FrancophonIA/ELRC3.0 huggingface dataset:
English: It should not be heated (e.g. microwaved) or added to heated foods or liquids.
Slovenian: v mikrovalovni pečici) ali ga dodajati segreti hrani oziroma tekočini.
English: Veltassa contains calcium as part of the counterion complex.
Slovenian: Zdravilo Veltassa vsebuje kalcij kot del protiionskega kompleksa.
English: INFORMATION IN BRAILLE VELTASSA 25.2 G
Slovenian: PODATKI V BRAILLOVI PISAVI VELTASSA 25,2 G
English: The following side effects have been reported: Common, may affect up to 1 in 10 people:
Slovenian: Pogosti, pojavijo se lahko pri največ 1 od 10 bolnikov:
English: Veltassa contains sorbitol as part of the counterion complex.
Slovenian: Zdravilo Veltassa vsebuje sorbitol kot del protiionskega kompleksa.
English: Patients may store Veltassa below 25°C for up to 6 months.
Slovenian: Bolniki lahko zdravilo Veltassa shranjujejo pri temperaturi do 25 °C do 6 mesecev.
English: Each sachet contains 8.4 g patiromer (as patiromer sorbitex calcium) Each sachet contains 16.8 g patiromer (as patiromer sorbitex calcium) Each sachet contains 25.2 g patiromer (as patiromer sorbitex calcium)
Slovenian: Ena vrečica vsebuje 8,4 g patiromera (kot kalcijev sorbiteks patiromerat) Ena vrečica vsebuje 16,8 g patiromera (kot kalcijev sorbiteks patiromerat) Ena vrečica vsebuje 25,2 g patiromera (kot kalcijev sorbiteks patiromerat)
English: If you have missed a dose, take it as soon as possible on the same day.
Slovenian: Če ste pozabili vzeti odmerek zdravila, ga vzemite čim prej isti dan. Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: You may need to do this again to make sure that you have taken all the powder.
Slovenian: To boste morali ponavljati, dokler ne boste vzeli celotnega odmerka.
English: In vitro studies have shown no potential interaction of patiromer with the following active substances: allopurinol, amoxicillin, apixaban, acetylsalicylic acid, atorvastatin, cephalexin, digoxin, glipizide, lisinopril, phenytoin, riboflavin, rivaroxaban, spironolactone and valsartan.
Slovenian: Študije in vitro niso pokazale potencialnega medsebojnega delovanja patiromera z naslednjimi učinkovinami: alopurinol, amoksicilin, apiksaban, acetilsalicilna kislina, atorvastatin, cefaleksin,
English: Veltassa works by attaching to potassium in your gut.
Slovenian: Zdravilo Veltassa deluje tako, da se veže na kalij v vašem črevesju.
English: INFORMATION IN BRAILLE VELTASSA 16.8 G
Slovenian: PODATKI V BRAILLOVI PISAVI VELTASSA 16,8 G
English: • severe stomach or bowel problems
Slovenian: • če imate resne težave z želodcem ali črevesjem;
English: In patients with a baseline serum potassium of >5.0 to 5.5 mEq/L who received an initial dose of 8.4 g patiromer per day, the mean daily dose was 14 g; in those with a baseline serum potassium of >5.5 to <6.0 mEq/L who received an initial dose of 16.8 g patiromer per day, the mean daily dose was 20 g during the entire study.
Slovenian: Pri bolnikih z izhodiščno vrednostjo kalija v serumu med > 5,0 in 5,5 mEq/l, ki so prejemali začetni odmerek 8,4 g patiromera na dan, je bil med trajanjem študije mediani dnevni odmerek 14 g. Pri bolnikih z izhodiščno vrednostjo kalija v serumu med > 5,5 in < 6,0 mEq/l, ki so prejemali začetni odmerek 16,8 g patiromera na dan, pa je bil mediani dnevni odmerek med trajanjem študije 20 g.
English: • Veltassa 16.8 g powder for oral suspension: each sachet contains 16.8 g of patiromer.
