FrancophonIA/ELRC3.0 huggingface dataset:
English: Tumour lysis syndrome (sometimes fatal) has been reported following the use of etoposide in association with other chemotherapeutic drugs.
Croatian: Sindrom lize tumora (ponekad sa smrtnim ishodom) zabilježen je nakon primjene etopozida s drugim kemoterapeuticima.
English: VEPESID and associated names should only be administered and monitored under the supervision of a qualified physician experienced in the use of anti-neoplastic medicinal products.
Croatian: Liječenje VEPESIDOM i pridruženim imenima smije se započeti i provoditi samo pod nadzorom kvalificiranog liječnika iskusnog u primjeni antineoplastičnih lijekova.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 50 mg etoposide
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna kapsula sadrži 50 mg etopozida Jedna kapsula sadrži 100 mg etopozida
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally] {Name and Address} <{tel}> <{fax}> <{e-mail}>
Croatian: 11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET [Vidjeti Prilog I.
English: Concomitant cisplatin therapy is associated with reduced total body clearance of etoposide.
Croatian: Istodobna primjena cisplatina povezana je sa sniženim ukupnim tjelesnim klirensom etopozida.
English: Sodium ethyl parahydroxybenzoate (E215) Sodium propyl parahydroxybenzoate (E217) Titanium dioxide (E171) Red iron oxide (E172)
Croatian: Ovojnica kapsule glicerol (85 postotni) (E422) želatina (E441) natrijev etilparahidroksibenzoat (E215) natrijev propilparahidroksibenzoat (E217) titanijev dioksid (E171) crveni željezov oksid (E172)
English: Haematological Toxicity
Croatian: Hematološka toksičnost
English: - The active substance is etoposide.
Croatian: - Djelatna tvar je etopozid.
English: Acute myeloid leukaemia
Croatian: Akutna mijeloična leukemija
English: SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Croatian: SAŽETAK OPISA SVOJSTAVA LIJEKA, OZNAČIVANJE I UPUTA O LIJEKU
English: In the paragraphs below the incidences of adverse events, given as the mean percent, are derived from studies that utilized single agent VEPESID and associated names therapy.
Croatian: U sljedećim odlomcima, incidencija nuspojava prikazana kao srednji postotak, dobivena je iz ispitivanja u kojima se VEPESID i pridružena imena koristio kao monoterapija.
English: The dose multiple (based on mg/m2 doses) for these findings at the no-observed adverse-effect-level in the preclinical studies were ≥ approximately
Croatian: Višekratnik doze (na osnovu doza u mg/m2) za te nalaze pri razini bez opaženog štetnog učinka u pretkliničkim ispitivanjima iznosio je ≥ približno 0,05 puta u usporedbi s najvišom kliničkom dozom.
English: Reports than 50,000 platelets/mm of fever and infection were also very common in patients with neutropenia treated with etoposide.
Croatian: Prijave vrućice i infekcije također su bile vrlo česte u bolesnika s neutropenijom liječenih etopozidom.
English: The predominant macromolecular effect of etoposide seems to be the rupture of the double strand by an interaction with DNA
Croatian: Čini se da je glavni makromolekularni učinak etopozida taj što izaziva pucanja dvostruke uzvojnice DNK interakcijom s DNK topoizomerazom II ili stvaranjem slobodnih radikala.
English: Care must be taken whenever handling cytostatic products.
Croatian: Oprez je nužan kod svakog rukovanja citostatičkim lijekovima.
English: Impaired hepatic function
Croatian: Oštećenje funkcije bubrega
English: [To be completed nationally]
Croatian: [Ispunjava država članica]
English: PHARMACEUTICAL FORM [To be completed nationally]
Croatian: 14. NAČIN IZDAVANJA LIJEKA [Ispunjava država članica]
English: • face and tongue swelling
Croatian: • oticanje lica i jezika
English: The effect of renal disease on plasma etoposide clearance is not known in children.
Croatian: Nije poznato kako bolest bubrega utječe na klirens etopozida iz plazme u djece.
English: • generally feeling unwell (malaise)
Croatian: • opća slabost (malaksalost)
English: • 0.47 mg of sodium propyl parahydroxybenzoate (E217).
Croatian: • 0,47 mg natrijevog propilparahidroksibenzoata (E217).
