FrancophonIA/ELRC3.0 huggingface dataset:
English: The following adverse events have been reported with some statins: - Nightmares - Memory loss - Depression - Exceptional cases of interstitial lung disease, especially with long term therapy (see section 4.4).
Croatian: Prijavljene su sljedeće nuspojave s nekim statinima: - noćne more - gubitak pamćenja
English: EU/1/11/679/006 90 hard capsules
Croatian: EU/1/11/679/006 90 tvrdih kapsula
English: Blood creatinine increased, creatinine renal clearance decreased, creatinine renal clearance increased, Renal failure
Croatian: Poremećaji bubrega i mokraćnog sustava povišen kreatinin u krvi, snižen bubrežni klirens kreatinina, povišen bubrežni klirens kreatinina, zatajenje bubrega
English: • Digestive effects: gastric or intestinal disorders (abdominal pain, nausea, vomiting, diarrhoea and flatulence, constipation, dry mouth, upper abdominal pain with bloating (dyspepsia), burping
Croatian: • Učinci na probavni sustav: želučani ili crijevni poremećaji (bol u trbuhu, mučnina, povraćanje,
English: NAME OF THE MEDICINAL PRODUCT Pravafenix 40 mg/160 mg hard capsules Pravastatin/Fenofibrate
Croatian: UPUTA O LIJEKU: PODACI ZA OSOBE Pravafenix 40 mg/160 mg tvrde kapsule pravastatin/fenofibrat
English: Suomi/Finland Laboratoires SMB S.A. Puh/Tel: + 32.2.411.48.28.
Croatian: Puh/Tel: + 32.2.411.48.28.
English: EU/1/11/679/003 90 hard capsules
Croatian: EU/1/11/679/003 90 tvrdih kapsula
English: EXP
Croatian: SEb
English: Dizziness, headache, paraesthesia
Croatian: Poremećaji živčanog sustava omaglica, glavobolja, parestezija
English: Rare side effects (may affect up to 1 in 1,000 people) • Decrease in haemoglobin (oxygen-carrying pigment in blood) and leukocytes (white blood cells).
Croatian: • Snjiženje hemoglobina (krvnog pigmenta zaduženog za prijenos kisika) i leukocita (bijelih krvnih stanica).
English: No posology adjustment is required in patients with mild hepatic impairment.
Croatian: Kod bolesnika s blagim oštećenjem jetre nije potrebna prilagodba doziranja.
English: Investigation
Croatian: Doziranje
English: In patients where the use of systemic fusidic acid is considered essential, statin treatment should be discontinued throughout the duration of fusidic acid treatment.
Croatian: U bolesnika u kojih je primjena sistemske fusidatne kiseline smatra neophodnom,
English: and/or AST ≥ 3 times the ULN, < 5 times the ULN) was 0.83% for patients treated with Pravafenix.
Croatian: U kliničkim ispitivanjima incidencija značajnih povišenja transaminaza u serumu (ALT i/ili AST ≥ 3 puta GGN, < 5 puta GGN) bila su kod 0,83% bolesnika liječenih Pravafenixom.
English: If you take more Pravafenix than you should Please contact your doctor or pharmacist
Croatian: Ako uzmete više Pravafenixa nego što ste trebali
English: Intersticial pneumopathies
Croatian: Synapsis Trading Limited
English: Oreškovićeva 6H, 10010 Zagreb,
Croatian: Oreškovićeva 6H, 10010 Zagreb, Croatia
English: Estrada Consiglieri Pedroso, 69 A
Croatian: Estrada Consiglieri Pedroso, 69 A Queluz de Baixo
English: 56 Eirinis Ave., 151 21, Pefki,
Croatian: 151 21, Pefki,
English: Queluz de Baixo 2734-503 Barcarena Portugal
Croatian: 2734-503 Barcarena Portugal
English: 92787 ISSY-LESMOULINEAUX Cedex 9 France
Croatian: 92787 ISSY-LES-MOULINEAUX Cedex
English: JANSSEN-CILAG 1, rue Camille Desmoulins TSA 91003
Croatian: 1, rue Camille Desmoulins TSA 91003
English: JANSSEN-CILAG GmbH Johnson & Johnson Platz 1 41470 Neuss, Germany
Croatian: GmbH Johnson & Johnson Platz 1 41470 Neuss, Germany
English: Janssen-Cilag Pharma GmbH, 1020 Vienna, Vorgartenstraße 206B
Croatian: Janssen-Cilag Pharma GmbH, 1020 Vienna, Vorgartenstraße 206B Austria
English: Czech Republic Janssen-Cilag s.r.o., Karla Engliše 3201/6, Prague 5, 150 00
Croatian: Janssen-Cilag s.r.o., Karla Engliše 3201/6, Prague 5, 150 00
English: Luxembourg Janssen-Cilag N.V. Antwerpseweg 15-17
Croatian: Luksemburg Janssen-Cilag N.V. Antwerpseweg 15-17
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES
Croatian: POPIS NAZIVA, FARMACEUTSKOG OBLIKA, JAČINE LIJEKA, PUTA PRIMJENE,
English: Šmartinska cesta 53, 1000 Ljubljana Slovenia
Croatian: Johnson & Johnson d.o.o. Šmartinska cesta 53, 1000 Ljubljana Slovenia
English: Janssen-Cilag Pharmaceutical S.A.C.I.
