FrancophonIA/ELRC3.0 huggingface dataset:
English: This results in an abnormal number or arrangement of chromosomes, which can reduce fertility in men and, if it happens during pregnancy, can harm the developing baby in the womb.
Croatian: To rezultira abnormalnim brojem ili rasporedom kromosoma, što može smanjiti plodnost u muškaraca te, ako se dogodi tijekom trudnoće, može oštetiti embrij u razvoju u maternici.
English: The Committee concluded that in the light of current evidence the benefit-risk for the medicine remained positive provided appropriate risk-mitigating measures were taken, including restricting the maximum dose and duration of use and contra-indicating use during pregnancy and lactation and in children.
Croatian: Povjerenstvo je zaključilo da, u svjetlu postojećih dokaza, omjer koristi i rizika za lijek ostaje pozitivan ako se poduzmu odgovarajuće mjere za smanjivanje rizika, uključujući i ograničavanje maksimalne doze i trajanje primjene, kao i kontraindiciranje primjene tijekom trudnoće i laktacije te u djece.
English: As a result AIFA asked the CHMP to examine the safety profile of this medicine and consider what regulatory action might be appropriate.
Croatian: Stoga je AIFA zatražila od CHMP-a da preispita sigurnosni profil ovog lijeka te da razmotri odgovarajuće regulatorne radnje.
English: • The current findings do not apply to topical preparations of thiocolchicoside.
Croatian: • Aktualni nalazi ne primjenjuju se na topikalne pripravke tiokolhikozida.
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally-binding decision, valid across the EU, on 17 January 2014.
Croatian: Mišljenje CHMP-a dostavljeno je Europskoj Komisiji koja je donijela konačnu pravno obvezujuću odluku na razini EU-a 17. siječnja 2014.
English: It is available for use by mouth or by injection into the muscles.
Croatian: Dostupan je za primjenu peroralno ili injekcijom u mišić.
English: Aneuploidy is a risk factor for harm to the developing fetus, reduced fertility in men and in theory could increase the risk of developing cancer.
Croatian: Aneuploidija je faktor rizika od oštećenja embrija u razvoju, smanjene plodnosti u muškaraca, te u teoriji može povećati rizik od pojave raka.
English: Medicine only to be used at low doses for additional short-term relief of painful muscle contractures
Croatian: Lijek treba primjenjivati samo u malim dozama za dodatno kratkotrajno ublažavanje bolnih mišićnih kontraktura
English: • Medicines containing thiocolchicoside should not be used during pregnancy and lactation, nor in women of childbearing potential who are not taking appropriate contraceptive measures.
Croatian: • Lijekovi koji sadrže tiokolhikozid ne smiju se primjenjivati tijekom trudnoće i laktacije, ni u žena reproduktivne dobi koje ne poduzimaju odgovarajuće kontracepcijske mjere.
English: Aneuploidy is an established risk factor for teratogenicity, embryotoxicity or spontaneous abortion, and impaired male fertility.
Croatian: Aneuploidija je utvrđeni faktor rizika za teratogenost, embriotoksičnost ili spontani pobačaj, kao i za oštećenu mušku plodnost.
English: • Thiocolchicoside-containing medicines are also available for application to the skin but these do not produce the same levels of M2 in the body and are not thought to affect the genetic material of cells.
Croatian: • Lijekovi koji sadrže tiokolhikozid također su dostupni za primjenu na koži, no ovi lijekovi ne stvaraju iste razine M2 u tijelu te se smatra da ne utječu na genetski materijal stanica.
English: The Italian medicines regulatory authority therefore requested the CHMP to carry out a full assessment of the benefit-risk balance of systemic medicines containing thiocolchicoside, and issue an opinion on whether their marketing authorisations should be maintained, varied, suspended or withdrawn across the European Union.
Croatian: Stoga je talijansko regulatorno tijelo za lijekove zatražilo od CHMP-a da provede potpunu ocjenu omjera koristi i rizika sistemskih lijekova koji sadrže tiokolhikozid te da izda mišljenje o tome treba li odobrenja za stavljanje tih lijekova u promet zadržati, izmijeniti, suspendirati ili povući na razini Europske unije.