Slovenian: • Veltassa 16,8 g praška za peroralno suspenzijo: ena 16,8-g vrečica vsebuje 16,8 g patiromera
English: • Veltassa 8.4 g powder for oral suspension: each sachet contains 8.4 g of patiromer
Slovenian: • Veltassa 8,4 g praška za peroralno suspenzijo: ena 8,4-g vrečica vsebuje 8,4 g patiromera
English: The potential of patiromer to enable concomitant RAAS inhibitor treatment was also assessed in part B. Fifty two percent (52%) of subjects receiving placebo discontinued RAAS inhibitor treatment because of recurrent hyperkalaemia compared with 5% of subjects treated with patiromer.
Slovenian: Dvainpetdeset odstotkov (52 %) preiskovancev, ki so prejemali placebo, se je prenehalo zdraviti z zaviralcem RAAS, saj se je pri njih znova pojavila hiperkaliemija v primerjavi s 5 % preiskovancev, ki so prejemali patiromer.
English: Patients on dialysis
Slovenian: Bolezni prebavil
English: INFORMATION IN BRAILLE VELTASSA 8.4 G
Slovenian: PODATKI V BRAILLOVI PISAVI VELTASSA 8,4 G
English: Patients with a history of bowel obstruction or major gastrointestinal surgery, severe gastrointestinal disorders, or swallowing disorders were not included in the clinical studies.
Slovenian: V te klinične študije niso bili vključeni bolniki z anamnezo črevesne zapore ali večjega gastrointestinalnega kirurškega posega, bolniki s hujšimi boleznimi prebavil ali težavami pri požiranju.
English: Serum potassium levels
Slovenian: Ravni kalija v serumu
English: How to store Veltassa
Slovenian: Shranjevanje zdravila Veltassa
English: 21 [0.07] mEq/L) as compared to the placebo group (LS mean [SEM]: +0.23 [0.07] mEq/L).
Slovenian: 28-dnevnega obdobja zdravljenja in je bila pomembno manjša (p < 0,001) v skupini, ki je prejemala patiromer, (povprečni LS [SEM]: −0,21 [0,07] mEq/l) v primerjavi s skupino, ki je prejemala placebo (povprečni LS [SEM]: +0,23 [0,07] mEq/l).
English: Low blood magnesium can occur when taking Veltassa.
Slovenian: Med jemanjem zdravila Veltassa se lahko pojavi nizka raven magnezija v krvi.
English: Gastrointestinal ischaemia, necrosis and/or intestinal perforation have been reported with other potassium binders.
Slovenian: Pri uporabi drugih vezalcev kalija so poročali o gastrointestinalni ishemiji, nekrozi in/ali perforaciji črevesja.
English: Part B than patiromer patients (15% [95% CI: 6%, 24%]), p<0.001.
Slovenian: [95% IZ: 30 %, 56 %]), p < 0,001.
English: The daily dose may be adjusted in intervals of one week or longer, based on the serum potassium level and the desired target range.
Slovenian: Dnevni odmerek se glede na raven kalija v serumu in želeno ciljno območje lahko prilagaja v enotedenskih ali daljših intervalih.
English: In Part B, 107 patients with a Part A baseline serum potassium of 5.5 mEq/L to <6.5 mEq/L and whose serum potassium was in the target range (3.8 mEq/L to <5.1 mEq/L) at Part A Week 4 and still receiving RAAS inhibitor treatment were randomised to continue patiromer or to receive placebo for 8 weeks to evaluate the effect of withdrawing patiromer on serum potassium.
Slovenian: 107 bolnikov, pri katerih je bila izhodiščna vrednost kalija v delu A med 5,5 mEq/l in < 6,5 mEq/l in pri katerih je bila vrednost kalija v serumu 4. teden dela A v ciljnem območju (med 3,8 mEq/l in < 5,1 mEq/l) ter ki so se še vedno zdravili z zaviralcem RAAS, so v delu B naključno razvrstili dve skupini, od katerih je ena še naprej 8 tednov jemala patiromer, druga pa je 8 tednov prejemala placebo, da bi ocenili učinek odtegnitve patiromera na kalij v serumu.
