FrancophonIA/ELRC3.0 huggingface dataset:
English: The effects include: changes in bone mineral density (thinning of the bones) cataract (clouding of the lens in the eye) glaucoma (increased pressure in the eye) a slowing of the rate of growth of children and adolescents an effect on the adrenal gland (a small gland next to the kidney).
Slovenian: katarakta (motnost očesne leče), glavkom (zvišan tlak v očesu), upočasnjena rast pri otrocih in mladostnikih, vpliv na nadledvično žlezo (majhna žleza nad ledvico).
English: 1 inhalation twice daily
Slovenian: vdiha dvakrat na dan.
English: • Low levels of potassium in your blood.
Slovenian: Redki: nizka koncentracija kalija v krvi,
English: BiResp Spiromax 160 micrograms / 4.5 micrograms inhalation powder
Slovenian: BiResp Spiromax 160 mikrogramov/4,5 mikrogramov prašek za inhaliranje
English: Your doctor may increase this to 2 inhalations twice a day.
Slovenian: Zdravnik vam lahko poveča uporabo na 2 vdiha dvakrat na dan.
English: BiResp Spiromax 320 micrograms/9 micrograms inhalation powder
Slovenian: BiResp Spiromax 320 mikrogramov/9 mikrogramov prašek za inhaliranje
English: Inhalation powder
Slovenian: OVOJNINAH INHALATOR
English: Not more than 6 inhalations should be taken on any single occasion.
Slovenian: Naenkrat ne smejo narediti več kot 6 vdihov.
English: Patients should be reassessed regularly by their prescriber/health care provider so that the dose of BiResp Spiromax remains optimal.
Slovenian: Zdravljenje bolnikov mora redno ovrednotiti zdravnik, ki predpisuje zdravilo, tako da odmerek zdravila BiResp Spiromax ostane optimalen.
English: Adults (18 years and older)
Slovenian: Priporočeni odmerek: Odrasli (18 let in več)
English: • cataract (clouding of the lens in the eye)
Slovenian: • katarakta (motnost očesne leče),
English: BiResp Spiromax maintenance therapy
Slovenian: Zdravilo BiResp Spiromax za vzdrževalno zdravljenje
English: • Steroid tablets that you take by mouth (such as prednisolone).
Slovenian: • steroidne tablete za peroralno uporabo (npr. prednizolon).
English: Start
Slovenian: Začetek:
English: Study 6 months
Slovenian: 6.3 Rok uporabnosti
English: Symptoms of adrenal gland suppression could be tiredness, weakness, stomach problems including nausea, vomiting, pain and diarrhoea,
Slovenian: Simptomi slabšega delovanja nadledvične žleze so lahko utrujenost, šibkost, težave z želodcem, vključno z navzeo,
English: If the patient experiences paradoxical bronchopasm BiResp Spiromax should be discontinued immediately, the patient should be assessed and an alternative therapy instituted, if necessary.
Slovenian: V tem primeru je treba zdravljenje z zdravilom BiResp Spiromax takoj prekiniti, režim zdravljenja ponovno ovrednotiti in po potrebi uvesti drugo vrsto zdravljenja.
English: BiResp Spiromax pharmacokinetic profile
Slovenian: Farmakokinetični profil zdravila BiResp Spiromax
English: 2 inhalers each containing 60 doses.
Slovenian: 2 inhalatorja, ki vsebujeta vsak po 60 odmerkov.
English: Adults (18 years and older): 2 inhalations twice daily
Slovenian: Priporočeni odmerki: Odrasli (18 let in več): 2 vdiha dvakrat na dan
English: Preparing your new BiResp Spiromax
Slovenian: Priprava novega inhalatorja BiResp Spiromax
English: BiResp Spiromax maintenance and reliever therapy
Slovenian: Zdravilo BiResp Spiromax za vzdrževalno in olajševalno zdravljenje
English: 2 inhalers each containing 120 doses.
Slovenian: 2 inhalatorja, ki vsebujeta vsak po 120 odmerkov.
English: 1 inhalation (actuation), twice a day, taken in the morning and in the evening.
Slovenian: • 1 vdih dvakrat na dan, uporabi se zjutraj in zvečer.
English: Adults (18 years and older): 1 inhalation twice daily.
