natgillin/translations-raw huggingface dataset:
The effectiveness of the vaccine in preventing viraemia in sheep was studied in a laboratory trial using the vaccine in sheep from one month of age. 
Učinkovitost cepiva pri preprečevanju viremije pri ovcah so raziskovali v laboratorijski študiji, v kateri so cepili ovce, starejše od enega meseca.
Other information about ZULVAC 8 Ovis: 
Druge informacije o zdravilu ZULVAC 8 Ovis:
ZULVAC 8 Ovis is a vaccine. 
Zdravilo ZULVAC 8 Ovis je cepivo.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of ZULVAC 8 Ovis exceed the risks in the prevention of viraemia caused by the bluetongue virus serotype 8 in sheep from one and a half months of age. 
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so pri ovcah, starejših od enega meseca in pol, koristi cepiva ZULVAC 8 Ovis pri preprečevanju viremije, ki jo povzroča serotip 8 virusa bolezni modrikastega jezika, večje od z njim povezanih tveganj.
What benefit has ZULVAC 8 Ovis shown during the studies? 
Kakšne koristi je zdravilo ZULVAC 8 Ovis izkazalo med študijami?
The safety of the vaccine was studied in laboratory safety studies carried out with ZULVAC 8 Ovis in sheep. 
Varnost cepiva ZULVAC 8 Ovis je bila raziskana v laboratorijskih študijah varnosti z njegovo uporabo na ovcah.
The withdrawal period for ZULVAC 8 Ovis for meat and milk is zero days. 
Karenca za cepivo ZULVAC 8 Ovis za meso in mleko je nič dni.
ZULVAC 8 Ovis is used in sheep to protect them against bluetongue disease, an infection caused by the bluetongue virus which is transmitted by midges. 
Cepivo ZULVAC 8 Ovis se uporablja pri ovcah za zaščito pred boleznijo modrikastega jezika, tj. okužbo, ki jo povzroča virus bolezni modrikastega jezika, prenašajo pa jo trzače.
What is the risk associated with ZULVAC 8 Ovis? 
Kakšna tveganja so povezana z zdravilom ZULVAC 8 Ovis?
ZULVAC 8 Ovis contains bluetongue viruses that have been inactivated so that they cannot cause the disease. 
Cepivo ZULVAC 8 Ovis vsebuje inaktivirane viruse bolezni modrikastega jezika, ki ne povzročajo bolezni.
The virus exists in several forms (serotypes) throughout the world; the type used in ZULVAC 8 Ovis is serotype 8. 
Virus obstaja v različnih oblikah (serotipih) po vsem svetu.
Why has ZULVAC 8 Ovis been approved? 
Zakaj je bilo zdravilo ZULVAC 8 Ovis odobreno?
Inactivated vaccine against Bluetongue disease virus, serotype 8 
ZULVAC 8 Ovis inaktivirano cepivo proti virusu modrikastega jezika, serotip 8
ZULVAC 8 Ovis is a vaccine that contains inactivated (killed) bluetongue serotype 8 virus as the active substance. 
Zdravilo ZULVAC 8 Ovis je cepivo, ki kot zdravilno učinkovino vsebuje inaktiviran (uničen) virus bolezni modrikastega jezika, serotip 8.
What is ZULVAC 8 Ovis? 
Kaj je zdravilo ZULVAC 8 Ovis?
How has ZULVAC 8 Ovis been studied? 
Kako je bilo zdravilo ZULVAC 8 Ovis raziskano?
What is ZULVAC 8 Ovis used for? 
Za kaj se zdravilo ZULVAC 8 Ovis uporablja?
How does ZULVAC 8 Ovis work? 
Kako zdravilo ZULVAC 8 Ovis deluje?
This means that it was not possible to obtain complete information about ZULVAC 8 Ovis at the time of the initial authorisation. 
To pomeni, da ob prvotni izdaji dovoljenja za promet ni bilo mogoče pridobiti vseh podatkov o tem cepivu.
Information for patients and for healthcare professionals 
Informacije za bolnike in zdravstvene delavce
The specific recommendations of the CHMP are as follows: 
Konkretna priporočila odbora CHMP so:
• Patients should continue to take their medicines as prescribed. 
