FrancophonIA/ELRC3.0 huggingface dataset:
English: In the case of acute overdose, the possibility of multiple drug involvement should be considered.
Slovenian: V primeru akutnega prevelikega odmerjanja je treba upoštevati možnost, da je bolnik hkrati zaužil več zdravil.
English: • a change in the way you walk
Slovenian: • sprememba v načinu hoje
English: Tardive dyskinesia/extrapyramidal symptoms
Slovenian: Tardivna diskinezija/ekstrapiramidni simptomi
English: • sleep disorder, elated mood (mania), decreased sexual drive, nervousness, nightmares
Slovenian: • motnje spanja, stanje vznesenosti (manija), zmanjšana spolna sla, nervoznost, nočne more
English: This effect, if it occurs in humans, may mask the signs and symptoms of overdosage with certain medicinal products or of conditions such as intestinal obstruction, Reye's syndrome and brain tumour.
Slovenian: Če se to pojavi pri človeku, lahko prikrije znake in simptome prevelikega odmerjanja nekaterih zdravil ali stanj, kot so ileus, Reyev sindrom in možganski tumor.
English: Other signs of parkinsonism include a slow shuffling walk, a tremor while at rest, increased saliva and/or drooling, and a loss of expression on the face.
Slovenian: Drugi znaki parkinsonizma vključujejo počasne, negotove korake, tresenje med počivanjem, povečano izločanje sline in/ali slinjenje in brezizraznost obraza.
English: Your doctor may adjust your dose of this medicine based on your kidney function.
Slovenian: Zdravnik vam bo morda moral prilagoditi odmerek tega zdravila glede na delovanje ledvic.
English: Other medicines that have this effect include some medicines used to treat depression or to treat infection, and other antipsychotics.
Slovenian: Med druga zdravila s takim učinkom sodijo nekatera zdravila za zdravljenje depresije, nekatera zdravila za zdravljenje okužb in drugi antipsihotiki.
English: Maintaining symptom control and delaying relapse of schizophrenia The efficacy of Xeplion in maintaining symptomatic control and delaying relapse of schizophrenia was established in a longer-term double-blind, placebo-controlled, flexible-dose study involving 849 non-elderly adult subjects who met DSM-IV criteria for schizophrenia.
Slovenian: Vzdrževanje nadzora simptomov in zakasnitev relapsa shizofrenije Učinkovitost zdravila Xeplion pri vzdrževanju nadzora simptomov in zakasnitvi relapsa shizofrenije so ugotovili v dolgotrajni, dvojno slepi, s placebom nadzorovani študiji s spremenljivim odmerkom, v kateri je sodelovalo 849 odraslih (starostniki niso bili vključeni), ki so izpolnjevali merila za shizofrenijo DSM-IV.
English: If less than 6 weeks have elapsed since the last injection, then the previously stabilised dose should be administered as soon as possible, followed by injections at monthly intervals.
Slovenian: Če je od zadnjega injiciranja preteklo manj kot 6 tednov, je treba zadnji uporabljeni odmerek injicirati čim prej, nato pa zdravilo injicirati v mesečnih presledkih.
English: Based on in vitro studies utilising human liver enzymes, paliperidone is not a substrate for CYP1A2; smoking should, therefore, not have an effect on the pharmacokinetics of paliperidone.
Slovenian: Na podlagi študij in vitro, v katerih so uporabili humane jetrne encime, so ugotovili, da paliperidon ni substrat za encim CYP1A2, zato kajenje ne bi smelo vplivati na farmakokinetiko paliperidona.
English: • blurry vision, eye infection or "pink eye", dry eye
Slovenian: • zamegljen vid, okužba oči ali "rdeče oko", suhe oči
English: Xeplion should be used cautiously in patients with a history of seizures or other conditions that potentially lower the seizure threshold.
Slovenian: Zdravilo Xeplion je treba uporabljati previdno pri bolnikih z epileptičnimi napadi v anamnezi ali z drugimi stanji, ki lahko znižajo prag za epileptični napad.
English: The experience from risperidone cited below is considered valid also for paliperidone.
Slovenian: Spodaj navedene izkušnje z risperidonom veljajo tudi za paliperidon.
English: Paliperidone is excreted in the breast milk to such an extent that effects on the breast-fed infant are likely if therapeutic doses are administered to breast-feeding women.
