FrancophonIA/ELRC3.0 huggingface dataset:
English: Tell your doctor or nurse straight away if you notice any of the following serious side effects - you may need urgent medical treatment.
Slovenian: Če opazite katerega od naslednjih resnih neželenih učinkov, nemudoma obvestite zdravnika ali medicinsko sestro - morda boste potrebovali nujno zdravniško pomoč.
English: Men being treated with Polivy are advised not to father a child during treatment and for up to 6 months following the last dose.
Slovenian: Moški, ki prejemajo zdravilo Polivy, naj ne spočnejo otroka med zdravljenjem in še 6 mesecev po zadnjem odmerku zdravila.
English: For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
Slovenian: Za pogoje shranjevanja zdravila po rekonstituciji in razredčenju glejte poglavje 6.3. 6.5 Vrsta ovojnine in vsebina
English: Polivy has minor influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Polivy ima blag vpliv na sposobnost vožnje in upravljanja strojev.
English: Very common diarrhoea, nausea, constipation, vomiting, abdominal pain, upper abdominal pain
Slovenian: Zelo pogosti diareja, navzea, zaprtost, bruhanje, bolečine v trebuhu, bolečine v zgornjem delu trebuha
English: To be administered under the supervision of a physician experienced in the use of cytotoxic agents.
Slovenian: Aplicira se lahko le pod nadzorom zdravnika, ki ima izkušnje z uporabo citotoksičnih zdravil.
English: **6-8 weeks after Day 1 of Cycle 6 or last study treatment *** Stratification by duration of response to prior therapy (≤ 12 months vs > 12 months)
Slovenian: *** Stratifikacija glede na trajanje odgovora na predhodno zdravljenje (≤ 12 mesecev in > 12 mesecev).
English: Polivy and any concomitant chemotherapy should be withheld if PML is suspected and permanently discontinued if the diagnosis is confirmed.
Slovenian: V primeru suma na PML je treba uporabo zdravila Polivy in morebitne sočasne kemoterapije odložiti, v primeru potrjene diagnoze pa ukiniti.
English: Polivy must be administered using a dedicated infusion line equipped with sterile, non-pyrogenic, low-protein binding in-line or add-on filter (0.2 or 0.22 micrometer pore size) and catheter.
Slovenian: Zdravilo Polivy je treba aplicirati po namenski infuzijski liniji, opremljeni s sterilnim nepirogenim filtrom (v sami liniji ali kot dodatek), ki malo veže beljakovine (velikost por 0,2 ali 0,22 mikrona) in s katetrom.
English: Male patients with female partners of childbearing potential should be advised to use effective contraception during treatment with Polivy and for at least 6 months after the last dose (see section 4.6).
Slovenian: Moškim, ki imajo partnerke v rodni dobi, je treba svetovati, naj uporabljajo učinkovito kontracepcijo med zdravljenjem z zdravilom Polivy in še vsaj 6 mesecev po zadnjem odmerku (glejte poglavje 4.6).
English: More frequent lab monitoring and/or Polivy delays or discontinuation should be considered for patients with Grade 3 or Grade 4 neutropenia and thrombocytopenia (see section 4.2).
Slovenian: Pri bolnikih z nevtropenijo oziroma trombocitopenijo 3. ali 4. stopnje je treba pretehtati opravljanje pogostejših laboratorijskih kontrol in/ali odložitev ali ukinitev uporabe zdravila Polivy (glejte poglavje 4.2).
English: Procedures for proper handling and disposal of anticancer medicinal products should be considered.
Slovenian: Naslednje informacije so namenjene samo zdravstvenemu osebju: Treba je upoštevati postopke za primerno ravnanje in odstranjevanje zdravil za zdravljenje raka.
English: Tabulated list of ADRs from clinical trials
Slovenian: Povzetek neželenih učinkov iz kliničnih preskušanj v preglednici
English: 4.5 Interaction with other medicinal products and other forms of interaction
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Namenskih kliničnih študij medsebojnega delovanja zdravil s polatuzumabom vedotinom pri človeku niso izvedli.
English: Myelosuppression is a condition in which the production of blood cells is decreased, resulting in fewer red blood cells, white blood cells, and platelets.
