FrancophonIA/ELRC3.0 huggingface dataset:
English: A variety of reports show that the addition of codeine to common non-opioid analgesics provides additional pain relief at the cost of tolerability, compromising the benefit-risk ratio.
Slovenian: Različna poročila kažejo, da dodatek kodeina običajnim neopioidnim analgetikom zagotavlja dodatno olajšanje bolečine v škodo prenašanja, s čimer ogroža razmerje med tveganji in koristmi.
English: Overall, the data demonstrated that the use of the combination of paracetamol and ibuprofen at the given doses is safe and effective in the intended indication, duration of use and population, including the elderly.
Slovenian: Na splošno so podatki dokazali, da je uporaba kombinacije paracetamola in ibuprofena v danih odmerkih pri predvideni indikaciji, trajanju uporabe in populaciji, vključno s starejšimi, varna in učinkovita.
English: The proposed combination therefore offers an alternative therapeutic option to such opioid based combinations.
Slovenian: Predlagana kombinacija je torej alternativna možnost zdravljenja, ki lahko zamenja tovrstne kombinacije na osnovi opioidov.
English: The CHMP took these comments into account, and considered that with the additional amendments to the product information for the restriction of use to maxim of 3 days, and the additional data provided for special populations including the elderly, that the overall safety of this fixed-dese combination to be acceptable in the indication for the short-term symptomatic treatment of mild to moderate pain.
Slovenian: Odbor CHMP je te pripombe upošteval in presodil, da je z dodatnimi spremembami in dopolnitvami informacij o zdravilu, s katerimi se uporaba omeji na največ 3 dni, ter dodatnimi informacijami za posebne populacije, vključno s starejšimi, celokupna varnost te fiksne kombinacije odmerkov sprejemljiva za indikacijo kratkotrajnega simptomatskega zdravljenja blage do zmerne bolečine.
English: In the study the active substances have all been shown to be statistically superior to placebo.
Slovenian: V študiji se je izkazalo, da so bile vse zdravilne učinkovine statistično boljše od placeba.
English: Secondly the ratio of paracetamol to ibuprofen (3.3:1) is of paramount importance as there is a distinct additive effect in both acute and chronic pain models, which is lost if the ratio is decreased.
Slovenian: Drugič, razmerje med paracetamolom in ibuprofenom (3,3 : 1) je bistvenega pomena, saj pri modelih z akutno in kronično bolečino obstaja izrazit aditivni učinek, ki se z zmanjšanjem razmerja izgubi.
English: Median time to perceptible pain relief was significantly shorter for the combination than ibuprofen and placebo (p<0.05) and non-significant for the comparison with paracetamol.
Slovenian: Mediana časa do zaznavnega olajšanja bolečine je bila značilno krajša pri kombinaciji kot pri ibuprofenu in placebu (p < 0,05) in neznačilna pri primerjavi s paracetamolom.
English: In the potential of medication without the supervision by healthcare potential additional risk minimisation measure would be the restriction of the pack size in order not to exceed the maximum daily recommended dose of 3000 / 900 mg paracetamol/ibuprofen (6 tablets) for maximal duration of three days.
Slovenian: V primeru zdravljenja brez nadzora zdravstvenega delavca je nadaljnji možni ukrep za zmanjševanje tveganja omejitev velikosti pakiranja, da se ne preseže največji priporočeni dnevni odmerek 3 000/900 mg paracetamola/ibuprofena (6 tablet) v najdaljšem obdobju treh dni.
English: During the CHMP discussion, members expressed divergent views based mainly on the potential for increased risks of rare but severe adverse events due to overtreatment, uncertainty in some treatment populations, that the expected benefits are not considered sufficient to accept these increased risks and that no evidence was provided to support the need of this product or its first-line use.
Slovenian: Med razpravo odbora CHMP so članice izrazile različne poglede, v glavnem glede morebitnega povečanega tveganja redkih, a resnih neželenih učinkov zaradi pretiranega zdravljenja, negotovosti v nekaterih zdravljenih populacijah, dejstva, da pričakovane koristi niso zadostne, da bi lahko sprejeli povečana tveganja, in da ni dokazov v podporo potrebi po tem zdravilu ali njegovi uporabi kot zdravilu prve izbire.
