FrancophonIA/ELRC3.0 huggingface dataset:
English: The plasma elimination half-life of benazepril hydrochloride and benazeprilat, when dosed with FORTEKOR PLUS tablets is 0.36 h and 8.36 h, respectively.
Slovenian: 0,36 ure in benazeprilata 8,36 ure.
English: To be supplied only on veterinary prescription.
Slovenian: Zdravilo odstranite na okolju prijazen način.
English: If you have diabetes
Slovenian: • če imate sladkorno bolezen
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Slovenian: Po potrebi bodo pristojni nacionalni organi v sodelovanju z državo članico naknadno posodobili povzetek glavnih značilnosti zdravila in navodilo za uporabo v skladu s postopki, določenimi v poglavju 4 pod naslovom III Direktive 2001/83/ES.
English: The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically.
Slovenian: Potrebo bolnika po lajšanju simptomov in njegov odziv na zdravljenje je treba redno preverjati.
English: If you have angina, blood clots, high blood pressure, raised cholesterol or raised triglycerides
Slovenian: • če imate angino pektoris, krvne strdke, visok krvni tlak, povišan holesterol ali povišane trigliceride
English: This Summary of Product Characteristics and package leaflet is the outcome of the referral procedure.
Slovenian: Ta povzetek glavnih značilnosti in navodilo za uporabo sta izid napotitvenega postopka.
English: Established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
Slovenian: Potrjeno kongestivno srčno popuščanje (razred NYHA II-IV), ishemična bolezen srca, periferna arterijska bolezen in/ali možganskožilna bolezen.
English: Section 2 ‘What you need to know before you take <diclofenac containing medicinal product> [The wording below should be inserted in the relevant sections]
Slovenian: Poglavje 2 Kaj morate vedeti, preden boste vzeli zdravilo <ime zdravila, ki vsebuje diklofenak> [Spodnje besedilo je treba vključiti v ustrezna poglavja]
English: Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4 Special warnings and precautions for use).
Slovenian: Možnost neželenih učinkov se lahko zmanjša z uporabo najnižjega učinkovitega odmerka za najkrajše možno trajanje zdravljenja za obvladovanje (lajšanje) simptomov (glejte poglavje 4.4 Posebna opozorila in previdnostni ukrepi).
English: Patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with diclofenac after careful consideration.
Slovenian: Bolnike s pomembnimi dejavniki tveganja za srčnožilne bolezni (npr. visok krvni tlak, hiperlipidemija, diabetes mellitus, kajenje) se lahko zdravi z diklofenakom le po skrbni presoji.
English: Side effects may be minimised by using the lowest effective dose for the shortest duration necessary.
Slovenian: Možnost neželenih učinkov se lahko zmanjša z uporabo najnižjega učinkovitega odmerka za najkrajše možno trajanje zdravljenja.
English: As the cardiovascular risks of diclofenac may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used.
Slovenian: Kardiovaskularno tveganje zaradi diklofenaka se lahko poveča s povečevanjem odmerka in s trajanjem izpostavljenosti zdravilu, zato mora biti zdravljenje čim krajše in z najmanjšim učinkovitim dnevnim odmerkom.
English: Section 4.8 Undesirable effects: [The wording below should be inserted in this section]
Slovenian: Poglavje 4.8 Neželeni učinki: [V to poglavje je treba vključiti spodnje besedilo]
English: Annex III Amendments to relevant sections of the summary of product characteristics and package leaflet
Slovenian: Dopolnitve, ki jih je treba vključiti v ustrezna poglavja povzetka glavnih značilnosti zdravila in navodila za uporabo
English: A. Summary of Product Characteristics Section 4.2 Posology and method of administration: [The wording below should be inserted in this section]
Slovenian: A. Povzetek glavnih značilnosti zdravila Poglavje 4.2 Odmerjanje in način uporabe: [V to poglavje je treba vključiti spodnje besedilo]
English: Clinical trial and epidemiological data consistently point towards an increased risk of arterial thrombotic events (for example myocardial infarction or stroke) associated with the use of diclofenac, particularly at high dose (150mg daily) and in long term treatment.
Slovenian: Podatki iz kliničnih preizkušanj in epidemiološki podatki kažejo, da je uporaba diklofenaka (zlasti visokih odmerkov (150 mg na dan) in pri dolgotrajnem zdravljenju) povezana s povečanim tveganjem za pojav arterijskih trombotičnih dogodkov (npr. miokardnega infarkta ali možganske kapi) (glejte poglavji 4.3 Kontraindikacije in 4.4 Posebna opozorila in previdnostni ukrepi).
