natgillin/translations-raw huggingface dataset:
9/l, the platelet count is 
9/l, število trombocitov
HYCAMTIN capsules should only be prescribed and therapy supervised by a physician experienced in the use of chemotherapeutic agents. 
Le zdravnik, ki ima izkušnje z uporabo kemoterapevtikov, sme predpisati kapsule HYCAMTIN in nadzorovati zdravljenje.
Hycamtin 1 mg powder for concentrate for solution for infusion should be reconstituted with 1.1 ml of water for injections to provide 1 mg per ml of topotecan. 
Hycamtin 1 mg prašek za koncentrat za raztopino za infundiranje morate rekonstituirati z 1,1 ml vode za injekcije, da dobite raztopino s koncentracijo 1 mg topotekana na ml. Hycamtin 4 mg prašek za koncentrat za raztopino za infundiranje morate rekonstituirati s 4 ml vode za injekcije, da dobite raztopino s koncentracijo 1 mg topotekana na ml.
• the results of blood tests carried out before treatment The prescribed number of capsules should be swallowed whole, once a day for 5 days. 
Predpisano število kapsul morate jemati enkrat na dan 5 dni.
Topotecan was also shown to cause embryo-foetal lethality when given to rats and rabbits. 
Raziskave na kuncih in podganah so pokazale, da topotekan povzroča smrt zarodka oziroma ploda.
In another randomised Phase III study which compared intravenous (IV) topotecan to cyclophosphamide, doxorubicin and vincristine (CAV) in patients with relapsed, sensitive SCLC, the overall response rate was 24.3% for topotecan compared to 18.3% for the CAV group. 
Pri bolnikih s ponovitvijo dovzetnega drobnoceličnega pljučnega raka je bil celoten odstotek odziva na topotekan 24,3 %, na kombinacijo CAV pa 18,3 %.
These may affect up to 1 in 100 people treated with Hycamtin: 
Pojavijo se lahko pri največ 1 od 100 bolnikov, ki se zdravijo z zdravilom Hycamtin:
• Stomach pain, constipation, indigestion. 
• siljenje na bruhanje, bruhanje;
IV use 
Način uporabe
Check with your doctor or pharmacist if you are not sure. 
Če ste negotovi, se posvetujte z zdravnikom ali farmacevtom.
However, there are insufficient data available to make a dose recommendation for this patient group (see section 4.4). 
Pri tem so opažali zmanjšan očistek topotekana, vendar ni na voljo dovolj podatkov, da bi lahko oblikovali priporočila za odmerjanje za to skupino bolnikov (glejte poglavje 4.4).
The recommended dose of topotecan is 0.75 mg/m2/day administered as a 30-minute intravenous infusion on days 1, 2 and 3. 
Priporočeni odmerek topotekana je 0,75 mg/m2/dan.
There is little or no accumulation of topotecan with repeated daily dosing and there is no evidence of a change in pharmacokinetics after multiple doses. 
Prav tako ni znakov, da bi se farmakokinetika spremenila po večkratnem odmerjanju.
• Mouth sores, difficulty swallowing, abdominal pain, nausea, vomiting, diarrhoea, bloody stools 
• razjede v ustih, oteženo požiranje, bolečine v trebuhu, občutek slabosti, bruhanje, driska, kri v blatu (to so lahko znaki in simptomi vnetja sluznice v ustih, želodcu in/ali črevesu [vnetje sluznic])
These may affect up to 1 in 10 people treated with Hycamtin: 
Pojavijo se lahko pri največ 1 od 10 bolnikov, ki se zdravijo z zdravilom Hycamtin:
Plasma clearance in patients with renal impairment (creatinine clearance 41-60 ml/min.) 
Plazemski očistek pri bolnikih z ledvično okvaro (očistek kreatinina 41 60 ml/min) se je v primerjavi s kontrolno skupino zmanjšal na približno 67 %.
ITT population Cisplatin 50 mg/m on day 1, every 21 days 
Vključene bolnice (ITT populacija) cisplatin 50 mg/m na
Do not breast-feed if you are being treated with Hycamtin. 
