FrancophonIA/ELRC3.0 huggingface dataset:
English: You should not receive Grastofil in the 24 hours before and the 24 hours after receiving chemotherapy.
Slovenian: Zdravila Grastofil ne smete prejeti 24 ur pred kemoterapijo in 24 ur po njej.
English: Filgrastim is not indicated for use in these conditions.
Slovenian: Filgrastim pri teh boleznih ni indiciran.
English: What Grastofil is
Slovenian: Kaj je zdravilo Grastofil
English: Each pre-filled syringe contains 0.5 mL of solution.
Slovenian: Vsaka napolnjena injekcijska brizga vsebuje 0,5 ml raztopine.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 18. oktober 2013
English: Each syringe of 0.5 mL solution contains 48 MU (480 micrograms) of filgrastim (960 micrograms/mL).
Slovenian: Ena brizga z 0,5 ml raztopine vsebuje 48 M e. (480 mikrogramov) filgrastima (960 mikrogramov/ml).
English: Hyperuricaemia
Slovenian: Levkocitoza
English: If you are donating stem cells for yourself, the usual dose is 0.5 million units (5 micrograms) to 1 million units (10 micrograms) per kilogram bodyweight each day.
Slovenian: Če matične celice darujete zase, je običajni odmerek 0,5 milijonov enot (5 mikrogramov) do 1 milijona enot (10 mikrogramov) na kilogram telesne mase vsak dan. Zdravljenje z zdravilom Grastofil bo trajalo do 2 tedna.
English: The recommended dose of Grastofil is 0.5 MU/kg/day (5 micrograms/kg/day).
Slovenian: Priporočeni odmerek Grastofila je 0,5 M e./kg/dan (5 mikrogramov/kg/dan).
English: Each mL of solution contains 60 million units (MU) (equivalent to 600 micrograms [μg]) of filgrastim.
Slovenian: En ml raztopine vsebuje 60 milijonov enot (M e.) (kar ustreza 600 mikrogramom [μg]) filgrastima.
English: If the ANC decreases to < 1.0 x 10
Slovenian: Če se ANC med obdobjem zdravljenja zmanjša na < 1,0 x 10
English: Special precautions in sickle cell trait and sickle cell disease Sickle cell crises, in some cases fatal, have been reported with the use of filgrastim in patients with sickle cell trait or sickle cell disease.
Slovenian: Posebni previdnostni ukrepi pri srpastocelični zasnovi in srpastocelični anemiji Med uporabo filgrastima so pri bolnikih s srpastocelično zasnovo ali srpastocelično anemijo poročali o srpastoceličnih krizah, ki so bile v nekaterih primerih usodne.
English: • tingling or numbness of the hands or feet (paraesthesia)
Slovenian: • mravljinčenje ali odrevenelost v dlaneh ali stopalih (parestezija)
English: > 5.0 x 10
Slovenian: 9/l na > 5,0 x 10
English: What Grastofil contains
Slovenian: Kaj vsebuje zdravilo Grastofil
English: If leukocyte counts exceed 50 x 10
Slovenian: Če število belih krvnih celic po pričakovanem padcu nato preseže vrednost 50 x 10
English: Do not attempt to self-administer without this training.
Slovenian: Brez ustreznega usposabljanja si zdravila ne poskušajte injicirati sami.
English: Complete blood cell counts with differential and platelet counts and an evaluation of bone marrow morphology and karyotype should be performed prior to treatment.
Slovenian: Pred zdravljenjem je treba pregledati celotno krvno sliko, vključno z diferencialno krvno sliko in številom trombocitov, ter oceniti morfologijo kostnega mozga in kariotip.
English: Generally asymptomatic cases of splenomegaly and cases of splenic rupture have been reported in patients and normal donors following administration of filgrastim.
Slovenian: Pri zdravih darovalcih in bolnikih so po uporabi filgrastima poročali o primerih splenomegalije in raztrganja vranice, ki so bili na splošno asimptomatski.
English: • to increase the number of white blood cells after a bone marrow transplant to help prevent infections;
Slovenian: • za povečanje števila belih krvnih celic po presaditvi kostnega mozga za pomoč pri preprečevanju okužb;
English: A faster schedule of dose escalation may be considered in patients presenting with severe infections.
