FrancophonIA/ELRC3.0 huggingface dataset:
English: Signs include a fever, feeling tired, (persistent) cough, shortness of breath, weight loss, night sweats, diarrhea, wounds, dental problems, burning when urinating or ‘flulike' signs.
Croatian: Ti znakovi uključuju vrućicu, umor, (ustrajan) kašalj, nedostatak zraka, gubitak tjelesne težine, noćno znojenje, proljev, rane, probleme sa zubima, žarenje pri mokrenju ili simptome nalik gripi.
English: Post-marketing cases of hepatosplenic T-cell lymphoma have been reported in patients treated with TNFblocking agents including infliximab.
Croatian: Nakon stavljanja lijeka u promet prijavljeni su slučajevi hepatospleničkog limfoma T-stanica u bolesnika liječenih blokatorima TNF-a uključujući infliksimab.
English: How Flixabi is given
Croatian: Kako se primjenjuje Flixabi
English: a a p < 0.001, for each infliximab treatment group vs. placebo
Croatian: d a p < 0,001 za svaku skupinu liječenu infliksimabom u odnosu na kontrolnu skupinu.
English: Tuberculosis, bacterial infections, including sepsis and pneumonia, invasive fungal, viral, and other opportunistic infections have been observed in patients receiving infliximab.
Croatian: U bolesnika koji su primali infliksimab opažene su tuberkuloza, bakterijske infekcije uključujući sepsu i pneumoniju, invazivne gljivične, virusne i druge oportunističke infekcije.
English: Vertigo, dizziness, hypoaesthesia, paraesthesia.
Croatian: vrtoglavica, omaglica, hipoestezija, parestezija
English: Flixabi 100 mg powder for concentrate infliximab
Croatian: Flixabi 100 mg prašak za koncentrat infliksimab
English: c HAQ = Health Assessment Questionnaire; greater values indicate less disability.
Croatian: c HAQ = upitnik za procjenu zdravlja (engl.
English: Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF blocker therapy, including infliximab (see section 4.8).
Croatian: U bolesnika liječenih blokatorima TNF-a, uključujući infliksimab, prijavljeni su melanom i karcinom Merkelovih stanica (vidjeti dio 4.8).
English: Discontinuation of Flixabi should be considered if these disorders develop.
Croatian: Ako se razviju ovakvi poremećaji, treba razmotriti prekid primjene lijeka Flixabi.
English: Induction treatment in moderately to severely active Crohn's disease The efficacy of a single dose treatment with infliximab was assessed in 108 patients with active Crohn's disease (Crohn's Disease Activity Index (CDAI) ≥ 220 ≤ 400) in a randomised, double-blinded, placebocontrolled, dose-response study.
Croatian: Djelotvornost liječenja jednokratnom dozom infliksimaba ispitana je u 108 bolesnika s aktivnom Crohnovom bolešću (indeks aktivnosti Crohnove bolesti, engl.
English: Monobasic sodium phosphate monohydrate Dibasic sodium phosphate heptahydrate
Croatian: 6.1 Popis pomoćnih tvari saharoza polisorbat 80 natrijev dihidrogenfosfat hidrat natrijev hidrogenfosfat heptahidrat
English: It is also recommended that live vaccines not be given to infants after in utero exposure to infliximab for at least 6 months following birth (see section 4.4).
Croatian: Ne preporučuje se istodobna primjena živih cjepiva s lijekom Flixabi.Također se ne preporučuje davati živa cjepiva dojenčadi koja su in utero bila izložena infliksimabu, najmanje 6 mjeseci nakon rođenja (vidjeti dio 4.4).
English: If a patient does not respond by 6 weeks (i.e. after 2 doses), no additional treatment with Flixabi should be given.
Croatian: Ako bolesnik ne odgovori na terapiju nakon 6 tjedana (tj. nakon 2 doze), ne bi trebalo nastaviti liječenje lijekom Flixabi.
English: Tell your doctor straight away if you get new or worsening signs of heart failure during treatment with Flixabi.
Croatian: Odmah obavijestite svog liječnika ako dobijete nove simptome zatajenja srca ili se postojeći simptomi pogoršaju tijekom liječenja lijekom Flixabi.
English: One vial contains 100 mg of infliximab*.
