FrancophonIA/ELRC3.0 huggingface dataset:
English: Solution for injection: ‘Kytril solution for injection is indicated in adults for the prevention and treatment of
Maltese: Soluzzjoni għal injezzjoni: ‘Kytril soluzzjoni għal injezzjoni huwa indikat fl-adulti għall-prevenzjoni u l-kura ta'
English: Kytril film-coated tablets are indicated in adults for prevention of delayed nausea and vomiting associated with chemotherapy and radiotherapy.'
Maltese: Kytril pilloli miksija b'rita huma indikati fl-adulti għall-prevenzjoni ta' dardir u rimettar ittardjati assoċjati ma' kimoterapija u radjuterapija .'
English: Taking into consideration the comments by the CHMP, the wording of section 5.3 has been amended by the MAH, taking into account the safety margins based on mg/kg basis and the appropriate study durations.
Maltese: Wara li ġew ikkunsidrati l-kummenti mis-CHMP, il-formolazzjoni ta' kliem ta' sezzjoni 5.3 ġiet emendata mill-MAH, filwaqt li tqiesu l-marġini ta' sigurtà fuq il-bażi ta' mg/kg u d-dewmien addattat tal-istudju.
English: There is insufficient clinical evidence to recommend administration of Kytril solution for injection to children in the prevention and treatment of RINV and PONV.
Maltese: Ma hemmx biżżejjed evidenza klinika biex tirrakkomanda l-għoti ta' Kytril soluzzjoni għal injezzjoni lit-tfal filprevenzjoni u l-kura ta' RINV u PONV.
English: It was also endorsed by the CHMP that insomnia should be included in the SmPC as an adverse event, since it occurs with a frequency greater than 2 % compared with placebo, in the clinical study 285.
Maltese: Is-CHMP approva wkoll li l-insomnja għandha tiġi nkluża fl-SmPC bħala avveniment avvers, minħabba li sseħħ bi frekwenza ta' aktar minn 2 % meta mqabbla ma' plaċebo, fl-istudju kliniku 285.
English: However they may potentially become significant in increased risk subpopulations such as patients with cardiac co-morbidities, patients receiving cardiotoxic chemotherapy or patients having concomitant electrolyte abnormalities as described in section 4.4.
Maltese: Madankollu jistgħu jsiru potenzjalment sinifikanti f'sub-popolazzjonijiet b'riskju akbar bħal pazjenti b'ko-morbożitajiet kardijaċi, pazjenti li qegħdin jirċievu kimoterapija kardjotossika jew pazjenti li għandhom anormalitajiet konkomitanti tal-elettroliti kif deskritt f'sezzjoni 4.4.
English: Although there are some differences in wording, there are no significant discrepancies in this section.
Maltese: Minkejja li hemm xi differenzi fil-kliem, ma hemm l-ebda diskrepanza sinifikanti f'din is-sezzjoni.
English: Section 4.6 - Pregnancy and lactation
Maltese: Sezzjoni 4.6 - Tqala u treddigħ
English: Kytril solution for injection is indicated for the prevention of delayed nausea and vomiting associated with chemotherapy and radiotherapy.'
Maltese: Kytril soluzzjoni għal injezzjoni huwa indikat għall-prevenzjoni ta' dardir u rimettar ittardjati assoċjati ma' kimoterapija u radjuterapija .'
English: Taking into account the recommendation of the CHMP and the MAH's proposals, the following wording was agreed for the indication in adults, for the following pharmaceutical forms - tablets and solution for injection:
Maltese: Wara li tqieset ir-rakkomandazzjoni tas-CHMP u l-proposti tal-MAH, sar qbil fuq il-formolazzjoni talkliem li ġejja għall-indikazzjoni fl-adulti, għall-forom farmaċewtiċi li ġejjin - pilloli u soluzzjoni għal injezzjoni:
English: In response to the LoOI the MAH discussed their own safety data as well as data in published trials and well known databases, and it was agreed that extrapyramidal reactions would be included as an adverse event in section 4.8 of the SmPC.
