natgillin/translations-raw huggingface dataset:
If you may become pregnant, you should use an effective contraception during treatment with Lysodren and even after stopping it, ask your doctor for advice. 
Če lahko zanosite, morate med zdravljenjem z zdravilom Lysodren in tudi po njem uporabljati učinkovito kontracepcijsko metodo.
- if you have severe kidney problems - if you are using any medicines mentioned below (see "Other medicines and Lysodren") - if you have gynaecological problems such as bleeding and/ or pelvic pain. 
- če uporabljate katera koli spodaj omenjena zdravila (glejte poglavje »Druga zdravila in zdravilo Lysodren«);
Plasma triglycerides increased 
Zvišane vrednosti plazemskih trigliceridov
Mental impairment Polyneuropathy Movement disorder Dizziness Headache 
Motnje umskih sposobnosti Polinevropatija Motnje pri gibanju Omotica
Tell your doctor immediately if you have taken accidentally more Lysodren than you should or if a child has accidentally swallowed some. 
Če ste vzeli večji odmerek zdravila Lysodren, kot bi smeli Nemudoma obvestite zdravnika, če ste pomotoma zaužili večji odmerek zdravila Lysodren, kot bi smeli ali če nekaj zdravila Lysodren pogoltne otrok.
This medicine is used for the treatment of symptoms of advanced non operable, metastatic or recurrent malignant tumours of the adrenal glands. 
Uporablja se za zdravljenje simptomov napredovalega metastatskega ali ponavljajočega se malignega tumorja skorje nadledvične žleze, ki ga ni mogoče kirurško odstraniti.
Blood uric acid decreased Blood androstenedione decreased (in females) Blood testosterone decreased (in females) Sex hormone binding globulin increased Blood free testosterone decreased (in males) 
Znižane vrednosti androstendiona v krvi (pri ženskah) Znižane vrednosti testosterona v krvi (pri ženskah)
Non-malignant ovarian macrocysts (with symptoms such as pelvic pain, bleeding) have been described. 
Ženske pred menopavzo Opisane so bile nemaligne makrociste na jajčnikih (s simptomi, kot sta medenična bolečina in krvavitev).
Fat-rich food: Data with various mitotane formulations suggest that administration with fat-rich food enhances absorption of mitotane. 
Hrana, bogata z maščobami: Na podlagi podatkov o različnih pripravkih mitotana ugotavljajo, da jemanje s hrano, bogato z maščobo, pospeši absorpcijo mitotana (glejte poglavje 5.2).
Animal reproduction studies have not been conducted with mitotane. 
Študije vpliva mitotana na razmnoževanje pri živalih niso bile izvedene.
The target plasma mitotane concentration (14 mg/l) was reached in all patients within 3 to 5 months and the total mitotane dose ranged between 283 and 387 g (median value: 363 g). 
5 mesecih, pri čemer je bil skupen odmerek mitotana v območju 283 do 387 g (mediana vrednost:
Dose adjustment is aimed to reach a therapeutic window (mitotane plasma levels 14 - 20 mg/l) which ensures optimal use of Lysodren with acceptable safety. 
20 mg/l), ki zagotavlja optimalno uporabo zdravila Lysodren ob sprejemljivi varnosti.
Hepatotoxicity has been observed in patients treated with mitotane. 
Pri bolnikih, zdravljenih z mitotanom, so opazili hepatotoksičnost.
Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal. 
Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve PSUR za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
Hepatic or renal impairment: There are insufficient data to support the use of mitotane in patients with severe hepatic or renal impairment. 
Jetrna ali ledvična okvara: Pri bolnikih s hudo jetrno ali ledvično okvaro ni dovolj podatkov, s katerimi bi lahko upravičili uporabo mitotana.
Talk to your doctor or pharmacist before taking Lysodren. 
Pred začetkom jemanja zdravila Lysodren se posvetujte z zdravnikom ali farmacevtom.
- -if you have liver problems: Tell your doctor if you develop any of the following signs and symptoms of liver problems during Lysodren treatment: itching, yellow eyes or skin, dark urine, and pain or discomfort in the right upper stomach area. 
