natgillin/translations-raw huggingface dataset:
In addition, significant discrepancies between the information submitted and the posology and safety information in the proposed Summary of product characteristics (SmPC) were also identified by the RMS.
Poleg tega je referenčna država članica odkrila tudi pomembna neskladja med predloženimi podatki in podatki o odmerjanju ter varnosti v predlaganem povzetku glavnih značilnosti zdravila.
Following the submission of a marketing authorisation application under the decentralised procedure (DCP) for a generic nicardipine-containing product for intravenous (IV) use (10 mg/10ml solution for injection) and the assessment of the application dossier, the reference member state (RMS) UK considered the clinical data submitted to be insufficient to determine the efficacy, safety and overall benefit-risk of IV nicardipine in the proposed indications.
uporabo, ki vsebuje nikardipin (10 mg/10 ml raztopina za injiciranje), in oceni dokumentacije, priložene vlogi, je referenčna država članica, Združeno kraljestvo, menila, da predloženi klinični podatki niso zadostni za določitev učinkovitosti, varnosti ter razmerja med tveganji in koristmi i.v.
In view of the available evidence and current medical knowledge on the use of intravenous nicardipine, and considering the potentially serious adverse reactions associated with the use of nicardipine, the CHMP considered that the benefit-risk balance of IV nicardipine is negative in some indications due to serious limitations of the efficacy data.
Na podlagi razpoložljivih dokazov in trenutnega medicinskega znanja o uporabi intravenskega nikardipina ter upoštevajoč morebitno resne neželene učinke, povezane z uporabo nikardipina, je odbor CHMP menil, da je razmerje med tveganji in koristmi i.v.
Additionally, significant concerns were raised regarding the administration of IV nicardipine by bolus dose injection or direct intravenous administration due to a higher potential risk of iatrogenic hypotension, in particular in pre-eclampsia.
nikardipina z injiciranjem bolusnega odmerka ali direktnim intravenskim dajanjem, saj obstaja morebitno povečano tveganje iatrogene hipotenzije, predvsem pri preeklampsiji.
The CHMP considered that there is a role for intravenous nicardipine in aortic dissection based on the information submitted, the evidence of widespread use, the expert statements and the absence of new safety signals in this patient population; however, in line with the available evidence, the CHMP recommended the clinical use as second line treatment, when short acting beta-blocker therapy is not suitable, or in combination with a beta-blocker when beta-blockade alone is not effective.
Na podlagi predloženih podatkov, dokazov razširjene uporabe, strokovnih izjav in odsotnosti novih varnostnih težav pri populaciji bolnikov je odbor CHMP menil, da ima lahko intravenski nikardipin vlogo pri aortni disekciji, vendar je skladno z razpoložljivimi dokazi priporočil klinično uporabo kot zdravljenje druge izbire, kadar kratkodelujoči agonisti beta-adrenergičnih receptorjev niso primerni, ali v kombinaciji z agonistom beta-adrenergičnih receptorjev, kadar agonisti beta-adrenergičnih receptorjev v obliki monoterapije niso učinkoviti.
The CHMP therefore concluded that nicardipine for intravenous use should only be administered by continuous infusion and not by bolus dose administration, due to the abovementioned safety concerns.
Odbor CHMP je zato sklenil, da se sme intravenski nikardipin zaradi zgoraj navedenih varnostnih težav uporabljati samo kot neprekinjeno infundiranje in ne z dajanjem bolusnega odmerka.
Having reviewed the available safety data, the CHMP noted that most common adverse effects and those that most frequently result in drug discontinuance are cardiovascular and nervous system effects related to the expected vasodilator effects of the drug, in particular headache, hypotension, flushing, oedema and tachycardia.
kardiovaskularni učinki ter učinki na živčevje, povezani s pričakovanimi vazodilatacijskimi učinki zdravila, predvsem glavobol, hipotenzija, vročinski oblivi, edem in tahikardija.
