natgillin/translations-raw huggingface dataset:
The risk of congenital malformations is increased by a factor of 2 to 3 in the offspring of mothers treated with antiepileptic medicinal products compared with the expected incidence in the general population of approximately 3%.
Pri otrocih mater, zdravljenih z antiepileptiki, je tveganje za prirojene hibe 2- do 3-krat večje od pričakovane incidence med prebivalstvom na splošno, ki je približno 3 %.
There was no meaningful change in digoxin Cmax.
Cmax digoksina se ni pomembno spremenila.
However, steady-state data from a limited number of patients in smaller phase II studies indicated that: - phenytoin can reduce retigabine systemic exposure by 35% - carbamazepine can reduce retigabine systemic exposure by 33%
faze so pokazali, da: - lahko fenitoin zmanjša sistemsko izpostavljenost retigabinu za 35 %, - lahko karbamazepin zmanjša sistemsko izpostavljenost retigabinu za 33 %.
In addition, a single supplemental dose is recommended immediately after haemodialysis.
Priporoča se, da bolnik takoj po hemodializi vzame še en odmerek.
How to store Trobalt
Kako jemati zdravilo Trobalt
Trobalt with alcohol
Zdravilo Trobalt z alkoholom
Very common side effects These may affect more than 1 in 10 people:
Zelo pogosti neželeni učinki Pojavijo se lahko pri več kot 1 od 10 oseb:
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Glaxo Group Limited
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Glaxo Group Limited
In a developmental study in rats whose mothers were treated with retigabine during pregnancy, there was a delay in auditory startle response development of the offspring (see section 5.3).
V razvojni študiji podgan so pri mladičih samic, ki so med nosečnostjo prejemale retigabin, ugotovili zapoznel razvoj zdrznitve na slušni dražljaj (glejte poglavje 5.3).
If you take more Trobalt than you should If you take too many tablets of Trobalt, you may be more likely to have side effects, or any of these symptoms:
Če ste vzeli večji odmerek zdravila Trobalt, kot bi smeli Če vzamete preveč tablet zdravila Trobalt, lahko obstaja večja verjetnost neželenih učinkov ali katerega od teh simptomov: • vznemirjenost, agresivnost ali razdražljivost,
An open-label, multiple dose pharmacokinetic, safety and tolerability study in five subjects aged between 12 years to less than 18 years with partial onset seizures determined that the pharmacokinetics of retigabine in adolescents were consistent with the pharmacokinetics of retigabine in adults.
Pri petih preiskovancih starih med 12 in manj kot 18 let, ki imajo konvulzije s parcialnim začetkom, so z odprto, farmakokinetično, varnostno in tolerančno študijo večkratnega odmejanja ugotovili, da je farmakokinetika retigabina pri mladostnikih skladna s farmakokinetiko pri odraslih.
The majority of events occurred in the first 8 weeks of treatment, and there was no apparent dose-relationship.
Večina učinkov se je pojavila v prvih 8 mesecih zdravljenja in očitne povezanosti z odmerkom ni bilo opaziti.
The following convention has been used for the classification of adverse reactions:
Tabelarični pregled neželenih učinkov Za razvrstitev neželenih učinkov je uporabljen naslednji dogovor:
However, this increase is not considered to be clinically meaningful, and since retigabine is titrated according to individual patient response and tolerability, dose-adjustments are not required on the basis of body weight.
Vendar to povečanje ne velja za klinično pomembno; ker titriranje retigabina poteka glede na odziv in prenašanje posameznega bolnika, prilagajanje odmerka glede na telesno maso ni potrebno.
NAME OF THE MARKETING AUTHORISATION HOLDER Glaxo Group Limited
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Glaxo Group Limited
Data from elderly patients indicates that they may be more likely to experience certain central nervous system events, including somnolence, amnesia, coordination abnormal, vertigo, tremor, balance disorder, memory impairment and gait disturbance.
Podatki pri starejših bolnikih kažejo, da je verjetneje, da bodo starejši imeli določene neželene učinke centralnega živčnega sistema, vključno s somnolenco, amnezijo, nenormalno koordinacijo, vrtoglavico, tremorjem, motnjami ravnotežja, okvaro spomina in motnjami hoje.
