FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/08/470/001 14 film-coated tablets EU/1/08/470/002 56 film-coated tablets EU/1/08/470/003 168 film-coated tablets EU/1/08/470/020 56 x 1 film-coated tablet EU/1/08/470/024 14 x 1 film-coated tablet EU/1/08/470/025 28 film-coated tablets EU/1/08/470/032 60 film-coated tablets
Slovenian: EU/1/08/470/001 14 filmsko obloženih tablet EU/1/08/470/002 56 filmsko obloženih tablet EU/1/08/470/003 168 filmsko obloženih tablet EU/1/08/470/020 56 x 1 filmsko obložena tableta EU/1/08/470/024 14 x 1 filmsko obložena tableta EU/1/08/470/025 28 filmsko obloženih tablet EU/1/08/470/032 60 filmsko obloženih tablet
English: In children from 4 years of age with a body weight of 30 to under 50 kg: • the usual starting dose is 1 mg (0.1 ml), for each kilogram (kg) of body weight, twice a day.
Slovenian: Pri otrocih od 4. leta starosti, ki tehtajo od 30 kg do manj kot 50 kg: • običajen začetni odmerek je 1 mg (0,1 ml) za vsak kilogram (kg) telesne mase, dvakrat na dan.
English: To be taken twice daily for children from 4 years of age weighing less than 40 kg
Slovenian: Jemanje dvakrat na dan za otroke od 4. leta starosti, ki tehtajo manj kot 40 kg Telesna masa
English: Vimpat 150 mg film-coated tablets polyvinyl alcohol polyethylene glycol 3350 talc titanium dioxide (E171) yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172)
Slovenian: Vimpat 150 mg filmsko obložene tablete polivinilalkohol polietilenglikol 3350 smukec titanov dioksid (E171) rumeni železov oksid (E172), rdeči železov oksid (E172), črni železov oksid (E172) Vimpat 200 mg filmsko obložene tablete polivinilalkohol polietilenglikol 3350 smukec titanov dioksid (E171) indigotin (E132)
English: To be used twice daily for children and adolescents from 4 years of age weighing 20 kg to under
Slovenian: Uporaba dvakrat na dan za otroke in mladostnike od 4. leta starosti, ki tehtajo od 20 do manj kot 30 kg:
English: Vimpat 100 mg <Justification for not including Braille accepted> 56 x 1 and 14 x 1 film-coated tablet
Slovenian: Vimpat 100 mg <Sprejeta razlaga, da Braillova pisava ni potrebna> 56 x 1 in 14 x 1 filmsko obložena tableta
English: Vimpat 50 mg <Justification for not including Braille accepted> 56 x 1 and 14 x 1 film-coated tablet
Slovenian: Vimpat 50 mg <Sprejeta razlaga, da Braillova pisava ni potrebna> 56 x 1 in 14 x 1 filmsko obložena tableta
English: To be taken twice daily for children from 4 years of age weighing less than 20 kg
Slovenian: Jemanje dvakrat na dan za otroke od 4. leta starosti, ki tehtajo manj kot 20 kg Telesna masa
English: Aggression Agitation(1) Euphoric mood(1) Psychotic disorder(1) Suicide attempt (1) Suicidal ideation Hallucination (1)
Slovenian: samomorilno razmišljanje halucinacije(1)
English: Taking Vimpat with other antiepileptic medicines - Children and adolescents with a body weight of 20 kg to under 30 kg - This is for information only.
Slovenian: Jemanje zdravila Vimpat skupaj z drugimi antiepileptiki - otroci in mladostniki, ki tehtajo od 20 kg do manj kot 30 kg - to navodilo je le informativno.
English: Taking Vimpat with other antiepileptic medicines - Children and adolescents with a body weight of 30 kg to under 50 kg - This is for information only.
Slovenian: Jemanje zdravila Vimpat skupaj z drugimi antiepileptiki - otroci in mladostniki, ki tehtajo od 30 kg do manj kot 50 kg - to navodilo je le informativno.
