FrancophonIA/ELRC3.0 huggingface dataset:
English: Pull back on the plunger slowly to draw just more than the dose prescribed by your doctor into the syringe.
Slovenian: Počasi potegnite bat nazaj in v brizgo posesajte malo več od odmerka, ki vam ga je predpisal zdravnik.
English: - Remove the protective cap from the ViraferonPeg vial.
Slovenian: - Odstranite zaščitni pokrovček z viale zdravila ViraferonPeg.
English: *, cough
Slovenian: *, kašelj
English: If blood comes into the syringe, the needle has entered a blood vessel.
Slovenian: Če pride v brizgo kri, je igla zabodena v žilo.
English: Combination therapy with ribavirin
Slovenian: Kombinirana terapija z ribavirinom
English: Therefore, the combination of ViraferonPeg with telbivudine is contraindicated (see section 4.3).
Slovenian: Kombinacija zdravila ViraferonPeg in telbivudina je zato kontraindicirana (glejte poglavje 4.3).
English: The purpose of the study was to evaluate the durability of sustained virologic response (SVR) and assess the impact of continued viral negativity on clinical outcomes.
Slovenian: Namen te študije je bil oceniti trajanje trajnega virološkega odziva (SVR) in vpliv nadaljnjega negativnega izvida glede prisotnosti virusa na klinični izid zdravljenja.
English: If you take telbivudine with this medicine or any type of injectable interferon product, your risk of developing peripheral neuropathy (numbness, tingling and/or burning sensations in the arms and/or legs) is higher.
Slovenian: Če jemljete telbivudin s tem zdravilom ali katerim koli interferonskim zdravilom za injiciranje, imate povečano tveganje za nastanek periferne nevropatije (odrevenelost, mravljinci in/ali pekoč občutek v rokah in/ali nogah).
English: A positive predictive value of 50 % (52/104; Study 1) was observed for HCV/HIV co-infected patients receiving bitherapy.
Slovenian: 50 % pozitivno napovedno vrednost (52/104, študija 1) so opazili pri bolnikih, ki so bili sočasno okuženi s HCV/HIV in so prejemali dvojno terapijo.
English: The relative non-toxicity of monomethoxy-polyethylene glycol (mPEG), which is liberated from ViraferonPeg by metabolism in vivo has been demonstrated in preclinical acute and subchronic toxicity studies in rodents and monkeys, standard embryo-foetal development studies and in in vitro mutagenicity assays.
Slovenian: Relativna netoksičnost monometoksipolietilenglikola (mPEG), ki se sprošča iz zdravila ViraferonPeg ob njegovi presnovi in vivo, je bila potrjena v predkliničnih študijah akutne in subkronične toksičnosti pri glodalcih in opicah, v standardnih raziskavah embriofetalnega razvoja in s testi mutagenosti in vitro.
English: The side effect may develop at various time points during treatment, typically several months after starting treatment with ViraferonPeg.
Slovenian: Neželeni učinek se lahko pojavi ob različnih časovnih točkah zdravljenja, običajno nekaj mesecev po začetku zdravljenja z zdravilom ViraferonPeg.
English: > 4 mg/dl (for > 4 weeks)
Slovenian: > 4 mg/dl (za > 4 tedne)
English: What ViraferonPeg is and what it is used for
Slovenian: Kaj je zdravilo ViraferonPeg in za kaj ga uporabljamo
English: The clinical incidence of neutralising factors in patients who received ViraferonPeg 0.5 micrograms/kg is 1.1 %.
Slovenian: Klinična pojavnost nevtralizacijskih dejavnikov pri bolnikih, ki so prejemali zdravilo ViraferonPeg v odmerku 0,5 mikrograma/kg, je bila 1,1 %.
English: Long-term data available in children treated with the combination therapy of pegylated interferon/ribavirin are indicative of substantial growth retardation.
Slovenian: Dolgoročni podatki, ki so na voljo za otroke, ki so se zdravili s kombinirano terapijo s pegiliranim interferonom/ribavirinom, kažejo znatno upočasnitev rasti.
English: Overall, approximately 36 % (821/2,286) of patients had undetectable plasma HCV-RNA levels at week 12 of therapy measured using a research-based test (limit of detection 125 IU/ml).