Croatian: Jedna bočica sadrži 100 mg infliksimaba*.
English: • You may get infections more easily when you are being treated with Flixabi.
Croatian: • Tijekom liječenja lijekom Flixabi možete postati osjetljiviji na infekcije.
English: Transient visual loss occurring during or within 2 hours of infusion.
Croatian: prolazan gubitak vida koji se javlja tijekom ili do 2 sata nakon infuzije
English: Adult psoriasis
Croatian: Plak psorijaza
English: Vaccine breakthrough infection (after in utero exposure to infliximab) Neoplasms benign, malignant and unspecified (including cysts and polyps) Rare:
Croatian: Dobroćudne, zloćudne i nespecificirane novotvorine (uključujući ciste i polipe) Rijetko:
English: AZA Monotherapy
Croatian: Monoterapija AZA
English: If a patient does not respond after 2 doses, no additional treatment with Flixabi should be given.
Croatian: Ako bolesnik ne odgovori na terapiju nakon 2 doze, ne bi trebalo nastaviti daljnje liječenje lijekom Flixabi.
English: • A rare blood cancer affecting mostly teenage boys or young men (hepatosplenic T-cell lymphoma)
Croatian: • rijedak rak krvnih stanica koji se najčešće javlja u dječaka tinejdžerske dobi ili mlađih muškaraca
English: st dose rd dose
Croatian: Ukupan broj bodova d
English: A risk for the development of malignancies in children and adolescents treated with TNF-blockers cannot be excluded.
Croatian: U djece i adolescenata koji se liječe blokatorima TNF-a ne može se isključiti rizik od razvoja zloćudnih bolesti.
English: In the post-marketing setting, cases of leukaemia have been reported in patients treated with a TNF-antagonist.
Croatian: U razdoblju nakon stavljanja lijeka u promet u bolesnika liječenih antagonistom TNF-a prijavljeni su slučajevi leukemije.
English: Conjunctivitis.
Croatian: konjunktivitis
English: • Severely decreased numbers of white blood cells have been reported in infants born to women treated with Flixabi during pregnancy.
Croatian: • U dojenčadi čije su majke tijekom trudnoće liječene lijekom Flixabi prijavljeno je značajno smanjenje bijelih krvnih stanica.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodiumfree'.However, before Flixabi is given to you, it is mixed with a solution that contains sodium.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po dozi, tj. zanemarive količine natrija.
English: How much Flixabi is given
Croatian: Koliko lijeka Flixabi ćete primiti
English: Tell your doctor straight away if you get symptoms of low blood counts during treatment with Flixabi.
Croatian: Odmah obavijestite svog liječnika ako dobijete simptome smanjenog broja krvnih stanica za vrijeme liječenja lijekom Flixabi.
English: Adult Crohn's disease Flixabi is indicated for:  treatment of moderately to severely active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
Croatian: • liječenje umjerenog do teškog oblika aktivne Crohnove bolesti u odraslih bolesnika koji nisu odgovorili na punu i odgovarajuću terapiju nekim kortikosteroidom i/ili imunosupresivom, odnosno u onih koji ne podnose ili imaju medicinske kontraindikacije za takve terapije
English: Each Flixabi vial contains 100 mg infliximab.
Croatian: Jedna bočica lijeka Flixabi sadrži 100 mg infliksimaba.
English: Dizziness may occur following administration of Flixabi (see section 4.8).
Croatian: Nakon primjene lijeka Flixabi može nastupiti omaglica (vidjeti dio 4.8).
English: After reconstitution, each ml contains 10 mg of infliximab.
Croatian: Nakon rekonstitucije, jedan ml sadrži 10 mg infliksimaba.
English: • Children should receive recommended vaccinations before starting Flixabi treatment.
Croatian: • prije započinjanja liječenja lijekom Flixabi djeca trebaju primiti preporučena cjepiva.
English: • You have heart failure that is moderate or severe.
Croatian: • ako imate umjeren ili težak stupanj zatajenja srca.
English: If a patient does not respond after 3 doses, no additional treatment with Flixabi should be given.
Croatian: Ako bolesnik ne odgovori na terapiju nakon 3 doze, ne bi trebalo nastaviti liječenje lijekom Flixabi.
English: Cases of jaundice and non-infectious hepatitis, some with features of autoimmune hepatitis, have been observed in the post-marketing experience of infliximab.
Croatian: Nakon stavljanja infliksimaba u promet, primijećeni su slučajevi žutice i neinfektivnog hepatitisa, koji je ponekad imao značajke autoimunog hepatitisa.
English: In patients treated with Flixabi, an invasive fungal infection such as aspergillosis, candidiasis, pneumocystosis, histoplasmosis, coccidioidomycosis or blastomycosis should be suspected if they develop a serious systemic illness, and a physician with expertise in the diagnosis and treatment of invasive fungal infections should be consulted at an early stage when investigating these patients.
Croatian: U bolesnika liječenih lijekom Flixabi u kojih se razvije ozbiljna sistemska bolest treba posumnjati na neku invazivnu gljivičnu infekciju poput aspergiloze, kandidijaze, pneumocistoze, histoplazmoze, kokcidioidomikoze ili blastomikoze.
English: Neutropenia, leucopenia, anaemia, lymphadenopathy.
Croatian: neutropenija, leukopenija, anemija, limfadenopatija
English: Infliximab does not cross react with TNFα from species other than human and chimpanzees.
Croatian: Infliksimab pokazuje križnu reakciju samo s TNFα ljudi i čimpanza, ali ne i drugih vrsta, stoga su konvencionalni neklinički podaci o sigurnosti primjene lijeka ograničeni.
English: Caution should be exercised in considering treatment of patients with increased risk for malignancy due to heavy smoking.
Croatian: U bolesnika koji imaju povećan rizik za razvoj zloćudne bolesti jer su teški pušači mogućnost liječenja treba razmotriti uz oprez.
English: Patients with ACR20 response/ Patients evaluated (%) Total scored (van der Heijde-modified Sharp score) Change from baseline (Mean ± SD
Croatian: Bolesnici s odgovorom ACR20/ evaluirani bolesnici (%)
English: • Do not breast-feed when you are being treated with Flixabi or for 6 months after your last treatment with Flixabi.
Croatian: • Nemojte dojiti dok se liječite lijekom Flixabi niti 6 mjeseci nakon posljednje doze lijeka Flixabi.Ako ste primali Flixabi tijekom trudnoće, kod Vašeg djeteta može postojati povećan rizik od infekcije.
English: Combined
Croatian: Cijepljenje
English: A risk for the development of malignancies in patients treated with TNF-blockers cannot be excluded.
Croatian: U bolesnika koji se liječe blokatorima TNF-a ne može se isključiti rizik od razvoja zloćudnih bolesti.
English: Tell your doctor straight away if you get symptoms of liver problems during treatment with Flixabi.
Croatian: Odmah obavijestite svog liječnika ako dobijete simptome jetrenih tegoba za vrijeme liječenja lijekom Flixabi.
English: Sustained response (clinical response at both week
Croatian: Održani odgovor (klinički odgovor i u 8. i u 30. tjednu)
English: Instructions for use and handling - reconstitution, dilution and administration In order to improve the traceability of biological medicinal products, the tradename and batch number of the administered medicinal product should be clearly recorded.
Croatian: Upute za uporabu i rukovanje - rekonstitucija, razrjeđivanje i primjena otopine
English: In responding patients, the alternative strategies for continued treatment are:  Maintenance: Additional infusions of 5 mg/kg every 8 weeks or  Re-administration: Infusion of 5 mg/kg if signs and symptoms of the disease recur followed by infusions of 5 mg/kg every 8 weeks (see ‘Re-administration' below and section 4.4).
Croatian: nakon čega slijede infuzije u dozi od 5 mg/kg svakih 8 tjedana (vidjeti "Ponovna primjena" u daljnjem tekstu i dio 4.4).
English: • You should receive recommended vaccinations before starting Flixabi treatment.
Croatian: • Prije početka liječenja lijekom Flixabi trebate primiti sva preporučena cjepiva.
English: Complement factor abnormal.
Croatian: Neprirodni otvori na koži
English: Instructions for use and handling - storage conditions Store at 2°C - 8°C.
Croatian: Upute za uporabu i rukovanje - uvjeti čuvanja
English: Tell your doctor straight away if you get signs of infection during treatment with Flixabi.
Croatian: Odmah obavijestite svog liječnika ako tijekom liječenja lijekom Flixabi dobijete simptome infekcije.
English: Respiratory, thoracic and mediastinal disorders Very common:
Croatian: zatajenje cirkulacije, petehije, vazospazam Poremećaji dišnog sustava, prsišta i sredoprsja Vrlo često:
English: Live vaccines such as BCG should not be given to your baby within 6 months after birth.
Croatian: Vaše dijete ne smije primiti živo cjepivo poput BCG-a u razdoblju od 6 mjeseci nakon rođenja.Za dodatne informacije vidjeti dio o cijepljenju.
English: Chest pain, fatigue, fever, injection site reaction, chills, oedema.
Croatian: reakcije povezane s infuzijom, bol bol u prsištu, umor, vrućica, reakcije na mjestu injekcije, zimica,
English: For patients who have resided in or travelled to regions where invasive fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are endemic, the benefits and risks of Flixabi treatment should be carefully considered before initiation of Flixabi therapy.
Croatian: Prije uvođenja lijeka Flixabi treba pažljivo ocijeniti koristi i rizike liječenja ovim lijekom u bolesnika koji su boravili ili putovali u područja za koja su karakteristične endemske invazivne gljivične infekcije kao što su histoplazmoza, kokcidioidomikoza ili blastomikoza.
English: 10 mg/kg q 4 wks
Croatian: 10 mg/kg svaka 4 tjedna
English: Each vial contains 100 mg of infliximab.
Croatian: Jedna bočica sadrži 100 mg infliksimaba.
English: Reproductive system and breast disorders Uncommon:
Croatian: infekcija mokraćnih puteva pijelonefritis Poremećaji reproduktivnog sustava i dojki Manje često:
English: Autoantibody positive.
Croatian: pozitivan nalaz na autoprotutijela odstupanje od normalne vrijednosti faktora komplementa
English: Discontinuation of Flixabi therapy should be considered in patients with confirmed significant haematologic abnormalities.
Croatian: Prije početka terapije lijekom Flixabi, preporučuje se po mogućnosti cijepiti pedijatrijske bolesnike u skladu s važećim programom cijepljenja.
English: Tell your doctor straight away if you get signs of TB during treatment with Flixabi.
Croatian: Odmah obavijestite svog liječnika ako tijekom liječenja lijekom Flixabi dobijete simptome tuberkuloze.
English: Tell your doctor straight away if you get symptoms of a nerve disease during treatment with Flixabi.
Croatian: Odmah obavijestite svog liječnika ako tijekom liječenja lijekom Flixabi dobijete simptome neke bolesti živčanog sustava.
English: Flixabi should be administered  in combination with methotrexate  or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated.
Croatian: • ili kao jedinu terapiju u bolesnika koji ne podnose metotreksat ili je kod njih metotreksat kontraindiciran.
English: Date of first authorisation: 8 December 2016
Croatian: Datum prvog odobrenja: 8. prosinca 2016
English: - Risk Management Plan (RMP)
Croatian: - Plan upravljanja rizikom (RMP)
English: Get tested for HIV regularly.
Croatian: Redovito se testirajte na HIV.
English: Shelf life after first opening of the bottle: 1 month.
Croatian: Rok valjanosti nakon prvog otvaranja boce: 1 mjesec.
English: - Additional risk minimisation measures
Croatian: - Dodatne mjere minimizacije rizika
English: - Reminders on what the individual should know before and while taking
Croatian: - Podsjetnici o tome što osoba mora znati prije i za vrijeme uzimanja lijeka
English: Always take this medicine exactly as your doctor has told you.
Croatian: - Uvijek uzmite ovaj lijek točno onako kako Vam je rekao liječnik.
English: Any signs of inflammation or infection.
Croatian: - Bilo koji znak upale ili infekcije.
English: allergic reaction
Croatian: alergijska reakcija
English: Always take the dose recommended by your doctor.
Croatian: - Uvijek uzimajte onu dozu koju Vam je preporučio liječnik.
English: → Tell your doctor if you are taking any of these medicines.
Croatian: Obavijestite svog liječnika ako uzimate bilo koje od tih lijekova.
English: Patients were followed for a median of 71 weeks and 87 weeks, respectively.
Croatian: Bolesnici su bili praćeni tijekom medijana od 71 tjedna odnosno 87 tjedana.
English: Keep the bottle tightly closed in order to protect from moisture and light.
Croatian: Bocu čuvati čvrsto zatvorenu radi zaštite od svjetlosti i vlage.
English: Subjects were followed for 4,237 personyears.
Croatian: Ispitanici su bili praćeni tijekom 4237 osoba-godina.
English: → Tell your doctor immediately about new or unusual symptoms after you stop treatment, particularly symptoms you associate with hepatitis B infection
Croatian: Odmah obavijestite liječnika o novim ili neobičnim simptomima nakon što se prestanete liječiti, osobito o simptomima koje dovodite u vezu s infekcijom hepatitisom B.
English: OPA/Alu/PE+DES/ - Aluminium blisters.
Croatian: OPA/Al/PE+DES/ - Aluminijski blisteri.
English: - Reminders for evaluations/counselling at the initial visit and follow-up.
Croatian: - Podsjetnici za ocjenu/savjetovanje prilikom prvog posjeta i kontrolnih posjeta.
English: - Get tested for other sexually transmitted infections such as syphilis and gonorrhoea.
Croatian: - Testirajte se na druge spolno prenosive bolesti kao što su sifilis i gonoreja.
English: If you get a flu-like illness, it could mean you have recently been infected with HIV.
Croatian: Ako dobijete bolest nalik gripi, to može značiti da ste se nedavno zarazili HIV-om.
English: However, a benefit is expected for the adolescent population based on extrapolation of adult data and comparative pharmacokinetic data (see section 5.2).
Croatian: Međutim, korist za adolescentsku populaciju očekuje se na temelju ekstrapolacije podataka za odrasle i usporednih farmakokinetičkih podataka (vidjeti dio 5.2).
English: P-value a, b mITT Analysis
Croatian: P-vrijednost a, b
English: → If this applies to you, tell your doctor immediately.
Croatian: Ako se ovo odnosi na Vas, odmah o tome obavijestite liječnika.
English: This is to make sure that your medicine is fully effective, and to reduce the risk of developing resistance to the treatment.
Croatian: To je zato da budete sigurni da je lijek koji uzimate potpuno djelotvoran te da smanjite rizik od razvoja otpornosti na liječenje.
English: BLISTER (OPA/Alu/PE+DES-Alu FOIL)
Croatian: BLISTER (OPA/Al/PE+DES-Al FOLIJA)
English: Number with Tenofovir Detected/ Total Samples (%)
Croatian: Broj uzoraka s detektiranim tenofovirom/ukupni broj uzoraka (%)
English: Seroconversions / N
Croatian: Serokonverzije / N
English: However, as would be expected in this patient population, elevations in AST and ALT occurred more frequently than in the general HIV infected population.
Croatian: No, kao što se u toj populaciji bolesnika moglo očekivati, porast vrijednosti AST i ALT bio je češći nego u općoj populaciji zaraženoj HIV-om.
English: for bottle:
Croatian: za bocu:
English: → If you think you may have lactic acidosis, get medical help immediately.
Croatian: Ako mislite da možda imate laktacidozu, odmah potražite liječničku pomoć.
English: Many HIV tests can miss a recent infection.
Croatian: - Mnogi testovi na HIV možda neće otkriti nedavnu infekciju.
English: → If you notice these or any symptoms of inflammation or infection, get medical help immediately.
Croatian: Ako primijetite ove simptome ili bilo koji simptom upale ili infekcije, odmah potražite liječničku pomoć.
English: - Do not share or re-use needles or other injection or drug equipment.
Croatian: - Nemojte s drugima dijeliti ili koristiti već upotrijebljene igle ili drugi pribor za injekcije ili ubrizgavanje droge.
English: Thirteen percent of the emtricitabine dose was recovered in urine as three metabolites.
Croatian: Trinaest posto doze emtricitabina izolirano je u urinu kao tri metabolita.
English: - Do not share personal items that can have blood or body fluids on them, such as toothbrushes and razor blades.
Croatian: - Nemojte s drugima dijeliti osobne predmete na kojima može biti krvi ili tjelesnih tekućina, kao što su četkice za zube i britvice za brijanje.
English: Do not use this medicine after the expiry date which is stated on the packaging after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju iza oznake "EXP".
English: Store in the original blister in order to protect from moisture and light.
Croatian: Čuvati u originalnom blisteru radi zaštite od svjetlosti i vlage.
English: If you think you were infected with HIV, tell your doctor straight away.
Croatian: Ako mislite da ste bili zaraženi HIV-om, odmah obavijestite liječnika.
English: P-values by logrank test. P-values for URAI refer to the null hypothesis that efficacy differed between subgroup strata (URAI, no URAI).
Croatian: P-vrijednosti za URAI odnose se na nultu hipotezu da se djelotvornost razlikuje između podskupina (URAI, bez URAI).
English: Elderly: No dose adjustment is required (see section 5.2).
Croatian: Starije osobe: Nije potrebna prilagodbai doziranja (vidjeti dio 5.2).
English: rhabdomyolysis 1, muscular weakness
Croatian: rabdomioliza 1, mišićna slabost
English: Then mix the powder with about 100 mL (half a glass) of water, orange juice or grape juice, and drink immediately.
Croatian: Prašak onda pomiješajte s oko 100 ml (pola čaše) vode, soka od naranče ili soka od grožđa, pa odmah popijte.
English: Contains also lactose monohydrate.
Croatian: Sadrži također laktozu hidrat.
English: EXP for bottle
Croatian: EXP za bocu
English: Use for pre exposure prophylaxis in individuals with unknown or positive HIV 1 status.
Croatian: Primjena za predekspozicijsku profilaksu u osoba s nepoznatim ili pozitivnim HIV-1 statusom.
English: osteomalacia (manifested as bone pain and infrequently contributing to fractures)
Croatian: osteomalacija (koja se očituje bolovima u kostima i rijetko pridonosi prijelomima)
English: Adults: one tablet each day, whenever possible with food.
Croatian: - Odrasli: jedna tableta svaki dan, kad god je to moguće s hranom.
English: - No virus analysed contained the K65R or K70E mutation.
Croatian: Nijedan analizirani virus nije sadržavao mutaciju K65R ili K70E.
English: Not recommended because appropriate dose reductions cannot be achieved with the combination tablet.
Croatian: Primjena se ne preporučuje jer se kombiniranom tabletom ne mogu postići prikladna smanjenja doze.
English: Effects on drug levels Mean percent change in AUC, Cmax, Cmin with 90% confidence intervals if available (mechanism)
Croatian: Lijek prema terapijskim područjima Učinci na razinu lijekova Postotak prosječne promjene za AUC, Cmax, Cmin uz 90% intervale pouzdanosti ako su dostupni (mehanizam)
English: Missing doses may increase your risk of getting HIV infection.
Croatian: Propuštanje doza može povećati rizik od dobivanja HIV infekcije.
English: Study conducted with additional voxilaprevir 100 mg to achieve voxilaprevir exposures expected in HCV-infected patients.
Croatian: Ispitivanje provedeno s dodatnom dozom voksilaprevira od 100 mg kako bi se dosegle izloženosti voksilapreviru očekivane u bolesnika zaraženih HCV-om.
English: It is also used to treat HIV in adolescents aged 12 to less than 18 years who weigh at least 35 kg, and who have already been treated with other HIV medicines that are no longer effective or have caused side effects.
Croatian: - Također se primjenjuje za liječenje HIV-a u adolescenata u dobi od 12 do manje od 18 godina, tjelesne težine najmanje 35 kg, te su već liječeni drugim lijekovima za HIV koji više nisu učinkoviti ili su izazvali nuspojave.
English: Although there are limited clinical data on the use of emtricitabine/tenofovir disoproxil in pregnant women, it is not usually used unless absolutely necessary.
Croatian: Iako postoje ograničeni klinički podaci o uporabi emtricitabin/tenofovirdizoproksila u trudnica, lijek se obično ne primjenjuje osim ako to nije apsolutno potrebno.
English: Lactic acidosis (excess lactic acid in the blood) is a rare but potentially life-threatening side effect.
Croatian: - Laktacidoza (prekomjerna količina mliječne kiseline u krvi) je rijetka ali životno ugrožavajuća nuspojava.