Slovenian: Paliperidon se izloča v materino mleko v tolikšni meri, da bi verjetno vplival na dojenčka, če bi doječa mati jemala terapevtske odmerke zdravila.
English: You will receive the first injection (150 mg) and second injection (100 mg) of this medicine in the upper arm approximately one week apart.
Slovenian: Prvo (150 mg) in drugo (100 mg) injekcijo tega zdravila boste prejeli v zgornji del roke v razmiku približno enega tedna.
English: Withdrawal of this medicine may be needed.
Slovenian: Morda bo potrebno prekiniti zdravljenje s tem zdravilom.
English: If Xeplion is discontinued, its prolonged release characteristics must be considered.
Slovenian: Če prekinemo zdravljenje z zdravilom Xeplion, je treba upoštevati njegovo podaljšano sproščanje.
English: A third Xeplion injection of 75 mg in either the deltoid or gluteal muscles should be administered 5 weeks after the first injection (regardless of the timing of the second injection).
Slovenian: Tretje injiciranje zdravila Xeplion v odmerku 75 mg v deltoidno ali glutealno mišico je treba opraviti 5 tednov po prvem injiciranju (ne glede na čas drugega injiciranja).
English: The efficacy of Xeplion in the acute treatment of schizophrenia was established in four short-term (one 9-week and three 13-week) double-blind, randomised, placebo-controlled, fixed-dose studies of acutely relapsed adult inpatients who met DSM-IV criteria for schizophrenia.
Slovenian: Učinkovitost zdravila Xeplion pri zdravljenju akutne shizofrenije so ugotavljali v štirih (eni 9-tedenski in treh 13-tedenskih) kratkotrajnih, dvojno slepih, randomiziranih, s placebom nadzorovanih študijah s fiksnim odmerkom pri hospitaliziranih odraslih bolnikih z akutnim relapsom, ki so ustrezali merilom za shizofrenijo DSM-IV.
English: Medicinal products with dopamine receptor antagonistic properties have been associated with the induction of tardive dyskinesia characterised by rhythmical, involuntary movements, predominantly of the tongue and/or face.
Slovenian: Zdravila z antagonističnim delovanjem na dopaminske receptorje, so povezana z razvojem tardivne diskinezije, za katero so značilni ritmični, nehoteni gibi, predvsem jezika in/ali obraza.
English: Male rats showed a statistically significant increase in mammary gland adenomas and carcinomas at 30 and 60 mg/kg/month which is 1.2 and 2.2 times the exposure level at the maximum recommended human 150 mg dose.
Slovenian: Pri podganjih samcih so ugotovili statistično značilno povečanje pojavnosti adenomov in karcinomov mlečnih žlez, in sicer pri odmerkih 30 in 60 mg/kg/mesec, kar je enako 1,2-oziroma 2,2-kratni izpostavljenosti največjemu priporočenemu odmerku pri človeku (150 mg).
English: The day 1 and day 8 initiation doses must each be administered in the deltoid muscle in order to attain therapeutic concentrations rapidly (see section 5.2).
Slovenian: Odmerka na prvi in osmi dan je treba injicirati v deltoidno mišico, da hitro dosežemo terapevtske koncentracije (glejte poglavje 5.2).
English: The recommended monthly maintenance dose is 75 mg; some patients may benefit from lower or higher doses within the recommended range of 25 to 150 mg based on individual patient tolerability and/or efficacy.
Slovenian: Priporočeni mesečni vzdrževalni odmerek je 75 mg; nekaterim bolnikom koristijo manjši ali večji odmerki, ki so v priporočenem razponu odmerkov od 25 do 150 mg. Odmerek je odvisen od prenašanja zdravila in/ali učinkovitosti pri posameznem bolniku.
English: Patients treated with Xeplion should be monitored for symptoms of hyperglycaemia (such as polydipsia, polyuria, polyphagia and weakness) and patients with diabetes mellitus should be monitored regularly for worsening of glucose control.
Slovenian: Bolnike, ki prejemajo zdravilo Xeplion, je treba spremljati glede simptomov hiperglikemije (kot so polidipsija, poliurija in šibkost) ter redno spremljati bolnike s sladkorno boleznijo glede poslabšanja nadzora koncentracije glukoze v krvi.
English: In patients with pre-existing diabetes mellitus blood glucose should be monitored regularly.
