FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not use if reconstituted solution is cloudy or discoloured.
Slovenian: Če je pripravljena raztopina motna ali spremenjene barve, je ne uporabite.
English: Cases of interstitial lung disease (ILD), including pneumonitis, some leading to acute respiratory distress syndrome or a fatal outcome, have been reported in clinical studies with trastuzumab emtansine (see section 4.8).
Slovenian: Pri nekaterih je prišlo do sindroma akutne respiratorne stiske ali smrti (glejte poglavje 4.8).
English: Trastuzumab emtansine has not been studied in patients with severe hepatic impairment.
Slovenian: Pri bolnikih, zdravljenih s trastuzumabom emtanzinom, so opažali resne hepatobiliarne zaplete,
English: peripheral neuropathy until resolution to ≤ Grade 2.
Slovenian: 4. stopnje, in sicer za toliko časa, da se zmanjša na ≤ 2. stopnjo.
English: Radiotherapy-Related Pneumonitis
Slovenian: vključno s pnevmonitisom.
English: 3 August 2009 Doc.
Slovenian: 3 avgust 2009 Doc.
English: The final opinion was converted into a Decision by the European Commission on 3 August 2009.
Slovenian: Končno mnenje je bilo spremenjeno v Odločbo Evropske komisije dne 3 avgusta 2009.
English: The Mutual Recognition Procedure started on 28 February 2008.
Slovenian: Postopek medsebojnega priznavanja se je začel 28. februarja 2008.
English: The application was submitted in the framework of Article 32 of Directive 2001/82/EC, as amended, where the Reference Member State was the United Kingdom and the Concerned Member States were Austria, Belgium, France, Germany, Ireland, Italy, The Netherlands, Poland, Portugal and Spain.
Slovenian: Vloga je bila predložena v skladu s členom 32 Direktive 2001/82/ES, kakor je bila spremenjena, pri čemer je bilo Združeno kraljestvo referenčna država članica, Avstrija, Belgija, Francija, Nemčija, Irska, Italija, Nizozemska, Poljska, Portugalska in Španija pa zadevne države članice.
English: Florfenicol is a synthetic broad spectrum antibiotic with a range of activity, including many Gramnegative and Gram-positive organisms.
Slovenian: Florfenikol je sintetični antibiotik s širokim spektrom delovanja, tudi proti gramnegativnim in grampozitivnim organizmom.
English: Ref.EMEA/313849/2009
Slovenian: EMEA/520063/2009
English: Due to concerns raised by Germany and The Netherlands during the Mutual Recognition Procedure that Fenflor 300 mg/ml solution for injection for cattle could present a potential serious risk to the environment, the United Kingdom referred the matter to the EMEA on 31 July 2008 under Article 33(4) of Directive 2001/82/EC.
Slovenian: Zaradi zadržkov, ki sta jih med postopkom medsebojnega priznavanja izrazili Nemčija in Nizozemska, da bi lahko Fenflor 300 mg/ml raztopina za injiciranje za govedo pomenila morebitno resno okoljsko tveganje, je Združeno kraljestvo dne 31. Julija 2008 vprašanje napotilo na agencijo EMEA v skladu s členom 33(4)Direktive 2001/82/ES.
English: OPINION FOLLOWING AN ARTICLE 33 (4)1 REFERRAL FOR FENFLOR 300 MG/ML SOLUTION FOR INJECTION FOR CATTLE International Non-Proprietary Name (INN): Florfenicol
Slovenian: MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 33(4)1 ZA FENFLOR 300 MG/ML RAZTOPINA ZA INJICIRANJE ZA GOVEDO MEDNARODNO NELASTNIŠKO IME (INN):
English: The Marketing Authorisation Holder, Gosmore Ltd, submitted an application via mutual recognition for Fenflor 300 mg/ml solution for injection for cattle, on the basis of the marketing authorisation granted by the United Kingdom.
Slovenian: Imetnik dovoljenja za promet z zdravilom, družba Gosmore Ltd., je vložil prošnjo za postopek medsebojnega priznavanja za zdravilo Fenflor 300 mg/ml, raztopino za injiciranje za govedo na podlagi dovoljenja za promet, ki ga je bilo odobreno v Združenem kraljestvu.
English: Moreover, the intended uses do not require medical supervision.
Slovenian: Poleg tega predvidena uporaba ne zahteva zdravniškega nadzora.
English: Agrimony should only be used in adults and children over the age of 12 years.
Slovenian: Zel navadnega repika se lahko uporablja samo pri odraslih in otrocih, starejših od 12 let.
