natgillin/translations-raw huggingface dataset:
Thymanax must not be used in patients who have problems with their liver, such as cirrhosis (scarring of the liver) or active liver disease, nor in patients whose level of transaminases (liver enzymes) in the blood is more than three times the normal level.
Zdravilo Thymanax se ne sme uporabljati pri bolnikih, ki imajo težave z jetri, kot sta ciroza (brazgotinjenje jeter) ali aktivna jetrna bolezen, in pri bolnikih, katerih ravni transaminaz (jetrnih encimov) v krvi so trikrat višje od normalnih.
A patient booklet will also be distributed to all patients who are prescribed Thymanax so that they are aware of the risk to the liver, the importance of monitoring liver function and the signs of liver problems to look out for.
Informativno knjižico bodo prav tako prejeli bolniki, katerim je bilo predpisano zdravilo Thymanax, da bi se zavedali tveganj za jetra, pomena nadzora delovanja jeter ter prepoznavanja znakov, ki kažejo na težave z njimi.
Other information about Thymanax
Druge informacije o zdravilu Thymanax
Two other main studies compared the ability of Thymanax and placebo to prevent symptoms returning in 706 patients whose depression had already been controlled with Thymanax.
V dveh drugih glavnih študijah so učinkovitost zdravila Thymanax in placeba pri preprečevanju ponovnega pojava simptomov primerjali pri 706 bolnikih, pri katerih so depresijo že nadzorovali z zdravilom Thymanax.
It must also not be used in patients who are taking medicines that slow down the breakdown of Thymanax in the body, such as fluvoxamine (another antidepressant) and ciprofloxacin (an antibiotic).
Prav tako ga ne smejo uporabljati bolniki, ki jemljejo zdravila, ki upočasnjujejo presnovo zdravila Thymanax v telesu, kot sta fluvoksamin (drug antidepresiv) in ciprofloksacin (antibiotik).
In the other three studies, which did include an active comparator, there were no differences in scores between the patients taking Thymanax and those taking placebo.
V drugih treh študijah, ki so vključevale aktivno primerjalno zdravilo, razlik v rezultatih med bolniki, ki so jemali zdravilo Thymanax, in tistimi, ki so jemali placebo, ni bilo.
What benefits of Thymanax have been shown in studies?
Kakšne koristi je zdravilo Thymanax izkazalo v študijah?
For practical information about using Thymanax, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Thymanax naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
What is Thymanax and what is it used for?
Kaj je zdravilo Thymanax in za kaj se uporablja?
What are the risks associated with Thymanax?
Kakšna tveganja so povezana z zdravilom Thymanax?
Why is Thymanax approved?
Zakaj je bilo zdravilo Thymanax odobreno?
In the two studies where no active comparator was used Thymanax was seen to be more effective than placebo.
V dveh študijah, v katerih niso uporabili nobenega aktivnega primerjalnega zdravila, so opazili, da je bilo zdravilo Thymanax učinkovitejše od placeba.
For the full list of all side effects reported with Thymanax, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Thymanax, glejte navodilo za uporabo.
Thymanax contains the active substance agomelatine.
Zdravilo Thymanax vsebuje zdravilno učinkovino agomelatin.
It is not intended to provide practical advice on how to use Thymanax.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
The patient's liver function should be checked with blood tests before starting treatment and when the dose is increased, followed by further tests around 3, 6, 12 and 24 weeks later.
Ob začetku zdravljenja in ob povečanju odmerka, nato pa ponovno po približno treh, šestih, 12 in 24 tednih zdravljenja je treba s krvnimi preiskavami preveriti delovanje bolnikovih jeter.
How is Thymanax used?
Kako se zdravilo Thymanax uporablja?
How does Thymanax work?
Kako zdravilo Thymanax deluje?
Treatment should not be started or should be stopped in patients with abnormal liver enzyme levels in the blood (more than three times the normal level).
Pri bolnikih z nenormalno količino jetrnih encimov v krvi (za več kot trikratne normalne vrednosti) se zdravljenje ne sme začeti ali se mora prekiniti.
