FrancophonIA/ELRC3.0 huggingface dataset:
English: What Onpattro is and what it is used for What you need to know before you are given Onpattro How Onpattro is given
Slovenian: Kaj je zdravilo Onpattro in za kaj ga uporabljamo Kaj morate vedeti, preden prejmete zdravilo Onpattro Kako se daje zdravilo Onpattro Možni neželeni učinki
English: What you need to know before you are given Onpattro You must not be given Onpattro
Slovenian: Kaj morate vedeti, preden prejmete zdravilo Onpattro
English: Disodium hydrogen phosphate, heptahydrate Potassium dihydrogen phosphate, anhydrous Sodium chloride
Slovenian: DSPC holesterol natrijev hidrogenfosfat heptahidrat brezvodni kalijev dihidrogenfosfat natrijev klorid voda za injekcije
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Onpattro 2 mg/mL sterile concentrate patisiran
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Onpattro 2 mg/ml sterilni koncentrat patisiran i.v.
English: METHOD OF ADMINISTRATION Do not shake or vortex.
Slovenian: POSTOPEK UPORABE Ne stresajte in ne mešajte v stresalniku Vortex.
English: Reactions to this infusion may happen during treatment with Onpattro.
Slovenian: Med zdravljenjem z zdravilom Onpattro se lahko pojavijo reakcije na infuzijo.
English: Each vial contains patisiran sodium equivalent to 10 mg patisiran formulated as lipid nanoparticles.
Slovenian: Ena viala vsebuje natrijev patisiranat, ki ustreza 10 mg patisirana, v obliki lipidnih nanodelcev.
English: The duration of infusion may be extended in the event of an IRR.
Slovenian: V primeru reakcije, povezane z infuzijo, je možno trajanje infundiranja podaljšati.
English: DSPC (1,2-distearoyl-sn-glycero-3-phosphocholine) Cholesterol
Slovenian: DSPC (1,2-distearoil-sn-glicero-3-fosfoholin) holesterol natrijev hidrogenfosfat heptahidrat brezvodni kalijev dihidrogenfosfat natrijev klorid voda za injekcije
English: How Onpattro is given
Slovenian: Kako se daje zdravilo Onpattro
English: • Onpattro must be administered through a free-flowing venous access line.
Slovenian: • Zdravilo Onpattro je treba infundirati skozi stalno linijo venskega dostopa.
English: • Indigestion (dyspepsia)
Slovenian: • prebavne motnje (dispepsija)
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva artralgija pogosti mišični krči pogosti
English: Referral for ophthalmological assessment is recommended if patients develop ocular symptoms suggestive of vitamin A deficiency, including reduced night vision or night blindness, persistent dry eyes, eye inflammation, corneal inflammation or ulceration, corneal thickening or corneal perforation.
Slovenian: Če se pri bolnikih razvijejo očesni simptomi, ki kažejo na pomanjkanje vitamina A, vključno s poslabšanjem nočnega vida ali nočno slepoto, dolgotrajno suhostjo oči, vnetjem oči, vnetjem ali ulceracijo roženice, zadebelitvijo roženice ali perforacijo roženice, je priporočljiva napotitev k oftalmologu.
English: No dose adjustment is necessary in patients with mild or moderate renal impairment (estimated glomerular filtration rate [eGFR] ≥ 30 to < 90 mL/min/1.73m2).
Slovenian: Pri bolnikih z blago do zmerno okvaro ledvic (ocenjena hitrost glomerulne filtracije [eGFR] ≥ 30 do < 90 ml/min/1,73 m2) prilagajanje odmerka ni potrebno.
English: Population pharmacokinetic and pharmacodynamic analyses indicated no impact of mild hepatic impairment (bilirubin ≤ 1 x ULN and AST > 1 x ULN, or bilirubin > 1.0 to 1.5 x ULN and any AST) on patisiran exposure or TTR reduction compared to patients with normal hepatic function.
Slovenian: Populacijske farmakokinetične in farmakodinamične analize niso pokazale vpliva blage jetrne okvare (vrednost bilirubina ≤ 1-kratnik zgornje meje normalnih vrednosti in vrednost AST > 1-kratnik zgornje meje normalnih vrednosti ali vrednost bilirubina > 1,0- do 1,5-kratnik zgornje meje normalnih vrednosti in katera koli vrednost AST) na izpostavljenost patisiranu ali zmanjšanje TTR v primerjavi z bolniki z normalnim delovanjem jeter.
