FrancophonIA/ELRC3.0 huggingface dataset:
English: After single oral administration of Lonsurf with [14C]-trifluridine, the total cumulative excretion of radioactivity was 60% of the administered dose.
Maltese: C]-trifluridine, l-eliminazzjoni kumulattiva totali ta' radjoattività kienet ta' 60% tad-doża mogħtija.
English: Adverse reaction
Maltese: Kontraċezzjoni
English: Following multiple doses of Lonsurf (35 mg/m2/dose twice daily) in patients with advanced solid tumours, the mean times to peak plasma concentrations (tmax) of trifluridine and tipiracil hydrochloride were around 2 hours and 3 hours, respectively.
Maltese: Wara dożi multipli ta' Lonsurf (35 mg/m2/doża darbtejn kuljum) f'pazjenti b'tumuri solidi avvanzati, ilħinijiet medji biex tintlaħaq il-konċentrazzjoni massima tal-plażma (tmax) ta' trifluridine u tipiracil hydrochloride kienu madwar sagħtejn u 3 sigħat, rispettivament.
English: Urinary tract infection Gingivitis
Maltese: Newtropenija Lewkopenija Anemija
English: No adjustment of the starting dose is required on the basis of patient's race (see sections 5.1 and 5.2).
Maltese: Mhux meħtieġ aġġustament tad-doża abbażi tar-razza tal-pazjent (ara sezzjonijiet 5.1 u 5.2).
English: • a reduced number of certain types of white blood cells (neutropenia) which are important for protecting the body against bacterial or fungal infections.
Maltese: • numru mnaqqas ta' ċerta tipi ta' ċelloli bojod tad-demm (newtropenija) li huma importanti sabiex iħarsu lill-ġisem kontra infezzjonijiet battaerjali jew fungali.
English: • one-year marketing protection
Maltese: • proteina fl-awrina tiegħek
English: Flatulence
Maltese: Esofaġite
English: Hyperbilirubinaemia Hepatotoxicity Biliary dilatation
Maltese: MILL-AĠENZIJA EWROPEA GĦALLMEDIĊINI
English: Efficacy and safety data in patients over 75 years old is limited.
Maltese: Id-data dwar l-effikaċja u s-sigurtà f'pazjenti li għandhom aktar minn 75 sena hija limitata.
English: The PK of trifluridine and tipiracil hydrochloride have not been studied in patients with severe renal impairment or end-stage renal disease (see section 4.4).
Maltese: Il-PK ta' trifluridine u tipiracil hydrochloride ma ġewx studjati f'pazjenti b'indeboliment sever tal-kliewi jew mard tal- kliewi tal-aħħar stadju (ara sezzjoni 4.4).
English: Thrombocytopenia
Maltese: Qalba tal-pillola
English: Gout
Maltese: Gidy
English: Lonsurf is a type of cancer chemotherapy which belongs to the group of medicines called "cytostatic antimetabolite medicines".
Maltese: Lonsurf huwa tip ta' kimoterapija tal-kanċer li jagħmel parti minn grupp ta' mediċini li jissejħu "mediċini ċitostatiċi antimetaboliti".
English: Trifluridine was shown to be genotoxic in a reverse mutation test in bacteria, a chromosomal aberration test in mammal-cultured cells, and a micronucleus test in mice.
Maltese: Trifluridine ntwera li kellu effett tossiku fuq il-ġeni f'test tal-mutazzjoni riversiva filbatterji, test dwar anormalità fil-kromożomi f'ċelluli kkulturati tal-mammiferi u test tal-mikronukleu fil-ġrieden.
English: Neither trifluridine nor tipiracil hydrochloride was an inhibitor of or substrate for human uptake and efflux transporters based on in vitro studies, except for OCT2 and MATE1.
Maltese: La trifluridine u lanqas tipiracil hydrochloride ma kienu inibituri ta' jew substrat tal-assorbiment tal-bniedem u trasportaturi tal-effluss abbażi ta' studji in vitro ħlief għal OCT2 u MATE1.