English: • Medicines containing thiocolchicoside must never be taken if you are pregnant or breast-feeding.
Croatian: • Lijekovi koji sadrže tiokolhikozid ne smiju se uzimati ako ste trudni ili dojite.
English: • New evidence has shown that thiocolchicoside is broken down in the body into a substance called M2, which in sufficient amounts can affect the genetic material of the cells.
Croatian: • Novi dokaz je potvrdio da se tiokolhikozid razgrađuje u tijelu u tvar naziva M2, koja u dovoljnim količinama može utjecati na genetski materijal stanica.
English: The CHMP therefore recommended measures to ensure thiocolchicoside-containing medicines are used as safely as possible.
Croatian: Stoga je CHMP preporučio mjere kojima se osigurava što sigurnija primjena lijekova koji sadrže tiokolhikozid.
English: • In order to minimise the amount of M2 produced in the body, and therefore any associated risks, medicines containing thiocolchicoside are now only recommended for short-term use as an addition to other treatment for pain due to permanent tightening of the muscles where there are problems with the spine, in adults and teenagers from 16 years of age.
Croatian: • Kako bi se smanjila količina M2 koja se proizvodi u tijelu, te tako i svi povezani rizici, lijekovi koji sadrže tiokolhikozid sada su preporučeni samo za kratkotrajnu primjenu kao dodatak uz druga liječenja protiv boli zbog trajnog zatezanja mišića u slučajevima kada postoje problemi s kralježnicom u odraslih osoba i adolescenata u dobi od 16 godina i starijih.
English: Preclinical studies indicated that the thiocolchicoside metabolite 3demethylthiocolchicine (M2, SL59.0955) may be associated with aneuploidy (abnormal chromosome number and loss of heterozygosity) in dividing cells, at levels of exposure not much greater than those achieved in the body with maximum recommended oral doses.
Croatian: Predklinička ispitivanja ukazuju na to da se metabolit tiokolhikozida 3-demetiltiokolhicin (M2, SL59.0955) može povezati s aneuploidijom (abnormalnim brojem kromosoma i gubitkom heterozigosnosti) u stanica koje se dijele pri razinama izlaganja koje nisu veće od onih postignutih u tijelu s maksimalnim preporučenim peroralnim dozama.
English: • Patients being treated with systemic thiocolchicoside should have their treatment reviewed at the next scheduled appointment, and appropriate alternative treatments should be considered.
Croatian: • Terapija bolesnika liječenih sistemskim tiokolhikozidom treba biti pregledana pri sljedećem zakazanom pregledu te je potrebno razmotriti odgovarajuća alternativna liječenja.
English: The CHMP opinion was forwarded to the European Commission, which endorsed it and issued a final legally-binding decision, valid across the EU, on 17 January 2014.
Croatian: Mišljenje CHMP-a proslijeđeno je Europskoj Komisiji, koja ga je potvrdila i dana 17. siječnja 2014. donijela konačnu pravno obvezujuću odluku valjanu na razini EU-a.
English: Patients who are taking thiocolchicoside for a long-term condition should have their treatment reviewed by their doctor at the next scheduled appointment.
Croatian: Bolesnici koji uzimaju tiokolhikozid za kronična stanja trebaju zatražiti od svog liječnika da pregleda njihovu terapiju pri sljedećem zakazanom pregledu.
English: These medicines are now recommended only as an add-on treatment for painful muscle contractures (permanent tightening of the muscle tissue) resulting from spinal conditions in adults and adolescents 16 years of age or older.
Croatian: Ovi su lijekovi sada preporučeni samo kao dodatna terapija za bolne mišićne kontrakture (trajno zatezanje mišićnog tkiva) koje su prouzročene stanjima kralježnice u odraslih osoba i adolescenata u dobi od 16 godina ili starijih.
English: • Systemic thiocolchicoside is recommended only as adjuvant treatment for acute muscle contractures in spinal pathology, for adults and adolescents from 16 years of age.
