FrancophonIA/ELRC3.0 huggingface dataset:
English: The dose of atorvastatin should not exceed a daily dose of 20 mg when co-administered with ZEPATIER.
Polish: W przypadku jednoczesnego podawania z produktem leczniczym ZEPATIER, nie należy przekraczać dobowej dawki atorwastatyny wynoszącej 20 mg.
English: If you have any questions about your medicines, please ask your doctor or pharmacist.
Polish: W razie jakichkolwiek wątpliwości dotyczących przyjmowanych leków, należy zwrócić się do lekarza lub farmaceuty.
English: Film-coating Lactose monohydrate Hypromellose Titanium dioxide Triacetin
Polish: Tytanu dwutlenek Triacetyna
English: ↔ Elbasvir AUC 1.05 (0.93, 1.18) Cmax 1.02 (0.92, 1.14) C24 1.03 (0.92, 1.17)
Polish: ↔ Elbaswir AUC 1,05 (0,93; 1,18) Cmax 1,02 (0,92; 1,14) C24 1,03 (0,92; 1,17)
English: Rifampicin (600 mg IV single dose)/ elbasvir (50 mg single dose)
Polish: Ryfampicyna (dawka pojedyncza 600 mg dożylnie)/ elbaswir (dawka pojedyncza 50 mg)
English: ↔ Grazoprevir AUC 0.79 (0.68, 0.91) Cmax 0.57 (0.40, 0.83) C24 0.77 (0.61, 0.99)
Polish: ↔ Grazoprewir AUC 0,79 (0,68; 0,91) Cmax 0,57 (0,40; 0,83) C24 0,77 (0,61; 0,99)
English: ↔ Naloxone AUC 0.88 (0.76, 1.02) Cmax 0.85 (0.66, 1.09)
Polish: ↔ Nalokson AUC 0,88 (0,76; 1,02) Cmax 0,85 (0,66; 1,09)
English: ↔ Grazoprevir AUC 0.89 (0.72, 1.09) Cmax 0.85 (0.62, 1.16) C24 0.90 (0.82, 0.99)
Polish: ↔ Grazoprewir AUC 0,89 (0,72; 1,09) Cmax 0,85 (0,62; 1,16) C24 0,90 (0,82; 0,99)
English: ↔ Efavirenz AUC 0.82 (0.78, 0.86) Cmax 0.74 (0.67, 0.82) C24 0.91 (0.87, 0.96)
Polish: ↔ Efawirenz AUC 0,82 (0,78; 0,86) Cmax 0,74 (0,67; 0,82) C24 0,91 (0,87; 0,96)
English: Midazolam (2 mg single dose)/ grazoprevir (200 mg once daily)
Polish: Midazolam (dawka pojedyncza 2 mg)/ grazoprewir (200 mg raz na dobę)
English: ↔ Grazoprevir AUC 0.98 (0.89, 1.07) Cmax 0.97 (0.83, 1.14) C24 1.00 (0.93, 1.07)
Polish: ↔ Grazoprewir AUC 0,98 (0,89; 1,07) Cmax 0,97 (0,83; 1,14) C24 1,00 (0,93; 1,07)
English: ↔ Grazoprevir AUC 1.09 (0.95, 1.25) Cmax 1.34 (1.10, 1.62) C24 0.93 (0.87, 1.00)
Polish: ↔ Grazoprewir AUC 1,09 (0,95; 1,25) Cmax 1,34 (1,10; 1,62) C24 0,93 (0,87; 1,00)
English: ↔ Grazoprevir AUC 0.81 (0.70, 0.95) Cmax 0.72 (0.57, 0.92) C24 0.91 (0.82, 1.01)