English: Overall Survival Number of deaths, N (%) Median OS (months)a [95% CI]b Hazard ratio [95% CI] P-valuec
Maltese: Sopravivenza totali (OS) Numru ta' mwiet, N (%) OS medjana (xhur)
English: Following a single dose of Lonsurf (35 mg/m2) in patients with advanced solid tumours, the oral clearance (CL/F) for trifluridine and tipiracil hydrochloride were 10.5 L/hr and 109 L/hr, respectively.
Maltese: Wara doża waħda ta' Lonsurf (35 mg/m2) f'pazjenti b'tumuri solidi avvanzati, it-tneħħija mill-ħalq (CL/F) ta' trifluridine u tipiracil hydrochloride kienu madwar 10.
English: Figure 4 - Kaplan-Meier curves of progression-free survival in patients with metastatic gastric cancer
Maltese: Kaplan-Meier għas-sopravivenza bla progressjoni f'pazjenti bil-kanċer gastriku metastatiku
English: Patients with nausea, vomiting, diarrhoea and other gastrointestinal toxicities should be carefully monitored, and anti-emetic, anti-diarrhoeal and other measures, such as fluid/electrolyte replacement therapy, should be administered as clinically indicated.
Maltese: Pazjenti bid-dardir, rimettar, dijarea u effetti tossiċi gastrointestinali oħrajn għandhom ikunu mmonitorjati b'attenzjoni, u miżuri kontra t-tqallih, kontra d-dijarea u oħrajn, bħat-terapija ta' sostituzzjoni ta' fluwidu/elettrolit, għandhom ikunu mogħtija kif indikat klinikament.
English: • constipation
Maltese: • ansjetà
English: The efficacy and safety of Lonsurf in metastatic colorectal cancer was compared between a high exposure group (>median) and a low-exposure group (≤median) based on the median AUC value of trifluridine.
Maltese: L-effikaċja u sigurtà ta' Lonsurf fil-kanċer kolorettali metastatiku kienu mqabbla bejn grupp b'esponiment għoli (> medjan) u grupp b'esponiment baxx (≤ medjan) abbażi tal-valur tal-AUC ta' trifluridine.
English: Vertigo Ear discomfort
Maltese: Vertigo Skonfort fil-widnejn
English: Treatment with Lonsurf plus BSC resulted in a statistically significant prolongation of PS <2 in comparison to placebo plus BSC.
Maltese: Il-kura b'Lonsurf kif ukoll BSC irriżultat f'dewmien statistikament sinifikanti ta' PS <2 meta mqabbel ma' plaċebo kif ukoll BSC.
English: • Severe renal impairment (CrCl below 30 mL/min) or end stage renal disease Administration is not recommended in patients with severe renal impairment or end stage renal disease as there are no data available for these patients (see section 4.4).
Maltese: • Indeboliment sever tal-kliewi (CrCl taħt 30 mL/min) jew mard tal-kliewi tal-aħħar stadju L-għoti mhuwiex rakkomandat f'pazjenti b'indeboliment sever tal-kliewi jew mard tal-kliewi tal-aħħar stadju minħabba li ma hemmx data disponibbli għal dawn il-pazjenti (ara sezzjoni 4.4).
English: Lonsurf is used to treat adults with colon or rectal cancer - sometimes called ‘colorectal' cancer and stomach cancer (including cancer of the junction between the oesophagus and the stomach).
Maltese: Lonsurf huwa użat sabiex jikkura adulti b'kanċer tal-kolon u tar-rektum - xi drabi jissejjaħ kanċer ‘kolorettali' u kanċer tal-istonku (inkluż kanċer tal-ġunzjoni bejn l-esofagu u l-istonku).
English: Activated partial thromboplastin time prolonged
Maltese: Ħin ta' thromboplastin parzjali attivat imtawwal
English: The mean relative ratio of AUC in patients with mild (n=38) and moderate (n=16) renal impairment compared to patients with normal renal function (n=84) were 1.31 and 1.43 for trifluridine, respectively, and 1.34 and 1.65 for tipiracil hydrochloride, respectively.
Maltese: 31 u 1.43 għal trifluridine, rispettivament, u 1.34 u 1.65 għal tipiracil hydrochloride, rispettivament.
