natgillin/translations-raw huggingface dataset:
What information is still awaited for Holoclar? 
Katere informacije o zdravilu Holoclar še pričakujemo?
Holoclar ex vivo expanded autologous human corneal epithelial cells containing stem cells 
Holoclar ex vivo ekspandiran avtologen humani roženični epitelij, ki vsebuje matične celice
The most common side effect with Holoclar (seen in more than 1 patient in 10) is blepharitis (inflammation of the eye lid). 
Najpogostejši neželeni učinek zdravila Holoclar (ki lahko prizadene več kot 1 osebo od 10) je blefaritis (vnetje očesne veke).
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Holoclar treatment was effective in restoring healthy corneal surfaces in patients with moderate or severe limbal stem-cell deficiency caused by burns as well as in improving their symptoms and vision. 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo zdravilo Holoclar učinkovito pri ponovni vzpostavitvi zdrave površine roženice pri bolnikih z zmernim ali hudim pomanjkanjem limbusnih matičnih celic zaradi opekline ter pri izboljšanju njihovih simptomov in vida.
Holoclar must only be used by an appropriately trained and qualified eye surgeon in a hospital, and must only be given to the patient whose limbal cells were used to manufacture the medicine. 
Zdravilo Holoclar lahko uporablja le ustrezno izšolan in usposobljen očesni kirurg v bolnišnici, daje pa se lahko le tistemu bolniku, katerega limbusne celice so bile uporabljene za izdelavo zdravila.
Holoclar, comprising the cells and the membrane, is then sent back to the hospital, where it is immediately surgically implanted in the patient's eye. 
Zdravilo Holoclar, ki je sestavljeno iz celic in membrane, se nato pošlje nazaj v bolnišnico, kjer se nemudoma kirurško vsadi v bolnikovo oko.
It is used in adult patients with moderate to severe limbal stem-cell deficiency caused by burns, including chemical burns, to the eyes. 
Uporablja se pri odraslih bolnikih z zmernim do hudim pomanjkanjem limbusnih matičnih celic zaradi opekline očesa, vključno s kemično opeklino.
Educational material will also be provided to patients undergoing treatment. 
Izobraževalno gradivo bodo prejeli tudi bolniki, ki bodo zdravljeni z zdravilom Holoclar.
Once implanted in the eye, the corneal cells of Holoclar help to replace the corneal surface, while the limbal stem cells serve as a reservoir of new cells that continuously replenish the cornea. 
Ko se vsadijo v oko, roženične celice v zdravilu Holoclar pomagajo nadomestiti površino roženice, medtem ko limbusne matične celice služijo kot rezervoar za nove celice, ki nenehno obnavljajo roženico.
For more information about treatment with Holoclar, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Holoclar preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Holoclar, including the appropriate precautions to be followed by healthcare professionals and patients. 
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Holoclar in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
For practical information about using Holoclar, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Holoclar naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Before Holoclar is used, the damaged corneal surface tissue of the affected eye is removed. 
Pred uporabo zdravila Holoclar se iz očesa odstrani poškodovano tkivo na površini roženice.
Thawed cells are used to make Holoclar by growing them on a membrane made of a protein called fibrin. 
Odtaljene celice se uporabijo za izdelavo zdravila Holoclar, tako da se vzgojijo na membrani iz beljakovine, imenovane fibrin.
How does Holoclar work? 
Kako zdravilo Holoclar deluje?
Since Holoclar has been granted a conditional approval, the company that markets Holoclar will provide further data on Holoclar. 
Ker je zdravilo Holoclar pridobilo pogojno dovoljenje za promet, bo družba, ki ga trži, zagotovila nadaljnje podatke o tem zdravilu.
The active substance in Holoclar is the patient's own limbal cells, which include cells from the surface of the cornea and limbal stem cells grown in a laboratory. 
