natgillin/translations-raw huggingface dataset:
The recommended dose in cardiac transplant patients is 1.5°g administered twice daily (3°g daily dose).
Priporočeni odmerek pri bolnikih s srčnim presadkom je 1,5 g dvakrat na dan (dnevni odmerek 3 g).
• Microphthalmia;
• mikroftalmija,
• 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.
• Pri nosečnicah, izpostavljenih mofetilmikofenolatu, so poročali o spontanih splavih pri 45 do 49 %
The pharmacokinetics of oral contraceptives were unaffected by co-administration of mycophenolate mofetil (see also section 4.5).
Sočasno jemanje mofetilmikofenolata in peroralnih kontraceptivov ni vplivalo na farmakokinetiko peroralnih kontraceptivov (glejte tudi poglavje 4.5).
Hepatitis, jaundice, hyperbilirubinaemia
Bolezni jeter, žolčnika in žolčevodov zelo pogosti pogosti hepatitis, zlatenica, hiperbilirubinemija
Name and address of the manufacturers responsible for batch release
A. IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ Ime in naslov izdelovalca, odgovornega za sproščanje serij
The recommended daily dose is 12°capsules (3°g of the active ingredient) taken as 2 separate doses.
Priporočeni dnevni odmerek je 12 kapsul (3 g zdravilne učinkovine), razdeljenih na dva posamezna odmerka.
The recommended oral dose in hepatic transplant patients is 1.5°g administered twice daily (3°g daily dose).
Priporočeni peroralni odmerek pri bolnikih z jetrnim presadkom je 1,5 g dvakrat na dan (dnevni odmerek 3 g).
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.
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.
The recommended daily dose is 4°tablets (2°g of the active ingredient) taken as 2°separate doses.
Priporočeni dnevni odmerek je 4 tablete (2 g zdravilne učinkovine), zaužite kot 2 posamezna odmerka.
• fungal infection of the digestive tract
• glivična okužba prebavil
Iron oxide red (E172)
Telo rdeči železov oksid (E172)
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.
Srednja biološka uporabnost peroralne oblike mofetilmikofenolata, temelječa na AUC mikofenolne kisline, znaša 94 % glede na intravenske oblike mofetilmikofenolata.
• The active substance is mycophenolate mofetil.
Aktivni presnovek mofetilmikofenolata je mikofenolna kislina (MFK).
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.
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,
Myfenax 250mg hard capsules Mycophenolate mofetil
Navodilo za uporabo Myfenax 250 mg trde kapsule mofetilmikofenolat
Hypromellose (HPMC 2910) Titanium dioxide (E171) Macrogol (PEG 400) Talc
Obloga tablete hipromeloza (E464) titanov dioksid (E171) makrogol smukec indigotin (E132)
The recommended daily dose is 6°tablets (3°g of the active ingredient) taken as 2°separate doses.
Priporočeni dnevni odmerek je 6 tablet (3 g zdravilne učinkovine), razdeljenih na 2 posamezna odmerka.
This includes:
Vsebujejo naj naslednje ključne elemente:
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.
in Cmax mikofenolne kisline, aktivnega presnovka mofetilmikofenolata, zaradi sočasnega dajanja takrolimusa ni bila pomembna.
• infection of the digestive tract
• okužba sečil
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.
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.
Medicinal products that affect glucuronidation (e.g. isavuconazole, telmisartan) Concomitant administration of drugs inhibiting glucuronidation of MPA may increase MPA exposure.
Sočasna uporaba zdravil, ki zavirajo glukuronidacijo mikofenolne kisline, lahko poveča izpostavljenost mikofenolni kislini.
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.
vključno z lanzoprazolom in pantroprazolom, skupaj z zdravilom Myfenax, so opazili zmanjšano izpostavljenost mikofenolni kislini.
However, keep taking Myfenax until you see him or her.
Vendar pa do obiska zdravnika nadaljujte z jemanjem zdravila Myfenax.