Despite being used as a first line treatment in some member states, the CHMP considered a second-line indication to be appropriate for IV nicardipine for pre-eclampsia and agreed on an indication in severe pre-eclampsia, when other intravenous antihypertensive agents are not recommended or are contra-indicated.
nikardipin v nekaterih državah članicah uporablja kot zdravljenje prve izbire, je odbor CHMP menil, da je za indikacijo preeklampsije nikardipin primeren kot zdravljenje druge izbire.
No suitable risk minimisation measures were identified to reduce the associated risks, given the nature of the patient population and the possible emergency setting in which IV nicardipine is used.
nikardipin, niso ugotovili nobenih primernih ukrepov za zmanjševanje tveganja, ki bi lahko zmanjšali povezana tveganja.
It is a ‘hybrid medicine'.
Je „hibridno zdravilo“.
The full EPAR and risk management plan summary for Neofordex 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) in povzetek načrta obvladovanja tveganj za zdravilo Neofordex sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
It does this by interacting with different proteins (nuclear factor kB and caspase 9) that regulate cell death.
To doseže tako, da medsebojno deluje z beljakovinama (nuklearnim dejavnikom kB in kaspazo 9), ki uravnavata celično smrt.
Multiple myeloma is a cancer of a type of white blood cell called plasma cells, which are part of the immune system (the body's natural defences).
Multipli mielom je rak določene vrste belih krvnih celic, ki se imenujejo plazemske celice in so del imunskega sistema (naravne obrambe telesa).
This is a summary of the European public assessment report (EPAR) for Neofordex.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Neofordex.
This means that it is similar to a reference medicine containing the same active substance, but Neofordex is available at a higher strength.
To pomeni, da je podobno referenčnemu zdravilu, ki vsebuje isto zdravilno učinkovino, vendar je zdravilo Neofordex na voljo v večji jakosti.
What measures are being taken to ensure the safe and effective use of Neofordex?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Neofordex?
The CHMP therefore decided that Neofordex's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor je zato zaključil, da so koristi zdravila Neofordex večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
Less common but serious side effects include pneumonia (infection of the lungs) and other infections and psychiatric disorders such as depression.
Manj pogosti, a resni neželeni učinki vključujejo pljučnico (pljučno okužbo) ter druge okužbe in psihiatrične motnje, na primer depresijo.
A risk management plan has been developed to ensure that Neofordex is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Neofordex je bil pripravljen načrt obvladovanja tveganj.
In addition, a bioequivalence study was carried out in 24 healthy volunteers which showed that Neofordex has comparable quality to the reference medicine, Dectancyl.
Poleg tega so opravili študijo biološke enakovrednosti pri 24 zdravih prostovoljcih, ki je pokazala, da je zdravilo Neofordex po kakovosti primerljivo referenčnemu zdravilu, zdravilu Dectancyl.
Neofordex must not be used in patients with active viral disease (especially hepatitis, cold sores, shingles or chicken pox) or with uncontrolled psychoses (altered sense of reality).
Zdravila Neofordex ne smemo uporabljati pri bolnikih z aktivno virusno boleznijo (zlasti hepatitisom, herpesom na ustnici, pasovcem ali noricami) ali z nenadzorovanimi psihozami (spremenjenim občutkom za resničnost).
The most common side effects with Neofordex (which may affect more than 1 in 10 people) include hyperglycaemia (high blood sugar levels), insomnia (difficulty sleeping), muscle pain and weakness, asthenia (weakness), tiredness, oedema (swelling) and weight increase.
Najpogostejši neželeni učinki zdravila Neofordex (ki lahko prizadenejo več kot 1 osebo od 10), vključujejo hiperglikemijo (povišano raven sladkorja v krvi), nespečnost (težave s spanjem), bolečine v mišicah in šibkost mišic, astenijo (šibkost), utrujenost, edem (otekanje) in povečanje telesne mase.
The usual dose is 40 mg once a day, taken preferably in the morning.
Zdravilo Neofordex je na voljo v obliki tablet po 40 mg. Običajni odmerek je 40 mg enkrat na dan, najbolje zjutraj.
However, the dose and how frequently Neofordex is given varies depending on the medicines it is given with and the patient's condition.
Odmerek in pogostnost dajanja zdravila Neofordex sta odvisna od zdravil, s katerimi se daje, in od bolnikovega stanja.
