FrancophonIA/ELRC3.0 huggingface dataset:
English: Bone discolouration (in the absence of histological findings), which was not fully reversible over recovery periods of up to 7-weeks, was observed in rats and monkeys after 13 weeks of dosing.
Slovenian: Pri podganah in opicah so po 13 tednih odmerjanja odkrili obarvanje kosti (brez histoloških sprememb); to v obdobju okrevanja do sedem tednov ni bilo popolnoma reverzibilno.
English: Efficacy has been demonstrated in clinical studies against the pathogens listed for cIAI that were susceptible to eravacycline in vitro:
Slovenian: V kliničnih študijah so dokazali učinkovitost proti patogenom, navedenim za komplicirane intraabdominalne okužbe, ki so bili občutljivi za eravaciklin in vitro:
English: Dizziness may occur following administration of eravacycline (see section 4.8).
Slovenian: Po dajanju eravaciklina se lahko pojavi omotica (glejte poglavje 4.8).
English: Unchanged eravacycline is the major medicinal product-related component in human plasma and human urine.
Slovenian: Glavni sestavni del v človeški plazmi in urinu, povezan z zdravilom, je nespremenjeni eravaciklin.
English: Elderly (≥ 65 years old) No dose adjustment is required in elderly patients (see section 5.2).
Slovenian: Pri starejših bolnikih prilagoditev odmerka ni potrebna (glejte poglavje 5.2).
English: Eravacycline, TP-498 and TP-6208 are not inhibitors of BCRP, BSEP, OATP1B1, OATP1B3, OAT1, OAT3, OCT1, OCT2, MATE1 or MATE2-K transporters.
Slovenian: Eravaciklin, TP-498 in TP-6208 niso zaviralci prenašalcev BCRP, BSEP, OATP1B1, OATP1B3, OAT1, OAT3, OCT1, OCT2, MATE1 ali MATE2-K. Presnovka TP-498 in TP-6208 in vitro nista zaviralca P-gp.
English: Package leaflet: Information for the patient Xerava 50 mg powder for concentrate for solution for infusion eravacycline This medicine is subject to additional monitoring.
Slovenian: Navodilo za uporabo Xerava 50 mg prašek za koncentrat za raztopino za infundiranje eravaciklin Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: No adverse effects on mating or fertility were observed in female rats.
Slovenian: Pri samicah podgan niso opazili neželenih učinkov na parjenje ali plodnost.
English: In a population pharmacokinetic analysis of eravacycline, no clinically relevant differences in the pharmacokinetics of eravacycline were observed with respect to age.
Slovenian: Starejši (≥ 65 let) V populacijski farmakokinetični analizi eravaciklina niso opazili klinično pomembnih razlik v farmakokinetiki eravaciklina glede na starost.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON: 1 VIAL
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA: 1 VIALA
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING INNER CARTON: MULTIPACK, CONTAINS NO BLUE BOX
Slovenian: NOTRANJA ŠKATLA: SKUPNO PAKIRANJE, BREZ MODREGA OKENCA
English: For single use only, any unused solution should be discarded.
Slovenian: Neuporabljeno raztopino je treba zavreči.
English: In the case of suspected overdose Xerava should be discontinued and the patient monitored for adverse reactions.
Slovenian: Če obstaja sum na prevelik odmerek, je treba dajanje zdravila Xerava prekiniti, pri bolniku pa spremljati neželene učinke.
English: Each vial contains 50 mg eravacycline.
Slovenian: Ena viala vsebuje 50 mg eravaciklina.
English: • Feeling lightheaded or faint
Slovenian: • omotičnost ali omedlevica;
English: 100 mL
Slovenian: odmerka 60 mg
English: Mild to moderate infusion site reactions, including pain or discomfort, erythema and swelling or inflammation at the injection site as well as superficial thrombophlebitis and/or phlebitis have been reported in patients treated with eravacycline.
Slovenian: Pri bolnikih, ki so bili zdravljeni z eravaciklinom, so poročali o blagih do zmernih reakcijah na mestu infuzije, vključno z bolečino ali neugodjem, eritemom in otekanjem ali vnetjem na mestu vboda ter površinskim tromboflebitisom in/ali flebitisom.
English: The ready to use solution should be inspected visually for particulate matter prior to administration.
Slovenian: Pred dajanjem raztopine, pripravljene za uporabo, jo je treba vizualno pregledati, da ne vsebuje trdnih delcev.
English: However, patients receiving strong CYP3A inhibitors (for example ritonavir, itraconazole, clarithromycin) with a combination of factors that may increase the exposure, such as severe hepatic impairment and/or obesity should be monitored for adverse reactions (see sections 4.4 and 4.8).
Slovenian: Ni verjetno, da bi bila povečana izpostavljenost klinično pomembna, zato pri sočasnem dajanju eravaciklina skupaj z zaviralci CYP3A odmerka ni treba prilagoditi, vendar pa je treba pri bolnikih, ki prejemajo močne zaviralce CYP3A (na primer ritonavir, itrakonazol, klaritromicin) in pri katerih je prisotna kombinacija dejavnikov, ki lahko povečajo izpostavljenost, kot so huda okvara jeter in/ali debelost, spremljati neželene učinke (glejte poglavji 4.4 in 4.8).
English: Infusion-site erythema, pain/tenderness, phlebitis and thrombophlebitis were observed with intravenous eravacycline in clinical trials (see section 4.8).
Slovenian: V kliničnih preskušanjih so pri intravenskem dajanju eravaciklina na mestu infuzije opazili eritem, bolečino/občutljivost, flebitis in tromboflebitis (glejte poglavje 4.8).
English: After reconstitution each mL contains 10 mg eravacycline.
Slovenian: Po rekonstituciji 1 ml vsebuje 10 mg eravaciklina.
English: Xerava 50 mg powder for concentrate eravacycline
Slovenian: Xerava 50 mg prašek za koncentrat eravaciklin i.v.
English: Antibiotic-associated colitis and pseudomembranous colitis have been reported with the use of nearly all antibiotics and may range in severity from mild to life-threatening.
Slovenian: Pri uporabi skoraj vseh antibiotikov so poročali o kolitisu, povezanem z antibiotiki, in psevdomembranskem kolitisu; ti dogodki so obsegali vse od blagih do smrtno nevarnih.
English: There is no target-based cross-resistance between eravacycline and other classes of antibiotics such as quinolones, penicillins, cephalosporins, and carbapenems.
Slovenian: Med eravaciklinom in drugimi skupinami antibiotikov, kot so kinoloni, penicilini, cefalosporini in karbapenemi, ni navzkrižne odpornosti na podlagi prijemališča.
English: Other side effects have been reported with other tetracycline antibiotics including minocycline and doxycycline.
Slovenian: Pri drugih tetraciklinskih antibiotikih, vključno z minociklinom in doksiciklinom, so poročali o drugih neželenih učinkih.
English: It belongs to a group of antibiotics called ‘tetracyclines' which work by stopping the growth of certain infectious bacteria.
Slovenian: Ti delujejo tako, da ustavijo rast določenih bakterij, ki povzročijo okužbo.
English: Intravenous administration of high doses of eravacycline has been associated with cutaneous responses (including hives, scratching, swelling, and/or skin erythema) in rat and dog studies.
Slovenian: V študijah pri podganah in psih so intravensko dajanje visokih odmerkov eravaciklina povezali s kožnimi odzivi (vključno s koprivnico, praskanjem, otekanjem in/ali kožnim eritemom).
English: Xerava must be reconstituted with water for injections and subsequently diluted using sodium chloride 9 mg/mL (0.9%) solution for injection.
Slovenian: Zdravilo Xerava je treba rekonstituirati z vodo za injekcije in nato razredčiti z raztopino natrijevega klorida 9 mg/ml (0,9 %) za injiciranje.