Slovenian: Mielosupresija je motnja, pri kateri je nastajanje krvnih celic zmanjšano.
English: Upon binding CD79b, polatuzumab vedotin is rapidly internalized and the linker is cleaved by lysosomal proteases to enable intracellular delivery of MMAE.
Slovenian: CD79b polatuzumab vedotin hitro vstopi v celico, kjer lizosomske proteaze razcepijo povezovalno molekulo, kar omogoči znotrajcelično sprostitev MMAE.
English: Strong CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenobarbital, phenytoin, St John's wort [Hypericum perforatum]) may decrease the exposure of unconjugated MMAE.
Slovenian: Močni induktorji CYP3A4 (npr. rifampicin, karbamazepin, fenobarbital, fenitoin, šentjanževka
English: Defined as all adverse reactions reported as related to study treatment within 24 hours after treatment infusion Uncommon, rare and very rare ADRs: none
Slovenian: b Opredeljene kot vsi neželeni učinki, o katerih so med preskušanjem poročali v povezavi z zdravljenjem v 24 urah po infundiranju zdravila.
English: What Polivy is used for
Slovenian: Za kaj uporabljamo zdravilo Polivy
English: Men
Slovenian: O
English: Each vial contains 140 milligrams (mg) polatuzumab vedotin.
Slovenian: Ena viala vsebuje 140 miligramov (mg) polatuzumaba vedotina.
English: Age did not have an effect on the pharmacokinetics of acMMAE and unconjugated MMAE based on a population PK analysis with patients aged 20-89 years.
Slovenian: Na podlagi populacijske farmakokinetične analize pri bolnikih, starih od 20 do 89 let, starost ni vplivala na farmakokinetiko acMMAE in nekonjugiranega MMAE.
English: In nonclinical studies, polatuzumab vedotin has resulted in testicular toxicity, and may impair male reproductive function and fertility (see section 5.3).
Slovenian: V predkliničnih študijah je polatuzumab vedotin toksično deloval na moda, zato sklepamo, da lahko poslabša reproduktivno funkcijo in plodnost pri moških (glejte poglavje 5.3).
English: Grade 3-4 Neutropenia
Slovenian: 3.-4. stopnje
English: There are insufficient data to assess the impact of severe renal impairment (CrCL 15-29 mL/min, n = 3) on PK. No data are available in patients with end-stage renal disease and/or who are on dialysis.
Slovenian: (očistek kreatinina 15-29 ml/min, n = 3) na farmakokinetiko ni dovolj podatkov.
English: The study excluded patients with prior allogeneic HSCT, central nervous system lymphoma, transformed indolent lymphoma, grade 3b FL, significant cardiovascular or pulmonary disease, active infections, AST or alanine transaminase (ALT) >2.5× ULN or total bilirubin ≥1.5 x ULN, creatinine >1.5 x ULN (or CrCl <40 mL/min) unless due to underlying lymphoma.
Slovenian: V študijo niso bili vključeni bolniki s predhodno alogenično PKMC, limfomom osrednjega živčevja, transformiranim indolentnim limfomom, folikularnim limfomom gradusa 3b, pomembno srčno-žilno ali pljučno boleznijo, aktivno okužbo, aspartat transaminazo (AST) ali alanin transaminazo
English: Polivy should be discontinued immediately and permanently if the patient experiences a life-threatening reaction.
Slovenian: Če se pri bolniku pojavi življenje ogrožajoča reakcija, je treba uporabo zdravila Polivy nemudoma in trajno ukiniti.
English: The infusion rate of Polivy should be slowed or interrupted if the patient develops an infusion-related reaction.
Slovenian: Če se pri bolniku pojavi z infundiranjem povezana reakcija, je treba hitrost infundiranja zdravila Polivy upočasniti ali infundiranje prekiniti.
English: As with all therapeutic proteins, there is the potential for an immune response in patients treated with polatuzumab vedotin.
Slovenian: Pri bolnikih, zdravljenih s polatuzumabom vedotinom, obstaja možnost imunskega odziva na zdravilo, tako kot pri vseh terapevtskih beljakovinah.
