FrancophonIA/ELRC3.0 huggingface dataset:
English: Brinzolamide and N-desethylbrinzolamide are the predominant components in the urine along with trace levels (<1%) of the N-desmethoxypropyl and O-desmethyl metabolites.
Slovenian: V seču najdemo predvsem brinzolamid in N-desetilbrinzolamid, poleg N-desmetoksipropil in O-desmetil presnovkov, ki so prisotni le v sledovih.
English: What AZOPT contains
Slovenian: Kaj vsebuje zdravilo AZOPT
English: No unexpected adverse reactions have been observed with AZOPT when used as adjunctive therapy to travoprost.
Slovenian: Pri uporabi zdravila AZOPT za dodatno zdravljenje ob travoprostu niso opazili nepričakovanih neželenih učinkov.
English: How to store AZOPT
Slovenian: Shranjevanje zdravila AZOPT
English: CLINICAL PARTICULARS
Slovenian: Psihiatrične motnje
English: Edetate disodium
Slovenian: Bolezni sečil
English: Alcon Cusí, S.A., Camil Fabra 58, 08320 El Masnou, Barcelona, Spain.
Slovenian: 08320 El Masnou (Barcelona) Španija
English: - Effects in the eye: blurred vision, eye irritation, eye pain, eye discharge, itchy eye, dry eye, abnormal eye sensation, redness of the eye.
Slovenian: - Učinki na oko: zamegljen vid, draženje očesa, očesna bolečina, izcedek iz očesa, srbeče oko, suho oko, nenavaden občutek v očesu, rdečina očesa
English: • Bring the bottle tip close to the eye. Use the mirror if it helps
Slovenian: Če vam pomaga, uporabite ogledalo.
English: The same types of adverse reactions that are attributable to sulphonamides may occur with topical administration.
Slovenian: Pri topikalni uporabi zdravila se lahko pojavijo enake vrste neželenih reakcij kot pri drugih sulfonamidih.
English: Each millilitre contains 10 mg of brinzolamide.
Slovenian: - Učinkovina je brinzolamid 10 mg/ml.
English: Metabolism and nutrition disorders Not known: decreased appetite Psychiatric disorders
Slovenian: Bolezni jeter, žolčnika in žolčevodov Neznana: nenormalni izvidi preiskav delovanja jeter Bolezni kože in podkožja
English: Hepatic and renal impairment
Slovenian: Presnovne in prehranske motnje
English: Further information on Grastofil can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Nadaljnje informacije o zdravilu Grastofil so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This means that Grastofil is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Slovenian: To pomeni, da je zelo podobno drugemu biološkemu zdravilu („referenčnemu zdravilu“), ki je že odobreno v EU.
English: Grastofil received a marketing authorisation valid throughout the EU on 18 October 2013.
Slovenian: Za zdravilo Grastofil je bilo 18. oktobra 2013 izdano dovoljenje za promet, veljavno po vsej EU.
English: Severe neutropenia lasted on average for 1.4 days which compared with 1.6 days and 1.8 days reported in studies using filgrastim found in the literature.
Slovenian: Huda nevtropenija je trajala v povprečju 1,4 dneva, kar je primerljivo z 1,6 dneva in 1,8 dneva, zabeleženih v študijah iz literature, v katerih so uporabljali filgrastim.
English: What measures are being taken to ensure the safe and effective use of Grastofil?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Grastofil?
English: An overview of Grastofil and why it is authorised in the EU
Slovenian: Pregled zdravila Grastofil in zakaj je odobreno v EU
English: Other information about Grastofil
Slovenian: Druge informacije o zdravilu Grastofil
English: As for all medicines, data on the use of Grastofil are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Grastofil stalno spremljajo.
English: Data from published studies indicate that the benefits and safety of filgrastim are similar in both adults and children receiving chemotherapy.
Slovenian: Podatki iz objavljenih študij kažejo, da so koristi in varnost filgrastima pri odraslih in otrocih, ki prejemajo kemoterapijo, podobne.
English: Patients were given the chemotherapy on day 1 of a three-week cycle, and then received one dose of Grastofil the next day and daily for up to 14 days.
Slovenian: Bolnice so prvi dan tritedenskega ciklusa prejele kemoterapijo, naslednji dan pa en odmerek zdravila Grastofil, ki so ga nato vsak dan prejemale še največ 14 dni.
English: Grastofil was studied in one main study involving 120 female adult patients with breast cancer treated with chemotherapy (medicines to treat cancer) known to cause neutropenia.
