natgillin/translations-raw huggingface dataset:
• Cases of ergotism or potentially related symptoms were most frequently reported with dihydroergotamine.
• o primerih ergotizma ali simptomih, ki bi lahko bili povezani z njim, so najpogosteje poročali pri uporabi dihidroergotamina.
The CHMP noted that there is a plausible mechanism by which ergot-derivatives could cause fibrosis and ergotism.
Odbor CHMP je ugotovil, da obstaja verjeten mehanizem, s katerim bi derivati ergot-alkaloidov lahko povzročali fibrozo in ergotizem.
− Symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in the elderly (excluding Alzheimer's disease and other dementia);
− simptomatsko zdravljenje kronične patološke kognitivne in nevrosenzorične okvare pri starejših (izključujoč Alzheimerjevo bolezen in druge oblike demence);
The CHMP noted the difficulty of diagnosing fibrosis (due to delayed onset of symptoms) and the probability of under-reporting of fibrotic reactions.
Odbor CHMP je izpostavil, da je fibrozo težko odkriti (zaradi zapoznelega nastopa simptomov) in da zato obstaja verjetnost, da niso poročali o vseh fibrotičnih reakcijah;
− Orthostatic hypotension;
− ortostatska hipotenzija;
The re-examination concluded on 24 October 2013 with the Committee maintaining its previous recommendation, which will now be sent to the European Commission.
Ponoven pregled mnenja se je zaključil dne 24 ktobra 2013, odbor pa je potrdil svoja prejšnja priporočila.
The varying affinity for serotoninergic receptors of the different ergot derivatives, and the therapeutic doses used, may explain the differences observed in reporting frequencies for the fibrotic reactions.
Različna afiniteta za serotoninergične receptorje, ki jo imajo različni derivati ergot-alkaloidov in uporabljeni terapevtski odmerki bi lahko pojasnila razlike, opažene pri pogostnosti poročanja o fibrotičnih reakcijah;
− Ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin;
− dodatno zdravljenje zmanjšane ostrine vida in motenj vidnega polja, za katere se domneva, da so žilnega izvora;
Medicines containing ergot derivatives have an effect on blood circulation and they have been used for decades to treat conditions involving circulatory problems.
Zdravila, ki vsebujejo derivate ergot-alkaloidov, učinkujejo na krvni obtok in se že desetletja uporabljajo za zdravljenje bolezni, za katere so značilne težave s prekrvavitvijo.
They have also been used for treating chronic pathological cognitive and neurosensorial impairment (problems with memory and sensation) and for preventing migraine headaches.
Uporabljajo se tudi za zdravljenje kroničnih patoloških kognitivnih in nevrosenzoričnih okvar (težav s spominom in občutljivostjo) ter za preprečevanje migrenskih glavobolov.
− Ancillary treatment of Raynaud's syndrome;
− dodatno zdravljenje Raynaudovega sindroma;
This is based on a review of data showing an increased risk of fibrosis (formation of excess connective tissue that can damage organs and body structures) and ergotism (symptoms of ergot poisoning, such as spasms and obstructed blood circulation) with these medicines.
Priporočila temeljijo na pregledu podatkov, ki kažejo, da uporaba teh zdravil poveča tveganje za fibrozo (tvorbo odvečnega vezivnega tkiva, ki lahko poškoduje organe in telesne strukture) ter ergotizem (simptome zastrupitve z ergot-alkaloidi, kot so krči in zapora krvnega obtoka).
In its review, the CHMP considered all available data on the benefits and risks of ergot derivatives, including data from clinical studies, post-marketing safety reports and the published literature.
Med pregledom je odbor CHMP proučil vse razpoložljive podatke o koristih in tveganjih, povezanih z derivati ergot-alkaloidov, vključno s podatki iz kliničnih študij, poročil o varnosti iz obdobja trženja in objavljene literature.
