FrancophonIA/ELRC3.0 huggingface dataset:
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Clopidogrel Teva Pharma.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Clopidogrel HCS.
English: • peripheral arterial disease (problems with blood flow in the arteries);
Croatian: • bolesnika s bolesti perifernih arterija (problemima s protokom krvi u arterijama);
English: The standard dose of Clopidogrel Teva Pharma is one 75-mg tablet once a day.
Croatian: Standardna doza lijeka Clopidogrel HCS je jedna tableta od 75 mg na dan.
English: This means that Clopidogrel Teva Pharma is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Croatian: To znači da je Clopidogrel HCS sličan „referentnom lijeku” koji je već odobren u Europskoj uniji pod nazivom Plavix.
English: Clopidogrel Teva Pharma can be started between seven days and six months after the stroke;
Croatian: Terapija lijekom Clopidogrel HCS može se započeti od sedam dana do šest mjeseci nakon udara;
English: It is used in those patients who have at least one risk factor for vascular events such as a heart attack or stroke, cannot take vitamin K antagonists (other medicines that prevent blood clots) and are at low risk of bleeding.
Croatian: Koristi se u bolesnika s najmanje jednim čimbenikom rizika za slučajeve poput infarkta miokarda ili moždanog udara koji ne mogu uzimati antagoniste vitamina K (druge lijekove koji sprječavaju krvne ugruške) i koji su izloženi niskom riziku od krvarenja.
English: Clopidogrel Teva Pharma can be started between a few days and 35 days after the attack;
Croatian: Terapija lijekom Clopidogrel HCS može se započeti od nekoliko dana do 35 dana nakon infarkta;
English: In acute coronary syndrome, treatment generally starts with a loading dose of four 75-mg tablets.
Croatian: U slučaju akutnog koronarnog sindroma, terapija načelno započinje dozom punjenja od četiri tablete.
English: What are the benefit and risk of Clopidogrel Teva Pharma?
Croatian: Koje su koristi i rizici lijeka Clopidogrel HCS?
English: The CHMP concluded that, in accordance with EU requirements, Clopidogrel Teva Pharma has been shown to have comparable quality and to be bioequivalent to Plavix.
Croatian: CHMP je zaključio da je, u skladu sa zahtjevima EU-a, potvrđeno kako Clopidogrel HCS posjeduje usporedivu kvalitetu te je bioekvivalentan lijeku Plavix.
English: Because Clopidogrel Teva Pharma is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine's.
Croatian: Budući da je Clopidogrel HCS generički lijek te je bioekvivalentan referentnom lijeku, smatra se da su njegovi koristi i rizici isti kao i oni referentnog lijeka.
English: This document is a summary of the European Public Assessment Report (EPAR) for Clopidogrel Teva Pharma.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Clopidogrel HCS.
English: • recently had an ischaemic stroke (stroke caused by failure of the blood supply to part of the brain).
Croatian: • bolesnika koji su nedavno pretrpjeli ishemijski moždani udar (udar uzrokovan neprimjerenom isporukom krvi u dio mozga).
English: Clopidogrel Teva Pharma is a ‘generic medicine'.
Croatian: Clopidogrel HCS je „generički lijek”.
English: The full EPAR for Clopidogrel Teva Pharma can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Clopidogrel HCS nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports Više informacija o terapiji lijekom Clopidogrel HCS pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel HCS on 21 September 2009.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Clopidogrel HCS na snazi u Europskoj uniji od 28. listopada 2010.
English: Because Clopidogrel Teva Pharma is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Croatian: Budući da je Clopidogrel HCS generički lijek, ispitivanja na bolesnicima bila su ograničena na ispitivanja za utvrđivanje je li lijek bioekvivalentan referentnom lijeku Plavix.
English: The active substance in Clopidogrel Teva Pharma, clopidogrel, is an inhibitor of platelet aggregation.
Croatian: Djelatna tvar lijeka Clopidogrel HCS, klopidogrel, jest inhibitor nakupljanja trombcita.
English: Clopidogrel Teva Pharma is used to prevent problems caused by blood clots in adults who have:
Croatian: Clopidogrel HCS se koristi u odraslih osoba za sprječavanje problema uzrokovanih krvnim ugrušcima.
English: Why has Clopidogrel Teva Pharma been approved?
Croatian: Zašto je Clopidogrel HCS odobren?
English: 1 Previously known as Clopidogrel HCS.
Croatian: Clopidogrel HCS
English: The Committee recommended that Clopidogrel Teva Pharma be given marketing authorisation.
Croatian: Odbor je preporučio izdavanje odobrenja za stavljanje u promet lijeka Clopidogrel HCS.
