FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not add other medicinal products to the prepared Adcetris infusion solution or intravenous infusion set.
Slovenian: Pripravljeni raztopini za infundiranje ali intravenskemu kompletu za infundiranje z zdravilom ADCETRIS ne dodajajte drugih zdravil.
English: The efficacy in elderly patients with Stage IV disease in the A + AVD arm (patients ≥ 60 years of age [n = 118] [HR = 0.80, 95% CI (0.42, 1.53)] and ≥ 65 years of age [n = 78] [HR = 0.78, 95% CI (0.36, 1.67)]) showed better benefit compared with elderly patients in ITT population.
Slovenian: Rezultati učinkovitosti so pri starejših bolnikih z boleznijo stadija IV v kraku A + AVD (bolniki, stari ≥ 60 let [n = 118] [HR = 0,80; 95% CI (0,42; 1,53)] in ≥ 65 let [n = 78] [HR = 0,78;
English: Study-C25007
Slovenian: Študija C25007
English: Each vial contains a 10% overfill giving 55 mg of ADCETRIS per vial and a total reconstituted volume of 11 mL.
Slovenian: Ena viala vsebuje 10% prebitek, kar pomeni 55 mg zdravila Adcetris na vialo.
English: Each vial contains a 10% overfill giving 55 mg of Adcetris per vial and a total reconstituted volume of 11 mL.
Slovenian: Ena viala vsebuje 10% prebitek, kar pomeni 55 mg zdravila ADCETRIS na vialo.
English: After reconstitution each vial contains 5 mg/ml of brentuximab vedotin
Slovenian: Po rekonstituciji vsebuje ena viala 5 mg/ml brentuksimaba vedotina.
English: Consider G-CSF or GMCSF in subsequent cycles for patients who develop Grade 3 or Grade 4 neutropenia.
Slovenian: Za bolnike, pri katerih se razvije nevtropenija 3. stopnje ali 4. stopnje, razmislite o podpori z G-CSF ali GM-CSF pri naslednjih ciklih.
English: Adcetris is used alone to treat classical Hodgkin lymphoma that has: - come back after or not responded to an infusion of your own healthy stem cells into your body (autologous stem cell transplant), or - come back after or never responded to at least two previous therapies, and where you cannot receive additional combination anti-cancer treatments or have an autologous stem cell transplant.
Slovenian: (avtologna presaditev matičnih celic) ali - se je ponovil ali se ni nikoli odzval na vsaj dve predhodni terapiji, in ko ne morete prejeti dodatnih kombiniranih oblik zdravljenja proti raku ali imeti avtologne presaditve matičnih celic.
English: Very common side effects (may affect more than 1 in 10 people) decreased level of white blood cells decreased level of blood platelets decreased level of white blood cells with a fever upper respiratory tract infection decrease in weight infection nausea abdominal pain unusual hair loss or thinning muscle pain joint pain or painful, swollen joints dizziness increased liver enzyme levels decreased appetite not being able to sleep bone pain sore or inflammation in the mouth
Slovenian: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov) - zmanjšanje števila belih krvnih celic - zmanjšanje števila trombocitov - zmanjšanje števila belih krvnih celic z zvišano telesno temperaturo - okužba zgornjih dihal - zmanjšanje telesne mase - okužba - siljenje na bruhanje - bolečine v trebuhu - neobičajno izpadanje ali redčenje las - bolečine v mišicah - oboleli ali boleči sklepi, otekli sklepi - omotica - povečane vrednosti jetrnih encimov - zmanjšan tek - nespečnost - bolečine v kosteh - razjede ali vnetje ustne sluznice
English: Infusion-related reactions a, chills
Slovenian: mrzlica reakcije, povezane z infundiranjem a,
English: Adcetris 50 mg powder for concentrate for solution for infusion brentuximab vedotin
Slovenian: Adcetris 50 mg prašek za koncentrat za raztopino za infundiranje brentuksimab vedotin
English: IRRs, such as headache, rash, back pain, vomiting, chills, nausea, dyspnoea, pruritus and cough were reported in 13% of patients.
Slovenian: O IRR, kot so glavobol, izpuščaj, bolečine v hrbtu, bruhanje, mrzlica, navzea, dispneja, pruritus in kašelj, so poročali pri 13% bolnikov.Poročali so o anafilaktičnih reakcijah (glejte poglavje 4.4).
