FrancophonIA/ELRC3.0 huggingface dataset:
English: In contrast, there was an increase of approximately 20% in tacrolimus AUC when multiple doses of mycophenolate mofetil (1.5°g taken twice a day [BID], morning and evening) were administered to hepatic transplant patients taking tacrolimus.
Slovenian: Nasprotno, po dajanju večkratnih odmerkov mofetilmikofenolata (1,5 g dvakrat na dan, zjutraj in zvečer) bolnikom z jetrnim presadkom, ki so jemali takrolimus, se je AUC takrolimusa povečala za približno 20 %.
English: The systemic exposure at this dose was approximately 0.5°times the clinical exposure at the recommended clinical dose of 2 g/day for renal transplant patients and approximately 0.3°times the clinical exposure at the recommended clinical dose of 3 g/day for cardiac transplant patients.
Slovenian: Sistemska izpostavljenost pri tem odmerku je bila približno 0,5-krat večja kot klinična izpostavljenost pri priporočenem kliničnem odmerku 2 g na dan pri bolnikih z ledvičnim presadkom in približno 0,3-krat večja kot klinična izpostavljenost pri priporočenem kliničnem odmerku 3 g na dan pri bolnikih s srčnim presadkom.
English: Precautions to be taken before handling or administering the medicinal product Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbits, Myfenax tablets should not be crushed.
Slovenian: Ker ima mofetilmikofenolat dokazane teratogene učinke pri podganah in kuncih, filmsko obloženih tablet zdravila Myfenax ne smemo drobiti.
English: • You plan to become pregnant.
Slovenian: • če ste noseči, načrtujete nosečnost ali menite, da bi lahko bili noseči,
English: Myfenax capsules at a dose of 750 mg twice daily (1.5 g daily dose).
Slovenian: predpišemo kapsule zdravila Myfenax v odmerku 1 g dvakrat na dan (dnevni odmerek 2 g).
English: pancreatitis (≥1/100 to <1/10) and intestinal villous atrophy.
Slovenian: (≥ 1/100 do < 1/10), pancreatitis (≥ 1/100 do < 1/10) in atrofija črevesne sluznice.
English: • Facial malformations such as cleft lip, cleft palate, micrognathia and hypertelorism of the orbits;
Slovenian: • nenormalna ušesa (npr. nenormalna oblika ali manjkajoče zunanje uho), atrezija zunanjega sluhovoda (srednjega ušesa), • malformacije obraza, kot so razcep ustnice, razcep neba, mikrognatija in orbitalni hipertelorizem,
English: Caution should be used during concomitant administration because of the potential to reduce efficacy of mycophenolate mofetil.
Slovenian: Pri sočasni uporabi holestiramina in mofetilmikofenolata je potrebna previdnost, saj je lahko učinkovitost mofetilmikofenolata zmanjšana.
English: Yellow iron oxide (E172)
Slovenian: rumeni železov oksid (E172).
English: Men must not donate semen during treatment with Myfenax and for at least 90°days after stopping treatment.
Slovenian: Bolniki med zdravljenjem in vsaj še 90 dni po končanem zdravljenju z zdravilom Myfenax ne smete darovati sperme.
English: Pneumonia, influenza, respiratory tract infection, respiratory moniliasis, gastrointestinal infection, candidiasis, gastroenteritis, infection, bronchitis, pharyngitis, sinusitis, fungal skin infection, skin candida, vaginal candidiasis, rhinitis
Slovenian: Infekcijske in parazitske bolezni zelo pogosti sepsa, gastrointestinalna kandidoza, okužba urinarnega trakta, herpes simpleks, herpes zoster pogosti pljučnica, gripa, okužba respiratornega trakta, respiratorna moniliaza, gastrointestinalna okužba, kandidoza, gastroenteritis,
English: Mycophenolic acid (MPA) is the active metabolite of mycophenolate mofetil. Renal transplant rejection does not lead to changes in MPA pharmacokinetics; dosage reduction or interruption of Myfenax is not required.
Slovenian: Zavrnitev ledvičnega presadka ne spremeni farmakokinetike mikofenolne kisline, zmanjšanje odmerkov ali prekinitev zdravljenja z zdravilom Myfenax ni potrebna.
English: Talk to your doctor or pharmacist before taking Myfenax.
