2 i pogoršavala se unatoč liječenju lijekom trastuzumab i drugim lijekovima protiv raka (uključujući antracikline i taksane).
English: Women taking Tyverb with capecitabine survived for an average of 75 weeks, and those taking capecitabine alone survived for an average of 64.7 weeks.
Croatian: Žene koje su uzimale Tyverb s kapecitabinom preživjele su prosječno 75 tjedana, a one koje su uzimale monoterapiju kapecitabina preživjele su prosječno 64,7 tjedana.
English: The company that markets Tyverb will evaluate ways to predict resistance (the medicine becoming less effective) in breast cancer patients taking Tyverb with other cancer medicines.
Croatian: Tvrtka koja stavlja na tržište Tyverb također će procijeniti načine predviđanja otpornosti (smanjene djelotvornosti lijeka) u osoba s rakom dojke koje primaju lijek Tyverb u kombinaciji s drugim lijekovima protiv raka.
English: How is Tyverb used?
Croatian: Kako se Tyverb koristi?
English: These medicines work by blocking enzymes known as protein kinases, which can be found in some receptors (targets) on the surface of cancer cells including HER2.
Croatian: Ti lijekovi djeluju inhibirajući enzime poznate pod nazivom protein-kinaze koji se nalaze u nekim receptorima na površini stanica raka, uključujući HER2.
English: • in combination with trastuzumab for metastatic cancer that does not respond to hormones (hormone receptor-negative disease), and which got worse when previously treated with a combination of trastuzumab and other cancer medicines (chemotherapy);
Croatian: • u kombinaciji s trastuzumabom za metastatski rak koji ne odgovara na hormone (bolest s negativnim hormonskim receptorima) i koji se pogoršao tijekom prethodnog liječenja trastuzumabom u kombinaciji s drugim lijekovima protiv raka (kemoterapijom);
English: How does Tyverb work?
Croatian: Kako djeluje Tyverb?
English: Tyverb is a cancer medicine used to treat patients with breast cancer that has been shown to be ‘expressing' large amounts of HER2.
Croatian: Tyverb je lijek protiv raka koji se koristi za liječenje bolesnika s rakom dojke koji „izlučuje” velike količine proteina HER2.
English: Tyverb in combination with other cancer medicines has been shown to improve survival of patients with breast cancer that produces large quantities of HER2, and its side effects are considered acceptable.
Croatian: Dokazano je da Tyverb u kombinaciji s drugim lijekovima protiv raka poboljšava stopu preživljenja bolesnica s rakom dojke koji proizvodi velike količine HER2 te se njegove nuspojave smatraju prihvatljivima.
English: The women whose cancer was producing large quantities of HER2 taking Tyverb in combination with letrozole survived for an average of 35.4 weeks without their disease getting worse.
Croatian: Žene u kojih je rak proizvodio velike količine proteina HER2, a koje su uzimale lijek Tyverb u kombinaciji s letrozolom, preživjele su u prosjeku 35,4 tjedna bez pogoršanja bolesti.
English: What benefits of Tyverb have been shown in studies?
Croatian: Koje su koristi lijeka Tyverb utvrđene u ispitivanjima?
English: • in combination with capecitabine (another cancer medicine) when the cancer is advanced or metastatic and got worse following previous treatment including an anthracycline and a taxane (other types of cancer medicine), and following treatment of the patient's metastatic disease with trastuzumab (another cancer medicine).
Croatian: • u kombinaciji s kapecitabinom (drugim lijekom protiv raka) ako je riječ o uznapredovalom ili metastatskom raku ili o raku koji se pogoršao nakon prethodnog liječenja koje je uključivalo antraciklin i taksan (druge vrste lijekova protiv raka) te nakon liječenja metastatske bolesti trastuzumabom (drugim lijekom protiv raka).
English: The women taking Tyverb in combination with capecitabine lived for an average of 23.9 weeks without their disease getting worse, as assessed by their doctors, compared with 18.3 weeks in the women taking capecitabine alone.
Croatian: Žene koje su uzimale lijek Tyverb u kombinaciji s kapecitabinom živjele su u prosjeku 23,9 tjedana bez pogoršanja bolesti, prema procjeni njihovih liječnika, dok je u žena koje su primale monoterapiju kapecitabinom to razdoblje trajalo 18,3 tjedna.
English: In addition, women taking the combination survived for 14.0 months on average, compared with 9.5 months in those taking Tyverb alone.
Croatian: Osim toga, žene koje su uzimale kombinaciju lijekova preživjele su u prosjeku 14,0 mjeseci, a one koje su uzimale samo lijek Tyverb 9,5 mjeseci.
English: This compared with 13.0 weeks in those taking placebo in combination with letrozole.
Croatian: U onih koje su uzimale placebo u kombinaciji s letrozolom to je razdoblje trajalo 13,0 tjedana.
English: Women taking Tyverb with trastuzumab lived without their disease getting worse for 12.0 weeks on average, compared with 8.1 weeks in those taking Tyverb alone.
