natgillin/translations-raw huggingface dataset:
Severe forms associated with changes in consciousness in the context of hyperammonaemic encephalopathy, may occur in patients treated with deferasirox, particularly in children. 
Pri bolnikih, ki prejemajo deferasiroks, zlasti pri otrocih, lahko pride do hudih oblik ledvične odpovedi v povezavi z motnjami zavesti v okviru hiperamoniemične encefalopatije.
90 film-coated tablets 300 film-coated tablets 
90 filmsko obloženih tablet 300 filmsko obloženih tablet
Most of these patients had pre-existing haematological disorders that are frequently associated with bone marrow failure. 
Pri večini teh bolnikov so bile že prej prisotne hematološke bolezni, ki so pogosto povezane z depresijo kostnega mozga, vendar ni mogoče izključiti možnosti, da zdravilo Deferasiroks Mylan prispeva k nastopu citopenije ali jo poslabša.
In a 5-year observational study in which 267 children aged 2 to <6 years (at enrollment) with transfusional haemosiderosis received deferasirox, there were no clinically meaningful differences in the safety and tolerability profile of deferasirox in paediatric patients aged 2 to <6 years compared to the overall adult and older paediatric population, including increases in serum creatinine of >33% and above the upper limit of normal on ≥2 consecutive occasions (3.1%), and elevation of alanine aminotransferase (ALT) greater than 5 times the upper limit of normal (4.3%). 
V 5-letni opazovalni študiji, v kateri je deferasiroks prejemalo 267 otrok, ki so bili ob vključitvi stari od 2 do 6 let in so imeli transfuzijsko hemosiderozo, ni bilo klinično pomembnih razlik v profilih varnosti in prenašanja deferasiroksa med pediatričnimi bolniki v starosti od 2 do 6 let in celotno populacijo odraslih ter starejših pediatričnih bolnikov.
• Medication errors due to switching between formulations available on the market by different 
• napak pri uporabi zdravil različnih imetnikov dovoljenj za promet z zdravili, ki vsebujejo deferasiroks, zaradi prehoda med formulacijami deferasiroksa, ki so dostopna na trgu (z disperzibilnih tablet na filmsko obložene tablete oziroma zrnca ali obratno).
Twice (2×) 
(50 x 10
30 film-coated tablets 90 film-coated tablets 
30 filmsko obloženih tablet 90 filmsko obloženih tablet
• Swelling of arms or legs 
• otekanje rok ali nog
Table 2 Recommended doses for non-transfusion-dependent thalassaemia syndromes 
Preglednica 2 Priporočeni odmerki pri sindromih talasemije, ki niso odvisni od transfuzij filmsko obložene tablete koncentracija železa v jetrih*
- if you develop a severe rash, or difficulty breathing and dizziness or swelling mainly of the face and throat (signs of severe allergic reaction, see also section 4 “Possible side effects”). 
• Če dobite hud izpuščaj ali pride do težav z dihanjem in omotičnosti ali otekanja pretežno v obraz in grlo/žrelo (znaki hude alergijske reakcije),
How to take Deferasirox Mylan 
Kako jemati zdravilo Deferasiroks Mylan
≥7 mg Fe/g dw or >2,000 µg/l 
≥7 mg Fe/g suhe teže ali
Anxiety, sleep disorder Nervous system disorders Common: 
1, poslabšanje anemije nevtropenija1 Bolezni imunskega sistema neznana pogostnost:
• Tiredness 
• srbenje
Vision and hearing 
Vid in sluh
In clinical studies, elderly patients experienced a higher frequency of adverse reactions than younger patients (in particular, diarrhoea) and should be monitored closely for adverse reactions that may require a dose adjustment. 
V kliničnih študijah je pri starejših bolnikih pogosteje prihajalo do neželenih učinkov kot pri mlajših bolnikih (zlasti do diareje).
Every 2 weeks during first month of therapy. 
