FrancophonIA/ELRC3.0 huggingface dataset:
English: In such cases, a switch to a different asparaginase preparation should be considered.
Slovenian: V takih primerih je treba razmisliti o prehodu na drugačno zdravilo z asparaginazo.
English: Preferably, levels should be measured three days after the last asparaginase administration, i.e. usually directly before the next dose of asparaginase is given.
Slovenian: Raven je treba po možnosti izmeriti tri dni po zadnjem dajanju asparaginaze, navadno torej neposredno pred dajanjem naslednjega odmerka asparaginaze.
English: In addition to asparagine, asparaginase is also able to cleave the amino acid glutamine to glutamic acid and ammonia, however with much less efficiency.
Slovenian: Poleg asparagina lahko asparaginaza cepi tudi aminokislino glutamin v glutaminsko kislino in amoniak, vendar mnogo manj učinkovito.
English: Median (range)
Slovenian: Mediana (razpon)
English: EXP: In-use stability has been demonstrated for 2 days at 2 °C - 8 °C.
Slovenian: EXP: Stabilnost med uporabo so dokazali za 2 dni pri 2 °C - 8 °C.
English: Common Depression, hallucination, confusion
Slovenian: Pogosti depresija, halucinacije, zmedenost
English: Concomitant use of glucocorticoids and/ or anticoagulants with asparaginase may increase the risk of a change in coagulation parameters (see section 4.4).
Slovenian: Sočasna uporaba glukokortikoidov in/ali antikoagulantov z asparaginazo lahko zveča tveganje sprememb koagulacijskih parametrov (glejte poglavje 4.4).
English: 0 (0 - 2) h
Slovenian: 0 (0-2) h razpolovni čas
English: Asparaginase lowers asparagine level in blood cancer cells and stops the cancer growing.
Slovenian: Asparaginaza znižuje raven asparagina v celicah krvnega raka in zaustavi njegovo rast.
English: In very rare cases, severe hyperammonaemia has been reported which may induce neurologic disorders such as seizures and coma.
Slovenian: V zelo redkih primerih so poročali o hudi hiperamonemiji, ki lahko povzroča nevrološke težave, na primer epileptične napade in komo.
English: Due to the asparagine concentration gradient between the extra- and intravascular space, asparagine levels are subsequently also reduced in the extravascular spaces, e.g. the cerebrospinal fluid.
Slovenian: Zaradi koncentracijskega gradienta asparagina med ekstravaskularnim in intravaskularnim prostorom se nato koncentracija asparagina zniža tudi v ekstravaskularnih prostorih, npr. cerebrospinalni tekočini.
English: All cells need an amino acid called asparagine to stay alive.
Slovenian: Vse celice potrebujejo za življenje aminokislino, ki se imenuje asparagin.
English: This syndrome is characterised in magnetic resonance imaging (MRI) by reversible (from a few days to months) lesions/oedema, primarily in the posterior region of the brain.
Slovenian: Za ta sindrom so na magnetno-resonančnih slikah značilne reverzibilne (od nekaj dni do nekaj mesecev trajajoče) lezije/edemi, predvsem v zadajšnjih predelih možganov.
English: This can promote tendency to bleeding (anticoagulants) or thrombosis (glucocorticoids).
Slovenian: To lahko zveča nagnjenost h krvavitvi (antikoagulanti) ali trombozi (glukokortikoidi).
English: Spectrila is used as part of a combination therapy.
Slovenian: Zdravilo Spectrila se uporablja kot del kombiniranega zdravljenja.
English: Discontinuation or dose reduction of concomitantly administered immunosuppressive medicinal products may be necessary.
Slovenian: Mogoče bo potrebna ukinitev ali zmanjšanje odmerka sočasno uporabljenih imunosupresivnih zdravil.
English: Patients received asparaginase at a dose of 10,000 U/m², adjusted to the current age of the patient at the time of administration (< 6 months: 6,700 U/m²; 6 - 12 months: 7,500 U/m²; > 12 months: 10,000 U/m²) on days 15, 18, 22, 25, 29, and 33 of induction treatment.