Maltese: Bħala tweġiba għal-LoOI, il-MAH iddiskuta s-sigurtà tad-dejta tagħhom stess kif ukoll dejta minn provi ppubblikati u databases magħrufa, u ġie miftiehem li reazzjonijiet ekstrapiramidi jiġu nklużi bħala avveniment avvers f'sezzjoni 4.8 tal-SmPC.
English: Based on the theoretical possibility of cross-sensitivity reactions with granisetron, the MAH has proposed to include cautionary wording in this section of the SmPC.
Maltese: Fuq il-bażi tal-possibbiltà teoretika ta' reazzjonijiet kross-sensittivi bi granisetron, il-MAH ippropona li jżid termini ta' twissija f'din is-sezzjoni tal-SmPC.
English: There is insufficient clinical experience to recommend administration of Kytril tablets to children for CINV, RINV or PONV.
Maltese: Ma hemmx biżżejjed esperjenza klinika biex tirrakkomanda l-għoti tal-pilloli Kytril lit-tfal fil-każ ta' CINV, RINV jew PONV.
English: Overall summary of the scientific evaluation of Kytril and associated names (see Annex I)
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika ta' Kytril u l-ismijiet assoċjati (ara Anness I)
English: Section 4.5- Interaction with other medicinal products and other forms of interaction There is a need to apply caution when giving medication, which is known to prolong the QT interval, concurrently with 5-HT3 antagonists such as Kytril.
Maltese: Sezzjoni 4.5- Prodotti mediċinali oħra li ma jaqblux ma' dan il-prodott u affarijiet oħra li jistgħu jibdlu l-effett farmaċewtiku tal-prodott Jeħtieġ li wieħed juża l-kawtela meta jagħti mediċina, li hija magħrufa li sejra ttawwal l-intervall tal-QT, flimkien ma' antagonisti 5-HT3 bħal Kytril.
English: Section 4.7 - Effects on ability to drive and use machines The proposed SmPC text reflects the recommendations regarding section 4.7 in the European SmPC guideline.
Maltese: Sezzjoni 4.7 - Effetti fuq il-ħila biex issuq u tħaddem magni
English: --1 Rabies virus, strain SPBN GASGAS, live - 106.8 to 108.1 FFU* per 1.7 ml dose * Focus forming units
Maltese: Virus tar-rabja, razza SPBN GASGAS, ħaj - 106.8 sa 108.1
English: Packaging Content
Maltese: Ippakkjar Kontenut
English: • The Committee considered the (Co-)Rapporteur's assessment report;
Maltese: • Il-Kumitat qies ir-rapport ta' valutazzjoni tal-(ko)relatur;
English: Moreover, following an Article 30 procedure of Directive 2001/83/EC for Losec and associated names (EMEA/H/A-30/1001), the harmonised indications for omeprazole products include the prevention of NSAID-associated gastric and duodenal ulcers in patients at risk with omeprazole dosed at 20 mg
Maltese: Avviż għall-Applikanti Volum 2A Kapitolu 1 https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-2/a/vol2a_chap1_201507.pdf proċedura skont l-Artikolu 30 tad-Direttiva 2001/83/KE għal Losec u ismijiet assoċjati (EMEA/H/A30/1001), l-indikazzjonijiet armonizzati għall-prodotti li fihom omeprazole jinkludu l-prevenzjoni ta' ulċeri gastriċi u duwodenali assoċjati ma' NSAIDs f'pazjenti f'riskju b'doża ta' 20 mg ta' omeprazole kuljum.
English: The applicant has submitted a review of the literature relating to the use of diclofenac and omeprazole in combination.
Maltese: L-applikant ippreżenta reviżjoni tal-letteratura relatata mal-użu ta' diclofenac u ta' omeprazole f'kombinazzjoni.
English: However, according to Notice to Applicants Volume 2A Chapter 1 Section 5.51 , a mixed-dossier can be accepted.
