FrancophonIA/ELRC3.0 huggingface dataset:
English: How does Porcilis AR-T DF work?
Slovenian: Kako zdravilo Porcilis AR-T DF deluje?
English: Outcome of re-examination
Slovenian: Izid ponovne proučitve
English: The applicant had requested a re-examination of the opinion.
Slovenian: Predlagatelj je zahteval ponoven pregled mnenja.
English: The summaries of the opinion of the Committee for Orphan Medicinal Products for Heparesc can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Slovenian: Povzetki mnenja Odbora za zdravila sirote o zdravilu Heparesc so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The Committee thus considered that the benefits of treatment had not been sufficiently demonstrated.
Slovenian: Odbor je zato presodil, da koristi zdravljenja niso bile dokazane v zadostni meri.
English: The effects of Heparesc were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila Heparesc so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
English: This is a type of medicine containing cells or tissues that have been manipulated so that they can be used to cure, diagnose or prevent a disease.
Slovenian: Gre za skupino zdravil, ki vsebujejo celice ali tkiva, ki so bili spremenjeni tako, da se lahko uporabljajo za zdravljenje, diagnosticiranje ali preprečevanje bolezni.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom23 October 2015 EMA/684158/2015 EMEA/H/C/003750
Slovenian: oktober 2015 EMA/684158/2015 EMEA/H/C/003750
English: As a result, toxic waste products build up in the blood in the form of ammonia which can lead to brain damage, convulsions (fits), coma and death.
Slovenian: Posledično se v krvi kopičijo strupeni odpadni produkti v obliki amonijaka, kar lahko privede do možganskih poškodb, konvulzij (napadov), kome in smrti.
English: After considering the grounds for this request, the CHMP re-examined the initial opinion and confirmed the refusal of the marketing authorisation on 22 October 2015.
Slovenian: Po proučitvi razlogov za to zahtevo je odbor CHMP ponovno pregledal prvotno mnenje in dne 22. oktobra 2015 potrdil zavrnitev vloge za dovoljenje za promet.
English: The company that applied for authorisation is Cytonet GmbH & Ci KG.
Slovenian: Vlogo za dovoljenje za promet z zdravilom je predložila družba Cytonet GmbH & Ci KG.
English: Both Committees confirmed their opinion that the effectiveness of Heparesc in the treatment of these disorders had not been sufficiently demonstrated.
Slovenian: Oba odbora sta potrdila mnenje, da učinkovitost zdravila Heparesc pri zdravljenju teh motenj ni bila dokazana v zadostni meri.
English: The main measures of effectiveness were the change in the levels of 13C-labelled urea production (a test intended to show the ability to produce urea) after treatment as compared to before, and the number, length and severity of any episodes of high ammonia in the blood during the studies.
Slovenian: Glavni merili učinkovitosti sta bili sprememba količine nastale sečnine, označene s 13C (test, ki naj bi pokazal zmožnost tvorjenja sečnine), po zdravljenju v primerjavi s količino pred zdravljenjem ter število, dolžina in resnost epizod visokega amonijaka v krvi v času študije.
English: The CHMP had concerns about the design and conduct of the studies, which cast doubt on their results and whether these could have occurred by chance.
Slovenian: Odbor CHMP je imel pomisleke o zasnovi in izvedbi študij, ki sta vzbudili dvom o njihovih rezultatih in o tem, ali niso morda naključni.
English: In addition, the CHMP had concerns about the clinical relevance of the results of the tests that measured the ability to produce urea.
Slovenian: Poleg tega je imel odbor CHMP pomisleke o kliničnem pomenu rezultatov testov, ki so merili zmožnost tvorbe sečnine.
English: Heparesc was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 14 September 2007 for ornithine transcarbamylase deficiency, and 17 December 2010 for the other above conditions.