English: Nausea Vomiting
Slovenian: slabost bruhanje
English: Pharmacotherapeutic group: Drugs for treatment of hyperkalaemia and hyperphosphataemia.
Slovenian: Farmakoterapevtska skupina: zdravila za zdravljenje hiperkaliemije in hiperfosfatemije, oznaka ATC: V03AE09
English: (CKD) on stable doses of at least one RAAS inhibitor (i.e. angiotensin converting enzyme inhibitor [ACEI], angiotensin II receptor blocker [ARB] or aldosterone antagonist [AA]).
Slovenian: Varnost in učinkovitost patiromera so ocenili v dvodelni, enojno slepi, randomizirani odtegnitveni študiji, kjer so ocenjevali to zdravljenje pri hiperkaliemičnih bolnikih s kronično ledvično boleznijo (KLB), ki so prejemali stabilne odmerke vsaj enega zaviralca RAAS (tj. zaviralca angiotenzinske konvertaze [ACE], antagonista receptorjev za angiotenzin II [ARB] ali antagonista aldosterona [AA]).
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Veltassa Vsebina pakiranja in dodatne informacije
English: • Veltassa 25.2 g powder for oral suspension: each sachet contains 25.2 g of patiromer.
Slovenian: • Veltassa 25,2 g praška za peroralno suspenzijo: ena 25,2-g vrečica vsebuje 25,2 g patiromera Druga sestavina je ksantan gumi.
English: The mean daily doses of patiromer were 13 g and 21 g in patients with serum potassium of 5.1 to <5.5 mEq/L and 5.5 to <6.5 mEq/L, respectively.
Slovenian: 13 g pri bolnikih z vrednostjo kalija v serumu med 5,1 in < 5,5 mEq/l in 21 g pri bolnikih z vrednostjo kalija v serumu med 5,5 in < 6,5 mEq/l.
English: Oral use.
Slovenian: Način uporabe Peroralna uporaba.
English: The Part B primary endpoint was the change in serum potassium from Part B baseline to the earliest visit at which the patient's serum potassium was first outside of the range of 3.8 to <5.5 mEq/L or to Part B Week 4 if the patient's serum potassium remained in the range.
Slovenian: do prvega naslednjega obiska, pri katerem je bil pri bolniku kalij v serumu najprej zunaj območja od 3,8 do < 5,5 mEq/l, ali od izhodišča dela B do 4. tedna dela B, če je kalij v serumu bolnika ostal znotraj območja.
English: Constipation Diarrhoea Abdominal pain Flatulence
Slovenian: Bolezni prebavil zaprtje driska bolečine v trebuhu vetrovi slabost bruhanje
English: The mean age of patients was 66 years (59.9% aged 65 and over, 19.7% aged 75 and over), 63% of patients were men, and all were Caucasian.
Slovenian: 19,7 % bolnikov starih 75 let in več), 63 % bolnikov je bilo moških, vsi bolniki pa so bili belci.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - Veltassa 25.2 g
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA - Veltassa 25,2 g
English: • starting dose: 8.4 g patiromer (the content of one 8.4 g sachet) once daily
Slovenian: • začetni odmerek: 8,4 g patiromera (vsebina ene 8,4-g vrečice) enkrat na dan • največji odmerek: 25,2 g patiromera (vsebina ene 25,2-g vrečice) enkrat na dan
English: Mean serum potassium levels and change in serum potassium from Part A Baseline to Part A Week 4 is shown in Table 1.
