FrancophonIA/ELRC3.0 huggingface dataset:
English: An extended series of safety pharmacology studies with special emphasis on cardiovascular parameters showed no relevant changes in haemodynamic and ECG derived parameters (QTc) with the exception of a modest increase in heart rate and blood pressure observed in anaesthetised pigs after intravenous administration, and an increase in blood pressure in conscious dogs after bolus intravenous administration, which was not observed either in anaesthetised dogs or after oral administration in dogs reaching similar plasma levels.
Croatian: Izuzetak je umjereno povišenje srčane frekvencije i krvnog tlaka opaženo u anesteziranih svinja nakon intravenske primjene i povišenje krvnog tlaka u budnih pasa nakon intravenske bolus injekcije, koje nije bilo opaženo u anesteziranih pasa ili nakon peroralne primjene u pasa u kojih su postignute slične razine u plazmi.
English: - if you are on renal dialysis, - if you suffer from perforation or obstruction of the gut wall, severe inflammation of the intestinal tract, such as Crohn's disease, ulcerative colitis or toxic megacolon/megarectum.
Croatian: - Perforacija ili opstrukcija crijeva zbog strukturnog ili funkcionalnog poremećaja stijenke crijeva, opstruktivnog ileusa, teških upalnih stanja crijeva, kao što su Crohnova bolest i ulcerozni kolitis i toksični megakolon/megarektum.
English: System/Organ Class
Croatian: Klasifikacija organskih sustava
English: The proportion of female patients in whom laxatives fail to provide adequate relief treated with the recommended dose of 2 mg Resolor (n=458) that reached an average of ≥3 SCBM per week was 31.0% (week 4) and 24.7% (week 12), versus 8.6% (week 4) and 9.2% (week 12) on placebo.
Croatian: Udio žena u kojih laksativi nisu uspjeli osigurati odgovarajuće olakšanje liječenih preporučenom dozom od 2 mg lijeka Resolor (n = 458) koje su postigle prosječno ≥ 3 spontanih kompletnih pražnjenja crijeva na tjedan iznosio je 31,0% (4. tjedan) i 24,7% (12. tjedan), u usporedbi s 8,6% (4. tjedan) i 9,2% (12. tjedan) onih na placebu.
English: Resolor contains the active substance prucalopride.
Croatian: Resolor sadrži djelatnu tvar prukaloprid.
English: No dose adjustment is required for patients with mild to moderate hepatic impairment.
Croatian: Nije potrebna prilagodba doze u bolesnika s blagim do umjerenim oštećenjem funkcije bubrega.
English: The efficacy and safety of Resolor in paediatric patients (aged 6 months to 18 years) with functional constipation, were evaluated in an 8-week double-blind, placebo-controlled trial (N=213), followed by a 16 week open-label comparator-controlled (Polyethylene glycol 4000) study of up to 24 weeks (N=197).
Croatian: Djelotvornost i sigurnost lijeka Resolor u pedijatrijskim bolesnicima (u dobi od 6 mjeseci do 18 godina) s funkcionalnom konstipacijom procijenjene su u 8-tjednom dvostruko slijepom, placebom kontroliranom ispitivanju (N= 213), nakon čega je uslijedilo otvoreno ispitivanje kontrolirano s usporednim lijekom (polietilen glikol 4000) u trajanju do 24 tjedana (N= 197).
English: The following uncommon side effects have also been seen (may affect up to 1 in 100 people): tremors, pounding heart, rectal bleeding, increase in frequency of passing urine (pollakiuria), fever and feeling unwell.
Croatian: Opažene su i sljedeće manje česte nuspojave (mogu se javiti u do 1 na 100 osoba): nevoljno drhtanje, lupanje srca, krvarenje iz debelog crijeva, učestalo mokrenje (polakizurija), vrućica i loše osjećanje.
English: The following side effects have been reported commonly (may affect up to 1 in 10 people): decreased appetite, dizziness, vomiting, disturbed digestion (dyspepsia), windiness, abnormal bowel sounds, tiredness.
Croatian: Sljedeće nuspojave zabilježene su često (mogu se javiti u do 1 na 10 osoba): smanjen apetit, omaglica, povraćanje, probavne tegobe (dispepsija), vjetrovi, neprirodni probavni zvukovi, umor.
English: Furthermore, giant migrating contractions are induced by prucalopride.
Croatian: Nadalje, prukaloprid izaziva opsežne migrirajuće kontrakcije.
English: Extensive fluid loss by diarrhoea or vomiting may require correction of electrolyte disturbances.
Croatian: Korekcija poremećaja elektrolita može biti potrebna u slučaju opsežnog gubitka tekućine zbog proljeva ili povraćanja.
English: Excipients with known effect: Each film-coated tablet contains 156.75 mg lactose (as monohydrate).
Croatian: Jedna filmom obložena tableta sadrži 156,75 mg laktoze (u obliku monohidrata).
English: How to store Resolor
Croatian: Kako čuvati Resolor
English: Titanium dioxide (E171) Macrogol
Croatian: Ovojnica tablete hipromeloza laktoza hidrat triacetin titanijev dioksid (E171) makrogol
English: Date of first authorisation:15 October 2009 Date of latest renewal: 06 June 2014
Croatian: Datum prvog odobrenja:15. listopada 2009.
English: A dose of 1 mg is recommended in subjects with severe renal impairment (see section 4.2).
Croatian: U osoba s teškim oštećenjem funkcije bubrega preporučuje se doza od 1 mg (vidjeti dio 4.2).
English: A clinically meaningful improvement of ≥1 SCBM per week, the most important secondary efficacy endpoint, was achieved in 51.0% (week 4) and 44.2% (week 12) treated with 2 mg Resolor versus 21.7% (week 4) and 22.6% (week 12) of placebo patients.
Croatian: Klinički značajno poboljšanje od ≥ 1 spontanog kompletnog pražnjenja crijeva na tjedan, najvažnije sekundarne mjere ishoda djelotvornosti, postiglo je 51,0% (4. tjedan) i 44,2% (12. tjedan) bolesnika liječenih dozom od 2 mg lijeka Resolor u usporedbi s 21,7% (4. tjedan) i 22,6% (12. tjedan) bolesnika na placebu.
English: Resolor 2 mg film-coated tablets are pink round shaped tablets marked “PRU 2” on one side.
Croatian: Resolor 2 mg filmom obložene tablete ružičaste su, okrugle tablete s oznakom “PRU 2” na jednoj strani.
English: Marketing authorisation holder Shire Pharmaceuticals Ireland Limited Block 2 & 3 Miesian Plaza 50 - 58 Baggot Street Lower Dublin 2
Croatian: Nositelj odobrenja za stavljanje gotovog lijeka u promet Shire Pharmaceuticals Ireland Limited Block 2 & 3 Miesian Plaza
English: In vitro, only at concentrations exceeding its 5-HT4 receptor affinity by at least 150-fold, affinity for other receptors was detected.
Croatian: In vitro je otkriven afinitet za druge receptore, ali samo pri koncentracijama koje su bile 150 puta veće od njegovog afiniteta prema receptorima 5-HT4.
English: Pink, round, biconvex tablets marked “PRU 2” on one side.
Croatian: Ružičaste, okrugle, bikonveksne tablete s oznakom “PRU 2” na jednoj strani.
English: A subcutaneous neonatal/juvenile toxicity study performed in rats 7-55 days of age resulted in a NOAEL of 10 mg/kg/day.
Croatian: Ispitivanje neonatalne/juvenilne toksičnosti sa supkutanom primjenom na štakorima u dobi od 7 do 55 dana starosti rezultiralo je dozom bez zapaženog štetnog učinka (engl.
English: Similar results were observed at Week 12: 43.4%, 42.9%, and 31.7% respectively in 2 mg Resolor patients versus 26.9%, 27.2%, and 23.4% in placebo patients (p<0.001 vs placebo).
Croatian: Slični rezultati primijećeni su u 12. tjednu: 43,4%, 42,9% odnosno 31,7% u bolesnika na lijeku Resolor 2 mg naspram 26,9%, 27,2% odnosno 23,4% u bolesnika na placebu (p<0,001 naspram placeba).
English: At week 4, the proportion of patients with an improvement of ≥1 versus baseline in the PAC-SYM abdominal, stool, and rectal symptom subscales was 41.3%, 41.6%, and 31.3% respectively in patients treated with Resolor 2 mg compared with 26.9%, 24.4% and 22.9% in patients on placebo.
Croatian: U 4. tjednu, udio bolesnika s poboljšanjem od ≥1 naspram početne vrijednosti na PAC-SYM podljestvicama trbušnih simptoma, stolice i rektalnih simptoma bio je 41,3%, 41,6% odnosno 31,3% u bolesnika liječenih lijekom Resolor 2 mg u usporedbi s 26,9%, 24,4% odnosno 22,9% u bolesnika na placebu.