Takoj obvestite zdravnika, ki se bo morda odločil začasno prekiniti zdravljenje; - če imate težave z jetri: povejte svojemu zdravniku, če med zdravljenjem z zdravilom Lysodren opazite katerega od naslednjih znakov in simptomov težav z jetri: srbenje, rumena obarvanost oči ali kože, temen urin in bolečine ali neprijeten občutek v desnem zgornjem delu trebuha.
HRA Pharma Rare Diseases 
Imetnik dovoljenja za promet z zdravilom HRA Pharma Rare Diseases
In patients with mild or moderate hepatic or renal impairment, caution should be exercised and monitoring of mitotane plasma levels is particularly recommended (see section 4.2). 
Pri bolnikih z blago ali zmerno jetrno ali ledvično okvaro je potrebna previdnost, zlasti pa je priporočeno spremljanje plazemskih koncentracij mitotana
Lysodren may harm the foetus. 
Zdravilo Lysodren lahko škoduje plodu.
Caution should be exercised and frequent monitoring of mitotane plasma levels is especially recommended in these patients. 
Pri teh bolnikih je treba je biti previden, predvsem pa je priporočljivo redno nadzorovati plazemske koncentracije mitotana.
NAME AND ADDRESS OF THE MARKETING AUTORISATION HOLDER 
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM HRA Pharma Rare Diseases
Red blood cell, white blood cell and platelet counts should be monitored during mitotane treatment. 
Med zdravljenjem z mitotanom je treba spremljati število rdečih in belih krvničk ter trombocitov.
- if you are being treated with medicines containing spironolactone (see "Other medicines and 
Med jemanjem zdravila Lysodren ne smete dojiti; - če se zdravite z zdravili, ki vsebujejo spironolakton (glejte poglavje »Druga zdravila in zdravilo
Hypouricaemia 
Hipourikemija
Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.emea.europa.eu/. 
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu, kjer so na voljo tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju..
Your doctor may prescribe you some hormonal treatment (steroids) while you are taking Lysodren. 
Zdravnik vam bo med zdravljenjem z zdravilom Lysodren morda predpisal zdravljenje s hormoni
Ataxia Paresthesia Vertigo Sleepiness 
Ataksija Parestezija Vrtoglavica Zaspanost
Patients should carry with them the Lysodren Patient Card provided with the package leaflet indicating that they are prone to adrenal insufficiency and that, in case of emergency care, adequate precautionary measures should be taken. 
Izkaznica navaja, da so nagnjeni k insuficienci nadledvične žleze in da naj se v primeru nujne zdravstvene oskrbe izvedejo primerni previdnostni ukrepi.
The patient should be followed closely, taking into account that impairment is reversible, but given the long half-life and the lipophilic nature of mitotane, it may take weeks to return to normal. 
vendar lahko pa zaradi dolge razpolovne dobe in lipofilne narave mitotana, traja več tednov, da se stanje normalizira.
Therefore, patients should be closely monitored for a change in anticoagulant dose requirements when mitotane is administered to patients on coumarin-like anticoagulants. 
Zato je treba bolnike, ki se sočasno zdravijo z mitotanom in kumarinu podobnimi antikoagulacijskimi zdravili, skrbno spremljati zaradi morebitne spremembe odmerka antikoagulacijskega zdravila.
There is no experience on the use of mitotane in older patients, so data are insufficient to give a dose recommendation in this group. 
Pri uporabi mitotana pri starejših bolnikih ni izkušenj, zato ni podatkov s katerimi bi se lahko priporočil odmerek za to skupino bolnikov.
Nausea 
Bruhanje
Your doctor may decide to stop treatment with Lysodren temporarily or to lower the dose if you experience certain side effects. 
Če se pojavijo nekateri neželeni učinki, se bo zdravnik morda odločil začasno prekiniti zdravljenje z zdravilom Lysodren ali zmanjšati odmerek.