• Bolniki naj svoja zdravila jemljejo, kot jim je bilo predpisano.
More about the medicines 
Več o zdravilih
So far no alternative studies from other sources have been provided. 
Do zdaj niso bile predložene druge študije iz drugih virov;
Its suspension is therefore not expected to have any impact on patients in the EU. 
Tako torej ni pričakovati, da bi imel začasni umik dovoljenja za promet vpliv na bolnike v EU.
The findings cast doubts on the quality management system in place at the site, and thus on the reliability of the data of bioequivalence studies conducted between March 2013 and March 2015. 
Ti izsledki vzbujajo dvome o vzpostavljenem sistemu za upravljanje kakovosti na tem mestu in s tem o zanesljivosti podatkov iz študij biološke enakovrednosti, opravljenih med marcem 2013 in marcem 2015.
The review of Alkem was initiated on 1 April 2016 at the request of the German medicines authority (BfArM), under Article 31 of Directive 2001/83/EC. 
Pregled družbe Alkem se je začel 1. aprila 2016 na zahtevo nemške agencije za zdravila (BfArM) v skladu s členom 31 Direktive 2001/83/ES.
The review was carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which has adopted the Agency's opinion. 
Pregled je opravil Odbor za zdravila za uporabo v humani medicini (CHMP), odgovoren za vprašanja glede zdravil za uporabo v humani medicini, ki je sprejel mnenje agencije.
Other riluzole-containing medicines remain available. 
Druga zdravila, ki vsebujejo riluzol, ostajajo na voljo.
The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 8 September 2016. 
Mnenje odbora CHMP je bilo predloženo Evropski komisiji, ki je 8. septembra 2016 izdala končni pravno zavezujoč sklep, ki velja za vse države članice EU.
The review covered medicines authorised via national procedures in individual EU Member States, whose marketing authorisation applications included data from studies conducted by Alkem Laboratories Ltd, Department of Bioequivalence, C-17/7, MIDC Industrial Estate, Taloja, Dist. Raigad410208 India. 
Pregled je zajel zdravila, ki so dovoljenje za promet prejela po nacionalnem postopku v posameznih državah članicah EU, njihove vloge za pridobitev dovoljenja za promet pa so vključevale podatke iz študij, opravljenih v družbi Alkem Laboratories Ltd, Department of Bioequivalence, C-17/7, MIDC Industrial Estate, Taloja, Dist. Raigad - 410208 Indija.
The CHMP's recommendations concerning these medicines were sent to the European Commission, which issued a legally binding decision valid throughout the EU. 
Priporočila odbora CHMP v zvezi s temi zdravili so bila nato posredovana Evropski komisiji, ki je izdala pravno zavezujoč sklep, veljaven v vsej EU.
EMA will continue to work closely with national authorities and international partners to ensure that studies underpinning marketing authorisations in the EU are carried out to the highest standards and that companies continue to comply fully with all aspects of Good Clinical Practice (GCP). 
Agencija EMA bo še naprej tesno sodelovala z nacionalnimi organi in mednarodnimi partnerji, s čimer bo zagotovila, da se študije, ki podpirajo dovoljenja za promet z zdravili v EU, izvajajo skladno z najvišjimi standardi, in da vpletene družbe delujejo skladno z vsemi vidiki dobre klinične prakse.
The recommendations followed a joint routine inspection by German and Dutch authorities in March 2015, which revealed misrepresentation of data during the conduct of two different trials performed in 2013 and 2014 at the Taloja site. 
Priporočila so sledila skupnemu rutinskemu inšpekcijskemu pregledu, ki sta ga marca 2015 opravila nemški in nizozemski organ, med katerim so odkrili napačno prikazovanje podatkov v času izvajanja dveh različnih preskušanj, ki so ju leta 2013 in 2014 opravili v Taloji.
EMA recommends suspension of one medicine 
Agencija EMA priporoča začasen umik dovoljenja za promet z enim zdravilom
Therefore, the Committee recommended that medicines authorised or being evaluated on the basis of these studies should be suspended or refused authorisation, unless alternative data are available from other sources. 
