FrancophonIA/ELRC3.0 huggingface dataset:
English: R-CHOP was associated with improvements in outcome for both high- and low-risk patients according to age adjusted IPI.
Slovenian: Zdravljenje z R-CHOP je bilo glede na starost prilagojen mednarodni prognostični indeks ugodno za bolnike z majhnim in velikim
English: Name and address of the manufacturer of the biological active substance CELLTRION Inc.,
Slovenian: SPROŠČANJE SERIJ Ime in naslov izdelovalca biološke učinkovine
English: Patients treated with rituximab may receive non-live vaccinations.
Slovenian: Bolniki, ki se zdravijo z rituksimabom, lahko prejmejo mrtva cepiva, vendar je lahko odgovor nanje zmanjšan.
English: The incidence of infusion-related symptoms decreased substantially with subsequent infusions and is <1% of patients by the eighth cycle of rituximab-containing
Slovenian: Incidenca simptomov in znakov, povezanih z infuzijo, se je z nadaljnjimi infuzijami precej zmanjšala in je bila do osmega cikla
English: The antigen is expressed on >95 % of
Slovenian: Razlika (95-% IZ)
English: Mean pre-therapeutic antibody titres against a panel of antigens (Streptococcus pneumoniae, influenza A, mumps, rubella, varicella) were maintained for at least 6 months after treatment with rituximab.
Slovenian: mumps, rdečke, norice) so se ohranili najmanj 6 mesecev po zdravljenju z rituksimabom.
English: Limited information from one study in relapsed/refractory CLL patients suggests that rituximab treatment may also worsen the outcome of primary hepatitis B infections.
Slovenian: Omejeni podatki iz ene študije pri bolnikih s KLL, pri katerih se je bolezen ponovila oziroma so bili neodzivni na zdravljenje, kažejo, da lahko zdravljenje z rituksimabom poslabša tudi izid primarnih okužb z virusom hepatitisa B. Pri vseh bolnikih je treba pred začetkom zdravljenja z rituksimabom narediti presejalni test na virus hepatitisa B. To vključuje najmanj določanje statusa HBsAg in HBcAb, ki ju lahko dopolnimo z ostalimi primernimi označevalci v skladu z lokalnimi smernicami.
English: Table 5a First-line treatment of chronic lymphocytic leukaemia Overview of efficacy results for rituximab plus FC vs. FC alone - 48.1 months
Slovenian: Pregled rezultatov o učinkovitosti za rituksimab v kombinaciji s kemoterapijo FC v primerjavi s samo kemoterapijo FC - mediana opazovanja 48,1 meseca.
English: EXP
Slovenian: ORR
English: Patients in both arms received 1000mg of pulse intravenous (IV) methylprednisolone (or another equivalent-dose glucocorticoid) per day for 1 to 3 days, followed by oral prednisone (1 mg/kg/day, not exceeding 80 mg/day).
Slovenian: Bolniki v obeh terapevtskih skupinah so prejemali 1.000 mg metilprednizolona (ali drugega glukokortikoida v enakovrednem odmerku) na dan pulzno intravensko (i.v.)
English: • heart problems - such as heart attack and uneven or fast heart rate
Slovenian: težave s srcem - na primer srčni infarkt in neredno ali hitro bitje srca, visok ali nizek krvni tlak (nizek krvni tlak zlasti po hitrem vstajanju),
English: Re-treatment
Slovenian: Samostojno zdravljenje
English: Immunisations
Slovenian: Cepljenje
English: Premedication consisting of an anti-pyretic and an antihistaminic, e.g. paracetamol and diphenhydramine, should always be given before each administration of Rituzena.
Slovenian: Pred uporabo zdravila Rituzena mora bolnik vedno dobiti premedikacijo, ki obsega antipiretik in antihistaminik, npr. paracetamol in difenhidramin.
English: For the 60 re-treatments on study, the ORR was 38% (CI95 % 26% - 51%; 10% CR, 28% PR) with a projected median TTP for responding patients of 17.8 months (range 5.4 - 26.6).
Slovenian: Za 60 ponovnih zdravljenj je bil celokupen odgovor na zdravljenje 38 % (95-% interval zaupanja 26-51 %; 10 % popoln odgovor, 28 % delni odgovor).