- fever - general aching - flushing, high or low blood pressure, feeling of dizziness/vertigo when you suddenly stand up - increased production of saliva - eye disorders: visual impairment, vision blurred, double vision, distortion of images, complain of glare - fungal infection - liver damage (may cause yellowing of the skin and eyes, dark coloured urine) - decreased uric acid in blood tests - bladder inflammation with bleeding - presence of blood in urine, presence of proteins in urine - balance disorder - distortion of the sense of taste - impaired digestion - ovarian macrocysts (with symptoms such as pelvic pain, bleeding) - decreased androstenedione (precursor of sex hormones) in blood tests in females - decreased testosterone (sex hormone) in blood tests in females - sex hormone binding globulin (a protein which binds sex hormones) increased in blood tests - decreased free testosterone (sex hormone) in blood tests in males 
- splošne bolečine; - vročinski oblivi, visok ali nizek krvni tlak, občutek omotice/vrtoglavice pri hitrem vstajanju; - povečano izločanje sline; - očesne bolezni: okvare vida, zamegljen vid, dvojni vid, popačena slika, pritožbe nad bleščanjem; - glivične okužbe; - okvare jeter (lahko povzročijo porumenelost kože in oči, temno obarvan urin); - znižanje ravni sečne kisline pri krvnih preiskavah; - vnetje sečnega mehurja s krvavitvami;
- vomiting, nausea (feeling sick), diarrhoea, belly pain - lack of appetite - abnormal sensations like pins and needles - movement and coordination disorders, vertigo, confusion - feeling sleepy, fatigue, muscle weakness (fatigue of muscle during effort) - inflammation (swelling, heat, pain) of mucosa, skin rash - blood disorders (bleeding time prolonged) - increase of cholesterol, triglycerides (fats) and liver enzymes (in blood tests) - decrease in white blood cells count - breast overdevelopment in men - adrenal insufficiency 
- zaspanost, utrujenost, mišična šibkost (utrujenost mišic pri naporih); - vnetje (otekanje, toplota, bolečina) sluznice, kožni izpuščaj; - bolezni krvi (podaljšan čas krvavitev); - zvišanje ravni holesterola, trigliceridov (maščob) in jetrnih encimov (v krvnih preiskavah);
There is no experience in the use of mitotane in patients with renal impairment, so data are insufficient to give a dose recommendation in this group. 
Jetrna okvara Pri uporabi mitotana pri bolnikih z jetrno okvaro ni izkušenj, zato ni dovolj podatkov, s katerimi bi se lahko priporočil odmerek za to skupino bolnikov.
Dyspepsia 
Diplopija
20 mg/l (see section 4.8). 
14 mg/l.
This medicine should not be handled by persons other than the patient and his/her caregivers, and especially not by pregnant women. 
S tem zdravilom lahko rokuje le bolnik in njegovi skrbniki.
Cases of liver damage (hepatocellular, cholestatic and mixed) and autoimmune hepatitis were observed. 
(hepatocelularne, holestatske in mešane) in avtoimunega hepatitisa.
- dizziness, headache 
- omotica, glavobol;
It is recommended to increase frequency of mitotane plasma level monitoring (e.g. every two weeks) in patients at risk of overdose (e.g. in case of renal or hepatic impairment, obese patients or patients with a recent weight loss). 
Pri bolnikih, pri katerih obstaja tveganje za preveliko odmerjanje (npr. pri bolnikih z ledvično ali jetrno okvaro, bolnikih s čezmerno telesno maso ali bolnikih, ki so nedavno shujšali), je priporočeno povečati pogostnost spremljanja plazemske koncentracije mitotana (npr. vsaka dva tedna).
How to store Lysodren 
Shranjevanje zdravila Lysodren
Pack size of 1 bottle. 
Velikost pakiranja je ena plastenka.
Hypertension Orthostatic hypotension Flushing 
Ortostatska hipotenzija
Ovarian macrocysts 
Makrociste na jajčnikih
MARKETING AUTORISATION NUMBER 
IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
Bleeding time: Prolonged bleeding time has been reported in patients treated with mitotane and this should be taken into account when surgery is considered (see section 4.8). 
Čas krvavitve: Pri bolnikih zdravljenih z mitotanom so poročali o podaljšanem času krvavitve.
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) 
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
Reproductive toxicity studies have not been performed with mitotane. 
Študije vpliva mitotana na sposobnost razmnoževanja niso bile izvedene.
- Keep this leaflet. 
Glejte poglavje
Breast-feeding is contraindicated while taking mitotane (see section 4.3) and after treatment discontinuation as long as mitotane plasma levels are detectable. 