Slovenian: Skupaj je imelo v 12. tednu zdravljenja približno 36 % (821/2.286) bolnikov nemerljive koncentracije HCV-RNA v plazmi, kar so merili s študijskim testom (meja detekcije 125 i.e./ml).
English: Hypocalcemia, hyperuricemia, dehydration, increased appetite
Slovenian: hipokalciemija, hiperurikemija, dehidracija, povečan apetit
English: If the chest X-ray shows pulmonary infiltrates or there is evidence of pulmonary function impairment, the patient is to be monitored closely, and, if appropriate, discontinue interferon alpha.
Slovenian: Če rentgenogram prsnega koša pokaže pljučne infiltrate ali znake poslabšanja pljučne funkcije, morate bolnika skrbno nadzorovati in po potrebi prekiniti zdravljenje z interferonom alfa.
English: Table 11 Virologic response at treatment week 12, end of treatment response, relapse rate *and Sustained Virologic Response (SVR) Treatment group
Slovenian: Preglednica 11 Virološki odziv v 12. tednu zdravljenja, odziv ob koncu zdravljenja, delež ponovitev bolezni* in trajni virološki odziv (SVR) Terapevtska skupina
English: Data are not available for the use of ViraferonPeg in patients with creatinine clearance < 15 ml/minute (see section 5.2).
Slovenian: Ni podatkov o uporabi zdravila ViraferonPeg pri bolnikih z očistkom kreatinina < 15 ml/minuto (glejte poglavje 5.2).
English: Concomitant administration of peginterferon alfa-2b (ViraferonPeg) with caffeine or desipramine modestly increased the exposure of caffeine and desipramine.
Slovenian: Sočasna uporaba peginterferona alfa-2b (zdravila ViraferonPeg) s kofeinom ali dezipraminom je zmerno povečala izpostavljenost kofeinu in dezipraminu.
English: Response at treatment week
Slovenian: Odziv v tednu zdravljenja
English: - have received an organ transplant, either kidney or liver, interferon treatment may increase the risk of rejection.
Slovenian: - imate presajen organ, bodisi ledvico ali jetra; zdravljenje z interferonom lahko poveča tveganje za zavrnitev presajenega organa.
English: If psychiatric symptoms persist or worsen, or suicidal or homicidal ideation is identified, it is recommended that treatment with ViraferonPeg be discontinued, and the patient followed, with psychiatric intervention as appropriate.
Slovenian: Če psihiatrični simptomi trajajo dlje časa ali se celo poslabšajo ali če ugotovite, da ima bolnik samomorilne ali morilske misli, je priporočljivo, da se zdravljenje z zdravilom ViraferonPeg ukine in da bolnika spremljate, po potrebi tudi s psihiatrično intervencijo.
English: In these studies, the effects of multiple-dose regimens of peginterferon alfa-2b (ViraferonPeg) were investigated in Hepatitis C subjects (1.5 mcg/week) or healthy subjects (1 mcg/week or 3 mcg/week) (Table 4).
Slovenian: V teh študijah so raziskali učinke režimov z večkratnimi odmerki peginterferona alfa-2b (zdravila ViraferonPeg) pri preiskovancih s hepatitisom C (1,5 mcg/teden) in zdravih preiskovancih (1 mcg/teden ali 3 mcg/teden) (preglednica 4).
English: Case by case benefit/risk assessment in children The expected benefit of treatment should be carefully weighed against the safety findings observed for children and adolescents in the clinical trials (see sections 4.8 and 5.1).
Slovenian: Individualna ocena razmerja med koristmi in tveganji pri otrocih Pričakovano korist zdravljenja je treba skrbno pretehtati glede na znane izsledke kliničnih preskušanj o varnosti zdravila pri otrocih in mladostnikih (glejte poglavji 4.8 in 5.1).
English: It has been demonstrated in a clinical study that peginterferon alfa-2b at low-dose (0.5 μg/kg/week) is not effective in long term maintenance monotherapy (for a mean duration of 2.5 years) for the prevention of disease progression in non responders with compensated cirrhosis.
Slovenian: V klinični študiji so dokazali, da peginterferon alfa-2b v majhnih odmerkih (0,5 μg/kg na teden) ni učinkovit za dolgoročno vzdrževalno monoterapijo (pri srednji dolžini zdravljenja 2,5 let) z namenom preprečevanja napredovanja bolezni pri bolnikih s kompenzirano cirozo, ki se ne odzivajo na zdravljenje.
