natgillin/translations-raw huggingface dataset:
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
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.
The currently authorised therapeutic indication in France is as « Adjuvant therapy of overweight diabetics, in combination with an appropriate diet».
Trenutno odobrena terapevtska indikacija v Franciji je „adjuvantno zdravljenje prekomerno težkih bolnikov s sladkorno boleznijo v kombinaciji z ustrezno dieto“.
Furthermore, the results of an additional study (cohort study conducted by the French National Insurance Fund) were commented upon by the MAH in their response document to the List of Questions adopted by the Committee.
Poleg tega je imetnik dovoljenja za promet z zdravilom komentiral rezultate dodatne študije (kohortna študija, ki jo je izvedel francoski nacionalni zavarovalni sklad) v svojem dokumentu z odgovori na seznam vprašanj, ki jih je sprejel Odbor.
The Committee is of the opinion that the link is supported by the results shown in the REGULATE study which confirms the risk of valvulopathy with benfluorex and reveals the occurrence of morphological and functional valve anomalies after an average of only 328 days of exposure.
Odbor meni, da povezavo potrjujejo rezultati REGULATIVNE študije, ki potrjuje tveganje valvulopatije pri uporabi benfluoreksa in razkriva pogostost morfoloških in funkcionalnih anomalij zaklopk po povprečno 328 dneh izpostavljenosti.
Following the provisions under Article 107(2) of Directive 2001/83/EC, as amended, the Agency's Committee for Medicinal Products for Human Use (CHMP) recommends the revocation of the Marketing Authorisations for all benfluorex containing medicinal products listed in Annex I.
V skladu z določbami člena 107(2) Direktive 2001/83/ES, kakor je bila spremenjena, je Odbor za zdravila za uporabo v humani medicini (CHMP) pri Agenciji priporočil razveljavitev dovoljenj za promet z vsemi zdravili, ki vsebujejo benfluoreks in so navedena v Dodatku I.
Therefore, the CHMP is of the opinion that aggravation of the functional anomalies in case of prolonged exposure could not be ruled out, particularly given the prolonged use of the product based on utilisation data, which showed an average exposure time of 3 years.
CHMP zato meni, da poslabšanja funkcionalnih anomalij pri podaljšani izpostavljenosti ni mogoče izključiti, zlasti ob upoštevanju dolgoročne uporabe zdravila na podlagi podatkov o uporabi, ki kažejo, da je povprečno trajanje izpostavljenosti 3 leta.
However the CHMP notes that benfluorex is approved only as an adjuvant therapy in the treatment of type 2 diabetes in overweight patients: on the basis of very limited relevance of efficacy in diabetic patients, an indication as monotherapy for treatment of diabetes was never granted for benfluorex.
Vendar pa CHMP meni, da je benfluoreks odobren le kot dodatno zdravilo pri zdravljenju sladkorne bolezni tipa 2 pri prekomerno težkih bolnikih: zaradi zelo omejene učinkovitosti pri bolnikih s sladkorno boleznijo indikacija kot monoterapija za zdravljenje sladkorne bolezni za benfluoreks ni bila nikoli odobrena.
GROUNDS FOR THE REVOCATION OF THE MARKETING AUTHORISATIONS
PODLAGA ZA RAZVELJAVITEV DOVOLJENJ ZA PROMET Z ZDRAVILOM
Therefore, the CHMP, after review of the data provided by the MAH and the Member State, considers that the benefit of benfluorex is only limited in the management of type 2 diabetes.
Zato CHMP po pregledu podatkov, ki sta jih predložila imetnik dovoljenja za promet z zdravilom in država članica, meni, da so koristi benfluoreksa omejene le na obvladovanje sladkorne bolezni tipa 2.
Based on the aforementioned data, the CHMP considers that the link between exposure to benfluorex and the occurrence of cardiac valve diseases is confirmed.
Na podlagi zgoraj navedenih podatkov CHMP meni, da je povezava med izpostavljenostjo benfluoreksu in pojavom bolezni srčnih zaklopk potrjena.
The CHMP is of the opinion that additional echocardiographic monitoring as proposed by the MAH could not solve this issue due to the fact that echocardiographic monitoring prevent the use in patients with previous valvulopathy but do not prevent the development in patients who have no previous abnormalities.
CHMP meni, da dodatno ehokardiografsko opazovanje, ki ga predlaga imetnik dovoljenja za promet z zdravilom, ne more rešiti tega vprašanja, saj ehokardiografsko opazovanje preprečuje uporabo benfluoreksa pri bolnikih s predhodno valvulopatijo, ne preprečuje pa njenega pojava pri bolnikih brez predhodnih nepravilnosti.
J. 2009; 33: 684-688) lead to the conclusion of an existence of cardiac valvulopathy and PHT in the general population of patients using benfluorex.
J. 2009; 33: 684-688) so privedli do zaključka, da je prisoten obstoj srčne valvulopatije in pljučne hipertenzije v splošni populaciji bolnikov, ki uporabljajo benfluoreks.
Whereas,
Ob upoštevanju naslednjega:
The MAH, in their written response, considers that there is a consistent significant clinical effect on blood glucose control in all the studies performed with benfluorex in overweight type 2 diabetic patients.
Imetnik dovoljenja za promet z zdravilom v svojem pisnem odgovoru meni, da obstaja trajen in pomemben kliničen učinek na nadzorovanje ravni glukoze v krvi v vseh študijah, izvedenih z benfluoreksom pri prekomerno težkih bolnikih s sladkorno boleznijo tipa 2.
Taking all these elements into account, the CHMP concluded that the medicinal products containing benfluorex are harmful under the normal conditions of use, and that the benefit/risk balance for benfluorex is not considered favourable.
