FrancophonIA/ELRC3.0 huggingface dataset:
English: Budesonide/Formoterol Teva Pharma B.V. is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate: -in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists.
Slovenian: ko je primerna kombinacija zdravil (inhalacijski kortikosteroid in dolgodelujoči agonist adenoreceptorjev β2): - pri bolnikih, pri katerih bolezni ne moremo ustrezno nadzorovati z inhalacijskimi kortikosteroidi ter kratkodelujočimi inhalacijskimi agonisti adrenergičnih receptorjev β2, ki so predpisani za uporabo po potrebi.
English: To treat your asthma your doctor will prescribe two asthma inhalers: Budesonide/Formoterol Teva Pharma B.V. together with a separate ‘reliever inhaler' such as salbutamol.
Slovenian: Za zdravljenje astme vam bo zdravnipredpisal dva inhalator Budezonid/formoterol Teva Pharma B.V.
English: • It is important to use Budesonide/Formoterol Teva Pharma B.V. every day, even if you have no asthma symptoms at the time.
Slovenian: uporabite vsak dan, tudi če trenutno nimate simptomov astme.
English: The prolonged treatment with high doses of inhaled corticosteroids, particularly higher than recommended doses, may also result in clinically significant adrenal suppression.
Slovenian: Klinično pomembna adrenalna supresija se lahko pojavi tudi pri bolnikih, ki so imeli podaljšano zdravljenje z visokimi odmerki inhalacijskih kortikosteroidov, še posebej v odmerkih, višjih od priporočenih.
English: Once your asthma is well controlled your doctor may consider it appropriate to gradually reduce the dose of Budesonide/Formoterol Teva Pharma B.V.
Slovenian: Ko so simptomi astme dobro obvladani, bo vaš zdravnik morda predlagal, da odmerek zdravila Budezonid/formoterol Teva Pharma B.V.
English: How to use Budesonide/Formoterol Teva Pharma B.V.
Slovenian: Kako uporabljati zdravilo Budezonid/formoterol Teva Pharma B.V.
English: Patients should also be advised to rinse their mouth with water after inhaling (see section 4.4) The patient may notice a taste when using Budesonide/Formoterol Teva Pharma B.V. due to the lactose excipient.
Slovenian: Bolnikom svetujte tudi, naj si po inhaliranju sperejo usta z vodo (glejte poglavje 4.4).
English: If you feel you are getting breathless or wheezy while using Budesonide/Formoterol Teva Pharma B.V., you should continue to use Budesonide/Formoterol Teva Pharma B.V. but go to see your doctor as soon as possible, as you may need additional treatment.
Slovenian: zdi, da dihanje postaja težje ali piskajoče, zdravilo uporabljajte še naprej, vendar pa čim prej obiščite zdravnika, saj boste morda potrebovali dodatno zdravljenje.
English: To treat your asthma your doctor will prescribe Budesonide/Formoterol Teva Pharma B.V. together with a separate ‘reliever inhaler' such as salbutamol.
Slovenian: Astma Za zdravljenje astme vam bo zdravnik predpisal inhalator Budezonid/formoterol Teva Pharma B.V.
English: • Steroid medicines that you take by mouth (such as prednisolone).
Slovenian: • steroidna zdravila za peroralno uporabo (npr. prednizolon).
English: Preparing your new Budesonide/Formoterol Teva Pharma B.V.
Slovenian: Priprava novega inhalatorja Budezonid/formoterol Teva Pharma B.V.
English: The use of Budesonide/Formoterol Teva Pharma B.V. follows three simple steps: open, breathe and close which are outlined below.
Slovenian: zajema tri preproste korake: odprite, vdihnite in zaprite, ki so opisani spodaj.
English: - in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists.
Slovenian: - pri bolnikih, pri katerih bolezni ne moremo ustrezno nadzorovati z inhalacijskimi kortikosteroidi ter kratkodelujočimi inhalacijskimi agonisti adrenergičnih receptorjev β2, ki so predpisani za uporabo po potrebi; ali - pri bolnikih, pri katerih bolezen že ustrezno nadzorujemo tako z inhalacijskimi kortikosteroidi kot z dolgodelujočimi agonisti adrenergičnih receptorjev β2.
