FrancophonIA/ELRC3.0 huggingface dataset:
English: • To reduce the risk to a minimum, new measures have been agreed for these medicines to ensure they are used for as short a time as possible at the lowest effective dose, and that their use is avoided in those at higher risk.
Slovenian: • Za čim večje zmanjšanje tega tveganja so bili za ta zdravila sprejeti novi ukrepi, ki zagotavljajo, da se zdravila uporabljajo čim krajše obdobje in v najmanjšem učinkovitem odmerku ter da se njihova uporaba prepreči pri bolnikih z največjim tveganjem.
English: A letter explaining the changes will be sent to healthcare professionals.
Slovenian: Zdravstveni delavci bodo prejeli dopis z razlago sprememb.
English: On 25 March 2015 the CMDh adopted its position by consensus, so the measures recommended by the PRAC will be directly implemented by the Member States where the medicines are authorised, according to an agreed timetable.
Slovenian: Skupina CMDh je 25. marca 2015 soglasno sprejela dokončen sklep, da morajo ukrepe, ki jih je priporočil odbor PRAC, neposredno uvesti države članice, v katerih so ta zdravila odobrena, v skladu z dogovorjenim časovnim razporedom.
English: Elderly patients should not use these medicines, but if they do the maximum dose should be 50 mg a day.
Slovenian: Starejši bolniki ne smejo uporabljati teh zdravil, če pa jih uporabljajo, največji dovoljeni odmerek ne sme preseči 50 mg na dan.
English: • The dose in adults should not add up to more than a total of 100 mg a day.
Slovenian: • Odmerek pri odraslih ne sme preseči skupno 100 mg na dan.
English: As the CMDh has now agreed the PRAC measures by consensus, the measures will be directly implemented by the Member States where the medicines are authorised, according to an agreed timetable.
Slovenian: Ker je skupina CMDh soglasno sprejela ukrepe odbora PRAC, bodo ukrepe neposredno uvedle države članice, v katerih so ta zdravila odobrena, v skladu z dogovorjenim časovnim razporedom.
English: • Hydroxyzine must not be taken by patients who already have disturbances of heart rhythm or are taking other medicines that can cause similar effects on the heart.
Slovenian: • Hidroksizina ne smejo jemati bolniki z obstoječimi motnjami srčnega ritma ali bolniki, ki jemljejo druga zdravila, ki lahko povzročijo podobne učinke na srce.
English: • Use of hydroxyzine is contraindicated in patients with known acquired or congenital QT interval prolongation, or with a known risk factor for QT interval prolongation such as cardiovascular disease, significant electrolyte imbalance (hypokalaemia, hypomagnesaemia), family history of sudden cardiac death, significant bradycardia, or concomitant use of drugs known to prolong the QT interval and/or induce torsades de pointes.
Slovenian: • Uporaba hidroksizina je kontraindicirana pri bolnikih z znanim pridobljenim ali prirojenim podaljšanim intervalom QT ter znanimi dejavniki tveganja za podaljšanje intervala QT, kot so znana bolezen srca in ožilja, znatno neravnovesje elektrolitov (hipokaliemija, hipomagneziemija), nenadna srčna smrt v družinski anamnezi, znatna bradikardija ali sočasna uporaba zdravil, ki podaljšujejo interval QT in/ali povzročajo aritmijo tipa torsade de pointes.
English: • The potential risk of QT interval prolongation and torsades de pointes can therefore be adequately minimised through measures targeting the identified risk factors and restricting the use of hydroxyzine to the lowest effective dose for the shortest possible duration.
Slovenian: • Morebitno tveganje za podaljšanje intervala QT in aritmijo tipa torsade de pointes je mogoče zadovoljivo zmanjšati z ukrepi, ki bi bili usmerjeni na ugotovljene dejavnike tveganja in bi omejili uporabo hidroksizina na najmanjši učinkoviti odmerek ter najkrajše mogoče obdobje.
English: The measures include restricting use of hydroxyzine in patients at high risk of heart rhythm problems and using the medicine at the lowest effective dose for as short a time as possible.
