FrancophonIA/ELRC3.0 huggingface dataset:
English: No studies in patients with inhaled anthrax or inhaled tularaemia have been carried out and the company presented data from laboratory studies.
Slovenian: Pri bolnikih z inhalacijskim vraničnim prisadom ali inhalacijsko tularemijo ni bilo izvedenih nobenih študij, družba pa je predstavila podatke iz laboratorijskih študij.
English: There were also concerns that solithromycin could be harmful to the liver.
Slovenian: Obstajali so tudi zadržki, da lahko solitromicin škoduje jetrom.
English: In addition, it had concerns about the manufacturing process of the active substance, which did not exclude the presence of impurities, and the test for ensuring sterility of the product for infusion was not considered valid.
Slovenian: Poleg tega je izrazil zadržke tudi o proizvodnem postopku zdravilne učinkovine, ki ni izključeval prisotnosti nečistot, preskus zagotavljanja sterilnosti zdravila za infundiranje pa ni bil ocenjen kot veljaven.
English: • community-acquired pneumonia (an infection of the lungs caught outside of hospital);
Slovenian: • zunajbolnišnične pljučnice (okužbe pljuč, pridobljene zunaj bolnišnice);
English: The company presented data from three studies in a total of 1,855 patients with community-acquired pneumonia, in which Solithromycin Triskel EU Services was compared with other antibiotics (levofloxacin and moxifloxacin).
Slovenian: Družba je predstavila podatke iz treh študij, ki so skupaj vključevale 1 855 bolnikov z zunajbolnišnično pljučnico, v katerih so zdravilo Solithromycin Triskel EU Services primerjali z drugima antibiotikoma (levofloksacinom in moksifloksacinom).
English: • inhaled tularaemia (another serious disease caught by inhaling bacteria).
Slovenian: • inhalacijske tularemije (še ene hude bolezni, pridobljene z vdihavanjem bakterij).
English: The active substance in Solithromycin Triskel EU Services, solithromycin, is a type of antibiotic similar to a group of antibiotics known as ‘macrolides'.
Slovenian: Zdravilna učinkovina v zdravilu Solithromycin Triskel EU Services, solitromicin, je vrsta antibiotika, podobnega skupini antibiotikov, znanih kot „makrolidi“.
English: Solithromycin Triskel EU Services was expected to be used to treat the following bacterial infections:
Slovenian: Zdravilo Solithromycin Triskel EU Services naj bi se uporabljalo za zdravljenje naslednjih bakterijskih okužb:
English: It was to be available as capsules to be taken by mouth and as a powder to be made into a solution for infusion (drip) into a vein.
Slovenian: Na voljo naj bi bilo v obliki kapsul za peroralno uporabo in v obliki praška za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Solithromycin Triskel EU Services.
Slovenian: Družba je odbor CHMP obvestila, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih zdravila Solithromycin Triskel EU Services.
English: On 27 March 2017, Triskel EU Services Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Solithromycin Triskel EU Services, intended for the treatment of community-acquired pneumonia, inhaled anthrax and inhaled tularaemia.
Slovenian: Družba Triskel EU Services Ltd je 27. marca 2017 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Solithromycin Triskel EU Services, namenjenim zdravljenju zunajbolnišnične pljučnice, inhalacijskega vraničnega prisada in inhalacijske tularemije.
English: The CHMP was concerned that not enough data had been provided to support use in inhaled anthrax and inhaled tularaemia.
Slovenian: Odbor CHMP je izrazil zadržke, da ni bilo dovolj predloženih podatkov v podporo uporabi pri inhalacijskem vraničnem prisadu in inhalacijski tularemiji.
English: Solithromycin Triskel EU Services is a medicine that contains the active substance solithromycin.
Slovenian: Solithromycin Triskel EU Services je zdravilo, ki vsebuje zdravilno učinkovino solitromicin.
