natgillin/translations-raw huggingface dataset:
A dose finding study by Pijpers, 1990b6, investigated the prophylactic effect of doxycycline in feed against challenge with Actinobacillus pleuropneumoniae. 
V študiji za določanje odmerka avtorja Pijpersa, 1990b6, so primerjali profilaktični učinek doksiciklina v krmi z izzivom z Actinobacillus pleuropneumoniae.
• Enteritis caused by Clostridium perfringens and Clostridium colinum. 
• Enteritis, ki ga povzročata Clostridium perfringens in Clostridium colinum.
Interactions with other medicinal products and other forms of interaction Do not use in conjunction with bactericidal antibiotics, such as penicillins and cephalosporins. 
Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Ne uporabljajte v povezavi z baktericidnimi antibiotiki, kot so penicilini in cefalosporini.
In this study, doses of doxycycline equivalent to 16, 7.5 and 3.6 mg/kg body weight/day were effective in preventing disease in 6/6, 5/6 and 1/6 pigs, respectively. 
V tej študiji se je pokazalo, da so bili odmerki doksiciklina, ki so enakovredni 16, 7,5 oz. 3,6 mg na kg telesne mase na dan, učinkoviti pri preprečevanju bolezni pri 6/6, 5/6 oz. 1/6 prašičev.
It inhibits bacterial protein synthesis intracellularly by binding on the 30-S ribosome subunits. 
Zavira znotrajcelično sintezo bakterijskih beljakovin, tako da se veže na ribosomske podenote 30-S.
4941 VX Raamsdonksveer The Netherlands research@dopharma.com 
4941 VX Raamsdonksveer Nizozemska research@dopharma.com
The main sections of disharmony of the existing SPCs were: 
Največja neskladja med obstoječimi povzetki glavnih značilnosti zdravila so bila pri:
This interferes with binding of aminoacetyl-tRNA to the acceptor site on the mRNA ribosome complex and prevents coupling of amino acids to the elongating peptide chains. 
To moti vezanje aminoacetila-tRNA na sprejemno mesto na kompleksu ribosoma in mRNA in preprečuje spajanje aminokislin z nastajajočimi peptidnimi verigami.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Active substance: 
NAVEDBA ZDRAVILNE UČINKOVIN(E) IN DRUGE(IH) SNOVI
No Minimum Inhibitory Concentration (MIC) data were submitted that were specifically relevant to isolates from target pathogens from chickens. 
Predloženi niso bili nobeni podatki glede minimalne inhibitorne koncentracije (MIC), ki bi bili posebej pomembni za izolate iz ciljnih patogenov pri piščancih.
A Good Clinical Practice standard field study was provided investigating the efficacy of Doxycycline 50% WSP to treat naturally occurring outbreaks of colibacillosis on 5 farms in The Netherlands in 1998. 
Predložena je bila tudi terenska študija, ki so jo opravili v skladu s standardi dobre klinične prakse in s katero so preučevali učinkovitost zdravila Doxycycline 50% WSP za zdravljenje naravnih izbruhov kolibaciloze na petih farmah na Nizozemskem leta 1998.
4.4 Special warnings for each target species 
4.4 Posebna opozorila za posamezne ciljne živalske vrste Jih ni.
Data from Goren, 19831, on the in vitro susceptibility of pathogens isolated from poultry between 1978 and 1981 showed that susceptibility of P. multocida was > 70%, but that of E. coli varied between 4 to 34% over the time period studied. 
Podatki avtorja Gorena1, 1983, o občutljivosti in vitro patogenov, izoliranih iz piščancev med letoma 1978 in 1981, so pokazali, da je bila občutljivost P. multocida > 70 %, občutljivost E. coli pa je v preučevanem obdobju nihala med 4 in 34 %.
High levels of resistance to tetracyclines in swine respiratory pathogens have also been documented (ARBAO-II study, 2008)7. 
Dokumentirane so bile visoke stopnje odpornosti na tetracikline pri prašičjih respiratornih patogenih (študija ARBAO-II, 2008).
Doxycycline is a broad spectrum antibiotic. 
Doksiciklin je antibiotik s širokim spektrom delovanja.
8 Meijer et al, Pharmacokinetics and bioavailability of doxycycline hyclate after oral administration in calves, Vet. Quart. 
