FrancophonIA/ELRC3.0 huggingface dataset:
English: The Committee, as a consequence, recommends the variation to the terms of the marketing authorisations for medicinal products containing lactose of bovine origin for intravenous/intramuscular (IV/IM) use in acute allergic conditions.
Slovenian: Odbor zato priporoča spremembo pogojev dovoljenj za promet z zdravili, ki vsebujejo laktozo govejega izvora, za intravensko/intramuskularno (i.v./i.m.)
English: Serious cases of allergic reactions have been reported in patients allergic to cow's milk administered Solu-Medrol for acute allergic conditions, including cases reporting a positive skin prick test for Solu-Medrol, a skin test for immunoglobulin E mediated allergic response.
Slovenian: Poročali so o hudih primerih alergijskih reakcij pri bolnikih, ki so alergični na kravje mleko in so prejeli zdravilo Solu-Medrol za akutna alergijska stanja, vključno s primeri pozitivnega kožnega vbodnega testa za Solu-Medrol, kožnega testa za alergijski odziv, ki ga posreduje imunoglobulin E. Ker se zdravilo Solu-Medrol uporablja za akutno alergijsko stanje, se morebitna anafilaktična reakcija, ki jo lahko povzročijo sledovi mlečnih beljakovin v izdelku, lahko napačno razlaga kot pomanjkanje terapevtskega učinka, kar odloži ustrezno oskrbo bolnika.
English: • The PRAC considers that, in patients allergic to cow's milk, a risk of serious allergic reactions, including anaphylactic reactions, is associated to IV/IM treatment of acute allergic conditions with methylprednisolone-containing products formulated with lactose of bovine origin.
Slovenian: • odbor meni, da je pri bolnikih, alergičnih na kravje mleko, tveganje resnih alergijskih reakcij, vključno z anafilaktičnimi reakcijami, povezano z i.v./i.m.
English: Therefore the CMDh recommends the variation to the terms of the marketing authorisations for medicinal products containing lactose of bovine origin for IV/IM use in acute allergic conditions.
Slovenian: Zato odbor CMDh priporoča spremembo pogojev dovoljenj za promet z zdravili, ki vsebujejo laktozo govejega izvora, za intravensko/intramuskularno (i.v./i.m.)
English: In view of the above, the Committee considers that the benefit-risk balance of medicinal products containing lactose of bovine origin for intravenous/intramuscular (IV/IM) use in acute allergic conditions remains favourable subject to the agreed condition to the marketing authorisations, and taking into account the agreed amendments to the product information.
Slovenian: uporabo pri akutnih alergijskih stanjih, ostane ugodno, če se izpolni dogovorjeni pogoj za dovoljenje za promet in se uvedejo dogovorjene spremembe informacij o zdravilu.
English: Thus, data currently available does not allow establishing a safe IV/IM intake threshold for patients allergic to cow's milk and the risk of serious allergic reactions in these patients applies to all products formulated with Ph. Eur.
Slovenian: vnos pri bolnikih, alergičnih na kravje mleko, obstaja tveganje resnih alergijskih reakcij pri teh bolnikih v primeru uporabe zdravil, pripravljenih z laktozo Ph. Eur.
English: The CMDh, as a consequence, considers that the benefit-risk balance of medicinal products containing lactose of bovine origin for IV/IM use in acute allergic conditions remains favourable subject to the amendments to the product information and to the condition described above.
Slovenian: uporabo pri akutnih alergijskih stanjih, še naprej ugodno, če se upoštevajo spremembe informacij o zdravilu in pogoj, opisan zgoraj.
English: Methylprednisolone-containing products formulated with lactose of bovine origin are authorised for IV/IM use in a range of different indications across EU MSs, including in relation to acute allergic conditions.
Slovenian: Zdravila, ki vsebujejo metilprednizolon, pripravljena z laktozo govejega izvora, so odobrena za i.v./i.m.
English: It is also approved in Norway and Iceland.
Slovenian: Odobren je tudi na Norveškem in v Islandiji.
English: The Member States' competent authorities will continue to keep the product under regular review.