English: You will always be given Rituzena as a drip (intravenous infusion).
Slovenian: Zdravilo Rituzena boste dobili v intravenski infuziji.
English: and appropriate measures to diagnose PML
Slovenian: vključno s PML.
English: • low number of red blood cells (anaemia)
Slovenian: majhno število rdečih krvnih celic (anemija), majhno število vseh krvnih celic, alergijske reakcije (preobčutljivost),
English: vasculitis (predominatel y cutaneous), leukocytoclast ic vasculiti interstitial lung disease7
Slovenian: levkocitoklastični vaskulitis intersticijska bolezen pljuč7
English: Mean terminal elimination half-life after the second infusion, following the second course, was 19 days for 2 x 500 mg dose and ranged from 21 to 22 days for the 2 x 1000 mg dose.
Slovenian: Povprečni končni razpolovni čas izločanja po drugi infuziji, po drugem ciklu zdravljenja, je bil 19 dni za 2 x
English: The ADRs listed in Table 3 were all adverse events which occurred at an incidence of ≥ 5% in the
Slovenian: Neželeni učinki, navedeni v preglednici 3, so se v skupini, ki je prejemala rituksimab, pojavili z
English: In a multicentre, single-arm trial, 58 patients with relapsed or chemoresistant low grade or follicular B cell NHL, who had achieved an objective clinical response to a prior course of rituximab, were re-treated with 375 mg/m2 of rituximab as intravenous infusion weekly for four doses.
Slovenian: V multicentričnem preskušanju brez primerjalne skupine je 58 bolnikov, pri katerih se je nizko maligni ali folikularni B-celični ne-Hodgkinov limfom ponovil ali pa so bili bolniki neodzivni na kemoterapijo ter so dosegli objektivni klinični odgovor na predhodno zdravljenje z rituksimabom, ponovno prejelo 4
English: For retreatment with Rituzena monotherapy for patients who have responded to previous treatment with Rituzena monotherapy for relapsed/refractory follicular lymphoma, the recommended dose is: 375 mg/m2 body surface area, administered as an intravenous infusion once weekly for four weeks
Slovenian: Priporočeni odmerek zdravila Rituzena za ponovno samostojno zdravljenje bolnikov s folikularnim limfomom, ki so se odzvali na prejšnje samostojno zdravljenje z zdravilom Rituzena po tem, ko se na predhodno zdravljenje niso odzvali ali se je pri njih bolezen ponovila, je: 375 mg/m2 telesne površine v obliki intravenske infuzije enkrat na teden 4 tedne (glejte poglavje 5.1).
English: This is usually given
Slovenian: Temu mora slediti
English: Table 3 Adverse drug reactions occurring at 6-months in ≥ 5% of patients receiving rituximab, and at a higher frequency than the comparator group, in the
Slovenian: bolnikov, ki so prejeli rituksimab, in pogosteje kot v primerjalni skupini.
English: Malignancies
Slovenian: Ciklofosfamid
English: Syndrome), Stevens-Johnson Syndrome5
Slovenian: miokardni infarkt atrijska undulacija toksična epidermalna nekroliza (Lyellov sindrom), StevensJohnsonov sindrom5
English: The recommended dose of Rituzena monotherapy used as induction treatment for adult patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy is: 375 mg/m2 body surface area, administered as an intravenous infusion once
Slovenian: • Bolniki, ki se na prejšnje zdravljenje niso odzvali ali se je pri njih bolezen ponovila Priporočeni odmerek zdravila Rituzena za samostojno indukcijsko zdravljenje odraslih bolnikov s III. in IV. stadijem folikularnih limfomov, ki so neodzivni na kemoterapijo ali se je pri njih bolezen po kemoterapiji drugič ali že večkrat ponovila, je: 375 mg/m2 telesne površine v obliki intravenske infuzije
English: • infections of the blood (sepsis), pneumonia, shingles, cold, bronchial tube infections, fungal infections, infections of unknown origin, sinus inflammation, hepatitis B
Slovenian: okužbe neznanega vzroka, vnetje obnosnih votlin (sinusov), hepatitis B,
English: The effect of multiple rituximab courses on the development of neutropenia in granulomatosis with polyangiitis and microscopic polyangiitis patients has not been
Slovenian: V kliničnih preskušanjih niso raziskali vpliva več ciklov rituksimaba na pojav nevtropenije pri bolnikih z granulomatozo s poliangiitisom ali mikroskopskim poliangiitisom.
English: General disorders and administratio nsite conditions fever , chills, asthenia, headache tumour pain, flushing, malaise, cold syndrome, +fatigue, +shivering,
Slovenian: Splošne težave in spremembe na mestu aplikacije zvišana telesna temperatura, mrzlica, astenija, glavobol tumorska bolečina,
English: If you are being treated for granulomatosis with polyangiitis or microscopic polyangiitis
Slovenian: b) Če se zdravite zaradi granulomatoze s poliangiitisom ali mikroskopskega poliangiitisa
English: It is recommended that immunoglobulin levels are determined prior to initiating treatment with rituximab.
Slovenian: Pred začetkom zdravljenja z rituksimabom je priporočljivo
English: Clinical experience in granulomatosis with polyangiitis (Wegener's) and microscopic polyangiitis A total of 197 patients aged 15 years or older with severely, active granulomatosis with polyangiitis
Slovenian: V randomiziranem, dvojno slepem, s placebom kontroliranem multicentričnem preskušanju neinferiornosti z aktivnim primerjalnim zdravilom so vključili in v njej zdravili skupno 197 bolnikov, starih 15 let ali več s hudo, aktivno granulomatozo s poliangiitisom (75 %) in mikroskopskim
English: This medicine may make you more likely to get infections.
Slovenian: Ker prejemate zdravilo Rituzena, je večja verjetnost, da dobite okužbo.
English: ORR, % CR,%
Slovenian: OS (%)
English: Pharmacotherapeutic group: antineoplastic agents, monoclonal antibodies, ATC code: L01XC02
Slovenian: Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, monoklonska protitelesa, oznaka
English: adjusted)
Slovenian: Rituksimab
English: Co-administration with methotrexate had no effect on the pharmacokinetics of rituximab in
Slovenian: Sočasna uporaba metotreksata pri bolnikih z revmatoidnim artritisom ni vplivala na farmakokinetiko rituksimaba.
English: respiratory failure4
Slovenian: ledvična odpoved4
English: Rituzena is a clear, colourless solution, supplied as a concentrate for solution for infusion in a glass vial.
Slovenian: Na voljo je v obliki koncentrata za raztopino za infundiranje v stekleni viali.
English: Cases of hepatitis B reactivation, including those with a fatal outcome, have been reported in rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis patients receiving
Slovenian: V kliničnih preskušanjih so bile z infuzijo povezane reakcije pri bolnikih z granulomatozo s poliangiitisom in mikroskopskim poliangiitisom podobne kot pri bolnikih z revmatoidnim artritisom
English: This is in case you get any
Slovenian: To je potrebno, ker se vam lahko pojavijo
English: The chemotherapy should be given after the Rituzena infusion.
Slovenian: Kemoterapijo boste dobili po infuziji zdravila
English: In rheumatoid arthritis premedication with glucocorticoids should also be administered before each infusion of rituximab in order to reduce the frequency and severity of IRRs
Slovenian: Pri revmatoidnem artritisu je treba bolniku pred vsako infuzijo rituksimaba dati tudi premedikacijo z glukokortikoidi, da bi zmanjšali pogostnost in resnost reakcij, povezanih z infuzijo (glejte poglavji 4.2 in 4.8).
English: Pneumocystis jiroveci pneumonia (PCP) prophylaxis is recommended for patients with granulomatosis with polyangiitis or microscopic polyangiitis during and following Rituzena
Slovenian: Pri bolnikih z granulomatozo s poliangiitisom ali mikroskopskim poliangiitisom je med zdravljenjem z zdravilom Rituzena in po njem priporočljiva profilaksa proti pljučnici, ki jo povzroča Pneumocystis
English: Also some other medicines can
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN
English: This is a type of protein called a “monoclonal antibody”.
Slovenian: Zdravilo Rituzena vsebuje učinkovino rituksimab, ki je vrsta beljkovine, imenovana monoklonsko protitelo.
English: Patients treated with Rituzena must be given the patient alert card with each infusion.