English: Do not open any <bottle> <blister> in which there is evidence of capsule leakage.
Croatian: Ne otvarati <bocu> <blister> ako su na njima vidljivi tragovi propuštanja kapsule.
English: Genetic consultation is recommended if the patient wishes to have children after ending the treatment.
Croatian: Bolesnicima koji nakon završetka liječenja žele imati djecu preporučuje se genetičko savjetovanje.
English: • 0.61 mg of sodium propyl parahydroxybenzoate (E217).
Croatian: • 0,61 mg natrijevog propilparahidroksibenzoata (E217).
English: 3) were seen in 22 to 41% and 1 to 20%, respectively, for etoposide.
Croatian: trombocita/mm3 zabilježene su kod 22 do 41%, odnosno 1 do 20% bolesnika, za etopozid.
English: Nadirs tend to occur earlier with intravenous administration compared to oral
Croatian: Najniže vrijednosti se ranije javljaju kod intravenske primjene u usporedbi s peroralnom primjenom.
English: What VEPESID and associated names contains
Croatian: Što VEPESID i pridružena imena sadrži
English: Reproductive system and breast disorders not known infertility
Croatian: Poremećaji reproduktivnog sustava i dojki nepoznato neplodnost
English: VEPESID and associated names contains sodium ethyl parahydroxybenzoate and sodium propyl parahydroxybenzoate
Croatian: VEPESID i pridružena imena sadrže natrijev etilparahidroksibenzoat i natrijev propilparahidroksibenzoat
English: - if you have had radiotherapy or chemotherapy recently.
Croatian: - ako imate bilo kakve infekcije. - ako ste nedavno primali radioterapiju ili kemoterapiju. - ako u krvi imate nisku razinu proteina pod nazivom albumin.
English: 56% (45% of the dose was excreted as etoposide) and faecal recovery of radioactivity was 44% of the administered dose at 120 hours.
Croatian: Nakon intravenske primjene 14C-etopozida (100 do 124 mg/m2 ), prosječna pronađena radioaktivnost u mokraći iznosila je 56% (45% doze se izlučilo u obliku etopozida) i pronađena radioaktivnost u stolici iznosila je 44% primijenjene doze nakon 120 sati.
English: • a change in the way things taste
Croatian: • promjena okusa
English: In children, elevated SGPT levels are associated with reduced drug total body clearance.
Croatian: U djece su povišene razine ALT-a povezane sa smanjenim ukupnim tjelesnim klirensom etopozida.
English: VEPESID and associated names is indicated for the treatment of platinum-resistant/refractory epithelial ovarian cancer in adults.
Croatian: VEPESID i pridružena imena indiciran je za liječenje rezistentnog na platinu/refraktornog epitelnog raka jajnika u odraslih.
English: Thrombocytopenia and severe thrombocytopenia (less
Croatian: Trombocitopenija i teška trombocitopenija (manje od 50 000
English: Metabolic acidosis and cases of serious hepatic toxicity have been reported in patients receiving higher than recommended intravenous doses of etoposide.
Croatian: U bolesnika koji su primali intravenske doze etopozida doze veće od preporučenih, prijavljene su metabolička acidoza i slučajevi ozbiljne hepatotoksičnosti.
English: The usual dose is 100 to 200 mg/m2 body surface area, daily for 5 days in a row or 200 mg/m2 body surface area on days 1, 3
Croatian: do 200 mg/m2 površine tijela na dan primijenjena tijekom 5 uzastopnih dana ili 200 mg/m2 površine tijela na dan primijenjena 1., 3. i 5. dana.
English: Each 100 mg capsule, soft contains:
Croatian: Jedna meka kapsula od 100 mg sadrži:
English: General disorders and administration site conditions very common asthenia, malaise rare pyrexia
Croatian: Opći poremećaji i reakcije na mjestu primjene vrlo često astenija, malaksalost rijetko pireksija
English: How to take VEPESID and associated names
Croatian: Kako uzimati VEPESID i pridružena imena
English: MARKETING AUTHORISATION NUMBER(S) [To be completed nationally]
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET [Ispunjava država članica]
English: Cross resistance between anthracyclines and etoposide has been reported in preclinical experiments.