This summary was last updated in 01-2009.
Povzetek je bil nazadnje posodobljen 01-2009.
The marketing authorisation was renewed on 23 April 2002 and on 23 April 2007.
Dovoljenje za promet je bilo obnovljeno dne 23. aprila 2002 in 23. aprila 2007.
This disease can cause loss of vision.
To obolenje lahko povzroči izgubo vida.
Other information about Vistide:
Druge informacije o zdravilu Vistide:
In both studies, the main measure of effectiveness was the time taken for the disease to get worse.
V obeh študijah je bilo glavno merilo učinkovitosti čas do poslabšanja bolezni.
It should only be used when other medicines are unsuitable.
Zdravilo se lahko uporablja le takrat, kadar druga zdravila niso primerna.
When the virus cannot produce DNA, it cannot reproduce, slowing down the spread of infection.
Če virus ne more tvoriti DNK, se ne more razmnoževati, kar upočasni širjenje okužbe.
Then, during the ‘maintenance' phase, it is given once every two weeks.
Nato se med vzdrževalnim obdobjem daje enkrat vsaka dva tedna.
Vistide should not be injected directly into the eye.
Zdravilo Vistide se ne sme injicirati neposredno v oko.
The marketing authorisation holder is Gilead Sciences International.
Imetnik dovoljena za promet je družba Gilead Sciences International.
The European Commission granted a marketing authorisation valid throughout the European Union for Vistide on 23 April 1997.
Evropska komisija je dovoljenje za promet z zdravilom Vistide, veljavno po vsej Evropski uniji, odobrila dne 23. aprila 1997.
It contains the active substance cidofovir (75 mg/ml).
Vsebuje zdravilno učinkovino cidofovir (75 mg/ml).
What benefit has Vistide shown during the studies?
Kakšne koristi je zdravilo Vistide izkazalo med študijami?
What is the risk associated with Vistide?
Kakšna tveganja so povezana z zdravilom Vistide?
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) VISTIDE EPAR summary for the public
EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) VISTIDE Povzetek EPAR za javnost
The Committee recommended that Vistide be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Vistide odobri dovoljenje za promet.
To reduce the risk of kidney damage, patients must also take another medicine called probenecid (2 g three hours before the infusion, then 1 g two and eight hours after the infusion) and receive an infusion of one litre of saline solution one hour before the infusion of Vistide.
Da bi zmanjšali tveganje za okvare ledvic, morajo bolniki dobivati tudi drugo zdravilo, imenovano probenecid (2 g tri ure pred infuzijo in nato 1 g dve in osem ur po infuziji), ter prejeti infuzijo enega litra fiziološke raztopine eno uro pred infuzijo zdravila Vistide.
Why has Vistide been approved?
Zakaj je bilo zdravilo Vistide odobreno?
The most common side effects with Vistide (seen in more than 1 patient in 10) are neutropenia (low white blood cell counts), headache, nausea (feeling sick), vomiting, alopecia (hair loss), rash, proteinuria (protein in the urine), increased blood creatinine levels (a breakdown product of muscles), asthenia (weakness) and fever.
Najpogostejši neželeni učinki zdravila Vistide (opaženi pri več kot 1 bolniku od 10) so nevtropenija (nizko število belih krvničk), glavobol, navzeja (slabost), bruhanje, alopecija (izpadanje las), izpuščaji, proteinurija (beljakovine v urinu), povečane ravni kreatinina v krvi (produkt metabolizma mišic), astenija (šibkost) in povišana telesna temperatura.
In the maintenance study, the 5-mg/kg dose was more effective than the 3-mg/kg dose (115 days and 49 days, respectively).
V vzdrževalni študiji je bil odmerek 5 mg/kg učinkovitejši od odmerka 3 mg/kg (115 oziroma 49 dni do napredovanja bolezni).
It should also not be used in patients who have kidney disease or who are taking other medicines that might be harmful to the kidneys, or in patients who cannot take probenecid or other ‘sulfa-containing' medicines.