Slovenian: Granulomatoza s poliangiitisom in mikroskopski poliangiitis Bolniku je treba ob vsaki infuziji zdravila Rituzena dati opozorilno kartico za bolnike.
English: What are the signs of getting an infection?
Slovenian: • Kaj storite, če menite, da imate morda okužbo
English: inflammation, irritation in the lungs, throat or sinuses, being short of breath, runny nose
Slovenian: skrčenje mišic v dihalih, ki povzroči piskajoče dihanje (bronhospazem), vnetje, draženje pljuč, žrela ali obnosnih votlin, kratka sapa, izcedek iz nosu,
English: Very common side effects (may affect more than 1 in 10 people):
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov):
English: Cases of posterior reversible encephalopathy syndrome (PRES) reversible posterior leukoencephalopathy syndrome (RPLS) have been reported.
Slovenian: reversible posterior leukoencephalopathy syndrome).
English: Regular full blood counts, including neutrophil and platelet counts, should be performed during
Slovenian: Med zdravljenjem z rituksimabom je treba redno kontrolirati celotno krvno sliko, vključno s številom
English: • diarrhoea
Slovenian: Maligne bolezni
English: Very Rare Not known serious viral infection2
Slovenian: Resnih neželenih reakcij, povezanih z infuzijo, niso opazili.
English: If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before you are given Rituzena.
Slovenian: Če kar koli od naštetega velja za vas (ali če ste negotovi), se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, preden dobite zdravilo Rituzena.
English: There was no increased rate in overall infections or serious infections in
Slovenian: Bolnikom z nizkimi IgA, IgG ali IgM se ni povečal delež vseh okužb ali resnih okužb.
English: Mean Cmax for serum rituximab following first infusion was 170 to 175 µg/mL for 2 x 500 mg dose and 317 to 370 µg/mL for 2 x 1000 mg dose.
Slovenian: do 175 μg/ml za 2 x 500 mg odmerek ter 317 do 370 μg/ml za 2 x 1.000 mg odmerek.
English: dysgeusia peripheral neuropathy, facial nerve cranial neuropathy, loss of other
Slovenian: sprememba okusa periferna nevropatija, paraliza obraznega živca5
English: Median TTP:
Slovenian: • Znaki PML vključujejo:
English: Neurologic disorders
Slovenian: motnje živčnost
English: In the relapsed/refractory study, the median progression-free survival (primary endpoint) was 30.6 months in the R-FC group and 20.6 months in the FC group (p=0.0002, log-rank test).
Slovenian: 20,6 meseca v skupini FC (p = 0,0002, test log rank).
English: Dyspnoea Epistaxis Nasal congestion
Slovenian: Bolezni imunskega sistema sindrom sproščanja citokinov
English: Eye disorders lacrimation disorder, conjunctivitis severe vision loss5
Slovenian: kranialna nevropatija, poslabšanje drugih čutov5
English: Binet stage A Binet stage B Binet stage C CI: Confidence Interval
Slovenian: CI: interval zaupanja (Confidence Interval)
English: Tell your doctor or nurse if you are taking or have previously taken medicines which
Slovenian: Zdravniku ali medicinski sestri povejte, če jemljete ali ste jemali zdravila, ki lahko vplivajo na vaš imunski sistem, kar vključuje tudi kemoterapijo.
English: A small number of cases of hepatitis B reactivation, some with fatal outcome, have been reported in granulomatosis with polyangiitis and microscopic polyangiitis patients receiving rituximab in the post
Slovenian: Pri bolnikih z granulomatozo s poliangiitisom in mikroskopskim poliangiitisom, ki so rituksimab prejemali v obdobju trženja, so poročali o majhnem številu primerov reaktivacije hepatitisa B; nekateri od
English: The efficacy and safety of rituximab in maintenance therapy has not been established.
