FrancophonIA/ELRC3.0 huggingface dataset:
English: These include: anti-bacterial medicines (gentamycin, tobramycin, ciprofloxacin), anti-fungal medicines which contain amphotericin B, medicines used for urinary tract infections which contain trimethoprim, medicines for cancer which contain melphalan, medicines used to lower the amount of acid in your stomach (acid secretion inhibitors of the H2-receptor antagonist type), tacrolimus, pain killers (non-steroid antiinflammatory medicines such as diclofenac), fibric acid medicines (used to lower the amount of fat in the blood).
Maltese: Dawn jinkludu: mediċini antibatteriċi (gentamycin, tobramycin, ciprofloxacin), mediċini antifungali li fihom amphotericin B, mediċini użati biex jikkuraw infezzjonijiet fil-passaġġ tal-awrina li fihom trimethoprim, mediċini għall-kanċer li fihom melphalan, mediċini użati biex ibaxxu l-ammont ta' aċdu fl istonku tiegħek (inibituri tal-ħruġ tal-aċdu tar-riċettur H2 tat-tip antagonist), tacrolimu, pilloli li jrażżnu l-uġigħ (mediċini antiinfjammatorji mhux sterojdi bħal diclofenac), mediċini tal-aċidi fibriċi (użati biex jitbaxxa l-ammont ta' xaħam fid-demm).
English: Tear off the sealing ring completely.
Maltese: Barra minn hekk,
English: Vascular disorders Very common
Maltese: Emikranja Disturbi vaskulari
English: There is only limited experience with the use of Sandimmun Neoral in children with endogenous uveitis.
Maltese: Teżisti biss esperjenza limitata bl-użu ta' Sandimmukn Neoral fi tfal b'endogenous uveitis.
English: If a significant impairment of renal function occurs, the dosage of the co-administered medicinal product should be reduced or alternative treatment considered.
Maltese: Jekk ikun hemm indeboliment qawwi tal-funzjoni tal-kliewi, id-doża tal prodott mediċinali mogħti fl-istess ħin għandha titnaqqas jew jitqies trattament alternattiv.
English: Sandimmun Neoral with food and drink
Maltese: Sandimmun Neoral m' ikel u xorb
English: When to take Sandimmun Neoral
Maltese: Meta tieħu Sandimmun Neoral
English: The relationship between administered dose and exposure (AUC) of ciclosporin is linear within the therapeutic dose range.
Maltese: Ir-relazzjoni bejn id-doża mogħtija u l-espożizzjoni (AUC) ta' ciclosporin hi linerai skont il-firxa tad-doża terapewtika.
English: What Sandimmun Neoral looks like and contents of the pack Sandimmun Neoral 10 mg soft capsules are yellow to white oval, and marked with “NVR 10” in red.
Maltese: Kif jidher Sandimmun Neoral u l-kontenut tal-pakkett Sandimmun Neoral 10 mg kapsuli rotob huma sofor fl-abjad ovali, u mmarkati b'“NVR 10mg” bl aħmar.
English: How to take Sandimmun Neoral
Maltese: X'inhu Sandimmun Neoral
English: The total dose each day is usually between 3 mg per kilogram of your body weight and 5 mg per kilogram body weight.
Maltese: - Id-doża totali għal kuljum hi normalment ta' bejn 3 mg għal kull kilo tal-piż tiegħek u 5 mg għal kull kilo tal-piż tiegħek.
English: The excretion is primarily biliary, with only 6% of the oral dose excreted in the urine; only 0.1% is excreted in the urine as unchanged parent compound.
Maltese: Eliminazzjoni L-eliminazzjoni hi primarjament biljari, b'6% tad-doża orali tgħaddi mal-awrina; 0.1% tgħaddi mal awrina bħala komponent parentali mhux mibdul.
English: Co-administration of drugs that are substrates of CYP3A4, P-gp and OATP with ciclosporin may increase plasma levels of co-medications that are substrates of this enzyme and/or transporter.