• Ergot derivatives are recognised as being capable of inducing fibrosis, in particular heart valve fibrosis, through serotoninergic receptor activation, which is extensively described in the literature.
• znano je, da lahko derivati ergot-alkaloidov povzročijo fibrozo, še zlasti fibrozo srčne zaklopke, z aktivacijo serotoninergičnih receptorjev, kar je obširno opisano v literaturi.
• Medicines containing substances known as ergot derivatives can have serious side effects, called fibrosis and ergotism.
• Zdravila, ki vsebujejo učinkovine, imenovane derivati ergot-alkaloidov, lahko povzročijo resne neželene učinke, imenovane fibroza in ergotizem.
The CHMP opinion follows a review of available safety and efficacy data on ergot derivatives in the above indications, including clinical studies, post-marketing data in Europe and the published literature:
Odbor CHMP je mnenje izdal na podlagi pregleda razpoložljivih podatkov o varnosti in učinkovitosti derivatov ergot-alkaloidov pri zgoraj navedenih indikacijah, vključno s podatki iz kliničnih študij, podatki iz obdobja trženja v Evropi in objavljene literature:
Several cases of ergotism or symptoms potentially related to ergotism (including severe cases of symptoms of constriction of peripheral blood vessels) were also identified with the other ergot derivatives.
Več primerov ergotizma ali simptomov, ki bi lahko bili povezani z njim (vključno s hudimi primeri simptomov zožitve perifernih žil), so zabeležili tudi pri drugih derivatih ergotalkaloidov;
These medicines should no longer be used to treat several conditions involving blood circulation problems or problems with memory and sensation, or to prevent migraine headaches, since the risks are greater than the benefits in these indications.
Ta zdravila se ne smejo več uporabljati za zdravljenje različnih bolezni, ki vključujejo težave s krvnim obtokom ter težave s spominom in občutljivostjo, ter za preprečevanje migrenskega glavobola, saj so pri teh indikacijah tveganja večja od koristi.
• Fibrosis was most frequently reported with dihydroergotamine, including retroperitoneal, cardiac, pulmonary and pleural fibrosis.
• o fibrozi so najpogosteje poročali pri uporabi dihidroergotamina, in sicer o fibrozi v retroperitonealnem prostoru, predelu srca, pljuč in plevralnem predelu.
− Acute retinopathies of vascular origin;
− akutna retinopatija žilnega izvora;
As a result, they should no longer be used in the EU to treat a number of conditions involving blood circulation problems (that usually affect elderly patients) or problems with memory and sensation, or to prevent migraine headaches, as the risks outweigh the benefits.
Ta zdravila se zato v EU ne smejo več uporabljati za zdravljenje različnih bolezni, ki vključujejo težave s krvnim obtokom (ki običajno prizadenejo starejše bolnike) ter težave s spominom in občutljivostjo, ter za preprečevanje migrenskega glavobola, saj so tveganja večja od koristi.
− Prophylaxis of migraine headache;
− preprečevanje migrenskega glavobola;
Ergot derivatives are substances derived from a group of fungi commonly known as ergot.
Derivati ergot-alkaloidov so snovi, pridobljene iz skupine gliv, ki so splošno znane pod imenom rženi rožički.
• Healthcare professionals should stop prescribing medicines containing dihydroergocristine, dihydroergotamine, dihydroergotoxine, nicergoline or a combination of dihydroergocryptine with caffeine, for any of the following indications:
• Zdravstveni delavci ne smejo več predpisovati zdravil, ki vsebujejo dihidroergokristin, dihidroergotamin, dihidroergotoksin, nicergolin ali kombinacijo dihidroergokriptina in kofeina, za naslednje indikacije:
There were fewer reports of fibrotic reactions with the other ergot derivatives.
Pri uporabi drugih derivatov ergot-alkaloidov je bilo poročil o fibrotičnih reakcijah manj.