Maltese: Madankollu, skont l-Avviż għall-Applikanti, il-Volum 2A l-Kapitolu 1 it-Taqsima 5.51, jista' jiġi aċċettat dossier imħallat.
English: This specific dose is also supported by bibliographical evidence submitted by the applicant.
Maltese: Din id-doża speċifika hija sostnuta wkoll minn evidenza bibljografika ppreżentata mill-applikant.
English: Diotop 75 mg / 20 mg is a fixed dose combination product consisting of diclofenac sodium and omeprazole.
Maltese: Diotop 75 mg/20 mg huwa prodott ta' kombinazzjoni ta' dożi fissi magħmul minn diclofenac sodium u omeprazole.
English: Diotop 75 mg / 20 mg is intended for symptomatic treatment of rheumatoid arthritis, osteoarthritis and ankylosing spondylitis in adult patients at risk of developing NSAID associated gastric and/or duodenal ulcers, who are adequately controlled with diclofenac and omeprazole.
Maltese: Diotop 75 mg/20 mg huwa maħsub għall-kura sintomatika ta' artrite rewmatika, osteoartrite u spondilite ankilosanti f'pazjenti adulti f'riskju li jiżviluppaw ulċeri gastriċi u/jew duwodenali assoċjati mal-NSAIDs, li huma kkontrollati b'mod adegwat b'diclofenac u b'omeprazole.
English: The proposed indication is: symptomatic treatment of rheumatoid arthritis, osteoarthritis and ankylosing spondylitis in adult patients at risk of developing NSAID associated gastric and/or duodenal ulcers who are adequately controlled with diclofenac and omeprazole.
Maltese: L-indikazzjoni proposta hija: kura sintomatika ta' artrite rewmatika, osteoartrite u spondilite ankilosanti f'pazjenti adulti f'riskju li jiżviluppaw ulċeri gastriċi u/jew duwodenali assoċjati mal-NSAIDs li huma kkontrollati b'mod adegwat b'diclofenac u b'omeprazole.
English: Each modified release capsule contains 75 mg diclofenac sodium (25 mg as gastroresistant pellets and 50 mg as prolonged release pellets) and 20 mg of omeprazole (gastro-resistant pellets).
Maltese: Kull kapsula li terħi l-mediċina b'mod modifikat fiha 75 mg ta' diclofenac sodium (25 mg bħala granuli gastroreżistenti u 50 mg bħala granuli li jerħu l-mediċina fit-tul) u 20 mg ta' omeprazole (granuli gastroreżistenti).
English: DE is in agreement with the CHMP conclusion.
Maltese: Il-Ġermanja taqbel mal-konklużjoni tas-CHMP.
English: • The Committee considered the referral under Article 29(4) of Directive 2001/83/EC where Germany raised objections as a potential serious risk to public health;
Maltese: • Il-Kumitat ikkunsidra r-riferiment skont l-Artikolu 29(4) tad-Direttiva 2001/83/KE fejn il-Ġermanja qajmet oġġezzjonijiet minħabba riskju potenzjalment serju għas-saħħa pubblika;
English: A decentralised procedure (DCP) with the UK as reference Member State (RMS) and AT, EE, LT, LV and MT as CMSs, concluded positively on 7 November 2016 (UK/H/6135/001/DC).
Maltese: GmbH ippreżenta applikazzjoni għal Awtorizzazzjoni għat-Tqegħid fisSuq (MA) fil-Ġermanja (DE) għal Diotop 75 mg / 20 mg kapsuli iebsin li jerħu l-mediċina b'mod modifikat, skont l-Artikolu 10b tad-Direttiva 2001/83/KE. Fis-7 ta' Novembru 2016, proċedura diċentralizzata (DCP) bir-Renju Unit bħala l-Istat Membru ta' Referenza (RMS) u l-Awstrija, l-Estonja, il-Litwanja, il-Latvja u Malta bħala l-Istati Membri Kkonċernati (CMSs), ġiet konkluża b'deċiżjoni pożittiva (UK/H/6135/001/DC).