Slovenian: Zdravilo Grastofil so proučili v eni glavni študiji, v katero so vključili 120 odraslih bolnic z rakom dojke, ki so se zdravile s kemoterapijo (zdravili za zdravljenje raka), za katero je znano, da povzroča nevtropenijo.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Grastofil has been shown to have a comparable quality, safety and effectiveness to Neupogen.
Slovenian: Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU glede podobnih bioloških zdravil dokazano, da je zdravilo Grastofil po kakovosti, varnosti in učinkovitosti primerljivo zdravilu Neupogen.
English: The active substance in Grastofil, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G-CSF).
Slovenian: Učinkovina v zdravilu Grastofil, filgrastim, je zelo podobna človeški beljakovini, imenovani granulocitne kolonije spodbujajoči faktor (G-CSF).
English: What benefits of Grastofil have been shown in studies?
Slovenian: Kakšne koristi zdravila Grastofil so se pokazale v študijah?
English: What is Grastofil and what is it used for?
Slovenian: Kaj je zdravilo Grastofil in za kaj se uporablja?
English: Side effects reported with Grastofil are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Grastofil, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: • to help release cells from the bone marrow in patients who are about to donate blood stem cells for transplant;
Slovenian: • za spodbujanje sproščanja celic iz kostnega mozga pri bolnikih, ki naj bi darovali krvotvorne matične celice za presaditev;
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Grastofil have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Grastofil upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: The way Grastofil is given, its dose and the duration of treatment depend on why it is being used, the patient's body weight and the response to treatment.
Slovenian: Način dajanja in odmerjanje zdravila Grastofil ter trajanje zdravljenja z njim so odvisni od razloga za uporabo zdravila, telesne mase bolnika in odziva na zdravljenje.
English: What are the risks associated with Grastofil?
Slovenian: Kakšna tveganja so povezana z zdravilom Grastofil?
English: For more information about using Grastofil, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Grastofil glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: The most common side effects with Grastofil (which may affect more than 1 in 10 people) are fever, musculoskeletal pain (pain in the muscles and bones), anaemia (low red blood cell counts), vomiting and nausea (feeling sick).
Slovenian: Najpogostejši neželeni učinki zdravila Grastofil (ki se lahko pojavijo pri več kot 1 bolniku od 10) so povišana telesna temperatura, mišično-skeletne bolečine (bolečine v mišicah in kosteh), anemija (nizko število rdečih krvnih celic), bruhanje in navzeja (slabost).
English: Grastofil can only be obtained with a prescription and treatment should be given in collaboration with a centre for cancer treatment.
Slovenian: Predpisovanje in izdaja zdravila Grastofil je le na recept, zdravljenje pa se lahko uvede v sodelovanju z bolnišnico za zdravljenje raka.
English: Grastofil is a medicine that stimulates the production of white blood cells and is used:
Slovenian: Grastofil je zdravilo, ki se uporablja za spodbujanje tvorbe belih krvnih celic v naslednjih primerih:
English: Why is Grastofil approved?
Slovenian: Zakaj je bilo zdravilo Grastofil odobreno?
English: The medicine is available in prefilled syringes and is given by injection under the skin or infusion (drip) into a vein.
Slovenian: Zdravilo je na voljo v obliki napolnjenih injekcijskih brizg in se daje z injiciranjem v podkožje ali infundiranjem (kapalno infuzijo) v veno.
English: Other side effects may be seen in more than 1 patient in 10, depending on the condition that Grastofil is being used for.
Slovenian: Pri več kot 1 bolniku od 10 se lahko pojavijo drugi neželeni učinki, ki so odvisni od bolezenskega stanja, zaradi katerega se zdravilo Grastofil uporablja.
English: Therefore, the Agency's view was that, as for Neupogen, the benefits of Grastofil are greater than its risks and it can be authorised for use in the EU.
Slovenian: Menila je, da so koristi zdravila Grastofil, enako kot pri zdravilu Neupogen, večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: • to treat persistent neutropenia in patients with advanced human-immunodeficiency-virus (HIV) infection, to reduce the risk of bacterial infections when other treatments are not appropriate.
Slovenian: • za zdravljenje trdovratne nevtropenije pri bolnikih z napredovalo okužbo z virusom humane imunske pomanjkljivosti (HIV), za zmanjšanje bakterijskih okužb, kadar druge vrste zdravljenja niso primerne.
English: Studies were also carried out to show that Grastofil produces levels of the active substance in the body that are comparable to the reference medicine, Neupogen.