Slovenian: Pristojni organi držav članic bodo zdravilo še naprej redno nadzorovali.
English: The Rapporteur and Co-Rapporteur appointed were Dr Julia Dunne and Dr Ingemar Persson, respectively.
Slovenian: Poročevalec oz. soporočevalec sta bila dr. Julia Dunne oz. dr. Ingemar Persson.
English: The final opinion was converted into a Decision by the European Commission on 03.09.2007.
Slovenian: Končno mnenje je Evropska komisija dne 03.09.2007 spremenila v odločbo.
English: E-mail: mail@emea.eu.int http://www.emea.eu.int©.EMEA 2006 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
Slovenian: E-mail: mail@emea.europa.eu http://www.emea.europa.eu©.EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
English: SUMMARY INFORMATION ON REFERRAL OPINION PURSUANT TO ARTICLE 31 OF COUNCIL DIRECTIVE 2001/83/EC, AS AMENDED, FOR
Slovenian: POVZETEK MNENJA, SPREJETEGA V OKVIRU POSTOPKA NAPOTITVE V SKLADU S ČLENOM 31 DIREKTIVE SVETA 2001/83/ES, KAKOR JE BILA SPREMENJENA, ZA
English: International Non-Proprietary Name (INN): bicalutamide
Slovenian: Mednarodno nelastniško ime (INN): bikalutamid
English: To address this concern, a new epidemiological study will be performed, as part of an agreed Risk Management Plan.
Slovenian: Za razjasnitev tega pomisleka bo v okviru dogovorjenega načrta za obvladovanje tveganj izvedena nova epidemiološka raziskava.
English: * Note: The information given in this document and Annexes reflect only the CHMP Opinion dated 24 May 2007.
Slovenian: * Opomba: Informacije, podane v tem dokumentu in dodatkih, odražajo le mnenje CHMP z dne 24. maja 2007.
English: Oral explanations were given on 22 May 2007.
Slovenian: Ustna pojasnila so bila podana 22. maja 2007.
English: The referral procedure started on 27 July 2006.
Slovenian: Postopek obravnave se je začel 27. julija 2006.
English: On 27 July 2006, Belgium presented a referral to the EMEA under Article 31 of Directive 2001/83, as amended.
Slovenian: Belgija je 27. julija 2006 EMEA posredovala napotitev v skladu s členom 31 Direktive 2001/83/ES, kakor je bila spremenjena.
English: Written explanations were provided by the Marketing Authorisation Holders on 20 October 2006, 22 March 2007 and on 15 May 2007.
Slovenian: Imetniki dovoljenj za promet z zdravilom so podali pisna pojasnila 20. oktobra 2006, 22. marca 2007 in 15. maja 2007.
English: London, 16 August 2007 EMEA/378451/2007
Slovenian: London, 16. avgust 2007 EMEA/378451/2007
English: The 4 issues raised in the referral concerned the analyses of the Early Prostate Cancer Programme (EPC):
Slovenian: Štiri vprašanja, izpostavljena v napotitvi, so se nanašala na analizo programa v zvezi z zgodnjo fazo raka prostate (Early Prostate Cancer Programme - EPC):
English: Bicalutamide 150 mg is marketed in the EU following national and Mutual Recognition application procedures.
Slovenian: Bikalutamid 150 mg se v EU trži na podlagi nacionalnih postopkov in postopka medsebojnega priznavanja.
English: Its authorised indications include the treatment of patients with locally advanced prostate cancer, as an immediate therapy either alone or as adjuvant to treatment by radical prostatectomy or radiotherapy.
Slovenian: Odobrene indikacije vključujejo zdravljenje bolnikov z lokalno napredovalim rakom prostate, in sicer kot takojšnje samostojno zdravljenje ali kot dodatek pri zdravljenju z radikalno prostatektomijo ali radioterapijo.
English: - the lack of an overall survival benefit versus adverse events in ‘locally advanced prostate cancer'; - statistical concerns regarding multiplicity; - the standard of care for the placebo group in the relevant studies; - the number of deaths due to cardiac failure.
