FrancophonIA/ELRC3.0 huggingface dataset:
English: Dose reduction recommended Patients aged ≥80 years daily dose of 220 mg Pradaxa taken as one 110 mg capsule twice daily
Slovenian: Dnevni odmerek zdravila Pradaxa po 220 mg, in sicer kot eno kapsulo po 110 mg, dvakrat na dan
English: Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (DVT/PE)
Slovenian: Zdravljenje globoke venske tromboze (GVT) in pljučne embolije (PE) ter preprečevanje ponovitve GVT in PE pri odraslih (GVT/PE)
English: - Blood-stained discharge from the site of entry of a catheter into a vein - Coughing of blood or blood stained sputum - A fall in the number of platelets in the blood - A fall in the number of red cells in the blood after an operation - Serious allergic reaction which causes difficulty in breathing or dizziness - Serious allergic reaction which causes swelling of the face or throat - Skin rash notable for dark red, raised, itchy bumps caused by an allergic reaction - Sudden change of the skin which affects its colour and appearance - Itching - Ulcer in the stomach or bowel (incl.
Slovenian: krvavitev se lahko pojavi v možganih, pri kirurškem rezu, na mestu vboda pri injiciranju ali na mestu vstavitve katetra v veno; - krvavi izloček iz mesta vstavitve katetra (cevke) v veno, - izkašljevanje krvi ali kri v izpljunku (sputumu), - zmanjšanje števila trombocitov v krvi, - zmanjšanje števila rdečih krvničk po operaciji, - resna alergijska reakcija, ki povzroča težave z dihanjem ali omotico; - resna alergijska reakcija, ki povzroča zatekanje obraza ali grla; - kožni izpuščaj s temno rdečimi, srbečimi izboklinami, ki ga povzroča alergijska reakcija; - nenadna sprememba barve in videza kože, - srbenje, - razjeda v želodcu ali črevesju (vključno z razjedo v požiralniku), - vnetje požiralnika in želodca, -vračanje želodčnega soka v požiralnik, - trebušna ali želodčna bolečina, - prebavne motnje, - težave s požiranjem, -izcedek iz rane, -izcedek tekočine iz operacijske rane.
English: Rare (may affect up to 1 in 1,000 people): - Bleeding may happen, from a surgical incision, or from the site of entry of an injection or from the site of entry of a catheter into a vein or from the brain - A fall in the number of platelets in the blood - Serious allergic reaction which causes difficulty in breathing or dizziness - Serious allergic reaction which causes swelling of the face or throat - Skin rash notable for dark red, raised, itchy bumps caused by an allergic reaction - Difficulty in swallowing - A decrease in the proportion of red cells in the blood
Slovenian: Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov): - krvavitev iz kirurškega reza ali mesta vboda z injekcijo ali vstavitve katetra v veno ali iz možganov, - zmanjšanje števila krvnih ploščic v krvi, - resna alergijska reakcija, ki povzroči težave z dihanjem ali omotico; - resna alergijska reakcija, ki povzroči otekanje obraza ali grla; - kožni izpuščaj, ki je temno rdeče barve, nad ravnijo kože in srbeč, in je posledica alergijske reakcije; - oteženo požiranje, - zmanjšan delež rdečih krvničk v krvi.
English: Table 14 shows bleeding events in pivotal study RE-SONATE testing prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE).
Slovenian: V preglednici 14 so podatki o krvavitvah v ključni študiji RE-SONATE, študiji o preprečevanju globoke venske tromboze (GVT) in pljučne embolije (PE).
English: Table 10: Analysis of major VTE and VTE-related mortality during the treatment period in the RE-MODEL and the RE-NOVATE orthopaedic surgery studies
Slovenian: Analiza hujše VTE in z VTE povezane umrljivosti med zdravljenjem v študijah na področju ortopedske kirurgije RE-NOVATE in RE-MODEL
English: Table 12 shows bleeding events in the pooled pivotal studies RE-COVER and RE-COVER II testing the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).