Zdravilna učinkovina zdravila Holoclar so bolnikove lastne limbusne celice, ki vključujejo celice s površine roženice in limbusne matične celice, vzgojene v laboratoriju.
Holoclar is a stem-cell treatment used in the eye to replace damaged cells on surface (epithelium) of the cornea, the transparent layer in front of the eye covering the iris (the coloured part). 
Zdravilo Holoclar vsebuje matične celice in se uporablja v očesu za nadomestitev poškodovanih celic na površini (epiteliju) roženice, tj. prozorne plasti v sprednjem delu očesa, ki prekriva šarenico (obarvani del).
How is Holoclar used? 
Kako se zdravilo Holoclar uporablja?
Antibiotics to prevent eye infection should be given to patients after limbal tissue has been taken from them. 
Po odstranitvi limbusnega tkiva je treba bolniku dajati antibiotike, da se prepreči okužba očesa.
Holoclar was shown to be effective in restoring a stable corneal surface in patients with moderate or severe limbal stem-cell deficiency caused by burns in a retrospective study using patients' past medical records. 
Zdravilo Holoclar se je v retrospektivni študiji, v kateri so uporabili zdravniške izvide bolnikov iz preteklosti, izkazalo za učinkovito pri ponovnem vzpostavljanju stabilne površine roženice pri bolnikih z zmernim ali hudim pomanjkanjem limbusnih matičnih celic zaradi opekline.
International Non-proprietary Name (INN): cytarabine 
Mednarodno nelastniško ime (INN): citarabin
The evaluation was finished and the CHMP would have given a negative opinion. 
Ocenjevanje je bilo takrat končano, CHMP pa bi podal negativno mnenje.
They had concerns with the way the data were analysed. 
Zadržki so se nanašali na način analize podatkov.
If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you. 
Če ste vključeni v klinično preizkušanje ali program sočutne uporabe ter potrebujete več podatkov o vašem zdravljenju, se obrnite na zdravnika, ki vam je zdravljenje predpisal.
The letter from the Company notifying the EMEA of the withdrawal of DepoCyte is available here. 
Dopis, s katerim je podjetje obvestilo EMEA o umiku zdravila DepoCyte, je na voljo tukaj.
QUESTIONS AND ANSWERS ON WITHDRAWAL OF APPLICATION FOR A VARIATION OF MARKETING AUTHORISATION for DEPOCYTE 
VPRAŠANJA IN ODGOVORI GLEDE UMIKA VLOGE ZA SPREMEMBO DOVOLJENJA ZA PROMET za zdravilo DEPOCYTE
Cytarabine has been used as an anti-cancer medicine since the 1970s. 
Citarabin je v uporabi kot zdravilo proti raku že od 1970-ih dalje.
There are no consequences for DepoCyte's use in the indications for which it is already authorised, where the known benefit and risk remain unchanged. 
Omenjeno nima posledic za uporabo zdravila DepoCyte za indikacije, za katere je bilo zdravilo že odobreno in pri katerih ostajajo koristi in tveganja nespremenjeni.
DepoCyte helps control the symptoms of the disease. 
Zdravilo DepoCyte pomaga obvladovati simptome bolezni.
The studies measured how long it would take before the disease would progress. 
Raziskavi sta merili čas do napredovanja bolezni.
Following CHMP opinion, it usually takes around 6 weeks for the European Commission to update the licence. 
Ko CHMP poda mnenje, Evropska komisija v približno 6 tednih posodobi dovoljenje.
The company has informed the CHMP that the decision has no consequences for patients enrolled in clinical trials or compassionate use programmes. 
Podjetje je obvestilo CHMP, da odločitev nima posledic za bolnike, ki so vključeni v klinična preizkušanja ali programe sočutne uporabe.
The company presented the results of two studies, involving 164 patients with solid tumour neoplastic meningitis. 
Podjetje je predstavilo izsledke dveh raziskav, ki sta zajemali 164 bolnikov z neoplastičnim meningitisom zaradi trdnega tumorja.
