FrancophonIA/ELRC3.0 huggingface dataset:
English: Further information on LysaKare can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/lysakare.
Slovenian: Nadaljnje informacije za zdravilo LysaKare so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/lysakare.
English: The European Medicines Agency therefore decided that LysaKare's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zato zaključila, da so koristi zdravila LysaKare večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: What measures are being taken to ensure the safe and effective use of LysaKare?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila LysaKare?
English: Other information about LysaKare
Slovenian: Druge informacije o zdravilu LysaKare
English: As for all medicines, data on the use of LysaKare are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila LysaKare stalno spremljajo.
English: LysaKare (arginine / lysine)
Slovenian: LysaKare (arginin/lizin)
English: What is LysaKare and what is it used for?
Slovenian: Kaj je zdravilo LysaKare in za kaj se uporablja?
English: As a result, the radioactive medicine leaves the body in the urine and the kidneys are exposed to less radiation.
Slovenian: Posledično radioaktivno zdravilo zapusti telo z urinom, ledvice pa so izpostavljene manjšemu sevanju.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of LysaKare have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila LysaKare upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: Why is LysaKare authorised in the EU?
Slovenian: Zakaj je bilo zdravilo LysaKare odobreno v EU?
English: What benefits of LysaKare have been shown in studies?
Slovenian: Kakšne koristi je zdravilo LysaKare izkazalo v študijah?
English: Side effects reported with LysaKare are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu LysaKare, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: Because the use of arginine and lysine to protect the kidneys during this type of cancer treatment is well established, the company presented data from the scientific literature.
Slovenian: Ker je uporaba arginina in lizina za zaščito ledvic med tovrstnim zdravljenjem raka dobro uveljavljena, je družba predstavila podatke iz znanstvene literature.
English: LysaKare must not be given to patients with high levels of potassium in the blood if this has not been corrected before treatment.
Slovenian: Zdravilo LysaKare se ne sme dajati bolnikom z visoko vsebnostjo kalija v krvi, če ta pred zdravljenjem ni bila uravnana.
English: An overview of LysaKare and why it is authorised in the EU
Slovenian: Pregled zdravila LysaKare in zakaj je odobreno v EU
English: The most common side effects with LysaKare (which may affect more than 1 in 10 people) are nausea and vomiting.
Slovenian: Najpogostejša neželena učinka zdravila LysaKare (ki se lahko pojavita pri več kot 1 bolniku od 10) sta navzeja in bruhanje.
English: For more information about using LysaKare, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila LysaKare glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: What are the risks associated with LysaKare?
Slovenian: Kakšna tveganja so povezana z zdravilom LysaKare?
English: LysaKare is also associated with hyperkalaemia (high blood potassium levels), but the frequency of this side effect is not known.
Slovenian: Zdravilo LysaKare je povezano tudi s hiperkaliemijo (visokimi ravnmi kalija v krvi), vendar pogostnost tega neželenega učinka ni znana.
English: Side effects with LysaKare are usually mild or moderate.
Slovenian: Neželeni učinki zdravila LysaKare so večinoma blagi ali zmerni.
English: The main risk with LysaKare is a dangerous rise of blood potassium levels but this side effect can be managed if recognised and treated appropriately.
Slovenian: Glavno tveganje pri zdravilu LysaKare je nevarno povišanje ravni kalija v krvi, vendar se lahko ta neželeni učinek obvladuje, če je ugotovljen in ustrezno zdravljen.
English: LysaKare (arginine / lysine) EMA/378037/2019
Slovenian: LysaKare (arginin/lizin) EMA/314645/2019
English: Because LysaKare can cause nausea (feeling sick) and vomiting, patients will be given medicines to prevent nausea and vomiting before receiving LysaKare.
Slovenian: Zdravilo LysaKare lahko povzroči navzejo (siljenje na bruhanje) in bruhanje, zato bolniki pred prejetjem zdravila LysaKare prejmejo zdravilo za preprečevanje siljenja na bruhanje in bruhanja.