(glejte poglavje 4.3) in po prekinitvi zdravljenja, dokler so plazemske koncentracije mitotana zaznavne, je dojenje kontraindicirano.
Monitoring should be more frequent (e.g. every week) when a high starting dose has been used. 
Pri večjih začetnih odmerkih je treba plazemske koncentracije nadzorovati pogosteje (npr. vsak teden).
Haemorrhagic cystitis Haematuria Proteinuria 
Oslabljeno delovanje nadledvične žleze
6.6 Special precautions for disposal and other handling 
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom S tem zdravilom lahko rokuje le bolnik in njegovi skrbniki.
Behavioural and neurological assessments should be made at regular intervals, especially when mitotane plasma levels exceed 
V rednih intervalih je potrebno opravljati vedenjske in nevrološke ocene bolnikov, še posebej če plazemske koncentracije presežejo 20 mg/l (glejte poglavje 4.8).
No proven antidotes have been established for mitotane overdose. 
Dokazanih antidotov v primeru prevelikega odmerjanja mitotana ni. Bolnika je potrebno skrbno nadzorovati.
Serious undesirable effects appear linked to the cumulative exposure to mitotane and are most likely to occur when mitotane plasma levels are at 20 mg/l or above. 
Izgleda, da so hudi neželeni učinki vezani na kumulativno izpostavitev mitotanu.
- peripheral nervous system disorders (association of sensory disorders, muscular weakness and atrophy, decrease of tendon reflex and vasomotor symptoms such as hot flushes, sweat and sleep disorders) - mental impairment (such as memory loss, concentration difficulty) - movement disorder - decrease of red blood cells (anaemia, with symptoms such as skin pallor and fatigue), decrease in blood platelets (may make you more prone to bruising and bleeding) - hepatitis (auto-immune) (may cause yellowing of the skin and eyes, dark coloured urine) - difficulty of coordinating muscles 
- motnje perifernega živčevja: asociacija čutilnih motenj, mišična šibkost in atrofija, zmanjšanje kitnih refleksov in vazomotorični simptomi, kot so vročinski oblivi, potenje in motnje spanja);
Do not use after the expiry date which is stated on the carton and the bottle after EXP. Any unused product or waste material should be disposed of in accordance with local requirements for cytotoxic medicines. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatlici in steklenici poleg oznake »Uporabno do«.
Common 
Miastenija
Posology 
ŠKATLICA
Maculopathy Retinal toxicity Diplopia 
Hematurija Proteinurija
Package leaflet: Information for the user Lysodren 500 mg tablets mitotane 
Navodilo za uporabo Lysodren 500 mg tablete mitotan
OUTER CARTON BOTTLE LABEL 
NALEPKA NA PLASTENKI
Very common side effects 
Pogosti neželeni učinki
Tell your doctor immediately if you experience any of the following side effects: - Adrenal insufficiency: fatigue, abdominal pain, nausea, vomiting, diarrhoea, confusion - Anaemia: cutaneous pallor, muscular fatigability, feeling breathless, vertigo especially when standing up - Liver damage: yellowing of the skin and eyes, itching, nausea, diarrhoea, fatigue, dark coloured urine - Neurological disorders: movement and coordination disorders, abnormal sensations like pins and needles, memory loss, concentration difficulty, difficulty to talk, vertigo 
Takoj obvestite zdravnika, če opazite kateregakoli izmed naslednjih neželenih učinkov: - oslabljeno delovanje nadledvične žleze: utrujenost, bolečine v trebuhu, slabost, bruhanje, driska,
This medicinal product should not be handled by persons other than the patient and his/her caregivers, and especially not by pregnant women. 
Izrecno pa z zdravilom ne smejo rokovati nosečnice.
LYSODREN PATIENT CARD I am on Lysodren (mitotane) treatment I am prone to acute adrenal insufficiency In case I need emergency care, adequate precautionary measures should be taken 
LYSODREN - IZKAZNICA BOLNIKA Zdravim se z zdravilom Lysodren (mitotanom)
The use of mitotane in patients with severe renal impairment is not recommended and, in cases of mild to moderate renal impairment, caution should be exercised. 
