natgillin/translations-raw huggingface dataset:
Close monitoring for dose-related adverse reactions is needed in patients who frequently take high numbers of BiResp Spiromax as-needed inhalations. 
Pri bolnikih, ki pogosto uporabljajo veliko število inhalacij zdravila BiResp Spiromax po potrebi, je treba skrbno nadzorovati z odmerkom povezane neželene učinke.
(A) Using BiResp Spiromax and a separate ‘reliever inhaler' 
(A) Uporaba zdravila BiResp Spiromax in ločenega inhalatorja z olajševalcem Zdravilo BiResp Spiromax uporabljajte vsak dan.
How to store BiResp Spiromax 
Shranjevanje zdravila BiResp Spiromax
Package leaflet: Information for the patient BiResp Spiromax 320 micrograms/9 micrograms, inhalation powder budesonide/formoterol fumarate dihydrate 
Navodilo za uporabo BiResp Spiromax 320 mikrogramov/9 mikrogramov, prašek za inhaliranje budezonid/formoterolijev fumarat dihidrat
Tell your doctor if you have any of the following while taking BiResp Spiromax they could be symptoms of a lung infection: 
• 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:
BiResp Spiromax 160 micrograms / 4.5 micrograms inhalation powder budesonide/ formoterol fumarate dihydrate Inhalation use. 
BiResp Spiromax 160 mikrogramov/4,5 mikrogramov prašek za inhaliranje budezonid/formoterolijev fumarat dihidrat za inhaliranje
• Increased mucus production, change in mucus colour 
• zvišano telesno temperaturo ali mrzlico, • obilnejše nastajanje sluzi, spremenjeno barvo sluzi,
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. 
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.
Package leaflet: Information for the patient BiResp Spiromax 160 micrograms/4.5 micrograms, inhalation powder budesonide/formoterol fumarate dihydrate 
Navodilo za uporabo BiResp Spiromax 160 mikrogramov/4,5 mikrogramov, prašek za inhaliranje budezonid/formoterolijev fumarat dihidrat
BiResp Spiromax 320 micrograms/9 micrograms inhalation powder budesonide/formoterol fumarate dihydrate Inhalation use. 
BiResp Spiromax 320 mikrogramov/9 mikrogramov prašek za inhaliranje budezonid/formoterolijev fumarat dihidrat za inhaliranje
Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation with BiResp Spiromax. 
Če po uvedbi zdravila BiResp Spiromax simptomi astme niso nadzorovani ali se poslabšajo, naj bolniki nadaljujejo z zdravljenjem in poiščejo zdravniško pomoč.
EXPIRY DATE 
Občasni navzea
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. 
Kljub temu je lahko v določenih omejenih časovnih obdobjih celotni dnevni odmerek 12 vdihov.
Budesonide/formoterol maintenance and reliever therapy 
Vzdrževalno in olajševalno zdravljenje astme z budezonidom/formoterolom
N Severe exacerbationsa Events Events/ patient-year 
N Huda poslabšanja a
Tachycardia 
Občasni tahikardija
Palpitations 
Pogosti palpitacije
• If you have been prescribed BiResp Spiromax and a separate reliever inhaler, read the section called (A) 
• Če vam je zdravnik predpisal zdravilo BiResp Spiromax in ločen inhalator z olajševalcem,
Oral solution Neonatal calves less than 12 hours of age 
Zdravilo Locatim je peroralna raztopina, ki se jo pridobiva iz kolostruma in se jo daje teletom v prvih 12 urah življenja.
60 ml 
Stran 2/2
Packaging Content Package sizeWithdrawal period 
Za zdravilo Locatim ni posebnih previdnostnih ukrepov.
Type III glass bottles 
Zdravilna učinkovina zdravila so specifični imunoglobulini G (vrsta protiteles) proti adhezinu Escherichia coli F5.
1 bottle Zero days 
Obdobje karence je nič dni.
38.5 mcg Powder for concentrate and solution for solution for infusion 
38,5 mcg Prašek za koncentrat in raztopina za raztopino za infundiranje
Powder: 38.5 mcg Solution: 10 mL 
38,5 mcg Raztopina: 10 ml
1 vial (powder) + 1 vial (solution) 
1 viala (prašek) + 1 viala (raztopina)
Intravenous use Powder: vial (glass) 
Prašek: viala (steklena) Raztopina: viala (steklena)
Pack size 
Prašek:
The companies that market these medicines include Bayer GmbH and Lundbeck A/S. 
