FrancophonIA/ELRC3.0 huggingface dataset:
English: In a 3-month study, exposures were 2 times higher at Day 29 but returned to Day 1 values at days 56 and 87.
Slovenian: V tromesečni študiji je bila izpostavljenost 2-krat višja 29. dan vendar se je vrnila na vrednost s prvega dne 56. in 87. dan. Spol živali nima vpliva na farmakokinetične parametre.
English: If the bodyweight loss since previous monthly weighing has been <3% bodyweight per month, the dose should be increased without adjusting for the dog's current bodyweight.
Slovenian: Če je bila izguba telesne mase glede na prejšnje mesečno preverjanje ≤3 % telesne mase na mesec, se odmerek zdravila poveča brez prilagajanja glede na trenutno maso psa.
English: 3% bodyweight loss per month = 0.7% per week = 0.1% per day The lowest validated dose for the dosing device is 0.05 ml.
Slovenian: 3 % izgube telesne mase na mesec = 0,7 % na teden = 0,1 % na dan Najnižji veljavni odmerek za odmerno napravo je 0,05 ml.
English: Medicines should not be disposed of via wastewater or household waste.
Slovenian: ZDRAVILA ALI ODPADNIH SNOVI, ČE OBSTAJAJO Ne odvrzite zdravila v odpadno vodo ali v gospodinjske odpadke.
English: DOSE PROGRESSION TABLE DURING WEIGHT LOSS
Slovenian: TABELA PRILAGAJANJA ODMERKOV MED IZGUBLJANJEM
English: In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other
Slovenian: Zaradi pomanjkanja študij kompatibilnosti tega zdravila ne smemo mešati z drugimi zdravili za
English: Sporadic and mild serum alanine aminotransferase (ALT) elevations up to 4 times the upper reference range are not a reason for discontinuing therapy in the absence of any indication of liver dysfunction.
Slovenian: Sporadično ali blago povečanje vrednosti alanin amino transferaze (ALT) do 4x zgornje referenčne vrednosti ni razlog za prekinitev zdravljenja, če ni prisotnih drugih znakov odpovedovanja jetrnih funkcij.
English: These signs will resolve spontaneously following treatment discontinuation.
Slovenian: Znaki bodo spontano prenehali po prenehanju zdravljenja.
English: Shelf life after first opening the container: 3 months
Slovenian: Rok uporabnosti po prvem odpiranju stične ovojnine: 3 mesece
English: The duration of treatment must not exceed 12 months and the dose must not exceed a maximum of 0.2 ml /kg current bodyweight (1 mg/kg dirlotapide).
Slovenian: Trajanje zdravljenja ne sme biti daljše od 12 mesecev, odmerek zdravila pa ne sme preseči maksimuma 0,2 ml/kg trenutne telesne mase (1 mg/kg dirlotapida).
English: According to clinical studies, a mean weight loss of about 18 to 20% after six months of weight loss therapy can be anticipated.
Slovenian: Glede na klinične študije se lahko predvideva povprečna izguba 18 do 20 % začetne telesne mase v šestih mesecih zdravljenja.
English: The MTP is pivotal for the absorption and distribution of fat.
Slovenian: Mikrosomalni protein za prenos trigliceridov (MTP) je ključen za absorpcijo in distribucijo maščob.
English: During treatment, because food intake is reduced as when using a traditional non-medical calorie restriction method, care must be taken to ensure that protein, vitamins, essential fatty acids and minerals supplied by the daily food ration meet minimal recommended requirements in order to ensure a complete and balanced nutritional supply.
Slovenian: Ko je vnos hrane zmanjšan pri tradicionalnih metodah omejevanja kalorij brez uporabe zdravil, je treba v času zdravljenja zagotoviti dnevno količino beljakovin, vitaminov, esencialnih maščobnih kislin in mineralov, ki ustreza najmanjšim priporočenim zahtevam za popolno in uravnoteženo prehransko oskrbo.
English: After two weeks of therapy, the initial dose volume should be doubled.
Slovenian: Začetni odmerek se po dveh tednih zdravljenja podvoji.
