FrancophonIA/ELRC3.0 huggingface dataset:
English: Corbilta 50 mg/12.5 mg/200 mg film-coated tablets Corbilta 75 mg/18.75 mg/200 mg film-coated tablets Corbilta 100 mg/25 mg/200 mg film-coated tablets Corbilta 125 mg/31.25 mg/200 mg film-coated tablets Corbilta 150 mg/37.5 mg/200 mg film-coated tablets Corbilta 175 mg/43.75 mg/200 mg film-coated tablets Corbilta 200 mg/50 mg/200 mg film-coated tablets
Slovenian: Corbilta 50 mg/12,5 mg/200 mg filmsko obložene tablete Corbilta 75 mg/18,75 mg/200 mg filmsko obložene tablete Corbilta 100 mg/25 mg/200 mg filmsko obložene tablete Corbilta 125 mg/31,25 mg/200 mg filmsko obložene tablete Corbilta 150 mg/37,5 mg/200 mg filmsko obložene tablete Corbilta 175 mg/43,75 mg/200 mg filmsko obložene tablete Corbilta 200 mg/50 mg/200 mg filmsko obložene tablete
English: Patients and carers should be made aware that behavioural symptoms of impulse control disorders including pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments containing levodopa including Corbilta.
Slovenian: Bolnike in njihove skrbnike je treba opozoriti, da pri bolnikih, ki se zdravijo z agonisti dopamina in/ali drugimi dopaminergičnimi zdravljenji, ki vsebujejo levodopo, vključno z zdravilom Corbilta, lahko pride do vedenjskih simptomov, ki so znak motenj pri obvladovanju impulzov, kar vključuje patološko hazardiranje, povečan libido, hiperseksualnost, kompulzivno zapravljanje ali nakupovanje, prenajedanje in kompulzivno prenajedanje.
English: corbilta 75/18.75/200 mg [carton only]
Slovenian: corbilta 75/18,75/200 mg [samo škatla]
English: corbilta 125/31.25/200 mg [carton only]
Slovenian: corbilta 125/31,25/200 mg [samo škatla]
English: b. When initiating Corbilta therapy for patients currently treated with entacapone and levodopa/carbidopa in doses not equal to Corbilta tablets (50 mg/12.5 mg/200 mg or 75 mg/18.75 mg/200 mg or 100 mg/25 mg/200 mg or 125 mg/31.25 mg/200 mg or 150 mg/37.5 mg/200 mg or 175 mg/43.75 mg/200 mg or 200 mg/50 mg/200 mg), Corbilta dosing should be carefully titrated for optimal clinical response.
Slovenian: b. Ob uvajanju terapije z zdravilom Corbilta pri bolnikih, ki trenutno prejemajo entakapon in levodopo/karbidopo v odmerkih, ki se razlikujejo od tablet zdravila Corbilta (50 mg/12,5 mg/200 mg ali 75 mg/18,75 mg/200 mg ali 100 mg/25 mg/200 mg ali 125 mg/31,25 mg/200 mg ali 150 mg/37,5 mg/200 mg ali 175 mg/43,75 mg/200 mg ali 200 mg/50 mg/200 mg), je treba za dosego optimalnega kliničnega odgovora odmerjanje zdravila Corbilta skrbno titrirati.
English: Always leave at least an hour between Corbilta tablets, to avoid possible side effects.
Slovenian: Da bi se izognili morebitnim neželenim učinkom, vedno pustite, da preteče med jemanjem prejšnje in naslednje tablete zdravila Corbilta vsaj ena ura.
English: How to store Corbilta
Slovenian: Shranjevanje zdravila Corbilta
English: Talk to your doctor or pharmacist if you think the effect of Corbilta is too strong or too weak, or if you experience possible side effects.
Slovenian: Če menite, da je učinek zdravila Corbilta premočan ali prešibak, ali če doživite možne neželene učinke, se posvetujte s svojim zdravnikom ali farmacevtom.
English: corbilta 175/43.75/200 mg [carton only]
Slovenian: corbilta 175/43,75/200 mg [samo škatla]
English: Hepatic impairment: It is advised that Corbilta should be administered cautiously to patients with mild to moderate hepatic impairment.
Slovenian: Okvara jeter: Pri bolnikih z blago do zmerno okvaro jeter se priporoča previdnost pri uporabi zdravila Corbilta.