Croatian: Janssen-Cilag Pharmaceutical S.A.C.I. 56 Eirinis Ave.,
English: Belgium Janssen-Cilag N.V. Antwerpseweg 15-17
Croatian: Janssen-Cilag N.V. Antwerpseweg 15-17 B-2340 Beerse Belgium
English: Durogesic 12 mikrogramm/óra transzdermális tapasz
Croatian: Durogesic 12 mikrogramm/ór a transzdermális tapasz
English: Durogesic 12 microgrammes/h eure, dispositif transdermique
Croatian: Durogesic 12 microgrammes/ heure, dispositif transdermique
English: Durogesic 100 microgrammes/h eure, dispositif transdermique
Croatian: Durogesic 100 microgrammes/ heure, dispositif transdermique
English: Durogesic 100 mikrogramm/óra transzdermális tapasz
Croatian: Durogesic 100 mikrogramm/ór a transzdermális tapasz
English: JANSSEN-CILAG SpA Via M. Buonarroti, 23
Croatian: Buonarroti, 23
English: Durogesic 75 mikrogramm/óra transzdermális tapasz
Croatian: Durogesic 75 mikrogramm/ór a transzdermális tapasz
English: Durogesic 25 mikrogramm/óra transzdermális tapasz
Croatian: Durogesic 25 mikrogramm/ór a transzdermális tapasz
English: Durogesic 75 microgrammes/h eure, dispositif transdermique
Croatian: Durogesic 75 microgrammes/ heure, dispositif transdermique
English: Durogesic 50 mikrogramm/óra transzdermális tapasz
Croatian: Durogesic 50 mikrogramm/ór a transzdermális tapasz
English: Durogesic 50 microgrammes/h eure, dispositif transdermique
Croatian: Durogesic 50 microgrammes/ heure, dispositif transdermique
English: Durogesic 25 microgrammes/h eure, dispositif transdermique
Croatian: Durogesic 25 microgrammes/ heure, dispositif transdermique
English: d.o.o.
Croatian: SpA Via M.
English: This summary was last updated in July 2015.
Croatian: Ovaj sažetak je posljednji put ažuriran u srpnju 2015.
English: Fortekor Plus is given twice daily approximately one hour before feeding.
Croatian: Fortekor Plus primjenjuje se dvaput dnevno otprilike jedan sat prije unosa hrane.
English: The full EPAR for Fortekor Plus can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Croatian: Plus nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Fortekor Plus on 8 September 2015.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za VMP Fortekor Plus na snazi u Europskoj uniji od 8. rujna 2015.
English: The dose is adjusted according to bodyweight.
Croatian: Doza se prilagođava tjelesnoj težini.
English: When the production of angiotensin II is lowered, the blood vessels relax and widen.
Croatian: Kada se proizvodnja angiotenzina II smanji, krvne žile se opuštaju i šire.
English: Pimobendan/benazepril hydrochloride
Croatian: Pimobendan/benazepril hidroklorid
English: Why is Fortekor Plus approved?
Croatian: Zašto je Fortekor Plus odobren?
English: Fortekor Plus is available as tablets (pimobendan 1.25 mg/benazepril hydrochloride 2.5 mg and pimobendan 5 mg/benazepril hydrochloride 10 mg) and can only be obtained with a prescription.
Croatian: Plus je dostupan kao tablete (pimobendan 1,25 mg/benazepril hidroklorid 2,5 mg i pimobendan 5 mg/benazepril hidroklorid 10 mg) te se izdaje samo na liječnički recept.
English: It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use.
Croatian: Objašnjava kako je Agencija ocijenila ovaj VMP da bi preporučila njegovo odobrenje u EU-u te uvjete za njegovu primjenu.
English: What is Fortekor Plus and what is it used for?
Croatian: Što je Fortekor Plus i za što se koristi?