English: If the same intravenous line is used for sequential infusion of several different medicinal products, the line should be flushed before and after infusion with sodium chloride 9 mg/ml (0.9%) solution for injection.
Slovenian: Če se za zaporedno infuzijo več različnih zdravil uporablja ista intravenska linija, jo je treba pred infuzijo in po njej splakniti z raztopino natrijevega klorida 9 mg/ml (0,9 %) za injiciranje.
English: Tell your doctor or nurse if you notice any of these side effects during your treatment with Xerava.
Slovenian: Obvestite zdravnika ali medicinsko sestro, če med zdravljenjem z zdravilom Xerava opazite katerega koli od teh neželenih učinkov.
English: Calculate the required volume of the reconstituted solution based on the patient's weight and inject into a 250 mL infusion bag.
Slovenian: Izračunajte zahtevano količino rekonstituirane raztopine na podlagi telesne mase bolnika in jo injicirajte v 250mililitrsko infuzijsko vrečo.
English: The geometric mean Cmax for eravacycline was increased by 13.9%, 16.3%, and 19.7% for subjects with mild (Child-Pugh Class A), moderate (Child-Pugh Class B), and severe (Child-Pugh Class C) hepatic impairment versus healthy subjects, respectively.
Slovenian: Geometrijska srednja vrednost Cmax za eravaciklin se je pri osebah z blago (razreda A po ChildPughu), zmerno (razreda B po Child-Pughu) in hudo (razreda C po Child-Pughu) okvaro jeter v primerjavi z zdravimi osebami povečala za 13,9, 16,3 oziroma 19,7 %.
English: Eravacycline dosing
Slovenian: Odmerjanje eravaciklina
English: If the same intravenous line is used for sequential infusion of different medicinal products, the line should be flushed before and after infusion with sodium chloride 9 mg/ml (0.9%) solution for injection.
Slovenian: Če se za zaporedno infuzijo različnih zdravil uporablja ista intravenska linija, jo je treba pred infuzijo in po njej splakniti z raztopino natrijevega klorida 9 mg/ml (0,9 %) za injiciranje.
English: Potential for drug-drug interactions
Slovenian: Možnost medsebojnega delovanja zdravil
English: The reconstituted solution will be withdrawn from the vial and added to an infusion bag of sodium chloride 9 mg/mL (0.9%) solution for injection in the hospital.
Slovenian: Rekonstituirana raztopina se v bolnišnici odvzame iz viale in doda v infuzijsko vrečo z raztopino natrijevega klorida 9 mg/ml (0,9 %) za injiciranje.
English: Powder for concentrate for solution for infusion 1 vial.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA prašek za koncentrat za raztopino za infundiranje 1 viala.
English: Susceptibility testing breakpoints
Slovenian: Mejne koncentracije testiranja občutljivosti
English: Calculate the required volume of the reconstituted solution based on the patient's weight and inject into a 500 mL infusion bag.
Slovenian: Izračunajte zahtevano količino rekonstituirane raztopine na podlagi telesne mase bolnika in jo injicirajte v 500mililitrsko infuzijsko vrečo.
English: Aspartate aminotransferase (AST) increased Alanine aminotransferase (ALT) increased Hyperbilirubinaemia
Slovenian: zvišana raven alanin-aminotransferaze
English: Calculate the required volume of the reconstituted solution based on the patient's weight and inject into a 100 mL infusion bag.
Slovenian: Izračunajte zahtevano količino rekonstituirane raztopine na podlagi telesne mase bolnika in jo injicirajte v 100mililitrsko infuzijsko vrečo.
English: Resistance to eravacycline has been observed in Enterococcus harbouring mutations in rpsJ.
Slovenian: Pri bakteriji Enterococcus, ki vsebuje mutacije gena rpsJ, so opazili odpornost proti eravaciklinu.
English: Eravacycline did affect mating and fertility in male rats at clinically relevant exposures (see section 5.3).