On 28 June 2006, SkyePharma PLC officially notified the Committee for Medicinal Products for Human Use (CHMP) that they wish to withdraw their application for a new indication for DepoCyte 50 mg suspension for injection, in the intrathecal treatment of solid tumour neoplastic meningitis. 
Podjetje SkyePharma PLC je 28. junija 2006 uradno obvestilo Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za novo indikacijo za zdravilo DepoCyte 50 mg suspenzijo za injiciranje, ki se uporablja pri intratekalnem zdravljenju neoplastičnega meningitisa zaradi trdnega tumorja.
What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with DepoCyte? 
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preizkušanjih / programih sočutne uporabe zdravila DepoCyte?
DepoCyte was to be injected intrathecally. 
Zdravilo DepoCyte naj bi se vbrizgavalo intratekalno.
The CHMP had concerns that the studies presented by the Company had not sufficiently shown that Depocyte was as effective as, or more effective than intrathecal methotrexate. 
CHMP je imel zadržke, da raziskave, ki jih je predstavilo podjetje, niso v zadostni meri dokazale, da je zdravilo DepoCyte enako ali bolj učinkovito kot intratekalni metotreksat.
DepoCyte is a suspension for injection that contains 50 mg of the active substance cytarabine. 
Zdravilo DepoCyte je suspenzija za injiciranje, ki vsebuje 50 mg zdravilne učinkovine citarabin.
What is happening for DepoCyte for the treatment of lymphomatous meningitis? 
Kaj to pomeni za nadaljnjo uporabo zdravila DepoCyte za zdravljenje limfomatoznega meningitisa?
The application was at Day 90 when the Company withdrew. 
Podjetje je umaknilo vlogo na 90. dan postopka.
DepoCyte is injected directly into the nervous system, in the space between the lining of the spinal cord and brain (intrathecal injection). 
Zdravilo DepoCyte se vbrizga naravnost v živčni sistem, v prostor med ovojnice hrbtenjače in možganov (intratekalno vbrizgavanje).
Therefore, at the time of the withdrawal, the CHMP's view was that it had not been shown that the benefits of DepoCyte in the treatment of solid tumour neoplastic meningitis were greater that its risks. 
Zato je bil v času umika vloge CHMP mnenja, da ni bilo dokazano, da so koristni učinki zdravila DepoCyte pri zdravljenju neoplastičnega meningitisa zaradi trdnega tumorja večji od z njim povezanih tveganj.
DepoCyte was compared with methotrexate (another anti-cancer medicine), both medicines being administered intrathecally. 
V njih so zdravilo DepoCyte primerjali z zdravilom metotreksat (prav tako zdravilo proti raku), obe zdravili pa sta bili dajani intratekalno.
Based on the review of the data at the time of the withdrawal, the CHMP had concerns and was of the provisional opinion that DepoCyte could not be approved for the intrathecal treatment of solid tumour neoplastic meningitis. 
Na podlagi podatkov na razpolago v času umika je imel CHMP zadržke in bil začasnega mnenja, da zdravilo DepoCyte ne more biti odobreno za intratekalno zdravljenje neoplastičnega meningitisa zaradi trdnega tumorja.
It is a cytotoxic (a medicine that kills cells that are dividing, such as cancer cells) that belongs to the group of anti-metabolites. 
Zdravilo je citotoksin (zdravilo, ki ubija deleče se celice, kakršne so rakaste celice), ki spada v skupino antimetabolitov.
What was DepoCyte expected to be used for? 
Za kaj naj bi se zdravilo DepoCyte uporabljalo?
DepoCyte contains cytarabine in a special formulation: the active substance is contained in liposomes (small fatty particles) from which it is slowly released. 
Zdravilo DepoCyte vsebuje citarabin v posebni formulaciji: zdravilna učinkovina se nahaja v liposomih (majhnih maščobnih delcih), iz katerih se počasi sprošča.