Slovenian: Pri bolnikih s hudimi okužbami je treba premisliti o hitrejšem povečevanju odmerka.
English: Hypersensitivity-type reactions including anaphylaxis, rash, urticaria, angioedema, dyspnoea and hypotension occurring on initial or subsequent treatment have been reported in clinical studies and in post-marketing experience.
Slovenian: V kliničnih študijah in v obdobju trženja zdravila so poročali o preobčutljivostnih reakcijah, ki vključujejo anafilaksijo, izpuščaj, urtikarijo, angioedem, dispnejo in hipotenzijo ter se pojavijo na začetku ali v nadaljevanju zdravljenja.
English: Each syringe of 0.5 mL solution contains 30 MU (300 micrograms) of filgrastim (600 micrograms/mL).
Slovenian: Ena brizga z 0,5 ml raztopine vsebuje 30 M e. (300 mikrogramov) filgrastima (600 mikrogramov/ml).
English: The recommended dose of Grastofil for PBPC mobilisation when used alone is 1.0 MU/kg/day (10 micrograms/kg/day) for 5-7 consecutive days.
Slovenian: Če se Grastofil uporablja samostojno, je priporočeni odmerek za izplavljanje PBPC 1,0 M e./kg/dan (10 mikrogramov/kg/dan) 5-7 zaporednih dni.
English: • bone density decreased
Slovenian: • zmanjšana kostna gostota
English: Hypersensitivity, including anaphylactic reactions, occurring on initial or subsequent treatment have been reported in patients treated with filgrastim.
Slovenian: Pri bolnikih, ki so prejemali zdravljenje s filgrastimom, so poročali o preobčutljivosti, vključno z anafilaktičnimi reakcijami, ki so se pojavile na začetku ali v nadaljevanju zdravljenja.
English: It is recommended that the ANC is measured daily for the first 2 to 3 days of filgrastim administration.
Slovenian: Prva 2 do 3 dni zdravljenja je priporočljivo ANC določati vsak dan.
English: • bleeding from the lung (pulmonary haemorrhage)
Slovenian: • krvavitev iz pljuč (pljučna krvavitev)
English: The first dose of Grastofil should be administered at least 24 hours after cytotoxic chemotherapy.
Slovenian: Bolnik mora prvi odmerek Grastofila prejeti vsaj 24 ur po citotoksični kemoterapiji.
English: Each pre-filled syringe contains 48 MU (480 μg) filgrastim in 0.5 mL solution.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 48 M e. (480 μg) filgrastima v 0,5 ml raztopine.
English: Suomi/Finland
Slovenian: Suomi
English: The Grastofil syringe has a scale on the syringe barrel.
Slovenian: Injekcijska brizga z zdravilom Grastofil ima na telesu zarisano merilo.
English: PBPC mobilisation should be considered only in donors who meet normal clinical and laboratory eligibility criteria for stem cell donation with special attention to haematological values and infectious diseases.
Slovenian: Izplavljanje matičnih celic v periferno kri je primerno le pri darovalcih, ki izpolnjujejo običajna klinična in laboratorijska merila za darovanje matičnih celic.
English: Cases of splenomegaly and splenic rupture have been reported following administration of filgrastim.
Slovenian: Po uporabi filgrastima so poročali o primerih splenomegalije in raztrganja vranice.
English: Glomerulonephritis has been reported in patients receiving filgrastim and pegfilgrastim.
Slovenian: Pri bolnikih, ki so dobivali filgrastim in pegfilgrastim, so poročali o glomerulonefritisu.
English: Filgrastim should be permanently discontinued in patients who experience a serious allergic reaction.
Slovenian: Pri bolnikih, pri katerih se pojavi resna alergijska reakcija, je treba z uporabo filgrastima trajno prenehati.
English: For PBPC mobilisation in normal donors, Grastofil should be administered at 1.0 MU/kg/day (10 micrograms/kg/day) for 4 - 5 consecutive days.
Slovenian: Za izplavljanje matičnih celic v periferno kri pri zdravih darovalcih je treba Grastofil 4-5 zaporednih dni uporabljati v odmerku 1,0 M e./kg/dan (10 mikrogramov/kg/dan).
English: The cells are collected using a process called apheresis (ay-fer-ree-sis).
Slovenian: Celice se odvzamejo v postopku, imenovanem afereza.
English: • lungs do not function as they should, causing breathlessness (respiratory failure)
Slovenian: • težave s pljuči kar povzroči zasoplost (dihalna odpoved)
English: Vascular disorders, including veno-occlusive disease and fluid volume disturbances, have been reported occasionally in patients undergoing high dose chemotherapy followed by transplantation.
Slovenian: Občasno so pri bolnikih, zdravljenih z velikimi odmerki kemoterapije, ki ji je sledila presaditev, poročali o žilnih boleznih, vključno z vensko-okluzivno boleznijo in motnjami ravnovesja tekočin.
English: Patients with renal/hepatic impairment
Slovenian: Bolniki z ledvično ali jetrno okvaro
English: Cases of capillary leak syndrome have been reported with granulocyte colony-stimulating factor use.
Slovenian: Po dajanju granulocitne kolonije spodbujajočega faktorja so poročali o sindromu povečane prepustnosti kapilar.
English: Long-term treatment with Grastofil is required for reduction in neutropenia.
Slovenian: Pri nevtropeniji je potrebno dolgotrajno zdravljenje z zdravilom Grastofil.
English: Pulmonary adverse reactions, in particular interstitial lung disease, have been reported after G-CSF administration.
Slovenian: Po dajanju G-CSF so poročali o neželenih učinkih na pljučih, zlasti o intersticijski pljučni bolezni.
English: Consideration should be given to temporary discontinuation or dose reduction of filgrastim in patients with severe chronic neutropenia who develop thrombocytopenia (platelet count < 100 x 10
Slovenian: Pri bolnikih s hudo kronično nevtropenijo, pri katerih se razvije trombocitopenija (število trombocitov < 100 x 10
English: 9/L) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.
Slovenian: Zdravilo Grastofil je indicirano za zdravljenje trdovratne nevtropenije (ANC manjše ali enako 1,0 x 9/l) pri bolnikih z napredovalo okužbo s HIV z namenom zmanjšanja tveganja bakterijskih okužb, ko druge oblike zdravljenja nevtropenije niso primerne.
English: Cases of decreased bone density and osteoporosis have been reported in paediatric patients with severe chronic neutropenia receiving chronic treatment with filgrastim.
Slovenian: Pediatrični bolniki s hudo kronično nevtropenijo Pri pediatričnih bolnikih s hudo kronično nevtropenijo, ki prejemajo kronično zdravljenje s filgrastimom, so poročali o primerih zmanjšane gostote kosti in osteoporoze.
English: In patients with severe chronic neutropenia (SCN)
Slovenian: Pri bolnikih s hudo kronično nevtropenijo Odmerjanje
English: Discontinue Grastofil
Slovenian: Prekinite zdravljenje z Grastofilom
English: Each mL of solution contains 96 million units (MU) (equivalent to 960 micrograms [μg]) of filgrastim.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA En ml raztopine vsebuje 96 milijonov enot (M e.) (kar ustreza 960 mikrogramom [μg]) filgrastima.
English: Effect of chemotherapy on erythrocytes and thrombocytes Treatment with filgrastim alone does not preclude thrombocytopenia and anaemia due to myelosuppressive chemotherapy.
Slovenian: Zdravljenje s filgrastimom samim ne prepreči trombocitopenije in anemije, ki se pojavita zaradi mielosupresivne kemoterapije.
English: Magyarország STADA Arzneimittel AG Telephone +49/6101.603.0
Slovenian: Magyarország STADA Arzneimittel AG Tel.: +49/6101.603.0
English: Neutrophils produced in response to filgrastim show normal or enhanced function as demonstrated by tests of chemotactic and phagocytic function.
Slovenian: Preizkusi kemotaktične in fagocitne funkcije so pokazali, da delujejo nevtrofilci, ki nastanejo kot odziv na zdravljenje s filgrastimom, normalno ali močneje.
English: If you are acting as a stem cell donor for another person, the usual dose is 1 million units (10 micrograms) per kilogram bodyweight each day.
