FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment may be paused or stopped permanently if the patient experiences severe side effects.
Slovenian: Če se pri bolniku pojavijo resni neželeni učinki, je treba zdravljenje z zdravilom Imfinzi začasno prekiniti ali trajno ukiniti.
English: The safety of the medicine is in line with other similar medicines.
Slovenian: Varnost zdravila je skladna z drugimi podobnimi zdravili.
English: This overview was last updated in 09-2019.
Slovenian: Povzetek je bil nazadnje posodobljen 08-2019.
English: Further information on Inbrija can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Inbrija.
Slovenian: Nadaljnje informacije o zdravilu Inbrija so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/Inbrija.
English: The European Medicines Agency therefore decided that Inbrija's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Inbrija večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: What measures are being taken to ensure the safe and effective use of Inbrija?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Inbrija?
English: As for all medicines, data on the use of Inbrija are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Inbrija stalno spremljajo.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Inbrija 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 Inbrija upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: The recommended dose is 2 capsules in each ‘off' period up to a maximum of 10 capsules per day.
Slovenian: Priporočeni odmerek je dve kapsuli za vsako epizodo „izklopa“, vendar ne več kot 10 kapsul na dan.
English: Effects were measured using a standard symptom scale known as the unified Parkinson's disease rating scale, UPDRS, part III.
Slovenian: Učinki so bili izmerjeni z uporabo standardne lestvice simptomov, znane kot enotna lestvica za oceno Parkinsonove bolezni (UPDRS), del III.
English: An overview of Inbrija and why it is authorised in the EU
Slovenian: Pregled zdravila Inbrija in zakaj je odobreno v EU
English: What benefits of Inbrija have been shown in studies?
Slovenian: Kakšne koristi zdravila Inbrija so se pokazale v študijah?
English: Side effects reported with Inbrija are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Inbrija, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: Why is Inbrija authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Inbrija odobreno v EU?
English: What is Inbrija and what is it used for?
Slovenian: Kaj je zdravilo Inbrija in za kaj se uporablja?
English: For more information about using Inbrija, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Inbrija glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: The first study involved 226 patients who had 12 weeks of standard treatment with levodopa and a dopa-decarboxylase inhibitor.
Slovenian: V prvo študijo je bilo vključenih 226 bolnikov, ki so 12 tednov prejemali standardno zdravljenje s kombinacijo levodope in zaviralca dopa-dekarboksilaze.
English: What are the risks associated with Inbrija?
Slovenian: Kakšna tveganja so povezana z zdravilom Inbrija?
English: Of patients treated with Inbrija, 71% reported that their symptoms were improved, compared with 46% of patients on placebo.
Slovenian: Pri bolnikih, ki so se zdravili z zdravilom Inbrija, jih je 71 % poročalo o izboljšanju simptomov v primerjavi s 46 % bolnikov, ki so prejemali placebo.
English: Other information about Inbrija
Slovenian: Druge informacije o zdravilu Inbrija
English: Because it is inhaled, Inbrija provides rapid relief of symptoms, which improves patients' quality of life.
Slovenian: Ker se zdravilo Inbrija vdihava, privede do hitrega olajšanja simptomov, kar izboljšuje kakovost življenja bolnikov.
English: Two main studies have shown that Inbrija is effective at improving patients' symptoms during ‘off' periods.
Slovenian: Dve glavni študiji sta pokazali, da je zdravilo Inbrija učinkovito pri izboljšanju bolnikovih simptomov med epizodami „izklopa“.
English: Inbrija contains levodopa which converts into dopamine in the brain and helps to restore dopamine levels, thereby improving the symptoms of the condition.
Slovenian: Zdravilo Inbrija vsebuje levodopo, ki se v možganih pretvori v dopamin, kar pomaga ponovno vzpostaviti ustrezne ravni dopamina in posledično izboljšati simptome bolezni.
English: Inbrija contains the active substance levodopa.
Slovenian: Zdravilo Inbrija vsebuje učinkovino levodopa.