Other information about Neofordex
Druge informacije o zdravilu Neofordex
For more information about treatment with Neofordex, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Neofordex preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Neofordex has been shown to have comparable quality to Dectancyl and the use of high-dose dexamethasone in multiple meyloma is well established.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo dokazano, da je zdravilo Neofordex po kakovosti primerljivo zdravilu Dectancyl in da je uporaba deksametazona v velikem odmerku pri multiplem mielomu dobro uveljavljena.
Because the effects of high-dose dexamethasone in multiple myeloma are well established, the company for Neofordex presented studies from the literature on the use of dexamethasone for the treatment of multiple myeloma.
Ker so učinki deksametazona v velikem odmerku pri multiplem mielomu dobro raziskani, je podjetje za zdravilo Neofordex predložilo študije iz literature o uporabi deksametazona za zdravljenje multiplega mieloma.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Neofordex, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Neofordex may also reduce certain side effects of cancer treatment, such as nausea (feeling sick) and vomiting.
Zdravilo Neofordex lahko tudi zmanjša določene neželene učinke zdravil za zdravljenje raka, kot sta slabost (siljenje na bruhanje) in bruhanje.
Neofordex can only be obtained with a prescription and treatment must be started and monitored by a doctor experienced in the management of multiple myeloma.
Izdaja zdravila Neofordex je le na recept, zdravljenje pa mora začeti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem multiplega mieloma.
Neofordex is a medicine used together with cancer medicines to treat adults with multiple myeloma who have developed symptoms.
Neofordex je zdravilo, ki se uporablja skupaj z zdravili za zdravljenje raka pri odraslih z multiplim mielomom, pri katerih so se pojavili simptomi.
What benefits of Neofordex have been shown in studies?
Kakšne koristi je zdravilo Neofordex izkazalo v študijah?
What is Neofordex and what is it used for?
Kaj je zdravilo Neofordex in za kaj se uporablja?
What are the risks associated with Neofordex?
Kakšna tveganja so povezana z zdravilom Neofordex?
The reference medicine for Neofordex is Dectancyl.
Referenčno zdravilo za zdravilo Neofordex je zdravilo Dectancyl.
For practical information about using Neofordex, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Neofordex naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
The active substance in Neofordex, dexamethasone, belongs to a group of medicines known as corticosteroids.
Zdravilna učinkovina zdravila Neofordex, deksametazon, spada v skupino zdravil, znanih kot kortikosteroidi.
For the full list of all side effects reported with Neofordex, see the package leaflet.
Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila Neofordex, glejte navodilo za uporabo.
Why is Neofordex approved?
Zakaj je bilo zdravilo Neofordex odobreno?
In multiple myeloma, Neofordex is used together with cancer medicines to kill cancerous plasma cells.
Pri multiplem mielomu se zdravilo Neofordex uporablja skupaj z zdravili za zdravljenje raka in tako uniči rakave plazemske celice.
It is not intended to provide practical advice on how to use Neofordex.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
How does Neofordex work?
Kako zdravilo Neofordex deluje?
How is Neofordex used?
Kako se zdravilo Neofordex uporablja?
Neofordex contains the active substance dexamethasone.
Zdravilo Neofordex vsebuje zdravilno učinkovino deksametazon.
It is available as capsules (250 mg) and tablets (500 mg).
Na voljo je v obliki kapsul (250 mg) in tablet (500 mg).
This makes them less effective at recognising and attacking the transplanted organ, lowering the risk of the organ being rejected.
Ti so zato pri prepoznavanju in napadanju presajenega organa manj učinkoviti, kar zmanjšuje tveganje zavrnitve organa.
The dose may need to be adjusted in patients with liver or kidney disease.
Odmerek bo morda treba prilagoditi pri bolnikih z obolenjem ledvic ali jeter.
This enzyme is important for the formation of DNA in cells, particularly in the lymphocytes (a type of white blood cell which is involved in the rejection of organ transplants).
