natgillin/translations-raw huggingface dataset:
Each tablet contains 5 mg ruxolitinib (as phosphate). 
Ena tableta vsebuje 5 mg ruksolitiniba (v obliki fosfata).
Pneumonia 
Trombocitopenija
A single dose of 20 mg or two doses of 10 mg given 12 hours apart is recommended for MF patients with platelet count of >200,000/mm Subsequent doses (single administration or two doses of 10 mg given 12 hours apart) should be administered only on haemodialysis days following each dialysis session. 
Enkraten odmerek 20 mg ali dva odmerka po 10 mg z 12-urnim presledkom je priporočeno odmerjanje za bolnike z mielofibrozo in številom trombocitov >200.000/mm
Patients should be closely monitored (e.g. twice weekly) for cytopenias and dose titrated based on safety and efficacy (see section 4.2). 
Pri sočasnem odmerjanju ruksolitiniba z močnimi zaviralci CYP3A4 je treba posamezen odmerek ruksolitiniba znižati za približno 50 % in ga odmerjati dvakrat na dan. Bolnike je treba skrbno spremljati (na primer dvakrat tedensko) glede citopenije in odmerke titrirati glede na varnost in učinkovitost (glejte poglavje 4.2).
Lipid abnormalities/elevations 
Zvišane oziroma patološke vrednosti lipidov
Number (%) of subjects with spleen volume reduced by 
število (%) oseb z zmanjšanjem volumna vranice za čas opazovanja po 24 tednih po 48 tednih
Each tablet contains 15 mg ruxolitinib (as phosphate). 
Ena tableta vsebuje 15 mg ruksolitiniba (v obliki fosfata).
Each tablet contains 10 mg ruxolitinib (as phosphate). 
Ena tableta vsebuje 10 mg ruksolitiniba (v obliki fosfata).
Any CTCAE 
pogosti občasni katere koli stopnje po CTCAE
3, with the goal of avoiding dose interruptions for thrombocytopenia. 
3, je treba razmisliti o znižanju odmerka, da ne bi bilo treba zaradi trombocitopenije povsem prekiniti odmerjanja.
Myelofibrosis 
Mielofibroza
Hypertriglyceridaemia b 
c zelo pogosti zelo pogosti hipertrigliceridemija b stopnje 1 po CTCAE
c grade 1 and 2 
NAVEDBA ENE ALI VEČ UČINKOVIN
CARTON OF UNIT PACK 
ŠKATLA ZA POSAMEZNO PAKIRANJE
Ruxolitinib dose can be titrated to reduce the risk of cytopenia. 
Da bi zmanjšali tveganje za citopenijo, je mogoče odmerke ruksolitiniba titrirati.
Constipation a 
Uporabno do
Nevertheless, studies have shown that the medicine benefits patients and has no significant side effects. 
Kljub temu so študije pokazale, da zdravilo bolnikom koristi in nima pomembnih neželenih učinkov.
Most patients also had improvements in symptoms of the disease: all reported an improvement in diarrhoea, 89% of patients showed an improvement in their mental ability, 60% of patients showed improvement in mobility, and 85% and 77% of patients showed psychiatric improvement based on two different scores. 
Pri večini bolnikov so se izboljšali tudi simptomi bolezni: vsi so poročali o izboljšanju driske, pri 89 % bolnikov se je pokazalo izboljšanje miselnih sposobnosti, pri 60 % izboljšanje mobilnosti in pri 85 oziroma 77 % bolnikov izboljšanje duševnega zdravja na podlagi dveh različnih merjenj.
This means that it is similar to a ‘reference medicine' containing the same active substance. 
To pomeni, da je podobno referenčnemu zdravilu in vsebuje enako zdravilno učinkovino.
However, due to the rarity of the disease, there are still limited data available on the use of the medicine. 
Glede na redkost te bolezni so razpoložljivi podatki o uporabi zdravila še vedno omejeni.
