FrancophonIA/ELRC3.0 huggingface dataset:
English: Concerning Porcilis M Hyo the marketing authorisation holder has submitted data of adjuvant content (dl--tocopherol acetate), pH and sterility of the mixture after reconstitution of 2 batches of Porcilis PRRS in 2 batches of Porcilis M Hyo after storage for 3 hours at room temperature.
Maltese: Fir-rigward ta' Porcilis M Hyo, id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq issottometta dejta dwar il-kontenut tas-sustanza aġġuntiva (dl-α-tocopherol acetate), il-pH u l-isterilità tat-taħlita wara rikostituzzjoni ta' 2 lottijiet ta' Porcilis PRRS f'2 lottijiet ta' Porcilis M Hyo wara ħżin għal 3 sigħat f'temperatura ambjentali.
English: Thereby the following instructions should be used:
Maltese: - Tieni vaċċinazzjoni:
English: The marketing authorisation holder has provided data of the PRRS virus titration after mixing Porcilis PRRS with Porcilis M Hyo at 0, 1, 2 and 3 hours.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq ipprovda dejta dwar it-titrazzjoni talvirus tal-PRRS wara li Porcilis PRRS jitħallat ma' Porcilis M Hyo fi żmien 0, 1, 2 u 3 sigħat.
English: Boxmeer
Maltese: Ċipru
English: Strength
Maltese: Stat
English: The National Competent Authority of Spain was concerned that some aspects regarding the quality, safety and the efficacy after mixing the two products (Porcilis PRRS and Porcilis M Hyo) were not adequately justified.
Maltese: L-Awtorità Kompetenti Nazzjonali ta' Spanja kienet imħassba dwar ilfatt li xi aspetti relatati mal-kwalità, sigurtà u l-effikaċja wara t-taħlita taż-żewġ prodotti (Porcilis PRRS and Porcilis M Hyo) ma ġewx iġġustifikati b'mod adegwat.
English: Following the absence of agreement between the Reference Member State (the United Kingdom acted on behalf of France as the Reference Member State in a work-sharing arrangement) and one of the Concerned Member States (Spain) at day 90 of the CMDv procedure, the matter was referred to the CVMP on 2 October 2009.
Maltese: Wara n-nuqqas ta' qbil bejn l-Istat Membru ta' Referenza (ir-Renju Unit aġixxa f'isem Franza bħala l-Istat Membru ta' Referenza fi ftehim ta' qsim tax-xogħol) u wieħed mill-Istati Membri Kkonċernati (Spanja) fil-jum 90 tal-proċedura tas-CMDv, il-kwistjoni ġiet riferuta lis-CVMP fit-2 ta' Ottubru 2009.
English: Before using the vaccine allow it to reach room temperature (15-25C) and shake well before use.
Maltese: Qabel tużgħa t-tilqima, ħalliha tilħaq it-temperatura tal-kamra (15-25°C) u ħawwad sew qabel l-użu.
English: In order to ascertain that there is no significant decrease in the titre right after mixing (i.e., at t=0), it was considered important to know the titre at release (or after reconstitution in the diluent fraction of Porcilis PRRS).
Maltese: Sabiex jiġi żgurat li ma hemm ebda tnaqqis sinifikanti fit-titre eżattament wara t-taħlita (jiġifieri, meta t=0), tqies li huwa importanti li jkun magħruf it-titre mar-rilaxx (jew wara rikostituzzjoni fil-frazzjoni dilwenti ta' Porcilis PRRS).
English: Denmark Intervet International bv Wim de
Maltese: Danimarka Intervet International bv Wim de
English: Luxembourg Intervet International bv Wim de
Maltese: Lussemburgu Intervet International bv Wim de
English: 4.6 Adverse reactions (frequency and seriousness) A mean transient temperature increase in body temperature of about 0.3C, in individual pigs up to 2.0C, may occur on the first 1 to 2 days after vaccination.
Maltese: Żieda temporanja tat-temperatura medja tal-ġisem ta'madwar 0.3°C, fi ħnieżer individwali sa 2.0°C, tista seħħ fl-ewwel ġurnata sa 2 ġurnata wara l-vaċċinazzjoni.
English: As regards justifying why no potency test of the Porcilis M Hyo component has been carried out on the mixed vaccines both immediately after mixing and after the proposed in-use shelf life, the marketing authorisation holder has justified not performing a potency test for the Porcilis M Hyo component on the mixed vaccines that by provision of safety and efficacy studies using the mixed product the marketing authorisation holder has shown that there are no interactions within the mixture affecting the potency of the mixed product.