In some EU Member States, ergot derivatives are also authorised for other indications such as treatment of dementia, including Alzheimer's disease, and treatment (as opposed to prevention) of acute migraine headache.
V nekaterih državah članicah EU pa so derivati ergot-alkaloidov odobreni tudi za druge indikacije, kot sta na primer zdravljenje demence, vključno z Alzheimerjevo boleznijo, in zdravljenje (namesto preprečevanja) akutnega migrenskega glavobola.
Certain ergot derivatives have been used to treat conditions usually affecting elderly patients, such as peripheral arterial occlusive disease (PAOD, where the body's large arteries become obstructed) causing pain when walking, and Raynaud's syndrome (where the blood supply is blocked to the extremities, usually the fingers and toes), as well as eyesight disturbances due to blood circulation problems.
To so na primer periferna arterijska okluzivna bolezen (PAOD, za katero je značilna zamašitev velikih arterij v telesu), ki povzroča bolečine pri hoji, Raynaudov sindrom (bolezen, pri kateri je oviran pretok krvi v ude, zlasti prste na rokah in nogah) ter motnje vida zaradi težav s prekrvavitvijo.
Five ergot derivatives were considered in the CHMP review: dihydroergocristine, dihydroergotamine, dihydroergotoxine, nicergoline and the combination of dihydroergocryptine with caffeine.
V pregledu, ki ga je opravil odbor CHMP, so obravnavali pet derivatov ergot-alkaloidov: dihidroergokristin, dihidroergotamin, dihidroergotoksin, nicergolin ter kombinacijo dihidroergokriptina in kofeina.
• Some ergot derivatives are approved in some EU Member States for use in other therapeutic indications, including other circulatory disorders, treatment of dementia (including Alzheimer's disease) and treatment of acute migraine.
• Nekateri derivati ergot-alkaloidov so v nekaterih državah članicah EU odobreni za uporabo pri drugih terapevtskih indikacijah, ki vključujejo druge motnje krvnega obtoka, zdravljenje demence (vključno z Alzheimerjevo boleznijo) in zdravljenje akutne migrene.
• You should make a non-urgent appointment with your doctor if you are taking a medicine containing any of these substances: dihydroergocristine, dihydroergotamine, dihydroergotoxine, nicergoline or a combination of dihydroergocryptine with caffeine.
• Naročite se na neurgenten obisk pri zdravniku, če jemljete zdravilo, ki vsebuje katero koli od naslednjih učinkovin: dihidroergokristin, dihidroergotamin, dihidroergotoksin, nicergolin ali kombinacijo dihidroergokriptina in kofeina.
In some EU countries, certain ergot derivatives are also authorised for other indications not covered by the CHMP review, including other circulatory disorders, treatment of dementia (including Alzheimer's disease) and treatment of acute migraine.
Nekateri derivati ergot-alkaloidov so v nekaterih državah EU odobreni tudi za druge indikacije, ki jih odbor CHMP med pregledom ni obravnaval in vključujejo druge motnje krvnega obtoka, zdravljenje demence (vključno z Alzheimerjevo boleznijo) ter zdravljenje akutne migrene.
Ergot derivatives that are only indicated for these conditions will have their marketing authorisations suspended across the EU.
Dovoljenja za promet z derivati ergot-alkaloidov, ki so indicirani samo za te bolezni, bodo v EU začasno umaknjena.
The European Commission has already endorsed the CHMP opinion for 4 other ergot derivatives (dihydroergocristine, dihydroergotamine, nicergoline dihydroergocryptine), adopting a final legally binding decision on 27 September 2013.
Evropska komisija je dne 27. septembra 2013 potrdila mnenje odbora CHMP o dihidroergokristinu, dihidroergotaminu, nicergolinu in dihidroergokriptinu, dne 18. decembra 2013 pa tudi mnenje o dihidroergotoksinu.
The CHMP opinion on dihydroergotoxine will now be forwarded to the European Commission, which will issue a final decision in due course.