English: In the second study involving 77 patients who had 4 weeks of standard treatment, patients who took Inbrija during ‘off' periods had an average improvement of 10 points on the scale 10 to 60 minutes later, compared with 3 points for patients taking placebo.
Slovenian: V drugi študiji, v katero je bilo vključenih 77 bolnikov, ki so štiri tedne prejemali standardno zdravljenje, so pri bolnikih, ki so med epizodami „izklopa“ prejemali zdravilo Inbrija, od 10 do 60 minut po prejetju zdravila zabeležili povprečno izboljšanje za 10 točk na lestvici, v primerjavi s tremi točkami pri bolnikih, ki so prejemali placebo.
English: Inbrija is a medicine used to treat adults with Parkinson's disease (a progressive brain disease that causes shaking and muscle stiffness and slows movement).
Slovenian: Inbrija je zdravilo, ki se uporablja za zdravljenje odraslih s Parkinsonovo boleznijo (napredujočim obolenjem možganov, ki povzroča tresenje in togost mišic ter upočasnjeno gibanje).
English: Other common side effects, which may affect up to 1 in 10 people, are falls, upper respiratory tract infection (nose and throat infection), dyskinesia (difficulty controlling movement) and discoloured sputum (phlegm).
Slovenian: Drugi pogosti neželeni učinki, ki se lahko pojavijo pri največ 1 bolniku od 10, so padci, okužbe zgornjih dihal (okužbe nosu in grla), diskinezija (težave pri nadzorovanju gibov) in razbarvan izpljunek (sluz).
English: In patients with Parkinson's disease, the cells in the brain that produce dopamine, a neurotransmitter important for controlling movement, begin to die and the amount of dopamine in the brain decreases.
Slovenian: Pri bolnikih s Parkinsonovo boleznijo začnejo celice v možganih, ki proizvajajo dopamin, tj. živčni prenašalec, pomemben za nadzorovanje gibov, odmirati, zato se količina dopamina v možganih zmanjša.
English: Inbrija is available as capsules containing a powder for inhalation and can only be obtained with a prescription.
Slovenian: Zdravilo Inbrija je na voljo v obliki kapsul, ki vsebujejo prašek za inhaliranje, njegovo predpisovanje in izdaja pa je le na recept.
English: The most common side effect with Inbrija is cough (which may affect more than 1 in 10 people).
Slovenian: Najpogostejši neželeni učinek zdravila Inbrija (ki se lahko pojavi pri več kot 1 bolniku od 10) je kašelj.
English: It must also not be used in patients taking medicines known as non-selective monoamine oxidase (MAO) inhibitors or in patients with a history of neuroleptic malignant syndrome or rhabdomyolysis.
Slovenian: Prav tako ga ne smejo uporabljati bolniki, ki jemljejo zdravila, imenovana neselektivni zaviralci monoaminoksidaze, ali bolniki, ki so preboleli nevroleptični maligni sindrom ali rabdomiolizo.
English: Medicines containing levodopa and a dopa-decarboxylase inhibitor have shown side effects of symptoms like neuroleptic malignant syndrome (a nervous disorder) and rhabdomyolysis (breakdown of muscle fibres).
Slovenian: Pri zdravilih, ki vsebujejo levodopo in zaviralec dopa-dekarboksilaze, so se pojavili neželeni učinki, kot sta nevroleptični maligni sindrom (obolenje živcev) in rabdomioliza (razkroj mišičnih vlaken).
English: Inbrija is used to treat symptoms during ‘off' periods (times when the patient has more difficulty moving about) that occur while the patient is taking their usual treatment of a combination of levodopa and an inhibitor of dopa-decarboxylase.
Slovenian: Uporablja se za zdravljenje simptomov v epizodah „izklopa“ (obdobjih, v katerih ima bolnik več težav z gibanjem), do katerih pride v času, ko se bolnik zdravi s svojo običajno kombinacijo levodope in zaviralca dopa-dekarboksilaze.
English: How is Inbrija used?
Slovenian: Kako se zdravilo Inbrija uporablja?
