FrancophonIA/ELRC3.0 huggingface dataset:
English: {Invented Name} may cause thinning or wasting of your bones (osteoporosis) due to the reduction of oestrogens in your body.
Slovenian: Zdravilo {Izmišljeno ime} lahko zaradi zmanjševanja količine estrogenov v telesu povzroča redčenje kostnine oziroma izgubljanje kostne mase (osteoporozo).
English: No clinically relevant changes were found in the plasma concentrations of cortisol, aldosterone, 11-deoxycortisol, 17-hydroxyprogesterone, and ACTH or in plasma renin activity among postmenopausal patients treated with a daily dose of letrozole 0.1 to 5 mg.
Slovenian: Pri bolnicah v pomenopavzi, ki so jih zdravili z dnevnim odmerkom 0,1 do 5 mg letrozola, niso opažali klinično pomembnih sprememb v koncentracijah kortizola, aldosterona, 11deoksikortizola, 17-hidroksiprogesterona in ACTH v plazmi ali sprememb aktivnosti renina v plazmi.
English: Infections and infestations Uncommon:
Slovenian: Infekcijske in parazitske bolezni občasni:
English: If any of these affects you severely, tell your doctor.
Slovenian: Če se kateri od teh neželenih učinkov pri vas pojavi v hujši obliki, obvestite svojega zdravnika.
English: Peripheral oedema
Slovenian: periferni edemi občasni:
English: BIG 1-98 was a multicentre, double-blind study in which over 8,000 postmenopausal women with hormone receptor-positive early breast cancer were randomised to one of the following treatments:
Slovenian: Študija BIG-98 je bila multicentrična, dvojno slepa študija, v kateri so več kot 8.000 žensk v pomenopavzi z zgodnjim rakom dojke, pozitivnim na hormonske receptorje, randomizirali tako, da so prejemale eno od naslednjih shem zdravljenja: A. tamoksifen 5 let; B. zdravilo {Izmišljeno ime} 5 let; C. 2 leti tamoksifen, nato 3 leta zdravilo {Izmišljeno ime}; D. 2 leti zdravilo {Izmišljeno ime}, nato 3 leta tamoksifen.
English: Two well-controlled clinical trials were conducted comparing two letrozole doses (0.5 mg and 2.5 mg) to megestrol acetate and to aminoglutethimide, respectively, in postmenopausal women with advanced breast cancer previously treated with anti-oestrogens.
Slovenian: Izvedli so dva dobro kontrolirana klinična preskušanja, v katerih so pri ženskah v pomenopavzi z napredovalim rakom dojke, ki so že prejemale antiestrogene, primerjali dva odmerka letrozola (0,5 mg in 2,5 mg) z uporabo megestrol acetata oziroma aminoglutetimida.
English: Immune system disorders Not known:
Slovenian: levkopenija Bolezni imunskega sistema pogostnost neznana:
English: Censored analysis of DFS3
Slovenian: analiza cenz.
English: Vascular disorders Very common:
Slovenian: Žilne bolezni zelo pogosti:
English: Increased sweating
Slovenian: povečano znojenje pogosti:
English: Neoadjuvant treatment
Slovenian: Neoadjuvantno zdravljenje
English: Vaginal discharge or dryness
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: No dose adjustment of {Invented Name} is required for patients with mild to moderate hepatic insufficiency (Child-Pugh A or B).
Slovenian: Pri bolnicah z blago do zmerno poslabšanim delovanjem jeter (Child-Pugh razreda A ali B) ni potrebno prilagajanje odmerkov zdravila {Izmišljeno ime}.
English: Vaginal discharge, vaginal dryness, breast pain General disorders and administration site conditions Very common:
Slovenian: izcedek iz nožnice, suhost nožnice, bolečine v dojkah Splošne težave in spremembe na mestu aplikacije zelo pogosti:
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients [To be completed nationally] 6.2 Incompatibilities [To be completed nationally] 6.3 Shelf life [To be completed nationally]
Slovenian: 6.2 Inkompatibilnosti [izpolni država članica]
English: What {Invented Name} is and how it works {Invented Name} contains an active substance called letrozole.