English: In subsequent required conditional increases, the dose should be increased by 50% (increasing the dose volume to 1.5 times the volume administered in the previous month) up to a maximum dose of the veterinary medicinal product of 0.2 ml/kg current bodyweight.
Slovenian: Pri naslednjih pogojnih povečanjih odmerka se le-ta poveča za 50 % (odmerek zdravila se poveča za 1,5 odmerka, ki se je dajal prejšnji mesec) do maksimalnega odmerka zdravila 0,2 ml/kg trenutne telesne mase.
English: On rare occasions, reports of change of behaviour such as polyphagia, or very rarely reports of aggression associated with food and feeding have been observed in Slentrol-treated dogs.
Slovenian: V redkih primerih so pri psih, ki so prejemali Slentrol, poročali o spremembah v obnašanju, kot je polifagija, v zelo redkih primerih pa o opaženi agresiji povezani s hrano in hranjenjem.
English: To ensure correct dosing during the treatment period the owner should seek advice from the responsible veterinarian in connection to each monthly dose adjustment.
Slovenian: Da se zagotovi pravilno odmerjanje zdravila v času zdravljenja, naj lastnik poišče nasvet o mesečnem prilagajanju odmerka pri odgovornem veterinarju.
English: The veterinary medicinal product is not miscible with water.
Slovenian: Zdravila za uporabo v veterinarski medicini ne mešajte z vodo.
English: 20 ml packed with 2 dosing devices of 1 ml 50 ml packed with 2 dosing devices of 3 ml 150 ml packed with 2 dosing devices of 10 ml
Slovenian: 20 ml z 2 pripravama za odmerjanje po 1 ml 50 ml z 2 pripravama za odmerjanje po 3 ml 150 ml z 2 pripravama za odmerjanje po 10 ml
English: To ensure correct dosing during the treatment period the owner should seek advice from the responsible veterinarian in connection to each monthly
Slovenian: Da se zagotovi pravilno odmerjanje zdravila v času zdravljenja naj lastnik poišče nasvet o mesečnem prilagajanju odmerka pri odgovornem veterinarju.
English: In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Slovenian: V primeru naključnega zaužitja, takoj poiščite zdravniško pomoč in pokažite zdravniku navodilo za uporabo ali ovojnino.
English: Dirlotapide 5 mg/ml is a colourless to pale yellow solution.
Slovenian: NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SESTAVIN Dirlotapid 5 mg/ml je brezbarvna do bledo rumena raztopina.
English: These adjustments should be continued until the weight targeted at the start of therapy is achieved.
Slovenian: Odmerek zdravila se tako prilagaja dokler se ne doseže na začetku zdravljenja
English: If vomiting, diarrhoea or significantly reduced appetite or excessive weight loss occurs, treatment should be interrupted and the advice of a veterinarian should be sought.
Slovenian: Če se pojavi bruhanje, driska, občutno zmanjšanje apetita ali čezmerna izguba telesne mase, se zdravljenje prekine in poišče nasvet veterinarja.
English: At the end of each month of therapy, the percentage of bodyweight loss should be determined.
Slovenian: Procent izgubljene telesne mase se določi na koncu vsakega meseca zdravljenja.
English: Slentrol must not be used during pregnancy and lactation.
Slovenian: Slentrola se ne sme uporabljati med brejostjo ali v času laktacije.
English: If vomiting, diarrhoea or significantly reduced appetite or excessive weight loss occurs, treatment should be interrupted.
Slovenian: Če se pojavi bruhanje, diareja ali občutno zmanjšanje apetita ali prevelika izguba telesne mase, se zdravljenje prekine.
English: Manufacturer responsible for batch release:
Slovenian: Izdelovalec, odgovoren za sproščanje serij:
English: If accidental eye exposure occurs, flush the eyes immediately with clean
Slovenian: Če pride zdravilo nenamerno v oči, jih takoj sperite s čisto vodo.
English: Following these initial 4 weeks of therapy, dogs should be weighed monthly during treatment and dose adjustments are made monthly according to effect as described below.
Slovenian: Po začetnih 4 tednih zdravljenja je potrebno pse med zdravljenjem mesečno tehtati in mesečno prilagajati odmerek glede na učinek, ki je opisan spodaj.