Polish: ↔ Grazoprewir AUC 0,81 (0,70; 0,95) Cmax 0,72 (0,57; 0,92) C24 0,91 (0,82; 1,01)
English: ↔ Darunavir AUC 1.11 (0.99, 1.24) Cmax 1.10 (0.96, 1.25) C12 1.00 (0.85, 1.18)
Polish: ↔ Darunawir AUC 1,11 (0,99; 1,24) Cmax 1,10 (0,96; 1,25) C12 1,00 (0,85; 1,18)
English: ↔ Grazoprevir AUC 0.74 (0.60, 0.92) Cmax 0.58 (0.42, 0.82) C24 0.97 (0.89, 1.06)
Polish: ↔ Grazoprewir AUC 0,74 (0,60; 0,92) Cmax 0,58 (0,42; 0,82) C24 0,97 (0,89; 1,06)
English: Mycophenolate mofetil (1,000 mg single dose)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily)
Polish: Mykofenolan mofetylu (dawka pojedyncza 1000 mg)/ elbaswir (50 mg raz na dobę)/ grazoprewir (200 mg raz na dobę)
English: ↔ Elbasvir AUC 1.17 (0.98, 1.39) Cmax 1.29 (1.06, 1.58) C24 1.21 (1.03, 1.43)
Polish: ↔ Elbaswir AUC 1,17 (0,98; 1,39) Cmax 1,29 (1,06; 1,58) C24 1,21 (1,03; 1,43)
English: ↔ Grazoprevir AUC 1.01 (0.79, 1.28) Cmax 0.97 (0.63, 1.50) C24 0.95 (0.87, 1.04)
Polish: ↔ Grazoprewir AUC 1,01 (0,79; 1,28) Cmax 0,97 (0,63; 1,50) C24 0,95 (0,87; 1,04)
English: Rilpivirine (25 mg once daily)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily)
Polish: Rylpiwiryna (25 mg raz na dobę)/ elbaswir (50 mg raz na dobę)/ grazoprewir (200 mg raz na dobę)
English: In genotype 4 replicons, single NS3 substitutions D168A/V reduced grazoprevir antiviral activity by 110to 320-fold.
Polish: W replikonach genotypu 4 pojedyncze podstawienia D168A/V w NS3 powodowały 110- do
English: ↔ Grazoprevir AUC 1.12 (0.96, 1.30) Cmax 1.10 (0.89, 1.37) C24 1.17 (1.02, 1.34)
Polish: ↔ Grazoprewir AUC 1,12 (0,96; 1,30) Cmax 1,10 (0,89; 1,37) C24 1,17 (1,02; 1,34)
English: ↔ Elbasvir AUC 0.81 (0.57, 1.17) Cmax 0.89 (0.61, 1.29) C24 0.80 (0.55, 1.16)
Polish: ↔ Elbaswir AUC 0,81 (0,57; 1,17) Cmax 0,89 (0,61; 1,29) C24 0,80 (0,55; 1,16)
English: Talk to your doctor or pharmacist before taking ZEPATIER if you have ever taken any medicines for hepatitis C or if you have any other medical condition.
Polish: Jeśli pacjent kiedykolwiek przyjmował jakiekolwiek leki stosowane w wirusowym zapaleniu wątroby typu C lub ma jakąkolwiek inną chorobę, powinien poinformować o tym lekarza lub farmaceutę przed rozpoczęciem przyjmowania leku ZEPATIER.
