FrancophonIA/ELRC3.0 huggingface dataset:
English: Levact is also known as Ribomustin.
Slovenian: Zdravilo Levact je znano tudi kot zdravilo Ribomustin
English: The active substance in Levact, bendamustine hydrochloride, belongs to a group of anticancer medicines called ‘alkylating agents'.
Slovenian: Zdravilna učinkovina v zdravilu Levact, bendamustin hidroklorid, spada v skupino zdravil proti raku, imenovanih „alkilirajoče učinkovine“.
English: • non-Hodgkin's lymphoma (a cancer of the lymph tissue, part of the immune system) in patients whose cancer got worse during or following treatment containing rituximab (another anticancer medicine);
Slovenian: • ne-Hodgkinovega limfoma (raka limfnega tkiva, dela imunskega sistema) pri bolnikih, pri katerih se je rak poslabšal med zdravljenjem z zdravilom, ki vsebuje rituksimab (drugo zdravilo proti raku), ali po njem;
English: • chronic lymphocytic leukaemia (a cancer of a type of white blood cell called lymphocytes) in patients for whom treatment with fludarabine (another anticancer medicine) is not appropriate;
Slovenian: • kronične limfocitne levkemije (rak belih krvnih celic, imenovanih limfociti) pri bolnikih, pri katerih zdravljenje s fludarabinom (drugim zdravilom proti raku) ni ustrezno;
English: Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion)
Slovenian: (bendamustin hidroklorid, 2,5 mg/ml, prašek za koncentrat za raztopino za infundiranje)
English: Referral start date:
Slovenian: Datum začetka napotitvenega postopka:
English: What is Levact?
Slovenian: Kaj je zdravilo Levact?
English: • multiple myeloma (a cancer of the bone marrow) in combination with prednisone in patients older than 65 years who are not eligible for stem-cell transplantation and cannot be treated with thalidomide or bortezomib (other anticancer medicines).
Slovenian: 65 let, ki niso primerni za presaditev matičnih celic in jih ni mogoče zdraviti s talidomidom ali bortezomibom (drugima vrstama zdravil proti raku).
English: Although side effects were common, they appeared to be within acceptable limits.
Slovenian: Čeprav so bili neželeni učinki pogosti, so ti znotraj dopustnih meja.
English: Further planned or ongoing studies are expected to provide more information on Trumenba's effectiveness.
Slovenian: Načrtovane ali potekajoče študije naj bi zagotovile več informacij o učinkovitosti zdravila Trumenba.
English: Other information about Trumenba
Slovenian: Druge informacije o zdravilu Trumenba
English: This is a summary of the European public assessment report (EPAR) for Trumenba.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Trumenba.
English: What measures are being taken to ensure the safe and effective use of Trumenba?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Trumenba?
English: The full EPAR for Trumenba 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 Trumenba je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Initial treatment may either involve 2 injections at least 6 months apart, or 2 injections at least 1 month apart followed by a third injection at least 4 months later.
Slovenian: Začetno zdravljenje lahko vključuje bodisi dve injekciji v razmiku vsaj šestih mesecev ali dve injekciji v razmiku vsaj enega meseca, ki jima sledi tretja injekcija vsaj štiri mesece pozneje.
English: In patients at greater risk of invasive meningococcal disease, an additional booster dose may be considered later on.
Slovenian: Pri bolnikih z dodatnim tveganjem za invazivno meningokokno bolezen se lahko pozneje razmisli še o dodatnem obnovitvenem odmerku.
English: It is available in a pre-filled syringe and is given by injection into a muscle, preferably in the shoulder.
Slovenian: Na voljo je v napolnjeni injekcijski brizgi in se daje z injiciranjem v mišico, najbolje v ramo.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that based on available data Trumenba's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Trumenba večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: The most common side effects with Trumenba (which may affect more than 1 in 10 people) are pain, redness or swelling at the site of the injection, headache, tiredness, chills, diarrhoea, nausea (feeling sick), and muscle or joint pain.
Slovenian: Najpogostejši neželeni učinki zdravila Trumenba (ki se lahko pojavijo pri več kot 1 osebi od 10) so bolečina, pordelost ali oteklina na mestu injiciranja, glavobol, utrujenost, mrzlica, driska, navzeja (slabost) in bolečine v mišicah ali sklepih.
English: Antibody responses were also seen against the 10 secondary strains and confirmed the responses seen with the 4 main strains.
