FrancophonIA/ELRC3.0 huggingface dataset:
English: Detrimental effects on developing eggs of avian scavengers were reported when these birds ingest livestock meat from animals previously administered with fluoroquinolone.
Croatian: Prijavljeno je detrimentalno djelovanje na jajašca u razvoju ptica strvinara ako su se ove ptice hranile mesom životinja koje su prethodno tretirane fluorkinolonom.
English: The product can be used in pregnant cows during the 1st quarter of pregnancy.
Croatian: Proizvod se može primjenjivati kravama tijekom 1. četvrtine graviditeta.
English: Overall drug concentrations peak at 2 hours after treatment showing an approximately 3-fold higher total exposure over the 24 hours dosing interval compared to plasma.
Croatian: Ukupna vršna koncentracija postigne se 2 sata nakon primjene; tijekom doznog intervala od 24 sata ukupna izloženost je približno 3 puta veća u odnosu na plazmu.
English: aureus LAMRSA (ST398, spa types t034 and t5210) occurring in rabbits raised intensively for meat production and involving farm workers or their family members5.
Croatian: Aureus otpornog na metilicin povezanog sa stokom LA-MRSA (ST398, spa tipovi t034 i t5210) koji je nastupio u zečeva uzgajanih intenzivno za potrebe mesa i uključivao radnike na farmi ili članove njihovih obitelji5.
English: The use of the product in cows during the 3 last quarters of pregnancy should be based on a benefit/risk assessment by the responsible veterinarian.
Croatian: Primjena proizvoda u krava tijekom zadnje 3 četvrtine graviditeta treba se temeljiti na procjeni veterinara o odnosu koristi/rizika.
English: As enrofloxacin is known to cause CNS stimulation, the contraindications in epileptic animals or in animals that suffer from seizures are justified.
Croatian: Budući da je poznato da enrofloksacin uzrokuje stimulaciju CNS-a, kontraindikacije u životinja s epileptičkim napadajima ili u životinja koje pate od napadaja su opravdane.
English: Use in pregnancy and lactation
Croatian: Uporaba tijekom gravidnosti i laktacije
English: Bayer Hispania S.L.
Croatian: Španjolska Bayer Hispania S.L.
English: Therefore in order to optimise the dosage and to avoid development of resistance it has been concluded, that the dose rate of 2.5 mg/kg bw/day should be deleted for all the indications in cattle.
Croatian: Stoga kako bi se optimizirala doza i izbjegao razvoj rezistentnosti, zaključeno je da dozu od 2,5 mg/kg tjelesne težine/danu treba obrisati iz svih indikacija za goveda.
English: They may persist up to 28 days after the injection.
Croatian: One mogu potrajati do 28 dana nakon injekcije.
English: The latter also applies for alimentary tract infections and septicaemia caused by E. coli in pigs.
Croatian: Posljednje se također primjenjuje na infekcije alimentarnog trakta i septikemiju uzrokovanu E. coli u svinja.
English: Duration of treatment should be based on the duration of treatment approved for the appropriate indication in the product information of the tablet product.
Croatian: Trajanje liječenja trebalo bi temeljiti na odobrenom trajanju liječenja za indikaciju navedenu u uputi za tablete.
English: Taking into account all the documentation provided, the CVMP considered that this indication can be accepted, but in the 50 mg/ml strength it should be stated as “Treatment of acute mycoplasma-associated arthritis due to enrofloxacin susceptible strains of Mycoplasma bovis”.
Croatian: Uzimajući u obzir cjelokupnu dostavljenu dokumentaciju, CVMP smatra da se ova indikacija može prihvatiti, no u jačini od 50 mg/ml mora biti navedeno „Liječenje akutnog artritisa povezanog s mikoplazmom zbog sojeva patogena Mycoplasma bovis podložnih enrofloksacinu”.
English: Further to the concerns expressed by the CVMP regarding the aforementioned two indications CVMP recommended the removal of these from the product information.
Croatian: Vezano uz zbrinutost koju je izrazio CVMP s obzirom na prethodno spomenute indikacije, CVMP je preporučio uklanjanje istih iz informacija o proizvodu.
English: Mild and transient digestive tract disorders are common with many antibiotics, including fluoroquinolones.
Croatian: Blagi i prolazni poremećaji probavnog trakta uobičajeni su s većinom antibiotika, uključujući fluorkinolone.
English: Several proprietary studies and numerous scientific publications, documenting the efficacy of enrofloxacin, either by injectable and/or oral route of administration, were provided to demonstrate the efficacy against the above specified bacteria for the intended indications in both dogs and cats
Croatian: Dostavljeno je nekoliko vlasničkih ispitivanja i brojne znanstvene publikacije, koje dokumentiraju djelotvornost enrofloksacina bilo primjenom injekcije i/ili oralnim putem, kako bi se demonstrirala djelotvornost protiv gore navedenih bakterija za predviđene indikacije kako u pasa tako i u mačaka.
English: Pregnancy and lactation and lay:
Croatian: Graviditet, laktacija i nesenje:
English: Both strengths share the same indications, but differences exist in terms of target animal species i.e. in the 50 mg/ml strength the species were stated as dairy ewes/lambs and dairy goats/kids whereas in the 100 mg/ml strength the species were sheep and goats.
Croatian: Obje jačine dijele iste indikacije, no razlike postoje u pogledu vrsta ciljnih životinja, odnosno u slučaju jačine od 50 mg/ml navedene su mliječne ovce/janjad i mliječne koze/kozlići kao ciljne vrste, a ovce i koze su navedene kao ciljne vrste za jačinu od 100 mg/ml.
English: Laboratory studies in rats and rabbits have not produced any evidence of teratogenic effects but have shown evidence of foetotoxic effects at maternotoxic doses.
Croatian: Laboratorijskim istraživanjima na štakorima i kunićima nisu utvrđeni teratogeni učinci, ali su zabilježeni fetotoksični učinci primjenom maternotoksičnih doza.
English: African Grey Parrots serum ciprofloxacin concentrations were 3-78% of the enrofloxacin dose, with an increasing ciprofloxacin/enrofloxacin ratio with multiple doses.
Croatian: Koncentracije ciprofloksacina u serumu afričkih sivih papiga iznosile su 3-78% doze enrofloksacina, s povećanjem omjera ciprofloksacin/enrofloksacin nakon višestrukih doza.
English: The data provided are insufficient to justify two indications in cattle (i) ‘treatment of infections of the respiratory tract caused by enrofloxacin susceptible strains of Histophilus somni' and (ii) ‘treatment of acute severe mastitis caused by enrofloxacin susceptible strains of Staphylococcus aureus'.
Croatian: Dostavljeni podaci nisu dostatni da bi opravdali dvije indikacije u goveda (i.) „liječenje infekcija respiratornog trakta uzrokovanih sojevima bakterije Histophilus somni koji su osjetljivi na enrofloksacin” i (ii.) „liječenje akutnog teškog mastitisa uzrokovanog sojevima bakterije Staphylococcus aureus koji su osjetljivi na enrofloksacin”.
English: The overall evaluation of the submitted data (clinical, PK/PD and resistance data) show that the dose of 2.5 mg/kg bw/day may not allow for a complete elimination of bacteria and it could lead to an increased resistance development.
Croatian: Cjelokupna evaluacija dostavljenih podataka (klinički, farmakokinetički/farmakodinamički podaci i podaci o rezistenciji) pokazala je da doza od 2,5 mg/kg tjelesne težine/danu ne mora omogućiti potpunu eliminaciju bakterija i može uzrokovati povećani razvoj otpornosti.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Croatian: Učestalost nuspojava prosuđena je prema sljedećim standardima: - vrlo česte (više od jedne od 10 životinja očituju nuspojave tijekom trajanja jednog tretmana) - česte (više od jedne ali manje od 10 životinja na 100 životinja) - manje česte (više od jedne ali manje od 10 životinja na 1.000 životinja) - rijetke (više od jedne ali manje od 10 životinja na 10.000 životinja) - vrlo rijetke (manje od jedne životinje od 10.000 životinja, uključujući izolirane slučajeve).
