FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Kljub temu so rezultati, dobljeni pri ženskah, starih 74 let ali več, ki so imele posebno šibki stegnenici, pokazali, da je zdravilo Protelos zmanjšalo tveganje za zlom kolka.
English: Protelos has been studied in almost 7,000 elderly women in two large studies.
Slovenian: Zdravilo Protelos so proučevali v dveh obsežnih študijah, ki sta vključevali skoraj 7 000 starejših žensk.
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.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Protelos in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: Protelos has also been compared with placebo in a main study involving 261 male patients at increased risk of breaking a bone.
Slovenian: Zdravilo Protelos so s placebom primerjali tudi v glavni študiji, ki je vključevala 261 bolnikov, pri katerih obstaja povečano tveganje za zlom kosti.
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.
Slovenian: Poleg tega bodo bolniki in zdravniki, ki bodo predpisovali zdravilo Protelos, prejeli izobraževalno gradivo z opozorilom, da obstaja pri jemanju zdravila tveganje za nastanek težav s srcem in obtočili ter da je treba bolnike redno spremljati.
English: Why has Protelos been approved?
Slovenian: Zakaj je bilo zdravilo Protelos odobreno?
English: Protelos is a medicine that contains the active substance strontium ranelate.
Slovenian: Protelos je zdravilo, ki vsebuje zdravilno učinkovino stroncijev ranelat.
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.
Slovenian: V prvi študiji je bilo tako za osnovo vzeto število bolnic, pri katerih je v triletnem obdobju prišlo do novega zloma v hrbtenici, v drugi študiji pa število bolnic, pri katerih je prišlo do novega zloma kosti zaradi osteoporoze v katerem koli drugem predelu okostja razen v hrbtenici.
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).
Slovenian: Na podlagi rezultatov obeh študij skupaj je mogoče ugotoviti, da je do zlomov kosti na katerem koli predelu okostja razen hrbtenice (vključno s kolkom) prišlo pri manj ženskah iz skupine, ki je jemala zdravilo Protelos, kot pri tistih iz skupine, ki je jemala placebo (331 od 3 295 v skupini, ki je jemala zdravilo Protelos, v primerjavi s 389 od 3 256 v skupini, ki je jemala placebo).
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.
Slovenian: V prvi študiji je zdravilo Protelos v triletnem obdobju za 41 % zmanjšalo tveganje za nove zlome v hrbtenici: do novega zloma kosti v hrbtenici je prišlo pri 21 % od 719 žensk, ki so jemale zdravilo Protelos, v primerjavi s 33 % od 723 žensk, ki so jemale placebo.
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.
Slovenian: V študiji, ki je vključevala moške bolnike, se je po enem letu zdravljenja gostota kosti v spodnjem delu hrbtenice pri tistih, ki so jemali zdravilo Protelos, povečala za 7 %, medtem ko se je pri bolnikih, ki so jemali placebo, povečala za 1,7 %.
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.
Slovenian: V obeh študijah so učinke zdravila Protelos primerjali z učinki placeba (zdravila brez zdravilne učinkovine), glavno merilo učinkovitosti pa je bilo zmanjšanje tveganja za nove zlome ob jemanju zdravila.
English: The active substance in Protelos, strontium ranelate, acts on the bone structure.
Slovenian: Zdravilna učinkovina v zdravilu Protelos, stroncijev ranelat, učinkuje na zgradbo kosti.
English: For the full list of all side effects reported with Protelos, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Protelos, glejte navodilo za uporabo.
English: In postmenopausal women, Protelos reduces the risk of vertebral and hip fractures.
Slovenian: Pri ženskah po menopavzi zdravilo zmanjša tveganje za zlom kosti v hrbtenici in kolkih.
English: What is Protelos used for?
Slovenian: Za kaj se zdravilo Protelos uporablja?
English: What is Protelos?
Slovenian: Kaj je zdravilo Protelos?
English: How is Protelos used?
Slovenian: Kako se zdravilo Protelos uporablja?
English: How has Protelos been studied?
Slovenian: Kako je bilo zdravilo Protelos raziskano?
English: How does Protelos work?
Slovenian: Kako zdravilo Protelos deluje?
English: These products are not widely authorised in the European Union and therefore availability of data is limited.
Slovenian: Ti izdelki v Evropski uniji niso splošno sprejeti, zato je razpoložljivost podatkov omejena.
English: The mechanism of action is not fully understood.
Slovenian: Mehanizem njegovega delovanja ni popolnoma pojasnjen.
English: Nevertheless, the picture of the mode of action remains incomplete until today.
Slovenian: Kljub temu do zdaj ostaja slika načina delovanja nepopolna.
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.
