FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common side effects with Ranexa (seen in between 1 and 10 patients in 100) are dizziness, headache, constipation, vomiting, nausea (feeling sick) and asthenia (weakness).
Maltese: L-effetti sekondarji l-aktar komuni b'Ranexa (dehru f'madwar pazjent 1 u 10 minn kull 100) huma sturdament, uġigħ ta' ras, stitikezza, rimettar, nawżea (dardir) u astenija (dgħjufija).
English: The recommended starting dose of Ranexa is 375 mg twice a day.
Maltese: Id-doża tal-bidu rakkomandata ta' Ranexa hija ta' 375 mg darbtejn kuljum.
English: This interferes with the activity of special channels on the cell surface called ‘sodium-dependent calcium channels' through which calcium ions normally enter the cells.
Maltese: Dan jinterferixxi mal-attività ta' kanali speċjali fil-wiċċ taċċellola li jissejħu ‘kanali tal-kalċju li jiddependu fuq is-sodju' li minnhom normalment il-joni talkalċju normalment jidħlu fiċ-ċelloli.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Latixa on 9 July 2008.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea għal Latixa fid-9 ta' Lulju 2008.
English: What is the risk associated with Ranexa?
Maltese: X'inhu r-riskju assoċjat ma' Ranexa?
English: Ranexa is used to treat the symptoms of stable angina pectoris (chest pain caused by reduced blood flow to the heart).
Maltese: Ranexa jintuża bħala trattament għas-sintomi ta' anġina pectoris stabbli (uġigħ fis-sider ikkawżat minn tnaqqis ta' fluss tad-demm lejn il-qalb).
English: Why has Ranexa been approved?
Maltese: Għaliex ġie approvat Ranexa?
English: Other information about Ranexa:
Maltese: Aktar tagħrif dwar Ranexa:
English: The active substance in Ranexa, ranolazine, is thought to work by reducing the flow of sodium ions into the heart muscle cells.
Maltese: Is-sustanza attiva f'Ranexa, ranolazine hija maħsuba sabiex taħdem fuq it-tnaqqis tal-fluss ta' joni tassodju fiċ-ċelloli tal-muskoli tal-qalb.
English: Doc.
Maltese: Ranolzine
English: The Committee decided that Ranexa's benefits are greater than its risks as an add-on treatment of the symptoms of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line anti-anginal medicines (such as beta-blockers and/or calcium antagonists).
Maltese: Il-Kumitat iddeċieda li l-benefiċċji ta' Ranexa huma akbar mir-riskji tiegħu bħala trattament addizzjonali tas-sintomi tal-pazjenti b'anġina pectoris stabbli li huma kkontrollati b'mod mhux xieraq jew li huma intolleranti għal mediċini kontra l-anġina tat-tip tal-ewwel linja (bħal imblukkaturi-beta u/jew antagonisti tal-kalċju).
English: For the full list of all side effects reported with Ranexa, see the Package Leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Ranexa, ara l-Fuljett ta' Tagħrif.
English: At the start of the study, the patients could exercise for about 7 minutes.
Maltese: Fil-bidu tal-istudju il-pazjenti setgħu jagħmlu eżerċizzju għal madwar 7 minuti.
English: The Committee for Medicinal Products for Human Use (CHMP) noted that the effectiveness of Ranexa in improving the symptoms of patients with stable angina pectoris is modest but that it could be of value in patients who have not responded fully to other medicines.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) innota li l-effikaċja ta' Ranexa fit-titjib tas-sintomi f'pazjenti b'anġina pectoris stabbli hija modesta iżda li tista' tkun ta' valur f'pazjenti li ma rrispondewx bi sħiħ għal mediċini oħrajn.
English: How has Ranexa been studied?
Maltese: Kif ġie studjat Ranexa?
English: Which measures are being taken to ensure the safe use of Ranexa?
Maltese: Liema miżuri qegħdin jittieħdu sabiex jiżguraw l-użu sikur ta' Ranexa?
English: Doses may need to be lower in patients who have certain side effects.
Maltese: Jista' jkun hemm bżonn li d-doża tkun anqas għal pazjenti li għandhom ċerti effetti sekondarji.
English: Member State EU/EEA
Maltese: Stat Membru EU/EEA
English: Whipworms: Trichuris vulpis (adults).
Maltese: Trichuris vulpis (adulti).
English: ATC vet code: QP52AA51
Maltese: QP52AA51
English: 2, 4, 6, 8 tablets.
Maltese: 2, 4, 6, 8 pilloli.
English: Febantel, a probenzimidazole
Maltese: Febantel, tip ta' probenzimidazole
English: Lactose monohydrate, Microcrystalline cellulose, Magnesium stearate, Colloidal anhydrous silica, Croscarmellose sodium, Sodium laurilsulfate Pork flavour
Maltese: Lactose monohydrate, Microcrystalline cellulose, Magnesium stearate, Colloidal anhydrous silica, Croscarmellose sodium, Sodium laurilsulfate Ħwawar b'togħma ta' majjal
English: Direct benefits
Maltese: Benefiċċji diretti
English: Pyrantel acts as a cholinergic agonist.
Maltese: Pyrantel jaġixxi bħala agonista kolinerġiku.
English: Hookworms: Uncinaria stenocephala, Ancylostoma caninum (adults).
Maltese: Hookworms: Uncinaria stenocephala, Ancylostoma caninum (adulti).
English: BN{number}
Maltese: BN{numru}
English: Formation of microtubules is thereby prevented, resulting in disruption of structures vital to the normal functioning of the helminth.
Maltese: B'hekk tiġi evitata l-formazzjoni ta' mikrotubuli, li twassal għat-tfixkil ta' strutturi vitali għal funzjonament normali tal-helminth.
English: Discussion of the data available
Maltese: Diskussjoni dwar id-dejta disponibbli
English: Individual strips composed of aluminium foil 30 µm/30 gsm extruded polythene, containing 2, 4, 6, 8, 10, 12, 14, 16, 18 or 20 tablets.
Maltese: Strixxi individwali magħmula minn fojl tal-aluminju ta' 30 µm/30 gsm ta' polythene estruż, li fihom 2, 4, 6, 8, 10, 12, 14, 16, 18 jew 20 pillola.
English: PHARMACEUTICAL FORM
Maltese: Forma farmaċewtika
English: Poland
Maltese: Polonja
English: 106, 120, 140, 150, 180, 200, 204, 206, 250, 280, 300, 500 and 1000 tablets.
Maltese: 106, 120, 140, 150, 180, 200, 204, 206, 250, 280, 300, 500 u 1000 pillola.
English: 1 tablet per 10 kg
Maltese: 1 pillola għal kull 10 kg
English: BN {number}
Maltese: U AKTAR}
English: {CARTON FOR PACK SIZES OF 2, 4, 6 AND 8 TABLETS}
Maltese: {KARTUNA GĦAL DAQSIJIET TA' PAKKETTI TA' 2, 4, 6 U 8 PILLOLI}
English: Tapeworms: Echinococcus species, (E. granulosus, E. multilocularis), Taenia species, (T. hydatigena, T. pisiformis, T. taeniformis), Dipylidium caninum (adult and immature forms).
Maltese: Tapeworms: l-ispeċi Echinococcus, (E. granulosus, E. multilocularis), l-ispeċi Taenia, (T. hydatigena, T. pisiformis, T. taeniformis), Dipylidium caninum (forom adulti u immaturi).
English: This combination shows synergistic activity in the case of hookworms and febantel is effective against T. vulpis.
Maltese: Din il-kombinazzjoni turi attività sinerġistika fil-każ ta' hookworms u febantel huwa attiv kontra T. vulpis.
English: While plasma concentrations are not a direct measure of the concentrations of active available locally in the gastro intestinal tract, it is considered that similar systemic availability (similar extent of absorption) is indicative of similar behaviour locally in the gastro intestinal tract following product administration.
Maltese: Filwaqt li lkonċentrazzjonijiet ta' plasma mhumiex kejl dirett tal-konċentrazzjonijiet ta' attiva disponibbli lokalment fl-apparat gastrointestinali, huwa kkunsidrat li disponibilità sistemika simili (grad simili ta' assorbiment) hija indikattiva ta' imġiba lokali simili fl-apparat gastrointestinali wara amministrazzjoni tal-prodott.
English: 50mg (equivalent to 144 mg pyrantel embonate)
Maltese: 50mg (ekwivalenti għal 144 mg ta' pyrantel embonate)
English: Ascarids: Toxocara canis, Toxascaris leonina (adult and late immature forms).
Maltese: Toxocara canis, Toxascaris leonina (forom adulti u forom immaturi żviluppati).
English: 150, 180, 200, 204, 206, 250, 280, 300, 500 or 1000 tablets.
Maltese: 200, 204, 206, 250, 280, 300, 500 jew 1000 pillola.
English: Portugal
Maltese: Portugall
English: After absorption, the drug is distributed to all organs.
Maltese: Wara li tiġi assorbita, il-mediċina tiġi distribwita lill-organi kollha.
English: Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus, Prazitel Plus and associated names are tablets for dogs containing praziquantel, pyrantel embonate and febantel and indicated for various parasitic infections.
Maltese: Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus, Prazitel Plus u ismijiet assoċjati huma pinnoli għall-klieb li fihom praziquantel, pyrantel embonate u febantel u indikati għal diversi infezzjonijiet parasitiċi.
English: • the CVMP considered the primary scope of the referral regarding efficacy against Echinococcus granulosus and Echinococcus multilocularis;
Maltese: • is-CVMP ikkunsidra l-kamp ta' applikazzjoni primarju tar-riferiment rigward l-effikaċja kontra Echinococcus granulosus u Echinococcus multilocularis;
English: This rapid contraction has been explained by changes in divalent cation fluxes, especially calcium.
Maltese: Din il-kontrazzjoni rapida ġiet spjegata permezz ta' divalent cation fluxes, speċjalment tal-kalċju.
English: The products are tablets for dogs containing praziquantel, pyrantel embonate and febantel and indicated for various parasitic infections.
Maltese: Il-prodotti huma pilloli għal klieb li fihom praziquantel, pyrantel embonate u febantel u indikati għal diversi infezzjonijiet parasitiċi.
English: Febantel is absorbed relatively rapidly and metabolized to a number of metabolites including fenbendazole and oxfendazole, which have anthelmintic activity.
Maltese: Febantel jiġi assorbit relattivament malajr u jiġi metabolizzat f'għadd ta' metaboliti nkluż fenbendazole u oxfendazole, li għandhom attività antelmintika.
English: Cestodes:
Maltese: Whipworms:
English: It is excreted within 24 hours to more than 95% of the administered dosage.
Maltese: Aktar minn 95% tad-doża mogħtija tiġi eliminata fi żmien 24 siegħa.
English: Perorally administered praziquantel is absorbed almost completely from the intestinal tract.
Maltese: Praziquantel mogħti oralment jiġi kważi kompletament assorbit mill-passaġġ intestinali.
English: Pyrantel embonate (pamoate), a tetrahydropyrimidine derivative Praziquantel, a partially hydrogenated pyrazinoisoquinoline derivative In this fixed combination, pyrantel and febantel act against all relevant nematodes (ascarids, hookworms, and whipworms) in dogs.
Maltese: Praziquantel, derivattiv parzjalment idroġenat ta' pyrazinoisoquinoline F'din il-kombinazzjoni fissa, pyrantel u febantel jaġixxu kontra n-nematodi (askaridi, hookworms, u whipworms) rilevanti kollha fil-klieb.
English: INN/Strength
Maltese: INN/Qawwa
English: Excipients: For a full list of excipients, see section 6.1.
Maltese: Għal-lista sħiħa ta' l-ingredjenti (mhux attivi), ara s-sezzjoni 6.1.
English: Prazitel Plus was first launched in the EU market in May 2009.
Maltese: L-ewwel, Prazitel Plus tnieda fissuq tal-UE f'Mejju 2009.
English: The products concerned are seven duplicates with identical hybrid application dossiers for which the reference product is Drontal Plus (Bayer Animal Health).
Maltese: Il-prodotti kkonċernati huma seba' duplikati b'dossiers identiċi ta' applikazzjoni ibrida li l-prodott ta' referenza tagħhom huwa Drontal Plus (Bayer Animal Health).
English: 50 mg/tablet Praziquantel, 50 mg/tablet Pyrantel (equivalent to 144 mg pyrantel embonate) and 150 mg/tablet Febantel.
Maltese: 50 mg/pillola Praziquantel, 50 mg/pillola Pyrantel (ekwivalenti għal 144 mg pyrantel embonate) u 150 mg Febantel.
English: Regardless of the administration route and the formulation, praziquantel at a dose of 5 mg/kg bw was consistently shown to be up to 100% effective against immature and mature forms of E. granulosus and E. multilocularis.
Maltese: Indipendentement mill-mod minn fejn jingħata u l-formulazzjoni, intwera b'konsistenza li praziquantel f'doża ta' 5 mg/kg bw huwa sa 100% effettiv kontra forom immaturi u maturi ta' E. granulosus u E. multilocularis.
English: {BLISTER FOIL TEXT}
Maltese: Jiskadi {xahar / sena}
English: The strips or blisters are packed into cartons containing either 2,4, 6, 8, 10, 12, 14, 16, 18, 20,
Maltese: L-istrixxi jew il-folji jiġu ppakkjati f'kartun li fihom jew 2,4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28,
English: MARKETING AUTHORISATION HOLDER Chanelle Pharmaceuticals Manufacturing Limited, Loughrea,
Maltese: Chanelle Pharmaceuticals Manufacturing Limited, Loughrea,
English: The marketing authorisation holder for the concerned product is Chanelle Pharmaceuticals Manufacturing Ltd. Prazitel Plus, Exitel Plus, Cazitel Plus and associated names were authorised in many Member States (EU/EEA) by mutual recognition procedure (MRP) IE/V/0241-0243/001/MR as duplicate hybrid applications under Article 13(3) of Directive 2001/82/EC as amended.
Maltese: Prazitel Plus, Exitel Plus, Cazitel Plus u ismijiet assoċjati ġew awtorizzati f'bosta Stati Membri (UE/ŻEE) permezz ta' proċedura ta' rikonoxximent reċiproku (MRP) IE/V/0241-0243/001/MR bħala applikazzjonijiet ibridi duplikati skont l-Artikolu 13(3) tad-Direttiva 2001/82/KE, kif emendata.
English: Fleas serve as intermediate hosts for one common type of tapeworm - Dipylidium caninum.
Maltese: Il-briegħed iservu bħala ospiti intermedjarji għal tip komuni ta' dud - Dipylidium caninum.
English: Praziquantel is very rapidly absorbed through the parasite's surface and distributed throughout the parasite.
Maltese: Praziquantel jiġi assorbit malajr ħafna mis-superfiċje tal-parassita u jiġi distribwit fil-parassita kollha.
English: This product contains anthelmintics active against gastrointestinal roundworms and tapeworms.
Maltese: Dan il-prodott fih antelmintiċi attivi kontra roundworms u dud gastrointestinali.
English: The bibliographic data provided by the marketing authorisation holder confirmed the well established efficacy of praziquantel at a dose of 5 mg/kg against E. granulosus and E. multilocularis.
Maltese: Id-dejta biblijografika pprovduta mid-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq ikkonfermat l-effikaċja ferm stabbilita ta' praziquantel f'doża ta' 5 mg/kg kontra E. granulosus u E. multilocularis.
English: In particular, the activity spectrum covers Toxocara canis, Toxascaris leonina, Uncinaria stenocephala, Ancylostoma caninum and Trichuris vulpis.
Maltese: B'mod partikolari, l-ispettru ta' attività jkopri lil Toxocara canis, Toxascaris leonina, Uncinaria stenocephala, Ancylostoma caninum u Trichuris vulpis.
English: In a number of the studies reported, praziquantel was shown to be highly effective against E. granulosus and E. multilocularis at doses less than 5 mg/kg bw.
Maltese: studji rraportati, intwera li praziquantel huwa ferm effettiv kontra E. granulosus u E. multilocularis f'dożi inqas minn 5 mg/kg bw.
English: Dosage table: Bodyweight (kg)
Maltese: Piż tal-ġisem (kg)
English: or
Maltese: IEĦOR
English: This conclusion is in line with the view taken during the various mutual recognition procedures (IE/V/0241-0243/001/MR).
Maltese: Din il-konklużjoni hija konformi mal-fehma ddikkjarata matul id-diversi proċeduri ta' rikonoxximent reċiproku (IE/V/02410243/001/MR).
English: List of the names, pharmaceutical form, strength of the veterinary medicinal products, animal species, route of administration marketing authorisation holder in the Member States.
Maltese: Lista ta 'ismijiet, forma farmaċewtika, is-saħħa tal-prodotti mediċinali veterinarji, speċi ta' annimali, rotta ta 'amministrazzjoni, id-detentur awtorizzazzjoni fl-Istati Membri.
English: Chanelle Pharmaceuticals Manufacturing Ltd.has extrapolated the efficacy data available in the public domain for the Bayer Animal Health products (Droncit and Drontal Plus) to the concerned product (Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus and Prazitel Plus and associated names) by presenting a comparative pharmacokinetic study conducted with the concerned product and Drontal Plus (Bayer Aniamal Health).
Maltese: Chanelle Pharmaceuticals Manufacturing Ltd. estrapolat id-dejta dwar l-effikaċja disponibbli fiddominju pubbliku għall-prodotti Bayer Animal Health (Droncit u Drontal Plus) għall-prodott ikkonċernat (Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus and Prazitel Plus u ismijiet assoċjati) billi ppreżentat studju farmakokinetiku komparattiv imwettaq bejn il-prodott ikkonċernat u Drontal Plus (Bayer Aniamal Health).
English: Evaluation of the benefit - risk balance
Maltese: Valutazzjoni tar-riskji
English: While the majority of references cited by Chanelle Pharmaceuticals Manufacturing Ltd.reported on the efficacy of praziquantel when presented as a monosubstance tablet (Droncit, Bayer Animal Health), a number of the references reported on the efficacy of praziquantel when presented in other pharmaceutical forms (injectable, paste, powder) and/or for administration by other routes (intramuscular, subcutaneous) and/or when combined with other active substances (e.g. Drontal Plus, Bayer Animal Health).
Maltese: Filwaqt li l-parti l-kbira tar-referenzi ċċitati minn Chanelle Pharmaceuticals Manufacturing Ltd. irrapportaw dwar l-effikaċja ta' praziquantel meta din tkun ippreżentata bħala pillola b'sustanza waħda (Droncit, Bayer Animal Health), numru mir-referenzi rrapportaw dwar leffikaċja ta' praziquantel meta ppreżentata f'forom farmaċewtiċi oħrajn (injettabbli, pejst, trab) u/jew modi differenti minn fejn jingħata (intramuskolari, subkutanja) u/jew meta kombinata ma' sustanzi attivi oħrajn (eż.
English: Following absorption, pyrantel pamoate is quickly and almost completely metabolized into inactive metabolites that are excreted rapidly in the urine.
Maltese: Wara l-assorbiment, pyrantel pamoate jiġi kważi kompletament metabolizzat u metabolizzat malajr f'metaboliti inattivi li jiġu eliminati malajr fl-awrina.
English: 1 tablet per 10 kg (22 lbs) bodyweight.
Maltese: Pillola 1 ta' kull 10 kg (22 lbs) tal-piż tal-ġisem.
English: 1 tablet per 10kg (22lbs) bodyweight.
Maltese: 1 pillola għal kull 10kg (22lbs) piż tal-ġisem.
English: In addition the Chanelle Pharmaceuticals Manufacturing Ltd.was requested to provide a proposal for harmonised product information and supportive data for the harmonised product information.
Maltese: Barra minn hekk, Chanelle Pharmaceuticals Manufacturing Ltd. intalbet tipprovdi proposta għal informazzjoni dwar il-prodott armonizzata u dejta ta' appoġġ għall-informazzjoni dwar il-prodott armonizzata.
English: ANNEX I:
Maltese: Anness I
English: Praziquantel is metabolized into inactive forms in the liver and secreted in bile.
Maltese: Praziquantel jiġi metabolizzat f'forom inattivi fil-fwied u jiġi eliminat fil-bili.
English: {CARTON FOR PACK SIZES OF 10 TABLETS, AND UPWARDS}
Maltese: {KARTUNA GĦAL DAQSIJIET TA' PAKKETTI TA' 10 PILLOLI
English: Each tablet contains: Active substances: Praziquantel
Maltese: Kull pillola fiha: Sustanzi attivi:
English: Tapeworm infestation is unlikely in pups less than 6 weeks of age.
Maltese: Infestazzjoni bid-dud hija improbabbli li sseħħ fil-ġriewi ta' inqas minn 6 ġimgħat.
English: 5.2 Pharmacokinetic particulars
Maltese: .2 Tagħrif Farmakokinetiku
English: Individual blisters composed of 45 µm, soft temper aluminium foil and 25 µm hard temper aluminium foil, containing 2 or 8 tablets.
Maltese: Folji individwali magħmula minn fojl tal-aluminju ittemprat artab ta' 45 µm, u fojl tal-aluminju ittemprat iebes ta' 25 µm, li fihom 2 jew 8 pilloli.
English: 1 tablet per 10 kg bodyweight.
Maltese: 1 pillola għal kull 10 kg piż tal-ġisem.
English: The combination of praziquantel, pyrantel embonate and febantel is well tolerated in dogs.
Maltese: Il-kombinazzjoni ta' praziquantel, pyrantel embonate u febantel hija ttollerata sew fil-klieb.
English: The indication for the treatment of immature and mature forms of E. granulosus and E. multilocularis can be accepted for the concerned product (Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus and Prazitel Plus and associated names).
Maltese: L-indikazzjoni għat-trattament ta' forom immaturi u maturi ta' E. granulosus u E. multilocularis tista' tiġi aċċettata għall-prodott ikkonċernat (Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus and Prazitel Plus u ismijiet assoċjati).
English: 1 pork flavoured tablet contains 50 mg Praziquantel, 50 mg Pyrantel (equivalent to 144 mg pyrantel embonate) and 150 mg Febantel.
Maltese: Pillola 1 b'togħma ta' majjal li fiha 50 mg Praziquantel, 50 mg Pyrantel (ekwivalenti għal 144 mg pyrantel embonate) u 150 mg Febantel.
English: Overall summary of the scientific evaluation of Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus, Prazitel Plus and associated names (see annex I)
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika ta' Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus, Prazitel Plus u ismijiet assoċjati (ara Anness I)
English: The recommended dose rates are: 15 mg/kg bodyweight febantel, 5 mg/kg pyrantel (equivalent to 14.4 mg/kg pyrantel embonate) and 5 mg/kg praziquantel.
Maltese: Id-dożi rakkomandati huma: febantel 15 mg/kg tal-piż tal-ġisem, pyrantel 5 mg/kg (ekwivalenti għal 14.4 mg/kg pyrantel embonate) u praziquantel 5 mg/kg.
English: The products are not expected to pose a risk to the environment.
Maltese: Il-prodotti mhumiex mistennija jkunu ta' riskju għall-ambjent.
English: The recommended dose rates are: 15mg/kg bodyweight febantel, 5 mg/kg pyrantel (equivalent to 14.4 mg/kg pyrantel embonate) and 5 mg/kg praziquantel.
Maltese: Id-dożi rakkomandati huma: febantel 15mg/kg tal-piż tal-ġisem, pyrantel 5 mg/kg (ekwivalenti għal 14.4 mg/kg pyrantel embonate) u praziquantel 5 mg/kg.
English: The spectrum of activity of praziquantel covers all important cestode species in dogs, in particular Taenia spp., Dipylidium caninum, Echinococcus granulosus and Echinococcus multilocularis.
Maltese: Taenia spp., Dipylidium caninum, Echinococcus granulosus u Echinococcus multilocularis.
English: There is an almost instantaneous tetanic contraction of the parasite musculature and a rapid vacuolization of the syncytial tegument.
Maltese: Kontrazzjoni tetanika tal-muskolatura tal-parassita sseħħ kważi b'mod istantanju kif ukoll vakulizzazzjoni rapida tattegument sinktjali.
English: A target animal safety study confirmed that the concerned product (Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus, Prazitel Plus and associated names) is well tolerated when administered to pups (9 weeks of age) at doses up to five times the recommended treatment dose or when administered at the recommended treatment dose for up to three days.
Maltese: Studju dwar is-sikurezza tal-annimali fil-mira kkonferma li l-prodott ikkonċernat (Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus, Prazitel Plus u ismijiet assoċjati) huwa tollerat sew meta jiġi amministrat lil ġriewi (ta' 9 ġimgħat) f'dożi ta' ħames darbiet id-doża ta' trattament irrakkomandata jew meta amministrat fid-doża ta' trattament rakkomandata għal mhux aktar minn tliet ijiem.
English: Praziquantel acts against all adult and immature forms of these parasites.
Maltese: Praziquantel jaġixxi kontra l-forom adulti u immaturi kollha ta' dawn ilparassiti.
English: This is equivalent to 1 tablet per 10 kg (22 lbs) bodyweight.
Maltese: Dan huwa ekwivalenti għal pillola 1 kull 10 kg (22 lbs) tal-piż tal-ġisem.
English: In further support of the safety and efficacy of the product, Chanelle Pharmaceuticals Manufacturing Ltd.provided pharmacovigilance data for Prazitel Plus and related duplicate products which include in the SPC the claim for efficacy against Echinococcus.
Maltese: B'appoġġ ulterjuri tassikurezza u l-effikaċja tal-prodott, Chanelle Pharmaceuticals Manufacturing Ltd. ipprovdiet dejta ta' farmakoviġilanza għal Prazitel Plus u prodotti duplikati relatati li fis-Sommarju tal-Karatteristiċi talProdott jinkludu d-dikjarazzjoni ta' effikaċja kontra Echinococcus.
English: PACKAGE LEAFLET
Maltese: FIL-PAKKETT