Slovenian: Ukrepi vključujejo omejitev uporabe hidroksizina pri bolnikih z velikim tveganjem težav s srčnim ritmom in uporabo zdravila z najmanjšim učinkovitim odmerkom v čim krajšem obdobju.
English: Most cases had other risk factors, electrolyte abnormalities or concomitant treatment that may have been contributory.
Slovenian: Pri večini primerov so bili prisotni drugi dejavniki tveganja, nenormalnosti elektrolitov ali sočasno zdravljenje, ki je lahko prispevalo k tem učinkom.
English: Recommendations for these new measures were originally made by EMA's Pharmacovigilance Risk Assessment Committee (PRAC), which confirmed a previously known risk of QT interval prolongation and torsades de pointes, alterations in the electrical activity of the heart that can lead to abnormal heart rhythms and cardiac arrest (stopping of the heart).
Slovenian: Priporočila za te nove ukrepe je prvotno pripravil Odbor za oceno tveganja na področju farmakovigilance (PRAC), ki je potrdil znano tveganje podaljšanja intervala QT ter aritmije tipa torsade de pointes, ki sta spremembi električnega delovanja srca in lahko povzročita nenormalen srčni ritem ter srčni zastoj (prenehanje delovanja srca).
English: • In countries where the medicines are approved for use in children, the maximum dose depends on their weight, and the daily total should not be more than 2 mg per kg of body weight in children weighing up to 40 kg (children over 40 kg should be given the adult dose).
Slovenian: • V državah, kjer so ta zdravila odobrena za uporabo pri otrocih, je največji dovoljeni odmerek odvisen od njihove telesne mase, dnevni skupni odmerek pri otrocih s telesno maso do 40 kg pa ne sme preseči 2 mg na kg telesne mase (otrokom s telesno maso nad 40 kg je treba dati odmerek za odrasle).
English: The CMDh1 has agreed by consensus new measures to minimise the risk of effects on heart rhythm with medicines containing the antihistamine hydroxyzine.
Slovenian: Skupina CMDh1 je soglasno sprejela nove ukrepe za zmanjševanje tveganj učinkov na srčni ritem pri zdravilih, ki vsebujejo antihistaminik hidroksizin.
English: Use to be avoided in patients at greatest risk and doses to be kept low
Slovenian: Uporabi se je treba izogibati pri bolnikih z največjim tveganjem, odmerki pa morajo biti majhni
English: In particular, the product information of hydroxyzine-containing medicines will be updated with new dosing recommendations and warnings on use in patients who have risk factors for heart rhythm disturbances or who are taking certain other medicines.
Slovenian: To pomeni, da bodo informacije o zdravilih, ki vsebujejo hidroksizin, dopolnjene z novimi priporočili za odmerjanje in opozorili glede uporabe pri bolnikih z dejavniki tveganja za motnje srčnega ritma ali bolnikih, ki jemljejo nekatera druga zdravila.
English: • Hydroxyzine has the potential to block hERG channels and other types of cardiac channels, resulting in a potential risk of QT interval prolongation and cardiac arrhythmia events.
Slovenian: • Hidroksizin lahko blokira kanalčke hERG in druge vrste kanalčkov v srcu, zaradi česar lahko obstaja tveganje za podaljšanje intervala QT in dogodke, povezane s srčno aritmijo.
English: • The maximum daily dose in children up to 40 kg in weight should be 2 mg/kg/day; children over 40 kg should be given the adult dose.
Slovenian: • Največji dnevni odmerek pri otrocih s telesno maso do 40 kg mora biti 2 mg/kg/dan; otrokom s telesno maso nad 40 kg je treba dati odmerek za odrasle.
English: The PRAC therefore recommended that the risk be managed by restricting hydroxyzine use in those most at risk of heart rhythm problems and reducing exposure to the medicine.
Slovenian: Odbor PRAC je zato priporočil, da je treba tveganje obravnavati z omejevanjem uporabe hidroksizina pri bolnikih z največjim tveganjem težav s srčnim ritmom in zmanjševanjem izpostavljenosti zdravilu.