Družbi, ki tržita ta zdravila, sta Bayer GmbH in Lundbeck A/S.
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. 
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.
The European Commission issued a decision on this opinion on 08/05/2017. 
Evropska komisija je o tem mnenju izdala odločbo dne 8. maja 2017.
The medicine should not be given to children to treat depression or pain. 
Zdravilo se ne sme dajati otrokom za zdravljenje depresije ali bolečin.
Why was Saroten reviewed? 
Zakaj je bilo zdravilo Saroten pregledano?
On 23 February 2017, the European Medicines Agency completed a review of Saroten. 
Evropska agencija za zdravila je 23. februarja 2017 zaključila pregled zdravila Saroten.
• treatment to prevent migraine. 
• zdravljenje za preprečevanje migrene.
Saroten is authorised in the EU via national procedures. 
Zdravilo Saroten je bilo v EU odobreno po nacionalnih postopkih.
The Committee agreed that the medicine could also be used in children from 6 years of age to treat nocturnal enuresis. 
Odbor se je strinjal, da se zdravilo lahko uporablja tudi za otroke, starejše od 6 let, za zdravljenje nočne enureze.
Amitriptyline is also available in EU countries as generic amitriptyline. 
Amitriptilin je v državah EU na voljo tudi kot generični amitriptilin.
Use is not permitted in children less than 6 years of age. 
Uporaba zdravila ni priporočljiva pri otrocih, mlajših od 6 let.
Other amendments included the information on interactions with other medicines (4.5), and the list of side effects (4.8). 
Druge spremembe so vključevale informacijo o medsebojnem delovanju z drugimi zdravili (poglavje 4.5) in seznam neželenih učinkov (poglavje 4.8).
• the treatment of serious depression (major depressive disorder) 
• zdravljenje hude depresije (velike depresivne motnje);
4.1 Therapeutic indications The CHMP agreed that Saroten and associated names could be used in adults for: 
4.1 Terapevtske indikacije Odbor CHMP se je strinjal, da se zdravilo Saroten in povezana imena lahko uporabljajo pri odraslih za:
Questions and answers on Saroten and associated names (amitriptyline) 
Vprašanja in odgovori o zdravilu Saroten in povezanih imenih (amitriptilin)
The CHMP harmonised the doses to be used in the approved indications. 
Odbor CHMP je uskladil odmerke, ki se uporabljajo za odobrene indikacije.
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. 
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.
• treatment to prevent chronic tension-type headache (CTTH) 
• zdravljenje za preprečevanje kroničnega glavobola tenzijskega tipa (CTTH);
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). 
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).
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. 
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.
What is Saroten? 
Kaj je zdravilo Saroten?
It contains the active substance amitriptyline. 
Vsebuje zdravilno učinkovino amitriptilin.
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. 
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.
• the treatment of neuropathic pain (long-lasting pain caused by nerve damage) 
• zdravljenje nevropatske bolečine (dolgotrajne bolečine, ki jo povzroča poškodba živcev);
Saroten must not be used in patients who are hypersensitive (allergic) to the medicine or any of its ingredients. 
Zdravilo Saroten se ne sme uporabljati pri bolnikih, ki so preobčutljivi za (alergični na) zdravilo ali katero koli od sestavin zdravila.
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. 
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.
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. 
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.
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. 
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.
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. 
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.
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). 
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).
For initial treatment in hospital patients, Saroten can also be given as an injection into a muscle or a drip (infusion) into a vein. 
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.
Saroten is available as modified-release capsules, tablets (including modifiedrelease tablets), and as a solution for injection. 
Zdravilo Saroten je na voljo v obliki kapsul s prirejenim sproščanjem, tablet (vključno s tabletami s prirejenim sproščanjem) in raztopine za injiciranje.
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. 
Pri zdravljenju depresije ali kronične bolezni lahko traja od 2 do 4 tedne, da zdravilo začne učinkovati.
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. 
Ker se jakosti različnih tablet in kapsul lahko razlikujejo, je treba izbrati tako jakost, da se zagotovi dajanje ustreznega odmerka.
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. 
Narediti morajo premor (običajno dva tedna) od konca jemanja teh zdravil do začetka jemanja zdravila Saroten ali obratno.
These recommendations should be reflected in the product information and communicated to healthcare professionals via a dedicated letter. 