Croatian: • Sistemski tiokolhikozid preporučuje se samo kao dodatna terapija za akutne mišićne kontrakture u spinalnoj patologiji, za odrasle osobe i adolescente u dobi od 16 godina i starije.
English: • Thiocolchicoside is a medicine used in some EU countries for conditions associated with muscle pain.
Croatian: • Tiokolhikozid je lijek koji se primjenjuje u pojedinim državama članicama EU-a za stanja povezana s mišićnom boli.
English: The review of thiocolchicoside was triggered by the Italian medicines regulatory agency, AIFA, following new experimental evidence which suggested that thiocolchicoside was broken down in the body into a metabolite called M2 or SL59.0955 that could damage dividing cells, resulting in aneuploidy (an abnormal number or arrangement of chromosomes).
Croatian: Pregled tiokolhikozida pokrenula je talijansko regulatorno tijelo za lijekove, AIFA, nakon novog eksperimentalnog dokaza koji je ukazao na razgradnju tiokolhikozida u tijelu u metabolit naziva M2 ili SL59.0955 koji može oštetiti stanice koje se dijele, što rezultira aneuploidijom (abnormalnim brojem ili rasporedom kromosoma).
English: On 21 November 2013 the European Medicines Agency's Committee on Human Medicinal Products (CHMP) recommended that the authorised uses for thiocolchicoside-containing medicines for use by mouth or injection should be restricted across the European Union (EU).
Croatian: Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) pri Europskoj agenciji za lijekove preporučilo je da se odobrene primjene za lijekove koji sadrže tiokolhikozid za peroralnu primjenu ili injekciju trebaju ograničiti na razini Europske unije (EU).
English: In addition, the dose of thiocolchicoside by mouth or injection should be restricted.
Croatian: Nadalje, treba ograničiti dozu tiokolhikozida koja se primjenjuje peroralno ili injekcijom.
English: The CHMP reviewed the evidence, including the opinions of experts in the field of medicines safety, and concluded that aneuploidy could occur with M2 at levels not much greater than those seen after recommended doses of thiocolchicoside taken by mouth.
Croatian: CHMP je pregledao dokaz, uključujući i mišljenja stručnjaka s područja sigurne primjene lijekova, te je zaključio da aneuploidija može nastupiti kod razina metabolita M2 koje nisu mnogo više od onih uočenih s preporučenim dozama tiokolhikozida koji se primjenjuje peroralno.
English: Thiocolchicoside is used as a muscle relaxant in the treatment of painful muscular conditions.
Croatian: Tiokolhikozid se primjenjuje kao mišićni relaksans u liječenju bolnih mišićnih stanja.
English: Thiocolchicoside is a muscle relaxant that has been authorised by national procedures in several EU Member States1 for use by mouth or injection into the muscles in the treatment of painful muscular disorders.
Croatian: Tiokolhikozid je mišićni relaksans koji je odobren za primjenu nacionalnim postupcima u nekoliko država članica EU-a1 za peroralnu primjenu ili injekciju u mišiće za potrebe liječenja bolnih mišićnih poremećaja.
English: This followed new evidence from experimental studies carried out by a marketing authorisation holder which suggested an effect on chromosomes by a metabolite of thiocolchicoside.
Croatian: Postupak je pokrenut nakon novog dokaza iz eksperimentalnih ispitivanja koja su proveli nositelji odobrenja za stavljanje lijeka u promet, što je ukazalo na djelovanje metabolita tiokolhikozida na kromosome.
English: Preparations for local application to the skin, which do not produce substantial levels of M2 in the body, are not affected by this review.
Croatian: Ovim pregledom nisu obuhvaćeni pripravci za lokalnu primjenu na koži, koji ne stvaraju značajne razine M2 u tijelu.
English: • Pharmacists should refer any patients who present a repeat prescription to their treating physician.
Croatian: • Ljekarnici kojima bolesnik dostavi ponovljeni recept moraju uputiti te bolesnike njihovom ordinirajućem liječniku.
