FrancophonIA/ELRC3.0 huggingface dataset:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION IMBRUVICA 140 mg film-coated tablets Each film-coated tablet contains 140 mg of ibrutinib.
Croatian: IMBRUVICA 140 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 140 mg ibrutiniba.
English: The dose of ibrutinib should be reduced to 280 mg once daily when used concomitantly with moderate CYP3A4 inhibitors.
Croatian: Kada se uzima istodobno s umjerenim CYP3A4 inhibitorima, doza ibrutiniba mora se sniziti na 280 mg jedanput na dan.
English: EU/1/14/945/007 - 28 tablets (2 wallet packs of 14) EU/1/14/945/008 - 30 tablets (3 wallet packs of 10)
Croatian: EU/1/14/945/007 - 28 tableta (2 pakiranja omota s po 14) EU/1/14/945/008 - 30 tableta (3 pakiranja omota s po 10)
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 560 mg film-coated tablets ibrutinib
Croatian: IMBRUVICA 560 mg filmom obložene tablete ibrutinib
English: At baseline, the median serum IgM value was 3.2 g/dL (range, 0.6 to 8.3 g/dL), 63% of patients were anaemic (haemoglobin ≤11 g/dL or 6.8 mmol/L) and MYD88 L265P mutations were present in 77% of patients, absent in 13% of patients, and 9% of patients were not evaluable for mutation status.
Croatian: Na početku ispitivanja medijan serumske vrijednosti IgM iznosio je 3,2 g/dl (raspon: 0,6 do 8,3 g/dl), 63% bolesnika imalo je anemiju (hemoglobin ≤ 11 g/dl ili 6,8
English: How to store IMBRUVICA
Croatian: Kako čuvati lijek IMBRUVICA
English: Stomatitis
Croatian: IMBRUVICA
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 140 mg capsules ibrutinib
Croatian: IMBRUVICA 140 mg kapsule ibrutinib
English: Figure 3: Kaplan-Meier curve of OS (ITT Population) in Study PCYC-1115-CA
Croatian: Slika 3: Kaplan-Meierova krivulja OS-a (ITT populacija) u ispitivanju PCYC-1115-CA
English: Figure 2: Kaplan-Meier curve of PFS (ITT Population) in Study PCYC-1115-CA
Croatian: Slika 2: Kaplan-Meierova krivulja PFS-a (ITT populacija) u ispitivanju PCYC-1115-CA
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 280 mg film-coated tablets ibrutinib
Croatian: IMBRUVICA 280 mg filmom obložene tablete ibrutinib
English: Ninety-three percent of patients had a baseline ECOG performance status of 0 or 1, and 7% of patients had a baseline ECOG performance status of 2.
Croatian: Na početku ispitivanja 93% bolesnika imalo je ECOG funkcionalni status 0 ili 1, dok je njih 7% imalo ECOG funkcionalni status 2. Četrdeset i pet posto (45%) bolesnika prethodno nije primalo liječenje, dok je njih 55% bilo prethodno liječeno.
English: EU/1/14/945/012 - 28 tablets (2 wallet packs of 14) EU/1/14/945/006 - 30 tablets (3 wallet packs of 10)
Croatian: EU/1/14/945/012 - 28 tableta (2 pakiranja omota s po 14) EU/1/14/945/006 - 30 tableta (3 pakiranja omota s po 10)
English: : +359 2 489 94 00 jjsafety@its.jnj.com
Croatian: България „Джонсън & Джонсън България” ЕООД Тел.: +359 2 489 94 00 jjsafety@its.jnj.com
English: EU/1/14/945/011 - 28 tablets (2 wallet packs of 14) EU/1/14/945/005 - 30 tablets (3 wallet packs of 10)
Croatian: EU/1/14/945/011 - 28 tableta (2 pakiranja omota s po 14) EU/1/14/945/005 - 30 tableta (3 pakiranja omota s po 10)
English: See package leaflet for further information.
Croatian: Za dodatne informacije vidjeti uputu o lijeku.