Ta priporočila se morajo izražati v informacijah o zdravilu, zdravstvenim delavcem pa jih je treba sporočiti s posebnim dopisom.
These measures will be further reviewed as part of the ongoing Article 20 procedure. 
Ti ukrepi bodo nadalje revidirani kot del potekajočega postopka v skladu s členom 20.
The PRAC concluded that the risks observed were unlikely to be due to bias. 
Odbor PRAC je ugotovil, da je malo verjetno, da bi ugotovljena tveganja lahko pripisali pristranskosti.
Interim results of the REASSURE study report also a significant concomitant use with enzalutamide in clinical practice (22%). 
V vmesnih rezultatih študije REASSURE se tudi poroča o tem, da je v klinični praksi precejšna (22 %) sočasna uporaba enzalutamida.
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. 
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.
• 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. 
• 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.
• Further to the review of the preliminary analyses available, the underlying mechanism for the increased risks of fracture and mortality observed in ERA 233, and therefore the potential impact of these findings in the authorised indication, remain uncertain. 
• Na podlagi pregleda predhodne analize, ki je na voljo, ostaja nejasen osnovni mehanizem za večje tveganje zlomov in smrtnosti, ugotovljen v študiji ERA 223, ter s tem morebitni učinek teh ugotovitev pri odobreni indikaciji.
The PRAC also considered data from the pivotal clinical trial ALSYMPCA which supported the marketing authorisation of Xofigo, as well as data from other completed and ongoing studies which became available since the marketing authorisation. 
Proučil je tudi podatke iz osrednjega kliničnega preskušanja ALSYMPCA, s katerim se je podprlo dovoljenje za promet z zdravilom Xofigo, ter podatke iz drugih zaključenih in začetih študij, ki so bili na voljo od začetka veljave dovoljenja za promet.
The Committee, as a consequence, recommends the variation to the terms of the marketing authorisation for Xofigo (radium Ra223 dichloride). 
Odbor posledično priporoča spremembo pogojev dovoljenja za promet z zdravilom Xofigo ([223Ra]radijev diklorid).
Whilst the exact extent of use of radium-223 in combination with abiraterone acetate and prednisolone/prednisone in clinical practice is not known, interim data from an observational study (REASSURE) reported that 5% of patients were treated with this combination. 
Čeprav natančen obseg uporabe [223Ra]radijevega diklorida v kombinaciji z abirateron acetatom in prednizonom/prednizolonom v klinični praksi ni znan, se je v vmesnih podatkih iz opazovalne študije (REASSURE) poročalo, da je bilo s to kombinacijo zdravljenih 5 % bolnikov.
The current recommendation relates only to provisional measures recommended by the PRAC for radium-223 dichloride based on the preliminary data available at this time. 
Trenutno priporočilo se nanaša le na začasne ukrepe, ki jih na podlagi predhodnih podatkov, ki so ob tem času na voljo, za [223Ra]radijev diklorid priporoča odbor PRAC.
The clinical efficacy of radium-223 dichloride in the authorised indication was established during the initial marketing authorisation application based on the assessment of data from one pivotal phase III study (15245/BC1-06, ALSYMPCA), in which an improved overall survival and delayed symptomatic skeletal events were observed. 
Klinična učinkovitost [223Ra]radijevega diklorida pri odobreni indikaciji je bila ugotovljena med vlogo za prvotno dovoljenje za promet na podlagi ocene podatkov iz ene osrednje študije faze III (15245/BC1-06, ALSYMPCA), pri kateri so bili ugotovljeni boljše celokupno preživetje in zapozneli simptomatski dogodki v kosteh.
• The PRAC noted that the use of radium Ra223 dichloride in Study ERA 223 was at earlier stages of the disease, albeit partially overlapping with that included in the authorised indication. 
• Odbor PRAC je opozoril, da se je [223Ra]radijev diklorid v študiji ERA 223 uporabljal na začetnih stopnjah bolezni, čeprav se je to delno prekrivalo z uporabo, vključeno v odobreno indikacijo.
In view of the above, the Committee considers that the benefit-risk balance of Xofigo (radium Ra223 dichloride) remains favourable subject to the agreed provisional amendments to the product information. 
Odbor glede na navedeno meni, da je razmerje med tveganji in koristmi zdravila Xofigo ([223Ra]radijev diklorid) še naprej ugodno, če se upoštevajo dogovorjene začasne spremembe informacij o zdravilu.