English: • There is a small risk of altered electrical activity of the heart when taking these medicines, which can lead to abnormal heart rhythm or even cause the heart to stop (cardiac arrest).
Slovenian: • Pri jemanju teh zdravil je prisotno majhno tveganje spremenjenega električnega delovanja srca, kar lahko povzroči nenormalni srčni ritem ali prenehanje delovanja srca (srčni zastoj).
English: • The maximum dose in adults should be a total of 100 mg daily; in the elderly, if use cannot be avoided the maximum daily dose should be 50 mg.
Slovenian: • Največji odmerek pri odraslih je skupno 100 mg na dan; če se uporabi zdravila pri starejših ni mogoče izogniti, mora biti največji dnevni odmerek 50 mg.
English: New restrictions to minimise the risks of effects on heart rhythm with hydroxyzine-containing medicines
Slovenian: Nove omejitve za zmanjšanje tveganj učinkov na srčni ritem pri zdravilih, ki vsebujejo hidroksizin
English: It should be used with care if taking certain other medicines that slow the heart rate or decrease the level of potassium in the blood.
Slovenian: Pri bolnikih, ki jemljejo nekatera druga zdravila, ki upočasnijo srčni utrip ali znižajo raven kalija v krvi, je treba hidroksizin uporabljati previdno.
English: It was considered appropriate to restrict the maximum daily dose in adults, with corresponding changes in the paediatric and elderly populations based on pharmacokinetic data, in order to minimise exposure.
Slovenian: Na podlagi farmakokinetičnih podatkov so menili, da je za zmanjševanje izpostavljenosti ustrezno omejiti največji dnevni odmerek pri odraslih, vključno z ustrezajočimi spremembami pri pediatričnih in starejših populacijah.
English: The medicine should be used with caution in patients with bradycardia, or who are taking hypokalaemia-inducing medicines.
Slovenian: Pri bolnikih z bradikardijo ali bolnikih, ki jemljejo zdravila, ki povzročajo hipokaliemijo, je treba zdravilo uporabljati previdno.
English: The approved uses are different in different countries, but may include treatment of anxiety, relief of itching, use as one of the medicines given before an operation (premedication) or treatment of sleep problems.
Slovenian: Odobrena uporaba se razlikuje po posamičnih državah in lahko vključuje zdravljenje tesnobe (anksioznosti), lajšanje srbenja, uporabo kot eno od zdravil, ki se dajejo pred kirurškim posegom (premedikacija), ali zdravljenje težav s spanjem.
English: Their approved uses (indications) vary between countries and may include use to treat anxiety disorders, for relief of pruritus (itching), as premedication before surgery, and treatment of sleep disorders.
Slovenian: Njihova odobrena uporaba (indikacije) se med državami razlikuje in lahko vključuje zdravljenje anksioznih motenj, lajšanje pruritusa (srbenja), premedikacijo pred kirurškim posegom ter zdravljenje motenj spanja.
English: • Use is not recommended in elderly patients, due to reduced elimination of hydroxyzine in these patients and greater vulnerability to anticholinergic effects and other adverse reactions.
Slovenian: • Zaradi zmanjšanega izločanja hidroksizina in večje dovzetnosti za antiholinergčne učinke ter druge neželene učinke uporaba pri starejših bolnikih ni priporočljiva.
English: Approved uses vary between countries, but may include treatment of anxiety disorders, relief of pruritus (itching) including that due to urticaria, premedication before surgery, and treatment of sleep disorders.
Slovenian: Odobrena uporaba se med državami razlikuje in lahko vključuje zdravljenje anksioznih motenj, lajšanje pruritusa (srbenja), vključno s srbenjem zaradi urtikarije (koprivnice), premedikacijo pred kirurškim posegom ter zdravljenjem motenj spanja.
English: The SmPC and package leaflet of the affected medicines will be amended accordingly.