English: Bulky disease <5 cm
Croatian: Broj prethodnih linija liječenja velika tumorska masa < 5 cm
English: Tel.: +386 1 401 18 00
Croatian: Johnson & Johnson d.o.o. Tel.: +386 1 401 18 00
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 140 mg of ibrutinib
Croatian: Jedna filmom obložena tableta sadrži 140 mg ibrutiniba
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 560 mg of ibrutinib
Croatian: Jedna filmom obložena tableta sadrži 560 mg ibrutiniba
English: Metabolism
Croatian: Monoterapija
English: Refractory disease to purine analog Yes
Croatian: Svi ispitanici Delecija 17p Da Ne Bolest refraktorna na analoge purina Da Ne Dob
English: The updated Kaplan-Meier curve for PFS is shown in Figure 7.
Croatian: Na Slici 7 prikazana je ažurirana Kaplan-Meierova krivulja PFS-a.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 420 mg of ibrutinib
Croatian: Jedna filmom obložena tableta sadrži 420 mg ibrutiniba
English: EU/1/14/945/008 (30 tablets)
Croatian: EU/1/14/945/007 (28 tableta) EU/1/14/945/008 (30 tableta)
English: d.o.o.
Croatian: PRILOG II.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 280 mg of ibrutinib
Croatian: Jedna filmom obložena tableta sadrži 280 mg ibrutiniba
English: Very common Headache Common
Croatian: Teška bolest srca
English: Hazard Ratio
Croatian: Rai stadij
English: • inflammation of the fatty tissue underneath the skin
Croatian: • upala potkožnog masnog tkiva
English: EU/1/14/945/010 (30 tablets)
Croatian: EU/1/14/945/009 (28 tableta) EU/1/14/945/010 (30 tableta)
English: Titanium dioxide (E171) Black iron oxide (E172) Red iron oxide (E172)
Croatian: IMBRUVICA 280 mg filmom obložene tablete makrogol poli(vinilni alkohol) talk titanijev dioksid (E171) željezov oksid, crni (E172) željezov oksid, crveni (E172)
English: ECOG per CRF
Croatian: ECOG funkcionalni status prema test listi ispitanika (CRF)
English: Talc
Croatian: tkiva
English: The updated Kaplan-Meier curve for PFS is shown in Figure 4.
Croatian: Na Slici 4 prikazana je ažurirana Kaplan-Meierova krivulja PFS-a.
English: Onychoclasis
Croatian: Onihoklazija
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 140 MG CAPSULE
Croatian: VANJSKA KUTIJA 140 MG KAPSULE
English: Single agent
Croatian: Starije osobe
English: Cases of ILD have been reported in patients treated with IMBRUVICA.
Croatian: U bolesnika koji su liječeni lijekom IMBRUVICA prijavljeni su slučajevi intersticijske bolesti pluća.
English: Tumour lysis syndrome Hyperuricaemia Nervous system disorders Very common Headache Common
Croatian: Poremećaji živčanog sustava Vrlo često Glavobolja
English: Janssen-Cilag Polska Sp. z o.o.
Croatian: Janssen-Cilag B.V.
English: Progression free survival (PFS) as assessed by IRC indicated an 80% statistically significant reduction in the risk of death or progression in the IMBRUVICA arm. Efficacy results for Study PCYC-1127CA are shown in Table 11 and the Kaplan-Meier curve for PFS is shown in Figure 8.
Croatian: Preživljenje bez progresije bolesti (PFS) prema ocjeni IRC-a ukazalo je na statistički značajno smanjenje rizika od smrti ili progresije bolesti za 80% u skupini koja je primala lijek IMBRUVICA.
English: Angioedema Panniculitis
Croatian: Krvožilni poremećaji
English: discontinue IMBRUVICA
Croatian: prekinite primjenu lijeka IMBRUVICA
English: Titanium dioxide (E171) Red iron oxide (E172) Yellow iron oxide (E172)
Croatian: IMBRUVICA 560 mg filmom obložene tablete makrogol poli(vinilni alkohol) talk titanijev dioksid (E171) željezov oksid, crveni (E172) željezov oksid, žuti (E172)
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER 140 MG TABLET
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP
English: A cycle lasts 3 weeks.