Slovenian: Povprečne ravni kalija v serumu ter spremembe vrednosti kalija v serumu od izhodišča v delu A do
English: NAME OF THE MEDICINAL PRODUCT Veltassa 8.4 g powder for oral suspension patiromer
Slovenian: IME ZDRAVILA Veltassa 8,4 g prašek za peroralno suspenzijo patiromer
English: 5.5 to <6.5 mEq/L (n=147) Serum Potassium (mEq/L)
Slovenian: med 5,5 in < 6,5 mEq/l (n = 147)
English: Veltassa 8.4 g powder for oral suspension Veltassa 16.8 g powder for oral suspension Veltassa 25.2 g powder for oral suspension patiromer (as patiromer sorbitex calcium)
Slovenian: Veltassa 8,4 g prašek za peroralno suspenzijo Veltassa 16,8 g prašek za peroralno suspenzijo Veltassa 25,2 g prašek za peroralno suspenzijo
English: NAME OF THE MEDICINAL PRODUCT Veltassa 16.8 g powder for oral suspension patiromer
Slovenian: IME ZDRAVILA Veltassa 16,8 g prašek za peroralno suspenzijo patiromer
English: The effect of treatment with patiromer for up to 52 weeks was evaluated in an open label study of 304 hyperkalaemic patients with CKD and type 2 diabetes mellitus on stable doses of a RAAS inhibitor.
Slovenian: 304 hiperkaliemičnih bolnikov s KLB in sladkorno boleznijo tipa 2, ki so prejemali stabilne odmerke zaviralca RAAS.
English: NAME OF THE MEDICINAL PRODUCT Veltassa 25.2 g powder for oral suspension patiromer
Slovenian: IME ZDRAVILA Veltassa 25,2 g prašek za peroralno suspenzijo patiromer
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each sachet contains 25.2 g patiromer (as patiromer sorbitex calcium)
Slovenian: Ena vrečica vsebuje 25,2 g patiromera (kot kalcijev sorbiteks patiromerat)
English: The benefits and risks of administering patiromer should be carefully evaluated in patients with current or history of severe gastrointestinal disorders, before and during treatment.
Slovenian: Pred začetkom zdravljenja in med zdravljenjem je pri bolnikih, ki imajo ali so imeli bolezni prebavil, treba skrbno pretehtati koristi in tveganja jemanja patiromera.
English: Veltassa is a medicine that contains the active substance patiromer.
Slovenian: Kaj je zdravilo Veltassa in za kaj ga uporabljamo Zdravilo Veltassa je zdravilo, ki vsebuje učinkovino patiromer.
English: Stop taking Veltassa and talk to your doctor or pharmacist immediately.
Slovenian: Pred začetkom jemanja zdravila Veltassa se posvetujte z zdravnikom ali s farmacevtom:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - Veltassa 16.8 g
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA - Veltassa 16,8 g
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - Veltassa 8.4 g
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA - Veltassa 8,4 g
English: More placebo patients (91% [95% CI: 83%, 99%]) developed a serum potassium ≥5.1 mEq/L at any time during Part B than patiromer patients (43% [95% CI: 30%, 56%]), p<0.001.
Slovenian: Raven kalija v serumu kadar koli med trajanjem dela B je bila ≥ 5,1 mEq/l pri več bolnikih, ki so prejemali placebo, (91 % [95% IZ: 83 %, 99 %]), v primerjavi z bolniki, ki so jemali patiromer, (43 %
English: Patients with a baseline serum potassium of 5.1 mEq/L to <5.5 mEq/L (mmol/L) received a starting dose of 8.4 g patiromer per day (as a divided dose) and patients with a baseline serum potassium of 5.5 mEq/L to <6.5 mEq/L received a starting dose of 16.8 g patiromer per day (as a divided dose).
Slovenian: Bolniki, pri katerih je bila izhodiščna vrednost kalija v serumu med 5,1 mEq/l in < 5,5 mEq/l (mmol/l), so prejemali začetni odmerek 8,4 g patiromera na dan (kot razdeljeni odmerek), bolniki z izhodiščno vrednostjo kalija v serumu med
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each sachet contains 16.8 g patiromer (as patiromer sorbitex calcium)
Slovenian: Ena vrečica vsebuje 16,8 g patiromera (kot kalcijev sorbiteks patiromerat)
English: Patiromer increases faecal potassium excretion through binding of potassium in the lumen of the gastrointestinal tract.