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Croatian: Bilo koji neupotrjebljeni veterinarsko-medicinski proizvod ili otpadni materijali dobiveni primjenom tih veterinarsko-medicinskih proizvoda trebaju se odlagati u skladu s propisima o zbrinjavanju otpada.
English: Resistance to fluoroquinolones has been reported to arise from five sources, (i) point mutations in the genes encoding for DNA gyrase and/or topoisomerase IV leading to alterations of the respective enzyme, (ii) alterations of drug permeability in Gram-negative bacteria, (iii) efflux mechanisms, (iv) plasmid mediated resistance and (v) gyrase protecting proteins.
Croatian: Zabilježeno je da rezistencija na fluorokinolone može nastati na pet načina: (i) točkaste mutacije u genima koji kodiraju DNK girazu i/ili topoizomerazu IV, a što dovodi do promjena navedenih enzima, (ii) promjene propusnosti stjenke gram-negativnih bakterija za lijek, (iii) mehanizmi efluksa, (iv) plazmidima posredovana rezistencija i (v) zaštitni proteini giraze.
English: Further to the assessment of the available data withdrawal periods were established and several contraindications and warning sentences are recommended to ensure the safe use of the products.
Croatian: Daljnjom ocjenom dostupnih podataka utvrđena su razdoblja karencije te je preporučeno nekoliko rečenica upozorenja kako bi se osigurala sigurna primjena proizvoda.
English: • Target species;
Croatian: • Ciljne vrste;
English: Primary degenerative lesions were noted in stifle joints of all calves that were treated with 90 mg/kg bw and in one calf that was treated with 30 mg/kg bw.
Croatian: Primarne degenerativne lezije uočene su u ugušenim zglobovima sve teladi koja je bila liječena s 90 mg/kg tjelesne težine i u jednom teletu koje je liječeno s 30 mg/kg tjelesne težine.
English: In calves, transient local tissue reactions may occur in very rare cases and may be observed up to 14 days.
Croatian: U teladi, u vrlo rijetkim slučajevima, mogu se javiti prolazne lokalne reakcije tkiva koje mogu biti vidljive do 14 dana.
English: Ortega et al. Characterisation and public health risks of antimicrobial resistance in Staphylococcus aureus in intensive rabbit breeding.
Croatian: Characterisation and public health risks of antimicrobial resistance in Staphylococcus aureus in intensive rabbit breeding.
English: 30 mg. For the full list of excipients, see section 6.1.
Croatian: Potpuni popis pomoćnih tvari vidi u odjeljku 6.1.
English: On 26 October 2012, France sent a referral notification under Article 34(1) of Directive 2001/82/EC, as amended, to the CVMP/European Medicines Agency for Baytril 2.5% injectable, Baytril 5% injectable and Baytril 10% injectable and their associated names.
Croatian: Dana 26. listopada 2012., Francuska je poslala obavijest o upućivanju u skladu sa člankom 34(1) Direktive 2001/82/EZ, s dopunama, CVMP-u/Europskoj agenciji za lijekove za Baytril 2,5% injektabilan, Baytril 5% injektabilan i Baytril 10% injektabilan i njihove povezane nazive.
English: Clear light-yellow solution.
Croatian: Bistra svjetlo-žuta otopina.
English: For cats weighting less than 5 kg, the dosage of 25 mg/ml is more appropriate to avoid risk of overdosage (see section 4.10).
Croatian: Za mačke lakše od 5 kg, doza 25 mg/mL je puno prikladnija kako bi se izbjegla mogućnost predoziranja (vidi odjeljak 4.10).
English: France referred the issue due to divergent national decisions having been taken by the Member States (EU/EEA) resulting in discrepancies in the product information for Baytril 2.5% injectable, Baytril 5% injectable and Baytril 10% injectable and their associated names.
Croatian: Francuska je uputila ovaj predmet zbog različitih nacionalnih odluka koje su donijele države članice (EU/EEA) što je rezultiralo razlikama u informacijama o proizvodu za Baytril 2,5% injektabilan, Baytril 5% injektabilan i Baytril 10% injektabilan i njihove povezane nazive.
English: Do not use in growing horses because of possible deleterious damage on articular cartilage.
