FrancophonIA/ELRC3.0 huggingface dataset:
English: This recommendation is also supported by the inconsistency of recognition and professional rights of chiropodist profession across EU.
Croatian: Ovu preporuku također potkrepljuju i nedosljednosti u pogledu priznavanja zvanja pedikera i njihovih profesionalnih prava na području EU-a.
English: If sedatives are used to reduce patient anxiety, lower doses of the anaesthetic should be used, since there is increased risk of adverse effects when central nervous system (CNS) depressants are combined.
Croatian: Ako se primjenjuju sedativi radi ublažavanja anksioznosti bolesnika, potrebne su niže doze anestetika zbog povećanog rizika od štetnih učinaka prilikom kombinirane primjene depresora središnjeg živčanog sustava.
English: The CHMP noted that there is literature evidence that mepivacaine provides vasoconstrictive features compared with anaesthetics from other pharmaceutical groups, however this cannot consist an indication itself.
Croatian: CHMP je uočio da postoje dokazi u literaturi da mepivakain u usporedbi s anesteticima iz drugih farmaceutskih skupina ima vazokonstrikcijski efekt, međutim to samo po sebi ne može činiti indikaciju.
English: The CHMP considers that the data submitted in support of the chiropody procedures indication are not adequate to establish the efficacy of using mepivacaine for all chiropody applications and recommended the deletion of this indication.
Croatian: CHMP smatra da podatci dostavljeni u prilog indikacije za primjenu prilikom tretmana pedikure nisu odgovarajući za utvrđivanje djelotvornosti mepivakaina u svim primjenama pedikure te je preporučio brisanje ove indikacije.
English: The MAH proposed harmonised dosing recommendations based on the doses studied in clinical trials and supported by pharmacodynamic and pharmacokinetic data and in line with international, European and national guidelines.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet iznio je prijedlog usklađenih preporuka o dozama na temelju doza ispitanih u kliničkim ispitivanjima koje podupiru farmakodinamički i farmakokinetički podatci, te u skladu s međunarodnim, europskim i nacionalnim smjernicama.
English: A harmonised version of section 4.8 of adverse events has been agreed by the CHMP after assessing data from global pharmacovigilance database and literature and in line with data assessed in previous periodic update assessment reports (PSURs).
Croatian: CHMP je dao suglasnost u pogledu usklađene verzije odjeljka 4.8 o nuspojavama nakon ocjenjivanja podataka iz globalne baze podataka o farmakovigilanciji i literature te u skladu s podatcima koji su ocijenjeni u prethodnim periodičkim izvješćima o neškodljivosti lijeka (PSURs).
English: Thus, local anaesthetics should not be used in epileptic patients whose seizures are poorly controlled.
Croatian: Zbog toga lokalne anestetike ne bi trebalo primjenjivati u bolesnika s epilepsijom u kojih napadaji nisu odgovarajuće kontrolirani.
English: The revised therapeutic indications in section 4.1 of the SmPC are:
Croatian: Revidirane terapijske indikacije u odjeljku 4.1 sažetka opisa svojstava lijeka jesu:
English: Therefore, the CHMP recommended that the statement regarding mepivacaine's use when vasoconstrictor is contraindicated should be moved from section 4.1 to 5.1 (pharmacodynamic properties) of the SmPC.
Croatian: Stoga je CHMP preporučio da se izjava u pogledu primjene mepivakaina kada je primjena vazokonstriktora kontraindicirana prebaci iz odjeljka 4.1 u odjeljak 5.1 (farmakodinamička svojstva) sažetka opisa svojstava lijeka.
English: {(Invented) name and associated names, strength pharmaceutical form} is a local anaesthetic indicated for the local and loco-regional anaesthesia in dental surgery in adults, adolescents and children above 4 years of age (c.a.
Croatian: {(Novoizumljeno) ime i pridružena imena, jačina, farmaceutski oblik} je lokalni anestetik indiciran za lokalnu i lokoregionalnu anesteziju prilikom stomatoloških zahvata u odraslih osoba, adolescenata i djece u dobi od četiri godine i starije (iznad 20 kg tjelesne težine).
English: Mepivacaine was first approved in 1960 by the US Food and Drug Administration.