Slovenian: Opravili so tudi študije, v katerih so pokazali, da zdravilo Grastofil doseže podobne ravni učinkovine v telesu kot referenčno zdravilo Neupogen.
English: • to increase levels of neutrophils and reduce the risk of infections in patients with neutropenia who have a history of severe, repeated infections;
Slovenian: • za povišanje ravni nevtrofilcev in zmanjšanje tveganja okužb pri bolnikih z nevtropenijo, ki imajo anamnezo hudih, ponavljajočih se okuž;
English: For the full list of side effects and restrictions with Grastofil, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Grastofil glejte navodilo za uporabo.
English: • to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell) and to prevent febrile neutropenia (neutropenia with fever) in cancer patients (excluding patients with chronic myeloid leukaemia or with myelodysplastic syndromes).
Slovenian: • za skrajšanje trajanja nevtropenije (nizke ravni nevtrofilcev, vrste belih krvnih celic) in preprečevanje pojava febrilne nevtropenije (nevtropenije s povišano telesno temperaturo) pri rakavih bolnikih (razen pri bolnikih s kronično mieloično levkemijo ali mielodisplastičnimi sindromi).
English: Grastofil is a ‘biosimilar medicine'.
Slovenian: Zdravilo Grastofil je „podobno biološko zdravilo“.
English: Neutropenia is a common side effect of cancer treatment and can leave patients vulnerable to infections;
Slovenian: Nevtropenija je pogost neželeni učinek zdravljenja raka, zaradi česar so ti bolniki bolj dovzetni za okužbe;
English: The reference medicine for Grastofil is Neupogen.
Slovenian: Referenčno zdravilo za zdravilo Grastofil je zdravilo Neupogen.
English: How does Grastofil work?
Slovenian: Kako zdravilo Grastofil deluje?
English: How is Grastofil used?
Slovenian: Kako se zdravilo Grastofil uporablja?
English: Ref.: EMEA/327260/2009 EMEA/H/C/230
Slovenian: : EMEA/268267/2009 EMEA/H/C/230
English: A similar benefit was seen in the second study.
Slovenian: Podobne koristi so opazili tudi v drugi študiji.
English: The marketing authorisation was renewed on 1 July 2004 and on 1 July 2009.
Slovenian: Dovoljenje za promet z zdravilom je bilo podaljšano 1. julija 2004 in 1. julija 2009.
English: Other information about Integrilin:
Slovenian: Druge informacije o zdravilu Integrilin:
English: In both studies, patients also received other medicines to prevent the blood clotting.
Slovenian: V obeh študijah so bolniki prejeli tudi druga zdravila za preprečevanje krvnih strdkov.
English: The recommended dose is a single injection of 180 micrograms per kilogram body weight given as soon as possible after diagnosis.
Slovenian: Priporočeni odmerek je ena injekcija v odmerku 180 mikrogramov na kilogram telesne mase, ki jo je treba dati čim prej po postavitvi diagnoze.
English: Integrilin eptifibatide EPAR summary for the public
Slovenian: Integrilin eptifibatid Povzetek EPAR za javnost
English: The main measure of effectiveness was the number of patients who had a heart attack or who died within 30 days of treatment.
Slovenian: Glavno merilo učinkovitosti je bilo število bolnikov, ki so imeli srčni napad ali so umrli v obdobju 30 dni po zdravljenju.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Integrilin on 1 July 1999.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Integrilin, veljavno po vsej Evropski uniji, odobrila dne 1. julija 1999.
English: What benefit has Integrilin shown during the studies?
Slovenian: Kakšne koristi je zdravilo Integrilin izkazalo med študijami?
English: This is followed by a continuous infusion of 2.0 microgram/kg per minute which is continued for up to 72 hours, until the start of surgery, or until discharge from the hospital, whichever occurs first.
Slovenian: Temu sledi kontinuirana infuzija 2,0 mikrograma/kg na minuto v trajanju do 72 ur, ki se izvaja bodisi do začetka kirurškega posega ali do odpusta iz bolnišnice, karkoli pač nastopi prej.
English: The main benefit was in the reduction in further heart attacks.
Slovenian: Najpomembnejša korist je bila v zmanjšanju števila ponovnih srčnih napadov.
English: It must not be used in patients who have bleeding problems or have a disease that may cause bleeding (such as stroke or severe high blood pressure), or in patients with severe liver or kidney problems.
Slovenian: Ne sme se uporabljati pri bolnikih, ki imajo težave s krvavitvami ali imajo obolenje, ki lahko povzroči krvavitev (kot na primer kap ali močno povišan krvni tlak), ali pri bolnikih s hudimi jetrnimi ali ledvičnimi težavami.