English: LysaKare is for use in adults and contains the active substances arginine and lysine.
Slovenian: Zdravilo LysaKare se uporablja pri odraslih in vsebuje učinkovini arginin in lizin.
English: LysaKare can only be obtained with a prescription and should only be given by a healthcare professional experienced in the use of radioactive medicines.
Slovenian: Predpisovanje in izdaja zdravila LysaKare je le na recept, zdravljenje pa mora izvajati le zdravnik, ki ima izkušnje z uporabo radoaktivnih zdravil.
English: In another published study involving 229 patients, measurement of creatinine clearance (an indication of how well the kidneys are working) did not show kidney damage 14 months after patients were treated with arginine and lysine at the same time as lutetium (177Lu) oxodotreotide.
Slovenian: V drugi objavljeni študiji, ki je vključevala 229 bolnikov, meritev očistka kreatinina (kazalnik, kako dobro ledvice delujejo) ni pokazala poškodb ledvic 14 mesecev po prenehanju zdravljenja bolnikov z argininom in lizinom sočasno z lutecijevim (177Lu) oksodotreotidom.
English: For the full list of side effects and restrictions with LysaKare, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila LysaKare glejte navodilo za uporabo.
English: These included data from over 1,200 cancer patients treated with lutetium (177Lu) oxodotreotide, which showed that arginine and lysine were effective at preventing kidney damage.
Slovenian: Ti so vključevali podatke za več kot 1 200 bolnikov z rakom, zdravljenih z lutecijevim (177Lu) oksodotreotidom, ki so pokazali, da sta arginin in lizin učinkovita pri preprečevanju poškodb ledvic.
English: Infusion with LysaKare is started 30 minutes before the patient is given lutetium (177Lu) oxodotreotide (also by infusion).
Slovenian: Infundiranje zdravila LysaKare se začne 30 minut preden se bolniku da lutecijev (177Lu) oksodotreotid (tudi z infuzijo).
English: LysaKare is a medicine used to protect the kidneys from radiation damage during cancer treatment with a radioactive medicine called lutetium (177Lu) oxodotreotide.
Slovenian: LysaKare je zdravilo, ki se uporablja za zaščito ledvic pred poškodbami zaradi sevanja med zdravljenjem raka z radioaktivnim zdravilom, imenovanim lutecijev (177Lu) oksodotreotid.
English: How is LysaKare used?
Slovenian: Kako se zdravilo LysaKare uporablja?
English: The use of arginine and lysine during treatment with lutetium (177Lu) oxodotreotide has been shown to reduce kidney damage and allow patients to be given an effective dose of radioactive treatment for their cancer.
Slovenian: Dokazano je bilo, da uporaba arginina in lizina med zdravljenjem z lutecijevim (177Lu) oksodotreotidom zmanjšuje poškodbe ledvic in bolnikom omogoča, da dobijo učinkovit odmerek radioaktivnega zdravljenja za zdravljenje raka.
English: How does LysaKare work?
Slovenian: Kako zdravilo LysaKare deluje?
English: Radiation from lutetium (177Lu) oxodotreotide can cause damage when the medicine passes through tubules in the kidney.
Slovenian: Sevanje iz lutecijevega (177Lu) oksodotreotida lahko poškoduje ledvične tubule, ko prehaja skoznje.
English: The active substances in LysaKare, arginine and lysine, interfere with the passage of lutetium (177Lu) oxodotreotide through these kidney tubules.
Slovenian: Učinkovini v zdravilu LysaKare, arginin in lizin, vplivata na prehod lutecijevega (177Lu) oksodotreotida skozi ledvične tubule.
English: LysaKare is given by infusion (drip) in to a vein over 4 hours.
Slovenian: Zdravilo LysaKare se daje kot štiriurna (kapalna) infuzija v veno.
