FrancophonIA/ELRC3.0 huggingface dataset:
English: Lesion mean ratio (95% CI)
Croatian: (95% CI)
English: Record date and location
Croatian: Zabilježite datum i mjesto injekcije
English: Each 94 microgram pre-filled pen contains 94 micrograms of peginterferon beta-1a in 0.5 mL solution for injection.
Croatian: Jedna napunjena brizgalica od 94 mikrograma sadrži 94 mikrograma peginterferona beta-1a u 0,5 ml otopine za injekciju.
English: Plegridy pre-filled syringe (see Figure A) Before Use - Parts of your Plegridy pre-filled syringe (Figure A)
Croatian: Prije primjene - dijelovi napunjene štrcaljke Plegridyja (slika A)
English: (may affect up to 1 in 10 people) - Feeling or being sick (nausea or vomiting) - Hair loss (alopecia) - Itchy skin (pruritus) - Increase in body temperature - Changes around the place you have injected such as swelling, inflammation, bruising, warmth,
Croatian: - povećanje tjelesne temperature - promjene oko mjesta injiciranja kao oteklina, upala, modrice, toplina, osip ili promjena boje
English: HR 95% CI P-value p=0.0383
Croatian: P-vrijednost p=0,0383
English: Read the instructions in section 7 “Instructions for injecting Plegridy pre-filled pen” at the end of this leaflet before you start using Plegridy.
Croatian: Pročitajte upute u dijelu 7 „Upute za ubrizgavanje Plegridyja u napunjenoj brizgalici“ na kraju ove
English: Hypothyroidism and hyperthyroidism have been observed with the use of interferon beta products.
Croatian: Tijekom primjene lijekova koji sadrže interferon beta uočena je pojava hipotireoze i hipertireoze.
English: Baseline characteristics
Croatian: srednja vrijednost omjera lezija
English: Plegridy pre-filled pen” before you start.
Croatian: Plegridyja s mjesta ubrizgavanja prije nego što ste potisnuli klip do kraja.
English: • If you see blood at your injection site, wipe it off with the gauze pad and apply an adhesive bandage or plaster
Croatian: • Ako opazite krv na mjestu injekcije,
English: HR 95% CI P-value p=0.0069
Croatian: P-vrijednost p=0,0069
English: Mean/Median disease duration (years) Mean number of relapses within the past 3 years 2.5 Mean EDSS score at baseline EDSS: Expanded Disability Status Scale Gd+: Gadolinium-enhancing
Croatian: Srednja vrijednost broja relapsa u prošle 3 godine 2,5 Srednja ocjena rezultata EDSS-a na početku
English: Gamma-glutamyltransferase increased
Croatian: proizvod enzima GTP-ciklohidrolaze
English: Hepatic injury
Croatian: Epileptički napadaj
English: Alopecia$
Croatian: - gubitak kose (alopecija)
English: Musculoskeletal and connective tissue disorders
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva mialgija vrlo često artralgija
English: Do not use the Plegridy pre-filled syringe if the liquid is coloured, cloudy, or has floating particles in it. o You might see air bubbles in the Plegridy medicine.
Croatian: ako je brizgalica slomljena ako je otopina obojena, zamućena ili u njoj možete vidjeti plutajuće čestice.
English: Pre-Filled Pen 125 mcg Multipack (without bluebox)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA MEĐUPAKIRANJU UNUTARNJA KUTIJA VIŠESTRUKOG PAKIRANJA Višestruko pakiranje napunjene brizgalice od 125 μg (bez plavog okvira)
English: As a result of these new measures:
Croatian: Te nove mjere znače sljedeće:
English: This means it must not be used in this patient group.
Croatian: To znači da se ne smije upotrebljavati za navedenu skupinu bolesnika.
English: The review of codeine when used for cough and cold in children was initiated in April 2014 at the request of the German medicines agency (BfArM), under Article 31 of Directive 2001/83/EC.
Croatian: Pregled primjene kodeina za liječenje kašlja i prehlade u djece pokrenut je u travnju 2014. godine na zahtjev njemačke agencije za lijekove (BfArM) na temelju članka 31. Direktive 2001/83/EZ.
English: High levels of morphine can lead to serious effects, such as breathing difficulties.
Croatian: Visoke razine morfina mogu dovesti do ozbiljnih posljedica kao što su poteškoće s disanjem.
English: 1 The CMDh is a medicines regulatory body representing the European Union (EU) Member States, Iceland, Liechtenstein and Norway.
Croatian: 1 CMDh je regulatorno je tijelo za lijekove koje zastupa države članice Europske unije (EU), Island, Lihtenštajn i Norvešku.
English: • If you or your child are being treated with codeine and have any questions or concerns about your treatment, speak to your doctor or pharmacist.
Croatian: • Ako se vi ili vaše dijete liječite kodeinom i imate pitanja ili nedoumice povezane s liječenjem, obratite se svojem liječniku ili ljekarniku.
English: The CMDh is a body representing EU Member States as well as Iceland, Lichtenstein and Norway, and is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
Croatian: CMDh je tijelo koje zastupa države članice EUa te Island, Lihtenštajn i Norvešku, a odgovorno je za osiguravanje usklađenih sigurnosnih standarda za lijekove odobrene u okviru nacionalnih postupaka na području EU-a.
English: The review was carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), EMA's Committee responsible for the evaluation of safety issues for human medicines, which has made a set of recommendations.
Croatian: Pregled je proveo Odbor za procjenu rizika u području farmakovigilancije (PRAC), EMA-in odbor odgovoran za procjenu sigurnosnih pitanja u pogledu lijekova za humanu uporabu, koji je iznio niz preporuka.
English: Codeine is marketed as a single-ingredient medicine or in combination with other active substances.
Croatian: Kodein je stavljen u promet kao lijek s jednim sastojkom ili u kombinaciji s drugim aktivnim tvarima.
English: The new measures follow a review by EMA's Pharmacovigilance Risk Assessment Committee (PRAC).
Croatian: Nove se mjere nastavljaju na pregled koji je pripremio EMA-in Odbor za procjenu rizika u području farmakovigilancije (PRAC).
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom24 April 2015 EMA/249413/2015
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: As it was realised that similar considerations could apply to the use of codeine for cough and cold in children, a second EU-wide review of such use was started.
Croatian: Budući da se otkrilo da bi se slična razmatranja mogla primijeniti na primjenu kodeina za liječenje kašlja i prehlade u djece, pokrenut je drugi pregled takve primjene na razini EU-a.
English: In addition, children who already have problems with their breathing may be more susceptible to respiratory problems due to codeine.
Croatian: Osim toga, djeca koja već imaju problema s disanjem mogla bi biti osjetljivija na probleme s dišnim sustavom prouzročene kodeinom.
English: Some people convert codeine to morphine at a faster rate than normal, resulting in high levels of morphine in their blood.
Croatian: Neke osobe pretvaraju kodein u morfin brzinom većom od uobičajene, čime nastaju visoke razine morfina u njihovoj krvi.
English: The restrictions for codeine for cough and cold are largely in line with the previous recommendations for codeine when used for pain relief.
Croatian: Ograničenja primjene kodeina za liječenje kašlja i prehlade većinski su u skladu s prethodnim preporukama za kodein kada se upotrebljava za ublažavanje boli.
English: These new measures follow a review of available safety and efficacy data on codeine when used for cough and cold, including data from clinical studies, observational studies and meta-analyses, postmarketing data in Europe and other published literature on the use of codeine in children.
Croatian: Te nove mjere uslijedile su nakon pregleda dostupnih podataka o sigurnosti i učinkovitosti kodeina u liječenju kašlja i prehlade, uključujući podatke iz kliničkih ispitivanja, studija promatranja i metaanaliza, podataka nakon izdavanja odobrenja za stavljanje lijeka u promet u Europi i drugoj objavljenoj literaturi o primjeni kodeina u djece.
English: This review comes after a previous review of codeine for pain relief in children, which resulted in several restrictions being introduced in order to ensure that the medicine was used as safely as possible.
Croatian: Ovaj pregled napravljen je nakon prethodnog pregleda primjene kodeina za ublažavanje boli u djece koji je doveo do uvođenja određenih ograničenja kako bi se osigurala što je moguće sigurnija primjena lijeka.
English: In the EU, codeine-containing medicines have been approved via national procedures, and are available either on prescription or over the counter in the different Member States.
Croatian: U EU-u se lijekovi koji sadržavaju kodein odobravaju u okviru nacionalnih postupaka, a izdaju se na recept ili bez recepta u različitim državama članicama.
English: The CMDh1 has agreed by consensus new measures to minimise the risk of serious side effects, including breathing problems, with codeine-containing medicines when used for cough and cold in children.
Croatian: CMDh1 je konsenzusom donio nove mjere za smanjenje rizika od ozbiljnih nuspojava, uključujući probleme s disanjem, kod lijekova koji sadrže kodein kada se upotrebljavaju za liječenje kašlja i prehlade u djece.
English: Codeine is an opioid medicine that is converted into morphine in the body.
Croatian: Kodein je opioid koji se u tijelu pretvara u morfin.
English: As codeine-containing medicines are all authorised nationally, the PRAC recommendations were forwarded to the CMDh for its position.
Croatian: Budući da se lijekovi koji sadržavaju kodein odobravaju na nacionalnoj razini, preporuke PRAC-a proslijeđene su CMDh-u radi iznošenja mišljenja.
English: • Following an EU-wide review of codeine when used for cough and cold, changes have been made to the way the medicine is used to ensure that the benefits continue to outweigh the risks in children and adolescents.
Croatian: • Nakon pregleda primjene kodeina za liječenje kašlja i prehlade na razini EU-a promijenjen je način primjene lijeka kako bi se osiguralo da njegove dobrobiti nadilaze rizike za djecu i adolescente.
English: It is widely used for pain relief and for the treatment of the symptoms of coughs and colds.
Croatian: U širokoj je primjeni za ublažavanje boli i liječenje simptoma kašlja i prehlade.
English: In addition, the evidence that codeine is effective at treating cough in children is limited and international guidelines emphasise that cough associated with viral infections may be satisfactorily managed with fluids and increased ambient humidity; in the case of chronic cough, treatment should be directed at the underlying disease.
Croatian: Usto, postoji mali broj dokaza o učinkovitosti kodeina u liječenju kašlja u djece, a u međunarodnim se smjernicama ističe da se kašalj povezan s virusnim upalama može zadovoljavajuće liječiti tekućinama i povećanom količinom vlage u okolini; u slučaju kroničnog kašlja liječenje bi se trebalo usmjeriti na uzročnu bolest.
English: The PRAC also noted that cough and cold are generally self-limiting conditions and the evidence that codeine is effective at treating cough in children is limited.
Croatian: PRAC je također primijetio da su kašalj i prehlada u pravilu samoograničavajuća stanja, a postoji mali broj dokaza o učinkovitosti kodeina u liječenju kašlja u djece.
English: In total, 14 cases of codeine intoxication in children (aged from 17 days to 6 years) related to the treatment of cough and respiratory infection were identified in the published literature, four of which had a fatal outcome.
Croatian: U objavljenoj je literaturi u djece (u dobi od 17 dana do šest godina) utvrđeno ukupno 14 slučajeva trovanja kodeinom koja su povezana s liječenjem kašlja i respiratorne infekcije, a od toga su četiri bila smrtni slučajevi.