English: In this study, patients who took Inbrija during their ‘off' periods had an average improvement of 10 points on the scale 30 minutes later, compared with 6 points for patients taking placebo (a dummy treatment).
Slovenian: V tej študiji je prišlo pri bolnikih, ki so med epizodami „izklopa“ prejemali zdravilo Inbrija, 30 minut po prejetju zdravila do povprečnega izboljšanja simptomov za 10 točk na lestvici v primerjavi s šestimi točkami pri bolnikih, ki so prejemali placebo (zdravilo brez učinkovine).
English: Because Inbrija is inhaled, it can supply extra levodopa (and hence dopamine) quickly when needed during an ‘off' period.
Slovenian: Ker se zdravilo Inbrija vdihava, lahko hitro dovede potrebne količine levodope (in s tem dvigne raven dopamina), kadar se pojavi potreba po tem med epizodo „izklopa“.
English: Inbrija should be inhaled using the Inbrija inhaler device when the patient recognises the symptoms of an ‘off' period.
Slovenian: Zdravilo Inbrija je treba inhalirati z inhalatorjem, prirejenim posebej za to zdravilo, takoj ko bolnik opazi nastop simptomov epizode „izklopa“.
English: Studies show that Inbrija is effective at reducing symptoms during ‘off' periods in patients with Parkinson's disease on levodopa/dopa-decarboxylase-inhibitor treatment.
Slovenian: Študije so pokazale, da je zdravilo Inbrija učinkovito pri zmanjševanju simptomov med epizodami „izklopa“ pri bolnikih s Parkinsonovo boleznijo, ki se zdravijo s kombinacijo levodope in zaviralca dopadekarboksilaze.
English: Inbrija must not be used in patients with narrow angle glaucoma (an eye disorder) or pheochromocytoma (a tumour of the adrenal glands).
Slovenian: Zdravila Inbrija ne smejo uporabljati bolniki z glavkomom z ozkim zakotjem (očesno boleznijo) ali feokromocitomom (tumorjem nadledvične žleze).
English: Allergic oedema (swelling) and gastrointestinal haemorrhage (bleeding in the gut) have been reported for other medicines containing levodopa.
Slovenian: Pri drugih zdravilih, ki vsebujejo levodopo, so poročali o alergijskem edemu (oteklini) in gastrointestinalnih krvavitvah (krvavitev v črevesju).
English: How does Inbrija work?
Slovenian: Kako zdravilo Inbrija deluje?
English: (see section 4.4.)
Slovenian: (glejte poglavje 4.4)
English: • If you are taking or will be taking paracetamol
Slovenian: • Če jemljete ali boste jemali paracetamol
English: Adopted at the 25-29 September 2017 PRAC
Slovenian: Sprejeto na seji odbora PRAC med 25. in 29. septembrom 2017
English: The frequency of this side effect is not known (cannot be estimated from the available data).
Slovenian: Pogostnost tega neželenega učinka ni znana (ni je mogoče oceniti iz razpoložljivih podatkov).
English: Some of these reactions with <product name> have resulted in recurrent symptoms and required a longer period of observation and treatment.
Slovenian: Nekatere od teh reakcij pri zdravilu <ime zdravila> so povzročile ponavljajoče se simptome in potrebno je bilo daljše obdobje opazovanja in zdravljenja.
English: Possible side effects [The following adverse drug reaction should be added with a frequency very rare (may affect up to 1 in 10,000 people)]
Slovenian: Možni neželeni učinki [Dodati je treba naslednjo neželeno reakcijo na zdravila, ki se pojavlja zelo redko (pojavi se lahko pri največ 1 od 10 000 bolnikov)]
English: If you had these symptoms prior to treatment with cladribine, tell your doctor about any change in these symptoms.
Slovenian: Če ste imeli te simptome pred začetkom zdravljenja s kladribinom, o kakršni koli njihovi spremembi obvestite zdravnika.
English: Physicians should consider PML in the differential diagnosis in patients with new or worsening neurological, cognitive or behavioural signs or symptoms.
Slovenian: Zdravniki morajo PML upoštevati pri diferencialni diagnozi pri bolnikih z novimi ali napredujočimi nevrološkimi, kognitivnimi ali vedenjskimi znaki ali simptomi.