Meijer et al, Pharmacokinetics and bioavailability of doxycycline hyclate after oral administration in calves.
These warnings have been broadened to take account of resistance to tetracyclines recognised in isolates from pigs and 
Ta opozorila so nekoliko razširili, tako da vključujejo tudi odpornost na tetracikline, ki so jo odkrili v izolatih iz prašičev in telet.
A high resistance rate of E. coli, isolated from chickens, against tetracyclines has been documented. 
Dokumentirali so visoko stopnjo odpornosti E. coli, izolirane iz piščancev, na tetraciklin.
Calves are a target species on all current SPCs (except for the product in the Netherlands). 
Teleta so ciljna živalska vrsta v vseh trenutno veljavnih povzetkih glavnih značilnosti zdravila (razen za zdravilo na Nizozemskem).
In the absence of data supporting the dose regimen for infections other than colibacillosis, the harmonised dose regimen of 25 mg doxycycline hyclate/kg body weight for 3 to 5 days, for all indications can be accepted as this is the higher end of the dose range that has been historically used and poses no risk for safety. 
Ker razen za kolibacilozo ni podatkov v podporo režimu odmerjanja za okužbe, se lahko za vse indikacije potrdi usklajeni režim odmerjanja z 25 mg doksiciklinijevega hiklata na kg telesne mase 3 do 5 dni, saj je tak odmerek na zgornji meji razpona odmerjanja, ki pa se je uporabljal v preteklosti in ne predstavlja nobenega varnostnega tveganja.
Following absorption, tetracyclines are hardly metabolized. 
Po absorpciji se tetraciklini presnavljajo s težavo.
As data on calves presented in the dossier to support clinical data concern pre-ruminant calves, with a non clear rumen maturity for some studies presented in the dossier, and considering changes to the key pharmacokinetic parameters after i.v. 
Ker podatki v podporo kliničnim podatkom, predstavljeni v dokumentaciji, zadevajo teleta neprežvekovalce, in ker pri nekaterih študijah, predstavljenih v dokumentaciji, ni jasno razvidna stopnja zrelosti vampa ter ob upoštevanju sprememb pri ključnih farmakokinetičnih parametrih po uporabi i.v.
Calves: 7 days Pigs: 8 days Chickens: 5 days 
Teleta pred nastopom prežvekovanja: 7 dni Prašiči: 8 dni
administration in non-ruminating vs. ruminating calves and the fact that there is no clear margin of safety that might allow for review of the daily dose in calves, the target species should be clearly stated to be pre-ruminating calves. 
pri teletih neprežvekovalcih v primerjavi s teleti prežvekovalci in dejstva, da ni jasne stopnje varnosti, ki bi omogočala pregled dnevnega odmerka pri teletih, je treba kot ciljno živalsko vrsto jasno navesti teleta neprežvekovalce.
Tetracyclines can chelate cations (e.g. Mg, Mn, Fe and Al) and this may lead to decreased bioavailability 
Tetraciklini lahko kelirajo katione (npr. Mg, Mn, Fe in Al), kar lahko vodi do zmanjšanja biološke razpoložljivosti
The pharmacovigilance data (summary of Periodic Safety Update Reports (PSURs)) from use of the product in chickens covering the past 5 years has been reviewed under the recent Article 35 referral for all strengths of water soluble powders and oral solutions containing doxycycline hyclate indicated for use in poultry and intended for administration via the drinking water (EMEA/V/A/047). 
Farmakovigilančni podatki (povzetek z zadnjimi podatki dopolnjenih rednih poročil o varnosti zdravila) o uporabi zdravila pri piščancih, ki zajemajo zadnjih pet let, so bili pregledani v skladu z nedavno napotitvijo iz člena 35 za vse jakosti v vodi topnih praškov in peroralnih raztopin, ki vsebujejo doksiciklinijev hiklat ter so indicirani za dajanje perutnini s pitno vodo (EMEA/V/A/047).
MARKETING AUTHORISATION NUMBER(S) To be completed nationally 
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET Izpolni se na nacionalni ravni
mg product / kg body weight / day x 
mg zdravila/kg telesne mase/dan x
Shelf life of the veterinary medicinal product as packaged for sale: 36 months. 
Rok uporabnosti zdravila za uporabo v veterini v ovojnini za prodajo: 36 mesece.
Non-laying poultry 
Kokoši nenesnice
In consistency with the recent Article 35 referral for all strengths of water soluble powders and oral solutions containing doxycycline hyclate indicated for use in poultry and intended for administration via the drinking water (EMEA/V/A/047), the following indications can be agreed: 
V skladu z nedavno napotitvijo iz člena 35 za vse jakosti v vodi topnih praškov in peroralnih raztopin, ki vsebujejo doksiciklinijev hiklat in so indicirani za dajanje perutnini s pitno vodo (EMEA/V/A/047), se lahko potrdijo naslednje indikacije:
Due to variability (time, geographical) in susceptibility of bacteria for doxycycline, bacteriological sampling and susceptibility testing of micro-organisms from diseased animals on farm are highly recommended. 
Posebni previdnostni ukrepi za uporabo pri živalih Zaradi raznolikosti (časovna, geografska) v občutljivosti bakterij na doksiciklin, je močno priporočeno bakteriološko vzorčenje in testiranje občutljivosti mikroorganizmov iz obolelih živali na kmetiji.
During the handling of the product, skin contact and inhalation has to be avoided, taking into account the risk of sensitisation and contact dermatitis. 
Med uporabo zdravila se izogibajte stiku s kožo in vdihavanju, pri tem pa je potrebno upoštevati tveganje pojava preobčutljivosti in kontaktnega dermatitisa.
Overdose (symptoms, emergency procedures, antidotes) In calves acute, sometimes fatal myocardial degeneration can occur following singe or multiple dosages. 
Preveliki odmerki (simptomi, ukrepi v sili, protistrupi) Pri teletih lahko pride po enem samem ali več odmerkih do akutne miokardialne degeneracije včasih s smrtnim izidom.
Appropriate definition of indications giving the users of the product clear information on the expected efficacy, together with appropriate dosing for the indications is necessary in order to ensure effective and safe use of the product in the field. 
Za zagotovitev učinkovite in varne uporabe zdravila na terenu sta potrebna ustrezna opredelitev indikacij, ki daje uporabnikom zdravila jasne informacije o pričakovani učinkovitosti, ter pravilno odmerjanje pri indikacijah.
In a study by Goren, 19884, using a challenge infection with an E. coli strain with an MIC of 1 μg/ml, a dose related therapeutic effect was demonstrated, with moderate to good effects noticed in groups receiving doxycycline doses of 96 to 196 mg/kg body weight/day, which gave plasma concentrations of 1.7 to 3.6 μg/ml. 
V študiji Gorena, 19884, pri kateri so uporabljali izzvano okužbo s sevom E.coli z vrednostjo MIC 1 μg/ml, je bil dokazan z odmerkom povezan terapevtski učinek in so bili ugotovljeni zmerni do dobri učinki pri skupinah, ki so prejemale odmerek doksiciklina od 96 do 196 mg na kg telesne mase na dan, kar je zagotovilo plazemsko koncentracijo od 1,7 do
Due to deposit of doxycycline in young bone tissue, use of the product should be limited during pregnancy and lactation. 
Zaradi odlaganja doksiciklina v mladem kostnem tkivu je treba omejiti uporabo tega zdravila med brejostjo in laktacijo.
Manufacturer responsible for the batch release: Dopharma B.V. 
Izdelovalec, odgovoren za sprostitev serije: Dopharma B.V.
The precautions recommended by the CVMP to limit the development of resistance, which resulted from the Article 35 referral, have been included in section 4.5 of the SPC. 
Obvladovanje tveganja ali ukrepi za zmanjševanje tveganja Previdnostni ukrepi za zmanjševanje razvoja odpornosti, ki jih je priporočil CVMP med napotitvijo v skladu s členom 35, so bili vključeni v poglavje 4.5 povzetka glavnih značilnosti zdravila.
No clinical data were submitted to support use of Doxycyline 50% WSP in the treatment of atrophic rhinitis or bronchopneumonia. 
Predloženi niso bili nobeni podatki v podporo uporabi zdravila Doxycycline 50% WSP pri zdravljenju atrofičnega rinitisa ali bronhopnevmonije.
4.2 Indications for use, specifying the target species Treatment of the following specified infections of the respiratory tract and the alimentary tract caused by micro-organisms susceptible to doxycycline. 