English: The estimated patisiran mean ± SD steady-state peak concentration (Cmax), trough concentration (Ctrough), and area under the curve (AUCτ) were 7.15 ± 2.14 µg/mL, 0.021 ± 0.044 µg/mL, and 184 ± 159 µg·h/mL, respectively.
Slovenian: Ocenjena povprečna največja koncentracija patisirana (Cmax) ± SN v stanju dinamičnega ravnovesja, najmanjša koncentracija (Ctrough) in območje pod krivuljo (AUCτ) so bili 7,15 ± 2,14 µg/ml, 0,021 ± 0,044 µg/ml oz. 184 ± 159 µg·h/ml.
English: Do not shake or vortex.
Slovenian: Ne stresajte ga in ne mešajte ga v stresalniku Vortex.
English: Product quality is not impacted by presence of the white to off-white coating.
Slovenian: Prisotnost bele do belkaste obloge ne vpliva na kakovost zdravila.
English: NAME OF THE MEDICINAL PRODUCT Onpattro 2 mg/mL concentrate for solution for infusion.
Slovenian: IME ZDRAVILA Onpattro 2 mg/ml koncentrat za raztopino za infundiranje.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Onpattro, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Slovenian: Onpattro, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: Thereafter, vitamin A supplementation of 2500 IU per day should be resumed in the second and third trimesters if serum vitamin A levels have not returned to normal, because of the increased risk of vitamin A deficiency in the third trimester.
Slovenian: Nosečnica mora v prvem trimesečju prenehati z jemanjem nadomestka vitamina A, razen če se pri njej pojavijo klinični znaki pomanjkanja vitamina A. Če so prisotni takšni znaki, odmerek nadomestka vitamina A ne sme presegati 2.500 i.e. na dan. Za tem je treba z dajanjem nadomestka vitamina A v odmerku 2.500 i.e. na dan nadaljevati v drugem in tretjem trimesečju, če se ravni vitamina A v serumu niso vrnile na normalno vrednost, saj obstaja povečano tveganje pomanjkanja vitamina A v tretjem trimesečju.
English: Onpattro must be diluted with sodium chloride 9 mg/mL (0.9%) solution prior to intravenous infusion.
Slovenian: Zdravilo Onpattro je treba pred intravenskim infundiranjem razredčiti z 0,9-odstotno raztopino natrijevega klorida (9 mg/ml).
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja eritem pogosti
English: Onpattro is believed to have no or negligible influence on the ability to drive or use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Onpattro naj ne bi imelo vpliva ali naj bi imelo zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: The estimated PEG2000-C-DMG mean ± SD steady-state Cmax, Ctrough and AUCτ were 4.22 ± 1.22 µg/mL, 0.0236 ± 0.0093 µg/mL, and 145 ± 64.7 µg·h/mL, respectively.
Slovenian: Ocenjena povprečna koncentracija Cmax lipidne komponente PEG2000-C-DMG ± SN v stanju dinamičnega ravnovesja, koncentracija Ctrough in vrednost AUCτ so bile 4,22 ± 1,22 µg/ml, 0,0236 ± 0,0093 µg/ml oz. 145 ± 64,7 µg·h/ml.
English: The infusion sets must be free of di(2-ethylhexyl)phthalate (DEHP).
Slovenian: Infuzijski komplet ne sme vsebovati di-(2-etilheksil)-ftalata (DEHP).
English: The patient should receive at least 3 consecutive IV infusions of Onpattro without experiencing IRRs before each reduction in corticosteroid premedication.
Slovenian: Bolnik mora pred vsakim zmanjšanjem odmerka kortikosteroida za premedikacijo prejeti vsaj 3 zaporedne infuzije brez pojava reakcij, povezanih z infuzijo.
English: All patients should receive premedication prior to Onpattro administration to reduce the risk of infusion-related reactions (IRRs).
Slovenian: Vsi bolniki morajo pred infundiranjem zdravila Onpattro prejeti premedikacijo za zmanjšanje tveganj reakcij, povezanih z infuzijo.
English: The estimated DLin-MC3-DMA mean ± SD steady-state Cmax, Ctrough and AUCτ were 40.2 ± 11.5 µg/mL, 1.75 ± 0.698 µg/mL, and 1403 ± 105 µg·h/mL, respectively.