English: This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
Slovenian: To pomeni, da je kljub pomanjkljivim dokazom iz kliničnih preskušanj učinkovitost teh zdravil rastlinskega izvora verjetna in da obstajajo dokazi, da so se na navedene načine varno uporabljala že vsaj 30 let (najmanj 15 let tudi v EU).
English: These may also be used to prepare liquid extracts with water and alcohol.
Slovenian: Ti se lahko uporabljajo tudi za pripravo tekočih izvlečkov z vodo in alkoholom.
English: It can also be applied to the skin for relief of minor inflammation and small superficial wounds.
Slovenian: Prav tako se lahko nanaša na kožo za lajšanje blagega vnetja in majhnih površinskih ran.
English: Agrimony preparations are obtained by comminuting (reducing into tiny pieces) the dried plant parts.
Slovenian: Pripravki zeli navadnega repika se pridobivajo z drobljenjem (zmanjševanjem na majhne delce) posušenih rastlinskih delov.
English: The HMPC conclusions on the use of agrimony medicines for the relief of mild diarrhoea, mild inflammation of the mouth and throat, skin inflammation and wounds are based on their ‘traditional use' in these conditions.
Slovenian: Zaključki odbora HMPC o uporabi zdravil, ki vsebujejo zel navadnega repika, za lajšanje blage driske, blagega vnetja ust ter žrela, kožnega vnetja in ran temeljijo na njihovi „tradicionalni uporabi“ pri teh stanjih.
English: This summary is not intended to provide practical advice on how to use medicines containing agrimony.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o uporabi zdravil, ki vsebujejo zel navadnega repika.
English: For further information, see the HMPC assessment report.
Slovenian: Za podrobnejše informacije glejte poročilo odbora HMPC o oceni zdravila.
English: Agrimony is the common name for the flowering tops of the plant Agrimonia eupatoria L. The plant is cultivated or gathered to obtain the plant parts for medicinal use.
Slovenian: Zel navadnega repika je splošno ime za cvetoče vršičke rastline Agrimonia eupatoria L. Rastlina se goji ali nabira za pridobivanje rastlinskih delov za medicinsko uporabo.
English: Agrimony can also be found in combination with other herbal substances in some herbal medicines.
Slovenian: Zel navadnega repika je lahko na voljo tudi v kombinaciji z drugimi rastlinskimi snovmi v nekaterih zdravilih rastlinskega izvora.
English: The HMPC noted the lack of clinical studies with agrimony, but took into account the well documented use of this herbal medicine for the above uses.
Slovenian: Odbor HMPC je izpostavil pomanjkanje kliničnih študij z zeljo navadnega repika, vendar je upošteval dobro dokumentirano uporabo tega zdravila rastlinskega izvora pri zgoraj navedenih področjih uporabe.
English: They are also available as liquids to be applied to the skin or used as a bath additive.
Slovenian: Prav tako so na razpolago kot tekočine za nanos na kožo ali dodatki za kopel.
English: Agrimony EMA/HMPC/332849/2015
Slovenian: Zel navadnega repika EMA/HMPC/332849/2015
English: Further information on the risks associated with agrimony medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Slovenian: Dodatne informacije o tveganjih, povezanih z zdravili, ki vsebujejo zel navadnega repika, vključno z ustreznimi previdnostnimi ukrepi za njihovo varno uporabo, so na voljo v monografiji na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of agrimony.
Slovenian: To je povzetek znanstvenih zaključkov Odbora za zdravila rastlinskega izvora (HMPC) v zvezi z medicinsko uporabo zeli navadnega repika.
English: Information on the use and licensing of agrimony medicines in EU Member States should be obtained from the relevant national authorities.
Slovenian: Za informacije o uporabi in dovoljenjih za promet z zdravili, ki vsebujejo zel navadnega repika, v državah članicah EU se obrnite na pristojni nacionalni organ.
English: The HMPC concluded that, on the basis of its long-standing use, agrimony can be taken by mouth for the relief of mild diarrhoea, or used as a gargle to relieve mild inflammation of the mouth and throat.
Slovenian: Odbor HMPC je zaključil, da se lahko zel navadnega repika na podlagi svoje dolgotrajne uporabe uživa peroralno (skozi usta) za lajšanje blage driske ali uporablja kot raztopina za grgranje za lajšanje blagega vnetja ust ter žrela.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing agrimony.