English: This study is an acute pain study for mild-moderate pain since arthroscopy is a minor surgical procedure which results in little ongoing pain and in fact as discussed below pain dissipates rapidly.
Slovenian: Ta študija je študija akutne bolečine pri blagi do zmerni bolečini, saj je artroskopija manjši kirurški poseg, ki ima za posledico le manjše stalne bolečine, ki, kot je navedeno v nadaljevanju, hitro minejo.
English: • The Committee concluded by majority that the benefit risk balance of this medicinal product in the short-term symptomatic treatment of mild to moderate pain is favourable.
Slovenian: • odbor je večinsko zaključil, da je razmerje med tveganji in koristmi tega zdravila pri kratkotrajnem simptomatskem zdravljenju blage do zmerne bolečine ugodno.
English: The safety outcomes evaluated were upper gastrointestinal events, myocardial infarction, stroke, renal failure (excluding chronic), congestive heart failure, intentional or accidental overdose, suicidal behaviour and mortality.
Slovenian: Ovrednoteni varnostni izidi so bili dogodki v zgornjem delu prebavil, miokardni infarkt, možganska kap, ledvična odpoved (razen kronične), kongestivno srčno popuščanje, namerno ali nenamerno preveliko odmerjanje, samomorilno vedenje in umrljivost.
English: The results from AFT-MX-6 are consistent with AFT-MX-1 which in fact further reinforces the validity of the AFT-MX-1 results.
Slovenian: Rezultati študije AFT-MX-6 so skladni s študijo AFT-MX-1, kar nadalje potrjuje veljavnost rezultatov študije AFT-MX-1.
English: In addition the safety information on special populations, including elderly, hepatic and renal impaired patients was strengthened to reflect the warnings related to mono-component use.
Slovenian: Poleg tega so bile informacije o varnosti pri posebnih populacijah, vključno s starejšimi bolniki ter bolniki z jetrno ali ledvično okvaro, okrepljene tako, da vključujejo opozorilo v zvezi z uporabo posamičnih komponent;
English: The dose strengths used in the proposed fixed dose combination are well within the recommended dose range, particularly with regards to the dose of ibuprofen.
Slovenian: Jakosti, uporabljeni v predlagani fiksni kombinaciji odmerkov, sta znotraj priporočenega razpona odmerkov, zlasti glede odmerka ibuprofena.
English: In absence of this fixed dose combination the rescue remedy for the pain is resulting in use of opioids, instead.
Slovenian: V odsotnosti te fiksne kombinacije odmerkov reševalno zdravilo postane uporaba opioidov.
English: Finally in terms of safety there is supportive data to exclude any additive adverse effects on gastric erosions and bleeding when paracetamol is added to ibuprofen in the ratio of 3.3:1, and the efficacy provided by the fixed dose combination over either of the individual components does show any decreased tolerability/safety.
Slovenian: In končno, glede varnosti obstajajo podporni podatki, ki izključujejo dodatne neželene učinke na želodčne erozije in krvavitev, kadar se paracetamol dodaja ibuprofenu v razmerju 3,3 : 1, učinkovitost fiksne kombinacije odmerkov, ki je večja od učinkovitosti ene ali druge posamične komponente, pa ne zmanjšuje prenašanja/varnosti.
English: The incidence of adverse events is as expected and most commonly involves the gastrointestinal tract.
Slovenian: Pojavnost neželenih učinkov je pričakovana, najpogosteje pa vključujejo prebavila.
English: During the review process the superior efficacy of the fixed dose combination were compared to each mono-component.
Slovenian: Med pregledom so primerjali učinkovitost fiksne kombinacije odmerkov s posamičnima komponentama.
English: The data obtained in AFT-MX-1 is reinforced by the large Phase III efficacy study AFT-MX-6.
Slovenian: Podatke, pridobljene v študiji AFT-MX-1, dodatno potrjuje velika študija učinkovitosti III. faze AFT-MX-6.