Slovenian: Pri bolnikih z obstoječo sladkorno boleznijo je treba redno spremljati koncentracije sladkorja v krvi.
English: • have dementia and experience a sudden change in your mental state or sudden weakness or numbness of your face, arms or legs, especially on one side, or slurred speech, even for a short period of time.
Slovenian: • imate demenco in opazite nenadne spremembe svojega duševnega stanja, šibkost ali odrevenelost (največkrat ene strani) obraza, rok ali nog ali nerazločnost govora, četudi samo za kratek čas.
English: Based on pooled data from the three placebo-controlled, 6-week, fixed-dose trials with oral paliperidone prolonged release tablets (3, 6, 9, and 12 mg), orthostatic hypotension was reported by 2.5% of subjects treated with oral paliperidone compared with 0.8% of subjects treated with placebo.
Slovenian: Po zbranih podatkih iz treh s placebom nadzorovanih, šest-tedenskih, preskušanj peroralnih tablet paliperidona s podaljšanim sproščanjem s stalnimi odmerki (3, 6, 9 in 12 mg) je o ortostatski hipotenziji poročalo 2,5% preiskovancev, ki so se zdravili s peroralnim paliperidonom, v primerjavi z 0,8% preiskovancev, ki so prejemali placebo.
English: • dystonia: This is a condition involving slow or sustained involuntary contraction of muscles.
Slovenian: • distonija: stanje, ki vključuje počasno in neprekinjeno krčenje mišic.
English: Seek medical attention right away if you experience a rash, swelling of your throat, itching, or problems breathing as these may be signs of a serious allergic reaction.
Slovenian: Če opazite izpuščaj, vam oteče grlo, vas srbi ali imate težave z dihanjem, takoj poiščite zdravniško pomoč, ker so to lahki znaki hude alergijske reakcije.
English: • increased GGT (a liver enzyme called gamma-glutamyltransferase) in your blood, increased liver enzymes in your blood
Slovenian: • povečana koncentracija GGT (jetrnega encima, ki ga imenujemo gama glutamil transferaza) v krvi, povečana koncentracija jetrnih encimov v krvi
English: Occasionally abscess formation occurred.
Slovenian: V nekaterih primerih se je pojavil absces.
English: The disposition of a single oral dose paliperidone 3 mg prolonged release tablet was studied in subjects with varying degrees of renal function.
Slovenian: Izločanje enkratnega odmerka 3 mg paliperidona v obliki tablet s podaljšanim sproščanjem so preučevali pri preizkušancih z različnimi stopnjami delovanja ledvic.
English: • problems with movement of your eyes, eye rolling, oversensitivity of the eyes to light, increased tears, redness of the eyes
Slovenian: • težave pri premikanju oči, zavijanje z očmi, preobčutljivost na svetlobo, povečano solzenje,
English: Tissue culture studies suggest that cell growth in human breast tumours may be stimulated by prolactin.
Slovenian: Študije tkivnih kultur so pokazale, da prolaktin lahko spodbuja celično rast v tumorjih dojke pri ljudeh.
English: Xeplion has not been studied in elderly patients with dementia.
Slovenian: Zdravila Xeplion niso preučevali pri starejših bolnikih z demenco.
English: Repeat-dose toxicity studies of intramuscularly injected paliperidone palmitate (the 1-month formulation) and orally administered paliperidone in rat and dog showed mainly pharmacological effects, such as sedation and prolactin-mediated effects on mammary glands and genitals.
Slovenian: Študije toksičnosti z večkratnimi odmerki intramuskularno injiciranega paliperidonijevega palmitata ( v obliki 1-mesečnih injekcij) in peroralnega paliperidona na podganah in psih so večinoma pokazale farmakološke učinke, kot so sedacija ter učinki prolaktina na mlečne žleze in spolovila.
English: Hyperprolactinaemia
Slovenian: Hiperprolaktinemija
English: Given the primary central nervous system (CNS) effects of paliperidone (see section 4.8), Xeplion should be used with caution in combination with other centrally acting medicinal products, e.g., anxiolytics, most antipsychotics, hypnotics, opiates, etc. or alcohol.