Slovenian: Patiromer zaradi vezave kalija v lumnu prebavnega trakta povečuje izločanje kalija z blatom.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each sachet contains 8.4 g patiromer (as patiromer sorbitex calcium)
Slovenian: Ena vrečica vsebuje 8,4 g patiromera (kot kalcijev sorbiteks patiromerat)
English: Baseline, mean (SD) Week 4 Change from Baseline, Mean ± SE (95% CI) p value
Slovenian: mediana ± SE (95% IZ) Vrednost p
English: • constipation
Slovenian: Odmerjanje
English: The dose was titrated, as needed, based on the serum potassium level, assessed starting on Day 3 and then at weekly visits to the end of the 4 week treatment period, with the aim of maintaining serum potassium in the target range (3.8 mEq/L to <5.1 mEq/L).
Slovenian: Po potrebi je bil odmerek titriran glede na raven kalija v serumu, ocenjevali pa so ga 3. dan in nato ob tedenskih obiskih do konca 4tedenskega obdobja zdravljenja.
English: Patiromer has been studied only in a limited number of patients with estimated glomerular filtration rate (eGFR) <15 mL/min/1.73 m² and patients receiving dialysis treatment.
Slovenian: < 15 ml/min/1,73 m² in bolnikov na dializi.
English: Patients with end-stage renal disease (ESRD)
Slovenian: Bolniki z ledvično boleznijo končnega stadija (ESRD) Patiromer je bil preiskovan le pri omejenem številu bolnikov z ocenjeno glomerulno filtracijo (eGFR)
English: The active substance is patiromer (as patiromer sorbitex calcium).
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Veltassa Učinkovina je patiromer (kot kalcijev sorbiteks patiromerat).
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING SACHET of Veltassa 25.2 g
Slovenian: PODATKI NA PRIMARNI OVOJNINI VREČICA z zdravilom Veltassa 25,2 g
English: EU/1/17/1179/005 60 sachets
Slovenian: EU/1/17/1179/004 30 vrečic EU/1/17/1179/005 60 vrečic EU/1/17/1179/006 90 vrečic
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING SACHET of Veltassa 16.8 g
Slovenian: PODATKI NA PRIMARNI OVOJNINI VREČICA z zdravilom Veltassa 16,8 g
English: EU/1/17/1179/002 60 sachets
Slovenian: EU/1/17/1179/001 30 vrečic EU/1/17/1179/002 60 vrečic EU/1/17/1179/003 90 vrečic
English: EU/1/17/1179/008 60 sachets
Slovenian: EU/1/17/1179/007 30 vrečic EU/1/17/1179/008 60 vrečic EU/1/17/1179/009 90 vrečic
English: Figure 1: Mean (95% CI) serum potassium over time Baseline Serum K+ > 5.0 to 5.5 mEq/L
Slovenian: Izhodiščni serumski K+ med > 5,0 in 5,5 mEq/l
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING SACHET of Veltassa 8.4 g
Slovenian: PODATKI NA PRIMARNI OVOJNINI VREČICA z zdravilom Veltassa 8,4 g
English: More placebo patients (60% [95% CI: 47%, 74%]) developed a serum potassium ≥5.5 mEq/L at any time during
Slovenian: Raven kalija v serumu kadar koli med trajanjem dela B je bila ≥ 5,5 mEq/l pri več bolnikih, ki so prejemali placebo, (60 % [95% IZ: 47 %, 74 %]), v primerjavi z bolniki, ki so jemali patiromer, (15 % [95% IZ: 6 %, 24 %]), p < 0,001.
English: Always take this medicine exactly as your doctor or pharmacist has told you.
Slovenian: Kako jemati zdravilo Veltassa Pri jemanju tega zdravila natančno upoštevajte navodila zdravnika ali farmacevta.