Če se zdravite z zdravilom Hycamtin, ne smete dojiti.
Anhydrous ethanol - see leaflet for further information Propylene glycol 
Črno barvilo črni železov oksid (E172) šelak brezvodni etanol - za dodatne informacije glejte navodilo propilenglikol izopropilalkohol butanol koncentrirana raztopina amoniaka kalijev hidroksid
Should diarrhoea occur during treatment with oral topotecan, physicians are advised to aggressively manage diarrhoea. 
Če se pojavi med zdravljenjem s peroralnim topotekanom,
This summary was last updated in April 2017. 
Povzetek je bil nazadnje posodobljen aprila 2017.
When used before an operation it is given at least 3 hours before the operation and treatment may be continued for up to one week. 
Kadar se uporablja pred kirurškim posegom, se daje najmanj tri ure pred njim, zdravljenje pa se lahko nadaljuje do največ enega tedna.
The full EPAR for Quadrisol can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Quadrisol je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
The amount of gel given in each dose is adjusted depending on the weight of the animal. 
Količina gela v vsakem odmerku se prilagodi glede na telesno maso živali.
The European Commission granted a marketing authorisation valid throughout the EU for Quadrisol on 4 December 1997. 
Evropska komisija je dovoljenje za promet z zdravilom Quadrisol, veljavno po vsej Evropski uniji, izdala 4. decembra 1997.
This is a summary of the European public assessment report (EPAR) for Quadrisol. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Quadrisol.
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Quadrisol's benefits are greater than its risks and recommended that it be approved for use in the EU. 
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da so koristi zdravila Quadrisol večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
For the full list of restrictions, see the package leaflet. 
Za celoten seznam omejitev glejte navodilo za uporabo.
In horses, skin rashes (urticaria) have been reported. 
Pri konjih so poročali tudi o kožnih izpuščajih (urtikariji).
Quadrisol has been studied in both laboratory and field studies. 
Zdravilo Quadrisol je bilo proučevano v laboratorijskih in terenskih študijah.
Quadrisol, available as an oral (mouth) gel, is given twice daily before feeding for a maximum of two weeks. 
Zdravilo Quadrisol je na voljo kot peroralni gel in se daje dvakrat na dan pred hranjenjem največ dva tedna.
It is not intended to provide practical advice on how to use Quadrisol. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
The withdrawal period for meat from horses treated with Quadrisol is 12 days. 
Karenca za meso konj, zdravljenih z zdravilom Quadrisol, je 12 dni.
It contains the active substance vedaprofen. 
Vsebuje zdravilno učinkovino vedaprofen.
Side effects are generally reversible once the medicine is stopped. 
Neželeni učinki v splošnem izginejo po prenehanju dajanja zdravila.
As prostaglandins are substances that trigger inflammation, pain, and fever, vedaprofen reduces these signs of injury. 
Ker so prostaglandini snovi, ki povzročajo vnetje, bolečino in povišano telesno temperaturo, vedaprofen zmanjšuje te znake poškodbe.
What are the risks associated with Quadrisol? 
Kakšna tveganja so povezana z zdravilom Quadrisol?
The medicine is not authorised for use in horses producing milk for human consumption. 
Zdravilo ni odobreno za uporabo pri konjih, katerih mleko je namenjeno prehrani ljudi.
It must not be given to foals aged less than six months or to mares producing milk. 
Ne sme se dajati žrebetom do šestega meseca starosti ali kobilam, ki dajejo mleko.
Vedaprofen blocks an enzyme called cyclooxygenase which is involved in the production of prostaglandins. 
Zavira encim, imenovan ciklooksigenaza, ki sodeluje pri tvorjenju prostaglandinov.
Quadrisol contains vedaprofen, which belongs to a class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). 
Zdravilo Quadrisol vsebuje vedaprofen, ki spada v skupino zdravil, imenovanih nesteroidna protivnetna zdravila (NSAID).