Croatian: Žene koje su uzimale lijek Tyverb u kombinaciji s trastuzumabom živjele su u prosjeku 12,0 tjedana bez pogoršanja bolesti, a one koje su uzimale samo lijek Tyverb 8,1 tjedan.
English: For the full list of side effects and restrictions with Tyverb, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja pri primjeni lijeka Tyverb potražite u uputi o lijeku.
English: The second study compared Tyverb alone with a combination of Tyverb plus trastuzumab.
Croatian: U drugom je ispitivanju monoterapija lijekom Tyverb uspoređena s kombinacijom lijeka Tyverb i trastuzumaba.
English: • in combination with an aromatase inhibitor (another type of cancer medicine) in women who have been through the menopause, when the cancer is metastatic and responds to hormones.
Croatian: • u kombinaciji s inhibitorom aromataze (drugim lijekom protiv raka) u žena u postmenopauzi s metastatskom bolesti uz pozitivne hormonske receptore.
English: The first study compared Tyverb in combination with capecitabine, with capecitabine taken alone.
Croatian: U prvom je ispitivanju uspoređena kombinacija lijeka Tyverb i kapecitabina s monoterapijom kapecitabinom.
English: Portugal capsule
Croatian: Portugal kapsula
English: Unit 34/35, Block A Dunboyne Business Park Dunboyne
Croatian: Unit 34/35, Block A Dunboyne Business Park Dunboyne Co.
English: Castilla 2, Edificio Berlín 2ª planta Parque Empresarial San Fernando
Croatian: Edificio Berlín 2ª planta Parque Empresarial San Fernando
English: Sopharma AD 16"Iliensko shose" Str. Sofia
Croatian: Sopharma AD 16"Iliensko shose" Str.
English: Meda AS, Askerveien 61, Postboks 194, 1371 Asker
Croatian: Meda AS Askerveien 61 Postboks 194 1371 Asker Norway
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states for bromocriptine-containing medicinal products indicated in the “prevention or suppression of physiological lactation in the immediate post-partum period and in the late post-partum period”
Croatian: Dodatak I Popis imena, farmaceutskih oblika, jačina lijekova, puta primjene, nositelja odobrenja u zemljama članicama
English: MEDA PHARMACEUTICALS S.A., GREECE 3 Evrytanias Str., Halandri, 15231, Attiki, Greece
Croatian: 3 Evrytanias Str., Halandri 15231, Attiki
English: United Kingdom Meda Pharmaceuticals Limited,
Croatian: Meda Pharmaceuticals Limited
English: 170 09 Solana Box 906
Croatian: 170 09 Solna Box 906
English: Belgium Meda Pharma s.a. Chaussée de la Hulpe 166 1170 Brussels
Croatian: Chaussée de la Hulpe 166 1170 Brussels Belgium
English: Maksimirska 120/V, Zagreb
Croatian: Maksimirska 120/V Zagreb 10 000 Croatia
English: MEDA PHARMA 25, boulevard de l'Amiral Bruix,
Croatian: MEDA PHARMA 25, boulevard de l'Amiral Bruix 75016 Paris France
English: Skyway House,
Croatian: Skyway House Parsonage Road
English: Medochemie Ltd., 1-10 Astronafton Str. Limassol
Croatian: Medochemie Ltd. 1-10 Astronafton Str.
English: Czech Republic Medochemie Ltd. Konstantinoupoleos Str. 1_10 3011 Limassol - Tsiflikoudia Cyprus
Croatian: Constantinoupoleos Str. 1_10 3011 Limassol - Tsiflikoudia Cyprus
English: MEDA PHARMA, S.A.U.
Croatian: MEDA PHARMA, S.A.U. Avda.
English: Verovškova 57, 1000 Ljubljana, Slovenia
Croatian: 1526 Ljubljana Slovenia
English: MEDA Pharma GmbH & Co. KG
Croatian: MEDA Pharma GmbH & Co.
English: Lek farmacevtska družba d.d.,
Croatian: Lek farmacevtska družba d.d. Verovškova 57
English: MEDOCRIPTINE 2,5 mg
Croatian: MEDOCRIPTINE 2,5 mg 2,5 mg
English: Bromocriptin AbZ 2,5 mg
Croatian: Bromocriptin AbZ 2,5 mg 2,5 mg
English: Meda AS, Solvang 8, DK-3450 Allerød, Denmark
Croatian: DK-3450 Allerød Denmark
English: Parlodel 10 mg 10 mg
Croatian: Parlodel 10 mg
English: Co. Meath
Croatian: Meath Ireland
English: CT Arzneimittel GmbH Graf-Arco-Str. 3
Croatian: AbZ-Pharma GmbH Graf-Arco-Str.
English: Parlodel 5mg Tablets capsule
Croatian: Parlodel 5mg Tablets kapsula
English: S.C. BIOFARM S.A. Str. Logofăt Tăutu nr. 99, sector 3,
Croatian: Logofăt Tăutu nr. 99 sector 3, Bucureşti
English: United Kingdom Teva UK Limited, Brampton Road,
Croatian: Teva UK Limited Brampton Road, Hampden Park Eastbourne, East Sussex BN22 9AG
English: BROMOCRIPTINRICHTER
Croatian: BROMOCRIPTIN
English: Gedeon Richter Plc Gyömrői út 19-21.