English: Citric acid, anhydrous
Slovenian: • zdravilo za HIV, ki se imenuje ritonavir
English: To be taken twice daily for children and adolescents from 4 years of age weighing 30 kg to under
Slovenian: Jemanje dvakrat na dan za otroke in mladostnike od 4. leta starosti, ki tehtajo od 30 do manj kot 50 kg:
English: Using Vimpat with other antiepileptic medicines - Children and adolescents with a body weight of 30 kg to under 50 kg - This is for information only.
Slovenian: Uporaba zdravila Vimpat skupaj z drugimi antiepileptiki - otroci in mladostniki, ki tehtajo od 30 kg do manj kot 50 kg - to navodilo je le informativno.
English: In children from 4 years of age with a body weight of under 20 kg: • the usual starting dose is 1 mg (0.1 ml), for each kilogram (kg) of body weight, twice a day.
Slovenian: Pri otrocih od 4. leta starosti, ki tehtajo manj kot 20 kg: • običajen začetni odmerek je 1 mg (0,1 ml) za vsak kilogram (kg) telesne mase, dvakrat na dan.
English: System organ class Very common
Slovenian: organski sistem zelo pogosti pogosti občasni neznana
English: Administration of a loading dose has not been studied in children.
Slovenian: Pri otrocih niso preučevali uporabe začetnega (polnilnega) odmerka.
English: To be used twice daily for children and adolescents from 4 years of age weighing 30 kg to under
Slovenian: Uporaba dvakrat na dan za otroke in mladostnike od 4. leta starosti, ki tehtajo od 30 do manj kot 50 kg:
English: Package leaflet: Information for the patient Vimpat 10 mg/ml solution for infusion lacosamide
Slovenian: IME ZDRAVILA Vimpat 10 mg/ml raztopina za infundiranje
English: Using Vimpat with other antiepileptic medicines - Children and adolescents with a body weight of 20 to under 30 kg - This is for information only.
Slovenian: Uporaba zdravila Vimpat skupaj z drugimi antiepileptiki - otroci in mladostniki, ki tehtajo od 20 kg do manj kot 30 kg - to navodilo je le informativno.
English: Vimpat 50 mg film-coated tablets Each film-coated tablet contains 50 mg lacosamide.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Vimpat 50 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 50 mg lakozamida.
English: 6.6 Special precautions for disposal and other handling
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje Ni posebnih zahtev za odstranjevanje.
English: Vimpat 150 mg film-coated tablets lacosamide
Slovenian: Vimpat 150 mg filmsko obložene tablete lakozamid
English: Adjunctive therapy doses to be taken twice daily for children and adolescents from 4 years of age weighing 20 kg to under 30 kg(1):
Slovenian: Odmerki pri dopolnilnem zdravljenju, pri otrocih od 4. leta starosti, ki tehtajo od 20 kg do manj kot 30 kg(1), ki jih je treba vzeti dvakrat na dan:
English: Vimpat 200 mg film-coated tablets lacosamide
Slovenian: Vimpat 200 mg filmsko obložene tablete lakozamid
English: If you have missed a dose beyond the first 6 hours of the scheduled dose, do not take the missed syrup anymore.
Slovenian: • Če ste z odmerkom zamudili več kot 6 ur od predvidenega časa za odmerek, ne vzemite dodatno še izpuščenega odmerka, Namesto tega zdravilo Vimpat vzemite ob času naslednjega odmerka, ko bi ga običajno vzeli.
English: Adjunctive therapy doses to be taken twice daily for children and adolescents from 4 years of age weighing 30 kg to under 50 kg(1):
Slovenian: Odmerki pri dopolnilnem zdravljenju, pri otrocih od 4. leta starosti, ki tehtajo od 30 kg do manj kot 50 kg(1), ki jih je treba vzeti dvakrat na dan:
English: Drug hypersensitivity(1)
Slovenian: evforično razpoloženje(1)
English: Bradycardia(1,2) Atrial Fibrillation
Slovenian: atrijska fibrilacija(1,2)
English: Package leaflet: Information for the patient Vimpat 10 mg/ml syrup lacosamide
Slovenian: IME ZDRAVILA Vimpat 10 mg/ml sirup
English: Vimpat 50 mg film-coated tablets lacosamide
Slovenian: Vimpat 50 mg filmsko obložene tablete lakozamid
English: (1) children and adolescents less than 50 kg should preferably start the treatment with Vimpat 10 mg/ml syrup (2) Dosage in adolescents 50 kg or more is the same as in adults.
