FrancophonIA/ELRC3.0 huggingface dataset:
English: 1 pre-filled syringe with 0.6 ml solution for injection contains 2 000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Croatian: 1 napunjena štrcaljka s 0,6 ml otopine za injekciju sadrži 2000 internacionalnih jedinica (IU) epoetina zeta (rekombinantni humani eritropoetin).
English: Retacrit 1 000 IU/0.3 ml solution for injection in pre-filled syringe
Croatian: Retacrit 1000 IU/0,3 ml otopina za injekciju u napunjenoj štrcaljki
English: 1 pre-filled syringe contains 1 000 IU epoetin zeta.
Croatian: 1 napunjena štrcaljka sadrži 1000 IU epoetina zeta.
English: A less defined profile was observed for RBCs and haemoglobin.
Croatian: Za crvene krvne stanice i hemoglobin, profil krivulje bio je slabije definiran.
English: Retacrit 40 000 IU/1 ml solution for injection in pre-filled syringe EU/1/07/431/019 1 pre-filled syringe EU/1/07/431/024 4 pre-filled syringes EU/1/07/431/025 6 pre-filled syringes EU/1/07/431/044 1 pre-filled syringe with needle guard EU/1/07/431/049 4 pre-filled syringes with needle guard EU/1/07/431/050 6 pre-filled syringes with needle guard EU/1/07/431/053 4 (4 x 1) pre-filled syringes (multipack) EU/1/07/431/076 1 pre-filled syringe with needle-trap
Croatian: Retacrit 40 000 IU/1 ml otopina za injekciju u napunjenoj štrcaljki EU/1/07/431/019 1 napunjena štrcaljka EU/1/07/431/024 4 napunjene štrcaljke EU/1/07/431/025 6 napunjenih štrcaljki EU/1/07/431/044 1 napunjena štrcaljka sa štitnikom za iglu EU/1/07/431/049 4 napunjene štrcaljke sa štitnikom za iglu EU/1/07/431/050 6 napunjenih štrcaljki bez štitnika za iglu EU/1/07/431/053 4 (4 x 1) napunjene štrcaljke (višestruko pakiranje) EU/1/07/431/076 1 napunjena štrcaljka s klopkom za iglu EU/1/07/431/077 4 napunjene štrcaljke s klopkom za iglu EU/1/07/431/078 6 napunjenih štrcaljki bez klopke za iglu
English: 1 pre-filled syringe without needle guard containing 1 ml solution for injection 6 pre-filled syringes without needle guard containing 1 ml solution for injection 1 pre-filled syringe with needle guard containing 1 ml solution for injection 6 pre-filled syringes with needle guard containing 1 ml solution for injection 1 pre-filled syringe with needle-trap containing 1 ml solution for injection 6 pre-filled syringes with needle-trap containing 1 ml solution for injection
Croatian: 1 napunjena štrcaljka bez štitnika za iglu s 1 ml otopine za injekciju 6 napunjenih štrcaljki bez štitnika za iglu s 1 ml otopine za injekciju 1 napunjena štrcaljka sa štitnikom za iglu s 1 ml otopine za injekciju 6 napunjenih štrcaljki sa štitnikom za iglu s 1 ml otopine za injekciju 1 napunjena štrcaljka s klopkom za iglu s 1 ml otopine za injekciju 6 napunjenih štrcaljki s klopkom za iglu s 1 ml otopine za injekciju
English: 1 pre-filled syringe without needle guard containing 0.3 ml solution for injection 6 pre-filled syringes without needle guard containing 0.3 ml solution for injection 1 pre-filled syringe with needle guard containing 0.3 ml solution for injection 6 pre-filled syringes with needle guard containing 0.3 ml solution for injection 1 pre-filled syringe with needle-trap containing 0.3 ml solution for injection 6 pre-filled syringes with needle-trap containing 0.3 ml solution for injection