English: Oesophagitis
Maltese: Reazzjoni avversa
English: Trifluridine is a substrate of TPase, but is not metabolised by cytochrome P450 (CYP).
Maltese: Trifluridine huwa substrat ta' TPase, imma mhuwiex metabolizzat miċ-ċitokromu P450 (CYP). Tipiracil hydrochloride mhuwiex metabolizzat kemm fl-S9 tal-fwied tal-bnedmin jew fiċ-ċelloli talfwied krijopriservati.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1096/004 20 film-coated tablets
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/16/1096/004 20 pillola miksija b'rita
English: The clinical efficacy and safety of Lonsurf were evaluated in an international, randomised, doubleblind, placebo-controlled Phase III study (TAGS) in patients with previously treated metastatic gastric cancer (including adenocarcinoma of the gastroesophageal junction), who had been previously treated with at least two prior systemic treatment regimens for advanced disease, including fluoropyrimidine-, platinum-, and either taxane- or irinotecan-based chemotherapy, plus if appropriate human epidermal growth factor receptor 2 (HER2) -targeted therapy.
Maltese: P<0.0001 permezz ta' test log-rank qabel (inkluż adenokarċinoma tal-ġunzjoni gastroesofagali), li ġew ikkurati qabel b'tal-inqas żewġ korsijiet ta' kura sistemika preċedenti għal marda avvanzata, inkluż kimoterapija bbażata fuq fluoropyrimidine, platinu, u jew tassan jew irinotecan, kif ukoll, jekk xieraq, terapija mmirata lejn riċettur 2 tal-fattur tat-tkabbir epidermali tal-bniedem (HER2).
English: The signs include chills, fever, sweating or other sign of bacterial or fungal infection (see section 2).
Maltese: Issinjali jinkludu tertir, deni, għaraq jew sinjali oħra ta' infezzjoni batterika jew fungali (ara sezzjoni 2).
English: The protein binding of trifluridine in human plasma was over 96% and trifluridine bound mainly to human serum albumin.
Maltese: It-twaħħil tal-proteina ta' trifluridine fil-plażma tal-bnedmin kien ‘il fuq minn 96% u trifluridine imwaħħal prinċiparjament mas-serum tal-bnedmin albumina.
English: Feeling of body temperature change Xerosis
Maltese: Sensazzjoni ta' bidla fit-temperatura tal-ġisem
English: Breath odour
Maltese: Doża talbidu
English: Lonsurf 15 mg/6.14 mg film-coated tablets
Maltese: Lonsurf 15-il mg/6.14 mg pilloli miksija b'rita
English: In the event of haematological and/or non-haematological toxicities patients should follow the dose interruption, resumption and reduction criteria stated in Table 2, Table 3 and Table 4.
Maltese: F'każ ta' tossiċitajiet ematoloġiċi u/jew li mhumiex ematoloġiċi l-pazjenti għandhom isegwu l-kriterja tal-interruzzjoni, it-tkomplija mill-ġdid u t-tnaqqis dikjarata f'Tabella 2, Tabella 3 u Tabella 4.
English: Buccal polyp
Maltese: TAGĦRIF
English: The cytotoxic activity of trifluridine/tipiracil hydrochloride against several human tumour xenografts correlated highly with the amount of trifluridine incorporated into DNA, suggesting this as the primary mechanism of action.
Maltese: L-attività ċitotossoka ta' trifluridine/tipiracil hydrochloride kontra diversi xenografts ta' tumur uman kienet korrelata ħafna mal-ammont ta' trifluridine inkorportat fid-DNA, li jissuġerixxi dan bħala l-mekkaniżmu ewlieni ta' azzjoni.
