FrancophonIA/ELRC3.0 huggingface dataset:
English: In these trials, the most common reactions occurring after vaccine administration were pain at the site of injection, fever (axillary ≥ 37.5°C; rectal ≥ 38°C) and irritability, which were associated with about 50% of the doses administered.
Slovenian: Najpogostejše reakcije v teh raziskavah so bile bolečina na mestu injiciranja, zvišana telesna temperatura (aksilarna ≥ 37,5 ºC; rektalna ≥ 38 ºC) in razdražljivost.
English: Hepatitis B carriers can infect others throughout their lives.
Slovenian: Imenujejo se klicenosci virusa hepatitisa B in lahko ves čas življenja prenašajo virus hepatitisa B na druge.
English: The immunoprophylactic measures for hepatitis B should not be modified for children born to hepatitis B virus carrying mothers.
Slovenian: V primeru, da je mati novorojenčka nosilka virusa hepatitisa B, se ukrepov imunoprofilakse proti hepatitisu B ne sme spreminjati.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING FOR MULTIDOSE PRESENTATIONS
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZA VIALE, KI VSEBUJEJO VEČ ODMERKOV
English: Gastrointestinal disorders: very common: loss of appetite
Slovenian: Bolezni prebavil: zelo pogosti: izguba apetita
English: After reconstitution, the vaccine should be injected promptly.
Slovenian: Cepivo je potrebno injicirati takoj po rekonstituciji.
English: Both components are presented in a glass vial for 2 doses or for 10 doses and must be mixed together before your child receives the vaccine.
Slovenian: Obe komponenti sta na voljo v steklenih vialah, ki vsebujejo 2 odmerka ali 10 odmerkov.
English: General disorders and administration site conditions: very common: pain, redness and swelling, fever (axillary ≥ 37.5°C; rectal ≥ 38°C) common: induration, fever (axillary > 39°C; rectal > 39.5°C)
Slovenian: Splošne težave in spremembe na mestu aplikacije: zelo pogosti: bolečina, rdečina in oteklina, zvišana telesna temperatura (aksilarna ≥ 37,5 ºC; rektalna ≥ 38 ºC) pogosti: induracija, zvišana telesna temperatura (aksilarna > 39 ºC; rektalna > 39,5 ºC)
English: Chiron-Behring GmbH & Co. Postfach 1630-35006 Marburg Germany
Slovenian: Postfach 1630-35006 Marburg
English: Powder and suspension for suspension for injection The liquid diphtheria, tetanus, pertussis (whole cell), hepatitis B (DTPw-HBV) component is a turbid white suspension.
Slovenian: Prašek in suspenzija za pripravo suspenzije za injiciranje Komponente cepiva proti davici (D), tetanusu (T), oslovskemu kašlju (celotna celica; Pw) in hepatitisu B (HBV) (DTPw-HBV) so v tekočem stanju in sicer v obliki motne bele suspenzije.
English: General disorders and administration site conditions: very common: pain, redness and swelling, fever (axillary ≥ 37.5°C; rectal ≥ 38°C) common: fever (axillary > 39°C; rectal > 39.5°C) uncommon: induration
Slovenian: Splošne težave in spremembe na mestu aplikacije: zelo pogosti: bolečina, rdečina in oteklina, zvišana telesna temperatura (aksilarna ≥ 37,5 ºC; rektalna ≥ 38 ºC) pogosti: zvišana telesna temperatura (aksilarna > 39 ºC; rektalna > 39,5 ºC) občasni: induracija
English: Read all of this leaflet carefully before your child starts receiving this medicine.
Slovenian: Preden vaš otrok prične dobivati to cepivo, natančno preberite navodilo!
English: Lyophilised HIB component:
Slovenian: Komponenta HIB v liofiliziranem stanju: laktoza
English: It can be expected that hepatitis D will also be prevented by immunisation with Quintanrix as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.
Slovenian: Ker se hepatitis D (povzroča ga agens delta) v odsotnosti okužbe z virusom hepatitisa B ne pojavlja, se lahko po imunizaciji s cepivom Quintanrix pričakuje tudi preventiva hepatitisa D.
English: 0.5 ml of suspension in a vial (type I glass) for 1 dose with a stopper (rubber butyl) in the following pack sizes: - pack size of 1 vial of powder plus 1 vial of suspension - pack size of 100 vials of powder plus 100 vials of suspension Not all pack sizes may be marketed.
Slovenian: 0,5 ml suspenzije v viali (steklo tipa I) za 1 odmerek z zamaškom (butilna guma) v naslednjih velikostih pakiranja: - 1 viala s praškom in 1 viala s suspenzijo - 100 vial s praškom in 100 vial s suspenzijo
English: Powder in a vial (type I glass) for 1 dose with a stopper (rubber butyl).
Slovenian: Prašek v viali (steklo tipa I) za 1 odmerek z zamaškom (butilna guma).
English: • Coughing
Slovenian: • kašelj
English: Nervous system disorders: very common: drowsiness
Slovenian: Bolezni živčevja: zelo pogosti: zaspanost
English: Allergic reactions, including anaphylactoid reactions and urticaria, have been reported very rarely following vaccination with DTP, hepatitis B and HIB containing vaccines.
Slovenian: Po cepljenju s cepivi, ki so vsebovala komponento DTP, komponento proti hepatitisu B in komponento HIB, so zelo redko poročali o alergijskih reakcijah, kar velja tudi za anafilaktoidne reakcije in urtikarijo.
English: Powder in a vial (type I glass) for 2 doses with a stopper (rubber butyl).
Slovenian: Prašek v viali (steklo tipa I) za 2 odmerka z zamaškom (butilna guma).
English: Quintanrix powder and suspension for suspension for injection Diphtheria, tetanus, pertussis (whole cell), hepatitis B (rDNA) and Haemophilus type b conjugate vaccine (adsorbed) - The active substances contained in 1 dose (0.5 ml) of Quintanrix are:
Slovenian: Quintanrix, prašek in suspenzija za pripravo suspenzije za injiciranje Adsorbirano cepivo proti davici, tetanusu, oslovskemu kašlju (celotna celica), hepatitisu B (rekombinantno) in hemofilusu tipa b (konjugirano) - Učinkovine v 1 odmerku (0,5 ml) cepiva Quintanrix so:
English: Powder in a vial (type I glass) for 10 doses with a stopper (rubber butyl).
Slovenian: Prašek v viali (steklo tipa I) za 10 odmerkov z zamaškom (butilna guma).
English: Tell you doctor if your child has any known allergies.
Slovenian: Če ima otrok kakršno koli alergijo, to povejte svojemu zdravniku.
English: Medicinal product subject to medical prescription
Slovenian: DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS FOR MULTIDOSE PRESENTATIONS
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH (VIALE, KI VSEBUJEJO VEČ ODMERKOV)
English: Lactose
Slovenian: • krči
English: Both components are presented in a glass vial for 1 dose and must be mixed together before your child receives the vaccine.
Slovenian: Pred cepljenjem vašega otroka je potrebno obe komponenti zmešati skupaj.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/301/001
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/04/301/001
English: Quintanrix powder and suspension for suspension for injection, multidose Diphtheria, tetanus, pertussis (whole cell), hepatitis B (rDNA) and Haemophilus type b conjugate vaccine (adsorbed)
Slovenian: Quintanrix, prašek in suspenzija za pripravo večih odmerkov suspenzije za injiciranje Adsorbirano cepivo proti davici, tetanusu, oslovskemu kašlju (celotna celica), hepatitisu B (rekombinantno) in hemofilusu tipa b (konjugirano)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/301/005
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/04/301/005
English: Quintanrix powder and suspension for suspension for injection Diphtheria, tetanus, pertussis (whole cell), hepatitis B (rDNA) and Haemophilus type b conjugate vaccine (adsorbed)
Slovenian: Quintanrix, prašek in suspenzija za pripravo suspenzije za injiciranje Adsorbirano cepivo proti davici, tetanusu, oslovskemu kašlju (celotna celica), hepatitisu B (rekombinantno) in hemofilusu tipa b (konjugirano)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/301/003
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/04/301/003
English: For 2 doses : - pack size of 1 vial of powder plus 1 vial of liquid - pack size of 100 vials of powder plus 100 vials of liquid
Slovenian: - 1 viala s praškom in 1 viala s tekočino - 100 vial s praškom in 100 vial s tekočino
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2 doses
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 2 odmerka
English: Diphtheria toxoid, tetanus toxoid, pertussis (whole cell):
Slovenian: Davični toksoid, tetanusni toksoid, oslovski kašelj (celotna celica): Chiron-Behring GmbH & Co.
English: Liquid DTPw-HBV component:
Slovenian: Komponenta DTPw-HBV v tekočem stanju: tiomersal natrijev klorid voda za injiciranje
English: In drinking water use.
Slovenian: Za uporabo v vodi za pitje.
English: The marketing authorisation application was submitted to the United Kingdom as reference Member State and Austria, Belgium, Czech Republic, Denmark, France, Germany, Greece, Hungary, Ireland, Italy, Luxembourg, Poland, Portugal, Slovakia, Spain and The Netherlands as concerned Member States.
Slovenian: Vloga za pridobitev dovoljenja za promet z zdravilom je bila predložena v Združenem kraljestvu kot referenčni državi članici ter v Avstriji, Belgiji, Češki republiki, na Danskem, v Franciji, Nemčiji, Grčiji, na Madžarskem, Irskem, v Italiji, Luksemburgu, na Poljskem, Portugalskem, Slovaškem, v Španiji in na Nizozemskem kot zadevnih državah članicah.
English: Add the following text in the relevant sections of the product information:
Slovenian: Dodajte naslednje besedilo v ustrezne oddelke informacije o izdelku:
English: Having considered all the data submitted the CVMP concluded that:
Slovenian: Ob upoštevanju vseh predloženih podatkov je odbor CVMP zaključil naslednje:
English: Advice for prudent use
Slovenian: Nasvet za preudarno rabo
English: During the decentralised procedure Denmark, as a concerned Member State, considered that Solamocta may present a potential serious risk to human and animal health.
Slovenian: Med decentraliziranim postopkom je Danska, zadevna država članica, menila, da lahko zdravilo Solamocta predstavlja morebitno resno tveganje za zdravje ljudi in živali.
English: Exemption from the requirement for bioequivalence studies
Slovenian: Opustitev zahteve za bioekvivalenčne študije
English: Any unused medicated water should be discarded after 12 hours.
Slovenian: Neuporabljeno raztopino z zdravilom je po 12 urah treba zavreči.
English: Prepare the solution with fresh tap water immediately before use.
Slovenian: Raztopino pripraviti s svežo vodo iz vodovoda tik pred uporabo.
English: Each of these excipients is well-established and widely used in medicinal products and foodstuffs.
Slovenian: Vsaka od teh pomožnih snovi je dobro uveljavljena in se pogosto uporablja v zdravilih in živilih.
English: Extrapolation of the safety and efficacy of the reference product to Solamocta
Slovenian: Ekstrapolacija varnosti in učinkovitosti referenčnega zdravila na zdravilo Solamocta
English: They have demonstrated that the highest therapeutic concentration is fully soluble within 10 minutes in hard/high pH water and soft/low pH water and have determined the maximum solubility (within 10 minutes) in water of different qualities and different temperatures, including very cold (4 °C) water.
Slovenian: Ti so pokazali, da je najvišja terapevtska koncentracija popolnoma topna v 10 minutah v trdi vodi (visoka vrednost pH) in mehki vodi (nizka vrednost pH), in so določili največjo topnost (v 10 minutah) v vodi različnih kakovosti in različnih temperatur, tudi v zelo mrzli (4 °C) vodi.
English: Official, national and regional antimicrobial policies should be taken into account when the product is used.
Slovenian: Pri uporabi izdelka upoštevati uradne, nacionalne in regionalne proti-mikrobne smernice.
English: After the end of the medication period the water supply system should be cleaned appropriately to avoid intake of sub-therapeutic amounts of the active substance.
Slovenian: Po končanem zdravljenju je treba napajalni sistem ustrezno očistiti, da se prepreči vnos pod-terapevtske količine aktivne snovi.
English: In addition, Denmark raised a concern that the advice for prudent use in the product information is insufficient, particularly in the context of increasing concerns regarding development of antimicrobial resistance and the widespread use of in-feed and in-water antimicrobial products.
Slovenian: Poleg tega je Danska izpostavila zaskrbljenost, da je nasvet za preudarno rabo v informacijah o zdravilu nezadosten, zlasti v smislu večje zaskrbljenosti glede razvoja protimikrobne odpornosti in široke uporabe protimikrobnih izdelkov v krmi in vodi.
English: • Revised information on solubility and advice on prudent use should be included in the product information.
Slovenian: • Revidirane podatke o topnosti in nasvete o preudarni uporabi je treba vključiti v informacije o zdravilu.
English: List of the names, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, applicant in the Member States
Slovenian: Seznam imen, farmacevtskih oblik, jakosti veterinarskega zdravila, živalskih vrst, načinov uporabe zdravila, imetnikov dovoljenja za promet z zdravilom v državah članicah
English: The CVMP was asked to consider the issues raised by Denmark and conclude whether marketing authorisations for Solamocta should be granted.
Slovenian: Odbor CVMP je bil naprošen, da preuči vprašanja, ki jih je izpostavila Danska, in ugotovi, ali je treba odobriti dovoljenje za promet z zdravilom Solamocta.
English: The uptake of medicated water depends on the clinical condition of the birds.
Slovenian: Vnos vode, v kateri je zdravilo, je odvisen od kliničnega stanja ptic.
English: Since the issues raised by Denmark remained unresolved, the Member States concerned failed to reach agreement regarding the marketing authorisation for the product Solamocta and consequently the matter was referred to the CVMP on 28 May 2015 under Article 33(4) of Directive 2001/82/EC.
Slovenian: Ker pa so vprašanja, ki jih je izpostavila Danska, ostala nerazrešena, zadevne države članice niso uspele doseči soglasja v zvezi z dovoljenjem za promet z zdravilom Solamocta, zato je bila zadeva dne 28. maja 2015 predložena odboru CVMP v skladu s členom 33(4) Direktive 2001/82/ES.
English: The following formula may be used to calculate the required concentration of product (in milligrams of product per litre drinking water): ___ mg product per kg body weight per day
Slovenian: Naslednja formula se lahko uporabi za izračun potrebne koncentracije izdelka (v miligramih izdelka na liter pitne vode): ___ mg zdravila na kg telesne teže na dan
English: These excipients have well-established use in other similar EU-authorised veterinary medicinal products and are of negligible toxicological concern at the proposed administration rate.
Slovenian: Te pomožne snovi imajo dobro uveljavljeno uporabo v drugih podobnih zdravilih za uporabo v veterinarski medicini, odobrenih v EU, in predstavljajo zanemarljivo toksikološko zaskrbljenost ob predlagani stopnji dajanja.
English: Maximum solubility of the product in water of at least 10 °C is approximately 6 g/l within 10 minutes.
Slovenian: Največja topnost produkta v vodi pri najmanj 10 °C je približno 6 g/L v 10 minutah.
English: In particular, Denmark considered that Solamocta is essentially different from the reference product Amoxinsol and that these differences could be sufficient to require a formal bioequivalence study.
Slovenian: Danska je med drugim menila, da se zdravilo Solamocta bistveno razlikuje od referenčnega zdravila Amoxinsol in da lahko te razlike zadostujejo za zahtevo formalne bioekvivalenčne študije.
English: There are three main mechanisms of resistance to beta-lactams: beta-lactamase production, altered expression and/or modification of penicillin binding proteins (PBP), and decreased penetration of the outer membrane.
Slovenian: Obstajajo trije glavni mehanizmi odpornosti na beta-laktame: proizvodnja beta-laktamaze, spremenjeno izražanje in / ali modifikacija beljakovin, ki vežejo penicilin (PBP), in zmanjšanje predirnosti zunanje membrane.
English: The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination Group procedure with the following amendments:
Slovenian: Veljavni povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so zadnje različice, ki so bile pripravljene v postopku koordinacijske skupine z naslednjimi dopolnitvami:
English: Advice on prudent use has been proposed to address responsible use in relation to development of antimicrobial resistance.
Slovenian: Predlagan je bil nasvet o preudarni uporabi za obravnavanje odgovorne uporabe v zvezi z razvojem protimikrobne odpornosti.
English: At lower temperatures (4 °C), the maximum solubility is approximately 5 g/l within 10 minutes.
Slovenian: Pri nižjih temperaturah (4 °C), je največja topnost približno 5 g/L v 10 minutah.
English: Sufficient guidance is provided in the product information to ensure that the product can be properly prepared and is fully in solution at the time of administration in accordance with the requirements for the therapeutic dose.
Slovenian: V informacijah o zdravilu so podane zadostne smernice za zagotovitev, da se izdelek lahko ustrezno pripravi in je v celoti raztopljen v času dajanja v skladu z zahtevami za terapevtski odmerek.
English: Overall, the CVMP considered that the concerns expressed by Denmark should not prevent the granting of marketing authorisations and the benefit-risk evaluation is deemed to be positive for Solamocta provided that the product information is amended to include revised instructions on product administration and prudent use warnings.
Slovenian: Na splošno je odbor CVMP menil, da skrbi, ki jih je izrazila Danska, ne bi smele preprečiti podelitve dovoljenja za promet z zdravilom in da ocena razmerja med tveganji in koristmi velja za pozitivno za zdravilo Solamocta pod pogojem, da se informacije o zdravilu spremenijo tako, da vključujejo popravljena navodila o dajanju izdelka in opozorila o preudarni uporabi.
English: In order to ensure consumption of the medicated water, animals should not have access to other water supplies whilst being treated.
Slovenian: Da se zagotovi pitne vode z zdravilom, je treba med zdravljenjem živalim preprečiti dostop do drugih virov vode.
English: The beta-lactamase could be encoded in chromosomal or plasmidic genes.
Slovenian: Beta-laktamaza se lahko kodira v kromosomskih ali plazmidnih genih.
English: Cross-resistance is observed between amoxicillin and other penicillins, particularly with aminopenicillins.
Slovenian: Opaziti je navzkrižno odpornost med amoksicilinom in drugimi penicilini, zlasti aminopenicilini.
English: Sodium carbonate increases the pH of the solution allowing more concentrated solutions to be used and therefore facilitating administration via automatic water supply systems.
Slovenian: Natrijev karbonat poveča vrednost pH raztopine, kar omogoča uporabo bolj koncentriranih raztopin in s tem olajša dajanje prek samodejnih sistemov za oskrbo z vodo.
English: It inhibits the formation of bridges between the chains of linear polymers constituting the peptidoglycan cell wall of Gram positive bacteria.
Slovenian: Zavira tvorbo mostov med verigami linearnih polimerov, ki tvorijo peptidoglikansko celično steno gram-pozitivnih bakterij.
English: The use of extended spectrum beta-lactam drugs (e.g. aminopenicillins) might lead to the selection of multi-resistant bacterial phenotypes (e.g. those producing extended spectrum beta-lactamases (ESBLs)).
Slovenian: Uporaba beta-laktamskih zdravil z razširjenim spektrom (npr. aminopenicilinov) lahko vodi do selekcije večkratno odpornih bakterijskih fenotipov (npr. fenotipov, ki tvorijo beta-laktamaze z razširjenim spektrom (ESBL)).
English: Luxembourg Eurovet Animal Health BV Handelsweg 25
Slovenian: Luksemburg Eurovet Animal Health BV Handelsweg 25
English: Solamocta is indicated for treatment of infections in chickens, turkeys and ducks caused by bacteria susceptible to amoxicillin.
Slovenian: Zdravilo Solamocta je indicirano za zdravljenje okužb pri piščancih, puranih in racah, ki jih povzročajo bakterije, občutljive na amoksicilin.
English: The amended sections of the summary of product characteristics and package leaflet of the reference Member State are set out in Annex III.
Slovenian: Spremenjeni poglavji povzetka glavnih značilnosti zdravila in navodila za uporabo referenčne države članice sta navedeni v Prilogi III.
English: No reference can be found to any evidence that they can affect the gastrointestinal transit, absorption or in vivo stability of amoxicillin.
Slovenian: Ni nobenih dokazov, da lahko vplivajo na prehod skozi prebavni trakt, absorpcijo ali in vivo stabilnost amoksicilina.
English: Sodium citrate binds calcium and magnesium ions (present in hard water) and prevents the formation of insoluble carbonate salts.
Slovenian: Natrijev citrat veže kalcijeve in magnezijeve ione (prisotne v trdi vodi) ter preprečuje nastanek netopnih karbonatnih soli.
English: The formulation of Solamocta does not alter the pH of the medicated drinking water beyond the naturally occurring range of drinking water.
Slovenian: Formulacija zdravila Solamocta ne spremeni vrednosti pH medicirane pitne vode, kot je njena vrednost v običajni pitni vodi.
English: Therefore, the CVMP recommended granting of the marketing authorisation for the veterinary medicinal products referred to in Annex I with amendments to the summary of product characteristics and package leaflet of the reference Member State.
Slovenian: Odbor CVMP je zato priporočil izdajo dovoljenja za promet z zdravili za uporabo v veterinarski medicini, navedenimi v Prilogi I, skupaj s spremembami povzetka glavnih značilnosti zdravila in navodila za uporabo referenčne države članice.
English: Grounds for the granting of the marketing authorisations for Solamocta
Slovenian: Podlaga za izdajo dovoljenj za promet z zdravilom Solamocta
English: In order to obtain the correct dosage the concentration of amoxicillin has to be adjusted taking into account water intake.
Slovenian: Da zagotovimo pravilen odmerek, moramo prilagoditi koncentracijo amoksicilina količini popite vode.
English: The rationale for the inclusion of the excipients was provided.
Slovenian: Podan je bil razlog za vključitev pomožnih snovi.
English: Amoxicillin is a time-dependent bactericidal antibiotic which acts by inhibiting the synthesis of bacterial cell walls during bacterial replication.
Slovenian: Amoksicilin je časovno odvisen baktericidni antibiotik, ki deluje z zaviranjem sinteze bakterijske celične stene med replikacijo bakterij.
English: Overall summary of the scientific evaluation of Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila Solamocta 697 mg/g prašek za uporabo v pitni vodi za piščance, race in purane (glejte Prilogo I)
English: These enzymes are capable of cleaving the beta-lactam ring of penicillins, making them inactive.
Slovenian: Ti encimi so sposobni cepiti beta-laktamski obroč v penicilinih, tako da niso več aktivni.
English: INN Strength Pharmaceutical form
Slovenian: Farmacevtska oblika
English: The SPC section 4.5 Special precautions for use in animals, now includes the standard wording regarding use based on susceptibility testing where possible and advising to follow the instructions given in the product information, and the SPC section 5.1 Pharmacodynamic properties, now includes up-to-date information regarding the mode of action of amoxicillin and the three main mechanisms of resistance to beta-lactams.
Slovenian: Poglavje povzetka glavnih značilnosti zdravila 4.5 Posebni previdnostni ukrepi za uporabo pri živalih sedaj vključuje standardno besedilo v zvezi z uporabo, ki temelji na preskušanju odpornosti, kjer je to mogoče, in svetuje, da je treba slediti navodilom v informacijah o zdravilu, in poglavje povzetka glavnih značilnosti zdravila 5.1 Farmakodinamične lastnosti zdaj vključuje najnovejše informacije o načinu delovanja amoksicilina in treh glavnih mehanizmih odpornosti na betalaktame.