Slovenian: 21 ml (210 mg) (1) Otroci in mladostniki, ki tehtajo manj kot 50 kg, naj zdravljenje po možnosti začnejo z zdravilom
English: UCB Pharma S.A. Tél: + 33 / (0)1 47 29 44 35
Slovenian: Tél: + 33 / (0)1 47 29 44 35
English: Vimpat 100 mg film-coated tablets lacosamide
Slovenian: Vimpat 100 mg filmsko obložene tablete lakozamid
English: Pharmasud Ltd. Tel: + 356 / 21 37 64 36
Slovenian: Tel: + 356 / 21 37 64 36
English: An unusual fracture in a healthy woman on long term alendronate.
Slovenian: An unusual fracture in a healthy woman on longterm alendronate.
English: Epidemiological studies
Slovenian: Epidemiološke študije
English: Non-clinical data
Slovenian: Neklinični podatki
English: Post-marketing reports
Slovenian: Poročila v obdobju trženja
English: • The Committee considered the referral made under Article 31 of Directive 2001/83/EC, as amended for biphosphonates containing medicines;
Slovenian: • Odbor je upošteval napotitev v skladu s členom 31 Direktive 2001/83/ES, kakor je bila spremenjena, za zdravila, ki vsebujejo difosfonate.
English: Overall summary of the scientific evaluation of Bisphosphonate-containing medicinal products (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravil, ki vsebujejo difosfonat (glejte Dodatek I)
English: However, the optimal duration of use of bisphosphonates for osteoporosis is not known.
Slovenian: Vendar pa optimalno trajanje uporabe difosfonatov za osteoporozo ni znano.
English: The CHMP concluded that the findings of this review do not change the overall balance of risks and benefits of individual bisphosphonates in their authorised indications.
Slovenian: CHMP je zaključil, da ugotovitve tega pregleda ne vplivajo na celotno razmerje med tveganji in koristmi posameznih difosfonatov za njihove odobrene indikacije.
English: Mechanism of atypical fractures
Slovenian: Mehanizem atipičnih zlomov
English: However these studies do not specifically relate to atypical fracture of the femur as they do not contain information about radiographic fracture pattern.
Slovenian: Vendar pa se te študije ne nanašajo posebej na atipične zlome stegnenice, saj ne vsebujejo informacij o rentgenskih vzorcih zlomov.
English: There is currently no robust evidence regarding the value of interrupting treatment with bisphosphonates.
Slovenian: Trenutno ni na voljo robustnih dokazov glede pomena prekinitve zdravljenja z difosfonati.
English: The CHMP reviewed the available data from non-clinical and histological studies, relevant clinical trials, epidemiological studies, post-marketing reports and published literature.
Slovenian: CHMP je pregledal razpoložljive podatke iz nekliničnih in histoloških študij, zadevnih kliničnih preskušanj, epidemioloških študij, poročil iz obdobja trženja in objavljene literature.
English: Concomitant treatment with other anti-resorptive drugs such as hormone replacement therapy and raloxifene have also been proposed as possible risk factors.
Slovenian: Sočasno zdravljenje z drugimi antiresorpcijskimi zdravili, kot sta hormonsko nadomestno zdravljenje in zdravljenje z raloksifenom, je bilo prav tako predstavljeno kot možni dejavnik tveganja.
English: The main postulated mechanism is the suppression of bone turnover leading indirectly to ageing bone and the delay or prevention of repair of naturally occurring stress fractures although the evidence is not conclusive.
Slovenian: Kot glavni možni mehanizem je bilo opredeljeno zaviranje kostne presnove, ki lahko posredno povzroča staranje kosti in zakasnitev oziroma preprečevanje zdravljenja naravno pojavljajočih se stresnih zlomov, vendar dokazi niso dokončni.
English: Bisphosphonates are medicinal products that are used to treat and prevent bone disorders including hypercalcaemia and the prevention of bone problems in patients with cancer, the treatment of osteoporosis and Paget's disease.