Other information about Quadrisol: 
Druge informacije o zdravilu Quadrisol
Quadrisol oral gel improved lameness and soft tissue injuries in horses and the response to treatment with Quadrisol was similar to the response to either flunixine meglumine or phenylbutazone, which are other NSAIDs used to treat these conditions. 
Zdravilo Quadrisol peroralni gel je pri konjih izboljšalo šepavost in poškodbe mehkega tkiva, odziv na zdravljenje z zdravilom Quadrisol pa je bil podoben odzivu na fluniksin meglumin ali fenilbutazon, ki sta drugi zdravili iz skupine NSAID za zdravljenje teh stanj.
Quadrisol can also be used to relieve pain and reduce inflammation after an operation. 
Lahko se uporablja tudi za lajšanje bolečine in zmanjšanje vnetja po kirurškem posegu.
Why is Quadrisol approved? 
Zakaj je bilo zdravilo Quadrisol odobreno?
What is Quadrisol and what is it used for? 
Kaj je zdravilo Quadrisol in za kaj se uporablja?
What benefits of Quadrisol have been shown in studies? 
Kakšne koristi je zdravilo Quadrisol izkazalo v študijah?
It is also the time required after administration of a medicine before milk may be used for human consumption. 
Pomeni tudi čas, ki mora preteči po dajanju zdravila, preden se lahko mleko uporabi za prehrano ljudi.
For practical information about using Quadrisol, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist. 
Za praktične informacije o uporabi zdravila Quadrisol naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
For more information about treatment with Quadrisol, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist. 
Za več informacij o zdravljenju z zdravilom Quadrisol naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
Quadrisol must not be given to horses with stomach and gut disorders or to horses with reduced heart, liver and kidney function. 
Zdravilo Quadrisol se ne sme dajati konjem, ki imajo obolenja želodca ali črevesja ali konjem z oslabljenim delovanjem srca, jeter in ledvic.
The side effects of Quadrisol are typical for those seen with other medicines from this product class (NSAIDs) such as lethargy or damage to (lesions) the mouth, stomach, intestines (including soft stools or diarrhoea) and kidneys. 
Neželeni učinki, opaženi pri zdravilu Quadrisol, so značilni za zdravila iz te skupine (NSAID), kot so letargija ali poškodbe (lezije) ust, želodca, črevesja (vključno z mehkim blatom ali drisko) in ledvic.
This included studies in a large number of horses with bone, muscle and other soft tissue and joint problems. 
Vanje je bilo vključenih veliko število konjev s kostnimi in mišičnimi težavami ter težavami z mehkim tkivom in sklepi.
Quadrisol is a veterinary medicine used in horses to relieve pain and reduce inflammation due to injury to the muscle, bones and joints as well as to other non-bony areas of the body (so called soft tissue lesions). 
Zdravilo Quadrisol je zdravilo za uporabo v veterinarski medicini, ki se uporablja pri konjih za lajšanje bolečine in zmanjšanje vnetja zaradi poškodb mišic, kosti in sklepov, kot tudi nekostnih delov telesa (tj. poškodb mehkega tkiva).
How does Quadrisol work? 
Kako zdravilo Quadrisol deluje?
How is Quadrisol used? 
Kako se zdravilo Quadrisol uporablja?
The medicine can only be obtained with a prescription For further information, see the package leaflet. 
Predpisovanje in izdaja zdravila je le na recept.
Unpublished internal report. 
Neobjavljeno interno poročilo.
o Is not favourable in all other currently approved indications. 
o ni ugodno za vse druge trenutno odobrene indikacije,
However it is important that this be confirmed in an appropriate pharmacokinetic study. 
Vendar pa je pomembno, da se to potrdi v ustrezni farmakokinetični študiji.
However new cases of cardiotoxicity continued to be reported. 
Kljub temu so še naprej poročali o novih primerih kardiotoksičnosti.
CMDh position 
Stališče skupine CMDh
Domperidone is commonly used across Europe since 1970s when it was first time authorized via national procedures. 
Domperidon se pogosto uporablja v Evropi od 70. let prejšnjega stoletja, ko so ga prvič odobrili po nacionalnih postopkih.
