FrancophonIA/ELRC3.0 huggingface dataset:
English: • Common (may affect 1 to 10 users in 100): infection of the upper chest or lungs, infection of the urinary tract, inflamed stomach or gut usually caused by an infection (gastroenteritis), infection of the sinuses with a feeling of pain and fullness behind your cheeks and eyes (sinusitis), inflamed nose or throat (nasopharyngitis) (signs of this may include a cold or a sore throat), headache, muscle pain (myalgia), vomiting, inflammation of the stomach (gastritis), stomach ache and indigestion (dyspepsia).
Slovenian: • Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov): okužba zgornjega dela prsnega koša ali pljuč, okužba sečil, vnetje želodca ali črevesa, ki je po navadi posledica okužbe (gastroenteritis), okužba sinusov z bolečinami in občutkom polnosti v licih in za očmi (sinuzitis), vnetje nosu ali žrela (nazofaringitis), med njegovimi znaki so lahko nahod ali vnetje žrela, glavobol, bolečine v mišicah (mialgija), bruhanje, vnetje želodca (gastritis), bolečine v trebuhu in motnje prebavne funkcije (dispepsija).
English: The incidence of hypersensitivity reactions was 1.1% in both Onglyza-treated patients and placebotreated patients.
Slovenian: Incidenca preobčutljivostnih reakcij je bila 1,1 % tako pri bolnikih, ki so prejemali zdravilo Onglyza, kot pri tistih, ki so prejemali placebo.
English: • Common: infection of the upper chest or lungs, infection of the urinary tract, inflamed stomach or gut usually caused by an infection (gastroenteritis), infection of the sinuses with a feeling of pain and fullness behind your cheeks and eyes (sinusitis), headache, vomiting, stomach ache and swelling of the hands, ankles or feet (peripheral oedema).
Slovenian: • Pogosti: okužba zgornjega dela prsnega koša ali pljuč, okužba sečil, vnetje želodca ali črevesa, ki je po navadi posledica okužbe (gastroenteritis), okužba sinusov z bolečinami in občutkom polnosti v licih in za očmi (sinuzitis), glavobol, bruhanje, bolečine v trebuhu in oteklost dlani, gležnjev ali stopal (periferni edemi).
English: Onglyza 2.5 mg film-coated tablets Each tablet contains 2.5 mg saxagliptin (as hydrochloride).
Slovenian: Onglyza 2,5 mg filmsko obložene tablete Ena tableta vsebuje 2,5 mg saksagliptina (v obliki klorida).
English: Saxagliptin add-on combination therapy with metformin and sulphonylurea A total of 257 patients with type 2 diabetes participated in a 24-week randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of saxagliptin (5 mg once daily) in combination with metformin plus sulphonylurea (SU) in patients with inadequate glycemic control (HbA1c ≥ 7% and ≤ 10%).
Slovenian: Dodatek saksagliptina kombiniranemu zdravljenju z metforminom in sulfonilsečnino Skupno 257 bolnikov s sladkorno boleznijo tipa 2 je sodelovalo v 24-tedenski randomizirani, dvojno slepi, s placebom kontrolirani študiji za oceno učinkovitosti in varnosti saksagliptina (5 mg enkrat na dan) v kombinaciji z metforminom in sulfonilsečnino (SU - sulphonylurea) pri bolnikih z nezadostno urejeno glikemijo (HbA1c ≥ 7 % in ≤ 10 %).
English: The incidence of adjudicated pancreatitis events was 0.3% in both Onglyza-treated patients and placebo-treated patients in the intent-to-treat population.
Slovenian: Incidenca presojenih pankreatitičnih dogodkov je bila v populaciji z namenom zdravljenja 0,3 % tako med bolniki, ki so prejemali zdravilo Onglyza, kot med tistimi, ki so prejemali placebo.