Croatian: Prvo odobrenje mepivakaina izdala je 1960.
English: The CHMP agreed on a common wording, on fertility, pregnancy and lactation (section 4.6) with data supported from pre-clinical studies.
Croatian: CHMP je dao suglasnost u pogledu teksta o plodnosti, trudnoći i dojenju (odjeljak 4.6) i podataka koji se temelje na pretkliničkim ispitivanjima.
English: Module 3 - Quality
Croatian: Modul 3 - Kakvoća
English: • The Committee considered the identified divergences for Scandonest and associated names, for the indications, posology, contraindications, special warnings and precaution for use, as well as the remaining sections of the SmPC, labelling and package leaflet;
Croatian: • Odbor je razmotrio utvrđene različitosti u pogledu indikacija, doziranja, kontraindikacija, posebnih upozorenja i mjera opreza pri uporabi te preostale odjeljke sažetka opisa svojstava lijeka, označivanje i uputu o lijeku za lijek Scandonest i pridružena imena;
English: The CHMP concluded that the benefit-risk balance of Scandonest and associated names remains favourable, subject to the agreed changes to the product information.
Croatian: CHMP je zaključio da omjer koristi i rizika za lijek Scandonest i pridružena imena ostaje povoljan pod uvjetom da se u informacije o lijeku unesu dogovorene izmjene.
English: The recommended posology in children of an average 0.75 mg (0.025 ml) of mepivacaine solution per kg of body weight is in line with the work-sharing procedure led by EMA in 2010 in accordance with Article 45 of the Paediatric Regulation 1901/2006 (AT/W/0002/pdWS/001).
Croatian: Preporučeno doziranje u djece u prosjeku iznosi 0,75 mg (0,025 ml) otopine mepivakaina po kilogramu tjelesne težine te je u skladu s postupkom razmjene podataka koji je, u koordinaciji EMA-e, proveden 2010. sukladno članku 45.
English: Other warnings not related with the above categories were harmonised, such as for patients with coagulation disorder and coadministration of antiplatelet/anticoagulant medicines.
Croatian: Usklađena su druga upozorenja koja nisu povezana s navedenim kategorijama, primjerice u slučaju bolesnika s poremećajem zgrušavanja krvi i istodobne primjene antitrombocitnih lijekova ili antikoagulansa.
English: A harmonised description of the symptoms and the management of overdose has been agreed in accordance with the EMA SmPC guideline (2009).
Croatian: Dogovoren je usklađen opis simptoma i liječenja predoziranja u skladu sa smjernicama EMA-e o sažetku opisa svojstava lijeka (2009.).
English: The statement regarding the risk of possible accumulation of the product leading to toxicity in special populations (elderly and patients with renal and hepatic impairment) has been however endorsed by the CHMP.
Croatian: Međutim, CHMP je prihvatio izjavu u pogledu rizika od moguće akumulacije lijeka koja u posebnih populacija dovodi do toksičnosti (starije osobe i bolesnici s oštećenom funkcijom jetre ili bubrega).
English: Information for medical staff on how to avoid a blood vessel penetration during injection as well as instructions to avoid injections to inflamed or infected tissues are maintained in the SmPC.
Croatian: Zadržane su informacije za medicinsko osoblje u sažetku opisa svojstava lijeka o tome kako izbjeći ulazak igle u krvnu žilu tijekom ubrizgavanja, kao i upute o izbjegavanju davanja injekcija u upaljeno ili zaraženo tkivo.
English: Mepivacaine is contraindicated in patients with a history of hypersensitivity to the product, to any other amide anaesthetics or to any of the excipients.
Croatian: Primjena mepivakaina kontraindicirana je u bolesnika s anamnezom preosjetljivosti na lijek, na bilo koji drugi anestetik amidnog tipa ili na neku od pomoćnih tvari.
English: Labelling and Package Leaflet
Croatian: Označivanje i uputa o lijeku
English: The finished product is presented as a solution for injection containing 30 mg/ml of mepivacaine hydrochloride as active substance.
Croatian: Gotov lijek dostupan je u obliku otopine za injekciju koja sadrži 30 mg/ml djelatne tvari mepivakain hidroklorida.
English: Changes introduced in the SmPC were consistently reflected in the labelling, with some sections left to be completed nationally.
Croatian: Izmjene sažetka opisa svojstava lijeka dosljedno su se odražavale u označivanju, a sadržaj nekih odjeljaka određivao se na nacionalnoj razini.
English: Consequently, metabolism and elimination of mepivacaine can be significantly altered by the presence of hepatic or renal diseases.
Croatian: Slijedom toga, bolesti jetre ili bubrega mogu znatno izmijeniti metaboliziranje i eliminaciju mepivakaina.
English: Therefore, mepivacaine is contraindicated in patients with atrioventricular disorders not compensated by a pacemaker.
Croatian: Stoga je mepivakain kontraindiciran u bolesnika s atrioventrikularnim poremećajima koji nisu regulirani elektrostimulatorom srca.
English: Grounds for the CHMP opinion
Croatian: Razlozi za mišljenje CHMP-a Budući da:
English: • In addition, the Committee reviewed the documentation submitted by the MAH in support of the proposed harmonised Quality documentation (Module 3);
Croatian: • Nadalje, Odbor je pregledao dokumentaciju koju je u prilog predloženog usklađivanja dokumentacije o kakvoći (Modul 3) dostavio nositelj odobrenja za stavljanje lijeka u promet.
English: As the drug concentration rises in the brain, the excitatory pathways are inhibited and CNS depression occurs.
Croatian: S porastom koncentracije lijeka u mozgu dolazi do inhibicije ekscitatornih putova i nastanka depresije središnjeg živčanog sustava.
English: As a result of the review of mepivacaine during a worksharing procedure in accordance to Article 45 of Regulation No 1901/2006, in 2010, the use of mepivacaine is contraindicated in children below 4 years of age (and less than 20kg of body weight).
Croatian: Uredbe br. 1901/2006, primjena mepivakaina kontraindicirana je u djece mlađe od četiri godine (i s tjelesnom težinom manjom od 20 kg).
English: The CHMP recommended the variation to the terms of the marketing authorisations for which the summary of product characteristics, labelling and package leaflets are set out in Annex III for Scandonest and associated names (see Annex I).
Croatian: CHMP je preporučio izmjene uvjeta odobrenja za stavljanje lijeka u promet za koje su sažetak opisa svojstava lijeka, označivanje i uputa o lijeku utvrđeni u Prilogu III. za lijek Scandonest i pridružena imena.
English: 20 kg of body weight).
Croatian: - Djeca mlađa od četiri godine (i s manje od 20 kg tjelesne težine).
English: On 25 August 2017 Septodont on behalf of all marketing authorisation holders (MAHs) presented to the European Medicines Agency a referral under Article 30 of Directive 2001/83/EC, in order to harmonise the national summary of product characteristics (SmPC), labelling, package leaflet and quality Module 3 of the medicinal products Scandonest and associated names (see Annex I of CHMP opinion).
Croatian: Direktive 2001/83/EZ radi usklađivanja nacionalnog sažetka opisa svojstava lijeka, označivanja, upute o lijeku i modula o kakvoći (Modul 3) za lijek Scandonest i pridružena imena (vidjeti Prilog I. mišljenju CHMP-a).
English: The CHMP deemed the submitted evidence adequate to support the indication in adults and in children from 4 years of age (ca. 20 kg body weight).
Croatian: Nositelj odobrenja za stavljanje lijeka u promet dostavio je sažetak iz literature i ispitivanja kako bi potkrijepio indikaciju „anestezija u stomatološkim zahvatima” CHMP smatra da su dostavljeni odgovarajući dokazi kako bi se potkrijepila navedena indikacija u odraslih osoba i djece u dobi od četiri godine i starije (iznad 20 kg tjelesne težine).
English: Therefore, the CHMP concluded in the inclusion of the contraindications summarised below: - Hypersensitivity to the active substance (or any local anaesthetics agent of the amide type) or to any of the excipients listed in section 6.1, - Children below 4 years of age (ca. 20 kg body weight), - Severe disorders of atrioventicular conduction not compensated by pace maker, - Poorly controlled epileptic patient.
Croatian: Stoga je CHMP odlučio uvrstiti kontraindikacije navedene u nastavku: - Preosjetljivost na djelatnu tvar (ili na bilo koji drugi agens iz lokalnog anestetika amidnog tipa) ili neku od pomoćnih tvari navedenih u odjeljku 6.1.
English: Section 4.2 - Posology and methods of administration Posology
Croatian: Odjeljak 4.2 - Doziranje i način primjene
English: The package leaflet (PL) was amended in accordance with the changes made to the SmPC.
Croatian: Uputa o lijeku izmijenjena je u skladu s izmjenama sažetka opisa svojstava lijeka.
English: The additional risk becomes clear within a few years.
Croatian: Dodatni rizik postaje jasan u roku od nekoliko godina.
English: You are advised to:
Croatian: Savjetuje Vam se da:
English: Regularly check your breasts.
Croatian: Redovito provjeravajte svoje dojke.
English: This applies to the following medicines:
Croatian: To se odnosi na sljedeće lijekove:
English: There is no specific antidote.
Croatian: Ne postoji specifičan antidot.
English: Your doctor may decide to perform a physical examination.
Croatian: Liječnik može odlučiti obaviti fizikalni pregled.
English: Treatment should not be restarted until the woman is completely mobilised.
Croatian: Liječenje ne treba ponovno započeti sve dok žena ne bude potpuno pokretna.
English: If you are having an operation
Croatian: Ako idete na operaciju
English: Therapy should then be continued as before.
Croatian: Liječenje potom treba nastaviti kao prije.
English: The recommended dose is one tablet once daily.
Croatian: Preporučena doza je jedna tableta jedanput na dan.
English: County Kildare Ireland
Croatian: County Kildare Irska
English: If you notice any of the following:
Croatian: Ako primijetite bilo što od sljedećeg:
English: This medicine is not for use in children and adolescents below 18 years old.
Croatian: Ovaj lijek nije namijenjen za primjenu u djece i adolescenata mlađih od 18 godina.
English: • if you have cancer.
Croatian: • ako imate rak.
English: • if you become pregnant
Croatian: • ako zatrudnite
English: The experience treating women older than 65 years is limited.
Croatian: Iskustvo u liječenju žena starijih od 65 godina je ograničeno.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Croatian: 4.5 Interakcija s drugim lijekovima i drugi oblici interakcija
English: Speak to your doctor if you think this dose is too strong or not strong enough.
Croatian: Obratite se svom liječniku ako smatrate da je doza prejaka ili nije dovoljno jaka.
English: Ask your doctor when you can start taking this medicine again.
Croatian: Pitajte svog liječnika kad možete početi ponovno uzimati ovaj lijek.
English: Do not take this medicine if you are pregnant, or if you think you might be pregnant.
Croatian: Ne uzimajte ovaj lijek ako ste trudni ili mislite da biste mogli biti trudni.
English: • any of the conditions mentioned under ‘Do not take DUAVIVE'
Croatian: • bilo koje od stanja navedenih u dijelu „Nemojte uzimati DUAVIVE”
English: • if you are unable to walk for a long time because of major surgery, injury or illness (see also section 3, if you need to have surgery)
Croatian: • ako ne možete hodati dulji period zbog veće operacije, ozljede ili bolesti (pogledajte također dio 3., ako trebate na operaciju)
English: DUAVIVE is used for:
Croatian: DUAVIVE se koristi za:
English: The occurrence of such a reaction is more likely in the first year of treatment.
Croatian: Pojava takve reakcije vjerojatnija je u prvoj godini liječenja.
English: You can take the tablet at any time of the day, with or without food; however, it is advisable to take your tablet at the same time each day as this will help to remind you to take your medicine.
Croatian: Tabletu možete uzeti u bilo koje vrijeme dana, sa ili bez hrane; savjetuje se, međutim, uzimati tabletu u isto vrijeme svaki dan jer će Vam to pomoći da ne zaboravite uzeti lijek.
English: Free or biological active hormone concentrations are unchanged.
Croatian: Koncentracije slobodnih ili biološki aktivnih hormona ostaju nepromijenjene.
English: However, it returns to normal within a few years (at most 5) after stopping treatment.
Croatian: Međutim, vraća se u normalu u roku od nekoliko godina (najviše 5) nakon prestanka liječenja.
English: No overall differences in safety or efficacy were observed between women aged >65 years and younger women, but greater sensitivity of some older individuals cannot be ruled out.
Croatian: Ukupne razlike u sigurnosti i djelotvornosti nisu uočene u žena u dobi >65 godina i mlađih žena, no ne može se isključiti veća osjetljivost nekih starijih bolesnica.
English: In all cases, a careful appraisal of the risks and benefits should be undertaken at least annually, and treatment should only be continued as long as the benefit outweighs the risk.
Croatian: U svim slučajevima najmanje jedanput na godinu dana treba pažljivo procijeniti rizike i koristi, a liječenje treba nastaviti samo dok je korist veća od rizika.
English: The absolute bioavailability of BZA is approximately 6%.
Croatian: Apsolutna bioraspoloživost BZA otprilike je 6%.
English: CE/BZA can be administered with or without food.
Croatian: KE/BZA se može primijeniti sa ili bez hrane.
English: Free T4 and free T3 concentrations are unaltered.
Croatian: Koncentracije slobodnog T4 i T3 ostaju nepromijenjene.
English: In order for this medicine to work, it should be taken daily as prescribed.
Croatian: Kako bi ovaj lijek djelovao, treba ga uzimati svaki dan onako kako Vam je propisano.
English: • migraine-like headaches which happen for the first time
Croatian: • glavobolje nalik migreni koje se javljaju prvi put
English: Relief of menopausal symptoms was achieved during the first few weeks of treatment.
Croatian: Ublažavanje simptoma menopauze postignuto je tijekom prvih nekoliko tjedana liječenja.
English: Conditions which need supervision
Croatian: Stanja koja zahtijevaju nadzor
English: BZA is eliminated with a half-life of approximately 30 hours.
Croatian: BZA se eliminira s poluvijekom od otprilike 30 sati.
English: AUCss (nghr/mL)
Croatian: AUCss (ngh/ml)
English: Before you start taking this medicine, your doctor will ask you about your own and your family's medical history.
Croatian: Prije nego počnete uzimati ovaj lijek, liječnik će Vas ispitati o Vašoj vlastitoj i obiteljskoj povijesti bolesti.
English: Negligible (1%) amounts of BZA are eliminated in urine.
Croatian: Zanemariva (1%) količina BZA eliminirana je putem urina.
English: Swallow the tablet whole with a glass of water.
Croatian: Tabletu progutajte cijelu uz čašu vode.
English: Check with your doctor or pharmacist if you are not sure.
Croatian: Provjerite sliječnikom ili ljekarnikom ako niste sigurni.
English: What DUAVIVE is and what it is used for
Croatian: Što je DUAVIVE i za što se koristi
English: Call your doctor or pharmacist.
Croatian: Nazovite svog liječnika ili ljekarnika.
English: • any lumps you can see or feel
Croatian: • kvržice koje možete vidjeti ili napipati
English: Other things that can increase the risk of stroke include:
Croatian: Druge stvari koje mogu povećati rizik od moždanog udara su:
English: The relative risk does not change with age or time since menopause.
Croatian: Relativni rizik se ne mijenja s godinama niti s vremenom proteklim od menopauze.
English: What DUAVIVE looks like and contents of the pack
Croatian: Kako DUAVIVE izgleda i sadržaj pakiranja
English: EU/1/14/960/001 28 tablets
Croatian: EU/1/14/960/001 28 tableta
English: Oestrogen therapy will not prevent memory loss.
Croatian: Estrogenska terapija neće spriječiti gubitak pamćenja.
English: Once you have started this medicine you should see your doctor for regular check-ups (at least once a year).
Croatian: Kad počnete uzimati ovaj lijek trebate redovito odlaziti na liječničke preglede (najmanje jednom godišnje).
English: Your doctor will aim to prescribe the lowest dose to treat your symptom for as short as necessary.
Croatian: Vaš liječnik će nastoji prepisati najnižu dozu za liječenje Vaših simptoma tijekom što kraćeg razdoblja.
English: Pfizer Ireland Pharmaceuticals, Little Connell, Newbridge, County Kildare, Ireland.
Croatian: Pfizer Ireland Pharmaceuticals, Little Connell Newbridge, County Kildare, Irska.
English: Serious venous thromboembolic events may occur rarely (less than 1 case per 1,000 patients).
Croatian: Događaj ozbiljne venska tromboembolije može se pojaviti rijetko (manje od 1 na 1000 bolesnica).
English: Tmax (hr)
Croatian: Tmax (h)
English: • Increase in hair growth
Croatian: • Pojačani rast dlaka
English: Talk to your doctor if you have any concerns.
Croatian: Porazgovarajte sa svojim liječnikom ako Vas bilo što brine.
English: • if you have systemic lupus erythematosus (SLE).
Croatian: • ako imate sistemski eritemski lupus (SEL)
English: During the menopause, the amount of the oestrogen produced by a woman's body drops.
Croatian: Tijekom menopauze, razina estrogena proizvedenog u tijelu žene opada.
English: Reasons for immediate withdrawal of therapy
Croatian: Razlozi za trenutni prekid liječenja
English: These may be signs of a liver disease
Croatian: To mogu biti znakovi bolesti jetre.
English: If any of the following conditions are present, have occurred previously, and/or have been aggravated during pregnancy or previous hormone treatment, the patient should be closely supervised.
Croatian: Ako je bilo koje od sljedećih stanja prisutno, prethodno je nastupilo i/ili se pogoršalo tijekom trudnoće ili prethodnog hormonskog liječenja, bolesnicu se mora pomno nadzirati.
English: Talk to your doctor before taking this medicine if you have ever had any of the following problems, as these may return or become worse during treatment with DUAVIVE.
Croatian: Obratite se svom liječniku prije nego uzmete ovaj lijek ako ste ikada imali neki od sljedećih problema, jer se mogu ponovno pojaviti ili pogoršati tijekom liječenja lijekom DUAVIVE.
English: If you feel drowsy after taking this medicine, you should avoid driving or operating machines.
Croatian: Ako osjećate pospanost nakon uzimanja ovog lijeka, nemojte voziti ili upravljati strojevima.
English: • Difficulty wearing contact lenses
Croatian: • Poteškoće pri nošenju kontaktnih leća
English: Women should be advised what changes in their breasts should be reported to their doctor or nurse (see ‘Breast cancer' below).
Croatian: Ženama se mora savjetovati o kojim promjenama na dojkama moraju obavijestiti liječnika ili medicinsku sestru (vidjeti „Rak dojke“ u nastavku).
English: Tell your doctor if you have any medical problems or illnesses.
Croatian: Obavijestite svog liječnika ako imate neki zdravstveni problem ili bolest.
English: Medical examination/follow-up
Croatian: Liječnički pregled/praćenje
English: • if you are seriously overweight (BMI >30 kg/m
Croatian: • ako ste izrazito pretili (ITM >30 kg/m
English: The use of DUAVIVE carries risks, which need to be considered when deciding whether to start taking it, or whether to carry on taking it.
Croatian: Primjena lijeka DUAVIVE nosi sa sobom rizike koji se moraju uzeti u obzir kad se odlučuje o tome hoće li se primjena započeti ili nastaviti.
English: • Discolouration of the skin on the face or other parts of the body
Croatian: • Promjena boje kože na licu ili drugim dijelovima tijela
English: Pharmacotherapeutic group: Sex hormones and modulators of the genital system; estrogens, combinations with other drugs; ATC code: G03CC07
Croatian: Farmakoterapijska skupina: spolni hormoni i modulatori spolnog sustava; estrogeni, kombinacije s drugim lijekovima; ATK oznaka: G03CC07
English: Other medicines and DUAVIVE
Croatian: Drugi lijekovi i DUAVIVE
English: • drinking too much alcohol
Croatian: • prekomjerno konzumiranje alkohola
English: You may need to stop taking DUAVIVE about 4 to 6 weeks before the operation, to reduce the risk of a blood clot (see Blood clots in a vein).
Croatian: Možda ćete morati prestati uzimati lijek DUAVIVE otprilike 4 do 6 tjedana prije operacije kako bi se smanjio rizik od nastanka krvnih ugrušaka (vidjeti dio „Krvni ugrušci u venama“).