English: Do not use diclofenac if you have established heart disease and /or cerebrovascular disease e.g. if you have had a heart attack, stroke, mini-stroke (TIA) or blockages to blood vessels to the heart or brain or an operation to clear or bypass blockages if you have or have had problems with your blood circulation (peripheral arterial disease)
Slovenian: • če imate potrjeno srčno bolezen in/ali možganskožilno bolezen, npr. če ste doživeli srčni napad, možgansko kap, lažjo obliko kapi (tranzitorno ishemično atako - TIA) ali ste imeli zamašitev žil, ki vodijo do srca ali možganov, ali operativno odstranitev ali obvod zamašenega dela
English: Section 4.4 Special warnings and precautions for use: [The wording below should be inserted in this section]
Slovenian: Poglavje 4.4 Posebna opozorila in previdnostni ukrepi: [V to poglavje je treba vključiti spodnje besedilo]
English: Section 4.3 Contraindications: [The wording below should be inserted in this section]
Slovenian: Poglavje 4.3 Kontraindikacije: [V to poglavje je treba vključiti spodnje besedilo]
English: Make sure your doctor knows, before you are given diclofenac If you smoke
Slovenian: Pred uporabo diklofenaka morate zdravniku povedati
English: Strength Pharmaceutical
Slovenian: Farmacevtska oblika Pot uporabe Stična ovojnina
English: 23 May 2014 EMA/232003/2014 EMEA/H/C/000560 EMEA/H/C/000561
Slovenian: EMA/232003/2014 EMEA/H/C/000560 EMEA/H/C/000561
English: Protelos/Osseor has been authorised since September 2004.
Slovenian: Zdravilo Protelos/Osseor je odobreno od septembra 2004.
English: The full European Public Assessment Report for Protelos/Osseor 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/Osseor je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The applicant presented data from one main study involving 1,683 patients with osteoarthritis of the knee.
Slovenian: Predlagatelj je predložil podatke iz ene glavne študije, v kateri je sodelovalo 1 683 bolnikov z osteoartritisom kolena.
English: The main measure of effectiveness was the effect in slowing the loss of cartilage from the joint as measured by X-rays after 3 years of treatment.
Slovenian: Glavno merilo učinkovitosti je bil učinek na upočasnitev izgube hrustanca v sklepu, izmerjen z rentgenskimi slikanji po 3 letih zdravljenja.
English: In addition, the Committee had some concerns about the way in which the loss of cartilage had been evaluated.
Slovenian: Poleg tega je imel odbor CHMP določene pomisleke glede načina ocenjevanja izgube hrustanca.
English: The CHMP noted that the size of the benefit seen in the study was small and the long-term benefit unclear, whereas the medicine had an established risk of serious side effects.
Slovenian: Odbor CHMP je izpostavil, da je bila korist, ki so jo opazili v študiji, majhna in da je dolgoročna korist nejasna, medtem ko je bilo v povezavi z zdravilom ugotovljeno tveganje za resne neželene učinke.
English: The applications were withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Slovenian: Vlogi so umaknili potem, ko je CHMP ocenil dokumentacijo, ki jo je predložila družba, in oblikoval sezname vprašanj.
English: After the CHMP had assessed the company's responses to the last round of questions, there were still some unresolved issues.
Slovenian: Potem ko je CHMP ocenil odgovore družbe na zadnja vprašanja, so nekatera še vedno ostala nerešena.
English: It is currently used to treat severe osteoporosis (a disease that makes bones fragile) in post-menopausal women and men who have a high risk of fracture.
Slovenian: Trenutno se uporablja za zdravljenje hude osteoporoze (bolezni, ki povzroča krhkost kosti) pri ženskah po menopavzi in moških z velikim tveganjem za zlome.
English: In this study, strontium ranelate 1 or 2 g was compared with placebo (a dummy treatment).
Slovenian: V njej so stroncijev ranelat v odmerku 1 ali 2 g primerjali s placebom (zdravilom brez zdravilne učinkovine).
English: Protelos and Osseor are identical medicines that contain the active substance strontium ranelate.
Slovenian: Protelos in Osseor sta identični zdravili, ki vsebujeta zdravilno učinkovino stroncijev ranelat.