English: Figure 1- Kaplan-Meier curves of overall survival in patients with metastatic colorectal cancer
Maltese: Kaplan-Meier għas-sopravivenza totali f'pazjenti bil-kanċer kolorettali metastatiku
English: The European Medicines Agency has waived the obligation to submit the results of studies with Lonsurf in all subsets of the paediatric population in refractory metastatic colorectal cancer and in refractory metastatic gastric cancer (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini irrinunzjat għall-obbligu li jiġu ppreżentati r-riżultati tal-istudji b'Lonsurf f'kull sett tal-popolazzjoni pedjatrika fil-kanċer kolorettali metastatiku refrattarju u filkanċer gastriku metastatiku refrattarju (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: • bone pain, muscle pain, muscle weakness or spasms, pain in tendons, nerves or ligaments
Maltese: • uġigħ fl-għadam, uġigħ fil-muskoli, dgħufija fil-muskoli jew spażmi, uġigħ fl-għerq, nervaturi jew ligament
English: Gastrooesophageal reflux disease Proctalgia
Maltese: Marda ta' rifluss gastroosofaġali Proktalġja
English: Mucosal inflammation Malaise
Maltese: Infezzjonijiet u infestazzjonijiet
English: Tipiracil hydrochloride was not metabolised in human liver S9 or in cryopreserved human hepatocytes.
Maltese: Tipiracil hydrochloride ma kienx metabolizzat fl-S9 tal-fwied tal-bnedmin jew fiċ-ċelloli tal-fwied talbnedmin krijopriservati.
English: Renal failure Cystitis noninfective Micturition disorder Haematuria Leukocyturia
Maltese: Deidrazzjoni Ipergliċemija Iperkalimja Ipokalimja Ipofosfatimja Ipernatremja Iponatremja Ipokalċimja Gotta
English: Treatment-related proteinuria occurred more frequently in Lonsurf-treated patients (1.8%) compared to those receiving placebo (0.9%), all of which were Grade 1 or 2 in severity (see section 4.4).
Maltese: Proteinurija relatata mal-kura seħħet b'mod aktar frekwenti f'pazjenti kkurati b'Lonsurf (1.8%) meta mqabbla ma' dawk li rċevew plaċebo (0.9%), fejn kollha kienu ta' Grad 1 jew 2 fis-severità tagħhom (ara sezzjoni 4.4).
English: Bone pain
Maltese: Eλλάδα
English: When Lonsurf at a single dose of 35 mg/m2 was administered to 14 patients with solid tumours after a standardised high-fat, high-calorie meal, trifluridine area under the concentration-time curve (AUC) did not change, but trifluridine Cmax, tipiracil hydrochloride Cmax and AUC decreased by approximately 40% compared to those in a fasting state.
Maltese: Effett tal-ikel Meta Lonsurf b'doża waħda ta' 35 mg/m kien mogħti lil 14-il pazjent b'tumuri solidi wara ikla standardizzata b'kontenut għoli ta' xaħam u kaloriji, l-erja ta' trifluridine taħt il-kurva talkonċentrazzjoni fil-ħin (AUC) ma nbidlitx, imma trifluridine Cmax, tipiracil hydrochloride Cmax u AUC naqsu b'bejn wieħed u ieħor 40% meta mqabbel ma' dawk fi stat tas-sawm.
English: • Swallow the tablets whole with a glass of water.
Maltese: • Ibla l-pilloli sħaħ b'tazza ilma.
English: • a reduced number of platelets in the blood (thrombocytopenia) which are important to stop bleeding and work by clumping and clotting blood vessel injuries
Maltese: • numru mnaqqas ta' plejtlits fid-demm (tromboċitopenija) li huma importanti sabiex iwaqqfu lfsada u jaħdmu billi jgħaqqdu l-korrimenti tal-vini/arterji
English: Amitraz is a formamidine acaricide.
Maltese: Amitraz huwa akariċida formamidine.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients N, N-Diethyl-m-toluamide 1-Methoxy-2-propyl-acetate Dimethyl sulfoxide
Maltese: N, N-Diethyl-m-toluamide 1-Methoxy-2-propyl-acetate Dimethyl sulfoxide 1, 8-Cineole
English: Each ml contains 150 mg metaflumizone and 150 mg amitraz.
Maltese: Kull ml fih 150 mg metaflumizone u 150 mg amitraz.
English: *Due to limited space on the packaging, the abbreviations "S", "M", "M/L", "L" and "XL", which represent "small", “medium”,” medium/large”, “large” and “extra large”, respectively, are used on the blister foil and applicator pipettes.