Slovenian: Zdravilo Heparesc je bilo dne 14. septembra 2007 določeno kot „zdravilo sirota“(zdravilo za zdravljenje redkih bolezni) za pomanjkanje ornitin-transkarbamilaze in 17. decembra 2010 za druga zgoraj navedena stanja.
English: Because Heparesc is an advanced therapy medicine, it was assessed by the Committee for Advanced Therapies (CAT).
Slovenian: Zdravilo Heparesc je zdravilo za napredno zdravljenje, zato ga je ocenjeval Odbor za napredno zdravljenje (CAT).
English: Heparesc is a medicine that contains living cells from the liver of a healthy donor which have been manipulated and then frozen for long-term storage.
Slovenian: Heparesc je zdravilo, ki vsebuje žive celice iz jeter zdravega darovalca, ki so bile najprej spremenjene in nato zamrznjene za dolgotrajno shranjevanje.
English: The company presented the results of two main studies involving a total of 20 children with urea cycle disorders in which the effects of Heparesc were compared with historical results in children who had not received Heparesc treatment.
Slovenian: Družba je predstavila rezultate dveh glavnih študij, ki so skupaj zajele 20 otrok z motnjami cikla sečnine, pri kateri so učinke zdravila Heparesc primerjali s starimi rezultati pri otrocih, ki niso prejemali zdravljenja z zdravilom Heparesc.
English: The specific urea cycle disorders for which Heparesc was intended to be used are called carbamoylphosphate synthetase 1 deficiency, ornithine transcarbamylase deficiency, argininosuccinate synthetase deficiency (citrullinaemia type 1), argininosuccinate lyase deficiency (argininosuccinic aciduria) and arginase deficiency (hyperargininaemia).
Slovenian: Specifične motnje cikla sečnine, za katere naj bi se uporabljalo zdravilo Heparesc, se imenujejo pomanjkanje karbamoilfosfat-sintetaze 1, pomanjkanje ornitin-transkarbamilaze, pomanjkanje argininosukcinat-sintetaze (citrulinemija tipa 1), pomanjkanje argininosukcinat-liaze (argininosukcinična acidurija) in pomanjkanje arginaze (hiperargininemija).
English: The company informed the CHMP that the refusal had no consequences for patients in clinical trials or compassionate use programmes.
Slovenian: Družba je obvestila CHMP, da zavrnitev nima posledic za bolnike, ki so vključeni v klinična preizkušanja ali programe sočutne uporabe.
English: On 25 June 2015, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Heparesc, intended for the treatment of urea cycle disorders.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je v svojem negativnem mnenju z dne 25. junija 2015 priporočil zavrnitev vloge za dovoljenje za promet z zdravilom Heparesc, namenjenim zdravljenju motenj cikla sečnine.
English: These are rare inborn conditions in which the liver does not produce particular enzymes involved in removing nitrogen from the body via a substance called urea.
Slovenian: To so redka prirojena bolezenska stanja, pri katerih jetra ne proizvajajo določenih encimov, vključenih v odstranjevanje dušika iz telesa prek snovi, imenovane sečnina.
English: When the medicine is injected into the portal vein leading to the liver, some of the liver cells it contains are expected to settle in the recipient's liver and start producing the missing liver enzyme, thus helping to reduce the symptoms of the disease.
Slovenian: Ko se zdravilo injicira v portalno veno, ki vodi do jeter, naj bi se nekatere jetrne celice, ki jih vsebuje, ustalile v prejemnikovih jetrih in začele proizvajati manjkajoči jetrni encim, s čimer bi pripomogle k zmanjšanju simptomov bolezni.
English: During the re-examination the CAT and CHMP looked again at the data from the company, and also consulted experts in the treatment of urea cycle disorders.
Slovenian: Med ponovno presojo sta odbora CAT in CHMP ponovno pregledala podatke, ki jih je posredovala družba, ter se posvetovala tudi s strokovnjaki za zdravljenje motenj cikla sečnine.