Maltese: Fir-rigward tal-ġustifikazzjoni l-għala ma twettaq ebda test tal-qawwa tal-komponent ta' Porcilis M Hyo fuq il-vaċċini mħallta kemm immedjatament wara t-taħlita kif ukoll wara lħajja waqt l-użu proposta, id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq iġġustifika lgħala ma sarx test tal-qawwa għall-komponent ta' Porcilis M Hyo fuq il-vaċċini mħallta billi qal li permezz tar-riżultati tal-istudji ta' sigurtà u effikaċja bil-prodott imħallat, id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq wera li ma hemm ebda interazzjoni fi ħdan it-taħlita li taffettwa l-qawwa tal-prodott imħallat.
English: There is no reason to believe that other efficacy parameters would be influenced any differently in the field.
Maltese: Ma hemm ebda raġuni għaliex wieħed jemmen li parametri tal-effikaċja oħrajn ikunu influwenzati b'xi mod differenti fil-prattika.
English: 4) this means that in the worst case scenario of a batch at the end of shelf being mixed there will be no statistically significant drop below the minimum titre over the claimed in-use shelf life of 1 hour.
Maltese: 4) dan ifisser li fix-xenarju tal-agħar każ, jiġifieri li lott li jkun fit-tmiem tal-ħajja miftuħ waqt l-użu tiegħu jitħallat, ma jkun hemm ebda waqa' statistikament sinifikanti taħt it-titre minimu fuq il-ħajja miftuħ waqt l-użu ta' siegħa.
English: The efficacy studies using appropriate challenges for Porcilis M Hyo and Porcilis PRRS have shown that there is no affect of simultaneous administration on the efficacy parameters of reduced viraemia and a reduction in lung lesions.
Maltese: L-istudji tal-effikaċja li jużaw sfidi xierqa għal Porcilis M Hyo u Porcilis PRRS urew li ma hemm ebda effett ta' amministrazzjoni simultanja fuq il-parametri tal-effikaċja ta' viraemija mnaqqsa u tnaqqis fil-leżjonijiet tal-pulmuni.
English: The marketing authorisation holder has presented data on safety studies (single dose, overdose, repeated dose) starting at 4 weeks of age with Porcilis PRRS mixed with Porcilis M Hyo, considering that 4 weeks is the youngest age recommended for the administration of the mixed product.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq ippreżenta dejta dwar l-istudju tassigurtà (doża waħda, doża eċċessiva, doża ripetuta) minn 4 ġimgħat ta' età b'Porcilis PRRS imħallat ma' Porcilis M Hyo, meta jitqies li 4 ġimgħat hija l-iżgħar età rrakkomandata għallgħoti tal-prodott imħallat.
English: In addition, it is considered that potency of the Porcilis M Hyo component after mixing should have been analysed in order to the exclude a quality interference right after mixing (at t=0) and after the proposed in-use shelf life.
Maltese: Barra minn hekk, huwa meqjus li lqawwa tal-komponent ta' Porcilis M Hyo wara t-taħlita kellha tiġi analizzata sabiex tkun impeduta interferenza tal-kwalità eżattament wara t-taħlit (meta t=0) u wara l-ħajja waqt lużu proposta.
English: Data on laboratory efficacy studies and on one field study were provided showing that the reduction of lung lesion score of pigs vaccinated with the mixed product is similar to the reduction of lung lesion score of pigs vaccinated with Porcilis M Hyo alone.
Maltese: Dejta dwar l-istudji tal-effikaċja tal-laboratorju u studju prattiku wieħed urew li t-tnaqqis fliskor ta' majjali b'leżjoni pulmonari mlaqqma bil-prodott imħallat huwa simili għat-tnaqqis fliskor ta' majjali b'leżjoni pulmonari mlaqqma b'Porcilis M Hyo waħdu.
English: Vaccinate pigs twice with a three week interval.
Maltese: Il-majjali għandhom jitlaqqmu darbtejn f'intervall ta' 3 ġimgħat.
English: Belgium Intervet International bv Wim de
Maltese: Finlandja Intervet International bv Wim de
English: In isolated cases hypersensitivity reactions may occur.
Maltese: Każijiet iżolati ta' ipersensittivita jistgħu jiġru.