Croatian: 1 napunjena štrcaljka bez štitnika za iglu s 0,3 ml otopine za injekciju 6 napunjenih štrcaljki bez štitnika za iglu s 0,3 ml otopine za injekciju 1 napunjena štrcaljka sa štitnikom za iglu s 0,3 ml otopine za injekciju 6 napunjenih štrcaljki sa štitnikom za iglu s 0,3 ml otopine za injekciju 1 napunjena štrcaljka s klopkom za iglu s 0,3 ml otopine za injekciju 6 napunjenih štrcaljki s klopkom za iglu s 0,3 ml otopine za injekciju
English: 1 pre-filled syringe without needle guard containing 0.6 ml solution for injection 6 pre-filled syringes without needle guard containing 0.6 ml solution for injection 1 pre-filled syringe with needle guard containing 0.6 ml solution for injection 6 pre-filled syringes with needle guard containing 0.6 ml solution for injection 1 pre-filled syringe with needle-trap containing 0.6 ml solution for injection 6 pre-filled syringes with needle-trap containing 0.6 ml solution for injection
Croatian: 1 napunjena štrcaljka bez štitnika za iglu s 0,6 ml otopine za injekciju 6 napunjenih štrcaljki bez štitnika za iglu s 0,6 ml otopine za injekciju 1 napunjena štrcaljka sa štitnikom za iglu s 0,6 ml otopine za injekciju 6 napunjenih štrcaljki sa štitnikom za iglu s 0,6 ml otopine za injekciju 1 napunjena štrcaljka s klopkom za iglu s 0,6 ml otopine za injekciju 6 napunjenih štrcaljki s klopkom za iglu s 0,6 ml otopine za injekciju
English: Retacrit 3 000 IU/0.9 ml solution for injection in pre-filled syringe Pre-filled syringe Type I glass with a fixed steel injection needle and a plunger stopper with PTFE coating with or without a needle guard or needle-trap device.
Croatian: Retacrit 3000 IU/0,9 ml otopina za injekciju u napunjenoj štrcaljki Napunjena štrcaljka od stakla tipa I, s pričvršćenom čeličnom iglom za injekciju i čepom klipa obloženim politetrafluoroetilenom (PTFE-om) sa ili bez štitnika za iglu ili s klopkom za iglu.
English: Excipients with known effect Each pre-filled syringe contains 0.50 mg phenylalanine.
Croatian: Pomoćne tvari s poznatim učinkom Jedna napunjena štrcaljka sadrži 0,50 mg fenilalanina.
English: Retacrit 40 000 IU/1 ml solution for injection in pre-filled syringe Pre-filled syringe Type I glass with a fixed steel injection needle and a plunger stopper with PTFE coating with or without a needle guard or needle-trap device.
Croatian: Retacrit 40 000 IU/1 ml otopina za injekciju u napunjenoj štrcaljki Napunjena štrcaljka od stakla tipa I, s pričvršćenom čeličnom iglom za injekciju i čepom klipa obloženim politetrafluoroetilenom (PTFE-om) sa ili bez štitnika za iglu ili s klopkom za iglu.
English: If you get any side effects, talk to your doctor, pharmacist or nurse.
Croatian: - Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ljekarnika ili medicinsku sestru.
English: Retacrit 2 000 IU/0.6 ml solution for injection in pre-filled syringe EU/1/07/431/003 1 pre-filled syringe EU/1/07/431/004 6 pre-filled syringes EU/1/07/431/028 1 pre-filled syringe with needle guard EU/1/07/431/029 6 pre-filled syringes with needle guard EU/1/07/431/056 1 pre-filled syringe with needle-trap EU/1/07/431/057 6 pre-filled syringes with needle-trap
Croatian: Retacrit 2000 IU/0,6 ml otopina za injekciju u napunjenoj štrcaljki EU/1/07/431/003 1 napunjena štrcaljka EU/1/07/431/004 6 napunjenih štrcaljki EU/1/07/431/028 1 napunjena štrcaljka sa štitnikom za iglu EU/1/07/431/029 6 napunjenih štrcaljki bez štitnika za iglu EU/1/07/431/056 1 napunjena štrcaljka s klopkom za iglu EU/1/07/431/057 6 napunjenih štrcaljki bez klopke za iglu
English: Retacrit 30 000 IU injection epoetin zeta
Croatian: Retacrit 30 000 IU injekcija epoetin zeta i.v./s.c.