Maltese: Mediċini li jżidu l-livelli ta' ciclosporin L-indutturi kollha ta' CYP3A4 u/jew tal-glikoproteina-P huma mistennija li jnaqqsu l-livelli ta'
English: Special caution should be observed if Sandimmun Neoral is used in combination with methotrexate due to nephrotoxic synergy.
Maltese: Wieħed għandu joqgħod ħafna attent jekk Sandimmun Neoral jintuża ma' methotrexate minħabba sinerġija nefrotossika.
English: The elimination half-life in kidney-transplanted patients was approximately 11 hours, with a range between 4 and 25 hours.
Maltese: Il-half-life tal-eliminazzjoni f'pazjenti bi trapjant tal-kliewi kien ta' madwar 11-il siegħa, b'medda ta' bejn 4 u 25 siegħa.
English: If eGFR decreases by more than 25% below baseline at more than one measurement, the dosage of Sandimmun Neoral should be reduced by 25 to 50%.
Maltese: Jekk l-eGFR tonqos b'aktar minn 25% taħt il-linja bażi f'aktar minn kejl wieħed, id-doża mogħtija ta' Sandimmun Neoral għandha titnaqqas b'25 sa 50%.
English: The 4-ml syringe is used to measure doses greater than 1 ml and up to 4 ml (each graduation of 0.1 ml corresponds to 10 mg of ciclosporin).
Maltese: (kull gradwazzjoni ta' 0.1 ml tikkorrispondi għal 10 mg ciclosporin).
English: In addition, the absorption of ciclosporin from Sandimmun Neoral is less variable and the correlation between ciclosporin trough concentrations and exposure (in terms of AUC) is stronger than with Sandimmun.
Maltese: ciclosporin minn Sandimmun Neoral hu anqas varjabbli u l-korrelazzjoni bejn il-konċentrazzjonijiet baxxi u l-espożizzjoni ta' ciclosporin (f'termini ta' AUC) hi aktar qawwija milli hi b'Sandimmun.
English: The name of your medicine is Sandimmun Neoral.
Maltese: L-isem tal-mediċina tiegħek hu Sandimmun Neoral.
English: Special excipients: Polyoxyl 40 hydrogenated castor oil Sandimmun Neoral contains polyoxyl 40 hydrogenated castor oil, which may cause stomach upsets and diarrhoea.
Maltese: Żejt ir-riġnu idroġenat polyoxyl 40 Sandimmun Neoral fih żejt ir-riġnu u idroġenat polyoxyl 40, li jista' jikkawża dwejjaq fl-istonku u dijarrea.
English: • Headache.
Maltese: bl-aħmar.
English: Your doctor may decide to change to this medicine, Sandimmun Neoral soft gelatin capsules.
Maltese: ambrisentan u mediċini speċifikament kontra l-kanċer imsejħin anthracyclines (bħal doxorubicin).
English: Pharmacokinetic data from paediatric patients given Sandimmun Neoral or Sandimmun are very limited.
Maltese: L-esperjenza b'Sandimmun Neoral fl-anzjani hi limitata.
English: Pregnant rats which received 12 mg/kg/day of ciclosporin intravenously (twice the recommended human intravenous dose) had foetuses with an increased incidence of ventricular septal defect.
Maltese: 12 mg/kg/kuljum ciclosporin mill-vina (darbtejn id-doża rrakkomandata għall-bnedmin mill-vina)
English: - Medicines which may decrease the level of ciclosporin in your blood include: barbiturates (used to help you to sleep), some anti-convulsant medicines (such as carbamazepine or phenytoine), octreotide (used to treat acromegaly or neuroendocrine tumours in the gut), anti-bacterial medicines used to treat tuberculosis, orlistat (used to help weight loss), herbal medicines containing St. John's wort, ticlopidine (used after a stroke), certain medicines which lower blood pressure (bosentan), and terbinafine (an anti-fungal medicine used to treat infections of the toes and nails).