English: ANTIARRHYTHMICS
Polish: LEKI PRZECIWASTMATYCZNE
English: ↔ Elbasvir AUC 0.92 (0.75, 1.14) Cmax 0.86 (0.71, 1.04) C24 0.87 (0.70, 1.09)
Polish: ↔ Elbaswir AUC 0,92 (0,75; 1,14) Cmax 0,86 (0,71; 1,04) C24 0,87 (0,70; 1,09)
English: Calcium acetate (2,668 mg single dose)/ elbasvir (50 mg single dose)/ grazoprevir (100 mg single dose)
Polish: Octan wapnia (dawka pojedyncza 2668 mg)/ elbaswir (dawka pojedyncza 50 mg)/ grazoprewir (dawka pojedyncza 100 mg)
English: Pitavastatin (1 mg single dose)/ grazoprevir (200 mg once daily)
Polish: Pitawastatyna (dawka pojedyncza 1 mg)/ grazoprewir (200 mg raz na dobę)
English: (300 mg once daily)/elbasvir (50 mg once daily)/grazoprevir (100 mg once daily)
Polish: (300 mg raz na dobę)/ elbaswir (50 mg raz na dobę)/ grazoprewir (100 mg raz na dobę)
English: ↔ Elbasvir AUC 0.93 (0.82, 1.05) Cmax 0.88 (0.77, 1.00) C24 0.92 (0.18, 1.05)
Polish: ↔ Elbaswir AUC 0,93 (0,82; 1,05) Cmax 0,88 (0,77; 1,00) C24 0,92 (0,18; 1,05)
English: Overall SVR Outcome for subjects without SVR On-treatment virologic failure Relapse Other SVR by cirrhosis status Non-cirrhotic Cirrhotic SVR by presence of baseline NS5A resistance-associated polymorphisms Absent Present SVR by baseline HCV RNA <=800,000 IU/mL >800,000 IU/mL
Polish: N=58 SVR w zależności od obecności w punkcie początkowym polimorfizmu związanego z opornością w NS5A Brak polimorfizmu Obecny polimorfizm SVR w zależności od początkowego miana RNA HCV < =800 000 j.m./ml > 800 000 j.m./ml
English: ↔ Grazoprevir AUC 1.12 (0.97, 1.30) Cmax 1.07 (0.83, 1.37) C24 0.94 (0.87, 1.02)
Polish: ↔ Grazoprewir AUC 1,12 (0,97; 1,30) Cmax 1,07 (0,83; 1,37) C24 0,94 (0,87; 1,02)
English: In population pharmacokinetic analyses, elbasvir and grazoprevir AUCs are estimated to be 16 % and 45 % higher, respectively, in subjects ≥ 65 years of age compared to subjects less than 65 years of age.
Polish: W analizach farmakokinetyki populacyjnej szacunkowe wartości AUC elbaswiru i grazoprewiru są odpowiednio o 16% i 45% większe u pacjentów w wieku ≥ 65 lat niż u pacjentów w wieku poniżej 65 lat. Zmiany te nie są znaczące klinicznie; w związku z tym nie zaleca się dostosowywania dawki elbaswiru/grazoprewiru ze względu na wiek (patrz punkty 4.2 i 4.4).
English: ↔ Ciclosporin AUC 0.96 (0.90, 1.02) Cmax 0.90 (0.85, 0.97) C12 1.00 (0.92, 1.08)
Polish: ↔ Cyklosporyna AUC 0,96 (0,90; 1,02) Cmax 0,90 (0,85; 0,97) C12 1,00 (0,92; 1,08)
English: Hepatic impairment
Polish: Często zawroty głowy
English: ↔ Elbasvir AUC 1.07 (1.00, 1.15) Cmax 1.07 (0.99, 1.16) C24 1.04 (0.98, 1.11)
Polish: ↔ Elbaswir AUC 1,07 (1,00; 1,15) Cmax 1,07 (0,99; 1,16) C24 1,04 (0,98; 1,11)
English: ↔ Elbasvir AUC 1.07 (1.00, 1.14) Cmax 1.07 (0.98, 1.16) C24 1.05 (0.97, 1.14)
Polish: ↔ Elbaswir AUC 1,07 (1,00; 1,14) Cmax 1,07 (0,98; 1,16) C24 1,05 (0,97; 1,14)
English: GT 1, 3 TN with or without cirrhosis TE Null Responder with or without cirrhosis TN HCV/HIV1 co-infection without cirrhosis
Polish: GT 1, 3 TN z maskością wątroby lub bez marskości wątroby TE całkowicie niereagujący na leczenie z marskością wątroby lub bez marskości wątroby TN z jednoczesnym zakażeniem HCV i HIV-1 bez marskości wątroby
English: Common asthenia, irritability
Polish: Często osłabienie, drażliwość
English: Less than 1 % of subjects treated with ZEPATIER with or without ribavirin had serious adverse reactions (abdominal pain, transient ischaemic attack and anaemia).
Polish: Ciężkie działania niepożądane (ból brzucha, przemijający napad niedokrwienny i niedokrwistość) wystąpiły u mniej niż 1% pacjentów leczonych produktem leczniczym ZEPATIER z rybawiryną lub bez rybawiryny.
English: ↔ Grazoprevir AUC 0.82 (0.68, 0.99) Cmax 0.53 (0.37, 0.76) C24 0.84 (0.71, 0.99)
Polish: ↔ Grazoprewir AUC 0,82 (0,68; 0,99) Cmax 0,53 (0,37; 0,76) C24 0,84 (0,71; 0,99)
English: Grazoprevir was excreted into the milk of lactating rats with concentrations < 1-fold of the maternal plasma concentrations.
Polish: Grazoprewir wydzielany jest do mleka samic szczura w okresie laktacji, przy czym jego stężenie jest mniejsze od stężenia w osoczu samicy.
English: • EBR* + GZR* for 12 weeks (N=14)
Polish: * + GZR przez 12 tygodni (N=14)
English: ↔ Elbasvir AUC 0.98 (0.93, 1.04) Cmax 0.97 (0.89, 1.05) C24 0.98 (0.93, 1.03)
Polish: ↔ Elbaswir AUC 0,98 (0,93; 1,04) Cmax 0,97 (0,89; 1,05) C24 0,98 (0,93; 1,03)
English: Subjects without baseline NS3 polymorphisms, % (n/N)
Polish: Pacjenci bez polimorfizmów NS3 w punkcie początkowym, % (n/N)
English: Subjects without baseline NS5A polymorphisms, % (n/N)
Polish: Pacjenci bez polimorfizmów NS5A w punkcie początkowym, % (n/N)
English: (combination of OATP1B and CYP3A inhibition)
Polish: (skojarzone zahamowanie aktywności OATP1B i CYP3A)
English: ↔ Elbasvir AUC 0.98 (0.93, 1.02) Cmax 0.97 (0.89, 1.05) C24 0.97 (0.92, 1.02)
Polish: ↔ Elbaswir AUC 0,98 (0,93; 1,02) Cmax 0,97 (0,89; 1,05) C24 0,97 (0,92; 1,02)
English: (due in part to OATP1B and CYP3A inhibition)
Polish: (częściowo w wyniku zahamowania aktywności OATP1B i CYP3A)
English: (300 mg once daily)/ ritonavir (100 mg once daily/ grazoprevir (200 mg once daily)
Polish: (300 mg raz na dobę)/ rytonawir (100 mg raz na dobę/ grazoprewir (200 mg raz na dobę)
English: Atorvastatin (20 mg single dose)/ grazoprevir (200 mg once daily)
Polish: Atorwastatyna (dawka pojedyncza 20 mg)/ grazoprewir (200 mg raz na dobę)
English: (10 mg single dose)/ elbasvir (50 mg once daily) / grazoprevir (200 mg once daily)
Polish: (dawka pojedyncza 10 mg)/ elbaswir (50 mg raz na dobę)/ grazoprewir (200 mg raz na dobę)
English: Sofosbuvir (400 mg single dose sofosbuvir)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily
Polish: Sofosbuwir (sofosbuwir w dawce pojedynczej 400 mg)/ elbaswir (50 mg raz na dobę)/ grazoprewir (200 mg raz na dobę)
English: The dose of rosuvastatin should not exceed a daily dose of 10 mg when co-administered with ZEPATIER.
Polish: W przypadku jednoczesnego podawania z produktem leczniczym ZEPATIER, nie należy przekraczać dobowej dawki rozuwastatyny wynoszącej 10 mg.