English: Gently place the needle tip against the glass wall of the vial without touching the cleaned top of the vial with your hands.
Slovenian: Nežno prislonite konico igle ob steno viale, ne da bi se dotaknili očiščenega zgornjega dela viale z rokami.
English: The dose administered in adults depends on whether it is used in combination therapy (bitherapy or tritherapy) or as monotherapy.
Slovenian: Odmerek zdravila za odrasle je odvisen od tega, ali se uporablja v kombinaciji (dvojna ali trojna terapija) ali v obliki monoterapije.
English: • Turn the dial to your prescribed dose (see Figure 8).
Slovenian: • Obrnite gumb za nastavitev na svoj predpisani odmerek (glejte sliko 8).
English: This decline was significant among responders (-0.3 for Metavir and -1.2 for Ishak) and stable (-0.1 for Metavir and -0.2 for Ishak) among non-responders.
Slovenian: To zmanjšanje je bilo pomembno pri bolnikih, ki so se odzvali na zdravljenje (-0,3 pri oceni po Metavirju in -1,2 pri oceni po Ishaku), in stabilno (-0,1 pri oceni po Metavirju in -0,2 pri oceni po Ishaku) pri tistih, ki se niso odzvali na zdravljenje.
English: These are thigh, outer surface of the upper arm (you may need the assistance of another person to use this site) and abdomen (except the navel or waistline).
Slovenian: To so stegno, zunanja stran nadlakti (za injiciranje zdravila na tem mestu boste morda potrebovali pomoč druge osebe) in trebuh (razen popka in pasu).
English: Preliminary data indicate that interferon alpha therapy may be associated with an increased rate of kidney graft rejection.
Slovenian: Preliminarni podatki kažejo, da je lahko terapija z interferonom alfa povezana s povečano pogostnostjo zavrnitve ledvičnega presadka.
English: Table 5 Precautions for co-administration (ViraferonPeg should be administered with care when co-administered with the following medicines)
Slovenian: Preglednica 5 Previdnost pri sočasni uporabi (zdravilo ViraferonPeg je treba uporabljati previdno, kadar se uporablja sočasno z naslednjimi zdravili)
English: Press the injection site with a small bandage or sterile gauze if necessary for several seconds.
Slovenian: Po potrebi za nekaj sekund pritisnite na injekcijsko mesto z majhnim obližem ali sterilno gazo.
English: - pain in joints and muscles, muscle and bone pain.
Slovenian: - bolečine v sklepih in mišicah, mišične in kostne bolečine.
English: Important treatment-emergent adverse reactions that occurred in this patient population were nervousness (8 %), aggression (3 %), anger (2 %), depression/depressed mood (4 %) and hypothyroidism (3 %) and 5 subjects received levothyroxine treatment for hypothyroidism/elevated TSH.
Slovenian: Pomembni neželeni učinki, ki so se pojavili med zdravljenjem pri tej populaciji bolnikov, so bili živčnost (8 %), agresivnost (3 %), jeza (2 %), depresija/depresivno razpoloženje (4 %) ter hipotiroidizem (3 %), 5 preiskovancev pa je prejelo levotiroksin zaradi hipotiroidizma oziroma zvišane vrednosti TSH.
English: This would be particularly important in patients with a known history of zidovudine-induced anaemia.
Slovenian: To je lahko še posebej pomembno pri bolnikih, pri katerih je znano, da so imeli v preteklosti že anemijo zaradi jemanja zidovudina.
English: As for all parenteral medicinal products, the reconstituted solution is to be inspected visually prior to administration.
Slovenian: Kot pri vseh parenteralnih zdravilih morate tudi tukaj rekonstituirano raztopino pred uporabo vizualno pregledati.
English: The population enrolled mainly consisted of children with mild to moderate hepatitis C. Due to the lack of data in children with severe progression of the disease, and the potential for undesirable effects, the benefit/risk of the combination of ViraferonPeg with ribavirin needs to be carefully considered in this population (see sections 4.1, 4.4 and 4.8).
Slovenian: Populacija bolnikov, vključenih v preskušanje, je bila sestavljena predvsem iz otrok z blagim do zmernim hepatitisom C. Zaradi pomanjkanja podatkov pri otrocih z močno napredovalo boleznijo in zaradi nevarnosti za pojav neželenih učinkov je treba pri tej populaciji skrbno pretehtati razmerje med tveganji in koristmi zdravljenja s kombinacijo zdravila ViraferonPeg in ribavirina (glejte poglavja 4.1, 4.4 in 4.8).