English: Annex I List of the names, pharmaceutical forms, strength of the medicinal products, routes of administration, Marketing Authorisation Holders in the Member States
Croatian: Popis naziva, farmaceutskih oblika, jačina lijekova, putova primjene, nositelja odobrenja u državama članicama
English: Concentrate for solution for injection / infusion
Croatian: Koncentrat za otopinu za injekciju / infuziju
English: 25, Boulevard de l'Amiral Bruix F-75016
Croatian: Francuska MEDA Pharma S.A.S. 25, Boulevard de l'Amiral Bruix F-75016
English: MEDA Pharma S.A.S.
Croatian: MEDA Pharma S.p.A.
English: MEDA Pharma S.A.U.
Croatian: Španjolska MEDA Pharma S.A.U.
English: Concentrate for solution for infusion or solution for intrapleural or intraperitoneal use
Croatian: Koncentrat za otopinu za infuziju ili otopina za primjenu u šupljinu plućne maramice ili u trbušnu šupljinu
English: Elsep 2 mg/ml, solution à diluer pour perfusion
Croatian: 2 mg/ml, solution à diluer pour perfusion
English: MEDA Pharma S.p.A. Viale Brenta 18 IT-20139
Croatian: Felice Casati, 20 IT-20124
English: Intravenous use Intrapleural use Intraperitoneal use
Croatian: U šupljinu plućne maramice
English: However, the analyses are based on a limited number of women, especially in the highest body weight/BMI categories, which subsequently result in very wide and overlapping 95% confidence limits.
Croatian: No, analize se temelje na ograničenom broju žena, posebice u kategorijama s najvišom tjelesnom težinom/BMIom, što posljedično rezultira vrlo širokim i preklapajućim 95% ograničenjima pouzdanosti.
English: Annex IV Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
Croatian: Dodatak IV Znanstveni zaključci i razlozi za izmjenu uvjeta odobrenja za stavljanje proizvoda u promet
English: 2 von Hertzen H et al. Low dose mifepristone and two regimens of levonorgestrel for emergency contraception: a WHO multicentre randomised trial.
Croatian: Low dose mifepristone and two regimens of levonorgestrel for emergency contraception: a WHO multicentre randomised trial.
English: All together, the current data are considered not robust enough to support the current recommendation of decreased efficacy in women with body weight above 75 kg and inefficacy in women with body weight above 80 kg as is currently included in the product information of one
Croatian: Sveukupno, aktualni podaci se ne smatraju dovoljno čvrstima kako bi se podržale aktualne preporuke za smanjenu djelotvornost u žena s tjelesnom težinom većom od 75 kg i nedjelotvornosti u žena s tjelesnom težinom većom od 80 kg kako je trenutno uključeno u informacije o proizvodu jednog hitnog kontraceptiva koji sadrži LNG (Norlevo).
English: 4 Creinin MD et al. Progesterone receptor modulator for emergency contraception: a randomized controlled trial.
Croatian: Progesterone receptor modulator for emergency contraception: a randomized controlled trial.
English: Table 1: Meta-analysis on three WHO studies (Von Hertzen et al., 1998 and 2002; Dada et al.,
Croatian: Tabela 1.: Meta-analiza tri WHO ispitivanja (Von Hertzen et al., 1998. i 2002.; Dada et al., 2010.)
English: In contrast, in the two comparative studies of Creinin and colleagues (2006) and Glasier and colleagues (2010), primarily including Caucasian women, a reduced contraceptive efficacy was observed with increasing body weight or BMI (Table
Croatian: Nasuprot tome, u dva usporedba ispitivanja provedena od strane Creinin i kolega (2006.) te Glasier i kolega (2010.), koja su prvenstveno obuhvaćala bjelkinje, uočena je smanjena učinkovitost kontraceptiva u slučaju
English: Both meta-analyses excluded intake later than 72 hours after unprotected intercourse (i.e. offlabel use of LNG) and women who had further acts of unprotected intercourse.
Croatian: Obje meta-analize isključuju unos lijeka nakon 72 sata nakon nezaštićenog odnosa (odnosno uporaba LNG-a mimo indikacija) i u žena koje i dalje prakticiraju nezaštićene seksualne odnose.
