natgillin/translations-raw huggingface dataset:
The rapporteur and co-rapporteur appointed were: Dr Cornelia Ibrahim and Prof. Christian Friis, respectively. 
Imenovana poročevalka je bila dr. Cornelia Ibrahim, soporočevalec pa prof. Christian Friis.
CVMP revised guideline on the SPC for antimicrobial products (EMEA/CVMP/SAGAM/383441/2005)http://www.ema.europa.eu/pdfs/vet/sagam/38344105enfin.pdf 
Revidirana smernica CVMP v zvezi s povzetkom glavnih značilnosti protimikrobnih zdravil (EMEA/CVMP/SAGAM/383441/2005) - http://www.ema.europa.eu/pdfs/vet/sagam/38344105enfin.pdf
Written explanations were provided by the applicants/marketing authorisation holders on 21 April 2009 and 16 September 2009. 
Predlagatelji/imetniki dovoljenj za promet z zdravilom so predložili pisna pojasnila dne 21. aprila 2009 in 16. septembra 2009.
However, due to the known prevalence of resistance to this antimicrobial, changes to the product literature of the relevant products were recommended to reflect the principles for prudent use. 
Vendar je zaradi znane razširjenosti odpornosti proti temu protimikrobnemu zdravilu priporočil spremembe v literaturi za zadevna zdravila, tako da se odražajo načela preudarne uporabe.
Doxycycline is a tetracycline derivative with uses similar to those of tetracycline antibiotics. 
Doksiciklin je derivat tetraciklina, ki se uporablja podobno kot antibiotiki tetraciklini.
During its 13-15 October 2009 meeting, the Committee agreed on a request from one marketing authorisation holder to provide an oral explanation to the CVMP which was subsequently withdrawn by the marketing authorisation holder. 
Na svojem zasedanju 13.-15. oktobra 2009 je Odbor sprejel zahtevo enega imetnika dovoljenja za promet z zdravilom, da poda ustno obrazložitev, ki pa jo je nato sam umaknil.
Based on the rapporteurs' assessment of the currently available data, the CVMP did not identify emerging risks to human or animal health arising as a result of differences in the posology, dose range, duration of treatment and withdrawal periods established across the European Union and did not therefore recommend changes to these aspects of the summary of the product characteristics (SPC), labelling and package leaflet. 
Na podlagi poročevalčevih ocen trenutno razpoložljivih podatkov odbor CVMP ni opredelil novo nastalih tveganj za zdravje ljudi in živali zaradi razlik v odmerjanju, razponu odmerkov, trajanju zdravljenja in karenci, ki veljajo v Evropski uniji, zato ni priporočil sprememb teh vidikov povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo.
Due to concerns that the differences in the posology, dose range, duration of treatment and withdrawal periods established across the European Union for all strengths of water soluble powders and oral solutions containing doxycycline hyclate indicated for use in poultry and intended for administration via drinking water may present a potential serious risk to public and animal health, the United Kingdom referred the matter to the Agency on 11 February 2009, under Article 35 of Directive 2001/82/EC. 
Zaradi zadržkov, da lahko razlike v odmerjanju, razponu odmerkov, trajanju zdravljenja in karenci, ki veljajo v Evropski uniji za vse jakosti v vodi topnih praškov in peroralnih raztopin, vsebujočih doksiciklinijev hiklat, indiciranih za uporabo pri perutnini in namenjenih za dajanje s pitno vodo, pomenijo morebitno resno tveganje za zdravje ljudi in živali, je Združeno kraljestvo zadevo napotilo na agencijo dne 11. februarja 2009 v skladu s členom 35 Direktive 2001/82/ES.
The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amended SPC, labelling and package leaflet in the Annex III. 
Seznam zadevnih imen zdravil je naveden v Dodatku I. Znanstveni zaključki so na voljo v Dodatku II skupaj z dopolnjenim povzetkom glavnih značilnosti zdravila, označevanjem in navodilom za uporabo v Dodatku III.