Ob upoštevanju vseh teh elementov je CHMP sklenil, da so zdravila, ki vsebujejo benfluoreks, pod normalnimi pogoji uporabe škodljiva in da razmerje med koristmi in tveganji za benfluoreks ni ugodno.
Further to receipt of the Rapid Alert, the Portuguese Competent Authority also decided to suspend the marketing authorisation of all benfluorex containing medicinal products in Portugal on 30 November
Na podlagi hitrega opozorila se je na Portugalskem dne 30. novembra 2009 portugalski pristojni organ prav tako odločil za umik dovoljenja za promet z vsemi zdravili, ki vsebujejo benfluoreks.
Pharmaceutical Form Route of administration
Farmacevtska oblika
In addition, the retrospective case-control study conducted in Brest in order to look for a link between exposure to benfluorex and the occurrence of unexplained mitral insufficiency, establishes an association between the exposure to benfluorex and the occurrence of valvulopathy.
Poleg tega je retrospektivna študija primerov in kontrol, ki je bila izvedena v Brestu in katere namen je bil ugotavljanje povezave med izpostavljenostjo benfluoreksu in pogostostjo primerov nerazložene mitralne insuficience, ugotovila povezavo med izpostavljenostjo benfluoreksu in pogostostjo primerov valvulopatije.
• The Committee concluded, after having reviewed the available data, that benfluorex is harmful under normal conditions of use leading to pulmonary hypertension and cardiac valvulopathies.
• Odbor je po preučitvi razpoložljivih podatkov sklenil, da je benfluoreks pod normalnimi pogoji uporabe škodljiv, saj povzroča pljučno hipertenzijo in srčne valvulopatije.
• The Committee considered the benefit-risk ratio of benfluorex under the normal conditions of use and considered that the aforementioned proven risk of cardiac valve disease is not acceptable, taking into account that the benefit of benfluorex is only limited in the treatment of type 2 diabetes.
• Odbor je upošteval razmerje med koristmi in tveganji za benfluoreks pod normalnimi pogoji uporabe in menil, da zgoraj navedeno dokazano tveganje za bolezni srčnih zaklopk ni sprejemljivo glede na to, da so koristi benfluoreksa omejene le na zdravljenje sladkorne bolezni tipa 2.
Benfluorex has an action on carbohydrate metabolism.
Benfluoreks učinkuje na presnovo ogljikovih hidratov.
As stated in the MAH's written response, at the time of the national evaluation of the cardiac valvular abnormality, the MAH proposed to maintain benfluorex on the market with a restriction to the indication in patients with no ultrasound evidence of valve anomalies and the implementation of echocardiographic monitoring.
Imetnik dovoljenja za promet z zdravilom je v pisnem odgovoru v trenutku nacionalnega vrednotenja nepravilnosti srčnih zaklopk predlagal, da benfluoreks ostane na trgu, vendar z omejitvijo na indikacijo pri bolnikih brez ultrazvočnih dokazov anomalij zaklopk in izvajanje ehokardiografskega opazovanja.
Benfluorex is used as an adjunct in the management of type 2 diabetes mellitus in overweight patients.
Benfluoreks se uporablja kot dodatek pri zdravljenju sladkorne bolezni tipa 2 pri bolnikih s prekomerno telesno maso.
The MAH projected to discontinue the treatment in the event of echocardiographic anomalies.
Imetnik dovoljenja za promet z zdravilom je predlagal prenehanje njegove uporabe pri zdravljenju ehokardiografskih anomalij.
Benfluorex is used as an “Adjuvant therapy of overweight diabetics, in combination with an appropriate diet”.
Benfluoreks se uporablja kot „adjuvantno zdravljenje prekomerno težkih bolnikov s sladkorno boleznijo v kombinaciji z ustrezno dieto“.
The updated results of the second national Pharmacovigilance survey, the preliminary data from 3 clinical studies (the retrospective case-control study performed in a Brest hospital, the REGULATE trial and the data from the French National Insurance Fund) and the recent publication from K. Boutet demonstrate the serious risk of cardiac morphological and functional valvulopathies and pulmonary hypertension associated with the use of benfluorex.
Posodobljeni podatki druge nacionalne raziskave farmakovigilance, uvodni podatki iz treh kliničnih študij (retrospektivne študije primerov in kontrol iz bolnišnice Brest, REGULATIVNEGA preskušanja ter podatkov francoskega nacionalnega zavarovalnega sklada) ter nedavna objava K. Boutet dokazujejo resno tveganje srčnih morfoloških in funkcionalnih valvulopatij ter pljučne hipertenzije, povezane z uporabo benfluoreksa.
• The Committee, in light of the above findings, concluded that the benefit/risk balance of benfluorex containing medicinal products is not favourable under the normal conditions of use.
• Odbor je na podlagi zgoraj navedenih ugotovitev sklenil, da razmerje med koristmi in tveganji za zdravila, ki vsebujejo benfluoreks, pod normalnimi pogoji uporabe ni ugodno.
Updated results of the pharmacovigilance survey regarding the risk of cardiac valve diseases with benfluorex and data from a recent publication on this subject (K. Boutet Fenfluramine-like cardiovascular side-effects of benfluorex, Eur Respir.
Posodobljeni rezultati raziskave farmakovigilance v zvezi s tveganjem za bolezni srčnih zaklopk zaradi uporabe benfluoreksa in podatki iz nedavne objave o tej temi (K. Boutet Fenfluramine-like cardiovascular side-effects of benfluorex (Fenfluraminu podobni kardiovaskularni neželeni učinki benfluoreksa), Eur Respir.