Croatian: Ciklus traje 3 tjedna.
English: This means that it changes the activity of the immune system (the body's natural defences).
Croatian: To znači da mijenja aktivnost imunosnog sustava (prirodne obrane organizma).
English: This can increase the length of time the patient stays in remission.
Croatian: To može povećati vrijeme koje bolesnik ostaje u remisije.
English: Every year, the Agency will review any new information that may become available and this summary will be updated as necessary.
Croatian: Svake godine Agencija će procijeniti sve nove informacije koje postanu dostupne te će se ovaj sažetak po potrebi ažurirati.
English: This overview was last updated in 07-2018.
Croatian: Ovaj pregled informacija posljednji je put ažuriran u 7. 2018.
English: Histamine is a substance occurring naturally in the body that is involved in many processes.
Croatian: Histamin je tvar koja prirodno nastaje u tijelu i sudjeluje u mnogim procesima.
English: Ceplene has been authorised under ‘exceptional circumstances'.
Croatian: Lijek Ceplene je odobren u „iznimnim okolnostima”.
English: It is used during the patients' first ‘remission' (a period without symptoms of the disease after the first course of treatment).
Croatian: Koristi se tijekom bolesnikove prve „remisije” (razdoblje bez simptoma bolesti nakon prvog liječenja).
English: Between each cycle there should be a treatment-free period of 3 weeks.
Croatian: Između svakog ciklusa mora biti razdoblje od 3 tjedna bez liječenja.
English: What is Ceplene and what is it used for?
Croatian: Što je Ceplene i za što se koristi?
English: What measures are being taken to ensure the safe and effective use of Ceplene?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Ceplene?
English: Further information on Ceplene can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Ceplene nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Ceplene
Croatian: Ostale informacije o lijeku Ceplene
English: An overview of Ceplene and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Ceplene i zašto je odobren u EU-u
English: This is because it has not been possible to obtain complete information about Ceplene due to the rarity of the disease.
Croatian: Razlog tome je nemogućnost dobivanja potpunih informacija o lijeku Ceplene zbog male učestalosti bolesti.
English: When Ceplene is first given, the patient's blood pressure, heart rate and lung function must be checked.
Croatian: Kada se lijek Ceplene primjenjuje prvi put, mora se provjeriti bolesnikov krvni tlak, srčana frekvencija i funkcija pluća.
English: The recommended dose of Ceplene is one injection twice a day, one to three minutes after an interleukin-2 injection.
Croatian: Preporučena doza lijeka Ceplene je jedna injekcija dvaput na dan, jednu do tri minute nakon injekcije interleukina-2.
English: Ceplene must not be used in patients who have severe heart problems or in women who are pregnant or breastfeeding.
Croatian: Ceplene se ne smije primjenjivati u bolesnika koji imaju teške probleme sa srcem ili u žena tijekom trudnoće ili dojenja.
English: AML is rare, and Ceplene was designated an ‘orphan medicine' (a medicine used in rare diseases) on 11 April 2005.
Croatian: AML je rijetka bolest, a Ceplene je dobio status „lijeka za rijetku bolest” 11. travnja 2005.
English: Ceplene (histamine dihydrochloride)
Croatian: Ceplene (histamin dihidroklorid)
English: Depending on the patient's response to treatment and side effects, the treatment may have to be suspended or the dose adjusted.
Croatian: Ovisno o bolesnikovom reagiranju na liječenje i nuspojavama, možda će trebati prekinuti liječenje ili prilagoditi dozu.
English: For patients who were into their first remission the combination of Ceplene and interleukin-2 was more effective than no treatment in increasing the time until AML came back or the patient died from any cause: the average time without disease increased from 291 days with no treatment to 450 days after treatment with Ceplene and interleukin-2.
Croatian: Za bolesnike koji su bili u svojoj prvoj remisiji kombinacija lijekova Ceplene i interleukin-2 bila je učinkovitija nego neuzimanje terapije u produljenju vremena do povratka AML-a ili smrti bolesnika od bilo kojeg uzroka: prosječno vrijeme bez bolesti povećano je s 291 dan bez terapije na 450 dana nakon liječenja lijekovima Ceplene i interleukin-2.