The water soluble powders and oral solutions containing doxycycline hyclate indicated for use in poultry and intended for administration via drinking water, are used for treatment of respiratory and gastrointestinal infections caused by different bacterial pathogens susceptible to doxycycline. 
V vodi topni praški in peroralne raztopine, vsebujoči doksiciklinijev hiklat, indicirani za uporabo pri perutnini in namenjeni za dajanje s pitno vodo, se uporabljajo za zdravljenje respiratornih in gastrointestinalnih okužb, ki jih povzročajo različni bakterijski patogeni, občutljivi na doksiciklin.
referral for all strengths of water soluble powders and oral solutions containing doxycycline hyclate indicated for use in poultry and intended for administration via drinking water 
za vse jakosti v vodi topnih praškov in peroralnih raztopin, vsebujočih doksiciklinijev hiklat, indiciranih za uporabo pri perutnini in namenjenih za dajanje s pitno vodo
Opinion following an Article 35F F referral for all strengths of water soluble powders and oral solutions containing doxycycline hyclate indicated for use in poultry and intended for administration via drinking water EMA/190025/2010 
Mnenje v zvezi z napotitvijo v skladu s členom 35F F za vse jakosti v vodi topnih praškov in peroralnih raztopin, vsebujočih doksiciklinijev hiklat, indiciranih za uporabo pri perutnini in namenjenih za dajanje s pitno vodo EMA/434471/2010
and oral solutions containing doxycycline hyclate indicated for use in poultry and intended for administration via drinking water in order to amend the SPC, labelling and package leaflet to include appropriate standard prudent use statements in line with recommendations of the CVMP revised guideline on the SPC for antimicrobial products2 and to include additional information regarding the correct administration of the concerned products. 
navodila za uporabo, tako da vključujejo ustrezne izjave o standardu preudarne uporabe v skladu s priporočili revidirane smernice CVMP v zvezi s povzetkom glavnih značilnosti protimikrobnih zdravil2 ter da vključujejo dodatne informacije glede pravilnega dajanja zadevnih zdravil.
Therefore the Committee, adopted on 11 February 2010, an opinion recommending variations of the marketing authorisations for all strengths of water soluble powders 
Odbor je 11. februarja 2010 zato sprejel mnenje, v katerem je priporočil spremembe dovoljenj za promet z zdravilom za vse jakosti v vodi topnih praškov in peroralnih raztopin, vsebujočih doksiciklinijev hiklat, indiciranih za uporabo pri perutnini in namenjenih za dajanje s pitno vodo, z namenom dopolnitve povzetka glavnih značilnosti zdravila, označevanja in
London, 19 December 2008 Doc. 
London, 19. december 2008 Sklic dok.
The main measure of effectiveness was the number of patients who responded to treatment. 
Glavno merilo učinkovitosti je bilo število bolnikov, ki so se odzvali na zdravljenje.
In addition, it was not clear whether all the patients included in the study had resistant or recurrent disease. 
Poleg tega ni bilo jasno, ali so imeli vsi bolniki, vključeni v študijo, odporno ali ponavljajočo bolezen.
International non-proprietary name (INN): nimotuzumab 
Mednarodno nelastniško ime (INN): nimotuzumab
Theraloc was designated as an orphan medicinal product on 2 September 2004. 
Zdravilo Theraloc je bilo dne 2. septembra 2004 določeno kot zdravilo sirota.
The CHMP was also concerned about the medicine's safety. 
CHMP je prav tako izrazil zadržke glede varnosti zdravila.
Questions and answers on the withdrawal of the marketing application for Theraloc 
VPRAŠANJA IN ODGOVORI V ZVEZI Z UMIKOM VLOGE ZA DOVOLJENJE ZA PROMET z zdravilom Theraloc
Theraloc was to be used when the glioma was ‘resistant' (it did not respond to other treatments) or ‘recurrent' (it had come back after previous treatment). 