Odbor CHMP je priporočila posredoval Evropski komisiji, ki jih je potrdila in izdala končne pravno zavezujoče odločbe, ki veljajo za celotno EU.
7 vials + 7 pre-filled syringes + 14 injection needles + 14 alcohol swabs
7 vial + 7 napolnjenih injekcijskih brizg + 14 injekcijskih igli + 14 alkoholni blazinici
1 vial + 1 pre-filled syringe + 2 injection needles + 2 alcohol swabs
1 viala + 1 napolnjena injekcijska brizga + 2 injekcijski igli + 2 alkoholni blazinici
Strength Pharmaceutical form Route of administration
Številka EU Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina vsebina (koncentracija)
It is available as tablets (500 mg) and capsules (250 mg).
Na voljo je v obliki tablet (500 mg) in kapsul (250 mg).
This makes them less effective at recognising and attacking the transplanted organ, lowering the risk of the organ being rejected.
Zaradi tega so manj učinkoviti pri prepoznavanju in napadanju presajenega organa, kar zmanjšuje tveganje zavrnitve organa.
The full EPAR for Myclausen can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Myclausen je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
This means that Myclausen is similar to a ‘reference medicine' already authorised in the European Union (EU) called Cellcept.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu CellCept.
The European Commission granted a marketing authorisation valid throughout the EU for Myclausen on 7 October 2010.
Evropska komisija je dovoljenje za promet z zdravilom Myclausen, veljavno po vsej Evropski uniji, odobrila dne 7. oktobra 2010.
In children aged between two and 18 years, the dose of Myclausen is calculated depending on height and weight.
Pri otrocih, starih od 2 do 18 let, se odmerek zdravila Myclausen izračuna na osnovi telesne višine in mase.
What are the benefit and risk of Myclausen?
Kakšne so koristi in tveganja, povezani z zdravilom Myclausen?
Other information about Myclausen:
Druge informacije o zdravilu Myclausen:
For more information about treatment with Myclausen, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Myclausen preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Myclausen.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Myclausen, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Myclausen is not recommended for use in children after heart or liver transplants because of a lack of information on its effects in this group.
Uporaba zdravila Myclausen po presaditvi srca ali jeter pri otrocih ni priporočljiva zaradi nezadostnih podatkov o učinkih v tej starostni skupini.
Myclausen treatment should be initiated and maintained by a qualified transplant specialist.
Zdravljenje z zdravilom Myclausen mora uvesti in voditi specialist za presaditve.
Because Myclausen is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Ker je zdravilo Myclausen generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaka kot pri referenčnem zdravilu.
This document is a summary of the European public assessment report (EPAR) for Myclausen.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Myclausen.
In the body, it is converted into mycophenolic acid, which blocks an enzyme called ‘inosine monophosphate dehydrogenase'.
V telesu se pretvori v mikofenolno kislino, ki zavira encim, imenovan „inozin monofosfat-dehidrogenaza“.
Myclausen is a ‘generic medicine'.
Zdravilo Myclausen je „generično zdravilo“.
The CHMP concluded that, in accordance with EU requirements, Myclausen has been shown to have comparable quality and to be bioequivalent to Cellcept.
CHMP je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Myclausen primerljivo raven kakovosti kot zdravilo Cellcept ter da mu je biološko enakovredno.
Myclausen is used to prevent the body from rejecting a transplanted kidney, heart or liver.
Zdravilo Myclausen se uporablja za preprečevanje zavrnitve ledvice, srca in jeter po presaditvi.
For heart transplants, the recommended adult dose is 1.5 g twice a day, starting within five days following the transplant.
Pri presaditvah srca je priporočeni odmerek za odrasle bolnike 1,5 g zdravila dvakrat na dan z začetkom v petih dneh po presaditvi.