English: Side effects reported with Ceplene are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Ceplene pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: What are the risks associated with Ceplene?
Croatian: Koji su rizici povezani s lijekom Ceplene?
English: This improves the effectiveness of interleukin-2, a medicine that stimulates the immune system to attack cancerous cells.
Croatian: To poboljšava učinkovitost interleukina-2, lijeka koji stimulira imunosni sustav da napada stanice raka.
English: The European Medicines Agency decided that Ceplene's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Ceplene nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: Ceplene received a marketing authorisation valid throughout the EU on 7 October 2008.
Croatian: Lijek Ceplene dobio je odobrenje za stavljanje lijeka u promet koje vrijedi na prostoru EU-a od 7. listopada 2008.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ceplene have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Ceplene nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Patients can inject themselves once they have been trained appropriately.
Croatian: Bolesnici se mogu sami injicirati kada ih se osposobi za to.
English: Each Ceplene injection must be given slowly over five to 15 minutes, in a different site from the interleukin-2 injection, and preferably in the thigh or abdomen (belly).
Croatian: Svaka injekcija lijeka Ceplene mora se primjenjivati polagano tijekom 5 do 15 minuta, na različito mjesto od injekcije interleukina-2, a po mogućnosti u bedro ili abdomen (trbuh).
English: The effectiveness of Ceplene has been studied in one main study involving 320 adults with AML who were in remission following leukaemia treatment.
Croatian: Učinkovitost lijeka Ceplene ispitivana je u jednoj glavnoj studiji koja je obuhvatila 320 odraslih osoba s AML-om koje su bile u remisiji nakon liječenja leukemije.
English: It must also not be used in patients who have received a bone marrow transplant from a donor, or who are taking steroids (medicines used to reduce or prevent inflammation) given systemically (given by mouth or by injection), clonidine (used to reduce high blood pressure) or histamine H2 blockers (used to treat stomach ulcers, indigestion or heartburn).
Croatian: Također se ne smije primjenjivati u bolesnika kojima je presađena koštana srž od donora ili koji uzimaju steroide (lijekove koji se upotrebljavaju za smanjenje ili sprječavanje upale) primijenjene sistemski (kroz usta ili injekcijom), klonidin (upotrebljava se za snižavanje visokog krvnog tlaka) ili histamin H2 blokatore (upotrebljava se za liječenje čireva na želucu, probavnih tegoba ili žgaravice).
English: Ceplene is a medicine used in combination with interleukin-2 (a cancer medicine) as maintenance treatment in adults with acute myeloid leukaemia (AML), a type of cancer affecting the white blood cells.
Croatian: Ceplene je lijek koji se koristi u kombinaciji s interleukinom-2 (lijekom za liječenje raka) kao terapija održavanja u odraslih bolesnika s akutnom mijeloičnom leukemijom (AML), vrstom raka koji utječe na bijele krvne stanice.
English: For more information about using Ceplene, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Ceplene pročitajte u uputi o lijeku ili se obratite liječniku ili ljekarniku.
English: As for all medicines, data on the use of Ceplene are continuously monitored.
Croatian: Kao za sve lijekove, podatci o primjeni lijeka Ceplene kontinuirano se prate.
English: In the treatment of AML, it is thought to work by protecting immune system cells from damage.
Croatian: U liječenju AML-a smatra se da djeluje tako da štiti stanice imunosnog sustava od oštećenja.
English: Why has Ceplene been approved?
Croatian: Zašto je lijek Ceplene odobren?
English: The company that markets Ceplene will provide yearly updates on the safety and effectiveness of Ceplene in combination with interleukin-2 in AML patients in first remission.
Croatian: Tvrtka koja stavlja lijek Ceplene u promet dostavit će godišnja ažuriranja o sigurnosti i učinkovitosti lijeka Ceplene u kombinaciji s interleukinom-2 u bolesnika s AML-om u prvoj remisiji.