English: Radlická 3185/1c 150 00 Praha 5, Czech Republic
Maltese: Radlická 3185/1c 150 00 Praha 5,
English: CILAZAPRIL TEVA 5 MG
Maltese: CILAZAPRIL TEVA 5
English: Annex I List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, marketing authorisation holders in the member states
Maltese: L-ISMIJIET, GĦAMLA FARMAĊEWTIKA, QAWWIET TAL-PRODOTT(I)
English: 2 tubes 10 tubes 20 tubes
Maltese: 2 tubi 10 tubi 20 tubu
English: EU/2/19/246/001 (2 tubes) EU/2/19/246/002 (10 tubes) EU/2/19/246/003 (20 tubes)
Maltese: EU/2/19/246/001 (2 tubi) EU/2/19/246/002 (10 tubi) EU/2/19/246/003 (20 tubu)
English: ATCvet code: QS02CA91
Maltese: QS02CA91
English: 24106 Kiel
Maltese: 324 24106 Kiel IL-ĠERMANJA
English: Date of first authorisation: 10/12/2019.
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 10/12/2019.
English: Pack sizes: 2, 10 or 20 tubes.
Maltese: IEĦOR Daqsijiet tal-pakkett: 2, 10 jew 20 tubu.
English: Shake well before use for 5 seconds.
Maltese: Ċaqlaq sew qabel l-użu għal 5 sekondi.
English: Propylene carbonate Propylene glycol Ethanol (96 per cent) Macrogol 8000
Maltese: Ethanol (96 fil-mija) Macrogol 8000
English: Do not store above 25°C.
Maltese: Taħżinx f'temperaturi ogħla minn 25 °C.
English: Terbinafine hydrochloride is an allylamine with a pronounced fungicidal activity.
Maltese: Terbinafine hydrochloride huwa allylamine b'attività fungiċida notevoli.
English: Mean peak plasma concentrations (Cmax) were low with 1.73 ng/ml florfenicol, 0.35 ng/ml mometasone furoate and 7.83 ng/ml terbinafine HCl reached at the tmax of 24 h, 0.5 h and 20 h after treatment, respectively.
Maltese: Il-konċentrazzjonijiet massimi fil-plażma medji (Cmax) kienu baxxi b'1.73 ng/mL florfenicol, 0.35 ng/mL mometasone furoate u 7.83 ng/mL terbinafine Hcl jintlaħqu fit-tmax ta' 24 siegħa, 0.5 sigħat u 20 siegħa wara t-trattament, rispettivament.
English: KVP Pharma + Veterinär Produkte GmbH Projensdorfer Str. 324
Maltese: KVP Pharma + Veterinär Produkte GmbH
English: Other potentially treatment-related effects included mild changes to aspartate aminotransferase (AST), total protein, cholesterol, inorganic phosphorus, creatinine and calcium.
Maltese: Effetti oħra potenzjalment relatati mat-trattament jinkludu bidliet ta' natura ħafifa fl-aspartate aminotransferase (AST), fil-proteina totali, fil-kolesterol, fil-fosforu inorganiku, fil-krejatinina u fil kalċju.
English: Neptra ear drops for dogs terbinafine hydrochloride, florfenicol, mometasone furoate (EN or Latin)
Maltese: Neptra qtar tal-widnejn għall-klieb terbinafine hydrochloride, florfenicol, mometasone furoate (EN jew Latin)
English: Pharmacotherapeutic group: Otologicals/Corticosteroids and anti-infectives in combination.
Maltese: Otoloġiċi/Kortikosterojdi u anti-infettivi flimkien.
English: The veterinary medicinal product is a fixed combination of three active substances (corticosteroid, antifungal and antibiotic).
Maltese: Il-prodott mediċinali veterinarju huwa kombinazzjoni fissa ta' tliet sustanzi attivi (kortikosterojde, aġent antifungali, u antibijotiku).
English: 1 dose (1 ml) contains:
Maltese: U KWANTITATTIVA Doża waħda (1 mL) fiha:
English: Prolonged and intensive use of topical corticosteroid preparations is known to trigger systemic effects, including suppression of adrenal function (see section 4.10).
Maltese: L-użu fit-tul u intensiv ta' preparazzjoni ta' kortikosterojdi topiċi hi magħrufa li tikkawża effetti sistemiċi, li jinkludu t-trażżin tal-funzjoni adrenali (ara sezzjoni 4.10).
English: Its spectrum of activity includes Gram-positive and Gram-negative bacteria including Staphylococcus pseudintermedius (MIC90 of 2 μg/ml).
Maltese: L-ispettru tal-attività tiegħu jinkludi batterji Gram-pożittivi u Gram-negattivi, inkluż Staphylococcus pseudintermedius (MIC90 ta'
English: 1 dose (1 ml): 16.7 mg terbinafine hydrochloride, 16.7 mg florfenicol, 2.2 mg mometasone furoate
Maltese: Doża waħda (1 mL): 16.7 mg terbinafine hydrochloride, 16.7 mg florfenicol, 2.2 mg mometasone furoate
English: Carton containing 2, 10 or 20 blisters.
Maltese: Kartuna li fiha 2, 10 jew 20 folja.
English: (Reference is made to the pictogram of a dog in section 1).
Maltese: (Issir referenza għall-pittogramma ta' kelb f'sezzjoni 1).
English: Ataxia, internal ear disorder, nystagmus, emesis, application site erythema, hyperactivity, anorexia and application site inflammation were reported very rarely in spontaneous (pharmacovigilance) reports.
Maltese: Atassja, disturb fuq ġewwa tal-widna, nistagmus, emeżi, eritema fis-sit tal-applikazzjoni, attività eċċessiva, anoressija u infjammazzjoni fis-sit tal-applikazzjoni ġew irrapportati b'mod rari ħafna f'rapporti spontanji (ta' farmakoviġilanza).
English: Cfr modifies the RNA in the drug binding site (causing reduced affinity to chloramphenicol, florfenicol and clindamycin) and the cfr gene can be present in plasmids or other transmissible elements.
Maltese: Cfr jimmodifika l-RNA fis-sit ta' rbit tal-mediċina (li jikkawża tnaqqis fl-affinità għal chloramphenicol, florfenicol u clindamycin) u l-ġene cfr jista' jkun preżenti fi plażmidi u elementi trasmissibbli oħra.
English: Decreased cortisol levels were observed after product instillation in tolerance studies (before and after ACTH stimulation), indicating that mometasone furoate is absorbed and enters the systemic circulation.
Maltese: Kienu osservati livelli mnaqqsa ta' cortisol wara l-istillazzjoni tal-prodott fi studji tat-tolleranza (qabel u wara l-istimulazzjoni ACTH), li jindikaw li mometasone furoate huwa assorbit u jidħol fiċċirkolazzjoni sistemika.
English: It selectively inhibits the early synthesis of ergosterol, which is an essential component of the membrane of yeasts and fungi including Malassezia pachydermatis (MIC90 of 1 μg/ml).
Maltese: Huwa jinibixxi b'mod selettiv is-sinteżi bikrija ta' ergosterol, li huwa komponent essenzjali tal-membrana tal-ħmira u l-fungi, inkluż Malassezia pachydermatis (MIC90 ta' 1 μg/mL).
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Maltese: - komuni ħafna (aktar minn annimal 1 minn kull 10 kkurati juru reazzjoni(jiet) avversa(i)) - komuni (aktar minn annimal 1 iżda inqas minn 10 annimali minn kull 100 annimal ikkurat) - mhux komuni (aktar minn annimal 1 iżda inqas minn 10 annimali minn kull 1,000 annimal ikkurat) - rari (aktar minn annimal 1 iżda inqas minn 10 annimali minn kull 10,000 annimal ikkurat) - rari ħafna (inqas minn annimal 1 minn kull 10,000 annimal ikkurat, inkluż rapporti iżolati).
English: Terbinafine hydrochloride: 16.7 mg, equivalent to terbinafine base: 14.9 mg Mometasone furoate: 2.2 mg
Maltese: Terbinafine hydrochloride: 16.7 mg, ekwivalenti għal bażi ta' terbinafine: 14.9 mg
English: Terbinafine hydrochloride has a different mode of action to azole antifungals, therefore there is no cross-resistance with azole antifungals.
Maltese: Terbinafine hydrochloride għandu mod ta' azzjoni differenti mill-antifungali azole, għalhekk m'hemmx reżistenza inkroċjata ma' antifungali azole.
English: Prolonged and intensive use of topical corticosteroid preparations is known to trigger systemic effects, including suppression of adrenal function.
Maltese: L-użu fit-tul u intensiv ta' preparazzjoni ta' kortikosterojdi topiċi hi magħrufa li tikkawża effetti sistemiċi, li jinkludu t-trażżin tal-funzjoni adrenali.
English: Florfenicol resistance genes detected in staphylococci include cfr and fexA.