English: • inhaled anthrax (the most serious form of anthrax caught by inhaling bacterial spores);
Slovenian: • inhalacijskega vraničnega prisada (najresnejše oblike vraničnega prisada, pridobljene z vdihavanjem spor bakterij);
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Solithromycin Triskel EU Services did not outweigh its risks.
Slovenian: Zato je odbor CHMP ob umiku vloge menil, da koristi zdravila Solithromycin Triskel EU Services ne odtehtajo z njim povezanih tveganj.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had several concerns and was of the provisional opinion that Solithromycin Triskel EU Services could not have been approved for the treatment of community-acquired pneumonia, inhaled anthrax and inhaled tularaemia.
Slovenian: Odbor CHMP je na podlagi pregleda podatkov ob umiku vloge izrazil določene zadržke in je začasno menil, da zdravila Solithromycin Triskel EU Services ni mogoče odobriti za zdravljenje zunajbolnišnične pljučnice, inhalacijskega vraničnega prisada in inhalacijske tularemije.
English: How does Solithromycin Triskel EU Services work?
Slovenian: Kako zdravilo Solithromycin Triskel EU Services deluje?
English: What is Solithromycin Triskel EU Services?
Slovenian: Kaj je zdravilo Solithromycin Triskel EU Services?
English: What was Solithromycin Triskel EU Services expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Solithromycin Triskel EU Services uporabljalo?
English: • development of 1 or more symptom from at least 2 of the following groups:
Slovenian: • enega ali več simptomov iz vsaj DVEH od naslednjih skupin:
English: • if they drink alcohol
Slovenian: • če uživajo alkohol
English: • The usual dose is one tablet once a day
Slovenian: • Običajni odmerek je ena tableta enkrat dnevno.
English: So it is very important to talk to your doctor about any changes in your health.
Slovenian: Zato je zelo pomembno, da se posvetujete z zdravnikom o vsaki spremembi vašega zdravja.
English: To date, there is no established biological mechanism to explain a potential increase in risk.
Slovenian: Do sedaj ni ugotovljen biološki mehanizem, ki bi pojasnil morebitno povečanje tveganja.
English: Laboratorios ViiV Healthcare, S.L.
Slovenian: España Laboratorios ViiV Healthcare, S.L.
English: 85 days
Slovenian: 85 dni
English: Typically, such reactions have been observed within the first few weeks or months of initiation of CART.
Slovenian: Običajno so se takšne reakcije pojavile v prvih nekaj tednih ali mesecih po uvedbi CART.
English: It also increases the number of CD4 cells in your blood.
Slovenian: Poveča tudi število celic CD4 v krvi.
English: Reference should be made to treatment guidelines.
Slovenian: Sklicevati se je treba na smernice zdravljenja.
English: This medicine is not for children under 12 years of age.
Slovenian: To zdravilo ni za otroke, mlajše od 12 let.
English: This is not considered clinically significant (see Absorption).
Slovenian: To ne velja za klinično pomembno (glejte Absorpcija).
English: The median time from first starting ART was around 4.5 years.
Slovenian: Mediani čas od prve uvedbe ART je bil približno 4,5 leta.
English: • weakness beginning in the hands and feet and moving up towards the trunk of the body.
Slovenian: • oslabelost, ki se začne v rokah in stopalih in se širi navzgor proti trupu.
English: All treatments were given open-label.
Slovenian: Vsa zdravljenja so se izvajala odprto.
English: 28 days
Slovenian: 28 dni
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorization: 2nd September 2014 Date of latest renewal:
Slovenian: Datum prve odobritve: 02. september 2014 Datum zadnjega podaljšanja:
English: • methadone, used as a heroin substitute.
Slovenian: • metadon, ki se uporablja kot nadomestek heroina.
English: ATC code: J05AR13
Slovenian: Oznaka ATC: J05AR13
English: Reasons
Slovenian: Razlogi
English: • if they have been taking combination therapy for a long time
Slovenian: • če jemljejo kombinirano terapijo dalj časa
English: Your methadone dose may need to be changed.