Slovenian: Priporočeni odmerki: Odrasli (18 let in več): 1 vdih dvakrat na dan.
English: Before using your BiResp Spiromax for the first time, you need to prepare it for use as follows:
Slovenian: Preden prvikrat uporabite nov inhalator BiResp Spiromax, ga morate pripraviti za uporabo na naslednji način: • Vrečko iz folije odprite, tako da jo raztrgate na zarezi na vrhu vrečke iz folije, in iz nje vzemite inhalator.
English: The most common symptoms that may occur after when you use more BiResp Spiromax than you should are trembling, headache or a rapid heartbeat.
Slovenian: Najpogostejši simptomi, ki se lahko pojavijo, če ste uporabili večji odmerek zdravila BiResp
English: BiResp Spiromax 320 mcg/9 mcg inhalation powder budesonide/formoterol fumarate dihydrate Inhalation use.
Slovenian: BiResp Spiromax 320 mcg/9 mcg prašek za inhaliranje budezonid/formoterolijev fumarat dihidrat za inhaliranje
English: You might experience symptoms such as a stuffy or runny nose, weakness or joint or muscle pain and rash (eczema).
Slovenian: Pojavijo se lahko simptomi, kot so zamašen nos ali izcedek iz nosu, šibkost,
English: Each BiResp Spiromax inhaler contains 60 inhalations and has a white body with a semi-transparent wine red mouthpiece cover.
Slovenian: 60 inhalacij zdravila in ima belo ohišje s polprozornim vinsko rdečim pokrovčkom ustnika.
English: BiResp Spiromax 160 mcg/4.5 mcg inhalation powder budesonide/formoterol fumarate dihydrate Inhalation use.
Slovenian: BiResp Spiromax 160 mcg/4,5 mcg prašek za inhaliranje budezonid/formoterolijev fumarat dihidrat za inhaliranje
English: What you need to know before you use BiResp Spiromax 3.
Slovenian: Kaj je zdravilo BiResp Spiromax in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo BiResp Spiromax Kako uporabljati zdravilo BiResp Spiromax
English: BiResp Spiromax 160 micrograms /4.5 micrograms inhalation powder budesonide / formoterol fumarate dihydrate
Slovenian: BiResp Spiromax 160 mikrogramov/4,5 mikrogramov prašek za inhaliranje budezonid/formoterolijev fumarat dihidrat
English: BiResp Spiromax 320 micrograms/9 micrograms inhalation powder budesonide/formoterol fumarate dihydrate
Slovenian: BiResp Spiromax 320 mikrogramov/9 mikrogramov prašek za inhaliranje budezonid/formoterolijev fumarat dihidrat
English: Serious asthma-related adverse reactions and exacerbations may occur during treatment with BiResp Spiromax.
Slovenian: Med zdravljenjem z zdravilom BiResp Spiromax se lahko pojavijo resni neželeni učinki, povezani z astmo, in poslabšanje bolezni.
English: Using BiResp Spiromax and a separate ‘reliever inhaler'.
Slovenian: potem preberite poglavje »(A) Uporaba zdravila BiResp Spiromax in ločenega inhalatorja z olajševalcem«.
English: Immune system disorders Rare
Slovenian: Zelo redki motnje okušanja
English: Close monitoring for dose-related adverse reactions is needed in patients who frequently take high numbers of BiResp Spiromax as-needed inhalations.
Slovenian: Pri bolnikih, ki pogosto uporabljajo veliko število inhalacij zdravila BiResp Spiromax po potrebi, je treba skrbno nadzorovati z odmerkom povezane neželene učinke.
English: (A) Using BiResp Spiromax and a separate ‘reliever inhaler'
Slovenian: (A) Uporaba zdravila BiResp Spiromax in ločenega inhalatorja z olajševalcem Zdravilo BiResp Spiromax uporabljajte vsak dan.