Slovenian: Zdravilo {Izmišljeno ime} vsebuje zdravilno učinkovino, ki jo imenujemo letrozol.
English: How to store {Invented Name} [To be completed nationally]
Slovenian: Shranjevanje zdravila {Izmišljeno ime} [izpolni država članica]
English: Bone fractures
Slovenian: Vpliv na kosti
English: Increased level of cholesterol (hypercholesterolaemia) Fatigue
Slovenian: - vročinski oblivi - zvišana raven holesterola (hiperholesterolemija) - utrujenost - povečano potenje - bolečine v kosteh in sklepih (artralgija)
English: Bone effects {Invented Name} is a potent oestrogen-lowering agent.
Slovenian: Zdravilo {Izmišljeno ime} močno znižuje koncentracijo estrogenov.
English: Do not stop taking {Invented Name} unless your doctor tells you to. See also the section above “How long to take {Invented Name}”.
Slovenian: Glejte tudi zgornje poglavje "Kako dolgo je treba jemati zdravilo {Izmišljeno ime}".
English: Disease-free survival
Slovenian: Preživetje brez ponovitve bolezni dogodki
English: Letrozole was embryotoxic and foetotoxic in pregnant rats and rabbits following oral administration at clinically relevant doses.
Slovenian: Pri brejih podganah in kuncih je letrozol po peroralnem vnosu odmerkov, ki ustrezajo kliničnim, deloval embriotoksično in fetotoksično.
English: No dosage adjustment of {Invented Name} is required for patients with renal insufficiency with creatinine clearance ≥10 ml/min.
Slovenian: Pri bolnicah s poslabšanim delovanjem ledvic z očistkom kreatinina ≥10 ml/min prilagajanje odmerkov zdravila {Izmišljeno ime} ni potrebno.
English: Thirst, taste disorder, dry mouth
Slovenian: generalizirani edemi, suhost sluznic, žeja, zvišana telesna temperatura
English: Special populations
Slovenian: Pediatrična populacija
English: You should only take {Invented Name} when you have gone through the menopause.
Slovenian: Nosečnost, dojenje in plodnost - Zdravilo {Izmišljeno ime} smete jemati le, če ste imeli menopavzo (zadnjo menstrualno krvavitev).
English: Cardiac disorders Uncommon:
Slovenian: srbenje, urtikarija pogostnost neznana:
English: The cytochrome P450 isoenzymes 3A4 and 2A6 were found to be capable of converting letrozole to this metabolite.
Slovenian: Ugotovili so, da letrozol v navedeni presnovek lahko presnovita izoencima citokroma P450 3A4 in 2A6.
English: Hair loss
Slovenian: brez pon.
English: Difficulty breathing, chest pain, fainting, rapid heart rate, bluish skin discoloration, or sudden arm, leg or foot pain (signs that a blood clot may have formed).
Slovenian: bolezenska zaspanost, nespečnost - motnje zaznavanja, zlasti dotika - težave z očmi, na primer zamegljen vid ali vnetje očesa - palpitacije, hitro bitje srca - spremembe na koži, kot je srbenje (urtikarija) - izcedek iz nožnice ali suhost nožnice - okorelost sklepov (artritis) - bolečine v dojkah - zvišana telesna temperatura - žeja, motnje okušanja, suha usta - suhost sluznic - zmanjšanje telesne mase - okužba sečil, pogostejše uriniranje - kašelj - zvišane vrednosti encimov
English: What {Invented Name} contains
Slovenian: Zdravilo {Izmišljeno ime} vsebuje laktozo
English: Thinning or wasting of your bones (osteoporosis), leading to bone fractures in some cases (see also “Follow-up during {Invented Name} treatment” in section 3) Swelling of arms, hands, feet, ankles (oedema)
Slovenian: - kožni izpuščaj - glavobol - omotičnost - splošno slabo počutje - prebavne težave, kot so občutek slabosti, bruhanje, tiščanje v želodcu, zapeka, driska - povečan apetit ali izguba apetita - bolečine v mišicah - redčenje kostnine oziroma izgubljanje kostne mase (osteoporoza), zaradi česar lahko v nekaterih primerih pride do zlomov kosti (glejte tudi "Pregledi v času zdravljenja z zdravilom {Izmišljeno ime}" v poglavju 3) - otekanje zgornjih okončin, dlani, stopal ali gležnjev (edemi) - depresija - povečanje telesne mase - izpadanje las - zvišan krvni tlak (hipertenzija) - bolečine v trebuhu - suha koža - krvavitev iz nožnice Če se kateri od teh neželenih učinkov pri vas pojavi v hujši obliki, obvestite svojega zdravnika.