Slovenian: Vaš odmerek metadona bo morda potrebno spremeniti.
English: (see reverse of card)
Slovenian: (glejte drugo stran kartice)
English: The difference in the endpoint remained statistically significant (p=0.006).
Slovenian: Razlika v končni točki je ostala statistično značilna (p=0,006).
English: The proportion with a positive HCV serology was 7%.
Slovenian: Delež bolnikov s pozitivno HCV-serologijo je bil 7 %.
English: Patients were mainly white (66%) or black (28%) of male sex (87%).
Slovenian: Bolniki so bili v glavnem belci (66 %) ali črnci (28 %) moškega spola (87 %).
English: The educational material includes 3 model case studies to demonstrate different clinical scenarios and their management.
Slovenian: Izobraževalni material vključuje tri modelne študije primerov, ki prikazujejo različne klinične scenarije in njihovo obravnavo.
English: Individual components have been investigated in adolescents (12 to 17 years).
Slovenian: Posamezne komponente so raziskovali pri mladostnikih, starih od 12 do 17 let.
English: These reactions have often been transitory.
Slovenian: Ti neželeni učinku so bili pogosto prehodni.
English: At 96 weeks, the response was 80% vs 72%, respectively.
Slovenian: Po 96 tednih je bil odziv 80% proti 72%.
English: → Don't drive or operate machinery unless you are sure your alertness has not been affected.
Slovenian: → Ne vozite ali upravljajte strojev, če niste prepričani, da vaša zbranost ni bila prizadeta.
English: The table should not be considered exhaustive but is representative of the classes studied.
Slovenian: Preglednice ne gre jemati, kot da je izčrpna, je pa reprezentativna za preučevane skupine.
English: CD4 cells are a type of white blood cells that are important in helping your body to fight infection.
Slovenian: Celice CD4 so vrsta belih krvnih celic, ki telesu pomagajo pri premagovanju okužb.
English: Tell your doctor if you are taking any of the medicines in the following list:
Slovenian: Povejte zdravniku, če jemljete katero od zdravil z naslednjega seznama:
English: In such cases medicinal products containing abacavir should be permanently discontinued.
Slovenian: V takih primerih je treba zdravila, ki vsebujejo abakavir, trajno ukiniti.
English: HIV-1 - human immunodeficiency virus type 1
Slovenian: HIV-1 - virus humane imunske pomanjkljivosti tipa 1
English: Your doctor may decide to adjust your dose or that you need extra checkups.
Slovenian: Zdravnik se lahko odloči, da vam prilagodi odmerek ali da potrebujete dodatne kontrolne preglede.
English: Who gets these reactions?
Slovenian: Pri kom se pojavijo te reakcije?
English: → Tell your doctor if you have heart problems, if you smoke, or have other illnesses that may increase your risk of heart disease such as high blood pressure or diabetes.
Slovenian: → Posvetujte se z zdravnikom, če imate težave s srcem, če kadite ali če imate druge bolezni, ki lahko povečajo tveganje za nastanek bolezni srca, npr. visok krvni tlak ali sladkorno bolezen.
English: Hepatitis B co-infection was one of main exclusion criteria.
Slovenian: Sočasna okužba s hepatitisom B je bila ena glavnih meril za nevključitev.
English: Those reported in at least 10% of patients with a hypersensitivity reaction are in bold text.
Slovenian: Tisti, o katerih poročajo pri najmanj 10% bolnikov s preobčutljivostno reakcijo, so v krepkem tisku.
English: * Adjusted for baseline stratification factors, p=0.025.
Slovenian: * Prilagojeno za izhodiščne dejavnike stratifikacije, p=0,025.
English: While the clinical relevance of these findings is unknown, these data suggest that a potential carcinogenic risk to humans is outweighed by the clinical benefit.