English: Heparesc was developed as a type of advanced therapy medicine called a ‘somatic cell therapy product'.
Slovenian: Zdravilo Heparesc so razvili kot vrsto zdravila za napredno zdravljenje, ki se imenuje „zdravilo za somatsko celično zdravljenje“.
English: Heparesc was to be used for the treatment of children from birth up to 3 years of age with specific urea cycle disorders.
Slovenian: Zdravilo Heparesc naj bi se uporabljajo za zdravljenje otrok od rojstva do starosti treh let s posebnimi motnjami cikla sečnine.
English: The medicine was to be given by slow injection through a tube inserted by a surgical procedure into the portal vein (a vein leading directly to the patient's liver).
Slovenian: Zdravilo naj bi se dajalo s počasnim injiciranjem skozi cevko, vstavljeno s kirurškim posegom, v portalno veno (veno, ki vodi neposredno v bolnikova jetra).
English: What is Heparesc?
Slovenian: Kaj je zdravilo Heparesc?
English: Heparesc was intended to help temporary management of these conditions in children until they are big enough to be given a liver transplant to cure them.
Slovenian: Zdravilo Heparesc naj bil pomagalo pri začasnem obvladovanju teh stanj pri otrocih, dokler ti niso dovolj stari, da jim lahko presadijo jetra in jih tako ozdravijo.
English: What was Heparesc expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Heparesc uporabljalo?
English: Although taking into account the challenges of developing the medicine, including the difficulty of enrolling patients due to the rarity of the disease, the CHMP therefore concluded that the benefits of Heparesc did not outweigh its risks and maintained the previous recommendation that the medicine be refused marketing authorisation.
Slovenian: Kljub temu da je upošteval izzive pri razvoju zdravila, vključno s težavami pri vključevanju bolnikov zaradi redkosti bolezni, je odbor CHMP zato zaključil, da koristi zdravila Heparesc ne odtehtajo njegovih tveganj, in je obdržal prehodno priporočilo, da se dovoljenje za promet z zdravilom zavrne.
English: Taking into account the assessments performed by the CAT, the CHMP concluded that Heparesc could not be approved for the treatment of children with urea cycle disorders.
Slovenian: Z upoštevanjem ocen, ki jih je opravil odbor CAT, je odbor CHMP zaključil, da zdravila Heparesc ni mogoče odobriti za zdravljenje otrok z motnjami cikla sečnine.
English: Heparesc is made of liver cells from an organ donor who can produce the enzyme that is missing in patients with urea cycle disorders.
Slovenian: Zdravilo Heparesc je narejeno iz jetrnih celic organa darovalca, ki lahko pri bolnikih z motnjami cikla sečnine proizvajajo manjkajoči encim.
English: Therefore, at the time of the initial evaluation, the CHMP was of the opinion that the benefits of Heparesc did not outweigh its risks and recommended that it be refused marketing authorisation.
Slovenian: Posledično je CHMP v času začetnega vrednotenja menil, da koristi zdravila Heparesc ne odtehtajo z njim povezanih tveganj in priporočil, da se dovoljenje za promet z njim zavrne.
English: How is Heparesc expected to work?
Slovenian: Kako naj bi zdravilo Heparesc delovalo?
English: EU number
Slovenian: Ovojnina
English: The European Commission issued a decision on 21 February 2011.
Slovenian: Evropska komisija je odločbo izdala dne 21. februarja 2011.
English: Other sections
Slovenian: Druga poglavja
English: It is used to treat a wide range of bacterial infections.
Slovenian: Uporablja se za zdravljenje številnih bakterijskih okužb.
English: Tazocin is authorised in the EU via national procedures.
Slovenian: Zdravilo Tazocin je v EU odobreno z nacionalnimi postopki.
English: Tazocin is also available in the EU under other trade names: Tazobac, Tazocel, Tazocilline and Tazonam.