English: The Committee recommended that Integrilin be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Integrilin odobri dovoljenje za promet.
English: Patients who have moderate problems with their kidneys should receive a lower dose during the infusion.
Slovenian: Bolniki z zmernimi težavami z ledvicami morajo z infuzijo prejeti manjši odmerek.
English: Integrilin must not be used in patients with severe kidney problems.
Slovenian: Zdravilo Integrilin se ne sme uporabljati pri bolnikih s hudimi ledvičnimi težavami.
English: Integrilin is used to prevent a myocardial infarction (heart attack) in adults.
Slovenian: Zdravilo Integrilin se uporablja za preprečevanje miokardnega infarkta (srčnega napada) pri odraslih.
English: The most common side effect with Integrilin (seen in more than 1 patient in 10) is bleeding, which may be severe.
Slovenian: Najpogostejši neželeni učinek zdravila Integrilin (opažen pri več kot 1 bolniku od 10) je krvavitev, ki je lahko včasih zelo huda.
English: Integrilin should not be used in people who may be hypersensitive (allergic) to eptifibatide or any of the other ingredients.
Slovenian: Zdravila Integrilin ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) eptifibatid ali katero koli drugo sestavino zdravila.
English: Integrilin greatly reduces the risk of a blood clot forming and helps prevent another heart attack.
Slovenian: Zdravilo Integrilin v veliki meri zmanjšuje tveganje za nastanek krvnih strdkov ter prispeva k preprečevanju ponovnega srčnega napada.
English: Integrilin is given with aspirin and unfractionated heparin (other medicines that prevent blood clots).
Slovenian: Zdravilo Integrilin se daje hkrati z aspirinom in nefrakcioniranim heparinom (drugi zdravili za preprečevanje krvnih strdkov).
English: Integrilin is a medicine that contains the active substance eptifibatide.
Slovenian: Integrilin je zdravilo, ki vsebuje zdravilno učinkovino eptifibatid.
English: The active substance in Integrilin, eptifibatide, stops the platelets aggregating by blocking a protein called glycoprotein IIb/III on their surface that helps make them sticky.
Slovenian: Zdravilna učinkovina v zdravilu Integrilin, eptifibatid, zaustavi zlepljanje trombocitov tako, da blokira beljakovino glikoprotein IIb/III, zaradi katere so trombociti lepljivi, na njihovi površini.
English: What is the risk associated with Integrilin?
Slovenian: Kakšna tveganja so povezana z zdravilom Integrilin?
English: The patients most likely to benefit from a treatment with Integrilin are those at high risk of myocardial infarction in the three to four days after the start of acute (sudden) angina.
Slovenian: Bolniki, pri katerih obstaja večja verjetnost, da bi jim zdravljenje z zdravilom Integrilin koristilo, so bolniki z visokim tveganjem za nastop miokardnega infarkta v treh do štirih dneh po pojavu akutne (nenadne) angine.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Integrilin's benefits are greater than its risks when used to prevent early myocardial infarction.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Integrilin pri preprečevanju zgodnjega miokardnega infarkta večje od z njim povezanih tveganj.
English: Integrilin has been compared with placebo (dummy treatment) in a study involving 11,000 patients who were in hospital and had signs that they may soon develop a heart attack, or who had already had a small heart attack.
Slovenian: Zdravilo Integrilin so primerjali s placebom (zdravilom brez zdravilne učinkovine) v študiji, ki je vključevala 11 000 hospitaliziranih bolnikov, ki so kazali znake za skorajšnji srčni napad ali pa so že imeli manjši srčni napad.
English: This includes patients who are having percutaneous transluminal coronary angiography (PTCA, a type of surgery to clear the arteries supplying the heart).
Slovenian: Sem spadajo bolniki, pri katerih naj bi se izvedla perkutana transluminalna koronarna angioplastika (PTCA, vrsta kirurškega posega za čiščenje arterij, ki oskrbujejo srce).
English: If the patient undergoes a percutaneous coronary intervention (PCI or angioplasty, a surgical procedure that is used to unblock narrowed coronary arteries), the treatment can be continued for up to 24 hours after surgery, with a maximum treatment duration of 96 hours.
Slovenian: Kadar se pri bolniku opravi perkutani koronarni poseg (PCI ali angioplastika, tj. kirurški poseg za odmašitev zoženih koronarnih arterij), se lahko zdravljenje nadaljuje še največ 24 ur po kirurškem posegu, najdaljše skupno trajanje zdravljenja pa je 96 ur.