Slovenian: - odsotnost celokupne koristi zaradi podaljšanja preživetja v primerjavi z neželenimi učinki pri lokalno napredovalem raku prostate; - statistični pomisleki v zvezi z multipliciteto; - standardno zdravljenje v skupini s placebom v zadevnih raziskavah; - število smrti zaradi srčne odpovedi.
English: Bicalutamide 150 mg-containing medicinal products (See Annex 1)
Slovenian: zdravila, ki vsebujejo 150 mg bikalutamida (glejte Dodatek I)
English: Locally advanced prostate cancer refers to larger tumours or tumours with spread to lymph nodes, but not involving spread to other organs.
Slovenian: Lokalno napredovali rak predstavlja večje tumorje ali tumorje s širitvijo na bezgavke, vendar ne vključuje širitve na druge organe.
English: Bicalutamide is an oral anti-androgen used in the management of prostate cancer.
Slovenian: Bikalutamid je peroralni antiandrogen, ki se uporablja pri zdravljenju raka prostate.
English: In view of the available data, the CHMP concluded that a potential association between the use of bicalutamide 150 mg and heart failure cannot be ruled out and therefore considered that the need to further study cardiovascular morbidity and mortality remains.
Slovenian: Z ozirom na razpoložljive podatke je CHMP zaključil, da potencialne povezave med uporabo bikalutamida 150 mg in srčno odpovedjo ni mogoče izključiti ter da posledično obstaja potreba po nadaljnjem preučevanju kardiovaskularne obolevnosti in smrtnosti.
English: Based on evaluation of the available data and the Rapporteurs' assessment reports, the CHMP considered that the benefit/risk profile of bicalutamide 150 mg-containing medicinal products remains favourable, and therefore adopted an opinion on 24 May 2007 recommending the maintenance or the granting, as appropriate, of the Marketing Authorisations with amendments to the relevant sections of the Summary of Product Characteristics, for bicalutamide 150 mg-containing medicinal products.
Slovenian: Na podlagi ovrednotenja razpoložljivih podatkov in poročil o oceni, ki so jih podali poročevalci, je CHMP menil, da ostaja razmerje med koristmi in tveganji za zdravila, ki vsebujejo 150 mg bikalutamida, pozitivno ter je zato 24. maja 2007 sprejel mnenje, s katerim priporoča ohranitev ali podelitev, kot ustreza, dovoljenj za promet z zdravilom z dopolnitvami ustreznih poglavij Povzetka glavnih značilnosti zdravila, za zdravila, ki vsebujejo 150 mg bikalutamida.
English: The CHMP considered that bicalutamide 150 mg is effective in the treatment of locally advanced prostate cancer; however the CHMP considered that the therapeutic indication should be restricted to treatment of patients at high risk of disease progression.
Slovenian: CHMP je ocenil, da je bikalutamid 150 mg učinkovit pri zdravljenju lokalno napredovalega raka prostate, vendar pa je CHMP menil tudi, da je treba terapevtsko indikacijo omejiti na zdravljenje bolnikov, pri katerih obstaja veliko tveganje za napredovanje bolezni.
English: The list of product names concerned is given in the Annex I. The scientific conclusions are provided in the Annex II, together with the amended relevant sections of the Summary of Product Characteristics in the Annex III, and the conditions of the marketing authorisations in the Annex IV.
Slovenian: Seznam zadevnih imen zdravil je naveden v Dodatku I. Dodatek II vsebuje znanstvene zaključke, Dodatek III dopolnjen povzetek glavnih značilnosti zdravila, Dodatek IV pa vsebuje pogoje dovoljenja za promet z zdravilom.
English: The reasons for referral concerned a review of the benefit/risk profile of medicinal products containing bicalutamide 150 mg.
Slovenian: Razlog za napotitev je bila preverba razmerja med tveganji in koristmi za zdravila, ki vsebujejo bikalutamid 150 mg.
English: Annex
Slovenian: Dodatek
English: The Member States shall ensure that the following conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Slovenian: Države članice morajo zagotoviti, da so implementirani naslednji spodaj opisani pogoji ali omejitve v zvezi z varno in učinkovito uporabo zdravila.