English: More water may be added to the mixture as needed for desired consistency.
Slovenian: Glede na to, kakšno konsistenco želi bolnik, lahko mešanici doda več vode.
English: 28x1 tablets l t o r
Slovenian: 28x1 tableta o č
English: Package size blister (OPA/Al/PVC - Al), calendar
Slovenian: 75 mg Filmsko obložene tablete Peroralna uporaba Pretisni omot (OPA/Al/PVCAl), koledarski
English: Pack size bottle (HDPE) 30 tablets bottle (HDPE) 90 (3 x 30) tablets (multipack)
Slovenian: 90 (3 x 30) tablet (skupno pakiranje)
English: MA (EU) Numbers Invented name
Slovenian: (Izmišljeno) ime
English: Intravenous use vial (glass)
Slovenian: 1 mg/ml koncentrat za raztopino za infundiranje intravenska uporaba viala (steklena) 20 ml
English: The absolute bioavailability was 74 %.
Slovenian: Absolutna biorazpoložljivost je 74%.
English: Treatment schedule:
Slovenian: Razpored zdravljenja:
English: EU/2/13/159/001 EU/2/13/159/002 EU/2/13/159/003 EU/2/13/159/004 EU/2/13/159/005 EU/2/13/159/006 EU/2/13/159/007 EU/2/13/159/008 EU/2/13/159/009 EU/2/13/159/010 EU/2/13/159/011 EU/2/13/159/012 EU/2/13/159/013 EU/2/13/159/014 EU/2/13/159/015 EU/2/13/159/016
Slovenian: EU/2/13/159/001 EU/2/13/159/002 EU/2/13/159/003 EU/2/13/159/004 EU/2/13/159/005 EU/2/13/159/006 EU/2/13/159/007 EU/2/13/159/008 EU/2/13/159/009
English: NexGard kills fleas within 8 hours and ticks within 48h.
Slovenian: Zdravilo NexGard ubije bolhe v največ 8 urah in klope najkasneje v 48 urah.
English: Date of first authorisation: 11/02/2014 Date of last renewal:
Slovenian: Datum pridobitve dovoljenja za promet: Datum zadnjega podaljšanja dovoljenja za promet: 19/12/2018
English: Afoxolaner (mg)
Slovenian: NexGard afoksolaner (mg)
English: Treatment of tick infestation in dogs (Dermacentor reticulatus, Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus).
Slovenian: Zdravljenje infestacije s klopi pri psih (Dermacentor reticulatus, Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus).
English: Carton with 1 blister of 1, 3 or 6 chewable tablets or 15 blisters of 1 chewable tablet.
Slovenian: Ena škatla z enim pretisnim omotom z 1, 3 ali 6 žvečljivimi tabletami, ali 15 pretisnih omotov z
English: - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Slovenian: Pogostost neželenih učinkov je določena po naslednjem dogovoru: zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali) pogosti (pri več kot 1, toda manj kot 10 živali od 100 zdravljenih živali) občasni (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali) redki (pri več kot 1, toda manj kot 10 živali od 10.000 zdravljenih živali) zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri).
English: NexGard is active against adult fleas as well as several tick species such as Dermacentor reticulatus and D. variabilis, Ixodes ricinus, Ixodes hexagonus and I. scapularis, Rhipicephalus sanguineus, Amblyomma americanum, and Haemaphysalis longicornis.
Slovenian: Zdravilo NexGard učinkuje na odrasle bolhe kot tudi številne vrste klopov, kot so Dermacentor reticulatus in D. variabilis, Ixodes ricinus, Ixodes hexagonus and I. scapularis, Rhipicephalus sanguineus, Amblyomma americanum, in Haemaphysalis longicornis.
English: Treatment of flea and tick infestations:
Slovenian: Zdravljenje infestacij z bolhami in klopi:
English: One carton contains one blister of 1, 3 or 6 chewable tablets or 15 blisters of 1 chewable tablet.