English: The most common side effects with Ceplene (seen in more than 1 patient in 10) are flushing (reddening), headache, tiredness, fever and inflammation or redness at the injection site.
Croatian: Najčešće nuspojave pri primjeni lijeka Ceplene (uočeni u više od 1 na 10 bolesnika) su osjećaj vrućine (crvenilo), glavobolja, umor, vrućica i upala ili crvenilo na mjestu injiciranja.
English: When Ceplene is given with interleukin-2, it helps the immune system to kill the leukaemia cells that may remain in the body during remission.
Croatian: Kad se lijek Ceplene primjenjuje s interleukinom-2 on pomaže imunosnom sustavu ubiti stanice leukemije koje mogu ostati u tijelu tijekom remisije.
English: Ceplene was given in combination with interleukin-2 and compared with no treatment.
Croatian: Ceplene je primijenjen u kombinaciji s interleukinom-2 i uspoređivan sa slučajevima bez liječenja.
English: Ceplene can only be obtained with a prescription and should be given under the supervision of a doctor who has experience in the treatment of AML.
Croatian: Ceplene se izdaje samo na recept, a liječenje je potrebno provoditi pod nadzorom liječnika s iskustvom u liječenju AML-a.
English: What information is still awaited for Ceplene?
Croatian: Koje se još informacije očekuju o lijeku Ceplene?
English: Ceplene and interleukin-2 are given for 10 cycles.
Croatian: Ceplene i interleukin-2 primjenjuju se kroz 10 ciklusa liječenja.
English: How does Ceplene work?
Croatian: Kako djeluje Ceplene?
English: It is available as a solution for injection under the skin.
Croatian: Lijek je dostupan u obliku otopine za potkožnu injekciju.
English: How is Ceplene used?
Croatian: Kako se Ceplene koristi?
English: The active substance in Ceplene, histamine dihydrochloride, is an immune modulator.
Croatian: Djelatna tvar u lijeku Ceplene, histamin dihidroklorid, je imunomodulator.
English: Ceplene contains the active substance histamine dihydrochloride.
Croatian: Ceplene sadrži djelatnu tvar histamin dihidroklorid.
English: What benefit of Ceplene have been shown in studies?
Croatian: Koje su koristi lijeka Ceplene utvrđene u ispitivanjima?
English: For the full list of side effects of Ceplene, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Ceplene potražite u uputi o lijeku.
English: No effect of Ceplene and interleukin-2 was seen in patients in second or later remission.
Croatian: Kod bolesnika u drugoj ili kasnijoj remisiji nije primijećen učinak lijekova Ceplene i interleukin-2.
English: 1 Parry 2000 & 2002; Kirsch-Volders 2002 2 Kirkland DJ Et al. 2001
Croatian: 1 Parry 2000 & 2002; Kirsch-Volders 2002 2 Kirkland DJ
English: Hence no safety margin could be calculated.
Croatian: Stoga, granica za sigurnu primjenu nije mogla biti izračunata.
English: • Teratogenicity is classified as an important identified risk.
Croatian: • Teratogenost je klasificirana kao važan identificiran rizik.
English: • The CHMP also agreed on the need of a RMP.
Croatian: • CHMP je također suglasan s potrebom RMP-a.
English: • four cases of spontaneous abortion,
Croatian: • četiri slučaja spontanog pobačaja,
English: Carcinogenicity is an important potential risk.
Croatian: Karcinogenost je značajan potencijalan rizik.
English: This DUS should be conducted over a three year period.
Croatian: Ovaj se DUS mora provoditi u razdoblju od tri godine.
English: The package size should be adapted to new recommended treatment-days.
Croatian: Veličina ambalaže mora se prilagoditi novom preporučenom broju dana liječenja.
English: These measures are to be included in the RMP.
Croatian: Ove mjere moraju biti uključene u RMP.
English: Clinical Safety
Croatian: Klinička sigurnost
English: The CHMP also considered that the use of TCC should be avoided during puberty (12 to 16-18 years) due to potential risk on fertility.