Slovenian: Pred začetkom jemanja zdravila Myfenax se posvetujte z zdravnikom ali farmacevtom.
English: Contact your nearest hospital Accident and Emergency department or a doctor for advice if you have swallowed more capsules than you have been told to take or if you think a child has swallowed any.
Slovenian: Če ste zaužili več kapsul, kot vam je bilo predpisano, ali če mislite, da je otrok zaužil kapsulo, takoj poiščite zdravnika ali pojdite v bolnišnico.
English: How to store Myfenax
Slovenian: Shranjevanje zdravila Myfenax
English: There have been isolated reports of interstitial lung disease and pulmonary fibrosis in patients treated with mycophenolate mofetil in combination with other immunosuppressants, some of which have been fatal.
Slovenian: Pri bolnikih, ki so dobivali mofetilmikofenolat skupaj z drugimi imunosupresivi, so poročali o posameznih primerih intersticijske pljučne bolezni in pljučne fibroze; nekateri primeri so bili smrtni.
English: Caution should be used with medicinal products that interfere with enterohepatic circulation because of their potential to reduce the efficacy of mycophenolate mofetil.
Slovenian: Pri sočasni uporabi holestiramina in zdravila Myfenax je potrebna previdnost, saj je lahko učinkovitost mofetilmikofenolata zmanjšana.
English: The recommended dose in cardiac transplant patients is 1.5°g administered twice daily (3°g daily dose).
Slovenian: Priporočeni odmerek pri bolnikih s srčnim presadkom je 1,5 g dvakrat na dan (dnevni odmerek 3 g).
English: • Microphthalmia;
Slovenian: • mikroftalmija,
English: • Spontaneous abortions have been reported in 45 to 49% of pregnant women exposed to mycophenolate mofetil, compared to a reported rate of between 12 and 33% in solid organ transplant patients treated with immunosuppressants other than mycophenolate mofetil.
Slovenian: • Pri nosečnicah, izpostavljenih mofetilmikofenolatu, so poročali o spontanih splavih pri 45 do 49 %
English: The pharmacokinetics of oral contraceptives were unaffected by co-administration of mycophenolate mofetil (see also section 4.5).
Slovenian: Sočasno jemanje mofetilmikofenolata in peroralnih kontraceptivov ni vplivalo na farmakokinetiko peroralnih kontraceptivov (glejte tudi poglavje 4.5).
English: Hepatitis, jaundice, hyperbilirubinaemia
Slovenian: Bolezni jeter, žolčnika in žolčevodov zelo pogosti pogosti hepatitis, zlatenica, hiperbilirubinemija
English: Name and address of the manufacturers responsible for batch release
Slovenian: A. IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ Ime in naslov izdelovalca, odgovornega za sproščanje serij
English: The recommended daily dose is 12°capsules (3°g of the active ingredient) taken as 2 separate doses.
Slovenian: Priporočeni dnevni odmerek je 12 kapsul (3 g zdravilne učinkovine), razdeljenih na dva posamezna odmerka.
English: The recommended oral dose in hepatic transplant patients is 1.5°g administered twice daily (3°g daily dose).
Slovenian: Priporočeni peroralni odmerek pri bolnikih z jetrnim presadkom je 1,5 g dvakrat na dan (dnevni odmerek 3 g).
English: The mean single dose MPAG AUC was 3-6-fold higher in subjects with severe renal impairment than in subjects with mild renal impairment or normal healthy subjects, consistent with the known renal elimination of MPAG.
Slovenian: Pri bolnikih s hudo ledvično okvaro je bil srednji AUC mikofenolglukuronida po enkratnem odmerku od 3- do 6-krat večji kot pri bolnikih z blažjimi stopnjami ledvične okvare ali pri zdravih prostovoljcih.
English: The recommended daily dose is 4°tablets (2°g of the active ingredient) taken as 2°separate doses.
Slovenian: Priporočeni dnevni odmerek je 4 tablete (2 g zdravilne učinkovine), zaužite kot 2 posamezna odmerka.
English: • fungal infection of the digestive tract
Slovenian: • glivična okužba prebavil
English: Iron oxide red (E172)
Slovenian: Telo rdeči železov oksid (E172)
English: The mean bioavailability of oral mycophenolate mofetil, based on MPA AUC, is 94% relative to intravenous mycophenolate mofetil. Food had no effect on the extent of absorption (MPA AUC) of mycophenolate mofetil when administered at doses of 1.5°g BID to renal transplant patients.