• vsak teden v prvem mesecu po uvedbi ali spremembi zdravljenja,
- if you experience a combination of any of the following symptoms: rash, red skin, blistering of the lips, eyes or mouth, skin peeling, high fever, flu-like symptoms, enlarged lymph nodes 
mehurčast izpuščaj na ustnicah, očeh ali v ustih, luščenje kože, močno zvišana telesna temperatura, gripi podobni simptomi, povečane bezgavke (znaki hude kožne reakcije),
Before initiating treatment 
• dvakrat pred uvedbo zdravljenja,
The recommended initial daily dose of Deferasirox Mylan film-coated tablets in patients with nontransfusion-dependent thalassaemia syndromes is 7 mg/kg body weight. 
Pri bolnikih, ki imajo katerega od sindromov talasemije, neodvisnih od transfuzij, je priporočen začetni odmerek zdravila Deferasiroks Mylan v obliki filmsko obloženih tablet 7 mg/kg telesne mase.
Mylan Hungary Kft., Mylan utca 1, Komárom 2900, Hungary 
Mylan Hungary Kft., Mylan utca 1, Komárom 2900, Madžarska Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
It is recommended that hyperammonaemic encephalopathy be considered and ammonia levels measured in patients who develop unexplained changes in mental status while on Deferasirox Mylan therapy. 
Pri bolnikih, pri katerih v času zdravljenja z zdravilom Deferasiroks Mylan pride do nepojasnjenih sprememb duševnega stanja, je priporočeno upoštevati možnost, da gre za hiperamoniemično encefalopatijo, in jim meriti koncentracijo amonijaka.
Adjustment Steps (every 3 
>800 μg/l spremljanje enkrat na mesec koraki za prilagajanje (vsakih 3-6 mesecev)
In patients treated with doses greater than 21 mg/kg, dose reductions in steps of 3.5 to 7 mg/kg should be considered when control has been achieved (e.g. serum ferritin levels persistently below 2,500 µg/l and showing a decreasing trend over time). 
Ko bolniki, ki se zdravijo z odmerki nad 21 mg/kg, dosežejo urejenost (na primer koncentracijo feritina v serumu vztrajno pod 2.500 µg/l skupaj s trendom zniževanja s časom), je treba razmisliti o postopnem zniževanju odmerka v korakih po 3,5 do 7 mg/kg.
Deafness Respiratory, thoracic and mediastinal disorders Uncommon: 
gluhost Bolezni dihal, prsnega koša in mediastinalnega prostora občasni:
It traps and removes excess iron which is then excreted mainly in the stools. 
Zdravilo Deferasiroks Mylan veže in odstrani presežno železo, ki se potem večinoma izloči z blatom.
500 - 1,000 µg/l 
500-1.000 µg/l koraki za prilagajanje (vsakih 3-6 mesecev)
It is recommended that hyperammonaemic encephalopathy be considered and ammonia levels measured in patients who develop unexplained changes in mental status while on Deferasirox Mylan. 
Pri bolnikih, pri katerih v času zdravljenja z zdravilom Deferasiroks Mylan pride do nepojasnjenih sprememb duševnega stanja,
Deferasirox Mylan 180 mg film-coated tablets deferasirox 
Deferasiroks Mylan 180 mg filmsko obložene tablete deferasiroks
Deferasirox Mylan 360 mg film-coated tablets deferasirox 
Deferasiroks Mylan 360 mg filmsko obložene tablete deferasiroks
Each film-coated tablet contains 360 mg deferasirox. 
Ena tableta vsebuje 360 mg deferasiroksa.
Breast-feeding is not recommended during treatment with Deferasirox Mylan. 
Med zdravljenjem z zdravilom Deferasiroks Mylan dojenje ni priporočljivo.
Interruption of treatment should be considered in patients who develop unexplained cytopenia. 
Pri bolnikih, pri katerih pride do nepojasnjene citopenije, je treba razmisliti o prekinitvi zdravljenja.
How to store Deferasirox Mylan 
Shranjevanje zdravila Deferasiroks Mylan
Coating material: 
proteinurija občasni:
When to take Deferasirox Mylan 
Kdaj jemati zdravilo Deferasiroks Mylan
A peach, film-coated, modified capsule shaped, biconvex tablet debossed with “ ” on one side of the tablet and ‘DF 1' on the other side. 