English: How to store BiResp Spiromax
Slovenian: Shranjevanje zdravila BiResp Spiromax
English: Package leaflet: Information for the patient BiResp Spiromax 320 micrograms/9 micrograms, inhalation powder budesonide/formoterol fumarate dihydrate
Slovenian: Navodilo za uporabo BiResp Spiromax 320 mikrogramov/9 mikrogramov, prašek za inhaliranje budezonid/formoterolijev fumarat dihidrat
English: Tell your doctor if you have any of the following while taking BiResp Spiromax they could be symptoms of a lung infection:
Slovenian: • pljučnica (okužba pljuč) pri bolnikih s KOPB (pogost neželen učinek) Svojemu zdravniku morate povedati, če imate med jemanjem zdravila BiResp Spiromax kar koli od naštetega, ker so to lahko simptomi okužbe pljuč:
English: BiResp Spiromax 160 micrograms / 4.5 micrograms inhalation powder budesonide/ formoterol fumarate dihydrate Inhalation use.
Slovenian: BiResp Spiromax 160 mikrogramov/4,5 mikrogramov prašek za inhaliranje budezonid/formoterolijev fumarat dihidrat za inhaliranje
English: • Increased mucus production, change in mucus colour
Slovenian: • zvišano telesno temperaturo ali mrzlico, • obilnejše nastajanje sluzi, spremenjeno barvo sluzi,
English: Your doctor may consider adding steroid tablets to your usual treatment if you have an illness such as a chest infection or before an operation.
Slovenian: Če ste bolni, npr. imate okužbo v prsnem košu ali pred operacijo vam bo zdravnik morda poleg vašega običajnega zdravljenja predpisal še steroide v tabletah.
English: Package leaflet: Information for the patient BiResp Spiromax 160 micrograms/4.5 micrograms, inhalation powder budesonide/formoterol fumarate dihydrate
Slovenian: Navodilo za uporabo BiResp Spiromax 160 mikrogramov/4,5 mikrogramov, prašek za inhaliranje budezonid/formoterolijev fumarat dihidrat
English: BiResp Spiromax 320 micrograms/9 micrograms inhalation powder budesonide/formoterol fumarate dihydrate Inhalation use.
Slovenian: BiResp Spiromax 320 mikrogramov/9 mikrogramov prašek za inhaliranje budezonid/formoterolijev fumarat dihidrat za inhaliranje
English: Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation with BiResp Spiromax.
Slovenian: Če po uvedbi zdravila BiResp Spiromax simptomi astme niso nadzorovani ali se poslabšajo, naj bolniki nadaljujejo z zdravljenjem in poiščejo zdravniško pomoč.
English: EXPIRY DATE
Slovenian: Občasni navzea
English: A total daily dose of more than 8 inhalations is not normally needed; however, a total daily dose of up to 12 inhalations could be used for a limited period.
Slovenian: Kljub temu je lahko v določenih omejenih časovnih obdobjih celotni dnevni odmerek 12 vdihov.
English: Budesonide/formoterol maintenance and reliever therapy
Slovenian: Vzdrževalno in olajševalno zdravljenje astme z budezonidom/formoterolom
English: N Severe exacerbationsa Events Events/ patient-year
Slovenian: N Huda poslabšanja a
English: Tachycardia
Slovenian: Občasni tahikardija
English: Palpitations
Slovenian: Pogosti palpitacije
English: • If you have been prescribed BiResp Spiromax and a separate reliever inhaler, read the section called (A)
Slovenian: • Če vam je zdravnik predpisal zdravilo BiResp Spiromax in ločen inhalator z olajševalcem,
English: Pharmaceutical Form
Slovenian: European Medicines Agency Veterinary Medicines
English: Oral solution Neonatal calves less than 12 hours of age
Slovenian: Zdravilo Locatim je peroralna raztopina, ki se jo pridobiva iz kolostruma in se jo daje teletom v prvih 12 urah življenja.
English: EU/2/99/011/001 Locatim >2.8log10 /ml bovine concentrated lactoserum
Slovenian: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 47 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
English: 60 ml
Slovenian: Stran 2/2
English: Strength
Slovenian: ©EMEA 2007
English: Packaging Content Package sizeWithdrawal period
Slovenian: Za zdravilo Locatim ni posebnih previdnostnih ukrepov.
English: Type III glass bottles
Slovenian: Zdravilna učinkovina zdravila so specifični imunoglobulini G (vrsta protiteles) proti adhezinu Escherichia coli F5.
English: 1 bottle Zero days
Slovenian: Obdobje karence je nič dni.