English: Adults scheduled for major orthopaedic surgery
Croatian: Odrasli u kojih se planira velika ortopedska operacija
English: Retacrit 6 000 IU/0.6 ml solution for injection in pre-filled syringe Pre-filled syringe Type I glass with a fixed steel injection needle and a plunger stopper with PTFE coating with or without a needle guard or needle-trap device.
Croatian: Retacrit 6000 IU/0,6 ml otopina za injekciju u napunjenoj štrcaljki Napunjena štrcaljka od stakla tipa I, s pričvršćenom čeličnom iglom za injekciju i čepom klipa obloženim politetrafluoroetilenom (PTFE-om) sa ili bez štitnika za iglu ili s klopkom za iglu.
English: In clinical trials, an increased risk of death and serious cardiovascular events was observed when ESAs were administered to achieve a haemoglobin concentration level of greater than 12 g/dL (7.5 mmol/L).
Croatian: U bolesnika s kroničnim zatajenjem bubrega, održavana koncentracija hemoglobina ne smije prelaziti gornju granicu raspona koncentracije hemoglobina preporučenog u dijelu 4.2. U kliničkim ispitivanjima opažen je povećan rizik od smrti i ozbiljnih kardiovaskularnih događaja kada su za postizanje razine koncentracije hemoglobina veće od 12 g/dl (7,5 mmol/l) primjenjivani ESA lijekovi.
English: Retacrit 10 000 IU/1 ml solution for injection in pre-filled syringe Pre-filled syringe Type I glass with a fixed steel injection needle and a plunger stopper with PTFE coating with or without a needle guard or needle-trap device.
Croatian: Retacrit 10 000 IU/1 ml otopina za injekciju u napunjenoj štrcaljki Napunjena štrcaljka od stakla tipa I, s pričvršćenom čeličnom iglom za injekciju i čepom klipa obloženim politetrafluoroetilenom (PTFE-om) sa ili bez štitnika za iglu ili s klopkom za iglu.
English: Retacrit 4 000 IU injection epoetin zeta
Croatian: Retacrit 4000 IU injekcija epoetin zeta i.v./s.c.
English: Retacrit 2 000 IU/0.6 ml solution for injection in pre-filled syringe
Croatian: Retacrit 2000 IU/0,6 ml otopina za injekciju u napunjenoj štrcaljki
English: Retacrit 2 000 IU injection epoetin zeta
Croatian: Retacrit 2000 IU injekcija epoetin zeta i.v./s.c.
English: It is important to tell your doctor if any of the following apply to you.
Croatian: Ako se nešto od sljedećeg odnosi na Vas, važno je da to kažete svom liječniku.
English: Retacrit 40 000 IU injection epoetin zeta
Croatian: Retacrit 40 000 IU injekcija epoetin zeta i.v./s.c.
English: Retacrit 1 000 IU/0.3 ml solution for injection in pre-filled syringe Pre-filled syringe Type I glass with a fixed steel injection needle and a plunger stopper with PTFE coating with or without a needle guard or needle-trap device.
Croatian: Retacrit 1000 IU/0,3 ml otopina za injekciju u napunjenoj štrcaljki Napunjena štrcaljka od stakla tipa I, s pričvršćenom čeličnom iglom za injekciju i čepom klipa obloženim politetrafluoroetilenom (PTFE-om) sa ili bez štitnika za iglu ili s klopkom za iglu.
English: Serum electrolytes should be monitored in chronic renal failure patients.
Croatian: U bolesnika s kroničnim zatajenjem bubrega potrebno je pratiti elektrolite u serumu.
English: Retacrit 10 000 IU injection epoetin zeta
Croatian: Retacrit 10 000 IU injekcija epoetin zeta i.v./s.c.
English: Retacrit 3 000 IU injection epoetin zeta
Croatian: Retacrit 3000 IU injekcija epoetin zeta i.v./s.c.
English: Retacrit 2 000 IU/0.6 ml solution for injection in pre-filled syringe Pre-filled syringe Type I glass with a fixed steel injection needle and a plunger stopper with PTFE coating with or without a needle guard or needle-trap device.