English: 50 mg Powder for solution for infusion
Slovenian: 50 mg prašek za raztopino za infundiranje intravenska uporaba viala (steklo)
English: ≥30% Reduction in Skin Pain b
Slovenian: ≥ 30 % zmanjšanje bolečine na koži b
English: If you forget to give yourself an injection, you should inject it as soon as you remember.
Slovenian: Če si pozabite dati injekcijo, si jo morate injicirati, čim se spomnite.
English: CI 95% for HR
Slovenian: IZ 95 % za RT
English: Date of first authorisation: 22 March 2017
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 22. marec 2017
English: • That Solymbic treatment may increase the potential risks of serious infections, sepsis,
Slovenian: • Da zdravljenje z zdravilom Solymbic lahko poveča možna tveganja za resne okužbe, sepso,
English: When you are ready to inject, press the blue start button.
Slovenian: Ko ste pripravljeni na injiciranje, pritisnite modri sprožilni gumb.
English: Results from the overall UC-II study population are shown in table 22.
Slovenian: Rezultate celotne populacije v študiji UC-II prikazuje preglednica 22.
English: Steroid-free remission for ≥ 90 days
Slovenian: Remisija brez steroidov za ≥ 90 dni
English: Your child's doctor will tell you the correct dose to use.
Slovenian: Otrokov zdravnik vam bo povedal kakšen je ustrezen odmerek, ki ga boste uporabljali.
English: TNF-antagonists, such as SOLYMBIC affect the immune system and their use may affect the body's defence against infection and cancer.
Slovenian: TNF-antagonisti, kot je zdravilo SOLYMBIC, prizadanejo imunski sistem in njihova uporaba lahko vpliva na obrambo telesa proti okužbi in raku.
English: • autoantibodies present in the blood.
Slovenian: • avtoprotitelesa prisotna v krvi.
English: * further information is found elsewhere in sections 4.3, 4.4 and 4.8 ** including open-label extension studies 1) including spontaneous reporting data
Slovenian: * Nadaljnje informacije v zvezi s tem najdete v poglavjih 4.3, 4.4 in 4.8 ** Vključno pri podaljšanih študijah brez placeba Vključno s podatki iz spontanega poročanja
English: SOLYMBIC in combination with methotrexate, is indicated for:
Slovenian: Zdravilo SOLYMBIC je v kombinaciji z metotreksatom indicirano za:
English: Height (cm)
Slovenian: Višina (cm)
English: The MAH shall ensure that in each Member State where Solymbic is marketed, all healthcare professionals who are expected to prescribe Solymbic have are provided with the following educational package:
Slovenian: Imetnik dovoljenja za promet mora zagotoviti, da bodo v vsaki državi članici, ki bodo tržila zdravilo Solymbic, vsi zdravstveni delavci, od katerih se pričakuje, da bodo predpisovali zdravilo Solymbic, prejeli sledeče izobraževalne pakete:
English: Patients above 4 years of age but with a weight less than 23 kg or between 29 and 46 kg are not possible to dose with this product.
Slovenian: Bolnikom, starim več kot 4 leta, vendar s telesno maso manj kot 23 kg ali med 29 in 46 kg, tega zdravila ni mogoče odmeriti.
English: ASDAS Inactive Disease hs-CRP
Slovenian: ASDAS neaktivna bolezen hs-CRP
English: Contains latex, read the package leaflet before use.
Slovenian: Vsebuje lateks, pred uporabo preberite priloženo navodilo.
English: Significant response was first observed at week 2 and maintained through 24 weeks (table 8).
Slovenian: Značilen odziv so najprej opazili po 2 tednih in se je ohranil do 24. tedna (preglednica 8).
English: Rare side effects (may affect up to 1 in 1,000 people): • low blood measurements for white blood cells, red blood cells and platelet count.
Slovenian: Redki neželeni učinki (lahko prizadenejo do 1 od 1000 bolnikov): • nizke krvne vrednosti za bele krvne celice, rdeče krvne celice in trombocite.
English: You and your doctor should pay special attention to signs of infection while you are being treated with SOLYMBIC.