English: In order to avoid this rebound weight gain, it is necessary to feed the animals to maintenance energy requirements.
Slovenian: Da se izognete ponovnemu povečanju telesne mase, je potrebno hraniti živali tako, da prejemajo le vzdrževalno količino energije.
English: Although not observed in clinical trials, in the case where bodyweight loss since previous monthly weighing has been 12% per month (equivalent to 0.4% bodyweight per day), the dose should be reduced by 25%.
Slovenian: Čeprav v kliničnih poskusih ni bilo opaženo, se v primerih zmanjšanja telesne mase glede na prejšnji mesec za ≥12 % na mesec (enako 0,4 % telesne mase na dan), priporoča zmanjšanje odmerka za 25 %.
English: Detailed information on this product is available on the website of the European Medicines Agency
Slovenian: Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) http://www.ema.europa.eu/.
English: In case of excessive weight loss greater than 12% per month, the dose volume of the veterinary medicinal product should be reduced (by 25%).
Slovenian: Izboljšanje stranskih učinkov se bo pojavilo hitro po prenehanju zdravljenja.V primeru izgube telesne mase več kot 12 % na mesec je treba količino zdravila zmanjšati (za 25 %).
English: If your dog suffers from repeated vomiting, diarrhoea or significantly reduced appetite and excessive weight loss, you should consult your veterinary surgeon who may
Slovenian: Če vaš pes trpi zaradi ponavljajočega bruhanja, diareje ali ima občutno zmanjšan apetit in je izgubil pretirano veliko telesne mase, se posvetujte z veterinarjem, ki bo morda svetoval prekinitev zdravljenja.
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE
English: Slentrol may cause eye-irritation.
Slovenian: Slentrol lahko draži oči.
English: Do not use in dogs with impaired liver function.
Slovenian: Ne uporabite zdravila pri psih z okvarjenim delovanjem jeter.
English: Resolution of adverse reactions will occur shortly after suspension of treatment.
Slovenian: Vsi neželeni učinki bodo prenehali v kratkem času po prekinitvi zdravljenja.
English: In case of contact with the skin, wash off any veterinary medicinal product immediately with soap and
Slovenian: V primeru kontakta s kožo, zdravilo za uporabo v veterinarski medicini takoj sperite z milom in vodo.
English: The recommended starting dose is 0.05 mg/kg initial bodyweight per day (0.01 ml/kg/day).
Slovenian: Priporočen začetni odmerek zdravila je 0,05 mg/kg začetne telesne mase na dan (0,01ml/kg/dan).
English: Dogs should undergo a physical examination by a veterinarian before commencing treatment, and a desired bodyweight or body condition score identified.
Slovenian: Pred začetkom zdravljenja mora pse pregledati veterinar in zabeležiti želeno ciljno maso ali telesno kondicijo.
English: In clinical trials, treated animals rapidly regained weight following cessation of treatment when diet was not restricted.
Slovenian: V kliničnih poskusih so zdravljene živali po prenehanju zdravljenja hitro spet pridobile izgubljeno maso, če prehrana ni bila omejena.
English: The recommended starting dose of Slentrol is 0.05 mg/kg (0.01ml/kg) by oral administration.
Slovenian: Priporočen začetni odmerek zdravila Slentrol je 0,05mg/kg (0,01 ml/kg) za peroralno dajanje.
English: In clinical studies, vomiting, sometimes accompanied by signs of lethargy, anorexia or diarrhoea was observed during treatment with the veterinary medicinal product.
Slovenian: V kliničnih raziskavah se je pri zdravljenju pojavilo bruhanje, ki so ga občasno spremljali zaspanost, anoreksija ali driska.
English: Do not use in dogs in the growth phase.
Slovenian: Ne uporabite zdravila pri psih v rasti.
English: Sporadic and mild ALT (alanine aminotransferase) elevations up to 4 times the upper reference range and not associated with histopathological liver lesions or noticeable changes in other liver parameters may be observed in some dogs during the course of treatment.
Slovenian: Pri nekaterih psih se lahko med zdravljenjem opazi sporadično in blago zvišanje vrednosti ALT (alanin aminotransferaze) do 4-kratne referenčne vrednosti, ki pa ni povezano s histopatološkimi spremembami v jetrih ali drugimi opaznimi spremembami v vrednosti jetrnih parametrov.