Slovenian: V preglednici 12 so združeni podatki o krvavitvah iz ključnih študij RE-COVER in RE-COVER II, v katerih so zdravilo preskušali v zdravljenju globoke venske tromboze (GVT) in pljučne embolije (PE).
English: Table 14 shows bleeding events in the pooled pivotal studies RE-COVER and RE-COVER II testing the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).
Slovenian: V preglednici 14 so združeni podatki o krvavitvah iz ključnih študij RE-COVER in RE-COVER II, v katerih so zdravilo preskušali v zdravljenju globoke venske tromboze (GVT) in pljučne embolije (PE).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/442/016
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/442/016
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/442/015
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/442/015
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK OF 100 (2 PACKS OF 50 HARD-CAPSULES) - WITHOUT BLUE BOX110 mg HARD CAPSULES
Slovenian: VEČKRATNO PAKIRANJE PO 100 (2 ENOTI S 50 TRDIMI KAPSULAMI) - BREZ PODATKOV ZA 'BLUE BOX' - TRDE KAPSULE PO 110 mg
English: Table 13 shows bleeding events in pivotal study RE-MEDY testing prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE).
Slovenian: V preglednici 13 so podatki o krvavitvah v ključni študiji RE-MEDY, študiji o preprečevanju globoke venske tromboze (GVT) in pljučne embolije (PE).
English: Rare (may affect up to 1 in 1,000 people): - Bleeding - Bleeding may happen in the brain, from a surgical incision, from the site of entry of an injection or from the site of entry of a catheter into a vein
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100bolnikov): -krvavitev, -možna je krvavitev iz hemoroidov, izzadnjikaali v možganih; -nastanek hematoma, -izkašljevanje krvi ali krvav izpljunek (sputum), -zmanjšanje števila trombocitov v krvi,
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 75 mg dabigatran etexilate (as mesilate).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena trda kapsula vsebuje 75 mg dabigatran eteksilata (v obliki mesilata).
English: The clinical evidence for the efficacy of dabigatran etexilate is derived from the RE-LY study (Randomized Evaluation of Long -term anticoagulant therapy) a multi-centre, multi-national, randomized parallel group study of two blinded doses of dabigatran etexilate (110 mg and 150 mg twice daily) compared to open-label warfarin in patients with atrial fibrillation at moderate to high risk of stroke and systemic embolism.
Slovenian: V njej so dva prikrita odmerka dabigatran eteksilata (110 mg in 150 mg, dvakrat na dan) primerjali z odprtim zdravljenjem z varfarinom pri bolnikih z atrijsko fibrilacijo in zmernim do velikim tveganjem možganske kapi in sistemskih emboličnih dogodkov.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/442/012
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/442/012
English: Tear off one individual blister from the blister card along the perforated line
Slovenian: Po perforaciji odtrgajte eno enoto s pretisnega omota.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/442/013
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/442/013
English: if you are receiving medicines which could increase the risk of bleeding.
Slovenian: ® lahko poveča tveganje za pojav krvavitev.
English: The dabigatran geometric mean trough concentration, measured at trough in the morning, at the end of the dosing interval (i.e. 12 hours after the 150 mg dabigatran evening dose), was on average 91.0 ng/mL, with a range of 61.0-143 ng/mL (25
Slovenian: 12 ur po odmerku 150 mg zvečer), je bila v povprečju 91.0 ng/ml, njen razpon pa je bil 61.0-143 ng/ml (25. do 75. percentile).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/442/014
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/442/014
English: Intracranial bleeding GI bleeding Fatal bleeding Minor bleeding Any bleeding
Slovenian: Žilne bolezni hematom občasni krvavitev rane občasni krvavitev redki
English: A specific reversal agent for dabigatran, idarucizumab, is available in case of uncontrollable bleeding (see Section 4.9).
Slovenian: V primeru krvavitve, ki je ni mogoče nadzorovati, je na voljo specifična protiučinkovina za dabigatran - idarucizumab (glejte poglavje 4.9).