Slovenian: Srednja biološka uporabnost peroralne oblike mofetilmikofenolata, temelječa na AUC mikofenolne kisline, znaša 94 % glede na intravenske oblike mofetilmikofenolata.
English: • The active substance is mycophenolate mofetil.
Slovenian: Aktivni presnovek mofetilmikofenolata je mikofenolna kislina (MFK).
English: Caution should be exercised when switching combination therapy from regimens containing immunosuppressants, which interfere with MPA enterohepatic recirculation, e.g. ciclosporin, to others devoid of this effect, e.g. tacrolimus, sirolimus, belatacept, or vice versa, as this might result in changes of MPA exposure.
Slovenian: Pri prehodu s kombiniranega zdravljenja s shemo z imunosupresivi, ki ovirajo enterohepatični obtok mikofenolne kisline (npr. ciklosporin) na druge, ki nimajo takega učinka (npr. takrolimus, sirolimus,
English: Myfenax 250mg hard capsules Mycophenolate mofetil
Slovenian: Navodilo za uporabo Myfenax 250 mg trde kapsule mofetilmikofenolat
English: Hypromellose (HPMC 2910) Titanium dioxide (E171) Macrogol (PEG 400) Talc
Slovenian: Obloga tablete hipromeloza (E464) titanov dioksid (E171) makrogol smukec indigotin (E132)
English: The recommended daily dose is 6°tablets (3°g of the active ingredient) taken as 2°separate doses.
Slovenian: Priporočeni dnevni odmerek je 6 tablet (3 g zdravilne učinkovine), razdeljenih na 2 posamezna odmerka.
English: This includes:
Slovenian: Vsebujejo naj naslednje ključne elemente:
English: In hepatic transplant patients initiated on mycophenolate mofetil and tacrolimus, the AUC and Cmax of MPA, the active metabolite of mycophenolate mofetil, were not significantly affected by coadministration with tacrolimus.
Slovenian: in Cmax mikofenolne kisline, aktivnega presnovka mofetilmikofenolata, zaradi sočasnega dajanja takrolimusa ni bila pomembna.
English: • infection of the digestive tract
Slovenian: • okužba sečil
English: Contact your nearest hospital Accident and Emergency department or a doctor for advice if you have swallowed more tablets than you have been told to take or if you think a child has swallowed any.
Slovenian: Če ste zaužili več tablet, kot vam je bilo predpisano, ali če mislite, da je otrok zaužil tableto, takoj poiščite zdravnika ali pojdite v bolnišnico.
English: Medicinal products that affect glucuronidation (e.g. isavuconazole, telmisartan) Concomitant administration of drugs inhibiting glucuronidation of MPA may increase MPA exposure.
Slovenian: Sočasna uporaba zdravil, ki zavirajo glukuronidacijo mikofenolne kisline, lahko poveča izpostavljenost mikofenolni kislini.
English: Decreased MPA exposure has been observed when antacids, such as magnesium and aluminium hydroxides, and PPIs, including lansoprazole and pantoprazole, were administered with mycophenolate mofetil.
Slovenian: vključno z lanzoprazolom in pantroprazolom, skupaj z zdravilom Myfenax, so opazili zmanjšano izpostavljenost mikofenolni kislini.
English: However, keep taking Myfenax until you see him or her.
Slovenian: Vendar pa do obiska zdravnika nadaljujte z jemanjem zdravila Myfenax.
English: Very common Vomiting, abdominal pain, diarrhoea, nausea Common
Slovenian: Žilne bolezni zelo pogosti pogosti hipotenzija, hipertenzija, vazodilatacija
English: System organ class Frequency Adverse drug reactions hypercholesterolaemia, hyperlipidaemia, hypophosphataemia, hyperuricaemia, gout, anorexia Psychiatric disorders Very commonCommon
Slovenian: Bolezni krvi in limfatičnega sistema zelo pogosti levkopenija, trombocitopenija, anemija pogosti pancitopenija, levkocitoza
English: Body
Slovenian: Telo:
English: Men should not donate semen during therapy or for 90 days following discontinuation of mycophenolate.