Zato je odbor priporočil, da se za zdravila, ki so dovoljenje za promet prejela na podlagi teh študij, oziroma za zdravila v postopku vrednotenja dovoljenje za promet začasno umakne oziroma se zavrne, razen če so na voljo drugi podatki iz drugih virov.
• Cefuroxime Alkem and Cefuroxime Krka (antibiotics) can remain on the market in the EU, as alternative studies have been provided that support a positive benefit-risk balance. 
• zdravili Cefuroxime Alkem in Cefuroxime Krka (antibiotika) lahko ostaneta na trgu v EU, ker so bile predložene druge študije, ki podpirajo pozitivno razmerje med tveganji in koristmi.
On 23 June 2016, the European Medicines Agency (EMA) recommended the suspension of a medicine (Riluzole Alkem), for which studies were conducted at the Alkem Laboratories Ltd site in Taloja, India, and has required companies to provide new data for another medicine before it can be authorised in the EU. 
Evropska agencija za zdravila (EMA) je 23. junija 2016 priporočila začasen umik dovoljenja za promet z zdravilom (Riluzole Alkem), za katerega so bile študije opravljene v družbi Alkem Laboratories Ltd v Taloji v Indiji, za drugo zdravilo pa je od družb zahtevala, naj zanj predložijo nove podatke, šele nato bo lahko prejelo dovoljenje za promet v EU.
EMA's Committee for Medicinal Products for Human Use (CHMP) noted that, although there is no evidence of harm or lack of effectiveness linked to the conduct of studies by Alkem Laboratories Ltd, the studies cannot be accepted in marketing authorisation applications in the EU. 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji EMA je ugotovil, da kljub odsotnosti dokazov o škodljivosti in pomanjkanju učinkovitosti, povezanih s študijami, ki jih je opravila družba Alkem Laboratories Ltd, te študije v okviru vlog za pridobitev dovoljenja za promet z zdravilom v EU niso sprejemljive.
• Cefuroxime Ingen Pharma, currently under evaluation by national authorities, can still be considered for authorisation, as studies from other sources have been provided. 
• zdravilo Cefuroxime Ingen Pharma, ki je trenutno v postopku vrednotenja pri nacionalnih organih, še vedno lahko pridobi dovoljenje za promet, ker so bile predložene študije iz drugih virov;
It also included ongoing marketing authorisation applications for medicines which use study data from the site. 
Pregled je vključeval tudi postopke za pridobitev dovoljenja za promet z zdravili, ki še potekajo in pri katerih so uporabljeni podatki iz študij s tega mesta.
• The medicine being suspended, Riluzole Alkem, contains riluzole and is not yet on the market in the EU. 
• Zdravilo Riluzole Alkem, katerega dovoljenje za promet je bilo začasno umaknjeno, vsebuje riluzol in še ni na trgu v EU.
As a result, a medicine is being suspended. 
Zato je dovoljenje za promet z enim zdravilom začasno umaknjeno.
• Ibuprofen Orion, a painkiller currently under evaluation by national authorities, cannot be authorised on the basis of studies carried out at Alkem Laboratories Ltd. 
• protibolečinsko zdravilo Ibuprofen Orion, ki je trenutno v postopku vrednotenja pri nacionalnih organih, na podlagi študij, opravljenih v družbi Alkem Laboratories Ltd, ne more prejeti dovoljenja za promet.
• Some studies carried out at the Alkem Laboratories Ltd site have been found to be flawed. 
• Ugotovljeno je bilo, da so nekatere študije, opravljene v družbi Alkem Laboratories Ltd, prirejene.
• Riluzole Alkem, a medicine for amyotrophic lateral sclerosis (ALS) which has yet to be marketed in the EU, should now be suspended. 
• dovoljenje za promet z zdravilom Riluzole Alkem, zdravilom za amiotrofično lateralno sklerozo (ALS), ki se v EU še ne trži, se začasno umakne;
Medicines under evaluation cannot be granted authorisation on the basis of these studies; further data would have to be provided to support authorisation. 
Zdravila v postopku vrednotenja na podlagi teh študij ne morejo prejeti dovoljenja za promet.
• There is no evidence of harm or lack of effectiveness with any of the medicines linked to studies conducted by Alkem Laboratories Ltd. 