English: How far into the evaluation were the applications when they were withdrawn?
Slovenian: Kako daleč je bil postopek ocenjevanja vlog ob njunem umiku?
English: In its letter notifying the Agency of the withdrawal of the applications, the company stated that the withdrawal was due to the fact that the data so far available were insufficient to address the CHMP's concerns.
Slovenian: Družba je v dopisu, s katerim agencijo obvešča o umiku vlog, navedla, da se je za umik odločila zaradi dejstva, da trenutno razpoložljivi podatki niso zadostni, da bi lahko odpravili pomisleke odbora CHMP.
English: They are available as sachets containing strontium ranelate (2 g) as granules to be made up into a suspension to be taken by mouth.
Slovenian: Na voljo sta v vrečkah, ki vsebujejo stroncijev ranelat (2 g) v obliki zrnc za pripravo suspenzije, ki se jemlje peroralno.
English: On 21 March 2014, Les Laboratoires Servier officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its applications to extend the indication of Protelos/Osseor to include the treatment of osteoarthritis of the knee and hip.
Slovenian: Družba Les Laboratoires Servier je dne 21. marca 2014 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogi za razširitev indikacije zdravila Protelos/Osseor na vključitev zdravljenja osteoartritisa kolena in kolka.
English: What were the reasons given by the company for withdrawing the applications?
Slovenian: Kakšni so bili razlogi družbe za umik vlog?
English: There are no consequences on the use of Protelos/Osseor in its authorised indications.
Slovenian: Umik nima nobenih posledic za uporabo zdravila Protelos/Osseor pri odobrenih indikacijah.
English: In osteoarthritis, the cartilage, a smooth layer that lines the joints and helps them to move easily, is gradually lost, and the bone underneath becomes damaged and exposed.
Slovenian: Pri osteoartritisu se hrustanec, tj. gladka plast, ki obdaja sklepe in jim omogoča lažje premikanje, postopno tanjša, zaradi česar se kost pod njim poškoduje in ni več zaščitena.
English: What did the company present to support its applications?
Slovenian: Katero dokumentacijo je družba predložila v podporo svojima vlogama?
English: Protelos/Osseor was also expected to be used to treat osteoarthritis (a long-term disease that damages joints and makes them stiff and painful) in the knee and hip.
Slovenian: Zdravilo Protelos/Osseor naj bi se uporabljalo tudi za zdravljenje osteoartritisa (dolgotrajne bolezni, ki poškoduje sklepe, tako da postanejo okoreli in boleči) kolena in kolka.
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Protelos/Osseor could not have been approved for the treatment of osteoarthritis.
Slovenian: Na podlagi pregleda podatkov in odgovorov družbe na sezname vprašanj, ki jih je zastavil CHMP, je odbor v času umika izrazil določene zadržke in je začasno menil, da zdravila Protelos/Osseor ni mogoče odobriti za zdravljenje osteoartritisa.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Protelos/Osseor in the treatment of osteoarthritis did not outweigh its risks.
Slovenian: Zato je CHMP v času umika menil, da koristi zdravila Protelos/Osseor pri zdravljenju osteoartritisa ne odtehtajo z njim povezanih tveganj.
English: The company informed the CHMP that there are no consequences for any ongoing clinical trials with Protelos/Osseor.
Slovenian: Družba je obvestila CHMP, da umik nima nobenih posledic za klinična preskušanja zdravila Protelos/Osseor, ki trenutno potekajo.
English: What is Protelos/Osseor?
Slovenian: Kaj je zdravilo Protelos/Osseor?
English: What is happening with Protelos/Osseor for the treatment of osteoporosis?
Slovenian: Kakšne so posledice za zdravilo Protelos/Osseor, indicirano za zdravljenje osteoporoze?
English: Strontium ranelate, the active substance in Protelos/Osseor, is expected to stimulate formation of new cartilage and reduce bone breakdown.
Slovenian: Zdravilna učinkovina v zdravilu Protelos/Osseor, stroncijev ranelat, naj bi spodbujala nastajanje novega hrustanca in zmanjšala razgradnjo kosti.
English: This causes pain and
Slovenian: To povzroči, da je sklep pri premikanju boleč in okorel.
English: What was Protelos/Osseor expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Protelos/Osseor uporabljalo?
English: How is Protelos/Osseor expected to work?
Slovenian: Kako naj bi zdravilo Protelos/Osseor delovalo?