English: If an allergic reaction occurs, the drug should be discontinued and appropriate therapy should be instituted.
Slovenian: Če se pojavi alergijska reakcija, je treba uporabo zdravila prekiniti in uvesti ustrezno zdravljenje.
English: A negative JCV PCR does not exclude PML.
Slovenian: Za JCV negativen izvid PCR ne izključuje PML.
English: Undesirable effects Investigations
Slovenian: Neželeni učinki
English: Serious skin reactions
Slovenian: Resne kožne reakcije
English: These may all be symptoms of a serious and potentially fatal brain condition known as progressive multifocal leukoencephalopathy (PML).
Slovenian: Kar koli od naštetega je lahko simptom resne in potencialno smrtne možganske bolezni, imenovane progresivna multifokalna levkoencefalopatija (PML).
English: Frequency ‘Not known': Jarisch-Herxheimer reaction (see section 4.4)
Slovenian: Neznana pogostnost: Jarisch-Herxheimerjeva reakcija (glejte poglavje 4.4)
English: Medicinal products concerned: cladribine-containing products authorised for oncology indications.
Slovenian: Zdravila, ki jih to zadeva: zdravila, ki vsebujejo kladribin in so bila odobrena za onkološke indikacije.
English: Patients with suspected PML should not receive further treatment with cladribine.
Slovenian: Bolniki s sumom na PML ne smejo prejemati nadaljnjega zdravljenja s kladribinom.
English: Progressive multifocal leukoencephalopathy (PML)
Slovenian: Progresivna multifokalna levkoencefalopatija (PML)
English: Patients should be reassured that this is a usually self-limiting consequence of antibiotic treatment of spirochete infections.
Slovenian: Bolnikom je treba pojasniti, da gre za običajno posledico antibiotičnega zdravljenja okužb s spirohetami, ki izzveni sama.
English: PML was reported 6 months to several years after treatment with cladribine.
Slovenian: O nastopu PML so poročali od šest mesecev do več let po zdravljenju s kladribinom.
English: Physicians should be aware that reappearance of the allergic symptoms may occur when symptomatic therapy is discontinued.
Slovenian: Zdravniki se morajo zavedati, da se ob prekinitvi simptomatskega zdravljenja alergijski simptomi lahko ponovno pojavijo.
English: In case of AGEP diagnosis, acetazolamide should be discontinued and any subsequent administration of acetazolamide contraindicated.
Slovenian: V primeru diagnoze AGEP je treba prenehati z jemanjem acetazolamida in tudi vsaka nadaljnja uporaba acetazolamida je kontraindicirana.
English: Talk to your doctor or pharmacist before taking this medicine:
Slovenian: Pred začetkom jemanja tega zdravila se posvetujte z zdravnikom ali farmacevtom:
English: Patients at high risk for HAGMA are in particular those with severe renal impairment, sepsis or malnutrition especially if the maximum daily doses of paracetamol are used.
Slovenian: Bolniki z velikim tveganjem za HAGMA so zlasti tisti s hudo okvaro ledvic, sepso ali nedohranjenostjo, še posebej pri uporabi največjega dnevnega odmerka paracetamola.
English: What you need to know before taking <product name> Warnings and precautions
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo <ime zdravila> Opozorila in previdnostni ukrepi
English: Some patients with spirochete infections may experience a Jarisch-Herxheimer reaction shortly after doxycycline treatment is started.
Slovenian: Nekateri okuženi bolniki lahko kmalu po začetku zdravljenja z doksiciklinom doživijo JarischHerxheimerjevo reakcijo.
English: Severe bullous reactions
Slovenian: Hude bulozne reakcije
English: High anion gap metabolic acidosis is a serious disease that must have urgent treatment.
Slovenian: Presnovna acidoza s povečano anionsko vrzeljo je resna bolezen, ki jo je treba nujno zdraviti.
English: Additional follow-up and evaluation may be warranted if no alternative diagnosis can be established.