4.2 Indikacije za uporabo z opredelitvijo ciljnih živalskih vrst Zdravljenje okužb dihal in prebavil, ki jih povzročajo mikroorganizmi, občutljivi na doksiciklin.
6.4 Special precautions for storage 
6,4 Posebna navodila za shranjevanje
Steady state plasma concentrations of 2.05 ± 0.47 μg/ml were reached within 6 hours after start of the medication and varied between 1.28 and 2.18 μg/ml with a dosage of 25 mg/kg body weight during 5 days. 
Ustaljene plazemske koncentracije, 2,05 ± 0,47 μg/ml, so dosegli v 6 urah po začetku zdravljenja, nihale pa so se med 1,28 in 2,18 μg/ml ob odmerku 25 mg/kg v času 5 dni.
Tetracyclines can chelate cations (e.g. Mg, Mn, Fe and Al) and this may lead to decreased bioavailability. 
Tetraciklini lahko kelirajo katione (npr. Mg, Mn, Fe in Al) pri tem pa pride do zmanjšanja biološke razpoložljivosti.
To ensure that the product is only used in young calves prior to rumination being established, the target species has been updated to read “pre-ruminant calves.” Evaluation of the Benefit-risk balance 
Da bi zagotovili, da se zdravilo uporablja samo pri mladih teletih pred nastopom prežvekovanja, so bile ciljne živalske vrste posodobljene tako, da je zdaj navedeno „teleta neprežvekovalci“.
A dose of doxycyline hyclate of 25 mg/kg body weight/day in drinking water for 3 days produced decreased mortalities and resolution of clinical signs on all farms except one by the end of treatment. 
Odmerek doksiciklinijevega hiklata 25 mg na kg telesne mase na dan v pitni vodi 3 dni je do konca zdravljenja zmanjšal pogin in izboljšal klinične znake na vseh farmah razen na eni.
Doxycycline 50% WSP and associated names is a powder for use in drinking water containing the active substance doxycycline hyclate 500 mg/g. 
Zdravilo Doxycycline 50% WSP in povezana imena je prašek za uporabo v pitni vodi, ki vsebuje zdravilno učinkovino doksiciklinijev hiklat 500 mg/g.
After a dosage of 10 mg/kg body weight /day during 5 days, an elimination halftime varying between 15 and 28 hours was found. 
Po odmerjanju 10 mg/kg/dan, ki traja 5 dni, so ugotovili razpolovni čas izločanja, ki je znašal med 15 in 28 urami.
In the group treated with doxycycline at 16 mg/kg body weight/day, plasma levels were between 1.28 and 1.83 μg/ml, and exceeded the MIC of the challenge strain (1 μg/ml). 
V skupini, ki so jo zdravili z doksiciklinom z odmerkom 16 mg na kg telesne mase na dan, so bile plazemske ravni med 1,28 in 1,83 μg/ml in so presegale vrednost MIC izzivalnega seva (1 μg/ml).
It was identified at the time of the Article 35 referral for water soluble powders and oral solutions containing doxycycline hyclate that a high resistance rate to tetracyclines existed in E. coli isolated from chickens (De Jong et al, 2009)15. 
členom 35 za v vodi topne praške in peroralne raztopine, ki vsebujejo doksiciklinijev hiklat, je bilo ugotovljeno, da je obstajala visoka stopnja odpornosti na tetracikline pri bakteriji E.coli, izolirani iz piščancev (De Jong et al., 2009)15.
• the CVMP considered that the scope of the referral was the harmonisation of the summary of products characteristics, labelling and package leaflet; 
• CVMP je upošteval, da je bil namen napotitve uskladitev povzetka glavnih značilnosti zdravila,
Mean daily water consumption (litre) per animal 
Povprečna telesna masa (kg) živali, ki jih boste zdravili Povprečna dnevna poraba vode (v litrih) na žival
Not permitted for use in laying birds producing eggs for human consumption. 
Ni dovoljeno za uporabo pri pticah nesnicah za proizvodnjo jajc za prehrano ljudi.
This was an uncontrolled study and poultry houses where E. coli strains were found not to be susceptible to 
To je bila nenadzorovana študija in perutninski hlevi, v katerih so bili odkriti sevi E.coli, neobčutljivi na doksiciklin pri testiranju in vitro, so bili izključeni.