Slovenian: Ugotovitve odbora HMPC države članice EU upoštevajo pri ocenjevanju vlog za izdajo dovoljenja za promet z zdravili rastlinskega izvora, ki vsebujejo zel navadnega repika.
English: Any applications for the licensing of medicines containing agrimony have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Slovenian: Vlogo za izdajo dovoljenja za promet z zdravili, ki vsebujejo zel navadnega repika, je treba predložiti pristojnemu nacionalnemu organu za zdravila, ki bo to vlogo za izdajo dovoljenja za promet z zdravilom rastlinskega izvora ocenil in upošteval znanstvene zaključke odbora HMPC.
English: treatment, or if mouth, throat or skin symptoms persist for more than a week during treatment.
Slovenian: Če driska med zdravljenjem traja več kot tri dni ali če simptomi ust, žrela in kože trajajo več kot teden dni, se je treba posvetovati z zdravnikom ali usposobljenim zdravstvenim delavcem.
English: Further information on the HMPC assessment of agrimony medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Slovenian: Dodatne informacije o oceni zdravil, ki vsebujejo zel navadnega repika, ki jo je opravil odbor HMPC, vključno z njegovimi znanstvenimi zaključki, so na voljo na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: How are agrimony medicines approved in the EU?
Slovenian: Kako so zdravila, ki vsebujejo zel navadnega repika, odobrena v EU?
English: Herbal medicines containing agrimony are usually available as herbal teas to be drunk, or as gargles.
Slovenian: Zdravila rastlinskega izvora, ki vsebujejo zel navadnega repika, so navadno na voljo v obliki rastlinskih čajev za pitje ali raztopin za grgranje.
English: What evidence supports the use of agrimony medicines?
Slovenian: Kateri dokazi podpirajo uporabo zdravil, ki vsebujejo zel navadnega repika?
English: Detailed instruction on how to take agrimony medicines and who can use them can be found in the package leaflet that comes with the medicine.
Slovenian: Podrobna navodila o jemanju zdravil, ki vsebujejo zel navadnega repika, in o tem, kdo lahko ta zdravila jemlje, so v navodilu za uporabo, ki je priloženo posameznemu zdravilu.
English: For more information about treatment with Agrimony medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravili, ki vsebujejo zel navadnega repika, preberite navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujte z zdravnikom ali farmacevtom.
English: For practical information about using agrimony medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o njihovi uporabi naj bolniki preberejo navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujejo z zdravnikom ali farmacevtom.
English: What are the risks associated with agrimony medicines?
Slovenian: Kakšna tveganja so povezana z zdravili, ki vsebujejo zel navadnega repika?
English: What is agrimony?
Slovenian: Kaj je zel navadnega repika?
English: Other information about agrimony medicines
Slovenian: Druge informacije o zdravilih, ki vsebujejo zel navadnega repika
English: The European Commission granted a marketing authorisation valid throughout the European Union for Toviaz on 20 April 2007.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Toviaz, veljavno po vsej Evropski uniji, odobrila dne 20. aprila 2007.
English: Toviaz fesoterodine
Slovenian: Toviaz fesoterodin
English: Toviaz must also not be used in patients with:
Slovenian: Zdravila Toviaz ne smejo uporabljati bolniki z:
English: Based upon individual response, the dose may be increased to 8 mg once daily.
Slovenian: Glede na odziv posameznega bolnika na zdravilo, se lahko odmerek poveča na 8 mg enkrat na dan.
English: The full EPAR for Toviaz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Toviaz je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: It blocks some receptors in the body, the muscarinic receptors.
Slovenian: Zavira nekatere receptorje v telesu, imenovane muskarinski receptorji.
English: Other information about Toviaz
Slovenian: Druge informacije o zdravilu Toviaz
English: This is a summary of the European public assessment report (EPAR) for Toviaz.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Toviaz.
English: The patient normally gets the full effect of the treatment after two to eight weeks.
Slovenian: Poln učinek zdravljenja se pri bolniku navadno pokaže po 2 do 8 tednih.
English: This number was reduced by 1.74 and 1.86 with the 4 mg dose of Toviaz and by 1.94 with the 8 mg dose.
Slovenian: To število se je zmanjšalo za 1,74 in 1,86 z 4-miligramskim odmerkom zdravila Toviaz in za 1,94 z 8-miligramskim odmerkom.
English: Prolonged-release means that fesoterodine is released slowly from the tablet over a few hours.
Slovenian: Podaljšano sproščanje pomeni, da se fesoterodin iz tablete sprošča počasi v trajanju nekaj ur.
English: This helps Toviaz to prevent unwanted urination.