Slovenian: Če darujete matične celice za drugo osebo, potem je običajni odmerek na kilogram telesne mase 1 milijon enot (10 mikrogramov) vsak dan. Zdravljenje z zdravilom Grastofil bo trajalo 4 do 5 dni.
English: Permanently discontinue filgrastim in patients with clinically significant hypersensitivity.
Slovenian: Pri bolnikih s klinično pomembno preobčutljivostjo je treba zdravljenje s filgrastimom trajno prenehati.
English: EU/1/13/877/003 1 prefilled syringe EU/1/13/877/004 5 prefilled syringes
Slovenian: EU/1/13/877/003 1 napolnjena injekcijska brizga EU/1/13/877/004 5 napolnjenih injekcijskih brizg
English: STADA Arzneimittel AG Telephone +49/6101.603.0
Slovenian: STADA Arzneimittel AG Tel +49/6101.603.0
English: • tiredness (fatigue)
Slovenian: • utrujenost (izčrpanost)
English: Telephone +386/1-589.67.10
Slovenian: Tel:+ 386 (0)1 589 67 10
English: How Grastofil is given
Slovenian: Kako se daje zdravilo Grastofil
English: Latvija STADA Arzneimittel AG
Slovenian: STADA Arzneimittel AG Teл.
English: Cases of Sweets syndrome (acute febrile neutrophilic dermatosis) have been reported in patients treated with filgrastim.
Slovenian: Pri bolnikih, zdravljenih s filgrastimom, so poročali o primerih Sweetovega sindroma (akutna febrilna nevtrofilna dermatoza).
English: EU/1/13/877/001 1 prefilled syringe EU/1/13/877/002 5 prefilled syringes
Slovenian: EU/1/13/877/001 1 napolnjena injekcijska brizga EU/1/13/877/002 5 napolnjenih injekcijskih brizg
English: Each pre-filled syringe contains 30 MU (300 μg) filgrastim in 0.5 mL solution.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 30 M e. (300 μg) filgrastima v 0,5 ml raztopine.
English: Glacial acetic acid Sodium hydroxide Sorbitol (E420) Polysorbate 80
Slovenian: 6.1 Seznam pomožnih snovi ledocetna kislina natrijev hidroksid sorbitol (E420) polisorbat 80 voda za injekcije
English: What Grastofil is used for
Slovenian: Za kaj uporabljamo zdravilo Grastofil
English: Telephone +44/1484-842.217
Slovenian: United Kingdom Thornton & Ross Ltd. Tel:+44/1484-842.217
English: 9/L prior to leukapheresis; in general apheresis should not be performed if platelets are
Slovenian: 9/l; običajno se afereze ne sme narediti, če je število trombocitov < 75 x 10
English: Sixty-five percent of patients studied in a SCN trial program, were under 18 years of age.
Slovenian: Pediatrična uporaba pri bolnikih s hudo kronično nevtropenijo in rakom V kliničnih preskušanjih je bilo 65 % bolnikov, ki so se zdravili zaradi hude kronične nevtropenije, mlajših od 18 let.
English: 9/L or greater have been observed in less than 5% of cancer patients receiving filgrastim at doses above 0.3 MU/kg/day (3 µg/kg/day).
Slovenian: Pri manj kot 5 % bolnikov z rakom, ki so prejemali filgrastim v odmerku, večjem od 0,3 M e./kg/dan (3 mikrograme/kg/dan), so opazili število belih krvnih celic, 100 x 10
English: PRE-FILLED SYRINGE
Slovenian: Kožni vaskulitis
English: Acute respiratory distress syndrome a mediastinal disorders
Slovenian: Žilne bolezni hipertenzija hipotenzija vensko-okluzivna bolezen d sindrom povečane prepustnosti kapilar a aortitis
English: In clinical studies, dosing with 30 MU/day (300 micrograms/day) on 1 - 7 days per week was required to maintain the ANC > 2.0 x 10
Slovenian: Začetni odmerek je priporočljivo prilagoditi na 30 M e./dan (300 mikrogramov/dan) vsak drugi dan. Za vzdrževanje števila nevtrofilcev na ravni > 2,0 x 10
English: There was a low frequency (approximately 3%) of myelodysplastic syndromes (MDS) or leukaemia in clinical trial patients with SCN treated with filgrastim.