Zdravila prav tako ne smejo uporabljati bolniki z ledvičnimi obolenji, bolniki, ki jemljejo druga zdravila, ki lahko škodujejo ledvicam, ali bolniki, ki ne morejo jemati probenecida ali drugih zdravil, ki vsebujejo žveplo.
The maintenance study compared two maintenance doses of Vistide (5 and 3 mg/kg body weight) in 100 patients who had stopped responding to, or could not receive other medicines for CMV retinitis (ganciclovir or foscarnet).
V vzdrževalni študiji so primerjali dva vzdrževalna odmerka zdravila Vistide (5 in 3 mg/kg telesne mase) pri 100 bolnikih, ki so se nehali odzivati na druga zdravila za citomegalovirusni retinitis (ganciklovir ali foskarnet) ali pa teh niso mogli jemati.
It took an average of 120 days for CMV retinitis to get worse in patients receiving Vistide, compared with 22 days in those who did not receive any treatment.
V povprečju se je citomegalovirusni retinitis pri bolnikih, ki so jemali Vistide, poslabšal v 120 dneh, v primerjavi z 22 dnevi pri bolnikih, ki zdravljenja niso prejemali.
Vistide should not be used in people who may be hypersensitive (allergic) to cidofovir or any of the other ingredients.
Zdravila Vistide ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) cidofovir ali katero koli drugo sestavino zdravila.
The effects of Vistide in CMV retinitis in AIDS patients were studied in one treatment study and one maintenance study.
Učinke zdravila Vistide pri bolnikih z aidsom in citomegalovirusnim retinitisom so raziskovali v eni študiji zdravljenja in eni študiji vzdrževanja.
Treatment with Vistide should be prescribed by a doctor who has experience in the management of human immunodeficiency virus (HIV) infection.
Zdravljenje z zdravilom Vistide lahko predpiše le zdravnik, ki ima izkušnje z zdravljenjem okužbe z virusom človeške imunske pomanjkljivosti (HIV).
The active substance in Vistide, cidofovir, is an antiviral medicine that belongs to the class ‘nucleotide analogues'.
Zdravilna učinkovina v zdravilu Vistide, cidofocir, je protivirusno zdravilo, ki spada v razred „nukleotidnih analogov“.
In the treatment study, Vistide was more effective than no treatment.
V študiji zdravljenja je bilo jemanje zdravila Vistide učinkovitejše od nejemanja.
Vistide is used in patients with acquired immunodeficiency syndrome (AIDS) who do not have kidney disease.
Zdravilo Vistide se uporablja pri bolnikih s sindromom pridobljene imunske pomanjkljivosti (AIDS), ki nimajo obolenja ledvic.
Before receiving Vistide, the patient's kidneys must be checked, as the medicine must not be given to patients with kidney disease.
Pred začetkom jemanja zdravila Vistide je treba preveriti delovanje ledvic bolnika, saj bolniki z ledvičnimi obolenji zdravila ne smejo jemati.
Probenecid is used because it prevents cidofovir building up in the kidneys, and saline is used to prevent dehydration.
Probenecid se uporablja za preprečevanje kopičenja cidofovirja v ledvicah, fiziološka raztopina pa se uporablja za preprečevanje dehidracije.
For the full list of all side effects reported with Vistide, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Vistide, glejte navodilo za uporabo.
The treatment study compared Vistide with no treatment in 48 patients who had not been treated with any medicine for CMV retinitis before.
V študiji zdravljenja so primerjali jemanje in nejemanje zdravila Vistide pri 48 bolnikih, ki se pred tem še niso zdravili zaradi citomegalovirusnega retinitisa.
It blocks the activity of enzymes called ‘DNA polymerases' in CMV, which the virus uses to produce DNA.
Zavira aktivnost encimov v citomegalovirusu, imenovanih DNK polimeraze, ki jih virus uporablja za tvorjenje DNK.
Treatment is continued for as long as recommended in local guidelines on the management of HIV-infected patients.