Slovenian: Bolniki med zdravljenjem z mofetilmikofenolatom in vsaj še 90 dni po njegovi ukinitvi ne smejo darovati sperme.
English: Do not open or crush the capsules and breathe the powder inside the capsules or allow it to touch your skin.
Slovenian: Kapsul ne smete lomiti ali zmečkati.
English: Myfenax 500 mg film-coated tablets Mycophenolate mofetil
Slovenian: Myfenax 500 mg filmsko obložene tablete mofetilmikofenolat
English: If you are not sure, talk to your doctor or pharmacist before taking Myfenax.
Slovenian: Myfenax, se pred tem pogovorite s svojim zdravnikom ali farmacevtom.
English: You must not donate blood during treatment with Myfenax and for at least 6 weeks after stopping treatment.
Slovenian: Med zdravljenjem in vsaj še 6 tednov po končanem zdravljenju z zdravilom Myfenax ne smete darovati krvi.
English: However, the following treatment-related adverse events were more frequent in the paediatric population, particularly in children under 6°years of age, when compared to adults: diarrhoea, sepsis, leucopenia, anaemia and infection.
Slovenian: 2 do 18 let, ki so prejemali 600 mg/m2 mofetilmikofenolata peroralno dvakrat na dan, sta bila podobna neželenim učinkom, opaženim pri odraslih bolnikih, ki so prejemali 1 g mofetilmikofenolata dvakrat na dan. Naslednji neželeni učinki povezani z zdravljenjem pa so bili v primerjavi z odraslimi pogostejši pri pediatrični populaciji, zlasti pri otrocih, mlajših od 6 let: driska, sepsa, levkopenija, anemija in okužba.
English: Indigo carmine aluminium lake (E132) Iron oxide black (E172) Iron oxide red (E172)
Slovenian: Pokrovček indigotin (E132) titanov dioksid (E171) želatina
English: Pharmacokinetic parameters were evaluated in 49 paediatric renal transplant patients (aged 2 to 18°years) given 600°mg/m2 mycophenolate mofetil orally twice daily.
Slovenian: Pediatrična populacija Farmakokinetične parametre so opazovali pri 49 otrocih in mladostnikih z ledvičnim presadkom (starih od
English: There is no basis for Myfenax dose adjustment following cardiac transplant rejection.
Slovenian: Pri zavrnitvi srčnega presadka prilagajanje odmerkov zdravila Myfenax ni potrebno.
English: Acidosis, hyperkalaemia, hypokalaemia, hyperglycaemia, hypomagnesaemia, hypocalcaemia,
Slovenian: okužba, bronhitis, faringitis, sinuzitis, glivična okužba kože,
English: Pleural effusion, dyspnoea, cough
Slovenian: kandidoza kože, vaginalna kandidoza, rinitis
English: Myfenax should be administered with caution in patients with active serious digestive system disease.
Slovenian: Bolnikom s hujšimi boleznimi prebavil v aktivnih fazah dajemo zdravilo Myfenax zelo previdno in pod skrbnim zdravniškim nadzorom.
English: • The Package Leaflet
Slovenian: • vnetje prebavil
English: Indigo carmine aluminium lake (E132) Iron oxide black (E172)
Slovenian: indigotin (E132) titanov dioksid (E171) želatina
English: In a single dose study (6 subjects/group), mean plasma MPA AUC observed in subjects with severe chronic renal impairment (glomerular filtration rate < 25 mL/min/1.73 m2) were 28-75% higher relative to the means observed in normal healthy subjects or subjects with lesser degrees of renal impairment.
Slovenian: (glomerulna filtracija < 25 ml/mim/1,73 m2) srednji AUC mikofenolne kisline v plazmi za 28 do 75 %
English: • if you are breast-feeding.
Slovenian: • če dojite.
English: These data support extrapolation of this finding to all antacids because the reduction in exposure when mycophenolate mofetil was co- administered with magnesium and aluminium hydroxides is considerably less than when mycophenolate mofetil was co-administered with PPIs.
Slovenian: Myfenax sočasno uporabljeno z magnezijevimi in aluminijevi hidroksidi, občutno manjše v primerjavi s sočasno uporabo zdravila Myfenax in zaviralcev protonske črpalke.
English: If you take more Myfenax than you should
Slovenian: Če ste vzeli večji odmerek zdravila Myfenax, kot bi smeli Pomembno je, da ne vzamete preveč tablet.