Slovenian: Ker paliperidon primarno deluje na osrednje živčevje (glejte poglavje 4.8), je treba zdravilo Xeplion uporabljati previdno v kombinaciji z drugimi zdravili, ki tudi delujejo na osrednje živčevje, kot so anksiolitiki, večina antipsihotikov, uspavala, opioidi in podobno ali z alkoholom.
English: In animals treated with paliperidone palmitate an inflammatory reaction was seen at the intramuscular injection site.
Slovenian: Pri živalih, ki jim aplicirali paliperidonijev palmitat, so opazili vnetno reakcijo na mestu intramuskularnega injiciranja.
English: • tardive dyskinesia (twitching or jerking movements that you cannot control in your face, tongue,
Slovenian: • tardivna diskinezija (nenadzorovano trzanje ali sunkoviti gibi, ki jih ne morete nadzorovati, na obrazu, jeziku ali drugih delih telesa).
English: CARDBOARD CARTON
Slovenian: KARTONASTA ŠKATLA
English: The need for continuing existing extrapyramidal symptoms (EPS) medicine should be re-evaluated periodically.
Slovenian: Potrebo po zdravilih proti ekstrapiramidnim simptomom je treba redno spremljati.
English: In placebo-controlled trials, diabetes mellitus was reported in 0.32% in Xeplion-treated subjects compared to a rate of 0.39% in placebo group.
Slovenian: V s placebom nadzorovanih preskušanjih so pri bolnikih, zdravljenih z zdravilom Xeplion poročali o sladkorni bolezni pri 0,32% bolnikov v primerjavi s 0,39% bolnikov v skupini, ki je prejemala placebo.
English: • a decrease in body temperature
Slovenian: • znižanje telesne temperature
English: The use of the Xeplion initiation regimen allowed patients to stay in this exposure window of 6-12 mg prolonged release oral paliperidone even on trough pre-dose days (day 8 and day 36).
Slovenian: Uporaba uvajalnega režima zdravila Xeplion je omogočila, da so plazemske koncentracije pri bolnikih ostale znotraj razpona izpostavitve 6-12 mg peroralnega paliperidona s podaljšanim sproščanjem, tudi v dnevih pred naslednjim odmerkom (8. in 36. dan).
English: 37.5 mg every 2 weeks
Slovenian: 37,5 mg vsaka 2 tedna
English: To avoid a missed monthly dose, patients may be given the injection up to 7 days before or after the monthly time point.
Slovenian: Da preprečite spuščanje mesečnega odmerka, lahko zdravilo injicirate do 7 dni pred mesečnim časovnim rokom ali 7 dni po njem.
English: Other medicines that have this effect include some medicines used to treat the rhythm of the heart or to treat infection, and other antipsychotics.
Slovenian: Med druga zdravila s takim učinkom sodijo nekatera zdravila za zdravljenje srčnega ritma, nekatera zdravila za zdravljenje okužb in drugi antipsihotiki.
English: During the 33-week open-label transition/maintenance period of the long-term recurrence prevention trial, 12% of Xeplion-treated subjects met this criterion (weight gain of ≥ 7% from double-blind phase to endpoint); the mean (SD) weight change from open-label baseline was + 0.7 (4.79) kg.
Slovenian: Med 33-tedenskim odprtim prehodnim/vzdrževalnim obdobjem preskušanja dolgotrajnega preprečevanja ponovitve bolezni je to merilo doseglo 12% preiskovancev, ki so jih zdravili z zdravilom Xeplion (povečanje telesne mase za  7% od dvojno slepe faze do zaključka); povprečna sprememba telesne mase (standardni odklon) od začetka odprte faze je bila +0,7 (4,79) kg.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC ODGOVOREN ZA SPROŠČANJE SERIJE
English: Concomitant administration of oral paliperidone with paroxetine, a potent CYP2D6 inhibitor, showed no clinically significant effect on the pharmacokinetics of paliperidone.
Slovenian: Pri sočasni uporabi peroralnega paliperidona in paroksetina, močnega zaviralca encima CYP2D6, ni bilo klinično pomembnih učinkov na farmakokinetiko paliperidona.
English: The recommended needle size for initial and maintenance administration of Xeplion into the deltoid muscle is determined by the patient's weight.
Slovenian: Priporočeno velikost igle za uvajalno in vzdrževalno injiciranje zdravila Xeplion v deltoidno mišico določimo glede na bolnikovo telesno maso.
English: It should be injected slowly, deep into the deltoid or gluteal muscle.
Slovenian: Injicirati ga je treba počasi, globoko v deltoidno ali glutealno mišico.
English: Due to its extremely low water solubility, paliperidone palmitate dissolves slowly after intramuscular injection before being hydrolysed to paliperidone and absorbed into the systemic circulation.
Slovenian: Zaradi izjemno majhne topnosti v vodi se po intramuskularnem injiciranju paliperidonijev palmitat počasi raztaplja, nato pride do hidrolize v paliperidon in absorpcije v sistemski krvi obtok.
English: • a reaction at the injection site, including itching, pain or swelling.
Slovenian: • reakcija ne mestu injiciranja, vključno s srbenjem, bolečino ali otekanjem
English: Immune system disorders hypersensitivity anaphylactic reaction
Slovenian: Bolezni imunskega sistema preobčutljivost anafilaktična reakcija
English: Paliperidone may antagonise the effect of levodopa and other dopamine agonists.
Slovenian: Paliperidon ima lahko antagonističen učinek na levodopo in druge agoniste dopamina.
English: • experience involuntary rhythmic movements of the tongue, mouth and face.
Slovenian: • imate nehotene ritmične gibe jezika, ust in obraza.
English: To avoid a missed dose, patients may be given the second dose 4 days before or after the one-week (day 8) time point.
Slovenian: Da preprečite spuščanje odmerka, lahko bolnikom drugi odmerek injicirate tudi 4 dni pred tedenskim časovnim rokom (8. dan) ali 4 dni po njem.
English: Missed monthly maintenance dose (> 6 weeks to 6 months) If more than 6 weeks have elapsed since the last injection of Xeplion, the recommendation is as follows:
Slovenian: Spuščen mesečni vzdrževalni odmerek (> 6 tednov do 6 mesecev) Če je od zadnjega injiciranja zdravila Xeplion preteklo več kot 6 tednov, priporočamo:
English: It is recommended that the second initiation dose of Xeplion be given one week after the first dose.
Slovenian: Priporočeno je, da se drugi uvajalni odmerek zdravila Xeplion injicira en teden po prvem odmerku.
English: The absolute bioavailability of paliperidone palmitate following Xeplion administration is 100%.
Slovenian: Absolutna biološka uporabnost paliperidonijevega palmitata po injiciranju zdravila Xeplion je 100%.
English: The median apparent half-life of paliperidone following Xeplion administration over the dose range of 25-150 mg ranged from 25-49 days.
Slovenian: Mediana vrednost navideznega razpolovnega časa paliperidona po injiciranju zdravila Xeplion v razponu odmerkov od 25 do 150 mg je bila od 25 do 49 dni.
English: In rat reproduction studies with oral risperidone, which is extensively converted to paliperidone in rats and humans, adverse effects were seen on the birth weight and survival of the offspring.
Slovenian: V študijah reprodukcije pri podganah z uporabo peroralnega risperidona, ki se, tako pri podganah kot pri človeku, v velikem obsegu pretvarja v paliperidon, so opazili neželene učinke v smislu zmanjšanje porodne teže in preživetja mladičev.
English: • blood clot in the lungs causing chest pain and difficulty in breathing.
Slovenian: • krvni strdki v pljučih, ki povzročajo bolečino v prsnem košu in oteženo dihanje.
English: The trial was stopped early for efficacy reasons as a significantly longer time to relapse (p < 0.0001, Figure 1) was seen in patients treated with Xeplion compared to placebo (hazard ratio = 4.32; 95% CI: 2.4-7.7).
Slovenian: Preskušanje je bilo predčasno prekinjeno zaradi učinkovitosti zdravila, saj so pri bolnikih, ki so se zdravili z zdravilom Xeplion, opazili pomembno daljši čas do relapsa (p < 0,0001, slika 1) kot pri bolnikih, ki so prejemali placebo (razmerje tveganja = 4,32; 95% IZ: 2,4-7,7).
English: Discard the syringe with needle appropriately.
Slovenian: Brizgo skupaj z iglo ustrezno zavrzite.
English: Although Xeplion was not studied on patients with hepatic impairment, no dose adjustment is required in patients with mild or moderate hepatic impairment.
Slovenian: Čeprav zdravila Xeplion niso preučevali pri bolnikih z okvaro jeter, pri bolnikih z blago ali zmerno okvaro jeter ni treba prilagajati odmerka.