Trajanje zdravljenja mora biti usklajeno z lokalnimi priporočili za zdravljenje bolnikov, okuženih z virusom HIV.
During the ‘induction' phase, Vistide is given as a one-hour infusion of 5 mg per kilogram body weight once a week for the first two weeks.
Med obdobjem uvajanja se zdravilo Vistide prva dva tedna daje enkrat tedensko kot eno uro trajajoča infuzija v odmerku 5 mg na kilogram telesne mase.
Vistide is used to treat cytomegalovirus (CMV) retinitis, a viral infection of the retina (the lightsensitive surface at the back of the eye).
Zdravilo Vistide se uporablja za zdravljenje citomegalovirusnega (CMV) retinitisa, virusne okužbe mrežnice (površine na zadnji steni očesa, ki je občutljiva na svetlobo).
The Committee for Medicinal Products for Human Use (CHMP) decided that Vistide's benefits are greater than its risks for the treatment of CMV retinitis in patients with AIDS and without kidney disease.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Vistide pri zdravljenju citomegalovirusnega retinitisa pri bolnikih z AIDS-om, ki nimajo obolenja ledvic, večje od z njim povezanih tveganj.
The full EPAR for Vistide is available here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Vistide je na voljo tukaj.
Vistide is a concentrate that is made up into a solution for infusion (drip into a vein).
Zdravilo Vistide je koncentrat, ki se pripravi v raztopino za infundiranje (kapalno infuzijo v veno).
What is Vistide used for?
Za kaj se zdravilo Vistide uporablja?
How has Vistide been studied?
Kako je bilo zdravilo Vistide raziskano?
How is Vistide used?
Kako se zdravilo Vistide uporablja?
What is Vistide?
Kaj je zdravilo Vistide?
How does Vistide work?
Kako zdravilo Vistide deluje?
treatment initiation pack: 14 tablets + 14 tablets + 14 tablets + 14 tablets
Paket za začetno zdravljenje: 14 tablet + 14 tablet + 14 tablet + 14 tablet
Syrup
mg
1 bottle + 1 measuring cup + 1 oral syringe
1 steklenica + 1 merica + 1 brizga za peroralno odmerjanje
Oral use bottle (glass)
Steklenica (steklena) 200 ml
MA (EU) Number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size EU/1/12/750/001 Esmya
(Izmišljeno) ime Jakost Farmacevtska oblika
7 July 2011
7. julija 2011
Outcome of a procedure under Article 29 of Directive 2001/83/EC as amended
Izid postopka v skladu s členom 29 Direktive 2001/83/ES, kakor je bila spremenjena
The European Commission issued a decision on 7 July 2011.
Evropska komisija je odločbo izdala dne 7. julija 2011.
What are the conclusions of the CHMP?
Kakšni so zaključki CHMP?
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Docetaxel Teva Generics outweigh its risks, and that the marketing authorisation can be granted in the Netherlands as well as in Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Poland, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom and Norway.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da koristi zdravila Docetaxel Teva Generics odtehtajo z njim povezana tveganja ter da se lahko dovoljenje za promet z zdravilom odobri na Nizozemskem ter v Avstriji, Belgiji, Bolgariji, na Cipru, Češkem, Danskem, v Estoniji, na Finskem, v Franciji, Nemčiji, Grčiji, na Madžarskem, Irskem, v Italiji, Latviji, Litvi, Luksemburgu, Malti, na Poljskem, v Romuniji, na Slovaškem, v Sloveniji, Španiji, na Švedskem, v Združenem kraljestvu in na Norveškem.
However, the Member States were not able to reach an agreement and the Netherlands referred the matter to the CHMP on 29 July 2010 for arbitration.
Vendar se države članice niso mogle doseči soglasja, zato je Nizozemska dne 29. julija 2010 zadevo napotila na CHMP v arbitražo.
in this instance the Netherlands) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance all other EU Member States (except Portugal) and Norway).
To je postopek, v katerem ena država članica („referenčna država članica“, v tem primeru Nizozemska) oceni zdravilo z namenom odobritve dovoljenja za promet z zdravilom, ki bo veljavno v tej državi in drugih državah članicah („zadevne države članice“, v tem primeru vse druge države članice EU (razen Portugalske) in Norveška).