Slovenian: Bolniki so prejeli asparaginazo v odmerku 10.000 E/m², prilagojenem glede na trenutno starost bolnika v času dajanja (<6 mesecev: 6.700 E/m²; 6 - 12 mesecev: 7.500 E/m²; >12 mesecev: 10.000 E/m²) na 15., 18., 22., 25., 29. in 33. dan indukcijskega zdravljenja.
English: These patients should no longer be treated with any asparaginase preparation.
Slovenian: Ti bolniki se ne smejo več zdraviti z nobenim zdravilom z asparaginazo.
English: Pharmacokinetic parameters of Spectrila were determined in 7 adult patients after intravenous infusion of 5,000 U/m².
Slovenian: Farmakokinetične parametre zdravila Spectrila so določili pri 7 odraslih bolnikih po intravenski infuziji 5.000 E/m².
English: Philadelphia chromosome-positive patients
Slovenian: Bolniki, pozitivni na kromosom Philadelphia
English: Changes in endocrine pancreatic function are observed very commonly during treatment with asparaginase and manifest predominantly as hyperglycaemia.
Slovenian: Spremembe endokrine funkcije pankreasa zelo pogosto ugotavljajo med zdravljenjem z asparaginazo, kažejo pa se pretežno kot hiperglikemija.
English: Aggressive alkalinisation of the urine and use of allopurinol can prevent urate nephropathy.
Slovenian: Agresivna alkalizacija urina in uporaba alopurinola lahko preprečita uratno nefropatijo.
English: • Hypersensitivity to the active substance, any native (non-pegylated) E. coli-asparaginase preparation or to any of the excipients listed in section 6.1.
Slovenian: • Preobčutljivost na zdravilno učinkovino, kateri koli nativen (nepegiliran) pripravek asparaginaze E. coli ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: The primary toxicity of asparaginase results from immunologic reactions caused by exposure to the bacterial protein.
Slovenian: Primarna toksičnost asparaginaze je posledica imunoloških reakcij, ki jih povzroča izpostavljanje bakterijski beljakovini.
English: Vaccination
Slovenian: Vakcinacija
English: OTHER Store in a refrigerator.
Slovenian: DRUGI PODATKI Shranjujte v hladilniku.
English: To dissolve the powder, 3.7 ml of water for injections are carefully squirted against the inner wall of the vial with an injection syringe (do not squirt directly on or into the powder).
Slovenian: Prašek raztopite tako, da z injekcijsko brizgo previdno izbrizgate 3,7 ml vode za injekcije proti notranji steni viale (ne brizgajte vode neposredno na prašek ali vanj).
English: Spectrila should not be used during pregnancy unless the clinical condition of the woman requires treatment with asparaginase.
Slovenian: Zdravila Spectrila ne smete uporabljati pri nosečnicah, razen če klinično stanje nosečnice zahteva zdravljenje z asparaginazo.
English: In the majority of cases, your treatment can be continued by switching to other medicines containing different forms of asparaginase.
Slovenian: Večinoma je zdravljenje mogoče nadaljevati tako, da zdravilo zamenjamo z drugimi zdravili, ki vsebujejo drugačne oblike asparaginaze.
English: A comparable proportion of patients in both groups developed anti-asparaginase antibodies before the start of the post-induction treatment phase (Spectrila 54.6 % vs. reference E. coli-asparaginase 52.5 %).
Slovenian: V obeh skupinah so se pri primerljivem deležu bolnikov razvila antiasparaginazna protitelesa pred začetkom faze postindukcijskega zdravljenja (zdravilo Spectrila 54,6 % proti referenčni asparaginazi E. coli 52,5 %).
English: Treatment with asparaginase should be discontinued in patients developing acute pancreatitis.
Slovenian: Zdravljenje z asparaginazo je treba prekiniti pri bolnikih, pri katerih se razvije akutni pankreatitis.
English: Paediatric population Data on safety of Spectrila in infants < 1 year of age is limited.
Slovenian: Pediatrična populacija Podatkov o varnosti zdravila Spectrila pri dojenčkih, mlajših od 1 leta, je malo.
English: Table 2: Frequency of patients with allergic reactions (MC-ASP.5/ALL; Safety analysis set) Treatment group
Slovenian: Preglednica 2: Pogostnost bolnikov z alergijskimi reakcijami (MC-ASP.5/ALL; skupina za varnostno analizo)
English: On the basis of the scientific conclusions for asparaginase (centrally authorised product) the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing asparaginase (centrally authorised product) is unchanged subject to the proposed changes to the product information.