Slovenian: Opazili so tudi odziv protiteles proti desetim sekundarnim sevom ter potrdili odzive, opažene proti štirim glavnim sevom.
English: What benefits of Trumenba have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Trumenba izkazalo v študijah?
English: Invasive disease occurs when these bacteria spread through the body causing serious infections such as meningitis (infection of the membranes that surround the brain and spinal cord) and septicaemia (blood infection).
Slovenian: Invazivna bolezen se pojavi, ko se te bakterije razširijo po telesu in povzročijo resne okužbe, kot sta meningitis (okužba membran, ki obdajajo možgane in hrbtenjačo) in sepsa (okužba krvi).
English: What are the risks associated with Trumenba?
Slovenian: Kakšna tveganja so povezana z zdravilom Trumenba?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Trumenba have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Trumenba upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: As the protection provided seemed to decline over time, a booster dose should be considered in recipients who were thought to be at continued risk of invasive meningococcal disease.
Slovenian: Ker kaže, da zaščita sčasoma upada, je treba pri prejemnikih, pri katerih obstaja stalno tveganje za invazivno meningokokno bolezen, razmisliti o obnovitvenem odmerku.
English: For more information about treatment with Trumenba, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Trumenba preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Trumenba can only be obtained with a prescription and should be used according to official recommendations.
Slovenian: Predpisovanje in izdaja zdravila Trumenba je le na recept, uporabljati pa se mora v skladu z uradnimi priporočili.
English: What is Trumenba and what is it used for?
Slovenian: Kaj je zdravilo Trumenba in za kaj se uporablja?
English: In the second study sufficient amounts of antibodies were produced in 79 to 90% of cases, and protective levels of antibodies against all 4 strains were seen in 85% of participants.
Slovenian: V drugi študiji je nastalo dovolj protiteles pri 79 do 90 % primerov, zaščitne ravni protiteles proti vsem štirim sevom pa so opazili pri 85 % udeležencev.
English: Trumenba meningococcal group B vaccine (recombinant, adsorbed)
Slovenian: Trumenba cepivo proti meningokokom skupine B (rekombinantno, adsorbirano)
English: The studies also looked at response to 10 other, secondary strains of N. meningitidis group B.
Slovenian: V študijah so proučevali tudi odziv na deset drugih, sekundarnih sevov bakterije N. meningitidis skupine B.
English: Why is Trumenba approved?
Slovenian: Zakaj je bilo zdravilo Trumenba odobreno?
English: When the person is then exposed to the bacterium, these antibodies together with other components of the immune system will be able to kill the bacteria and help protect against the disease.
Slovenian: Ko je oseba izpostavljena bakteriji, ta protitelesa skupaj z drugimi deli imunskega sistema uničijo bakterije in pomagajo pri obrambi proti bolezni.
English: Supportive studies were also carried out, which showed that 2 doses of the vaccine achieved a broadly similar antibody response to 3 doses, and that even though protective antibody levels declined over time they could be improved by an additional booster dose after both 2- and 3-dose treatments.
Slovenian: Izvedli so tudi podporne študije, ki so pokazale, da se z dvema odmerkoma cepiva doseže na splošno podoben odziv protiteles kot pri treh odmerkih, in da ravni zaščitnih protiteles sicer sčasoma upadejo, vendar se lahko izboljšajo z dodatnim obnovitvenim odmerkom po cepljenju z dvema odmerkoma in tudi po cepljenju s tremi odmerki.
English: For the full list of all side effects and restrictions with Trumenba, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Trumenba glejte navodilo za uporabo.
English: It is not intended to provide practical advice on how to use Trumenba.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Trumenba is a vaccine used to protect individuals from 10 years old against invasive meningococcal disease caused by a group of bacteria called Neisseria meningitidis group B.
Slovenian: Zdravilo Trumenba je cepivo, ki se uporablja za zaščito posameznikov od 10. leta dalje pred invazivno meningokokno boleznijo, ki jo povzroča skupina bakterij, imenovane Neisseria meningitidis skupine B.
English: For practical information about using Trumenba, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Trumenba naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: The available data indicated that Trumenba should provide broad protection against the strains of Neisseria meningitidis group B that are currently found in Europe, whether given in a 3-dose or a 2dose schedule.
Slovenian: Razpoložljivi podatki so pokazali, da naj bi zdravilo Trumenba zagotovilo široko zaščito proti sevom Neisseria meningitidis skupine B, ki so trenutno prisotni v Evropi, ne glede na to, ali se daje po shemi z dvema ali tremi odmerki.