Slovenian: Učinkovitost in varnost vzdrževalnega zdravljenja z
English: • indigestion
Slovenian: omotičnost,
English: This includes rheumatoid arthritis and off-label autoimmune diseases, including Systemic Lupus Erythematosus (SLE) and
Slovenian: Pri uporabi rituksimaba za zdravljenje revmatoidnega artritisa in avtoimunskih bolezni, ki vključujejo sistemski eritematozni lupus (SLE) in vaskulitis, so poročali o zelo redkih primerih smrtne progresivne
English: • The need for close supervision during administration in an environment where full resuscitation facilities are immediately available
Slovenian: Nadaljnja analiza trajanja celokupnega preživetja, ki so jo izvedli po mediani časa sledenja
English: • general discomfort or feeling uneasy or tired, shaking, signs of flu
Slovenian: zardevanje, splošno slabo počutje, prehladni sindrom,
English: The authorisation was subsequently renewed.
Slovenian: Dovoljenje je bilo nato obnovljeno.
English: The cream should be applied to the area twice daily for 7-14 days.
Slovenian: Kremo je treba na predel nanašati dvakrat na dan 7 do 14 dni.
English: A trial is humans had also been conducted.
Slovenian: Izvedeno je bilo tudi preskušanje na ljudeh.
English: The results of these studies are reflected in the contraindications.
Slovenian: Rezultati teh študij so razvidni iz kontraindikacij.
English: Lesions should be monitored closely for signs of infection.
Slovenian: Poškodbe je treba skrbno spremljati, da se odkrijejo znaki okužbe.
English: Other information about Pruban:
Slovenian: Druge informacije o zdravilu Pruban:
English: In the studies of dogs suffering from acute moist dermatitis almost 80% of cases were cured or improved following treatment for 7 to 14 days.
Slovenian: V študijah pri psih, ki so imeli akutni vlažni dermatitis, se je pri skoraj 80 % primerov stanje pozdravilo ali izboljšalo po zdravljenju, ki je trajalo od 7 do 14 dni.
English: Pruban should not be used in puppies under 6 months of age.
Slovenian: Zdravilo Pruban se ne sme uporabljati pri kužkih, mlajših od 6 mesecev.
English: The trial showed low level irritation, but no toxicity.
Slovenian: Preskušanje je pokazalo rahlo draženje, vendar ne toksičnosti.
English: Once the skin is irritated, an itch-scratch cycle starts and this may lead to lesions that are quite severe in appearance within a few hours.
Slovenian: Ko je koža razdražena, se začne krog srbenja in praskanja, kar lahko pripelje do poškodb, ki po nekaj urah postanejo zelo hude.
English: In case of diabetes mellitus, the potential systemic effects of the product may influence blood glucose concentrations.
Slovenian: Pri živalih s sladkorno boleznijo lahko morebitni sistemski učinki zdravila vplivajo na koncentracije glukoze v krvi.
English: Since glucocorticosteroids can slow growth, the use of the product in young, growing animals should be well controlled and large lesions should not be treated.
Slovenian: Ker lahko glukokortikosteroidi upočasnijo rast, je treba njihovo uporabo pri mladih živalih, ki še rastejo, skrbno nadzorovati in jih ne uporabljati za zdravljenje velikih poškodb.
English: Resocortol butyrate is a corticosteroid.
Slovenian: Resokortol butirat je kortikosteroid.
English: What benefit has Pruban shown during the studies?
Slovenian: Kakšne koristi je zdravilo Pruban izkazalo med študijami?
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Pruban to Intervet International B.V. on 16 November 2000.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Pruban, veljavno po vsej Evropski uniji, odobrila družbi Intervet International B.V.
English: Pruban reduces the inflammation of the skin locally.
Slovenian: Zdravilo Pruban zmanjšuje lokalno vnetje kože.
English: Most cases of acute moist dermatitis are due to complications of flea bite hypersensitivity, although they may also be caused by other ectoparasites, allergic skin diseases, anal sac problems or foreign bodies (such as grass awns).
Slovenian: Večina primerov akutnega vlažnega dermatitisa se pojavi zaradi zapletov, povezanih s preobčutljivostjo na ugriz bolh, čeprav ga lahko povzročajo tudi drugi ektoparaziti, alergijske kožne bolezni, težave z zadnjičnimi žlezami ali tuja telesa (kot so strešni glistniki).
English: What is the risk associated with Pruban?
Slovenian: Kakšna tveganja so povezana z zdravilom Pruban?
English: Pruban should not be used in dogs with extensive, infected or ulcerated skin lesions or in animals suffering from Cushing's syndrome (hyperadrenocorticism).
Slovenian: Zdravilo Pruban se ne sme uporabljati pri psih z obsežnimi, okuženimi ali zagnojenimi kožnimi poškodbami ali pri živalih, ki imajo Cushingov sindromom (hiperadrenokorticizem).
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) PRUBAN EPAR summary for the public
Slovenian: EMEA/V/C/048 EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) PRUBAN Povzetek EPAR za javnost
English: On rare occasions, hyperaemia of the treated area has been observed.
Slovenian: Redko so na zdravljenem predelu opazili hiperemijo.
English: Resocortol butyrate belongs to the group of glucocorticosteroids which have anti-inflammatory effects.
Slovenian: Resokortol butirat spada v skupino glukokortikosteroidov, ki imajo protivnetni učinek.
English: Do not use in dogs for breeding or in pregnant or lactating bitches.
Slovenian: Ne uporabite pri psih, ki so namenjeni vzreji, in pri brejih ali doječih psicah.
English: The therapeutic use of these substances in humans has been recognised to induce local side effects such as skin thinning, skin weakness, delayed healing and secondary infections.
Slovenian: Pri terapevtski uporabi teh snovi pri ljudeh so ugotovili, da imajo lokalne neželene učinke, kot so na primer tanjšanje kože, ohlapnost kože, upočasnjeno cepljenje in sekundarne okužbe.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Pruban exceeded the risks for the treatment of acute localised moist dermatitis in dogs, and recommended that Pruban be granted a market authorisation.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Pruban pri zdravljenju akutnega, lokalnega vlažnega dermatitisa pri psih večje od z njim povezanih tveganj, in priporočil, da se za zdravilo Pruban odobri dovoljenje za promet.
English: Why has Pruban been approved?
Slovenian: Zakaj je bilo zdravilo Pruban odobreno?
English: Several studies were performed in rats, rabbits and dogs to examine the safety of Pruban.
Slovenian: Za preučitev varnosti zdravila Pruban so izvedli več študij na podganah, zajcih in psih.
English: Pruban is applied to the skin for the treatment of small areas of sudden onset moist irritated skin (acute moist dermatitis in dogs.
Slovenian: Zdravilo Pruban se nanaša na kožo za zdravljenje manjših predelov kože, ki je razdražena zaradi nenadnega pojava vlage (akutnega vlažnega dermatitisa), pri psih.
English: Pruban is a white to off-white cream containing resocortol butyrate as the active substance.
Slovenian: Zdravilo Pruban je sivo bela krema, ki kot zdravilno učinkovino vsebuje resokortol butirat.
English: What is Pruban used for?
Slovenian: Za kaj se zdravilo Pruban uporablja?
English: For details on dosing, please see the Package Leaflet.
Slovenian: Za podrobnejše informacije glede odmerjanja glejte navodilo za uporabo.
English: How does Pruban work?
Slovenian: Kako zdravilo Pruban deluje?
English: What is Pruban?
Slovenian: Kaj je zdravilo Pruban?
English: How has Pruban been studied?
Slovenian: Kako je bilo zdravilo Pruban raziskano?
English: Sprimeo HCT may have been prescribed to you because your previous treatment did not lower your blood pressure enough.
Slovenian: Zdravilo Sprimeo HCT so vam morda predpisali zato, ker vaše predhodno zdravljenje ni dovolj znižalo krvnega tlaka.
English: Your doctor will normally advise you to stop taking Sprimeo HCT before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Sprimeo HCT.
Slovenian: Zdravnik vam bo praviloma svetoval, da prenehate z jemanjem zdravila Sprimeo HCT še preden zanosite oziroma takoj, ko ugotovite, da ste noseči in vam bo svetoval jemanje drugega zdravila namesto zdravila Sprimeo HCT.
English: The safety of Sprimeo HCT has been evaluated in 9 clinical trials with more than 3,900 patients, including over 700 treated for over 6 months, and 190 for over 1 year.
Slovenian: Varnost zdravila Sprimeo HCT so ocenjevali v 9 kliničnih preskušanjih z več kot 3.900 bolniki, med katerimi je bilo več kot 700 bolnikov zdravljenih več kot 6 mesecev, 190 pa več kot 1 leto.