English: Congestive heart failure is a condition where the heart cannot pump enough blood around the body.
Croatian: Kongestivno zatajenje srca je stanje kod kojeg srce ne može istisnuti dovoljnu količinu krvi kroz tijelo.
English: The most common side effects with benazepril are short-lived episodes of vomiting, incoordination or signs of tiredness.
Croatian: Najčešće nuspojave benazeprila kratke su epizode povraćanja, nekoordinacije ili znakova umora.
English: People who are hypersensitive (allergic) to pimobendan or benazepril hydrochloride should avoid contact with Fortekor Plus.
Croatian: Osobe koje su preosjetljive (alergične) na pimobendan ili benazepril hidroklorid trebaju izbjegavati kontakt s VMP-om Fortekor Plus.
English: Fortekor Plus is a veterinary medicine used to treat congestive heart failure in dogs.
Croatian: Plus je veterinarsko-medicinski proizvod koji se koristi za liječenje kongestivnog zatajenja srca u pasa.
English: The most common side effects with pimobendan (which may affect more than 1 in 10,000 dogs) are an increase in heart rate and vomiting.
Croatian: Najčešće nuspojave pimobendana (koje se mogu javiti u više od 1 na 10.000 pasa) povećanje su srčane frekvencije i povraćanje.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) decided that Fortekor Plus' benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za veterinarsko-medicinske proizvode (CVMP) pri Agenciji odlučio je da koristi od VMP-a Fortekor Plus nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za primjenu u Europskoj uniji.
English: ACE inhibitors lower the production of angiotensin II, a powerful vasoconstrictor (a substance that narrows blood vessels).
Croatian: ACE inhibitori smanjuju proizvodnju angiotenzina II, snažnog vazokonstriktora (tvari koja suzuje krvne žile).
English: The main measure of effectiveness was the total score of exercise intolerance, demeanour, breathing effort, coughing and difficulty of breathing at night.
Croatian: Glavna mjera djelotvornosti bio je ukupan rezultat u pogledu intolerancije na tjelesnu aktivnost, ponašanja, napora pri disanju, kašljanja i otežanog disanja tijekom noći.
English: It is not intended to provide practical advice on how to use Fortekor Plus.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni VMP-a Fortekor Plus.
English: If the product is accidentally swallowed by a person, the advice of a doctor should be sought immediately and the package leaflet or label shown to the doctor.
Croatian: U slučaju nehotičnog gutanja ovog proizvoda treba smjesta potražiti savjet liječnika te mu pokazati uputu o VMP-u ili etiketu proizvoda.
English: Benazepril is a prodrug, a substance that is converted to benazeprilat in the body.
Croatian: Benazepril je prolijek, tvar koja se pretvara u benazeprilat u tijelu.
English: Fortekor Plus must not be given to dogs with hypertrophic cardiomyopathy (heart muscle disease where the walls of the heart thicken reducing blood output), clinical conditions where heart output cannot increase because of functional or anatomical reasons (e.g. narrowing of the aorta or pulmonary artery).
Croatian: Fortekor Plus ne smije se primjenjivati u pasa s hipertrofičnom kardiomiopatijom (oboljenjem srčanog mišića uslijed kojeg dolazi do zadebljanja stjenki srca što smanjuje protok krvi), kliničkim stanjima kod kojih nije moguće povećanje istisne funkcije srca zbog funkcionalnih ili anatomskih razloga (primjerice, stenoze aorte ili plućne arterije).
English: Fortekor Plus contains two active substances, pimobendan and benazepril hydrochloride.
Croatian: Fortekor Plus sadrži dvije djelatne tvari, pimobendan i benazepril hidroklorid.
English: This is a summary of the European public assessment report (EPAR) for Fortekor Plus.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) veterinarsko-medicinskog proizvoda Fortekor Plus.
English: Both pimobendan and benazepril are already authorised for dogs as separate medicines.
Croatian: Pimobendan i benazepril već su odobreni za primjenu u pasa kao zasebni veterinarsko-medicinski proizvodi.
English: Pimobendan is an inotropic (heart stimulant) substance which increases the strength of the contraction of heart muscle and opens up blood vessels carrying blood to and from the heart, which reduces the work of the heart.
Croatian: Pimobendan je inotropna tvar (srčani stimulans) koja povećava jačinu kontrakcije srčanog mišića i otvara krvne žile koje prenose krv u srce i iz njega, čime se smanjuje rad srca.
English: Benazeprilat is an ‘angiotensin converting enzyme (ACE) inhibitor'.
Croatian: Benazeprilat je „inhibitor enzima koji konvertiraju angiotenzin (ACE)”.