Croatian: U pretkliničkim ispitivanjima zabilježena je križna rezistencija između antraciklina i etopozida.
English: DATE OF REVISION OF THE TEXT <{MM/YYYY}> <{DD/MM/YYYY}> <{DD month YYYY}> [To be completed nationally]
Croatian: <{MM/GGGG}> <{DD/MM/GGGG}> <{DD mjesec GGGG}>
English: Each soft capsule contains 50mg of etoposide
Croatian: Jedna meka kapsula sadrži 50 mg etopozida
English: VEPESID and associated names contains sodium ethyl parahydroxybenzoate and sodium propyl parahydroxybenzoate.
Croatian: VEPESID i pridružena imena sadrže natrijev etilparahidroksibenzoat i natrijev propilparahidroksibenzoat.
English: • feeling weak (asthenia)
Croatian: • osjećaj slabosti (astenija)
English: Citric acid, anhydrous (E330) Macrogol 400 (E1521) Glycerol (85 per cent) (E422) Water, purified
Croatian: Sadržaj kapsule citratna kiselina, bezvodna (E330) makrogol 400 (E1521) glicerol (85 postotni) (E422)
English: Each 50 mg capsule, soft contains:
Croatian: Jedna meka kapsula od 50 mg sadrži:
English: Vascular disorders common hypertension not known haemorrhage
Croatian: Krvožilni poremećaji često hipertenzija nepoznato krvarenje
English: Measured Creatinine Clearance
Croatian: Izmjereni klirens kreatinina
English: Each soft capsule contains 100mg of etoposide
Croatian: Jedna meka kapsula sadrži 100 mg etopozida
English: NAME OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally] Name
Croatian: NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET [Vidjeti Prilog I.
English: VEPESID and associated names should not be administered to patients with neutrophil counts less than 1,500 cell/mm3 or platelet counts less than 100,000cells/mm
Croatian: VEPESID i pridružena imena ne smiju se primjenjivati bolesnicima čiji je broj neutrofila manji od 1500 stanica/mm3 ili je broj trombocita manji od 100 000 stanica/mm3, osim ako je to uzrokovano malignom bolešću.
English: The usual dose of VEPESID and associated names administered orally is 100 to 200 mg/m2/day on days 1 to 5 or 200 mg/m2/day on days 1, 3 and 5 every 3 to 4 weeks in combination with other drugs approved for use in the disease to be treated.
Croatian: 2/dan primijenjeno 1., 3. i 5. dana svaka 3 do 4 tjedna u kombinaciji s 1. do 5. dana ili 200 mg/m drugim lijekovima odobrenima za liječenje te bolesti.
English: Bacterial infections should be brought under control before treatment with VEPESID and associated names.
Croatian: Prije liječenja VEPESIDOM i pridruženim imenima, bakterijske infekcije treba dovesti pod kontrolu.
English: VEPESID and associated names (see Annex I) 50 mg capsule, soft VEPESID and associated names (see Annex I) 100 mg capsule, soft
Croatian: VEPESID i pridružena imena (vidjeti Prilog I.) 50 mg meke kapsule VEPESID i pridružena imena (vidjeti Prilog I.) 100 mg meke kapsule etopozid
English: How to store VEPESID and associated names
Croatian: Kako čuvati VEPESID i pridružena imena
English: VEPESID and associated names is indicated in combination with other approved chemotherapeutic agents for the second line treatment of Hodgkin's lymphoma in adults.
Croatian: VEPESID i pridružena imena indiciran je u kombinaciji s drugim odobrenim kemoterapeuticima za drugu liniju liječenja Hodgkinovog limfoma u odraslih.
English: • 0.93 mg of sodium ethyl parahydroxybenzoate (E215) and
Croatian: • 0,93 mg natrijevog etilparahidroksibenzoata (E215) i
English: Etoposide may cause adverse reactions that affect the ability to drive and use machines such as fatigue, somnolence,
Croatian: Etopozid može uzrokovati nuspojave koje utječu na sposobnost upravljanja vozilima i rada sa strojevima, poput umora, somnolencije, mučnine, povraćanja, kortikalne sljepoće, reakcije preosjetljivosti s hipotenzijom.