Deferasiroks Mylan 180 mg filmsko obložene tablete Ovalna bikonveksna filmsko obložena tableta marelične barve z vtisnjeno oznako “ ” na eni strani tablete in ‘DF 1' na drugi strani.
Optic neuritis Ear and labyrinth disorders Uncommon: 
optični nevritis Ušesne bolezni, vključno z motnjami labirinta občasni:
Deferasirox Mylan 90 mg film-coated tablets deferasirox 
Deferasiroks Mylan 90 mg filmsko obložene tablete deferasiroks
Non-transfusion-dependent thalassaemia syndromes 
Sindromi talasemije, neodvisni od transfuzij
Each film-coated tablet contains 180 mg deferasirox. 
Ena tableta vsebuje 180 mg deferasiroksa.
Blood creatinine increased 
zvišana koncentracija kreatinina v krvi pogosti:
≥5 mg Fe/g dw or >800 µg/l 
≥5 mg Fe/g suhe teže ali
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
PODATKI NA PRIMARNI OVOJNINI NALEPKA NA PLASTENKI
30 film-coated tablets 90 film -coated tablets 300 film-coated tablets 
filmsko obložena tableta (tableta) 90 filmsko obloženih tablet 300 filmsko obloženih tablet
◦ The need to reduce by 10 mg/kg the dose if serum creatinine rises: Adults: >33% above baseline and creatinine clearance <LLN (90 ml/min) Paediatrics: either >ULN or creatinine clearance falls to <LLN at two consecutive visits. 
• pri odraslih: >33% od izhodiščne vrednosti, očistek kreatinina pa pade pod SMN (spodnjo mejo normale: 90 ml/min)
What Deferasirox Mylan contains 
Kaj vsebuje zdravilo Deferasiroks Mylan
Gastrointestinal disorders Common: 
glikozurija neznana pogostnost:
• Patient guide 
• Vodnik za bolnika
For adults not assessed and ≤2,000 µg/l 
14 mg/kg/dan 7 mg/kg/dan pri odraslih pri pediatričnih bolnikih ni ocenjeno in ≤2.000 µg/l prekinitev zdravljenja
It is recommended that serum ferritin be monitored every month to assess the patient's response to therapy and to minimise the risk of over-chelation (see section 4.4). 
Za oceno bolnikovega odziva na zdravljenje in za zmanjšanje tveganja za prekomerno kelacijo je priporočeno vrednost feritina v serumu spremljati vsak mesec (glejte poglavje 4.4).
<2,500 µg/l 
≤2.000 µg/l najvišji odmerek
What Deferasirox Mylan is 
Kaj je zdravilo Deferasiroks Mylan
Maximum dose 28 mg/kg/day Consider interruption 
500- 1.000 µg/l najvišji odmerek 28 mg/kg/dan razmislek o prekinitvi zdravljenja pri <500 µg/l
Close clinical monitoring is required when deferasirox is combined with these substances. 
V primerih uporabe deferasiroksa v kombinaciji z navedenimi zdravilnimi učinkovinami je treba bolnike natančno klinično pregledovati.
6 months) 
6.3 Rok uporabnosti
Postmarketing cases of hepatic failure, sometimes fatal, have been reported in patients treated with deferasirox. 
Poročali so o primerih resnih preobčutljivostnih reakcij (kot sta anafilaksija in angioedem) pri bolnikih, ki so prejemali deferasiroks.
Creatinine clearance 
peroralna uporaba
• That deferasirox causes rises in serum creatinine in some patients ◦ The need to monitor serum creatinine On two occasions prior to initiation of treatment Every week during the first month of initiation of treatment or after therapy modification 
• dejstvo, da deferasiroks pri nekaterih bolnikih povzroča zvišanje koncentracije kreatinina v serumu o potreba po spremljanju koncentracije kreatinina v serumu,
Liver function test elevations have been observed in patients treated with deferasirox. 