Croatian: Ne primjenjivati konjima koji još rastu zbog mogućih štetnih učinaka na hrskavicu zglobova.
English: These signs are generally mild and transient.
Croatian: Ovi su znakovi načelno blagi i prolazni.
English: Bioavailability is high (approximately 100% in pig and cattle) with a low to moderate plasma protein binding (approximately 20 to 50%).
Croatian: Biodostupnost mu je visoka (približno 100% kod svinja i goveda), a slabo do umjereno vezan je na plazmine proteine (približno 20 do 50%).
English: Pharmacotherapeutic group: Antibacterials for systemic use, fluoroquinolones.
Croatian: Farmakoterapijska grupa: antibakterijski lijekovi za sustavnu primjenu, fluorokinoloni.
English: Whenever possible fluoroquinolones should only be used based on susceptibility testing.
Croatian: Kada je god moguće fluorokinolone treba primjenjivati na osnovi nalaza testova osjetljivosti (antibiogram).
English: Shelf life after the first opening of the immediate packaging: 28 days.
Croatian: Rok valjanosti poslije prvog otvaranja unutarnjeg pakovanja: 28 dana.
English: Bioavailability is high (approximately 100% in pigs) with a low to moderate plasma protein binding (approximately from 20 to 50%).
Croatian: Biodostupnost mu je visoka (približno 100% kod svinja), a slabo do umjereno vezan je na plazmine proteine (približno 20 do 50%).
English: In pigs, no adverse effects were reported after the administration of 5 times the recommended dose.
Croatian: U svinja nisu zabilježeni štetni učinci nakon primjene 5 puta veće doze od preporučene.
English: For cats weighting less than 5 kg, the dosage of 25 mg/ml is more appropriate to avoid risk of overdosage (see Overdose).
Croatian: Za mačke lakše od 5 kg, doza 25 mg/mL je puno prikladnija kako bi se izbjegla mogućnost predoziranja (vidi Predoziranje).
English: Cmax (µg/ml) AUC (µg∙h/ml) Terminal half-life (h) Elimination half-life (h) F (%)
Croatian: Cmax (µg/ml) AUC (µg∙h/ml) Završni poluživot (h) Vrijeme polueliminacije (h)
English: The section on interactions takes into account for all relevant interactions between enrofloxacin and other substances.
Croatian: Interakcija s drugim veterinarsko-medicinskim proizvodima Dio o interakcijama uzima u obzir sve relevantne interakcije između enrofloksacina i drugih tvari.
English: Because of known effects of quinolones on articular joints in growing dogs, the contraindication in such animals is justified.
Croatian: Budući da je poznato djelovanje kinolona na zglobove pasa u razvoju, opravdane su kontraindikacije u takvih životinja.
English: Terminal half-life (h) Elimination half-life (h) F (%)
Croatian: AUC (µg∙h/ml) Završni poluživot (h) Vrijeme polueliminacije (h) F (%)
English: This section takes into account a possible hypersensitivity to fluoroquinolones or to any excipients of the product.
Croatian: Ovaj dio uzima u obzir moguću preosjetljivost na fluorkinolone ili na ekscipijente proizvoda.
English: The specific properties of enrofloxacin regarding both its use in animals with renal disorders and retinal toxicity in cats are also stated.
Croatian: Također su navedena specifična svojstva enrofloksacina u vezi s njegovom primjenom u životinja s poremećajem bubrega i retinalnom toksičnošću u mačaka.
English: Fluoroquinolones should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other classes of antimicrobials.
Croatian: trebaju biti rezervirani za liječenje kliničkih stanja koja do sada nisu adekvatno odgovorila ili za koje se očekuje da neće dobro odgovoriti na druge klase antimikrobika.
English: The data provided consist of studies performed with several posology regimens where the more frequent dose of 5 mg/kg bw was used.
Croatian: Dostavljeni podaci sastoje se od ispitivanja provedenih s nekoliko režima doziranja, pri čemu je najčešće primjena doza iznosila 5 mg/kg tjelesne težine.
English: SPECIAL STORAGE CONDITIONS Do not refrigerate or freeze.
Croatian: 11. POSEBNI UVJETI ČUVANJA Ne hladiti ili zamrzavati.