English: The Committee, as a consequence, concluded that the benefit-risk balance of emergency contraceptive medicinal products containing LNG or UPA remains positive, subject to the warnings and changes to the product information agreed.
Croatian: Stoga je Povjerenstvo zaključilo da omjer koristi i rizika hitnih kontraceptiva koji sadrže LNG ili UPA ostaje pozitivan, što je predmetom usuglašenih upozorenja i izmjena u informacijama o proizvodu.
English: Lancet, 2002; 360: 1803-10 3 Dada OA et al. A randomized, double-blind, noninferiority study to compare two regimens of levonorgestrel for emergency contraception in Nigeria.
Croatian: A randomized, double-blind, noninferiority study to compare two regimens of levonorgestrel for emergency contraception in Nigeria.
English: Aristo Pharma GmbH Wallenroder Strasse 8-10 D-13435 Berlin Germany
Croatian: Aristo Pharma GmbH Wallenroder Strasse 8-10 D-13435 Berlin Njemačka
English: (Invented) Name Strength Pharmaceutica l form
Croatian: Jačina Farmaceutski oblik
English: Applicant
Croatian: Diotop
English: Diotop 75 mg / 20 mg modified release hard capsules
Croatian: 75 mg / 20 mg tvrde kapsule s prilagođenim oslobađanjem
English: Talk to your doctor for further information.
Croatian: Obratite se svom liječniku za dodatne informacije.
English: The events were most frequently reported during the first months on treatment.
Croatian: Događaji su najčešće prijavljivani tijekom prvih mjeseci liječenja.
English: If you forgot to inject a dose and:
Croatian: Ako ste zaboravili injicirati dozu i:
English: once weekly
Croatian: jedanput na tjedan
English: • You can give yourself the injection at any time of the day - regardless of meals.
Croatian: • Injekciju si možete dati u bilo koje doba dana, bez obzira na obroke.
English: The treatment difference appeared early and persisted throughout the trial.
Croatian: Razlika u liječenju javila se rano i trajala je tijekom cijelog ispitivanja.
English: Atorvastatin Cmax was decreased by 38%.
Croatian: Cmax atorvastatina smanjio se za 38%.
English: If you wish to become pregnant, you should stop using this medicine at least two months in advance.
Croatian: Ako želite zatrudnjeti, trebali biste prestati uzimati ovaj lijek najmanje dva mjeseca prije.
English: Your doctor may reduce your dose of these medicines before you start using this medicine.
Croatian: Liječnik Vam može smanjiti dozu ovih lijekova prije nego započnete s primjenom ovog lijeka.
English: Patients with event (%)
Croatian: Bolesnici s događajem (%)
English: Ozempic is to be administered once weekly at any time of the day, with or without meals.
Croatian: Ozempic se primjenjuje jedanput na tjedan u bilo koje doba dana, s ili bez obroka.
English: Then inject your next dose as usual on your scheduled day.
Croatian: Potom injicirajte sljedeću dozu kao i obično na odabrani dan.
English: These reactions have usually been mild.
Croatian: Te su reakcije obično bile blage.
English: • change in the way food or drink tastes
Croatian: • promjena okusa hrane ili pića
English: How much solution is left
Croatian: Koliko je otopine preostalo
English: This was assessed not to be clinically relevant.
Croatian: Procjenjeno je da to nije klinički značajno.
English: It is important that you drink plenty of fluids to prevent dehydration.
Croatian: Važno je piti puno tekućine kako bi se izbjegla dehidracija.
English: In total 98% of the patients completed the trial and the vital status was known at the end of the trial for 99.6% of the patients.
Croatian: Ukupno 98% bolesnika završilo je ispitivanje, a podaci o vitalnom statusu na kraju ispitivanja bili su poznati za 99,6% bolesnika.
English: • You should use this medicine once a week on the same day each week if possible.
Croatian: • Ovaj lijek se primjenjuje jedanput na tjedan istog dana u tjednu ako je to moguće.