Therefore some of the high dose formulations can no longer be recommended. 
Nekatere visokoodmerne farmacevtske oblike zato niso več priporočene;
Therefore, in accordance with Article 116 of Directive 2001/83/EC, the PRAC recommends: 
Zato odbor PRAC skladno s členom 116 Direktive 2001/83/ES priporoča:
As a consequence, the intravenous formulation was withdrawn worldwide. 
Posledično so intravensko obliko zdravila umaknili s trgov po vsem svetu.
• Nausea and vomiting of functional, organic, infectious or dietetic origin 
• slabost in bruhanje funkcionalnega, organskega, infekcijskega ali prehranskega izvora;
However, it is not expected that the mechanism of action will differ between adults and children, and there is in some Member States long-lasting clinical experience with this product in children. 
Kljub temu ni pričakovati, da bi bil mehanizem delovanja pri otrocih drugačen kot pri odraslih, poleg tega pa v nekaterih državah članicah beležijo dolgoletne klinične izkušnje s tem zdravilom pri otrocih.
these circumstances patients should not be exposed to the additional risk associated to a combination product. 
V teh okoliščinah bolniki ne bi smeli biti izpostavljeni dodatnemu tveganju, ki je povezano s kombiniranim zdravilom.
The CMDh agreed to: 
Skupina CMDh se je strinjala, da:
Minor amendments were also introduced in the Product Information for clarity. 
Manjše spremembe so zaradi jasnosti vključili tudi v informacije o zdravilu.
Overall summary of the scientific evaluation by PRAC 
Splošni povzetek znanstvenega vrednotenja odbora PRAC
• radiotherapy or drug therapy 
• radioterapija ali zdravljenje z zdravili,
• dopamine agonists (such as L-dopa and bromocriptine) used in the treatment of Parkinson's disease 
• dopaminski agonisti (kot sta na primer L-dopa in bromokriptin), ki se uporabljajo za zdravljenje Parkinsonove bolezni.
• The revocation of the marketing authorisations for: 
• odvzem dovoljenj za promet z zdravilom za:
1 - PRAC recommendation 
1 - Priporočilo odbora PRAC
Having reviewed the PRAC recommendation, the CMDh agreed with the overall scientific conclusions and grounds for recommendation. 
Potem ko je skupina CMDh pregledala priporočilo odbora PRAC, se je strinjala s splošnimi znanstvenimi zaključki in podlago za priporočilo.
• The CMDh considered that the drug utilisation study in condition 3 needs to be performed in more than one Member State in order to achieve its goal of monitoring off-label use. 
• skupina CMDh je menila, da je treba študijo o uporabi zdravil za izpolnitev pogoja 3 izvesti v več kot eni državi članici, da bi s študijo izpolnili cilj spremljanja nenamenske uporabe.
• The PRAC considered the procedure under Article 31 of Directive 2001/83/EC for domperidonecontaining medicinal products. 
• odbor PRAC je obravnaval napotitev v skladu s členom 31 Direktive 2001/83/ES za zdravila, ki vsebujejo domperidon;
The International Birth Date for domperidone has been designated as March 1978, based on the first approval of domperidone in Belgium. 
Za mednarodni rojstni dan (International Birth Date) domperidona je bil na podlagi njegove prve odobritve v Belgiji določen marec 1978.
In view of the cardiac risk, off-label use should be monitored. 
Zaradi tveganja za bolezni srca je treba nenamensko uporabo spremljati.
In October 2011 the PhVWP agreed on amendments to the product information, and the Marketing Authorisation Holder of the originator product was requested to conduct a pharmacoepidemiological study and a thorough QTc study. 
Skupina PhVWP se je oktobra 2011 dogovorila o spremembah informacij o zdravilu in od imetnika dovoljenja za promet z originatorskim zdravilom zahtevala, da izvede farmakoepidemiološko študijo ter poglobljeno študijo intervala QTc.
Domperidone is not approved in all Member States for paediatric use in the subpopulation under 12 years of age and adolescents weighing <35 kg. 