English: Dyspepsia
Slovenian: Pantoprazol
English: Rectal haemorrhage
Slovenian: peroralna uporaba
English: Post procedural haemorrhage
Slovenian: Operacija kolčnega zloma
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 150 mg dabigatran etexilate (as mesilate).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena trda kapsula vsebuje 150 mg dabigatran eteksilata (v obliki mesilata).
English: • Pradaxa
Slovenian: • Zdravila Pradaxa
English: There is no data on the use of Pradaxa in patients undergoing hip fracture surgery.
Slovenian: O uporabi zdravila Pradaxa pri bolnikih z operacijo kolčnega zloma ni podatkov, zato zdravljenja ne priporočamo.
English: The primary objective of these studies was to determine if dabigatran etexilate was non-inferior to warfarin in reducing the occurrence of the primary endpoint which was the composite of recurrent symptomatic DVT and/or PE and related deaths within the 6 month treatment period.
Slovenian: V njih so dabigatran eteksilat (150 mg dvakrat na dan) primerjali z varfarinom (ciljni INR 2,0 do 3,0) pri bolnikih z akutno GVT in/ali PE. Primarni cilj študij je bil ugotoviti, ali je dabigatran eteksilat enakovreden varfarinu glede na pojav primarnega opazovanega dogodka, ki je bil sestavljen iz ponovitve simptomatične GVT in/ali PE in z njima povezane umrljivosti v 6-mesečnem obdobju zdravljenja.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 110 mg dabigatran etexilate (as mesilate).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena trda kapsula vsebuje 110 mg dabigatran eteksilata (v obliki mesilata).
English: under the skin, into a joint, from or after an injury or after an operation - Haematoma formation or bruising occurring after an operation - Blood detected in the stools by a laboratory test - A fall in the number of red cells in the blood - A decrease in the proportion of red cells in the blood - Allergic reaction - Vomiting - Frequent loose or liquid bowel movements - Feeling sick - Wound secretion (liquid exuding from the surgical wound) - Liver enzymes increased - Yellowing of the skin or whites of the eyes, caused by liver or blood problems
Slovenian: kri v blatu pri laboratorijskih raziskavah, zmanjšanje števila rdečih krvničk v krvi, znižanje razmerja rdečih krvničk v krvi, alergijska reakcija, bruhanje, pogosto mehko ali tekoče blato, siljenje na bruhanje, izcedek iz rane (iztekanje tekočine iz kirurške rane), povečane vrednosti jetrnih encimov, porumenelost kože ali beločnic zaradi motenj jeter ali krvi.
English: Caution should be exercised when Pradaxa is co-administered with posaconazole.
Slovenian: Pri sočasnem dajanju zdravila Pradaxa in posakonazola je potrebna previdnost.
English: Not calculable*
Slovenian: življenjsko nevarna krvavitev izračun ni možen*
English: Nausea
Slovenian: Krvavitve
English: Consideration should also be given to administration of platelet concentrates in cases where thrombocytopenia is present or long acting antiplatelet medicinal products have been used.
Slovenian: Kadar se pojavi trombocitopenija ali če je bolnik prejel dolgodelujoče antitromobotike, je treba presoditi tudi o uporabi trombocitnih koncentratov.
English: glomerular filtration rate (CrCL,) [mL/min]
Slovenian: Razpolovna doba skupnega dabigatrana pri zdravih preizkušancih in preizkušancih z okvarjenim ledvičnim delovanjem hitrost glomerulne filtracije (CrCl) [ml/min]
English: Should not be performed
Slovenian: ga ne določamo ga ne določamo
English: The dossier submitted to the Netherlands was only bibliographic.
Slovenian: Dokumentacija, ki je bila predložena Nizozemski, je bila zgolj bibliografska.
English: The residues were rapidly depleted.
Slovenian: Ostanki so se hitro izločili.
English: The CVMP can accept the proposed revision of the indication:
Slovenian: CVMP lahko sprejme predlagano revizijo indikacije:
English: It can be concluded that the dossiers on which the Member States took their decisions were largely similar but not identical.
Slovenian: Povzamemo lahko, da so bile dokumentacije, na podlagi katerih so države članice sprejele odločitve, večidel podobne, a ne identične.