• Pri nobenih zdravilih, povezanih s študijami, izvedenimi v družbi Alkem Laboratories Ltd, ni dokazov o škodljivosti ali pomanjkanju učinkovitosti.
The European Commission issued a decision on 28 September 2017. 
Evropska komisija je sklep izdala 28. septembra 2017.
Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/124) 
Izid napotitvenega postopka v skladu s členom 35 Direktive 2001/82/ES (EMEA/V/A/124)
Which data has the CVMP reviewed? 
Katere podatke je odbor CVMP pregledal?
Consequently, on 1 September 2016, France initiated a procedure under Article 35 of Directive 2001/82/EC for the aforementioned veterinary medicinal products. 
Zato je Francija 1. septembra 2016 v skladu s členom 35 Direktive 2001/82/ES sprožila postopek za zgoraj navedena zdravila za uporabo v veterinarski medicini.
On 13 July 2017, the European Medicines Agency (the Agency) completed a review of the consumer safety of the withdrawal periods (meat, milk and offal) for cattle, sheep and goats for Zanil and associated names, and generic products thereof. 
Evropska agencija za zdravila (agencija) je 13. julija 2017 zaključila pregled varnosti potrošnikov glede karenc (mesa, mleka in organov) za govedo, ovce in koze za zdravilo Zanil in povezana imena ter njegova generična zdravila.
The CVMP recommended that variations to the terms of the marketing authorisations for the aforementioned veterinary medicinal products are required in order to amend the product information accordingly. 
Odbor CVMP je priporočil, da so za ustrezno spreminjanje informacij o zdravilu potrebne spremembe pogojev dovoljenj za promet z zgoraj navedenimi zdravili za uporabo v veterinarski medicini.
Proprietary data and scientific references on residue depletion were provided by the marketing authorisation holders. 
Imetniki dovoljenja za promet z zdravili so predložili lastniške podatke o izločanju ostankov ter znanstvena sklicevanja nanje.
Why were Zanil and associated names, and generic products thereof reviewed? 
Zakaj so bili zdravilo Zanil in povezana imena ter njegova generična zdravila pregledani?
France noted that across the European Union for Zanil and associated names, and generic products thereof, there are different approved withdrawal periods for cattle, sheep and goats, e.g. cattle meat and offal from 10 days to 28 days; cattle milk from zero hours to 108 hours; sheep meat and offal from 14 days to 28 days; sheep milk from ‘do not use in sheep producing milk for human consumption' to 7 days; goat meat and offal 14 days; goat milk zero days. 
Npr. karenca za govedino in organe je od 10 dni do 28 dni, za kravje mleko od nič ur do 108 ur, za ovčje meso in organe od 14 dni do 28 dni, za ovčje mleko od „ne uporabljajte pri ovcah, ki proizvajajo mleko za prehrano ljudi“ do 7 dni, za kozje meso in organe 14 dni, za kozje mleko nič dni.
The CVMP was requested to review all available residue depletion data and recommend withdrawal periods for milk, meat and offal derived from treated cattle, sheep and goats. 
Odbor CVMP je bil zaprošen, naj pregleda vse razpoložljive podatke o izločanju ostankov in priporoči karenco za meso, mleko in organe, pridobljene iz zdravljenega goveda, ovac in koz.
Based on the evaluation of the currently-available data, the CVMP concluded that the overall benefitrisk balance for Zanil and associated names, and generic products thereof, is positive and agreed that the withdrawal periods (meat, milk and offal) for cattle, sheep and goats should be amended to provide assurance for consumer safety. 
Na podlagi ocene trenutno razpoložljivih podatkov je odbor CVMP zaključil, da je splošno razmerje med tveganji in koristmi za zdravilo Zanil in povezana imena ter njegova generična zdravila pozitivno, in je soglašal, da je treba zaradi zagotavljanja varnosti potrošnikov spremeniti karence (mesa, mleka in organov) za govedo, ovce in koze.
What are Zanil and associated names, and generic products thereof? 
Kaj so zdravilo Zanil in povezana imena ter njegova generična zdravila?
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the overall benefit-risk balance for the concerned products is positive and recommended amendments to withdrawal periods for cattle, sheep and goats to provide assurance for consumer safety. 