Maltese: *Minħabba nuqqas ta' spazju, l-abbrevjazzjonijiet “S”, “M”, “M/L”, “L” u “XL”, li jirrappreżentaw “żgħir”, “medju”, “medju/kbir”, “kbir” u “kbir ħafna” rispettivament, huma użati fuq l-istrixxi u l-pipetti tal-applikazzjoni.
English: Metaflumizone is an insecticide belonging to the semicarbazone group of compounds.
Maltese: Metaflumizone huwa insettiċida li jagħmel parti mill-grupp ta' sustanzi semicarbazone.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris Duo M/L
Maltese: VETERINARJU ProMeris Duo M/L
English: For the treatment and prevention of infestations by fleas (Ctenocephalides canis and C. felis), and ticks (Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus, Dermacentor reticulatus and Dermacentor variabilis), and treatment of demodicosis (caused by Demodex spp.)
Maltese: Għall-kura u l-prevenzjoni ta' infestazzjonijiet minn briegħed (Ctenocephalides canis u C. felis) u qurdien (Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus, Dermacentor reticulatus u Dermacentor variabilis), u għall-kura ta' demodikosi (ikkawżata minn Demodex spp.) u tal-qamel
English: ProMeris Duo Spot-on for Small Dogs (≤ 5 kg)*
Maltese: għall-klieb żgħar (≤ 5 kg) *
English: ProMeris Duo 100.5 mg + 100.5 mg Spot-on for small dogs ProMeris Duo 199.5 mg + 199.5 mg Spot-on for medium sized dogs ProMeris Duo 499.5 mg + 499.5 mg Spot-on for medium/large sized dogs ProMeris Duo 799.5 mg + 799.5 mg Spot-on for large dogs ProMeris Duo 999 mg + 999mg Spot-on for extra large dogs
Maltese: mg għall-Użu Lokalizzat għall-klieb żgħar ProMeris Duo 199.5 mg + 199.5 mg għall-Użu Lokalizzat għall-klieb ta' daqs medju ProMeris Duo 499.5 mg + 499.5 mg għall-Użu Lokalizzat għall-klieb ta' daqs medju/kbir ProMeris Duo 799.5 mg + 799.5 mg għall-Użu Lokalizzat għall-klieb kbar ProMeris Duo 999 mg + 999mg għall-Użu Lokalizzat għall-klieb kbar ħafna
English: Box of 1 or 2 blister card of 3 x 0.67 ml pipettes Box of 1 or 2 blister card of 3 x 1.33 ml pipette Box of 1 or 2 blister card of 3 x 3.33 ml pipettes Box of 1 or 2 blister card of 3 x 5.33 ml pipettes Box of 1 or 2 blister card of 3 x 6.66 ml pipettes
Maltese: Kaxxa ta' 1 jew 2 pakketti f'folja ta' 3 x pipetti ta' 0.67 ml Kaxxa ta' 1 jew 2 pakketti f'folja ta' 3 x pipetti ta' 1.33 ml Kaxxa ta' 1 jew 2 pakketti f'folja ta' 3 x pipetti ta' 3.33 ml Kaxxa ta' 1 jew 2 pakketti f'folja ta' 3 x pipetti ta' 5.33 ml Kaxxa ta' 1 jew 2 pakketti f'folja ta' 3 x pipetti ta' 6.66 ml
English: Active substance: 199.5 mg metaflumizone and 199.5 mg amitraz
Maltese: Sustanza attiva: 199.5 mg metaflumizone u 199.5 mg amitraz
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/065/001-010
Maltese: NUMRU(I) TA' L-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/06/065/001-010
English: and lice (Trichodectes canis) in dogs.
Maltese: (Trichodectes canis) fil-klieb.
English: Amitraz is a monoamine oxidase inhibitor (MOAI); therefore, people taking MOAI-containing medication should take particular care when handling this product.
Maltese: Amitraz huwa inibitur ta' monoamine oxidase (MOAI); għalhekk, persuni li qed jieħdu mediċini li fihom MOAI għandhom jimmaniġġjaw dan il-prodott b'attenzjoni speċjali.
English: For further information see package leaflet.
