FrancophonIA/ELRC3.0 huggingface dataset:
English: Each film-coated tablet contains 250 mg levetiracetam.
Slovenian: Ena filmsko obložena tableta vsebuje 250 mg levetiracetama.
English: Levetiracetam Actavis 250 mg tablets Levetiracetam
Slovenian: Levetiracetam Actavis 250 mg tablete levetiracetam
English: EU/1/11/713/018 30 tablets EU/1/11/713/019 100 tablets EU/1/11/713/020 200 tablets
Slovenian: EU/1/11/713/018 30 tablet EU/1/11/713/019 100 tablet EU/1/11/713/020 200 tablet
English: Levetiracetam Actavis 750 mg tablets Levetiracetam
Slovenian: Levetiracetam Actavis 750 mg tablete levetiracetam
English: Perforated unit dose blisters: EU/1/11/713/041 60 x 1 tablets
Slovenian: Perforiranem pretisnem omotu za enkratni odmerek: EU/1/11/713/041 60 x 1 tablet
English: Levetiracetam Actavis 500 mg tablets Levetiracetam
Slovenian: Levetiracetam Actavis 500 mg tablete levetiracetam
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton of 1,000 mg film-coated tablets in tablet containers
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla za vsebnik za tablete za 1000 mg filmsko obložene tablete
English: Talk to your doctor before taking Levetiracetam Actavis
Slovenian: Pred začetkom jemanja zdravila Levetiracetam Actavis se posvetujte s svojim zdravnikom.
English: INFORMATION IN BRAILLE 17.
Slovenian: NAVODILA ZA UPORABO 16.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton of 750 mg film-coated tablets in tablet containers
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla za vsebnik za tablete za 750 mg filmsko obložene tablete
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton of 250 mg film-coated tablets in tablet containers
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla za vsebnik za tablete za 250 mg filmsko obložene tablete
English: EU/1/11/713/028 30 tablets EU/1/11/713/029 100 tablets EU/1/11/713/030 200 tablets
Slovenian: EU/1/11/713/028 30 tablet EU/1/11/713/029 100 tablet EU/1/11/713/030 200 tablet
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton of 500 mg film-coated tablets in tablet containers
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla za vsebnik za tablete za 500 mg filmsko obložene tablete
English: EU/1/11/713/008 30 tablets EU/1/11/713/009 100 tablets EU/1/11/713/010 200 tablets
Slovenian: EU/1/11/713/008 30 tablet EU/1/11/713/009 100 tablet EU/1/11/713/010 200 tablet
English: How to store Levetiracetam Actavis
Slovenian: Shranjevanje zdravila Levetiracetam Actavis
English: EU/1/11/713/038 30 tablets EU/1/11/713/039 100 tablets EU/1/11/713/040 200 tablets
Slovenian: EU/1/11/713/038 30 tablet EU/1/11/713/039 100 tablet EU/1/11/713/040 200 tablet
English: Levetiracetam Actavis 500 mg film-coated tablets
Slovenian: Levetiracetam Actavis 500 mg filmsko obložene tablete
English: 7 to 14 mg/kg (0.07 to 0.14 ml/kg) once daily
Slovenian: 7 do 14 mg/kg (0,07 do 0,14 ml/kg) enkrat na dan (2) (4)
English: Each tablet contains 750 mg levetiracetam.
Slovenian: Ena tabletavsebuje 750 mg levetiracetama.
English: - Keep this leaflet.
Slovenian: − Navodilo shranite.
English: Titanium dioxide (E171) Indigo carmine (E132) Sunset yellow (E110) Iron oxide red (E172)
Slovenian: sončno rumeno (E110) rdeči železov oksid (E172)
English: Levetiracetam Actavis 750 mg film-coated tablets
Slovenian: Levetiracetam Actavis 750 mg filmsko obložene tablete
English: 72.2 % of the levetiracetam treated patients and 45.2 % of the patients on placebo had a 50 % or greater decrease in the frequency of PGTC seizures per week.