Zdravilo Theraloc naj bi se uporabljalo, ko je gliom „odporen“ (se ni odzival na druga zdravljenja) ali „ponavljajoč“ (se je ponovil po predhodnem zdravljenju).
The effects of Theraloc were first tested in experimental models before being studied in humans. 
Učinki zdravila Theraloc so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
Theraloc was not compared with any other treatment. 
Zdravila Theraloc niso primerjali z nobenim drugim zdravilom.
What are the consequences of the withdrawal for patients undergoing clinical trials or compassionate use programmes with Theraloc? 
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Theraloc?
On 1 December 2008, Oncoscience AG officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Theraloc, for the treatment of children and adolescents with resistant or recurrent high-grade glioma. 
Družba Oncoscience AG je dne 1. decembra 2008 je uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti svojo vlogo za dovoljenje za promet z zdravilom Theraloc, namenjenim za zdravljenje otrok in mladostnikov z odpornim ali ponavljajočim se gliomom visoke stopnje.
Theraloc was expected to be used to treat adolescents and children from the age of three years with high-grade glioma. 
Zdravilo Theraloc naj bi se uporabljalo za zdravljenje mladostnikov in otrok od tretjega leta starosti z gliomom visoke stopnje.
The application was at day 173 when the company withdrew. 
Družba je vlogo umaknila na 173. dan postopka.
A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called an antigen) that is found on certain cells in the body. 
Monoklonsko protitelo je protitelo (vrsta beljakovine), ki je bilo oblikovano tako, da prepozna in se veže na specifièno strukturo (imenovano antigen), ki se nahaja na določenih celicah v telesu.
Theraloc has been studied in one main study involving 47 children and adolescents with glioma who had no treatments available that could cure their disease. 
Zdravilo Theraloc so raziskali v eni glavni študiji, ki je vključevala 47 otrok in mladostnikov z gliomom, pri katerih zdravila, ki bi lahko ozdravila njihovo bolezen, niso bila na voljo.
Glioma is a type of brain tumour that begins in ‘glial' cells (the cells that surround and support nerve cells). 
Gliom je oblika možganskega tumorja, ki se začne v glialnih celicah (celicah, ki obdajajo in podpirajo živčne celice).
Following the CHMP's opinion, it usually takes around two months for the European Commission to grant a licence. 
Potem ko CHMP poda svoje mnenje, Evropska komisija v približno dveh mesecih izda dovoljenje.
A patient was classified as a responder if the tumours disappeared, shrank or stayed the same size. 
Bolnika so uvrstili med odzivne, če so tumorji izginili, se zmanjšali ali ostali nespremenjeni.
What is Theraloc? 
Kaj je zdravilo Theraloc?
No information was provided on whether the body would produce antibodies against the medicine and there was a high rate of serious side effects. 
Podatki o tem, ali bi telo proizvedlo protitelesa proti zdravilu, niso bili na voljo, poleg tega pa so zabeležili visoko stopnjo resnih neželenih učinkov.
Nimotuzumab binds to an antigen called epidermal growth factor receptor (EGFR), a protein that can be found on the surface of certain tumour cells. 
Nimotuzumab se veže na antigen, imenovan receptor za epidermalni rastni faktor (EGFR), beljakovino, ki se nahaja na površini nekaterih tumorskih celic.
The Committee had concerns that the benefits of Theraloc had not been demonstrated, because the main study did not show a benefit in terms of survival and none of the patients treated with Theraloc showed a complete disappearance of the tumours. 
Odbor je menil, da koristi zdravila Theraloc niso bile dokazane, saj glavna študija ni pokazala koristi v smislu preživetja in pri nobenem bolniku, zdravljenim z zdravilom Theraloc, ni tumor v celoti izginil.
Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Theraloc could not have been approved for the treatment of children and adolescents with recurrent high-grade glioma. 
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je do umika vloge zastavil CHMP, je Odbor izrazil določene zadržke in je začasno menil, da zdravila Theraloc ni mogoče odobriti za zdravljenje otrok in mladostnikov s ponavljajočim gliomom visoke stopnje.
Theraloc is a concentrate that is made up into a solution for infusion (drip into a vein). 
Zdravilo Theraloc je koncentrat, ki se pripravi v raztopino za infundiranje (vnašanje po kapljicah v veno).
The active substance in Theraloc, nimotuzumab, is a monoclonal antibody. 
Zdravilna učinkovina zdravila Theraloc, nimotuzumab, je monoklonsko protitelo.
What was Theraloc expected to be used for? 
Za kaj naj bi se zdravilo Theraloc uporabljalo?
The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes with Theraloc. 
Družba je obvestila CHMP, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Theraloc.
When activated, EGFR helps the tumour cells grow, multiply and spread. 
Ko je receptor za epidermalni rastni faktor aktiviran, pomaga pri rasti, razmnoževanju in širjenju tumorskih celic.
How is Theraloc expected to work? 
Kako naj bi zdravilo Theraloc delovalo?
The CHMP was concerned that the company had not supplied sufficient evidence to demonstrate that Theraloc could be made in a reliable manner, and that insufficient information was provided on the way the product was treated by the body. 
CHMP je bil izrazil zaskrbljenost, da družba ni predložila zadostnih dokazov glede zanesljivosti priprave zdravila Theraloc in da so podatki o presnovi zdravila v telesu nezadostni.
It contains the active substance nimotuzumab. 
Vsebuje zdravilno učinkovino nimotuzumab.
Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Theraloc had not been sufficiently demonstrated and any benefits did not outweigh the identified risks. 
CHMP je v času umika menil, da koristi zdravila Theraloc niso bile zadostno dokazane in da ne odtehtajo znanih tveganj.
By blocking EGFR, nimotuzumab was expected to slow down the progression of glioma. 
Pričakovali so, da bo nimotuzumab z zaviranjem receptorjev za epidermalni rastni faktor upoèasnil napredovanje glioma.
(Study 070701) 
(študija 070701)
Do not infuse any faster than 4 mL per minute. 
Ne infundirajte hitreje kot 4 ml na minuto.
Filtration does not influence dosage calculations. 
Filtracija ne vpliva na izračune odmerka.
2304 Orth an der Donau AUSTRIA 
2304 Orth an der Donau AVSTRIJA
Chemical and physical in-use stability has been demonstrated for 3 hours at 25°C. 
Kemijska in fizikalna stabilnost med uporabo sta bili dokazani za obdobje 3 ur pri temperaturi 25 °C.
In all three studies, subjects were evaluated in the non-bleeding state. 
V vseh treh študijah so bili preiskovanci ocenjeni v stanju brez krvavitve.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6 
Zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 6.6.
ATC code: B02BD10 
Oznaka ATC: B02BD10
In patients with the disease the blood does not clot normally leading to a prolonged bleeding time. 
Pri bolnikih z boleznijo se kri ne strjuje normalno, kar vodi do podaljšanega časa krvavitve.
This will be checked by your doctor. 
Zdravnik bo stanje preveril.
It is used when treatment with another medicine, desmopressin, is not effective or cannot be given. 
Uporablja se, če zdravljenje z drugim zdravilom, dezmopresinom, ni učinkovito ali ne pride v poštev
If such inhibitors occur, the condition may manifest itself as an inadequate clinical response. 
Če se pojavijo taki inhibitorji, se bo stanje lahko pokazalo kot nezadosten klinični odziv.
Neutralizing antibodies (Inhibitors) 
Nevtralizirajoča protitelesa (inhibitorji)
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. 