English: Powder and solvent for prolonged release suspension for injection Powder and solvent for prolonged release suspension for injection Powder and solvent for prolonged release suspension for injection
Slovenian: Zypadhera 210 mg prašek in vehikel za raztopino za injiciranje s podaljšanim sproščanjem
English: Invented Strength Pharmaceutical Form Route of Administration
Slovenian: Jakost Farmacevtska oblika
English: Packaging name
Slovenian: (Izmišljeno) ime
English: 5 million cells/ml Suspension for injection
Slovenian: 5 milijonov celic/ml suspenzija za injiciranje intralezijska uporaba viala (steklena) 6 ml
English: Pharmaceutica l Form
Slovenian: Farmacevtska oblika
English: Intralesional use vial (glass)
Slovenian: Pot uporabe Stična ovojnina Vsebina
English: The European Commission granted a marketing authorisation valid throughout the European Union for Gardasil on 20 September 2006.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Gardasil, veljavno po vsej Evropski uniji, izdala 20. septembra 2006.
English: The women were followed up for around three years after the third dose of the vaccine.
Slovenian: Ženske so spremljali približno tri leta po prejemu tretjega odmerka cepiva.
English: These virus-like particles are not capable of causing infection.
Slovenian: Ti virusom podobni delci ne morejo povzročiti okužbe.
English: The vaccine also contains an ‘adjuvant' (a compound containing aluminium) to stimulate a better response.
Slovenian: Cepivo vsebuje tudi adjuvans (spojino, ki vsebuje aluminij) za spodbujanje boljšega odziva.
English: Other information about Gardasil:
Slovenian: Druge informacije o zdravilu Gardasil:
English: What measures are being taken to ensure the safe and effective use of Gardasil?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Gardasil?
English: There are more than 100 types of papillomavirus, some of which are associated with genital cancers.
Slovenian: Obstaja več kot 100 tipov papilomavirusov, od katerih nekatere povezujejo z rakom na spolovilih.
English: The vaccine is given as an injection into a muscle, preferably in the shoulder or the thigh.
Slovenian: Cepivo se daje v obliki injekcije v mišico, po možnosti v ramo ali stegno.
English: Gardasil is given according to official recommendations.
Slovenian: Zdravilo Gardasil se daje v skladu z uradnimi priporočili.
English: For the full list of all restrictions, see the package leaflet.
Slovenian: Za celoten seznam vseh omejitev glejte navodilo za uporabo.
English: Human papillomaviruses are viruses that cause warts and abnormal tissue growth.
Slovenian: Humani papilomavirusi so virusi, ki povzročajo bradavice in nenormalno rast tkiva.
English: This document is a summary of the European public assessment report (EPAR) for Gardasil.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Gardasil.
English: A risk management plan has been developed to ensure that Gardasil is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Gardasil je bil pripravljen načrt obvladovanja tveganj.
English: It is a suspension for injection that contains purified proteins for four types of the human papillomavirus (types 6, 11, 16 and 18).
Slovenian: Gre za suspenzijo za injiciranje, ki vsebuje prečiščene beljakovine za štiri tipe humanega papilomavirusa (tipe 6, 11, 16 in 18).
English: When a patient is given the vaccine, the immune system makes antibodies against the L1 proteins.
Slovenian: Ko oseba prejme cepivo, začne imunski sistem tvoriti protitelesa proti beljakovinam L1.
English: There were no cases of anal cancer in the study but it is expected that protection against precancerous anal lesions will translate into protection against the cancer.
Slovenian: V študiji ni bilo nobenega primera raka zadnjika, a se domneva, da lahko zaščita pred predrakavimi lezijami na zadnjiku pomeni tudi zaščito pred nastankom raka.
English: The CHMP decided that Gardasil's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Gardasil večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: Patients who show signs of an allergy after a dose of Gardasil should not receive further doses of the vaccine.
Slovenian: Osebe, ki po odmerku zdravila Gardasil kažejo znake alergije, ne smejo prejeti nadaljnjih odmerkov cepiva.
English: Gardasil is a vaccine.
Slovenian: Zdravilo Gardasil je cepivo.
English: What benefit has Gardasil shown during the studies?
Slovenian: Kakšne koristi je zdravilo Gardasil izkazalo med študijami?