Maltese: Mediċini li jistgħu jnaqqsu l-livell ta' ciclosporin fid-demm tiegħek jinkludu: barbiturates (użati biex jgħinuk torqod), xi mediċini antikonvulsanti (bħal carbamazepine jew phenytoine), octreotide (użat biex jittratta akromegalija jew tumuri newroendokriniċi fl-imsaren), antimediċini antibatteriċi użati biex jittrattaw it-tuberkolożi, orlistat (użat biex jgħinek titlef il-piż), mediċini tal-ħxejjex li fihom St.
English: Patients on Sandimmun Neoral should not receive concomitant ultraviolet B irradiation or PUVA photochemotherapy.
Maltese: Kien hemm disturbi limfoproliferattivi f'xi pazjenti bi psorjasi ttrattati b'Sandimmun Neoral.
English: Talk to your doctor before taking Sandimmun Neoral:
Maltese: Jekk it-tabib tiegħek jaqleb minn Sandimmun għal Sandimmun Neoral:
English: Yellow-white, oval soft gelatin capsules, imprinted “NVR 10” in red.
Maltese: Kapsuli rotob tal-ġelatina ovali, sofor fl-abjad, bil-kitba “NVR 10mg” stampata bl-aħmar.
English: LIST OF EXCIPIENTS Contains ethanol (see leaflet for further information).
Maltese: jew bosentan u aliskiren (użati biex inaqqsu l-pressjoni għolja).
English: Additional precautions in nephrotic syndrome
Maltese: • Fit-tfal Sindrome nefrotiku
English: anti-bacterial medicines used to treat tuberculosis, orlistat (used to help weight loss), herbal medicines containing St. John's wort, ticlopidine (used after a stroke), certain medicines which lower blood pressure (bosentan), and terbinafine (an anti-fungal medicine used to treat infections of the toes and nails).
Maltese: John's wort, ticlopidine (użat wara puplesija), ċerti mediċini li jbaxxu l-pressjoni tad-demm tiegħek (bosentan), u terbinafine (mediċina antifungali użata biex tittratta infezzjonijiet tas-swaba' u d dwiefer).
English: When Sandimmun Neoral is used in transplant patients, routine monitoring of ciclosporin blood levels is an important safety measure.
Maltese: Meta Sandimmun Neoral jintuża f'pazjenti bi trapjant, monitoraġġ ta' rutina tal-livelli ta' ciclosporin fid-demm jitqies miżura importanti ta' sigurtà.
English: Prevention of graft rejection following allogeneic bone marrow and stem cell transplantation.
Maltese: Prevenzjoni ta' riġettar ta' trapjant wara trapjant alloġeniku tal-mudullun u taċ-ċellula staminali.
English: 100mg
Maltese: 25 mg/ml
English: 25 mg/ml powder for suspension for injection subcutaneous use vial (glass)
Maltese: Trab għal suspensjoni għall-injezzjoni
English: Content (concentration)
Maltese: Kontenut (konċentrazzjoni) Daqs tal-pakkett
English: EMA/704200/2014 EMEA/V/C/003842
Maltese: EMEA/V/C/003842
English: A laboratory study involved 20 dogs artificially infected with lungworm larvae.
Maltese: Studju tal-laboratorju involva 20 kelb infettati artifiċjalment bil-larva tad-dud fil-pulmun.
English: Nexgard Spectra received a marketing authorisation valid throughout the EU on 15 January 2015.
Maltese: Nexgard Spectra rċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-EU kollha fil-15 ta' Jannar 2015.
English: Milbemycin oxime acts as an ‘endoparasiticide'.
Maltese: Il-milbemiċin ossima taġixxi bħala “endoparassitiċida”.
English: Further information on Nexgard Spectra can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPARs/nexgard-spectra.
Maltese: ema.europa.eu/medicines/veterinary/EPARs/nexgard-spectra.
English: Sarcoptic mange
Maltese: Ġarab sarkoptiku
English: Other information about Nexgard Spectra
Maltese: Informazzjoni oħra dwar Nexgard Spectra
English: This overview was last updated in July 2019.
Maltese: Din il-ħarsa ġenerali ġiet aġġornata l-aħħar f'Lulju 2019.
English: Nexgard Spectra contains the active substances afoxolaner and milbemycin oxime.
Maltese: Nexgard Spectra fih is-sustanzi attivi afossolaner u milbemiċin ossima.