Slovenian: Če ni mogoče postaviti alternativne diagnoze, sta upravičena dodatno spremljanje in diagnostika.
English: Rare: skin eruption that is characterised by the rapid appearance of areas of red skin studded with small pustules (small blisters filled with white/yellow fluid).
Slovenian: Redki: kožna reakcija, za katero je značilen hiter pojav predelov rdeče kože, polnih majhnih pustul (mehurčkov, napolnjenih z belo/rumeno tekočino).
English: Suggested evaluation for PML includes neurology consultation, magnetic resonance imaging of the brain, and cerebrospinal fluid analysis for JC virus (JCV) DNA by polymerase chain reaction (PCR) or a brain biopsy with testing for JCV.
Slovenian: Predlagana diagnostika za PML vključuje nevrološko posvetovanje, magnetnoresonančno slikanje možganov in analizo cerebrospinalnega likvorja za DNK virusa JC (JCV) z verižno reakcijo s polimerazo (PCR, polymerase chain reaction) ali biopsijo možganov s preiskavo za JCV.
English: If flucloxacillin is continued after cessation of paracetamol, it is advisable to ensure that there are no signals of HAGMA, as there is a possibility of flucloxacillin maintaining the clinical picture of HAGMA (see section 4.5).
Slovenian: Če se zdravljenje s flukloksacilinom nadaljuje po prenehanju zdravljenja s paracetamolom, se je priporočljivo prepričati, da ni znakov HAGMA, saj obstaja možnost, da flukloksacilin ohranja klinično sliko HAGMA (glejte poglavje 4.5).
English: If any of the side effects listed below occur, contact your doctor as soon as possible: - the Jarisch-Herxheimer reaction which causes fever, chills, headache, muscle pain, and skin rash that is usually self-limiting.
Slovenian: Če se pojavi kateri koli od naslednjih neželenih učinkov, se čim prej posvetujte z zdravnikom: - Jarisch-Herxheimerjeva reakcija, ki povzroča vročino, mrzlico, glavobol, bolečine v mišicah in kožni izpuščaj.
English: After co-administration of flucloxacillin and paracetamol, a close monitoring is recommended in order to detect the appearance of acid-base disorders, namely HAGMA, including the search of urinary 5oxoproline.
Slovenian: Po sočasnem dajanju flukloksacilina in paracetamola se priporoča natančno spremljanje, da se ugotovi pojav kislinsko-bazičnih motenj, tj. HAGMA, vključno z iskanjem 5-oksoprolina v urinu.
English: Loratadine
Slovenian: Loratadin
English: Talk to your doctor <or> <pharmacist> <or nurse> before <taking> <using> <product name> At any time during or after your treatment, tell your doctor or nurse immediately if you: experience blurred, loss of or double vision, difficulty speaking, weakness in an arm or a leg, a change in the way you walk or problems with your balance, persistent numbness, decreased sensation or loss of sensation, memory loss or confusion.
Slovenian: Če se kadar koli med zdravljenjem ali po njem pojavi kaj od naslednjega, o tem takoj obvestite zdravnika ali medicinsko sestro: zamegljen vid, izguba vida ali dvojni vid, težave pri govorjenju, oslabelost roke ali noge, sprememba načina hoje ali težave z ravnotežjem, dolgotrajna otrplost, zmanjšano zaznavanje ali izguba zaznavanja, izguba spomina ali zmedenost.
English: Cladribine - Progressive multifocal leukoencephalopathy (PML) (EPITT no 18875)
Slovenian: Kladribin - progresivna multifokalna levkoencefalopatija (PML) (št. EPITT 18875)
English: The occurrence at the treatment initiation of a feverish generalised erythema associated with pustula may be a symptom of acute generalised exanthematous pustulosis (AGEP) (see section 4.8).
Slovenian: Pojav vročinskega generaliziranega eritema, povezanega s pustulo, na začetku zdravljenja je lahko simptom akutne generalizirane eksantematozne pustuloze (AGEP) (glejte poglavje 4.8).
English: As with other macrolides, rare serious allergic reactions, including acute generalised exanthematous pustulosis (AGEP) have been reported.