English: METHOD OF ADMINISTRATION For IV use after reconstitution and dilution
Slovenian: uporabo po rekonstituciji in redčenju
English: Polivy contains sodium
Slovenian: Zdravilo Polivy vsebuje natrij
English: IRRs, PN, fatigue, and dizziness may occur during treatment with Polivy (see sections 4.4 and 4.8).
Slovenian: utrujenost in omotica (glejte poglavji 4.4 in 4.8).
English: Serious adverse reactions were reported in 27% of Polivy plus BR treated patients, which includes febrile neutropenia (6.7%), pyrexia (4.4%), and pneumonia (4.4%).
Slovenian: vključevali so febrilno nevtropenijo (6,7 %), zvišano telesno temperaturo (4,4 %) in pljučnico (4,4 %).
English: In order to provide further evidence of efficacy and safety of polatuzumab vedotin in DLBCL, the MAH will provide Study GO39942, a randomized, double-blind, placebo controlled trial that evaluates polatuzumab vedotin in combination with R-CHP (rituximab, cyclophosphamide, doxorubicin, prednisone) versus R-CHOP in patients with previously untreated diffuse large B-cell lymphoma.
Slovenian: GO39942: randomizirano, dvojno slepo, s placebom kontrolirano preskušanje, ki ocenjuje polatuzumab vedotin v kombinaciji z R-CHP (rituksimab, ciklofosfamid,
English: Pharmacotherapeutic group: antineoplastic agents; other antineoplastic agents; monoclonal antibodies ATC code: L01XC37
Slovenian: Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe (citostatiki), drugi pripravki za zdravljenje novotvorb, monoklonska protitelesa.
English: Table 3: Polivy, bendamustine and rituximab dose modifications for Infusion-related reactions (IRRs)
Slovenian: Prilagoditve odmerka zdravila Polivy, bendamustina in rituksimaba v primeru reakcij, povezanih z infundiranjem
English: Polivy is given in combination with two other cancer medicines called rituximab and bendamustine.
Slovenian: Katera druga zdravila uporabljamo z zdravilom Polivy Zdravilo Polivy uporabljamo v kombinaciji z dvema drugima zdraviloma za zdravljenje raka, imenovanima rituksimab in bendamustin.
English: 6.6 Special precautions for disposal and other handling General precautions
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje
English: How Polivy is given
Slovenian: Kako se daje zdravilo Polivy
English: PML is a very rare and life threatening infection in the brain, that has occured in one patient treated with Polivy together with bendamustine and another medicine called obinutuzumab.
Slovenian: PML je zelo redka in življenje ogrožajoča okužba v možganih, ki se je pojavila pri enem bolniku,
English: No dedicated teratogenicity studies in animals have been performed with polatuzumab vedotin.
Slovenian: Namenskih študij teratogenosti na živalih s polatuzumabom vedotinom niso izvedli.
English: Table 2 Polivy, bendamustine and rituximab dose modifications for myelosuppression Severity of myelosuppression on
Slovenian: Prilagoditve odmerka zdravila Polivy, bendamustina in rituksimaba v primeru mielosupresije
English: Roche Pharma AG Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany
Slovenian: 79639 Grenzach-Wyhlen Nemčija
English: What Polivy contains
Slovenian: Kaj vsebuje zdravilo Polivy
English: The pharmacokinetics (PK) of rituximab and bendamustine are not affected by co-administration with polatuzumab vedotin.
Slovenian: Medsebojna delovanja rituksimaba in bendamustina v kombinaciji s polatuzumabom vedotinom Sočasna uporaba polatuzumaba vedotina ne vpliva na farmakokinetiko rituksimaba in bendamustina.
English: Thrombocytopenia events led to discontinuation of treatment in 11.1% of patients in the Polivy plus BR arm and 5.1% of patients in the BR arm. No patients discontinued treatment due to anaemia in either the Polivy plus BR arm or BR arm.
Slovenian: Zaradi nevtropenije so zdravljenje ukinili pri 8,9 % bolnikov v skupini, zdravljeni z zdravilom Polivy in BR, ter 2,6 % bolnikov v skupini, zdravljeni z BR. Zaradi trombocitopenije je bilo treba ukiniti zdravljenje pri 11,1 % bolnikov v skupini, zdravljeni z zdravilom Polivy in BR, ter pri 5,1 % bolnikov v skupini, zdravljeni z BR.