Slovenian: V kliničnem preskušanju bolnikov s hudo kronično nevtropenijo, ki so dobivali filgrastim, so poročali o mielodisplastičnih sindromih (MDS) ali levkemiji, ki pa niso bili pogosti (pri približno 3 %).
English: MU/day (300 micrograms/day) on 1 - 7 days per week was required to maintain the ANC > 2.0 x 10
Slovenian: 9/l uporabljati 30 M e./dan (300 mikrogramov/dan) v obdobju od enega do sedmih dni na teden; mediana pogostnosti dajanja je znašala 3 dni na teden.
English: Solution for injection/infusion.
Slovenian: raztopina za injiciranje/infundiranje bistra, brezbarvna raztopina
English: Grastofil 48 MU/0.5 mL solution for injection/infusion in pre-filled syringe filgrastim
Slovenian: Grastofil 48 M e./0,5 ml raztopina za injiciranje/infundiranje v napolnjeni injekcijski brizgi filgrastim
English: Grastofil 30 MU/0.5 mL solution for injection/infusion in pre-filled syringe filgrastim
Slovenian: Grastofil 30 M e./0,5 ml raztopina za injiciranje/infundiranje v napolnjeni injekcijski brizgi filgrastim
English: There have been reports of GvHD and fatalities in patients after allogeneic bone marrow transplantation (see section Description of selected adverse reactions)
Slovenian: Poškodbe in zastrupitve in zapleti pri posegih reakcija na transfuzijo e glejte poglavje Opis izbranih neželenih učinkov
English: Haematuria
Slovenian: Izplavljanje
English: Publication
Slovenian: Objava
English: • soreness and swelling of the digestive tract lining which runs from the mouth to the anus
Slovenian: • občutljivost in otekanje sluznice prebavil, ki poteka od ust do zadnjika (sluznično vnetje)
English: Grastofil 48 MU/0.5 mL solution for injection/infusion in pre-filled syringe
Slovenian: Grastofil 48 M e./0,5 ml raztopina za injiciranje/infundiranje v napolnjeni injekcijski brizgi
English: Cutaneous vasculitis has been reported in patients treated with filgrastim.
Slovenian: Pri bolnikih, zdravljenih s filgrastimom, so poročali o kožnem vaskulitisu.
English: The results of flow cytometric analysis of
Slovenian: Meta-analiza študij alogenskih presaditev,
English: 9/L.A faster schedule of dose escalation may be considered in patients presenting with severe infections.
Slovenian: 9/l bi utegnile biti potrebne nadaljnje prilagoditve odmerka glede na bolnikovo absolutno število nevtrofilcev.
English: Capillary leak syndrome, which can be life-threatening if treatment is delayed, has been reported after granulocyte colony-stimulating factor administration, and is characterised by hypotension, hypoalbuminaemia, oedema and hemoconcentration.
Slovenian: O sindromu povečane prepustnosti kapilar, ki je lahko v primeru zakasnjenega zdravljenja tudi življenjsko ogrožajoč,so poročali po dajanju granulocitne kolonije spodbujajočega faktorja.
English: Hepatomegaly
Slovenian: • omotica
English: Grastofil 30 MU/0.5 mL solution for injection/infusion in pre-filled syringe
Slovenian: Grastofil 30 M e./0,5 ml raztopina za injiciranje/infundiranje v napolnjeni injekcijski brizgi
English: Transient cytogenetic abnormalities have been observed in normal donors following G-CSF use.
Slovenian: Pri zdravih darovalcih, ki so prejemali G-CSF, so opazili prehodne citogenetske spremembe.
English: Capillary leak syndrome
Slovenian: Sindrom povečane prepustnosti kapilar
English: Further dose adjustment may be necessary, as determined by the patient's ANC, to maintain the neutrophil count at > 2.0 x 10
Slovenian: V kliničnih študijah so morali za vzdrževanje absolutnega števila nevtrofilcev na ravni > 2,0 x 10
English: Exacerbation of rheumatoid arthritis
Slovenian: Učinek kemoterapije na eritrocite in trombocite
English: Sickle cell anaemia with crisis
Slovenian: Bolezni sečil dizurija hematurija proteinurija glomerulonefritis nenormalnosti urina
English: The European Commission granted a marketing authorisation valid throughout the European Union for Galvus on 26 September 2007.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Galvus, veljavno po vsej Evropski uniji, odobrila dne 26. septembra 2007.