English: When a person is given the vaccine, the immune system recognises the parts of the bacterium contained in the vaccine as ‘foreign' and makes antibodies against them.
Slovenian: Ko oseba prejme cepivo, imunski sistem prepozna dele bakterije v cepivu kot tujek in proti njim razvije protitelesa.
English: How does Trumenba work?
Slovenian: Kako zdravilo Trumenba deluje?
English: The first study involved around 3,600 participants aged 10 to 18 years, and the second study involved around 3,300 young adults between 18 and 25 years of age; none of the participants had previously been vaccinated against N. meningitidis group B. Those taking part were given 3 doses of the vaccine and antibody response against 4 main test strains of the bacteria (the ones usually responsible for disease in Europe) was measured one month after the last injection.
Slovenian: Nihče od udeležencev predhodno ni bil cepljen proti N. meningitidis skupine B. Udeleženci so prejeli tri odmerke cepiva, nato pa so jim en mesec po zadnji injekciji izmerili odziv protiteles proti štirim glavnim testnim sevom bakterije (sevom, ki so običajno odgovorni za bolezen v Evropi).
English: How is Trumenba used?
Slovenian: Kako se zdravilo Trumenba uporablja?
English: These proteins are fixed onto a compound containing aluminium (adsorbed), which helps to stabilise them, allowing the immune system to respond to them.
Slovenian: Zdravilo Trumenba vsebuje dve sestavini, in sicer beljakovini zunanje ovojnice bakterij Neisseria meningitidis skupine B. Ti beljakovini sta pritrjeni (adsorbirani) na spojino, ki vsebuje aluminij, kar ju stabilizira in omogoči, da se imunski sistem odzove nanju.
English: Antibodies were produced in sufficient quantities to provide protection against the 4 main test strains in between 80 and 90% of those in the first study, depending on the strain; 84% of those given the vaccine had protective antibodies against all 4 strains when tested.
Slovenian: V prvi študiji so protitelesa nastala v zadostnih količinah, da so zagotovila zaščito proti štirim glavnim testnim sevom, pri 80 do 90 % cepljenih, odvisno od seva.
English: This may take up to 60 minutes.
Slovenian: To lahko traja do 60 minut.
English: Participation in the registry is voluntary.
Slovenian: Sodelovanje v registru je prostovoljno.
English: These reactions usually go away within a few days.
Slovenian: Te reakcije običajno izzvenijo v nekaj dneh.
English: Wash your hands thoroughly.
Slovenian: Roke si temeljito umijte.
English: Potential complications can often be avoided by:
Slovenian: Možnim zapletom se lahko pogosto izognemo tako, da:
English: Currently available data are described in sections 4.8, 5.1 and 5.2.
Slovenian: Trenutno razpoložljivi podatki so opisani v poglavjih 4.8, 5.1 in 5.2.
English: Prepare a clean work area.
Slovenian: Pripravite čisto delovno površino.
English: Tmax [days]
Slovenian: Tmax [dni]
English: National unique code included.
Slovenian: Vključena je edinstvena nacionalna koda.
English: Date of first authorisation: 16 May 2013 Date of renewal: 8 Jan 2018
Slovenian: Datum prve odobritve: 16. maj 2013 Datum podaljšanja: 8. januar 2018
English: Allow to dry (at least 30 seconds).
Slovenian: Počakajte, da se mesto posuši (vsaj 30 sekund).
English: Thrombosis may also occur in the absence of known risk factors.
Slovenian: Tromboza se lahko pojavi tudi v odsotnosti znanih dejavnikov tveganja.
English: Signs or symptoms of these rare allergic reactions include:
Slovenian: Znaki ali simptomi teh redkih alergijskih reakcij so med drugim:
English: Frequency not known (cannot be estimated from the available data):
Slovenian: Pogostnost neznana (ni mogoče oceniti iz razpoložljivih podatkov):
English: Protein (grams)
Slovenian: Beljakovine (grami)
English: Partially used vials should be discarded.
Slovenian: Delno uporabljene viale morate zavreči.
English: Consequences of an overdose are not known.
Slovenian: Posledice prekomernega odmerjanja niso znane.
English: Higher incidences of AMS were seen in women.
Slovenian: Višjo pojavnost AMS so ugotovili pri ženskah.
English: Push the air into the vial.
Slovenian: Ves zrak potisnite v vialo.