Croatian: Retacrit 2000 IU/0,6 ml otopina za injekciju u napunjenoj štrcaljki Napunjena štrcaljka od stakla tipa I, s pričvršćenom čeličnom iglom za injekciju i čepom klipa obloženim politetrafluoroetilenom (PTFE-om) sa ili bez štitnika za iglu ili s klopkom za iglu.
English: Retacrit 6 000 IU injection epoetin zeta
Croatian: Retacrit 6000 IU injekcija epoetin zeta i.v./s.c.
English: 6.4 Special precautions for storage
Croatian: Posebne mjere pri čuvanju lijeka
English: 28 patches (7x 2mg/24h, 7x 4mg/24h, 7x 6mg/24h, 7x 8mg/24h)
Croatian: 28 flastera (7x 2mg/24h, 7x 4mg/24h, 7x 6mg/24h, 7x 8mg/24h)
English: Transdermal patch Transdermal use sachet (paper/LDPE/alu/ET copolymer PE/Alu/ ET copolymer/paper)
Croatian: Transdermalni flaster
English: The European Commission issued a decision on 24 October 2011.
Croatian: Europska komisija izdala je odluku dana 5. rujna 2013.
English: Outcome of a procedure under Article 29 of Directive 2001/83/EC as amended
Croatian: Ishod postupka sukladno članku 29. Direktive 2001/83/EC s izmjenama
English: 24 October 2011
Croatian: 5. rujna 2013.
English: It is available as an oral solution (0.4 mg/ml).
Croatian: Dostupan je kao oralna otopina (6mg/ml).
English: However, the Member States were not able to reach an agreement and the Maltese medicines regulatory agency referred the matter to the CHMP for arbitration on 30 May 2011.
Croatian: No, države članice nisu postigle dogovor i Ujedinjena Kraljevina je uputila predmet CHMP-u na arbitražu dana 5. ožujka 2013. godine.
English: The CHMP concluded that the benefits of Dexamethasone Alapis outweigh its risks, and therefore the marketing authorisation for Dexamethasone Alapis should be granted in all concerned Member States.
Croatian: Stoga je CHMP zaključio da prednosti lijeka Okrido nadmašuju njegove rizike, te se shodno tome odobrenje za stavljanje u promet lijeka Okrido treba odobriti u svim državama članicama sudionicama u postupku.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the data submitted was sufficient to show that Dexamethasone Alapis could be used safely and effectively based on the well established use of dexamethasone.
Croatian: Na temelju ocjene trenutno dostupnih podataka i znanstvene rasprave unutar Povjerenstva, CHMP je zaključio da se na temelju dostavljenih podataka očekuje da Okrido stvara razine djelatne tvari u tijelu usporedive s referentnim lijekom.
English: Why was Dexamethasone Alapis reviewed?
Croatian: Zašto je proveden pregled lijeka Okrido?
English: The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Dexamethasone Alapis.
Croatian: Dana 27. lipnja 2013. godine, Europska agencija za lijekove zaključila je arbitražni postupak nakon neslaganja država članica Europske unije (EU) u svezi s odobrenjem lijeka Okrido.
English: Dexamethasone Alapis is intended for use principally as an anti-inflammatory or immunosuppressant (a medicine that reduces the activity of the immune system) in a range of specific disorders affecting different parts of the body, including the blood, liver, kidney, stomach and gut, muscles, eye, lungs and skin, as well as in certain cancers and in the management of anaphylaxis (severe allergic reaction).
Croatian: • bolesti pluća (uključujući astmu), gornjih dišnih putova (krupa), krvnih žila i srca, crijeva ili bubrega, mišića i zglobova (uključujući reumatoidni artritis) odnosno oka ili živčanog sustava;
English: Dexamethasone Alapis is a medicine that contains the active substance dexamethasone.
Croatian: Okrido je lijek koji sadrži djelatnu tvar prednisolon natrijev fosfat.
English: The active substance in Dexamethasone Alapis, dexamethasone, belongs to a group of anti-inflammatory medicines known as corticosteroids.