English: Bioequivalence has been demonstrated between Diotop 75 mg / 20 mg and the free combination of the recognised reference formulations of the individual mono-components.
Maltese: Il-bijoekwivalenza bejn Diotop 75 mg/20 mg u l-kombinazzjoni ħielsa tal-formulazzjonijiet ta' referenza rikonoxxuti tal-monokomponenti individwali ntweriet.
English: CHMP also noted that there is a risk of GI complications with diclofenac 75 mg QD based on epidemiological data.
Maltese: Is-CHMP innota wkoll li abbażi ta' data epidemjoloġika hemm riskju ta' kumplikazzjonijiet gastrointestinali b'diclofenac 75 mg kuljum.
English: According to Article 10b of Directive 2001/83/EC, new clinical or non-clinical trials relating to the combination (although not the individual active substances) should be submitted.
Maltese: Skont l-Artikolu 10b tad-Direttiva 2001/83/KE, għandhom jiġi pprovduti r-riżultati ta' provi kliniċi jew mhux kliniċi ġodda li jirrigwardaw il-kombinazzjoni (għalkemm mhux għal kull sustanza attiva individwali).
English: The 75 mg daily dose of diclofenac is approved for other diclofenac products in the EU for the symptomatic treatment of rheumatic disease.
Maltese: Id-doża ta' 75 mg ta' diclofenac kuljum hija approvata għal prodotti oħra li fihom diclofenac fl-UE għallkura sintomatika ta' mard rewmatiku.
English: • The Committee considered the totality of the data submitted by the applicant in support of Diotop 75 mg / 20 mg modified-release capsules, hard;
Maltese: • Il-Kumitat qies it-totalità tad-data ppreżentat mill-applikant b'appoġġ għal Diotop 75 mg/20 mg kapsuli iebsin li jerħu l-mediċina b'mod modifikat;
English: Therefore, the CHMP considered that in the context of the harmonised gastro protection indication for omeprazole products in the European Union, the totality of the data presented by the applicant and the well-known safety and efficacy profile of omeprazole and diclofenac, the therapeutic efficacy and the safety of Diotop 75 mg/20 mg is adequately justified.
Maltese: Għalhekk, is-CHMP qies li fil-kuntest tal-indikazzjoni armonizzata ta' gastroprotezzjoni għall-prodotti li fihom omeprazole fl-Unjoni Ewropea, it-totalità tad-data ppreżentata mill-applikant u l-profil magħruf sew tas-sigurtà u tal-effikaċja ta' omeprazole u ta' diclofenac, l-effikaċja terapewtika u s-sigurtà ta' Diotop 75 mg/20 mg huma ġustifikati b'mod adegwat.
English: The CHMP acknowledged that there is no literature data regarding the specific free combination of diclofenac 75 mg QD and omeprazole 20 mg QD.
Maltese: Is-CHMP irrikonoxxa li ma hemm l-ebda data mil-letteratura dwar il-kombinazzjoni ħielsa speċifika ta' diclofenac 75 mg kuljum u omeprazole 20 mg kuljum.
English: In addition, there are literature data from several large RCTs supporting the safety and efficacy of omeprazole 20 mg daily for the treatment, maintenance and/or prevention of NSAID-associated gastroduodenal ulceration in patients with arthritis.
Maltese: Barra minn hekk, teżisti data mil-letteratura minn diversi provi kkontrollati randomizzati (RCTs) kbar li tappoġġja s-sigurtà u l-effikaċja ta' omeprazole 20 mg kuljum għall-kura, għall-manteniment u/jew għall-prevenzjoni ta' ulċeri gastroduwodenali assoċjati ma' NSAIDs f'pazjenti bl-artrite.
English: The DCP application was withdrawn from EE, LT, MT and LV during the national phase.