English: 10 minutes
Slovenian: 10 minut
English: AUC per week [g*days/l]
Slovenian: AUC na teden [g*dni/l]
English: Direct Coombs' test positive
Slovenian: Preiskave pozitiven direkten Coombsov test
English: Infusions of medicines like HyQvia can occasionally result in serious, but rare, allergic reactions.
Slovenian: Infuzije zdravil, kot je HyQvia, lahko občasno privedejo do resnih, vendar redkih alergijskih reakcij.
English: This medicinal product does not contain sugars.
Slovenian: To zdravilo ne vsebuje sladkorjev.
English: See sections 4.2 and 4.8.
Slovenian: Glejte poglavji 4.2 in 4.8.
English: • This medicinal product is comprised of two vials.
Slovenian: • To zdravilo je sestavljeno iz dveh vial.
English: Replacement therapy in adults, children and adolescents (0-18 years) in:
Slovenian: Nadomestno zdravljenje odraslih, otrok in mladostnikov (0-18 let) pri:
English: • Pull the needle wings straight up and out.
Slovenian: • Metuljčka igle povlecite naravnost gor in ven.
English: Effects on blood tests
Slovenian: Učinek na krvne preiskave
English: IgG and IgG-complexes are broken down in cells of the reticuloendothelial system.
Slovenian: IgG in kompleksi IgG se razgrajujejo v celicah retikuloendotelijskega sistema.
English: Apparent clearance or clearance [ml/kg/day] 1.6 (1.4 to 1.79)
Slovenian: Navidezni očistek ali očistek [ml/kg/dan] 1,6 (1,4 do 1,79)
English: The majority of these ARs were mild to moderate.
Slovenian: Večina teh neželenih učinkov je bila blagih do zmernih.
English: The purpose of such registry is to collect and share data only with the public health authorities responsible for monitoring the safety of this product.
Slovenian: Namen registra je zbiranje in širjenje podatkov samo z javnozdravstvenimi organizacijami, ki so pristojne za spremljanje varnosti tega zdravila.
English: Consider using longer needles and/or more than one infusion site.
Slovenian: Razmislite o uporabi daljših igel in/ali več kot enem mestu infundiranja.
English: Produced from the plasma of human donors.
Slovenian: Izdelano iz darovane človeške plazme.
English: The contents of each vial are described below:
Slovenian: Vsebina posamezne viale je opisana v nadaljevanju:
English: It is usually prepared from pooled human plasma from not fewer than 1,000 donations.
Slovenian: Ponavadi se pripravlja iz združene človeške plazme od najmanj 1000 darovanih enot.
English: Antibodies are part of the immune system (the body's natural defences) and help your body to fight infections.
Slovenian: Protitelesa so del imunskega sistema (naravne telesne obrambe) in pomagajo telesu v boju proti okužbam.
English: Frequencies per infusion have been evaluated using the following convention: Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from available data).
Slovenian: Pogostnosti na infuzijo so bile ocenjene po naslednjem dogovoru: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do <1/1.000), zelo redki (<1/10.000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: The effects of the hyaluronidase are reversible and permeability of the subcutaneous tissue is restored within 24 to 48 hours.
Slovenian: Učinki hialuronidaze so reverzibilni in permeabilnost subkutanega tkiva se povrne v 24 do 48 urah.
English: Unlike the stable structural components of the interstitial matrix, hyaluronan has a very fast turnover with half-life of approximately 0.5 days.
Slovenian: V nasprotju s stabilnimi strukturnimi komponentami intersticijskega matriksa se hialuronan zelo hitro pretvarja, z razpolovno dobo približno 0,5 dneva.
English: Spread of localised infections
Slovenian: Širjenje lokaliziranih okužb
English: Excipients with known effects:
Slovenian: Pomožne snovi z znanimi učinki:
English: Results of clinical studies indicate similar safety profiles in adults and paediatric population, including the nature, frequency, seriousness and reversibility of adverse reactions.
Slovenian: Rezultati kliničnih študij nakazujejo podoben varnostni profil pri odraslih in pediatrični populaciji, vključno z naravo, pogostnostjo, resnostjo in reverzibilnostjo neželenih učinkov.
English: If this happens, you should wait until the reactions have disappeared.
Slovenian: V takšnem primeru morate počakati, da učinki izzvenijo.
English: Remove HyQvia from the box:
Slovenian: Vzemite zdravilo HyQvia iz škatle:
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/
English: Like all medicines, this medicine can have side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: It is unknown whether these antibodies may have any clinical significance in humans.