English: MONOTHERAPY STUDIES
Slovenian: PRESKUŠANJA MONOTERAPIJE
English: Across clinical studies, the incidence of laboratory adverse events was similar in patients treated with saxagliptin 5 mg compared to patients treated with placebo.
Slovenian: Incidenca laboratorijskih neželenih učinkov je bila v kliničnih študijah med uporabo 5 mg saksagliptina in med uporabo placeba podobna.
English: Mean HbA1c change is the difference between the saxagliptin+dapagliflozin+metformin and dapagliflozin+metformin groups (p< 0.0001).
Slovenian: povprečna sprememba HbA1c je razlika med skupinama saksagliptin+metformin in samim metforminom (p < 0,0001) povprečna sprememba HbA1c je razlika med skupinama saksagliptin+metformin in samim metforminom povprečna sprememba HbA1c je razlika med skupinama saksagliptin+dapagliflozin+metformin in dapagliflozin+metformin (p < 0,0001)
English: In patients with GFR < 45 mL/min, the recommended dose is 2.5 mg once daily.
Slovenian: Bolnikom z zmerno okvaro ledvic, ki imajo GFR < 45 ml/min, in bolnikom s hudo okvaro ledvic je treba odmerek zmanjšati na 2,5 mg enkrat na dan.
English: Onglyza 2.5 mg film-coated tablets Onglyza 5 mg film-coated tablets
Slovenian: Onglyza 2,5 mg filmsko obložene tablete Onglyza 5 mg filmsko obložene tablete
English: Each film-coated tablet contains 2.5 mg saxagliptin (as hydrochloride).
Slovenian: Ena filmsko obložena tableta vsebuje 2,5 mg saksagliptina (v obliki klorida).
English: Saxagliptin add-on to dapagliflozin plus metformin therapy A 24-week randomised, double-blind, placebo-controlled study conducted in patients with type 2 diabetes mellitus compared saxagliptin 5 mg with placebo as add-on therapy in individuals with HbA1c 7-10.5% treated with dapagliflozin (a SGLT2-inhibtor) and metformin.
Slovenian: Dodatek saksagliptina zdravljenju s kombinacijo dapagliflozin + metformin 24-tedenska randomizirana, dvojno slepa, s placebom kontrolirana študija pri bolnikih s sladkorno boleznijo tipa 2 je primerjala 5 mg saksagliptina in placebo kot dodatek zdravljenju pri bolnikih, ki so imeli med zdravljenjem z dapagliflozinom (zaviralec SGLT2) in metforminom HbA1c od 7 do 10,5 %.
English: Saxagliptin (n=186) provided significant improvements in HbA1c, FPG, and PPG compared to placebo (n=175).
Slovenian: Saksagliptin (n = 186) je izboljšal HbA1c, glukozo v plazmi na tešče in postprandialno glukozo bistveno bolj kot placebo (n = 175).
English: From a baseline mean absolute lymphocyte count of approximately 2,200 cells/μl, a mean decrease of approximately 100 cells/μl relative to placebo was observed in the placebo-controlled-pooled analysis.
Slovenian: V kumulativni analizi petih s placebom kontroliranih kliničnih študij je bilo povprečno izhodiščno število limfocitov približno 2.200 celic/μl in se je v primerjavi s placebom v povprečju zmanjšalo za približno 100 celic/μl.
English: Saxagliptin (n=183) provided significant improvements in HbA1c, FPG, and PPG compared to placebo (n=180).
Slovenian: Saksagliptin (n = 183) je izboljšal HbA1c, glukozo v plazmi na tešče in postprandialno glukozo bistveno bolj kot placebo (n = 180).
English: Each film-coated tablet contains 5 mg saxagliptin (as hydrochloride).
Slovenian: Ena filmsko obložena tableta vsebuje 5 mg saksagliptina (v obliki klorida).