English: • a condition known as ‘acute coronary syndrome', when it should be given with aspirin (another medicine that prevents blood clots).
Croatian: • bolesnika s akutnim koronarnim sindromom (stanjem pri kojem se smanjuje isporuka krvi u srce), kada se treba primjenjivati s aspirinom (drugim lijekom koji sprječava krvne ugruške), uključujući bolesnike koji imaju ugrađen stent (kratku cijev koja se stavlja u arteriju i sprječava zatvaranje).
English: Clopidogrel Teva Pharma is a medicine that contains the active substance clopidogrel.
Croatian: Clopidogrel HCS je lijek za razrjeđivanje krvi koji sadrži djelatnu tvar klopidogrel.
English: Clopidogrel Teva Pharma clopidogrel
Croatian: klopidogrel
English: What is Clopidogrel Teva Pharma used for?
Croatian: Za što se Clopidogrel HCS koristi?
English: Other information about Clopidogrel Teva Pharma:
Croatian: Ostale informacije o lijeku Clopidogrel HCS
English: How has Clopidogrel Teva Pharma been studied?
Croatian: Kako je Clopidogrel HCS ispitivan?
English: How is Clopidogrel Teva Pharma used?
Croatian: Kako se Clopidogrel HCS koristi?
English: Acute coronary syndrome is a group of heart problems that include heart attacks and unstable angina (a severe type of chest pain).
Croatian: Može se također primjenjivati u bolesnika koji nemaju abnormalne rezultate EKG-a, ako imaju nestabilnu anginu (snažnu bol u prsima) ili ako su imali „non-Q” infarkt miokarda.
English: How does Clopidogrel Teva Pharma work?
Croatian: Kako djeluje Clopidogrel HCS?
English: What is Clopidogrel Teva Pharma?
Croatian: Što je Clopidogrel HCS?
English: Serious infections such as pneumonia, staphylococcal bacteraemia, sepsis/septic shock (including fatal outcomes) and herpes zoster, Cytomegalovirus (CMV) (reactivation) and opportunistic infections such as Pneumocystis jiroveci pneumonia and oral candidiasis have been reported in patients treated with brentuximab vedotin.
Croatian: U bolesnika liječenih brentuksimab vedotinom zabilježene su ozbiljne infekcije kao što su pneumonija, stafilokokna bakterijemija, sepsa/ septički šok (uključujući smrtne ishode) i herpes zoster, citomegalovirus (CMV) (reaktivacija) te oportunističke infekcije kao što su pneumonija uzrokovana s Pneumocystis jiroveci i oralna kandidijaza.
English: Brentuximab vedotin - Cytomegalovirus (CMV) reactivation (EPITT no 18789)
Croatian: Brentuksimab vedotin - reaktivacija citomegalovirusa (CMV) (EPITT br. 18799)
English: Adopted at the 2-5 May 2017 PRAC
Croatian: Usvojeno na sjednici PRAC-a 2. - 5. svibnja 2017.
English: New product information wording - Extracts from PRAC recommendations on signals EMA/PRAC/252868/2017
Croatian: Novi tekst informacija o lijeku - izvadci iz preporuka PRAC-a vezanih uz signale EMA/PRAC/306036/2017
English: Uncommon side effects (affects less than 1 in 100 people) - new or recurring cytomegalovirus (CMV) infection
Croatian: Manje česte nuspojave (javljaju se u manje od 1 na 100 osoba): - nova ili ponavljajuća infekcija citomegalovirusom (CMV)
English: Frequency ‘uncommon': Cytomegalovirus infection or reactivation
Croatian: Učestalost „manje često”: infekcija citomegalovirusom ili njegova reaktivacija
English: Package leaflet
Croatian: Nuspojave
English: Date of first authorisation: 18 September 2015
Croatian: Datum prvog odobrenja: 18. rujan 2015.
English: This leaflet was last revised in
Croatian: Ova uputa je zadnji puta revidirana u.
English: Read all of this leaflet carefully before you start receiving this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete uzimati ovaj lijek jer sadrži Vama važne podatke.
English: • Infection including sepsis
Croatian: • Infekcija, uključujući sepsu
English: The following information is intended for healthcare professionals only:
Croatian: Sljedeće informacije namijenjene su samo liječnicima i zdravstvenim radnicima:
English: U Nákladového nádraží 10 CZ-130 00 Praha 3
Croatian: Nákladového nádraží 10 CZ-130 00 Praha 3
English: Unopened vial 2 years
Croatian: Neotvorena bočica 2 godine.
English: *Definition of frequency terms: Very common - ≥ 10%; Common - > 5% and < 10%.