Very common Vomiting, abdominal pain, diarrhoea, nausea Common
Žilne bolezni zelo pogosti pogosti hipotenzija, hipertenzija, vazodilatacija
System organ class Frequency Adverse drug reactions hypercholesterolaemia, hyperlipidaemia, hypophosphataemia, hyperuricaemia, gout, anorexia Psychiatric disorders Very commonCommon
Bolezni krvi in limfatičnega sistema zelo pogosti levkopenija, trombocitopenija, anemija pogosti pancitopenija, levkocitoza
Body
Telo:
Men should not donate semen during therapy or for 90 days following discontinuation of mycophenolate.
Bolniki med zdravljenjem z mofetilmikofenolatom in vsaj še 90 dni po njegovi ukinitvi ne smejo darovati sperme.
Do not open or crush the capsules and breathe the powder inside the capsules or allow it to touch your skin.
Kapsul ne smete lomiti ali zmečkati.
Myfenax 500 mg film-coated tablets Mycophenolate mofetil
Myfenax 500 mg filmsko obložene tablete mofetilmikofenolat
If you are not sure, talk to your doctor or pharmacist before taking Myfenax.
Myfenax, se pred tem pogovorite s svojim zdravnikom ali farmacevtom.
You must not donate blood during treatment with Myfenax and for at least 6 weeks after stopping treatment.
Med zdravljenjem in vsaj še 6 tednov po končanem zdravljenju z zdravilom Myfenax ne smete darovati krvi.
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.
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.
Indigo carmine aluminium lake (E132) Iron oxide black (E172) Iron oxide red (E172)
Pokrovček indigotin (E132) titanov dioksid (E171) želatina
Pharmacokinetic parameters were evaluated in 49 paediatric renal transplant patients (aged 2 to 18°years) given 600°mg/m2 mycophenolate mofetil orally twice daily.
Pediatrična populacija Farmakokinetične parametre so opazovali pri 49 otrocih in mladostnikih z ledvičnim presadkom (starih od
There is no basis for Myfenax dose adjustment following cardiac transplant rejection.
Pri zavrnitvi srčnega presadka prilagajanje odmerkov zdravila Myfenax ni potrebno.
Acidosis, hyperkalaemia, hypokalaemia, hyperglycaemia, hypomagnesaemia, hypocalcaemia,
okužba, bronhitis, faringitis, sinuzitis, glivična okužba kože,
Pleural effusion, dyspnoea, cough
kandidoza kože, vaginalna kandidoza, rinitis
Myfenax should be administered with caution in patients with active serious digestive system disease.
Bolnikom s hujšimi boleznimi prebavil v aktivnih fazah dajemo zdravilo Myfenax zelo previdno in pod skrbnim zdravniškim nadzorom.
• The Package Leaflet
• vnetje prebavil
Indigo carmine aluminium lake (E132) Iron oxide black (E172)
indigotin (E132) titanov dioksid (E171) želatina
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.
(glomerulna filtracija < 25 ml/mim/1,73 m2) srednji AUC mikofenolne kisline v plazmi za 28 do 75 %
• if you are breast-feeding.
• če dojite.
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.
Myfenax sočasno uporabljeno z magnezijevimi in aluminijevi hidroksidi, občutno manjše v primerjavi s sočasno uporabo zdravila Myfenax in zaviralcev protonske črpalke.
If you take more Myfenax than you should
Če ste vzeli večji odmerek zdravila Myfenax, kot bi smeli Pomembno je, da ne vzamete preveč tablet.
Furthermore, men should not donate semen during therapy or for 90 days following discontinuation of mycophenolate.
Bolniki prav tako ne smejo darovati semena med zdravljenjem in 90
Hard capsules
100 kapsul
Intravenous use vial (glass) 1 ml
Intravenska uporaba viala (steklena)
In addition, the Committee considered that the proposed risk minimisation activities were not able to reduce the risks to an acceptable level.
Poleg tega je Odbor menil, da predlagani ukrepi ne morejo zmanjšati tveganja na sprejemljivo raven.
Risk Minimisation Measures
Ukrepi za zmanjševanje tveganja
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.