English: White to off-white, round, biconvex tablets marked “PRU 1” on one side.
Croatian: Bijele do bjelkaste, okrugle, bikonveksne tablete s oznakom “PRU 1” na jednoj strani.
English: Similar results were observed at Week 12: 46.9% in 2 mg Resolor patients versus 19.0% in placebo patients (p<0.001 vs placebo).
Croatian: Slični rezultati primijećeni su u 12. tjednu: 46,9% u bolesnika na lijeku Resolor 2 mg naspram 19,0% u bolesnika na placebu (p<0,001 naspram placebo).
English: The efficacy and safety of Resolor in patients (aged ≥18 or older) with chronic constipation, were evaluated in a 24 week multicentre, randomised, double-blind, placebo controlled study (N=361).
Croatian: Djelotvornost i sigurnost lijeka Resolor u bolesnika (u dobi od ≥18 godina) s kroničnom konstipacijom procijenjene su u multicentričnom, randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju u trajanju od 24 tjedana (N=361).
English: This study did not show significant differences between Resolor and placebo at either dose, based on mean QT measurements and outlier analysis.
Croatian: U ovom se ispitivanju, na temelju prosjeka izmjerenih QT vrijednosti i analize netipičnih vrijednosti (engl. outliers), nisu pokazale značajne razlike između lijeka Resolor i placeba ni kod jedne doze.
English: At Week 4, the proportion of patients with an improvement of ≥1 versus baseline in the Patient Assessment of Constipation-Quality of Life satisfaction subscale (PAC-QOL) was 47.7% in patients treated with Resolor 2 mg compared with 20.2% in patients on placebo.
Croatian: - Podljestvica zadovoljstva kvalitetom života (PACQOL) bio je 47,7% u bolesnika liječenih lijekom Resolor 2 mg u usporedbi s 20,2% u bolesnika na placebu.
English: At week 12, 68.3% of patients treated with 2 mg Resolor had an average increase of ≥1 SBM/week versus 37.0% of placebo patients (p<0.001 vs placebo).
Croatian: U 12. tjednu, 68,3% bolesnika liječenih s 2 mg lijeka Resolor imalo je prosječno povećanje od ≥1spontanog pražnjenja crijeva na tjedan u usporedbi s 37,0% bolesnika na placebu (p<0,001 naspram placeba).
English: The proportion of patients with an average weekly frequency of ≥3 Spontaneous Complete Bowel Movements (SCBMs) per week (i.e., responders) over the 24-week double-blind treatment phase was not statistically different (p=0.367) between the prucalopride (25.1%) and placebo (20.7%) treatment groups.
Croatian: Udio ispitanika s prosječnom tjednom učestalosti od tri ili više spontanih kompletnih pražnjenja crijeva na tjedan (tj. ispitanici koji su odgovorili na terapiju) u 24-tjednoj, dvostruko slijepoj fazi liječenja nije se statistički razlikovao (p=0,367) u skupini ispitanika liječenoj prukalopridom (25,1%) u usporedbi sa skupinom ispitanika koji su primali placebo (20,7%).
English: Iron oxide red (E172) Iron oxide yellow (E172) Indigo carmine aluminium lake (E132)
Croatian: Ovojnica tablete hipromeloza laktoza hidrat triacetin titanijev dioksid (E171) makrogol željezov oksid, crveni (E172) željezov oksid, žuti (E172) bojilo indigo karmin aluminum lake (E132)
English: Breast-feeding is not recommended during treatment with Resolor.
Croatian: Za vrijeme liječenja lijekom Resolor, dojenje se ne preporučuje.
English: The proportion of patients with an average weekly frequency of ≥3 Spontaneous Complete Bowel Movements (SCBMs) per week (i.e., responders) over the 24-week double-blind treatment phase was not statistically different (p=0.367) between the Resolor (25.1%) and placebo (20.7%) treatment groups.
Croatian: Udio ispitanika s prosječnom tjednom učestalosti od tri ili više spontanih kompletnih pražnjenja crijeva na tjedan (tj. ispitanici koji su odgovorili na terapiju) u 24-tjednoj, dvostruko slijepoj fazi liječenja nije se statistički razlikovao (p=0,367) u skupini ispitanika liječenoj lijekom Resolor (25,1%) u usporedbi sa skupinom ispitanika koji su primali placebo (20,7%).