Whilst at this stage it is not excluded that the concurrent administration of radium-223 + abiraterone + prednisolone/prednisone is critical to the subsequent increased risks of fractures and death, it cannot be excluded either that the risks observed could apply to other effective androgen receptor antagonists. 
Čeprav na tej stopnji ni izključeno, da je sočasna uporaba [223Ra]radijevega diklorida v kombinaciji z abirateron acetatom in prednizonom/prednizolonom bistvena za poznejše večje tveganje zlomov in smrtnosti, prav tako ni mogoče izključiti, da bi se ugotovljena tveganja lahko nanašala na druge učinkovite antagoniste androgenskega receptorja.
The PRAC also noted that data available show that radium Ra223 dichloride is used to some extent in clinical practice in combination with anti-androgens such as abiraterone and enzalutamide. 
Opozoril je tudi, da razpoložljivi podatki kažejo, da se [223Ra]radijev diklorid v klinični praksi v določenem obsegu uporablja v kombinaciji z antiandrogeni, kot sta abirateron in enzalutamid.
The PRAC also considered other available data, including further data from the ALSYMPCA clinical trial submitted in support of the initial marketing authorisation, in relation to the potential impact of results of Study ERA 223 on the benefit-risk balance of radium Ra223 dichloride in its authorised indication. 
Proučil je tudi druge razpoložljive podatke, vključno z dodatnimi podatki kliničnega preskušanja ALSYMPCA, predloženimi ob izdaji prvega dovoljenja za promet, v povezavi z morebitnim učinkom rezultatov študije ERA 223 na razmerje med tveganji in koristmi [223Ra]radijevega diklorida pri njegovi odobreni indikaciji.
In view of the significance of the findings of the ERA 223 clinical trial, it was considered that they should be thoroughly reviewed in the context of all available data related to radium-223 dichloride (including evidence from non-authorised use that might impact the authorised use) in order to assess their potential impact on the benefit-risk balance of Xofigo in the authorised indication of the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases. 
Glede na pomembnost ugotovitev klinične študije ERA 223 se je zdelo, da bi morale biti analize temeljito pregledane ob upoštevanju vseh razpoložljivih podatkov, povezanih z [223Ra]radijevim dikloridom (vključno z dokazi o neodobreni uporabi, ki bi lahko vplivali na odobreno uporabo), da se oceni morebitni učinek na razmerje med tveganji in koristmi zdravila Xofigo pri odobreni indikaciji za zdravljenje odraslih moških z na kastracijo odpornim rakom prostate (CRPC - castration resistant prostate carcinoma), s simptomatskimi kostnimi metastazami in brez znanih metastaz v notranjih organih.
In view of the seriousness of these results, the fact that they were observed in a patient population with earlier disease characteristics but partly overlapping with that described in the authorised indication, and considering that the mechanism behind the events observed remain largely unexplained at this stage, the PRAC considered that, as a provisional measure, the use of radium-223 in combination with abiraterone acetate and prednisone/prednisolone should be contraindicated. 
Glede na resnost teh rezultatov je odbor PRAC ob upoštevanju dejstva, da so bili opaženi v populaciji bolnikov s predhodnimi značilnostmi bolezni, ki pa so se delno prekrivale z značilnostmi, opisanimi pri odobreni indikaciji, in tega, da ostaja mehanizem, na katerem temeljijo opaženi dogodki, na tej stopnji večinoma nepojasnjeni, menil, da bi morala biti uporaba [223Ra]radijevega diklorida v kombinaciji z abirateron acetatom in prednizonom/prednizolonom začasno kontraindicirana.
Considering current therapeutic options available for patients with symptomatic castration resistant prostate cancer with bone metastases, the PRAC considered that as a provisional measure, a warning that the safety and efficacy of Xofigo in combination with second-generation androgen receptor antagonists such as enzalutamide have not been established, should be included in the product information. 
Odbor PRAC je ob upoštevanju trenutnih terapevtskih možnosti, ki so na voljo bolnikom s simptomatskim na kastracijo odpornim rakom prostate s kostnimi metastazami, menil, da bi bilo treba v informacije o zdravilu kot začasni ukrep vključiti opozorilo, da varnost in učinkovitost zdravila Xofigo v kombinaciji z antagonisti androgenskega receptorja druge generacije, kot je enzalutamid, nista bili dokazani.