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.
- The Committee considered the referral made under article 31 of Directive 2001/83/EC, as amended for medicinal products containing dextropropoxyphene;
- Odbor je obravnaval napotitev v skladu s členom 31 Direktive 2001/83/ES, kakor je bila spremenjena, za zdravila, ki vsebujejo dekstropropoksifen;
- 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;
- 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;
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR WITHDRAWAL OF THE MARKETING AUTHORISATIONS PRESENTED BY THE EUROPEAN MEDICINES AGENCY
DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA UMIK DOVOLJENJ ZA PROMET Z ZDRAVILOM, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
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.
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.
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”.
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“.
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.
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.
Therefore the CHMP recommended the withdrawal of all Marketing Authorisations for medicinal products containing dextropropoxyphene.
Zato je CHMP priporočil umik vseh dovoljenj za promet z zdravili, ki vsebujejo dekstropropoksifen.
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF DEXTROPROPOXYPHENE CONTAINING MEDICINAL PRODUCTS (see Annex I)
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVIL, KI VSEBUJEJO DEKSTROPROPOKSIFEN (glejte Dodatek I)
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.
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.
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.
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.
A group of MAHs disagreed with the opinion recommending the withdrawal of the Marketing Authorisations and requested a re-examination of the opinion.
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.
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.
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.
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.
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.
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.
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.
Rectal use
Rektalna uporaba
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.
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.
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATIONS AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
Furthermore, the lack of long term efficacy data did not allow any definite conclusions to be drawn on the efficacy of the dextropropoxyphene medicinal products as a long-term treatment.
Poleg tega pomanjkanje podatkov o dolgoročni učinkovitosti ne omogoča dokončnih zaključkov o učinkovitosti zdravil, ki vsebujejo dekstropropoksifen, za dolgoročno zdravljenje.
The overall safety profile of the dextropropoxyphene containing medicinal products is based on an extensive post-marketing experience (over 40 years).
Skupni varnostni profil zdravil, ki vsebujejo dekstropropoksifen, temelji na obsežnih izkušnjah, pridobljenih, odkar je zdravilo na trgu (več kot 40 let).
The most frequently reported adverse reactions with fatal outcome involved hepatobiliary disorders, skin disorders, general disorders, blood and lymphatic disorders, nervous system disorders, gastrointestinal disorders and cardiac disorders.
Najpogosteje opisani neželeni učinki s smrtnim izidom so bila obolenja jeter, žolčnika in žolčevodov, bolezni kože, splošne težave, bolezni krvi in limfnega sistema, bolezni živčevja, bolezni prebavil in srčne bolezni.
This means that one in every eight subjects with pain of moderate to severe intensity would experience at least 50% pain relief with dextropropoxyphene 65 mg who would not have done so with placebo.
To pomeni, da bi se vsakemu osmemu preiskovancu z bolečino zmerne do hude intenzivnosti z dekstropropoksifenom 65 mg bolečina zmanjšala za najmanj 50 %, kar se ne bi zgodilo s placebom.
Available efficacy data are limited due to methodological shortcomings such as the absence of a sample size calculation in the majority of the double-blind studies in acute pain and the lack of long term efficacy data to support the use of the fixed combination of dextropropoxyphene and paracetamol as a prolonged treatment.
Razpoložljivi podatki o učinkovitosti so omejeni zaradi metodoloških pomanjkljivosti, kot sta odsotnost izračuna velikosti vzorca v večini dvojno slepih študij akutne bolečine in pomanjkanje podatkov o dolgoročni učinkovitosti v podporo uporabi fiksne kombinacije dekstropropoksifena in paracetamola za dolgoročno zdravljenje.
Pharmaceutical Form Route of Administration
Farmacevtska oblika Pot uporabe zdravila
Risk Minimisation measures proposed by the MAHs included restriction of the use of the product (i.e. changes in SPC to restrict the population; pack size reduction), modification of the posology (e.g. reduction of posology in elderly population) and addition of further safety warnings (e.g. on concomitant use with alcohol, dependence and tolerance, combination with other central acting analgesics and overdose in children).