English: • Patients of all ages who are known to be ‘ultra-rapid metabolisers', which means that they convert codeine into morphine very rapidly, must not use codeine for cough and cold as they are more at risk of serious side effects with codeine.
Croatian: • Bolesnici svih dobi za koje je utvrđeno da su „vrlo brzi metabolizatori”, odnosno da vrlo brzo pretvaraju kodein u morfin, ne smiju upotrebljavati kodein za liječenje kašlja i prehlade jer su zbog kodeina u većem riziku od ozbiljnih nuspojava.
English: On 22 April 2015 the CMDh adopted its position by consensus, so the measures recommended by the PRAC will be directly implemented by the Member States where the medicines are authorised, according to an agreed timetable.
Croatian: Dana 22. travnja 2015. CMDh je konsenzusom donio mišljenje pa će se mjere koje je predložio PRAC, u skladu s dogovorenim rasporedom, izravno provoditi u državama članicama u kojima su lijekovi odobreni.
English: In addition to the new measures for children, codeine must also not be used in people of any age who are known to convert codeine into morphine at a faster rate than normal (‘ultra-rapid metabolisers') nor in breastfeeding mothers, as codeine can harm the baby because it passes into breast milk.
Croatian: Osim u djece u skladu s novim mjerama, kodein se također ne smije upotrebljavati u osoba bilo koje dobi za koje je utvrđeno da kodein pretvaraju u morfin brzinom većom od uobičajene („vrlo brzi metabolizatori”) te u dojilja jer kodein može naštetiti djetetu s obzirom na to da prelazi u majčino mlijeko.
English: • Codeine is also contraindicated in women during breastfeeding and patients known to be CYP2D6
Croatian: • Primjena kodeina također je kontraindicirana u dojilja i bolesnika za koje je utvrđeno da su vrlo brzi metabolizatori putem enzima CYP2D6.
English: As the CMDh has now agreed the PRAC measures by consensus, the measures will be directly implemented by the Member States where the medicines are authorised, according to an agreed timetable.
Croatian: Budući da je CMDh sada konsenzusom odobrio PRAC-ove mjere, te će se mjere, u skladu s dogovorenim rasporedom, izravno provoditi u državama članicama u kojima su lijekovi odobreni.
English: The effects of codeine are due to its conversion into morphine in the body.
Croatian: Učinci kodeina nastaju kada se on u tijelu pretvori u morfin.
English: • Use of codeine for cough and cold is now contraindicated in children below 12 years.
Croatian: • Primjena kodeina za liječenje kašlja i prehlade sada je kontraindicirana u djece mlađe od 12 godina.
English: The available data indicate that the way codeine is converted into morphine in children below 12 years is more variable and unpredictable, making this population at special risk of morphine-induced side effects.
Croatian: Dostupni podaci ukazuju na to da je u djece mlađe od 12 godina pretvorba kodeina u morfin raznolikija i nepredvidljivija zbog čega je ta populacija u znatnom riziku od nuspojava prouzročenih morfinom.
English: • Codeine for cough and cold is now contraindicated in children below 12 years, and not recommended in children between 12 and 18 years with compromised respiratory function.
Croatian: • Primjena kodeina za liječenje kašlja i prehlade sada je kontraindicirana u djece mlađe od 12 godina i ne preporučuje se za djecu u dobi od 12 do 18 godina s narušenom respiratornom funkcijom.
English: • Codeine-containing medicines for cough and cold must not be used in children below 12 years of age because of the risk of serious side effects, including breathing problems.
Croatian: • Lijekovi koji sadržavaju kodein, a služe za liječenje kašlja i prehlade ne smiju se primjenjivati u djece mlađe od 12 godina jer postoji rizik od ozbiljnih nuspojava, uključujući probleme s disanjem.
English: • Mothers who are breastfeeding must not take codeine as codeine can harm the baby because it passes into breast milk.
Croatian: • Dojilje ne smiju upotrebljavati kodein jer kodein može naštetiti djetetu s obzirom na to da prelazi u majčino mlijeko.
English: • Use of codeine for cough and cold is not recommended in children and adolescents between 12 and 18 years who have breathing problems.
Croatian: • Primjena kodeina za liječenje kašlja i prehlade ne preporučuje se u djece i adolescenata u dobi od 12 do 18 godina koji imaju probleme s disanjem.
English: The PRAC considered that, although morphine-induced side effects may occur in patients of all ages, the way codeine is converted into morphine in children below 12 years is more variable and unpredictable, making this population at special risk of such side effects.
Croatian: Iako se nuspojave prouzročene morfinom mogu pojaviti u bolesnika svih dobi, PRAC je smatrao da je u djece mlađe od 12 godina pretvorba kodeina u morfin raznolikija i nepredvidljivija zbog čega je ta populacija u znatnom riziku od navedenih nuspojava.
English: • Parents and caregivers who notice any of the following symptoms in a patient given codeine should stop giving the medicine and seek medical attention immediately: slow or shallow breathing,
Croatian: • Ako u bolesnika koji je primio kodein primijete bilo koji od sljedećih simptoma, roditelji i njegovatelji trebali bi prekinuti primjenu lijeka i odmah zatražiti liječničku pomoć: sporo ili plitko disanje, zbunjenost, pospanost, male zjenice, osjećaj mučnine ili povraćanje, zatvor i manjak apetita.
English: • In children and adolescents between 12 and 18 years who have problems with their breathing,
Croatian: • Primjena kodeina ne preporučuje se u djece i adolescenata u dobi od 12 do 18 godina koji imaju probleme s disanjem jer bi ta populacija mogla biti osjetljivija na probleme s disanjem prouzročene kodeinom.
English: • inactivated polioviruses;
Croatian: • inaktivirane polioviruse,
English: The main measure of effectiveness was the production of protective antibodies.
Croatian: Glavno mjerilo učinkovitosti bila je proizvodnja zaštitnih antitijela.
English: This summary was last updated in 11-2017.
Croatian: Sažetak je posljednji put ažuriran: 11. 2017.
English: This means that the active substances are fixed onto aluminium compounds, to stimulate a better response.
Croatian: To znači da su djelatne tvari vezane na aluminijske spojeve radi poticanja boljeg odgovora.
English: The full EPAR for Infanrix hexa can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za cjepivo Infanrix hexa nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) to defend the body against the infections.
Croatian: Cjepiva djeluju „učeći” imunosni sustav (prirodnu obranu tijela) kako obraniti tijelo od infekcija.
English: • parts of the hepatitis B virus;
Croatian: • dijelove virusa hepatitisa B,
English: This is a summary of the European public assessment report (EPAR) for Infanrix hexa.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) za cjepivo Infanrix hexa.
English: Infanrix hexa has been studied in nine studies, involving a total of almost 5,000 children aged between 6 weeks and 2 years.
Croatian: Cjepivo Infanrix hexa ispitano je u devet ispitivanja koja su uključivala gotovo 5 000 djece u dobi između 6 tjedana i 2 godine.
English: Subsequent injections should be given in different areas.
Croatian: Svaku narednu dozu potrebno je dati na drugo mjesto.
English: When a child is given the vaccine, the immune system recognises the parts of the bacteria and viruses in the vaccine as ‘foreign' and makes antibodies against them.
Croatian: Kad se djetetu daje cjepivo, imunosni sustav prepoznaje dijelove bakterija i virusa u cjepivu kao „strana tijela” i proizvodi antitijela protiv njih.
English: The choice of booster vaccine depends on official recommendations.
Croatian: Dodatno cjepivo odabire se prema službenim preporukama.
English: • toxoids (chemically weakened toxins) from diphtheria and tetanus;
Croatian: • toksoide (kemijski oslabljene toksine) difterije i tetanusa,
English: The European Medicines Agency therefore decided that Infanrix hexa's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Stoga je Europska agencija za lijekove zaključila da koristi cjepiva Infanrix hexa nadmašuju s njim povezane rizike te je preporučila davanje odobrenja za stavljanje cjepiva u promet.
English: What measures are being taken to ensure the safe and effective use of Infanrix hexa?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena cjepiva Infanrix hexa?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Infanrix hexa 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 cjepiva Infanrix hexa nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: A booster dose of Infanrix hexa or a similar vaccine must be given at least 6 months after the last dose of the initial course.
Croatian: Dodatna doza cjepiva Infanrix hexa ili sličnog cjepiva mora se dati najmanje 6 mjeseci nakon posljednje doze primarnog cijepljenja.
English: • polysaccharides (sugars) from Haemophilus influenzae type b.
Croatian: • polisaharide (šećere) iz bakterije Haemophilus influenzae tipa B.
English: Infanrix hexa contains the following active substances:
Croatian: Infanrix hexa sadržava sljedeće djelatne tvari:
English: Infanrix hexa must not be used in infants who have had encephalopathy (brain disease) of unknown cause within 7 days of receiving a pertussis vaccine.
Croatian: Ne smije se primjenjivati u dojenčadi koja je imala encefalopatiju (bolest mozga) nepoznatog uzroka u roku od sedam dana od primanja cjepiva protiv pertusisa.
English: Other information about Infanrix hexa:
Croatian: Ostale informacije o cjepivu Infanrix hexa:
English: The European Commission granted a marketing authorisation valid throughout the EU for Infanrix hexa on 23 October 2000.
Croatian: Europska komisija izdala je odobrenje za stavljanje cjepiva Infanrix hexa u promet koje na prostoru Europske unije vrijedi od 23. listopada 2000.
English: The most common side effects with Infanrix hexa (seen in more than 1 in 10 doses of the vaccine) are swelling, pain and redness at the injection site, loss of appetite, fever of 38ºC or more, tiredness, abnormal crying, irritability and restlessness.
Croatian: Najčešće nuspojave lijeka Infanrix hexa (koje se mogu javiti u više od 1 na 10 doza cjepiva) jesu oticanje, bol i crvenilo na mjestu injekcije, gubitak apetita, vrućica od 38 ºC ili više, umor, abnormalni plač, razdražljivost i nemir.
English: • parts of Bordetella pertussis (B. pertussis, a bacterium that causes whooping cough);
Croatian: • dijelove bakterije Bordetelle pertussis (B. Pertussis, bakterija koja uzrokuje kašalj hripavac),
English: Infanrix hexa is available as a powder and suspension that are made up into a suspension for injection.
Croatian: Cjepivo Infanrix hexa dostupno je kao prašak i suspenzija od kojih se priprema suspenzija za injekciju.
English: Over 3,000 of the children received a course of vaccination with Infanrix hexa.
Croatian: Više od 3 000 djece primilo je cjepivo Infanrix hexa.
English: It is not intended to provide practical advice on how to use Infanrix hexa.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni cjepiva Infanrix hexa.
English: Infanrix hexa is a vaccine that protects against a range of infections.
Croatian: Infanrix hexa je cjepivo koje štiti od niza infekcija.
English: The vaccination schedule for Infanrix hexa is a course of 2 or 3 doses, given at least 1 month apart, according to official recommendations, usually in the first 6 months of life.
Croatian: Cijepljenje cjepivom Infanrix hexa prema službenim preporukama provodi se u 2 ili 3 doze, s razmakom od najmanje mjesec dana, obično u prvih 6 mjeseci života.
English: An additional five studies looked at the effects of a booster vaccination with Infanrix hexa.
Croatian: U dodatnih pet ispitivanja proučavali su se učinci docjepljivanja cjepivom Infanrix hexa.