Slovenian: Difosfonati so zdravila, ki se uporabljajo za zdravljenje in preprečevanje kostnih bolezni, vključno s hiperkalcemijo, za preprečevanje težav s kostmi pri bolnikih z rakom ter za zdravljenje osteoporoze in Pagetove bolezni.
English: The CHMP also concluded that main risk factor associated with these fractures appears to be long-term bisphosphonate treatment.
Slovenian: CHMP je tudi zaključil, da kaže, da je glavni dejavnik tveganja, povezan s temi zlomi, dolgotrajno zdravljenje z difosfonati.
English: In view of the above, the CHMP has recommended the variation to the terms of the Marketing Authorisations for Bisphosphonate-containing medicinal products (see Annex I), for which the relevant sections of the Summary of Product Characteristics and Package Leaflets are set out in Annex III and subject to the conditions set out in Annex IV of this Opinion.
Slovenian: V skladu z navedenim je CHMP priporočil spremembo dovoljenj za promet z zdravili, ki vsebujejo difosfonate (glejte Dodatek I), katerih zadevna poglavja povzetka glavnih značilnosti zdravila in navodila za uporabo so navedena v Dodatku III in za katera veljajo pogoji v Dodatku IV tega mnenja.
English: Taking into account all the available evidence, the CHMP concluded that use of biphosphonates can be associated with the risk of atypical femoral fractures and therefore recommended that the following information is included in the Product Information of all biphosphonates:
Slovenian: Ob upoštevanju vseh razpoložljivih dokazov je CHMP sklenil, da je uporaba difosfonatov lahko povezana s tveganjem za atipične zlome stegnenice in zato priporočil, da se v informacije o zdravilu za vse difosfonate vključijo naslednje informacije:
English: Evidence from studies that do provide specific information about atypical femoral fractures identified from radiographs suggests that these fractures may be causally related to bisphosphonate use.
Slovenian: Dokazi iz študij, ki zagotavljajo specifične informacije o atipičnih zlomih stegnenice, ugotovljenih z rentgenskimi posnetki, kažejo, da so ti zlomi morda vzročno povezani z uporabo difosfonatov.
English: The potential risk of atypical fractures at sites other than the femur will be kept under review.
Slovenian: Možno tveganje za atipične zlome na drugih mestih kot na stegnenici se bo še naprej preučevalo.
English: The effects of high-dose, long-term alendronate treatment on microarchitecture and bone mineral density of compact and trabecular bone in the proximal femur of adult male rabbits.
Slovenian: Hofstaetter JG et al. The effects of high-dose, long-term alendronate treatment on microarchitecture and bone mineral density of compact and trabecular bone in the proximal femur of adult male rabbits.
English: • The Committee considered all the available data submitted (pre-clinical, clinical, epidemiological studies, post-marketing reports, published literature) in relation to the risk of atypical femoral fractures with biphosphonates.
Slovenian: • Odbor je upošteval vse razpoložljive predložene podatke (predklinične, klinične, epidemiološke študije, poročila v obdobju trženja, objavljena literatura) v zvezi s tveganjem za atipične zlome stegnenice pri uporabi difosfonatov.
English: The lack of reports with the remaining bisphosphonates, clodronic acid, neridronic acid and tiludronic acid may be related to the lower exposure of these medicinal products compared with other bisphosphonates and a lack of an association can not be excluded.
Slovenian: Pomanjkanje poročil o preostalih difosfonatih, klodronski kislini, neridronski kislini in tiludronski kislini je lahko povezano z manjšo izpostavljenostjo tem zdravilom v primerjavi z drugimi difosfonati, pomanjkljive povezave pa ni mogoče izključiti.
English: • On the basis of the available evidence, mainly from epidemiological studies and post-marketing reports, the Committee concluded that use of bisphosphonates may be associated with the risk of atypical femoral fractures.
Slovenian: • Na podlagi razpoložljivih dokazov, predvsem iz epidemioloških študij in poročil v obdobju trženja, je Odbor sklenil, da je uporaba difosfonatov lahko povezana s tveganjem za atipične zlome stegnenice.