Domperidon v nekaterih državah članicah ni odobren za pediatrično uporabo pri podskupini bolnikov, mlajših od 12 let, in mladostnikih, ki tehtajo manj kot 35 kg.
In light of the above, on 01 March 2013 Belgium informed the European Medicines Agency, pursuant to Article 31 of Directive 2001/83/EC, of their decision to trigger an Art. 31 referral procedure to ask for the PRAC's recommendation on whether the balance of benefits and risks for these products is still positive in the approved indications, and whether the marketing authorisations for medicinal products containing domperidone should be maintained, varied, suspended or withdrawn. 
Zaradi vsega navedenega je Belgija 1. marca 2013 v skladu s členom 31 Direktive 2001/83/ES obvestila Evropsko agencijo za zdravila o svoji odločitvi, da sproži napotitveni postopek v skladu s členom 31 in zaprosi odbor PRAC, da poda priporočilo v zvezi s tem, ali je razmerje med tveganji in koristmi za ta zdravila pri odobrenih indikacijah še vedno pozitivno in ali se lahko dovoljenja za promet z zdravili, ki vsebujejo domperidon, ohranijo ali pa jih je treba spremeniti, začasno preklicati ali umakniti.
Whenever available, paediatric patients should make use of other formulations that allow for more accurate dosing (e.g. oral solution) and these should be supplied with an appropriate measuring device. 
Če so na voljo, morajo pediatrični bolniki uporabljati druge farmacevtske oblike, ki omogočajo natančnejše odmerjanje (npr. peroralno raztopino), te pa morajo imeti priložen primeren odmerni pripomoček.
The CMDh highly recommends that MAHs collaborate in order to avoid unnecessary duplication of studies. 
Skupina CMDh zelo priporoča, da imetniki dovoljenja za promet z zdravilom med seboj sodelujejo, da preprečijo nepotrebno podvajanje študij;
The data in support of the paediatric use in relief of symptoms of nausea and vomiting is limited. 
Podatki v podporo pediatrični uporabi za lajšanje simptomov slabosti in bruhanja so omejeni.
• Nausea and vomiting induced by: 
• slabost in bruhanje, ki ju povzročijo:
• Extend the timeframe for the submission of the final study report on condition 1 (generation of paediatric efficacy data). 
• podaljša rok za predložitev končnega poročila o študiji za izpolnitev pogoja 1 (pridobitev podatkov o učinkovitosti pri pediatrični populaciji).
The PRAC nevertheless considered appropriate that further studies be performed to document the efficacy of domperidone in children in this indication and in the newly recommended posology. 
Odbor PRAC je vseeno menil, da bi bilo primerno izvesti dodatne študije, da se dokumentira učinkovitost domperidona pri otrocih pri tej indikaciji in novem priporočenem odmerjanju.
However, in order to ensure that the study will provide relevant data, MAHs are requested to submit the protocols for agreement to the National Competent Authorities. 
Da pa bi zagotovili, da se bodo s študijo pridobili ustrezni podatki, morajo imetniki dovoljenja za promet z zdravilom predložiti protokole v potrditev pristojnim nacionalnim organom.
When considering existing data in support of the efficacy of domperidone, the PRAC concluded that overall there is sufficient evidence1,2,3 in support of the use in a general indication in the relief of symptoms of nausea and vomiting in adults. 
Potem ko je odbor PRAC proučil obstoječe podatke v podporo učinkovitosti domperidona, je zaključil, da je na splošno dovolj dokazov1,2,3, ki podpirajo uporabo pri splošni indikaciji za lajšanje simptomov slabosti in bruhanja pri odraslih.
Domperidone is a peripheral dopamine D2-receptor antagonist with gastrokinetic and anti-emetic properties. 
Domperidon je antagonist perifernih dopaminskih receptorjev D2 s prokinetičnimi in antiemetičnimi lastnostmi.
It is used in the treatment of symptoms of nausea and vomiting of variable origin. 
Uporablja se za zdravljenje simptomov slabosti in bruhanja različnega izvora.