Slovenian: Zdravilo Tazocin je v EU na voljo tudi pod drugima tržnima imenoma: Tazobac, Tazocel, Tazocilline in Tazonam.
English: The CHMP agreed that Tazocin should be used to treat the following infections in adults and adolescents:
Slovenian: CHMP se je strinjal, da se zdravilo Tazocin uporablja za zdravljenje naslednjih okužb pri odraslih in mladostnikih:
English: Tazocin can be used to treat complicated intra-abdominal infections in children aged from two to 12 years.
Slovenian: Zdravilo Tazocin se lahko uporablja za zdravljenje zapletenih intraabdominalnih okužb pri otrocih, starih od dveh do 12 let.
English: This prevents the bacteria from building their cell walls, and eventually kills them.
Slovenian: Na ta način preprečuje, da bi bakterije zgradile celične stene, ter jih naposled uniči.
English: The European Medicines Agency has completed a review of Tazocin.
Slovenian: Evropska agencija za zdravila je zaključila pregled zdravila Tazocin.
English: Why was Tazocin reviewed?
Slovenian: Zakaj je bilo zdravilo Tazocin pregledano?
English: The Committee also harmonised other sections of the SmPC including the sections on contraindications, special warnings and pregnancy and lactation.
Slovenian: Odbor je uskladil tudi druga poglavja povzetka glavnih značilnosti zdravila, vključno s poglavji o kontraindikacijah, posebnih opozorilih ter nosečnosti in dojenju.
English: This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.
Slovenian: To je v različnih državah članicah privedlo do razhajanj glede uporabe zdravila, kakor je razvidno iz razlik med povzetki glavnih značilnosti zdravila, označevanjem in navodili za uporabo v državah, kjer se zdravilo trži.
English: Tazocin may also be used to manage children, adolescents and adults with neutropenia (low levels of neutrophils, a type of white blood cell) who also have fever suspected to be caused by bacterial infection.
Slovenian: Zdravilo Tazocin se lahko uporablja tudi za zdravljenje otrok, mladostnikov in odraslih z nevtropenijo (nizkimi ravnmi nevtrofilcev, vrste belih krvnih celic), ki imajo hkrati tudi vročino, katere vzrok naj bi bila bakterijska okužba.
English: What is Tazocin?
Slovenian: Kaj je zdravilo Tazocin?
English: It works by attaching to proteins on the surface of bacteria.
Slovenian: Deluje tako, da se veže na beljakovine na površini bakterije.
English: Questions and answers on Tazocin and associated names (piperacillin and tazobactam, 2/0.25 g and 4/0.5 g powder for solution for infusion) EMA/656918/2010
Slovenian: Vprašanja in odgovori v zvezi z zdravilom Tazocin in povezanimi imeni (piperacilin in tazobaktam, 2/0,25 g in 4/0,5 g prašek za raztopino za infundiranje) EMA/656918/2010
English: • severe pneumonia (infection of the lungs), including infections acquired in hospital or by patients on a mechanical ventilator
Slovenian: • huda pljučnica (okužba pljuč), vključno z okužbami, pridobljenimi v bolnišnici ali pri bolnikih na mehanski ventilaciji;
English: • complicated skin and soft tissue infections, including diabetic foot infections.
Slovenian: • zapletene okužbe kože in mehkih tkiv, vključno z okužbami diabetičnega stopala.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Tazocin in the European Union (EU).
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je treba v Evropski uniji (EU) uskladiti podatke o predpisovanju zdravila Tazocin.
English: Tazocin is a medicine that contains the active substances piperacillin and tazobactam.
Slovenian: Tazocin je zdravilo, ki vsebuje zdravilni učinkovini piperacilin in tazobaktam.
English: Piperacillin is an antibiotic that belongs to the group ‘beta-lactams'.
Slovenian: Piperacilin je antibiotik, ki sodi v skupino „betalaktamov“.