Croatian: Gedeon Richter Plc Gyömrői út 19-21 H-1103 Budapest Hungary
English: Bishops Stortford
Croatian: Skyway House Parsonage Road Takeley Bishops Stortford
English: Parlodel 10 mg capsules
Croatian: Parlodel 10 mg capsules 10 mg
English: Parlodel 10mg Tablets capsule
Croatian: Parlodel 10mg Tablets 10 mg kapsula
English: Parlodel 5 mg capsules
Croatian: Parlodel 5 mg capsules 5 mg
English: Germany ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Croatian: 3 89079 Ulm Germany
English: Gyömröi út 19-21 1103 Budapest, Hungary
Croatian: Gedeon Richter Plc. Gyömröi út 19-21 1103 Budapest Hungary
English: Bromocriptinratiopharm 2,5mg Tabletten
Croatian: Bromocriptin-ratiopharm 2,5mg Tabletten
English: Pravidel 2,5 mg Tabletten
Croatian: Pravidel 2,5 mg Tabletten 2,5 mg
English: Parlodel 2,5 mg 2.5 mg
Croatian: Parlodel 2,5 mg
English: BromocriptinRichter 2,5 mg tabletta
Croatian: Bromocriptin-Richter 2,5 mg tabletta
English: Slovak Republic Medochemie Ltd. 1-10 Constantinoupoleos St. 3011 Limassol,
Croatian: 1-10 Constantinoupoleos St. 3011 Limassol Cyprus
English: Slovak Republic MEDA Pharma s.r.o.
Croatian: Meda Pharma s.a.
English: Kodaňská 1441/46
Croatian: MEDA Pharma s.r.o. Kodaňská 1441/46 100 00 Praha 10
English: Annex I
Croatian: Castilla 2
English: TEVA ITALIA S.R.L.
Croatian: Medochemie Ltd.
English: Parlodel 2.5mg Tablets
Croatian: Parlodel 2.5mg Tablets 2,5 mg
English: BROMOCRIPTIN 2.5 mg coated tablet
Croatian: Bromocriptine 2.5mg Tablets
English: 16 December 2016 EMA/822769/2016 EMEA/H/C/004342
Croatian: EMA/822769/2016 EMEA/H/C/004342
English: What is Cavoley?
Croatian: Što je Cavoley?
English: Cavoley was developed as a ‘biosimilar' medicine.
Croatian: Cavoley je razvijen kao „biosličan” lijek.
English: On 16 November 2016, Gedeon Richter Plc officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Cavoley, for reducing neutropenia.
Croatian: Dana 16. studenog 2016., tvrtka Gedeon Richter Plc službeno je obavijestila Odbor za lijekove za humanu uporabu (CHMP) kako želi povući svoj zahtjev za odobrenje za stavljanje u promet lijeka Cavoley za liječenje neutropenije.
English: This means that Cavoley was intended to be highly similar to a biological medicine (the ‘reference medicine') already authorised in the European Union called Neulasta.
Croatian: To znači da je Cavoley trebao biti vrlo sličan biološkom lijeku („referentnom lijeku”) koji je već odobren u Europskoj uniji (EU) pod nazivom Neulasta.
English: What was Cavoley expected to be used for?
Croatian: Za što se Cavoley trebao koristiti?
English: A further study in patients receiving cancer medicines compared the safety and effectiveness of Cavoley and Neulasta.
Croatian: U dodatnom ispitivanju na bolesnicima koji su dobivali lijekove za liječenje raka uspoređena je sigurnost i učinkovitost lijekova Cavoley i Neulasta.
English: Withdrawal of the marketing authorisation application for Cavoley (pegfilgrastim)
Croatian: Povlačenje zahtjeva za davanje odobrenja za stavljanje u promet lijeka Cavoley (pegfilgrastim)
English: How does Cavoley work?
Croatian: Kako djeluje Cavoley?
English: The company presented results of studies in healthy people designed to show that Cavoley is highly similar to its reference medicine Neulasta in terms of chemical structure, purity, the way it works and how the body handles the medicine.
Croatian: Tvrtka je predstavila rezultate ispitivanja u zdravih ljudi koja su provedena kako bi se dokazalo da je lijek Cavoley vrlo sličan svojem referentnom lijeku Neulasta u smislu kemijske strukture, čistoće, djelovanja i načina na koji tijelo podnosi lijek.
English: After the CHMP had assessed the company's responses to the last round of questions, there were still some unresolved issues.
Croatian: Nakon što je CHMP ocijenio odgovore tvrtke na posljednji popis pitanja, još su uvijek postojale neke nedoumice.
English: Neutropenia is a side effect of certain cytotoxic (cell-killing) cancer treatments because the treatments also kill white blood cells.
Croatian: Neutropenija je nuspojava određenih citotoksičnih (koji ubijaju stanice) načina liječenja raka jer se takvim liječenjem ubijaju i bijele krvne stanice.