English: Resolor 1 mg film-coated tablets Resolor 2 mg film-coated tablets prucalopride
Croatian: Resolor 1 mg filmom obložene tablete Resolor 2 mg filmom obložene tablete prukaloprid
English: Resolor 1 mg tablets prucalopride
Croatian: Resolor 1 mg tablete prukaloprid
English: Your doctor may also recommend a lower dose of one 1 mg tablet daily if you have severe kidney disease.
Croatian: Ako imate tešku bolest bubrega, liječnik Vam može preporučiti i dozu koja je niža od jedne tablete od 1 mg na dan.
English: Resolor 2 mg tablets prucalopride
Croatian: Resolor 2 mg tablete prukaloprid
English: Resolor 1 mg film-coated tablets.
Croatian: Resolor 1 mg filmom obložene tablete.
English: Metabolism and nutrition disorders
Croatian: Poremećaji metabolizma i prehrane često smanjen apetit
English: What Resolor looks like and contents of the pack Resolor 1 mg film-coated tablets are white to off-white round shaped tablets marked “PRU 1” on one side.
Croatian: Resolor 1 mg filmom obložene tablete bijele su do bjelkaste, okrugle tablete s oznakom “PRU 1” na jednoj strani.
English: One film-coated tablet of Resolor 1 mg contains 1 mg prucalopride (as succinate).
Croatian: Jedna filmom obložena tableta lijeka Resolor 1 mg sadrži 1 mg prukaloprida (u obliku prukalopridsukcinata).
English: One film-coated tablet of Resolor 2 mg contains 2 mg prucalopride (as succinate).
Croatian: Jedna filmom obložena tableta lijeka Resolor 2 mg sadrži 2 mg prukaloprida (u obliku prukalopridsukcinata).
English: Ear and labyrinth disorders
Croatian: Poremećaji uha i labirinta manje često vrtoglavica
English: Vertigo
Croatian: Janssen
English: Resolor 2 mg film-coated tablets
Croatian: Resolor 2 mg filmom obložene tablete
English: Resolor 1 mg film-coated tablets prucalopride
Croatian: Resolor 1 mg filmom obložene tablete prukaloprid
English: Resolor 2 mg film-coated tablets prucalopride
Croatian: Resolor 2 mg filmom obložene tablete prukaloprid
English: Prucalopride o.d. displays time-independent kinetics during prolonged treatment.
Croatian: Tijekom produljenog liječenja, prukaloprid primijenjen jedanput na dan pokazuje kinetiku neovisnu o vremenu.
English: Do not take Resolor: - if you are allergic to prucalopride or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati Resolor: - ako ste alergični na prukaloprid ili neki drugi sastojak ovog lijeka (naveden u dijelu 6), - ako ste na bubrežnoj dijalizi, - ako bolujete od perforacije (puknuća) ili opstrukcije (začepljenosti) crijeva ili teške upalne bolesti crijeva, kao što su Crohnova bolest, ulcerozni kolitis ili toksični megakolon/megarektum.
English: Each film-coated tablet contains 2 mg prucalopride (as succinate).
Croatian: Jedna filmom obložena tableta sadrži 2 mg prukaloprida (u obliku sukcinata).
English: Each film-coated tablet contains 1 mg prucalopride (as succinate)
Croatian: Jedna filmom obložena tableta sadrži 1 mg prukaloprida (u obliku prukalopridsukcinata)
English: Vomiting, dyspepsia, flatulence, gastrointestinal sounds abnormal
Croatian: Poremećaji probavnog sustava vrlo često mučnina, proljev, bol u trbuhu često povraćanje, dispepsija, flatulencija, neprirodni probavni zvukovi manje često rektalno krvarenje
English: Each film-coated tablet contains 2 mg prucalopride (as succinate)
Croatian: Jedna filmom obložena tableta sadrži 2 mg prukaloprida (u obliku prukalopridsukcinata)
English: Each film-coated tablet contains 1 mg prucalopride (as succinate).
Croatian: Jedna filmom obložena tableta sadrži 1 mg prukaloprida (u obliku prukalopridsukcinata).