Croatian: * Definicije pojmova učestalosti: vrlo često - ≥ 10%; često - > 5% i < 10%.
English: UNIQUE IDENTIFIER - 2D BARCODE <2D barcode carrying the unique identifier included.>
Croatian: JEDINSTVENI IDENTIFIKATOR - 2D BARKOD Sadrži 2D barkod s jedinstvenim identifikatorom.
English: • Thirst and increased water consumption
Croatian: • Žeđanje i pojačano pijenje vode
English: • Increased skin pigmentation
Croatian: •Povećana pigmentacija kože
English: 1526 Ljubljana Slovenia
Croatian: 1526 Ljubljana Slovenija
English: If you are pregnant, think you may be pregnant or are planning to have a baby, tell your doctor.
Croatian: Ako ste trudni mislite da biste mogli biti trudni ili planirate imati dijete, obavijestite o tome svog liječnika.
English: Elderly: In clinical studies, there has been no indication that patients 65 years of age or older are at increased risk of adverse events compared to patients younger than 65 years old.
Croatian: Starije osobe: U kliničkim ispitivanjima nije bilo naznaka da bolesnici u dobi od 65 ili više godina imaju veći rizik nuspojava u usporedbi s bolesnicima mlađima od 65 godina.
English: Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Croatian: Obavijestite svog liječnika ili jekarnika ako uzimate ili ste nedavno uzeli bilo koje druge lijekove, uključujući lijekove koje ste nabavili bez recepta.
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) and not known (cannot be estimated from 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: Based on the planned date of your infusion of Pemetrexed Sandoz 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 Sandoz i/ili Vašoj bubrežnoj funkciji, liječnik Vam mora reći koje lijekove možete uzimati i kada ih možete uzimati.
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 je izuzela obvezu podnošenja rezultata ispitivanja pemetrekseda u svim podskupinama pedijatrijske populacije u odobrenim indikacijama (vidjeti dio 4.2).
English: Pharmacotherapeutic group: Antineoplastic agents, folic acid analogues, ATC code: L01BA04
Croatian: Farmakoterapijska skupina: Antineoplastici, analozi folatne kiseline, ATK oznaka: L01BA04
English: a Statistically significant for non-inferiority, with the entire confidence interval for HR well below the 1.17645 non-inferiority margin (p < 0.001).
Croatian: a Statistički značajan za neinferiornost, a cijeli interval pouzdanosti za HR nalazi se znatno ispod granice neinferiornosti od 1,17645 (p < 0,001).
English: • Some patients have experienced a heart attack, stroke or “mini-stroke” while receiving
Croatian: • Neki su bolesnici doživjeli srčani udar, moždani udar ili „mali moždani udar“ pri primjeni lijeka
English: Do not use Pemetrexed Sandoz: - if you are allergic (hypersensitive) to pemetrexed or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte primati lijek Pemetrexed Sandoz - ako ste alergični (preosjetljivi) na pemetreksed ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: A-4866 Unterach Austria
Croatian: 4866 Unterach
English: Between-patient variability in clearance is moderate at 19.3 %.
Croatian: Varijabilnost klirensa između pojedinih bolesnika je umjerena i iznosi 19,3%.
English: Bantry, Co. Cork, Ireland.
Croatian: Cork, Ireland.
English: • Pain, redness, swelling or sores in your mouth
Croatian: • Bol, crvenilo, oteklina ili ranice u ustima
English: Particular attention should be paid to these patients, and caution exercised with use of other radiosensitising agents.
Croatian: Treba obratiti posebnu pozornost na te bolesnike i uz oprez primjenjivati druge lijekove koji povećavaju osjetljivost na zračenje.
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: Many of the patients in whom these occurred had underlying risk factors for the development of renal events, including dehydration or pre-existing hypertension or diabetes.
Croatian: Mnogi bolesnici u kojih se to dogodilo imali su podležeće čimbenike rizika za razvoj bubrežnih događaja, uključujući dehidraciju, prethodno postojeću hipertenziju ili dijabetes.
English: Your doctor will discuss with you the potential risk of taking Pemetrexed Sandoz during pregnancy.
Croatian: Liječnik će s Vama razgovarati o mogućem riziku primjene lijeka Pemetrexed Sandoz u trudnoći.
English: Cisplatin is also given by infusion into one of your veins, and is given approximately 30 minutes after the infusion of Pemetrexed Sandoz has finished.
Croatian: Cisplatin se također primjenjuje infuzijom u jednu od vena i daje se približno 30 minuta nakon završetka infuzije lijeka Pemetrexed Sandoz.