English: The full EPAR for Galvus 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 Galvus je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Galvus.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Galvus.
English: Other information about Galvus
Slovenian: Druge informacije o zdravilu Galvus
English: In adults, the recommended dose of Galvus is:
Slovenian: Pri odraslih znaša priporočeni odmerek zdravila Galvus:
English: For more information about treatment with Galvus, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Galvus preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Galvus.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Galvus, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: In patients with moderate or severe kidney problems, the recommended dose is 50 mg once daily.
Slovenian: Pri bolnikih z zmernim ali hujšim ledvičnim obolenjem znaša priporočeni odmerek 50 mg enkrat na dan.
English: The active substance in Galvus, vildagliptin, is a dipeptidyl peptidase 4 (DPP-4) inhibitor.
Slovenian: Zdravilna učinkovina v zdravilu Galvus, vildagliptin, je zaviralec dipeptidil peptidaze 4 (DPP-4).
English: The most common side effect with Galvus (seen in between 1 and 10 patients in 100) is dizziness.
Slovenian: Najpogostejši neželeni učinek (opažen pri 1 do 10 bolnikih izmed 100) je omotica.
English: What benefit has Galvus shown during the studies?
Slovenian: Kakšne koristi je zdravilo Galvus izkazalo med študijami?
English: Galvus must not be used in people who are hypersensitive (allergic) to vildagliptin or any of the other ingredients.
Slovenian: Zdravila Galvus ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) vildagliptin ali katero koli drugo sestavino zdravila.
English: Galvus is a medicine that contains the active substance vildagliptin.
Slovenian: Galvus je zdravilo, ki vsebuje zdravilno učinkovino vildagliptin.
English: Galvus should therefore be used only in patients for whom metformin is inappropriate either because of side effects occurring with metformin or because they have a condition that makes metformin unsuitable for them.
Slovenian: Zdravilo Galvus naj bi torej uporabljali samo bolniki, za katere metformin ni primeren bodisi zaradi neželenih učinkov, ki se pojavijo zaradi jemanja metformina, bodisi ker imajo bolezen, pri kateri jemanje metformina zanje ni ustrezno.
English: The CHMP also considered the use of Galvus on its own and concluded that it was effective in reducing blood glucose but less so than metformin.
Slovenian: CHMP je proučil tudi samostojno uporabo zdravila Galvus in zaključil, da je sicer učinkovito pri zniževanju glukoze v krvi, a manj kot metformin.
English: What is the risk associated with Galvus?
Slovenian: Kakšna tveganja so povezana z zdravilom Galvus?
English: Because vildagliptin has been associated with liver problems, patients should have tests to check their liver function before treatment with Galvus and at regular intervals during treatment.
Slovenian: Ker vildagliptin povezujejo z okvaro jeter, morajo bolniki pred začetkom zdravljenja z zdravilom Galvus opraviti preiskave jeter in nato v rednih presledkih med zdravljenjem.
English: Galvus has been studied in eleven main studies involving a total of over 5,000 patients with type 2 diabetes and insufficient control of blood glucose levels.
Slovenian: Zdravilo Galvus so proučevali v 11 glavnih študijah, v katere je bilo vključenih skupno več kot 5 000 bolnikov s sladkorno boleznijo tipa 2, pri katerih koncentracija glukoze v krvi ni bila zadostno uravnana.
English: For the full list of all side effects reported with Galvus, including side effects occurring when Galvus is taken with other antidiabetes medicines, see the package leaflet.
Slovenian: Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila Galvus, vključno z neželenimi učinki, ki se pojavijo, kadar se zdravilo Galvus jemlje z drugimi zdravili proti sladkorni bolezni, glejte navodilo za uporabo.
English: A lower dose of the sulphonylurea may also be considered to reduce the risk of hypoglycaemia (low blood glucose levels).
Slovenian: Morda bo treba znižati odmerek sulfonilsečnine, da se zmanjša tveganje za pojav hipoglikemije (nizkih ravni krvnega sladkorja).