natgillin/translations-raw huggingface dataset:
• 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).
U pacientov s ťažkou poruchou funkcie obličiek alebo terminálnym štádiom ochorenia obličiek sa podávanie neodporúča, pretože k dispozícii nie sú žiadne údaje, týkajúce sa týchto pacientov (pozri časť 4.4).
• raised itchy rash, red skin, blisters, skin sloughing off, hives, acne
• rozšírená svrbiaca vyrážka, sčervenanie pokožky, pľuzgiere, odlupovanie kože, žihľavka, akné
Enterocolitis haemorrhagic Gastrointestinal haemorrhage Pancreatitis acute Ascites
Akútna pankreatitída Ascites
Following a single dose of Lonsurf (35 mg/m2) 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.
Po jednorazovej dávke Lonsurfu (35 mg/m2) pacientom s pokročilými solídnymi tumormi bol priemerný čas dosiahnutia maximálnej plazmatickej koncentrácie (tmax) trifluridínu približne 2 hodiny a tipiracilhydrochloridu približne 3 hodiny.
mild (CrCl = 60 to 89 mL/min) or moderate (CrCl = 30 to 59 mL/min) renal impairment subgroups.
90 ml/min), s miernou (CrCl = 60 až 89 ml/min) alebo stredne ťažkou (CrCl =
Figure 1- Kaplan-Meier curves of overall survival in patients with metastatic colorectal cancer
Obrázok 1 - Kaplanove-Meierove krivky celkového prežívania u pacientov s metastatickým kolorektálnym karcinómom
Hazard ratio [95% CI] P-valuec
%, p-hodnota =
An OS analysis of the study, carried out as planned at 76% (N = 384) of events, demonstrated that Lonsurf plus BSC resulted in a statistically significant improvement in OS compared to placebo plus BSC with an hazard ratio (HR) of 0.69 (95% CI: 0.56, 0.85; 1- and 2-sided p-values were 0.0003 and 0.0006, respectively) corresponding to a 31% reduction in the risk of death in the Lonsurf group.
384) príhod ukázala, že Lonsurf plus BSC predstavovalo štatisticky významné zlepšenie v OS v porovnaní so skupinou placebo plus BSC s mierou rizika (HR) 0,69 (95 % interval spoľahlivosti [IS]: 0,56, 0,85; 1-stranná a 2-stranná phodnota boli 0,0003 a 0,0006), čo zodpovedá 31
• bloating, passing gas, indigestion
• nafukovanie, plynatosť, porucha trávenia
The clinical efficacy and safety of Lonsurf were evaluated in an international, randomised, doubleblind, placebo-controlled Phase III study (RECOURSE) in patients with previously treated metastatic colorectal cancer.
Lonsurfu bola hodnotená v medzinárodnej randomizovanej dvojito zaslepenej placebom kontrolovanej štúdii III. fázy (RECOURSE)
KRAS status was wild (49%) or mutant (51%) at study entry.
%) alebo mutovaný (51
Musculoskeletal pain Muscular weakness Muscle spasms Pain in extremity
Svalová slabosť Svalové spazmy
Lonsurf 15 mg/6.14 mg film-coated tablets Lonsurf 20 mg/8.19 mg film-coated tablets trifluridine/tipiracil
Písomná informácia pre používateľa Lonsurf 15 mg/6,14 mg filmom obalené tablety Lonsurf 20 mg/8,19 mg filmom obalené tablety trifluridín/tipiracil
Figure 3- Kaplan-Meier curves of overall survival in patients with metastatic gastric cancer
Obrázok 3 - Kaplanove-Meierove krivky celkového prežívania u pacientov s metastatickým karcinómom žalúdka
Figure 4 - Kaplan-Meier curves of progression-free survival in patients with metastatic gastric cancer
Obrázok 4 - Kaplanove-Meierove krivky prežívania bez progresie u pacientov s metastatickým karcinómom žalúdka
Thrombocytopenia
Pancytopénia Granulocytopénia
Level 3 dose reduction: From 25 mg/m2 to 20 mg/m2 20 mg/m
: od 25 mg/m do 20 mg/m20 mg/m a
Resumption criteriaa
Kritérium pokračovania a
NAME OF THE MEDICINAL PRODUCT Lonsurf 20 mg/8.19 mg film-coated tablets trifluridine/tipiracil
Lonsurf 20 mg/8,19 mg filmom obalené tablety trifluridín/tipiracil
NAME OF THE MEDICINAL PRODUCT Lonsurf 15 mg/6.14 mg film-coated tablets trifluridine/tipiracil
Lonsurf 15 mg/6,14 mg filmom obalené tablety trifluridín/tipiracil
Enteritis infectious Lung infection
Infekčná enteritída
15 mg/6.14 mg 20 mg/8.19 mg
20 mg/8,19 mg
Cancer pain
Karcinóm žalúdka
• Mild renal impairment (CrCl 60 to 89 mL/min) or moderate renal impairment (CrCl 30 to
Mierna porucha funkcie obličiek (CrCl 60 až 89 ml/min) alebo stredne ťažká porucha funkcie obličiek (CrCl 30 až 59 ml/min)
Eighteen percent (18%, N = 144) of all randomised patients received regorafenib prior to randomisation.