Slovenian: Na ta način zdravilo Toviaz pomaga preprečiti neželeno uhajanje urina.
English: Before treatment, patients needed to urinate about 12 times in 24 hours.
Slovenian: Pred zdravljenjem je bolnik uriniral okoli 12-krat v 24 urah.
English: What benefit has Toviaz shown during the studies?
Slovenian: Kakšne koristi je zdravilo Toviaz izkazalo med študijami?
English: The most common side effect with Toviaz (seen in more than 1 patient in 10) is dry mouth.
Slovenian: Najpogostejši neželeni učinek zdravila Toviaz (opažen pri več kot 1 bolniku od 10) so suha usta.
English: These include medicines such as ketoconazole and itraconazole (used to treat fungal infections), atazanavir, indinavir, nelfinavir, ritonavir and saquinavir (medicines used in HIV-positive patients), clarithromycin and telithromycin (antibiotics), and nefazodone (used to treat depression).
Slovenian: Mednje spadajo zdravila, kot so ketokonazol in itrakonazol (za zdravljenje glivičnih okužb), atazanavir, indinavir, nelfinavir, ritonavir in sakvinavir (zdravila za bolnike, okužene z virusom HIV), klaritromicin in telitromicin (antibiotika) ter nefazodon (za zdravljenje depresije).
English: The CHMP decided that Toviaz's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Toviaz večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Toviaz.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Toviaz, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: The main measure of effectiveness was the change in the number of times the patients needed to urinate in a 24-hour period after 12 weeks of treatment.
Slovenian: Glavno merilo učinkovitosti je bila sprememba števila uriniranj v 24 urah po 12 tednih zdravljenja.
English: For more information about treatment with Toviaz, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Toviaz preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: One of the studies also compared Toviaz with tolterodine (another medicine used in overactive bladder syndrome).
Slovenian: V eni izmed študij so primerjali zdravilo Toviaz tudi s tolterodinom (drugim zdravilom, ki se uporablja pri sindromu čezmerno aktivnega sečnega mehurja).
English: In the bladder, this causes the muscles that push urine out of the bladder to relax, leading to an increase in the capacity of the bladder and to changes in the way the bladder muscles contract as the bladder fills up.
Slovenian: Zaradi tega se mišice v sečnem mehurju, ki potiskajo urin iz njega, sprostijo, kar vodi k povečanju prostornine sečnega mehurja in spremembi načina krčenja mišic mehurja med njegovim polnjenjem.
English: Toviaz is used in adults with overactive bladder syndrome to treat the symptoms of the disease: increased urinary frequency (need to urinate frequently), urgency (sudden urge to pass urine), and urgency incontinence (sudden lack of control over urination).
Slovenian: Zdravilo Toviaz se uporablja za zdravljenje naslednjih simptomov pri odraslih s sindromom čezmerno aktivnega sečnega mehurja: povečane pogostnosti uriniranja (potrebe po pogostem uriniranju), urgentne mikcije (nenadne potrebe po uriniranju) in urgentne inkontinence (nenadne izgube nadzora nad uriniranjem).
English: What is the risk associated with Toviaz?
Slovenian: Kakšna tveganja so povezana z zdravilom Toviaz?
English: The active substance in Toviaz, fesoterodine, is an anticholinergic medicine.
Slovenian: Zdravilna učinkovina zdravila Toviaz, fesoterodin, je antiholinergično zdravilo.
English: Toviaz is a medicine containing the active substance fesoterodine.
Slovenian: Toviaz je zdravilo, ki vsebuje zdravilno učinkovino fesoterodin.
English: Toviaz must not be given to patients with moderate liver or moderate to severe kidney disease at the same time as strong CYP3A4 inhibitor medicines.
Slovenian: Zdravilo Toviaz se bolnikom z zmernim obolenjem jeter ali z zmernim do hudim obolenjem ledvic ne sme dajati sočasno z močnimi zaviralci CYP3A4.
English: • severe ulcerative colitis (severe inflammation of the large intestine causing ulceration and bleeding);
Slovenian: • hudim ulceroznim kolitisom (hudim vnetjem debelega črevesa, ki povzroča razjede in krvavitve);
English: Why has Toviaz been approved?
Slovenian: Zakaj je bilo zdravilo Toviaz odobreno?
English: Toviaz must not be used in people who are hypersensitive (allergic) to fesoterodine, to any of the other ingredients, to peanut or to soya.
Slovenian: Zdravila Toviaz ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) fesoterodin, katero koli drugo sestavino zdravila, arašide ali sojo.