English: Furthermore, men should not donate semen during therapy or for 90 days following discontinuation of mycophenolate.
Slovenian: Bolniki prav tako ne smejo darovati semena med zdravljenjem in 90
English: Hard capsules
Slovenian: 100 kapsul
English: Intravenous use vial (glass) 1 ml
Slovenian: Intravenska uporaba viala (steklena)
English: 1 vial
Slovenian: 1 ml
English: In addition, the Committee considered that the proposed risk minimisation activities were not able to reduce the risks to an acceptable level.
Slovenian: Poleg tega je Odbor menil, da predlagani ukrepi ne morejo zmanjšati tveganja na sprejemljivo raven.
English: Risk Minimisation Measures
Slovenian: Ukrepi za zmanjševanje tveganja
English: In addition, in some member states it had been both difficult and time-consuming to collate the relevant data for the purposes of the Article 31 referral, and it would be impractical and, in the medium term, unfeasible to monitor the effectiveness of risk minimization activities in these countries.
Slovenian: V nekaterih državah članicah je bilo težavno in zamudno zbirati ustrezne podatke za namene napotitve v skladu s členom 31, poleg tega bi bilo nepraktično in, srednjeročno gledano, neizvedljivo spremljati učinkovitost aktivnosti za zmanjševanje tveganja v teh državah.
English: - The Committee considered the referral made under article 31 of Directive 2001/83/EC, as amended for medicinal products containing dextropropoxyphene;
Slovenian: - Odbor je obravnaval napotitev v skladu s členom 31 Direktive 2001/83/ES, kakor je bila spremenjena, za zdravila, ki vsebujejo dekstropropoksifen;
English: - The Committee assessed the grounds for re-examination submitted by a group of MAHs on 15 July 2009, the information provided by the MAHs at an oral explanation on 20 October 2009 and the scientific discussion within the Committee;
Slovenian: - Odbor je ocenil razloge za ponovno presojo, ki jih je dne 15. julija 2009 predložila skupina imetnikov dovoljenj za promet z zdravilom, ustno razlago imetnikov dovoljenj za promet z dne 20. oktobra 2009 in znanstveno razpravo v okviru Odbora;
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR WITHDRAWAL OF THE MARKETING AUTHORISATIONS PRESENTED BY THE EUROPEAN MEDICINES AGENCY
Slovenian: DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA UMIK DOVOLJENJ ZA PROMET Z ZDRAVILOM, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
English: Since the benefit/risk reviews of dextropropoxyphene containing products were carried out in the UK, Sweden, France, and Ireland in 2005 - following which the fixed dose combination product (paracetamol + dextropropoxyphene) was withdrawn from the market in the UK, Sweden, and Ireland - a substantial body of important new safety information has become available.
Slovenian: Pregledi koristi in tveganj za zdravila z dekstropropoksifenom, ki so bili izvedeni v Združenem kraljestvu, na Švedskem, v Franciji in na Irskem leta 2005 - posledica tega je bil umik kombiniranega zdravila s fiksnim odmerkom (paracetamol + dekstropropoksifen) s trga v Združenem kraljestvu, na Švedskem in Irskem - so zagotovili številne pomembne nove informacije o varnosti.
English: Across Member States, the authorised indications considerably vary from “moderate to severe pain”, “mild to moderate pain”, and “acute and chronic pains of different origins”.
Slovenian: V državah članicah so v odobrenih indikacijah velike razlike, in sicer segajo od „zmerne do hude bolečine“, „blage do zmerne bolečine“ do „akutne in kronične bolečine različnega izvora“.
English: On the basis of evidence of harm from reports of fatal overdose, of divergent safety reviews and previous regulatory action taken in several Member States, the European Commission initiated a referral under Article 31(2) of Directive 2001/83/EC, as amended, to address this public health issue for medicinal products containing dextropropoxyphene and paracetamol, and therefore referred the matter to the CHMP on 30 November 2007.
Slovenian: Na osnovi dokazov o škodljivih učinkih iz poročil o smrtnih izidih zaradi prevelikih odmerkov, različnih varnostnih pregledih in preteklih regulativnih ukrepov, opravljenih v več državah članicah, je Evropska komisija sprožila napotitveni postopek po členu 31(2) Direktive 2001/83/ES, kakor je bila spremenjena, za obravnavo tega vprašanja javnega zdravja za zdravila, ki vsebujejo dekstropropoksifen in paracetamol, in je zato dne 30. novembra 2007 napotila zadevo na CHMP.