English: Note: Once the pre-filled pen is removed from the skin, the needle shield will lock in place.
Slovenian: Opomba: Ko boste napolnjeni injekcijski peresnik odmaknili s kože, se bo ščitnik igle zaskočil na svojem mestu.
English: In a clinical trial with 107 children and adolescent patients (3 to 17 years of age) treated with combination therapy of ViraferonPeg and ribavirin, dose modifications were required in 25 % of patients, most commonly for anaemia, neutropenia and weight loss.
Slovenian: V kliničnem preskušanju pri 107 otrocih in mladostnikih (starih od 3 do 17 let), zdravljenih s kombinirano terapijo zdravila ViraferonPeg in ribavirina, je bila potrebna prilagoditev odmerka pri 25 % bolnikov, najpogosteje zaradi anemije, nevtropenije in izgube telesne mase.
English: In the presence of thyroid dysfunction, ViraferonPeg treatment may be continued if TSH levels can be maintained in the normal range by medicine.
Slovenian: V primeru motenj delovanja ščitnice lahko zdravljenje z zdravilom ViraferonPeg nadaljujete, če lahko z zdravilom ohranjate vrednosti TSH v normalnem razponu.
English: All patients should be screened for hepatitis B before starting treatment with interferon for hepatitis C; patients co-infected with hepatitis B and C must then be monitored and managed according to current clinical guidelines.
Slovenian: Pred začetkom zdravljenja hepatitisa C z interferonom je treba vse bolnike testirati za hepatitis B. Bolnike, sočasno okužene s hepatitisom B in C je nato treba spremljati in obravnavati v skladu s trenutnimi kliničnimi smernicami.
English: A clinically significant pharmacokinetic interaction was not observed between peginterferon alfa-2b (ViraferonPeg) and tolbutamide, midazolam or dapsone; therefore, no dosing adjustment is necessary when peginterferon alfa-2b (ViraferonPeg) is administered with medicines metabolized by CYP2C9, CYP3A4 and N-acetyltransferase.
Slovenian: Klinično pomembnih farmakokinetičnih interakcij med peginterferonom alfa-2b (zdravilom ViraferonPeg) in tolbutamidom, midazolamom ali dapsonom niso opazili, zato prilagoditev odmerka ni potrebna, kadar se peginterferon alfa-2b (zdravilo ViraferonPeg) uporablja sočasno z zdravili, ki se presnovijo s CYP2C9, CYP3A4 in N-acetiltransferazo.
English: If you have an intolerance to some sugars, contact your doctor before taking this medicine.
Slovenian: Če ne prenašate določenih sladkorjev, se posvetujte z zdravnikom preden začnete uporabljati to zdravilo.
English: Telbivudine
Slovenian: Telbivudin
English: The shield will automatically glide back to allow the needle to inject the medicine.
Slovenian: Ščitnik bo avtomatsko zdrsnil nazaj in zdravilo bo skozi iglo lahko injicirano.
English: (8/194) of patients and decrease in platelets below 50,000/mm
Slovenian: 3 pri 4 % (8/194) bolnikov in zmanjšanje števila trombocitov pod 50.000/mm
English: Based on single dose data, clearance was similar in patients with severe renal impairment not on dialysis and in patients who were receiving hemodialysis.
Slovenian: Glede na podatke za enkratni odmerek je bil očistek pri bolnikih s hudo ledvično okvaro, a ne na dializi, podoben kot pri tistih na hemodializi.
English: The use of ViraferonPeg in combination with ribavirin had no observable negative impact on the control of HIV viraemia during therapy or follow-up.
Slovenian: Uporaba zdravila ViraferonPeg v kombinaciji z ribavirinom ni imela opaznega negativnega vpliva na nadzor viremije HIV med samim zdravljenjem ali pozneje, med spremljanjem bolnikov.
English: It is important to consider that the combination therapy induced a growth inhibition, that resulted in reduced height in some patients.
Slovenian: Pomembno je upoštevati, da kombinirana terapija povzroči zastoj rasti, ki je pri nekaterih bolnikih povzročil manjšo telesno višino.
English: Renal clearance appears to account for 30 % of total clearance of ViraferonPeg.