English: Dry mouth, stomatitis1 Hepatobiliary disorders Uncommon:
Slovenian: suha usta, stomatitis1 Bolezni jeter, žolčnika in žolčevodov občasni:
English: Objective response rate (ORR)
Slovenian: cilj op.)2
English: {Invented Name}, incidence rate Tamoxifen, incidence rate
Slovenian: { Izmišljeno ime}, pogostnost tamoksifen, pogostnost zlom kosti osteoporoza trombembolični dogodki miokardni infarkt hiperplazija endometrija / rak endometrija
English: 5 Median follow-up 62 months.
Slovenian: mediano trajanje spremljanja 28 mesecev mediano trajanje spremljanja 62 mesecev letrozol N=2.582
English: Ritemvia received a marketing authorisation valid throughout the EU on 13 July 2017.
Slovenian: Za zdravilo Ritemvia je bilo 13. julija 2017 izdano dovoljenje za promet, veljavno po vsej EU.
English: This means that Ritemvia is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Slovenian: To pomeni, da je zelo podobno drugemu biološkemu zdravilu („referenčnemu zdravilu“), ki je že odobreno v EU.
English: What measures are being taken to ensure the safe and effective use of Ritemvia?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ritemvia?
English: The full EPAR for Ritemvia can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/ritemvia
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Ritemvia je na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/ritemvia
English: Ritemvia (rituximab)
Slovenian: Ritemvia (rituksimab)
English: An overview of Ritemvia and why it is authorised in the EU
Slovenian: Pregled zdravila Ritemvia in zakaj je odobreno v EU
English: Patients are also to receive an alert card, which they are to carry at all times, instructing them to contact their doctor immediately if they have any of the listed symptoms of infection.
Slovenian: Bolniki morajo prejeti tudi opozorilno kartico, ki jo morajo imeti stalno pri sebi in na kateri je navedeno, da se morajo takoj posvetovati z zdravnikom, če opazijo kakršne koli navedene simptome okužbe.
English: In this study improvement was seen in 96% of cases (67 of 70 patients) with Ritemvia and 90% (63 of 70 patients) with Rituxan.
Slovenian: V tej študiji so izboljšanje opazili pri 96 % primerov (67 bolnikih od 70), zdravljenih z zdravilom Ritemvia, in 90 % (63 bolnikih od 70), zdravljenih z zdravilom Rituxan.
English: What benefits of Ritemvia have been shown in studies?
Slovenian: Kakšne koristi zdravila Ritemvia so se pokazale v študijah?
English: Other information about Ritemvia
Slovenian: Druge informacije o zdravilu Ritemvia
English: As for all medicines, data on the use of Ritemvia are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Ritemvia stalno spremljajo.
English: Ritemvia is a medicine used in adults to treat the following blood cancers and inflammatory conditions:
Slovenian: Ritemvia je zdravilo, ki se uporablja pri odraslih za zdravljenje naslednjih vrst krvnega raka in vnetnih bolezni:
English: Other serious side effects include hepatitis B reactivation (return of previous active liver infection with hepatitis B virus) and a rare and severe brain infection known as progressive multifocal leukoencephalopathy (PML).
Slovenian: Drugi hudi neželeni učinki vključujejo reaktivacijo hepatitisa B (ponovitev predhodne aktivne okužbe jeter z virusom hepatitisa B) in redko hudo okužbo možganov, znano kot progresivna multifokalna levkoencefalopatija (PML).
English: Why is Ritemvia authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Ritemvia odobreno v EU?
English: The most common serious side effects are infusion reactions, infections and, in cancer patients, heart-related problems.