Slovenian: Vi sami in vaš zdravnik morata biti posebej pozorna na znake okužbe, medtem ko ste zdravljeni z zdravilom SOLYMBIC.
English: If an alternate dose is required, other adalimumab products offering such an option should be used.
Slovenian: Če je potreben drugačen odmerek, je treba uporabiti druga zdravila z adalimumabom, ki imajo takšno možnost odmerka.
English: Not known (frequency cannot be estimated from available data): • liver failure.
Slovenian: Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti): • odpoved jeter.
English: • Signs or symptoms of the safety concern and when to seek attention from a HCP
Slovenian: • Znake in simptome varnostnih zadržkov in kdaj poiskati pomoč zdravstvenega delavca.
English: Children or adolescents weighing 40 kg or more:
Slovenian: Otroci in mladostniki, ki tehtajo 40 kg ali več:
English: If you are over 65 years you may be more susceptible to infections while taking SOLYMBIC.
Slovenian: • Če ste starejši od 65 let, ste morda dovzetnejši za okužbe, če jemljete zdravilo SOLYMBIC.
English: Week 26 Placebo-controlled
Slovenian: 26. teden Kontrolirana s placebom
English: Undesirable effects in paediatric patients
Slovenian: Neželeni učinki pri pediatričnih bolnikih
English: Your doctor may recommend temporary discontinuation of SOLYMBIC.
Slovenian: Vaš zdravnik bo morda priporočil začasno prenehanje uporabe zdravila SOLYMBIC.
English: SOLYMBIC can also be given alone.
Slovenian: Zdravilo SOLYMBIC se lahko daje tudi samo.
English: Children or adolescents weighing less than 40 kg:
Slovenian: Otroci ali mladostniki, ki tehtajo manj kot 40 kg:
English: a HR of adalimumab versus placebo from proportional hazards regression with treatment as factor.
Slovenian: RT adalimumaba v primerjavi s placebom iz regresije proporcionalnih tveganj z zdravljenjem kot faktorjem.
English: Table 15 Efficacy results at 12 weeks, HS studies I and II
Slovenian: Preglednica 15: Rezultati učinkovitosti v 12. tednu, HS študiji I in II
English: If you think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Slovenian: Če menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z vašim zdravnikom ali farmacevtom, preden vzamete to zdravilo.
English: Other medicines and SOLYMBIC
Slovenian: Druga zdravila in zdravilo SOLYMBIC
English: Do not use SOLYMBIC:
Slovenian: Ne uporabljajte zdravila SOLYMBIC:
English: Adalimumab also modulates biological responses that are induced or regulated by TNF, including changes in the levels of adhesion molecules responsible for leucocyte migration (ELAM-1, VCAM-1, and ICAM-1 with an IC50 of 0.1-0.2 nM).
Slovenian: Adalimumab modulira tudi biološke odzive, ki jih sproži ali uravnava TNF, vključno s spremembami koncentracije adhezijskih molekul, odgovornih za migracijo levkocitov (ELAM-1, VCAM-1 in ICAM-1 z IK50 0,1-0,2 nM).
English: Prior to launch of Solymbic in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Slovenian: Še pred začetkom trženja zdravila Solymbic v vsaki državi članici, se mora imetnik dovoljenja za promet z zdravilom uskladiti z nacionalnimi pristojnimi organi o vsebini in obliki izobraževalnih gradiv, vključno s komunikacijskimi mediji, načini distribucije in vseh drugih vidikov gradiv.
English: b at weeks 24 and 36 after treatment reassignment from weekly adalimumab at week 12
Slovenian: b v 24. in 36. tednu po spremembi zdravljenja na jemanje adalimumaba vsak teden v 12. tednu
English: Re-introduction of SOLYMBIC after discontinuation for 70 days or longer should result in the same magnitudes of clinical response and similar safety profile as before dose interruption.