English: INSTRUCTIONS ON USE [To be completed nationally]
Croatian: 15. UPUTE ZA UPORABU [Ispunjava država članica]
English: • 1.22 mg of sodium ethyl parahydroxybenzoate (E215) and
Croatian: • 1,22 mg natrijevog etilparahidroksibenzoata (E215) i
English: Do not open any blister in which there is evidence of capsule leakage.
Croatian: Ne otvarati blister ako su na njemu vidljivi tragovi propuštanja kapsule.
English: An 11q23 chromosome abnormality has been observed in some cases of secondary leukaemia in patients who have received epipodophyllotoxins.
Croatian: U nekim slučajevima sekundarne leukemije bolesnika koji su primali epipodofilotoksine primijećena je abnormalnost kromosoma 11q23.
English: Other side effects experienced with VEPESID and associated names that are;
Croatian: Ostale nuspojave VEPESIDA i pridruženih imena;
English: Do not open any bottle in which there is evidence of capsule leakage.
Croatian: Ne otvarati bočicu ako su na njoj vidljivi tragovi propuštanja kapsule.
English: VEPESID and associated names is indicated in combination with other approved chemotherapeutic agents for the treatment of relapsed or refractory acute myeloid leukaemia in adults.
Croatian: VEPESID i pridružena imena indiciran je u kombinaciji s drugim odobrenim kemoterapeuticima za liječenje relapsa ili refraktorne akutne mijeloične leukemije u odraslih.
English: • flushing
Croatian: • omaglica
English: VEPESID and associated names is indicated in combination with other approved chemotherapeutic agents for the treatment of recurrent or refractory testicular cancer in adults.
Croatian: VEPESID i pridružena imena indiciran je u kombinaciji s drugim odobrenim kemoterapeuticima za liječenje recidiva ili refraktornog raka testisa u odraslih.
English: VEPESID and associated names is indicated in combination with other approved chemotherapeutic agents for the treatment of relapsed or refractory non-Hodgkin's lymphoma in adults.
Croatian: VEPESID i pridružena imena indiciran je u kombinaciji s drugim odobrenim kemoterapeuticima za liječenje relapsa ili refraktornog non-Hodgkinovog limfoma u odraslih.
English: VEPESID and associated names is indicated in combination with other approved chemotherapeutic agents for the treatment of small-cell lung cancer in adults.
Croatian: VEPESID i pridružena imena indiciran je u kombinaciji s drugim odobrenim kemoterapeuticima za liječenje raka pluća malih stanica u odraslih.
English: Dose limiting bone marrow suppression is the most significant toxicity associated with VEPESID and associated names therapy.
Croatian: Najznačajnija toksičnost povezana s terapijom VEPESIDOM i pridruženim imenima je supresija koštane srži koja ograničava dozu.
English: common acute leukaemia
Croatian: često akutna leukemija
English: OTHER Cytotoxic.
Croatian: DRUGO Citotoksično.
English: The following adverse reactions were reported from VEPESID and associated names clinical studies and post-marketing experience.
Croatian: U kliničkim ispitivanjima i nakon stavljanja lijeka u promet, prijavljene su sljedeće nuspojave VEPESIDA i pridruženih imena.
English: [See Annex 1 - To be completed nationally]
Croatian: <[Vidjeti Prilog I.
English: • acid reflux
Croatian: • navale crvenila
English: VEPESID and associated names 50mg Soft Capsules VEPESID and associated names 100mg Soft Capsules [See Annex I - To be completed nationally]
Croatian: VEPESID i pridružena imena 50 mg meke kapsule VEPESID i pridružena imena 100 mg meke kapsule [Vidjeti Prilog I.
English: VEPESID and associated names contains
Croatian: VEPESID i pridružena imena
English: • diarrhoea
Croatian: • neplodnost
English: • bleeding
Croatian: • krvarenje
English: VEPESID and associated names is indicated in combination with other approved chemotherapeutic agents for the treatment of non-epithelial ovarian cancer in adults.
Croatian: VEPESID i pridružena imena indiciran je u kombinaciji s drugim odobrenim kemoterapeuticima za liječenje neepitelnog raka jajnika u odraslih.
English: VEPESID and associated names (see Annex 1) 50 mg capsule, soft VEPESID and associated names (see Annex 1) 100 mg capsule, soft [See Annex I - To be completed nationally]
Croatian: VEPESID i pridružena imena (vidjeti Prilog I.) 50 mg meke kapsule VEPESID i pridružena imena (vidjeti Prilog I.) 100 mg meke kapsule [Vidjeti Prilog I.
English: Fatal myelosuppression has been reported following etoposide administration.
Croatian: Zabilježena je mijelosupresija sa smrtnim ishodom nakon primjene etopozida.
English: • sleepiness or tiredness
Croatian: • pospanost ili umor • problemi s disanjem
English: - If you get any side effects, talk to your doctor or pharmacist.
Croatian: - Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnikom ili ljekarnika.
English: Dose of Etoposide
Croatian: Doza etopozida
English: Nausea and vomiting are the major gastrointestinal toxicities of etoposide.
Croatian: Glavne gastrointestinalne toksičnosti etopozida su mučnina i povraćanje.
English: • dizziness
Croatian: I DOHVATA
English: PACKAGE LEAFLET
Croatian: Tablični sažetak nuspojava
English: Breastfeeding
Croatian: Dojenje
English: • breathing problems
Croatian: • bolovi u trbuhu
English: Capsule content
Croatian: Oštećenje jetre
English: • damage to the liver (hepatotoxicity) Common side effects (affecting between 1 in 10 and 1 in 100 people)
Croatian: Česte nuspojave (mogu se javiti kod između 1 na 10 i 1 na 100 osoba) • akutna leukemija
English: You must not breastfeed while you are taking VEPESID and associated names.
Croatian: Tijekom uzimanja VEPESIDA i pridruženih imena, ne smijete dojiti.
English: Frequency Adverse Reaction (MedDRA Terms)
Croatian: Nuspojava (pojmovi po MedDRA-i)
English: The MTD was not reached.
Croatian: MTD nije dosegnut.
English: Representative risk factors for these analyses were:
Croatian: Reprezentativni čimbenici rizika za te analize bili su:
English: Death without either prior progression or more than one missed assessment visit.
Croatian: Smrt bez prethodne progresije ili više od jednog propuštenog posjeta procjene.
English: The dose of this medicine depends on your body weight.
Croatian: Doza ovog lijeka ovisi o Vašoj tjelesnoj težini.
English: Events are death due to any cause.
Croatian: Slučajevi se odnose na smrt bilo kojeg uzroka.
English: Decreased appetite
Croatian: Smanjen apetit
English: • Two or more prior salvage therapies.
Croatian: • Dvije ili više prethodnih terapija spasa.
English: A risk to the newborn/infant cannot be excluded.
Croatian: Rizik za novorođenče/dojenče ne može se isključiti.
English: Date of first authorisation: 25 October 2012
Croatian: Datum prvog odobrenja: 25. listopada 2012.
English: Exposures were approximately dose proportional.
Croatian: Izloženost je bila približno proporcionalna dozi.
English: The safety and efficacy of ADCETRIS in children less than 18 years have not yet been established.
Croatian: Sigurnost i djelotvornost lijeka ADCETRIS u djece mlađe od 18 godina nisu još ustanovljene.
English: Indicates results from non-stratified analysis.
Croatian: Označava rezultate nestratificirane analize.
English: In this study in 36 patients, no new safety concerns were reported.
Croatian: U ovom ispitivanju provedenom na 36 bolesnika nisu zabilježena nova sigurnosna pitanja.
English: In general, these types of reactions occur within minutes to several hours following completion of the infusion.
Croatian: Općenito, ove vrste reakcija nastaju u roku od nekoliko minuta do nekoliko sati nakon završetka infuzije.
English: Continue with the same dose and schedule
Croatian: Nastavite s istom dozom i rasporedom
English: You and your partner must use two methods of effective contraception during your treatment with this medicine.
Croatian: Vi i Vaš partner morate koristiti dvije učinkovite metode kontracepcije tijekom Vašeg liječenja ovim lijekom.
English: Infusion reactions to this medicine may affect more than 1 in 10 people.
Croatian: Reakcije na infuziju ovog lijeka mogu se javiti u više od 1 na 10 osoba.
English: This leaflet was last revised in
Croatian: Ova uputa je zadnji puta revidirana
English: Thus, it is not likely to have any substantial contribution to the systemic effects of MMAE.
Croatian: Stoga je malo vjerojatno da ima bilo kakav značajan doprinos sistemskim učincima MMAE.
English: Grade 1 (paraesthesia and/or loss of reflexes, with no loss of function)
Croatian: Stupanj 1 (parestezija i/ili gubitak refleksa, bez gubitka funkcije)
English: Number of deaths c
Croatian: Broj smrtnih slučajeva c
English: It is not for use in children.
Croatian: Nije namijenjen za primjenu u djece.
English: However, they may develop more than several hours after completion of the infusion but this is uncommon.
Croatian: Međutim, mogu nastati i više od nekoliko sati nakon završetka infuzije ali to je manje često.
English: This includes herbal medicines and other medicines you can obtain without a prescription.
Croatian: To uključuje biljne lijekove i druge lijekove koji se mogu nabaviti bez recepta.
English: Gastrointestinal complications
Croatian: Gastrointestinalne komplikacije
English: Serious infections and opportunistic infections
Croatian: Ozbiljne infekcije i oportunističke infekcije
English: This being a conditional marketing authorisation and pursuant to Article 14(7) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:
Croatian: Budući je ovo uvjetno odobrenje, a temeljem članka 14(7) Uredbe (EZ) br. 726/2004, nositelj odobrenja će, unutar navedenog vremenskog okvira, dovršiti sljedeće mjere:
English: Insomnia a.
Croatian: Nesanica a.
English: The dosing recommendations for patients aged 65 and older are the same as for adults.
Croatian: Preporuke za doziranje za bolesnike u dobi od 65 i više godina iste su kao i za odrasle osobe.
English: If you feel unwell during treatment then do not drive or operate machines.
Croatian: Ako se ne osjećate dobro tijekom liječenja, nemojte upravljati vozilima niti raditi sa strojevima.
English: Determining dosage amount:
Croatian: Određivanje količine doze:
English: Stratified log-rank test was not performed for PFS per Investigator.
Croatian: Stratificirani log-rang test nije učinjen za PFS po ispitivaču.
English: Skin only
Croatian: Samo koža
English: Previously Untreated HL
Croatian: Prethodno neliječeni HL
English: The safety and efficacy results in these studies were consistent with results in Study C25001.
Croatian: Rezultati sigurnosti i djelotvornosti u ovim ispitivanjima bili su sukladni rezultatima ispitivanja C25001.
English: See section 2 for further information about sodium.
Croatian: Vidjeti dio 2 za dodatne informacije o natriju.
English: The results of these post-hoc analyses suggest increased clinical benefit for patients with two or more risk factors but no difference based on any of the individual risk factors.
Croatian: Rezultati ovih post-hoc analiza sugeriraju povećanu kliničku korist u bolesnika s dva ili više rizičnih čimbenika, ali ne i razliku temeljenu na bilo kojem od pojedinačnih rizičnih čimbenika.
English: Date of renewal: 10 September 2018
Croatian: Datum posljednje obnove odobrenja: 10. rujna 2018.
English: Discontinue treatment a.
Croatian: Prekinite liječenje a.
English: Number of patients with disease progression or death a
Croatian: Broj bolesnika s progresijom bolesti ili smrću a
English: Serious cases of hepatotoxicity, including fatal outcomes, have also occurred.
Croatian: Bilo je i ozbiljnih slučajeva hepatotoksičnosti, uključujući smrtne ishode.
English: Lonza AG Lonzastrasse 3930 Visp Switzerland
Croatian: Lonza AG Lonzastrasse 3930 Visp Švicarska
English: If you are an older patient (≥ 65 years of age) you may experience serious adverse events more frequently.
Croatian: Ako ste starija osoba (≥ 65 godina) mogli biste češće razviti ozbiljne nuspojave.
English: If you have these symptoms prior to treatment with this medicine, tell your doctor immediately about any changes in these symptoms.
Croatian: Ako imate ove simptome i prije započinjanja liječenja ovim lijekom, odmah obavijestite liječnika o svakoj promjeni u ovim simptomima.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Croatian: Zbog nedostatka ispitivanja kompatibilnosti ovaj lijek se ne smije miješati s drugim lijekovima osim onih navedenih u dijelu 6.6.