English: ↑ Grazoprevir AUC 3.02 (2.42, 3.76) Cmax 1.13 (0.77, 1.67)
Polish: AUC 3,02 (2,42; 3,76) Cmax 1,13 (0,77; 1,67) (zahamowanie aktywności CYP3A)
English: (300 mg once daily)/ grazoprevir (200 mg once daily)
Polish: (300 mg raz na dobę)/ grazoprewir (200 mg raz na dobę)
English: ↔ Atazanavir AUC 1.07 (0.98, 1.17) Cmax 1.02 (0.96, 1.08) C24 1.15 (1.02, 1.29)
Polish: ↔ Atazanawir AUC 1,07 (0,98; 1,17) Cmax 1,02 (0,96; 1,08) C24 1,15 (1,02; 1,29)
English: (600 mg twice daily)/ ritonavir (100 mg twice daily/ grazoprevir (200 mg once daily)
Polish: (600 mg dwa razy na dobę)/ rytonawir (100 mg dwa razy na dobę)/ grazoprewir (200 mg raz na dobę)
English: Subjects with baseline NS5A polymorphisms, % (n/N)
Polish: Pacjenci z polimorfizmami NS5A w punkcie początkowym, % (n/N)
English: (400 mg twice daily)/ ritonavir (100 mg twice daily/ grazoprevir (200 mg once daily)
Polish: (400 mg dwa razy na dobę)/ rytonawir (100 mg dwa razy na dobę)/ grazoprewir (200 mg raz na dobę)
English: Dolutegravir (50 mg single dose)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily)
Polish: Dolutegrawir (dawka pojedyncza 50 mg)/ elbaswir (50 mg raz na dobę)/ grazoprewir (200 mg raz na dobę)
English: Serum Late ALT elevations
Polish: Późne zwiększenie aktywności AlAT w surowicy
English: Talk to your doctor before taking ZEPATIER if you are breast-feeding.
Polish: Kobiety karmiące piersią powinny powiedzieć o tym lekarzowi prowadzącemu przed przyjęciem leku ZEPATIER.
English: Subjects with baseline NS3 polymorphisms, % (n/N)
Polish: Pacjenci z polimorfizmami NS3 w punkcie początkowym, % (n/N)
English: Do not stop taking ZEPATIER
Polish: Pominięcie przyjęcia leku ZEPATIER
English: Placebo-controlled study in subjects with CKD Stage 4 (eGFR 15-29 mL/min/1.73 m2) or Stage 5 (eGFR < 15 mL/min/1.73 m2), including subjects on hemodialysis, Subjects were randomised in a 1:1 ratio to one of the following treatment groups: EBR + GZR for 12 weeks (ITG) or placebo for 12 weeks followed by open-label treatment with EBR/GZR for 12 weeks (DTG).
Polish: Badanie z grupą kontrolną placebo prowadzone z udziałem pacjentów z przewlekłą chorobą nerek w stadium 4 (eGFR 15-29 ml/min/1,73 2) lub w stadium 5 (eGFR < 15 ml/min/1,73 m2), w tym u pacjentów poddawanych hemodializie.