Slovenian: Najpogostejši resni neželeni učinki so reakcije, povezane z infuzijo, in okužbe ter pri bolnikih z rakom težave s srcem.
English: Side effects reported with Ritemvia are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Ritemvia, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: For more information about using Ritemvia, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Ritemvia glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: Before each infusion, the patient should be given an antihistamine (to prevent allergic reactions) and an anti-pyretic (a medicine to reduce fever).
Slovenian: Pred vsakim infundiranjem je treba bolniku dati antihistaminik (zdravilo za preprečitev alergijskih reakcij) in antipiretik (zdravilo za znižanje zvišane telesne temperature).
English: • follicular lymphoma and diffuse large B cell non-Hodgkin's lymphoma (two types of non-Hodgkin's lymphoma, a blood cancer);
Slovenian: • folikularnega limfoma in difuznega velikoceličnega B ne-Hodgkinovega limfoma (dveh vrst ne-Hodgkinovega limfoma, tj. krvnega raka);
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ritemvia have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Ritemvia upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Further evidence came from supportive studies including one involving 121 patients with advanced follicular lymphoma, where adding Ritemvia to chemotherapy medicines was at least as effective as adding Rituxan, the US version of MabThera.
Slovenian: Dodatni dokazi izhajajo iz podpornih študij, vključno s študijo, v katero je bilo vključenih 121 bolnikov z napredovalim folikularnim limfomom, pri čemer je bilo dodajanje zdravila Ritemvia kemoterapiji vsaj tako učinkovito kot dodajanje zdravila Rituxan, ameriške različice zdravila MabThera.
English: The study showed that Ritemvia and MabThera had comparable effects on arthritis symptoms: after 24 weeks, the proportion of patients with a 20% improvement in symptom score (called ACR20) was 74% (114 of 155 patients) with Ritemvia and 73% (43 of 59 patients) with MabThera.
Slovenian: Študija je pokazala, da sta zdravili Ritemvia in MabThera primerljivo vplivali na simptome artritisa: po 24 tednih je delež bolnikov, pri katerih je bilo izboljšanje po lestvici simptomov (imenovani ACR20) 20-odstotno in so jemali zdravilo Ritemvia, znašal 74 % (114 bolnikov od 155), pri bolnikih, ki so jemali zdravilo MabThera, pa 73 % (43 bolnikov od 59).
English: What is Ritemvia and what is it used for?
Slovenian: Kaj je zdravilo Ritemvia in za kaj se uporablja?
English: Patients with GPA, MPA or pemphigus vulgaris must also not receive Ritemvia if they have severe heart problems.
Slovenian: Bolniki z Wegenerjevo granulomatozo, mikroskopskim poliangiitisom ali navadnim pemfigusom prav tako ne smejo prejemati zdravila Ritemvia, če imajo hude težave s srcem.
English: Ritemvia must not be used in people who are hypersensitive (allergic) to rituximab, mouse proteins or any of the other ingredients.
Slovenian: Zdravilo Ritemvia se ne sme uporabljati pri osebah, ki so preobčutljive za (alergične na) rituksimab, mišje beljakovine ali na katero koli drugo sestavino zdravila.
English: The active substance in Ritemvia, rituximab, is a monoclonal antibody (a type of protein) designed to recognise and attach to a protein called CD20 present on the surface of B cells (types of white blood cells).
Slovenian: Učinkovina v zdravilu Ritemvia, rituksimab, je monoklonsko protitelo (vrsta beljakovine), ki je bilo zasnovano tako, da prepozna beljakovino, imenovano CD20, ki je prisotna na površini celic B (vrste belih krvnih celic), in se veže nanjo.
English: What are the risks associated with Ritemvia?
Slovenian: Kakšna tveganja so povezana z zdravilom Ritemvia?
English: Ritemvia should be given under the close supervision of an experienced healthcare professional and in a place where facilities for resuscitating patients are immediately available.
Slovenian: Zdravilo Ritemvia se lahko daje samo pod skrbnim nadzorom izkušenega zdravnika in v ustanovi, kjer je nemudoma na voljo oprema za oživljanje.
English: The reference medicine for Ritemvia is MabThera.