English: Impulse control disorders: Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments containing levodopa including Corbilta (see section
Slovenian: Motnje pri obvladovanju impulzov: Pri bolnikih, ki se zdravijo z agonisti dopamina in/ali drugimi dopaminergičnimi zdravljenji, ki vsebujejo levodopo, vključno z zdravilom Corbilta, lahko pride do patološkega hazardiranja, povečanega libida, hiperseksualnosti, kompulzivnega zapravljanja ali nakupovanja, prenajedanja ali kompulzivnega prenajedanja (glejte poglavje 4.4).
English: Thus, a control of INR is recommended when Corbilta is initiated for patients receiving warfarin.
Slovenian: Zato je pri bolnikih, ki prejemajo varfarin ob uvedbi zdravila Corbilta priporočljivo nadzorovati vrednost INR.
English: corbilta 150/37.5/200 mg [carton only]
Slovenian: corbilta 150/37,5/200 mg [samo škatla]
English: - The other ingredients in the tablet core are croscarmellose sodium, magnesium stearate, maize starch, mannitol (E421) and povidone (E1201).
Slovenian: - Druge sestavine v jedru tablete so: natrijev karmelozat, premreženi (E468), magnezijev stearat, koruzni škrob, manitol (E421) in povidon (E1201).
English: corbilta 50/12.5/200 mg [carton only]
Slovenian: corbilta 50/12,5/200 mg [samo škatla]
English: corbilta 100/25/200 mg [carton only]
Slovenian: corbilta 100/25/200 mg [samo škatla]
English: corbilta 200/50/200 mg [carton only]
Slovenian: corbilta 200/50/200 mg [samo škatla]
English: Corbilta 150 mg/37.5 mg/200 mg: brownish or greyish red, elongated-ellipse shaped, unscored filmcoated tablets marked with ‘LCE 150' on one side.
Slovenian: Zdravilo Corbilta 150 mg/37,5 mg/200 mg so rjavkaste ali sivkasto-rdeče, podolgovate filmsko obložene tablete v obliki elipse brez zareze, z oznako »LCE 150« na eni strani.
English: - Periodic evaluation of hepatic, haematopoietic, cardiovascular and renal function is recommended during extended therapy with Corbilta.
Slovenian: - Med dolgotrajnejšim zdravljenjem z zdravilom Corbilta je priporočljivo občasno testirati delovanje jeter, srčno-žilnega sistema in ledvic.
English: Corbilta contains sucrose (1.89 mg/tablet).
Slovenian: Zdravilo Corbilta vsebuje saharozo (1,89 mg/tableto).
English: Corbilta 75 mg/18.75 mg/200 mg tablet comes in five different pack sizes (10, 30, 100, 130 or 175 tablets).
Slovenian: Zdravilo Corbilta 75 mg/18,75 mg/200 mg je na razpolago v petih različnih velikostih pakiranja (10, 30, 100, 130 ali 175 tablet).
English: Corbilta contains sucrose (2.3 mg/tablet).
Slovenian: Zdravilo Corbilta vsebuje saharozo (2,3 mg/tableto).
English: Corbilta 125 mg/31.25 mg/200 mg tablet comes in five different pack sizes (10, 30, 100, 130 or 175 tablets).
Slovenian: Zdravilo Corbilta 125 mg/31,25 mg/200 mg tablete je na razpolago v petih različnih velikostih pakiranja (10, 30, 100, 130 ali 175 tablet).
English: - are allergic to levodopa, carbidopa or entacapone, or any of the other ingredients of this medicine (listed in section 6) - have narrow-angle glaucoma (an eye disorder) - have a tumour of the adrenal gland - are taking certain medicines for treating depression (combinations of selective MAO-A and
Slovenian: - preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1 - huda okvara jeter - glavkom z zaprtim zakotjem (angularni glavkom) - feokromocitom - sočasna uporaba zdravila Corbilta z neselektivnimi zaviralci monoaminooksidaze (MAO-A in
English: Corbilta 75 mg/18.75 mg/200 mg: light brownish red, oval film-coated tablets marked with ‘LCE 75' on one side.
Slovenian: Zdravilo Corbilta 75 mg/18,75 mg/200 mg: svetlorjavkasto rdeče, ovalne filmsko obložene tablete z oznako »LCE 75« na eni strani.
English: The doses of other antiparkinsonian medicinal products may need to be adjusted when Corbilta treatment is substituted for a patient currently not treated with entacapone.
Slovenian: Kadar zdravilo Corbilta nadomešča terapijo pri bolniku, ki trenutno ne prejema entakapona, bo odmerke drugih antiparkinsonskih zdravil morda treba ustrezno prilagoditi.