Pri bolnikih, zdravljenih z deferasiroksom, so opazili zvišanje vrednosti testov jetrne funkcije.
Frequency 
Odmerjanje
Immune system disorders Not known: 
vnetje požiralnika neznana pogostnost:
Tablet core: 
6.1 Seznam pomožnih snovi Jedro tablete:
- if you experience difficulty thinking, remembering information, or solving problems, being less alert or aware or feeling very sleepy with low energy (signs of a high level of ammonia in your blood, which may be associated with liver or renal problems, see also section 4 “Possible side effects”). 
Pred začetkom jemanja zdravila Deferasiroks Mylan se posvetujte z zdravnikom ali farmacevtom: - če imate težave z ledvicami ali z jetri, - če imate težave s srcem zaradi preobremenitve z železom, - če opazite izrazito zmanjšanje izločanja urina (znak težav z ledvicami), - če dobite hud izpuščaj, če začnete težko dihati, postanete omotični ali začnete otekati pretežno v obraz in grlo/žrelo (znaki hude alergične reakcije, glejte tudi poglavje 4 “Možni neželeni učinki”), - če opazite kombinacijo katerih koli izmed naslednjih simptomov: izpuščaj, predeli rdeče kože,
A peach, film-coated, modified capsule shaped, biconvex tablet debossed with “ ” on one side of the tablet and ‘DF 2' on the other side. 
Deferasiroks Mylan360 mg filmsko obložene tablete Ovalna bikonveksna filmsko obložena tableta marelične barve z vtisnjeno oznako “ ” na eni strani tablete in ‘DF 2' na drugi strani.
Other considerations 
DRUGI PODATKI
This summary was last updated in August 2012. 
Povzetek je bil nazadnje posodobljen avgusta-2012.
It is available as a 4mg/5ml concentrate for a solution for infusion. 
Na voljo je v obliki 4 mg/5 ml koncentrata za raztopino za infundiranje.
The full EPAR for Zoledronic acid Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Zoledronska kislina Mylan je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
For more information about treatment with Zoledronic acid Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Zoledronska kislina Mylan preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
It stops the action of the osteoclasts, the cells in the body that are involved in breaking down the bone tissue. 
Ta zavira delovanje osteoklastov, celic v telesu, ki sodelujejo pri razgradnji kostnega tkiva.
This leads to less bone loss. 
To povzroči zmanjšanje izgube kostne mase.
The European Commission granted a marketing authorisation valid throughout the European Union for Zoledronic acid Mylan on 23 August 2012. 
Evropska komisija je dovoljenje za promet z zdravilom Zoledronska kislina Mylan, veljavno po vsej Evropski uniji, odobrila dne 23 avgusta 2012.
This includes fractures (breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders needing radiotherapy (treatment with radiation) or surgery, and hypercalcaemia (high levels of calcium in the blood). 
Ti zapleti so zlomi kosti, spinalna kompresija (ko hrbtenjačo stisne kost), kostni zapleti, ki zahtevajo radioterapijo (zdravljenje z obsevanjem) ali operacijo, ter hiperkalciemija (visoke ravni kalcija v krvi).
When used to prevent bone complications, the infusion can be repeated every three to four weeks, and patients should also take supplements of calcium and vitamin D. A lower dose is recommended for patients with bone metastases (when cancer has spread to the bone) if they have mild to moderate problems with their kidneys. 
Pri uporabi za preprečevanje zapletov, povezanih z okostjem, je infundiranje mogoče ponoviti vsake tri do štiri tedne, bolniki pa morajo prejemati tudi dodatek kalcija in vitamina D. Pri bolnikih s kostnimi metastazami (kadar se je rak razširil na kost), ki imajo blage do zmerne težave z ledvicami, je priporočljiv manjši odmerek zdravila.
Because Zoledronic acid Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's. 
Ker je zdravilo Zoledronska kislina Mylan generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
This is a summary of the European public assessment report (EPAR) for Zoledronic acid Mylan. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Zoledronska kislina Mylan.