English: Budesonide/Formoterol Teva Pharma B.V. has no or negligible influence on the ability to drive and use machines.
Slovenian: nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: Potentially serious hypokalaemia may result from high doses of β2 adrenoceptor agonists.
Slovenian: Pri uporabi velikih odmerkov agonistov adrenergičnih receptorjev β2 lahko nastopi potencialno huda hipokaliemija.
English: Each Budesonide/Formoterol Teva Pharma B.V. inhaler contains 120 inhalations and has a white body with a semi-transparent wine red mouthpiece cover.
Slovenian: vsebuje 120 inhalacij zdravila in ima belo ohišje s polprozornim vinsko rdečim ustnikom.
English: Budesonide/Formoterol Teva Pharma B.V. 160 micrograms/4.5 micrograms, inhalation powder (budesonide/formoterol fumarate dihydrate)
Slovenian: 160 mikrogramov/4,5 mikrogramov, prašek za inhaliranje (budezonid/formoterolijev fumarat dihidrat)
English: Budesonide/Formoterol Teva Pharma B.V. 320 micrograms/9 micrograms inhalation powder budesonide/formoterol fumarate dihydrate
Slovenian: 320 mikrogramov/9 mikrogramov prašek za inhaliranje budezonid/formoterolijev fumarat dihidrat
English: Budesonide/Formoterol Teva Pharma B.V. contains formoterol and budesonide, which have different modes of action and show additive effects in terms of reduction of asthma exacerbations.
Slovenian: vsebuje zdravilni učinkovini formoterol in budezonid, ki imata različna mehanizma delovanja, njuni učinki pri zmanjšanju pogostnosti poslabšanj astme pa so aditivni.
English: Each Budesonide/Formoterol Teva Pharma B.V. inhaler contains 60 inhalations and has a white body with a semi-transparent wine red mouthpiece cover.
Slovenian: vsebuje 60 inhalacij zdravila in ima belo ohišje s polprozornim vinsko rdečim pokrovčkom ustnika.
English: Budesonide/Formoterol Teva Pharma B.V. 160 micrograms /4.5 micrograms inhalation powder budesonide / formoterol fumarate dihydrate
Slovenian: 160 mikrogramov/4,5 mikrogramov prašek za inhaliranje budezonid/formoterolijev fumarat dihidrat
English: The most common symptoms that may occur after if you use more Budesonide/Formoterol Teva Pharma B.V. than you should are trembling, headache or a rapid heartbeat.
Slovenian: Budezonid/formoterol Teva Pharma B.V., kot bi smeli, so tresenje, glavobol in hitro bitje srca.
English: Not applicable.
Slovenian: ostane optimalen.
English: If you become wheezy or breathless, or develop any other symptoms of an asthma attack, use your ‘reliever inhaler', then seek medical advice.
Slovenian: Če se pojavi piskajoče ali oteženo dihanje ali kateri koli drug simptom astmatičnega napada,
English: Each delivered (inhaled) dose contains 160 micrograms of budesonide and 4.5 micrograms of formoterol fumarate dihydrate.
Slovenian: En dovedeni odmerek (odmerek, ki pride iz ustnika Spiromax) vsebuje 160 mikrogramov budezonida in 4,5 mikrogramov formoterolijevega fumarata dihidrata.
English: Budesonide/Formoterol Teva Pharma B.V. pharmacokinetic profile
Slovenian: Farmakokinetični profil zdravila Budezonid/formoterol Teva Pharma B.V.
English: No increased incidence of adverse reactions has been seen following concurrent administration of the two compounds.
Slovenian: Pri sočasni uporabi obeh učinkovin pa niso ugotavljali povečane incidence neželenih učinkov.
English: Budesonide/Formoterol Teva Pharma B.V. is not an appropriate treatment for the adult patient with only mild asthma who is not adequately controlled with an inhaled corticosteroid and “as needed” inhaled shortacting β2 adrenoreceptor agonists.
Slovenian: ni ustrezno pri odraslih bolnikih z blago obliko astme, ki ni ustrezno nadzorovana z inhalacijskim kortikosteroidi in inhalacijskimi kratkodelujočimi agonisti adrenoreceptorjev β2, ki se uporabljajo po potrebi.