English: Slovenská republika Zoetis Luxembourg Holding Sarl, o.z.
Slovenian: Česká republika Zoetis Česká republika, s.r.o.
English: In clinical trials, treated dogs rapidly regained weight following cessation of treatment when diet was not restricted.
Slovenian: V kliničnih poskusih so zdravljeni psi po prenehanju zdravljenja hitro spet pridobili izgubljeno maso, če prehrana ni bila omejena.
English: Therefore, for dogs receiving treatments in addition to the veterinary medicinal product, drug interactions should be
Slovenian: Zato je treba pri psih, hkrati zdravljenimi z drugimi zdravili, natančno opazovati njihovo medsebojno delovanje.
English: Bottles of 50 ml are packed with two dosing devices of 3 ml.
Slovenian: 50 ml stekleničke so v paketu z dvema napravama za odmerjanje 3 ml.
English: Thus, during treatment or at the end of treatment at the latest, an appropriate feeding and exercise regimen should be implemented in order to ensure long term maintenance of the bodyweight.
Slovenian: Med zdravljenjem ali ob koncu le-te je potrebno določiti pravilen način prehrane in gibanja, da se zagotovi dolgoročno ohranjanje telesne
English: Bottles of 150 ml are packed with two dosing devices of 10 ml.
Slovenian: 150 ml stekleničke so v paketu z dvema napravama za odmerjanje 10 ml.
English: Any clinical suspicion of liver disease or dysfunction during treatment should be investigated through the evaluation of liver function.
Slovenian: Vsak sum na jetrno obolenje ali njihovo zmanjšano delovanje je treba preučiti z oceno jetrnih funkcij.
English: In order to avoid this rebound weight gain, it is necessary to feed the dogs to maintenance energy requirements.
Slovenian: Da se izognete ponovnemu povečanju telesne mase, je potrebno hrani živali tako, da se vzdržujejo enegetske potrebe.
English: Administer the veterinary medicinal product once daily directly into the mouth or on a small amount of food.
Slovenian: Zdravilo dajte psu direktno v gobec ali naj ga zaužije z manjšo količino hrane.
English: Dogs should undergo a physical examination before commencing treatment, and a desired bodyweight or a body condition score identified.
Slovenian: Pred začetkom zdravljenja opravite klinični pregled psa in določite želeno ciljno maso ali telesno kondicijo.
English: In order to avoid this rebound weight gain, it is necessary during treatment or at the end of treatment at the latest, to establish the appropriate level of food intake and physical activity needed to ensure long term maintenance of the bodyweight.
Slovenian: Da se izognete ponovnemu povečanju telesne mase, je treba hraniti živali tako, da se pravilen način prehrane in gibanja vzpostavi že med zdravljenjem ali proti koncu zdravljenja, da se zagotovi dolgoročno vzdrževanje telesne mase.
English: Dosing may be recommenced at the same or at a reduced dose volume (reduced by 25%), but if vomiting reoccurs, the veterinary medicinal product may
Slovenian: Ponovno odmerjanje naj bo v enaki ali zmanjšani količini (zmanjšani za 25 %).
English: Polypropylene bottles of 20, 50 and 150 ml fitted with a low density polyethylene (LDPE) Press-In-bottle adapter and a child resistant closure.
Slovenian: Polietilenske plastenke po 20, 50 in 150 ml, zaščitene s pokrovčkom na pritisk iz polietilena nizke 20 ml stekleničke so v paketu z dvema napravama za odmerjanje 1 ml.
English: Zoetis Luxembourg Holding Sarl Tel: +386 (0) 1 52 11 670
Slovenian: Република България Zoetis Luxembourg Holding Sarl Teл: +359 2 970 41 72
English: If the bodyweight loss since previous monthly weighing has been 3% bodyweight per month (equivalent to 0.1% bodyweight per day); the dose (number of ml administered) should be kept the same.