English: • The Committee is also of the opinion that adequate information in order to minimise any risk of use outside of the recommended duration of use of maximum of 3 days has been included in the proposed product information and in the updated risk management plan, in this regard.
Slovenian: • odbor je prav tako menil, da so bile v predlagane informacije o zdravilu in posodobljen načrt za obvladovanje tveganja vključene ustrezne informacije za zmanjševanje tveganja za uporabo zunaj priporočenega, največ 3-dnevnega trajanja uporabe.
English: The main issues were the basis of the referral to CHMP which were that the rationale of the fixed dose combination is not considered justified, the additional benefit for this new fixed dose combination compared to the mono-components has not been demonstrated and that an acceptable safety profile of the new fixed-dose combination has not been shown.
Slovenian: Glavni pomisleki so bili osnova za napotitev na odbor CHMP, in sicer, da fiksna kombinacija odmerkov ni upravičena, da ni bila dokazana dodatna korist nove fiksne kombinacije odmerkov v primerjavi s posameznimi komponentami in da ni bil dokazan sprejemljiv varnostni profil nove fiksne kombinacije odmerkov.
English: CHMP members has expressed some concerns regarding the demonstrated superiority being limited to one post-operative pain model (molar extraction), that another pivot study failed to demonstrate the superiority of the association in another pain model (arthroscopy), and that there was no evidence available of superiority in the treatment of mild pain.
Slovenian: Članice odbora CHMP so izrazile nekaj pomislekov o dokazani superiornosti, ki je omejena le na en model pooperativne bolečine (ekstrakcija kočnikov), o dejstvu, da druga ključna študija ni dokazala superiornosti kombinacije na drugem bolečinskem modelu (artroskopija), in o odsotnosti razpoložljivih dokazov o superiornosti pri zdravljenju blage bolečine.
English: The results showed that the combination of paracetamol and ibuprofen had greater analgesic efficacy than the same dose of ibuprofen alone.
Slovenian: Rezultati so pokazali, da ima kombinacija paracetamola in ibuprofena večjo analgetično učinkovitost kot enak odmerek samega ibuprofena.
English: With regards the safety of this fixed dose combination, following the assessment of the data in the clinical trials as well as the PSUR and an extensive search of the published literature concluded that the known safety outcomes are expected by concomitant use of ibuprofen and paracetamol compared with the mono-components alone.
Slovenian: Kar zadeva varnost te fiksne kombinacije odmerkov, je bilo po ocenjevanju podatkov iz kliničnih preskušanj in poročil PSUR ter obširnem iskanju po objavljeni literaturi zaključeno, da so znani varnostni izidi, pričakovani ob sočasni uporabi ibuprofena in paracetamola, primerljivi z uporabo posamičnih komponent.
English: Clinical trials with the fixed dose combination have also not indicated any other undesirable effects other than those known for paracetamol alone or ibuprofen alone).
Slovenian: Klinična preskušanja s fiksno kombinacijo odmerkov niso pokazala drugih neželenih učinkov kot tistih, ki so že znani za sam paracetamol ali sam ibuprofen.
English: The CHMP also recommended the short term use (max for 3 days) of this fixed dose combination.
Slovenian: Odbor CHMP je tudi priporočil kratkotrajno uporabo (največ 3 dni) te fiksne kombinacije odmerkov.
English: Thirdly, there is a medical need for a new fixed dose combination analgesic that does not contain an opioid component for relief of acute pain.
Slovenian: Tretjič, za lajšanje akutne bolečine obstaja zdravstvena potreba po novem analgetiku s fiksno kombinacijo odmerkov, ki ne vsebuje opioidne komponente.
English: Having considered the above, the CHMP has recommended by majority the granting of the marketing authorisation for which the summary of product characteristics, labelling and package leaflet was amended following the final version achieved during the Coordination group procedure as mentioned in Annex III for Paracetamol/ibuprofen 500 mg / 150 mg film coated tablets and associated names fixed dose combination.