English: In reptiles and birds, muscle bruising may occur in very rare cases.
Croatian: Kod gmazova i ptica, u vrlo rijetkim slučajevima, mogu nastati mišićni podljevi.
English: Target inhibition is caused by noncovalent binding of fluoroquinolone molecules to these enzymes.
Croatian: Ciljanu inhibiciju tih enzima uzrokuje nekovalentno vezanje molekula fluorokinolona za njih.
English: The warning regarding possible degenerative changes of articular cartilage in calves is supported by a study in which calves (2 weeks old) were orally administered with 0, 30 or 90 mg/kg bw of enrofloxacin per day for 14 days.
Croatian: Upozorenje vezano uz moguće degenerativne promjene zglobne hrskavice u teladi potkrijepljeno je ispitivanjem, u kojem je telad (2 tjedan stara) peroralno primila 0.30 ili 90 mg/kg tjelesne težine enrofloksacina na dan tijekom 14 dana.
English: People with known hypersensitivity to fluoroquinolones should avoid any contact with the product.
Croatian: Osobe preosjetljive na fluorokinolone trebaju izbjegavati dodir s ovim VMP-om.
English: Baytril 2.5% injectable, Baytril 5% injectable and Baytril 10% injectable and their associated names are solutions for injection containing enrofloxacin at 25 mg/ml, 50 mg/ml and 100 mg/ml respectively.
Croatian: Baytril 2,5% injektabilan, Baytril 5% injektabilan i Baytril 10% injektabilan i povezani nazivi su otopine za injekciju koje sadrže enrofloksacin od 25 mg/ml, 50 mg/ml odnosno 100 mg/ml.
English: Accumulation in plasma does not occur following a treatment interval of 24 h.
Croatian: Do nakupljanja u plazmi ne dolazi kada je razmak između primjena VMP-a 24 sata.
English: Do not use enrofloxacin concomitantly with antimicrobial substances acting antagonistically to quinolones (e.g. macrolides, tetracyclines or phenicols).
Croatian: Enrofloksacin se ne smije primjenjivati istodobno s antimikrobnim tvarima koje djeluju antagonistički na kinolone (npr. makrolidi, tetraciklini ili fenikoli).
English: Enrofloxacin is rapidly absorbed after parenteral injection.
Croatian: Enrofloksacin se brzo resorbira nakon parenteralne primjene.
English: The safety of the veterinary medicinal product has been established in pregnant cows during the 1st quarter of pregnancy.
Croatian: Neškodljivost veterinarsko-medicinskog proizvoda utvrđena je kod gravidnih krava tijekom 1. četvrtine graviditeta.
English: In rabbits, reactions (from reddening to ulcerative lesions with deep loss of tissue), may occur.
Croatian: U kunića se mogu javiti reakcije (od crvenila do čireva s opsežnim gubitkom tkiva).
English: Tmax (h) Cmax (µg/ml)
Croatian: Cmax (µg/ml)
English: Rabbits are classified as minor species and thus the available data is assessed in the context of the CVMP guideline on efficacy and target animal safety data requirements for veterinary medicinal products intended for minor uses or minor species (EMEA/CVMP/EWP/117899/2004).
Croatian: Zečevi su klasificirani kao manje vrste, te su stoga dostupni podaci procijenjeni u kontekstu smjernice CVMP-a o zahtjevima za podatke o djelotvornosti i sigurnoj primjeni u ciljnih životinja za veterinarsko-medicinske proizvode predviđene za manju uporabu ili manje vrste (EMEA/CVMP/EWP/117899/2004).
English: In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Croatian: U nedostatku studija kompatibilnosti, ovaj veterinarsko-medicinski proizvod se ne smije miješati s drugim veterinarsko-medicinskim proizvodima.
English: The use of enrofloxacin in growing lambs at the recommended dose for 15 days caused histological changes in the articular cartilage, not associated to clinical signs.
Croatian: Primjena enrofloksacin u janjadi u razvoju u preporučenoj dozi u trajanju od 15 dana uzrokovalo je histološke promjene u zglobnoj hrskavici, što nije povezano s kliničkim znakovima.