English: • myasthenia gravis (a disease of the nerves causing muscle weakness);
Slovenian: • miastenijo gravis (boleznijo živčevja, ki povzroča šibkost mišic);
English: • urinary retention (difficulty in passing urine);
Slovenian: • retencijo urina (težavami z izpraznitvijo sečnega mehurja);
English: It is available as prolonged-release 4 mg tablets and 8 mg tablets.
Slovenian: Na voljo je v obliki 4- in 8-miligramskih tablet s podaljšanim sproščanjem.
English: Toviaz was more effective than placebo and as effective as tolterodine in reducing the number of times the patients urinated in a 24-hour period.
Slovenian: Zdravilo Toviaz je bilo pri zmanjševanju števila uriniranj v 24 urah učinkovitejše od placeba in enako učinkovito kot tolterodin.
English: For the full list of all side effects reported with Toviaz, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Toviaz, glejte navodilo za uporabo.
English: The reductions seen in patients taking placebo and tolterodine were 1.02 and 1.69, respectively.
Slovenian: Pri bolnikih, ki so jemali placebo, se je število uriniranj zmanjšalo za 1,02, pri tistih, ki so prejemali tolterodin, pa za 1,69.
English: The tablets are swallowed whole with a glass of water and must not be chewed.
Slovenian: Priporočeni začetni odmerek zdravila Toviaz je 4 mg enkrat na dan. Tablete je treba pogoltniti cele in jih poplakniti s kozarcem vode; nikakor se jih ne sme žvečiti.
English: • severe hepatic impairment (severe liver disease);
Slovenian: • hudo okvaro jeter (hudim obolenjem jeter);
English: What is Toviaz?
Slovenian: Kaj je zdravilo Toviaz?
English: How has Toviaz been studied?
Slovenian: Kako je bilo zdravilo Toviaz raziskano?
English: The two main studies involved 1,964 patients with overactive bladder syndrome and compared Toviaz (4 or 8 mg a day) with placebo (a dummy treatment).
Slovenian: Zdravilo Toviaz (4 ali 8 mg dnevno) so primerjali s placebom (zdravilom brez zdravilne učinkovine) v dveh glavnih študijah, ki sta vključevali 1 964 bolnikov s čezmerno aktivnim sečnim mehurjem.
English: What is Toviaz used for?
Slovenian: Za kaj se zdravilo Toviaz uporablja?
English: How does Toviaz work?
Slovenian: Kako zdravilo Toviaz deluje?
English: The dose of Toviaz must be adjusted, or the medicine not used at all, in patients with problems with their kidneys or liver, depending on whether they are also receiving ‘CYP3A4 inhibitors', a group of medicines that may affect the way Toviaz is broken down in the body.
Slovenian: Pri bolnikih, ki imajo težave z ledvicami ali jetri, zlasti če sočasno jemljejo zaviralce CYP3A4, tj. skupino zdravil, ki utegnejo vplivati na razgradnjo zdravila Toviaz v telesu, je treba odmerek zdravila prilagoditi ali pa ga sploh ne uporabljati.
English: How is Toviaz used?
Slovenian: Kako se zdravilo Toviaz uporablja?
English: The key elements of these educational materials will be the following:
Slovenian: Ključne točke teh izobraževalnih gradiv bodo sledeče:
English: The Marketing Authorisation Holder shall agree the format and content of the above materials with the National Competent Authority of each Member State.
Slovenian: Imetnik dovoljenja za promet mora obliko in vsebino zgoraj opisanih materialov uskladiti z nacionalnimi pristojnimi oblastmi vsake države članice.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Slovenian: POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE ZDRAVILA, KI MORAJO
English: • Information on how the KRAS testing should be appropriately conducted
Slovenian: • Informacija o tem, kako se testiranje za stanje KRAS primerno izvede.
English: The Marketing Authorisation Holder shall ensure that all physicians who are expected to prescribe Vectibix are provided with educational materials informing them of the importance of KRAS ascertainment before treatment with panitumumab.
Slovenian: Imetnik dovoljenja za promet mora zagotoviti, da bodo vsi zdravniki, od katerih se pričakuje predpisovanje zdravila Vectibix, prejeli izobraževalna gradiva, ki jih bodo informirala o pomembnosti določitve KRAS pred zdravljenjem s panitumumabom.
English: • Brief introduction to the Vectibix indication and the purpose of this tool
Slovenian: • Kratka predstavitev indikacij zdravila Vectibix in namen tega orodja.