English: Corbilta 125 mg/31.25 mg/200 mg: light brownish red, oval film-coated tablets marked with ‘LCE 125' on one side.
Slovenian: Zdravilo Corbilta 125 mg/31,25 mg/200 mg: svetlorjavkasto rdeče, ovalne tablete z oznako »LCE 125« na eni strani.
English: According to this daily carbidopa dose, the maximum recommended daily dose of Corbilta175 mg/43.75 mg/200 mg is 8 tablets per day and Corbilta 200 mg/50 mg/200 mg dose is 7 tablets per day.
Slovenian: 175 mg/43,75 mg/200 mg je 8 tablet na dan in zdravila Corbilta 200 mg/50 mg/200 mg 7 tablet dnevno.
English: Corbilta 50 mg/12.5 mg/200 mg: brownish or greyish red, round, convex unscored film-coated tablets marked with ‘LCE 50' on one side.
Slovenian: Zdravilo Corbilta 50 mg/12,5 mg/200 mg so rjavkaste ali sivkasto-rdeče, okrogle, konveksne filmsko obložene tablete brez zareze, z oznako »LCE 50« na eni strani.
English: Corbilta 175 mg/43.75 mg/200 mg tablet comes in five different pack sizes (10, 30, 100, 130 or 175 tablets).
Slovenian: Zdravilo Corbilta 175 mg/43,75 mg/200 mg tablete je na razpolago v petih različnih velikostih pakiranja (10, 30, 100, 130 ali 175 tablet).
English: Corbilta 200 mg/50 mg/200 mg tablet comes in five different pack sizes (10, 30, 100, 130 or 175).
Slovenian: Zdravilo Corbilta 200 mg/50 mg/200 mg so na voljo v petih različnih velikostih pakiranja (10, 30, 100, 130 ali 175 tablet).
English: Corbilta 75 mg/18.75 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Slovenian: Corbilta 75 mg/18,75 mg/200 mg filmsko obložene tablete levodopa/karbidopa/entakapon
English: - Each Corbilta 125 mg/31.25 mg/200 mg tablet contains 125 mg of levodopa, 31.25 mg of carbidopa and 200 mg of entacapone.
Slovenian: - Ena tableta zdravila Corbilta 125 mg/31,25 mg/200 mg vsebuje 125 mg levodope, 31,25 mg karbidope in 200 mg entakapona.
English: - Each Corbilta 175 mg/43.75 mg/200 mg tablet contains 175 mg of levodopa, 43.75 mg of carbidopa and 200 mg of entacapone.
Slovenian: - Ena tableta zdravila Corbilta 175 mg/43,75 mg/200 mg vsebuje 175 mg levodope, 43,75 mg karbidope in 200 mg entakapona.
English: - Each Corbilta 75 mg/18.75 mg/200 mg tablet contains 75 mg of levodopa, 18.75 mg of carbidopa and 200 mg of entacapone.
Slovenian: - Ena tableta zdravila Corbilta 75 mg/18,75 mg/200 mg vsebuje 75 mg levodope, 18,75 mg karbidope in 200 mg entakapona.
English: Corbilta contains sucrose (1.9 mg/tablet).
Slovenian: Zdravilo Corbilta vsebuje saharozo (1,9 mg/tableto).
English: - Each Corbilta 150 mg/37.5 mg/200 mg tablet contains 150 mg of levodopa, 37.5 mg of carbidopa and 200 mg of entacapone.
Slovenian: - Ena tableta zdravila Corbilta 150 mg/37,5 mg/200 mg vsebuje 150 mg levodope, 37,5 mg karbidope in 200 mg entakapona.
English: Corbilta 175 mg/43.75 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Slovenian: Corbilta 175 mg/43,75 mg/200 mg filmsko obložene tablete levodopa/karbidopa/entakapon
English: - Each Corbilta 100 mg/25 mg/200 mg tablet contains 100 mg of levodopa, 25 mg of carbidopa and 200 mg of entacapone.
Slovenian: - Ena tableta zdravila Corbilta 100 mg/25 mg/200 mg vsebuje 100 mg levodope, 25 mg karbidope in 200 mg entakapona.
English: Corbilta contains sucrose (1.6 mg/tablet).
Slovenian: Zdravilo Corbilta vsebuje saharozo (1,6 mg/tableto).