English: Bone pain, arthralgia, back pain, myalgia
Slovenian: artralgija, mialgija bolečina v kosteh, artralgija, bolečina v hrbtu, mialgija
English: 9/L) or Grade 2 (< 1500-1000/mm < 1.5-1.0 x 10
Slovenian: ali 2. stopnja (< 1500 - 1.000/mm < 1,5 - 1,0 x 10 9/l)
English: Patient Characteristics
Slovenian: Značilnosti bolnikov
English: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with ADCETRIS.
Slovenian: Pri zdravljenju z zdravilom ADCETRIS so poročali o Stevens-Johnsonovem sindromu (SJS) in toksični epidermalni nekrolizi (TEN).
English: (95% CI [0.36, 0.70])b
Slovenian: (95% IZ [0,36, 0,70])
English: Table 13 provides a summary of the baseline patient and disease characteristics.
Slovenian: V preglednici 13 je povzetek značilnosti bolnikov in bolezni ob izhodišču.
English: The median duration of response was 9.2 and 9.4 months in patients who achieved OR (CR+PR) and CR, respectively.
Slovenian: Pri bolnikih z objektivnim odzivom (CR+PR) je mediani čas trajanja odziva znašal 9,2 meseca, pri bolnikih s popolno remisijo (CR) pa 9,4 meseca.
English: Table 4 provides a summary of the baseline patient and disease characteristics.
Slovenian: V preglednici 4 je povzetek značilnosti bolnikov in bolezni ob izhodišču.
English: Hyperglycaemia
Slovenian: hiperglikemija hiperglikemija
English: MMAE were observed approximately 2 days after the end of infusion, and exhibited a mono-exponential decline with a t1/2z of approximately 3 to 4 days.
Slovenian: Največje koncentracije MMAE v plazmi so opazili približno 2 dni po koncu infundiranja, ugotovili pa so multieksponentno upadanje s končnim razpolovnim časom približno 3 do 4 dni.
English: For the patients who received > 1 prior cancer-related treatment, a best overall response of CR was reported for 6 patients (12%); PR was reported for 19 patients (39%).
Slovenian: Pri 6 bolnikih (12%), ki so prejeli > 1 predhodno zdravljenje, povezano z rakom, so poročali o popolni remisiji; pri 19 bolnikih (39%) pa so poročali o delni remisiji.
English: Very common side effects (may affect more than 1 in 10 people) decreased level of white blood cells upper respiratory tract infection decrease in weight infection nausea abdominal pain itching muscle pain joint pain or painful, swollen joints
Slovenian: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov) - zmanjšanje števila belih krvnih celic - okužba zgornjih dihal - povečanje telesne mase - okužba - siljenje na bruhanje - bolečine v trebuhu - srbenje - bolečine v mišicah - oboleli ali boleči sklepi, otekli sklepi
English: Common side effects (may affect up to1 in 10 people) pneumonia sore, creamy-yellow, raised patches in the mouth (thrush) decreased level of blood platelets dizziness blisters which may crust or scab increased level of blood sugar increased liver enzyme levels unusual hair loss or thinning
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov) - pljučnica - boleče, kremno-rumene, dvignjene lise v ustih (ustni oprh) - zmanjšanje števila trombocitov - omotica - mehurji, na katerih lahko nastaja skorja ali kraste - povečana vrednost sladkorja v krvi - povečane vrednosti jetrnih encimov - neobičajno izpadanje ali tanjšanje las
English: ADCETRIS should be held for any suspected case of PML.
Slovenian: Zdravilo ADCETRIS je treba v primeru suma na PML začasno prekiniti.
English: In nonclinical studies, thymus depletion has been observed (see section 5.3).
Slovenian: V predkliničnih študijah so opazili upadanje priželjca (glejte poglavje 5.3).
English: total dose divided by reconstituted vial concentration [5 mg/ mL])
Slovenian: Skupni volumen, ki ga je treba razredčiti b = skupni odmerek, razdeljen s koncentracijo rekonstituirane viale [5 mg/ml])
English: The already reconstituted Adcetris can also be diluted into 5% dextrose for injection or Lactated Ringer's for injection.
Slovenian: Priporočeni volumen vehikla je 150 ml. Že rekonstituirano zdravilo Adcetris lahko razredčite tudi s 5% raztopino glukoze za injiciranje ali z raztopino Ringerjevega laktata za injiciranje.