Maltese: Il-ġeni ta' reżistenza għal florfenicol identifikati fi staphylococci jinkludu cfr u fexA.
English: Ear drops solution
Maltese: B'MOD KORRETT
English: Excipients:
Maltese: Mometasone furoate:
English: Administration by a veterinarian surgeon or under their close supervision.
Maltese: Amministrazzjoni minn kirurgu veterinarju jew taħt superviżjoni mill-qrib tiegħu.
English: Neptra ear drops solution for dogs terbinafine hydrochloride/florfenicol/mometasone furoate
Maltese: Neptra soluzzjoni tal-qtar tal-widnejn għall-klieb terbinafine hydrochloride/florfenicol/mometasone furoate
English: The veterinary medicinal product has serious eye irritation potential.
Maltese: Il-prodott mediċinali veterinarju għandu l-potenzjal ta' irritazzjoni serja għall-għajnejn.
English: In case of accidental ocular exposure, flush the eyes thoroughly with water for 10 to 15 minutes.
Maltese: F'każ ta' esponiment okulari aċċidentali, laħlaħ l-għajnejn sew bl-ilma għal 10 sa 15-il minuta.
English: The most prominent effects were consistent with glucocorticoid administration; specific observations included suppression of the adrenal cortical response to ACTH-stimulation, decreased adrenal weight and atrophy of the adrenal cortex, decreased absolute lymphocyte and eosinophil counts, increased absolute neutrophil count, increased liver weight with hepatocellular enlargement/cytoplasmic change, and decreased thymus weight.
Maltese: L-effetti l-aktar prominenti kienu konsistenti mal-għoti tal-glukokortikojdi; osservazzjonijiet speċifiċi kienu jinkludu trażżin tar-rispons kortikali adrenali għall-istimulazzjoni ACTH, tnaqqis fil-piż adrenali u atrofija tal-kortiċi adrenali, tnaqqis fl-għadd assolut tal-limfoċiti u l-esinofili, żieda fl-għadd assolut tan-newtrofili, żieda fil-piż tal-fwied bi tkabbir epatoċellulari/bdil fiċ-ċitoplażma, u tnaqqis fil-piż tattimus.
English: Auricular use
Maltese: Il-Ġermanja
English: For the treatment of acute canine otitis externa or acute exacerbations of recurrent otitis caused by mixed infections of susceptible strains of bacteria sensitive to florfenicol (Staphylococcus pseudintermedius) and fungi sensitive to terbinafine (Malassezia pachydermatis).
Maltese: (Staphylococcus pseudintermedius) u fungi sensittivi għal terbinafine (Malassezia pachydermatis).
English: Single treatment.
Maltese: Trattament wieħed.
English: Neptra ear drops solution for dogs florfenicol/terbinafine hydrochloride/mometasone furoate
Maltese: Neptra soluzzjoni tal-qtar tal-widnejn għall-klieb florfenicol/terbinafine hydrochloride/mometasone furoate
English: Inflammation can increase the transcutaneous absorption of veterinary medicinal products across the skin adjacent to the external opening of the ear canal.
Maltese: L-infjammazzjoni tista' żżid l-assorbiment transkutanju ta' prodotti mediċinali veterinarji fil-ġilda biswit il-fetħa esterna tal-kanal tas-smigħ fil widna.
English: One dose (1 ml) contains 16.7 mg florfenicol, 16.7 mg terbinafine hydrochloride (equivalent to 14.9 mg terbinafine base) and 2.2 mg mometasone furoate.
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA U INGREDJENTI OĦRA Doża waħda (1 mL) fiha 16.7 mg florfenicol, 16.7 mg terbinafine hydrochloride (ekwivalenti għal 14.9 mg bażi ta' terbinafine) u 2.2 mg mometasone furoate.
English: Manufacturer responsible for batch release: KVP Pharma + Veterinär Produkte GmbH Projensdorfer Str. 324, 24106 Kiel
Maltese: Isem u indirizz tal-manifattur responsabbli mill-ħruġ tal-lott KVP Pharma + Veterinär Produkte GmbH
English: Vocalisation, head shaking and application site pain shortly after product application have been reported very rarely in spontaneous (pharmacovigilance) reports.
Maltese: Vokalizzazzjoni, tregħid tar-ras u uġigħ fis-sit tal-applikazzjoni ftit wara l-applikazzjoni tal-prodott ġew irrapportati b'mod rari ħafna f'rapporti spontanji (ta' farmakoviġilanza).
English: None known.