English: EU/1/15/1047/001 BLINCYTO
Slovenian: EU/1/15/1047/001
English: 38.5 mcg Powder for concentrate and solution for solution for infusion
Slovenian: 38,5 mcg Prašek za koncentrat in raztopina za raztopino za infundiranje
English: Powder: 38.5 mcg Solution: 10 mL
Slovenian: 38,5 mcg Raztopina: 10 ml
English: 1 vial (powder) + 1 vial (solution)
Slovenian: 1 viala (prašek) + 1 viala (raztopina)
English: Intravenous use Powder: vial (glass)
Slovenian: Prašek: viala (steklena) Raztopina: viala (steklena)
English: Pack size
Slovenian: Prašek:
English: The companies that market these medicines include Bayer GmbH and Lundbeck A/S.
Slovenian: Družbi, ki tržita ta zdravila, sta Bayer GmbH in Lundbeck A/S.
English: Saroten and associated names (such as Redomex and Sarotex) is marketed in Austria, Belgium, Cyprus, Denmark, Estonia, Germany, Greece, Luxembourg, the Netherlands and Sweden, and also in Norway.
Slovenian: Zdravilo Saroten in povezana imena (kot sta Redomex in Sarotex) se tržijo v Avstriji, Belgiji, Estoniji, Nemčiji, Grčiji, Luksemburgu,na Cipru, Danskem, Nizozemskem in Švedskem ter tudi na Norveškem.
English: The European Commission issued a decision on this opinion on 08/05/2017.
Slovenian: Evropska komisija je o tem mnenju izdala odločbo dne 8. maja 2017.
English: The medicine should not be given to children to treat depression or pain.
Slovenian: Zdravilo se ne sme dajati otrokom za zdravljenje depresije ali bolečin.
English: Why was Saroten reviewed?
Slovenian: Zakaj je bilo zdravilo Saroten pregledano?
English: On 23 February 2017, the European Medicines Agency completed a review of Saroten.
Slovenian: Evropska agencija za zdravila je 23. februarja 2017 zaključila pregled zdravila Saroten.
English: • treatment to prevent migraine.
Slovenian: • zdravljenje za preprečevanje migrene.
English: Saroten is authorised in the EU via national procedures.
Slovenian: Zdravilo Saroten je bilo v EU odobreno po nacionalnih postopkih.
English: The Committee agreed that the medicine could also be used in children from 6 years of age to treat nocturnal enuresis.
Slovenian: Odbor se je strinjal, da se zdravilo lahko uporablja tudi za otroke, starejše od 6 let, za zdravljenje nočne enureze.
English: Amitriptyline is also available in EU countries as generic amitriptyline.
Slovenian: Amitriptilin je v državah EU na voljo tudi kot generični amitriptilin.
English: Use is not permitted in children less than 6 years of age.
Slovenian: Uporaba zdravila ni priporočljiva pri otrocih, mlajših od 6 let.
English: Other amendments included the information on interactions with other medicines (4.5), and the list of side effects (4.8).
Slovenian: Druge spremembe so vključevale informacijo o medsebojnem delovanju z drugimi zdravili (poglavje 4.5) in seznam neželenih učinkov (poglavje 4.8).
English: • the treatment of serious depression (major depressive disorder)
Slovenian: • zdravljenje hude depresije (velike depresivne motnje);
English: 4.1 Therapeutic indications The CHMP agreed that Saroten and associated names could be used in adults for:
Slovenian: 4.1 Terapevtske indikacije Odbor CHMP se je strinjal, da se zdravilo Saroten in povezana imena lahko uporabljajo pri odraslih za:
English: Questions and answers on Saroten and associated names (amitriptyline)
Slovenian: Vprašanja in odgovori o zdravilu Saroten in povezanih imenih (amitriptilin)
English: The CHMP harmonised the doses to be used in the approved indications.
Slovenian: Odbor CHMP je uskladil odmerke, ki se uporabljajo za odobrene indikacije.
English: It must also not be used in patients who have recently had a heart attack or have disorders of the electrical activity or rhythm of the heart or reduced blood flow to the heart muscle, nor in those with severe liver disease.
Slovenian: Ne sme se uporabljati pri bolnikih, ki so imeli pred kratkim srčni napad ali imajo motnje električne aktivnosti srca ali srčnega ritma ali zmanjšan pritok krvi v srce, in pri bolnikih s hudim obolenjem jeter.