English: It is available as a solution for infusion (drip into a vein) and a solution for injection.
Slovenian: Na voljo je v obliki raztopine za infundiranje (kapalne infuzije v veno) in raztopine za injiciranje.
English: In the first study, Integrilin was more effective than placebo in preventing death or a heart attack during the 30 days after it was given.
Slovenian: V prvi študiji je bilo zdravilo Integrilin pri preprečevanju smrti ali srčnega napada v obdobju 30 dni po aplikaciji zdravila učinkovitejše od placeba.
English: • patients who have unstable angina (a severe type of chest pain that varies in intensity);
Slovenian: • bolnikih z nestabilno angino pektoris (hudo bolečino v prsnem košu, katere jakost se spreminja);
English: For the full list of all side effects reported with Integrilin, see the Package Leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Integrilin, glejte navodilo za uporabo.
English: Why has Integrilin been approved?
Slovenian: Zakaj je bilo zdravilo Integrilin odobreno?
English: An additional study compared Integrilin with placebo in 2,000 patients who were having PTCA to remove a blood clot from the coronary arteries and insert a stent (a short tube that remains in the artery to stop it closing).
Slovenian: V dodatni študiji so zdravilo Integrilin primerjali s placebom pri 2 000 bolnikih, pri katerih je bila opravljena perkutana transluminalna koronarna angioplastika za odstranitev krvnega strdka iz koronarne arterije in vstavljena žilna opornica (kratka cevka, ki se jo vstavi v arterijo za preprečevanje njene zamašitve).
English: The full EPAR for Integrilin can be found here.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) Integrilin je na voljo tukaj.
English: Integrilin is an inhibitor of platelet aggregation.
Slovenian: Zdravilo Integrilin je zaviralec agregacije trombocitov.
English: What is Integrilin used for?
Slovenian: Za kaj se zdravilo Integrilin uporablja?
English: How has Integrilin been studied?
Slovenian: Kako je bilo zdravilo Integrilin raziskano?
English: How is Integrilin used?
Slovenian: Kako se zdravilo Integrilin uporablja?
English: What is Integrilin?
Slovenian: Kaj je zdravilo Integrilin?
English: How does Integrilin work?
Slovenian: Kako zdravilo Integrilin deluje?
English: Integrilin should be given into a vein by a doctor who has experience in the management of heart conditions.
Slovenian: Zdravilo Integrilin lahko v veno injicira zdravnik specialist za srčna obolenja.
English: HDPE bottle polypropylene measuring syringe
Slovenian: Karenca steklenička iz polietilena visoke, polipropilensko odmerno brizgalko
English: Cattle: subcutaneous or intravenous use Pigs: intramuscular use Horses: intravenous use
Slovenian: injiciranje prašiči intravenska podkožna, prašiči: intramuskularna dni; (Goveda) Meso in organi: 5 dni (Prašiči)
English: Packaging
Slovenian: Način uporabe Pakiranje
English: Meat and offal: 15 days (Cattle), Milk: 5 days
Slovenian: 1.5 g 100 vrečk Meso in organi: 3 dni
English: Further information on Anoro Ellipta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Nadaljnje informacije o zdravilu Anoro Ellipta so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: In all 5 studies, involving over 5,600 patients, the main measure of effectiveness was based on changes in the patients' forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second).
Slovenian: V vseh petih študijah, v katerih je sodelovalo več kot 5 600 bolnikov, je bilo glavno merilo učinkovitosti sprememba bolnikovega forsiranega ekspiracijskega volumna (FEV1 - največja količina zraka, ki jo oseba lahko izdihne v eni sekundi).
English: (umeclidinium bromide / vilanterol)
Slovenian: (umeklidinijev bromid/vilanterol)
English: As medicines of the same class as Anoro Ellipta may have an effect on the heart and blood vessels in the brain, the company that markets the medicine will carry out a long-term study in patients to collect further information on its safety in comparison with tiotropium.
Slovenian: Ker lahko zdravila istega razreda kot zdravilo Anoro Ellipta vplivajo na srce in krvne žile v možganih, bo podjetje, ki trži zdravilo, izvedlo dolgoročno študijo pri bolnikih, da bo zbralo dodatne informacije o njegovi varnosti v primerjavi s tiotropijem.
English: The European Medicines Agency decided that Anoro Ellipta's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Anoro Ellipta večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: Previously known as Anoro.
Slovenian: Predhodno znano kot zdravilo Anoro.