English: • The need for intake of the 15 mg and 20 mg tablets with food
Slovenian: • o pomembnosti jemanja tablet po 15 mg in 20 mg skupaj s hrano
English: • The educational pack is aimed at increasing awareness about the potential risk of bleeding during treatment with Xarelto and providing guidance on how to manage that risk.
Slovenian: • To izobraževalno gradivo je namenjeno za osveščanje o možnem tveganju za krvavitve med zdravljenjem z zdravilom Xarelto in daje navodila za obvladovanje tega tveganja.
English: • Signs or symptoms of bleeding and when to seek attention from a health care provider.
Slovenian: • o znakih in simptomih krvavitve ter o tem, kdaj poiskati zdravniško pomoč
English: • Necessity to carry the Patient alert card with them at all times
Slovenian: • o potrebi, da imajo kartico za bolnika vedno pri sebi
English: • The content and format of the educational material, together with a communication plan, should be agreed with the MAH prior to distribution of the educational pack and launch of the new indication.
Slovenian: • Vsebino in obliko izobraževalnega gradiva in načrt obveščanja je treba pred distribucijo in pred prihodom nove indikacije na trg uskladiti z imetnikom dovoljenja za promet.
English: • The Prescriber Guide should contain the following key safety messages: Details of populations potentially at higher risk of bleeding Recommendations for dose reduction in at risk populations Guidance regarding switching from or to rivaroxaban treatment The need for intake of the 15 mg and 20 mg tablets with food Management of overdose situations The use of coagulation tests and their interpretation That all patients should be provided with a Patient alert card and be counselled about:
Slovenian: • Navodilo za predpisovalca mora vsebovati naslednja ključna sporočila o varnosti: podroben opis populacij, pri katerih obstaja povečano tveganje za krvavitve priporočila o zmanjšanju odmerka pri populacijah s povečanim tveganjem navodila glede zamenjave z ali na zdravljenje z rivaroksabanom pomembnost jemanja tablet po 15 mg in 20 mg skupaj s hrano opis ukrepov pri prevelikem odmerjanju uporaba koagulacijskih testov in njihova interpretacija vsi bolniki morajo prejeti kartico za bolnika in biti poučeni
English: • The physician educational pack should contain: o The Summary of Product Characteristics o Prescriber Guide o Patient Alert Cards
Slovenian: • Izobraževalno gradivo za zdravnike mora vsebovati: o povzetek glavnih značilnosti zdravila o navodilo za predpisovalca o kartico za bolnika
English: The need for intake of the 15 mg and 20 mg tablets with food Necessity to carry the Patient alert card with them at all times The need to inform Health Care Professionals that they are taking Xarelto if they need to have any surgery or invasive procedure.
Slovenian: • Kartica za bolnika mora vsebovati naslednja ključna sporočila o varnosti: podatke o znakih in simptomih krvavitve ter o tem, kdaj poiskati zdravniško pomoč pomen upoštevanja navodil za jemanje zdravila pomembnost jemanja tablet po 15 mg in 20 mg skupaj s hrano potreba, da imajo kartico za bolnika vedno pri sebi opozorilo, da morajo zdravnika pred vsakim kirurškim posegom ali invazivnim posegom obvestiti, da jemljejo rivaroksaban.
English: • The need to inform Health Care Professionals that they are taking Xarelto if they need to have any surgery or invasive procedure.
Slovenian: • o tem, da morajo zdravnika pred vsakim kirurškim posegom ali invazivnim posegom obvestiti, da jemljejo rivaroksaban.
English: • The MAH shall provide an educational pack, targeting all physicians who are expected to prescribe/use Xarelto prior to the launch of the new indication for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors.
Slovenian: • Preden bo zdravilo z navedbo nove indikacije - preprečevanje možganske kapi in sistemske embolije pri odraslih bolnikih z nevalvularno atrijsko fibrilacijo in enim ali več dejavniki tveganja - na trgu, mora imetnik dovoljenja za promet z zdravilom pripraviti izobraževalno gradivo za vse zdravnike, ki bodo predvidoma predpisovali ali uporabljali zdravilo Xarelto.