English: EU/1/09/581/004 (7 tablets) EU/1/09/581/006 (14 tablets) EU/1/09/581/002 (28 tablets) EU/1/09/581/008 (84 tablets)
Croatian: EU/1/09/581/004 (7 tableta) EU/1/09/581/006 (14 tableta) EU/1/09/581/002 (28 tableta) EU/1/09/581/008 (84 tablete)
English: EU/1/09/581/001 (28 tablets) EU/1/09/581/003 (7 tablets) EU/1/09/581/005 (14 tablets) EU/1/09/581/007 (84 tablets)
Croatian: EU/1/09/581/001 (28 tableta) EU/1/09/581/003 (7 tableta) EU/1/09/581/005 (14 tableta) EU/1/09/581/007 (84 tablete)
English: EU/1/09/581/002 (28 tablets) EU/1/09/581/004 (7 tablets) EU/1/09/581/006 (14 tablets) EU/1/09/581/008 (84 tablets)
Croatian: EU/1/09/581/002 (28 tableta) EU/1/09/581/004 (7 tableta) EU/1/09/581/006 (14 tableta) EU/1/09/581/008 (84 tablete)
English: EU/1/09/581/003 (7 tablets) EU/1/09/581/005 (14 tablets) EU/1/09/581/001 (28 tablets) EU/1/09/581/007 (84 tablets)
Croatian: EU/1/09/581/003 (7 tableta) EU/1/09/581/005 (14 tableta) EU/1/09/581/001 (28 tableta) EU/1/09/581/007 (84 tablete)
English: An updated version of the Risk Management Plan will be submitted to National Competent Authorities within 3 months of the Commission Decision for this procedure, to reflect the updated information on the paediatric population as agreed by CHMP.
Croatian: Ažurirana verzija Plana upravljanja rizikom mora se podnijeti nacionalnim nadležnim tijelima unutar 3 mjeseca od Odluke Europske Komisije o ovome postupku, kako bi se uključile ažurirane informacije o pedijatrijskoj populaciji dogovorene od strane CHMP-a.
English: National Competent Authorities (NCAs), coordinated by the Reference Member State where applicable, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders (MAHs):
Croatian: Nacionalna nadležna tijela, koja po potrebi koordinira referentna država članica, moraju se pobrinuti da nositelji odobrenja ispune sljedeće uvjete:
English: Conditions of the marketing authorisations
Croatian: Uvjeti odobrenja
English: Pack of 1 vial is available in a box.
Croatian: Dostupno je pakiranje od 1 bočice u kutiji.
English: • Non-inferiority p-value (HR)
Croatian: • p-vrijednost za neinferiornost (HR)
English: This is equivalent to 2.7% of the recommended maximum daily dietary intake of sodium for an adult.
Croatian: To odgovara 2,7% preporučenog maksimalnog dnevnog unosa soli za odraslu osobu.
English: Randomised and treated patients
Croatian: Randomizirani i liječeni bolesnici
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not be longer than 24 hours at 2°C to 8°C.
Croatian: Ako se ne primijeni odmah, vrijeme i uvjeti čuvanja lijeka prije primjene odgovornost su korisnika i ne bi trebali biti dulji od 24 sata na temperaturi od 2°C do 8C.
English: Do not use Pemetrexed Krka - if you are allergic to pemetrexed or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati Pemetrexed Krka - ako ste alergični na pemetreksed ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Date of first authorisation: 22.
Croatian: Datum prvog odobrenja: 22. svibnja 2018.
English: Based on the planned date of your infusion of Pemetrexed Krka and/or on the status of your kidney function, your doctor needs to advise you on which medicines you can take and when you can take them.
Croatian: Ovisno o planiranom datumu primjene infuzije lijeka Pemetrexed Krka i/ili Vašoj bubrežnoj funkciji, liječnik Vam mora reći koje lijekove možete uzimati i kada ih možete uzimati.
English: Reconstituted and diluted solution
Croatian: Rekonstituirana i razrjeđena otopina
English: The results of these analyses of efficacy are summarised in the table below.
Croatian: Rezultati tih analiza djelotvornosti su sažeti u tablici koja slijedi.
English: ITT population (N=1725)
Croatian: ITT populacija (N=1725)
English: Your doctor will discuss with you the potential risk of taking Pemetrexed Krka during pregnancy.
Croatian: Liječnik će s Vama razgovarati o mogućem riziku primjene lijeka Pemetrexed Krka u trudnoći.