English: • treatment to prevent chronic tension-type headache (CTTH)
Slovenian: • zdravljenje za preprečevanje kroničnega glavobola tenzijskega tipa (CTTH);
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for amitriptyline in the European Union (EU).
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je treba uskladiti podatke o predpisovanju amitriptilina v Evropski uniji (EU).
English: On 17 December 2015, the Greek medicines regulator, the National Organization for Medicines (EOF), referred the matter to the CHMP in order to harmonise the marketing authorisations for Saroten and associated names in the EU.
Slovenian: Grška regulativna agencija za zdravila, nacionalna organizacija za zdravila (EOF), je 17. decembra 2015 zadevo napotila na odbor CHMP, da bi se uskladila dovoljenja za promet z zdravilom Saroten in povezanimi imeni v EU.
English: What is Saroten?
Slovenian: Kaj je zdravilo Saroten?
English: It contains the active substance amitriptyline.
Slovenian: Vsebuje zdravilno učinkovino amitriptilin.
English: It should only be prescribed by a specialist doctor and should only be used when physical causes of the problem (including conditions such as spina bifida) have been ruled out and when other treatments, including other medicines used for this problem, have not worked.
Slovenian: Zdravilo lahko predpisuje le zdravnik specialist in se lahko uporablja le, kadar so bili fizični vzroki (vključno s stanji, kot je spina bifida) izključeni ter druga zdravljenja in zdravila za zdravljenje tega stanja niso delovala.
English: • the treatment of neuropathic pain (long-lasting pain caused by nerve damage)
Slovenian: • zdravljenje nevropatske bolečine (dolgotrajne bolečine, ki jo povzroča poškodba živcev);
English: Saroten must not be used in patients who are hypersensitive (allergic) to the medicine or any of its ingredients.
Slovenian: Zdravilo Saroten se ne sme uporabljati pri bolnikih, ki so preobčutljivi za (alergični na) zdravilo ali katero koli od sestavin zdravila.
English: Saroten is a medicine used to treat a variety of conditions in the EU, including depression and various depressive states, a number of disorders associated with chronic (long-term) pain including the prevention of migraine or recurring headaches, and for the treatment of nocturnal enuresis (bedwetting) in children.
Slovenian: Saroten je zdravilo, ki se uporablja za zdravljenje različnih bolezni v EU, vključno z zdravljenjem depresije in različnih depresivnih stanj, bolezni, povezanih s kronično (dolgotrajno) bolečino, vključno s preprečevanjem migrene in ponavljajočih se glavobolov, ter za zdravljenje nočne enureze (močenja postelje) pri otrocih.
English: While harmonising the use of Saroten in neuropathic pain and prevention of CTTH and migraine, the CHMP considered that Saroten should not be used for other forms of chronic pain.
Slovenian: Med usklajevanjem uporabe zdravila Saroten za zdravljenje nevropatske bolečine ter preprečevanje CTTH in migrene je odbor CHMP ugotovil, da se zdravilo Saroten ne sme uporabljati pri drugih oblikah kronične bolečine.
English: For the treatment of bedwetting the dose is given an hour to an hour-and-a-half before bedtime and a course of treatment should last for a maximum of 3 months.
Slovenian: Za zdravljenje močenja postelje se daje odmerek zdravila od ene ure do ene ure in pol pred spanjem, trajanje zdravljenja pa je največ 3 mesece.
English: This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.
Slovenian: Zato je med državami članicami prišlo do razlik v načinu uporabe zdravila, kot je razvidno iz razlik v povzetkih glavnih značilnosti zdravila, označevanju in navodilih za uporabo v državah, kjer se zdravilo trži.
English: The CHMP harmonised other sections of the SmPC including the warnings and precautions relating to treatment (4.4), and recommendations not to use the medicine during pregnancy and to consider the risks and benefits of use during breast feeding (4.6).
Slovenian: Odbor CHMP je uskladil druga poglavja v povzetkih glavnih značilnosti zdravila, vključno z opozorili in previdnostnimi ukrepi (poglavje 4.4) ter priporočiloma, da se zdravilo ne sme uporabljati med nosečnostjo ter da se pretehtajo tveganja in koristi uporabe med dojenjem (poglavje 4.6).