English: Hungary and Lithuania
Slovenian: Madžarska in Litva
English: No member states, other than Germany, have reported the refusal of a marketing authorisation.
Slovenian: Nobena država članica razen Nemčije ni poročala o zavrnitvi dovoljenja za promet.
English: Austria received a dossier similar to the original sent to Germany.
Slovenian: Avstrija je prejela dokumentacijo, podobno izvirniku, ki je bil poslan Nemčiji.
English: Clear and yellow
Slovenian: Bistra in rumena.
English: To consider in particular the issues to which reference is made in the Annex to the referral notification from Germany as to the grounds for refusing an authorisation.
Slovenian: Preuči naj zlasti vprašanja, na katere se sklicuje Priloga obvestila o napotitvi s strani Nemčije glede razlogov za zavrnitev odobritve.
English: The physical product manufactured for sale in the various markets appears to be identical.
Slovenian: Fizično je zdravilo, izdelano za prodajo na različnih trgih, povsem enako.
English: Do not freeze
Slovenian: Zdravilo ne sme zmrzniti.
English: Methoxasol-T was authorised through a national procedure in the Netherlands in 1999 but a marketing authorisation was refused in Germany in 2001.
Slovenian: Zdravilo Methoxasol-T je bilo odobreno na podlagi nacionalnega postopka na Nizozemskem leta 1999, vendar pa je bilo v Nemčiji dovoljenje za promet leta 2001 zavrnjeno.
English: Differences between dossiers
Slovenian: Razlike med dokumentacijami
English: The CVMP can also accept the dose as these are in accordance with those used in the experimental and field studies.
Slovenian: CVMP lahko sprejme tudi odmerjanje, saj je to skladno z odmerki, uporabljenimi v eksperimentalnih in terenskih študijah.
English: Hypersensitivity reactions can occur rarely.
Slovenian: Redko se lahko pojavijo preobčutljivostne reakcije.
English: However, for the use of the product confirmation of the presence of a specific infection and confirmation of a bacteriological cure is required.
Slovenian: Vendar pa je za uporabo zdravila potrebna potrditev prisotnosti specifične okužbe in potrditev bakteriološkega zdravljenja.
English: Germany considered that the efficacy of Methoxasol-T as proposed by the applicant was not adequately justified, therefore resulting in a potential serious risk for the target animals.
Slovenian: Nemčija je menila, da učinkovitost zdravila Methoxasol-T, predlagana v vlogi prijavitelja, ni ustrezno utemeljena, zato lahko predstavlja morebitno resno tveganje za ciljne živali.
English: Methoxasol-T As for The Netherlands
Slovenian: Methoxasol-T Kot za Nizozemsko
English: This section is strictly meant for contraindications relating to the safety of the treated animals.
Slovenian: To poglavje je namenjeno izključno za kontraindikacije, ki so povezane z varnostjo zdravljenih živali.
English: The dossier sent to Germany including the answers to the list of questions and to Poland, Hungary and Lithuania was almost the same, but with additional experimental clinical studies.
Slovenian: Dokumentacija, poslana Nemčiji skupaj z odgovori na seznam vprašanj, je bila skoraj identična dokumentaciji, ki je bila poslana Poljski, Madžarski in Litvi, le da je obsegala dodatne eksperimentalne klinične študije.
English: To justify compliance of the dossier, as it exists in each Member State or EEA country, with respect to the requirements of Annex I of Directive 2001/82/EC, as amended.
Slovenian: Utemelji naj skladnost dokumentacije, kot obstaja v posamezni državi članici ali državi EGP, z zahtevami iz Priloge I Direktive 2001/82/ES, z vsemi spremembami.
English: Do not use in animals with impaired haematopoietic systems.
Slovenian: Ne uporabite pri živalih z obolelim hematopoetskim sistemom.
English: 5.2: protein binding for TMP and SMX is not high (TMP 50, SMX 60), but the overall proposal of the MAH can be accepted.