English: Corbilta 125 mg/31.25 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Slovenian: Corbilta 125 mg/31,25 mg/200 mg filmsko obložene tablete levodopa/karbidopa/entakapon
English: Corbilta 175 mg/43.75 mg/200 mg: light brownish red, oval, unscored film-coated tablets marked with ‘LCE 175' on one side.
Slovenian: Zdravilo Corbilta 175 mg/43,75 mg/200 mg: svetlorjavkasto rdeče, ovalne tablete z oznako »LCE 175« na eni strani.
English: Corbilta 200 mg/50 mg/200 mg: dark brownish red, oval, unscored film-coated tablets marked with ‘LCE 200' on one side.
Slovenian: Zdravilo Corbilta 200 mg/50 mg/200 mg: temnorjavkasto rdeče ovalne filmsko obložene tablete brez zareze z oznako „LCE 200“ na eni strani.
English: - Each Corbilta 50 mg/12.5 mg/200 mg tablet contains 50 mg of levodopa, 12.5 mg of carbidopa and 200 mg of entacapone.
Slovenian: - Ena tableta zdravila Corbilta 50 mg/12,5 mg/200 mg vsebuje 50 mg levodope, 12,5 mg karbidope in 200 mg entakapona.
English: Corbilta may be taken with or without food.
Slovenian: Zdravilo Corbilta lahko jemljete med jedjo ali na tešče.
English: Corbilta contains sucrose (1.2 mg/tablet).
Slovenian: Zdravilo Corbilta vsebuje saharozo (1,2 mg/tableto).
English: Corbilta 100 mg/25 mg/200 mg: brownish or greyish red, oval, unscored film-coated tablets marked with ‘LCE 100' on one side.
Slovenian: Zdravilo Corbilta 100 mg/25 mg/200 mg so rjavkaste ali sivkasto-rdečkaste filmsko obložene ovalne tablete brez zareze, z oznako »LCE 100« na eni strani.
English: Corbilta 100 mg/25 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Slovenian: Corbilta 100 mg/25 mg/200 mg filmsko obložene tablete levodopa/karbidopa/entakapon
English: Corbilta contains sucrose (1.4 mg/tablet).
Slovenian: Zdravilo Corbilta vsebuje saharozo (1,4 mg/tableto).
English: EU/1/13/859/007 10 film-coated tablets EU/1/13/859/008 30 film-coated tablets EU/1/13/859/009 100 film-coated tablets EU/1/13/859/010 130 film-coated tablets EU/1/13/859/011 175 film-coated tablets
Slovenian: EU/1/13/859/007 10 filmsko obloženih tablet EU/1/13/859/008 30 filmsko obloženih tablet EU/1/13/859/009 100 filmsko obloženih tablet EU/1/13/859/010 130 filmsko obloženih tablet EU/1/13/859/011 175 filmsko obloženih tablet
English: Corbilta 50 mg/12.5 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Slovenian: Corbilta 50 mg/12,5 mg/200 mg filmsko obložene tablete levodopa/karbidopa/entakapon
English: - Each Corbilta 200 mg/50 mg/200 mg tablet contains 200 mg of levodopa, 50 mg of carbidopa and 200 mg of entacapone.
Slovenian: - Ena tableta zdravila Corbilta 200 mg/50 mg/200 mg vsebuje 200 mg levodope, 50 mg karbidope in 200 mg entakapona.
English: Corbilta 200 mg/50 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Slovenian: Corbilta 200 mg/50 mg/200 mg filmsko obložene tablete levodopa/karbidopa/entakapon
English: Corbilta 150 mg/37.5 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Slovenian: Corbilta 150 mg/37,5 mg/200 mg filmsko obložene tablete levodopa/karbidopa/entakapon
English: Film-coating of 50/12.5/200 mg, 100/25/200 mg and 150/37.5/200 mg: Glycerol (85 per cent) (E422)
Slovenian: Filmska obloga pri 50/12,5/200 mg, 100/25/200 mg in 150/37,5/200 mg: glicerol (85 odstotkov) (E422) hipromeloza (E464) magnezijev stearat polisorbat 80 (E433) rdeči železov oksid (E172) saharoza titanov dioksid (E171) rumeni železov oksid (E172)
English: While the experience with total daily dose greater than 200 mg carbidopa is limited, the maximum recommended daily dose of entacapone is 2,000 mg and therefore the maximum dose is 10 tablets per day for the Corbilta strengths of 50 mg/12.5 mg/200 mg, 75 mg/18.75 mg/200 mg, 100 mg/25 mg/200 mg, 125 mg/31.25 mg/200 mg and 150 mg/37.5 mg/200 mg.