English: For initial treatment in hospital patients, Saroten can also be given as an injection into a muscle or a drip (infusion) into a vein.
Slovenian: Za začetno zdravljenje pri bolnikih, ki se zdravijo v bolnišnici, se zdravilo Saroten lahko daje tudi z injiciranjem v mišico ali infundiranjem (kapalno infuzijo) v veno.
English: Saroten is available as modified-release capsules, tablets (including modifiedrelease tablets), and as a solution for injection.
Slovenian: Zdravilo Saroten je na voljo v obliki kapsul s prirejenim sproščanjem, tablet (vključno s tabletami s prirejenim sproščanjem) in raztopine za injiciranje.
English: Treatment for depression or chronic pain may take 2 to 4 weeks to start to work, and treatment for depression should be continued for up to 6 months after the patient gets better.
Slovenian: Pri zdravljenju depresije ali kronične bolezni lahko traja od 2 do 4 tedne, da zdravilo začne učinkovati.
English: Treatment is usually by mouth and the dose depends on the condition to be treated; as the strengths of the different tablets and capsules can vary, it is important to choose one that allows the right dose to be given.
Slovenian: Ker se jakosti različnih tablet in kapsul lahko razlikujejo, je treba izbrati tako jakost, da se zagotovi dajanje ustreznega odmerka.
English: Patients must not receive treatment with certain other medicines called monoamine oxidase inhibitors (MAOIs) at the same time as Saroten, and there should be a gap (usually of two weeks) between stopping one of these medicines and starting Saroten, or vice versa.
Slovenian: Narediti morajo premor (običajno dva tedna) od konca jemanja teh zdravil do začetka jemanja zdravila Saroten ali obratno.
English: These recommendations should be reflected in the product information and communicated to healthcare professionals via a dedicated letter.
Slovenian: Ta priporočila se morajo izražati v informacijah o zdravilu, zdravstvenim delavcem pa jih je treba sporočiti s posebnim dopisom.
English: These measures will be further reviewed as part of the ongoing Article 20 procedure.
Slovenian: Ti ukrepi bodo nadalje revidirani kot del potekajočega postopka v skladu s členom 20.
English: The PRAC concluded that the risks observed were unlikely to be due to bias.
Slovenian: Odbor PRAC je ugotovil, da je malo verjetno, da bi ugotovljena tveganja lahko pripisali pristranskosti.
English: Interim results of the REASSURE study report also a significant concomitant use with enzalutamide in clinical practice (22%).
Slovenian: V vmesnih rezultatih študije REASSURE se tudi poroča o tem, da je v klinični praksi precejšna (22 %) sočasna uporaba enzalutamida.
English: On 30 November 2017 the EC therefore triggered a procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data, and requested the PRAC to assess the impact of the above concerns on the benefit-risk balance of Xofigo and to issue a recommendation on whether the marketing authorisation of this product should be maintained, varied, suspended or revoked.
Slovenian: Zato je Evropska komisija 30. novembra 2017 na podlagi farmakovigilančnih podatkov začela postopek v skladu s členom 20 Uredbe (ES) št. 726/2004 in odbor PRAC prosila, naj oceni vpliv navedenih pomislekov na razmerje med tveganji in koristmi zdravila Xofigo ter izda priporočilo o tem, ali naj se dovoljenje za promet s tem zdravilom ohrani, spremeni, začasno odvzame ali ukine.
English: • The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data, in particular regarding the need for provisional measures in accordance with Article 20(3) of Regulation (EC) No 726/2004 for Xofigo (radium Ra223 dichloride) and taking into account the grounds set out in Articles 116 of Directive 2001/83/EC.
Slovenian: • odbor PRAC je upošteval postopek iz člena 20 Uredbe (ES) št. 726/2004, ki je bil v zvezi z zdravilom Xofigo ([223Ra]radijev diklorid) začet na podlagi farmakovigilančnih podatkov, zlasti zaradi potrebe po uvedbi začasnih ukrepov v skladu s členom 20(3) Uredbe (ES) št. 726/2004, in ob upoštevanju razlogov iz člena 116 Direktive 2001/83/ES.