Slovenian: Ocenjena povprečna koncentracija Cmax lipidne komponente DLin-MC3-DMA ± SN v stanju dinamičnega ravnovesja, koncentracija Ctrough in vrednost AUCτ so bile 40,2 ± 11,5 µg/ml, 1,75 ± 0,698 µg/ml oz. 1.403 ± 105 µg·h/ml.
English: • Gently invert the bag to mix the solution.
Slovenian: • Raztopino premešajte z nežnim obračanjem vreče.
English: Infusion of Onpattro at home may be considered for patients who have tolerated at least 3 infusions well in the clinic.
Slovenian: Pri bolnikih, ki so dobro prenesli vsaj 3 infundiranja v bolnišnici, lahko razmislite o infundiranju zdravila Onpattro na domu.
English: The estimated DLin-MC3-DMA mean ± SD steady-state CLss was 2.1 ± 0.8 mL/h/kg.
Slovenian: Ocenjena povprečna vrednost CLss za DLin-MC3-DMA ± SN v stanju dinamičnega ravnovesja je bila 2,1 ± 0,8 ml/h/kg.
English: The recommended dose of Onpattro is 300 micrograms per kg body weight administered via intravenous (IV) infusion once every 3 weeks.
Slovenian: Priporočeni odmerek zdravila Onpattro je 300 mikrogramov na kg telesne mase v obliki intravenske (i.v.)
English: • Intravenous H1 blocker (diphenhydramine 50 mg, or equivalent)
Slovenian: • intravenski zaviralec histaminskega receptorja H1 (difenhidramin 50 mg ali enakovredno zdravilo)
English: • Your doctor will work out how much Onpattro to give you - this will depend on your body weight.
Slovenian: • Vaš zdravnik bo na podlagi vaše telesne mase izračunal količino zdravila Onpattro, ki jo boste prejeli.
English: • Dilute the required volume of filtered Onpattro into an infusion bag containing sodium chloride 9 mg/mL (0.9%) solution for a total volume of 200 mL.
Slovenian: • Potreben volumen filtriranega zdravila Onpattro razredčite v infuzijski vreči, ki vsebuje 0,9-odstotno raztopino natrijevega klorida (9 mg/ml), da dobite skupni volumen 200 ml. Uporabite infuzijske vreče, ki ne vsebujejo di-(2-etilheksil)-ftalata (DEHP).
English: • Intravenous H2 blocker (ranitidine 50 mg, or equivalent)
Slovenian: • intravenski zaviralec histaminskega receptorja H2 (ranitidin 50 mg ali enakovredno zdravilo)
English: The estimated PEG2000-C-DMG mean ± SD steady-state CLss was 2.1 ± 0.6 mL/h/kg.
Slovenian: Ocenjena povprečna vrednost CLss za PEG2000-C-DMG ± SN v stanju dinamičnega ravnovesja je bila 2,1 ± 0,6 ml/h/kg.
English: (OnpattroPlacebo) Treatment Difference, LS Mean (95% CI)
Slovenian: (zdravilo Onpattroplacebo) Razlika v zdravljenju,
English: • Each mL contains patisiran sodium equivalent to 2 mg patisiran.
Slovenian: • En ml vsebuje natrijev patisiranat, ki ustreza 2 mg patisirana.
English: The diluted solution should be administered immediately after preparation.
Slovenian: Razredčeno raztopino infundirajte takoj po pripravi.
English: In patients with pre-defined cardiac involvement, centrally-assessed echocardiograms showed decreases in LV wall thickness (LS mean difference: −0.9 mm [95% CI −1.7, −0.2]) and longitudinal strain (LS mean difference: −1.37% [95% CI -2.48, -0.27]) with Onpattro treatment relative to placebo.
Slovenian: Pri bolnikih z vnaprej določeno prizadetostjo srca je centralna ocena ehokardiograma pokazala zmanjšanje debeline stene levega prekata (povprečna razlika v vrednosti LS: −0,9 mm [95 % IZ −1,7;
English: • Shortness of breath (dyspnoea)
Slovenian: • kratka sapa (dispneja)
English: The infusion sets and lines must be free of di(2ethylhexyl)phthalate (DEHP).
Slovenian: Uporabiti je treba infuzijske komplete in linije, ki ne vsebujejo di-(2-etilheksil)-ftalata (DEHP).
English: (≥ 75%) levels using a rat specific surrogate to patisiran, no effects were found on male or female fertility, embryo-foetal development, or pre-/post-natal development.