Slovenian: Če je bila izguba telesne mase v primerjavi s prejšnjim mesecem ≥3 % telesne mase na mesec (enako 0,1 % telesne mase na dan), se obdrži enak odmerek zdravila.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER IMETNIKA DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVORNEGA ZA SPROŠČANJE SERIJ V EGP, ČE STA RAZLIČNA Imetnik dovoljenja za promet z zdravilom
English: Do not use in dogs during pregnancy and lactation.
Slovenian: Ne uporabite pri psicah v obdobju brejosti in laktacije.
English: Any indication of progressive liver damage or of dysfunction should result in discontinuation of treatment.
Slovenian: Ob vsakem znaku napredujoče poškodbe jeter ali njihovega zmanjšanega delovanja, je treba zdravljenje prekiniti, saj je zdravilo kontraindicirano.
English: When the veterinary medicinal product is drawn into syringe, administer immediately.
Slovenian: Ko je zdravilo v brizgi, ga porabite takoj.
English: Sími: +354 540 80 00
Slovenian: Tel: +420 283 004 111
English: PHARMACOLOGICAL PROPERTIES
Slovenian: Zdravilo Slentrol se
English: MTP (Microsomal Trigylyceride transfer Protein) inhibitors as a class have the potential to disrupt yolk sac development and laboratory studies on rats and rabbits have shown evidence of embryolethality, teratogenicity, and developmental toxicity.
Slovenian: Laboratorijske preiskave na podganah in kuncih so dokazale embrioletalnost, teratogenost in razvojno toksičnost.
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Slovenian: POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE
English: Thus, during treatment or at the end of treatment at the latest, an appropriate feeding and exercise regimen should be implemented in order to ensure long term
Slovenian: Pravilen način prehrane in gibanja se vzpostavi že med zdravljenjem ali proti koncu zdravljenja, da se zagotovi dolgoročno vzdrževanje
English: 5.1 Pharmacodynamic properties
Slovenian: 4.11 Karenca
English: Suomi/Finland Zoetis Finland Oy Puh/Tel: +358 (0)9 4300 40
Slovenian: United Kingdom Zoetis UK Limited Tel: +44 (0) 845 300 8034
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE
Slovenian: B POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE
English: 4.2 Indications for use, specifying the target species
Slovenian: 4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Kot dodatek pri nadziranju prekomerne telesne mase in debelosti pri odraslih psih.
English: Italia
Slovenian: Luxembourg
English: Dogs with evidence of liver dysfunction should not be treated with the veterinary medicinal product.
Slovenian: Zaradi pomanjkanja študij kompatibilnosti tega zdravila ne smemo mešati z drugimi zdravili za uporabo v veterinarski medicini.
English: The liver function of dogs suspected of suffering from a liver disease or dysfunction should be evaluated, before commencing treatment with the veterinary medicinal product.
Slovenian: Pred uporabo zdravila za uporabo v veterinarski medicini morate oceniti delovanje jeter pri psih,, za katere se sumi, da so podvrženi kateremukoli jetrnemu obolenju ali zmanjšanemu delovanju jeter.
English: Ìsland
Slovenian: KARENCA
English: MTP inhibitors (microsomal trigylyceride transfer protein inhibitors) as a class have the potential to disrupt yolk sac development and laboratory studies on rats and rabbits have shown evidence of embryolethality, teratogenicity, and developmental
Slovenian: Zdravila iz skupine zaviralcev MTP (zaviralci mikrosomalnih proteinov za prenos trigliceridov) lahko povzročijo motnje v razvoju rumenjakove vrečke.
English: Fertility studies have not been conducted in the target species - use in dogs intended for breeding should be subject to a risk-benefit analysis by your veterinarian.
Slovenian: Raziskav plodnosti niso izvajali na ciljni živalski vrsti.
English: The liver function of dogs suspected of suffering from a liver disease or dysfunction should be evaluated before commencing treatment with the veterinary medicinal product.
Slovenian: Pred uporabo zdravila za uporabo v veterinarski medicini morate oceniti delovanje jeter pri psih, za katere se sumi, da so podvrženi kateremukoli jetrnemu obolenju ali zmanjšanemu delovanju jeter.