This means that Zoledronic acid Mylan is similar to a ‘reference medicine' already authorised in the European Union (EU) called Zometa. 
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Zometa.
The usual dose of Zoledronic acid Mylan is one infusion of 4 mg over at least 15 minutes. 
Običajni odmerek zdravila Zoledronska kislina Mylan je ena 4-miligramska infuzija v trajanju najmanj 15 minut.
The CHMP concluded that, in accordance with EU requirements, Zoledronic acid Mylan has been shown to have comparable quality and to be bioequivalent to Zometa. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Zoledronska kislina Mylan primerljivo raven kakovosti kot zdravilo Zometa ter da mu je biološko enakovredno.
Therefore, the CHMP's view was that, as for Zometa, the benefit outweighs the identified risk. 
Zato je CHMP menil, da njegove koristi, tako kot pri zdravilu Zometa, odtehtajo znana tveganja.
What are the benefits and risks of Zoledronic acid Mylan? 
Kakšne so koristi in tveganja, povezana z zdravilom Zoledronska kislina Mylan?
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 Zoledronic acid Mylan. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Zoledronska kislina Mylan, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
It is not recommended for patients with severe kidney problems. 
Za bolnike z resnimi težavami z ledvicami zdravilo ni priporočljivo.
EPAR summary for the public zoledronic acid 
Povzetek EPAR za javnost zoledronska kislina
The company provided data from the published literature on zoledronic acid. 
Družba je predstavila podatke o zoledronski kislini iz objavljene literature.
Zoledronic acid Mylan can be used to prevent bone complications in adults with advanced cancer that is affecting the bone. 
Zdravilo Zoledronska kislina Mylan se lahko uporablja za preprečevanje z okostjem povezanih zapletov pri odraslih z napredovalim rakom, ki zajame kosti.
The reduction of bone loss helps to make bones less likely to break, which is useful in preventing fractures in cancer patients with bone metastases. 
To pripomore k manjši verjetnosti zloma, kar je koristno za preprečevanje zlomov pri bolnikih z rakom in metastazami v kosteh.
Other information about Zoledronic acid Mylan 
Druge informacije o zdravilu Zoledronska kislina Mylan
Zoledronic acid Mylan must only be used by a doctor who has experience in the use of this type of medicine given into a vein. 
Zdravilo Zoledronska kislina Mylan smejo uporabljati le zdravniki z izkušnjami z uporabo te vrste zdravil za intravensko uporabo.
Zoledronic acid Mylan can also be used to treat the hypercalcaemia caused by tumours. 
Zdravilo Zoledronska kislina Mylan se lahko uporablja tudi za zdravljenje hiperkalciemije, ki jo povzročijo tumorji.
The Committee recommended that Zoledronic acid Mylan be given marketing authorisation. 
Odbor je zato priporočil, da se za zdravilo Zoledronska kislina Mylan odobri dovoljenje za promet.
By preventing the breakdown of bones, Zoledronic acid Mylan also helps to reduce the amount of calcium released into the blood. 
Zdravilo Zoledronska kislina Mylan s preprečevanjem razgradnje kosti pripomore tudi k znižanju ravni kalcija, ki se sprosti v kri.
Zoledronic acid Mylan is a medicine that contains the active substance zoledronic acid. 
Zoledronska kislina Mylan je zdravilo, ki vsebuje zdravilno učinkovino zoledronska kislina.
The active substance in Zoledronic acid Mylan, zoledronic acid, is a bisphosphonate. 
Zdravilna učinkovina zdravila Zoledronska kislina Mylan, zoledronska kislina, je difosfonat.
Zoledronic acid Mylan is a ‘generic medicine'. 
Zdravilo Zoledronska kislina Mylan je generično zdravilo.
Why has Zoledronic acid Mylan been approved? 
Zakaj je bilo zdravilo Zoledronska kislina Mylan odobreno?
No additional studies in patients were needed as Zoledronic acid Mylan is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Zometa. 