Croatian: Djelatna tvar u lijeku Okrido - prednisolon natrijev fosfat, ubraja se u grupu lijekova pod nazivom glukokortikoidi, koji su tvari koje pomažu u smanjivanju upale.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Dexamethasone Alapis outweigh its risks, and the marketing authorisation can be granted in Malta and in the following Member States of the EU: Belgium, Bulgaria, Cyprus, Germany, Greece, Portugal, Romania and the United Kingdom.
Croatian: Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) pri Agenciji zaključilo je da koristi lijeka Okrido nadmašuju s njim povezane rizike, te da se odobrenje za stavljanje lijeka u promet izdano u Ujedinjenoj Kraljevini može priznati u drugim državama članicama EU-a.
English: This is a procedure where one Member State (the ‘reference Member State', in this instance Malta) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Belgium, Bulgaria, Cyprus, Germany, Greece, Portugal, Romania and the United Kingdom).
Croatian: Tvrtka je zatražila priznavanje odobrenja u Njemačkoj i Nizozemskoj („države članice sudionice u postupku”).
English: The German medicines regulatory authority was of the opinion that the data submitted to support the application did not provide sufficient evidence to demonstrate the safety and effectiveness of Dexamethasone Alapis.
Croatian: Pharmapol Arzneimittelvertrieb GmbH podnio je za Okrido zahtjev za međusobno priznavanje na temelju prvotnog odobrenja koje je izdala Regulatorne agencije za lijekove i zdravstvene proizvode Ujedinjene Kraljevine dana 19. travnja 2010. godine.
English: What is Dexamethasone Alapis?
Croatian: Što je Okrido?
English: It works by entering cells and blocking the production of vascular endothelial growth factor (VEGF) and prostaglandins, substances that are involved in inflammation and swelling.
Croatian: Pitanja i odgovori o lijeku Okrido (prednisolon natrijev fosfat, oralna otopina, 6 mg/ml)
English: The grounds for the referral were that the application, which was supported by published literature rather than studies carried out with Dexamethasone Alapis, because dexamethasone has a history of well-established use in the EU for at least 10 years, was mainly supported by literature demonstrating the safety and efficacy of dexamethasone in tablet form rather than oral solution form and the bridging data provided were not considered adequate to conclude on the benefit-risk profile of the oral solution form.
Croatian: Prosljeđivanje se temeljilo na činjenici da nije dostavljeno dovoljno podataka koji potvrđuju da Okrido stvara razine djelatne tvari u tijelu usporedive s topivim tabletama Prednisolone 5 mg proizvođača Sovereign.
English: It is given once every three weeks as an infusion lasting 10 minutes.
Croatian: Lijek se daje jednom svaka tri tjedna u obliku infuzije koja traje 10 minuta.
English: The recommended dose is 500 mg per square metre of body surface area (calculated using the patient's height and weight).
Croatian: Preporučena doza lijeka iznosi 500 mg/m2 tjelesne površine (izračunata na temelju bolesnikove visine i težine).
English: The full EPAR and risk management plan summary for Pemetrexed Sandoz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjelovito europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) kao i plan upravljanja rizikom nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It can also be used as a maintenance treatment in patients who have received a platinum-based chemotherapy.
Croatian: Također ga se može primijeniti kao terapija održavanja u bolesnika koji su prethodno primili kemoterapiju na bazi platine.
English: The company provided data from the published literature on pemetrexed.
Croatian: Tvrtka je učinila dostupnima podatke iz objavljene literature o pemetreksedu.
English: The conversion of pemetrexed into its active form occurs more readily in cancer cells than in normal cells, leading to higher levels of the active form of the medicine and a longer duration of action in cancer cells.
Croatian: Pretvorba pemetrekseda u njegov djelatni oblik događa se prije u stanicama raka nego u normalnim stanicama, što rezultira višim razinama djelatnog oblika lijeka i duljim trajanjem njegova djelovanja u stanicama raka.
English: Because Pemetrexed Sandoz is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je Pemetrexed Sandoz generički lijek, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: In the body, pemetrexed is converted into an active form that blocks the activity of the enzymes that are involved in producing ‘nucleotides' (the building blocks of DNA and RNA, the genetic material of cells).