Slovenian: Pri podganah so z uporabo za podgane specifičnega nadomestka patisirana opazili zmanjšanja ravni TTR (≥ 90 %), tiroksina (≥ 66 %) in vitamina A (≥ 75 %) v serumu pri starših, nobenih učinkov pa niso opazili na plodnost samcev ali samic, vpliv na razvoj zarodka/ploda oziroma na prenatalni/ponatalni razvoj.
English: What Onpattro contains
Slovenian: Kaj vsebuje zdravilo Onpattro
English: Change from Baseline at 18 months, LS Mean (SEM)
Slovenian: Sprememba od izhodišča po 18 mesecih, povprečje
English: In rabbits, Onpattro generated spontaneous abortions, reduced embryo-foetal survival, and reduced foetal body weights at maternally toxic doses ≥ 1 mg/kg (HED 3.2 times the RHD).
Slovenian: Pri kuncih je zdravilo Onpattro pri odmerkih ≥ 1 mg/kg, toksičnih za mater (odmerek HED je bil 3,2-kratnik odmerka RHD), povzročilo spontane splave, zmanjšano preživetje zarodka/ploda in zmanjšano telesno maso ploda.
English: Bronchitis
Slovenian: ZDRAVILA
English: 6.6 Special precautions for disposal and other handling
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom To zdravilo je samo za enkratno uporabo.
English: Women of childbearing potential
Slovenian: Vpliv na sposobnost razmnoževanja
English: Treatment with Onpattro reduces serum levels of vitamin A. Both too high or too low vitamin A levels may be associated with an increased risk of foetal malformation.
Slovenian: Previsoke ali prenizke ravni vitamina A so lahko povezane s povečanim tveganjem malformacije ploda.
English: What Onpattro is and what it is used for
Slovenian: Kaj je zdravilo Onpattro in za kaj ga uporabljamo Zdravilna učinkovina v zdravilu Onpattro je patisiran.
English: Alnylam Portugal Tel: 707201512 (+351 707502642) medinfo@alnylam.com
Slovenian: Tel: 0707201512 (+351 1707502642) medinfo@alnylam.com
English: • Dizziness
Slovenian: • omotica
English: • Feeling dizzy or faint (vertigo)
Slovenian: • omotica ali omedlevica (vrtoglavica)
English: Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).
Slovenian: Podatkov o uporabi zdravila Onpattro pri nosečnicah ni. Ni dovolj študij na živalih o vplivu zdravila na sposobnost razmnoževanja (glejte poglavje 5.3).
English: Dyspnoea
Slovenian: Imunogenost
English: There is little to no metabolism of PEG2000-C-DMG.
Slovenian: Presnavljanja pri lipidni komponenti PEG2000-C-DMG ni ali pa ga je malo.
English: • The potential for IRRs to occur;
Slovenian: • možnosti pojava reakcij, povezanih z infuzijo;
English: IRRs have been observed in patients treated with Onpattro.
Slovenian: Pri bolnikih, zdravljenih z zdravilom Onpattro, so opazili reakcije, povezane z infuzijo.
English: Ear and labyrinth disorders
Slovenian: Ušesne bolezni, vključno z motnjami labirinta vrtoglavica pogosti
English: Rhinitis
Slovenian: VIALA
English: Cholesterol
Slovenian: • mrzlica
English: Dyspepsia
Slovenian: Dojenje
English: • Feeling sick (nausea)
Slovenian: • občutek slabosti (siljenje na bruhanje)
English: Very common
Slovenian: Po redčenju
English: Administration
Slovenian: Uporaba
English: How to store Onpattro
Slovenian: Shranjevanje zdravila Onpattro
English: Breast-feeding
Slovenian: NIS-Wb
English: ne ne ne
Slovenian: no no no
English: Your doctor will discuss this with you.
Slovenian: Vaš zdravnik se bo z vami o tem pogovoril.
English: Do not wait until the next planned cycle.
Slovenian: Ne čakamo do naslednjega planiranega cikla.
English: They are usually temporary.
Slovenian: Običajno so prehodni.
English: Final concentration
Slovenian: Končna koncentracija
English: The number of infusions you receive will depend on how you respond to the treatment.
Slovenian: Število infuzij, ki jih boste prejeli, bo odvisno od tega, kako se boste odzvali na zdravljenje.
English: Allow the vial to stand undisturbed for approximately 5 minutes.