English: Symptoms can include, but are not limited to, increasing shortness of breath, rapid increase in weight and swelling of the feet (pedal oedema);
Slovenian: Med simptomi so lahko kratka sapa, hiter porast telesne mase in oteklost stopal, lahko pa se pojavijo še drugi simptomi,
English: The HbA1c change for saxagliptin 5 mg (n=82) compared to TZD plus placebo (n=53) was -0.9% at Week 76.
Slovenian: Sprememba HbA1c s 5 mg saksagliptina (n = 82) je bila 76. teden v primerjavi s TZD v kombinaciji s placebom (n = 53) -0,9 %.
English: Saxagliptin in combination with metformin as initial therapy A 24-week study was conducted to evaluate the efficacy and safety of saxagliptin 5 mg in combination with metformin as initial combination therapy in treatment-naïve patients with inadequate glycaemic control (HbA1c 8-12%).
Slovenian: Saksagliptin v kombinaciji z metforminom kot uvodno zdravljenje Narejena je bila 24-tedenska študija za oceno učinkovitosti in varnosti 5 mg saksagliptina v kombinaciji z metforminom kot uvodnega kombiniranega zdravljenja pri bolnikih, ki še niso bili zdravljeni in niso imeli ustrezno urejene glikemije (HbA1c od 8 % do 12 %).
English: Nausea†
Slovenian: Okvara jeter
English: How to store Onglyza
Slovenian: Shranjevanje zdravila Onglyza
English: Onglyza 5 mg tablets saxagliptin
Slovenian: Onglyza 5 mg tablete saksagliptin
English: Saxagliptin produced gastrointestinal toxicity in dogs, including bloody/mucoid faeces and enteropathy at higher doses with a NOEL 4 and 2 times the human exposure for saxagliptin and the major metabolite, respectively, at RHD.
Slovenian: Saksagliptin je povzročil gastrointestinalne toksične učinke pri psih, vključno s krvavim ali mukoidnim blatom, in enteropatijo pri večjih odmerkih.
English: • Study CV181038 (n=69)
Slovenian: • preskušanje CV181011 (n = 103) • preskušanje CV181038 (n = 69)
English: This may be used to treat fungal infections.
Slovenian: • ketokonazol; uporablja se lahko za zdravljenje glivičnih okužb.
English: Talk to your doctor if you want to breast-feed while taking this medicine.
Slovenian: Če želite med jemanjem tega zdravila dojiti, se morate posvetovati z zdravnikom.
English: Onglyza 5 mg film-coated tablets
Slovenian: Onglyza 5 mg filmsko obložene tablete
English: The HbA1c change for saxagliptin 5 mg (n=56) compared to uptitrated glibenclamide plus placebo (n=27) was -0.7% at Week 76.
Slovenian: Sprememba HbA1c v skupini s 5 mg saksagliptina (n = 56) je bila 76. teden v primerjavi s povečanim odmerkom glibenklamida v kombinaciji s placebom (n = 27) -0,7 %.
English: In a pooled analysis of 1,681 patients with type 2 diabetes including 882 patients treated with Onglyza 5 mg, randomised in five double-blind, placebo-controlled clinical safety and efficacy studies conducted to evaluate the effects of saxagliptin on glycaemic control, the overall incidence of adverse events in patients treated with saxagliptin 5 mg was similar to placebo.
Slovenian: Kumulativna analiza petih dvojno slepih, s placebom kontroliranih kliničnih študij varnosti in učinkovitosti, narejenih za ovrednotenje vpliva saksagliptina na urejenost glikemije, je zajela 1.681 bolnikov s sladkorno boleznijo tipa 2, vključno z 882 bolniki, ki so prejemali 5 mg zdravila Onglyza.
English: Pack sizes of 14, 28, 56 and 98 film-coated tablets in non-perforated blisters.
Slovenian: Velikosti pakiranj: 14, 28, 56 in 98 filmsko obloženih tablet v neperforiranih pretisnih omotih.
English: These may be used to control fits (seizures) or chronic pain.
Slovenian: (konvulzij) ali kroničnih bolečin.