Croatian: U tijelu pemetreksed se pretvara u djelatni oblik koji blokira djelovanje enzima, koji sudjeluju u proizvodnji „nukleotida” (temeljni elementi koji formiraju DNK i RNK, genetski materijal stanica).
English: This means that Pemetrexed Sandoz is similar to a ‘reference medicine' already authorised in the European Union (EU) called Alimta.
Croatian: To znači da je Pemetrexed Sandoz sličan „referentnom lijeku” koji je već odobren u Europskoj uniji pod nazivom Alimta.
English: Pemetrexed Sandoz is a cancer medicine used to treat two types of lung cancer:
Croatian: Pemetrexed Sandoz je lijek protiv raka i koristi se za liječenje dvaju tipova raka pluća:
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pemetrexed Sandoz has been shown to be comparable to Alimta.
Croatian: Odbor za lijekove za primjenu kod ljudi (CHMP) pri Agenciji zaključio je kako je, u skladu s preduvjetima EU-a, potvrđeno da je Pemetrexed Sandoz usporediv s lijekom Alimta.
English: As a result, the active form of pemetrexed slows down the formation of DNA and RNA and prevents the cells from dividing and multiplying.
Croatian: Kao rezultat toga djelatni oblik pemetrekseda usporava formiranje DNK-a i RNK-a te sprječava podjelu i umnožavanje stanica.
English: This is a summary of the European public assessment report (EPAR) for Pemetrexed Sandoz.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za lijek Pemetrexed Sandoz.
English: Pemetrexed Sandoz is a ‘generic medicine'.
Croatian: Pemetrexed Sandoz je „generički lijek”.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Pemetrexed Sandoz, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Pemetrexed Sandoz nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: No additional studies were needed as Pemetrexed Sandoz is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Alimta.
Croatian: Nisu bila potrebna dodatna ispitivanja jer je Pemetrexed Sandoz generički lijek koji se daje infuzijom i sadrži istu djelatnu tvar kao i referentni lijek Alimta.
English: • malignant pleural mesothelioma (a cancer of the lining of the lungs that is usually caused by exposure to asbestos), where it is used together with cisplatin in patients who have not received chemotherapy before and whose cancer cannot be removed by surgery;
Croatian: • malignog pleuralnog mezotelioma (raka plućne ovojnice koji je obično uzrokovan izlaganjem azbestu), kada je u kombinaciji s cisplatinom indiciran za liječenje bolesnika s neoperabilnim malignim pleuralnim mezoteliomom koji prethodno nisu primili kemoterapiju;
English: A risk management plan has been developed to ensure that Pemetrexed Sandoz is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Pemetrexed Sandoz.
English: This results in the division of cancer cells being reduced, while normal cells are only slightly affected.
Croatian: Kao rezultat toga smanjuje se dijeljenje stanica, pri čemu je učinak na normalne stanice tek neznatan.
English: What measures are being taken to ensure the safe and effective use of Pemetrexed Sandoz?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Pemetrexed Sandoz?
English: It is not intended to provide practical advice on how to use Pemetrexed Sandoz.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Pemetrexed Sandoz.
English: The active substance in Pemetrexed Sandoz, pemetrexed, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells), which belongs to the group ‘antimetabolites'.
Croatian: Djelatna tvar u lijeku Pemetrexed Sandoz, pemetreksed, citotoksičan je lijek (lijek koji ubija stanice koje se dijele, kao što su stanice raka), koji pripada skupini „antimetabolita”.
English: The Committee recommended that Pemetrexed Sandoz be approved for use in the EU.
Croatian: Odbor je preporučio izdavanje odobrenja za stavljanje u promet lijeka Pemetrexed Sandoz u EU-u.
English: When Pemetrexed Sandoz is given with cisplatin, an ‘anti-emetic' medicine (to prevent vomiting) and fluids (to prevent dehydration) should also be given before or after the cisplatin dose.
Croatian: Kada se lijek Pemetrexed Sandoz primjenjuje u kombinaciji s cisplatinom, prije ili poslije doze cisplatinom bolesniku bi se trebali dati „antiemetik” (za sprječavanje povraćanja) i tekućina (za sprječavanje dehidracije).