English: Patients should be reassessed regularly by their prescriber/health care provider so that the dose of Budesonide/Formoterol Teva Pharma B.V. remains optimal.
Slovenian: Zdravnik , ki predpisuje zdravilo, mora bolnike redno ocenjevati, tako da odmerek zdravila Budezonid/formoterol Teva Pharma B.V.
English: • Feeling restless, nervous, agitated, anxious or angry.
Slovenian: Občasni: pojavijo se lahko pri največ 1 od 100 bolnikov • nemir, živčnost, agitiranost, tesnobnost ali jeza,
English: Start Teva Pharma B.V.
Slovenian: Pharma B.V.
English: Medicinal product subject to medical prescription.
Slovenian: V tem primeru je treba zdravljenje z zdravilom
English: The safety and efficacy of Budesonide/Formoterol Teva Pharma B.V. in children, 12 years and younger and adolescents, 13 to 17 years of age has not yet been established.
Slovenian: pri otrocih, starih 12 let in manj, ter pri mladostnikih, starih od 13 do 17 let, še nista bili dokazani.
English: Budesonide/formoterol maintenance therapy
Slovenian: Astma Vzdrževalno zdravljenje astme z budezonidom/formoterolom
English: • Bruising of the skin.
Slovenian: • hitro bitje srca, • podplutbe na koži,
English: Budesonide/Formoterol Teva Pharma B.V. is NOT indicated for use in children, 12 years of age and younger or adolescents, 13 to 17 years of age.
Slovenian: ni indicirano za uporabo pri otrocih, starih 12 let ali manj, ali mladostnikih, starih od 13 do 17 let.
English: If Budesonide/Formoterol Teva Pharma B.V. therapy has to be withdrawn due to overdose of the formoterol component of the medicinal product, provision of appropriate inhaled corticosteroid therapy must be considered.
Slovenian: prekiniti zaradi prevelikega odmerka formoterola, ki je sestavina zdravila, je treba poskrbeti za ustrezno zdravljenje z inhalacijskim kortikosteroidom.
English: Other medicines and Budesonide/Formoterol Teva Pharma B.V. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: Candida infections in the oropharynx
Slovenian: Infekcijske in parazitske bolezni pogosti okužbe s kandido v ustnih in žrelu
English: Budesonide/Formoterol Teva Pharma B.V.320 micrograms/9 micrograms, inhalation powder (budesonide/formoterol fumarate dihydrate)
Slovenian: 320 mikrogramov/9 mikrogramov, prašek za inhaliranje (budezonid/formoterolijev fumarat dihidrat)
English: Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht The Netherlands
Slovenian: Computerweg 10, 3542 DR Utrecht Nizozemska
English: Keep the mouthpiece cover closed after the removal of foil wrap.
Slovenian: Po odstranitvi ovoja iz folije naj bo pokrovček ustnika zaprt.
English: If any of the following happen to you, stop using Budesonide/Formoterol Teva Pharma B.V. and talk to your doctor immediately:
Slovenian: Če vas skrbi, ali je prav, da še naprej uporabljate zdravilo Budezonid/formoterol Teva Pharma B.V., se posvetujte z zdravnikom.
English: • you are diabetic.
Slovenian: • če imate sladkorno bolezen.
English: Prolongation of QTc-interval
Slovenian: supraventrikularna tahikardija, ekstrasistole angina pektoris podaljšanje intervala QTc
English: Budesonide/Formoterol Teva Pharma B.V. contains lactose Lactose is a type of sugar found in milk.
Slovenian: Laktoza je vrsta sladkorja, ki jo najdemo v mleku.
English: How to store Budesonide/Formoterol Teva Pharma B.V.
Slovenian: Kaj je zdravilo Budezonid/formoterol Teva Pharma B.V.
English: Each delivered (inhaled) dose contains 320 micrograms of budesonide and 9 micrograms of formoterol fumarate dihydrate.
Slovenian: odmerek vsebuje 320 mikrogramov budezonida in 9 mikrogramov formoterolijevega fumarata dihidrata.
English: Serious asthma-related adverse reactions and exacerbations may occur during treatment with Budesonide/Formoterol Teva Pharma B.V..