English: Questions and answers on Tazocin and associated names (piperacillin and tazobactam, 2/0.25 g and 4/0.5 g powder for solution for infusion)
Slovenian: Vprašanja in odgovori v zvezi z zdravilom Tazocin in povezanimi imeni (piperacilin in tazobaktam, 2/0,25 g in 4/0,5 g prašek za raztopino za infundiranje)
English: Tazocin can also be used in adults to treat bacteraemia (bacteria in the blood) that is associated with or suspected to be associated with the infections listed above.
Slovenian: Zdravilo Tazocin se lahko uporablja tudi pri odraslih za zdravljenje bakteriemije (bakterije v krvi), ki je povezana oz. je domnevno povezana z zgoraj navedenimi okužbami.
English: • complicated intra-abdominal infections (infections within the abdomen)
Slovenian: • zapletene intraabdominalne okužbe (okužbe v trebušni votlini);
English: In adults and adolescents the usual dose is 4 g piperacillin /0.5 g tazobactam given every eight hours.
Slovenian: Pri odraslih in mladostnikih je običajen odmerek 4 g piperacilina/0,5 g tazobaktama vsakih osem ur.
English: The dose for children is 80 mg piperacillin /10 mg tazobactam per kilogram body weight every six hours for neutropenic children and 100 mg piperacillin /12.5 mg tazobactam per kg body weight every eight hours for children with complicated intra-abdominal infections.
Slovenian: Pri otrocih z nevtropenijo je odmerek 80 mg piperacilina/10 mg tazobaktama na kilogram telesne mase vsakih šest ur, pri otrocih z zapletenimi intraabdominalnimi okužbami pa 100 mg piperacilina/12,5 mg tazobaktama na kilogram telesne mase vsakih osem ur.
English: On 12 June 2009, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Tazocin in the EU.
Slovenian: Da bi Evropska komisija uskladila dovoljenja za promet z zdravilom Tazocin v EU, je dne 12. junija 2009 zadevo napotila na CHMP.
English: For severe pneumonia and bacterial infections in neutropenic patients, the recommended dose is 4 g piperacillin /0.5 g tazobactam given every six hours.
Slovenian: Pri hudi pljučnici in bakterijskih okužbah pri bolnikih z nevtropenijo je priporočeni odmerek 4 g piperacilina/0,5 g tazobaktama vsakih šest ur.
English: Beta-lactamases break down beta-lactam antibiotics such as piperacillin, making the bacteria resistant to these medicines.
Slovenian: Betalaktamaze razgrajujejo betalaktamske antibiotike, npr. piperacilin, zato postanejo bakterije odporne na ta zdravila.
English: The company that markets these medicines is Pfizer.
Slovenian: Ta zdravila trži družba Pfizer.
English: Tazobactam blocks the action of bacterial enzymes called beta-lactamases.
Slovenian: Tazobaktam zavira delovanje bakterijskih encimov, imenovanih betalaktamaze.
English: By blocking the action of beta-lactamases, tazobactam stops bacteria from being resistant to piperacillin, thereby making piperacillin more effective at killing them.
Slovenian: Tazobaktam z zaviranjem delovanja betalaktamaz prepreči, da bi bile bakterije odporne na piperacilin, zato jih lahko piperacilin učinkoviteje uniči.
English: • complicated urinary tract infections, including pyelonephritis (kidney infection)
Slovenian: • zapletene okužbe sečil, vključno s pielonefritisom (okužbo ledvic);
English: Tazocin was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Slovenian: Usklajevalna skupina za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMD(h)) je ugotovila, da je za zdravilo Tazocin potrebno usklajevanje.
English: 4.8 Undesirable effects a.
Slovenian: 4.8 Neželeni učinki a.
English: NC= Failure
Slovenian: NC = neuspeh
English: Your doctor will discuss with you and determine which medicines are best for you.
Slovenian: Zdravnik se bo pogovoril z vami in presodil, katera zdravila so za vas najprimernejša.