Eye disorders caused by changes in the centre of the retina (maculopathy): this can be common in people taking Trobalt.
Težave z očmi, ki jih povzročajo spremembe v centru mrežnice (makulopatija): pri ljudeh, ki jemljejo zdravilo Trobalt so lahko pogoste.
The most frequently reported defects are cleft lip, cardiovascular malformations and neural tube defects.
Najpogosteje opisane hibe so heiloshiza, malformacije srca in ožilja in defekti nevralne cevi.
In addition, cases of acquired vitelliform-type maculopathy have been identified, both in clinical studies and as spontaneous reports.
Dodatno so bili v kliničnih študijah in spontano poročani primeri pridobljene viteliformne makulopatije.
When applicable, a cover letter highlighting the main changes should also be included as part of the educational materials.
• Navodilo za predpisovanje za zdravnike.Kadar je smiselno, mora biti del izobraževalnega gradiva tudi dopis, v katerem so poudarjene glavne spremembe.
INSTRUCTIONS ON USE
NAVODILO ZA UPORABO
Uncommon side effects These may affect up to 1 in 100 people:
Občasni neželeni učinki Pojavijo se lahko pri največ 1 od 100 oseb:
Problems passing urine
Težave z odvajanjem urina
Trobalt is indicated as adjunctive treatment of drug-resistant partial onset seizures with or without secondary generalization in patients aged 18 years or older with epilepsy, where other appropriate combinations with other medicinal products have proved inadequate or have not been tolerated.
4.1 Terapevtske indikacije Zdravilo Trobalt je indicirano za dodatno zdravljenje proti zdravilom odpornih konvulzij s parcialnim začetkom (s sekundarno generalizacijo ali brez nje) pri bolnikih z epilepsijo, starih 18 let ali več, v primerih, ko se druge primerne kombinacije z drugimi zdravili izkažejo za nezadostne ali jih bolnik ne prenaša.
Mental health problems These are common in people taking Trobalt, and are most likely to happen during the first few months of treatment.
Te so pri osebah, ki jemljejo zdravilo Trobalt, pogoste in verjetnost njihovega pojava je največja v prvih mesecih zdravljenja z zdravilom Trobalt.
There was an apparent dose-relationship for dizziness, somnolence, confusional state, aphasia, coordination abnormal, tremor, balance disorder, memory impairment, gait disturbance, blurred vision and constipation.
somnolentnost, stanje zmedenosti, afazijo, nenormalno koordinacijo, tremor, motnje ravnotežja, okvaro spomina, motnje hoje, zamegljen vid in zaprtost.
Further, based on pooled data, there were no clinically significant effects of the following antiepileptic medicinal products on retigabine pharmacokinetics: - lamotrigine, levetiracetam, oxcarbazepine, topiramate, valproate.
Razen tega na podlagi kumulativnih podatkov naslednji antiepileptiki niso klinično pomembno vplivali na farmakokinetiko retigabina: - lamotrigin, levetiracetam, okskarbazepin, topiramat, valproat.
Based upon the data that have become available since the granting of the initial Marketing Authorisation, the CHMP considers that the benefit-risk balance of Trobalt remains positive, but considers that its safety profile is to be closely monitored for the following reasons:
OSNOVE ZA ŠE ENO DODATNO PODALJŠANJE Na osnovi podatkov, ki so na voljo od prve odobritve dovoljenja za promet, CHMP meni, da je razmerje med koristjo in tveganjem za zdravilo Troblat, še vedno pozitivno, vendar je potrebno skrbno spremljati njegov varnostni profil zaradi sledečih razlogov: Pri uporabi zdravila Troblat so opazili težave z očmi, vključno s pigmentnimi spremembami mrežnice.
A mean increase in Individual Corrected QT Interval (QTcI) of up to 6.7 ms (upper bound of 95% one-sided CI 12.6 ms) was observed within 3 hours of dosing.
V treh urah po uporabi so opazili povprečno podaljšanje individualnega korigiranega intervala QT (QTcI) do 6,7 ms (zgornja meja enostranskega 95% IZ: 12,6 ms).
In a single-dose study in healthy volunteers and subjects with end stage renal disease, the retigabine AUC was increased by approximately 100% in the subjects with end stage renal disease relative to healthy volunteers.