Slovenian: Z upoštevanjem zgoraj navedenega je odbor CHMP večinsko priporočil odobritev dovoljenja za promet z zdravilom, za katerega so bili povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo posodobljeni po končni različici, dogovorjeni v postopku Skupine za usklajevanje, kot je navedeno v Prilogi III za zdravilo s fiksno kombinacijo odmerkov Paracetamol/ibuprofen 500 mg/150 mg filmsko obložene tablete in povezana imena.
English: This phase II exploratory study has shown that in osteoarthritis pain, the combination is effective.
Slovenian: faze je pokazala, da je kombinacija pri bolečini zaradi osteoartritisa učinkovita.
English: Instructions in the posology section and warnings for the duration of use were provided in the product information.
Slovenian: Navodila v poglavju o odmerjanju in opozorila glede trajanja uporabe so bila vključena v informacije o zdravilu.
English: Furthermore in a study population which included 1.2 million patients, whose aim was to evaluate and compare the risk of specific safety outcomes in patients prescribed ibuprofen and paracetamol concomitantly with those in patients prescribed ibuprofen or paracetamol alone, concluded that the known risk of the safety outcomes examined does not appear to be modified by concomitant use of ibuprofen and paracetamol compared with the mono-components alone.
Slovenian: V študiji s populacijo, ki je vključevala 1,2 milijona bolnikov, katere cilj je bil ovrednotiti in primerjati tveganje za določene varnostne izide pri bolnikih, ki jim je bil sočasno predpisan ibuprofen in paracetamol, in pri bolnikih, ki jim je bil predpisan samo ibuprofen ali paracetamol, so zaključili, da ne kaže, da bi sočasna uporaba ibuprofena in paracetamola spremenila znano tveganje za preučene varnostne izide v primerjavi s posamičnima komponentama.
English: Vale Pharmaceuticals submitted to the United Kingdom an application under the decentralised procedure (DCP) for Paracetamol 500mg and Ibuprofen 150mg fixed dose combination on 27 March 2015.
Slovenian: Družba Vale Pharmaceuticals je 27. marca 2015 Združenemu kraljestvu predložila vlogo po decentraliziranem postopku za zdravilo s fiksno kombinacijo odmerkov paracetamola 500 mg in ibuprofena 150 mg.
English: Study AFT -MX6 was another phase III, placebo-controlled, prospective, randomised, double-blind, parallel-design trial with a safety follow-up at Day 30.
Slovenian: Študija AFT -MX6 je bila še eno s placebom nadzorovano, prospektivno, randomizirano, dvojno slepo preskušanje III. faze z vzporedno zasnovo, v katerem so varnost spremljali do 30. dneva.
English: Male and female participants aged 18 and 60 years undergoing surgical removal of least two impacted third molars were eligible for this study.
Slovenian: Za to študijo so bili primerni udeleženci in udeleženke, stari od 18 do 60 let, ki so jim kirurško odstranili vsaj dva impaktirana tretja kočnika.
English: When comparing with past users, for most safety outcomes, current users of concomitant paracetamol and ibuprofen had relative rates between those for current users of ibuprofen alone and paracetamol alone.
Slovenian: Primerjalno z nekdanjimi uporabniki so bili relativni deleži večine varnostnih izidov pri trenutnih sočasnih uporabnikih paracetamola in ibuprofena med deleži pri trenutnih uporabnikih samega ibuprofena in samega paracetamola.
English: Its objective was to compare the analgesic effects and safety of paracetamol and ibuprofen combined versus paracetamol alone or ibuprofen alone in adults with postoperative pain.
Slovenian: Njen cilj je bil primerjati analgetični učinek in varnost kombinacije paracetamola in ibuprofena s samim paracetamolom ali samim ibuprofenom pri odraslih s pooperativno bolečino.
English: Its objective was to compare the analgesic efficacy and clinical safety of Combination (paracetamol 500mg and ibuprofen 150 mg) with the other 3 treatment groups (paracetamol 500 mg; low dose ibuprofen 150 mg; high dose ibuprofen 300mg) in patients who have painful osteoarthritis of the knee.