Slovenian: Skladno s tem se bosta posodobila povzetek glavnih značilnosti zdravila in navodila za uporabo zadevnih zdravil.
English: London, 30 July 2007 EMEA/CHMP/247760/2007
Slovenian: London, 30. julij 2007 EMEA/CHMP/247760/2007
English: The Mutual Recognition Procedure started on 23 August 2006.
Slovenian: Postopek medsebojnega priznavanja se je začel 23. avgusta 2006.
English: The final opinion was converted into a Decision by the European Commission on 30 July 2007.
Slovenian: Končno mnenje je bilo spremenjeno v Odločbo Evropske komisije dne 30. julija 2007.
English: The Reference Member State was Denmark and the Concerned Member States were Germany, Spain, Ireland, Italy and the United Kingdom.
Slovenian: Referenčna država članica je bila Danska, zadevne države članice pa so bile Nemčija, Španija, Irska, Italija in Združeno kraljestvo.
English: The arbitration procedure started on 22 February 2007 with the adoption of a list of questions.
Slovenian: Arbitražni postopek se je začel 22. februarja 2007 s sprejetjem seznama vprašanj.
English: A positive opinion was adopted by consensus on 24 May 2007.
Slovenian: Pozitivno mnenje je bilo soglasno sprejeto dne 24. maja 2007.
English: The reasons for disagreement was that, according to some Member States, the efficacy of Vantas was not demonstrated in comparison to other approved, effective treatments and that the safety of Vantas also was not adequately demonstrated.
Slovenian: Razlogi za nesoglasje so bili, da po mnenju nekaterih držav članic učinkovitost zdravila Vantas v primerjavi z drugimi odobrenimi, učinkovitimi zdravljenji ni bila dokazana, ter da ni bila zadostno dokazana varnost tega zdravila.
English: Germany, Spain, Ireland, Italy and the United Kingdom referred the reasons for disagreement to the EMEA on 1 February 2007.
Slovenian: Nemčija, Španija, Irska, Italija in Združeno kraljestvo so razloge za nesoglasje predložile EMEA dne 1. februarja 2007.
English: The Marketing Authorisation Holder provided written explanations on 7 March 2007.
Slovenian: Imetnik dovoljenja za promet z zdravilom je podal pisna pojasnila 7. marca 2007.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Vantas International Non-Proprietary Name (INN): Histrelin acetate BACKGROUND INFORMATION
Slovenian: ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI (CHMP) MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 29(4)1 ZA Vantas Mednarodno nelastniško ime (INN): Histrelin acetat OSNOVNE INFORMACIJE
English: Vantas, 50 mg, implant, is a luteinizing hormone-releasing hormone (LHRH) agonist indicated for the palliative treatment of advanced prostate cancer.
Slovenian: Vantas, 50 mg, implantat, je agonist hormona, ki sprošča luteinizirajoči hormon (LHRH) indiciran za paliativno zdravljenje napredovalega raka prostate.
English: During their May 2007 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Vantas, that the objections raised by Germany, Spain, Ireland, Italy and the United Kingdom should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Slovenian: Med svojim zasedanjem maja 2007 je CHMP na podlagi vseh posredovanih podatkov in znanstvene razprave v okviru Odbora, sprejel mnenje, da je razmerje med tveganji in koristmi za zdravilo Vantas ugodno, in da ugovori, podani s strani Nemčije, Španije, Irske, Italije in Združenega kraljestva, ne bi smeli preprečiti podelitve dovoljenja za promet z zdravilom, ter da je treba Povzetek glavnih značilnosti zdravila, označevanje in Navodilo za uporabo referenčne države članice dopolniti.
English: The Rapporteur was Dr Frits Lekkerkerker and Co-Rapporteur(s) was Dr Jens Ersbøll.
Slovenian: Poročevalec je bil dr. Frits Lekkerkerker, soporočevalec pa dr. Jens Ersbøll.
English: Valera Pharmaceuticals Ltd. submitted applications for mutual recognition of Vantas, 50 mg, implant, on the basis of the marketing authorisation granted by Denmark on 17 November 2005.