English: Frequency estimate: - Very common (1/10) - Common (1/100 to <1/10) - Uncommon (1/1,000 to <1/100) - Rare (1/10,000 to <1/1,000) - Very rare (<1/10,000) - Not known (cannot be estimated from the available data)
Croatian: Procjena učestalosti: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: What Pemetrexed Krka is and what it is used for
Croatian: Što je Pemetrexed Krka i za što se koristi
English: You will always receive Pemetrexed Krka by infusion into one of your veins.
Croatian: Pemetrexed Krka ćete uvijek primiti infuzijom u jednu od vena.
English: There are no data from the use of pemetrexed in pregnant women but pemetrexed, like other antimetabolites, is suspected to cause serious birth defects when administered during pregnancy.
Croatian: Nema podataka o primjeni pemetrekseda u trudnica, no sumnja se da pemetreksed, kao i ostali antimetaboliti, uzrokuje teške prirođene mane ako se primjenjuje tijekom trudnoće.
English: Each box contains one vial.
Croatian: Jedna kutija sadrži jednu bočicu.
English: See section 2 "Pemetrexed Krka contains sodium".
Croatian: Vidjeti dio 2. „Pemetrexed Krka sadrži natrij“.
English: The European Medicines Agency has waived the obligation to submit the results of studies with pemetrexed in all subsets of the paediatric population in the granted indications (see section 4.2).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja pemetrekseda u svim podskupinama pedijatrijske populacije za odobrene indikacije (vidjeti dio 4.2).
English: Warnings and precautions Talk to your doctor or hospital pharmacist before using Pemetrexed Krka.
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku ili bolničkom ljekarniku prije nego primite lijek Pemetrexed Krka.
English: Pharmacotherapeutic group: antineoplastic agents, folic acid analogues, ATC code: L01BA04.
Croatian: Farmakoterapijska skupina: antineoplastici, analozi folatne kiseline, ATK oznaka: L01BA04.
English: Cisplatin is also given by infusion into one of your veins, and is given approximately 30 minutes after the infusion of Pemetrexed Krka has finished.
Croatian: Cisplatin se također primjenjuje infuzijom u jednu od vena i daje se približno 30 minuta nakon završetka infuzije lijeka Pemetrexed Krka.
English: You must contact your doctor immediately if you notice any of the following: - Fever or infection (common): if you have a temperature of 38°C or greater, sweating or other signs of infection (since you might have less white blood cells than normal which is very common).
Croatian: Morate se odmah javiti svom liječniku ako primijetite bilo što od sljedećeg: - vrućicu ili infekciju (često): ako Vam je tjelesna temperatura 38°C ili viša, ako se znojite ili imate neke druge znakove infekcije (jer broj bijelih krvnih stanica može biti niži od normalnog, što je vrlo česta pojava).
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na djelatne tvari ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: - Allergic reaction: if you develop skin rash (very common) / burning or prickling sensation (common), or fever (common).
Croatian: - alergijska reakcija: ako dobijete osip na koži (vrlo često) / osjećaj pečenja ili bockanja (često) ili vrućicu (često).
English: What Pemetrexed Krka is and what it is used for What you need to know before you use Pemetrexed Krka How to use Pemetrexed Krka Possible side effects
Croatian: Što je Pemetrexed Krka i za što se koristi Što morate znati prije nego počnete uzimati Pemetrexed Krka Kako uzimati Pemetrexed Krka Moguće nuspojave
English: Alkaline phosphatase (AP), aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) should be ≤ 3-times upper limit of normal.
Croatian: Vrijednosti alkalne fosfataze (ALP), aspartat aminotransferaze (AST ili SGOT) i alanin aminotransferaze (ALT ili SGPT) moraju biti  3 puta iznad gornje granice normalnih vrijednosti.
English: *p-value refers to comparison between arms.
Croatian: * p-vrijednost se odnosi na usporedbu između dviju skupina bolesnika.
English: When using Pemetrexed Krka in combination with cisplatin:
Croatian: Kad se Pemetrexed Krka primjenjuje u kombinaciji s cisplatinom:
English: It is a white to either light yellow or green yellow lyophilized cake or powder.
Croatian: To je bijeli do svijetložuti ili zeleno-žuti liofilizirani kolačić ili prašak.
English: Concomitant use contraindicated Yellow fever vaccine: Risk of fatal generalised vaccinale disease (see section 4.3).
Croatian: Istodobna primjena koja je kontraindicirana Cjepivo protiv žute groznice: rizik od smrtonosne generalizirane vakcinalne bolesti (vidjeti dio 4.3).