Slovenian: Na podlagi znanstvenih zaključkov za asparaginazo (zdravilo, ki je pridobilo dovoljenje za promet po centraliziranem postopku) odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) asparaginazo (zdravilo, ki je pridobilo dovoljenje za promet po centraliziranem postopku) nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
English: Data on efficacy and safety of Spectrila in the post-induction treatment phases are very limited.
Slovenian: Podatkov o učinkovitosti in varnosti zdravila Spectrila v postindukcijskih fazah zdravljenja je zelo malo.
English: Therefore, Spectrila must not be used during breast-feeding.
Slovenian: Zato se zdravilo Spectrila med dojenjem ne sme uporabljati.
English: EU/1/15/1072/002 (5 vials)
Slovenian: EU/1/15/1072/002 (5 vial)
English: Complete asparagine depletion in CSF Yesc
Slovenian: Popolno izčrpanje asparagina v CSF
English: In the study in children/adolescents aged 1 - 18 years with de novo ALL (study MC-ASP.5/ALL), by day 33 of induction treatment 10 patients in the Spectrila group (10.3 %) and 9 in the reference group (8.9 %) were measured positive for anti-asparaginase antibodies at least at one time point.
Slovenian: V študiji pri otrocih in mladostnikih, starih 1-18 let, z de novo ALL (študija MC-ASP.5/ALL) je bilo do 33. dne indukcijskega zdravljenja 10 bolnikov v skupini z zdravilom Spectrila (10,3 %) in 9 v referenčni skupini (8,9 %) pozitivnih za antiasparaginazna protitelesa vsaj v eni časovni točki.
English: During treatment with asparaginase-containing regimens, myelosuppression, potentially affecting all three cell lines, and infections can occur.
Slovenian: Med zdravljenjem s terapevtskimi shemami, ki vsebujejo asparaginazo, se lahko pojavijo mielosupresija, ki lahko prizadene vse tri celične linije, in okužbe.
English: Patients with severe hypertriglyceridaemia are at increased risk of developing acute pancreatitis.
Slovenian: Pri bolnikih s hudo hipertrigliceridemijo je večje tveganje nastanka akutnega pankreatitisa.
English: If allergic symptoms occur, intravenous infusion of Spectrila must be discontinued immediately.
Slovenian: Če se pojavijo alergijski simptomi, je treba nemudoma prekiniti intravensko infuzijo zdravila Spectrila.
English: Conversely, the antitumour effects of methotrexate are enhanced when asparaginase is administered 24 hours following methotrexate treatment.
Slovenian: Nasprotno se protitumorsko delovanje metotreksata zveča, če damo asparaginazo 24 ur po zdravljenju z metotreksatom.
English: There is no known case of an overdose with asparaginase where patients showed any signs of an overdose.
Slovenian: Ne poznamo nobenega primera prevelikega odmerjanja asparaginaze, kjer bi bolniki kazali kakršne koli znake prevelikega odmerjanja.
English: To avoid this, vincristine is usually given 3 - 24 hours before asparaginase.
Slovenian: Temu se navadno izognemo tako, da vinkristin damo 3-24 ur pred asparaginazo.
English: Treatment may be monitored based on the trough serum asparaginase activity measured three days after administration of Spectrila.
Slovenian: Spremljanje zdravljenja lahko temelji na najmanjši aktivnosti serumske asparaginaze, izmerjene tri dni po dajanju zdravila Spectrila.
English: Patients received 5,000 U/m² asparaginase (Spectrila versus a reference E.coli- asparaginase) at days 12, 15, 18, 21, 24, 27, 30, and 33 of induction treatment.
Slovenian: Bolniki so prejeli po 5.000 E/m² asparaginaze (zdravila Spectrila oziroma referenčne asparaginaze E. coli) na 12., 15., 18., 21., 24., 27., 30. in 33. dan indukcijskega zdravljenja.
English: Median trough serum asparaginase activities were measured in 81 children/adolescents with de novo ALL three days after infusion of asparaginase (just before the next dose had to be given) during induction treatment and ranged from 168 to 184 U/l (study MC-ASP.5/ALL).