Ukrepi za zmanjševanje tveganja, ki so jih predlagali imetniki dovoljenja za promet z zdravilom, so vključevali omejitev uporabe zdravila (tj. spremembe v povzetku glavnih značilnosti zdravila za omejitev populacije, zmanjšanje velikosti pakiranja), spremembe načina odmerjanja (npr. zmanjšanje odmerjanja pri starejši populaciji) in dodajanje nadaljnjih varnostnih opozoril (npr. o sočasni uporabi z alkoholom, odvisnosti in toleranci, kombinaciji z drugimi analgetiki s centralnim delovanjem ter prekomernem odmerjanju pri otrocih).
Also, research in the UK demonstrated the benefits of the withdrawal of dextropropoxyphene from the market - with clear evidence of a fall in number of deaths associated with dextropropoxyphene, but without any rise in mortality from poisoning with other common analgesics.
Poleg tega je raziskava v Združenem kraljestvu dokazala koristi umika dekstropropoksifena s trga z jasno dokazanim zmanjšanjem števila smrti, povezanih z dekstropropoksifenom, vendar brez povečanja umrljivosti zaradi zastrupitve z drugimi običajnimi analgetiki.
The narrow therapeutic index means that accidental overdose is a real possibility under normal conditions of use, particularly for patients on certain concomitant medications or when combined with even a small amount of alcohol.
Ozek terapevtski indeks pomeni, da je nenamerno prekomerno odmerjanje dejansko možno pod normalnimi pogoji uporabe, zlasti pri bolnikih z določenimi sočasno uporabljanimi zdravili ali v kombinaciji z že zelo majhno količino alkohola.
Similarly, proposals to limit supplies for each prescription to at most 15 days, or one month, before review is needed by the prescriber, are unlikely to be of any significant benefit in risk minimisation: the patient will still have access to significant large quantity in excess of the lethal dose.
Podobno ni verjetno, da bi imeli predlogi za omejitev količine na posamezen recept za največ 15 dni oz. en mesec, preden zdravnik, ki predpisuje zdravilo, zahteva pregled, pomembne koristi pri zmanjševanju tveganja: bolnik bo še vedno imel dostop do količine, ki je bistveno večja od smrtnega odmerka.
Ibuprofen has also shown to be more effective, as a single dose, in the management of severe postoperative pain; tramadol being equally effective in this setting.
Za ibuprofen so dokazali, da je v enojnem odmerku učinkovitejši pri obvladovanju hude postoperativne bolečine, pri čemer je enako učinkovit tudi tramadol.
One possible risk minimisation measure, a reduced pack size (e.g. to only 10 tablets), is unlikely to be of any significant benefit in risk minimisation as the lethal dose (particularly when taken with alcohol) is under 10 tablets.
Eden izmed možnih ukrepov za zmanjševanje tveganja - zmanjšana velikost pakiranja (npr. na le 10 tablet) - najverjetneje ne bi pomenil bistvenih koristi za zmanjševanje tveganja, saj je smrtni odmerek (zlasti ob sočasni uporabi z alkoholom) manj kot 10 tablet.
The CHMP reviewed the data submitted by the MAHs to address the above-mentioned concerns as well as the available data from Member States in relation to drug poisoning that involves dextropropoxyphene and the investigation of suspicious deaths in their countries.
CHMP je pregledal podatke, ki so jih predložili imetniki dovoljenj za promet z zdravili za obravnavo zgoraj omenjenih zadržkov, ter razpoložljive podatke držav članic o zastrupitvah z zdravili, ki vsebujejo dekstropropoksifen, in o preiskavah sumljivih smrtnih primerov v posameznih državah.
Benefit-Risk
Razmerje med koristmi in tveganji
GROUNDS FOR WITHDRAWAL OF THE MARKETING AUTHORISATIONS
PODLAGA ZA UMIK DOVOLJENJ ZA PROMET Z ZDRAVILI