The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Docetaxel Teva Generics.
Evropska agencija za zdravila je končala postopek arbitraže, do katerega je prišlo po nesoglasju med državami članicami Evropske unije (EU) glede odobritve zdravila Docetaxel Teva Generics.
With the skeleton still in place, the cells cannot divide and they eventually die.
Ker ogrodje ostane nespremenjeno, se celice ne morejo deliti in sčasoma odmrejo.
Docetaxel Teva Generics is a generic medicine based on a ‘reference medicine', Taxotere, which has an EU-wide marketing authorisation since 1995.
Zdravilo Docetaxel Teva Generics je generično zdravilo, ki temelji na „referenčnem zdravilu“ Taxotere, ki ima dovoljenje za promet po vsej EU od leta 1995.
Docetaxel blocks the ability of cancer cells to destroy the internal ‘skeleton' that allows them to divide and multiply.
Docetaksel zavira sposobnost rakastih celic, da uničijo notranje „ogrodje“, ki jim omogoča, da se delijo in množijo.
It is available as a powder and solvent to be made up into a solution for infusion (drip into a vein).
Na voljo je v obliki praška in topila za pripravo raztopine za infundiranje (dajanje v veno).
Docetaxel Teva Generics is intended to treat the following types of cancer: breast cancer, non-small-cell lung cancer, prostate cancer, gastric adenocarcinoma (a type of stomach cancer), and head and neck cancer.
Zdravilo Docetaxel Teva Generics je namenjeno zdravljenju naslednjih vrst raka: rak dojke, nedrobnocelični rak pljuč, rak prostate, želodčni adenokarcinom (vrsta raka na želodcu) ter rak glave in vratu.
Based on an evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that additional data was not needed because Docetaxel Teva Generics is expected to produce comparable levels of the active substance in the body as the reference medicine.
Na podlagi vrednotenja trenutno razpoložljivih podatkov in znanstvene razprave v Odboru je CHMP sklenil, da dodatni podatki niso potrebni, saj naj bi zdravilo Docetaxel Teva Generics proizvajalo primerljive ravni zdravilne učinkovine v telesu kot referenčno zdravilo.
The CHMP therefore concluded that the benefits of Docetaxel Teva Generics outweigh its risks and recommended that the marketing authorisation be granted in the Netherlands and the concerned Member States.
CHMP je tako zaključil, da koristi zdravila Docetaxel Teva Generics odtehtajo z njim povezana tveganja in priporočil, da se zanj odobri dovoljenje za promet na Nizozemskem in v zadevnih državah članicah.
Why was Docetaxel Teva Generics reviewed?
Zakaj je bilo zdravilo Docetaxel Teva Generics pregledano?
Docetaxel also affects non-cancer cells such as blood cells, which can cause side effects.
Docetaksel učinkuje tudi na nerakave celice, kot so krvne celice, kar lahko povzroči neželene učinke.
Some Member States considered this needed since the form of Docetaxel Teva Generics (a powder and a solvent to be made into a solution) is different to the form of the reference medicine (a concentrated solution) and the two medicines contain different excipients (inactive ingredients).
Nekatere države članice so menile, da je študija potrebna, saj se oblika zdravila Docetaxel Teva Generics (prašek in topilo za pripravo raztopine) razlikuje od oblike referenčnega zdravila (koncentrirana raztopina) ter da zdravili vsebujeta različne pomožne snovi (sestavine brez zdravilnih učinkovin).
Questions and answers on Docetaxel Teva Generics (docetaxel, 20 mg and 80 mg powder and solvent for solution for infusion) EMA/125006/2011 rev. 1
Vprašanja in odgovori v zvezi z zdravilom Docetaxel Teva Generics (docetaksel, 20 mg in 80 mg prašek in topilo za raztopino za infundiranje) EMA/125006/2011 rev. 1
Questions and answers on Docetaxel Teva Generics (docetaxel, 20 mg and 80 mg powder and solvent for solution for infusion)
Vprašanja in odgovori v zvezi z zdravilom Docetaxel Teva Generics (docetaksel, 20 mg in 80 mg prašek in topilo za raztopino za infundiranje)
What is Docetaxel Teva Generics?