English: Nexgard Spectra reduced the number of live mites by 96% 56 days after starting treatment and by 98% 84 days after starting treatment.
Maltese: Nexgard Spectra naqqas l-għadd ta' dud ħaj b'96 % 56 jum wara l-bidu tal-kura u bi 98 % 84 jum wara l-bidu tal-kura.
English: The most common side effects (affecting inbetween 1 to 10 animals in 1,000 animals) were vomiting, diarrhoea, lack of energy, decreased appetite, and itching, which generally were short-lived and resolved spontaneously.
Maltese: L-effetti sekondarji l-aktar komuni (li jaffettwaw bejn annimal wieħed u 10 f'kull 1,000 annimal) kienu r-rimettar, id-dijarea, nuqqas ta' enerġija, tnaqqis fl-aptit, u ħakk, li ġeneralment ma damux u ġew riżolti b'mod spontanju.
English: Nexgard Spectra is a veterinary medicine used to treat infestations with fleas, ticks, as well as demodectic and sarcoptic mange (skin infestations caused by two different types of mites) in dogs when prevention of heartworm disease (caused by a worm that infects the heart and blood vessels and is transmitted by mosquitoes), lungworm disease, eye worm and/or treatment of gut worms (hookworms, roundworms and whipworm) is also required.
Maltese: Nexgard Spectra huwa mediċina veterinarja li tintuża biex tikkura infestazzjonijiet tal-briegħed u lqurdien, kif ukoll ġarab demodektiku u sarkoptiku (infestazzjonijiet tal-ġilda kkawżati minn żewġ tipi differenti ta' dud) fil-klieb meta tkun meħtieġa wkoll il-prevenzjoni tal-marda tad-dud fil-qalb (ikkawżata minn ħanex li jinfetta l-qalb u l-vażijiet u li tiġi trażmessa min-nemus), il-marda tad-dud fil-pulmun, id-dud fl-għajnejn u/jew il-kura tad-dud fl-imsaren (hookworms, roundworms u whipworm).
English: Demodectic mange
Maltese: Ġarab demodektiku
English: Nexgard Spectra reduced worm counts by 95% at 90-92 days after treatment.
Maltese: Nexgard Spectra naqqas l-għadd tad-dud b'95 % fid-90 jum u fit-92 jum wara l-kura.
English: Nexgard Spectra reduced the number of live mites by 99% 28 days after starting treatment and by 100% 56 days after starting treatment.
Maltese: Nexgard Spectra naqqas l-għadd ta' dud ħaj b'99 % 28 jum wara l-bidu tal-kura u b'100 % 56 jum wara l-bidu tal-kura.
English: In a field study, 408 dogs with gut worm infections were given either a single treatment with Nexgard Spectra or a medicine containing milbemycin oxime and praziquantel (another medicine for worms).
Maltese: Fi studju fuq il-post, 408 iklieb b'infezzjonijiet ta' dud fl-imsaren ingħataw jew kura waħda b'Nexgard Spectra jew mediċina li fiha l-milbemiċin ossima u l-prażikwantel (mediċina oħra għad-dud).
English: Nexgard Spectra reduced the number of fleas and ticks by at least 95% and was at least as effective as pyriprole.
Maltese: Nexgard Spectra naqqas lgħadd ta' briegħed u qurdien b'mill-inqas 95 % u kien tal-anqas effettiv daqs il-piripol.
English: All the dogs treated with Nexgard Spectra were free of eye worm at day 180 compared to 43% in the afoxolaner-treated group.
Maltese: Il-klieb kollha kkurati b'Nexgard Spectra ma kellhomx dud fl-għajnejn fil-jum 180 meta mqabbla ma' 43 % fil-grupp ikkurat blafossolaner.
English: In a field study, 324 dogs with flea and/or tick infestations were given a single treatment with Nexgard Spectra or a spot-on medicine containing another active substance, pyriprole, that controls fleas and ticks.