144) zo všetkých randomizovaných pacientov užívalo pred randomizáciou regorafenib.
40 film-coated tablets
20 filmom obalených tabliet 40 filmom obalených tabliet 60 filmom obalených tabliet
Table 6 - Efficacy results from the Phase III (RECOURSE) clinical trial in patients with metastatic colorectal cancer
Tabuľka 6- Výsledky účinnosti z klinického skúšania III. fázy (RECOURSE)
Nail Disorder
Porucha nechtov
• you have kidney problems
• ak máte problémy s obličkami
Hepatic impairment
Nádorová bolesť
Following a single dose of Lonsurf (35 mg/m2) in patients with advanced solid tumours, the apparent volume of distribution (Vd/F) for trifluridine and tipiracil hydrochloride was 21 L and 333 L, respectively.
Väzba tipiracilhydrochloridu na bielkoviny plazmy bola menej ako 8 %. Po jednorazovom podaní Lonsurfu (35 mg/m2) pacientom s pokročilými solídnymi tumormi bol zjavný distribučný objem (Vd/F) trifluridínu 21 l a tipiracilhydrochloridu 333 l.
Among these patients, the OS benefit with Lonsurf was maintained (hazard ratio: 0.69, 95% CI [0.45 to 1.05]).
Medzi týmito pacientmi bol prínos Lonsurfu pre OS zachovaný (miera rizika: 0,69; 95
Tinea pedis
Plesňová infekcia nôh (Tinea pedis)
EU/1/16/1096/005 40 film-coated tablets
EU/1/16/1096/004 20 filmom obalených tabliet EU/1/16/1096/005 40 filmom obalených tabliet EU/1/16/1096/006 60 filmom obalených tabliet
Blood lactate dehydrogenase increased
Zvýšenie laktátdehydrogenázy v krvi
Figure 2 - Kaplan-Meier curves of progression-free survival in patients with metastatic colorectal cancer
Kaplanove-Meierove krivky prežívania bez progresie u pacientov s metastatickým kolorektálnym karcinómom
Flatulence
Glositída
Abdominal pain Constipation Stomatitis Oral disorder
Porucha vyprázdňovania žalúdka Abdominálna distenzia
An OS analysis of the study, carried out as planned at 72% (N = 574) of events, demonstrated a clinically meaningful and statistically significant survival benefit of Lonsurf plus BSC compared to placebo plus BSC (hazard ratio: 0.68; 95% confidence interval [CI] [0.58 to 0.81]; p < 0.0001) and a median OS of 7.1 months vs 5.3 months, respectively; with 1-year survival rates of 26.6% and 17.6%, respectively.
574) príhod ukázala klinicky a štatisticky významný prínos v prežívaní v skupine Lonsurf plus BSC v porovnaní so skupinou placebo plus BSC (miera rizika: 0,68; 95 % interval spoľahlivosti [IS] [0,58 až 0,81]; p <
• swelling or pain in your joints or big toes
• opuch alebo bolesť kĺbov alebo palcov na nohách
An updated OS analysis, carried out at 89% (N = 712) of events, confirmed the clinically meaningful and statistically significant survival benefit of Lonsurf plus BSC compared to placebo plus BSC (hazard ratio: 0.69; 95% CI [0.59 to 0.81]; p < 0.0001) and a median OS of 7.2 months vs 5.2 months; with 1-year survival rates of 27.1% and 16.6%, respectively.