Maltese: L-Estonja, il-Litwanja, Malta u l-Latvja kienu rtiraw l-applikazzjoni għal DCP matul il-fażi nazzjonali.
English: EU/1/97/037/001 Vistide 75 mg/ml
Maltese: EU/1/97/037/001 Vistide
English: Packaging Content (concentration)
Maltese: Kontenut (koncentrazzjoni)
English: Strength Pharmaceutical Form Route of administration
Maltese: Prodott mediċinali li m'għadux awtorizzat
English: 5 ml
Maltese: Kunjett 1
English: Intravenous use Vial (glass)
Maltese: Użu ghal gol-vini Kunjett (Hgieg) 5 ml
English: ATC vet code: QP53BE03.
Maltese: Kodici ATĊ veterinarju: QP53BE03.
English: For the treatment of demodicosis (Demodex canis).
Maltese: Għat-trattament ta' demodikożi (Demodex canis).
English: EU/2/17/220/001 (5 mg, 3 tablets) EU/2/17/220/002 (10 mg, 3 tablets) EU/2/17/220/003 (20 mg, 3 tablets) EU/2/17/220/004 (40 mg, 3 tablets) EU/2/17/220/005 (80 mg, 3 tablets) EU/2/17/220/006 (120 mg, 3 tablets)
Maltese: EU/2/17/220/004 (40 mg, 3 pilloli) EU/2/17/220/005 (80 mg, 3 pilloli) EU/2/17/220/006 (120 mg, 3 pilloli)
English: For the treatment of sarcoptic mange (Sarcoptes scabiei).
Maltese: Għat-trattament tas-sarcoptic mange (Sarcoptes scabiei).
English: Plasma protein binding was determined in vitro and calculated at ≥99.9%.
Maltese: L-abbinar mal-proteini tal-plażma kien determinat in vitro u kkalkulat għal ≥ 99.9%.
English: Sarolaner was determined to have low clearance (0.12 ml/min/kg) and a moderate volume of distribution (2.81 l/kg).
Maltese: 12 ml/min/kg) u volum ta' distribuzzjoni moderat (2.81 l/kg).
English: Tablet strength (mg sarolaner)
Maltese: Saħħa tal-pillola (mg sarolaner)
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: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni: - komuni ħafna (aktar minn wieħed f'10 annimali kkurati li juru effetti mhux mixtieqa) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal ikkurat) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal ikkurat) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal ikkurat) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal ikkurat, inklużi rapporti iżolati).
English: The number embossed on one side refers to the strength (mg) of the tablets: “5”, “10”, ”20”, “40”, “80” or “120”.
Maltese: In-numri mnaqxa fuq naħa waħda jirreferu għas-saħħa (mg) tal-pilloli: “5”, “10”, ”20”, “40”, “80” jew “120”.
English: Hypromellose acetate succinate, medium grade Lactose monohydrate
Maltese: Hypromellose acetate succinate, grad medju Lattożju monoidrat
English: The veterinary medicinal product can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD).
Maltese: Il-prodott mediċinali veterinarju jista' jintuża bħala parti minn strateġija ta' trattament għall-kontroll ta' flea allergy dermatitis (FAD).
English: A distribution study determined that 14C-sarolaner-related residues were widely distributed to the tissues.
Maltese: Studju dwar id-distribuzzjoni iddetermina li residwi relatati ma' 14C-sarolaner tqassmu fit-tessuti b'firxa wiesgħa.
English: One carton contains one blister of 3 tablets.
Maltese: Kaxxa tal kartun waħda fiha strixxa waħda ta' 3 pilloli.
English: MiPet Easecto chewable tablets sarolaner (mg)
Maltese: MiPet Easecto pilloli li jintmagħdu sarolaner (mg)
English: Half-life was comparable for the intravenous and oral routes at 12 and 11
Maltese: Il-half-life għar-rotot intravenuż u orali kienu komparabbli b'12 u 11-il ġurnata, rispettivament.