English: Some patients have had the following side effects while taking Onglyza and metformin and a sulphonylurea:
Slovenian: Nekateri bolniki so imeli med jemanjem zdravila Onglyza, metformina in sulfonilsečnine naslednje neželene učinke:
English: There was also no apparent change in body weight associated with saxagliptin.
Slovenian: Uporabe saksagliptina tudi ni spremljala opazna sprememba telesne mase.
English: BLISTERS (PERFORATED/NON-PERFORATED) for Onglyza 5 mg tablets
Slovenian: PRETISNI OMOTI (PERFORIRANI/NEPERFORIRANI) Onglyza 5 mg tablete
English: BLISTERS (PERFORATED/NON-PERFORATED) for Onglyza 2.5 mg tablets
Slovenian: PRETISNI OMOTI (PERFORIRANI/NEPERFORIRANI) Onglyza 2,5 mg tablete
English: Onglyza 2.5 mg film-coated tablets
Slovenian: Onglyza 2,5 mg filmsko obložene tablete
English: Some patients have had the following side effects while taking Onglyza and metformin:
Slovenian: Nekateri bolniki so imeli med jemanjem zdravila Onglyza in metformina naslednje neželene učinke:
English: Pack sizes of 14, 28, and 98 film-coated tablets in non-perforated calendar blisters.
Slovenian: Velikosti pakiranj: 14, 28 in 98 filmsko obloženih tablet v neperforiranih koledarskih pretisnih omotih.
English: Only in the initial combination therapy.
Slovenian: PRESKUŠANJA Z DODATKOM V KOMBINIRANEM ZDRAVLJENJU
English: Dyslipidaemia
Slovenian: Odmerjanje
English: If you have reduced kidney function, your doctor may prescribe a lower dose.
Slovenian: Če imate zmanjšano delovanje ledvic, vam bo lahko zdravnik predpisal nižji odmerek, eno 2,5 mg tableto enkrat na dan.
English: Pack sizes of 14, 28, 56 and 98 film-coated tablets in non-perforated calendar blisters.
Slovenian: Velikosti pakiranj: 14, 28, 56 in 98 filmsko obloženih tablet v neperforiranih koledarskih pretisnih omotih.
English: In studies conducted in healthy subjects, neither the pharmacokinetics of saxagliptin nor its major metabolite, were meaningfully altered by metformin, glibenclamide, pioglitazone, digoxin, simvastatin, omeprazole, antacids or famotidine.
Slovenian: Metformin, glibenklamid, pioglitazon, digoksin, simvastatin, omeprazol, antacidi in famotidin v študijah zdravih prostovoljcev niso bistveno spremenili farmakokinetike saksagliptina niti njegovega glavnega presnovka.
English: Hepatic impairment
Slovenian: Bolezni živčevja omotica glavobol
English: printed on one side and “4214” printed on the other side, in blue ink.
Slovenian: Z modrim barvilom imajo na eni strani natisnjeno “2,5” in na drugi strani “4214”.
English: Two double-blind, placebo-controlled studies of 24-week duration were conducted to evaluate the efficacy and safety of saxagliptin monotherapy in patients with type 2 diabetes.
Slovenian: Za oceno učinkovitosti in varnosti monoterapije s saksagliptinom sta bili pri bolnikih s sladkorno boleznijo tipa 2 narejeni dve dvojno slepi, s placebom kontrolirani 24-tedenski študiji.
English: Improvements in HbA1c, PPG and FPG following initial therapy with saxagliptin 5 mg plus metformin were sustained up to Week 76.
Slovenian: Izboljšanja HbA1c, postprandialne glukoze in glukoze v plazmi na tešče so se po uvodnem zdravljenju s 5 mg saksagliptina v kombinaciji z metforminom ohranila do 76. tedna.