Slovenian: Referenčno zdravilo za zdravilo Ritemvia je zdravilo MabThera.
English: Doctors prescribing Ritemvia for cancer will be provided with educational material reminding them of the need to use the medicine only by infusion into a vein.
Slovenian: Zdravniki, ki predpisujejo zdravilo Ritemvia za zdravljenje raka, bodo prejeli izobraževalno gradivo, v katerem bodo opozorjeni na to, da je zdravilo treba dajati le z infundiranjem v veno.
English: In addition, a study comparing Ritemvia to MabThera in patients with rheumatoid arthritis (which can support its use in other inflammatory disorders such as GPA and MPA) showed that both medicines are similarly effective, and a supportive study in follicular lymphoma showed effectiveness in cancer.
Slovenian: Poleg tega so s študijo, v kateri so zdravilo Ritemvia primerjali z zdravilom MabThera pri bolnikih z revmatoidnim artritisom (kar podpira njegovo uporabo pri drugih vnetnih boleznih, kot sta Wegenerjeva granulomatoza in mikroskopski poliangiitis), dokazali, da sta obe zdravili podobno učinkoviti, podporna študija pri folikularnem limfomu pa je dokazala učinkovitost pri raku.
English: The most common side effects with rituximab are reactions related to the infusion (such as fever, chills and shivering) which occur in most cancer patients and in more than 1 in 10 GPA or MPA patients at the time of the first infusion.
Slovenian: Najpogostejši neželeni učinki rituksimaba so reakcije, povezane z infuzijo (kot so zvišana telesna temperatura, mrazenje in drgetanje), ki se pri prvi infuziji pojavljajo pri večini bolnikov z rakom in pri več kot 1 bolniku od 10 z Wegenerjevo granulomatozo ali mikroskopskim poliangiitisom.
English: The safety of Ritemvia has been evaluated, and on the basis of all the studies carried out the side effects of the medicine are considered to be comparable to those of the reference medicine MabThera.
Slovenian: Varnost zdravila Ritemvia je bila ocenjena, na podlagi vseh izvedenih študij pa so bili neželeni učinki zdravila ocenjeni kot primerljivi z neželenimi učinki referenčnega zdravila MabThera.
English: All these data were considered sufficient to conclude that Ritemvia will behave in the same way as MabThera in terms of its effectiveness and safety in its authorised uses.
Slovenian: Vsi ti podatki so bili ocenjeni kot zadostni za zaključek, da se bo zdravilo Ritemvia pri odobrenih uporabah z vidika učinkovitosti in varnosti vedlo enako kot zdravilo MabThera.
English: Because Ritemvia is a biosimilar medicine, the studies on effectiveness and safety of rituximab carried out with MabThera do not all need to be repeated for Ritemvia.
Slovenian: Zdravilo Ritemvia je „podobno biološko zdravilo“, zato vseh študij o učinkovitosti in varnosti rituksimaba, že izvedenih z zdravilom MabThera, z zdravilom Ritemvia ni treba ponavljati.
English: Depending on the condition it is used to treat, Ritemvia may be given with chemotherapy (other cancer medicines) or medicines used for inflammatory disorders (corticosteroids).
Slovenian: Zdravilo Ritemvia se odvisno od bolezni, za katero se uporablja, lahko daje sočasno s kemoterapijo (drugimi zdravili za zdravljenje raka) ali z zdravili za zdravljenje vnetnih bolezni (kortikosteroidi).
English: The company that markets Ritemvia will provide doctors and patients using the medicine for noncancer conditions with educational material including information on the need to give the medicine where facilities for resuscitation are available and on the risk of infection, including PML.
Slovenian: Podjetje, ki trži zdravilo Ritemvia, bo za zdravnike in bolnike, ki to zdravilo uporabljajo za zdravljenje nerakavih obolenj, pripravilo izobraževalno gradivo, v katerem bo opisano, da je zdravilo treba dajati v ustanovah, kjer je na voljo oprema za oživljanje, in da obstaja tveganje okužbe, vključno s progresivno multifokalno levkoencefalopatijo (PML).