English: total dose divided by reconstituted vial concentration [5 mg/mL])
Slovenian: Skupni volumen, ki ga je treba razredčiti b = skupni odmerek, deljen s koncentracijo rekonstituirane viale [5 mg/ml])
English: No effect was observed in patients with mild or moderate renal impairment.
Slovenian: Pri bolnikih z blago ali zmerno okvaro ledvic vpliva okvare ledvic na izpostavljenost niso opazili.
English: The recommended starting dose in patients with severe renal impairment is 1.2 mg/kg administered as an intravenous infusion over 30 minutes every 3 weeks.
Slovenian: Priporočeni začetni odmerek pri bolnikih s hudo okvaro ledvic je 1,2 mg/kg v obliki 30-minutne intravenske infuzije vsake 3 tedne.
English: Table 6: Summary of baseline patient and disease characteristics in the phase 3 HL post-ASCT Study
Slovenian: Preglednica 6: Povzetek značilnosti bolnikov in bolezni ob izhodišču v študiji 3. faze HL po avtologni PKMC
English: have new or worsening shortness of breath or cough as these may be symptoms of a serious and potentially fatal lung complication (pulmonary toxicity) are taking, or have previously taken, medicines which may affect your immune system, such as chemotherapy or immunosuppressive agents have, or think you have, an infection.
Slovenian: - jemljete ali ste jemali zdravila, ki vplivajo na vaš imunski sistem, kot so kemoterapija ali imunosupresivi.
English: The recommended starting dose in patients with mild hepatic impairment is 0.9 mg/kg administered as an intravenous infusion over 30 minutes every 2 weeks.
Slovenian: Priporočeni začetni odmerek pri bolnikih z blago okvaro jeter je 0,9 mg/kg v obliki 30-minutne intravenske infuzije vsaka 2 tedna.
English: Forty-six (46) patients with CD30-expressing haematologic malignancies were evaluable of the 52 patients who received 1.8 mg/kg of brentuximab vedotin every 3 weeks as part of a phase 1, single-arm, open-label, multicenter cardiac safety study.
Slovenian: Med 52 bolniki, ki so v okviru odprte, multicentrične študije 1. faze varnosti za srce z enim krakom prejemali 1,8 mg/kg brentuksimaba vedotina vsake 3 tedne, je bilo mogoče oceniti šestinštirideset (46) bolnikov s hematološkimi malignostmi, ki izražajo CD30.
English: Retreatment with ADCETRIS resulted in 6 CRs (55%) and 4 PRs (36%), for an ORR of 91%.
Slovenian: Pri ponovni uvedbi zdravljenja z zdravilom ADCETRIS so poročali o 6 primerih popolne remisije (CR) (55%) in 4 primerih delne remisije (PR) (36%).
English: have severe and persistent stomach pain, with or without nausea and vomiting, as these may be symptoms of a serious and potentially fatal condition known as pancreatitis (inflammation of the pancreas).
Slovenian: - se pojavi ali poslabša zadihanost ali kašelj, saj so to lahko simptomi hujšega in potencialno smrtnega zapleta v pljučih (toksičnost za pljuča).
English: Stratified Hazard Ratio
Slovenian: Stratificiran o razmerje ogroženosti
English: OTHER
Slovenian: Dogodki
English: • B symptoms at pre-ASCT relapse
Slovenian: • Simptomi B pri ponovitvi bolezni pred avtologno PKMC.
English: - Stevens-Johnson syndrome and toxic epidermal necrolysis - a rare, serious disorder in which you may experience flu-like symptoms followed by a painful red or purplish rash that spreads and blisters including extensive detachment of the skin - decreased level of white blood cells with a fever - damage to the nerves and nerve coverings (demyelinating polyneuropathy)
Slovenian: - nova ali ponavljajoča se okužba s citomegalovirusom (CMV) - okužba v krvi (sepsa) in/ali septični šok (življenjsko nevarna oblika sepse) - Stevens-Johnsonov sindrom in toksična epidermalna nekroliza - redka, resna bolezen, pri kateri se lahko pojavijo gripi podobni simptomi, ki jih spremlja boleč rdeč ali vijoličen izpuščaj, ki se širi, in mehurji, vključno z obsežnim luščenjem kože.
English: Once steady-state was achieved, the PK of ADC did not appear to change with time.