Slovenian: Pomembne informacije o simptomih astme Če se vam med zdravljenjem z zdravilom Budezonid/formoterol Teva Pharma B.V.
English: Budesonide/Formoterol Teva Pharma B.V. is not indicated for use in children, 12 years of age and younger or adolescents, 13 to 17 years of age.
Slovenian: NI namenjeno za uporabo pri otrocih, starih 12 let in manj, ali mladostnikih, starih od 13 do 17 let.
English: Breathe: Place the mouthpiece between the teeth with the lips closed around the mouthpiece, do not bite the mouthpiece of the inhaler.
Slovenian: Vdihnite: Namestite ustnik med zobe in stisnite ustnice okrog njega.
English: What you need to know before you use Budesonide/Formoterol Teva Pharma B.V. (page 5) 3.
Slovenian: in za kaj ga uporabljamo (stran 3) Kaj morate vedeti, preden boste uporabili zdravilo Budezonid/formoterol Teva Pharma B.V.
English: What Budesonide/Formoterol Teva Pharma B.V. looks like and contents of the pack Budesonide/Formoterol Teva Pharma B.V. is an inhalation powder.
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Budezonid/formoterol Teva Pharma B.V.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Budesonide/Formoterol Teva Pharma B.V.320 mcg/9 mcg inhalation powder budesonide/formoterol fumarate dihydrate
Slovenian: 320 mcg/9 mcg prašek za inhaliranje budezonid/formoterolijev fumarat dihidrat za inhaliranje
English: Important information about your asthma symptoms
Slovenian: za odpravljanje teh simptomov astme.
English: Patients should be reminded to take their Budesonide/Formoterol Teva Pharma B.V. maintenance dose as prescribed, even when asymptomatic.
Slovenian: Bolnike je treba opozoriti, naj uporabljajo vzdrževalni odmerek zdravila Budezonid/formoterol Teva
English: Dizziness
Slovenian: Odmerjanje
English: Patients should not be initiated on Budesonide/Formoterol Teva Pharma B.V. during an exacerbation, or if they have significantly worsening or acutely deteriorating asthma.
Slovenian: med poslabšanjem astme ali v obdobju pomembnega oziroma akutnega poslabšanja simptomov astme.
English: EU Number Invente d Name
Slovenian: EU številka Izmišljeno ime
English: Packaging Content (concentration)
Slovenian: Ovojnina Vsebina (koncentracija)
English: Lyophilisate and solvent for suspension for injection
Slovenian: Liofilizat in vehikel za suspenzijo za injiciranje
English: EU/2/04/049/002 Purevax log 10 EID50 per dose
Slovenian: EU/2/04/049/002 Purevax
English: Attenuated feline rhinotracheitis herpesvirus (FVH F2 strain): at least 4.9 log 10 CCID50 per
Slovenian: FHV F2): ≥ 104,9 CCID50 na odmerek Inaktivirani
English: 1 falcon tube with 1, 2 or 3 vials + 1 syringe + 18G intravenous catheter + 2
Slovenian: 1 epruveta Falcon z 1, 2 ali 3 vialami + 1 brizga + G 18 intravenski kateter + 2 Vicryl o č
English: Vial (glass/alu)
Slovenian: Viala (steklo/alu)
English: EU/1/09/563/001
Slovenian: EU/1/09/563/001 ChondroCelect 10 000 celic/µl
English: Invented name Strength Pharmaceutical Form
Slovenian: Številka EU Izmišljeno ime Jakost
English: Implantation suspension
Slovenian: Celična suspenzija za implantacijo
English: Route of Administration
Slovenian: Farmacevtska oblika Pot uporabe
English: The treatment will be repeated every two weeks.
Slovenian: Zdravljenje se bo ponovilo na vsaka dva tedna.
English: They may differ from the general information contained in this leaflet.
Slovenian: Lahko se razlikujejo od splošnih informacij v tem navodilu.
English: Do not interchange.
Slovenian: Ne zamenjujte.
English: Unopened vial 30 months.
Slovenian: Neodprta viala 30 mesecev
English: Volume (V)
Slovenian: Volumen (V)
English: All dose modifications should be based on the worst preceding toxicity.
Slovenian: Vse spremembe odmerkov morajo temeljiti na najhujši predhodni toksičnosti.