English: After reconstitution each mL contains 20 mg of polatuzumab vedotin.
Slovenian: Po rekonstituciji en ml vsebuje 20 mg polatuzumaba vedotina.
English: • difficulty walking
Slovenian: • težko hodite,
English: • fever or chills
Slovenian: • izpuščaj/koprivnica
English: Systemic exposure (AUC) in rats at a dose of 0.2 mg/kg MMAE is approximately 50% of the AUC in patients who received the recommended dose of 1.8 mg/kg Polivy every 21-days.
Slovenian: 50 % AUC pri bolnikih, ki so prejemali priporočeni odmerek zdravila Polivy, to je 1,8 mg/kg vsakih
English: Women of childbearing potential should be advised to use effective contraception during treatment with polatuzumab vedotin and for at least 9 months after the last dose.
Slovenian: Ženskam v rodni dobi je treba svetovati, naj uporabljajo učinkovito kontracepcijo med zdravljenjem s polatuzumabom vedotinom in vsaj še 9 mesecev po zadnjem odmerku polatuzumaba vedotina.
English: Polatuzumab vedotin did not prolong the mean QTc interval to any clinically relevant extent based on ECG data from two open-label studies in patients with previously treated B-cell malignancies at the recommended dosage.
Slovenian: Na podlagi elektrokardiografskih podatkov iz dveh odprtih študij pri bolnikih s predhodno zdravljenimi malignomi celic B polatuzumab vedotin v priporočenih odmerkih ni klinično pomembno podaljšal povprečnega intervala QTc.
English: Male patients with female partners of childbearing potential should be advised to use effective contraception during treatment with polatuzumab vedotin and for at least 6 months after the last dose.
Slovenian: Moškim, ki imajo partnerke v rodni dobi, je treba svetovati, naj uporabljajo učinkovito kontracepcijo med zdravljenjem s polatuzumabom vedotinom in vsaj še 6 mesecev po zadnjem odmerku polatuzumaba vedotina.
English: After reconstitution each millilitre (mL) contains 20 mg polatuzumab vedotin.
Slovenian: Po pripravi vsebuje en mililiter (ml) 20 mg polatuzumaba vedotina.
English: Patients should be monitored closely for TLS during treatment with Polivy.
Slovenian: Bolnike je treba med zdravljenjem z zdravilom
English: • a burning sensation
Slovenian: • siljenje na bruhanje
English: No adjustment in the starting dose is required when administering Polivy to patients with mild hepatic impairment (bilirubin greater than ULN to less than or equal to 1.5 × ULN or aspartate transaminase [AST] greater than ULN).
Slovenian: Bolnikom z blago okvaro jeter (vrednost bilirubina večja od ZNM in manjša ali enaka 1,5-kratni ZNM
English: Polivy 140 mg powder for concentrate for solution for infusion polatuzumab vedotin
Slovenian: Polivy 140 mg prašek za koncentrat za raztopino za infundiranje polatuzumab vedotin
English: What Polivy is
Slovenian: Kaj je zdravilo Polivy
English: Based on the mechanism of action and nonclinical studies, polatuzumab vedotin can be harmful to the foetus when administered to a pregnant woman.
Slovenian: Glede na mehanizem delovanja in rezultate predkliničnih študij lahko pri nosečnici uporabljeni polatuzumab vedotin škoduje plodu.
English: It is given into a vein, as a drip over 90 minutes.
Slovenian: Zdravilo boste dobili v veno v obliki 90-minutne infuzije (kapalne).
English: Polivy and any concomitant chemotherapy should be discontinued in patients who develop serious infections.
Slovenian: Pri bolnikih, pri katerih se pojavijo resne okužbe, je treba ukiniti zdravilo Polivy in sočasno kemoterapijo.
English: Per studied population in mild hepatic impairment (defined as AST or ALT >1.0 to 2.5 × ULN or total bilirubin >1.0 to 1.5 × ULN), there was a 40% increase in unconjugated MMAE exposure, which was not deemed clinically significant.