Ker je o teh reakcijah prostovoljno poročala populacija neznane velikosti, ni vedno mogoče zanesljivo oceniti pogostosti ali določiti vzorčne povezave z izpostavitvijo zdravilu.
Frequency categories are defined according to the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data). 
Kategorije pogostnosti so bile opredeljene v skladu z naslednjim dogovorom: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1000 do < 1/100), redki (≥ 1/10.000 do < 1/1000), zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Start of treatment 
Začetek zdravljenja
Within each frequency grouping, undesirable effects are presented in the order of decreasing seriousness. 
V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
Severe symptoms, including difficulty in breathing and dizziness, require prompt emergency treatment. 
Hudi simptomi, med katere sodijo težave z dihanjem in omotica, zahtevajo takojšnje nujno medicinsko zdravljenje.
In general, the frequency of VEYVONDI dosing for post-operative substitution should range from twice a day to every 48 hours. 
Na splošno mora biti pogostnost odmerjanja zdravila VEYVONDI za pooperativno nadomeščanje od dvakrat na dan do na vsakih 48 ur.
These could be early symptoms of a hypersensitivity reaction. 
To so lahko zgodnji simptomi preobčutljivostne reakcije.
Your doctor may adjust the dose according to your laboratory results. 
Zdravnik vam bo morda glede na rezultate laboratorijskih preiskav prilagodil odmerek.
FVIII products may contain varying amounts of VWF. 
Zdravila s FVIII lahko vsebujejo različne količine VWF.
The rate of administration should be slow enough to ensure the comfort of the patient, up to a maximum of 4 mL/min. 
Hitrost dajanja mora biti dovolj počasna, da zagotavlja ugodje bolnika, znašati pa sme do največ 4 ml/min.
Doing so may harm medicine. 
S tem lahko škodujete zdravilu.
Do not dispose of these supplies in ordinary household trash. 
Teh pripomočkov ne odvrzite med običajne gospodinjske odpadke.
Baxalta Manufacturing Sarl Route de Pierre-a-Bot 111 CH-2000 Neuchatel SWITZERLAND 
Baxalta Manufacturing Sarl Route de Pierre-a-Bot 111 CH-2000 Neuchatel ŠVICA
- This medicine is for single use only. 
- To zdravilo je samo za enkratno uporabo.
Your doctor will calculate your dose of VEYVONDI (in international units or IU). 
Zdravnik bo izračunal vaš odmerek zdravila VEYVONDI (v mednarodnih enotah ali i.e.).
EXP: Use immediately or within 3 hours after reconstitution. 
EXP: Zdravilo uporabite nemudoma oziroma najpozneje v 3 urah po rekonstituciji.
Detailed instructions for reconstitution and admnistration are given at the end of this package leaflet. 
Podrobna navodila za rekonstitucijo in uporabo so navedena na koncu tega navodila za uporabo.
If signs and symptoms of severe allergic reactions occur, immediately discontinue administration of VEYVONDI and provide appropriate supportive care. 
Če se pojavijo znaki in simptomi hudih alergijskih reakcij, nemudoma prekinite dajanje zdravila VEYVONDI in zagotovite ustrezno podporno oskrbo.
Known allergic reaction to mouse or hamster proteins. 
Dokazana alergijska reakcija na beljakovine miši ali hrčka.
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached. 
• ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben armakovigilančni ali povezan z zmanjševanjem tveganja).
Wash your hands and put on clean exam gloves (the use of gloves is optional). 
Umijte si roke in si nadenite čiste rokavice za enkratno uporabo (uporaba rokavic je neobvezna).
Therefore, patients experiencing hypersensitivity or anaphylactic reactions should be tested and evaluated for the presence of an inhibitor. 
Zato je treba bolnike s preobčutljivostno ali anafilaktično reakcijo pregledati in oceniti glede navzočnosti inhibitorja.
If you use VEYVONDI at home, your doctor will make sure that you are shown how to infuse it and how much to use. 