Slovenian: 5.2: stopnja vezave TMP in SMX na beljakovine ni visoka (TMP 50, SMX 60), vendar pa je splošni predlog imetnika dovoljenja za promet z zdravilom mogoče sprejeti.
English: ATC vet classification (of the combination): QJ01E W
Slovenian: Oznaka ATC vet (kombinacije): QJ01E W
English: To provide information on any addition, deletion or change made to the information as requested under point 1, after the initial application.
Slovenian: Predloži naj informacije o morebitnih dopolnitvah, črtanjih ali spremembah informacij, zahtevanih pod točko 1, po začetni vlogi.
English: The results of the in-use stability testing of the product after 15 months storage at 25°C/60% RH and in-use of 12 months after opening showed acceptable stability.
Slovenian: Rezultati preizkušanja stabilnosti po odprtju izdelka po 15 mesecih shranjevanja pri 25 °C/60 % relativne vlažnosti in po 12 mesecih po odprtju izdelka so pokazali sprejemljivo stabilnost.
English: • the availability of an authorised veterinary medicinal product containing active substances other than fluoroquinolones might be regarded an indirect benefit and not directly relevant to the scope of this referral procedure (as efficacy must be shown for each product independently);
Slovenian: • je razpoložljivost odobrenega veterinarskega zdravila, ki vsebuje zdravilne učinkovine, ki niso fluorokinoloni, mogoče šteti kot posredno korist, ki ni neposredno relevantna za predmet tega postopka napotitve (saj mora biti učinkovitost neodvisno dokazana za vsako zdravilo);
English: Box 179
Slovenian: P.O. Box 179
English: Oral, via the drinking water
Slovenian: Peroralno, s pitno vodo
English: As to where Methoxasol-T is also authorised in Austria, Poland, Hungary, and Lithuania, these marketing authorisations have been included in the scope of the procedure.
Slovenian: Glede na to, da je zdravilo Methoxasol-T odobreno tudi v Avstriji, na Poljskem, Madžarskem in v Litvi, so bila tudi ta dovoljenja za promet vključena v predmet postopka.
English: To provide the dossier submitted upon application for a marketing authorisation, for each Member State mentioned above (including Germany) and, if applicable, for any other Member State or country of the European Economic Area (EEA): a. Part I Summary of the dossier, including the Summary of Product Characteristics, the expert reports and the quantitative and qualitative composition of the product; b. Part IV Preclinical and clinical information.
Slovenian: Predloži naj dokumentacijo, ki jo je poslal ob vlogi za izdajo dovoljenja za promet, za vsako izmed zgoraj imenovanih držav članic (vključno z Nemčijo) in, če je smiselno, za vsako drugo državo članico ali državo Evropskega gospodarskega prostora (EGP), in sicer: a. Del I Povzetek dokumentacije, vključno s Povzetkom glavnih značilnosti zdravila, ekspertnimi poročili ter količinsko in kakovostno sestavo zdravila; b. Del IV Predklinične in klinične informacije.
English: In respect of the benefit/risk balance for target species poultry, the CVMP concludes that:
Slovenian: Z vidika razmerja med koristmi in tveganji za ciljno vrsto perutnine CVMP ugotavlja, da
English: Shelf-life after dilution or reconstitution according to directions: 24 hours
Slovenian: Rok uporabnosti po razredčenju ali rekonstituciji v skladu z navodili: 24 ur.
English: In pigs, elimination half-life for both substances is approximately 2.5 hours.
Slovenian: Pri prašičih je eliminacijski razpolovni čas za obe snovi približno 2,5 uri.
English: Elimination is relatively fast both in poultry and pigs.
Slovenian: Eliminacija je razmeroma hitra tako pri perutnini kot pri prašičih.
English: In the event of eye contact, rinse the eye with copious amounts of clean water and if irritation occurs, seek medical attention.
Slovenian: V primeru stika z očmi, oko sperite z veliko čiste vode, in, če se pojavi draženje, nemudoma poiščite zdravniško pomoč.
English: If necessary the concentration of the VMP in the drinking water should be adjusted to make sure that the recommended dosage is being consumed.