English: Onglyza 2.5 mg tablets saxagliptin
Slovenian: Onglyza 2,5 mg tablete saksagliptin
English: Some patients have had the following side effects while taking Onglyza and a thiazolidinedione:
Slovenian: Nekateri bolniki so imeli med jemanjem zdravila Onglyza in tiazolidindionov naslednje neželene učinke:
English: OUTER CARTON Onglyza 5 mg film-coated tablets
Slovenian: ZUNANJA ŠKATLA Onglyza 5 mg filmsko obložene tablete
English: CALENDAR BLISTERS (NON-PERFORATED) for Onglyza 5 mg tablets
Slovenian: KOLEDARSKI PRETISNI OMOTI (NEPERFORIRANI) Onglyza 5 mg tablete
English: The HbA1c change for saxagliptin 5 mg plus metformin (n=177) compared to metformin plus placebo (n=147) was -0.5% at Week 76.
Slovenian: Sprememba HbA1c je bila 76. teden v skupini s 5 mg saksagliptina v kombinaciji z metforminom (n = 177) -0,5 % v primerjavi s skupino s placebom v kombinaciji z metforminom (n = 147).
English: OUTER CARTON Onglyza 2.5 mg film-coated tablets
Slovenian: ZUNANJA ŠKATLA Onglyza 2,5 mg filmsko obložene tablete
English: Metabolism and nutrition disorders Hypoglycaemia
Slovenian: Prehranske in presnovne motnje hipoglikemija zelo pogosti dislipidemija občasni hipertrigliceridemija občasni
English: Rash has been seen with Onglyza (see section 4) and with certain anti-diabetic medicines in the same class as Onglyza.
Slovenian: Med uporabo zdravila Onglyza in nekaterih zdravil proti sladkorni bolezni, ki spadajo v isto skupino kot zdravilo Onglyza, so opažali izpuščaj (glejte poglavje 4).
English: CALENDAR BLISTERS (NON-PERFORATED) for Onglyza 2.5 mg tablets
Slovenian: KOLEDARSKI PRETISNI OMOTI (NEPERFORIRANI) Onglyza 2,5 mg tablete
English: An add-on to metformin placebo-controlled study of 24-week duration was conducted to evaluate the efficacy and safety of saxagliptin in combination with metformin in patients with inadequate glycaemic control (HbA1c 7-10%) on metformin alone.
Slovenian: Saksagliptin kot dodatek zdravljenju z metforminom Narejena je bila 24-tedenska s placebom kontrolirana študija za oceno učinkovitosti in varnosti saksagliptina v kombinaciji z metforminom pri bolnikih, ki med monoterapijo z metforminom glikemije niso imeli ustrezno urejene (HbA1c od 7 % do 10 %).
English: You should stop taking Onglyza and contact a doctor immediately if you notice any of the following serious side effects:
Slovenian: Če opazite katerega od naslednjih resnih neželenih učinkov, morate nehati jemati zdravilo Onglyza in se nemudoma posvetovati z zdravnikom:
English: Some patients have had the following side effects while taking Onglyza and a sulphonylurea:
Slovenian: Nekateri bolniki so imeli med jemanjem zdravila Onglyza in sulfonilsečnine naslednje neželene učinke:
English: Talk to your doctor before you take Onglyza if you are pregnant or plan to become pregnant.
Slovenian: Če ste noseči ali nameravate zanositi, se posvetujte z zdravnikom, preden vzamete zdravilo Onglyza.
English: Immune related findings of minimal, nonprogressive, lymphoid hyperplasia in spleen, lymph nodes and bone marrow with no adverse sequelae have been reported in all species tested at exposures starting from 7 times the RHD.
Slovenian: Pri vseh testiranih živalskih vrstah so ob izpostavljenosti, ki je bila vsaj 7-krat tolikšna kot izpostavljenost pri RHD, opazili imunske spremembe: minimalno, neprogresivno limfoidno hiperplazijo v vranici, bezgavkah in kostnem mozgu, brez neželenih posledic.