Odbor za zdravila za uporabo v veterinarskih medicini (CVMP) pri agenciji je sklenil, da je splošno razmerje med tveganji in koristmi za zadevne proizvode pozitivno, in zaradi zagotavljanja varnosti potrošnikov priporočil spremembe karenc za govedo, ovce in koze.
Questions and answers on Zanil and associated names, and generic products thereof 
Vprašanja in odgovori v zvezi z zdravilom Zanil in povezanimi imeni ter njegovimi generičnimi zdravili
The veterinary medicinal products Zanil and associated names, and generic products thereof, are oral suspensions containing 34 mg oxyclozanide per ml. 
Zdravilo Zanil in povezana imena za uporabo v veterinarski medicini ter njegova generična zdravila so peroralne suspenzije, ki vsebujejo 34 mg oksiklozanida na ml. Oksiklozanid je salicilanilidni antihelmintik, ki se uporablja za zdravljenje fascioloze pri govedu, ovcah in kozah ter za odstranjevanje odrivkov gravidnih trakulj (Moniezia spp).
EMA/586006/2017 
september 2017
Questions and answers on Zanil and associated names, and generic products thereof EMA/586006/2017 
Vprašanja in odgovori v zvezi z zdravilom Zanil in povezanimi imeni ter njegovimi generičnimi zdravili stran 2/2
The EU Member States shall ensure that: 
Države članice Evropske unije bodo zagotovile:
Continue to monitor aminotransferases at least every 2 weeks. 
Nadaljujte s spremljanjem vrednosti aminotransferaz najmanj vsaka 2 tedna.
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 ZADEVAJO DRŽAVE ČLANICE
o Contraindication in patients with elevated direct bilirubin > 2 x ULN prior to initiation of treatment. 
o Kontraindikacija pri bolnikih z zvišano vrednostjo direktnega bilirubina > 2 × ZMN pred začetkom zdravljenja.
Details of such a surveillance programme should be agreed with the National Competent Authorities in each member state and put in place prior to marketing of the product. 
S podrobnostmi takšnega nadzora se morajo strinjati pristojni nacionalni organi posamezne države članice, nadzor pa je potrebno vzpostaviti pred trženjem zdravila.
> 5 and ≤ 8 × ULN: Confirm by another liver test; if confirmed, stop treatment and monitor aminotransferase levels at least every 2 weeks until levels have normalised. 
> 5 in ≤ 8 × ZMN: Potrdite z drugo preiskavo jeter; če je stanje potrjeno, končajte zdravljenje in spremljajte vrednosti aminotransferaz najmanj vsaka 2 tedna, dokler se vrednosti ne normalizirajo.
> 8 x ULN: treatment must be stopped and reintroduction of Thelin is not to be considered. 
> 8 × ZMN: zdravljenje je treba končati in ponovna uvedba zdravila Thelin ne pride v poštev.
The MAH must agree the details of a controlled distribution system with the National Competent Authorities and must implement such programme nationally to ensure that, prior to prescribing, all doctors who intend to prescribe Thelin are provided with a physician information pack containing the following: 
Imetnik dovoljenja za promet se mora o podrobnostih sistema nadzorovane distribucije dogovoriti s pristojnimi nacionalnimi organi in mora program izvajati na nacionalni ravni, da zagotovi, da pred predpisovanjem zdravila, vsi zdravniki, ki nameravajo predpisovati zdravilo Thelin, dobijo dokumentacijo za zdravnike, ki vsebuje naslednje podatke:
• The need to tell their doctor that they are taking Thelin 
• da morajo bolniki svojim zdravnikom povedati, da jemljejo zdravilo Thelin.
• That the safety database of Thelin is limited and physicians are encouraged to enrol patients in a surveillance programme to increase knowledge about the incidence of important adverse drug reactions (ADRs). 
• da je baza podatkov o varnosti zdravila Thelin omejena, zato so zdravniki vabljeni, da bolnike vključijo v program nadzorovanja in s tem poglobijo znanje o incidenci pomembnih neželenih učinkov zdravila (ADRs).
The MAH shall set up a surveillance programme to collect information on: the demographics of patients prescribed Thelin, any adverse reactions and reasons for discontinuation of Thelin. 