English: It is recommended that INR (international normalised ratio) be monitored.
Slovenian: Priporočljivo je kontrolirati INR (internacionalno normalizirano razmerje).
English: − If you cannot contact your doctor, go to the hospital.
Slovenian: - Če ne morete kontaktirati zdravnika, pojdite v bolnišnico.
English: − Continue to take this medicine until your doctor tells you otherwise.
Slovenian: - To zdravilo jemljite, dokler vam zdravnik ne naroči drugače.
English: Currently available data are described in section 5.2 but no recommendation on a posology can be made.
Slovenian: Trenutno razpoložljivi podatki so opisani v poglavju 5.2, vendar priporočila o odmerjanju ni mogoče podati.
English: In children 2 years of age and older, the nature of the safety profile is similar to that seen in adults (see Table in section b).
Slovenian: Pri otrocih, starih 2 leti in več, je varnostni profil podoben kot pri odraslih (glejte preglednico v razdelku b).
English: Discuss with your doctor the precautions needed to avoid infecting other people.
Slovenian: Posvetujte se z zdravnikom o ukrepih, ki so potrebni, da se izognete okužbi drugih ljudi.
English: On rare occasions these muscle disorders have been serious.
Slovenian: V redkih primerih so bile te mišične motnje resne.
English: In vitro selection of resistance
Slovenian: In vitro selekcija odpornosti
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 January 2016
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 14.01.2016
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: Zahteve za predložitev PSUR za to zdravilo so določene v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in vseh nadaljnjih posodobitev, objavljenih na evropskem spletnem portalu o zdravilih.
English: If the condition persists or worsens, seek medical attention.
Slovenian: Če stanje vztraja ali se celo poslabša, poiščite zdravniško pomoč.
English: − You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy.
Slovenian: - Še vedno lahko prenašate virus HIV medtem, ko jemljete to zdravilo, čeprav je tveganje zmanjšano z učinkovitim protivirusnim zdravljenjem.
English: Patients should be closely monitored for signs related to venetoclax toxicities.
Slovenian: Bolnike je potrebno pozorno spremljati glede znakov, povezanih s toksičnostjo venetoklaksa.
English: Do not take a double dose to make up for a forgotten dose.
Slovenian: Ne vzemite dvojnega odmerka, da bi nadonestili pozabljeni odmerek.
English: Stevens-Johnson syndrome, erythema multiforme
Slovenian: Stevens-Johnsonov sindrom, multiformni eritem
English: Gender, Race and Age
Slovenian: Spol, rasa in starost
English: If an erection lasts longer than 4 hours, you should get medical help immediately to avoid permanent damage to your penis.
Slovenian: Če erekcija traja več kot 4 ure, takoj potrebujete zdravniško pomoč, da bi preprečili trajno kvaro spolnega uda.
English: It is believed that these symptoms are due to an improvement in the body's immune response, enabling the body to fight infections that may have been present with no obvious symptoms.
Slovenian: Predvideva se, da so simptomi posledica izboljšanega delovanja imunskema sistema, ki omogoča telesu, da se bori proti infekcijam, ki so lahko bile prisotne brez očitnih simptomov.
English: 1 See section 4.4: pancreatitis and lipids c.
Slovenian: 1 Glejte poglavje 4.4: pankreatitis in lipidi c.
English: Do not use this medicine after the expiry date which is stated on the carton after EXP.
Slovenian: Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake ''EXP:''.
English: If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment should be considered.
Slovenian: Če pri takšnih bolnikih obstajajo znaki slabšanja bolezni jeter, je treba razmisliti o prekinitvi ali opustitvi zdravljenja.
English: The safety and efficacy of lopinavir/ritonavir in children aged less than 2 years have not yet been established.
Slovenian: Varnost in učinkovitost uporabe lopinavirja/ritonavirja pri otrocih, mlajših od 2 let še ni bila ugotovljena.