Slovenian: Čeprav klinična pomembnost teh ugotovitev ni znana, ti podatki kažejo, da pri človeku klinična korist prevlada nad morebitnim tveganjem zaradi karcinogenosti.
English: Overall treatment differences at Week 96 are applicable to patients with high and low Baseline viral loads.
Slovenian: Splošne razlike zaradi zdravljenja po 96 tednih veljajo za bolnike z visokim in nizkim izhodiščnim virusnim bremenom.
English: No additional types of adverse reactions have been observed beyond those characterised for the adult population.
Slovenian: Pri tem niso opazili nobenih dodatnih vrst neželenih učinkov, poleg tistih, značilnih za odraslo populacijo.
English: • if they are also taking anti-inflammatory medicines called corticosteroids
Slovenian: • če obenem jemljejo protivnetna zdravila, imenovana kortikosteroidi
English: Methadone dosage adjustment likely not needed in majority of patients; occasionally methadone re-titration may be required.
Slovenian: Pri večini bolnikov prilagoditev odmerka metadona verjetno ni potrebna; občasno se lahko zahteva retitracija metadona.
English: Main prior transmission routes were homosexual (73%) or heterosexual (29%) contact.
Slovenian: Glavna predhodna pot prenosa je bil homoseksualni (73 %) ali heteroseksualni (29 %) stik.
English: GSK Services Sp. z o.o.
Slovenian: Polska GSK Services Sp. z o.o.
English: You should also never again take medicines containing dolutegravir.
Slovenian: Prav tako ne smete nikoli več vzeti zdravil, ki vsebujejo dolutegravir.
English: Rechallenge can result in a more rapid and severe reaction, which can be fatal, therefore rechallenge is contraindicated.
Slovenian: Ponovna provokacija lahko povzroči hitrejšo in hujšo reakcijo, ki je lahko usodna, zato je ponovna uporaba kontraindicirana.
English: If you know you have this gene, tell your doctor.
Slovenian: Če veste, da imate ta gen, povejte to zdravniku.
English: • suicidal thoughts and behaviours (particularly in patients who have had depression or mental health problems before)
Slovenian: • samomorilne misli in vedenje (zlasti pri bolnikih, ki so že imeli probleme z depresijo ali duševnim zdravjem)
English: If you are pregnant, think you may be pregnant, or if you are planning to have a baby:
Slovenian: Če ste noseči, če menite, da bi lahko bili noseči ali načrtujete zanositev:
English: Push here (with Alert card attached)
Slovenian: Povlecite tukaj (s priloženo Opozorilno kartico za bolnika)
English: Four subjects had virologic failure none of which had INI resistance at the time of virologic failure.
Slovenian: Štiri osebe so imele virološki neodziv, nobena od teh pa ob času virološkega neodziva ni imela odpornosti na INI.
English: • if their immune systems are very weak
Slovenian: • če imajo zelo oslabljen imunski sistem
English: Main demographics and outcomes are summarised in Table 5.
Slovenian: Glavni demografski podatki in izidi so povzeti v Preglednici 5.
English: (See ‘Patients with chronic hepatitis B or C' earlier in this section and also see section 4.8).
Slovenian: (Glejte ‘Bolniki s kroničnim hepatitisom B ali C' v začetku tega poglavja in tudi poglavje 4.8).
English: (Complex binding to polyvalent ions)
Slovenian: (Tvori kompleks s polivalentnimi ioni)
English: 10.5 (3.1% to 17.8%) [p=0.005].
Slovenian: 10,5 (3,1 % do 17,8 %) [p = 0,005].
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10,000 to < 1/1000), very rare
Slovenian: Pogostnosti so opredeljene kot: zelo pogosti (1/10), pogosti (1/100 do <1/10), občasni (1/1000 do <1/100), redki (1/10.000 do <1/1000), zelo redki (<1/10.000).
English: Triumeq should only be used during the second and third trimester of pregnancy when the expected benefit justifies the potential risk to the foetus.