English: It is only for use in dogs whose heart failure is already being controlled by the same doses of pimobendan and benazepril hydrochloride given as separate medicines.
Croatian: Koristi se samo za primjenu u pasa čije se zatajenje srca već kontrolira istim dozama pimobendana i benazepril hidroklorida koji se uzimaju zasebno.
English: For more information about treatment with Fortekor Plus, read the package leaflet (also part of the EPAR) or contact your veterinarian or pharmacist.
Croatian: Više informacija o terapiji VMP-om Fortekor Plus pročitajte u uputi o VMP-u (također dio EPAR-a), ili se obratite svom veterinaru ili ljekarniku.
English: What are the risks associated with Fortekor Plus?
Croatian: Koji su rizici povezani s veterinarsko-medicinskim proizvodom Fortekor Plus?
English: For the full list of all restrictions and side effects reported with Fortekor Plus, see the package leaflet.
Croatian: Potpuni popis svih ograničenja i nuspojava zabilježenih pri primjeni VMP-a Fortekor Plus potražite u uputi o lijeku.
English: How is Fortekor Plus used?
Croatian: Kako se Fortekor Plus koristi?
English: In a field study involving 67 dogs with congestive heart failure treatment with Fortekor Plus was compared to pimobendan and benazepril given as separate treatments.
Croatian: U terenskom ispitivanju kojim je obuhvaćeno 67 pasa s kongestivnim zatajenjem srca terapija VMP-om Fortekor Plus uspoređena je sa zasebnim terapijama pimobendanom i benazeprilom.
English: The study showed Fortekor Plus to be as effective as pimobendan and benazepril when given as separate treatments.
Croatian: U ispitivanju se pokazalo da je VMP Fortekor Plus podjednako djelotvoran kao pimobendan i benazepril kada ih se uzima kao zasebne terapije.
English: This allows the blood pressure to drop, reducing the load on the heart.
Croatian: Time se stvara manje opterećenje na srce, što dovodi do smanjenja krvnog tlaka.
English: For practical information about using Fortekor Plus, animal owners/keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Praktične informacije o primjeni VMP-a Fortekor Plus vlasnici životinja/uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti svom veterinaru ili ljekarniku.
English: It also must not be given to dogs with low blood pressure, low blood volume, low blood sodium levels or acute (short-term) kidney failure.
Croatian: Također se ne smije primjenjivati u pasa s hipotenzijom, hipovolemijom, hiponatrijemijom ili akutnim (kratkoročnim) zatajenjem bubrega.
English: Other information about Fortekor Plus
Croatian: Ostale informacije o veterinarsko-medicinskom proizvodu Fortekor Plus
English: Safety information has been included in the summary of product characteristics and the package leaflet for Fortekor Plus, including the appropriate precautions to be followed by healthcare professionals and animal owners/keepers.
Croatian: U sažetku opisa svojstava VMP-a kao i u uputi o VMP-u Fortekor Plus nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se veterinari te vlasnici životinja/uzgajivači trebaju pridržavati.
English: Pregnant women should take special care to avoid accidentally swallowing Fortekor Plus because angiotensin converting enzyme (ACE) inhibitors have been found to affect the unborn child during pregnancy.
Croatian: Plus jer je otkriveno da inhibitori enzima koji konvertiraju angiotenzin (ACE) utječu na nerođeno dijete tijekom trudnoće.
English: How does Fortekor Plus work?
Croatian: Kako djeluje Fortekor Plus?
English: What benefits of Fortekor Plus have been shown in studies?
Croatian: Koje su koristi veterinarsko-medicinskog proizvoda Fortekor Plus utvrđene u ispitivanjima?
English: 2 x 5 pre-filled syringes without safety device
Croatian: Put primjene Unutarnje pakiranje
English: Further information on Grasustek can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/grasustek.
Croatian: Više informacija o lijeku Grasustek dostupno je internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/grasustek.
English: What is Grasustek and what is it used for?
Croatian: Što je Grasustek i za što se koristi?
English: Severe neutropenia lasted just over one-and-a-half days on average with both medicines.
Croatian: Teška neutropenija trajala je u prosjeku malo dulje od 1,5 dana pri primjeni oba lijeka.
English: What measures are being taken to ensure the safe and effective use of Grasustek?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Grasustek?
English: This means that Grasustek is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Croatian: To znači da je Grasustek vrlo sličan drugom biološkom lijeku („referentnom lijeku”) koji je već odobren u EU-u.
English: Grasustek is given as a single dose of 6 mg injected under the skin at least 24 hours after the end of each cycle of cancer treatment.