Slovenian: Ko je bilo doseženo stanje dinamičnega ravnovesja, niso več zasledili spreminjanja farmakokinetike
English: The recommended starting dose in patients with hepatic impairment is 1.2 mg/kg administered as an intravenous infusion over 30 minutes every 3 weeks.
Slovenian: Priporočeni začetni odmerek pri bolnikih z okvaro jeter je 1,2 mg/kg v obliki 30-minutne intravenske infuzije vsake 3 tedne.
English: Nervous system disorders Very common:
Slovenian: Bolezni živčevja Zelo pogosti:
English: Adverse events led to treatment discontinuation in 24% of patients receiving ADCETRIS.
Slovenian: Zdravljenje z zdravilom ADCETRIS je bilo zaradi pojava neželenih dogodkov prekinjeno pri 24% bolnikov.
English: For more detailed information, see “Infusion reactions” in section 4. have any problems with a change in the sensitivity of the skin, especially in the hands or feet, such as numbness, tingling, a burning sensation, pain, discomfort or weakness (neuropathy) have headaches, feel tired, experience dizziness, look pale (anaemia), or have unusual bleeding or bruising under the skin, longer than usual bleeding after your blood has been drawn, or bleeding from your gums (thrombocytopenia) develop chills or shivering, or feel warm; you should take your temperature as you may have a fever.
Slovenian: - imate glavobole, ste utrujeni, čutite omotico, ste bledi (slabokrvnost) ali imate neobičajne krvavitve ali modrice pod kožo, po odvzemu krvi krvavite dlje kot običajno, ali krvavite iz dlesni (trombocitopenija).
English: Rash a, pruritus
Slovenian: izpuščaj a, pruritus alopecija, izpuščaj
English: 76M (46%)/89F (54%) 97M (59%)/67F (41%)
Slovenian: 76 moških (46%)/89 žensk (54%)
English: • Extranodal disease at pre-ASCT relapse
Slovenian: • Ekstranodalna bolezen pri ponovitvi pred avtologno PKMC.
English: Some infections may be serious and can be due to viruses, bacteria, or other causes that may be life-threatening experience a whistling sound during breathing (wheezing)/difficulty breathing, hives, itching, or swelling (signs of an infusion reaction).
Slovenian: - zaslišite piskajoč zvok med dihanjem (sopenje)/imate težave z dihanjem, koprivnico, srbenje ali oteklino (znaki infuzijske reakcije).
English: Anaphylactic reaction
Slovenian: anafilaktična reakcija anafilaktična reakcija
English: If you are breast-feeding, you should discuss with your doctor whether you should receive this medicine.
Slovenian: Če dojite, se o uporabi tega zdravila posvetujte z zdravnikom.
English: Cough, dyspnoea
Slovenian: kašelj, dispneja kašelj, dispneja
English: Demyelinating polyneuropathy Respiratory, thoracic and mediastinal disorders Very common:
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora Zelo pogosti:
English: No pulmonary toxicity or fatal events were reported with brentuximab vedotin + AVD.
Slovenian: Pri brentuksimabu vedotinu v kombinaciji z AVD niso poročali o toksičnih učinkih na pljuča ali smrtnih primerih.
English: Final Study Report by: Q1 2021
Slovenian: Končno poročilo študije do: 1. četrtletje
English: Your doctor may lower your starting dose to 1.2 mg/kg if you have kidney or liver problems.
Slovenian: Če imate težave z ledvicami ali jetri, lahko zdravnik začetni odmerek zmanjša na 1,2 mg/kg.
English: What you need to know before you are given Adcetris
Slovenian: Kaj morate vedeti, preden boste prejeli zdravilo Adcetris
English: Breastfeeding
Slovenian: Hiperglikemija
English: b risk factors, n (%)
Slovenian: b, n (%)
English: Herpes zoster, Pneumocystis jiroveci pneumonia
Slovenian: Bolniki z okvaro ledvic in jeter
English: The usual dose of Adcetris given alone is 1.8 mg/kg, given once every 3 weeks for no more than one year.
Slovenian: Običajni odmerek zdravila Adcetris kot samostojnega zdravila je 1,8 mg/kg, ki se ga daje vsake 3 tedne.
English: Withhold dose until toxicity returns to ≤ Grade 2 or baseline then resume treatment at the same dose and schedule .