For small children and children who cannot swallow capsules, the contents of the capsules can be mixed with sodium bicarbonate solution 8.4% to make a liquid. 
Majhnim otrokom in otrokom, ki ne morejo pogoltniti kapsul, lahko njihovo vsebino zmešamo z 8,4odstotno raztopino natrijevega bikarbonata, da dobimo tekočino.
This helps to reduce the production of abnormal substances and contributes to the normal activity of bile in the digestive system, thereby relieving the symptoms of the disease. 
To pomaga zmanjšati tvorbo nenormalnih snovi in prispeva k normalnemu delovanju žolča v prebavilih ter tako lajša simptome bolezni.
When primary bile acids are lacking, the body produces abnormal bile acids and other substances instead which accumulate throughout the body, causing damage. 
Kadar primarnih žolčnih kislin ni dovolj, telo namesto njih tvori nenormalne žolčne kisline in druge snovi, ki se kopičijo po vsem telesu in povzročajo škodo.
Among 23 patients for whom data on blood levels of bile acids were available, all had reductions in their levels (average reduction of 56-69 µmol/l). 
Pri vseh 23 bolnikih, za katere so bili dostopni podatki o ravneh žolčne kisline v krvi, se je ta znižala (povprečno znižanje od 56 do 69 µmol/l).
Chenodeoxycholic acid Leadiant is available as capsules (250 mg) which are taken 3 times a day at approximately the same time every day. 
Zdravilo Henodeoksiholna kislina Leadiant je na voljo v kapsulah (250 mg), ki se jemljejo trikrat na dan vsak dan približno ob istem času.
The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore decided that Chenodeoxycholic acid Leadiant's benefits are greater than its risks and recommended that it be approved for use in the EU. 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zato zaključil, da so koristi zdravila Henodeoksiholna kislina Leadiant večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The daily dose is chosen and adjusted during treatment for each patient depending on the patient's age, liver function and levels of bile acids in their blood and urine. 
Dnevni odmerek se določi in nato prilagaja med zdravljenjem za vsakega bolnika posebej glede na njegovo starost, delovanje jeter in ravni žolčnih kislin v krvi in urinu.
For the list of restrictions, see the package leaflet. 
Za celoten seznam omejitev glejte navodilo za uporabo.
Among 14 patients for whom data on urine levels of bile acids were available, 79% (11 out of 14) had reduced levels at their most recent test. 
Od 14 bolnikov, za katere so bili dostopni podatki o ravneh žolčne kisline v urinu, je imelo znižane ravni pri najnovejši analizi 79 % (11 od 14).
The side effects seen with Chenodeoxycholic acid Leadiant are constipation and abnormal liver test values; however their frequency could not be reliably estimated from the available limited data. 
Neželeni učinki, opaženi pri zdravilu Henodeoksiholna kislina Leadiant so zaprtje in nenormalne vrednosti testov jeter; vendar njihove pogostnosti ni bilo mogoče zanesljivo oceniti iz razpoložljivih omejenih podatkov.
Because the number of patients with this condition is low, the disease is considered ‘rare', and Chenodeoxycholic acid Leadiant was designated an ‘orphan medicine' (a medicine used in rare diseases) on 16 December 2014. 
Ker je bolnikov s to boleznijo malo, velja ta za redko, zato je bilo zdravilo Henodeoksiholna kislina Leadiant 16. decembra 2014 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
Chenodeoxycholic acid has been used to treat cerebrotendinous xanthomatosis for about 40 years, although it was not licensed for this use. 
Henodeoksiholna kislina se uporablja za zdravljenje cerebrotendinozne ksantomatoze približno 40 let, čeprav ni bila odobrena za to uporabo.
However, Xenbilox differs from Chenodeoxycholic acid Leadiant in that it is authorised for a different use (to dissolve cholesterol gallstones). 
