FrancophonIA/ELRC3.0 huggingface dataset:
English: The company will also conduct a study to evaluate the effectiveness of the measures that have been put in place to reduce risk of heart and circulatory problems.
Croatian: Tvrtka će također provesti ispitivanje za procjenu učinkovitosti uspostavljenih mjera za smanjivanje rizika od srčanih i krvožilnih problema.
English: Protelos is intended for long-term use.
Croatian: Protelos je namijenjen dugotrajnoj primjeni.
English: However, when looking only at women of 74 years of age or older with particularly weak thighbones, the results suggested a reduction of the risk of breaks in the hip with Protelos.
Croatian: Međutim, ako se uzmu u obzir samo žene starije od 74 godine s posebno slabom bedrenom kosti, rezultati pokazuju smanjenje rizika od prijeloma kuka s lijekom Protelos.
English: In order to reduce the risk of heart attack, Protelos must also not be used in patients with high blood pressure that is not properly controlled or in patients with a current or past history of any of the following:
Croatian: Kako bi se smanjio rizik od srčanog udara, lijek Protelos također se ne smije koristiti kod bolesnika s visokim krvnim tlakom koji se ne kontrolira ispravno ili kod bolesnika s trenutačnom ili prethodnom povijesti bolesti koja uključuje:
English: What is Protelos?
Croatian: Što je Protelos?
English: This showed that the risk of breaking a bone is reduced.
Croatian: To ukazuje na smanjenje rizika od prijeloma kosti.
English: As there has been some data showing an increased risk of heart attack with Protelos, the decision to prescribe Protelos should take into account the patient's individual heart risk.
Croatian: Budući da postoje podaci koji dokazuju povećani rizik od srčanog udara pri uporabi lijeka Protelos, pri donošenju odluke o propisivanju lijeka Protelos treba uzeti u obzir pojedinačni srčani rizik bolesnika.
English: This is a summary of the European public assessment report (EPAR) for Protelos.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Protelos.
English: What is the risk associated with Protelos?
Croatian: Koji su rizici povezani s lijekom Protelos?
English: The most common side effects with Protelos (which may affect more than 1 in 10 people) are hypersensitivity (allergic) skin reactions (rash, itching, urticaria or itchy rash, and swelling beneath the skin known as angioedema) and pain affecting muscles, bones and joints.
Croatian: Najčešće nuspojave s lijekom Protelos (koje se mogu pojaviti u više od 1 na 10 osoba) su kožne reakcije preosjetljivosti (alergijskog tipa) (osip, svrbež, koprivnjača i otekline ispod kože ili angioedem) i bolovi u mišićima, kostima i zglobovima.
English: When looking at results of the two studies taken together, fewer women in the Protelos group developed breaks at any site outside the spine (including the hip) than in the placebo group (331 out of 3,295 with Protelos compared with 389 out of 3,256 for placebo).
Croatian: Ako se gledaju rezultati dvaju ispitivanja zajedno, manje žena u skupini koja je uzimala Protelos doživjelo je prijelome na bilo kojem mjestu osim na kralježnici (uključujući kuk) nego u skupini koja je uzimala placebo (331 od 3295 s lijekom Protelos u usporedbi s 389 od 3256 za placebo).
English: Overall, the results of the second study taken alone were insufficient to demonstrate a benefit of Protelos in preventing bone breaks.
Croatian: Ukupno, ako se uzmu u obzir samo rezultati drugog ispitivanja, oni nisu bili dovoljni da bi pokazali korist lijeka Protelos u sprječavanju prijeloma kostiju.
English: Protelos must not be used in patients who have or have had venous thromboembolic events (problems due to the formation of blood clots in the veins, such as in the legs or lungs).
Croatian: Protelos se ne smije koristiti kod bolesnika koji imaju ili su imali događaje venske tromboembolije (problemi zbog nastanka krvnih ugrušaka u venama, npr. u nogama ili plućima).
English: In addition, education materials are sent to patients and healthcare professionals prescribing Protelos reminding them of the risk of heart and circulatory problems with the medicine and of the need for regular monitoring.
Croatian: Uz to, bolesnicima i zdravstvenim djelatnicima koji propisuju lijek Protelos šalju se edukativni materijali kojima ih se podsjeća na rizik od srčanih i krvožilnih problema s lijekom te na potrebu redovitog nadzora.
English: A risk management plan has been developed to ensure that Protelos is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Protelos.
English: For more information about treatment with Protelos, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Protelos pročitajte u uputama o lijeku (također dio EPAR-a) odnosno obratite se svom liječniku ili ljekarniku.
English: In both studies, Protelos was compared with placebo (a dummy treatment) and the main measure of effectiveness was the reduction in the risk of a new bone break with Protelos.
Croatian: U oba ispitivanja Protelos se uspoređivao s placebom (liječenje bez djelatne tvari), a glavna mjera učinkovitosti bilo je smanjenje rizika novog prijeloma kostiju s lijekom Protelos.
English: What benefit has Protelos shown during the studies?
Croatian: Koje su koristi lijeka Protelos dokazane u ispitivanjima?
English: In the first study, this was based on the number of patients who, over three years, developed a new break in the spine, and in the second study, it was based on the number of patients who had a new bone break due to osteoporosis at any site other than the spine.
Croatian: U prvom ispitivanju, ova se mjera temeljila na broju ispitanica koje su tijekom tri godine doživjele novi prijelom kralježnice, a u drugom ispitivanju temeljila se na broju ispitanica koje su doživjele novi prijelom kosti zbog osteoporoze na bilo kojoj kosti osim na kralježnici.
English: In the first study, Protelos reduced the risk of new breaks in the spine by 41% over three years: 21% of the 719 women who took Protelos developed a new break in the spine, compared with 33% of the 723 who took placebo.
Croatian: Protelos je smanjio rizik od novih prijeloma kralježnice za 41 % tijekom tri godine: 21 % od 719 žena koje su uzimale Protelos doživjelo je novi prijelom kralježnice, u usporedbi s 33 % od 723 žene koje su uzimale placebo.
English: Protelos has also been compared with placebo in a main study involving 261 male patients at increased risk of breaking a bone.
Croatian: Protelos se također uspoređivao s placebom u glavnom ispitivanju koje je obuhvatilo 261 ispitanika s povećanim rizikom od prijeloma kostiju.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Protelos, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana u sažetak opisa svojstava lijeka kao i u uputu o lijeku, za lijek Protelos uključene su sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: Protelos is a medicine that contains the active substance strontium ranelate.
Croatian: Protelos je lijek koji sadrži djelatnu tvar stroncijev ranelat.
English: In the study in male patients, the bone density in the lower part of the spine increased by 7% after one year of treatment in patients taking Protelos, compared with an increase of 1.7% in patients taking placebo.
Croatian: U ispitivanju s ispitanicima, gustoća kostiju u donjem dijelu kralježnice povećala se za 7 % nakon jedne godine liječenja kod ispitanika koji su uzimali Protelos, u usporedbi s povećanjem od 1,7 % kod ispitanika koji su uzimali placebo.
English: Protelos is used to treat severe osteoporosis (a disease that makes bones fragile) in post-menopausal women and men who have a high risk of fracture and cannot be treated with other medicines approved for osteoporosis.
Croatian: Protelos se koristi za liječenje teške osteoporoze (bolesti koja može dovesti do prijeloma kostiju) kod žena u poslijemenopauzi i muškaraca s visokim rizikom za nastanak prijeloma i ne može se koristiti s drugim lijekovima kojima se liječi osteoporoza.
English: Protelos has been studied in almost 7,000 elderly women in two large studies.
Croatian: Protelos se ispitivao u dva velika ispitivanja koja su obuhvatila gotovo 7 tisuća žena starije dobi.
English: Why has Protelos been approved?
Croatian: Zašto je lijek Protelos odobren?
English: The CHMP decided that Protelos's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) odlučilo je da koristi od lijeka Protelos nadmašuju s njim povezane rizike te je preporučilo njegovo odobrenje za stavljanje u promet.
English: The active substance in Protelos, strontium ranelate, acts on the bone structure.
Croatian: Djelatna tvar lijeka Protelos, stroncijev ranelat, djeluje na strukturu kostiju.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Protelos.
Croatian: Committee for Medicinal Products for Human Use) ocijenilo lijek da bi preporučilo njegovo odobrenje za stavljanje u promet te uključuje preporuke Povjerenstva o uvjetima za primjenu lijeka Protelos.
English: What is Protelos used for?
Croatian: Za što se Protelos koristi?
English: How is Protelos used?
Croatian: Kako se Protelos koristi?
English: For the full list of all side effects reported with Protelos, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Protelos potražite u uputi o lijeku.
English: How has Protelos been studied?
Croatian: Kako se Protelos ispitivao?
English: How does Protelos work?
Croatian: Kako djeluje Protelos?
English: In postmenopausal women, Protelos reduces the risk of vertebral and hip fractures.
Croatian: Protelos smanjuje rizik od prijeloma kralježnice i kukova kod žena u poslijemenopauzi.
English: These products are not widely authorised in the European Union and therefore availability of data is limited.
Croatian: Ti lijekovi nisu odobreni u cijeloj Europskoj uniji te je stoga dostupnost podataka ograničena.
English: The mechanism of action is not fully understood.
Croatian: Mehanizam djelovanja nije potpuno jasan.
English: European Journal of Pediatric Surgery.
Croatian: Pediatric Surgery.
English: 2017, Vol. 27, 3, pp. 269-273.
Croatian: 27, 3, pp. 269-273.
English: Thus, the more intrusive intramuscular injections could be avoided as intravenous administration is seen as a suitable alternative option.
Croatian: Stoga bi se invazivnije intramuskularne injekcije mogle izbjegavati jer se intravenska primjena smatra prikladnijom alternativnom mogućnošću.
English: It is available as monocomponent but also available in several combination products.
Croatian: Dostupan je kao jednokomponentni preparat, ali i u više kombiniranih lijekova.
English: 1 Fieler M et al. Metamizole for postoperative pain therapy in 1177 children: A prospective, multicentre, observational, postauthorisation safety study.
Croatian: Metamizole for postoperative pain therapy in 1177 children: A prospective, multicentre, observational, postauthorisation safety study.
English: Some data suggest that metamizole and its main metabolite 4-methyl-amino-antipyrine (MAA) may have a combined central and peripheral mechanism of action.
Croatian: Neki podatci upućuju na to da metamizol i njegov glavni metabolit 4-metil-amino-antipirin (MAA) može imati kombinirani centralni i periferni mehanizam djelovanja.
English: Whilst metamizolecontaining medicinal products were withdrawn in several European countries and also in the USA due to the risk of agranulocytosis, in other countries such as Spain, Poland and Germany, metamizole is frequently used.
Croatian: Iako su zbog rizika od agranulocitoze lijekovi koji sadržavaju metamizol povučeni u nekoliko europskih zemalja te SAD-u, u drugim se zemljama poput Španjolske, Poljske i Njemačke metamizol često primjenjuje.
English: The active substance is contraindicated in pregnancy and breastfeeding in some Member States, while in others it is contraindicated only in the third trimester of pregnancy and breastfeeding; furthermore, in some Member States it is contraindicated in the first and third trimester of pregnancy and breastfeeding.
Croatian: Djelatna tvar je kontraindicirana tijekom trudnoće i dojenja u nekim državama članicama, dok je u drugima kontraindicirana samo u trećem tromjesečju trudnoće i tijekom dojenja; nadalje, u nekim je državama članicama kontraindicirana u prvom i trećem tromjesečju trudnoće i tijekom dojenja.
English: Nevertheless, the picture of the mode of action remains incomplete until today.
Croatian: No, način djelovanja još uvijek nije u potpunosti razjašnjen.
English: In addition, a general rejection of the use of metamizole for administration in infants below the age of 3 months is not considered to be justified based on the fact that no particular concerns arose from the studies which included patients in this age group.
Croatian: Nadalje, opće odbacivanje primjene metamizola kod djece mlađe od tri mjeseca ne smatra se opravdanim na temelju činjenice da istraživanja koja su uključivala pacijente te dobne skupine nisu izazvala nikakvu posebnu zabrinutost.
English: 2 Sumpelmann R et al. Metamizole for Postoperative Pain Therapy in Infants Younger than 1 Year.
Croatian: Metamizole for Postoperative Pain Therapy in Infants Younger than 1 Year.
English: In view of the known risks associated with the use of metamizole, the differences between the product information of metamizole-containing medicines across the EU Member States raise concern.
Croatian: U pogledu poznatih rizika povezanih s primjenom metamizola, razlike između informacija o lijeku za lijekove koji sadržavaju metamizol diljem država članica EU-a uzrokuju zabrinutost.
English: An inhibition of prostaglandin (PG) synthesis is known, based on interaction with different cyclooxygenases (COX), resulting in changes in the arachidonic acid metabolism.
Croatian: Inhibicija sinteze prostaglandina poznata je na temelju interakcije s različitim ciklooksigenazama (COX), što uzrokuje promjene u metabolizmu arahidonske kiseline.
English: No data was available to support a change in posology recommendations for the suppository formulations dosed at 100 mg and 200 mg, as well as for the combination products.
Croatian: Nisu bili dostupni podatci koji bi išli u prilog promjeni u preporukama za doziranje čepića od 100 mg i 200 mg, kao ni za kombinirane lijekove.
English: Besides peripheral inhibition of PG synthesis, central activities have been supposed and documented.
Croatian: Uz perifernu inhibiciju sinteze prostaglandina, pretpostavljene su i dokumentirane centralne aktivnosti.
English: On 26 April 2018, Poland therefore triggered a referral under Article 31 of Directive 2001/83/EC, and requested the CHMP to assess all data available concerning the maximum daily dose and its contraindications on pregnancy and breastfeeding, and issue an opinion as to whether the relevant marketing authorisations should be varied.
Croatian: Poljska je stoga 26. travnja 2018. pokrenula arbitražni postupak u skladu s člankom 31. Direktive 2001/83/EZ i od Odbora za lijekove za humanu uporabu (CHMP) zatražila da ocijeni sve dostupne podatke o najvećoj dopuštenoj dnevnoj dozi i njezinim kontraindikacijama tijekom trudnoće i dojenja te da objavi mišljenje o tome treba li izmijeniti predmetna odobrenja za stavljanje u promet.
English: Current indications for metamizole (as single ingredient) include acute severe pain after trauma or surgery, painful colic, tumour pain, other acute or chronic pain, if other therapeutic measures are contraindicated, and high fever, not responding to other measures.
Croatian: Trenutačne indikacije za metamizol (kao jedini sastojak) uključuju snažnu akutnu bol nakon traume ili operacije, bolne grčeve, bol uzrokovanu tumorima, drugu akutnu ili kroničnu bol ako su druge terapijske mjere kontraindicirane, te visoku temperaturu koja ne reagira na druge mjere.
English: This single dose can be taken up to 4 times daily at intervals of 6-8 hours.
Croatian: Takva se pojedinačna doza može uzeti do četiri puta dnevno u intervalima od 6 do 8 sati.
English: However, it is appropriate to allow, if necessary, a parenteral single dose of 2500 mg metamizole and a maximum daily dose of 5000 mg metamizole.
Croatian: Međutim, ako je neophodno, dopušteno je uzeti parenteralnu pojedinačnu dozu od 2 500 mg metamizola te najveću dopuštenu dnevnu dozu od 5 000 mg metamizola.
English: In children and adolescents up to 14 years old, a dose of 8-16 mg metamizole per kg body weight as a single dose is recommended.
Croatian: Kod djece i adolescenata u dobi do 14 godina preporučuje se pojedinačna doza od 8 do 16 mg metamizola po kilogramu tjelesne težine.
English: However, there is evidence of fetotoxicity in terms of fetal renal impairment and ductus arteriosus constriction when used in the third trimester and so the Committee considered metamizole should be contraindicated during the third trimester.
Croatian: Međutim, postoje dokazi fetotoksičnosti u pogledu oštećenja funkcije bubrega ploda i začepljenja ductusa arteriosusa kod primjene u trećem tromjesečju te Odbor stoga smatra da bi metamizol trebao biti kontraindiciran u trećem tromjesečju.
English: With regards to pregnancy and lactation, although data is limited there is no evidence of teratogenic or embryotoxic effects of metamizole when used during the 1st trimester.
Croatian: U pogledu trudnoće i dojenja, ne postoji dokaz teratogenih ni embriotoksičnih učinaka metamizola kod primjene tijekom prvog tromjesečja iako su podatci ograničeni.
English: Metamizole has been associated with agranulocytosis and anaphylactic shock.
Croatian: Metamizol se povezuje s agranulocitozom i anafilaktičkim šokom.
English: The Committee also considered that metamizole containing medicinal products should be contraindicated in the third trimester of pregnancy due to the risks of fetal renal impairment and ductus arteriosus constriction.
Croatian: Odbor isto tako smatra da bi lijekovi koji sadržavaju metamizol trebali biti kontraindicirani u trećem tromjesečju trudnoće zbog rizika od oštećenja funkcije bubrega ploda i začepljenja ductusa arteriosusa.
English: Poland considered that it is in the interests of the Union to harmonise the information regarding maximum daily dose and contraindications in pregnancy and breastfeeding in the product information of all metamizole-containing medicinal products in the EU.
Croatian: Poljska smatra da je u interesu Unije uskladiti informacije o najvećoj dopuštenoj dnevnoj dozi i kontraindikacijama tijekom trudnoće i dojenja u informacijama o lijeku za sve lijekove u EU-u koji sadržavaju metamizol.
English: • The Committee concluded that the posology recommendations for metamizole-containing medicinal products should be harmonised.
Croatian: • Odbor je zaključio da preporuke za doziranje lijekova koji sadržavaju metamizol treba uskladiti.
English: In the frame of a Non Urgent Information (NUI) request, the maximum daily dose and contraindications in pregnancy and breastfeeding were investigated for all metamizole-containing products authorised in European Union (EU).
Croatian: U okviru zahtjeva za informacije koje ne zahtijevaju hitno postupanje istražena je najveća dopuštena dnevna doza i kontraindikacije tijekom trudnoće i dojenja za sve proizvode odobrene u Europskoj uniji (EU) koji sadržavaju metamizol.
English: The Committee also noted that the metabolites of metamizole pass into breastmilk in considerable amounts, and therefore recommended that repeated use of metamizole during breastfeeding should be avoided.
Croatian: Odbor je isto tako primijetio da metaboliti metamizola ulaze u majčino mlijeko u znatnoj količini te stoga preporuča izbjegavanje višekratne primjene metamizola tijekom dojenja.
English: Age appropriate formulations (oral drops, solution for injection) are available.
Croatian: Dostupne su formulacije prikladne određenoj dobi osobe (oralne kapi, otopina za injekciju).
English: Metamizole is available as tablets (film tablet or dispersible), oral drops, solution for injection, and suppositories.
Croatian: Metamizol je dostupan u obliku tableta (filmom obložene tablete ili tablete za oralnu suspenziju), oralnih kapi, otopine za primjenu injekcijom i u obliku čepića.
English: The CHMP further noted that two recent studies showed that single intravenous doses of metamizole used for prevention or treatment of postoperative pain were safe in more than 400 infants younger than 1 year (Fieler M et al. 20151, Sümpelmann R et al. 20172).
Croatian: Odbor za lijekove za humanu uporabu naglasio je i da su dva nedavna istraživanja pokazala da su pojedinačne intravenske doze metamizola koje se primjenjuju za prevenciju ili liječenje postoperativne boli bile sigurne kod više od 400 djece mlađe od jedne godine (Fieler M. et al.
English: In view of the above, the Committee considers that the benefit-risk balance of metamizole-containing medicinal products remains unchanged subject to the agreed amendments to the product information.
Croatian: S obzirom na prethodno navedeno, Odbor smatra da omjer koristi i rizika za lijekove koji sadržavaju metamizol ostaje nepromijenjen pod uvjetom da se u informacije o lijeku unesu dogovorene izmjene.
English: The Committee, as a consequence, recommends the variation to the terms of the marketing authorisations for metamizole-containing medicinal products.
Croatian: Slijedom toga, Odbor preporučuje izmjene uvjeta odobrenja za stavljanje u promet lijekova koji sadržavaju metamizol.
English: Article 31 of Directive 2001/83/EC for metamizole-containing medicinal products
Croatian: • Odbor za lijekove za humanu uporabu (CHMP) razmotrio je postupak u skladu sa člankom 31. Direktive 2001/83/EZ za lijekove koji sadržavaju metamizol.
English: The active substance metamizole (also referred to as dipyrone) is a non-addictive pyrazole-type analgesic, spasmolytic and antipyretic drug with weak anti-inflammatory effects.
Croatian: Djelatna tvar metamizol (poznat i pod nazivom dipiron) je pirazolni analgetik, spazmolitik i antipiretik koji ne izaziva ovisnost sa slabim protuupalnim učinkom.
English: • The Committee reviewed the totality of the data submitted in relation to the maximum daily dose and the use of metamizole in pregnancy and breastfeeding.
Croatian: • Odbor je pregledao sve podnesene podatke povezane s najvećom dopuštenom dnevnom dozom i primjenom metamizola tijekom trudnoće i dojenja.
English: • The Committee considered the identified divergences in the product information of metamizole containing medicinal products, relating to the maximum daily dose and the use of metamizole in pregnancy and breastfeeding.
Croatian: • Odbor je razmotrio utvrđena odstupanja u informacijama o lijeku za lijekove koji sadržavaju metamizol u pogledu najveće dopuštene dnevne doze i primjene metamizola tijekom trudnoće i dojenja.
English: In case of a single administration of metamizole, breastmilk should be discarded for a 48-hour period before breastfeeding can be resumed.
Croatian: Kod pojedinačne primjene metamizola s dojenjem se može nastaviti tek 48 sati nakon primjene, a u međuvremenu je potrebno baciti mlijeko.
English: As a result of this investigation, it was observed that the maximum daily dose of metamizole reflected in the Product Information of the different medicinal products varies from 1,5 g to 6 g. With regards to contraindication in pregnancy and breastfeeding, discrepancies were also noted.
Croatian: Rezultati istraživanja pokazali su da najveća dopuštena dnevna doza metamizola navedena u informacijama o lijeku za različite lijekove varira od 1,5 g do 6 g.