English: Gardasil human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed)
Slovenian: Gardasil cepivo proti humanim papilomavirusom [tipom 6, 11, 16, 18] (rekombinantno, adsorbirano)
English: With regard to precancerous anal lesions, there 5 cases in the vaccinated group (consisting of around 200 patients) compared with 24 cases in the placebo group (which also had around 200 patients).
Slovenian: Kar zadeva predrakave lezije na zadnjiku, je bilo pet primerov v skupini (z okoli 200 bolniki), ki je prejela cepivo, v primerjavi s 24 primeri v skupini, ki je prejela placebo (v kateri je bilo prav tako okoli 200 bolnikov).
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 Gardasil.
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: Gardasil is used in males and females from the age of nine years to protect against the following conditions caused by specific types of human papillomavirus (HPV):
Slovenian: Cepivo Gardasil se uporablja pri dečkih in deklicah, starejših od devet let, za zaščito pred naslednjimi vrstami obolenj, ki jih povzročajo posamezni tipi humanega papilomavirusa (HPV):
English: The studies also showed that the vaccine stimulates the production of sufficient amounts of antibodies against HPV in girls and boys aged between nine and 15 years.
Slovenian: Pokazale so tudi, da cepivo spodbuja proizvajanje zadostnih količin protiteles proti humanemu papilomavirusu pri deklicah in dečkih, starih od devet do 15 let.
English: After vaccination, the immune system is able to produce antibodies more quickly when it is exposed to the real viruses.
Slovenian: Po cepljenju je imunski sistem ob morebitni ponovni izpostavitvi dejanskim virusom zmožen hitreje tvoriti protitelesa.
English: What is the risk associated with Gardasil?
Slovenian: Kakšna tveganja so povezana z zdravilom Gardasil?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Gardasil, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Gardasil in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: A similar effect of Gardasil was seen when the analysis also included lesions of the cervix due to the other two HPV types (types 6 and 11).
Slovenian: Podoben učinek zdravila Gardasil so opazili v analizi, ki je vključevala tudi lezije na materničnem vratu, povzročene zaradi okužbe z drugima dvema tipoma HPV (tipoma 6 in 11).
English: In studies, the most common side effects with Gardasil (seen in more than 1 patient in 10) were headache and reactions at the site of the injection (redness, pain and swelling).
Slovenian: V študijah so bili najpogostejši neželeni učinki zdravila Gardasil (opaženi pri več kot 1 osebi od 10) glavobol in reakcije na mestu injiciranja (rdečina, bolečina in oteklina).
English: It is available in vials or prefilled syringes.
Slovenian: Na voljo je v vialah ali napolnjenih injekcijskih brizgah.
English: There should always be at least one month between the first and the second doses, and at least three months between the second and the third, and all doses should be given within a year.
Slovenian: Med prvim in drugim odmerkom mora biti najmanj enomesečni presledek, med drugim in tretjim odmerkom pa morajo preteči najmanj trije meseci; osebe morajo vse odmerke prejeti v obdobju enega leta.
English: • genital warts.
Slovenian: • bradavicami na spolovilih.
English: All papillomaviruses have a shell, or ‘capsid', that is made up of proteins called ‘L1 proteins'.
Slovenian: Vsi papilomavirusi imajo plašč ali kapsido iz beljakovin, imenovanih beljakovine L1.
English: Why has Gardasil been approved?
Slovenian: Zakaj je bilo zdravilo Gardasil odobreno?
English: In the study boys and men, there were 3 cases genital lesions among around 1,400 patients given the vaccines compared with 32 cases among around 1,400 given placebo.
Slovenian: V študiji, v katero so bili vključeni dečki in moški, so se v treh primerih od okoli 1 400 bolnikov, ki so bili cepljeni, pojavile lezije na spolovilih v primerjavi z 32 primeri med 1 400 bolniki, ki so prejeli placebo.
English: The study testing Gardasil given as 2 doses in girls aged 9 to 13 showed that that the two doses given six months apart were no less effective than the three-dose vaccination: all subjects had developed sufficient amounts of antibodies against HPV one month after their last dose.
Slovenian: Študija, v kateri je bilo zdravilo Gardasil dano v dveh odmerkih deklicam, starim od devet do trinajst let, je pokazala, da sta bila dva odmerka, ki so ju prejele v razmiku šestih mesecev, prav tako učinkovita kot cepljenje v treh odmerkih: pri vseh osebah je nastalo zadostno število protiteles proti humanemu papilomavirusu v enem mesecu po injiciranju zadnjega odmerka.