Slovenian: Njen cilj je bil primerjati analgetično učinkovitost in klinično varnost kombinacije (paracetamol 500 mg in ibuprofen 150 mg) z drugimi tremi skupinami zdravljenja (paracetamol 500 mg, majhen odmerek ibuprofena 150 mg, velik odmerek ibuprofena 300 mg) pri bolnikih z bolečim osteoartritisom kolena.
English: The CHMP accepted this justification by the applicant for the need for the fixed dose combination in short term treatment of acute pain is acceptable for the several reasons.
Slovenian: Odbor CHMP je sprejel predlagateljevo utemeljitev, da je fiksna kombinacija odmerkov pri kratkotrajnem zdravljenju akutne bolečine sprejemljiva zaradi več razlogov.
English: The CHMP was of the opinion that the benefit-risk balance of Paracetamol / ibuprofen 500 mg / 150 mg film coated tablets and associated names fixed dose combination is considered to be favourable when used in accordance with the terms of the product information.
Slovenian: Odbor CHMP je menil, da velja razmerje med tveganji in koristmi zdravila s fiksno kombinacijo odmerkov Paracetamol/ibuprofen 500 mg/150 mg filmsko obložene tablete in povezanih imen za ugodno, če se uporablja v skladu s pogoji v informacijah o zdravilu.
English: Appropriately, instructions in the posology section and warnings for the duration of use were provided in the product information.
Slovenian: Navodila v poglavju z odmerjanjem in opozorila glede trajanja uporabe so bila ustrezno vključena v informacije o zdravilu.
English: Overall benefit-risk balance
Slovenian: Skupno razmerje med tveganji in koristmi
English: The rationale of the applicant presented the need for the fixed dose combination in short term treatment of acute pain was presented to the CHMP.
Slovenian: Odboru CHMP je bila predložena predlagateljeva utemeljitev, v kateri je predstavil potrebo po fiksni kombinaciji odmerkov pri kratkotrajnem zdravljenju akutne bolečine.
English: Rescue medication consumption was accounted for in the primary endpoint analysis by carrying forward the pre-rescue VAS pain score.
Slovenian: Pri analizi primarnega opazovanega dogodka so upoštevali uporabo reševalnega zdravila, tako da so v nadaljevanju upoštevali jakost bolečine po vizualni analogni lestvici pred uporabo reševalnega zdravila.
English: This phase III study was designed as a prospective, parallel-group, double-blind, placebo comparison of the clinical efficacy and safety of fixed dose combination (2 tablets, each tablet containing 500 mg paracetamol and 150 mg ibuprofen) versus its individual components (either 1000 mg paracetamol or 300 mg ibuprofen) and versus placebo in 300 patients suffering of moderate to severe pain due to post-arthroscopy surgery of the knee.
Slovenian: Ta študija III. faze je bila zasnovana kot prospektivna, dvojno slepa študija z vzporednimi skupinami in placebom, v kateri so primerjali klinično učinkovitost in varnost fiksne kombinacije odmerkov (2 tableti, vsaka je vsebovala 500 mg paracetamola in 150 mg ibuprofena) v primerjavi s posamičnima komponentama (1 000 mg paracetamola ali 300 mg ibuprofena) in v primerjavi s placebom pri 300 bolnikih, ki so imeli zmerno do hudo bolečino po artroskopskem posegu na kolenu.
English: In conclusion, the known risk of the safety outcomes examined does not appear to be modified by concomitant use of ibuprofen and paracetamol compared with paracetamol or ibuprofen alone.
Slovenian: Kaže torej, da se znano tveganje za preučene varnostne izide s sočasno uporabo ibuprofena in paracetamola v primerjavi s samim paracetamolom ali ibuprofenom ne spremeni.
English: • The Committee reviewed all the data submitted by the applicant in support of the efficacy of Paracetamol/ibuprofen 500 mg / 150 mg film coated tablets and associated names fixed dose combination in short-term symptomatic treatment of mild to moderate pain.