Slovenian: Mediano najnižjo aktivnost asparaginaze v serumu so izmerili pri 81 otrocih/mladostnikih z de novo ALL tri dni po infuziji asparaginaze (tik preden je bilo treba dati naslednji odmerek) med indukcijskim zdravljenjem in je bila v mejah med 168 in 184 E/l (študija MC-ASP.5/ALL).
English: Symptomatic thromboses related to the use of central venous catheters have been described, too.
Slovenian: Opisali so tudi simptomatske tromboze, povezane z uporabo centralnih venskih katetrov.
English: However, when asparaginase was given after cytarabine a synergistic effect was observed.
Slovenian: Če pa damo asparaginazo po citarabinu, so ugotovili sinergističen učinek.
English: The toxicity of vincristine may be additive with that of asparaginase if both agents are administered concomitantly.
Slovenian: Toksičnost vinkristina se lahko sešteva s toksičnostjo asparaginaze, če damo bolniku obe zdravili sočasno.
English: Expert advice should be sought.
Slovenian: Treba je poiskati nasvet specialista.
English: Unconditional exact test of non-inferiority for binomial differences based on restricted maximum likelihood estimates c Patients were considered as responders if asparagine values in CSF on protocol day 33 were below the lower limit of quantification.
Slovenian: Brezpogojni natančni interval zaupanja po Chanu in Zhangu b Brezpogojni natančni preskus neinferiornosti za binomialne razlike na podlagi omejenih ocen največje verjetnosti c Veljalo je, da so se bolniki odzvali na zdravljenje, če so bile vrednosti asparagina v CSF na 33. dan po protokolu pod spodnjo mejo kvantitativnega določanja.
English: Effective contraception must be used during treatment and for at least 3 months after asparaginase discontinuation.
Slovenian: Med zdravljenjem in še vsaj 3 mesece po ukinitvi asparaginaze je treba uporabljati učinkovito kontracepcijo.
English: In a clinical trial in children with newly diagnosed ALL (study MC-ASP.5/ALL), the following frequencies of allergic events were observed (table 2).
Slovenian: V kliničnem preskušanju pri otrocih z na novo diagnosticirano ALL (študija MC-ASP.5/ALL) so ugotovili naslednje pogostnosti alergijskih dogodkov (preglednica 2).
English: Evidence from published data with asparaginase renders the mutagenic, clastogenic and carcinogenic potential of asparaginase negligible.
Slovenian: Sodeč po objavljenih podatkih za asparaginazo je mutageni, klastogeni in kancerogeni potencial asparaginaze zanemarljiv.
English: The metabolism of asparaginase is not known but thought to occur via degradation within the reticulohistiocytic system and by serum proteases.
Slovenian: Presnova asparaginaze ni znana, mislijo pa, da poteka preko degradacije v retikulo-histiocitnem sistemu in s posredovanjem serumskih proteaz.
English: What Spectrila is and what it is used for What you need to know before you are given Spectrila How to use Spectrila
Slovenian: Kaj je zdravilo Spectrila in za kaj ga uporabljamo Kaj morate vedeti, preden vam bodo dali zdravilo Spectrila Kako uporabljati zdravilo Spectrila Možni neželeni učinki
English: In case of occurrence of allergic symptoms, administration of Spectrila should be discontinued immediately (see section 4.4).
Slovenian: Če se pojavijo alergijski simptomi, je treba takoj prekiniti dajanje zdravila Spectrila (glejte poglavje 4.4).
English: Simultaneous vaccination with live vaccines may increase the risk of a serious infection.
Slovenian: Sočasno cepljenje z živimi cepivi lahko zveča tveganje za resne okužbe.
English: • severe liver function abnormalities (determined by laboratory tests),
Slovenian: • hude nenormalnosti v delovanju jeter (ugotavljajo se z laboratorijskim testiranjem),
English: Spectrila contains asparaginase, which is an enzyme that interferes with natural substances necessary for cancer cell growth.
Slovenian: Zdravilo Spectrila vsebuje asparaginazo, ki je encim, ki deluje na naravne snovi, potrebne za rast rakastih celic.
English: Asparaginase may increase the toxicity of other medicinal products through its effect on liver function, e.g. increased hepatotoxicity with potentially hepatotoxic medicines, increased toxicity of medicinal products metabolised by the liver or bound to plasma proteins and altered pharmacokinetics and pharmacodynamics of medicines bound to plasma proteins.