Ker je zdravilo Zoledronska kislina Mylan generično zdravilo, ki se daje z infundiranjem in vsebuje isto zdravilno učinkovino kot referenčno zdravilo Zometa, niso bile potrebne nobene dodatne študije pri bolnikih.
What is Zoledronic acid Mylan? 
Kaj je zdravilo Zoledronska kislina Mylan?
How has Zoledronic acid Mylan been studied? 
Kako je bilo zdravilo Zoledronska kislina Mylan raziskano?
How does Zoledronic acid Mylan work? 
Kako zdravilo Zoledronska kislina Mylan deluje?
How is Zoledronic acid Mylan used? 
Kako se zdravilo Zoledronska kislina Mylan uporablja?
What is Zoledronic acid Mylan used for? 
Za kaj se zdravilo Zoledronska kislina Mylan uporablja?
Annex 
Aneks
- The educational pack must be available for distribution for both therapeutic indications prior to the launch of the new indication (prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation with one or more risk factors) in the Member State. 
- Izobraževalno gradivo za obe terapevtski indikaciji mora biti pripravljeno za distribucijo pred lansiranjem nove indikacije (preprečevanje možganske kapi in sistemske embolije pri odraslih bolnikih z nevalvularno atrijsko fibrilacijo in enim ali več dejavniki tveganja) v državi članici.
This educational pack is aimed at increasing awareness about the potential risk of bleeding during treatment with Pradaxa and providing guidance on how to manage that risk. 
Namen izobraževalnega gradiva je osveščanje o možnem tveganju krvavitev med zdravljenjem s Pradaxo in svetovanje o načinih obvladovanja tega tveganja.
- The content and format of the educational material, together with a communication plan, is agreed with the MAH prior to distribution of the educational pack. 
- Vsebina in oblika izobraževalnega gradiva ter načrt sporočanja morata biti pred distribucijo usklajena z imetnikom dovoljenja za promet.
The Prescriber Guide should contain the following key safety messages: - Details of populations potentially at higher risk of bleeding - Recommendation not to use Pradaxa in patients with prosthetic heart valves - Recommendation for kidney function measurement - Recommendations for dose reduction in at risk populations - Management of overdose situations - The use of coagulation tests and their interpretation - That all patients should be provided with a Patient alert card and be counselled about: 
Navodilo za predpisovalca mora vsebovati naslednje ključne varnostne podatke: - podroben opis populacij, pri katerih je predvidoma povečano tveganje krvavitve - priporočilo, da zdravilo Pradaxa ni primerno za uporabo pri bolnikih z umetnimi srčnimi zaklopkami - priporočilo za merjenje ledvičnega delovanja - priporočila o zmanjšanju odmerka pri populacijah s povečanim tveganjem
o An instruction how to take Pradaxa 
o Navodila za jemanje zdravila Pradaxa
- An instruction how to take Pradaxa 
- Navodila za jemanje zdravila Pradaxa
The physician educational pack should contain: - The Summary of Product Characteristics - Prescriber Guide - Patient Alert Cards 
- navodilo za predpisovalca - kontrolno kartico za zdravnika
o Importance of treatment compliance o The need to inform Health Care Professionals that they are taking Pradaxa if they need to have any surgery or invasive procedure. 
o podatke o znakih in simptomih krvavitev in navodilo, kdaj poiskati zdravstveno pomoč o opozorilo o pomembnosti upoštevanja navodil o jemanju zdravila o navodilo, da mora imeti bolnik kontrolno kartico vedno pri sebi o opozorilo, da mora bolnik zdravstveno osebje pred vsako operacijo ali invazivnim posegom opozoriti, da jemlje Pradaxo.
The Member States shall ensure that the following conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented: - The MAH shall provide an educational pack for each therapeutic indication, targeting all physicians who are expected to prescribe/use Pradaxa. 
- Imetnik dovoljenja za promet z zdravilom bo za vsako terapevtsko indikacijo pripravil izobraževalno gradivo za vse zdravnike, ki bodo predvidoma predpisovali ali uporabljali Pradaxo.