Slovenian: Odložite odmerek, dokler se toksičnost ne vrne na ≤ 2. stopnjo ali izhodiščno, nato pa nadaljujte zdravljenje z enakim odmerkom in režimom b. Za bolnike, pri katerih se razvije nevtropenija 3. stopnje ali 4. stopnje, razmislite o podpori z G-CSF ali GM-CSF pri naslednjih ciklih.
English: Takeda AS
Slovenian: Takeda Italia S.p.A.
English: MMAE has been shown to have aneugenic properties in an in vivo rat bone marrow micronucleus study.
Slovenian: V študiji in vivo s podganjim kostnim mozgom se je pokazalo, da ima MMAE anevgenične lastnosti.
English: ADCETRIS should be discontinued if a diagnosis of acute pancreatitis is confirmed.
Slovenian: Če se diagnozo akutnega pankreatitisa potrdi, je treba zdravljenje z zdravilom ADCETRIS trajno ukiniti.
English: A fever with a low white blood cell count may be a sign of serious infection experience dizziness, decreased urination, confusion, vomiting, nausea, swelling, shortness of breath, or heart rhythm disturbances (this may be a potentially life-threatening complication known as tumour lysis syndrome) experience flu-like symptoms followed by a painful red or purplish rash that spreads and blisters including extensive detachment of the skin that may be life-threatening (this may be a serious skin reaction known as Stevens-Johnson syndrome and toxic epidermal necrolysis) have new or worsening stomach pain, nausea, vomiting, constipation as these may be symptoms of a serious and potentially fatal stomach or intestinal complication (gastrointestinal complications)
Slovenian: - imate gripi podobne simptome, ki jim sledi boleč rdeč ali vijoličast izpuščaj, ki se širi, in mehurje, vključno z obsežnim luščenjem kože, ki je lahko smrtno nevarno (to je lahko resna kožna reakcija, imenovana Stevens-Johnsonov sindrom in toksična epidermalna nekroliza).
English: Common side effects (may affect up to 1 in 10 people) - an infection in the blood (sepsis) and/or septic shock (a life-threatening form of sepsis);
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov) - okužba v krvi (sepsa) in/ali septični šok (življenjsko nevarna oblika sepse); pljučnica - mehurji, na katerih lahko nastaja skorja ali kraste - boleče, kremno-rumene, dvignjene lise v ustih (ustni oprh) - srbenje - povečana vrednost sladkorja v krvi
English: Table 7: Efficacy results in HL patients at increased risk of relapse or progression following ASCT treated with 1.8 mg/kg of ADCETRIS every 3 weeks
Slovenian: Preglednica 7: Rezultati učinkovitosti zdravljenja z 1,8 mg/kg zdravila ADCETRIS vsake 3 tedne pri bolnikih s HL s povečanjim tveganjem ponovitve ali napredovanja bolezni po avtologni PKMC
English: B symptoms a n (%)
Slovenian: a n (%)
English: The median number of cycles received was 6
Slovenian: Mediano število prejetih ciklov je bilo 6 (razpon od 1 do 6 ciklov).
English: White to off-white cake or powder.
Slovenian: prašek za koncentrat za raztopino za infundiranje bela do belkasta pogača ali prašek
English: Acute pancreatitis has been observed in patients treated with ADCETRIS.
Slovenian: V primeru suma na akutni pankreatitis je treba zdravljenje z zdravilom ADCETRIS začasno prekiniti.
English: Metabolism
Slovenian: Biotransformacija
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Slovenian: Celokupno preživetje (OS)
English: “Do not take more than 3 <if relevant include colour of the tablet> tablets (3 x 1000 microgram tablets) per day.”
Slovenian: “Ne vzemite več kot 3 <če je primerno vključite barvo tablete> tablet (3 x 1000 mikrogramov tablet) na dan.”
English: 4.8 Undesirable effects:
Slovenian: 4.8 Neželeni učinki:
English: If you experience any one of these symptoms you must tell your doctor immediately.”
Slovenian: Če opazite karkoli od navedenega, morate o tem nemudoma obvestiti svojega zdravnika."
English: There is evidence that higher dose and/or cumulative exposure are risk factors for development of valvular pathology.
Slovenian: Obstajajo podatki, da sta višji odmerek in/ali kumulativna izpostavljenost dejavnika tveganja za razvoj valvularne patologije.
English: Section 4 “Possible side effects”:
Slovenian: Poglavje 4 “Možni neželeni učinki”:
English: Additionally you should take care not becoming pregnant for at least one month once you have stopped treatment with cabergoline.”
Slovenian: Poleg tega morate poskrbeti, da med zdravljenjem ne zanosite, in da ne zanosite še vsaj en mesec po tem, ko ste kabergolin prenehali jemati."
English: Because clinical experience is still limited and the product has a long half-life, as a precautionary measure it is recommended that once regular ovulatory cycles have been achieved women seeking pregnancy discontinue product name] one month before intended conception.”
Slovenian: Ker so klinične izkušnje še omejene, zdravilo pa ima dolgo razpolovno dobo, je kot previdnostni ukrep priporočljivo, da ženske, ki želijo zanositi in imajo že redne ovulacijske cikluse, zdravilo prenehajo jemati en mesec pred načrtovano zanositvijo."
English: Valvulopathy has been associated with cumulative doses, therefore, patients should be treated with the lowest effective dose.
Slovenian: Valvulopatijo povezujejo s kumulativnimi odmerki, zato je potrebno bolnike zdraviti z najnižjimi še učinkovitimi odmerki.
English: “Before you can start using cabergoline you have to exclude that you are pregnant.
Slovenian: “Preden začnete uporabljati kabergolin, morate izključiti možnost, da ste noseči.
English: Following treatment initiation, the first echocardiogram must occur within 3-6 months, thereafter, the frequency of echocardiographic monitoring should be determined by appropriate individual clinical assessment with particular emphasis on the above-mentioned signs and symptoms, but must occur at least every 6 to 12 months.
Slovenian: Prvi ehokardiogram po začetku zdravljenja je potrebno opraviti v roku 3 do 6 mesecev, zatem pa pogostost ehokardiogramskega spremljanja določimo v odvisnosti od ustrezne klinične ocene posameznega bolnika, s posebnim poudarkom na zgoraj omenjenih simptomih in znakih, v vsakem primeru pa ga izvedemo najmanj vsakih 6 do 12 mesecev.
English: Before treatment your physician will check whether your heart, lungs and kidneys are in good condition.
Slovenian: Vaš zdravnik bo pred začetkom zdravljenja preveril, ali so vaše srce, pljuča in ledvice v dobrem stanju.
English: 4.4 Special warnings and precautions for use:
Slovenian: 4.4 Posebna opozorila in previdnostni ukrepi:
English: If fibrotic reactions occur treatment will have to be discontinued.”
Slovenian: Če pride do fibroznih reakcij, bo treba zdravljenje prekiniti.“
English: 4.3 Contraindication:
Slovenian: 4.3 Kontraindikacije:
English: “Fibrosis and cardiac valvulopathy and possibly related clinical phenomena:
Slovenian: “Fibroza in srčna valvulopatija in klinični pojavi, ki so verjetno povezani z njima:
English: All patients must undergo a cardiovascular evaluation, including echocardiogram, to assess the potential presence of asymptomatic valvular disease.
Slovenian: Vse bolnike je potrebno srčnožilno pregledati, vključno z ehokardiogramom, z namenom ocenitve potencialne prisotnosti asimptomatične valvularne bolezni.
English: The early symptoms may be one or more of the following: difficulty breathing, shortness of breath, chest or back pain and swollen legs.
Slovenian: Zgodnji znaki so lahko naslednji (eden ali več): težave pri dihanju, kratka sapa, bolečine v prsnem košu ali hrbtu in otečene noge.
English: Section 4.4 Special warnings and precautions for use (for cabergoline-containing medicinal products authorised in the indication of anovulation and infertility only)
Slovenian: Poglavje 4.4 Posebna opozorila in previdnostni ukrepi (samo za zdravila, ki vsebujejo kabergolin in so registrirana za indikacijo anovulacije in neplodnosti)
English: Erythrocyte sedimentation rate (ESR) has been found to be abnormally increased in association with pleural effusion/fibrosis.
Slovenian: Ugotovili so, da se je hitrost sedimentacije eritrocitov (ESR) zaradi plevralnega izliva/fibroze nenormalno povečala.
English: Section 3 How to take [product name]
Slovenian: Poglavje 3 Kako jemati zdravilo [ime zdravila]
English: However, valvulopathy and fibrotic reactions have been reported during treatment with pergolide at doses less than 0.5mg/day.
Slovenian: Vendar so med zdravljenjem s pergolidom pri odmerkih nižjih od 0,5 mg/dan poročali o valvulopatiji in fibrotičnih reakcijah.