Slovenian: Pri 72,2 % bolnikov, ki so se zdravili z levetiracetamom, in 45,2 % bolnikov, ki so prejemali placebo,
English: Amnesia, memory impairment, coordination abnormal/ataxia, paraesthesia, disturbance in attention
Slovenian: glavobol konvulzije, motnje ravnotežja, omotica, letargija, tremor amnezija, oslabljen spomin, poslabšana koordinacija/ataksija, parestezija, motnje pozornosti horeoatetoza, diskinezija, hiperkinezija, motnje hoje, encefalopatija
English: Silica colloidal anhydrous Magnesium stearate Polyvinyl alcohol - part. hydrolyzed Macrogol 4000
Slovenian: Levetiracetam Actavis 1.000 mg filmsko obložene tablete krospovidon povidon brezvodni koloidni silicijev dioksid magnezijev stearat polivinilalkohol, delno hidroliziran makrogol 4000 smukec titanov dioksid (E171)
English: EU/1/11/713/001 20 tablets EU/1/11/713/002 30 tablets EU/1/11/713/003 50 tablets EU/1/11/713/004 60 tablets EU/1/11/713/005 100 tablets EU/1/11/713/006 120 tablets EU/1/11/713/007 200 tablets
Slovenian: EU/1/11/713/001 20 tablet EU/1/11/713/002 30 tablet EU/1/11/713/003 50 tablet EU/1/11/713/004 60 tablet EU/1/11/713/005 100 tablet EU/1/11/713/006 120 tablet EU/1/11/713/007 200 tablet
English: 7 to 14 mg/kg (0.07 to 0.14 ml/kg) twice daily
Slovenian: 7 do 14 mg/kg (0,07 do 0,21 ml/kg) dvakrat na dan
English: EU/1/11/713/021 20 tablets EU/1/11/713/022 30 tablets EU/1/11/713/023 50 tablets EU/1/11/713/024 60 tablets EU/1/11/713/025 100 tablets EU/1/11/713/026 120 tablets EU/1/11/713/027 200 tablets
Slovenian: EU/1/11/713/021 20 tablet EU/1/11/713/022 30 tablet EU/1/11/713/023 50 tablet EU/1/11/713/024 60 tablet EU/1/11/713/025 100 tablet EU/1/11/713/026 120 tablet EU/1/11/713/027 200 tablet
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Label of 250 mg film-coated tablets in tablet containers
Slovenian: Nalepka za vsebnik za tablete za 250 mg filmsko obložene tablete IME ZDRAVILA
English: Levetiracetam Actavis 1,000 mg film-coated tablets Levetiracetam
Slovenian: Levetiracetam Actavis 1000 mg filmsko obložene tablete levetiracetam
English: EU/1/11/713/011 20 tablets EU/1/11/713/012 30 tablets EU/1/11/713/013 50 tablets EU/1/11/713/014 60 tablets EU/1/11/713/015 100 tablets EU/1/11/713/016 120 tablets EU/1/11/713/017 200 tablets
Slovenian: EU/1/11/713/011 20 tablet EU/1/11/713/012 30 tablet EU/1/11/713/013 50 tablet EU/1/11/713/014 60 tablet EU/1/11/713/015 100 tablet EU/1/11/713/016 120 tablet EU/1/11/713/017 200 tablet
English: EU/1/11/713/031 20 tablets EU/1/11/713/032 30 tablets EU/1/11/713/033 50 tablets EU/1/11/713/034 60 tablets EU/1/11/713/035 100 tablets EU/1/11/713/036 120 tablets EU/1/11/713/037 200 tablets
Slovenian: EU/1/11/713/031 20 tablet EU/1/11/713/032 30 tablet EU/1/11/713/033 50 tablet EU/1/11/713/034 60 tablet EU/1/11/713/035 100 tablet EU/1/11/713/036 120 tablet EU/1/11/713/037 200 tablet
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Label of 750 mg film-coated tablets in tablet containers
Slovenian: Nalepka za vsebnik za tablete za 750 mg filmsko obložene tablete IME ZDRAVILA
English: Infants 6 to 23 months, children and adolescents weighing less than 50 kg
Slovenian: (od 12 do 17 let), težke manj kot 50 kg
English: Levetiracetam Actavis 500 mg film-coated tablets Levetiracetam
Slovenian: Levetiracetam Actavis 500 mg filmsko obložene tablete levetiracetam
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Label of 1,000 mg film-coated tablets in tablet containers
Slovenian: Nalepka za vsebnik za tablete za 1000 mg filmsko obložene tablete IME ZDRAVILA
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Label of 500 mg film-coated tablets in tablet containers
Slovenian: Nalepka za vsebnik za tablete za 500 mg filmsko obložene tablete IME ZDRAVILA
English: A peri- and post-natal development study was performed in rats with levetiracetam doses of 70, 350 and 1,800 mg/kg/day.
Slovenian: Peri- in postnatalne razvojne študije z levetiracetamom pri podganah so izvedli pri odmerkih od 70,
English: The NOAEL (No Observed Adverse Effect Level) was 3,600 mg/kg/day for pregnant female rats (x 12 the MRHD on a mg/m2
Slovenian: 3600 mg/kg/dan (12-kratna vrednost največjega priporočenega odmerka pri ljudeh glede na mg/m2) in pri zarodkih 1200 mg/kg/dan.
English: Levetiracetam Actavis 250 mg, 500 mg and 1,000 mg film-coated tablets Blisters: 20, 30, 50, 60, 100, 120 and 200 film-coated tablets.
Slovenian: Velikosti pakiranj: Levetiracetam Actavis 250 mg, 500 mg in 1.000 mg filmsko obložene tablete
English: Levetiracetam Actavis 750 mg film-coated tablets Levetiracetam
Slovenian: Levetiracetam Actavis 750 mg filmsko obložene tablete levetiracetam
English: • myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy;
Slovenian: • kot dopolnilo drugim protiepileptičnim zdravilom za zdravljenje: parcialnih napadov z generalizacijo ali brez nje pri odraslih, mladostnikih, otrocih in dojenčkih od 1 meseca starosti miokloničnih napadov (kratki, nenadni trzaji mišice ali skupine mišic) pri bolnikih od 12.
English: Levetiracetam Actavis 250 mg film-coated tablets
Slovenian: Levetiracetam Actavis 250 mg filmsko obložene tablete
English: Levetiracetam Actavis 250 mg film-coated tablets Levetiracetam
Slovenian: Levetiracetam Actavis 250 mg filmsko obložene tablete levetiracetam
English: Hepatic impairment
Slovenian: Ušesne bolezni,
English: Children (4 to 12 years)
Slovenian: Dojenčki od 6. do 23. meseca,
English: EXPIRY DATE
Slovenian: Specifar S.A
English: 5 to 10 mg/kg (0.05 to 0.10 ml/kg) twice daily
Slovenian: 5 do 10 mg/kg (0,05 do 0,10 ml/kg) dvakrat na dan končna ledvična odpoved bolniki na dializi
English: Following single dose administration (20 mg/kg) of a 100 mg/ml oral solution to epileptic children (1 month to 4 years), levetiracetam was rapidly absorbed and peak plasma concentrations were observed approximately 1 hour after dosing.
Slovenian: (od 1 meseca do 4 let) se je levetiracetam hitro absorbiral in plazemska koncentracija je bila dosežena približno 1 uro po odmerku.
English: Completed suicide, personality disorder, thinking abnormal, delirium
Slovenian: napad panike, čustvena labilnost/nihanja v razpoloženju, agitacija samomor, osebnostne motnje, motnje mišljenja, delirij
English: Ref. EMEA/554626/2009 EMEA/H/C/1025
Slovenian: : EMA/554626/2009 EMEA/H/C/1025
English: London, 24 September 2009 Doc.
Slovenian: London, 24. septembra 2009 Sklic dok.
English: The letter from the company notifying the European Medicines Agency of the withdrawal of the application is available here.
Slovenian: Dopis, s katerim družba Evropsko agencijo za zdravila obvešča o umiku vloge, je na voljo tukaj.
English: Questions and answers on the withdrawal of the marketing authorisation application for Ramvocid oritavancin
Slovenian: Vprašanja in odgovori v zvezi z umikom vloge za dovoljenje za promet z zdravilom Ramvocid oritavancin
English: The main measure of effectiveness was the number of patients who were cured after treatment.
Slovenian: Glavno merilo učinkovitosti je bilo število bolnikov, pri katerih je bila okužba po koncu zdravljenja ozdravljena.
English: The company presented results from one main study involving 1,267 patients with complicated skin and soft tissue infections.
Slovenian: Družba je predstavila rezultate glavne študije, ki je vključevala 1 267 bolnikov z zapletenimi okužbami kože ali mehkega tkiva.
English: The effects of Ramvocid were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila Ramvocid so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
English: ‘Complicated' means that the infection is difficult to treat, because it has spread to the deep tissues below the skin, treatment with surgery might be needed, or the patient has other conditions that might affect the response to treatment.
Slovenian: „Zapleteno“ pomeni, da je okužbo težko zdraviti, ker je razširjena v tkiva globoko pod kožo, ker je morda potrebna operacija ali ker ima bolnik še druga stanja, ki utegnejo vplivati na zdravljenje.
English: Patients were given either Ramvocid for seven days or vancomycin with or without cephalexin (other antibiotic medicines) for between 10 and 14 days.
Slovenian: Bolniki so dobivali bodisi 7 dni zdravilo Ramvocid ali med 10 in 14 dni vankomicin z cefaleksinom (drugim antibiotikom) ali brez njega.
English: The Committee was also concerned over the way the company had measured the levels of impurities in the medicine.
Slovenian: Odbor prav tako ni bil zadovoljen z načinom, kako je družba merila ravni nečistoč v zdravilu.
English: These include Staphylococcus aureus (including ‘methicillin-resistant' forms known as ‘MRSA') and Streptococcus pyogenes.
Slovenian: Med temi bakterijami sta tudi Staphylococcus aureus (vključno z obliko, odporno na meticilin, znano kot „MRSA“) in Streptococcus pyogenes.
English: By disrupting this barrier, oritavancin is expected to kill the bacteria that are causing the infection.
Slovenian: Z oviranjem delovanja te pregrade naj bi oritavancin uničil bakterije, ki povzročajo okužbo.
English: What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using Ramvocid?
Slovenian: Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Ramvocid?
English: Ramvocid was to be used when the infection was caused by a group of bacteria known as ‘Grampositive' bacteria.
Slovenian: Zdravilo Ramvocid naj bi se uporabljalo, kadar je okužbo povzročila skupina bakterij, znana kot Gram pozitivne bakterije.
English: It is expected to work in two ways, both by stopping the bacteria making their cell walls and by disrupting their cell membranes.
Slovenian: Zdravilo naj bi delovalo na dva načina, in sicer naj bi preprečevalo bakterijam izgradnjo celičnih sten in oviralo delovanje njihovih celičnih membran.
English: What is Ramvocid?
Slovenian: Kaj je zdravilo Ramvocid?
English: The active substance in Ramvocid, oritavancin, is an antibiotic that belongs to the group ‘lipoglycopeptides'.
Slovenian: Zdravilna učinkovina zdravila Ramvocid, oritavancin, je antibiotik, ki spada v skupino lipoglikopeptidov.
English: The company informed the CHMP that, at the time of the withdrawal, there were no patients in clinical trials or compassionate use programmes for Ramvocid.
Slovenian: Družba je obvestila CHMP, da v času umika vloge ni bilo bolnikov, ki bi sodelovali v kliničnih preskušanjih ali programih sočutne uporabe zdravila Ramvocid.
English: The CHMP was concerned that the company had not provided enough evidence to support the use of Ramvocid to treat complicated skin and soft tissue infections at the dose proposed, particularly in patients with MRSA.
Slovenian: CHMP je imel zadržke, ker družba ni zagotovila zadostnih dokazov v podporo uporabi zdravila Ramvocid za zdravljenje zapletenih okužb kože in mehkega tkiva s predlaganim odmerkom, zlasti pri bolnikih z MRSA.
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Ramvocid could not have been approved for the treatment of complicated skin and soft tissue infections caused by Gram-positive bacteria.
Slovenian: 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 Ramvocid ni mogoče odobriti za zdravljenje zapletenih okužb kože in mehkega tkiva, ki jih povzročijo Gram pozitivne bakterije.
English: Ramvocid was expected to be used to treat adults with complicated infections of the skin and the ‘soft tissues' below the skin.
Slovenian: Zdravilo Ramvocid naj bi se uporabljalo za zdravljenje odraslih z zapletenimi okužbami kože in podkožnih „mehkih tkiv“.
English: On 20 August 2009, Targanta Netherlands B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Ramvocid, for the treatment of complicated skin and soft tissue infections caused by Gram-positive bacteria.
Slovenian: je dne 20. avgusta 2009 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom Ramvocid, namenjenim zdravljenju zapletenih okužb kože in mehkega tkiva, ki jih povzročajo Gram pozitivne bakterije.
English: What was Ramvocid expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Ramvocid uporabljalo?
English: Ramvocid is a powder to be made up into a solution for infusion (drip into a vein).
Slovenian: Zdravilo Ramvocid je prašek za pripravo raztopine za infundiranje (kapalne infuzije v veno).
English: How is Ramvocid expected to work?
Slovenian: Kako naj bi zdravilo Ramvocid delovalo?
English: 14 June 2010
Slovenian: 14. junij 2010
English: The final opinion was converted into a Decision by the European Commission on 14 June 2010.
Slovenian: Končno mnenje je bilo spremenjeno v odločbo Evropske komisije dne 14. junija 2010.
English: The referral procedure started on 11 February 2009.
Slovenian: Napotitveni postopek se je začel 11. februarja 2009.
English: The rapporteur and co-rapporteur appointed were: Dr Cornelia Ibrahim and Prof. Christian Friis, respectively.
Slovenian: Imenovana poročevalka je bila dr. Cornelia Ibrahim, soporočevalec pa prof. Christian Friis.
English: CVMP revised guideline on the SPC for antimicrobial products (EMEA/CVMP/SAGAM/383441/2005)http://www.ema.europa.eu/pdfs/vet/sagam/38344105enfin.pdf
Slovenian: 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
English: Written explanations were provided by the applicants/marketing authorisation holders on 21 April 2009 and 16 September 2009.
Slovenian: Predlagatelji/imetniki dovoljenj za promet z zdravilom so predložili pisna pojasnila dne 21. aprila 2009 in 16. septembra 2009.
English: 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.
Slovenian: Vendar je zaradi znane razširjenosti odpornosti proti temu protimikrobnemu zdravilu priporočil spremembe v literaturi za zadevna zdravila, tako da se odražajo načela preudarne uporabe.
English: Doxycycline is a tetracycline derivative with uses similar to those of tetracycline antibiotics.
Slovenian: Doksiciklin je derivat tetraciklina, ki se uporablja podobno kot antibiotiki tetraciklini.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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
Slovenian: 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
English: 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
Slovenian: 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
English: 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.
Slovenian: 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.
English: Therefore the Committee, adopted on 11 February 2010, an opinion recommending variations of the marketing authorisations for all strengths of water soluble powders
Slovenian: 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
English: Ref. EMEA/651597/2008
Slovenian: EMEA/651597/2008
English: London, 19 December 2008 Doc.
Slovenian: London, 19. december 2008 Sklic dok.
English: The main measure of effectiveness was the number of patients who responded to treatment.
Slovenian: Glavno merilo učinkovitosti je bilo število bolnikov, ki so se odzvali na zdravljenje.
English: In addition, it was not clear whether all the patients included in the study had resistant or recurrent disease.
Slovenian: Poleg tega ni bilo jasno, ali so imeli vsi bolniki, vključeni v študijo, odporno ali ponavljajočo bolezen.
English: International non-proprietary name (INN): nimotuzumab
Slovenian: Mednarodno nelastniško ime (INN): nimotuzumab