English: Lot {number}
Maltese: NUMRU/I TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID
English: Sarolaner was dose proportional in Beagle dogs when dosed from the intended use dose of 2-4 mg/kg, to 20 mg/kg.
Maltese: Sarolaner kien proporzjonali mad-doża fi klieb Beagle, mid-doża ta' 2-4 mg/kg intenzzjonata għall-użu, sa' 20 mg/kg.
English: Aluminium foil/foil blister package.
Maltese: Pakkett strixxa folja/folja tal-aluminju.
English: For the treatment of tick infestations (Dermacentor reticulatus, Ixodes hexagonus, Ixodes ricinus and Rhipicephalus sanguineus).
Maltese: Għat-trattament ta' infestazzjonijiet tal-qurdien (Dermacentor reticulatus, Ixodes hexagonus, Ixodes ricinus u Rhipicephalus sanguineus).
English: No treatment-related clinical signs were observed.
Maltese: Ma kienu osservati l-ebda sinjali kliniċi relatati mat-trattament.
English: For the treatment of flea infestations (Ctenocephalides felis and Ctenocephalides canis).
Maltese: Għat-trattament ta' infestazzjonijiet tal-briegħed (Ctenocephalides felis u Ctenocephalides canis).
English: Glucose, liquid (81.5% solids) Spray dried pork liver powder Hydrolysed vegetable protein Gelatin type A
Maltese: Glucose, likwidu (81.5% solidi)
English: Sarolaner does not interact with known insecticidal binding sites of nicotinic or other GABAergic insecticides such as neonicotinoids, fiproles, milbemycins, avermectins, and cyclodienes.
Maltese: Sarolaner ma jinteraġġixix ma' siti t'abbinar insettiċida magħrufa ta' insettiċidi nikotiniċi jew GABAerġiċi oħrajn bħal neonicotinoids, fiproles, milbemycins, avermectins u cyclodienes.
English: The primary route of elimination is biliary excretion of parent molecule, with elimination through the faeces.
Maltese: Ir-rotta prinċipali ta' eliminazzjoni hija t-tneħħija tal-molekola ewlenija mill-marrara, b'eliminazzjoni mall-ippurgar.
English: In laboratory safety studies, no interactions were observed when sarolaner was co-administered with milbemycin oxime, moxidectin and pyrantel pamoate.
Maltese: Fi studji tas-sigurtà fil-laboratorju, ma ġewx osservati interazzjonijiet meta sarolaner ingħata fl-istess ħin ma' milbemycin oxime, moxidectin u pyrantel pamoate.
English: For the treatment of ear mite infestations (Otodectes cynotis).
Maltese: Għat-trattament tal-infestazzjonijiet tal-muzalz tal-widnejn (Otodectes cynotis).
English: Sarolaner is active against adult fleas (Ctenocephalides felis and Ctenocephalides canis) as well as several tick species such as Dermacentor reticulatus, Ixodes hexagonus, Ixodes ricinus, Rhipicephalus sanguineus and the mites Demodex canis, Otodectes cynotis and Sarcoptes scabiei.
Maltese: Dermacentor reticulatus, Ixodes hexagonus, Ixodes ricinus, Rhipicephalus sanguineus u l-muzalz Demodex canis, Otodectes cynotis u Sarcoptes scabiei.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali veterinarju tinstab fuq il-websajt ta' lAġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu/).
English: In a margin of safety study, the veterinary medicinal product was administered orally to 8 week old Beagle puppies at doses of 0, 1, 3, and 5 times the maximum exposure dose of 4 mg/kg at 28 day intervals for 10 doses.
Maltese: Fi studju dwar il-marġni ta' sigurtà, il-prodott mediċinali veterinarju ġie amministrat b'mod orali lil ġriewi tar-razza Beagle ta' età ta' 8 ġimgħat b'dożi ta' 0, 1, 3 u 5 darbiet aktar mid-doża massima ta' 4 mg/kg f'intervalli ta' 28 ġurnata għal 10 dożi.