Maltese: Jista' jkun li mhux id-daqsijiet tal-pakketti kollha jitqegħdu fis-suq.
English: Active substance: 999 mg metaflumizone and 999 mg amitraz
Maltese: Sustanza attiva: 999 mg metaflumizone u 999 mg amitraz
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris Duo 999 mg + 999 mg Spot-on for extra large dogs {40.1 - 50.0 kg}
Maltese: VETERINARJU ProMeris Duo 999 mg + 999 mg għall-użu lokalizzat għall-klieb kbar ħafna {40.1 - 50.0 kg}
English: CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 199.5 mg + 199.5 mg
Maltese: 199.5 mg + 199.5 mg
English: Active substance: 799.5 mg metaflumizone and 799.5 mg amitraz
Maltese: Sustanza attiva: 799.5 mg metaflumizone u 799.5 mg amitraz
English: Known side-effects of amitraz and metabolites are sedation, lethargy, CNS depression, hyperglycaemia, bradycardia and slow, shallow breathing.
Maltese: Effetti mhux mixtieqa, magħrufa ta' amitraz u l-metaboliti, huma sedazzjoni, letarġija, depressjoni tasCNS, ipergliċemija, bradikarjda, u nifs baxx u bil-mod.
English: Active substance: 499.5 mg metaflumizone and 499.5 mg amitraz
Maltese: Sustanza attiva: 499.5 mg metaflumizone u 499.5 mg amitraz
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 mediku veterinarju tinstab fuq il-websajt ta' l-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu
English: CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 999 mg + 999 mg
Maltese: 999 mg + 999 mg
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/065/009 - 1 blister card of 3 pipettes of 6.66 ml EU/2/06/065/010 - 2 blister cards of 3 pipettes of 6.66 ml
Maltese: NUMRU/I TA' L-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/06/065/009 - Pakkett f'folja ta' 3 pipetti ta' 6.66 ml EU/2/06/065/010 - Żewġ pakketti f'folja ta' 3 pipetti ta'6.66 ml
English: Box of 1 blister card of 3 x 6.66 ml pipettes Box of 2 blister cards of 3 x 6.66 ml pipettes
Maltese: Kaxxa b'pakkett f'folja ta' 3 x pipetti ta' 6.66 ml Kaxxa b'2 pakketti f'folja ta' 3 x pipetti ta' 6.66 ml
English: No adverse effects were observed in healthy dogs and puppies aged 8 weeks and older treated 7 times at two-week intervals with 3-5 times the recommended dose.
Maltese: l-ebda effetti avversi ma kienu osservati fi klieb b'saħħithom u ġriewi b'età ta' 8 ġimgħat jew aktar trattati 7 darbiet f'intervalli ta' ġimagħtejn b'3-5 darbiet id-doża rakkomandata.
English: The recommended minimum dose is 20 mg/kg bodyweight for each of metaflumizone and amitraz, equivalent to 0.133ml/kg bodyweight.
Maltese: Id-doża minima rakkomandata hija ta' 20 mg/kg piż tal-ġisem għal metaflumizone kif ukoll għal amitraz, ekwivalent għal 0.133 ml/kg piż tal-ġisem.
English: Box of 1 blister card of 3 x 0.67 ml pipettes Box of 2 blister cards of 3 x 0.67 ml pipettes
Maltese: Kaxxa b'pakkett f'folja ta' 3 x pipetti ta' 0.67 ml Kaxxa b'2 pakketti f'folja ta' 3 x pipetti ta' 0.67 ml
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris Duo 199.5 mg + 199.5 mg Spot-on for medium sized dogs {5.1 - 10.0 kg}
Maltese: ProMeris Duo 199.5 mg + 199.5 mg għall-użu lokalizzat għall-klieb ta'daqs medju {5.1 - 10.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/065/005 - 1 blister card of 3 pipettes of 3.33 ml EU/2/06/065/006 - 2 blister cards of 3 pipettes of 3.33 ml
Maltese: NUMRU/I TA' L-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/06/065/005 - Pakkett f'folja ta' 3 pipetti ta' 3.33 ml EU/2/06/065/006 - Żewġ pakketti f'folja ta' 3 pipetti ta' 3.33 ml
English: for Small Dogs (≤ 5 kg) for Medium Sized Dogs - (5.1 - 10.0 kg) for Medium/Large Sized Dogs (10.1 - 25.0 kg) for Large Dogs (25.1 - 40.0 kg) for Extra Large Dogs (40.1 - 50.0 kg)
Maltese: kg) Ghall-Klieb Kbar (25.1 - 40.0 kg) Ghall-Klieb Kbar Ħafna (40.1 - 50.0 kg)
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris Duo 799.5 mg + 799.5 mg Spot-on for large dogs {25.1 - 40.0 kg}
Maltese: ProMeris Duo 799.5 mg + 799.5 mg għall-użu lokalizzat għall-klieb kbar {25.1 - 40.0 kg}
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris Duo 499.5 mg + 499.5 mg Spot-on for medium/large sized dogs {10.1 - 25.0 kg}
Maltese: ProMeris Duo 499.5 mg + 499.5 mg għall-użu lokalizzat għall-klieb ta'daqs medju/kbir {10.1 - 25.
English: CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 499.5 mg + 499.5 mg
Maltese: 499.5 mg + 499.5 mg
English: CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 799.5 mg + 799.5 mg
Maltese: 799.5 mg + 799.5 mg
English: Excipients
Maltese: IEĦOR
English: CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 100.5 mg + 100.5 mg
Maltese: 100.5 mg + 100.
English: ProMeris Duo contains components that, on very rare occasions, can cause respiratory irritation in certain people.
Maltese: ProMeris Duo fih komponenti li f'okkażjonijiet rari ħafna jistgħu jikkawżaw irritazzjoni respiratorja f'xi individwi.
English: ProMeris Duo Spot-on for Medium/Large Sized Dogs (10.1 - 25.0 kg)*
Maltese: kg) * għall-klieb ta' daqs medju/kbir (10.1 - 25.0 kg)
English: Pharmacotherapeutic group: Ectoparasiticides for topical use, ATC Vet Code QP 53AD51
Maltese: Ektoparasitiċidi għall-użu fuq il-ġilda, Kodici ATĊ veterinarja QP
English: The solvent in ProMeris Duo may stain certain materials including leather, fabrics, plastics and finished surfaces.
Maltese: Is-solvent li hemm f'Promeris Duo jista' jtebba' xi materjali bħalma hi l-ġilda, tessuti, plastiks u uċuħ iffinixxjati.
English: In very rare cases, pemphigus foliaceous-like cutaneous signs have been reported.
Maltese: F'każijiet rari ħafna ġew irrapportati sinjali kutanji li huma bħal pemphigus foliaceous.
English: PACKAGE LEAFLET
Maltese: PAKKETT
English: The veterinary medicinal product will prevent flea infestation for up to 6 weeks and tick infestation for 4 weeks following a single administration.
Maltese: Il-prodott mediċinali veterinarju iwaqqaf l-infestazzjoni mill-briegħed sa 6 ġimgħat u l-infestazzjoni tal-qurdien għal 4 ġimgħat wara amministrazzjoni waħda.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS FOIL 6.66ml
Maltese: FOLJA 6.66 ml
English: Box of 1 blister card of 3 x 5.33 ml pipettes Box of 2 blister cards of 3 x 5.33 ml pipettes
Maltese: Kaxxa b'pakkett f'folja ta' 3 x pipetti ta' 5.33 ml Kaxxa b'2 pakketti f'folja ta' 3 x pipetti ta' 5.33 ml
English: Remove the pipette from the package.
Maltese: jippersisti għal aktar fit-tul.
English: 1, 8-Cineole
Maltese: 1 L-ISEM
English: Active substance: 100.5 mg metaflumizone and 100.5 mg amitraz
Maltese: mg metaflumizone u 100.5 mg amitraz
English: Correct application will minimise licking of the application site.
Maltese: Applikazzjoni korretta tnaqqas li l-annimal jilgħaq il-post ta' l-applikazzjoni.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS FOIL 0.67ml
Maltese: FOLJA 0.67 ml