English: The relevance for humans is considered to be low, but cannot be completely excluded.
Croatian: Važnost tih nalaza za ljude smatra se malom, ali se ne može u potpunosti isključiti.
English: The mean duration of diabetes was 13.9 years.
Croatian: Srednja vrijednost trajanja šećerne bolesti iznosila je 13,9 godina.
English: The day of weekly administration can be changed if necessary as long as the time between two doses is at least 3 days (>72 hours).
Croatian: Dan tjedne primjene može se po potrebi promijeniti ako je vrijeme između dvije doze najmanje 3 dana (>72 sata).
English: Using the wrong medicine could cause severe harm to your health.
Croatian: Primjena pogrešnog lijeka može teško naštetiti Vašem zdravlju.
English: This is normal, but you must still check the flow, if you use a new pen for the first time.
Croatian: To je normalno, ali ipak morate provjeriti protok ako prvi put upotrebljavate novu brizgalicu.
English: Gender, race and ethnicity
Croatian: Spol, rasa i etničko porijeklo
English: Other secondary endpoints All cause death
Croatian: Druge sekundarne mjere ishoda Smrt zbog bilo kojeg uzroka
English: If you become pregnant when using this medicine, talk to your doctor right away, as your treatment will need to be changed.
Croatian: Ako zatrudnite dok uzimate ovaj lijek, odmah se obratite svom liječniku jer će biti potrebno promijeniti Vaše liječenje.
English: These patients should be monitored closely and treated according to clinical guidelines.
Croatian: Te je bolesnike potrebno pažljivo nadzirati i liječiti u skladu s kliničkim smjernicama.
English: This medicine is not recommended in children and adolescents under 18 years as the safety and efficacy in this age group have not yet been established.
Croatian: Primjena ovog lijeka se ne preporučuje u djece i adolescenata mlađih od 18 godina jer sigurnost i djelotvornost u tim dobnim skupinama nisu još ustanovljene.
English: What Ozempic is and what it is used for
Croatian: Što je Ozempic i za što se koristi
English: The safety and efficacy of semaglutide in children and adolescents below 18 years have not yet been established.
Croatian: Sigurnost i djelotvornost semaglutida u djece i adolescenata mlađih od 18 godina nisu još ustanovljene.
English: The events led to treatment discontinuation in 3.9% and 5% of patients.
Croatian: Događaji su doveli do prekida liječenja u 3,9% i 5% bolesnika.
English: Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines, including herbal medicines or other medicines you bought without a prescription.
Croatian: Obavijestite svog liječnika, ljekarnika ili medicinsku sestru ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući biljne lijekove ili druge lijekove koje ste kupili bez recepta.
English: • severe allergic reactions (anaphylactic reactions).
Croatian: • teške alergijske reakcije (anafilaktičke reakcije).
English: Change the needle as described in step 5 ‘After your injection' and repeat all steps starting with step 1 ‘Prepare your pen with a new needle'.
Croatian: Promijenite iglu kako je opisano u 5. koraku „Nakon injiciranja“ i ponovite sve korake počevši od 1. koraka „Pripremite brizgalicu s novom iglom“.
English: The warning signs of low blood sugar may come on suddenly.
Croatian: Znakovi upozorenja na nisku razinu šećera u krvi mogu se pojaviti iznenada.
English: If you stop using it, your blood sugar levels may increase.
Croatian: Ako ga prestanete primjenjivati, razina šećera u krvi može se povisiti.
English: - In this case, you have not received any medicine - even though the dose counter has moved from the original dose that you have set.
Croatian: - U tom slučaju niste primili nimalo lijeka - iako se brojčanik doze pomaknuo s početne doze koju ste odabrali.
English: Maximum concentration was reached 1 to 3 days post dose.
Croatian: Maksimalna koncentracija postignuta je 1 do 3 dana nakon doziranja.
English: Do not stop using this medicine without talking to your doctor.
Croatian: Nemojte prestati primjenjivati ovaj lijek bez razgovora s liječnikom.
English: If you are pregnant or breast-feeding, think you might be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego uzmete ovaj lijek.