English: MiPet Easecto 5 mg chewable tablets for dogs 1.3-2.5 kg MiPet Easecto 10 mg chewable tablets for dogs >2.5-5 kg MiPet Easecto 20 mg chewable tablets for dogs >5-10 kg MiPet Easecto 40 mg chewable tablets for dogs >10-20 kg MiPet Easecto 80 mg chewable tablets for dogs >20-40 kg MiPet Easecto 120 mg chewable tablets for dogs >40-60 kg
Maltese: MiPet Easecto 5 mg pilloli li jintmagħdu għal klieb 1.3-2.5 kg MiPet Easecto 10 mg pilloli li jintmagħdu għal klieb >2.5-5 kg MiPet Easecto 20 mg pilloli li jintmagħdu għal klieb >5-10 kg MiPet Easecto 40 mg pilloli li jintmagħdu għal klieb >10-20 kg MiPet Easecto 80 mg pilloli li jintmagħdu għal klieb >20-40 kg MiPet Easecto 120 mg pilloli li jintmagħdu għal klieb >40-60 kg
English: Sarolaner is well tolerated in Collies with a deficient multidrug-resistance-protein 1 (MDR1 -/-) following single oral administration at 5 times the recommended dose.
Maltese: Sarolaner huwa ttollerat sew fil-Collies b'defiċenza tal-multidrug-resistance-protein 1 (MDR1 -/-) wara doża waħda amministrata b'mod orali b'doża 5 darbiet aktar minn dik irrakkomandata.
English: MiPet Easecto 5 mg chewable tablets for dogs 1.3-2.5 kg MiPet Easecto 10 mg chewable tablets for dogs >2.5-5 kg MiPet Easecto 20 mg chewable tablets for dogs >5-10 kg MiPet Easecto 40 mg chewable tablets for dogs >10-20 kg MiPet Easecto 80 mg chewable tablets for dogs >20-40 kg MiPet Easecto 120 mg chewable tablets for dogs >40-60 kg sarolaner
Maltese: MiPet Easecto 5 mg pilloli li jintmagħdu għal klieb 1.3-2.5 kg MiPet Easecto 10 mg pilloli li jintmagħdu għal klieb >2.5-5 kg MiPet Easecto 20 mg pilloli li jintmagħdu għal klieb >5-10 kg MiPet Easecto 40 mg pilloli li jintmagħdu għal klieb >10-20 kg MiPet Easecto 80 mg pilloli li jintmagħdu għal klieb >20-40 kg MiPet Easecto 120 mg pilloli li jintmagħdu għal klieb >40-60 kg sarolaner
English: The depletion from tissues was consistent with the plasma half-life.
Maltese: It-tneħħija mit-tessuti kienet konsistenti mal-half-life tal-plażma.
English: During clinical field trials, no interactions between MiPet Easecto chewable tablets for dogs and routinely used veterinary medicinal products were observed.
Maltese: Waqt provi kliniċi, ma ġew osservati l-ebda interazzjonijiet bejn MiPet Easecto pilloli li jintmagħdu għal klieb u prodotti mediċinali veterinarji użati b'mod ta' rutina.
English: The veterinary medicinal product has immediate and persistent tick killing activity for at least 5 weeks.
Maltese: Il-prodott mediċinali veterinarju għandu attività immedjata u persistenti li toqtol il-qurdien għal tal-anqas 5 ġimgħat.
English: The veterinary medicinal product should be administered at a dose of 2-4 mg/kg bodyweight in accordance with the following table:
Maltese: Il-prodott mediċinali veterinarju għandu jiġi amministrat b'doża ta' 2-4 mg/kg piż skont it-tabella li ġejja:
English: Laboratory studies in rats and rabbits have not produced any evidence of any teratogenic effects.
Maltese: Studji fil-laboratorju fil-ġrieden u fil-fniek ma taw l-ebda evidenza ta' effetti teratoġeniċi.