English: At the present time there is little evidence from literature and spontaneous reports to support an association between bisphosphonates and atypical fracture at sites other than the femur.
Slovenian: Trenutno je na voljo malo dokazov iz literature in spontanih poročil, ki bi podpirali povezavo med difosfonati in atipičnimi zlomi na drugih mestih kot na stegnenici.
English: Following a Pharmacovigilance Working Party (PhVWP) review in 2008, it was concluded that a warning about atypical stress fractures of the proximal femoral shaft would be added to the product information for alendronic acid containing medicinal products across Europe.
Slovenian: Po pregledu delovne skupine za farmakovigilanco v letu 2008 je bilo sklenjeno, da se po vsej Evropi v informacije o zdravilih, ki vsebujejo alendronsko kislino, vključi opozorilo o atipičnih stresnih zlomih proksimalne stegnenice.
English: Although the highest number of possible atypical femoral fracture continue to be reported in association with alendronic acid for osteoporosis, post-marketing reports have also been reported for other bisphosphonates for osteoporosis (etidronic acid, ibandronic acid, risedronic acid and zoledronate), and also for Paget's disease (zoledronate) and oncology indications (ibandronic acid, pamidronic acid and zoledronate), suggesting that these fractures may be a class effect of bisphosphonates.
Slovenian: Čeprav se o največjem številu možnih atipičnih zlomov stegnenice še vedno poroča v zvezi z alendronsko kislino za osteoporozo, pa poročila v obdobju trženja vsebujejo tudi navedbe o drugih difosfonatih za osteoporozo (etidronska kislina, ibandronska kislina, risedronska kislina in zoledronat)) ter za Pagetovo bolezen (zoledronat) in onkološke indikacije (ibandronska kislina, pamidronska kislina in zoledronat), kar kaže, da so ti zlomi lahko učinek difosfonatov.
English: In addition, given the lack of evidence regarding the optimal duration of bisphosphonate treatment for osteoporosis, and considering that duration of treatment is a risk factor for atypical femoral fractures, the CHMP also recommended that information should be added to section 4.2. of the product information for bisphosphonates authorised for osteoporosis, about the need to periodically evaluate the need for continuing bisphosphonate treatment, particularly after 5 years of treatment, on an individual patient basis.
Slovenian: Ob upoštevanju pomanjkanja dokazov glede optimalnega trajanja zdravljenja osteoporoze z difosfonati in ob upoštevanju, da je trajanje zdravljenja dejavnik tveganja za atipične zlome stegnenice, je CHMP priporočil tudi, da se v poglavje 4.2 informacij o zdravilu za difosfonate, odobrene za osteoporozo, vključi informacija o potrebnem periodičnem ocenjevanju potrebe po nadaljnjem zdravljenju z difosfonati za posameznega bolnika, zlasti po petih letih zdravljenja.
English: Further to the PhVWP discussions and the emerging data from published literature and post-marketing reports that suggest that atypical stress fractures may be a class effect of bisphosphonates, the UK asked the CHMP in September 2010, to provide an opinion under Article 31 of directive 2001/83 EEC, as amended on whether the Marketing Authorisations for medicinal products containing bisphosphonates should be maintained, varied, suspended or withdrawn.
Slovenian: Po razpravah v delovni skupini za farmakovigilanco, novih podatkih iz objavljene literature in poročil, nastalih v obdobju trženja, ki kažejo, da so atipični stresni zlomi lahko učinek difosfonatov, je Združeno kraljestvo CHMP zaprosilo, da izda mnenje v skladu s členom 31 direktive 2001/83/EGS, kakor je bila spremenjena, v zvezi s tem, ali naj se dovoljenja za promet z zdravili, ki vsebujejo difosfonate, ohranijo, spremenijo, začasno umaknejo ali umaknejo.
English: • Addition of a warning in section 4.4 of the SmPC (Special warnings and precautions for use) to reflect this risk , the main features of these fractures and the potential need for discontinuation of treatment in case a fracture is suspected.