Not permitted for use in cattle producing milk for human consumption. 
Ni dovoljeno za uporabo pri govedu za proizvodnjo mleka za prehrano ljudi.
No data were provided in relation to poultry species other than chickens. 
V zvezi z drugo perutnino (poleg piščancev) niso bili predloženi nobeni podatki.
5 Pijpers A., Plasma levels of oxytetracycline, doxycycline and minocycline in pigs after oral administration in feed, Feed Medication with Tetracyclines in Pigs, 85-103 (1990) 
5 Pijpers A., Plasma levels of oxytetracycline, doxycycline and minocycline in pigs after oral administration in feed, Feed
No MIC data were submitted that were specifically relevant to isolates from target pathogens from calves. 
Predloženi niso bili nobeni podatki glede vrednosti MIC, ki bi bili posebej pomembni za izolate iz ciljnih patogenov pri teletih.
No data were submitted in relation to Haemophilus paragallinarum, Bordetella avium and Clostridia spp infections. 
V zvezi z okužbami s Haemophilus paragallinarum, Bordetella avium in Clostridia spp niso bili predloženi nobeni podatki.
Diergeneeskd., 119 (1), 17 (1994) 12 Gool et al, Caracteristiques pharmacocinetiques et bilan des essays cliniques pour le traitement ou la metaphylaxe des bronchopneumonies infectieuses des veaux par le roxanan, Proc. 14th World Congr. 
12 Gool et al, Caracteristiques pharmacocinetiques et bilan des essays cliniques pour le traitement ou la metaphylaxe des bronchopneumonies infectieuses des veaux par le roxanan, Proc. 14th World Congr.
7 The ARBAO-II study, Occurrence of antimicrobial resistance among bacterial pathogens and indicator bacteria in pigs in different European countries form year 2002-2004, Acta Veterinaria Scandinavica 50(19) (2008) 
7 The ARBAO-II study, Occurrence of antimicrobial resistance among bacterial pathogens and indicator bacteria in pigs in different European countries form year 2002-2004.
Treatment of the following specified infections of the respiratory tract and the alimentary tract caused by micro-organisms susceptible to doxycycline. 
Zdravljenje okužb dihal in prebavil, ki jih povzročajo mikroorganizmi, občutljivi na doksiciklin.
Although not submitted by the marketing authorisation holder, information from the ARBAO-II7 project reporting on the occurrence of antimicrobial resistance among bacteria causing infections in pigs in the European Union between 2002-2004 showed levels of resistance to tetracylines in Actinobacillus pleuropneumoniae between 0 and 46.0% and in Strep. suis between 48.0 and 92.0%. 
Čeprav jih ni predložil imetnik dovoljenja za promet z zdravilom, so podatki iz projekta ARBAO-II7 glede pojavljanja protimikrobne odpornosti pri bakterijah, ki povzročajo okužbe pri prašičih v Evropski uniji, med letoma 2002 in 2004 pri Actinobacillus pleuropneumoniae pokazali stopnjo odpornosti na
Do not use in case of hypersensitivity to tetracyclines or any of the excipients. 
Ne uporabite v primeru preobčutljivosti na tetracikline ali katero koli pomožno snov.
• Atrophic rhinitis caused by Pasteurella multocida and Bordetella bronchiseptica 
• Atrofični rinitis, ki ga povzročata Pasteurella multocida in Bordetella bronchiseptica.
Additional information has been added to the SPC regarding mechanisms of resistance totetracyclines in general. 
V povzetek glavnih značilnosti so bile dodane informacije glede splošnih mehanizmov odpornosti na tetracikline.
Store below 25 ºC. 
Shranjujte pri temperaturi pod 25 °C.
METHOD AND ROUTE OF ADMINISTRATION Oral use, after dissolution in drinking water/milk replacer. 
Peroralna uporaba po raztapljanju v pitni vodi/mlečnem nadomestku.
DATE OF THE FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION To be completed nationally 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Izpolni se na nacionalni ravni
MANUFACTURER'S BATCH NUMBER Batch <<number>> 
IZDELOVALČEVA ŠTEVILKA SERIJE IZDELAVE ZDRAVILA Lot številka serije
Poultry 
Piščanci
User warnings 
Opozorila za uporabnike
9 (1983) 2 George et al, Comparison of therapeutic efficacy of doxycycline, chlortetracycline and lincomycin-spectinomycin on E. 