Slovenian: Kaže, da izločanje zdravila skozi ledvica predstavlja 30 % celotnega očistka zdravila ViraferonPeg.
English: Patients with substance use/abuse
Slovenian: Bolniki, ki uživajo/zlorabljajo opojne substance
English: Interferon neutralising factors are antibodies which neutralise the antiviral activity of interferon.
Slovenian: Gre za protitelesa, ki nevtralizirajo protivirusno delovanje interferona.
English: Reports of mitochondrial toxicity, in particular lactic acidosis and pancreatitis, of which some fatal, have been reported (see ribavirin SmPC).
Slovenian: Objavljena so bila poročila o primerih mitohondrijske toksičnosti, še posebej v obliki laktacidoze in pankreatitisa, in nekateri od njih so bili smrtni (glejte SmPC za ribavirin).
English: Fatigue, alopecia, pruritus, nausea, anorexia, weight decreased, irritability and insomnia occur at a notably lower rate in patients treated with ViraferonPeg monotherapy compared to those treated with combination therapy (see Table 6).
Slovenian: Utrujenost, alopecija, pruritus, navzea, anoreksija, zmanjšanje telesne mase, razdražljivost in nespečnost se pojavljajo opazno redkeje pri bolnikih, zdravljenih z zdravilom ViraferonPeg v monoterapiji, kot pa pri tistih, ki prejemajo kombinirano zdravljenje (glejte preglednico 6).
English: Select the injection site.
Slovenian: Izberite si mesto injiciranja.
English: Patients treated with ViraferonPeg and ribavirin combination therapy and zidovudine are at increased risk of developing anaemia and therefore the concomitant use of this combination with zidovudine is not recommended (see section 4.5).
Slovenian: Bolniki, ki prejemajo kombinirano terapijo z zdravilom ViraferonPeg in ribavirinom ter zidovudin, imajo povečano tveganje za pojav anemije, zato sočasna uporaba te kombinacije z zidovudinom ni priporočljiva (glejte poglavje 4.5).
English: In patients co-infected with HCV/HIV, limited efficacy and safety data (N = 25) are available in subjects with CD4 counts less than 200 cells/µl.
Slovenian: Pri bolnikih, ki so sočasno okuženi s HCV/HIV, so na voljo omejeni podatki o učinkovitosti in varnosti zdravila (N = 25) za tiste, ki imajo število celic CD4 manjše od 200 celic/μl.
English: This medicine is a powder and solvent (liquid) for solution for injection.
Slovenian: To zdravilo je prašek in vehikel (tekočina) za raztopino za injiciranje.
English: 9/l (adults) ≥ 50 x 10
Slovenian: 9/l (odrasli) ≥ 50 x 10
English: Look carefully at the solution you prepared before you use it.
Slovenian: Pred uporabo si natančno oglejte raztopino, katero ste pripravili.
English: - develop symptoms associated with a cold or other respiratory infection, such as fever, cough, or any difficulty in breathing.
Slovenian: - ste dobili simptome prehlada ali druge okužbe dihal, npr. zvišano telesno temperaturo, kašelj ali kakršne koli težave z dihanjem.
English: Girls or women of childbearing potential need to use effective birth control during the treatment with this medicine.
Slovenian: Dekleta in ženske v rodni dobi morajo med zdravljenjem s tem zdravilom uporabljati učinkovito kontracepcijo.
English: Recombinant interferon alfa-2b also inhibits viral replication in vitro and in vivo.
Slovenian: Rekombinantni interferon alfa-2b zavira tudi razmnoževanje virusov in vitro ter in vivo.
English: Blood thyroid stimulating hormone increased, thyroglobulin increased
Slovenian: povečana količina tiroidnega stimulirajočega hormona v krvi, povečana količina tiroglobulina
English: Following single doses of ViraferonPeg between 0.25 and 2.0 micrograms/kg/week, serum neopterin concentration was increased in a dose-related manner.
Slovenian: Po enkratnih odmerkih zdravila ViraferonPeg med 0,25 in 2,0 mikrogramov/kg/teden se je serumska koncentracija neopterina povečala v odvisnosti od odmerka.
English: The effects on growth were less in those subjects treated for 24 weeks than those treated for 48 weeks.
Slovenian: Učinki na rast so bili pri preiskovancih, zdravljenih 24 tednov, manjši kot pri preiskovancih, zdravljenih 48 tednov.