For liver transplants in adults, mycophenolate mofetil should be given as an infusion (drip into a vein) for the first four days after the transplant, before the patient is switched to Myclausen 1.5 g twice a day as soon as it can be tolerated.
Pri presaditvah jeter pri odraslih bolnikih je treba mofetilmikofenolat dajati kot infuzijo (kapalno infuzijo v veno) prve štiri dni po presaditvi, nato bolnik jemlje 1,5 g zdravila Myclausen dvakrat na dan, takoj ko ga lahko prenaša.
By preventing the production of new DNA, Myclausen reduces the rate at which the lymphocytes multiply.
S preprečevanjem nastajanja novega DNK zdravilo Myclausen zmanjša hitrost razmnoževanja limfocitov.
The Committee recommended that Myclausen be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Myclausen odobri dovoljenje za promet.
Myclausen mycophenolate mofetil
Myclausen mofetilmikofenolat
The dose may need to be adjusted in patients with liver or kidney disease.
Pri bolnikih z okvaro jeter ali ledvic je morda treba odmerek prilagoditi.
The way that Myclausen should be given and the dose depend on the type of organ transplant.
Način uporabe zdravila Myclausen in njegov odmerek sta odvisna od vrste presaditve.
The active substance in Myclausen, mycophenolate mofetil, is an immunosuppressive medicine.
Zdravilna učinkovina v zdravilu Myclausen, mofetilmikofenolat, je imunosupresivno zdravilo.
Why has Myclausen been approved?
Zakaj je bilo zdravilo Myclausen odobreno?
Myclausen is a medicine that contains the active substance mycophenolate mofetil.
Myclausen je zdravilo, ki vsebuje zdravilno učinkovino mofetilmikofenolat.
For kidney transplants, the recommended dose in adults is 1 g twice a day by mouth starting within 72 hours after the transplant.
Pri presaditvah ledvic je priporočeni odmerek za odrasle bolnike 1 g zdravila peroralno dvakrat na dan v 72 urah po presaditvi.
Because Myclausen is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Cellcept.
Ker je zdravilo Myclausen generično zdravilo, so bile opravljene le tiste študije na bolnikih, s katerimi so želeli dokazati, da je biološko enakovredno referenčnemu zdravilu, tj. zdravilu Cellcept.
Therefore, the CHMP's view was that, as for Cellcept, the benefit outweighs the identified risk.
Zato je CHMP menil, da so koristi zdravila Myclausen, tako kot pri zdravilu CellCept, večje od znanih tveganj.
How has Myclausen been studied?
Kako je bilo zdravilo Myclausen raziskano?
What is Myclausen?
Kaj je zdravilo Myclausen?
How does Myclausen work?
Kako zdravilo Myclausen deluje?
How is Myclausen used?
Kako se zdravilo Myclausen uporablja?
What is Myclausen used for?
Za kaj se zdravilo Myclausen uporablja?
32 weeks 144 weeks
32 tednov 144 tednov
You need to keep taking it every day to stop your illness getting worse.
Jemati ga morate redno in vsak dan, da se vaša bolezen ne bo slabšala.
How to measure the dose and take the medicine
Kako odmeriti odmerek in vzeti zdravilo
• if they drink alcohol
• ki uživajo alkohol,
Date of first authorisation: 8 July 1999 Date of latest renewal: 21 March 2014
Datum prve odobritve: 8. julij 1999 Datum zadnjega podaljšanja : 21. marec 2014
Swallow the tablets with some water.
Tablete zaužijte z nekaj vode.
It is a potent selective inhibitor of HIV-1 and HIV-2.
Je močan selektiven zaviralec HIV-1 in HIV-2.
• if you are seriously overweight (especially if you are a woman)
• če imate prekomerno telesno maso (še posebej, če ste ženska),
After first opening the container: 2 months
2 leti Po prvem odprtju vsebnika: 2 meseca
The duration of double-blind treatment was at least 48 weeks.