712) príhod potvrdila klinicky a štatisticky významný prínos v prežívaní v skupine Lonsurf plus BSC v porovnaní so skupinou placebo plus BSC (miera rizika: 0,69; 95 % IS [0,59 až 0,81]; p <
Mucosal inflammation Malaise
Vyrážka Alopécia Svrbenie
What Lonsurf contains Lonsurf 15 mg/6.14 mg tablet
Lonsurf 15 mg/6,14 mg tableta
15 mg/6.14 mg 20 mg/8.19 mg Level 1 dose reduction: From 35 mg/m2 to 30 mg/m2 30 mg/m2
Úroveň 1 redukcie dávky: od 35 mg/m do 30 mg/m
Patients 65 years of age or older who received Lonsurf had a higher incidence of the following events compared to patients younger than 65 years: - metastatic colorectal cancer (RECOURSE): Grade 3 or 4 neutropenia (48% vs 30%), Grade 3 anaemia (26% vs 12%), Grade 3 or 4 leukopenia (26% vs 18%) and Grade 3 or 4 thrombocytopenia (9% vs 2%), - metastatic gastric cancer (TAGS): Grade 3 or 4 neutrophil count decrease (17.0% vs 6.6%), decreased appetite (37.3% vs 31.9%), asthenia (22.2% vs 17.0%) and stomatitis (7.2% vs 2.2%).
%) a trombocytopénia stupňa 3 alebo 4 (9 % vs 2 %), - metastatický karcinóm žalúdka (TAGS): 3 alebo 4 stupeň zníženia počtu neutrofilov (17,0
Number of deaths, N (%) Median OS (months)a [95% CI]b
Počet úmrtí, N (%)
• CTCAE* Grade 4 neutropenia (< 0.5 x 109/L) or thrombocytopenia (< 25 × 109/L) that results in more than 1 week's delay in start of next cycle
CTCAE*, ktorá vedie k oddialeniu začiatku nasledujúceho cyklu o viac ako 1 týždeň
Of the 533 patients in the RECOURSE study who received Lonsurf, 306 (57%) patients had normal renal function (CrCl ≥ 90 mL/min), 178 (33%) patients had mild renal impairment (CrCl 60 to 89 mL/min), and 47 (9%) had moderate renal impairment (CrCl 30 to 59 mL/min), with data missing for 2 patients.
%) pacientov malo miernu poruchu funkcie obličiek (CrCl 60 až 89 ml/min) a 47 (9
Monitoring of proteinuria by dipstick urinalysis is recommended prior to starting and during therapy (see section 4.8).
Pred začatím liečby a počas nej sa odporúča sledovanie proteinúrie pomocou analýzy moču (pozri časť
• skin flushing
• sčervenanie pokožky
Hazard ratio for death, 0.68 (95% CI, 0.58-0.81) P<0.0001
SI: 0,562, 0,854), p-hodnota =
The primary site of disease was colon (62%) or rectum (38%).
%) alebo rektum (38
• rash, itchy or flaky skin
• vyrážka, svrbenie alebo šupinatenie kože
In total, 507 patients were randomised 2:1 to receive Lonsurf (N = 337) plus best supportive care (BSC) or placebo (N = 170) plus BSC. Lonsurf dosing was based on BSA with a starting dose of 35 mg/m2/dose.
Celkovo bolo randomizovaných 507 pacientov v pomere 2:1, ktorí dostávali Lonsurf (N =
Blood alkaline phosphatase increased Weight decreased
Zvýšenie alkalickej fosfatázy v krvi
Hepatobiliary disorders
Hemoragická enterokolitída
Diarrhoea Nausea Vomiting
Orofaryngeálna bolesť Epistaxa
In total, 800 patients were randomised 2:1 to receive Lonsurf (N = 534) plus best supportive care (BSC) or matching placebo (N = 266) plus BSC. Lonsurf dosing was based on BSA with a starting dose of 35 mg/m2/dose.
Celkovo bolo randomizovaných 800 pacientov v pomere 2:1, ktorí dostávali Lonsurf (N =
Most of these signs are due to alpha-2adreno-receptor agonist effects.
Väčšina týchto nežiaducich účinkov je spôsobená účinkom alfa - 2 - adreno- receptorových agonistov.
Metaflumizone is an insecticide belonging to the semicarbazone group of compounds.
Metaflumizon je insekticíd patriaci do semikarbazónovej skupiny.
For a full list of excipients, see section 6.1.
Pomocné látky Úplný zoznam pomocných látok je uvedený v časti 6.1.
The solvent in ProMeris Duo may stain certain materials including leather, fabrics, plastics and finished surfaces.
Duo môže vytvárať škvrny na niektorých materiáloch, vrátane kože, tkanín, umelých hmôt a dokončených povrchov.