V študiji enkratnega odmerka pri zdravih prostovoljcih in preiskovancih s končno odpovedjo ledvic je bila AUC retigabina približno 100 % večja pri preiskovancih s končno odpovedjo ledvic kot pri zdravih prostovoljcih.
84 film-coated tablets
84 filmsko obloženih tablet
A post-hoc analysis across multiple healthy volunteer studies demonstrated a 20% reduction in retigabine clearance in healthy black volunteers relative to healthy Caucasian volunteers.
Post hoc analiza več študij zdravih prostovoljcev je pokazala pri zdravih prostovoljcih črnske rase 20 % manjši očistek retigabina kot pri zdravih prostovoljcih bele rase.
Adverse event data from clinical trial subjects showed a rate of event of discolouration of the nails, lips, skin and/or mucosa per patient year of exposure of 3.6%.
Podatki o neželenih učinkih, zbrani pri preiskovancih kliničnih preskušanj, so pokazali 3,6-odstoten delež sprememb barve nohtov, ustnic, kože in/ali sluznic na bolnikov-let izpostavljenosti.
The results of a single-dose study showed that in young adult volunteers, retigabine Cmax was approximately 65% higher in females than in males, and in elderly volunteers (66 to 82 years of age), retigabine Cmax was approximately 75% higher in females compared with males.
Spol Rezultati študije enega odmerka so pokazali, da je Cmax retigabina pri mladih odraslih prostovoljcih približno 65 % večja pri ženskah kot pri moških ter pri starejših prostovoljcih (starih od 66 do 82 let) približno 75 % večja pri ženskah kot pri moških.
Retigabine is approximately 80% bound to plasma protein over the concentration range of 0.1 to 2 µg/ml.
Porazdelitev V razponu koncentracij od 0,1 do 2 µg/ml je retigabin približno 80 % vezan na beljakovine v plazmi.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL (WITH BLUE BOX - MULTIPACK ONLY)
PODATKI NA ZUNANJI OVOJNINI ZUNANJA NALEPKA (Z MODRIM OKENCEM - SAMO SKUPNO PAKIRANJE)
Trobalt may affect some anaesthetics (for example thiopental sodium).
Zdravilo Trobalt lahko vpliva na nekatere anestetike (npr. natrijev tiopental).
The total daily starting dose is 150 mg/day and during the titration period the total daily dose should be increased by a maximum of 150 mg every week, according to the individual patient response and tolerability.
Celotni začetni dnevni odmerek je 150 mg/dan in med obdobjem titriranja, je treba celotni dnevni odmerek povečevati po največ 150 mg na teden, upoštevaje bolnikov odziv in prenašanje.
Elimination of retigabine occurs via a combination of hepatic metabolism and renal excretion.
Odstranjevanje retigabina poteka s kombinacijo presnove v jetrih in izločanja skozi ledvice.
However, the plasma levels achieved in these studies were less than those reached in humans at recommended doses (see section 5.3).
dosežena v teh študijah, je bila manjša, kot je dosežena pri človeku v priporočenih odmerkih (glejte poglavje 5.3).
The maximum total daily starting dose is 300 mg (100 mg three times daily).
Največji celotni začetni dnevni odmerek je 300 mg (100 mg trikrat na dan).
In addition, there was no clinically significant effect of the low dose combination oral contraceptive pill on the pharmacokinetics of retigabine.
Prav tako tudi nizkoodmerne kombinirane peroralne kontracepcijske tablete niso klinično pomembno vplivale na farmakokinetiko retigabina.
Other antiepileptic medicinal products
Drugi antiepileptiki
The need for treatment with antiepileptic medicinal products should be reviewed when a woman is planning to become pregnant.
Če ženska načrtuje nosečnost, je treba znova pretehtati potrebo po zdravljenju z antiepileptiki.
The majority of adverse reactions occurred in the first 8 weeks of treatment, and there was an apparent dose-relationship for confusional state only.
Večina neželenih učinkov se je pojavila v prvih 8 mesecih zdravljenja, očitna povezanost z odmerkom pa je bila le pri stanju zmedenosti.
In addition, there was a delay in auditory startle response development.
Poleg tega je bil razvoj zdrznitve na slušni dražljaj zapoznel.