Imetnik dovoljenja za promet bo vzpostavil program nadzorovanja, da zbere informacije o: demografiji bolnikov, ki jim je bilo predpisano zdravilo Thelin, neželenih učinkih in razlogih za ukinitev zdravljenja z zdravilom Thelin.
The surveillance programme should prompt doctors to report serious ADRs and certain selected ADRs as below immediately and other non-serious ADRs at three monthly intervals. 
V programu nadzorovanja morajo zdravniki resne neželene učinke in določene izbrane neželene učinke, ki so našteti spodaj, prijaviti takoj, ostale neželene učinke pa vsake tri mesece.
If the aminotransferase levels return to pre-treatment values consider resuming the initial treatment schedule. 
Če se vrednosti aminotransferaz vrnejo na vrednosti pred zdravljenjem, razmislite o nadaljevanju začetne sheme zdravljenja.
The information collected should include: o Anonymised patient details - age, sex and aetiology of PAH o Concomitant medications o Reason for discontinuation o ADRs o All serious ADRs o Increase in hepatic enzymes to > 3 × ULN o Elevated direct bilirubin > 2 × ULN o Anaemia o Haemorrhage o Pregnancy and outcome o Pulmonary oedema (associated with veno-occlusive disease) o Suspected interactions o Unexpected ADRs according to the SPC. 
Zbrani podatki morajo vsebovati: o anonimizirane podatke o bolniku - starost, spol in etiologijo PAH, o sočasna zdravljenja, o razloge za ukinitev, o neželene učinke, ○ vsi resni neželeni učinki, ○ povišani jetrni encimi na > 3 x ZMN, ○ povišani direktni bilirubin > 2 x ZMN, ○ anemija, ○ krvavitev, ○ nosečnost in izid, ○ pljučni edem (povezan z vensko-okluzivno boleznijo), ○ možna medsebojna delovanja, ○ neželeni učinki, ki niso navedeni v povzetku glavnih značilnosti zdravila
• That Thelin is teratogenic 
• da je zdravilo Thelin teratogeno;
The Patient information card should include the following information 
Podatki o zdravilu za bolnika morajo vsebovati naslednje informacije:
• The need to ensure that women of child bearing age are using effective contraception and that patients should inform their doctors of any possibility of pregnancy before a new prescription is issued 
• da morajo ženske v rodni dobi uporabljati učinkovito kontracepcijo in da morajo bolnice svoje zdravnike obvestiti o možnosti zanositve preden jim zdravnik izda nov recept;
• That there is an interaction with ciclosporin A which may lead to higher blood concentration of Thelin and hence an increased risk of adverse reactions. 
• da medsebojno delovanje s ciklosporinom A lahko povzroči višje koncentracije zdravila Thelin v krvi in posledično večje tveganje neželenih učinkov.
The physician information about Thelin should contain the following key elements: 
Podatki o zdravilu Thelin za zdravnika morajo vsebovati naslednje ključne podatke:
If the aminotransferase levels return to pre-treatment values, reintroducing Thelin may be considered. 
Če se vrednosti aminotransferaz vrnejo na vrednosti pred zdravljenjem, pride v poštev ponovna uvedba zdravila Thelin.
• That Thelin is hepatotoxic and they will need to attend for regular blood tests 
• da je zdravilo Thelin hepatotoksično in da morajo bolniki redno prihajati na krvne preiskave;
• That treatment with Thelin often causes a decrease in haemoglobin and related red cell parameters o Need for full blood count prior to use and monitoring at clinically appropriate intervals 
• da zdravljenje z zdravilom Thelin pogosto povzroči znižanje hemoglobina in sorodnih parametrov rdečih krvnih celic oPred začetkom jemanja je potrebno narediti krvno sliko in bolnika spremljati v klinično primernih intervalih.
• The need to tell their doctor about any adverse events 
• da morajo bolniki obvestiti svojega zdravnika o neželenih učinkih;
• Physician information about Thelin 
• podatke o zdravilu Thelin za zdravnika;
• The need for female patients to contact their treating doctor immediately if they suspect that they might be pregnant. 
• da morajo bolnice svojega zdravnika nemudoma obvestiti o morebitni nosečnosti;