Domperidone is authorised also as a fixed-dose combination product with cinnarizine and indicated for the prevention and treatment of symptoms associated with motion sickness. 
Domperidon je odobren tudi kot zdravilo s fiksno kombinacijo odmerkov s cinarizinom ter indicirano za preprečevanje in zdravljenje simptomov, povezanih z morsko boleznijo.
2 - Detailed explanation for the differences from the PRAC recommendation 
2 - Podrobna obrazložitev odstopanj od priporočila odbora PRAC
Domperidone is marketed in several formulations, for oral or rectal administration under various trade names. 
Domperidon se trži v različnih farmacevtskih oblikah za peroralno ali rektalno uporabo in pod različnimi trgovskimi imeni.
• The dyspeptic symptom complex that is often associated with delayed gastric emptying, gastro-oesophageal reflux, and oesophagitis: 
• dispeptični simptomi, ki so pogosto povezani z upočasnjenim praznjenjem želodca, gastroezofagealnim refluksom in ezofagitisom:
As a consequence of the new maximum recommended doses, the PRAC considered that certain formulations such as tablets dosed at 20 mg and suppositories dosed at 60 mg have a negative benefit-risk balance and should therefore be revoked. 
Zaradi novih največjih priporočenih odmerkov je odbor PRAC menil, da imajo nekatere farmacevtske oblike, kot so na primer tablete, ki vsebujejo 20 mg domperidona, in svečke, ki vsebujejo 60 mg domperidona, negativno razmerje med tveganji in koristmi in jih je zato treba ukiniti.
However, the CMDh considered that changes were necessary to proposed conditions to the Marketing Authorisations (Annex IV). 
Vendar pa je menila, da so potrebne spremembe predlaganih pogojev dovoljenj za promet z zdravili (Priloga IV).
o Is not favourable for high dose rectal formulations (60 mg) or rectal formulations approved for paediatric use (10 mg). 
o ni ugodno za visokoodmerne farmacevtske oblike za rektalno uporabo (60 mg) in farmacevtske oblike za rektalno uporabo, odobrene za pediatrično uporabo (10 mg),
The CMDh, having considered the PRAC recommendation dated 6 March 2014 pursuant to Article 107k(1) and (2) of Directive 2001/83/EC, reached a position on the variation or revocation as applicable of the marketing authorisations of domperidone-containing medicinal products for which the relevant sections of the summary of product characteristics and package leaflet are set out in Annex III and subject to the conditions set out in Annex IV. 
Skupina CMDh je na podlagi proučitve priporočila odbora PRAC z dne 6. marca 2014 v skladu s členom 107k(1) in (2) Direktive 2001/83/ES sprejela stališče glede spremembe oziroma odvzema dovoljenj za promet z zdravili, ki vsebujejo domperidon, skladno z besedili ustreznih poglavij povzetka glavnih značilnosti zdravila in navodila za uporabo, opredeljenimi v Prilogi III, in pod pogoji, določenimi v Prilogi IV.
In this respect, the PRAC further noted that not only the efficacy data is limited but it does not actually demonstrate the superiority of the combination over the single component product. 
Pri tem je izpostavil tudi, da podatki o učinkovitosti niso samo omejeni, ampak dejansko tudi ne potrjujejo, da bi bila kombinacija superiorna v primerjavi z zdravilom z eno sestavino.
o Is not favourable for the combination domperidone/cinnarizine. 
o ni ugodno za kombinacijo domperidona in cinarizina.
The authorized indications of domperidone, as listed in the Company Core Data Sheet of the originator, are presented below: 
Odobrene indikacije domperidona, navedene v krovnem dokumentu farmacevtske družbe za originatorsko zdravilo, so naštete v nadaljevanju:
• The PRAC was of the opinion that existing data, although limited, are indicative of efficacy in the indication ‘relief of symptoms of nausea and vomiting'. 
• odbor PRAC je menil, da obstoječi podatki (čeprav so omejeni) kažejo na učinkovitost pri indikaciji „lajšanje simptomov slabosti in bruhanja“;