Dvojno slepo zdravljenje je trajalo vsaj 48 tednov.
Stay in regular contact with your doctor
Bodite v rednih stikih z vašim zdravnikom.
If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.
Če obstajajo dokazi o poslabšanju jetrnega obolenja pri takih bolnikih, je treba razmisliti o prekinitvi ali prenehanju zdravljenja.
Hold the bottle firmly.
Trdno držite plastenko.
ALERT CARD TEXT SIDE 1
BESEDILO NA OPOZORILNI KARTICI STRAN 1
• methadone used as a heroin substitute.
• metadon, ki se uporablja kot nadomestilo za heroin.
Interaction with abacavir is possible but has not been studied.
Interakcija z abakavirjem je možna, vendar je niso preučevali.
Do not take this medicine after the expiry date which is stated on the carton.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli.
Food delayed absorption and decreased Cmax but did not affect overall plasma concentrations (AUC).
Hrana je zadržala absorpcijo in zmanjšala Cmax, vendar pa na celotno plazemsko koncentracijo (AUC) ni vplivala.
Sorbitol can have a mild laxative effect.
Sorbitol ima lahko blag odvajalni učinek.
The safety and efficacy of Ziagen in a number of different multidrug combination regimens is still not completely assessed (particularly in combination with NNRTIs).
Varnost in učinkovitost zdravila Ziagen v številnih kombinacijah z različnimi zdravili še vedno ni v celoti ocenjena (posebno v kombinaciji z NNRTI).
While the carcinogenic potential in humans is unknown, these data suggest that a carcinogenic risk to humans is outweighed by the potential clinical benefit.
Čeprav karcinogeni potencial pri človeku ni preučen, ti podatki kažejo, da potencialne klinične koristi pri človeku odtehtajo tveganje zaradi karcinogenih učinkov.
Tell your doctor if you have heart problems, if you smoke, or have other illnesses that may increase your risk of heart disease such as high blood pressure, or diabetes.
Zdravniku morate povedati, če imate kakšne težave s srcem, če kadite, ali če imate druge bolezni, ki lahko povečajo tveganje za koronarne bolezni srca (npr. visok krvni tlak ali sladkorno bolezen).
If your child gets the symptoms described below it is essential that you follow the instructions given.
Če se otroku pojavijo spodaj opisani simptomi, morate nujno upoštevati navedena navodila.
If your doctor is not available, you must urgently seek alternative medical advice (e.g. the emergency unit of the nearest hospital).
Če vaš zdravnik ni dosegljiv, morate nujno poiskati zdravniško pomoč drugje (npr. urgentna ambulanta najbližje bolnišnice).
Retinoids: retinoid compounds are eliminated via alcohol dehydrogenase.
Retinoidi: Retinoidi se izločajo s pomočjo alkoholne dehidrogenaze.
From these results, it can be concluded with 95% confidence that the true difference is no greater than 8.4% in favour of the twice daily regimen.
Iz teh rezultatov lahko s 95 % verjetnostjo zaključimo, da dejanska razlika, ki bi se nagibala v korist režima odmerjanja dvakrat na dan ni večja od 8,4 %.
Abacavir is a NRTI.
Abakavir je NRTI.
CD4 cells are a type of white blood cell that are important in helping your body to fight infection.
Celice CD4 so vrsta belih krvnih celic, ki so pomembne za premagovanje okužb.
No studies on the effects on ability to drive and use machines have been performed.
Študije o vplivu na sposobnost vožnje in upravljanja s stroji niso bile izvedene.
• weakness beginning in the hands and feet and moving up towards the trunk of the body
• šibkost, ki se začne v dlaneh in stopalih in se širi navzgor proti trupu.
If the date of the submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Če predložitev PSUR in posodobitev RMP sovpadata, se ju lahko predloži istočasno.
Many of the adverse reactions have not been treatment limiting.
Večina neželenih učinkov ni terjala omejitve zdravljenja.