Slovenian: • odbor je pregledal vse podatke, ki jih je predložil predlagatelj v podporo učinkovitosti zdravila s fiksno kombinacijo odmerkov Paracetamol/ibuprofen 500 mg/150 mg filmsko obložene tablete in povezanih imen pri kratkotrajnem simptomatskem zdravljenju blage do zmerne bolečine;
English: Study AFT-MX-1 was a phase III, pivotal study with a prospective, parallel group, double-blind comparison of the analgesic effect of a combination of paracetamol and ibuprofen, paracetamol alone, or ibuprofen alone in patients with postoperative pain.
Slovenian: Študija AFT-MX-1 je bila ključna, prospektivna, dvojno slepa študija III. faze z vzporednimi skupinami, v kateri so primerjali analgetični učinek kombinacije paracetamola in ibuprofena, samega paracetamola ali samega ibuprofena pri bolnikih s pooperativno bolečino.
English: The CHMP requested that specifically for the special populations of hepatic and renal impaired patients the warnings related to paracetamol use are all in line with the warnings existing in the mono-component's product information, for completeness of the safety information.
Slovenian: Odbor CHMP je zaradi zagotavljanja celovitosti informacij o varnosti zahteval, da morajo biti opozorila za posebne populacije bolnikov z jetrno ali ledvično okvaro glede uporabe paracetamola v skladu z obstoječimi opozorili v informacijah o zdravilu z eno samo komponento.
English: The important safety risk associated with prolonged use of paracetamol and ibuprofen are well known and are hepatotoxicity, peptic ulceration and gastrointestinal bleeding, nephrotoxicity, cardiac, cardiovascular and cerebrovascular effects .The applicant has provided a comprehensive review of the safety data both from the submitted studies and from overall pooled study data including the exposure of the combination in elderly patients.
Slovenian: Pomembna varnostna tveganja, povezana z dolgotrajno uporabo paracetamola in ibuprofena, so dobro znana in vključujejo hepatotoksičnost, peptične ulkuse in krvavitev iz prebavil, nefrotoksičnost ter srčne, kardiovaskularne in cerebrovaskularne učinke.
English: • The Committee is of the opinion that the available data is supportive of the efficacy of Paracetamol/ibuprofen 500 mg / 150 mg film coated tablets and associated names fixed dose combination in short-term symptomatic treatment of mild to moderate pain.
Slovenian: • odbor je mnenja, da razpoložljivi podatki podpirajo učinkovitost zdravila s fiksno kombinacijo odmerkov Paracetamol/ibuprofen 500 mg/150 mg filmsko obložene tablete in povezanih imen pri kratkotrajnem simptomatskem zdravljenju blage do zmerne bolečine;
English: The short term use (max for 3 days) of this fixed dose combination has been recommended by the CHMP and accepted by the applicant.
Slovenian: Odbor CHMP je priporočil kratkotrajno uporabo (največ 3 dni) te fiksne kombinacije odmerkov, kar je predlagatelj sprejel.
English: Study AFT-MX-3 was a dose response study and a double-blind, placebo-controlled, randomised, parallel group comparison of the effects of different paracetamol and ibuprofen combination doses and placebo in participants with pain from removal of 2-4 third molars.
Slovenian: Študija AFT-MX-3 je bila študija odzivnosti na odmerke in dvojno slepa, s placebom nadzorovana, randomizirana študija z vzporednimi skupinami, v kateri so primerjali učinke različnih odmerkov kombinacije paracetamola in ibuprofena ter placeba pri udeležencih z bolečino zaradi izdrtja 24 tretjih kočnikov.
English: In conclusion, the safety outcomes examined were consistent in the concomitant use of ibuprofen and paracetamol compared with paracetamol or ibuprofen alone.
Slovenian: Preučeni varnostni izidi pri sočasni uporabi ibuprofena in paracetamola v primerjavi s samostojno uporabo paracetamola ali ibuprofena so bili torej skladni.
English: Therefore the risk for prolonged use of the fixed dose combination and Paracetamol or Ibuprofen alone should have a similar risk/benefit profile.
Slovenian: Zato bi moralo biti razmerje med koristmi in tveganji fiksne kombinacije odmerkov in samega paracetamola ali ibuprofena podobno.