English: Therefore the CHMP recommended the withdrawal of all Marketing Authorisations for medicinal products containing dextropropoxyphene.
Slovenian: Zato je CHMP priporočil umik vseh dovoljenj za promet z zdravili, ki vsebujejo dekstropropoksifen.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF DEXTROPROPOXYPHENE CONTAINING MEDICINAL PRODUCTS (see Annex I)
Slovenian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVIL, KI VSEBUJEJO DEKSTROPROPOKSIFEN (glejte Dodatek I)
English: For the equivalent dose of dextropropoxyphene combined with paracetamol 650 mg the NNT was 4.4 (3.5 to 5.6) when compared with placebo, indicating higher efficacy.
Slovenian: Za enakovreden odmerek dekstropropoksifena v kombinaciji s paracetamolom 650 mg je bila vrednost NNT 4,4 (od 3,5 do 5,6) v primerjavi s placebom, kar kaže na večjo učinkovitost.
English: For a single dose of dextropropoxyphene 65 mg in postoperative pain the number needed to treat to benefit for at least 50% pain relief was 7.7 (95% confidence interval 4.6 to 22) when compared with placebo over 4-6 hours.
Slovenian: Za enojen odmerek dekstropropoksifena 65 mg za postoperativno bolečino je bilo število bolnikov, potrebnih za doseganje koristi vsaj 50-odstotnega olajšanja bolečine, 7,7 (95-odstotni interval zaupanja od 4,6 do 22) v primerjavi s placebom v obdobju 4-6 ur.
English: A group of MAHs disagreed with the opinion recommending the withdrawal of the Marketing Authorisations and requested a re-examination of the opinion.
Slovenian: Skupina imetnikov dovoljenja za promet z zdravilom se ni strinjala s priporočilom o umiku dovoljenja za promet z zdravilom in je zahtevala ponovno presojo mnenja.
English: Dextropropoxyphene containing medicinal products (as single component or combination with paracetamol or paracetamol/caffeine) are used in the symptomatic treatment of pain and are currently authorised in several Member States.
Slovenian: Zdravila, ki vsebujejo dekstropropoksifen (kot edino sestavino ali v kombinaciji s paracetamolom ali paracetamolom in kofeinom), se uporabljajo za simptomatsko zdravljenje bolečin in so trenutno odobrena v več državah članicah.
English: In addition, a smaller pack size is unlikely to result in smaller stocks of medication at home, since a patient being treated for chronic pain might well be given a month's supply in one go.
Slovenian: Poleg tega manjša velikost pakiranja najverjetneje ne bi vplivala na zmanjšanje količine zdravila doma, saj utegne bolnik, ki se zdravi za kroničnimi bolečinami, prejeti mesečno količino naenkrat.
English: The CHMP also considered that data collected from national poison centres have limitations in this situation as dextropropoxyphene can cause death extremely rapidly (in under an hour); if a patient dies before reaching medical attention, the poisons centre is unlikely to be contacted.
Slovenian: CHMP je menil, da so podatki, zbrani iz nacionalnih centrov za zastrupitve, v tem primeru omejeni, saj lahko dekstropropoksifen povzroči smrt zelo hitro (v manj kot eni uri); če bolnik umre preden dobi zdravniško pomoč, centri za zastrupitve verjetno niso obveščeni.
English: Rectal use
Slovenian: Rektalna uporaba
English: Similarly in Ireland, analysis in 2009 of further data from the Alcohol and Drug Research Unit of the Health Research Board revealed significant under-reporting of deaths associated with dextropropoxyphene-containing products - indicating fatality rates fifteen-fold higher than previously reported.
Slovenian: Podobno je leta 2009 na Irskem analiza nadaljnjih podatkov enote za raziskavo zlorabe alkohola in drog Raziskovalnega odbora za zdravje razkrila bistveno premajhno poročanje o smrtih, povezanih z zdravili, ki vsebujejo dekstropropoksifen, kar je pomenilo petnajstkrat večjo stopnjo umrljivosti od stopnje, o kateri so poročali dotlej.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATIONS AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Slovenian: DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH