FrancophonIA/ELRC3.0 huggingface dataset:
English: Total body oclacitinib clearance from plasma was low - 316 ml/h/kg bodyweight (5.3 ml/min/kg bodyweight), and the apparent volume of distribution at steady-state was 942 ml/kg bodyweight.
Maltese: It-total body clearance mill-plażma ta' oclacitinib kien baxx - 316 ml/h/kg piż (5.3 ml/min/kg piż), u lapparent volume of distribution f'steady state kien 942 ml/kg piż.
English: Pharmacotherapeutic group: Agents for dermatitis, excluding corticosteroids.
Maltese: Aġenti għad-dermatite, esklużi il-kortikosterojdi.
English: Papilloma was considered treatment related, but not dose related.
Maltese: Papilloma ġiet ikkonsidrata relatata mat-trattament imma mhux mad-doża.
English: The impact of oclacitinib administration on vaccination with modified live vaccines, canine parvovirus (CPV), canine distemper virus (CDV) and canine parainfluenza (CPI) and inactivated rabies vaccine (RV), on 16 week old vaccine naïve puppies has been studied.
Maltese: L-impatt tal-amministrazzjoni ta' oclacitinib ġie studjat fuq tilqim b'vaċċini ħajjin immodifikati, canine parvovirus (CPV), canine distemper virus (CDV) u canine parainfluenza (CPI) u vaċċin tarrabies inattivat (RV), fuq ġriewi ta' 16-il ġimgħa li kienu għadhom qatt ma ġew imlaqqma.
English: Oclacitinib exhibits low protein binding with 66.3% to 69.7% bound in fortified canine plasma at nominal concentrations ranging from 10 to 1,000 ng/ml.
Maltese: Oclacitinib juri abbinar baxx mal-proteini b'66.3% sa 69.7% abbinat ma' plażma msaħħa tal-klieb f'livelli nominali fil-plażma li jifirxu bejn 10 u 1,000 ng/ml.
English: Pack sizes of 20, 50 or 100 tablets.
Maltese: Id-daqsijiet tal-pakkett huma ta' 20, 50 jew 100 pillola.
English: Inhibition of canine cytochrome P450s is minimal with IC50s 50-fold greater than the observed mean Cmax (333 ng/ml or 0.997 µM) following 0.6 mg/kg bw oral administration in the target animal safety study.
Maltese: L-inibizzjoni ta' canine cytochrome P450s hija minima b'IC50s ħamsin darba ogħla mis-Cmax medju (333 ng/ml or 0.997 µM) osservat wara 0.6 mg/kg piż amministrati mill-ħalq fl-istudju dwar is-sigurtà fl-animali li fihom ser jintuża l-prodott.
English: One major oxidative metabolite was identified in plasma and urine.
Maltese: Metabolit ossidattiv maġġuri ġie identifikat filplażma u fl-urina.
English: EU/2/13/154/001 (1 x 20 tablets, 3.6 mg) EU/2/13/154/007 (1 x 50 tablets, 3.6 mg) EU/2/13/154/002 (1 x 100 tablets, 3.6 mg) EU/2/13/154/010 (20 tablets, 3.6 mg) EU/2/13/154/011 (50 tablets, 3.6 mg) EU/2/13/154/012 (100 tablets, 3.6 mg) EU/2/13/154/003 (1 x 20 tablets, 5.4 mg) EU/2/13/154/008 (1 x 50 tablets, 5.4 mg) EU/2/13/154/004 (1 x 100 tablets, 5.4 mg) EU/2/13/154/013 (20 tablets, 5.4 mg) EU/2/13/154/014 (50 tablets, 5.4 mg) EU/2/13/154/015 (100 tablets, 5.4 mg) EU/2/13/154/005 (1 x 20 tablets, 16 mg) EU/2/13/154/009 (1 x 50 tablets, 16 mg) EU/2/13/154/006 (1 x 100 tablets, 16 mg) EU/2/13/154/016 (20 tablets, 16 mg) EU/2/13/154/017 (50 tablets, 16 mg) EU/2/13/154/018 (100 tablets, 16 mg)
Maltese: EU/2/13/154/010 (20 pillola, 3.6 mg) EU/2/13/154/011 (50 pillola, 3.6 mg) EU/2/13/154/012 (100 pillola, 3.6 mg) EU/2/13/154/013 (20 pillola, 5.4 mg) EU/2/13/154/014 (50 pillola, 5.4 mg) EU/2/13/154/015 (100 pillola, 5.4 mg) EU/2/13/154/016 (20 pillola, 16 mg) EU/2/13/154/017 (50 pillola, 16 mg) EU/2/13/154/018 (100 pillola, 16 mg)
English: Overall the major clearance route is metabolism, with minor contributions from renal and biliary elimination.
Maltese: Ir-rotta maġġuri ta' clearance hija l-metaboliżmu, b'kontribuzzjonijiet minuri minn eliminazzjoni renali u biljari.
English: Each film-coated tablet contains 3.6 mg, 5.4 mg or 16 mg oclacitinib (as oclacitinib maleate).
Maltese: Kull pillola miksija b'rita fiha 3.6 mg, 5.4 mg jew 16 mg oclacitinib (bħala oclacitinib maleate).
English: Clinical observations that were considered likely to be related to oclacitinib treatment included: alopecia (local), papilloma, dermatitis, erythema, abrasions and scabbing/crusts, interdigital "cysts", and oedema of the feet.
Maltese: Osservazzjonijiet kliniċi li kienu kkonsidrati x'aktarx relatati mat-trattament b'oclacitinib, inkludew: alopexja (lokali), papilloma, dermatite, eritema, brix u qxur, “ċesti” bejn is-swaba, u edima tas-saqajn.
English: The letters "S", "M" and "L" refer to the different strengths of tablets: "S" is on the 3.6 mg tablets, "M" on the 5.4 mg tablets, and "L" on the 16 mg tablets.
Maltese: L-ittri "S", "M" u "L" jirreferu għallqawwiet differenti tal-pilloli: "S" huwa fuq il-pilloli 3.6 mg, "M" fuq il-pilloli 5.4 mg, u "L" fuq ilpilloli 16 mg.
English: An adequate immune response (serology) to CDV and CPV vaccination was achieved when puppies were administered oclacitinib at 1.8 mg/kg bodyweight (bw) twice daily for 84 days.
Maltese: Ġie miksub rispons immunitarju adegwat (seroloġija) għal tilqim b'CDV u CPV meta ġriewi ngħataw oclacitinib f'doża ta' 1.8 mg / kg piż (bw) darbtejn kuljum għal 84 jum.
English: Each film-coated tablet contains: Apoquel 3.6 mg:
Maltese: Kull pillola miksija b'rita fiha: Apoquel 3.6 mg:
English: Oclacitinib tablets were administered to healthy, one year old Beagle dogs twice daily for 6 weeks, followed by once per day for 20 weeks, at 0.6 mg/kg bw, 1.8 mg/kg bw and 3.0 mg/kg bw for a total of 26 weeks.
Maltese: Pilloli oclacitinib ġew amministrati lill-klieb f'saħħithom tar-razza Beagle ta' sena, darbtejn kuljum għal 6 ġimgħat, imbagħad darba kuljum għal 20 ġimgħa b'dożi ta' 0.6 mg/kg, 1.8 mg/kg u 3.0 mg/kg għal total ta' 26 ġimgħa.
English: Apoquel tablets are supplied in either blister packs or bottles with 20, 50 or 100 tablets per pack.
Maltese: Pilloli Apoquel huma pprovduti f'pakketti bi blisters jew fliexken b'20, 50 jew 100 pillola f'kull pakkett.
English: Therefore, the risk of metabolic drug-drug interactions due to oclacitinib inhibition is very low.
Maltese: Għalhekk, ir-riskju ta' interazzjonijiet metaboliċi bejn mediċina u oħra minħabba l-inibizzjoni minn oclacitinib hija baxxa ħafna.
English: Lack or loss of appetite (Anorexia)
Maltese: Tnaqqis jew telf ta' aptit (Anoressija)
English: Apoquel 16 mg tablets for dogs.
Maltese: Apoquel 16 mg pilloli għal klieb.
English: No drug interactions were observed in field studies where oclacitinib was administered concomitantly with veterinary medicinal products such as endo- and ectoparasiticides, antimicrobials and antiinflammatories.
Maltese: Ma ġiet osservata l-ebda interazzjoni mediċinali fi studji fuq il-post fejn oclacitinib ingħata flimkien ma' prodotti mediċinali veterinarji bħalma huma endo- u ektoparasitiċidi, antimikrobiċi u anti infjammatorji.
English: Apoquel 5.4 mg tablets for dogs.
Maltese: Apoquel 5.4 mg pilloli għal klieb.
English: Bodyweight (kg) of dog
Maltese: Piż (kg) tal-kelb
English: The tablets are breakable along the score line.
Maltese: Il-pilloli jistgħu jinqasmu mal linja mnaqqxa.
English: Strength and number of tablets to be administered: Apoquel 3.6 mg tablets Apoquel 5.4 mg tablets Apoquel 16 mg tablets
Maltese: Pilloli Apoquel 3.6 mg Pilloli Apoquel 5.4 mg Pilloli Apoquel 16 mg
English: Apoquel 3.6 mg tablets for dogs.
Maltese: Apoquel 3.6 mg pilloli għal klieb.
English: Oclacitinib is metabolised in the dog to multiple metabolites.
Maltese: Oclacitinib jiġi metaboliżat fil-klieb f'ħafna metaboliti.
English: EU/2/13/154/010 (20 tablets, 3.6 mg) EU/2/13/154/011 (50 tablets, 3.6 mg) EU/2/13/154/012 (100 tablets, 3.6 mg) EU/2/13/154/013 (20 tablets, 5.4 mg) EU/2/13/154/014 (50 tablets, 5.4 mg) EU/2/13/154/015 (100 tablets, 5.4 mg) EU/2/13/154/016 (20 tablets, 16 mg) EU/2/13/154/017 (50 tablets, 16 mg) EU/2/13/154/018 (100 tablets, 16 mg)
Maltese: EU/2/13/154/006 (1 x 100 pillola, 16 mg) EU/2/13/154/016 (20 pillola, 16 mg) EU/2/13/154/017 (50 pillola, 16 mg) EU/2/13/154/018 (100 pillola, 16 mg)
English: New cutaneous or subcutaneous lumps Lethargy
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA U SUSTANZI OĦRA
English: 3.6 mg oclacitinib (as oclacitinib maleate)
Maltese: 3.6 mg oclacitinib (bħala oclacitinib maleate)
English: Adverse reactions observed in pruritus study up to day 7
Maltese: Effetti mhux mixtieqa osservati sa jum 7 fi studju tal-prurite
English: 5.4 mg oclacitinib (as oclacitinib maleate)
Maltese: 5.4 mg oclacitinib (bħala oclacitinib maleate)
English: Film-coated tablets.
Maltese: sinifikat kliniku.
English: Treatment-related clinical pathology changes were restricted to an increase in mean serum cholesterol and a decrease in mean leukocyte count, however, all mean values remained within the laboratory reference range.
Maltese: Bidliet kliniċi patoloġiċi relatati mat-trattament kienu ristretti għal żieda fil-livell medju tal-kolesterol fis-serum u tnaqqis fl-għadd medju tal-lewkoċiti, imma l-livelli medji kollha baqgħu fil-medda ta' referenza tal-laboratorju.
English: When treating pruritus associated with allergic dermatitis with oclacitinib, investigate and treat any underlying causes (e.g. flea allergic dermatitis, contact dermatitis, food hypersensitivity).
Maltese: Meta tiġi kkurata b'oclacitinib ħakk assoċjata ma' dermatite allerġika, investiga u ttratta l-kaġun talkawża (eż. dermatite allerġika mil-briegħed, dermatite minn kuntatti, sensittività eċċessiva għal ikel).
English: It can inhibit the function of a variety of cytokines dependent on JAK enzyme activity.
Maltese: Jista' jinibixxi l-funzjoni ta' varjetà ta' cytokines li jiddependu fuq l-attività tal-enżimi JAK.
English: Diarrhoea
Maltese: Dijareja
English: The recommended initial dose of Apoquel tablets to be given to the dog is to achieve 0.4 to 0.6 mg oclacitinib/kg bodyweight, administered orally, twice daily for up to 14 days.
Maltese: Id-doża rakkomandata fil-bidu ta' Apoquel pilloli li għandha tingħata lill-kelb biex jikseb 0.4 sa 0.6 mg oclacitinib/kg piż, amministrati mill-ħalq, darbtejn kuljum sa 14-il jum.
English: Dosage and treatment schedule:
Maltese: Grupp farmako-terapewtiku:
English: Given the potential for effects on certain clinicopathological parameters (see section 4.6), periodic monitoring with complete blood counts and serum biochemistry is recommended when dogs are on long-term treatment.
Maltese: Billi hemm il-potenzjal ta' effetti fuq ċerti parametri klinikopatoloġiċi (ara sezzjoni 4.6), monitoraġġ perjodikament b'analiżi kompleta tad-demm u bijokimika tas-serum huwa rrakkomandat fi klieb li qegħdin fuq trattament fit-tul.
English: All tablets strengths are packaged in either aluminium/PVC/Aclar blisters (each strip containing 10 film-coated tablets) packed into an outer cardboard box, or white HDPE plastic bottle with child resistant closure.
Maltese: Il-qawwiet kollha tal-pilloli huma ppakkjati fi blisters tal-aluminjum/PVC/Aclar (kull strixxa fiha 10 pilloli miksija b'rita) ippakkjati f'kaxxa barranija tal-kartun jew fi flixkun abjad tal-plastik HDPE b'tapp li ma jinfetaħx mit-tfal.
English: For maintenance therapy (after the initial 14 days of treatment), the same dose (0.4 to 0.6 mg oclacitinib/kg bodyweight) should then be administered only once a day.
Maltese: Għal terapija ta'manteniment (wara l-ewwel 14-il jum tat-trattament), l-istess doża (0.4 sa 0.6 mg oclacitinib/kg piż) għandha mbagħad tingħata biss darba kuljum.
English: After day 16, the following adverse reactions have been observed: - pyoderma and non-specified dermal lumps have been observed very commonly; - otitis, vomiting, diarrhoea, histiocytoma, cystitis, yeast skin infections, pododermatitis, lipoma,
Maltese: - otite, remettar, dijareja, istjositoma, isitite, infezzjonijiet tal-ġilda bil-moffa, pododermatite, lipoma, polidipsja, limfadenopatija, dardir, żieda fl-aptit u aggressjoni kienu komuni.
English: For maintenance therapy, the same dose (0.4 to 0.6 mg oclacitinib/kg bodyweight) should then be administered only once a day.
Maltese: Għal terapija ta' manteniment, l-istess doża (0.4 sa 0.6 mg oclacitinib/kg piż) għandha mbagħad tingħata biss darba kuljum.
English: When treating pruritus associated with allergic dermatitis with oclacitinib, investigate and treat any underlying causes (e.g., flea allergic dermatitis, contact dermatitis, food hypersensitivity).
Maltese: Meta tiġi kkurata b'oclacitinib ħakk assoċjat ma' dermatite allerġika, investiga u ttratta l-kaġun tal-kawża (eż. dermatite allerġika mill-briegħed, dermatite minn kuntatti, sensittività eċċessiva għall-ikel).
English: Given the potential for effects on certain clinicopathological parameters (see section 6), periodic monitoring with complete blood counts and serum biochemistry is recommended when dogs are on long-term treatment.
Maltese: Billi hemm il-potenzjal ta' effetti fuq ċerti parametri klinikopatoloġiċi (are sezzjoni 6), monitoraġġ perjodikament b'analiżi kompleta tad-demm u bijokimika tas-serum huwa rrakkomandat fi klieb li qegħdin fuq trattament fit-tul.
English: Regarding susceptibility to infection and neoplastic conditions, see section 4.5.
Maltese: Ara sezzjoni 4.5 dwar suxxettibilità għall-infezzjoni u kundizzjonijiet neoplastiċi.
English: The recommended initial dose is 0.4 to 0.6 mg oclacitinib/kg bodyweight, administered orally, twice daily for up to 14 days.
Maltese: Id-doża irrakkomandata fil-bidu hija ta' 0.4 sa 0.6 mg oclacitinib/kg piż, amministrati mill-ħalq,
English: Do not use in dogs with evidence of immune suppression such as hyperadrenocorticisim or with evidence of progressive malignant neoplasia as the active substance has not been evaluated in these cases.
Maltese: Tużax fi klieb b'evindenza ta' immunità mnaqqsa, bħall-iperadrenokortiċiżmu, jew b'evidenza ta' neoplasja progressiva malinna billi s-sustanza attiva ma ġietx evalwata f'dawn il-każijiet.
English: Vomiting
Maltese: Klieb
English: The common adverse reactions seen up to day 16 of the field trials are listed in the following table: Adverse reactions observed in atopic dermatitis study up to day 16
Maltese: Wara jum 16, ġew osservati dawn l-effetti mhux mixtieqa:
English: Treatment of clinical manifestations of atopic dermatitis in dogs.
Maltese: Trattament ta' manifestazzjonijiet kliniċi ta' dermatite atopika fil-klieb.
English: 3.6 mg oclacitinib per tablet (as oclacitinib maleate).
Maltese: 3.6 mg oclacitinib (bħala oclacitinib maleate) f'kull pillola.
English: 16 mg oclacitinib per tablet (as oclacitinib maleate).
Maltese: 16 mg oclacitinib (bħala oclacitinib maleate)
English: Apoquel 3.6 mg film-coated tablets for dogs Apoquel 5.4 mg film-coated tablets for dogs Apoquel 16 mg film-coated tablets for dogs oclacitinib
Maltese: Apoquel 3.6 mg pilloli miksija b'rita għal klieb Apoquel 5.4 mg pilloli miksija b'rita għal klieb Apoquel 16 mg pilloli miksija b'rita għal klieb oclacitinib
English: Any remaining half tablet should be placed back in the opened blister and stored in the original cardboard carton, or in the HDPE bottle (for a maximum of 3 days).
Maltese: In-nofs ta' pillola li jista' jifdal għandu jitpoġġa lura fil-blister il-miftuħa u jinżamm fil-kaxxa tal-kartun oriġinali, jew fil-flixkun HDPE (għal massimu ta' 3 ijiem).
English: Following oral administration in dogs, oclacitinib maleate is rapidly and well absorbed, with a time to peak plasma concentration (tmax) of less than 1 hour.
Maltese: Wara amministrazzjoni mill-ħalq fil-klieb, oclacitinib maleate huwa assorbit malajr u tajjeb, b'anqas minn siegħa biex jilħaq l-ogħla livelli fil-plażma (tmax).
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: Limfadenopatija ta' nodi fil-periferiji ġiet innotata fil-gruppi kollha bil-frekwenza tiżdied ma' żieda fid-doża, u ta' spiss kienet assoċjata ma' furunkulożi ta' bejn is-swaba.
English: MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET RIGWARD
English: EU/2/13/154/001 (1 x 20 tablets, 3.6 mg) EU/2/13/154/007 (1 x 50 tablets, 3.6 mg) EU/2/13/154/002 (1 x 100 tablets, 3.6 mg) EU/2/13/154/003 (1 x 20 tablets, 5.4 mg) EU/2/13/154/008 (1 x 50 tablets, 5.4 mg) EU/2/13/154/004 (1 x 100 tablets, 5.4 mg) EU/2/13/154/005 (1 x 20 tablets, 16 mg) EU/2/13/154/009 (1 x 50 tablets, 16 mg) EU/2/13/154/006 (1 x 100 tablets, 16 mg)
Maltese: EU/2/13/154/004 (1 x 100 pillola, 5.4 mg) EU/2/13/154/005 (1 x 20 pillola, 16 mg)
English: 5.4 mg oclacitinib per tablet (as oclacitinib maleate).
Maltese: 5.4 mg oclacitinib (bħala oclacitinib maleate) f'kull pillola. 16 mg oclacitinib (bħala oclacitinib maleate) f'kull pillola.
English: Anorexia
Maltese: Dijarea Remettar Anoressija
English: White to off-white, oblong shaped film-coated tablets with a score-line on both sides and marked with the letters "AQ" and "S", "M" or "L" on both sides.
Maltese: Abjad għal abjad fl-isfar, pilloli miksija b'rita b'forma tawwalija b'linja fejn taqsam fuq żewġ naħat u mmarkati bl-ittri "AQ" u "S", "M" jew "L" fuq iż-żewġ naħat.
English: New cutaneous or subcutaneous lumps Weakness (Lethargy) Excessive thirst (Polydipsia)
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali veterinarju tinstab fuq il-websajt tal-Aġenzija
English: Shelf life of the veterinary medicinal product as packaged for sale in bottles: 18 months.
Maltese: Żmien kemm idum tajjeb l-prodott mediċinali veterinarju kif ippakkjat għal bejgħ fi fliexken: 18-il xhar.
English: 1348 Louvain-la-Neuve BELGIUM
Maltese: 4.7 Użu fit-tqala, fit-treddigħ u fi żmien il-bidien
English: • The CHMP considered the referral under Article 31 of Directive 2001/83/EC, as amended, for dialysis solutions produced at Castlebar by Baxter group of companies and associated companies.
Maltese: • Is-CHMP ikkunsidra r-referenza skont l-Artikolu 31 tad-Direttiva 2001/83/KE, kif emendata, għassoluzzjonijiet għad-dijalisi prodotti f'Castlebar mill-grupp ta' kumpaniji Baxter u kumpaniji assoċjati.
English: Annex II
Maltese: IV.
English: Overall summary of the scientific evaluation on the inclusion of additional sites into the existing licenses of dialysis solutions (Dianeal, Extraneal and Nutrineal) produced by Baxter group of companies and associated companies (see Annex I)
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika dwar l-inklużjoni ta' siti addizzjonali filliċenzji eżistenti tas-soluzzjonijiet għad-dijalisi (Dianeal, Extraneal u Nutrineal) prodotti mill-grupp ta' kumpaniji Baxter u kumpaniji assoċjati (ara Anness I)
English: Therefore, without prejudice to the ongoing article 31 procedure, the CHMP considers that sufficient information is available to issue a first opinion for this Article 31 procedure recommending the addition of Canada, Poland and Turkey manufacturing sites to the existing PD solutions' marketing authorisations, subject to conditions set out in the Annex IV.
Maltese: F'dan l-istadju tal-proċedura ta' eżami skont l-Artikolu 31, hija disponibbli biżżejjed dejta sabiex tiġi rakkomandata lvarjazzjoni fl-awtorizzazzjonijiet għat-tqegħid fis-suq li tikkonsisti fl-inklużjoni tal-Kanada, il-Polonja u t-Turkija bħala siti addizzjonali tal-manifattura, billi f'dawn is-siti ma kinux identifikati kwistjonijiet importanti dwar is-sigurtà.
English: An article 31 referral procedure of Directive 2001/83/EC, as amended was initiated by the European Commission (EC) following reports of out-of-specifications results for endotoxins in dialysis solutions produced at Castlebar by Baxter group of companies and associated companies.
Maltese: Il-Kummissjoni Ewropea (KE) bdiet proċedura ta' riferiment skont l-Artikolu 31 tad-Direttiva 2001/83/KE, kif emendata, wara rapporti ta' riżultati mhux fl-ispeċifikazzjonijiet għal endotossini fissoluzzjonijiet għad-dijalisi prodotti f'Castlebar mill-grupp ta' kumpaniji Baxter u kumpaniji assoċjati.
English: the CHMP recommends the variation to the terms of the marketing authorisations concerning the addition of three manufacturing sites (Canada, Turkey and Poland) and for which the relevant amendments to sections of the summaries of product characteristics and package leaflets are set out in Annex III for dialysis solutions produced by Baxter group of companies and associated companies (see Annex I).
Maltese: Is-CHMP jirrakkomanda l-varjazzjoni fit-termini tal-awtorizzazzjonijiet għat-tqegħid fis-suq fir-rigward taż-żieda ta' tliet siti tal-manifattura (Kanada, Turkija u Polonja) u li l-emendi rilevanti għalihom fissezzjonijiet tas-sommarji tal-karatteristiċi tal-prodott u l-fuljetti ta' tagħrif huma ppreżentati fl-Anness
English: • The CHMP considers that sufficient quality data is available to recommend the inclusion of manufacturing sites located in Canada, Poland and Turkey into the existing marketing authorisations for peritoneal dialysis solutions.
Maltese: • Il-CHMP iħoss li hemm biżżejjed dejta dwar il-kwalità biex jirrakkomanda l-inklużjoni tas-siti talmanifattura fil-Kanada, il-Polonja u t-Turkija fl-awtorizzazzjonijiet eżistenti għat-tqegħid fis-suq għas-soluzzjonijiet għad-dijalisi tal-peritonew.
English: Blister (PVC/PVDC) 63 (3 x 21) tablets
Maltese: 63 (3 x 21) pillola
English: Film-coated tablet
Maltese: Qawwa Għamla farmaċewtika
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration
Maltese: Numru ta' l-EU Numru tal-MA
English: EMA/520294/2010 EMEA/V/C/160
Maltese: EMEA/V/C/160
English: Other information about RHINISENG:
Maltese: Informazzjoni oħra dwar RHINISENG:
English: Zero days.
Maltese: Żero jiem.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for RHINISENG to Laboratorios Hipra S.A. on 16/09/2010.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea, għal RHINISENG lil Laboratorios Hipra S.A. fi 16/09/2010.
English: RHINISENG is a vaccine against a bacterial disease.
Maltese: RHINISENG huwa vaċċin kontra marda batterika.
English: • for the consumer: all components have been investigated and no risk for the consumer has been identified.
Maltese: • għall-konsumatur: il-komponenti kollha ġew investigati u ma ġie identifikat ebda riskju għallkonsumatur.
English: Rhiniseng is a vaccine containing a non-toxic recombinant derivative of the Pasteurella multocida toxin and inactivated Bordetella bronchiseptica cells (inactivated means that the bacteria are killed so that they cannot cause the disease anymore).
Maltese: Rhiniseng huwa vaċċin li fih id-derivat rikombinanti mhux tossiku tat-tossina Pasteurella multocida u ċelloli inattivati ta' Bordetella bronchiseptica (inattivati tfisser li l-batterji nqatlu sabiex ma jkunux jistgħu jikkawżaw aktar il-marda).
English: This summary was last updated on 16/09/2010.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi 16/09/2010.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of RHINISENG exceed the risks for the treatment of piglets via colostrum from sows and gilts actively immunised with the vaccine to prevent the clinical signs and lesions of progressive and nonprogressive atrophic rhinitis and recommended that RHINISENG be given a marketing authorisation.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' RHINISENG huma akbar mir-riskji għall-kura ta' qżieqeż permezz tal-kolostru minn majjali nisa u qżieqeż nisa mlaqqma b'mod attiv bil-vaċċin għall-prevenzjoni tas-sinjali kliniċi u leżjonijiet ta' rinite atrofika progressiva u mhux progressiva u rrakkomanda li RHINISENG jingħata awtorizzazzjoni għattqegħid fis-suq.
English: It is used to reduce the clinical signs and lesions of a disease called progressive and non-progressive atrophic rhinitis, as well as to reduce weight loss associated with Bordetella bronchiseptica and Pasteurella multocida infections during the fattening period.
Maltese: Huwa jintuża sabiex inaqqas is-sinjali kliniċi u lleżjonijiet ta' marda msemmija rinite atrofika progressiva u mhux progressiva, kif ukoll biex jitnaqqas it-telf fil-piż assoċjat ma' infezzjonijiet b'Bordetella bronchiseptica u Pasteurella multocida waqt ilperjodu ta' tismin.