Če uporabljate zdravilo VEYVONDI doma, bo zdravnik poskrbel, da boste poučeni, kako zdravilo infundirati in koliko ga morate uporabiti.
In the 2 spontaneous post-marketing cases reported, the symptoms resolved and the patients fully recovered in 20 minutes to 4 hours upon stopping the infusion. 
V dveh spontanih primerih po začetku trženja so simptomi izginili, bolnika pa sta si povsem opomogla po 20 minutah oziroma po 4 urah po prekinitvi infundiranja.
Therefore, patients at risk have to be monitored for early signs of thrombosis, and prophylaxis measures against thromboembolism should be instituted according to current recommendations and standard of care. 
Zato je treba bolnike s tveganjem spremljati za zgodnje znake tromboze in uvesti preventivne ukrepe proti trombemboliji v skladu z veljavnimi priporočili in standardom oskrbe.
13 If you need more than one vial of VEYVONDI to make up your dose: 
13 Če potrebujete več kot eno vialo zdravila VEYVONDI za vaš odmerek:
You will be monitored carefully for the possibility of having developed these inhibitors. 
Zato vas bodo skrbno spremljali glede nastanka teh zaviralcev.
Subsequent infusions: 
Naslednje infuzije:
Patients treated with this product may develop hypersensitivity reactions to these non-human mammalian proteins. 
Pri bolnikih, ki se zdravijo s tem zdravilom, se lahko pojavijo preobčutljivostne reakcije na te beljakovine sesalcev ne-humanega izvora.
Dosing guidance should be done based on the IR. 
Navodila za odmerjanje morajo temeljiti na IR.
• Leave the syringe attached to the vial until an additional vial is prepared. 
• Brizgo pustite na viali, dokler ne pripravite dodatne viale.
Adverse Reaction by Preferred Term (PT) 
Neželeni učinki po prednostnih izrazih (PT)
Disconnect the empty syringe. 
Odstranite prazno brizgo.
The clinical safety, efficacy and PK data were assessed in 3 completed trials, (070701, 071001 and 071101) which enrolled patients with VWD. 
Podatke o klinični varnosti, učinkovitosti in farmakokinetiki so ocenili v 3 zaključenih preskušanjih (070701, 071001 in 071101), v katerih so bili vključeni bolniki z VWB.
There is a low risk that you may experience a hypersensitivity reaction (a severe, sudden allergic reaction) to VEYVONDI. 
Obstaja majhno tveganje, da bi lahko pri vas nastopila preobčutljivostna reakcija (huda, nenadna alergijska reakcija) na zdravilo VEYVONDI.
In case large volumes of VEYVONDI are required, it is possible to pool two vials of VEYVONDI together. 
Če so potrebne velike količine zdravila VEYVONDI, je mogoče združiti dve viali zdravila VEYVONDI.
Lack of VWF increases the tendency to bleed. 
Pomanjkanje VWF povzroči nagnjenost h krvavitvam.
Image example 
Slikovni primer
The amount of air should equal the amount of reconstituted VEYVONDI that you will withdraw from the vial. 
Količina zraka mora biti enaka količini rekonstituiranega zdravila VEYVONDI, ki jo boste odvzeli iz viale.
Healthcare professionals should balance the potential risks and only prescribe VEYVONDI if needed 
Zdravnik mora presoditi morebitna tveganja in predpisati zdravilo VEYVONDI le po potrebi.
Table 5 Pharmacokinetic Assessment of VWF:RCo f 
Preglednica 5 Farmakokinetična ocena VWF:RCo f
Experience in the treatment of pregnant or breast-feeding women is not available. 
Izkušenj z zdravljenjem pri nosečnicah ali doječih materah ni.
VEYVONDI should not be used in the treatment of Haemophilia A. 
Zdravilo VEYVONDI se ne sme uporabljati pri zdravljenju hemofilije A.