Slovenian: Čeprav so bila zdravila, ki vsebujejo metamizol, v več evropskih državah in tudi v ZDA zaradi tveganja za agranulocitozo umaknjena, se v drugih državah, kot so Španija, Poljska in Nemčija, metamizol pogosto uporablja.
English: Thus, the more intrusive intramuscular injections could be avoided as intravenous administration is seen as a suitable alternative option.
Slovenian: Tako bi se bilo mogoče izogniti bolj invazivnim intramuskularnim injekcijam, saj velja intravensko dajanje za primerno nadomestno možnost.
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.
Slovenian: Nekateri podatki kažejo, da imata metamizol in njegov glavni presnovek 4-metil-amino-antipirin (MAA) morda kombinirani osrednji in periferni mehanizem delovanja.
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.
Slovenian: Poleg tega se splošna zavrnitev uporabe metamizola za dajanje dojenčkom, mlajšim od treh mesecev, ne šteje za upravičeno zaradi dejstva, da se v študijah, v katere so bili vključeni bolniki iz te starostne skupine, niso pojavili nobeni posebni pomisleki.
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.
Slovenian: Vendar pa je po potrebi primerno dovoliti posamezen parenteralni odmerek 2 500 mg metamizola in največji dnevni odmerek 5 000 mg metamizola.
English: Besides peripheral inhibition of PG synthesis, central activities have been supposed and documented.
Slovenian: Poleg perifernega zaviranja sinteze prostaglandinov je predpostavljeno in dokumentirano tudi osrednje delovanje.
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.
Slovenian: Kar zadeva nosečnost in dojenje, so podatki sicer omejeni, vendar ni dokazov o teratogenem ali embriotoksičnem učinku metamizola pri uporabi v prvem trimesečju.
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.
Slovenian: Ta učinkovina je v nekaterih državah kontraindicirana med nosečnostjo in dojenjem, v drugih pa je kontraindicirana samo v tretjem trimesečju nosečnosti in pri dojenju; v nekaterih državah članicah je kontraindicirana v prvem in tretjem trimesečju nosečnosti ter pri dojenju.
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.
Slovenian: Trenutne indikacije za metamizol (kot edino učinkovino) vključujejo akutno hudo bolečino po poškodbi ali operaciji, boleče kolike, tumorsko bolečino, drugo akutno ali kronično bolečino, če so drugi terapevtski ukrepi kontraindicirani, in visoko vročino, ki se ne odzove na druge ukrepe.
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.
Slovenian: Glede na poznana tveganja, povezana z uporabo metamizola, vzbujajo zaskrbljenost razlike v informacijah o zdravilu za zdravila, ki vsebujejo metamizol, med posameznimi državami članicami EU.
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.
Slovenian: Na voljo ni bil noben podatek, ki bi podprl spremembo priporočil za odmerjanje pripravkov v obliki svečk z odmerkom 100 mg ali 200 mg ali kombiniranih zdravil.
English: An inhibition of prostaglandin (PG) synthesis is known, based on interaction with different cyclooxygenases (COX), resulting in changes in the arachidonic acid metabolism.
Slovenian: Znano je tudi zaviranje sinteze prostaglandinov (PG), ki temelji na medsebojnem delovanju z različnimi ciklooksigenazami (COX), ki povzroča spremembe presnove arahidonske kisline.
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.
Slovenian: Pri otrocih in mladostnikih, starih do vključno 14 let, se priporoča odmerek od 8 do 16 mg metamizola na kilogram telesne mase v obliki posameznega odmerka.
English: It is available as monocomponent but also available in several combination products.
Slovenian: Na voljo je v monokomponentni obliki (z eno samo učinkovino), pa tudi v obliki več kombiniranih zdravil.
English: This single dose can be taken up to 4 times daily at intervals of 6-8 hours.
Slovenian: Ta posamezen odmerek se lahko jemlje do štirikrat dnevno v presledkih od 6 do 8 ur.
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).
Slovenian: Odbor CHMP je poleg tega upošteval, da so se posamezni intravenski odmerki metamizola, ki se uporabljajo za zdravljenje pooperacijske bolečine, izkazali kot varni v dveh nedavnih študijah pri več kot 400 dojenčkih, mlajših od enega leta (Fieler, M. et al., 20151, Sümpelmann, R. et al. 20172).
English: Metamizole has been associated with agranulocytosis and anaphylactic shock.
Slovenian: Metamizol je povezan z agranulocitozo in anafilaktičnim šokom.
English: Age appropriate formulations (oral drops, solution for injection) are available.
Slovenian: Na voljo so starosti primerne formulacije (peroralne kapljice, raztopina za injiciranje).
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.
Slovenian: Pri tej preiskavi je bilo ugotovljeno, da se največji dnevni odmerek metamizola, ki je naveden v informacijah o zdravilu, za različna zdravila giblje od 1,5 g do 6 g. Kar zadeva kontraindikacije med nosečnostjo in dojenjem, so bile ugotovljene tudi neskladnosti.
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.
Slovenian: Obstajajo pa dokazi o fetotoksičnosti v smislu okvare ledvic pri plodu in konstrikcije arterioznega duktusa ob uporabi v tretjem trimesečju, zato je odbor presodil, da mora biti metamizol v tretjem trimesečju kontraindiciran.
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.
Slovenian: Glede na zgoraj navedeno je odbor menil, da razmerje med tveganji in koristmi zdravil, ki vsebujejo metamizol, ostaja nespremenjeno, če se upoštevajo dogovorjene spremembe informacij o zdravilu.
English: In case of a single administration of metamizole, breastmilk should be discarded for a 48-hour period before breastfeeding can be resumed.
Slovenian: Ob posameznem odmerku metamizola je treba v naslednjih 48 urah materino mleko zavreči, preden se lahko dojenje nadaljuje.
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.
Slovenian: Odbor je upošteval tudi, da presnovki metamizola znatno prehajajo v materino mleko, zato je priporočil izogibanje večkratni uporabi metamizola ob dojenju.
English: • The Committee concluded that the posology recommendations for metamizole-containing medicinal products should be harmonised.
Slovenian: • Odbor je presodil, da je treba priporočila za odmerjanje zdravil, ki vsebujejo metamizol, uskladiti.
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.
Slovenian: Učinkovina metamizol (imenovana tudi dipiron) je analgetik pirazolske vrste, ki ne povzroča zasvojenosti, spazmolitik in antipiretik s šibkim protivnetnim učinkom.
English: The Committee, as a consequence, recommends the variation to the terms of the marketing authorisations for metamizole-containing medicinal products.
Slovenian: Odbor posledično priporoča spremembo pogojev dovoljenj za promet z zdravili, ki vsebujejo metamizol.
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.
Slovenian: Poleg tega je presodil tudi, da so zdravila, ki vsebujejo metamizol, v tretjem trimesečju nosečnosti kontraindicirana zaradi tveganja za okvaro ledvic pri plodu in konstrikcije arterioznega duktusa.
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.
Slovenian: • Odbor je pregledal vse predložene podatke v zvezi z največjim dnevnim odmerkom ter uporabo metamizola med nosečnostjo in dojenjem.
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.
Slovenian: Direktive 2001/83/ES in odbor CHMP zaprosila za oceno vseh razpoložljivih podatkov o največjem dnevnem odmerku ter kontraindikacijah med nosečnostjo in dojenjem ter izdajo mnenja o tem, ali je treba zadevna dovoljenja za promet z zdravilom spremeniti.
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.
Slovenian: • Odbor je obravnaval prepoznana razhajanja v informacijah o zdravilih za zdravila, ki vsebujejo metamizol, v zvezi z največjim dnevnim odmerkom in uporabo metamizola med nosečnostjo in dojenjem.
English: Article 31 of Directive 2001/83/EC for metamizole-containing medicinal products
Slovenian: • Odbor za zdravila za uporabo v humani medicini (CHMP) je obravnaval napotitev v skladu s členom 31 Direktive 2001/83/ES za zdravila, ki vsebujejo metamizol.
English: Metamizole is available as tablets (film tablet or dispersible), oral drops, solution for injection, and suppositories.
Slovenian: Na voljo je v obliki tablet (filmske ali disperzibilne tablete), peroralnih kapljic, raztopine za injiciranje in svečk.
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.
Slovenian: Poljska je presodila, da je v interesu Evropske unije, da se za vsa zdravila v EU, ki vsebujejo metamizol, v informacijah o zdravilu uskladijo informacije o največjem dnevnem odmerku ter kontraindikacijah med nosečnostjo in dojenjem.
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).
Slovenian: V okviru zahtevka za nenujne informacije (NUI) so bili za vsa zdravila, ki vsebujejo metamizol in so odobrena v Evropski uniji (EU), proučeni največji dnevni odmerki ter kontraindikacije med nosečnostjo in dojenjem.
English: Based on the data assessed, the Committee recommended a parenteral single dose in adults and adolescents aged 15 years or over of 500 - 1,000 mg. A single dose can be taken up to 4 times daily at intervals of 6-8 hours leading to a maximum daily dose of 4,000 mg.
Slovenian: Na podlagi ocenjenih podatkov je odbor priporočil posamezen parenteralni odmerek pri odraslih in otrocih, starih 15 let ali več, ki je večji od 500-1 000 mg.
English: The recommended oral single dose in adults and adolescents aged 15 years or over is also 500 to 1,000 mg. A single dose can be taken up to 4 times daily at intervals of 6-8 hours leading to a maximum daily dose of 4,000 mg.
Slovenian: Tudi priporočeni posamezni peroralni odmerek pri odraslih in mladostnikih, starih 15 let ali več, je od 500 do 1 000 mg.
English: Your doctor will explain more.
Slovenian: Vaš zdravnik vam bo razložil več.
English: (See sections 4.2 and 5.3.)
Slovenian: (Glejte poglavji 4.2 in 5.3).
English: c Tested using alpha of 0.05.
Slovenian: c Testirano z alfa 0,05.
English: Elderly patients (≥ 65 years old)
Slovenian: Starejši bolniki (≥ 65 let)
English: Their frequency cannot be estimated from available data.
Slovenian: Njihove pogostnosti ni mogoče oceniti iz razpoložljivih podatkov.
English: These findings were more marked in young animals.
Slovenian: Ta učinek je bil izrazitejši pri mladih živalih.
English: Symptoms are listed in section 4.
Slovenian: Simptomi so našteti v poglavju 4.
English: Currently available data are described in sections 4.8, 5.1, 5.2 and 5.3 but no recommendation on a posology can be made.
Slovenian: Podatki, ki so trenutno na voljo, so opisani v poglavjih 4.8, 5.1, 5.2 in 5.3, vendar priporočil o odmerjanju ni mogoče dati.
English: - Depression or mental health problems.
Slovenian: - Depresija ali duševne zdravstvene težave
English: Repeat cycle
Slovenian: Ponovitev cikla
English: The ampoule is labelled in English only.
Slovenian: Ampula ima le nalepko v angleščini.
English: Other side effects can include:
Slovenian: Drugi neželeni učinki lahko vključujejo:
English: Important information to know before you start - Each ampoule is for single use only.
Slovenian: Pomembne informacije, ki jih morate vedeti pred začetkom - Vsaka ampula je samo za enkratno uporabo.
English: Avoid any unnecessary exercise as this might increase the risk of a tendon rupture.
Slovenian: Izogibajte se morebitni nepotrebni vadbi, saj lahko poveča tveganje za pretrganje tetive.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26/03/2015
Slovenian: Datum prve odobritve: 26/03/2015
English: Your doctor may need to give you regular blood tests to check how well your blood can clot.
Slovenian: Vaš zdravnik bo morda redno opravljal krvne preiskave, s katerimi bo ugotovil, kako dobro se vaša kri strjuje.
English: - Resistance to antibiotics
Slovenian: - Odpornost na antibiotike
English: The patient should be observed and appropriate hydration maintained.
Slovenian: Bolnika je treba opazovati in ga ohranjati primerno hidriranega.
English: Via Martin Luther King, 13 20060 Pessano con Bornago (MI) Italy
Slovenian: Via Martin Luther King, 13 20060 Pessano con Bornago (MI) Italija
English: Patients who experience such symptoms should be advised not to drive or use machines.
Slovenian: Bolnikom, pri katerih se ti simptomi pojavijo, je treba svetovati, naj ne vozijo in ne uporabljajo strojev.
English: 6) When all of the medicine has been delivered, you will hear two ‘beeps', which means the treatment is complete.
Slovenian: 6) Ko je dostavljeno vse zdravilo, boste slišali dva piska, kar pomeni, da je zdravljenje končano.
English: Supportive studies
Slovenian: Podporne študije
English: Approximately 30 to 40% of levofloxacin is bound to serum protein.
Slovenian: Približno 30% do 40% levofloksacina je vezanega na beljakovine v serumu.
English: e P-value determined using a log-rank test.
Slovenian: e Vrednost P je bila določena s testom log-rank.
English: If the infection is not properly treated it will continue to damage the lungs, causing further problems with breathing.
Slovenian: Če se okužba ne zdravi ustrezno, še naprej kvari pljuča in tako povzroča nadaljnje težave z dihanjem.
English: Basic instructions for use are given below.
Slovenian: Spodaj so navedena osnovna navodila za uporabo.
English: Treatment will restart.
Slovenian: Zdravljenje se bo nadaljevalo.
English: Results obtained for the primary and key secondary endpoints are provided in Table 2.
Slovenian: Pridobljeni rezultati za primarne in ključne sekundarne opazovane dogodke so predstavljeni v preglednici 2.
English: - A severe allergic reaction.
Slovenian: - Huda alergijska reakcija.
English: If this happens to you, do not drive or use any tools or machines.
Slovenian: Če opazite te učinke, ne vozite in ne uporabljajte orodja ali strojev.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/973/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/973/001
English: How and when do I replace the Zirela Nebuliser Handset?
Slovenian: Kako in kdaj naj zamenjam nebulator Zirela?
English: What if I am using several different inhalers and other therapies for cystic fibrosis?
Slovenian: Kaj, če uporabljam več različnih inhalatorjev in druga zdravila za cistično fibrozo?