Slovenian: Valera Pharmaceuticals Ltd. Je predložil vlogo za medsebojno priznavanje zdravila Vantas, 50 mg, implantant na podlagi dovoljenja za promet z zdravilom, ki ga je odobrila Danska dne 17. novembra 2005.
English: Bristol-Myers Squibb 3, Rue Joseph Monier - BP 325, Rueil-Malmaison, 92506, France
Slovenian: Bristol-Myers Squibb AB 3, Rue Joseph Monier - BP 325, Rueil-Malmaison, 92506, Francija
English: Bristol-Myers Squibb AB BOX 1172, 171 23 Solna, Sweden
Slovenian: Bristol-Myers Squibb AB BOX 1172, 171 23 Solna, Švedska
English: United Kingdom Bristol-Myers Squibb Pharmaceuticals Limited Uxbridge Business Park, Sanderson Road, Uxbridge, UB8 1 DH, United Kingdom
Slovenian: Bristol-Myers Squibb Pharmaceuticals Limited Uxbridge Business Park, Sanderson Road, Uxbridge, UB8 1 DH, Velika Britanija
English: Annex I List of medicinal products and presentations
Slovenian: Priloga I Seznam nacionalno odobrenih zdravil
English: Vibativ must also not be given to pregnant women.
Slovenian: Prav tako se ne sme dajati nosečnicam.
English: The antibiotics were given for up to 21 days.
Slovenian: Oba antibiotika so dajali do največ 21 dni.
English: What measures are being taken to ensure the safe use of Vibativ?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Vibativ?
English: In all the studies, the main measure of effectiveness was the number of patients whose infection had been cured after the end of treatment.
Slovenian: V vseh študijah je bilo glavno merilo učinkovitosti število bolnikov, pri katerih je bila okužba po koncu zdravljenja ozdravljena.
English: The full EPAR for Vibativ 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 Vibativ je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The recommended dose is 10 mg per kg body weight once every 24 hours, for seven to 21 days.
Slovenian: Priporočeni odmerek je 10 mg na kilogram telesne mase enkrat na vsakih 24 ur, od 7 do 21 dni.
English: This is a summary of the European public assessment report (EPAR) for Vibativ.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Vibativ.
English: The European Commission granted a marketing authorisation valid throughout the European Union
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Vibativ, veljavno po vsej Evropski uniji, izdala
English: ‘Nosocomial' means the infection was caught in hospital.
Slovenian: „Bolnišnična“ pomeni, da se je bolnik okužil v bolnišnici.
English: What benefit has Vibativ shown during the studies?
Slovenian: Kakšne koristi je zdravilo Vibativ izkazalo med študijami?
English: It will also maintain a registry of patients inadvertently treated with Vibativ during pregnancy, to monitor the subsequent effect on development of children from birth to 12 months of age.
Slovenian: Vodila bo tudi register bolnic, ki so bile nenamerno zdravljene z Vibativom med nosečnostjo, s čimer bo spremljala posledične učinke na razvoj otrok od rojstva do starosti 12 let.
English: Why has Vibativ been approved?
Slovenian: Zakaj je bilo zdravilo Vibativ odobreno?
English: The company that markets Vibativ will ensure all doctors who are expected to prescribe or use Vibativ receive a letter and an educational pack containing the summary of product characteristics, package leaflet and a guide setting out important safety information on the correct use of Vibativ.
Slovenian: Družba, ki trži zdravilo Vibativ, bo zagotovila, da bodo vsi zdravniki, za katere se pričakuje, da bodo predpisovali ali uporabljali zdravilo Vibativ, prejeli dopis in izobraževalno gradivo, ki bo vsebovalo povzetek glavnih značilnosti zdravila, navodilo za uporabo in priročnik s pomembnimi varnostnimi informacijami o pravilni uporabi zdravila Vibativ.
English: This includes pneumonia caused by the use of a ventilator (a machine used in hospitals that helps patients to breathe).