Slovenian: Podatkov o učinku eravaciklina na plodnost pri človeku ni. Eravaciklin je pri podganjih samcih pri klinično pomembnih izpostavljenostih vplival na parjenje in plodnost (glejte poglavje 5.3).
English: Renal clearance and biliary and direct intestinal excretion account for approximately 35% and 48% of total body clearance after administration of a single IV dose of 60 mg 14C-eravacycline, respectively.
Slovenian: C-eravaciklina znašajo približno 35 oziroma 48 % celotnega telesnega očistka.
English: Women of childbearing potential should avoid becoming pregnant while receiving eravacycline.
Slovenian: Med prejemanjem eravaciklina morajo ženske v rodni dobi preprečevati zanositev.
English: For administration, the reconstituted solution must be further diluted using sodium chloride 9 mg/ml (0.9%) solution for injection.
Slovenian: Za dajanje je treba rekonstituirano raztopino dodatno razredčiti z raztopino natrijevega klorida 9 mg/ml (0,9 %) za injiciranje.
English: In a population pharmacokinetic analysis it was shown that eravacycline disposition (clearance and volume) was dependent on body weight.
Slovenian: V populacijski farmakokinetični analizi so dokazali, da je dispozicija eravaciklina (očistek in količina) odvisna od telesne mase, vendar posledična razlika v izpostavljenosti eravaciklinu v smislu vrednosti AUC v proučevanem razponu telesne mase ni podlaga za prilagoditve odmerka.
English: • Tightness of the chest
Slovenian: • stiskanje v prsih;
English: Name and address of the manufacturer(s) responsible for batch release Patheon Italia S.p.A.
Slovenian: Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serij
English: Shaking or rapid movement should be avoided as it may cause foaming.
Slovenian: Viale ne tresite in je ne premikajte hitro, saj lahko sicer nastane pena.
English: Dizziness Headache
Slovenian: Okvara ledvic
English: How to store Xerava
Slovenian: Shranjevanje zdravila Xerava
English: The infusion solution should be inspected visually for particulate matter prior to administration.
Slovenian: Pred dajanjem raztopine za infundiranje jo je treba vizualno pregledati, da ne vsebuje trdnih delcev.
English: The solution should not be used if it appears to contain any particles or the solution is cloudy.
Slovenian: Če se zdi, da so v raztopini kakršni koli delci, ali če je raztopina motna, se ne sme uporabiti.
English: and in children under 8 years of age) as it may cause permanent discolouration of the teeth (yellowgrey-brown) (see sections 4.2 and 4.6).
Slovenian: Zdravila Xerava se ne sme uporabljati v obdobju razvoja zob (med drugim in tretjim trimesečjem nosečnosti ter pri otrocih, mlajših od osem let), saj lahko povzroči trajno obarvanje zob (rumeno-sivorjavo) (glejte poglavji 4.2 in 4.6).
English: Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment)
Slovenian: 6.1 Seznam pomožnih snovi manitol (E421) natrijev hidroksid (za prilagoditev pH) klorovodikova kislina (za prilagoditev pH)
English: Powder for concentrate for solution for infusion (powder for concentrate).
Slovenian: FARMACEVTSKA OBLIKA prašek za koncentrat za raztopino za infundiranje (prašek za koncentrat) Svetlo do temno rumen skupek.
English: • Nausea
Slovenian: • navzea
English: Your doctor may increase your dose (1.5 mg/kg every 12 hours) if you are taking other medicines including rifampicin, phenobarbital, carbamazepine, phenytoin, or St. John's Wort.
Slovenian: Če jemljete druga zdravila, vključno z rifampicinom, fenobarbitalom, karbamazepinom, fenitoinom ali šentjanževko, vam zdravnik lahko odmerek poveča (na 1,5 mg/kg vsakih 12 ur).
English: EU/1/18/1312/001 EU/1/18/1312/002
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z EU/1/18/1312/001
English: Xerava 50 mg powder for concentrate for solution for infusion
Slovenian: IME ZDRAVILA Xerava 50 mg prašek za koncentrat za raztopino za infundiranje
English: Xerava 50 mg powder for concentrate for solution for infusion eravacycline
Slovenian: IME ZDRAVILA Xerava 50 mg prašek za koncentrat za raztopino za infundiranje eravaciklin
English: • Diarrhoea
Slovenian: • glavobol;
English: There is approximately a 45% accumulation following intravenous dosing of 1 mg/kg every 12 hours.
Slovenian: Po intravenskem odmerjanju 1 mg/kg vsakih 12 ur kopičenje znaša približno
English: The eravacycline dose should be increased by approximately 50% (1.5 mg/kg IV q12h) when co-administered with rifampicin or other strong CYP3A inducers such as phenobarbital, carbamazepine, phenytoin and St. John's Wort (see sections 4.2 and 4.4).
Slovenian: Če se eravaciklin daje sočasno z rifampicinom ali drugimi močnimi induktorji CYP3A, kot so fenobarbital, karmabazepin, fenitoin in šentjanževka, je treba njegov odmerek povečati za približno 50 % (1,5 mg/kg i.v.
English: • Increased sweating
Slovenian: • povečano potenje;
English: Pancreatitis Diarrhoea
Slovenian: Bolezni prebavil navzea bruhanje pankreatitis driska
English: • Dizziness
Slovenian: • izpuščaj;
English: In vitro data indicate that the following pathogen is not susceptible to eravacycline: • Pseudomonas aeruginosa
Slovenian: Protibakterijska dejavnost proti drugim zadevnim patogenom Podatki in vitro kažejo, da naslednji patogen ni občutljiv za eravaciklin:
English: General disorders and administration site conditions Infusion site reactionsc a. Thrombophlebitis includes the preferred terms thrombophlebitis and infusion site thrombosis b. Phlebitis includes the preferred terms phlebitis, infusion site phlebitis, superficial phlebitis and injection site phlebitis c. Infusion site reactions includes the preferred terms injection site erythema, infusion site hypoaesthesia,
Slovenian: b. Flebitis vključuje prednostne izraze flebitis, flebitis na mestu infuzije, površinski flebitis in flebitis na mestu vboda.
English: Hepatobiliary disorders
Slovenian: Žilne bolezni tromboflebitis a flebitisb
English: Patient weight (kg)
Slovenian: (kg)
English: Ask your doctor for advice before breast-feeding your baby.
Slovenian: Preden začnete dojiti otroka, se posvetujte z zdravnikom.
English: Talk to your doctor or nurse if you are suffering from diarrhoea before being given Xerava.
Slovenian: Če imate drisko, se pred prejemanjem zdravila Xerava posvetujte z zdravnikom ali medicinsko sestro.
English: Further information on Nordimet can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/nordimet.
Slovenian: Nadaljnje informacije za zdravilo Nordimet so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/nordimet.
English: Nordimet should be injected under the skin once a week on the same day each week.
Slovenian: Zdravilo Nordimet se injicira pod kožo enkrat tedensko, vedno na isti dan v tednu.
English: Nordimet received a marketing authorisation valid throughout the EU on 18 August 2016.
Slovenian: Za zdravilo Nordimet je bilo 18. avgusta 2016 izdano dovoljenje za promet, veljavno po vsej EU.
English: Nordimet (methotrexate)
Slovenian: Nordimet (metotreksat)
English: NSAIDs (non-steroidal anti-inflammatory drugs) have not worked well enough;
Slovenian: NSAID (nesteroidna protivnetna zdravila) ne delujejo dovolj dobro;
English: It must not be used if the patient is pregnant, breastfeeding or is receiving live vaccines.
Slovenian: Ne sme se uporabljati med nosečnostjo, dojenjem ali prejemanjem živih cepiv.
English: What measures are being taken to ensure the safe and effective use of Nordimet?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Nordimet?
English: It should be prescribed only by doctors with expertise in the use of methotrexate and a full understanding of the risks of methotrexate treatment.