DepoCyte was to be used in the treatment of solid tumour neoplastic meningitis: this is a disease where cancer cells, originally from a solid tumour (such as lung or breast cancer), spread to the membranes of the nervous system. 
Zdravilo DepoCyte je bilo namenjeno za uporabo pri zdravljenju neoplastičnega meningitisa zaradi trdnega tumorja: pri tej bolezni se rakaste celice, ki izvirajo iz trdnega tumorja (kot npr. rak pljuč ali dojke), razširijo na membrane živčnega sistema.
London, 29 June 2006 Doc.Ref. 
London, 29.06.06 Sklic dok.
The active substance in DepoCyte, cytarabine, is an anti-cancer agent. 
Zdravilna učinkovina v zdravilu DepoCyte, citarabin, je učinkovina proti raku.
How is DepoCyte expected to work? 
Kako naj bi zdravilo DepoCyte delovalo?
DepoCyte is used to treat lymphomatous meningitis: this is a condition where lymphoma tumour cells have spread to the membranes that surround the nervous system (meninges). 
Zdravilo DepoCyte se uporablja za zdravljenje limfomatoznega meningitisa: to je stanje, v katerem so se tumorske celice limfoma razširile na membrane, ki obdajajo živčni sistem (meninge).
06 August 2014 
6. avgust 2014
The European Commission issued a decision on 06 August 2014. 
Evropska komisija je izdala odločbo dne 6. avgusta 2014.
This is a procedure where one European country (the ‘reference Member State', in this instance the United Kingdom) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other European countries (the ‘concerned Member States', in this instance Denmark, Finland, Ireland, Luxembourg, the Netherlands, Norway, Spain, and Sweden). 
To je postopek, v katerem ena evropska država („referenčna država članica“, v tem primeru Združeno kraljestvo) oceni zdravilo zato, da se izda dovoljenje za promet, ki bo veljalo v tej državi in drugih evropskih državah („zadevnih državah članicah“, v tem primeru na Danskem, Finskem, Irskem, v Luksemburgu, na Nizozemskem, Norveškem, v Španiji in na Švedskem).
On 22 May 2014, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Dexamed (dexamfetamine sulphate). 
Evropska agencija za zdravila je dne 22. maja 2014 zaključila arbitražni postopek po nestrinjanju med državami članicami Evropske unije (EU) glede odobritve zdravila Dexamed (deksamfetaminijev sulfat).
Why was Dexamed reviewed? 
Zakaj je bilo zdravilo Dexamed pregledano?
However, the Member States were not able to reach an agreement and the UK medicines regulatory agency referred the matter to the CHMP for arbitration on 10 June 2013. 
Vendar države članice niso mogle doseči soglasja, zato je regulativna agencija Združenega kraljestva za zdravila 10. junija 2013 zadevo napotila na odbor CHMP v arbitražo.
Dexamed is a medicine that contains the active substance dexamfetamine sulphate. 
Dexamed je zdravilo, ki vsebuje zdravilno učinkovino deksamfetaminijev sulfat.
These conclusions were supported by a group of experts in childhood and adolescent behavioural problems consulted by the CHMP. 
Te zaključke je podprla tudi skupina izvedencev na področju vedenjskih motenj v otroštvu in mladostništvu, s katero se je posvetoval odbor CHMP.
ADHD is a condition that mainly affects children, resulting in a persistent inability to concentrate, hyperactivity and impulsive behaviour. 
ADHD je bolezen, ki v glavnem prizadene otroke in povzroči stalno nezmožnost koncentracije, hiperaktivnost ter impulzivno vedenje.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Dexamed outweigh its risks, and the marketing authorisation can be granted in the United Kingdom and in the following countries: Denmark, Finland, Ireland, Luxembourg, the Netherlands, Norway, Spain and Sweden. 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Dexamed večje od z njim povezanih tveganj in da se dovoljenje za promet lahko izda v Združenem kraljestvu in naslednjih državah: na Danskem, Finskem, Irskem, v Luksemburgu, na Nizozemskem, Norveškem, v Španiji in na Švedskem.
Educational material will also be given to pharmacists, parents and carers to help them identify any potential abuse or improper use of Dexamed. 
Prav tako bodo izobraževalno gradivo prejeli farmacevti, starši in negovalci, da bodo lažje prepoznali morebitno zlorabo ali napačno uporabo zdravila Dexamed.
Furthermore, the company that markets Dexamed will conduct additional studies on the risk of abuse for this medicine. 
Poleg tega bo družba, ki trži zdravilo Dexamed, izvedla dodatne študije o tveganju za zlorabo tega zdravila.
Dexamfetamine belongs to a group of medicines called ‘psychostimulants' and is thought to work by activating certain areas of the brain that control attention and concentration, thus helping to reduce impulsive behaviour. 
Deksamfetamin spada v skupino zdravil, imenovanih „psihostimulansi“, in domnevno deluje tako, da aktivira določene dele možganov, ki nadzorujejo pozornost in koncentracijo, s čimer pomaga zmanjšati impulzivno vedenje.
These measures include starting and regularly monitoring treatment with Dexamed under the supervision of a doctor experienced in treating childhood and adolescent behaviour disorders. 
Ti ukrepi vključujejo uvedbo in redno spremljanje zdravljenja z zdravilom Dexamed pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem vedenjskih motenj pri otrocih in mladostnikih.
It is to be available as tablets (5 mg) for the treatment of children between 6 and 17 years of age who have attention deficit hyperactivity disorder (ADHD) and in whom methylphenidate (another medicine for ADHD) was not effective (second-line treatment). 
Na voljo naj bi bilo v obliki tablet (5 mg) za zdravljenje otrok, starih od 6 do 17 let, ki imajo primanjkljaj pozornosti in motnjo hiperaktivnosti (attention deficit hyperactivity disorder - ADHD) ter pri katerih metilfenidat (drugo zdravilo za ADHD) ni bilo učinkovito (zdravilo druge izbire).
Educational material will be provided to doctors to help them decide if treatment with Dexamed is appropriate and to monitor patients receiving the medicine. 
Zdravniki bodo prejeli izobraževalno gradivo, da bodo lažje presodili, ali je zdravljenje z zdravilom Dexamed primerno, in spremljali bolnike, ki bodo prejemali zdravilo.
Kohne Pharma GmbH submitted Dexamed to the UK medicines regulatory agency for a decentralised procedure. 
Družba Kohne Pharma GmbH je regulativni agenciji Združenega kraljestva za zdravila predložila vlogo za začetek decentraliziranega postopka za zdravilo Dexamed.
Although the CHMP acknowledged that there is a risk of abuse and dependence with Dexamed, it concluded that the risk minimisation measures proposed to mitigate this risk are adequate. 
Čeprav je odbor CHMP potrdil, da pri uporabi zdravila Dexamed obstaja tveganje za zlorabo in odvisnost, je zaključil, da so ukrepi, ki so bili predlagani za zmanjšanje teh tveganj, zadostni.
The CHMP also noted that evidence from studies and clinical practice is available to show that dexamfetamine is effective in ADHD, including in patients in whom other treatments have failed. 
Odbor CHMP je upošteval tudi dejstvo, da so na voljo dokazi iz študij in klinične prakse, ki kažejo, da je deksamfetamin učinkovit pri ADHD, tudi pri bolnikih, pri katerih zdravljenje z drugimi zdravili ni bilo uspešno.
What is Dexamed? 
Kaj je zdravilo Dexamed?
Therefore, based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Dexamed outweigh its risks for second-line treatment of ADHD and recommended that the marketing authorisation be granted in all concerned Member States. 
Zato je na podlagi ocene trenutno razpoložljivih podatkov in interne znanstvene razprave odbor CHMP zaključil, da so koristi zdravila Dexamed večje od z njim povezanih tveganj, kadar se uporablja kot zdravilo druge izbire za ADHD, in priporočil, da se zanj izda dovoljenje za promet v vseh zadevnih državah članicah.
The grounds for the referral were concerns raised by the Netherlands that Dexamed presents a higher risk for abuse and dependence compared with other ADHD treatments, and that the data submitted to support the application did not provide sufficient evidence to demonstrate its effectiveness as a second-line treatment for ADHD. 
Podlaga za napotitev so bili zadržki Nizozemske, ki je menila, da zdravilo Dexamed predstavlja večje tveganje za zlorabo in odvisnost v primerjavi z drugimi zdravili za ADHD in da podatki, predloženi v podporo vlogi, niso zagotovili zadostnih dokazov, da bi lahko potrdili njegovo učinkovitost kot zdravila druge izbire za ADHD.
The experts' group advised that while there is some evidence that medicines of the same type as Dexamed are more likely to induce dependence than other treatments for ADHD, based on clinical practice the risk of developing dependence in patients treated with dexamfetamine is considered to be low and could be adequately managed with appropriate risk minimisation measures. 
Skupina izvedencev je menila, da nekateri dokazi sicer kažejo, da pri zdravilih iste vrste, kot je zdravilo Dexamed, obstaja večja verjetnost za odvisnost kot pri drugih zdravilih za ADHD, vendar se na podlagi klinične prakse ocenjuje, da je tveganje za razvoj odvisnosti pri bolnikih, ki se zdravijo z deksamfetaminom, majhno in ga je mogoče zadovoljivo obvladati z ustreznimi ukrepi za zmanjšanje tveganja.
MA (EU) Number (Invented) name Strength 
(Izmišljeno) ime Jakost
Date of first authorisation: 17 May 2002 Date of latest renewal: 17 May 2007 
Datum prve pridobitve dovoljenja: 17 maj 2002 Datum zadnjega podaljšanja dovoljenja: 17 maj 2007
Axura is not recommended for children and adolescents under the age of 18 years. 
Zdravila Axura ne priporočajo otrokom in mladostnikom, mlajšim od 18 let.
Axura with food and drink 
Zdravilo Axura skupaj s hrano in pijačo
The safety and efficacy of Axura in children aged below 18 years has not been established. 
Varnost in učinkovitost zdravila Axura pri otrocih, starih manj kot 18 let, nista bili dokazani.
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu. 
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
- If you find you have forgotten to take your dose of Axura, wait and take your next dose at the usual time. 
- ce ste ugotovili, da ste pozabili vzeti predpisani odmerek zdravila Axura, počakajte in vzemite naslednji odmerek ob običajnem času.
Once daily 
Enkrat dnevno
Other medicines and Axura 
Druga zdravila in zdravilo Axura
The Axura treatment initiation pack is only to be used for the beginning of the treatment with Axura. 
Začetni paket za zdravljenje z zdravilom Axura se uporablja samo za začetek zdravljenja s tem zdravilom.
At the beginning of treatment you will start by using Axura 5 mg film-coated tablets once a day. 
Na začetku boste zdravljenje začeli z jemanjem zdravila Axura 5 mg filmsko obložene tablete enkrat dnevno.
Axura belongs to a group of medicines known as anti-dementia medicines. 
Zdravilo Axura sodi v skupino zdravil, znanih kot zdravila za zdravljenje demence.
In postmarketing experience these events have been reported in patients treated with Axura. 
V okviru postmarketinških izkušenj so te dogodke navajali pri bolnikih, zdravljenih z zdravilom Axura.
If you go into hospital, let your doctor know that you are taking Axura. 
V primeru, da ste sprejeti v bolnišnico, obvestite zdravnika, da jemljete zdravilo Axura.
What you need to know before you take Axura Do not take Axura 
Kaj morate vedeti, preden boste vzeli zdravilo Axura Ne jemljite zdravila Axura