English: Ribavirin dose (mg/kg)
Slovenian: Odmerek ribavirina (mg/kg)
English: Recombinant interferon alfa-2b is covalently conjugated with monomethoxy polyethylene glycol at an average degree of substitution of 1 mole of polymer/mole of protein.
Slovenian: Rekombinantni interferon alfa-2b je kovalentno konjugiran z monometoksi polietilenglikolom pri povprečni stopnji substitucije 1 mol polimera na mol beljakovine.
English: The most common treatment-related adverse reactions reported during clinical trials with ViraferonPeg in combination with ribavirin in adults, seen in more than half of the study subjects, were fatigue, headache, and injection site reaction.
Slovenian: Najpogostejši z zdravljenjem povezani neželeni učinki, o katerih so poročali pri odraslih bolnikih med kliničnimi preskušanji z zdravilom ViraferonPeg v kombinaciji z ribavirinom in so ji opazili pri več kot polovici preiskovancev v teh preskušanjih, so bili utrujenost, glavobol in reakcija na mestu injiciranja.
English: Approximately 21 % of children treated with ViraferonPeg/ribavirin combination therapy developed increase in thyroid stimulating hormone (TSH).
Slovenian: Pri približno 21 % otrok, zdravljenih s kombinirano terapijo z zdravilom ViraferonPeg/ribavirin, se je pojavilo povečanje vrednosti tiroidnega stimulirajočega hormona (TSH).
English: Consideration should be given to replacing zidovudine in a combination anti-retroviral treatment (ART) regimen if this is already established.
Slovenian: Premisliti je treba, ali bi bilo treba pri zdravljenju z uveljavljeno kombinirano antiretrovirusno shemo (ART) morda zamenjati zidovudin.
English: The 6 month treatment duration in this trial was better tolerated than one year of treatment in the pivotal combination trial; for discontinuation 5 % vs. 14 %, for dose modification 18 % vs. 49 %.
Slovenian: Bolniki so v tem ključnem kombiniranem preskušanju bolje prenašali 6-mesečno terapijo kot enoletno terapijo; zdravljenje so prekinili pri 5 % oz. 14 % bolnikov, odmerek pa prilagodili pri 18 % oz. 49 % bolnikov.
English: Do not use the solution if it is discoloured (changed its colour from the original) or if there are bits of particles in the solution.
Slovenian: Raztopine ne smete uporabiti, če je obarvana (sprememba v prvotni barvi raztopine) ali če so v njej vidni delci.
English: Proteinuria
Slovenian: proteinurija
English: Failure to prior therapy was defined as relapse or non-response (HCV-RNA positive at the end of a minimum of 12 weeks of treatment).
Slovenian: Neuspešno predhodno zdravljenje so opredelili kot ponovitev bolezni (relaps) ali odsotnost odziva na zdravljenje (pozitivna HCV-RNA ob koncu najmanj 12-tedenskega zdravljenja).
English: • Turn the dial to number 1 (see Figure 1).
Slovenian: • Obrnite gumb za nastavitev do številke 1 (glejte sliko 1).
English: In those patients that received > 10.6 mg/kg ribavirin (800 mg dose in typical 75 kg patient), regardless of genotype or viral load, response rates were significantly higher than in those patients that received  10.6 mg/kg ribavirin (Table 9), while response rates in patients that received > 13.2 mg/kg ribavirin were even higher.
Slovenian: Pri tistih bolnikih, ki so prejeli > 10,6 mg/kg ribavirina (800 mg odmerek pri tipičnem 75 kg težkem bolniku), je bila stopnja odziva ne glede na genotip ali virusno breme pomembno višja kot pri bolnikih, ki so prejeli  10,6 mg/kg ribavirina (preglednica 9), medtem ko je bila stopnja odziva pri bolnikih, ki so prejeli > 13,2 mg/kg ribavirina, še večja.
English: Psychiatric and central nervous system:
Slovenian: Psihiatrične motnje in bolezni osrednjega živčevja:
English: If such symptoms appear, the potential seriousness of these undesirable effects must be borne in mind by the prescribing physician and the need for adequate therapeutic management should be considered.
Slovenian: Če se pojavijo takšni simptomi, mora zdravnik, ki predpiše zdravilo, upoštevati potencialno resnost teh neželenih učinkov in mora po potrebi uvesti ustrezne terapevtske ukrepe.