Ta encim je pomemben pri nastajanju DNK v celicah, zlasti v limfocitih (vrsti belih krvnih celic, ki sodelujejo pri zavrnitvi presajenih organov).
It is used with ciclosporin and corticosteroids (other medicines used to prevent organ rejection).
Uporablja se skupaj s ciklosporinom in kortikosteroidi (drugimi zdravili za preprečevanje zavrnitve organov).
The full EPAR for Mycophenolate mofetil Teva 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 Mycophenolate mofetil Teva je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
For more information about treatment with Mycophenolate mofetil Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Mycophenolate mofetil Teva preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
In children aged between two and 18 years, the dose of Mycophenolate mofetil Teva is calculated depending on height and weight.
Pri otrocih, starih od 2 do 18 let, se odmerek zdravila Mycophenolate mofetil Teva izračuna na podlagi telesne višine in mase.
This is a summary of the European public assessment report (EPAR) for Mycophenolate mofetil Teva.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Mycophenolate mofetil Teva.
The European Commission granted a marketing authorisation valid throughout the European Union for Mycophenolate mofetil Teva on 21 February 2008.
Evropska komisija je dovoljenje za promet z zdravilom Mycophenolate mofetil Teva, veljavno po vsej Evropski uniji, odobrila dne 21. februarja 2008.
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 monofosfatdehidrogenaza“.
This means that Mycophenolate mofetil Teva 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 full EPAR for the reference medicine can also be found on the EMEA's website.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za referenčno zdravilo je prav tako na voljo na spletni strani agencije.
For heart transplants, the recommended adult dose is 1.5 g twice a day, starting within five days following the transplant.
Pri presaditvi srca je priporočeni odmerek za odrasle bolnike 1,5 g zdravila dvakrat na dan, pri čemer je treba zdravilo začeti jemati v petih dneh po presaditvi.
Because Mycophenolate mofetil Teva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Mycophenolate mofetil Teva generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
The CHMP concluded that, in accordance with EU requirements, Mycophenolate mofetil Teva 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 Mycophenolate mofetil Teva primerljivo raven kakovosti kot zdravilo CellCept ter da mu je biološko enakovredno.
The way that Mycophenolate mofetil Teva should be given and the dose depend on the type of organ transplant and the patient's age and size.
Način uporabe zdravila Mycophenolate mofetil Teva in njegovo odmerjanje sta odvisna od vrste presajenega organa ter bolnikove starosti in velikosti.
For kidney transplants, the recommended dose in adults is 1.0 g twice a day starting within 72 hours after the transplant.
Priporočeni odmerek za odrasle po presaditvi ledvice je 1,0 g dvakrat na dan, pri čemer je treba zdravilo začeti jemati v 72 urah 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 1.5 g Mycophenolate mofetil Teva twice a day as soon as it can be tolerated.
Pri odraslih bolnikih s presajenimi jetri se mofetilmikofenolat prve štiri dni po presaditvi daje kot infuzija (kapalna infuzija v veno), ko je bolnik sposoben požirati, pa preide na jemanje 1,5 g zdravila Mycophenolate mofetil Teva dvakrat na dan.
Therefore, the CHMP's view was that, as for CellCept, the benefit outweighs the identified risk.
Zato je menil, da so njegove koristi, tako kot pri zdravilu CellCept, večje od znanih tveganj.
The Committee recommended that Mycophenolate mofetil Teva be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Mycophenolate mofetil Teva odobri dovoljenje za promet.
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 Mycophenolate mofetil Teva.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Mycophenolate mofetil Teva, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Mycophenolate mofetil Teva is used to prevent the body from rejecting a transplanted kidney, heart or liver.
Zdravilo Mycophenolate mofetil Teva se uporablja za preprečevanje zavrnitve ledvic, srca ali jeter po presaditvi.
What are the benefits and risks of Mycophenolate mofetil Teva?
Kakšne so koristi in tveganja, povezani z zdravilom Mycophenolate mofetil Teva?
Mycophenolate mofetil Teva is a ‘generic medicine'.
Mycophenolate mofetil Teva je „generično zdravilo“.
Because Mycophenolate mofetil Teva 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 Mycophenolate mofetil Teva generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu CellCept.