Maltese: Fi studju fuq il-post, 324 kelb b'infestazzjonijiet tal-briegħed u/jew tal-qurdien ingħataw kura waħda b'Nexgard Spectra jew mediċina għal użu lokalizzat li kien fiha sustanza attiva, il-piriprol, li tikkontrolla l-briegħed u l-qurdien.
English: What are the risks associated with Nexgard Spectra?
Maltese: X'inhuma r-riskji assoċjati ma' Nexgard Spectra?
English: Field studies involving 84 dogs in Japan and 320 dogs in the USA, none of which had heartworm before the treatment started, showed that Nexgard Spectra given monthly for six months prevented heartworm infection.
Maltese: Studji fuq il-post li involvew 84 kelb fil-Ġappun u 320 kelb fl-Istati Uniti tal-Amerika, li l-ebda wieħed minnhom ma kellu dud fil-qalb qabel ma bdiet il-kura, urew li Nexgard Spectra mogħti kull xahar għal sitt xhur ipprevjena l-infezzjoni tad-dud fil-qalb.
English: Afoxolaner acts as an ‘ectoparasiticide'.
Maltese: L-afossolaner taġixxi bħala “ektoparassitiċida”.
English: The active substances in Nexgard Spectra work by interfering with the way that signals are passed between nerve cells (neurotransmission) in the nervous system of parasites, resulting in paralysis and death of the parasitic organism.
Maltese: Is-sustanzi attivi f'Nexgard Spectra jaħdmu billi jinterferixxu fil-mod ta' kif jgħaddu s-sinjali bejn iċċelloli tan-nervituri (newrotrażmissjoni) fis-sistema nervuża tal-parassiti, u dan jirriżulta f'paraliżi u lmewt tal-organiżmu parassita.
English: Nexgard Spectra is available as chewable tablets in five different strengths for use in dogs of different weights.
Maltese: Nexgard Spectra jiġi bħala pilloli li jintmagħdu f'ħames qawwiet differenti għall-użu fi klieb ta' piżijiet differenti.
English: Flea and tick infestations
Maltese: Dud fil-pulmun
English: The study showed that Nexgard Spectra was effective in reducing gut worms and was at least as effective as the milbemycin oxime and praziquantel.
Maltese: L-istudju wera li Nexgard Spectra kien effettiv fit-tnaqqis tad-dud fl-imsaren u kien tal-inqas effettiv daqs ilmilbemiċin ossima u l-prażikwantel.
English: Thirty seven dogs were treated with Nexgard Spectra and 42 dogs were treated with afoxolaner alone, which has no action against eye worm.
Maltese: Seba' u tletin kelb ġew ikkurati b'Nexgard Spectra u 42 kelb ġew ikkurati bl-afossolaner waħdu, li ma għandu l-ebda azzjoni kontra d-dud fl-għajnejn.
English: Treatment for fleas and ticks should be repeated at monthly intervals during the flea or tick seasons; Nexgard Spectra can be used as part of the seasonal treatment of fleas and ticks in dogs infected with gut worms.
Maltese: Il-kura għall-briegħed u l-qurdien għandha tiġi ripetuta f'intervalli ta' xahar matul l-istaġuni talbriegħed jew tal-qurdien; Nexgard Spectra jista' jintuża bħala parti mill-kura staġjonali tal-briegħed u tal-qurdien fil-klieb infettati bid-dud fl-imsaren.
English: Nexgard Spectra (afoxolaner/milbemycin oxime)
Maltese: Ħarsa ġenerali lejn Nexgard Spectra u għalfejn huwa awtorizzat fl-UE
English: How does Nexgard Spectra work?
Maltese: Kif jintuża Nexgard Spectra?
English: For prevention of lungworm disease, in areas where infection regularly occurs, and for prevention of eye worm, monthly treatment is given.
Maltese: Għall-prevenzjoni tal-marda tad-dud fil-pulmun, f'postijiet fejn l-infezzjoni sseħħ b'mod regolari, u għall-prevenzjoni ta' dud fl-għajnejn, tingħata kura kull xahar.
English: In a field study, 27 dogs with sarcoptic mange were treated with Nexgard Spectra monthly for two months.