Slovenian: Vialo pustite stati pri miru približno pet minut.
English: Study BO15935
Slovenian: Študija BO15935
English: Trastuzumab is not genotoxic.
Slovenian: Trastuzumab ni genotoksičen.
English: Other side effects that have been reported (frequency cannot be estimated from the available data):
Slovenian: Drugi neželeni učinki, o katerih so poročali (pogostnosti ni mogoče oceniti iz podatkov, ki so na voljo):
English: Before starting the treatment your doctor will determine the amount of HER2 in your tumour.
Slovenian: Pred začetkom zdravljenja bo vaš zdravnik določil količino HER2 v vašem tumorju.
English: Sometimes, symptoms may improve and then get worse later.
Slovenian: Včasih se lahko simptomi izboljšajo in kasneje ponovno poslabšajo.
English: If this happens to you, contact your doctor immediately.
Slovenian: Če se vam to zgodi, nemudoma obvestite svojega zdravnika.
English: This medicinal product must not be mixed or diluted with other medicinal products except those mentioned under section 6.6.
Slovenian: Zdravila ne smemo mešati ali redčiti z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 6.6.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Do not shake.
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Ne stresajte.
English: Therefore your doctor may decide to continue to check your heart functions, even after you finish treatment.
Slovenian: Zato se bo vaš zdravnik morda odločil za nadaljevanje spremljanja delovanja vašega srca tudi po končanem zdravljenju.
English: Volume of sterile water for injections
Slovenian: Količina sterilne vode za injekcije
English: • Your doctor will advise you of the risks and benefits of taking KANJINTI during pregnancy.
Slovenian: • Zdravnik vam bo svetoval glede tveganja in koristi uporabe zdravila KANJINTI v času nosečnosti.
English: The effects may be moderate to severe and could cause death.
Slovenian: Učinki so lahko zmerni do hudi in lahko povzročijo smrt.
English: Aseptic preparation, handling and storage:
Slovenian: Aseptična priprava, ravnanje in shranjevanje:
English: Official recommendations on HER2 testing may also apply.
Slovenian: Veljajo tudi uradna priporočila za testiranje na HER2.
English: The majority of these events occur during or within 2.5 hours of the start of the first infusion.
Slovenian: Večina teh učinkov se pojavi med ali v 2,5 urah po začetku prvega infundiranja.
English: This could be more serious if you are already breathless.
Slovenian: Težave so lahko bolj resne, če že težko dihate.
English: This helps your medicine work as well as it can.
Slovenian: To omogoči vašemu zdravilu, da deluje kar najbolj učinkovito.
English: Regardless of the regimen used, most symptomatic cardiac events occurred within the first 18 months.
Slovenian: Ne glede na uporabljeni režim se je večina simptomatskih neželenih učinkov, povezanih s srcem, pojavila v prvih 18 mesecih.
English: The majority of the deaths were due to events related to the underlying cancer.
Slovenian: Večina smrti je nastopila zaradi dogodkov, ki so bili povezani z obstoječim rakom.
English: The primary endpoint was overall survival which was defined as the time from the date of randomisation to the date of death from any cause.
Slovenian: Primarni končni cilj preskušanja je bilo celokupno preživetje, ki so ga definirali kot čas od dneva randomizacije do dneva smrti iz katerega koli vzroka.
English: Specific percentages for these are not available.
Slovenian: O natančnih odstotkih ni podatkov.
English: Study MO16419
Slovenian: Študija MO16419
English: In other situations, the decision on the need for additional cytotoxic chemotherapy is determined based on individual factors.
Slovenian: V drugih primerih odločitev za potrebo po dodatni citotoksični kemoterapiji temelji na dejavnikih posameznika.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 May 2018
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 16. maj 2018
English: Warnings and precautions Your doctor will closely supervise your therapy.
Slovenian: Opozorila in previdnostni ukrepi Vaš zdravnik bo vaše zdravljenje pozorno spremljal.
English: The following information is intended for medical or healthcare professionals only
Slovenian: Naslednje informacije so namenjene samo zdravstvenemu osebju:
English: All doses should be taken at the right time every week or every three weeks (depending on your dosing schedule).
Slovenian: Vse odmerke morate prejeti v ustreznem času vsak teden ali vsake tri tedne (glede na vašo shemo odmerjanja).
English: Children and adolescents KANJINTI is not recommended for anyone under the age of 18 years.