Slovenian: (Pri proučevani populaciji z blago jetrno okvaro (opredeljeno z vrednostjo AST ali ALT > 1,0 in manjšo od 2,5-kratne ZNM, ali vrednostjo celokupnega bilirubina > 1,0 in manjšo od 1,5-kratne ZNM)
English: Grade 3-4 Thrombocytopenia
Slovenian: CYP3A4 in zaviralci P-gp
English: One patient (2.2%) in the Polivy plus BR arm discontinued treatment due to infection compared to 5.1% of patients in the BR arm.
Slovenian: V skupini, zdravljeni z zdravilom Polivy in BR, so zdravljenje zaradi okužbe ukinili pri enem bolniku (2,2 %), v skupini,
English: Musculoskeletal disorders
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva
English: These are a type of blood cells.
Slovenian: kar odkrijemo na preiskavah krvi.
English: Polatuzumab vedotin is a CD79b-targeted antibody-drug conjugate that preferentially delivers a potent anti-mitotic agent (monomethyl auristatin E, or MMAE) to B-cells, which results in the killing of malignant B-cells.
Slovenian: Polatuzumab vedotin je proti CD79b usmerjen konjugat protitelesa in zdravila, ki prednostno prenese močno antimitotično snov (monometil-avristatin E [MMAE]) do celic B; to povzroči smrt malignih celic B. Molekulo polatuzumaba vedotina sestavlja MMAE, z razcepljivo povezovalno molekulo kovalentno vezan na humanizirano imunoglobulinsko monoklonsko protitelo G1.
English: No dedicated mutagenicity studies have been performed with polatuzumab vedotin.
Slovenian: Namenskih študij mutagenosti s polatuzumabom vedotinom niso izvedli.
English: • have a fever
Slovenian: • prehlad
English: Roche (Hellas) A.E.
Slovenian: Roche (Magyarország) Kft.
English: How to store Polivy
Slovenian: Shranjevanje zdravila Polivy
English: Progressive multifocal leukoencephalopathy (PML) One case of PML, which was fatal, occurred in one patient treated with Polivy plus bendamustine and obinutuzumab.
Slovenian: Pri enem bolniku, zdravljenem z zdravilom Polivy v kombinaciji z bendamustinom in obinutuzumabom, se je pojavil primer PML, ki se je končal s smrtjo.
English: Diluent used to prepare solution for infusion
Slovenian: Vehikel za pripravo raztopine za infundiranje
English: If ANC recovers to > 1000/µL on or before Day 7, resume all treatment without any additional dose reductions.
Slovenian: 7. dne, nadaljujte celotno zdravljenje brez dodatnega zmanjšanja odmerkov.
English: Inspect the reconstituted solution for discoloration and particulate matter.
Slovenian: Rekonstituirano raztopino preglejte, da ni spremenjene barve in da ne vsebuje delcev.
English: 6.1 List of excipients
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi Sukcinska kislina
English: Polivy is a cancer medicine that contains the active substance polatuzumab vedotin.
Slovenian: Zdravilo Polivy je zdravilo proti raku, ki vsebuje učinkovino polatuzumab vedotin.
English: PN reported with treatment with Polivy is predominantly sensory PN.
Slovenian: Periferna nevropatija, o kateri so poročali med zdravljenjem z zdravilom Polivy, je bila v glavnem senzorična periferna nevropatija, vendar obstajajo tudi poročila o motorični in senzorimotorični periferni nevropatiji.
English: In most cases you will not have any symptoms but tell your doctor or nurse straight away if you get: • yellowing of your skin and of the whites of your eyes (jaundice).
Slovenian: Večinoma to ne povzroči simptomov, vendar morate zdravnika ali medicinsko sestro nemudoma obvestiti, če se pri vas pojavi:
English: There are insufficient data to assess the impact of moderate hepatic impairment (total bilirubin > 1.5-3×ULN, n = 2) on PK. No data are available in patients with severe hepatic impairment or liver transplantation.