Slovenian: Kot pri ostalih makrolidih so poročali o redkih resnih alergijskih reakcijah, vključno z akutno generalizirano eksantematozno pustulozo (AGEP).
English: There is a risk of blood and fluid abnormality (high anion gap metabolic acidosis) which occurs when there is an increase in plasma acidity, when flucloxacillin is used concomitantly with paracetamol, particularly in certain groups of patients at risk, e.g. patients with severe renal impairment, sepsis or malnutrition, especially if the maximum daily doses of paracetamol are used.
Slovenian: Obstaja tveganje nenormalnosti krvi in telesnih tekočin (presnovna acidoza s povečano anionsko vrzeljo), do česar pride pri povečani kislosti plazme, kadar se flukloksacilin in paracetamol uporabljata sočasno, zlasti pri nekaterih ogroženih skupinah bolnikov, npr. bolnikih s hudo okvaro ledvic, sepso ali nedohranjenostjo, še posebej pri uporabi največjih dnevnih odmerkov paracetamola.
English: As with erythromycin and other macrolides, rare serious allergic reactions, including angioneurotic oedema and anaphylaxis (rarely fatal), dermatologic reactions including acute generalised exanthematous pustulosis (AGEP), Stevens Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) (rarely fatal) and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported.
Slovenian: Kot pri eritromicinu in drugih makrolidih so poročali o redkih resnih alergijskih reakcijah, vključno z angionevrotičnim edemom in anafilaksijo (redko s smrtnim izidom), dermatološkimi reakcijami, vključno z akutno generalizirano eksantematozno pustulozo (AGEP), Stevens-Johnsonovim sindromom (SJS), toksično epidermalno nekrolizo (TEN) (redko s smrtnim izidom) in reakcijo na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS).
English: If symptoms or signs of AGEP, SJS or TEN (e.g. progressive skin rash often with blisters or mucosal lesions) are present, roxithromycin treatment should be discontinued.
Slovenian: V prisotnosti simptomov ali znakov AGEP, SJS ali TEN (npr. napredujočega kožnega izpuščaja z mehurji ali lezijami na sluznicah) je treba zdravljenje z roksitromicinom prekiniti.
English: Desloratadine; loratadine - Weight increased in children (EPITT no 18906)
Slovenian: Desloratadin; loratadin - povečana telesna masa pri otrocih (št. EPITT 18906)
English: Desloratadine
Slovenian: Desloratadin
English: An association with prolonged lymphopenia has been reported in several of these cases.
Slovenian: Pri več od teh primerov so poročali o povezavi z dolgotrajno limfopenijo.
English: Acetazolamide - Acute generalised exanthematous pustulosis (AGEP) (EPITT no 18892)
Slovenian: Acetazolamid - akutna generalizirana eksantematozna pustuloza (AGEP)(št. EPITT 18892)
English: This occurs shortly after starting doxycycline treatment for infections with spirochete such as Lyme disease.
Slovenian: Ta reakcija običajno izgine sama od sebe. Do tega pride kmalu po začetku zdravljenja okužb s spirohetami, npr. lymske borelioze, z doksiciklinom.
English: Cases of PML, including fatal cases, have been reported with cladribine.
Slovenian: Pri zdravljenju s kladribinom so poročali o primerih PML, vključno s smrtnim izidom.
English: Doxycycline - Doxycycline induced Jarisch-Herxheimer reaction (EPITT no 18937)
Slovenian: Doksiciklin - z doksiciklinom inducirana JarischHerxheimerjeva reakcija (št. EPITT 18937)
English: Post marketing experience: very rare cases of high anion gap metabolic acidosis, when flucloxacillin is used concomitantly with paracetamol, generaly in the presence of risk factors (see section 4.4.)
Slovenian: Izkušnje z zdravilom po začetku trženja: zelo redki primeri presnovne acidoze s povečano anionsko vrzeljo, če se flukloksacilin uporablja sočasno s paracetamolom, običajno v prisotnosti dejavnikov tveganja (glejte poglavje 4.4).