English: (OATP1B inhibition and CYP3A induction)
Polish: (zahamowanie aktywności OATP1B i indukcja aktywności CYP3A)
English: Tacrolimus (2 mg single dose)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily)
Polish: Takrolimus (dawka pojedyncza 2 mg)/ elbaswir (50 mg raz na dobę)/ grazoprewir (200 mg raz na dobę)
English: (600 mg once daily)/ grazoprevir (200 mg once daily)
Polish: (600 mg raz na dobę)/ grazoprewir (200 mg raz na dobę)
English: (400 mg twice daily)/ grazoprevir (200 mg once daily)
Polish: (400 mg dwa razy na dobę)/ grazoprewir (200 mg raz na dobę)
English: PHOSPHATE BINDERS
Polish: PRODUKTY WIĄŻĄCE FOSFORANY
English: Weight/BMI
Polish: Masa ciała i wskaźnik masy ciała (ang. BMI)
English: 0.15 mg LNG single-dose)/ elbasvir (50 mg once daily)
Polish: LNG)/ elbaswir (50 mg raz na dobę)
English: (600 mg PO single dose)/ grazoprevir (200 mg once daily)
Polish: (dawka pojedyncza 600 mg doustnie)/ grazoprewir (200 mg raz na dobę)
English: Ciclosporin (400 mg single dose)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily)
Polish: Cyklosporyna (dawka pojedyncza 400 mg)/ elbaswir (50 mg raz na dobę)/ grazoprewir (200 mg raz na dobę)
English: Musculoskeletal and connective tissue disorders: Common arthralgia, myalgia
Polish: Zaburzenia mięśniowo-szkieletowe i tkanki łącznej: Często ból stawów, ból mięśni Zaburzenia ogólne i stany w miejscu podania: Bardzo często zmęczenie
English: Overall prevalence of GT4-infected subjects with baseline NS3 polymorphisms in the pooled analyses was
Polish: Całkowity udział pacjentów zakażonych genotypem 4 wirusa z polimorfizmami NS3 w punkcie początkowym w zbiorczych analizach wyniósł 19% (7/36)
English: TN = Treatment-Naïve
Polish: TN = pacjenci wcześniej nieleczeni
English: NS3 polymorphisms considered were any amino acid substitution at positions 36, 54, 55, 56, 80, 107, 122, 132, 155, 156, 158, 168, 170, and 175.
Polish: (podstawienia w pozycjach 36, 54, 55, 56, 80, 107, 122, 132, 155, 156, 158, 168, 170 i 175) odpowiedzialnych za wyższe niż 5-krotne osłabienie przeciwwirusowego działania odpowiednio elbaswiru i grazoprewiru w warunkach in vitro.
English: Pravastatin (40 mg single dose)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily)
Polish: Prawastatyna (dawka pojedyncza 40 mg)/ elbaswir (50 mg raz na dobę)/ grazoprewir (200 mg raz na dobę)
English: NS5A polymorphisms (conferring > 5-fold potency loss to elbasvir) included M28T/A, Q30E/H/R/G/K/D, L31M/V/F, H58D, and Y93C/H/N
Polish: W zbiorczych analizach danych pacjentów, u których uzyskano trwałą odpowiedź wirusologiczną po 12 tygodniach leczenia (ang. SVR12, sustained virologic response) lub którzy spełnili kryteria niepowodzenia wirusologicznego, oceniono rozpowszechnienie i wpływ polimorfizmów NS5A (w tym M28T/A, Q30E/H/R/G/K/D, L31M/V/F, H58D i Y93C/H/N) oraz polimorfizmów NS3
English: Schering-Plough Labo N.V. Industriepark 30 - Zone A 2220 Heist-op-den-Berg BELGIUM
Polish: 2220 Heist-op-den-Berg
English: Prednisone (40 mg single dose)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily
Polish: Prednizon (dawka pojedyncza 40 mg)/ elbaswir (50 mg raz na dobę)/ grazoprewir (200 mg raz na dobę)
English: Common dizziness
Polish: Podanie doustne
English: NS5A Any of the following NS5A substitutions: M/L28A/G/T/S* Q30H/K/R/Y, L/M31F/M/I/V, H/P58D, Y93H/N/S
Polish: NS5A Którekolwiek z następujących podstawień w NS5A: M/L28A/G/T/S
English: Among genotype 1b/1 other-infected subjects, the median age was 55 years (range: 22 to 82); 61% were male; 60 % were White; 20% were Black or African American; 6% were Hispanic or Latino; 82% were treatment-naïve subjects; 18% were treatment-experienced subjects; mean body mass index was 26 kg/m2; 64 % had baseline HCV RNA levels greater than 800,000 IU/mL; 22 % had cirrhosis; 71% had non-C/C IL28B alleles (CT or TT); 18 % had HCV/HIV-1 co-infection.