Croatian: Lijek Grasustek daje se kao jedna doza od 6 mg koja se ubrizgava pod kožu najmanje 24 sata nakon završetka svakog ciklusa liječenja raka.
English: The most common side effect with Grasustek (which may affect more than 1 in 10 people) is pain in the bones.
Croatian: Najčešća nuspojava lijeka Grasustek (koja se može javiti u više od 1 na 10 osoba) jest bol u kostima.
English: Why is Grasustek authorised in the EU?
Croatian: Zašto je lijek Grasustek odobren u EU-u?
English: What are the risks associated with Grasustek?
Croatian: Koji su rizici povezani s lijekom Grasustek?
English: An overview of Grasustek and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Grasustek i zašto je odobren u EU-u
English: Grasustek is a ‘biosimilar medicine'.
Croatian: Grasustek je „biosličan lijek”.
English: Grasustek 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 Grasustek izdaje se samo na recept, a liječenje mora započeti i nadzirati liječnik s iskustvom u liječenju raka ili poremećaja krvi.
English: Side effects reported with Grasustek are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Grasustek pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: The reference medicine for Grasustek is Neulasta.
Croatian: Referentni lijek za Grasustek jest Neulasta.
English: Other information about Grasustek
Croatian: Ostale informacije o lijeku Grasustek
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Grasustek 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 kako je, u skladu sa zahtjevima EU-a za bioslične lijekove, utvrđeno da lijek Grasustek ima vrlo sličnu strukturu, čistoću i biološku aktivnost kao i lijek Neulasta te se u tijelu raspoređuje na isti način.
English: Because Grasustek is a biosimilar medicine, the studies on effectiveness and safety of pegfilgrastim carried out with Neulasta do not all need to be repeated for Grasustek.
Croatian: Budući da je lijek Grasustek biosličan lijek, ispitivanja učinkovitosti i sigurnosti primjene pegfilgrastima provedena za lijek Neulasta nije potrebno ponavljati za lijek Grasustek.
English: Therefore, the Agency's view was that, as for Neulasta, the benefits of Grasustek outweigh the identified risks and it can be authorised for use in the EU.
Croatian: Stoga je stav Agencije da, kao i kod lijeka Neulasta, koristi od lijeka Grasustek nadmašuju identificirane rizike te da lijek može biti odobren za primjenu u EU-u.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Grasustek 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 Grasustek nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: The safety of Grasustek 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 Grasustek i na temelju svih provedenih ispitivanja nuspojave lijeka smatraju se usporedivima s onima za referentni lijek Neulasta.
English: Grasustek 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: Grasustek nije namijenjen za primjenu u bolesnika oboljelih od raka krvi, kronične mijeloične leukemije ili mijelodisplastičnih sindroma (stanja kod kojih se stvara veliki broj abnormalnih krvnih stanica, koja se mogu razviti u leukemiju).
English: In addition, a study involving 248 patients who had chemotherapy after surgery for breast cancer showed that Grasustek was as effective as Neulasta in reducing the duration of neutropenia.
Croatian: Nadalje, ispitivanje koje obuhvatilo 248 bolesnika koji su prošli kemoterapiju nakon operativnog zahvata zbog raka dojke pokazalo je da je lijek Grasustek jednako učinkovit kao Neulasta u skraćivanju trajanja neutropenije.
English: The active substance in Grasustek, 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 Grasustek, pegfilgrastim, oblik je filgrastima, koji je vrlo sličan ljudskoj bjelančevini naziva faktor stimulacije rasta kolonije granulocita (G-CSF).
English: As for all medicines, data on the use of Grasustek are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Grasustek kontinuirano se prate.
English: For more information about using Grasustek, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Grasustek pročitajte uputu o lijeku odnosno obratite se liječniku ili ljekarniku.
English: All these data were considered sufficient to conclude that Grasustek 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 Grasustek za odobrene indikacije djelovati jednako kao lijek Neulasta u pogledu učinkovitosti i sigurnosti primjene.
English: In addition, studies in breast cancer patients undergoing chemotherapy have shown that the effectiveness of Grasustek in reducing the duration of neutropenia is equivalent to that of Neulasta.
Croatian: Nadalje, ispitivanja na bolesnicama oboljelima od raka dojke koje primaju kemoterapiju pokazala su da je učinkovitost lijeka Grasustek u skraćivanju trajanja neutropenije jednaka onoj lijeka Neulasta.
English: How does Grasustek work?
Croatian: Kako djeluje Grasustek?
English: What benefits of Grasustek have been shown in studies?
Croatian: Koje su koristi od lijeka Grasustek utvrđene u ispitivanjima?