George et al.: Comparison of therapeutic efficacy of doxycycline, chlortetracycline and lincomycin-spectinomycin on E. coli infection of young chickens.
When chickens are administered a dose of 25 mg doxycycline hyclate/kg bw/day for 5 days; pigs are administered 10 mg doxycycline hyclate/kg bw/day for 5 days; and calves are administered 5 mg doxycycline hyclate/kg bw, twice a day for 5 days; meat withdrawal periods of 5, 8 and 7 days respectively, will ensure consumer safety. 
Kadar piščanci 5 dni prejemajo odmerek 25 mg doksiciklinijevega hiklata na kg telesne mase na dan; prašiči 5 dni prejemajo 10 mg doksiciklinijevega hiklata na kg telesne mase na dan in teleta 5 dni prejemajo 5 mg doksiciklinijevega hiklata na kg telesne mase dvakrat na dan, karenca za meso posamezne živalske vrste 5, 8 oz. 7 dni zagotavlja varnost potrošnikov.
Chickens: - Infections of the respiratory tract caused by Mycoplasma spp., Escherichia coli, Haemophilus paragallinarum and Bordetella avium; - Enteritis caused by Clostridium perfringens and Clostridium colinum. 
Piščanci: - Okužbe dihal, ki jih povzročajo Mycoplasma spp., Escherichia coli, Haemophilus paragallinarum in Bordetella avium; - Enteritis, ki ga povzročata Clostridium perfringens in Clostridium colinum.
No clinical or field data have been presented to support use of the product in the treatment of pleuropneumonia (Histophilus somni) or bronchopneumonia involving H. somni, P. multocida, Streptococcus spp or Arcanobacterium pyogenes. 
Predstavljeni niso bili nobeni klinični podatki ali podatki s terena v podporo uporabi zdravila pri zdravljenju plevropnevmonije (Histophilus somni) ali bronhopnevmonije, ki jo povzroča H. somni, P. multocida, Streptococcus spp ali Arcanobacterium pyogenes.
The use of suitably calibrated weighing equipment is recommended if part packs are used. 
Če porabite samo del vsebine pakiranja, je priporočena uporaba primerno umerjene opreme za tehtanje.
Administration at up to 5 X Recommended Treatment Dose was well tolerated. 
Živali so dobro prenašale tudi petkratni priporočeni odmerek za zdravljenje.
ADVICE ON CORRECT ADMINISTRATION For the administration through the drinking water, the exact daily amount of product should be calculated, based on the recommended dose, and the number and weight of the animals to be treated, according to the following formula: mg product / kg body weight / day x 
NASVET O PRAVILNI UPORABI ZDRAVILA Za dajanje s pitno vodo je treba izračunati natančno dnevno količino zdravila glede na priporočeni odmerek, število in maso živali, ki jih boste zdravili, skladno s formulo: mg zdravila/kg telesne mase/dan x Povprečna telesna masa (kg) živali, ki jih boste zdravili Povprečna dnevna poraba vode (v litrih) na žival
Some field data were presented to support use of the product in the treatment of pneumonia caused by Mycoplasma and P. haemolytica in calves, but there were no clinical or field data to support use of the product in the treatment of pleuropneumonia (H. somni) or bronchopneumonia involving H. somni, P. multocida, Streptococcus spp or A. pyogenes. 
Predloženo je bilo nekaj terenskih podatkov v podporo uporabi zdravila pri zdravljenju pljučnice, ki jo pri teletih povzročata Mycoplasma in P. haemolytica, ni pa bilo nobenih kliničnih ali terenskih podatkov, ki bi podprli uporabo zdravila pri zdravljenju plevropnevmonije (H. somni) ali bronhopnevmonije zaradi H. somni, P. multocida, Streptococcus spp ali A. pyogenes.
The summary of PSURs data indicated no safety concerns or suspected lack of expected efficacy in relation to this indication or dose duration. 
Povzetek z zadnjimi podatki dopolnjenih poročil o varnosti zdravila v zvezi s to indikacijo ali trajanjem odmerka ni nakazoval nobenih varnostnih zadržkov ali domnevno manjše učinkovitosti od pričakovane.