Polish: 18% pacjentów było wcześniej leczonych; średni wskaźnik masy ciała wynosił 26 kg/m u 64% pacjentów początkowe miano RNA HCV było większe niż 800 000 j.m./ml; u 22% pacjentów występowała marskość wątroby; u 71% pacjentów wykazano obecność alleli IL28B nie-C/C (CT lub TT); u 18% pacjentów występowało jednoczesne zakażenie HCV i HIV-1.
English: Emergent Amino Acid Substitutions
Polish: LEKI HAMUJĄCE WYDZIELANIE KWASU ŻOŁĄDKOWEGO
English: • dry mouth
Polish: • zawroty głowy
English: Rosuvastatin (10 mg single dose)/ grazoprevir (200 mg once daily)
Polish: Rozuwastatyna (dawka pojedyncza 10 mg)/ grazoprewir (200 mg raz na dobę)
English: These measures should help to protect the environment.
Polish: Estas medidas devem contribuir para a protecção do ambiente.
English: Not applicable.
Polish: Não aplicável.
English: Avoid contact with eyes.
Polish: Evitar o contacto com os olhos.
English: Whatever the position
Polish: Qualquer que seja a posição
English: 4.6 Adverse reactions (frequency and seriousness)
Polish: 4.6 Reacções adversas (frequência e gravidade)
English: Not all pack sizes may be marketed.
Polish: Podem não ser comercializados todos os tamanhos das embalagens.
English: DATE OF REVISION OF THE TEXT
Polish: DATA DA REVISÃO DO TEXTO
English: For the full list of excipients, see section 6.1.
Polish: Excipientes: Para a lista completa de excipientes, ver secção 6.1.
English: ANNEX II
Polish: ANEXO II
English: Squeeze gently but firmly in the middle of the body of the pipette.
Polish: Apertar devagar mas firmemente no meio do corpo da pipeta.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Active substances:
Polish: COMPOSIÇÃO QUALITATIVA E QUANTITATIVA Substâncias activas:
English: 4.8 Interaction with other medicinal products and other forms of interaction
Polish: 4.8 Interacções medicamentosas e outras formas de interacção
English: Whatever the size
Polish: Qualquer que seja o tamanho
English: In all cases, treatment with the veterinary medicinal product was not discontinued and all dogs recovered without any specific therapy.
Polish: Em todos os casos, o tratamento com o medicamento veterinário não foi interrompido e todos os cães recuperaram sem qualquer terapia específica.
English: 6.2 Major incompatibilities
Polish: 6.2 Incompatibilidades Maiores
English: Do not use in dogs with generalised demodecosis.
Polish: Não administrar em cães com demodecose generalizada.
English: For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
Polish: Para quaisquer informações sobre este medicamento veterinário, queira contactar o representante local do titular da Autorização de Introdução no Mercado.
English: Since many bacterial strains may be involved in otitis externa in dogs, the mechanisms of resistance can vary.
Polish: Visto que são várias as estirpes bacterianas que podem estar envolvidas na otite externa em cães, os mecanismos de resistência podem variar.
English: OTHER INFORMATION
Polish: OUTRAS INFORMAÇÕES
English: 1 dose / ear / day for 5 days
Polish: ins 1 dose / ouvido / dia, durante 5 dias
English: Compatibility with ear cleaners has not been demonstrated.
Polish: Não foi demonstrada a compatibilidade com produtos de limpeza auricular.
English: 6.1 List of excipients
Polish: 6.1 Lista de excipientes
English: Auricular use.
Polish: Uso auricular.
English: Incompatibilities: Do not mix with other veterinary medicinal products.
Polish: Incompatibilidades: Não misturar com outros medicamentos veterinários.