English: The discard date should be recorded on the label of the glass vial after the vial was broached for the first time.
Croatian: Datum prestanka valjanosti treba zabilježiti na etiketu bočice nakon prvog otvaranja.
English: Digestive tract disorders (e.g. diarrhoea) may occur in very rare cases.
Croatian: Probavni poremećaji (npr. proljev) mogu se javiti u vrlo rijetkim slučajevima.
English: Enrofloxacin:
Croatian: Enrofloksacin:
English: Replication forks and translational complexes cannot proceed beyond such enzyme-DNA-fluoroquinolone complexes, and inhibition of DNA and mRNA synthesis triggers events resulting in a rapid, drug concentration-dependent killing of pathogenic bacteria.
Croatian: Replikacijske rašlje i translacijski kompleksi ne mogu se nastaviti uslijed stvaranja kompleksa enzim-DNK-fluorokinolon, te je inhibicija sinteze DNK i mRNK okidač koji dovodi do brzog i o koncentraciji ovisnog uništavanja patogenih bakterija.
English: Parent substance and active metabolite are cleared from the body via urine and faeces.
Croatian: Izvorna tvar i aktivni metabolit izlučuju se iz organizma mokraćom i izmetom.
English: 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Croatian: 6.6 Posebne mjere opreza prilikom odlaganja neupotrjebljenog veterinarskomedicinskog proizvoda ili otpadnih materijala dobivenih primjenom tih proizvoda
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
Croatian: NAČIN I PUT(EVI) PRIMJENE Pročitati uputu o VMP-u prije primjene.
English: Special caution should be taken when using enrofloxacin in animals with impaired renal function.
Croatian: Poseban oprez potreban je prilikom primjene enrofloksacina životinjama s poremećenom funkcijom bubrega.
English: In dogs, rabbits, small rodents, reptiles and birds, overdose has not been documented.
Croatian: U pasa, kunića, malih glodavaca, gmazova i ptica nisu zabilježeni slučajevi predoziranja.
English: Do not use in animals with known hypersensitivity to enrofloxacin or other fluoroquinolones or to any of the excipients.
Croatian: Ne primjenjivati životinjama preosjetljivim na enrofloksacin ili druge fluorokinolone ili na bilo koju pomoćnu tvar.
English: 6.1 List of excipients n-Butyl alcohol
Croatian: 6.1 Popis pomoćnih tvari n-butil-alkohol
English: Overall summary of the scientific evaluation of Baytril 2.5% injectable, Baytril 5% injectable and Baytril 10% injectable and their associated names (see Annex I)
Croatian: Cjelokupni sažetak znanstvene ocjene VMP-ova Baytril 2,5% injektabilan, Baytril 5% injektabilan i Baytril 10% injektabilan i njihovih povezanih naziva (vidjeti Dodatak I)
English: The product can be used in cows during lactation.
Croatian: VMP se može primjenjivati kravama tijekom laktacije.
English: Enrofloxacin
Croatian: Enrofloksacin
English: Goat meat and offal (50 mg/ml and 100 mg/ml strengths) No residue depletion data were made available.
Croatian: Kozje meso i iznutrice (jačine 50 mg/ml i 100 mg/ml) Nisu dostavljeni podaci o pražnjenu rezidua.
English: Acute severe mastitis caused by Staphylococcus aureus (100 mg/ml strength)
Croatian: Akutni ozbiljni mastitis kojeg uzrokuje Staphylococcus aureus (jačine 100 mg/ml)
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Glass vials
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKOVANJU Staklena bočica
English: the CVMP has recommended variations of the marketing authorisations for Baytril 2.5% injectable, Baytril 5% injectable and Baytril 10% injectable and their associated names as referred in Annex I for which the summaries of the product characteristics, labelling and package leaflets are set out in Annex III.
Croatian: CVMP je preporučio varijacije odobrenja za stavljanje VMP-a u promet za VMP-ove Baytril 2,5% injektabilan, Baytril 5% injektabilan i Baytril 10% injektabilan i njihove povezane nazive kako je navedeno u Dodatku I, za koje su sažetci opisa svojstava za VMP, etiketa i uputa za uporabu navedeni u Dodatku III.