Maltese: Fi studju fuq il-post, 27 kelb b'ġarab sarkoptiku ġew ikkurati b'Nexgard Spectra kull xahar għal xahrejn.
English: The study showed that Nexgard Spectra was effective in treating flea and tick infestations in dogs for up to 30 days after treatment.
Maltese: L-istudju wera li Nexgard Spectra kien effettiv fil-kura ta' infestazzjonijiet tal-briegħed u tal-qurdien fil-klieb sa 30 jum wara l-kura.
English: Oral Paste.
Maltese: Pejst Orali.
English: Member State Marketing Authorisation Holder/Applicant
Maltese: Stat Membru Detentur/Applikant ta' l
English: Ecomectin 18.7 mg/g Oral Paste for Horses is intended to be used in horses for the treatment of nematode or arthropod infections caused by Strongylus vulgaris, Strongylus edentatus, Strongylus equinus, Small strongyles (including benzimidazole resistant strains): Cyathostomum spp, Cylicocyclus spp., Cylicodontophorus spp., Cylicostephanus spp., Gyalocephalus spp., Ascarids: Parascaris equorum, Pinworms: Oxyuris equim, Neck threadworms: Onchocerca spp, Stomach bots: Gasterophilus spp
Maltese: Ecomectin 18.7 mg/g Pejst Orali għaż-Żwiemel huwa maħsub sabiex jintuża fuq żwiemel għall-kura ta' infezzjonijiet b'nematodi jew artropodi ikkaġunati minn Strongylus vulgaris, Strongylus edentatus, Strongylus equines, Strongyles żgħar (inklużi r-razez li huma reżistenti għal benzimidazole): Cyathostomum spp, Cylicocyclus spp., Cylicodontophorus spp., Cylicostephanus spp., Gyalocephalus spp., Askaridi:
English: PECSOIL- Intensively reared animals = 1.036 µg.kg-1
Maltese: PECĦAMRIJA- Annimali mrobbija b'mod intensiv = 1.036 µg.kg-1
English: The time frame agreed by the CVMP on 11 July 2007 was 58 days.
Maltese: Il-perijodu ta' żmien maqbul mis-CVMP fil-11 ta' Lulju 2007 kien ta' 58 jum.
English: • An updated Environmental Risk Assessment
Maltese: • Valutazzjoni tar-Riskju Ambjentali aġġornata
English: PECSOIL- Pasture animals = 0.48 µg.kg-1
Maltese: PECĦAMRIJA- Annimali tal-mergħa = 0.48 µg.kg-1
English: Pursuant to Article 33(4) of Council Directive 2001/82/EC, as amended, the matter has been referred to the CVMP.
Maltese: Skond l-Artikolu 33(4) tad-Direttiva tal-Kunsill 2001/82/KE, kif emendata, il-kwistjoni ġiet riferuta lill-CVMP.
English: Czech Republic As above
Maltese: Ir-Repubblika Ċeka
English: A white homogenous paste
Maltese: Pejst abjad omoġenju
English: One syringe division of paste per 100 kg body weight (based on a recommended dosage of 200 microgram ivermectin per kg body weight).
Maltese: Marka waħda ta' fuq issiringa ta'pejst għal kull 100 kg piż korporju (abbażi tad-doża irrakomandata ta' 200 mikrogramma ivermectin għal kull kg ta' piż korporju).
English: Ireland notified the EMEA on 4 July 2007 that the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Veterinary (CMD(v)) failed to reach an agreement regarding Ecomectin 18.7 mg/g Oral Paste for Horses.
Maltese: Fl-4 ta' Lulju 2007, l-Irlanda innotifikat lill-EMEA li l-Grupp ta' Koordinazzjoni għar-Rikonoxximent Reċiproku u Proċeduri Deċentralizzati - Veterinarji (CMD(v)) naqas milli jilħaq qbil dwar Ecomectin 18.5 mg/g Pejst Orali għaż-Żwiemel.
English: Ecomectin 18.7 mg/g Oral Paste for Horses is a generic product and as such an environmental risk assessment is now required under Directive 2001/82, as amended.