Slovenian: To pomeni, da znaša maksimalni odmerek 10 tablet na dan zdravila Corbilta jakosti 50 mg/12,5 mg/200 mg, 75 mg/18,75 mg/200 mg, 100 mg/25 mg/200 mg, 125 mg/31,25 mg/200 mg in 150 mg/37,5 mg/200 mg.
English: EU/1/13/859/023 10 film-coated tablets EU/1/13/859/024 30 film-coated tablets EU/1/13/859/025 100 film-coated tablets EU/1/13/859/026 130 film-coated tablets EU/1/13/859/027 175 film-coated tablets EU/1/13/859/028 250 film-coated tablets
Slovenian: EU/1/13/859/023 10 filmsko obloženih tablet EU/1/13/859/024 30 filmsko obloženih tablet EU/1/13/859/025 100 filmsko obloženih tablet EU/1/13/859/026 130 filmsko obloženih tablet EU/1/13/859/027 175 filmsko obloženih tablet EU/1/13/859/028 250 filmsko obloženih tablet
English: EU/1/13/859/001 10 film-coated tablets EU/1/13/859/002 30 film-coated tablets EU/1/13/859/003 100 film-coated tablets EU/1/13/859/004 130 film-coated tablets EU/1/13/859/005 175 film-coated tablets EU/1/13/859/006 250 film-coated tablets
Slovenian: EU/1/13/859/001 10 filmsko obloženih tablet EU/1/13/859/002 30 filmsko obloženih tablet EU/1/13/859/003 100 filmsko obloženih tablet EU/1/13/859/004 130 filmsko obloženih tablet EU/1/13/859/005 175 filmsko obloženih tablet EU/1/13/859/006 250 filmsko obloženih tablet
English: EU/1/13/859/018 10 film-coated tablets EU/1/13/859/019 30 film-coated tablets EU/1/13/859/020 100 film-coated tablets EU/1/13/859/021 130 film-coated tablets EU/1/13/859/022 175 film-coated tablets
Slovenian: EU/1/13/859/018 10 filmsko obloženih tablet EU/1/13/859/019 30 filmsko obloženih tablet EU/1/13/859/020 100 filmsko obloženih tablet EU/1/13/859/021 130 filmsko obloženih tablet EU/1/13/859/022 175 filmsko obloženih tablet
English: EU/1/13/859/034 10 film-coated tablets EU/1/13/859/035 30 film-coated tablets EU/1/13/859/036 100 film-coated tablets EU/1/13/859/037 130 film-coated tablets EU/1/13/859/038 175 film-coated tablets
Slovenian: EU/1/13/859/034 10 filmsko obloženih tablet EU/1/13/859/035 30 filmsko obloženih tablet EU/1/13/859/036 100 filmsko obloženih tablet EU/1/13/859/037 130 filmsko obloženih tablet EU/1/13/859/038 175 filmsko obloženih tablet
English: EU/1/13/859/029 10 film-coated tablets EU/1/13/859/030 30 film-coated tablets EU/1/13/859/031 100 film-coated tablets EU/1/13/859/032 130 film-coated tablets EU/1/13/859/033 175 film-coated tablets
Slovenian: EU/1/13/859/029 10 filmsko obloženih tablet EU/1/13/859/030 30 filmsko obloženih tablet EU/1/13/859/031 100 filmsko obloženih tablet EU/1/13/859/032 130 filmsko obloženih tablet EU/1/13/859/033 175 filmsko obloženih tablet
English: EU/1/13/859/012 10 film-coated tablets EU/1/13/859/013 30 film-coated tablets EU/1/13/859/014 100 film-coated tablets EU/1/13/859/015 130 film-coated tablets EU/1/13/859/016 175 film-coated tablets EU/1/13/859/017 250 film-coated tablets
Slovenian: EU/1/13/859/012 10 filmsko obloženih tablet EU/1/13/859/013 30 filmsko obloženih tablet EU/1/13/859/014 100 filmsko obloženih tablet EU/1/13/859/015 130 filmsko obloženih tablet EU/1/13/859/016 175 filmsko obloženih tablet EU/1/13/859/017 250 filmsko obloženih tablet
English: Corbilta contains sucrose
Slovenian: Zdravilo Corbilta vsebuje saharozo
English: Tablet core:
Slovenian: PC: {številka}
English: The European Commission granted a marketing authorisation valid throughout the European Union for Protelos on 21 September 2004.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Protelos, veljavno po vsej Evropski uniji, izdala 21. septembra 2004.
