FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients should be given intravenous diphenhydramine 25 mg to 50 mg (or similar antihistamine) approximately 30 minutes before the start of each dose of temsirolimus (see section 4.4).
Slovenian: Približno 30 minut pred začetkom vsakega odmerka temsirolimusa morajo bolniki intravensko prejeti od 25 mg do 50 mg difenhidramina (ali podobnega antihistaminika) (glejte poglavje 4.4).
English: if you have or have had liver problems.
Slovenian: - če imate ali ste kdaj imeli težave z jetri.
English: Polyvinyl chloride (PVC) bags and medical devices must not be used for the administration of preparations containing polysorbate 80, because polysorbate 80 leaches di-2-ethylhexylphthalate (DEHP) from PVC.
Slovenian: Za dajanje pripravkov, ki vsebujejo polisorbat 80, ne smete uporabljati vrečk in medicinskih pripomočkov iz polivinilklorida (PVC), ker polisorbat 80 ekstrahira di-2-etilheksilftalat (DEHP) iz PVC.
English: • Administration of the final diluted solution should be completed within six hours from the time that the Torisel is first added to sodium chloride 9 mg/ml (0.9%) solution for injection.
Slovenian: • Končna razredčena raztopina mora biti do konca porabljena v šestih urah od takrat, ko zdravilo Torisel prvič dodate raztopini natrijevega klorida 9 mg/ml (0,9 %) za injiciranje.
English: Patients receiving the higher dose of 175 mg of Torisel for the initial treatment of mantle cell lymphoma may receive a dose of ethanol equivalent to up to 123 ml beer or 51 ml wine per dose.
Slovenian: Bolniki, ki za začetno zdravljenje limfoma plaščnih celic prejemajo večji odmerek zdravila Torisel, to je 175 mg, lahko prejmejo količino alkohola, ki ustreza do 123 ml piva oziroma do 51 ml vina na odmerek.
English: After first dilution of the concentrate with 1.8 ml of the supplied solvent, the mixture may be stored for up to 24 hours below 25°C and protected from light prior to further dilution.
Slovenian: Po prvem redčenju koncentrata z 1,8 ml priloženega vehikla smete mešanico pred nadaljnjim redčenjem hraniti do 24 ur pri temperaturi do 25 C in zaščiteno pred svetlobo.
English: After first dilution of the concentrate with 1.8 ml of solvent, the concentration of temsirolimus is 10 mg/ml (see section 4.2).
Slovenian: Po prvem redčenju koncentrata z 1,8 ml vehikla je koncentracija temsirolimusa 10 mg/ml (glejte poglavje 4.2).
English: Read the leaflet for the shelf life of the diluted product.
Slovenian: Preberite navodilo glede roka uporabnosti razredčenega zdravila.
English: Each vial of 1.2 ml of concentrate for solution for infusion contains 30 mg temsirolimus.
Slovenian: Ena viala z 1,2 ml koncentrata za raztopino za infundiranje vsebuje 30 mg temsirolimusa.
English: In RCC clinical trial 1, temsirolimus 25 mg was associated with a statistically significant advantage over IFN-α in the primary endpoint of OS at the 2nd pre-specified interim analysis (n = 446 events,
Slovenian: V kliničnem preskušanju RCC 1 je bil temsirolimus v odmerku 25 mg ob 2. vnaprej specificirani vmesni analizi (n = 446 dogodkov, p = 0,0078) glede primarnega opazovanega dogodka OS statistično pomembno boljši od IFN-.
English: After first dilution of Torisel 30 mg concentrate with 1.8 ml of the supplied solvent 24 hours when stored below 25°C and protected from light.
Slovenian: Po prvem redčenju zdravila Torisel 30 mg koncentrat z 1,8 ml priloženega vehikla 24 ur, če je shranjeno pri temperaturi do 25 C in zaščiteno pred svetlobo
English: The adverse reactions (all grades) experienced by at least 20% of the patients in RCC and MCL registration studies include anaemia, nausea, rash (including rash, pruritic rash, maculopapular rash, pustular rash), decreased appetite, oedema asthenia, fatigue, thrombocytopenia, diarrhoea, pyrexia, epistaxis, mucosal inflammation, stomatitis, vomiting, hyperglycaemia, hypercholesterolemia, dysgeusia, pruritus, cough, infection, pneumonia, dyspnoea.
Slovenian: Neželeni učinki (vseh stopenj), ki so se pojavili pri vsaj 20 % bolnikov, ki so sodelovali v registracijskih preskušanjih pri RCC in MCL, vključujejo anemijo, navzeo, izpuščaje (vključno z izpuščajem, srbečim izpuščajem, makulopapuloznim izpuščajem, pustuloznim izpuščajem), zmanjšanje apetita, edeme, astenijo, utrujenost, trombocitopenijo, diarejo, pireksijo, epistakso, vnetje sluznic, stomatitis, bruhanje, hiperglikemijo, hiperholesterolemijo, disgevzijo, pruritus, kašelj, okužbe, pljučnico, dispnejo.
English: The adverse reactions reported by the highest percentage of patients were haematologic (anaemia, leukopenia, neutropenia, and thrombocytopenia), metabolic (hypercholesterolemia, hyperlipaemia, hyperglycaemia, increase of serum aspartate amino transferase (AST) and serum alanine aminotransferase (ALT) plasma levels), and digestive (mucositis, stomatitis, nausea, and vomiting).
Slovenian: Neželeni učinki, o katerih je poročal največji odstotek bolnikov, so bili hematološki (anemija, levkopenija, nevtropenija in trombocitopenija), presnovni (hiperholesterolemija, hiperlipidemija, hiperglikemija, povečanje ravni serumske aspartat-aminotransferaze (AST) in serumske alaninaminotransferaze (ALT) v plazmi) in povezani s prebavo (vnetje sluznic, stomatitis, navzea in bruhanje).
English: Holda a Upon recovery to ANC 1.0 x 109/l (1000 cells/mm3) and platelets to 50 x 109/l
Slovenian: 9/l (1.000 celic/mm 3) in trombocitov na  50 x 10
English: Months (97.5% CI)
Slovenian: Razmerje ogroženosti (97,5 % IZ)
English: For patients with severe hepatic impairment, a reduction of the temsirolimus dose to 10 mg is recommended to provide temsirolimus plus sirolimus exposures in blood (mean AUCsum approximately 6510 ng·h/ml; n=7), which approximate to those following the 25 mg dose (mean AUCsum approximately 6580 ng·h/ml; n=6) in patients with normal liver function (see sections 4.2 and 4.4).
Slovenian: Ta odmerek zagotovi izpostavljenost temsirolimusu in sirolimusu v krvi (povprečna AUCvsota približno 6.510 ng∙h/ml; n = 7), ki je podobna izpostavljenosti po odmerku 25 mg (povprečna AUCvsota približno 6.580 ng∙h/ml; n = 6) pri bolnikih z normalnim delovanjem jeter (glejte poglavji 4.2 in 4.4).
English: The solvent is a clear to slightly turbid, light-yellow to yellow solution.
Slovenian: Vehikel je bistra do rahlo motna, svetlo rumena do rumena raztopina.
English: Torisel is a concentrate and solvent for solution for infusion.
Slovenian: Zdravilo Torisel je koncentrat in vehikel za raztopino za infundiranje.
English: Caution should be used when treating patients with hepatic impairment.
Slovenian: Pri zdravljenju bolnikov z okvaro jeter je potrebna previdnost.
English: Amphiphilic agents
Slovenian: Amfifilna sredstva
English: Very common Hyperglycaemia Hypercholesterolaemia Hypertriglyceridaemia Decreased appetite Hypokalaemia
Slovenian: Presnovne in prehranske motnje zelo pogosti hiperglikemija hiperholesterolemija hipertrigliceridemija zmanjšan apetit hipokaliemija pogosti diabetes mellitus dehidracija hipokalciemija hipofosfatemija hiperlipidemija
English: if you experience any excessive thirst or increased frequency and quantity of urination.
Slovenian: - če ste prekomerno žejni ali pogosteje in obilneje odvajate vodo.
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja neznana
English: How to store Torisel
Slovenian: Kako boste prejeli zdravilo Torisel
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Torisel
Slovenian: IME ZDRAVILA IN POT(I) UPORABE
English: Following administration of [14C] temsirolimus, excretion was predominantly via the faeces (78%), with renal elimination of active substance and metabolites accounting for 4.6% of the administered dose.
Slovenian: C] temsirolimusa se je le-ta izločal iz telesa pretežno z blatom (78 %), 4,6 % danega odmerka učinkovine in presnovkov pa se je izločilo preko ledvic.
English: You should seek medical advice immediately if you feel confused, unusually tired, have difficulty in speaking or in swallowing and your pupils have different sizes.
Slovenian: Če ste zmedeni, nenavadno utrujeni, imate težave pri govoru ali požiranju in če so vaše zenice različnih velikosti, nemudoma poiščite zdravniško pomoč.
English: Uncommon Pulmonary embolism a
Slovenian: plevralni izliv a, b občasni pljučna embolija
English: General feeling of weakness, chills, swelling due to fluid retention, pain (including abdominal, back, chest and joint pain), feeling sick to the stomach (nausea and vomiting), diarrhoea, constipation , headache, fever, sores and inflammation in the mouth and/or the digestive tract, cough, pneumonia, nose bleed, rash, itching, dry skin, decreased appetite, shortness of breath, low levels of potassium in the blood (which may cause muscle weakness), low red blood cell count, decreased number of a type of white blood cells which is associated with an increased risk of infection, high blood sugar, high cholesterol, high triglycerides abscess, infections ( including eye infection, flu, viral infections, bronchitis), abnormal kidney function (including kidney failure), blood tests that show changes in the way the kidney is working, change in the sense of taste, difficulty falling asleep, low number of platelets which may cause bleeding and bruising.
Slovenian: Splošen občutek oslabelosti, mrzlica, otekanje zaradi zastoja tekočine, bolečine (med drugim v trebuhu, hrbtu, prsih in sklepih), občutek slabosti v želodcu (navzea in bruhanje), driska, zaprtje, glavobol, vročina, razjede in vnetje v ustih in/ali prebavilih, kašelj, pljučnica, krvavitev iz nosu, izpuščaj, srbenje, suha koža, zmanjšanje teka, kratka sapa, majhna koncentracija kalija v krvi (ki lahko povzroči mišično šibkost), zmanjšano število rdečih krvničk, zmanjšano število vrste belih krvničk, ki je povezano z večjim tveganjem za okužbe, zvišan krvni sladkor, zvišan holesterol, zvišani trigliceridi, absces, okužbe (vključno z okužbami oči, gripo, virusnimi okužbami, bronhitisom), nenormalno delovanje ledvic (vključno z ledvično odpovedjo), preiskave krvi, ki kažejo spremembe delovanja ledvic, spremenjen čut za okus, nespečnost, majhno število krvnih ploščic, kar lahko povzroči krvavitve ali podplutbe.
English: Clear glass vial (type 1), with butyl rubber stopper and a plastic flip-top closure sealed with aluminum containing 1.2 ml of concentrate
Slovenian: Viala iz prozornega stekla (tipa 1) z zaporko iz butilne gume in plastično zaporko, zavarjeno z aluminijem; viala vsebuje 1,2 ml koncentrata.
English: Runny nose, gum redness and swelling, mouth pain (including sores inside the mouth), stomach bloating, sore throat, high blood pressure, pink eye including watery eye disorder, taste loss, redness and swelling of the follicles in the skin, allergic reactions, severe scaling of the skin, increased blood clotting (including thrombosis of the veins), low levels of calcium in the blood, low levels of phosphates in the blood, upper respiratory infections, inflammation of the lung, fluid in the chest cavity, infection in the blood, dehydration, agitation, depression, numbness and tingling of the skin, dizziness, sleepiness, bleeding (from the lips, mouth, stomach or intestines), inflammation of the lining of the stomach, trouble with swallowing, skin bleeding (bruising), small pin-point haemorrage, nail disorder, acne, yeast infection, fungal infection, urinary tract infections, cystitis, blood tests that show changes in the way the liver is working, high blood fats other than triglycerides, diabetes, muscle pain.
Slovenian: Nahod, rdečina in otekanje dlesni, bolečina v ustih (vključno z razjedami v ustih), napihnjenost trebuha, bolečine v grlu, zvišan krvni tlak, pordelo oko, vključno s solzenjem, izguba okusa, rdečina in otekanje mešičkov v koži, alergijske reakcije, močno luščenje kože, zvečano strjevanje krvi (vključno z vensko trombozo), zmanjšana koncentracija kalcija v krvi, zmanjšana koncentracija fosfata v krvi, okužbe zgornjih dihalnih poti, vnetje pljuč, tekočina v prsnem košu, okužba krvi, dehidracija, agitacija, depresija, odrevenelost in mravljinčenje kože, omotica, zaspanost, krvavitev (iz ustnic, ust, želodca ali črevesa), vnetje želodčne sluznice, oteženo požiranje, kožne krvavitve (podplutbe), majhne, točkaste krvavitve, poškodbe nohtov, akne, okužba s kvasovkami, glivična okužba, okužbe sečil, vnetje mehurja, preiskave krvi, ki kažejo spremembe delovanja jeter, zvišane maščobe v krvi (razen trigliceridov), sladkorna bolezen, bolečine v mišicah.
English: It is important that the recommendations in sections 4.2 and 6.6 in the SmPC be followed closely.
Slovenian: Pomembno je, da natančno sledimo priporočilom v poglavjih 4.2 in 6.6 povzetka glavnih značilnosti zdravila Torisel.
English: • Withdraw 1.8 ml of the supplied solvent.
Slovenian: • Odvzemite 1,8 ml vehikla iz priložene viale.
English: Dose-limiting toxicities (Grade 3/4 erythematous maculopapular rash, gout/cellulitis requiring hospitalisation) were observed in 2 out of 3 patients treated in the first cohort of a Phase 1 study at doses of temsirolimus 15 mg intravenous per week and sunitinib 25 mg oral per day (Days 1-28 followed by a 2-week rest) (see section 4.5).
Slovenian: Toksičnosti, ki so omejevale odmerek (eritematozni makulopapulozni izpuščaj stopnje 3/4, protin/celulitis, ki je zahteval hospitalicazijo), so opazili pri 2 od 3 bolnikov, zdravljenih v prvi kohorti študije 1. faze pri odmerkih temsirolimusa 15 mg intravensko na teden in sunitiniba 25 mg peroralno na dan (1.-28. dan, nato 2 tedna premora) (glejte poglavje 4.5).
English: • Torisel is infused over a 30- to 60-minute period once a week.
Slovenian: • Zdravilo Torisel infundiramo enkrat na teden, infuzija naj traja 30-60 minut.
English: Dose-limiting toxicities (Grade 3/4 erythematous maculopapular rash, gout/cellulitis requiring hospitalisation) were observed in 2 out of 3 patients treated in the first cohort of a Phase 1 study at doses of temsirolimus 15 mg intravenous per week and sunitinib 25 mg oral per day (Days 1-28 followed by a 2-week rest) (see section 4.4).
Slovenian: Toksičnosti, ki so omejevale odmerek (eritematozni makulopapulozni izpuščaj stopnje 3/4, protin/celulitis, ki je zahteval hospitalicazijo), so opazili pri 2 od 3 bolnikov, zdravljenih v prvi kohorti študije 1. faze pri odmerkih temsirolimusa 15 mg intravensko na teden in sunitiniba 25 mg peroralno na dan (1.-28. dan, nato 2 tedna premora) (glejte poglavje 4.4).
English: Tell your doctor if you experience symptoms such as pain or sensation of pressure in chest, arm, shoulders or jaw, shortness of breath, feeling sick (nausea), anxiety, sweating or dizziness.
Slovenian: Če imate simptome, kot so bolečina ali občutek pritiska v prsnem košu, roki, ramah ali čeljusti, kratka sapa, občutek siljenja na bruhanje (navzea), anksioznost, potenje ali omotica, se posvetujte z zdravnikom.
English: Summary of efficacy results in temsirolimus RCC clinical trial 1 Parameter temsirolimus n = 209
Slovenian: Povzetek rezultatov učinkovitosti temsirolimusa v kliničnem preskušanju RCC 1
English: Cases of pneumocystis jiroveci pneumonia (PCP) some with fatal outcomes, have been reported in patients who received temsirolimus, many of whom also received corticosteroids or other immunosuppressive agents.
Slovenian: Pri bolnikih, ki so prejeli temsirolimus in med katerimi so številni prejeli tudi kortikosteroide ali druge imunosupresivne učinkovine, so poročali o primerih pljučnice, ki jo povzroča Pneumocystis jiroveci (PCP), od katerih so se nekateri končali s smrtnim izidom.
English: Temsirolimus and sirolimus pharmacokinetics are not significantly affected by gender.
Slovenian: Spol ne vpliva pomembno na farmakokinetiko temsirolimusa in sirolimusa.
English: Temsirolimus should not be used in the paediatric population for the treatment of neuroblastoma, rhabdomyosarcoma or high-grade glioma, because of efficacy concerns based on the available data (see section 5.1).
Slovenian: Zaradi pomislekov glede učinkovitosti, ki temeljijo na razpoložljivih podatkih, se temsirolimusa ne sme uporabljati pri pediatrični populaciji za zdravljenje nevroblastoma, rabdomiosarkoma ali glioma visoke stopnje (glejte poglavje 5.1).
English: Temsirolimus should not be used in patients with MCL and moderate or severe hepatic impairment (see section 4.3).
Slovenian: Pri bolnikih z MCL in zmerno ali hudo okvaro jeter se temsirolimusa ne sme uporabljati (glejte poglavje 4.3).
English: Torisel concentrate and solvent should be inspected visually for particulate matter and discolouration prior to administration.
Slovenian: Koncentrat in vehikel zdravila Torisel je treba pred dajanjem vizualno pregledati glede prisotnosti delcev in obarvanja.
English: The concentrate also contains: anhydrous ethanol, all-rac-α-tocopherol (E 307), propylene glycol and citric acid (E 330).
Slovenian: Koncentrat vsebuje tudi: brezvodni etanol, vseracemni-α-tokoferol (E307), propilenglikol in citronsko kislino (E330).
English: The required amount of concentrate--solvent mixture from each vial must be combined in one syringe for rapid injection into 250 ml of sodium chloride 9 mg/ml (0.9%) solution for injection (see section 4.2).
Slovenian: Potrebno količino mešanice koncentrata in vehikla iz vsake viale je treba zmešati v eni injekcijski brizgi za hitro injiciranje v 250 ml raztopine (9 mg/ml; 0,9 %) natrijevega klorida za injiciranje (glejte poglavje 4.2).
English: If you have any further questions, ask your doctor, pharmacist or nurse.
Slovenian: - Če imate dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Anhydrous ethanol all-rac-α-Tocopherol (E 307) Propylene glycol Citric acid (E 330)
Slovenian: Koncentrat brezvodni etanol vseracemni-α-tokoferol (E307) propilenglikol citronska kislina (E330)
English: The concentrate-solvent mixture should be inspected visually for particulate matter and discolouration.
Slovenian: Mešanico koncentrata in vehikla je treba pred dajanjem vizualno pregledati glede prisotnosti delcev in obarvanja.
English: Temsirolimus has not been studied in patients undergoing haemodialysis.
Slovenian: Pri bolnikih na hemodializi temsirolimusa niso proučevali.
English: The other ingredients in the concentrate are anhydrous ethanol, all-rac-α-tocopherol (E 307), propylene glycol and citric acid (E 330).
Slovenian: - Druge sestavine v koncentratu so brezvodni etanol, vseracemni-α-tokoferol (E307), propilenglikol in citronska kislina (E330).
English: You will usually be taken off Torisel if you are having an operation.
Slovenian: Običajno boste pred napovedano operacijo zdravljenje z zdravilom Torisel prekinili.
English: The vial of concentrate must first be diluted with 1.8 ml of the supplied solvent to achieve a concentration of temsirolimus of 10 mg/ml.
Slovenian: Vialo koncentrata je treba najprej razredčiti z 1,8 ml priloženega vehikla, da dobimo koncentracijo temsirolimusa 10 mg/ml.
English: In patients 65 or older, median overall survival was 8.6 months (95% CI 6.4, 11.5) with a hazard ratio of 1.15 (95% CI 0.78, 1.68) compared with those treated with IFN-α.
Slovenian: Pri bolnikih, mlajših od 65 let, je bilo mediano celokupno preživetje v primerjavi s tistimi, ki so bili zdravljeni z IFN- 12 mesecev (95 % IZ 9,9; 14,2) z razmerjem tveganja 0,67 (95 % IZ 0,52; 0,87)Pri bolnikih, starih 65 ali več let, je bilo mediano celokupno preživetje 8,6 meseca (95 % IZ 6,4; 11,5) z razmerjem tveganja 1,15 (95 % IZ 0,78; 1,68) v primerjavi s tistimi, ki so bili zdravljeni z IFN-
English: Based on the results of a Phase 3 study in MCL, elderly patients (65 years of age) may be more likely to experience certain adverse reactions, including pleural effusion, anxiety, depression, insomnia, dyspnoea, leukopenia, lymphopenia, myalgia, arthralgia, taste loss, dizziness, upper respiratory infection, mucositis, and rhinitis.
Slovenian: Glede na rezultate študije 3. faze MCL so pri starejših bolnikih ( 65 let starosti) verjetnejši nekateri neželeni učinki, med drugim plevralni izliv, anksioznost, depresija, nespečnost, dispneja, levkopenija, limfopenija, mialgija, artralgija, izguba okušanja, omotica, okužba zgornjih dihal, vnetje sluznic in rinitis.
English: While temsirolimus has been safely administered to patients with renal cancer with repeated intravenous doses as high as 220 mg/m2, in MCL, two administrations of 330 mg temsirolimus/week in one patient resulted in Grade 3 rectal bleeding and Grade 2 diarrhoea.
Slovenian: Medtem ko so temsirolimus varno dajali bolnikom z ledvičnim rakom v ponavljajočih se intravenskih odmerkih po 220 mg/m2, sta pri
English: Torisel 30 mg concentrate and solvent for solution for infusion
Slovenian: Torisel 30 mg koncentrat in vehikel za raztopino za infundiranje
English: Torisel 30 mg concentrate and solvent for solution for infusion temsirolimus
Slovenian: Torisel 30 mg koncentrat in vehikel za raztopino za infundiranje temsirolimus
English: No dose adjustment is recommended for patients with advanced -RCC and mild to moderate hepatic impairment.
Slovenian: Pri bolnikih z napredovalim RCC in blago do zmerno okvaro jeter prilagajanje odmerka ni priporočljivo.
English: Cataracts have been observed in some patients who received the combination of temsirolimus and interferon-α (IFN-α).
Slovenian: Pri nekaterih bolnikih, ki so prejeli kombinacijo temsirolimusa in interferona- (IFN-), so opazili katarakte.
English: Clear glass vial (type 1), with butyl rubber stopper and a plastic flip-top closure sealed with aluminum containing 2.2 ml of solvent
Slovenian: Viala iz prozornega stekla (tipa 1) z zamaškom iz butilne gume in plastično zaporko, zavarjeno z aluminijem; viala vsebuje 2,2 ml vehikla.
English: It is recommended that patients undergo baseline radiographic assessment by lung computed tomography scan or chest radiograph prior to the initiation of temsirolimus therapy.
Slovenian: Pred začetkom zdravljenja s temsirolimusom je priporočljivo opraviti osnovno rentgensko slikanje prsnega koša ali računalniško tomografijo.
English: Agents inducing CYP3A metabolism
Slovenian: Zdravila, ki inducirajo presnovo preko CYP3A
English: The concentrate is a clear, colourless to light-yellow solution.
Slovenian: Koncentrat je bistra, brezbarvna do svetlo rumena raztopina.
English: Contains: polysorbate 80 (E 433), macrogol 400, anhydrous ethanol.
Slovenian: Vsebuje: polisorbat 80 (E433), makrogol 400, brezvodni etanol.
English: For this reason, your doctor may recommend a lung assessment by computed tomography scan or chest x-ray before and during your Torisel treatment.
Slovenian: Zato se bo zdravnik pred in med zdravljenjem z zdravilom Torisel morda odločil za oceno delovanja pljuč s slikanjem z računalniško tomografijo ali rentgenom prsnega koša.
English: Promptly tell your doctor of any new or worsening respiratory symptoms such as shortness of breath or difficulty breathing.
Slovenian: Takoj povejte zdravniku, če se vam pojavijo novi simptomi, povezani z dihanjem (na primer kratka sapa) ali če se že obstoječi simptomi poslabšajo.
English: Based on the results of the phase 3 studies, elderly patients may be more likely to experience certain adverse reactions, including face oedema, pneumonia, pleural effusion, anxiety, depression, insomnia, dyspnoea, leukopenia, lymphopenia, myalgia, arthralgia, ageusia, dizziness, upper respiratory infection, mucositis, and rhinitis.
Slovenian: Na osnovi rezultatov študij 3. faze je pri starejših bolnikih večja verjetnost pojava nekaterih neželenih učinkov, vključno z edemom obraza, pljučnico, plevralnim izlivom, anksioznostjo, depresijo, nespečnostjo, dispnejo, levkopenijo, limfopenijo, mialgijo, artralgijo, agevzijo, omotico, okužbo zgornjih dihal, vnetjem sluznic in rinitisom.
English: These symptoms might be caused by a blood clot in your lung.
Slovenian: Te simptome morda povzroča krvni strdek v vaših pljučih.