English: Latvia filiāle K.Valdemāra iela 33-30 Rīga, LV1010
Croatian: Sandoz d..d Latvia filiāle K.Valdemāra iela 33-30 Rīga, LV1010
English: Creatinine clearance should be ≥ 45 ml/min.
Croatian: Klirens kreatinina mora biti  45 ml/min.
English: In clinical studies, patients with creatinine clearance of ≥ 45 ml/min required no dose adjustments other than those recommended for all patients.
Croatian: U kliničkim ispitivanjima u bolesnika s klirensom kreatinina  45 ml/min nisu bile potrebne druge prilagodbe doze osim onih preporučenih za sve bolesnike.
English: Pack of 1 vial with protective plastic overwrap.
Croatian: Pakiranje od 1 bočice sa zaštitnim plastičnim omotom.
English: • Low white blood cells
Croatian: • Nizak broj bijelih krvnih stanica
English: Log rank p-value*
Croatian: Log-rang p-vrijednost*
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: From a microbiological point of view, the product should be used immediately.
Croatian: S mikrobiološkog stajališta, razrijeđenu otopinu treba primijeniti odmah.
English: You will also receive an injection of vitamin B12 (1000 micrograms) in the week before administration of Pemetrexed Sandoz and then approximately every 9 weeks (corresponding to 3 courses of Pemetrexed Sandoz treatment).
Croatian: Također ćete dobiti injekciju vitamina B12 (1000 mikrograma) u tjednu prije primjene lijeka Pemetrexed Sandoz i zatim otprilike svakih 9 tjedana (što odgovara 3 ciklusa liječenja lijekom Pemetrexed Sandoz ).
English: 28023 (Aravaca) Madrid España
Croatian: Osa Mayor, nº 4 28023 (Aravaca) Madrid España
English: You must take at least 5 doses during the seven days before the first dose of Pemetrexed Sandoz.
Croatian: Morate uzeti barem 5 doza tijekom 7 dana prije prve doze lijeka Pemetrexed Sandoz.
English: • Radiation recall (a skin rash like severe sunburn) which can occur on skin that has previously been exposed to radiotherapy, from days to years after the radiation.
Croatian: • Radijacijski „recall“ dermatitis (kožni osip poput teške opekline od sunca) koji se može pojaviti na koži prethodno izloženoj zračenju, više dana ili više godina nakon zračenja.
English: OTHER SPECIAL WARNING(S), IF NECESSARY
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Citotoksično
English: Before each infusion you will have samples of your blood taken to evaluate if you have sufficient kidney and liver function and to check that you have enough blood cells to receive Pemetrexed Sandoz.
Croatian: Prije svake infuzije uzet će Vam se uzorak krvi kako bi se provjerilo jesu li Vam bubrežna ili jetrena funkcija dovoljno dobre i imate li dovoljno krvnih stanica da biste primili lijek Pemetrexed Sandoz.
English: It is a white to pale yellow lyophilised powder.
Croatian: To je bijeli do blijedožuti liofilizirani prašak.
English: • Taste change
Croatian: •Promjena okusa
English: Concomitant use not recommended: Live attenuated vaccines (except yellow fever, for which concomitant use is contraindicated): Risk of systemic, possibly fatal, disease.
Croatian: Ne preporučuje se istodobna primjena živih atenuiranih cjepiva (osim cjepiva protiv žute groznice, čija je istodobna primjena kontraindicirana), zbog rizika od sustavne bolesti koja može biti smrtonosna.
English: • Pancytopenia- combined low counts of white cells, red cells and platelets
Croatian: • Pancitopenija - udruženi nizak broj bijelih krvnih stanica, crvenih krvnih stanica i krvnih pločica)
English: Pemetrexed total systemic clearance is 91.8 ml/min and the elimination half-life from plasma is 3.5 hours in patients with normal renal function (creatinine clearance of 90ml/min).
Croatian: Ukupni sistemski klirens pemetrekseda iznosi 91,8 ml/min, a poluvrijeme eliminacije iz plazme iznosi 3,5 sati u bolesnika s normalnom bubrežnom funkcijom (klirens kreatinina 90 ml/min).
English: The use of Pemetrexed Sandoz should be avoided during pregnancy.
Croatian: Primjena lijeka Pemetrexed Sandoz mora se izbjegavati tijekom trudnoće.
English: Concomitant use contraindicated: Yellow fever vaccine: Risk of fatal generalised vaccinale disease (see section 4.3).
Croatian: Kontraindicirana je istodobna primjena cjepiva protiv žute groznice zbog rizika od smrtonosne generalizirane vakcinalne bolesti (vidjeti dio 4.3).