Slovenian: Zdravilo Triumeq se lahko uporablja v drugem in tretjem trimesečju nosečnosti samo, če pričakovana korist upravičuje morebitno tveganje za plod.
English: Notes: DTG = dolutegravir, RAL = raltegravir.
Slovenian: Opombe: DTG = dolutegravir, RAL = raltegravir.
English: Key elements included in the educational material to increase understanding and awareness of ABC HSR and expand on the information already included in the SmPC:
Slovenian: Ključni elementi, ki so vključeni v izobraževalno gradivo, da bi izboljšali razumevanje in ozaveščenost o preobčutljivosti za ABC in dopolnili informacije, zajete v SmPC:
English: If you have taken Triumeq during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
Slovenian: Če ste zdravilo Triumeq jemali med nosečnostjo, vas lahko zdravnik naroči na redne preiskave krvi in druge diagnostične preiskave, da bo spremljal razvoj vašega otroka.
English: Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in plastenki, poleg oznake »EXP«.
English: • if you have ever had liver disease, including hepatitis B or C (if you have hepatitis B infection, don't stop Triumeq without your doctor's advice, as your hepatitis may come back)
Slovenian: • če ste kdaj imeli bolezen jeter, vključno s hepatitisom B ali C (če imate okužbo s hepatitisom B, ne prenehajte jemati zdravila Triumeq brez nasveta vašega zdravnika, saj se lahko hepatitis ponovi)
English: Week 48 outcomes (including outcomes by key baseline covariates) are shown in Table 3.
Slovenian: Rezultati po 48 tednih (vključno z rezultati po ključnih osnovnih spremenljivkah) so prikazani v Preglednici 3.
English: Symptoms may include:
Slovenian: Simptomi so lahko:
English: Don't take other medicines for the infection without your doctor's advice.
Slovenian: Ne jemljite drugih zdravil proti okužbi, ne da bi se posvetovali z zdravnikom.
English: These hypersensitivity reactions have been seen more frequently in people taking medicines that contain abacavir.
Slovenian: Te preobčutljivostne reakcije so pogosteje opazili pri ljudeh, ki jemljejo zdravila, ki vsebujejo abakavir.
English: Like all medicines, this medicine can cause side effects, but not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: * Adjusted for baseline stratification factors.
Slovenian: * Prilagojeno za izhodiščne dejavnike stratifikacije.
English: The R263K mutation was also selected in vitro (see above).
Slovenian: Mutacija R263K je bila tudi izbrana in vitro (glejte zgoraj).
English: If you are taking methadone, you will be checked for any withdrawal symptoms.
Slovenian: Če jemljete metadon, vas bodo kontrolirali zaradi morebitnih odtegnitvenih simptomov.
English: Triumeq does not cure HIV infection; it reduces the amount of virus in your body, and keeps it at a low level.
Slovenian: Zdravilo Triumeq ne ozdravi okužbe z virusom HIV, zmanjša pa količino virusa v telesu in jo vzdržuje na nizki ravni.
English: It is important to read the information in this section under the heading ‘Other possible side effects of combination therapy for HIV'.
Slovenian: Pomembno je, da preberete informacije v tem poglavju pod naslovom »Drugi možni neželeni učinki kombiniranega zdravljenja okužbe z virusom HIV«.
English: When prescribing Triumeq, action should be taken to try to minimize all modifiable risk factors (e.g. smoking, hypertension, and hyperlipidaemia).
Slovenian: Pri predpisovanju zdravila Triumeq si je treba prizadevati za zmanjšanje vseh prilagodljivih dejavnikov tveganja (npr. kajenja, hipertenzije in hiperlipidemije).
English: De novo resistance in patients failing therapy in SINGLE, SPRING-2 and FLAMINGO
Slovenian: Na novo nastala odpornost pri bolnikih z neuspešnim zdravljenjem v študijah SINGLE, SPRING-2 in FLAMINGO
English: If possible, show them the Triumeq pack.