English: What measures are being taken to ensure the safe and effective use of Protelos?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Protelos?
English: The full EPAR for Protelos can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Protelos je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Protelos should be taken at least two hours after food, milk, milk products or calcium supplements, preferably at bedtime.
Slovenian: Zdravilo Protelos je treba vzeti najmanj dve uri po zaužitju hrane, mleka, mlečnih izdelkov ali kalcijevih dodatkov, najbolje pred spanjem.
English: The company will also conduct a study to evaluate the effectiveness of the measures that have been put in place to reduce risk of heart and circulatory problems.
Slovenian: Družba bo izvedla tudi študijo, v kateri bo ocenjevala učinkovitost vzpostavljenih ukrepov za zmanjšanje tveganja za nastanek težav s srcem in obtočili.
English: This is a summary of the European public assessment report (EPAR) for Protelos.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Protelos.
English: Other information about Protelos
Slovenian: Druge informacije o zdravilu Protelos
English: Protelos is intended for long-term use.
Slovenian: Namenjeno je dolgotrajni uporabi.
English: What benefit has Protelos shown during the studies?
Slovenian: Kakšne koristi je zdravilo Protelos izkazalo med študijami?
English: A risk management plan has been developed to ensure that Protelos is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Protelos je bil pripravljen načrt obvladovanja tveganj.
English: For more information about treatment with Protelos, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Protelos preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: The most common side effects with Protelos (which may affect more than 1 in 10 people) are hypersensitivity (allergic) skin reactions (rash, itching, urticaria or itchy rash, and swelling beneath the skin known as angioedema) and pain affecting muscles, bones and joints.
Slovenian: Najpogostejši neželeni učinki zdravila Protelos (ki lahko prizadenejo več kot 1 osebo od 10) so preobčutljivostne (alergijske) kožne reakcije (izpuščaji, srbenje, urtikarija ali srbeči izpuščaji in otekanje pod kožo, znano kot angioedem) ter bolečine, ki prizadenejo mišice, kosti in sklepe.
English: What is the risk associated with Protelos?
Slovenian: Kakšna tveganja so povezana z zdravilom Protelos?
English: In order to reduce the risk of heart attack, Protelos must also not be used in patients with high blood pressure that is not properly controlled or in patients with a current or past history of any of the following:
Slovenian: Za zmanjšanje tveganja za srčni napad ga ne smejo jemati bolniki z visokim krvnim tlakom, ki ni ustrezno nadzorovan, ali bolniki, ki imajo trenutno ali so v preteklosti imeli katerega koli od naslednjih obolenj:
English: This showed that the risk of breaking a bone is reduced.
Slovenian: To je dokaz, da se je tveganje za nastanek zloma zmanjšalo.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Protelos.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: The CHMP decided that Protelos's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Protelos večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: Overall, the results of the second study taken alone were insufficient to demonstrate a benefit of Protelos in preventing bone breaks.
Slovenian: Gledano v celoti, pa rezultati druge študije niso zadostno dokazali koristi zdravila Protelos pri preprečevanju zlomov kosti.
English: As there has been some data showing an increased risk of heart attack with Protelos, the decision to prescribe Protelos should take into account the patient's individual heart risk.
Slovenian: Ker nekateri podatki kažejo na povečano tveganje za srčni napad v povezavi z zdravilom Protelos, je treba pri predpisovanju zdravila upoštevati posameznikovo tveganje za srčni napad.
English: Protelos is used to treat severe osteoporosis (a disease that makes bones fragile) in post-menopausal women and men who have a high risk of fracture and cannot be treated with other medicines approved for osteoporosis.
Slovenian: Zdravilo Protelos se uporablja za zdravljenje hude osteoporoze (bolezni, ki povzroča krhkost kosti) pri ženskah po menopavzi in moških, pri katerih obstaja veliko tveganje za zlom kosti in ki jih ni mogoče zdraviti z drugimi zdravili, odobrenimi za osteoporozo.
English: Protelos is taken as one sachet once a day.
Slovenian: Zdravilo Protelos se jemlje v odmerku ene vrečke enkrat na dan.
English: Protelos must not be used in patients who have or have had venous thromboembolic events (problems due to the formation of blood clots in the veins, such as in the legs or lungs).
Slovenian: Zdravila ne smejo uporabljati bolniki, ki imajo ali so imeli vensko trombembolijo (težave zaradi nastajanja krvnih strdkov v venah, na primer v nogah ali pljučih).