Croatian: CHMP također smatra da se primjena TCC-a treba izbjegavati tijekom puberteta (12 do 16-18 godina) zbog potencijalnog rizika za plodnost.
English: The CHMP also recommended further changes to the product information including information on fertility.
Croatian: CHMP također preporuča daljnje promjene u informacijama o lijeku uključujući i informacije o plodnosti.
English: Aneuploidy is a common characteristic of cancer cells.
Croatian: Aneuploidija je zajednička karakteristika stanica raka.
English: • Lastly, evidence for carcinogenicity of aneugens is limited.
Croatian: • Naposljetku, dokaz karcinogenosti aneugena je skroman.
English: In females, a positive response was observed at doses of 25, 50, 70 and 100 mg/kg/d based on group mean and individual data.
Croatian: U ženki je uočen pozitivan odgovor u dozama od 25, 50, 70 i 100 mg/kg/d na temelju srednjih i individualnih podataka grupe.
English: Muscle relaxants are one of the many treatments currently employed in the management of non-specific low back pain.
Croatian: Mišićni relaksansi su jedna od mnogih terapija trenutno primijenjenih u upravljanju boli donjih leđa koja nema specifičnog uzroka.
English: Finally educational material for prescribers and for patients highlighting the risks and warnings of genotoxicity reactions will also be submitted to national competent authorities within the RMP.
Croatian: Naposljetku, edukacijski materijal za propisivače i bolesnike koji treba naglašavati rizike i upozorenja genotoksičnih reakcija također će se dostaviti nacionalnim nadležnim tijelima u sklopu RMP-a.
English: In most cases the treatment is for short-term use and not associated with the perception of increased cancer risk for both physicians and patients, therefore a causal relationship between cancer occurrence and treatment is difficult to establish.
Croatian: U većini slučajeva liječenje je kratkoročno i nije povezano s percepcijom povećanog rizika od raka za liječnike i bolesnike, stoga je teško utvrditi uzročnu vezu između nastupanja raka i liječenja.
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC for thiocolchicoside containing medicinal products for systemic use (see annex I).
Croatian: • Povjerenstvo je razmotrilo postupak u skladu sa člankom 31. Direktive 2001/83/EC za lijekove koji sadrže tiokolhikozid za sistemsku primjenu (vidjeti Dodatak I).
English: In the first database, 11 cases secondary to exposure during pregnancy were reported:
Croatian: U prvoj bazi podataka prijavljeno je 11 slučajeva koji su bili sekundarni u odnosu na izlaganje tijekom trudnoće:
English: • one case of threat of premature delivery.
Croatian: • jedan slučaj prijetnje prijevremenog poroda.
English: The CHMP was asked to give its opinion on whether the indication of TCC containing medicinal products should be restricted and/or other regulatory measures should be taken.
Croatian: Od CHMP-a je zatraženo da donese mišljenje o tome treba li se indikacija za lijekove koji sadrže TCC-a ograničiti i/ili se trebaju poduzeti regulatorne mjere.
English: In addition males and females showed only a slight gender difference in exposure.
Croatian: Nadalje, mužjaci i ženke demonstrirali su samo neznatnu razliku u spolu prilikom izlaganja.
English: Case review reports from 2004 up to 29 April 2013 from the second database reported 23 cases secondary to exposure during pregnancy and / or exposition in utero:
Croatian: Izvješća pregleda slučajeva od 2004. godine do 29. travnja 2013. godine iz druge baze podataka prijavila su 23 slučaja koji su bili sekundarni u odnosu na izlaganje tijekom trudnoće i / ili ekspozicije u maternici:
English: A significantly increased cancer risk would in general be dependent on long-term/chronic exposure/dosing with the aneugen.
Croatian: Značajno povišen rizik od raka načelno bi ovisio o dugoročnom/kroničnom izlaganju/doziranju s aneugenom.
English: On 21 February 2013, the CHMP started a referral procedure for TCC containing medicinal products.
Croatian: Dana 21. veljače 2013. godine, CHMP je započeo postupak upućivanja za lijekove koji sadrže TCC-a.