Slovenian: Asparaginaza lahko zveča toksičnost drugih zdravil s svojim vplivom na funkcijo jeter, na primer zvečana hepatotoksičnost potencialno hepatotoksičnih zdravil, zvečana toksičnost zdravil, ki se presnavljajo v jetrih ali vežejo na plazemske beljakovine, in spremenjena farmakokinetika in farmakodinamika zdravil, vezanih na plazemske beljakovine.
English: Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Slovenian: V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
English: Because of the risk of severe anaphylactic reactions asparaginase should not be administered as a bolus intravenous injection.
Slovenian: Zaradi tveganja hudih anafilaktičnih reakcij asparaginaze ne smemo dajati v obliki bolusne intravenske injekcije.
English: However, Spectrila should not be used in patients with severe hepatic impairment (see section 4.3).
Slovenian: Zdravilo Spectrila pa se ne sme uporabljati pri bolnikih s hudo okvaro jeter (glejte poglavje 4.3).
English: Hypersensitivity including bronchospasm Rare
Slovenian: Pogosti preobčutljivost, vključno z bronhospazmom
English: • if you have severe liver function problems,
Slovenian: • če imate velike težave z delovanjem jeter,
English: Laboratory in vitro and in vivo data indicate that the efficacy of high-dose cytarabine is reduced by prior administration of asparaginase.
Slovenian: Laboratorijski podatki in vitro in in vivo kažejo, da se učinkovitost velikih odmerkov citarabina zmanjša, če damo pred njim asparaginazo.
English: Clinical trials with asparaginase have shown that glutamine levels are only moderately affected with a very high interindividual variability.
Slovenian: Klinična preskušanja z asparaginazo so pokazala, da ta le zmerno vpliva na koncentracijo glutamina z zelo veliko interindividualno variabilnostjo.
English: Data on efficacy and safety of Spectrila in adults are limited.
Slovenian: Podatkov o učinkovitosti in varnosti zdravila Spectrila pri odraslih je malo.
English: The reconstituted solution may exhibit a slight opalescence.
Slovenian: Rekonstituirana raztopina je lahko rahlo opalescenčna.
English: The primary endpoint was the rate of patients with complete asparagine depletion in serum (defined as asparagine serum levels below the lower limit of quantification (< 0.5 µM) at all time points measured from day 12 up to day 33) during induction treatment.
Slovenian: Primarni končni opazovani dogodek je bil delež bolnikov s popolnim izčrpanjem asparagina v serumu (ki je bilo definirano kot koncentracija asparagina v serumu, nižja od spodnje meje kvantitativnega določanja (<0,5 µM) v vseh časovnih točkah, merjenih od 12. do 33. dne) med indukcijskim zdravljenjem.
English: Treatment group
Slovenian: Skupina zdravljenja
English: Spectrila is available in packs containing 1 or 5 vials.
Slovenian: Zdravilo Spectrila je na voljo v pakiranjih po 1 ali 5 vial.
English: • Medicines that reduce the ability of blood to clot, such as anticoagulants (e.g. warfarin and heparin), dipyridamole, acetylsalicylic acid or medicines to treat pain and inflammation, since using these medicines with asparaginase may increase the risk of bleeding.
Slovenian: • Zdravila, ki zmanjšujejo zmožnost krvi za strjevanje, na primer antikoagulanti (npr. varfarin in heparin), dipiridamol, acetilsalicilna kislina ali zdravila za zdravljenje bolečine in vnetja, ker uporaba teh zdravil skupaj z asparaginazo lahko zveča tveganje krvavitve.
English: Study in infants with de novo ALL
Slovenian: Študija pri dojenčkih z de novo ALL
English: Chemical and physical in-use stability has been demonstrated for 2 days at 2 °C - 8 °C.
Slovenian: Rekonstituirana in razredčena raztopina Kemijsko in fizikalno stabilnost med uporabo so dokazali za 2 dni pri 2 °C - 8 °C.