Mycophenolate mofetil Teva treatment should be initiated and maintained by a qualified transplant specialist.
Zdravljenje z zdravilom Mycophenolate mofetil Teva mora uvesti in voditi zdravnik specialist za presaditve.
Other information about Mycophenolate mofetil Teva
Druge informacije o zdravilu Mycophenolate mofetil Teva:
Mycophenolate mofetil Teva is a medicine containing the active substance mycophenolate mofetil.
Mycophenolate mofetil Teva je zdravilo, ki vsebuje zdravilno učinkovino mofetilmikofenolat.
By preventing the production of new DNA, Mycophenolate mofetil Teva reduces the rate at which the lymphocytes multiply.
Zdravilo Mycophenolate mofetil Teva s preprečevanjem tvorbe nove DNK zmanjša hitrost razmnoževanja limfocitov.
Why has Mycophenolate mofetil Teva been approved?
Zakaj je bilo zdravilo Mycophenolate mofetil Teva odobreno?
Mycophenolate mofetil Teva mycophenolate mofetil
Mycophenolate mofetil Teva mofetilmikofenolat
The active substance in Mycophenolate mofetil Teva, mycophenolate mofetil, is an immunosuppressive medicine.
Zdravilna učinkovina zdravila Mycophenolate mofetil Teva, mofetilmikofenolat, je zaviralec imunske odzivnosti.
How has Mycophenolate mofetil Teva been studied?
Kako je bilo zdravilo Mycophenolate mofetil Teva raziskano?
What is Mycophenolate mofetil Teva?
Kaj je zdravilo Mycophenolate mofetil Teva?
How is Mycophenolate mofetil Teva used?
Kako se zdravilo Mycophenolate mofetil Teva uporablja?
What is Mycophenolate mofetil Teva used for?
Za kaj se zdravilo Mycophenolate mofetil Teva uporablja?
• generalised anxiety disorder (long-term anxiety or nervousness about everyday matters).
• splošno anksiozno motnjo (dolgotrajno anksioznostjo ali živčnostjo v zvezi s vsakdanjimi stvarmi).
Pregabalin Sandoz is available as capsules (25, 50, 75, 100, 150, 200, 225 and 300 mg) and can only be obtained with a prescription.
Zdravilo Pregabalin Sandoz je na voljo v obliki kapsul (25, 50, 75, 100, 150, 200, 225 in 300 mg) in se izdaja le na recept.
This reduces the activity of some of the nerve cells in the brain and spinal cord, reducing the release of other neurotransmitters that are involved in pain, epilepsy and anxiety.
S tem se zmanjša dejavnost nekaterih živčnih celic v možganih in hrbtenjači, zaradi česar se zmanjša sproščanje drugih živčnih prenašalcev, ki so povezani z bolečino, epilepsijo in tesnobo.
• epilepsy, where it is used as an ‘add-on' to existing treatment in patients who have partial seizures (epileptic fits starting in one specific part of the brain) that cannot be controlled with their current treatment;
• epilepsijo, pri čemer se uporablja kot dodatek k obstoječemu zdravljenju pri bolnikih s parcialnimi napadi (epileptičnimi napadi, ki izvirajo iz določenega dela možganov), ki jih ni mogoče nadzorovati s trenutnim zdravljenjem;
The exact way that pregabalin works is not fully understood, but it is thought to affect the way that calcium enters nerve cells.
Natančno delovanje pregabalina ni popolnoma jasno, vendar pa naj bi vplival na vstopanje kalcija v živčne celice.
The full EPAR and risk management plan summary for Pregabalin Sandoz 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) in povzetek načrta obvladovanja tveganj za zdravilo Pregabalin Sandoz sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This is a summary of the European public assessment report (EPAR) for Pregabalin Sandoz.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Pregabalin Sandoz.
The European Commission granted a marketing authorisation valid throughout the European Union for Pregabalin Sandoz on 19 June 2015.
Evropska komisija je dovoljenje za promet z zdravilom Pregabalin Sandoz, veljavno po vsej Evropski uniji, izdala 19. junija 2015.