English: SD= standard deviation
Slovenian: SD = standardni odklon
English: It must be protected from light, and it must not be frozen.
Slovenian: Zaščititi jo morate pred svetlobo in je ne smete zamrzovati.
English: It is especially important that you tell your doctor if you have been given irinotecan in any form earlier.
Slovenian: Še zlasti je pomembno, da zdravniku poveste, če ste že kdaj prej prejemali irinotekan v kateri koli obliki.
English: Killed or inactivated vaccines may be administered; however, the response to such vaccines may be diminished.
Slovenian: Mrtva ali inaktivirana cepiva se lahko dajejo, vendar je odziv na takšna cepiva lahko zmanjšan.
English: What to do in case of diarrhoea
Slovenian: Kaj storiti v primeru driske
English: Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Slovenian: Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
English: Asian population
Slovenian: Azijska populacija
English: Genotoxic and carcinogenic potential
Slovenian: Genotoksični in kancerogeni potencial
English: Patients should be monitored for signs of infections.
Slovenian: Bolnike je treba spremljati glede znakov okužbe.
English: Patients received treatment until disease progression or unacceptable toxicity.
Slovenian: Bolniki so prejemali zdravljenje do napredovanja bolezni ali do nesprejemljive toksičnosti.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 October 2016
Slovenian: Datum prve odobritve: 14. oktober 2016
English: Clearance (CL)
Slovenian: Očistek (CL)
English: The appropriate starting dose for patients taking these anticonvulsants or other strong inducers has not been defined.
Slovenian: Ustrezen začetni odmerek za bolnike, ki jemljejo te antikonvulzive ali druge močne induktorje, ni bil določen.
English: The primary outcome measure was Overall Survival (OS).
Slovenian: Primarno merilo izida je bilo celokupno preživetje (OS, overall survival).
English: Patients who require further dose reduction should discontinue treatment.
Slovenian: Bolniki, ki potrebujejo nadaljnje zmanjšanje odmerka, morajo zdravljenje prekiniti.
English: Each pack contains one vial.
Slovenian: Eno pakiranje vsebuje eno vialo.
English: Your doctor may give you a medicine which contains loperamide to begin treatment at home but it must not be used for longer than 48 consecutive hours.
Slovenian: Zdravnik vam bo morda dal zdravilo, ki vsebuje loperamid, s katerim se boste začeli zdraviti doma, vendar ga ne smete uporabljati dlje kot 48 ur zaporedoma.
English: Immunosuppressive effects and vaccines
Slovenian: Imunosupresivni učinki in cepiva
English: Contact your doctor immediately to give you a suitable treatment.
Slovenian: Takoj se obrnite na zdravnika, ki bo uvedel primerno zdravljenje.
English: For more details see section 6.6.
Slovenian: Za več podrobnosti glejte poglavje 6.6.
English: Your doctor may need to adjust the dose or stop treatment.
Slovenian: Vaš zdravnik bo morda moral spremeniti odmerek ali zdravljenje prekiniti.
English: Grade 3 or 4
Slovenian: 3. ali 4. stopnje
English: stomatitis and pyrexia.
Slovenian: stomatitis in pireksija.
English: Per RECIST guidelines, v 1.1.
Slovenian: Skladno s smernicami RECIST, v 1.1.
English: Grade 3 or 4 (despite antiemetic therapy)
Slovenian: 3. ali 4. stopnje (kljub antiemetičnemu zdravljenju)
English: It is important that you are aware of what these side effects may be.
Slovenian: Pomembno je, da veste, kateri so možni neželeni učinki.
English: • The active substance is irinotecan.
Slovenian: • Učinkovina je irinotekan.
English: Results are shown in Table 4.
Slovenian: Rezultati so prikazani v preglednici 4.
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Slovenian: Če se zdravilo ne uporabi takoj, je za čas in pogoje shranjevanja odgovoren uporabnik.
English: You will need to have further (blood or other) tests during treatment so that your doctor can monitor your blood cells and assess how you are responding to the treatment.
Slovenian: Med zdravljenjem boste morali iti še na dodatne (krvne ali drugačne) preiskave, tako da bo zdravnik lahko spremljal krvne celice in ocenil, kako se odzivate na zdravljenje.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1130/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/16/1130/001
English: Overall survival is illustrated in Figure 1.