English: During induction treatment, asparaginase-typical adverse drug reactions like elevated liver enzymes/bilirubin (≥ CTCAE Grade III: 44.3 % vs. 39.6 %), haemorrhage or thromboembolism (≥ CTCAE Grade II: 2.1 % vs. 4.0 %), and neurotoxicity (≥ CTCAE Grade III: 4.1 % vs. 5.9 %) were observed in comparable frequencies in both groups (Spectrila versus reference).
Slovenian: Med indukcijskim zdravljenjem so ugotavljali za asparaginazo značilne neželene učinke, kot so zvišani jetrni encimi/bilirubin (≥CTCAE stopnje III: 44,3 % v primerjavi z 39,6 %), krvavitev ali trombembolija (≥ CTCAE stopnje II: 2,1 % v primerjavi s 4,0 %) in nevrotoksičnost (≥ CTCAE stopnje III: 4,1 % v primerjavi s 5,9 %), s primerljivimi pogostnostmi v obeh skupinah (zdravilo
English: Warnings and precautions Talk to your doctor or nurse before you are given Spectrila.
Slovenian: Opozorila in previdnostni ukrepi Preden vam dajo zdravilo Spectrila, se posvetujte z zdravnikom ali medicinsko sestro.
English: • Vincristine (used to treat certain types of cancer) since the simultaneous use of vincristine and asparaginase may increase the risk of certain side effects.
Slovenian: • Vinkristin (uporablja se za zdravljenje določenih vrst raka), ker lahko sočasna uporaba vinkristina in asparaginaze zveča tveganje za nekatere neželene učinke.
English: If severe liver problems occur, treatment with Spectrila must be interrupted immediately.
Slovenian: Če bodo nastopile hude težave z jetri, je treba nemudoma prekiniti zdravljenje z zdravilom Spectrila.
English: Spectrila is usually employed as part of combination chemotherapy protocols with other antineoplastic agents (see also section 4.5).
Slovenian: Zdravilo Spectrila se navadno uporablja kot del kombiniranih kemoterapevtskih protokolov z drugimi zdravili z delovanjem na novotvorbe (glejte tudi poglavje 4.5).
English: Efficacy and safety of Spectrila have not been established in Philadelphia chromosome-positive patients.
Slovenian: Varnosti in učinkovitosti zdravila Spectrila pri bolnikih, pozitivnih na kromosom Philadelphia, niso dokazali.
English: Symptoms of RPLS essentially include elevated blood pressure, seizures, headaches, changes in mental state and acute visual impairment (primarily cortical blindness or homonymous hemianopsia).
Slovenian: Simptomi RPLS v glavnem vključujejo zvišan krvni tlak, epileptične napade, glavobole, spremembe duševnega stanja in akutno okvaro vida (predvsem kortikalno slepoto ali homonimno hemianopsijo).
English: *Including all allergic reactions within 12 hours after asparaginase infusion and all adverse events with CTCAE terms syncope (fainting), hypotension, rash, flushing, pruritus, dyspnoea, injection site reaction or airway obstruction within 24 hours after asparaginase infusion
Slovenian: *Vključno z vsemi alergijskimi reakcijami v 12 urah po infuziji asparaginaze in vsemi neželenimi učinki, označenimi z izrazi CTCAE sinkopa (omedlevica), hipotenzija, izpuščaj, vročinski oblivi, pruritus, dispnea, reakcija na mestu injiciranja ali zapora dihalnih poti v 24 urah po infuziji asparaginaze.
English: Allergic reactions within 12 hours after asparaginase infusion during induction treatment Any allergic event* within 24 hours after asparaginase infusion during induction treatment
Slovenian: Zdravilo Spectrila Referenčna asparaginaza število bolnikov alergijske reakcije v 12 urah po infuziji asparaginaze med indukcijskim zdravljenjem kateri koli alergijski dogodek* v 24 urah po infuziji asparaginaze med indukcijskim zdravljenjem
English: Ischaemic strokes are rare.
Slovenian: Ishemične možganske kapi so redke.
English: It is unknown whether asparaginase is present in human breast milk.
Slovenian: Ni znano, ali je asparaginaza prisotna v materinem mleku.
English: Because potential serious adverse reactions may occur in nursing infants, Spectrila should be discontinued during breast-feeding.
Slovenian: Ker se lahko pri dojenih otrocih pojavijo potencialno resni neželeni učinki, je treba med dojenjem zdravljenje z zdravilom Spectrila prekiniti.