MARKETING AUTHORISATION NUMBER(S) EU/2/06/065/001-010
POVOLENIA NA UVEDENIE NA TRH EU/2/06/065/001-010
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.)
Liečba a prevencia zamorenia blchami (Ctenocephalides canis a C. felis) a kliešťami (Ixodes ricinus, Ixodes hexagonus,Rhipicephalus sanguineus,Dermacentor reticulatus a Dermacentor variabilis), a liečba demodikózy (spôsobenej Demodex spp.) a všivavosti (Trichodectes canis) pri psoch.
Gamma-hexalactone
Gamma-hexalactone 6.2 Inkompatibility
Amitraz is a monoamine oxidase inhibitor (MOAI); therefore, people taking MOAI-containing medication should take particular care when handling this product.
Amitraz je inhibítor monoaminoxidázy (MAOI), preto ľudia užívajúci lieky, ktoré obsahujú MAOinhibítory, musia byť veľmi opatrní pri ošetrovaní psa týmto liekom.
For use only under the supervision of a veterinary surgeon.
Používať iba pod dohľadom veterinárneho lekára.
*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.
„M/L“, „L“ a „XL“, ktoré predstavujú „malé“, „stredné“, „stredné/veľké“, „veľké“ a „extra veľké“.
Treatment with other products containing amitraz is not recommended whilst the dog is being treated with ProMeris Duo Spot-On for Dogs.
Liečba inými liekmi obsahujúcimi amitraz sa neodporúča, pokiaľ je pes ošetrený liekom ProMeris
PHARMACEUTICAL PARTICULARS 6.1 List of excipients N, N-Diethyl-m-toluamide 1-Methoxy-2-propyl-acetate Dimethyl sulfoxide
N,N-Diethyl-m-toluamide 1- Methoxy-2-propylacetate
*- Very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - Common (more than 1 but less than 10 animals in 100 animals) - Uncommon (more than 1 but less than 10 animals in 1,000 animals ) - Rare (more than 1 but less than 10 animals in 10,000 animals) - Very rare (less than 1 animal in 10,000 animals, including isolated reports).
* Veľmi časté (viac ako 1 z 10 zvierat prejavilo nežiaduci účinok (účinky) počas jedného ošetrenia) Časté (viac ako 1, ale menej ako 10 zvierat zo 100 zvierat)
Dogs over 8 weeks of age
Psy staršie ako 8 týždňov veku.
For optimal control of flea and/or tick infestation the product should be administered at monthly intervals throughout the flea and/or tick season, or the treatment schedule can be based on the local epidemiological situation.
Pre optimálnu kontrolu zamorenia blchami a /alebo kliešťami je potrebné podávať liek v mesačnom intervale alebo podľa lokálnej epidemiologickej situácie.
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
ProMeris Duo 100,5 mg + 100,5 mg Spot-on pre malé psy ProMeris Duo 199,5 mg + 199,5 mg Spot-on pre stredné psy ProMeris Duo 499,5 mg + 499,5 mg Spot-on pre stredné / veľké psy ProMeris Duo 799,5 mg + 799,5 mg Spot-on pre veľké psy ProMeris Duo 999 mg + 999 mg Spot-on pre extra veľké psy
Do not apply the veterinary medicinal product to the surface of the dog's hair coat.
Veterinárny liek nikdy neaplikujte na vonkajšiu vrstvu srsti psa.
ProMeris Duo contains components that, on very rare occasions, can cause respiratory irritation in certain people.
Duo obsahuje zložky, ktoré vo veľmi zriedkavých prípadoch môžu spôsobiť podráždenie dýchacích ciest u precitlivených ľudí.
Each unit dose (pipette) of ProMeris Duo delivers: ProMeris Duo Spot-on for Dogs
Každá dávka pipety ProMeris Duo obsahuje: ProMeris Duo Spot-on pre psy
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE Veterinary medicinal product subject to prescription The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Držiteľ tohto marketingového oprávnenia musí informovať Európsku komisiu o marketingových plánoch lieku schváleného týmto rozhodnutím
1, 8-Cineole
Dimethyl sulfoxide 1,8-Cineole
Dogs should be prevented from accessing streams and rivers for the 24-hour period following treatment.
Psy nesmú mať prístup k potokom a riekam 24 hodín po ošetrení liekom.V prípade častého pôsobenia vody môže byť účinnosť lieku znížená.
The recommended minimum dose is 20 mg/kg bodyweight for each of metaflumizone and amitraz, equivalent to 0.133ml/kg bodyweight.