Vendar pa se to od zdravila Henodeoksiholna kislina Leadiant razlikuje po tem, da je odobreno za drugačno uporabo (za raztapljanje holesterolnih kamnov).
The summary of the opinion of the Committee for Orphan Medicinal Products for Chenodeoxycholic acid Leadiant can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation. 
Povzetek mnenja Odbora za zdravila sirote o zdravilu Henodeoksiholna kislina Leadiant je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
The European Commission granted a marketing authorisation valid throughout the European Union for Chenodeoxycholic acid sigma-tau on 10 April 2017. 
Evropska komisija je dovoljenje za promet z zdravilom Henodeoksiholna kislina sigma-tau, veljavno po vsej Evropski uniji, izdala 10. aprila 2017.
This is a summary of the European public assessment report (EPAR) for Chenodeoxycholic acid Leadiant. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Henodeoksiholna kislina Leadiant.
Since Chenodeoxycholic acid Leadiant has been approved under exceptional circumstances, the company that markets this medicine will set up a registry to monitor the benefits and safety of the medicine. 
Ker je zdravilo Henodeoksiholna kislina Leadiant pridobilo dovoljenje za promet v izjemnih okoliščinah, bo družba, ki ga trži, vodila seznam za spremljanje njegovih koristi in varnosti.
This is a ‘primary bile acid', which is a main component of bile (a fluid produced by the liver that helps to digest fats). 
Ta spada med primarne žolčne kisline, ki so glavna sestavina žolča (tekočine, ki se tvori v jetrih in pomaga pri presnovi maščob).
For more information about treatment with Chenodeoxycholic acid Leadiant, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Henodeoksiholna kislina Leadiant preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Chenodeoxycholic acid Leadiant have been included in the summary of product characteristics and the package leaflet. 
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Henodeoksiholna kislina Leadiant upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
They were mild or moderate in severity and did not last. 
Njihova resnost je bila blaga do zmerna in niso trajali dolgo.
These patients cannot produce enough of the primary bile acid chenodeoxycholic acid due to genetic abnormalities that result in a lack of the liver enzyme sterol 27 hydroxylase. 
Pri teh bolnikih zaradi prirojenih napak proizvodnja primarne žolčne kisline henodeoksiholne kisline ni zadostna, kar ima za posledico pomanjkanje jetrnega encima sterol 27-hidroksilaze.
The full EPAR for Chenodeoxycholic acid Leadiant 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 Henodeoksiholna kislina Leadiant je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The name of the product was changed to Chenodeoxycholic acid Leadiant on 12 May 2017. 
Ime zdravila je bilo 12. maja 2017 spremenjeno v Henodeoksiholna kislina Leadiant.
Previously known as Chenodeoxycholic acid sigma-tau. 
Prej znano kot Henodeoksiholna kislina sigma-tau.
What measures are being taken to ensure the safe and effective use of Chenodeoxycholic acid Leadiant? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Henodeoksiholna kislina Leadiant?
Chenodeoxycholic acid Leadiant has been investigated in a study which looked at the records of 35 patients with cerebrotendinous xanthomatosis who received chenodeoxycholic acid for around 9 years. 
Zdravilo Henodeoksiholna kislina Leadiant so proučevali v študiji, v kateri so pregledali bolniške kartoteke 35 bolnikov s cerebrotendinozno ksantomatozo, ki so prejemali henodeoksiholno kislino približno 9 let.
Chenodeoxycholic acid is one of the main primary bile acids produced by the liver. 
Henodeoksiholna kislina je ena od glavnih primarnih žolčnih kislin, ki jih tvorijo jetra.
Chenodeoxycholic acid Leadiant can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in treating cerebrotendinous xanthomatosis or other diseases of primary bile acid production. 
Predpisovanje in izdaja zdravila Henodeoksiholna kislina Leadiant je le na recept, zdravljenje pa mora začeti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem cerebrotendinozne ksantomatoze ali drugih bolezni tvorjenja primarne žolčne kisline.