English: In GPA and MPA, destroying the B cells lowers the production of antibodies thought to play an important role in attacking the blood vessels and causing inflammation.
Slovenian: Pri Wegenerjevi granulomatozi in mikroskopskem poliangiitisu se z uničenjem celic B zniža tvorba protiteles, ki naj bi imela pomembno vlogo pri napadanju krvnih žil in povzročanju vnetja.
English: It is available as a concentrate for making a solution that must be given by infusion (drip) into a vein.
Slovenian: Na voljo je v obliki koncentrata za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Ritemvia has a highly similar structure, purity and biological activity to MabThera and is distributed in the body in the same way.
Slovenian: Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU glede podobnih bioloških zdravil dokazano, da je zdravilo Ritemvia po zgradbi, čistosti in biološkem delovanju zelo podobno zdravilu MabThera in da se enako porazdeli po telesu.
English: When rituximab attaches to CD20, it causes the death of B cells, which helps in lymphoma and CLL, where B cells have become cancerous.
Slovenian: Rituksimab z vezavo na CD20 povzroči odmrtje celic B, kar pripomore k zdravljenju limfoma in kronične limfocitne levkemije, pri katerih so celice B postale rakaste.
English: Therefore, the Agency's view was that, as for MabThera, the benefits of Ritemvia outweigh the identified risks and it can be authorised for use in the EU.
Slovenian: Zato je agencija menila, da koristi zdravila Ritemvia enako kot pri zdravilu MabThera odtehtajo znana tveganja in da se zdravilo lahko odobri v EU.
English: For the full list of side effects of Ritemvia, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov zdravila Ritemvia glejte navodilo za uporabo.
English: Ritemvia is a ‘biosimilar medicine'.
Slovenian: Zdravilo Ritemvia je „podobno biološko zdravilo“.
English: How is Ritemvia used?
Slovenian: Kako se zdravilo Ritemvia uporablja?
English: Laboratory studies comparing Ritemvia with MabThera have shown that the active substance in Ritemvia is highly similar to that in MabThera in terms of structure, purity and biological activity.
Slovenian: Laboratorijske študije, v katerih so zdravilo Ritemvia primerjali z zdravilom MabThera, so pokazale, da je zdravilo Ritemvia po zgradbi, čistosti in biološkem delovanju zelo podobno zdravilu MabThera.
English: How does Ritemvia work?
Slovenian: Kako zdravilo Ritemvia deluje?
English: Ritemvia can only be obtained with a prescription.
Slovenian: Predpisovanje in izdaja zdravila Ritemvia je le na recept.
English: In addition, Ritemvia has been compared with MabThera given into a vein in a main study involving 372 patients with active rheumatoid arthritis (an inflammatory disease).
Slovenian: Poleg tega so zdravilo Ritemvia v glavni študiji, v katero je bilo vključenih 372 bolnikov z aktivnim revmatoidnim artritisom (vnetno boleznijo), primerjali z zdravilom MabThera, injiciranim v veno.
English: Ritemvia contains the active substance rituximab.
Slovenian: Vsebuje učinkovino rituksimab.
English: Studies have also shown that giving Ritemvia produces similar levels of the active substance in the body to giving MabThera.
Slovenian: Študije so pokazale tudi, da je količina učinkovine v telesu pri zdravilu Ritemvia podobna kot pri zdravilu MabThera.
English: Strength Pharmaceutical form Route of administration Packaging Package size EU/1/09/536/001 Topotecan Actavis 1 mg l t o r
Slovenian: Jakost Farmacevtska oblika Pot uporabe
English: Date of first authorisation: 03rd October 2011 Date of latest renewal: 22nd July 2016
Slovenian: Datum prve odobritve: 3. oktober 2011 Datum zadnjega podaljšanja: 22. julij 2016
English: Package leaflet: Information for the patient
Slovenian: Navodilo za uporabo: Informacije za paciente
English: Levetiracetam Accord must be taken twice a day, once in the morning and once in the evening, at about the same time each day.
Slovenian: Zdravilo Levetiracetam Accord morate jemati dvakrat na dan, enkrat zjutraj in enkrat zvečer, vsak dan ob približno istem času.