English: • The MAH shall provide an educational pack, targeting all physicians who are expected to prescribe/use Xarelto prior to the launch of the new indication for the treatment of deep vein thrombosis (DVT) and prevention of recurrent DVT and pulmonary embolism (PE) following an acute DVT in adults.
Slovenian: • Preden bo zdravilo z navedbo nove indikacije - zdravljenje globoke venske tromboze (GVT) in preprečevanje ponovne GVT in pljučne embolije (PE) po akutni GVT pri odraslih - na trgu, mora imetnik dovoljenja za promet z zdravilom pripraviti izobraževalno gradivo za vse zdravnike, ki bodo predvidoma predpisovali ali uporabljali zdravilo Xarelto.
English: If this medicine has been prescribed for your child, please note that all the information in this leaflet is addressed to your child (in this case please read “your child” instead of “you”).
Slovenian: Če je bilo to zdravilo predpisano za vašega otroka, veljajo vsi podatki v tem navodilu za uporabo za vašega otroka (v tem primeru berite “vaš otrok” namesto “vi”).
English: • deep, rapid breathing
Slovenian: • globoko, hitro dihanje
English: • It is very important to tell your doctor if you are taking other medicines that may damage your kidneys.
Slovenian: • Zelo pomembno je, da zdravnika obvestite, če jemljete druga zdravila, ki bi lahko poškodovala vaše ledvice.
English: If no alternative treatment is available, prolonged dose intervals may be used as follows:
Slovenian: Če ni na voljo druge oblike zdravljenja, se lahko uporabijo podaljšani odmerni intervali, kot sledi:
English: If you miss a dose, work out how long since you should have taken it.
Slovenian: Če ste izpustili odmerek, izračunajte, koliko časa je minilo od takrat, ko bi ga morali vzeti.
English: The optimal duration of treatment is currently unknown.
Slovenian: Optimalno trajanje zdravljenja trenutno ni znano.
English: Then mix the powder with about 100 ml (half a glass) of water, orange juice or grape juice and drink immediately
Slovenian: Nato zmešajte prašek s približno 100 ml (pol kozarca) vode, pomarančnega ali grozdnega soka in nemudoma popijte.
English: Tests may also show: • decreases in phosphate in the blood
Slovenian: Preiskave lahko kažejo tudi: • zmanjšanje količine fosfata v krvi
English: You must use an effective method of contraception to avoid becoming pregnant.
Slovenian: Uporabljati morate učinkovito kontracepcijsko metodo, da bi s tem preprečili zanositev.
English: Date of first authorisation: 08 December 2016
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 08. december 2016
English: Week 192
Slovenian: 192. teden
English: • Adults: 1 tablet each day with food (for example, a meal or a snack).
Slovenian: • odrasli: 1 tableta vsak dan s hrano (na primer ob obroku ali prigrizku).
English: Staggered administration (12 hours apart) provided similar results.
Slovenian: Pri odmerjanju z zamikom (12 ur narazen) so bili rezultati podobni.
English: Other suitable formulations may be checked for their availability.
Slovenian: Lahko preverite, če so na voljo druge ustrezne oblike.
English: n/a = not applicable.
Slovenian: n/a (not applicable) = navedba ni smiselna
English: If you have hepatitis B infection, your doctor will carefully consider the best treatment for you.
Slovenian: Če ste okuženi s hepatitisom B, bo zdravnik skrbno razmislil o najboljšem zdravljenju za vas.
English: • interleukin-2 (to treat cancer),
Slovenian: • interlevkin-2 (za zdravljenje raka);
English: Week b e g i l o c f h j m p
Slovenian: Teden b e g i l o c f h j m p
English: However, a benefit is expected for the adolescent population based on extrapolation of adult data and comparative pharmacokinetic data (see section 5.2).