Slovenian: To vključuje tudi pljučnico, ki se razvije zaradi uporabe ventilatorja (naprave, ki se v bolnišnicah uporablja kot pomoč bolnikom pri dihanju).
English: In addition, care should be taken when giving Vibativ to patients taking other medicines that could cause kidney problems, those who already have kidney disease or have other diseases that make them more likely to have kidney problems, such as diabetes, congestive heart failure (a type of heart disease) and hypertension (high blood pressure).
Slovenian: Poleg tega je potrebna previdnost pri dajanju zdravila Vibativ bolnikom, ki jemljejo druga zdravila, ki bi lahko povzročila težave z ledvicami; bolnikom, ki že imajo ledvično obolenje ali imajo druge bolezni, zaradi katerih je verjetneje, da bodo imeli težave z ledvicami, na primer sladkorno bolezen, kongestivno srčno popuščanje (vrsto srčnega obolenja) in hipertenzijo (visok krvni tlak).
English: For more information about treatment with Vibativ, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Vibativ preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: For obese patients, a lower dose of 7.5 mg per kg body weight once every 24 hours is recommended.
Slovenian: Pri debelih bolnikih se priporoča uporaba nižjega odmerka 7,5 mg na kilogram telesne mase vsakih 24 ur.
English: It is effective against MRSA bacteria, which are resistant to other commonly used groups of antibiotics such as penicillins (including methicillin and oxacillin) and cephalosporins.
Slovenian: Učinkovit je proti bakteriji MRSA, ki je odporna proti pogosto rabljeni skupini antibiotikov, znani kot penicilini (vključno z meticilinom in oksacilinom) ter cefalosporini.
English: The most common side effects with Vibativ (seen in more than 1 patient in 10) are dysgeusia (taste disturbances) and nausea (feeling sick).
Slovenian: Najpogostejša neželena učinka zdravila Vibativ (opažena pri več kot 1 bolniku od 10) sta disgevzija (motnje okušanja) in navzeja (slabost).
English: Vibativ must not be given to patients with severe kidney problems or acute (sudden) kidney failure.
Slovenian: Zdravilo Vibativ se ne sme dajati bolnikom s hudimi težavami z ledvicami ali akutno (nenadno) odpovedjo ledvic.
English: The CHMP concluded that, although Vibativ had been shown to be effective in treating both nosocomial pneumonia and complicated infections of the skin and soft tissue, its toxic effect on the kidneys was an important safety concern.
Slovenian: CHMP je zaključil, da čeprav je zdravilo Vibativ dokazano učinkovito pri zdravljenju bolnišnične pljučnice ter zapletenih okužb kože in mehkih tkiv, njegov toksični učinek na ledvice pomeni pomemben varnostni zadržek.
English: Vibativ was as effective as vancomycin at curing nosocomial pneumonia and complicated infections of the skin and soft tissue.
Slovenian: Zdravilo Vibativ je bilo enako učinkovito kot vankomicin pri zdravljenju bolnišnične pljučnice ter zapletenih okužb kože in mehkih tkiv.
English: Therefore, the CHMP decided that Vibativ's benefits are only greater than its risks for patients who are severely ill with nosocomial pneumonia and are under close observation in hospital, and recommended that it be given marketing authorisation.
Slovenian: Zato je zaključil, da so koristi zdravila Vibativ večje od z njim povezanih tveganj le pri hudo bolnih bolnikih z bolnišnično pljučnico, ki jih skrbno spremljajo v bolnišnici, in priporočil, da se zanj izda dovoljenje za promet.
English: Vibativ is used to treat adults with nosocomial pneumonia (an infection of the lungs).
Slovenian: Zdravilo Vibativ se uporablja za zdravljenje odraslih oseb z bolnišnično pljučnico (okužbo pljuč).
English: It works by stopping the bacteria causing the infection from making their own cell walls and by disrupting their cell membranes, thereby killing the bacteria.
Slovenian: Deluje tako, da bakteriji, ki povzroča okužbo, preprečuje tvorbo celičnih sten in pretrga njene celične membrane in jo tako uniči.