Slovenian: Po možnosti jima pokažite škatlo zdravila Triumeq.
English: Possible interaction given common pathway of elimination via alcohol dehydrogenase (abacavircomponent).
Slovenian: Možna interakcija zaradi skupne poti izločanja preko alkoholne dehidrogenaze (komponenta abakavirja)
English: HIV infection is spread by sexual contact with someone who has the infection, or by transfer of infected blood (for example, by sharing injection needles).
Slovenian: Okužba z virusom HIV se prenaša s spolnim stikom z nekom, ki ima okužbo ali z okuženo krvjo (na primer s souporabo injekcijskih igel).
English: A clinically relevant phenotypic cut-off value (fold change vs wild type virus) has not been determined; genotypic resistance was a better predictor for outcome.
Slovenian: Klinično pomembna fenotipska presečna vrednost (sprememba občutljivosti proti virusu divjega tipa) ni bila določena; boljši napovedni dejavnik izida je bila genotipska odpornost.
English: The Marketing Authorisation Holder (MAH) shall ensure that all physicians who are expected to prescribe Triumeq are provided with a health care professional information pack containing the following:
Slovenian: Imetnik dovoljenja za promet z zdravilom (MAH) mora zagotoviti, da vsi zdravniki, ki bodo predpisovali zdravilo Triumeq, prejmejo informacijsko gradivo za zdravstvene delavce, ki vsebuje:
English: Antihistamines (histamine H2 receptor antagonists) Ranitidine
Slovenian: Antihistaminiki (antagonisti histaminskih receptorjev H2) ranitidin
English: The observed lamivudine half-life of elimination is 5 to 7 hours.
Slovenian: Opazovani eliminacijski razpolovni čas lamivudina znaša od 5 do 7 ur.
English: • a low red blood cell count (anaemia) or low white blood cell count (neutropenia)
Slovenian: • nizko število rdečih krvnih celic (anemija) ali nizko število belih krvnih celic (nevtropenija)
English: A small amount of the ingredients in Triumeq can also pass into your breast milk.
Slovenian: Majhna količina sestavin zdravila Triumeq lahko prehaja v materino mleko.
English: For the full list of excipients see section 6.1.
Slovenian: Za celotni seznam pomožnih snovi glejte poglavje 6.1.
English: In addition, ribavirin had no apparent effect on dolutegravir activity.
Slovenian: Poleg tega ribavirin ni imel opaznega vpliva na delovanje dolutegravirja.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Slovenian: • na zahtevo Evropske agencije za zdravila; • ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjšanjem tveganja).
English: If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.
Slovenian: Če pride pri teh bolnikih do poslabšanja bolezni jeter, je treba upoštevati možnost prekinitve ali ukinitve zdravljenja.
English: However, their main antiviral activity is through incorporation of the monophosphate form into the viral DNA chain, resulting in chain termination.
Slovenian: Glavni način njunega protivirusnega delovanja pa je vključitev monofosfatne oblike v verigo virusne DNK, kar ima za posledico prekinitev verige.
English: Effect of nevirapine on dolutegravir exposure is likely similar to or less than that of efavirenz.
Slovenian: Učinek nevirapina na izpostavljenost dolutegravirju je verjetno podoben ali manjši od učinka efavirenza.
English: Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Slovenian: Vse vnetne simptome je treba obravnavati in uvesti zdravljenje, kadar je to potrebno.
English: • palpitations (rapid or irregular heartbeat) or tremor
Slovenian: • palpitacije (hiter ali neenakomeren srčni utrip) ali tremor
English: Outcome Time Point
Slovenian: Čas izida
English: If overdose occurs, the patient should be treated supportively with appropriate monitoring, as necessary.
Slovenian: V primeru zaužitja prevelikega odmerka je treba bolnikom dajati podporno terapijo in jih po potrebi ustrezno spremljati.