Slovenian: • Vključitev opozorila v poglavje 4.4 povzetka glavnih značilnosti zdravila (Posebna opozorila in previdnostni ukrepi), ki naj odraža tveganje, glavne značilnosti teh zlomov in morebitno potrebo po prekinitvi zdravljenja v primeru suma na zlom.
English: The Committee also concluded that information should be added to section 4.2. of the product information for bisphosphonates authorised for osteoporosis, about the need to periodically evaluate the need for continuing bisphosphonate treatment, particularly after 5 years of treatment, on an individual patient basis.
Slovenian: Odbor je tudi sklenil, da je treba v poglavje 4.2 informacij o zdravilu za difosfonate vključiti informacijo o potrebnem periodičnem ocenjevanju potrebe po nadaljnjem zdravljenju z difosfonati za posameznega bolnika, zlasti po petih letih zdravljenja.
English: This issue was considered again by the PhVWP in April 2010, as cases had been reported in association with other bisphosphonates, supporting the view that atypical stress fractures are a class effect of bisphosphonates.
Slovenian: To vprašanje je delovna skupina za farmakovigilanco ponovno preučevala v aprilu 2010, saj so poročali o več primerih v zvezi z drugimi difosfonati, ki so potrjevali stališče, da so atipični stresni zlomi učinek difosfonatov.
English: Annex II Scientific conclusions and grounds for amendment of the summaries of product characteristics and package leaflets presented by the EMA
Slovenian: Dodatek II Znanstveni zaključki in podlaga za dopolnilo povzetkov glavnih značilnosti zdravila in navodil za uporabo, ki jih je predstavila Evropska agencija za zdravila
English: The task force of the American Society for Bone and Mineral Research (ASBMR) on atypical subtrochanteric and diaphyseal femoral fractures have defined major and minor features of atypical femoral fracture (Shane et al, 20103) and recommend that for a case to be considered an atypical femoral fracture all major features need to be present, whereas the minor features have commonly been described in cases of atypical femoral fractures, but are not present in all patients.
Slovenian: Delovna skupina ameriškega združenja za raziskovanje kosti in mineralov (ASBMR) za atipične subtrohanterne in diafizne zlome stegnenice je opredelila glavne in manj pomembne značilnosti atipičnih zlomov stegnenice (Shane et al., 20103) in priporočila, da morajo biti za določitev primera kot atipičnega zloma stegnenice prisotne vse glavne značilnosti, medtem ko so po drugi strani pri primerih atipičnih zlomov stegnenice pogosto opisane manj pomembne značilnosti, ki pa niso prisotne pri vseh bolnikih.
English: Based on the small number of spontaneous reports of comminuted atypical femoral fracture in association with bisphosphonates, one published case report (Schneider, 20064), as well as preliminary data presented at the October meeting of the ASBMR (Nitche et al, 20105), the CHMP for the purpose of its assessment agreed on a modified case definition that lists ‘noncomminuted' as a minor feature rather than a major feature of atypical femur femoral fracture.
Slovenian: Na podlagi majhnega števila spontanih poročil o zdrobljenih atipičnih zlomih stegnenice v zvezi z difosfonati, enega objavljenega poročila o primeru (Schneider, 20064) in predhodnih podatkov, predstavljenih na oktobrskem srečanju združenja ASBMR (Nitche et al., 20105), je CHMP za namen postopka vrednotenja potrdil spremenjeno opredelitev primera, ki navaja „zdrobljene“ zlome kot manj pomembno značilnost in ne glavno značilnost atipičnih zlomov stegnenice.
English: However not all preclinical studies have found adverse effects of alendronic acid on bone (Burr et al2).
Slovenian: Vendar pa se neželeni učinki alendronske kisline na kosti niso pokazali pri vseh predkliničnih študijah (Burr et al.2).
English: Other than osteoporosis the most prevalent co-morbid conditions in patients with atypical femur fracture were found to be chronic obstructive pulmonary disease or asthma, rheumatoid arthritis and diabetes.
Slovenian: Poleg osteoporoze so bile pri bolnikih z atipičnimi zlomi stegnenice kot najpogostejše sočasne bolezni ugotovljene kronična obstruktivna pljučna bolezen ali astma, revmatoidni artritis in diabetes.