English: Do not mix with any other veterinary medicinal product.
Polish: Não misturar com quaisquer outros medicamentos veterinários.
English: A. LABELLING
Polish: A. ROTULAGEM
English: Do not use concurrently with substances known to cause ototoxicity.
Polish: Não administrar concomitantemente com substâncias conhecidas de causarem ototoxicidade.
English: If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Polish: Se detectar quaisquer efeitos adversos, mesmo aqueles que ainda não se encontram listados neste folheto informativo ou considerar que o medicamento veterinário não funcionou, informe o seu médico veterinário..
English: ADVERSE REACTIONS
Polish: REACÇÕES ADVERSAS
English: The product as presented allows treating a dog suffering from bilateral otitis.
Polish: O medicamento veterinário, tal como é apresentado, permite tratar um cão que sofra de otite bilateral.
English: The veterinary medicinal product should be used at room temperature (i.e. do not instil cold product).
Polish: O medicamento veterinário deve ser administrado à temperatura ambiente (isto é, não instilar o medicamento veterinário frio).
English: Cardboard box containing 5, 10, 50, 100 or 200 pipettes.
Polish: Caixa de cartão contendo 5, 10, 50, 100 ou 200 pipetas
English: Special warnings:
Polish: Advertências especiais:
English: Interaction with other medicinal products and other forms of interaction: Compatibility with ear cleaners has not been demonstrated.
Polish: Interacções medicamentosas e outras formas de interação: Não foi demonstrada a compatibilidade com produtos de limpeza auricular.
English: A white suspension.
Polish: Suspensão de cor branca.
English: The diesters are lipophilic components ensuring an enhanced penetration into the skin associated with low systemic bioavailability.
Polish: Os diésteres são componentes lipofílicos que asseguram uma melhor penetração na pele, associada à baixa biodisponibilidade sistémica.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT
Polish: NOME DO MEDICAMENTO VETERINÁRIO
English: In very rare cases, the use of the veterinary medicinal product has been associated with hearing impairment (partial hearing loss or deafness), usually temporary, and primarily in geriatric dogs.
Polish: Em casos muito raros ,a administração do medicamento veterinário foi associada ao enfraquecimento da audição (perda parcial da audição ou surdez) geralmente temporária e principalmente em cães geriatricos.
English: 4.2 Indications for use, specifying the target species
Polish: 4.2 Indicações de utilização, especificando as espécies-alvo
English: Liquid paraffin.
Polish: Parafina líquida.
English: ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
Polish: ANEXO I RESUMO DAS CARACTERÍSTICAS DO MEDICAMENTO
English: In laboratory animals, hydrocortisone aceponate is eliminated the same way as hydrocortisone (other name for endogenous cortisol) through urine and faeces.
Polish: Em animais de laboratório, o aceponato de hidrocortisona é eliminado da mesma forma que a hidrocortisona (outro nome para o cortisol endógeno), através da urina e das fezes.
English: No standardised in-vitro susceptibility breakpoints have been defined for miconazole; however, using the method by Diagnostics Pasteur, no resistant strains were found.
Polish: Não foram determinados pontos de ruptura “in vitro”estandardizados para o miconazol, no entanto usando o método da Diagnostics Pasteur .nenhuma estirpe resistente foi encontrada
English: Papules were observed uncommonly (less than 1% of treated dogs).
Polish: Foram observadas, muito raramente, pápulas (em menos de 1% dos cães tratados).
English: See section 4.5 of the SPC.
Polish: Ver secção 4.5 do RCMV.
English: 6.5 Nature and composition of immediate packaging
Polish: 6.5 Natureza e composição do acondicionamento primário
English: • Take out one pipette from the box.
Polish: • Retirar uma pipeta da embalagem
English: ANNEX III LABELLING AND PACKAGE LEAFLET
Polish: ANEXO III ROTULAGEM E FOLHETO INFORMATIVO