English: • Fever or infection (common): if you have a temperature of 38ºC or greater, sweating or other signs of infection(since you might have less white blood cells than normal which is very common).
Croatian: 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: A significant increase in the incidence of possibly study-drug-related Grade 3/4 neutropenia was observed with longer exposure to pemetrexed (≤ 6 cycles: 3.3 %, > 6 cycles: 6.4 %: p=0.046).
Croatian: Zabilježeno je značajno povećanje incidencije neutropenije stupnja 3/4, koja je mogla biti povezana s lijekom, pri duljoj izloženosti pemetreksedu (≤ 6 ciklusa: 3,3%, > 6 ciklusa: 6,4%; p = 0,046).
English: Thus, drainage of third-space fluid collection prior to pemetrexed treatment should be considered, but may not be necessary.
Croatian: Stoga prije početka liječenja pemetreksedom treba razmotriti drenažu tekućine iz transcelularnog prostora, no ona možda neće biti nužna.
English: • Allergic reaction: skin rash / burning or prickling sensation
Croatian: • Alergijska reakcija: kožni osip / osjećaj pečenja ili bockanja
English: Eesti filiaal Pärnu mnt105
Croatian: Sandoz d.d. Eesti filiaal Pärnu mnt105
English: Pemetrexed Sandoz is a medicine used in the treatment of cancer.
Croatian: Pemetrexed Sandoz je lijek koji se koristi za liječenje raka.
English: For precautions to be taken before handling or administering Pemetrexed Sandoz, see section 6.6.
Croatian: Za mjere opreza koje je potrebno poduzeti prije rukovanja ili primjene lijeka Pemetrexed Sandoz, vidjeti dio 6.6.
English: Dose for Cisplatin (mg/m2)
Croatian: Doza cisplatina (mg/m2)
English: • Conjunctivitis (inflamed eye)
Croatian: • Konjunktivitis (upala oka)
English: A total of 169 patients (47.1%) completed ≥ 6 cycles maintenance treatment with pemetrexed, representing at least 10 total cycles of pemetrexed.
Croatian: Ukupno je 169 (47,1%) bolesnika završilo ≥ 6 ciklusa terapije održavanja pemetreksedom, što znači da su primili najmanje 10 ciklusa pemetreksedom.
English: Pemetrexed Sandoz should be administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
Croatian: Pemetrexed Sandoz se mora primjenjivati u obliku intravenske infuzije u trajanju od 10 minuta prvog dana svakog 21-dnevnog ciklusa.
English: If you currently have or have previously had problems with your kidneys, talk to your doctor or hospital pharmacist as you may not be able to receive Pemetrexed Sandoz.
Croatian: Ako trenutno imate ili ste prethodno imali problema s bubrezima, obratite se svom liječniku ili bolničkom ljekarniku jer možda nećete smjeti primati lijek Pemetrexed Sandoz.
English: To be taken into consideration by patients on a controlled sodium diet.
Croatian: To treba uzeti u obzir u bolesnika koji su na dijeti s kontroliranim unosom natrija.
English: The dose of Pemetrexed Sandoz is 500 milligrams for every square metre of your body's surface area.
Croatian: Doza lijeka Pemetrexed Sandoz je 500 miligrama po svakom kvadratnom metru Vaše površine tijela.
English: Sandoz Farmacéutica, S.A. Centro Empresarial Osa Mayor Avda.
Croatian: Sandoz Farmacéutica, S.A. Centro Empresarial Osa Mayor
English: White to off-white or pale yellow lyophilised powder.
Croatian: Bijeli do gotovo bijeli ili blijedožuti liofilizirani prašak.
English: Treatment with Pemetrexed Sandoz should be discontinued if a patient experiences any haematologic or non-haematologic Grade 3 or 4 toxicity after 2 dose reductions or immediately if Grade 3 or 4 neurotoxicity is observed.
Croatian: Liječenje lijekom Pemetrexed Sandoz se mora obustaviti ako se u bolesnika pojavi bilo kakva hematološka ili nehematološka toksičnost stupnja 3 ili 4 nakon dvaju sniženja doze, odnosno odmah ako se ustanovi neurotoksičnost stupnja 3 ili 4.
English: Pemetrexed Sandoz can be prescribed to you if you have lung cancer at an advanced stage if your disease has responded to treatment or it remains largely unchanged after initial chemotherapy.
Croatian: Pemetrexed Sandoz Vam se može propisati ako imate rak pluća u uznapredovaloj fazi i ako je Vaša bolest reagirala na liječenje ili ostala uglavnom nepromijenjena nakon početne kemoterapije.