English: Following a single intramuscular dose, the plasma concentrations of paliperidone gradually rise to reach maximum plasma concentrations at a median Tmax of 13 days.
Slovenian: Po enkratnem intramuskularnem odmerku se koncentracije paliperidona v plazmi postopoma večajo in pri mediani vrednosti Tmax 13 dni dosežejo največje koncentracije v plazmi.
English: Hyperglycaemia and diabetes mellitus
Slovenian: Hiperglikemija in sladkorna bolezen
English: The combined use of psychostimulants (e.g., methylphenidate) with paliperidone can lead to extrapyramidal symptoms upon change of either or both treatments (see section 4.4).
Slovenian: Kombinirana uporaba psihostimulansov (metilfenidata) in paliperidona lahko ob spremembi enega ali obeh zdravil povzroči ekstrapiramidne simptome (glejte poglavje 4.4).
English: Missed second initiation dose (< 4 weeks from first injection) If less than 4 weeks have elapsed since the first injection, then the patient should be administered the second injection of 100 mg in the deltoid muscle as soon as possible.
Slovenian: Spuščen drugi uvajalni odmerek (< 4 tedne od prvega injiciranja) Če je od prvega injiciranja preteklo manj kot 4 tedne, je treba bolniku čim prej injicirati drugi 100-miligramski odmerek v deltoidno mišico.
English: In clinical trials, median increases in serum prolactin were observed in subjects of both genders who received Xeplion.
Slovenian: V kliničnih preskušanjih so pri preiskovancih obeh spolov opazili povečanje mediane vrednosti serumskega prolaktina pri zdravljenju z zdravilom Xeplion.
English: In oral carcinogenicity studies of risperidone in rats and mice, increases in pituitary gland adenomas (mouse), endocrine pancreas adenomas (rat), and mammary gland adenomas (both species) were seen.
Slovenian: V študijah kancerogenosti peroralnega paliperidona na podganah in miših so opazili povečano pogostnost adenomov hipofize (pri miših), adenomov endokrinega dela trebušne slinavke (pri podganah) in adenomov mlečnih žlez (pri obeh vrstah).
English: 59% of the dose was excreted unchanged into urine, indicating that paliperidone is not extensively metabolised in the liver.
Slovenian: C-paliperidona s takojšnjim sproščanjem, se je 59% odmerka izločilo nespremenjenega z urinom, kar kaže, da se paliperidon v jetrih ne presnavlja v veliki meri.
English: In case of severe extrapyramidal symptoms, anticholinergic agents should be administered.
Slovenian: Če so ekstrapiramidni simptomi hudi, je treba uporabiti antiholinergik.
English: Effect of smoking on the pharmacokinetics of paliperidone was not studied with Xeplion.
Slovenian: Vpliv kajenja na farmakokinetiko paliperidona pri uporabi zdravila Xeplion niso preučevali.
English: Thereafter, you will receive an injection (ranging from 25 mg to 150 mg) in either the upper arm or buttocks once a month.
Slovenian: Nato boste prejeli injekcijo (v odmerkih od 25 mg do 150 mg) v zgornji del roke ali v zadnjico enkrat na mesec.
English: Pregnancy, puerperium and perinatal conditions drug withdrawal syndrome neonatal (see section 4.6)
Slovenian: Motnje v času nosečnosti, puerperija in perinatalnem obdobju sindrom odtegnitve zdravila pri novorojenčku (glejte poglavje 4.6)
English: • dangerously low numbers of a certain type of white blood cell needed to fight infection in your blood
Slovenian: • nevarno majhno število določenih vrst belih krvnih celic, ki jih potrebujete za obrambo pred okužbo v krvi
English: Orthostatic hypotension
Slovenian: Ortostatska hipotenzija
English: • an increase of CPK (creatine phosphokinase) in your blood, an enzyme which is sometimes released with muscle breakdown
Slovenian: • povečana koncentracija kreatin fosfokinaze (CPK) v krvi (encima, ki se včasih sprosti ob razpadanju mišic)
English: This medicine can pass from mother to baby through breast milk and may harm the baby.
Slovenian: To zdravilo lahko z materinim mlekom prehaja do dojenčka in mu lahko škoduje, zato ne smete dojiti, če uporabljate to zdravilo.