Slovenian: Celokupno preživetje je prikazano na sliki 1.
English: Total SN-38
Slovenian: Skupni SN-38
English: In certain cases, lower doses or longer dosing intervals may be required.
Slovenian: V določenih primerih so potrebni manjši odmerki ali daljši intervali med odmerjanjem.
English: The severity of effects was dose-related and reversible.
Slovenian: Resnost učinkov je bila povezana z odmerkom in je bila reverzibilna.
English: 92284 Suresnes cedex France
Slovenian: 92284 Suresnes cedex
English: The following side effects may occur:
Slovenian: Pojavijo se lahko naslednji neželeni učinki:
English: Tell your doctor if you are or think you may be pregnant.
Slovenian: Obvestite zdravnika, če ste noseči ali menite, da bi lahko bili noseči.
English: Median is the Kaplan-Meier estimate of the median survival time
Slovenian: Mediana je ocena srednjega časa preživetja po Kaplan-Meierju
English: Patients should be informed about the signs and symptoms of thromboembolism and advised to contact their physician or nurse immediately if any such signs or symptoms should occur.
Slovenian: Bolnike je treba obvestiti o znakih in simptomih trombembolije in jim svetovati, da se v primeru katerega od teh znakov ali simptomov takoj obrnejo na svojega zdravnika ali medicinsko sestro.
English: The concentrate has a pH of 7.2 and an osmolality of 295 mOsm/kg.
Slovenian: Koncentrat ima pH 7,2 in osmolalnost 295 mOsm/kg.
English: Figure 1: Overall survival
Slovenian: Slika 1 Celokupno preživetje
English: * MedDRA version 14.1 ** Rare occurrence cannot be estimated from the NAPOLI-1study due to the small sample size
Slovenian: * Različica MedDRA 14.1 ** Redkih pojavnosti iz študije NAPOLI-1 zaradi majhne velikosti vzorca ni mogoče oceniti
English: The adverse reactions in these patients were similar to those reported with the recommended dosage and regimen.
Slovenian: Neželeni učinki pri teh bolnikih so bili podobni kot tisti, o katerih so poročali pri priporočenih odmerkih in režimu odmerjanja.
English: • From a microbiological point of view, the product should be used as soon as possible after dilution.
Slovenian: • Z mikrobiološkega vidika je treba zdravilo uporabiti čim prej po razredčitvi.
English: ONIVYDE pegylated liposomal must not be mixed with other medicinal products except those mentioned in section 6.6.
Slovenian: Zdravila ONIVYDE pegilirani liposomski ne smemo mešati z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 6.6.
English: Patient demographic and entry disease characteristics were well balanced between trial arms.
Slovenian: Demografski podatki bolnikov in značilnosti bolezni ob vključitvi so bili uravnoteženi med vejami preskušanja.
English: Neutropenia/leukopenia was the most notable important haematological toxicity.
Slovenian: Nevtropenija/levkopenija je bila najopaznejša pomembna hematološka toksičnost.
English: Your doctor may also prescribe other medicines to help control your side effects.
Slovenian: Zdravnik vam lahko predpiše tudi druga zdravila, ki vam bodo pomagala obvladati neželene učinke.
English: Hypersensitivity reactions, including acute infusion reaction may occur.
Slovenian: Lahko se pojavijo preobčutljivostne reakcije, vključno z akutno infuzijsko reakcijo.
English: Each pack contains one vial with 10 ml of concentrate.
Slovenian: Eno pakiranje vsebuje eno vialo z 10 ml koncentrata.
English: You can also report side effects directly via the national reporting system listed in
Slovenian: O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v
English: During treatment patients should observe caution when driving or using machines.
Slovenian: Bolniki morajo biti med zdravljenjem pri vožnji in upravljanju strojev previdni.
English: Therefore, based on results from animal studies and the mechanism of action of irinotecan, ONIVYDE pegylated liposomal should not be used during pregnancy unless clearly necessary.
Slovenian: Zato na podlagi rezultatov študij na živalih in mehanizma delovanja irinotekana zdravila ONIVYDE pegilirani liposomski ne smemo uporabljati med nosečnostjo, razen če je nujno potrebno.