Slovenian: Za oceno vpliva zmerne okvare jeter (vrednost celokupnega bilirubina > 1,5- do 3-kratna ZNM, n = 2)
English: Table 1 Polivy dose modifications for peripheral neuropathy (PN) Severity of PN on
Slovenian: Prilagoditve odmerka zdravila Polivy v primeru pojava periferne nevropatije
English: • infusion-related reactions
Slovenian: • hujšanje • z infundiranjem povezane reakcije
English: • numbness
Slovenian: Nevtropenija
English: p-value (Log-Rank test, stratified***) Overall Response Rate* (INV-assessed) at End of Treatment** Responders (%) (CR, PR) Difference in response rate (%) [95% CI] p-value (CMH chi-squared test***) Complete Response (%) (CR) Difference in response rate (%) [95% CI] p-value (CMH chi-squared test***) Partial Response (%) (PR) 95% CI Clopper-Pearson Best Overall Response Rate* (INV-assessed) Responders (%) (CR, PR) Difference in response rate (%) [95% CI] Complete Response (%) (CR) 95% CI Clopper-Pearson Partial Response (%) (PR) 95% CI Clopper-Pearson
Slovenian: 95-% Clopper-Pearsonov IZ Najboljši celokupni odgovor*(po raziskovalčevi oceni) Odzivni bolniki (%) (CR, PR)
English: 8.9% of patients in the Polivy plus BR arm discontinued Polivy due to neutropenia compared to 2.6% of patients in the BR arm who discontinued treatment due to neutropenia.
Slovenian: Zaradi periferne nevropatije so pri 2,2 % bolnikov ukinili zdravljenje z zdravilom Polivy, pri
English: Respiratory, thoracic and mediastinal disorders Very common cough Common pneumonitis
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora
English: Women
Slovenian: Moški
English: No dedicated fertility studies in animals have been performed with polatuzumab vedotin.
Slovenian: Namenskih študij vpliva na plodnost na živalih s polatuzumabom vedotinom niso izvedli.
English: Common pancytopenia
Slovenian: Rekonstituirana raztopina
English: Table 5 Summary of efficacy in patients with previously treated DLBCL from study GO29365 Polivy + bendamustine + rituximab N = 40
Slovenian: Zdravilo Polivy + bendamustin + rituksimab n = 40
English: • abdominal (belly) pain
Slovenian: • pomanjkanje apetita • srbenje
English: Eye disorders Common vision blurred
Slovenian: Pogosti zamegljen vid
English: Patients were randomized 1:1 to receive Polivy plus BR or BR alone for six 21-day cycles.
Slovenian: Med 80 bolniki, randomiziranimi na prejemanje zdravila Polivy in BR (n = 40) ali kombinacije BR
English: If possible, the first dose should be given before this season starts.
Slovenian: Če je možno, je treba prvi odmerek dati pred začetkom tveganega obdobja.
English: It is used in the following groups of children, who are at high risk for this disease:
Slovenian: Uporablja se pri naslednjih skupinah otrok, ki jih takšna bolezen zelo ogroža:
English: In children born with heart disease, there was a reduction of 45%.
Slovenian: Pri otrocih s prirojenimi boleznimi srca je bilo zmanjšanje 45-odstotno.
English: Patients generally receive a total of five monthly injections into the thigh muscle.
Slovenian: Bolniki običajno prejmejo pet mesečnih injekcij v stegensko mišico.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Synagis on 13 August 1999.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Synagis, veljavno po vsej Evropski uniji, izdala 13. avgusta 1999.
English: • children who are less than two years of age and were born with a serious heart disease.
Slovenian: • pri otrocih, mlajših od dveh let, ki so se rodili s hudo boleznijo srca.
English: The full EPAR for Synagis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Synagis je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This helps to prevent RSV infection.
Slovenian: Zdravilo na ta način pomaga preprečiti okužbo z RSV.
English: This is a summary of the European public assessment report (EPAR) for Synagis.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Synagis.
English: When palivizumab is attached to this protein, the virus becomes unable to enter the body's cells, especially those in the lungs.
Slovenian: Ko se palivizumab veže na ta protein, virus ne more več vstopiti v telesne celice, še zlasti ne v pljučne celice.
English: This was a reduction of 55%.
Slovenian: To pomeni 55-odstotno zmanjšanje števila hospitalizacij.
English: For more information about treatment with Synagis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Synagis preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.