Slovenian: Ni znano, ali so ta protitelesa pri ljudeh klinično pomembna.
English: In the beginning you will receive one quarter of this dose at 1 week intervals.
Slovenian: Na začetku boste prejeli četrtino tega odmerka v enotedenskih presledkih.
English: The treatment required depends on the nature and severity of the adverse reaction.
Slovenian: Potrebno zdravljenje je odvisno od narave in resnosti neželenega učinka.
English: The following warnings and precautions should be taken into consideration before you receive or use HyQvia.
Slovenian: Naslednja opozorila in previdnostne ukrepe upoštevajte, preden prejmete ali uporabite zdravilo HyQvia.
English: Wash hands:
Slovenian: Umijte si roke:
English: o Select sites on the opposite sides of the body if instructed to infuse in two sites for doses above 600 ml.
Slovenian:  Izberite mesta na nasprotnih straneh telesa, če ste prejeli navodilo za infundiranje v dve mesti za odmerke nad 600 ml.
English: The overall combined exposure of PID patients in both studies was 187.69 patient-years; the longest exposure for adults was 3.8 years and 3.3 years for paediatric patients.
Slovenian: V obeh študijah je bila celotna skupna izpostavljenost bolnikov s PID 187,69 bolnikovih let; najdaljša izpostavljenost odraslih je bila 3,8 let, pri pediatričnih bolnikih pa 3,3 leta.
English: Gather all supplies: Collect all items for your infusion.
Slovenian: Zberite vse pripomočke: Zberite vse pripomočke za infundiranje.
English: In replacement therapy the dose may need to be individualized for each patient dependent on the pharmacokinetic and clinical response.
Slovenian: Pri nadomestnem zdravljenju boste odmerek morda morali prilagoditi vsakemu bolniku na podlagi farmakokinetičnega in kliničnega odziva.
English: The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials and therefore should only be given with caution to pregnant women and breast-feeding mothers.
Slovenian: Varnost tega zdravila za uporabo med nosečnostjo pri človeku ni bila ugotovljena v nadzorovanih kliničnih preskušanjih, zato se sme nosečnicam in doječim materam dajati samo s previdnostjo.
English: Hypertension, blood pressure increase
Slovenian: Žilne bolezni hipertenzija zvišan krvni tlak
English: For instructions on how to use the medicinal product, see section 6.6.
Slovenian: Za navodila o uporabi zdravila glejte poglavje 6.6.
English: To reduce the rate of infection, it may be necessary to increase the dosage and aim for higher trough levels (> 6 g/l).
Slovenian: Za zmanjšanje stopnje okužb boste morda morali povečati odmerek in doseči višje najnižje koncentracije zdravila v krvi (> 6 g/l).
English: Long-term animal studies to evaluate the carcinogenic or mutagenic potential of recombinant human hyaluronidase have not been conducted.
Slovenian: Dolgoročne študije na živalih za vrednotenje kancerogenega ali mutagenega potenciala rekombinantne humane hialuronidaze niso bile opravljene.
English: • Repeat this step if you have a second infusion site.
Slovenian: • Ponovite ta korak, če uporabljate še eno mesto infundiranja.
English: • initially infusing the product slowly (see section 4.2).
Slovenian: • zdravilo najprej infundiramo počasi (glejte poglavje 4.2).
English: Slowly and carefully push the plunger to remove any remaining air.
Slovenian: Počasi in previdno potisnite bat, da odstranite morebitno prisoten zrak.
English: Do not mix the components of this medicinal product.
Slovenian: Komponent tega zdravila ne mešajte.
English: HyQvia contains many different antibodies, some of which can affect blood tests (serological tests).
Slovenian: Zdravilo HyQvia vsebuje številna različna protiteles in nekatera od njih lahko vplivajo na krvne preiskave (serološke preiskave).
English: Firmly grasp and pinch at least 2 to 2.5 cm of skin between two fingers.
Slovenian: Z dvema prstoma odločno primite in stisnite vsaj 2 do 2,5 cm kože.
English: 3, predominantly from the granulocytic series, and elevated protein levels up to several hundred mg/dL.
Slovenian: 3, predvsem iz granulocitne vrste, in zvišanimi ravnmi beljakovin do nekaj sto mg/dL.
English: The rHuPH20 may be hand-pushed or infused by a pump.
Slovenian: Komponento rHuPH20 lahko potisnete ročno ali infundirate s črpalko.