English: 6 (conditional)
Slovenian: 6.2 Inkompatibilnosti
English: Zoetis Ireland Limited Tel: +353 (0) 1 467 6650
Slovenian: Magyarország Zoetis Hungary Kft. Tel: +361 488 3695
English: These measures should
Slovenian: Če opazite te
English: Icepharma hf.
Slovenian: Brejost in laktacija:
English: 5 (conditional)
Slovenian: POSEBNO(A) OPOZORILO(A)
English: Do not use during pregnancy or lactation.
Slovenian: Ne uporabite zdravila pri psicah v obdobju brejosti ali laktacije.
English: To be supplied only on veterinary prescription.
Slovenian: Če se bruhanje ponovi, se zdravilo za uporabo v veterinarski medicini preneha uporabljati.
English: Actira was initially approved in June 1999.
Slovenian: Zdravilo Actira je bilo prvič odobreno junija 1999.
English: QUÍMICA FARMACEUTICA BAYER, S. L.
Slovenian: FARMACEUTICA BAYER, S. L.
English: - The Committee considered the Referral made under Article 6(12) of Commission Regulation (EC) No 1084/2003, for Actira and associated names (See Annex 1).
Slovenian: - Odbor je preučil napotitev, pripravljeno v skladu s členom 6(12) Uredbe Komisije (ES) št. 1084/2003, za zdravilo Actira in z njim povezana imena (glejte Dodatek I).
English: This procedure is a referral following a Mutual Recognition Procedure concerning the above variation application which was submitted for Actira film-coated tablets to Germany as Reference Member State (RMS) and the Concerned Member States (CMS) AT, BE, DK, EL, ES, FI, IT, LU, PT and SE on 5 December 2006.
Slovenian: Ta postopek je napotitev na podlagi postopka medsebojnega priznavanja v zvezi z zgornjo vlogo za spremembo, ki je bila za zdravilo Actira - filmsko obložene tablete Nemčiji kot referenčni državi članici in zadevnim državam članicam AT, BE, DK, EL, ES, FI, IT, LU, PT in SE predložena dne 5. decembra 2006.
English: The MRP variation application DE/H/158/01/II/32 concerned an extension of the indication to include the treatment of mild to moderate pelvic inflammatory disease (PID), i.e. infections of upper genital tract, including salpingitis and endometritis.
Slovenian: Vloga za odobritev spremembe po postopku medsebojnega priznavanja DE/H/158/01/II/32 je zadevala razširitev indikacije, tako da bi vključevala zdravljenje blagih do zmernih pelvičnih vnetnih bolezni tj. okužb zgornjega genitalnega trakta, vključno s salpingitisom in endometritisom.
English: Actira film-coated tablets contain 400 mg moxifloxacin as hydrochloride.
Slovenian: Actira - filmsko obložene tablete vsebujejo 400 mg moksifloksacina v obliki klorida.
English: Objections and concerns over the efficacy and safety of Actira in the proposed indication were raised during the Mutual Recognition variation procedure.
Slovenian: Med postopkom medsebojnega priznavanja za prijavljeno spremembo so bili izraženi ugovori in pomisleki glede učinkovitosti in varnosti zdravila Actira pri predlagani indikaciji.
English: - The Committee considered that robust data is available showing the efficacy of Actira in the indication “Treatment of mild to moderate pelvic inflammatory disease (PID), i.e. infections of upper genital tract, including salpingitis and endometritis” , however due to emerging resistance of N. gonorrhoeae, moxifloxacin should not be used in empirical monotherapy, unless moxifloxacinresistant N. gonorrhoeae can be excluded.
Slovenian: - Odbor je sklenil, da so na voljo trdni podatki, ki dokazujejo učinkovitost zdravila Actira pri indikaciji „zdravljenje blagih do zmernih pelvičnih vnetnih bolezni, tj. okužb zgornjega genitalnega trakta, vključno s salpingitisom in endometritisom“, vendar pa se moksifloksacin zaradi pojava odpornosti na N. gonorrhoeae ne sme uporabljati v empirični monoterapiji, razen če je mogoče izključiti N. gonorrhoeae, odporno na moksifloksacin.
English: LU - Luxembourg Bayer Healthcare AG 51368 Leverkusen
Slovenian: LU - Luksemburg Bayer Healthcare AG 51368 Leverkusen