Slovenian: Zdravilo SOLYMBIC bi moralo po ponovni uvedbi, ki je sledila prekinitvi za 70 dni ali več, doseglo enako velik klinični odziv in je imelo podobne varnostne značilnosti kot pred prekinitvijo.
English: The effects of SOLYMBIC in pregnant women are not known and so the use of SOLYMBIC in pregnant women is not recommended.
Slovenian: Vplivi zdravila SOLYMBIC pri nosečnicah niso znani, zato uporaba zdravila SOLYMBIC pri nosečih ženskah ni priporočljiva.
English: In order to improve traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded.
Slovenian: Z namenom, da bi izboljšali sledljivost bioloških zdravil, morata biti zaščiteno ime in številka serije uporabljenega zdravila jasno zabeležena.
English: What SOLYMBIC is and what it is used for
Slovenian: Kaj je zdravilo SOLYMBIC in za kaj ga uporabljamo
English: For all of the above indications, available data suggest that the clinical response is usually achieved within 12 weeks of treatment.
Slovenian: Za vse zgornje indikacije razpoložljivi podatki kažejo, da se klinični odziv ponavadi pojavi v 12 tednih zdravljenja.
English: Should treatment be interrupted, SOLYMBIC 40 mg every week may be re-introduced (see section 5.1).
Slovenian: Če je potrebno z zdravljenjem prekiniti, lahko ponovno uvedete zdravljenje z zdravilom SOLYMBIC odmerkom 40 mg vsak teden (glejte poglavje 5.1).
English: Side effects may occur at least up to 4 months after the last SOLYMBIC injection.
Slovenian: Neželeni učinki se lahko pojavijo vsaj še 4 mesece po zadnji injekciji zdravila SOLYMBIC.
English: Clinical remission and clinical response (defined as reduction in PCDAI score of at least 15 points from baseline) rates are presented in table 20.
Slovenian: Stopnja klinične remisije in kliničnega odziva (definiran kot zmanjšanje vrednosti PCDAI vsaj za 15 točk od začetne vrednosti) sta predstavljena v preglednici 20.
English: If retreatment with SOLYMBIC is indicated, the above guidance on dose and treatment duration should be followed.
Slovenian: Če je indicirano vnovično zdravljenje z zdravilom SOLYMBIC, je treba upoštevati zgoraj navedena navodila za odmerjanje in trajanje zdravljena.
English: Treatment with SOLYMBIC can be initiated in combination with corticosteroids and/or with other non-biologic immunomodulatory agents.
Slovenian: Zdravljenje z zdravilom SOLYMBIC se lahko začne v kombinaciji s kortikosteroidi in/ali z drugimi nebiološkimi imunomodulatorji.
English: Formation of antiadalimumab antibodies is associated with increased clearance and reduced efficacy of adalimumab.
Slovenian: Nastanek protiteles proti adalimumabuje povezano z večjim očistkom in manjšo učinkovitostjo adalimumaba.
English: * Maximum single dose is 40 mg (0.8 mL)
Slovenian: * Največji enkratni odmerek je 40 mg (0,8 ml)
English: SOLYMBIC can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Slovenian: Zdravilo SOLYMBIC je mogoče uporabiti kot monoterapijo v primeru intolerance za metotreksat ali kadar nadaljnje zdravljenje z metotreksatom ni primerno.
English: For adalimumab, limited clinical data on exposed pregnancies are available.
Slovenian: Za adalimumab so na voljo omejeni klinični podatki od nosečnic, ki so bile izpostavljene zdravilu.
English: Keep this Patient Alert Card with you.
Slovenian: To opozorilno kartico imejte pri sebi.
English: This inflammation leads to a decrease of vision and/or the presence of floaters in the eye (black dots or wispy lines that move across the field of vision).
Slovenian: To vnetje povzroči poslabšanje vida in/ali prisotnost delcev v očesu (črnih pik ali koprenastih črt, ki se premikajo po vidnem polju).
English: If your doctor determines that methotrexate is inappropriate, SOLYMBIC can be given alone.
Slovenian: Če vaš zdravnik ugotovi, da metotreksat ni primeren, lahko zdravilo SOLYMBIC dobivate samo.
English: • lupus-like syndrome.
Slovenian: • sindrom podoben lupusu.
English: The impact of long-term treatment with SOLYMBIC on the development of autoimmune diseases is unknown.
Slovenian: Vpliv dolgoročnega zdravljenja z zdravilom SOLYMBIC na nastanek avtoimunskih bolezni ni znan.
English: It is important that you tell your baby's doctors and other health care professionals about your SOLYMBIC use during your pregnancy before the baby receives any vaccine (for more information see section on vaccination).
Slovenian: Zato je pomembno, da obvestite zdravnika vašega dojenčka in druge zdravstvene delavce, da ste med nosečnostjo prejemali zdravilo SOLYMBIC, preden bo vaš dojenček prejel katerokoli cepivo (za več informacij glejte poglavje o cepljenju).
English: The Guide for healthcare professionals shall contain the following key elements:
Slovenian: Vodnik za zdravstvene delavce mora vsebovati naslednje ključne točke:
English: The following list of adverse reactions is based on experience from clinical trials and on postmarketing experience and are displayed by system organ class and frequency in table 3 below: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); and not known (cannot be estimated from the available data).
Slovenian: Naslednji seznam neželenih učinkov je osnovan na izkušnjah iz kliničnih preskušanj in iz obdobja trženja zdravila in jih razvršča po organskih sistemih in pogostnosti v preglednici 3, spodaj: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1000 do <1/100), redki (≥1/10000 do <1/1000) in neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti).
English: The patient information pack should contain: • Patient information leaflet
Slovenian: Paket informacij za bolnike mora vsebovati: • Navodilo za uporabo.
English: You should continue to inject SOLYMBIC for as long as your doctor has told you.
Slovenian: Nadaljevati morate z injiciranjem zdravila SOLYMBIC tako dolgo, kot vam je naročil zdravnik.
English: Table 13 Ps study IV efficacy results at 16, 26 and 52 weeks
Slovenian: Študija pri psoriazi IV Rezultati učinkovitosti po 16, 26 in 52 tednih
English: When done, release your thumb, and gently lift the syringe off of your skin.
Slovenian: Ko ste opravili, odmaknite palec in brizgo previdno dvignite od kože.
English: If you received SOLYMBIC while you were pregnant, your baby may be at higher risk for getting such an infection for up to approximately five months after the last dose you received during pregnancy.
Slovenian: Če ste prejemali zdravilo SOLYMBIC med nosečnostjo, obstaja večje tveganje, da bo vaš otrok dobil takšno okužbo do približno pet mesecev po zadnjem odmerku, ki ste ga prejeli med nosečnostjo.
English: Before initiation of therapy with SOLYMBIC, all patients must be evaluated for both active or inactive (“latent”) tuberculosis infection.
Slovenian: Pred začetkom zdravljenja z zdravilom SOLYMBIC je vse bolnike treba pregledati glede aktivne ali neaktivne (latentne) tuberkulozne okužbe.
English: If you have or develop demyelinating disease such as multiple sclerosis, your doctor will decide if you should receive or continue to receive SOLYMBIC.
Slovenian: • Če imate ali pa se pri vas razvija demielinizirajoča bolezen, kot je multipla skleroza, bo zdravnik presodil, ali lahko dobivate oziroma tudi še nadalje dobivate zdravilo SOLYMBIC.
English: Antibiotics may be continued during treatment with SOLYMBIC if necessary.
Slovenian: Med zdravljenjem z zdravilom SOLYMBIC lahko nadaljujete z antibiotičnim zdravljenjem, če je potrebno.
English: tuberculosis and opportunistic infections; congestive heart failure; demyelinating disorders;
Slovenian: tuberkulozo in oportunistične okužbe; kongestivno srčno popuščanje; demielinizirajoče bolezni;