Maltese: JIS.
English: Single-use sealed laminated tube containing 1 ml solution, with polypropylene cap and separate LDPE applicator nozzle packed in a transparent plastic blister.
Maltese: In-natura u l-għamla tal-ippakkjar li jmiss mal-prodott Tubu laminat u ssiġillat li jkun fih soluzzjoni ta' 1 mL għal użu ta' darba biss b'għatu talpolypropylene u żennuna tal-applikatur tal-LDPE separata ppakkjat f'folja tal-plastik trasparenti.
English: In vitro activity of florfenicol against Pseudomonas spp.
Maltese: L-attività in vitro ta' florfenicol kontra Pseudomonas spp. hija baxxa (MIC90 > 128 µg/mL).
English: Decreased in vitro susceptibility to terbinafine has been reported for strains of Malassezia pachydermatis which form biofilms.
Maltese: Ġiet irrappurtata suxxettibilità in vitro mnaqqsa għal terbinafine għal razez ta' Malassezia pachydermatis li tifforma biofilms.
English: This combination is intended for the treatment of acute otitis when mixed infections caused by Staphylococcus pseudintermedius susceptible to florfenicol and Malassezia pachydermatis susceptible to terbinafine have been demonstrated.
Maltese: Din il-kombinazzjoni hija intenzjonata għat-trattament tal-otite akuta meta jkunu ġew murija infezzjonijiet imħallta kkawżati minn Staphylococcus pseudintermedius suxxettibbli għal florfenicol u Malassezia pachydermatis suxxettibbli għal terbinafine.
English: The maximum clinical response may not be seen until 28 days after administration.
Maltese: Ir-rispons kliniku massimu jista' ma jidhirx sa 28 jum wara l-għoti.
English: The extent of transcutaneous absorption of topical medications is determined by many factors including the integrity of the epidermal barrier.
Maltese: Il-grad ta' assorbiment transkutanju (li jidħol ġol-ġilda) ta' mediċini topiċi hu stabbilit minn ħafna fatturi li jinkludu l-integrità tal-barriera epidermali.
English: Use of the veterinary medicinal product deviating from the instructions given in the Summary of Product Characteristics (SPC) may increase the prevalence of bacteria resistant to florfenicol and fungi resistant to terbinafine and may decrease the effectiveness of treatment with other antibiotics and antifungal agents.
Maltese: L-użu tal-prodott mediċinali veterinarju li ma jikkonformax mal-istruzzjonijiet mogħtija filKaratteristiċi tal-Prodott fil-Qosor (SPC) jista' jżid il-prevalenza tal-batterji reżistenti għal florfenicol u reżistenti għall-fungi għal terbinafine u jista' jnaqqas l-effettività tat-trattament ma' antibijotiċi u aġenti antifungali oħra.
English: Ear drops, solution.
Maltese: PROJBIZZJONI TA' BEJGĦ, PROVVISTA
English: In animals with a history of recurrent otitis externa, the underlying causes of the condition such as allergy or anatomical conformation of the ear must be addressed in order to avoid ineffective treatment with a veterinary medicinal product.
Maltese: F'annimali li jkollhom storja medika ta' otite esterna rikorrenti, il-kawżi sottostanti tal-kondizzjoni bħal allerġija jew konformazzjoni anatomika tal-widna jridu jiġu indirizzati biex jiġi evitat trattament mhux effettiv bi prodott mediċinali veterinarju.
English: The recommended dosage is 1 single-dose container (i.e. 1 ml of solution) per infected ear.
Maltese: Id-dożaġġ rakkomandat huwa kontenitur wieħed b'doża waħda (i.e. 1 mL ta' soluzzjoni) għal kull widna nfettata.
English: Florfenicol is a bacteriostatic antibiotic which acts by inhibiting protein synthesis, through binding to and acting on the 50S ribosomal subunit of bacteria.
Maltese: Florfenicol huwa antibijotiku batterjostatiku li jaġixxi billi jinibixxi s-sinteżi tal-proteini, billi jeħel ma' u jaġixxi fuq is-sottounità tal-50S ribosomal tal-batterji.
English: If symptoms develop, seek medical advice and show the package leaflet or the label to the physician.
Maltese: Tużax dan il-prodott mediċinali veterinarju wara d-data ta' skadenza murija fuq il-kartuna ta' barra u t-tikketta tal-kartuna wara
English: Fertility:
Maltese: KWANTITÀ
English: The full EPAR for Rituzena can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.