Odporúčaná minimálna dávka je 20 mg metaflumizonu a 20 mg amitrazu / kg živej hmotnosti,
Do not store above 25 °C
Uchovávať pri teplote neprevyšujúcej 25°C
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each 6.66 ml pipette delivers:
Každá pipeta s objemom 6,66 ml obsahuje:
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS Active substances
ZLOŽENIE: ÚČINNÉ LÁTKY A POMOCNÉ LÁTKY
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each 0.67 ml pipette delivers:
Každá pipeta s objemom 0,67 ml obsahuje:
Special precautions for use in animals
Osobitné upozornenia pre cieľové druhy
The MAH must ensure that the system of pharmacovigilance, as described in Part I of the marketing authorisation application, is in place and functioning before and whilst the veterinary medicinal product is on the market.
I žiadosti o registráciu ako aj jeho fungovanie pred uvedením lieku na trh a počas celého obdobia, pokiaľ je veterinárny liek na trhu.
Pharmacotherapeutic group: Ectoparasiticides for topical use, ATC Vet Code QP 53AD51
Farmakoterapeutická skupina: ektoparazitikum kód ATCvet:
Maximum efficacy is achieved within 48 hours.
Maximálna účinnosť sa dosiahne do 48 hodín po podaní. 5.2 Farmakokinetické vlastnosti
The risk of experiencing adverse effects may however increase when overdosing, so animals should always be treated with the correct pipette size according to body weight.
Nebezpečenstvo predávkovania nastáva pri nesprávne zvolenej veľkosti pipety v závislosti od živej hmotnosti psa.
PHARMACEUTICAL FORM Spot-on solution
A SPÔSOB PODANIA LIEKU
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Osobitné bezpečnostné opatrenia, ktoré má urobiť osoba podávajúca liek zvieratám Uchovávajte mimo dosahu detí.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton box for 1 blister card - Carton box for 2 blister cards
Papierová škatuľa na 1 blister - Papierová škatuľa na 2 blistre
MINIMUM PARTICULARS TO APPEAR ON PIPETTES for extra large dogs
Duo pre veľké psy ProMeris Duo pre extra veľké psy
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}
ProMeris Duo 199,5 mg + 199,5 mg Spot-on pre stredné psy (5,1 - 10,0 kg)
NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris Duo 100.5 mg + 100.5 mg Spot-on for small dogs {≤ to 5 kg}
ProMeris Duo 100,5 mg + 100,5 mg Spot-on pre malé psy (≤
ADVERSE REACTION*
ÚČINKY*
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS FOIL 0.67ml
STRIPOCH Fólia 0,67 m
Pharmacovigilance system
FARMACEUTICKÉ ÚDAJE
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS FOIL 6.66ml
STRIPOCH Fólia 6.66 ml
NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris Duo 999 mg + 999 mg Spot-on for extra large dogs {40.1 - 50.0 kg}
ProMeris Duo 999 mg + 999 mg Spot-on pre extra veľké psy (40,1 - 50,0 kg)
4.7 Use during pregnancy, lactation or lay
Použitie počas gravidity, laktácie, znášky Môže byť použitý počas gravidity a laktácie.
Maximum concentrations in the hair were generally reached between 2 to 7 days post treatment and gradually declined through 56 days post treatment.
dňami po ošetrení a pozvoľne klesá počas 56 dní po ošetrení.
NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris Duo 799.5 mg + 799.5 mg Spot-on for large dogs {25.1 - 40.0 kg}
ProMeris Duo 799,5 mg + 799,5 mg Spot-on pre veľké psy (25,1 - 40,0 kg)
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each 5.33 ml pipette delivers:
Každá pipeta s objemom 5,33 ml obsahuje:
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 999 mg + 999 mg
999 mg + 999 mg
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each 1.33 ml pipette delivers:
Každá pipeta s objemom 1,33 ml obsahuje:
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}
ProMeris Duo 499,5 mg + 499,5 mg Spot-on pre stredné / veľké psy (10,1 - 25,0 kg)
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 100.5 mg + 100.5 mg
100,5 mg + 100,5 mg
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each 3.33 ml pipette delivers:
Každá pipeta s objemom 3,33 ml obsahuje:
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS FOIL 5.33ml
STRIPOCH Fólia 5.33 ml
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 799.5 mg + 799.5 mg
799,5 mg + 799,5 mg
NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris Duo M/L
ProMeris Duo M/L
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 499.5 mg + 499.5 mg
499,5 mg + 499,5 mg
ProMeris Duo Spot-on for Extra Large Dogs (40.1 - 50.0 kg)*
pre extra veľké psy (40,1 - 50,0 kg)*
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
EU/2/06/065/009 - 1 blister s 3 pipetami s objemom 6,66 ml EU/2/06/065/010 - 2 blistre s 3 pipetami s objemom 6,66 ml
MINIMUM PARTICULARS TO APPEAR ON PIPETTES for medium sized dogs
Duo pre malé psy ProMeris Duo pre stredné psy
Excipients
ŠARŽE
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 199.5 mg + 199.5 mg
199,5 mg + 199,5 mg
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS FOIL 1.33ml
STRIPOCH Fólia 1.33 m
MARKETING AUTHORISATION NUMBER(S) EU/2/06/065/007 - 1 blister card of 3 pipettes of 5.33 ml EU/2/06/065/008 - 2 blister cards of 3 pipettes of 5.33 ml
EU/2/06/065/007 - 1 blister s 3 pipetami s objemom 5,33 ml EU/2/06/065/008 - 2 blistre s 3 pipetami s objemom 5,33 ml
ProMeris Duo Spot-on for Medium/Large Sized Dogs (10.1 - 25.0 kg)*
pre stredné / veľké psy (10,1 - 25,0 kg)*
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)
5 kg) pre stredné psy (5,1 - 10,0 kg)
MARKETING AUTHORISATION NUMBER(S) EU/2/06/065/001 - 1 blister card of 3 pipettes of 0.67ml EU/2/06/065/002 - 2 blister cards of 3 pipettes of 0.67ml
EU/2/06/065/001 - 1 blister s 3 pipetami s objemom 0,67 ml EU/2/06/065/002 - 2 blistre s 3 pipetami s objemom 0,67 ml
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
EU/2/06/065/005 - 1 blister s 3 pipetami s objemom 3,33 ml EU/2/06/065/006 - 2 blistre s 3 pipetami s objemom 3,33 ml
ProMeris Duo Spot-on for Large Dogs (25.1 - 40.0 kg)*
pre veľké psy (25,1 - 40,0 kg)*
MARKETING AUTHORISATION NUMBER(S) EU/2/06/065/003 - 1 blister card of 3 pipettes of 1.33ml EU/2/06/065/004 - 2 blister cards of 3 pipettes of 1.33ml
EU/2/06/065/003- 1 blister s 3 pipetami s objemom 1,33 ml EU/2/06/065/004- 2 blistre s 3 pipetami s objemom 1,33 ml
ProMeris Duo Spot-on for Medium Sized Dogs(5.1 - 10.0 kg)*
5 kg)* pre stredné psy (5,1 - 10,0 kg)*
MINIMUM PARTICULARS TO APPEAR ON PIPETTES for medium/large sized dogs
Pre stredné / veľké psy
Do not apply the medicine to the surface of the dog's hair coat.
Preto sa liek nesmie dostať na kožu človeka.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS FOIL 3.33ml
STRIPOCH Fólia 3.33 m
and lice (Trichodectes canis) in dogs.
pre malé psy (≤
NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris Duo S
Duo pre stredné / veľké psy ProMeris
MINIMUM PARTICULARS TO APPEAR ON PIPETTES for large dogs
Duo pre veľké psy
In addition, injections do not need to be given frequently because the implant stays in the eye for several months.
Okrem toho sa injekcie nemusia podávať často, pretože implantát zostáva v oku počas niekoľkých mesiacov.
Ozurdex received a marketing authorisation valid throughout the European Union on 27 July 2010.
Lieku Ozurdex bolo dňa 27. júla 2010 udelené povolenie na uvedenie na trh platné v celej EÚ.
Patients were followed up for 3 years and could be given repeat treatment if appropriate.
Pacienti boli sledovaní 3 roky a ak sa to považovalo za vhodné, mohli dostať opakovanú liečbu.
Further information on Ozurdex can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/ozurdex.
Ozurdex sa nachádzajú na webovej stránke agentúry: ema.europa.eu/medicines/human/EPAR/ozurdex.
• blockage of the veins carrying blood from the back of the eye;
• so zablokovaním žíl odvádzajúcich krv zo zadnej časti oka,
Further treatments can be given if the patient's condition improves but then gets worse and if the doctor believes that the patient will benefit from further treatment.
V liečbe možno pokračovať, ak ochorenie pacienta najprv odpovie na liečbu, ale neskôr sa zhorší a ak sa lekár domnieva, že ďalšia liečba bude pre pacienta prínosom.