Maltese: Ecomectin 18.5 mg/g Pejst Orali għaż-Żwiemel huwa prodott ġeneriku u għalhekk ma tinħtieġ l-ebda valutazzjoni tar-riskju ambjentali skond id-Direttiva 2001/82, kif emendata.
English: Ivermax 18.7 mg/g Oral Paste for Horses
Maltese: Ivermax 18.7 mg/g Pejst Orali
English: An environmental risk was detected during the risk assessment Phase II Tier A for dung fauna organisms.
Maltese: Waqt il-valutazzjoni tar-riskju fil-Fażi II Livell A instab riskju ambjentali għal organiżmi tal-fawna fid-demel.
English: The Marketing Authorisation Holder submitted written responses to the List of Questions on 12 September 2007.
Maltese: Fit-12 ta' Settembru 2007 id-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq issottometta tweġibiet bil-miktub għal-Lista ta' Mistoqsijiet.
English: Ecomectin 18.7 mg/g Oral Paste for Horses
Maltese: Ecomectin 18.7 mg/g Pejst Orali
English: The referral procedure started on 11 July 2007.
Maltese: Il-proċedura ta' riferenza bdiet fil-11 ta' Lulju 2007.
English: • The complete information submitted to the Reference Member State and the CMD(v) in respect to environmental risk assessment.
Maltese: • It-tagħrif sħiħ ippreżentat lill-Istat Membru ta' Riferenza u lis-CMD(v) fir-rigward tal valutazzjoni tar-riskju ambjentali.
English: The Marketing Authorisation Holder provided an updated environmental risk assessment.
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq ipprovda valutazzjoni tar-riskju ambjentali aġġornat.
English: Animec 18.7 mg/g Oral Paste for Horses
Maltese: Animec 18.7 mg/g Pejst Orali
English: Divamectin 18.7 mg/g Oral Paste for Horses
Maltese: Divamectin 18.7 mg/g Pejst Orali
English: The Marketing Authorisation Holder considers it inconceivable that the risks posed to the environment associated with the use of Ecomectin 18.7 mg/g Oral Paste for Horses in particular are any greater than those posed by other ivermectin-based products, particularly as the concentration of the active ingredient and the proposed usage regime is identical to that of the reference and other similar products.
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq jikkunsidra li huwa inkonċepibbli li r-riskji fuq l-ambjent assoċjati b'mod partikolari ma' l-użu ta' Ecomectin 18.7 mg/g Pejst Orali għaż-Żwiemel huma akbar minn dawk ikkaġunati minn prodotti oħra ibbażati fuq l-ivermectin, partikolarment peress li l-konċentrazzjoni tas-sustanza attiva u l-mod ta' l-użu propost huma identiċi għal dawk tal-prodott ta' riferenza u oħrajn simili.
English: The List of Questions was sent to the Marketing Authorisation Holder.
Maltese: Il-Lista ta' Mistoqsijiet intbagħtet lid-Detentur ta' l-Awtorizzazzjoni għatTqegħid fis-Suq.
English: Pharmaceutical Strength Animal species Frequency and route Recommended dose
Maltese: Frekwenza u mod Doża irrakomandata
English: Horses
Maltese: Prodott
English: The applicant does not provide a formal justification for exemption of Phase II.
Maltese: L-applikant ma jipprovdix ġustifikazzjoni formali għalleżenzjoni mill-Fażi II.
English: Although oral paste is not used in major species (cattle, sheep, pigs), oral forms exist.
Maltese: Għalkemm pejst orali mhuwiex użat fi speċi maġġuri (baqar, ngħaġ, majjali), jeżistu forom orali.
English: Vetimec 18.7 mg/g Oral Paste for Horses
Maltese: Vetimec 18.7 mg/g Pejst Orali
English: The applicability of the following question of the VICH GL6 was considered:
Maltese: L-applikabbilità tal-mistoqsija li ġejja tal-VICH GL6 kienet ikkunsidrata:
English: Tizoval 18.7 mg/g Oral Paste for Horses
Maltese: Tizoval 18.7 mg/g Pejst Orali għażŻwiemel