For practical information about using Chenodeoxycholic acid Leadiant, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Henodeoksiholna kislina Leadiant naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Chenodeoxycholic acid Leadiant has been authorised under ‘exceptional circumstances'. 
Zdravilo Henodeoksiholna kislina Leadiant je pridobilo dovoljenje za promet v „izjemnih okoliščinah“.
Chenodeoxycholic acid Leadiant is used to treat adults and children from one month of age with cerebrotendinous xanthomatosis. 
Zdravilo Henodeoksiholna kislina Leadiant se uporablja za zdravljenje odraslih in otrok, starih en mesec ali več, s cerebrotendinozno ksantomatozo.
What is Chenodeoxycholic acid Leadiant and what is it used for? 
Kaj je zdravilo Henodeoksiholna kislina Leadiant in za kaj se uporablja?
Other information about Chenodeoxycholic acid Leadiant 
Druge informacije o zdravilu Henodeoksiholna kislina Leadiant
What benefits of Chenodeoxycholic acid Leadiant have been shown in studies? 
Kakšne koristi je zdravilo Henodeoksiholna kislina Leadiant izkazalo v študijah?
Chenodeoxycholic acid Leadiant is a ‘hybrid medicine'. 
Zdravilo Henodeoksiholna kislina Leadiant je „hibridno zdravilo“.
What are the risks associated with Chenodeoxycholic acid Leadiant? 
Kakšna tveganja so povezana z zdravilom Henodeoksiholna kislina Leadiant?
The chenodeoxycholic acid contained in this medicine replaces the patient's missing chenodeoxycholic acid. 
Henodeoksiholna kislinav tem zdravilu nadomesti henodeoksiholno kislino, ki je primanjkuje bolniku.
Chenodeoxycholic acid Leadiant is a medicine that contains the active substance chenodeoxycholic acid. 
Henodeoksiholna kislina Leadiant je zdravilo, ki vsebuje zdravilno učinkovino henodeoksiholno kislino.
What information is still awaited for Chenodeoxycholic acid Leadiant? 
Katere informacije o zdravilu Henodeoksiholna kislina Leadiant še pričakujemo?
Why is Chenodeoxycholic acid Leadiant approved? 
Zakaj je bilo zdravilo Henodeoksiholna kislina Leadiant odobreno?
The reference medicine for Chenodeoxycholic acid Leadiant is Xenbilox. 
Henodeoksiholna kislina Leadiant je zdravilo Xenbilox.
chenodeoxycholic acid 
Henodeoksiholna kislina Leadiant henodeoksiholna kislina
How is Chenodeoxycholic acid Leadiant used? 
Kako se zdravilo Henodeoksiholna kislina Leadiant uporablja?
This is because it has not been possible to obtain complete information about Chenodeoxycholic acid Leadiant due to the rarity of the disease. 
Do tega je prišlo zato, ker zaradi redkosti bolezni ni bilo mogoče pridobiti vseh informacij o njem.
How does Chenodeoxycholic acid Leadiant work? 
Kako zdravilo Henodeoksiholna kislina Leadiant deluje?
21 February 2011 
21. februar 2011
This leads to improvement in the patient's symptoms. 
Posledica tega je izboljšanje bolnikovih simptomov.
The European Commission issued a decision on this referral on 21 February 2011. 
Evropska komisija je izdala odločbo o tej napotitvi dne 21. februarja 2011.
Alfred E. Tiefenbacher GmbH & Co KG submitted Galantamine Stada to the Austrian medicines regulatory agency for a decentralised procedure. 
Alfred E. Tiefenbacher GmbH & Co KG je avstrijski regulatorni agenciji za zdravila predložil zdravilo Galantamine Stada v presojo po decentraliziranem postopku.
This is a procedure where one Member State (the ‘reference Member State', in this instance Austria) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance the Czech Republic, Denmark, Estonia, Finland, Ireland, Portugal, Slovakia and Spain). 
To je postopek, pri katerem ena država članica („referenčna država članica“, v tem primeru Avstrija) oceni zdravilo z namenom odobritve dovoljenja za promet, ki bo veljavno v tej državi in drugih državah članicah („zadevne države članice“, v tem primeru Češka republika, Danska, Estonija, Finska, Irska, Portugalska, Slovaška in Španija).
It is used to treat symptoms of mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour. 
Uporablja se za zdravljenje simptomov blage do zmerno hude Alzheimerjeve demence, napredujoče možganske bolezni, ki postopoma prizadene spomin, intelektualno sposobnost in vedenje.
Why was Galantamine Stada reviewed? 
Zakaj je bilo zdravilo Galantamine Stada pregledano?
The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Galantamine Stada. 
Evropska agencija za zdravila je zaradi nesoglasja med državami članicami Evropske unije (EU) glede odobritve zdravila Galantamine Stada zaključila arbitražni postopek.
Following the CHMP opinion on 23 September 2010, the Agency was informed on 15 October 2010 that the company withdrew the applications for marketing authorisation in all concerned Member States. 
Na podlagi mnenja odbora CHMP z dne 23. septembra 2010 je bila dne 15. oktobra 2010 agencija obveščena, da je podjetje umaknilo vloge za dovoljenje za promet z zdravilom v vseh zadevnih državah članicah.
Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that bioequivalence to the reference medicinal product has not been shown. 
Na podlagi ocene trenutno razpoložljivih podatkov in znanstvene razprave v odboru CHMP je slednji zaključil, da bioekvivalenca za referenčno zdravilo ni bila dokazana.
However, the Member States were not able to reach an agreement and the Czech Republic referred the matter to the CHMP for arbitration on 26 March 2010. 
Ker omenjene države članice niso dosegle soglasja, je Češka republika dne 26. marca 2010 zadevo napotila na odbor CHMP v arbitražo.
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Galantamine Stada do not outweigh its risks, and the marketing authorisation cannot be granted in Austria or in other Member States of the EU: Czech Republic, Denmark, Finland, Ireland, Portugal, Slovakia and Spain. 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da koristi zdravila Galantamine Stada ne odtehtajo z njim povezanih tveganj, in da se dovoljenje za promet z zdravilom ne more odobriti v Avstriji ali v drugih državah članicah EU: v Češki republiki, na Danskem, Finskem, Irskem, Portugalskem, Slovaškem in v Španiji.
The CHMP therefore concluded that the benefits of Galantamine Stada do not outweigh its risks and recommended that the marketing authorisation should not be granted in the concerned Member States. 
Odbor CHMP je zato sklenil, da koristi zdravila Galantamine Stada ne odtehtajo z njim povezanih tveganj, in priporočil, da se dovoljenje za promet z zdravilom v zadevnih državah članicah ne odobri.
Galantamine Stada is a generic medicine based on a ‘reference medicine', Reminyl. 
Galantamine Stada je generično zdravilo, ki temelji na „referenčnem zdravilu“, zdravilu Reminyl.
By blocking this enzyme, galantamine allows levels of acetylcholine to be increased in the parts of the brain associated with intellectual function. 
Z zaviranjem tega encima galantamin omogoči dvig ravni acetilholina v tistih delih možganov, ki so povezani z intelektualnimi sposobnostmi.
What is Galantamine Stada? 
Kaj je zdravilo Galantamine Stada?
The grounds for the referral were that bioequivalence studies, to show that Galantamine Stada produces the same levels of active substance in the body as Reminil, had not been conclusive. 
Razlog za napotitev je bilo dejstvo, da študije bioekvivalence, ki naj bi dokazale, da zdravilo Galantamine Stada ustvari enake koncentracije zdravilne učinkovine v telesu kot zdravilo Reminyl, niso bile prepričljive.
In patients with Alzheimer's disease, certain nerve cells die in the brain, resulting in low levels of the neurotransmitter acetylcholine (a substance that allows nerve cells to communicate with each other).Galantamine works by blocking acetylcholinesterase, an enzyme that breaks down acetylcholine. 
Pri bolnikih z Alzheimerjevo boleznijo nekatere živčne celice v možganih odmrejo, kar se odraža v nizkih ravneh živčnega prenašalca acetilholina (kemične snovi, ki omogoča medsebojno komunikacijo živčnih celic).
Galantamine Stada is a medicine that contains the active substance galantamine. 
Galantamine Stada je zdravilo, ki vsebuje zdravilno učinkovino galantamin.
EMA/83112/2012 
Vprašanja in odgovori o zdravilu Galantamine Stada in povezanih imenih (galantamin 8, 16 in 24 mg tablete s podaljšanim sproščanjem) EMA/83112/2012
The Safety Information Communication should contain the following: 
Dopis o varnostnih informacijah mora vsebovati:
The Marketing Authorisation Holder (MAH) should ensure that, at launch, all Healthcare Professionals who are expected to use and/or prescribe Topotecan Eagle are provided with a Safety Information Communication. 
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo ob začetku trženja zdravila vsi zdravstveni delavci, za katere se pričakuje, da bodo uporabljali in/ali predpisovali zdravilo Topotekan Eagle, prejeli dopis o varnostnih informacijah.
The anticipated effects of overdose (e.g. bone marrow suppression). 
• pričakovane učinke prevelikega odmerjanja (npr. supresija kostnega mozga);
Prior to launch of the product in each Member State, the Marketing Authorisation Holder shall agree the content and format of a Safety Information Communication with the national competent authority, including the need and the timing of any follow-up Safety Communication Information, as well as the distribution list of such information. 
Imetnik dovoljenja za promet z zdravilom se bo, preden da zdravilo v promet, v vsaki državi članici s pristojnim nacionalnim organom dogovoril o vsebini in obliki dopisa o varnostnih informacijah, vključno s potrebo po morebitnih naknadnih dopisih o varnostnih informacijah in njihovo časovno uskladitvijo ter seznamom prejemnikov tega dopisa.
The risk of medication error due to the higher concentration than the dilution concentration of the originator, with potentially life-threatening consequences. 
• navedbe glede tveganja za napačno zdravljenje zaradi večje koncentracije v primerjavi z razredčeno koncentracijo originatorskega zdravila, z možnimi življenjsko nevarnimi
Reference to the vial collar as visual reminder of this difference and the instruction that it must 
• sklic na obroček na viali kot vidni opomnik te razlike ter navodilo, da se ga ne sme nikoli
An encouragement of reporting of actual medication errors and any safety events that might be 
• spodbudo k poročanju o dejanskih napakah pri zdravljenju ter vseh varnostnih ukrepih, ki bi bili lahko posledica napake pri zdravljenju;
Annex 
DODATEK
• Information on crisis or infections 
• Informacije pri krizi ali okužbi
Conditions or restrictions with regard to the safe and effective use of the medicinal product to be implemented by the Member States 
POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI JIH IZVAJAJO DRŽAVE ČLANICE
• Key signs and symptoms of serious adverse reactions 
• Bistvene znake in simptome resnih neželenih učinkov
The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented: 
Države članice morajo zagotoviti, da so izpolnjeni vsi pogoji in omejitve v zvezi z varno in učinkovito uporabo zdravila, opisanimi v nadaljevanju:
The Marketing Authorisation Holder (MAH) shall ensure that, prior to launch, all physicians who are expected to prescribe Siklos are provided with a physician information pack containing the following: 
Imetnik dovoljenja za promet z zdravilom bo zagotovil, da bodo pred sprostitvijo vsi zdravniki, za katere se pričakuje, da bodo predpisovali zdravilo Siklos, dobili informacije za zdravnika, ki bodo vsebovale naslednje: