natgillin/translations-raw huggingface dataset:
Do not pick up the pre-filled syringe by the plunger or needle cover.
Napolnjene injekcijske brizge ne dvigujte za bat ali pokrovček igle.
Thrombocytopenia and leukocytosis have been reported (see section 4.4).
Poročali so o trombocitopeniji in levkocitozi (glejte poglavje 4.4).
The first pivotal (phase III) clinical study XM22-03 was an active-controlled study in 202 patients with stage II-IV breast cancer receiving up to 4 cycles of chemotherapy consisting of doxorubicin and docetaxel.
202 bolnikoma z rakom dojke stopnje II-IV, ki so prejemali do 4 cikle kemoterapije, sestavljene iz doksorubicina in docetaksela.
Glomerulonephritis has been reported in patients receiving filgrastim, lenograstim or pegfilgrastim.
Pri bolnikih, ki so prejemali filgrastim, lenograstim ali pegfilgrastim, so poročali o glomerulonefritisu.
**Filgrastim (recombinant methionyl human granulocyte-colony stimulating factor [G-CSF]) is produced in Escherichia coli cells by recombinant DNA technology.
granulocyte-colony stimulating factor]) je pridobljen s tehnologijo rekombinantne DNA v celicah Escherichiae coli.
• Reduction in blood platelets, which increases risk of bleeding or bruising.
Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov) - zmanjšanje števila krvnih ploščic, kar poveča tveganje za krvavitve ali modrice
Capillary leak syndrome, which can be life-threatening if treatment is delayed, has been reported mostly in cancer patients undergoing chemotherapy after administration of G-CSF or derivatives (see section 4.4 and section 4.8).
Zlasti pri bolnikih z rakom, ki so prejemali kemoterapijo, so po uporabi G-CSF ali derivatov poročali o sindromu kapilarne prepustnosti, ki je lahko smrtno nevaren, če ni zdravljen takoj; glejte poglavje 4.4 in poglavje 4.8.
• Damage to the tiny filters inside your kidneys (glomerulonephritis; see section 2 under
poškodujejo drobne filtre v ledvicah (glomerulonefritis; glejte poglavje 4, "Možni neželeni učinki").
A trend towards a decrease in lipegfilgrastim exposure was observed with increase in weight.
Z višanjem telesne mase so opazili trend proti nižanju izpostavljenosti lipegfilgrastimu.
Lipegfilgrastim is metabolised via intra- or extracellular degradation by proteolytic enzymes.
Lipegfilgrastim se presnavlja z znotrajcelično in zunajcelično razgradnjo s pomočjo proteolitičnih encimov.
When to use Lonquex
Kdaj uporabljati zdravilo Lonquex
Pulmonary adverse reactions, in particular interstitial pneumonia, have been reported after administration of lipegfilgrastim (see section 4.8).
Po dajanju lipegfilgrastima so poročali o neželenih učinkih na pljuča, še zlasti o intersticijski pljučnici (glejte poglavje 4.8).
Each pre-filled syringe contains 6 mg lipegfilgrastim.
Ena napolnjena injekcijska brizga vsebuje 6 mg lipegfilgrastima.
• Low blood levels of potassium, which can cause muscle weakness, twitching or abnormal heart rhythm.
- kožne reakcije, kot je rdečina ali izpuščaj - nizka raven kalija v krvi, kar povzroča mišično oslabelost, trzanje ali nenormalen srčni ritem - bolečine v prsnem košu
After a single subcutaneous injection of 6 mg lipegfilgrastim during the fourth cycle, the maximum blood concentrations were lower than observed in the first cycle (mean values 77 and 111 ng/ml) and were reached after median tmax of 8 hours.
Po enem subkutanem injiciranju 6 mg lipegfilgrastima v četrtem ciklu so bile največje koncentracije v krvi nižje kot v prvem ciklu (povprečni vrednosti 77 in
Filgrastim is an un-glycosylated recombinant methionyl human G-CSF.
Filgrastim je neglikozilirani rekombinantni metionil humani
How to use Lonquex
Kako uporabljati zdravilo Lonquex
Patients with renal or hepatic impairment
Bolniki z ledvično in jetrno okvaro
How Lonquex works
Kako deluje zdravilo Lonquex
Each pre-filled syringe contains 6 mg lipegfilgrastim in 0.6 ml solution.
Ena napolnjena injekcijska brizga vsebuje 6 mg lipegfilgrastima v 0,6 ml raztopine.
• Dispose of the full puncture-proof container as instructed by your doctor, pharmacist or nurse.
- Poln vsebnik, odporen na vbode, odvrzite v skladu z navodili, ki ste jih dobili pri svojem zdravniku, farmacevtu ali medicinski sestri.
Leukocytosis may occur (see section 4.8).
Pojavi se lahko levkocitoza (glejte poglavje 4.8).
Talk to your doctor, pharmacist or nurse BEFORE using Lonquex
PRED začetkom uporabe zdravila Lonquex se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
Sickle cell crisis has been associated with the use of G-CSF or derivatives in patients with sickle cell anaemia (see section 4.8).
Bolniki s srpastocelično anemijo Srpastocelična kriza je povezana z uporabo G-CSF ali derivatov pri bolnikih s srpastocelično anemijo
Each pre-filled syringe contains 6 mg of lipegfilgrastim* in 0.6 ml solution.
Ena napolnjena injekcijska brizga vsebuje 6 mg lipegfilgrastim a* v 0,6 ml raztopine.
Each ml solution contains 10 mg lipegfilgrastim.
En ml raztopine vsebuje 10 mg lipegfilgrastima.
Each ml of solution for injection contains 10 mg of lipegfilgrastim.
En mililiter raztopine za injiciranje vsebuje 10 mg lipegfilgrastima.
Lonquex 6 mg solution for injection in pre-filled syringe
Lonquex 6 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
Overweight patients
Bolniki s prekomerno telesno maso
What Lonquex is used for
Za kaj se uporablja zdravilo Lonquex
Lonquex 6 mg solution for injection in pre-filled syringe lipegfilgrastim
Lonquex 6 mg raztopina za injiciranje v napolnjeni injekcijski brizgi lipegfilgrastim
These findings are consistent with results from G-CSF and derivatives.
Dokazov o teratogenosti lipegfilgrastima ni. Ti izsledki so v skladu z rezultati za G-CSF in derivate.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
How to store Lonquex
Shranjevanje zdravila Lonquex
Information for injecting yourself
Informacije za samoinjiciranje
• Nausea.
• slabost
Patients with sickle cell anaemia
Žilne bolezni - sindrom kapilarne prepustnosti
Each pre-filled syringe contains 0.6 ml of solution.
Ena napolnjena injekcijska brizga vsebuje 0,6 ml raztopine.
Uncommon (may affect up to 1 in 100 people)
Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov) - povečanje števila belih krvnih celic
How Lonquex is used
Kako se uporablja zdravilo Lonquex
• Some changes may occur in your blood, but these will be detected by routine blood tests.
- lokalne reakcije na mestu injiciranja, kot sta bolečina ali otrdlina - nekatere spremembe v krvi, ki so zaznavne z rutinskimi krvnimi testi
• Increased spleen size has been reported uncommonly and cases of splenic ruptures have been reported with other medicines similar to Lonquex.
- Pri uporabi drugih zdravil, ki so podobna zdravilu Lonquex, so občasno poročali o povečanju velikosti vranice in raztrganjih vranice.
Hypersensitivity reactions*
Bolezni imunskega sistema Občasni preobčutljivostne reakcije*
Sodium hydroxide (for pH-adjustment) Sorbitol (E420)
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi koncentrirana ocetna kislina (ledocet) natrijev hidroksid (za uravnavanje pH) sorbitol (E420) polisorbat 20 voda za injekcije
Package leaflet: Information for the user Lonquex 6 mg solution for injection in pre-filled syringe lipegfilgrastim
Navodilo za uporabo Lonquex 6 mg raztopina za injiciranje v napolnjeni injekcijski brizgi lipegfilgrastim
Table 1: Adverse reactions System organ class
Preglednica 1: Neželeni učinki
The most suitable places to inject yourself are:
Najprimernejša mesta za samoinjiciranje so: - zgornji del stegen in
The second pivotal (phase III) clinical study XM22-04 was a placebo-controlled study in 375 patients with non-small cell lung cancer receiving up to 4 cycles of chemotherapy consisting of cisplatin and etoposide.
375 bolniki z nedrobnoceličnim rakom pljuč, ki so prejemali do 4 cikle kemoterapije, sestavljene iz cisplatina in etopozida.
Tabulated list of adverse reactions
Opis izbranih neželenih učinkov
Only for the pre-filled syringe with safety device: Important: read the package leaflet before handling syringe.
Samo za napolnjene injekcijske brizge z varnostnim pripomočkom:
Your doctor will also check your urine regularly as other medicines similar to this one (e.g. other granulocyte colony stimulating factors such as filgrastim, lenograstim or pegfilgrastim) can possibly harm the tiny filters inside your kidneys (glomerulonephritis; see section “4.
Neželeni učinki, ki so se pojavili s podobnimi zdravili, vendar še ne z zdravilom Lonquex - srpastocelična kriza pri bolnikih s srpastocelično anemijo - boleče izbočene rane vijolične barve na okončinah in včasih na obrazu in vratu z zvišano telesno temperaturo (Sweetov sindrom) - vnetje krvnih žil v koži - poškodba drobnih filtrov v ledvicah (glomerulonefritis; glejte poglavje 2 pod "Opozorila in previdnostni ukrepi")
Contents of the pack and other information
Shranjevanje zdravila Lonquex Vsebina pakiranja in dodatne informacije
Vascular disorders - Capillary leak syndrome Cases of capillary leak syndrome have been reported in postmarketing experience after administration of G-CSF or derivatives.
V obdobju trženja zdravila so poročali o primerih sindroma kapilarne prepustnosti po uporabi
Thrombocytopenia*
Pogosti trombocitopenija*
Metabolism
Bolezni živčevja
16 August 2010
16. avgusta 2010
The application was submitted in the framework of Article 6 of Commission Regulation (EC) No 1084/2003, where the Reference Member State was France2 and the Concerned Member States were Austria, Belgium, Cyprus, Czech Republic, Germany, Denmark, Estonia, Greece, Spain, Finland, Hungary, Ireland, Italy, Malta, Luxembourg, Lithuania, Latvia, the Netherlands, Norway, Poland, Portugal, Sweden, Slovenia, Slovakia and the United Kingdom.
Vloga je bila predložena v okviru člena 6 Uredbe Komisije (ES) št. 1084/2003, pri čemer je bila referenčna država članica Francija2, zadevne države članice pa Avstrija, Belgija, Ciper, Češka, Nemčija, Danska, Estonija, Grčija, Španija, Finska, Madžarska, Irska, Italija, Malta, Luksemburg, Litva, Latvija, Nizozemska, Norveška, Poljska, Portugalska, Švedska, Slovenija, Slovaška in Združeno kraljestvo.
Opinion following an Article 6(12)
Mnenje v zvezi z napotitvijo v skladu s členom 6(12)
The United Kingdom acted on behalf of France as the Reference Member State in a work-sharing arrangement
Združeno kraljestvo je delovalo v imenu Francije kot referenčna država članica v dogovoru o delitvi dela.
The Mutual Recognition Procedure (FR/V/0158/001/II/002) started on 30 January 2009.
Postopek medsebojnega priznavanja (FR/V/0158/001/II/002) se je začel dne 30. januarja 2009.
The referral procedure started on 14 October 2009.
Napotitveni postopek se je začel 14. oktobra 2009.
Pigs should be vaccinated twice with a 3 week interval.
Prašiče je treba cepiti dvakrat v razmiku 3 tednov.
Written explanations were provided by the marketing authorisation holder on 15 January 2010 and supplementary information was submitted on 20 April
Imetnik dovoljenja za promet z zdravilom je 15. januarja 2010 podal razlago v pisni obliki, dodatne informacije pa je predložil 20. aprila 2010.
On 2 October 2009 the United Kingdom on behalf of France, referred the matter to the Agency under Article 39 of Directive 2001/82/EC as amended by reference to Article 6(12) of Regulation (EC) No 1084/2003 due to concerns raised by Spain relating to the quality, safety and efficacy of the simultaneous administration of Porcilis M Hyo with Porcilis PRRS.
2. oktobra 2009 je Združeno kraljestvo v imenu Francije zadevo napotilo na agencijo v skladu s členom 39 Direktive 2001/82/ES, kakor je bila spremenjena, s sklicevanjem na člen 6(12) Uredbe (ES) št. 1084/2003 zaradi zadržkov, ki jih je imela Španija glede kakovosti, varnosti in učinkovitosti sočasne uporabe zdravil Porcilis M Hyo in Porcilis PRRS.
Porcilis M Hyo is an immunological veterinary medicinal product containing Mycoplasma hyopneumoniae.
Porcilis M Hyo je imunološko zdravilo za uporabo v veterinarski medicini, ki vsebuje Mycoplasma hyopneumoniae.
The product is indicated for finishing pigs from 1 week of age.
Zdravilo je indicirano za prašiče, ki se redijo za zakol, od 1. tedna starosti.
During the procedure Dr C. Muñoz Madero replaced Dr C. Rubio Montejano as rapporteur.
Med postopkom je dr. C. Muñoz Madero zamenjala dr. C. Rubio Montejano v vlogi poročevalke.
Based on the rapporteurs' assessment of the currently available data, the CVMP adopted, on 19 May 2010, an opinion recommending that the variation application applied for the veterinary medicinal product Porcilis M Hyo satisfies the criteria for approval.
Na podlagi poročevalčevih ocen trenutno razpoložljivih podatkov je CVMP dne 19. maja 2010 sprejel mnenje, v katerem je priporočil, da vloga za spremembo za zdravilo Porcilis M Hyo za uporabo v veterinarski medicini izpolnjuje kriterije za odobritev.
The Committee appointed Dr C. Rubio Montejano as rapporteur and Dr A.M. Brady as co-rapporteur.
Odbor je za poročevalko imenoval dr. C. Rubio Montejano, za soporočevalko pa dr. A.M. Brady.
The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amended Summary of Product Characteristics and package leaflet in the Annex III.
Seznam zadevnih imen zdravil je naveden v Dodatku I. Znanstveni zaključki so podani v Dodatku II skupaj z dopolnjenim povzetkom glavnih značilnosti zdravila in navodilom za uporabo v Dodatku III.
referral for Porcilis M
za zdravilo Porcilis M Hyo
The marketing authorisation holder Intervet International B.V. submitted an application for a Type II variation subject to Mutual Recognition Procedure for Porcilis M Hyo concerning simultaneous administration with Porcilis PRRS.
Imetnik dovoljenja za promet z zdravilom, družba Intervet International B.V., je predložil vlogo za spremembo tipa II, ki jo ureja postopek medsebojnega priznavanja za zdravilo Porcilis M Hyo v zvezi s sočasno uporabo z zdravilom Porcilis PRRS.
1 Article 6(12) of Commission Regulation (EC) No 1084/2003.
Končno mnenje je bilo spremenjeno v odločbo Evropske komisije dne 16. avgusta 2010. 1 Člen 6(12) Uredbe Komisije (ES) št. 1084/2003.
The reference Member State (RMS) is the Czech Republic and 10 concerned Member States (CMS) are involved: Austria, Denmark, France, Germany, Ireland, Italy, the Netherlands, Portugal, Spain and the United Kingdom.
Referenčna država članica je Češka republika, vključenih pa je še 10 zadevnih držav članic: Avstrija, Danska, Francija, Nemčija, Irska, Italija, Nizozemska, Portugalska, Španija in Združeno kraljestvo.
The Member States concerned failed to reach an agreement regarding the product and consequently the matter was referred to the CVMP on 11 July 2012.
Ker zadevne države članice niso uspele doseči dogovora v zvezi z zdravilom, je bila zadeva 11. julija 2012 predložena odboru CVMP.
The Committee considered whether the environmental risk assessment can be completed based on the information available, or further data needs to be provided.
Odbor je preučil, ali je na podlagi razpoložljivih informacij mogoče podati oceno tveganja za okolje ali pa bi bilo treba zagotoviti dodatne podatke.
Czech Republic Novartis Animal Health Inc. Schwarzwaldallee 215
Nizozemska Novartis Animal Health Inc. Schwarzwaldallee 215
Risk management or mitigation measures
Obvladovanje tveganja ali ukrepi za zmanjšanje tveganja
Having considered all data submitted the CVMP concluded that:
Na podlagi pregleda vseh predloženih podatkov je CHMP zaključil, da:
The combination of active substances is included in veterinary medicinal products currently authorised in the European Union for use in cattle, pigs, dogs and cats.
Omenjeno kombinacijo zdravilnih učinkovin vsebujejo zdravila za uporabo v veterinarski medicini, ki so trenutno odobrena v Evropski uniji za uporabo pri govedu, prašičih, psih in mačkah.
• The studies on the degradation in soil of amoxicillin and clavulanic acid and the adsorption/desorption of amoxicillin in soil provided by the applicant are acceptable;
• so študije o razgradnji amoksicilina in klavulanske kisline v tleh in adsorpciji/desorpciji amoksicilina v tleh, ki jih je predložil predlagatelj, sprejemljive;
Further assessment was required for algae, hence the applicant submitted advanced models for PECs in surfacewater (FOCUS).
Ker je bila za alge potrebna podrobnejša ocena, je predlagatelj predložil napredne modele za izračun PEC v površinski vodi (FOCUS).
List of the name, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, applicant in the Member States
Seznam imen, farmacevtskih oblik, jakosti zdravila za uporabo v veterinarski medicini, živalskih vrst, poti uporabe, vlagatelja v državah članicah
The assessment in phase II was required.
Potrebna je bila II.
According to the guideline on pharmaceutical fixed combination products (EMEA/CVMP/83804/2005) the Environmental Risk Assessment targets at effects of the combination product.
Skladno s smernicami za farmacevtske proizvode s fiksno kombinacijo (EMEA/CVMP/83804/2005) so v oceni tveganja za okolje obravnavani učinki kombiniranega zdravila.
Quality, Target animal safety, User safety, Residues, Resistance and Efficacy were not assessed in this referral procedure.
V tem napotitvenem postopku kakovost, varnost zdravila za ciljno živalsko vrsto, varnost zdravila za uporabnika, ostanki, odpornost in učinkovitost niso bili obravnavani.
Based on the PECsoil values the PECgroundwater and PECsurfacewater were calculated.
Na podlagi vrednosti PECtla so izračunali tudi vrednosti PECpodtalnica in PECpovršinska voda.
Amoxicillin is a semi-synthetic aminopenicillin with broad-spectrum bactericidal activity.
Amoksicilin je polsintetični aminopenicilin s širokim spektrom baktericidnega delovanja.
Considering the data submitted, the Committee concluded as follows on issues raised in the notification received from the Czech Republic.
Po preučitvi predloženih podatkov je odbor glede vprašanj, ki jih je v sporočilu poslala Češka republika, podal zaključke, ki so navedeni v nadaljevanju.
• The ERA can be completed and the product poses no unacceptable risk to the environment.
• je mogoče podati dokončno oceno tveganja za okolje in da zdravilo ne predstavlja nesprejemljivega tveganja za okolje.
• The publicly available scientific literature demonstrates that metabolites of amoxicillin wouldn't pose a higher risk than the parent compound, and using amoxicillin in the environmental impact assessment is justified;
• javno dostopna znanstvena literatura potrjuje, da presnovki amoksicilina ne predstavljajo večjega tveganja kot izhodna spojina in da je uporaba amoksicilina v oceni vpliva na okolje utemeljena;
The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Veljaven povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so končne različice, ki so nastale med postopkom Skupine za usklajevanje.
The applicant did not propose any risk mitigation measures, because they did not identify any environmental risks.
Ker predlagatelj ni ugotovil tveganja za okolje, ni predlagal nobenih ukrepov za zmanjšanje tveganja.
Potential serious risks were identified during the decentralised procedure by the Netherlands and the United Kingdom regarding lack of data on the degradation in soil of amoxicillin and clavulanic acid and the adsorption/desorption of amoxicillin in soil, due to which the environmental risk assessment (ERA) could not be completed.
Med decentraliziranim postopkom sta Nizozemska in Združeno kraljestvo izpostavila morebitna resna tveganja zaradi pomanjkljivih podatkov o razgradnji amoksicilina in klavulanske kisline v tleh ter adsorpciji/desorpciji amoksicilina v tleh, zaradi katerih ni bilo mogoče podati dokončne ocene tveganja za okolje.
The warnings in the product literature remain appropriate.
Opozorila v navodilih, priloženih zdravilu, so ustrezna.
Hence the applicant used advanced models for PEC calculation in groundwater (FOCUS), as described in the CVMP guideline on environmental impact assessment for veterinary medicinal products (EMEA/CVMP/ERA/418282/2005-Rev.1).
Predlagatelj je nato uporabil napredne modele za izračun PEC v podtalnici (FOCUS), kot priporočajo smernice CVMP za oceno vpliva zdravil za uporabo v veterinarski medicini na okolje (EMEA/CVMP/ERA/418282/2005-Rev.1).
Advanced models for PECs in groundwater with the lowest KOC value (40.4 ml/g) as the worst case confirm that predicted environmental concentrations in all scenarios were below the trigger value of 0.1 μg/l and the product does not pose any risk to groundwater.
Napredni modeli za PEC v podtalnici, ki so kot najslabši možni primer upoštevali najmanjšo vrednost KOC (40,4 ml/g), so potrdili, da so bile predvidene okoljske koncentracije v vseh primerih pod mejno vrednostjo 0,1 μg/l in da zdravilo ne predstavlja tveganja za podtalnico.
Environmental risk
Tveganje za okolje
The PECsoil value 217 μg/kg was used in the subsequent assessment.
Pri nadaljnjem ocenjevanju so uporabili vrednost PECtla 217 μg/kg.
The data collected from different public sources on metabolites indicate that there are no environmental risks (according to current ERA methodology).
Podatki o presnovkih, zbrani iz različnih javno dostopnih virov, kažejo, da ti ne predstavljajo tveganja za okolje (glede na trenutno metodologijo za oceno tveganja za okolje).
Therefore, the CVMP recommended the granting of the marketing authorisation for the veterinary medicinal products referred to in annex I for which the valid Summary of Product Characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in annex III.
Zato je CHMP priporočil odobritev dovoljenja za promet z zdravili za uporabo v veterinarski medicini, navedenimi v prilogi I, katerih povzetki glavnih značilnosti, označevanje in navodila za uporabo ostanejo enaki kot končne različice, dogovorjene med postopkom Skupine za usklajevanje, kakor je navedeno v prilogi III.
Considering the total evidence presented in the dossier and the data available in the public domain, the absence of the data concerning metabolites does not affect the positive benefit-risk ratio of the product.
Ob upoštevanju vseh dokazov, predloženih v dokumentaciji, in javno dostopnih podatkov je bilo ugotovljeno, da pomanjkanje podatkov o presnovkih ne vpliva na pozitivno razmerje med tveganji in koristmi zdravila.
Having considered all the overall submitted data in writing and in the oral explanation the CVMP concluded the data package regarding environmental risk assessment submitted by the applicant is considered sufficient and the overall benefit-risk balance of the product is positive.
Na podlagi pregleda vseh predloženih podatkov v obliki pisne dokumentacije in ustnih obrazložitev je CVMP zaključil, da je dokumentacija, ki jo je v zvezi z oceno tveganja za okolje predložil predlagatelj, zadostna, in da je na splošno razmerje med tveganji in koristmi za zdravilo pozitivno.
The PECsoil value 869 μg/kg was used in the subsequent assessment.
Pri nadaljnjem ocenjevanju so uporabili vrednost PECtla 869 μg/kg.
Based on the revised ERA and considering additional information from peer-reviewed scientific literature, no serious risk for the environment was identified and the risk can be properly managed by the proposed conditions for use of the product as per the currently proposed SPC.
Na podlagi posodobljene ocene okoljskega tveganja in pregleda dodatnih podatkov iz strokovno pregledane znanstvene literature niso bila ugotovljena resna tveganja za okolje, ostala tveganja pa je mogoče ustrezno obvladovati s predlaganimi pogoji za uporabo zdravila in trenutno predlaganim povzetkom glavnih značilnosti zdravila.
The product containing amoxicillin and clavulanic acid (in the form of the potassium salt) at a ratio 4:1 is indicated for treatment of infections caused by microorganisms in intensively reared pigs including respiratory diseases.
Zdravilo, ki vsebuje amoksicilin in klavulansko kislino (v obliki kalijeve soli) v razmerju 4 : 1, je indicirano za zdravljenje prašičev v intenzivni reji z okužbami, ki jih povzročajo mikroorganizmi, vključno z boleznimi dihal.