Slovenian: Vendar se koristi pričakujejo za populacijo mladostnikov na podlagi ekstrapolacije podatkov pri odraslih in primerljivih podatkov o farmakokinetiki (glejte poglavje 5.2).
English: • Other forms of this medicine may be more suitable for patients who have difficulty swallowing; ask your doctor or pharmacist.
Slovenian: • Za bolnike, ki imajo težave s požiranjem, bodo morda primernejše druge oblike tega zdravila; o tem povprašajte zdravnika ali farmacevta.
English: A large amount of data on pregnant women (more than 1,000 pregnancy outcomes) indicate no malformations or foetal/neonatal toxicity associated with tenofovir disoproxil.
Slovenian: Veliko število podatkov pri nosečnicah (več kot 1.000 izpostavljenih nosečnosti) ne kaže na malformacije ali feto/neonatalno toksičnost povezane z dizoproksiltenofoviratom.
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) or rare (≥ 1/10,000 to
Slovenian: Pogostnosti so definirane kot zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100) ali redki (≥ 1/10.000 do < 1/1.000).
English: The tablets are also available in blister packs containing 10, 30 or 30 x 1 (unit dose) tablets.
Slovenian: Tablete so na voljo tudi v pakiranjih s pretisnimi omoti, ki vsebujejo 10, 30 ali 30 x 1 (enojno pakiranje) tableto.
English: • adolescents aged 12 to less than 18 years.
Slovenian: • mladostnike, stare od 12 do manj kot 18 let.
English: Possible serious side effects: tell your doctor immediately
Slovenian: Možni resni neželeni učinki: nemudoma se posvetujte z zdravnikom
English: Do not use this medicine after the expiry date which is stated on the bottle and carton after {EXP}.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na plastenki in škatli poleg oznake “EXP”.
English: k One patient in this group became HBsAg negative for the first time at the 240 week visit and was ongoing in the study at the time of the data cut-off.
Slovenian: k En bolnik v tej skupini je postal prvič negativen na HBsAg ob obisku v 240. tednu, kar je ostalo ves čas študije do trenutka prvega zbiranja podatkov.
English: • Lactic acidosis (excess lactic acid in the blood) is a rare (can affect up to 1 in every 1,000 patients) but serious side effect that can be fatal.
Slovenian: • laktacidoza (povečana količina mlečne kisline v krvi) je redek (pojavi se lahko pri največ 1 od 1.000 bolnikov), a resen neželeni učinek, ki je lahko usoden.
English: At week 72, 96% (27/28) of immune-active patients (HBV DNA ≥ 10
Slovenian: V 72. tednu je 96% (27/28) imunsko aktivnih bolnikov (HBV DNA
English: • Talk to your doctor or pharmacist if you have had kidney disease or if tests have shown problems with your kidneys.
Slovenian: • Posvetujte se z zdravnikom ali farmacevtom, če ste kdaj imeli bolezni ledvic ali če so preiskave kazale na težave z ledvicami.
English: Consequently, patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucosegalactose malabsorption should not take this medicinal product.
Slovenian: Zato bolniki z redko dedno intoleranco za galaktozo, popolnim pomanjkanjem laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
English: • If you have taken Tenofovir disoproxil Mylan during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
Slovenian: • Če ste zdravilo Dizoproksiltenofovirat Mylan jemali med nosečnostjo, vas lahko zdravnik naroči na redne preiskave krvi in druge diagnostične preiskave, da bo spremljal razvoj vašega otroka.
English: Manufacturer:
Slovenian: Izdelovalca:
English: 1, muscular weakness
Slovenian: 1, mišična oslabelost
English: Do not eat the desiccant.
Slovenian: Sušilnega sredstva ne jejte.
English: If you think that you may have lactic acidosis, contact your doctor immediately.
Slovenian: Če menite, da bi lahko imeli laktacidozo, se nemudoma posvetujte z zdravnikom.
English: • non-steroidal anti-inflammatory drugs (NSAIDs, to relieve bone or muscle pains).
Slovenian: • nesteroidna protivnetna zdravila (NSAID, za lajšanje bolečin v kosteh ali mišicah).