V primerih blage do zmerne ledvične okvare pa je potrebna previdnost.
Batch 
Mukozitis
Endocrine disorders Adrenal insufficiency 
Bolezni endokrinega sistema
Lens opacity Visual impairment Vision blurred 
Motnje vida Zamegljen vid
Gastrointestinal disorders 
Motnja okusa Dispepsija
Driving and using machines 
OZNAČEVANJE IN NAVODILO ZA UPORABO
Invented name bottles 
Izmišljeno ime
(*) Antigen content (VP2 protein) by immune-assay 
(*) Vsebnost antigena (VP2 protein) z imunološkimi metodami
Zero days 
EU številka
BTV8 antigen ≥2.12 log10 pixels* (*) Antigen content (VP2 protein) by immune-assay 
BTV8 antigen ≥ 2.12 log10 pikslov* (*) Vsebnost antigena (VP2 protein) z imunološkimi metodami
BTV2 antigen ≥1.82 log10 pixels* BTV8 antigen ≥ 2.12 log10 pixels* 
--1 BTV2 antigen ≥1.82 log10 pikslov* BTV8 antigen ≥2.12 log10 pikslov*
BTV1 antigen ≥1.9 log10 pixels* BTV2 antigen ≥ 1.82 log10 pixels* 
--1 BTV1 antigen ≥1.9 log10 pikslov* BTV2 antigen ≥1.82 log10 pikslov*
BTV1 antigen ≥1.9 log10 pixels* BTV4 antigen ≥ 1.86 log10 pixels* 
--1 BTV1 antigen ≥1.9 log10 pikslov* BTV4 antigen ≥ 1,86 log10 pikslov*
--1 BTV4 antigen ≥1.86 log10 pixels* (*) Antigen content (VP2 protein) by immune-assay 
--1 BTV4 antigen ≥1,86 log10 pikslov* (*) Vsebnost antigena (VP2 protein) z imunološkimi metodami
--1 BTV2 antigen ≥1.82 log10 pixels* (*) Antigen content (VP2 protein) by immune-assay 
--1 BTV2 antigen ≥1.82 log10 pikslov* (*) Vsebnost antigena (VP2 protein) z imunološkimi metodami
BTV4 antigen ≥1.86 log10 pixels* BTV8 antigen ≥ 2.12 log10 pixels* 
--1 BTV4 antigen ≥1,86 log10 pikslov* BTV8 antigen ≥ 2,12 log10 pikslov*
BTV1 antigen ≥1.9 log10 pixels* (*) Antigen content (VP2 protein) by immune-assay 
--1 BTV1 antigen ≥1.9 log10 pikslov* (*) Vsebnost antigena (VP2 protein) z imunološkimi metodami
The CHMP did not accept this proposal. 
CHMP tega predloga ni sprejel.
Benefit/risk 
Koristi/tveganja
Safety 
Varnost
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF MEDICINAL PRODUCTS CONTAINING BENFLUOREX (see Annex I) 
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVIL, KI VSEBUJEJO BENFLUOREKS (glejte Dodatek I)
In Cyprus and Luxembourg, medicinal products containing benfluorex were not marketed any longer. 
Na Cipru in v Luksemburgu so bila zdravila, ki vsebujejo benfluoreks, umaknjena iz prometa.
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE REVOCATION OF THE MARKETING AUTHORISATIONS PRESENTED BY THE EUROPEAN MEDICINES AGENCY 
DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA RAZVELJAVITEV DOVOLJENJ ZA PROMET Z ZDRAVILOM, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
The CHMP considered the matter in accordance with Article 107(2) of Directive 2001/83/EC, as amended, during a written procedure, during the December 2009 and March 2010 CHMP plenary meetings. 
CHMP je preučil zadevo v skladu s členom 107(2) Direktive 2001/83/ES, kakor je bila spremenjena, med pisnim postopkom in na plenarnih zasedanjih CHMP decembra 2009 in marca 2010.
Therefore the Committee recommended the revocation of the Marketing Authorisations for the medicinal products referred to in Annex I. 
Odbor je zato priporočil razveljavitev dovoljenj za promet z zdravili, ki so navedena v Dodatku I.
Such valvulopathies have the potential to induce progressive impairment of cardiac function and associated clinical symptoms requiring, in the severe cases, cardiac surgery. 