Slovenian: Po potrebi je treba prilagoditi koncentracijo zdravila v pitni vodi, da zagotovimo zaužitje priporočenega odmerka.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Active substances:
Slovenian: NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGIH SNOVI Zdravilne učinkovine:
English: On the basis of further additional MIC data from various publications (including two 2004 published papers showing susceptibility of various isolates from pig respiratory samples from Denmark) and from resistance monitoring by the BVL in Germany in 2006, the CVMP can accept the proposed revision of the indication:
Slovenian: CVMP lahko na podlagi nadaljnjih dodatnih podatkov o MIK iz različnih publikacij (vključno z dvema, leta 2004 objavljenima člankoma, ki prikazujeta občutljivost različnih izolatov iz vzorcev izdihanega zraka prašičev na Danskem) in rezultatov spremljanja odpornosti s strani BVL v Nemčiji leta 2006 sprejme predlagano revizijo indikacije:
English: As for The Netherlands
Slovenian: Kot za Nizozemsko
English: In order to obtain the correct dosage the concentration of Methoxasol has to be adjusted accordingly.
Slovenian: Da dosežemo pravilno odmerjanje, je treba koncentracijo Methoxasola-T ustrezno prilagoditi.
English: To detail differences that exist between the dossiers with respect to the information as requested under point 1 and 2.
Slovenian: Podrobneje naj predstavi razlike med dokumentacijami glede informacij, zahtevanih pod točko 1 in
English: Resistance against potentiated sulphonamides may vary.
Slovenian: Odpornost na potencirane sulfonamide lahko variira.
English: 6 days Not authorised for use in laying birds producing eggs for human consumption
Slovenian: 6 dni Ni odobreno za uporabo pri pticah v obdobju nesnosti, katerih jajca so namenjena prehrani ljudi.
English: The CVMP agrees that as long as the treatment is directed against respiratory infections in pigs, it is not necessary to perform additional field studies to demonstrate efficacy against other organisms with similar MIC levels as A. pleuropleumonia.
Slovenian: CVMP se strinja, da dokler je namen zdravljenja zdraviti okužbe dihal pri prašičih, izvajanje dodatnih terenskih študij, ki bi dokazovale učinkovitost proti drugim organizmom s podobnimi vrednostmi MIK kot A. pleuropleumonia, ni potrebno.
English: Where the indications in both pigs and broilers are restricted to respiratory infections, the CVMP can accept this claim.
Slovenian: Če so indikacije pri prašičih in brojlerjih omejene na okužbe dihal, lahko CVMP sprejme ta zahtevek.
English: • notwithstanding the fact that a definitive clinical field study using the recommended dosage of the product has not been provided, taking into account the pre-clinical studies, the artificial infection model, the history of use and the other pertinent information provided, the various risk management steps now set out in the proposed SPC and noting the fact that the indications for use are restricted, the benefit / risk balance is positive;
Slovenian: • je kljub dejstvu, da dokončna klinična terenska študija s priporočljivim odmerkom zdravila ni bila izvedena, razmerje med koristmi in tveganji ob upoštevanju predkliničnih študij, umetnega modela okužbe, zgodovine uporabe in drugih ustreznih predloženih informacij ter različnih ukrepov za obvladovanje tveganja, ki so zdaj navedeni v predlaganem Povzetku glavnih značilnosti zdravila in kažejo na dejstvo, da so indikacije za uporabo omejene, pozitivno;
English: In vitro trimethoprim is generally bacteriostatic and has a broad spectrum of activity against both grampositive and gram-negative bacteria.
Slovenian: In vitro je trimetoprim splošno bakteriostatičen in ima širok spekter delovanja proti gram-pozitivnim kot tudi proti gram-negativnim bakterijam.
English: Comment is required on the current use of the product in poultry and in particular on the dose used or prescribed by veterinary surgeons under field conditions.
Slovenian: Potreben je komentar trenutne uporabe zdravila pri perutnini in zlasti komentar odmerka, ki so ga uporabljali ali predpisovali veterinarji v praksi.