English: The HbA1c change for saxagliptin 5 mg plus metformin (n=31) compared to placebo plus metformin (n=15) was -0.8% at Week 102.
Slovenian: Sprememba HbA1c je bila po 102 tednih v skupini s 5 mg saksagliptina in metforminom (n = 31) -0,8 % v primerjavi s skupino s placebom in metforminom (n = 15).
English: Improvements in HbA1c and PPG following treatment with saxagliptin 5 mg were sustained up to Week 76.
Slovenian: Izboljšanji HbA1c in postprandialne glukoze sta se ohranili do 76. tedna po zdravljenju s 5 mg saksagliptina.
English: There were 4,148 patients with type 2 diabetes, including 3,021 patients treated with Onglyza, randomised in six double-blind, controlled clinical safety and efficacy studies conducted to evaluate the effects of saxagliptin on glycaemic control.
Slovenian: V šestih dvojno slepih kontroliranih kliničnih študijah varnosti in učinkovitosti, narejenih za ovrednotenje učinkov saksagliptina na urejenost glikemije, je bilo randomiziranih 4.148 bolnikov s sladkorno boleznijo tipa 2, vključno s 3.021 bolniki, ki so dobivali zdravilo Onglyza.
English: An add-on placebo-controlled study of 24-week duration was conducted to evaluate the efficacy and safety of saxagliptin in combination with glibenclamide in patients with inadequate glycaemic control at enrollment (HbA1c 7.5-10%) on a sub-maximal dose of glibenclamide alone.
Slovenian: Saksagliptin kot dodatek zdravljenju z glibenklamidom Narejena je bila 24-tedenska s placebom kontrolirana študija za oceno učinkovitosti in varnosti saksagliptina v kombinaciji z glibenklamidom pri bolnikih, ki ob vključitvi z uporabo submaksimalnega odmerka samega glibenklamida niso imeli ustrezno urejene glikemije (HbA1c od 7,5 % do 10 %).
English: A total of 4,148 patients with type 2 diabetes, including 3,021 patients treated with, saxagliptin were randomised in 6 double-blind, controlled clinical safety and efficacy studies conducted to evaluate the effects of saxagliptin on glycaemic control.
Slovenian: V 6 dvojno slepih kontroliranih kliničnih študijah varnosti in učinkovitosti, narejenih za ovrednotenje učinkov saksagliptina na urejenost glikemije, je bilo v celoti randomiziranih 4.148 bolnikov s sladkorno boleznijo tipa 2, vključno s 3.021 bolniki, ki so dobivali saksagliptin.
English: Onglyza 5 mg film-coated tablets saxagliptin
Slovenian: Onglyza 5 mg filmsko obložene tablete saksagliptin
English: A placebo-controlled study of 24-week duration was conducted to evaluate the efficacy and safety of saxagliptin in combination with a thiazolidinedione (TZD) in patients with inadequate glycaemic control (HbA1c 7-10.5%) on TZD alone.
Slovenian: Saksagliptin kot dodatek zdravljenju s tiazolidindionom Narejena je bila 24-tedenska s placebom kontrolirana študija za oceno učinkovitosti in varnosti saksagliptina v kombinaciji s tiazolidindionom pri bolnikih, ki med monoterapijo s tiazolidindionom niso imeli ustrezno urejene glikemije (HbA1c od 7 % do 10,5 %).
English: Glycaemic control
Slovenian: Urejenost glikemije
English: Improvements in HbA1c, PPG and FPG following treatment with saxagliptin 5 mg were sustained up to Week 76.
Slovenian: Izboljšanja HbA1c, postprandialne glukoze in glukoze v plazmi na tešče so se ohranila do 76. tedna po zdravljenju s 5 mg saksagliptina.
English: Onglyza 2.5 mg film-coated tablets Saxagliptin
Slovenian: Onglyza 2,5 mg filmsko obložene tablete saksagliptin
English: Reproductive system and breast disorders
Slovenian: Motnje reprodukcije in dojk erektilna disfunkcija občasni
English: • Common: infection of the upper chest or lungs, infection of the urinary tract, inflamed stomach or gut usually caused by an infection (gastroenteritis), infection of the sinuses with a feeling of pain and fullness behind your cheeks and eyes (sinusitis), headache, stomach ache and vomiting.
Slovenian: ki je po navadi posledica okužbe (gastroenteritis), okužba sinusov z bolečinami in občutkom polnosti v licih in za očmi (sinuzitis), glavobol, bolečine v trebuhu in bruhanje.
English: Immune system disorders Hypersensitivity reactions
Slovenian: Organski sistemi Neželeni učinki
English: 2 from baseline HbA1c (%) at Week 24
Slovenian: Povprečna sprememba HbA1c od izhodišča (%) 24. teden
English: This is one 2.5 mg tablet once a day.
Slovenian: Po enem 50 mg odmerku
English: Radiographic changes were assessed in IMPACT 2.
Slovenian: Spremembe na rentgenskih slikah so ocenjevali v študiji IMPACT 2.
English: • Blood test result showing ‘antibodies' against your own body.
Slovenian: • rezultati krvnih preiskav, ki kažejo "protitelesa" proti lastnemu telesu.
English: The potential contribution of exposure to inflixumab and/or the severity of the underlying disease in these outcomes remains unclear.
Slovenian: Morebitni prispevek izpostavljenosti infliksimabu in/ali resnost obstoječe bolezni pri teh izidih ostajata nejasna.
English: • Medicines that affect your immune system.
Slovenian: • Zdravila, ki vplivajo na vaš imunski sistem.
English: • Depression, problems sleeping
Slovenian: • depresija, težave s spanjem,
English: Periodic skin examination is recommended, particularly for patients with risk factors for skin cancer.
Slovenian: Priporočljivo je redno pregledovanje kože, predvsem za tiste bolnike z dejavniki tveganja za kožnega raka.
English: • Eye problems, including red eyes and infections
Slovenian: • težave z očmi, vključno z rdečimi očmi in okužbami,
English: List of allergies:
Slovenian: Seznam alergij:
English: It is important that you and your doctor record the brand name and batch number of your medicine.
Slovenian: Pomembno je, da si vi in vaš zdravnik zabeležita ime in številko serije vašega zdravila.
English: Date of first authorisation: 26/05/2016
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 26/05/2016
English: • If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Slovenian: • Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
English: • It is recommended that when Flixabi is prepared for infusion, it is used as soon as possible (within 3 hours).
Slovenian: • Priporočljivo je, da se pripravljeno raztopino za infuzijo zdravila Flixabi, uporabi čim prej (v 3 urah).
English: • You are allergic to infliximab or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na infliksimab ali katero koli sestavino tega zdravila (navedeno v poglavju 6),
English: • Reduce the signs and symptoms of your disease,
Slovenian: • zmanjšanje znakov in simptomov vaše bolezni,
English: Clinical Response a
Slovenian: Klinični odziv a
English: • Lack of interest or emotion
Slovenian: • pomanjkanje interesa ali čustev,
English: EU/1/16/1106/001 1 vial EU/1/16/1106/002 2 vials EU/1/16/1106/003 3 vials EU/1/16/1106/004 4 vials EU/1/16/1106/005 5 vials
Slovenian: EU/1/16/1106/001 1 viala EU/1/16/1106/002 2 viali EU/1/16/1106/003 3 viale EU/1/16/1106/004 4 viale EU/1/16/1106/005 5 vial
English: The efficacy of infliximab through week 54 was assessed in the ACT 1 study.
Slovenian: Učinkovitost infliksimaba do 54. tedna so ocenjevali v preskušanju ACT 1.
English: Write the new expiry date on the carton including day/month/year.
Slovenian: Na škatlo napišite novi datum izteka roka uporabnosti, ki naj vključuje dan/mesec/leto.