Kaj je zdravilo Docetaxel Teva Generics?
The grounds for the referral were that a ‘bioequivalence' study in humans, to show that Docetaxel Teva Generics produces comparable levels of the active substance in the body as Taxotere, had not been performed.
Podlaga za napotitev je bilo dejstvo, da ni bila izvedena študija „biološke enakovrednosti“ pri ljudeh, ki bi dokazala, da zdravilo Docetaxel Teva Generics proizvaja primerljive ravni zdravilne učinkovine v telesu kot zdravilo Taxotere.
The active substance in Docetaxel Teva Generics, docetaxel, belongs to the group of anticancer medicines known as the taxanes.
Zdravilna učinkovina v zdravilu Docetaxel Teva Generics, docetaksel, spada v skupino zdravil proti raku, imenovanih taksani.
Docetaxel Teva Generics is a medicine that contains the active substance docetaxel.
Zdravilo Docetaxel Teva Generics je zdravilo, ki vsebuje zdravilno učinkovino docetaksel.
Teva Generics BV submitted an application for Docetaxel Teva Generics to the Netherlands for a decentralised procedure.
Družba Teva Generics BV je Nizozemski predložila vlogo za decentraliziran postopek za zdravilo Docetaxel Teva Generics.
The European Commission issued a decision on this opinion on 3 September 2012.
Evropska komisija je izdala odločbo o tem mnenju 3. septembra 2012.
Outcome of a procedure under Article 31 of Directive 2001/83/EC as amended
Izid postopka v skladu s členom 31 Direktive 2001/83/ES, kakor je bila spremenjena
What is trimetazidine?
Kaj je trimetazidin?
The full changes made to the information to doctors and patients are detailed here.
Celotne spremembe informacij za zdravnike in bolnike so na voljo tukaj.
Medicines containing trimetazidine have been available since the 1970s and are currently marketed in Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Poland, Portugal, Romania, Slovakia, Slovenia and Spain.
Zdravila, ki vsebujejo trimetazidin, so na voljo od 1970-ih let ter se trenutno tržijo v Bolgariji, na Cipru, Češkem, Danskem, v Estoniji, Franciji, Nemčiji, Grčiji, na Madžarskem, Irskem, v Italiji, Latviji,
• Patients who have any questions should speak to their doctor or pharmacist.
• Bolniki, ki imajo kakršna koli vprašanja, naj se posvetujejo s svojim zdravnikom ali farmacevtom.
What are the recommendations for patients?
Kakšna so priporočila za bolnike?
Why was trimetazidine reviewed?
Zakaj je bil trimetazidin pregledan?
Questions and answers on the review of medicines containing trimetazidine (20 mg tablets, 35 mg modified release tablet and 20 mg/ml oral solution)
Vprašanja in odgovori v zvezi s pregledom zdravil, ki vsebujejo trimetazidin (20 mg tablete, 35 mg tablete s prirejenim sproščanjem in peroralna raztopina 20 mg/ml)
Which data has the CHMP reviewed?
Katere podatke je odbor CHMP pregledal?
Written communication will be distributed to doctors at national level to inform them of the changes to the approved uses of trimetazidine.
Informacije bodo pisno predložene zdravnikom na nacionalni ravni, tako da bodo obveščeni o spremembah odobrene uporabe trimetazidina.
What are the conclusions of the CHMP?
Kakšni so zaključki odbora CHMP?
In addition, the Committee recommended new contraindications and warnings to reduce and manage the possible risk of movement disorders, associated with the use of this medicine.
Poleg tega je odbor priporočil nove kontraindikacije ter opozorila za zmanjšanje in obvladovanje morebitnega tveganja za motnje gibanja, ki so povezane z uporabo tega zdravila.