Slovenian: Uporaba pri otrocih in mladostnikih Zdravilo KANJINTI ni priporočljivo za mlajše od 18 let.
English: The bioactivity of D7D and the clinical impact of the elevation of this metabolite was unclear.
Slovenian: Biološka aktivnost D7D in klinični vpliv zaradi dviga ravni tega presnovka nista bila jasna.
English: The presence of trastuzumab in the serum of infant monkeys was not associated with any adverse effects on their growth or development from birth to 1 month of age.
Slovenian: Prisotnost trastuzumaba v serumu opičjih mladičev ni bila povezana z nobenimi neželenimi učinki na njihovo rast ali razvoj od rojstva do enega meseca starosti.
English: Clinical experience is limited in patients above 65 years of age.
Slovenian: Kliničnih izkušenj pri bolnikih, starejših od 65 let, je malo.
English: Care must be taken to ensure the sterility of prepared solutions.
Slovenian: Paziti je treba, da zagotovimo sterilnost pripravljenih raztopin.
English: HER2 is found in large amounts on the surface of some cancer cells where it stimulates their growth.
Slovenian: HER2 najdemo v velikih količinah na površini nekaterih rakavih celic, kjer spodbuja njihovo rast.
English: Patients should be warned of the possibility of such a late onset and should be instructed to contact their physician if these symptoms occur.
Slovenian: Bolnike je treba opozoriti na možnost tako poznega pojava simptomov in jim svetovati, da takoj obvestijo svojega zdravnika, če se ti simptomi pojavijo.
English: Patients classified as staining 2+ or 3+ were included, while those staining 0 or 1+ were excluded.
Slovenian: Bolniki z vrednostmi 2+ ali 3+ so bili vključeni, tisti z 0 ali 1+ pa izključeni.
English: KANJINTI can cause breathing difficulties, especially when it is first given.
Slovenian: Zdravilo KANJINTI lahko povzroči težave z dihanjem, še zlasti, ko ga prejmete prvič.
English: KANJINTI should only be given by a doctor or nurse.
Slovenian: Zdravilo KANJINTI lahko daje le zdravnik ali medicinska sestra.
English: Overexpression of HER2 is observed in 20%-30% of primary breast cancers.
Slovenian: Čezmerno izražanje HER2 so opazili pri 20 % do 30 % primarnega raka dojk.
English: It is estimated that approximately 40% of patients who are treated with trastuzumab will experience some form of infusion-related reaction.
Slovenian: Ocenjujejo, da se pri približno 40 % bolnikov, ki prejemajo trastuzumab, pojavi neka oblika reakcij, povezanih z infuzijo.
English: Your doctor will prescribe a dose and treatment regimen that is right for you.
Slovenian: Vaš zdravnik vam bo predpisal odmerek in režim zdravljenja, ki bo primeren le za vas.
English: Do not use KANJINTI if:
Slovenian: Ne uporabljajte zdravila KANJINTI, če:
English: You may also wish to make a note of these details in case you are asked for this information in the future.
Slovenian: Morda boste tudi vi želeli zapisati te podatke za primer, da jih bodo od vas še kdaj zahtevali.
English: All such patients should be referred for assessment by a cardiologist and followed up.
Slovenian: Vse take bolnike je treba napotiti na pregled h kardiologu in jih spremljati.
English: Interruption or slowing the rate of the infusion may help control such symptoms.
Slovenian: Prekinitev ali upočasnitev hitrosti dajanja infuzije lahko pomaga pri nadzoru teh simptomov.
English: It is not known whether trastuzumab can affect reproductive capacity.
Slovenian: Ni znano, ali lahko trastuzumab škodljivo vpliva na sposobnost za razmnoževanje.
English: The frequency of occurrence of hypoprothrombinaemia is not known.
Slovenian: Pogostnost pojavljanja hipoprotrombinemije ni znana.
English: Since the medicinal product does not contain any anti-microbial preservative or bacteriostatic agents, aseptic technique must be observed.
Slovenian: Ker zdravilo ne vsebuje protimikrobnih konzervansov ali bakteriostatikov, je treba upoštevati aseptično tehniko.
English: Do not use with glucose-containing solutions (see section 6.2).
Slovenian: Ne uporabljajte raztopin, ki vsebujejo glukozo (glejte poglavje 6.2).
English: These tissues were fixed in formalin or Bouin's fixative.
Slovenian: Tkiva so bila fiksirana s formalinom ali v Bouinsovem fiksativu.