Takšne valvulopatije lahko povzročijo postopno poslabšanje srčne funkcije in povezanih kliničnih simptomov, kar lahko v hudih primerih zahteva kirurški poseg na srcu.
PT - Portugal 
Portugalska
• The Committee considered the procedure under Article 107 of Directive 2001/83/EC, as amended, for medicinal products containing benfluorex. 
• Odbor je upošteval postopek iz člena 107 Direktive 2001/83/ES, kakor je bila spremenjena, za zdravila, ki vsebujejo benfluoreks.
Furthermore, aggravation of the functional abnormalities in case of prolonged exposure is not ruled out; this is of particular concern given the prolonged use of the product with an average exposure time of 3 years (based on utilisation data). 
Poleg tega poslabšanje funkcionalnih nepravilnosti pri podaljšani izpostavljenosti ni izključeno; to vzbuja skrb zlasti pri podaljšani uporabi zdravila s povprečnim trajanjem izpostavljenosti treh let (na podlagi podatkov o uporabi).
In animals, the following effects have been observed: - Facilitation of precipitation and use of glucose in cells (rats); - Reduction in hyperglycaemia in diabetic rats (insulin deprived or not), decrease in hyperglycaemia (measured by the glucose tolerance test area) in rabbits. 
Pri živalih so bili opaženi naslednji učinki: - spodbujanje obarjanja in uporabe glukoze v celicah (pri podganah); - zmanjšanje hiperglikemije pri podganah s sladkorno boleznijo (ki imajo pomanjkanje inzulina ali ne), zmanjšanje hiperglikemije (merjene s pomočjo območja preskusa tolerance za glukozo) pri zajcih.
Medicinal products containing benfluorex are authorised in four EU Member States with a tablet formulation, with only 2 countries (France and Portugal) in which the product was marketed up to the suspension of the Marketing Authorisations in November 2009 (see Annex I for the list of benfluorex containing medicinal products authorised in the EU). 
Zdravila, ki vsebujejo benfluoreks, so odobrena v štirih državah članicah EU v obliki tablet in le v dveh državah (v Franciji in na Portugalskem) se je zdravilo tržilo do začasne ukinitve dovoljenja za promet z zdravilom novembra 2009 (glejte Dodatek I za seznam zdravil, ki vsebujejo benfluoreks, odobrenih v EU).
ANNEX I LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORMS, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES (EEA) 
DODATEK I SEZNAM IZMIŠLJENIH IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVIL, POTI UPORABE ZDRAVIL IN IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH (EGP)
However, the CHMP maintains the opinion that these data further confirm the safety signal of a risk of cardiac valve disorders with the use of benfluorex. 
Vendar pa CHMP vztraja pri mnenju, da ti podatki nadalje potrjujejo varnostni signal tveganja za bolezni srčnih zaklopk pri uporabi benfluoreksa.
On 25 November 2009, the French Competent Authority (Afssaps) issued a Rapid Alert informing the Members States, the European Medicines Agency and the European Commission in accordance with Article 107 of Directive 2001/83/EC, as amended, of its decision to suspend the marketing authorisations of all benfluorex containing medicinal products in France due to an increased risk of a cardiotoxicity signal (valvular heart diseases) with benfluorex. 
Dne 25. novembra 2009 je francoski pristojni organ (Afssaps) posredoval hitro opozorilo in države članice, Evropsko agencijo za zdravila in Evropsko komisijo v skladu s členom 107 Direktive 2001/83/ES, kakor je bila spremenjena, obvestil o svoji odločitvi, da v Franciji začasno ukine dovoljenje za promet z vsemi zdravili, ki vsebujejo benfluoreks, zaradi povečanega tveganja znakov kardiotoksičnosti (bolezni srčnih zaklopk) pri uporabi benfluoreksa.
J. 2009; 33: 684-688) that have shown a risk of cardiac valve diseases and pulmonary hypertension (PHT) for patients treated with benfluorex. 
J. 2009; 33: 684-688), ki so pokazali tveganje za bolezni srčnih zaklopk in pljučne hipertenzije pri bolnikih, ki so se zdravili z benfluoreksom.