Slovenian: Predpisovati bi ga morali le zdravniki s strokovnim znanjem o uporabi metotreksata in celovitim razumevanjem tveganj zdravljenja z metotreksatom.
English: The dose injected each week depends on which condition it is being used for and how well the treatment is working and, for children, on the child's height and weight.
Slovenian: Odmerek, ki se vbrizga vsak teden, je odvisen od bolezni, za katero se zdravilo uporablja, in učinkovitosti zdravljenja, za otroke pa tudi od njihove višine in teže.
English: The Agency therefore decided that Nordimet's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Zato je sklenila, da so koristi zdravila Nordimet večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: Other information about Nordimet
Slovenian: Druge informacije o zdravilu Nordimet
English: As for all medicines, data on the use of Nordimet are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Nordimet stalno spremljajo.
English: The company that markets Nordimet will send out follow-up questionnaires for dosing errors that result in overdose.
Slovenian: Podjetje, ki trži zdravilo Nordimet, bo poslalo vprašalnike za nadaljnje spremljanje napak pri odmerjanju, ki privedejo do prevelikega odmerjanja.
English: What benefits of Nordimet have been shown in studies?
Slovenian: Kakšne koristi zdravila Nordimet so se pokazale v študijah?
English: The company provided data from the published literature on methotrexate.
Slovenian: Podjetje je predstavilo podatke o metotreksatu iz objavljene literature.
English: The European Medicines Agency concluded that Nordimet was comparable to its reference medicine.
Slovenian: Evropska agencija za zdravila je zaključila, da je zdravilo Nordimet primerljivo z referenčnim zdravilom.
English: Side effects reported with Nordimet are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Nordimet, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: An overview of Nordimet and why it is authorised in the EU
Slovenian: Pregled zdravila Nordimet in zakaj je odobreno v EU
English: • severe disabling psoriasis, a disease causing red, scaly patches on the skin, when other treatments have not worked well enough;
Slovenian: • hude oslabitvene psoriaze, bolezni, ki povzroča rdeče, luskaste zaplate na koži, ko druge oblike zdravljenja ne delujejo dovolj dobro;
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nordimet have also 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 Nordimet upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: For more information about using Nordimet, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Nordimet glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: Why is Nordimet authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Nordimet odobreno v EU?
English: What are the risks associated with Nordimet?
Slovenian: Kakšna tveganja so povezana z zdravilom Nordimet?
English: Nordimet is a ‘hybrid medicine'.
Slovenian: Zdravilo Nordimet je „hibridno zdravilo“.
English: • severe juvenile idiopathic arthritis (JIA), a joint disease in children, when medicines known as
Slovenian: • hudega juvenilnega idiopatskega artritisa (JIA), bolezni sklepov pri otrocih, ko zdravila, znana kot
English: Nordimet is a medicine used to treat the following inflammatory conditions:
Slovenian: Nordimet je zdravilo za zdravljenje naslednjih vnetnih stanj:
English: What is Nordimet and what is it used for?
Slovenian: Kaj je zdravil Nordimet in za kaj se uporablja?
English: This means that it is similar to a ‘reference medicines' containing the same active substance, but Nordimet is available in more strengths.
Slovenian: To pomeni, da je podobno referenčnemu zdravilu, ki vsebuje enako učinkovino, vendar je zdravilo Nordimet na voljo v več jakostih.
English: The way methotrexate, the active substance in Nordimet, works in patients with arthritis and psoriasis is not completely understood, but the benefits of methotrexate are thought to be due to its ability to reduce inflammation and suppress an overactive immune system.
Slovenian: Ni popolnoma znano, kako metotreksat, učinkovina v zdravilu Nordimet, učinkuje pri bolnikih z artritisom in psoriazo, domneva pa se, da so koristi metotreksata posledica njegove sposobnosti zmanjševanja vnetja in zaviranja čezmerno dejavnega imunskega sistema.
English: The reference medicine for Nordimet is Lantarel FS.
Slovenian: Referenčno zdravilo za zdravilo Nordimet je zdravilo Lantarel FS.