These findings were apparent at exposure levels lower than those obtained with clinically recommended doses and were accompanied by maternal toxicities (including ataxia, hypokinesia, tremor and reduced body weight gain).
Ti izsledki so bili opazni pri izpostavljenosti, ki je manjša, kot je dosežena s klinično priporočenimi odmerki; spremljali so jih toksični učinki pri materi (vključno z ataksijo, hipokinezijo,
Therefore, retigabine is unlikely to affect the pharmacokinetics of substrates of the major cytochrome P450 isoenzymes through inhibition or induction mechanisms.
Zato ni verjetno, da bi retigabin vplival na farmakokinetiko substratov glavnih izoencimov citokroma P450 z mehanizmom zavrtja ali indukcije.
A small number of people being treated with antiepileptics such as Trobalt have had thoughts of harming or killing themselves.
Razmišljanje o samopoškodovanju ali samomoru Pri majhnem številu oseb, ki so dobivale zdravila proti epilepsiji, kakršno je zdravilo Trobalt, se je pojavilo razmišljanje o samopoškodovanju ali samomoru.
All patients enrolled were to have had seizures that were not adequately controlled with 1 to 3 concomitant antiepileptic medicinal products, and more than 75% of all patients were taking ≥2 concurrent antiepileptic medicinal products.
Vsi vključeni bolniki so imeli napade, ki niso bili ustrezno obvladani z 1 do 3 sočasnimi antiepileptiki, in več kot
The other ingredients are: croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, titanium dioxide (E171) , talc (E553b), Lecithin (SOY) and Xanthan gum.
Pomožne snovi so: premreženi natrijev karmelozat, hipromeloza, magnezijev stearat, mikrokristalna celuloza, polivinilalkohol, titanov dioksid (E171), smukec (E553b), sojin lecitin in ksantanski
The 200 mg tablets also contain iron oxide yellow (E172).
200-mg tablete vsebujejo tudi rumeni železov oksid (E172).
There is no evidence for hepatic oxidative metabolism of retigabine or NAMR by cytochrome P450 enzymes.
Dokazov o jetrni oksidativni presnovi retigabina ali NAMR z encimi citokroma P450 ni.
Eye disorders caused by changes in the centre of the retina (maculopathy) have been reported in people taking Trobalt (see Section 4).
Poročali so o težavah z očmi, ki so jih povzročile spremembe v centru mrežnice (makulopatija) pri ljudeh, ki so jemali zdravilo Trobalt (glejte poglavje 4).
All patients should undergo comprehensive ophthalmological examinations at baseline and at least every six months, which should include visual acuity, slit-lamp examination, dilated fundus photography, and macular OCT imaging.
Pri vseh bolnikih je treba izhodiščno in vsaj vsakih 6 mesecev opraviti izčrpen oftalmološki pregled, ki mora vključevati pregled ostrine vida, pregled s špranjsko svetilko, slikanje očesnega ozadja ob dilataciji in optično koherentno tomografijo (OCT) makule.
The arrhythmias spontaneously resolved, and both volunteers recovered without sequelae.
Motnje srčnega ritma so minile spontano in oba prostovoljca sta okrevala brez posledic.
Urinary retention, dysuria and urinary hesitation were reported in controlled clinical studies with retigabine, generally within the first 8 weeks of treatment (see section 4.8).
V kontroliranih kliničnih študijah retigabina so bile opisane retenca urina, dizurija in zastajanje curka urina, na splošno v prvih 8 tednih zdravljenja (glejte poglavje 4.8).
No signs of gall bladder dysfunction were seen clinically.
Klinično niso opazili znakov motenega delovanja žolčnika.
• balance problems, lack of co-ordination, spinning sensation (vertigo), problems walking
• težave z ravnotežjem, zmanjšana koordinacija, občutek vrtenja (vrtoglavica), težave s hojo,
Retigabine overdoses in excess of 2,500 mg/day were reported during clinical studies.
Med kliničnimi študijami so bili opisani primeri prevelikega odmerjanja retigabina preko 2.500 mg/dan.
Trobalt may increase the duration of anaesthesia induced by some anaesthetics (for example thiopental sodium; see section 5.1).
Zdravilo Trobalt lahko podaljša trajanje anestezije z nekaterimi anestetiki (npr. z natrijevim tiopentalom, glejte poglavje 5.1).
Therefore, co-administration with inhibitors or inducers of cytochrome P450 enzymes is unlikely to affect the pharmacokinetics of retigabine or NAMR.
Zato ni verjetno, da bi sočasna uporaba z zaviralci ali induktorji encimov citokroma P450 vplivala na farmakokinetiko retigabina ali NAMR.
In a single-dose study, retigabine AUC was increased by approximately 30% in volunteers with mild renal impairment (creatinine clearance 50 to 80 ml/min) and by approximately 100% in volunteers with moderate to severe renal impairment (creatinine clearance <50 ml/min), relative to healthy volunteers.
V študiji enega odmerka se je AUC retigabina v primerjavi z zdravimi prostovoljci pri prostovoljcih z blago okvaro ledvic (očistek kreatinina od 50 do 80 ml/min) povečala za približno 30 % in pri prostovoljcih z zmerno do hudo okvaro ledvic (očistek kreatinina < 50 ml/min) za približno 100 %.
What you need to know before you take Trobalt
Kaj morate vedeti, preden boste vzeli zdravilo Trobalt Ne jemljite zdravila Trobalt
Therefore Trobalt is not recommended during pregnancy.You must use a reliable method of contraception to avoid becoming pregnant while you are being treated with Trobalt.
Med zdravljenjem z zdravilom Trobalt morate uporabljati zanesljivo kontracepcijsko zaščito, da ne boste zanosili.
The maximum dose is 400 mg taken three times a day (a total of 1,200 mg a day).
Največji odmerek je 400 mg trikrat na dan (skupaj 1.200 mg na dan).
At no observed effect levels, animal exposure in these studies was generally less than that reached in humans at recommended clinical doses.
(NOEL) je bila izpostavljenost živali v teh študijah na splošno manjša, kot je dosežena z uporabo priporočenih kliničnih odmerkov pri človeku.
There were no treatment-related effects of retigabine on fertility in animal studies.
V študijah na živalih niso ugotovili z retigabinom povezanih učinkov na plodnost.
Pack containing 84 film-coated tablets; multi-pack comprising 168 (2 x 84) film-coated tablets.
Pakiranje s 84 filmsko obloženimi tabletami; skupno pakiranje, ki vsebuje 168 (2 x 84) filmsko obloženih tablet.
In vitro studies using human liver microsomes showed little or no potential for retigabine to inhibit the major cytochrome P450 isoenzymes (including CYP1A2, CYP2A6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 and CYP3A4/5).
CYP1A2, CYP2A6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 in CYP3A4/5).
If you notice such changes while taking the medicine, tell your doctor.
Če opazite takšne spremembe med zdravljenjem z zdravilom
The retigabine AUC was increased by approximately 50% in volunteers with moderate hepatic impairment (Child-Pugh score 7 to 9) and by approximately 100% in volunteers with severe hepatic impairment (Child-Pugh score >9), relative to healthy volunteers.
V primerjavi z zdravimi prostovoljci je bila AUC retigabina pri prostovoljcih z zmerno okvaro jeter (7 do 9 po Child-Pughu) približno 50 % večja in pri prostovoljcih s hudo okvaro jeter (> 9 po Child-Pughu) približno 100 % večja.
Based on these pooled data, retigabine did not cause clinically significant effects on the plasma trough concentrations of the following antiepileptic medicinal products: - carbamazepine, clobazam, clonazepam, gabapentin, lamotrigine, levetiracetam, oxcarbazepine,
Na podlagi teh kumulativnih podatkov retigabin ni klinično pomembno vplival na najmanjšo plazemsko koncentracijo naslednjih antiepileptikov: - karbamazepina, klobazama, klonazepama, gabapentina, lamotrigina, levetiracetama,
The doctor will weigh up the benefit to you against any risk to your baby of taking Trobalt while you are pregnant.
Zdravnik bo pretehtal koristi, ki jih jemanje zdravila Trobalt med obdobjem nosečnosti pomeni za vas v primerjavi s kakršnimkoli tveganjem za vašega otroka.
Urinary retention
Zastoj urina
This sometimes occur together with discolouration of parts of the eye.
Spremembe barve se lahko včasih pojavijo skupaj s spremembami barve delov očesa.
In patients who develop these changes, treatment with Trobalt should only be continued after a careful re-assessment of the balance of benefits and risks.
Pri bolnikih, ki se jim razvijejo takšne spremembe se sme zdravljenje z zdravilom Trobalt nadaljevati le po skrbni ponovni oceni možnega tveganja v primerjavi s koristmi zdravljenja.
• difficulty in starting to urinate (urinary hesitation)
• bolečine pri odvajanju urina (dizurija), • težave pri začetku uriniranja,
No dose adjustment is required in patients with mild renal impairment (creatinine clearance 50 to 80 ml/min; see section 5.2).
Bolnikom z blago okvaro ledvic (očistek kreatinina od 50 do 80 ml/min) odmerka ni treba prilagoditi (glejte poglavje 5.2).
Multipack: 168 (2 packs of 84) film-coated tablets
Skupno pakiranje: 168 (2 pakiranji po 84) filmsko obloženih tablet
In a study in volunteers, cardiac arrhythmia (cardiac arrest/asystole or ventricular tachycardia) occurred in two subjects within 3 hours of receiving a single 900 mg retigabine dose.
V študiji prostovoljcev so se dvema osebama v treh urah po enem 900-mg odmerku retigabina pojavile motnje srčnega ritma (zastoj srca/asistolija oz. ventrikularna tahikardija).
Adverse reactions related to voiding dysfunction, including urinary retention, were reported in 5% of retigabine-treated patients in the pooled safety dataset (see section 4.4).
V kumulativnem naboru podatkov o varnosti so neželene učinke, povezane z mikcijo (vključno z retenco urina) zabeležili pri 5 % bolnikov, zdravljenih z retigabinom (glejte poglavje 4.4).
Discolouration of parts of the eye, including the retina (inside the back of the eye): this can be very common in people taking Trobalt for several years.
Spremenjena barva delov očesa, vključno z mrežnico (na zadnji notranji strani očesa): To je pogosto pri bolnikih, ki jemljejo zdravilo Trobalt več let.
Skin and subcutaneous disorders
Bolezni kože in podkožja kožni izpuščaj,
There is limited experience of overdose with retigabine.
Izkušenj s prevelikim odmerjanjem retigabina je malo.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ POGLEDA IN
Opaque PVC-PVDC-aluminium foil blisters.
Motni pretisni omoti iz PVC-PVDC-aluminijske folije.
Study 302 (n=538; n=471)
Študija 302 (n = 538, n = 471) Celotna odstotna sprememba pogostnosti parcialnih napadov (mediana)
The 50 mg and 400 mg tablets also contain indigo carmine aluminium lake (E132) and carmine (E120).
50-mg in 400-mg tablete vsebujejo tudi indigotin (E132) in karmin (E120).
Adverse reactions that were most frequently reported to lead to discontinuation were dizziness, somnolence, fatigue and confusional state.
Neželeni učinki, ki so najpogosteje povzročili prenehanje zdravljenja, so bili omotica, somnolentnost,
Retigabine was effective in adjunctive treatment of adults with partial onset seizures in three clinical studies (Table 1).
Retigabin je bil v vseh treh kliničnih študijah učinkovit kot dodatno zdravilo za zdravljenje odraslih bolnikov z napadi s parcialnim začetkom (preglednica 1).
Reversibility of retinal pigmentation after retigabine discontinuation has been reported in some subjects.
Pri nekaterih posameznikih so poročali o reverzibilnosti pigmentacije mrežnice po prenehanju uporabe retigabina.
If retinal pigment, vitelliform maculopathy or vision changes are detected, treatment with Trobalt should only be continued after a careful re-assessment of the balance of benefits and risks.
V primeru ugotovljene pigmentacije mrežnice, viteliformne makulopatije ali sprememb vida se lahko zdravljenje z zdravilom Troblat nadaljuje le po skrbno izvedeni ponovni oceni razmerja med koristjo in tveganjem.
Trobalt can cause serious side effects, including an inability to pass urine (urinary retention) and mental health problems.
Zdravilo Trobalt lahko povzroča resne neželene učinke, med drugim nezmožnost odvajanja urina