Slovenian: Za vsako jakost so žvečljive tablete pakirane v naslednjih velikostih pakiranja: Škatlica z 1 pretisnim omotom z 1, 3 ali 6 žvečljivimi tabletami, ali 15 pretisnih omotov z 1 žvečljivo tableto.
English: NexGard
Slovenian: Afoxolaner
English: − uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
Slovenian: občasni (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali)
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)).
Slovenian: Pogostost neželenih učinkov je določena po naslednjem dogovoru: zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali) pogosti (pri več kot 1, toda manj kot 10 živali od 100 zdravljenih živali)
English: Mottled red to reddish brown, circular shaped (tablets for dogs 2-4 kg), or rectangular shaped (tablets for dogs >4-10 kg, tablets for dogs >10-25 kg and tablets for dogs >25-50 kg).
Slovenian: Lisaste rdeče ali rdeče-rjave, okrogle (tablete za pse 2-4 kg) ali pravokotne tablete (tablete za pse > 4-10 kg, tablete za pse >10-25 kg in tablete za pse >25-50 kg).
English: Mottled red to reddish brown, circular shaped (tablets for dogs 2-4 kg) or rectangular shaped (tablets for dogs >4-10 kg, tablets for dogs >10-25 kg and tablets for dogs >25-50 kg).
Slovenian: Lisaste rdeče ali rdeče-rjave, okrogle (tablete za pse 2-4 kg) ali pravokotne tablete (tablete za pse >4-10 kg, tablete za pse >10-25 kg in tablete za pse >25-50 kg).
English: − very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Slovenian: redki (pri več kot 1, toda manj kot 10 živali od 10.000 zdravljenih živali) zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri).
English: NexGard 11 mg dogs 2-4 kg NexGard 28 mg dogs >4-10 kg NexGard 68 mg dogs >10-25 kg NexGard 136 mg dogs >25-50 kg afoxolaner
Slovenian: NexGard 11 mg psi 2-4 kg NexGard 28 mg psi >4-10 kg NexGard 68 mg psi >10-25 kg NexGard 136 mg psi >25-50 kg
English: NexGard 11 mg chewable tablets for dogs 2-4 kg NexGard 28 mg chewable tablets for dogs >4-10 kg NexGard 68 mg chewable tablets for dogs >10-25 kg NexGard 136 mg chewable tablets for dogs >25-50 kg afoxolaner
Slovenian: NexGard 11 mg žvečljive tablete za pse 2-4 kg NexGard 28 mg žvečljive tablete za pse >4-10 kg NexGard 68 mg žvečljive tablete za pse >10-25 kg NexGard 136 mg žvečljive tablete za pse >25-50 kg afoksolaner
English: NexGard 11 mg chewable tablets for dogs 2-4 kg NexGard 28 mg chewable tablets for dogs >4-10 kg NexGard 68 mg chewable tablets for dogs >10-25 kg NexGard 136 mg chewable tablets for dogs >25-50 kg
Slovenian: NexGard 11 mg žvečljive tablete za pse 2-4 kg NexGard 28 mg žvečljive tablete za pse >4-10 kg NexGard 68 mg žvečljive tablete za pse >10-25 kg NexGard 136 mg žvečljive tablete za pse >25-50 kg
English: Macrogol 15 hydroxystearate Glycerol (E422) Medium-chain triglycerides
Slovenian: trigliceridi, nasičeni, srednjeverižni
English: Within 6 months of Commission Decision.
Slovenian: V 6 mesecih od odločbe Komisije.
English: The device should be cleaned after each use.
Slovenian: Pripomoček je treba očistiti po vsaki uporabi.
English: ATCvet code: QI01AN01.
Slovenian: oznaka ATC vet QI01AN01.
English: Montanide IMS
Slovenian: montanid IMS
English: Duration of immunity: 60 weeks post-vaccination in an environment that permits oocysts recycling.
Slovenian: Trajanje imunosti: 60 tednov po cepljenju v okolju, ki dopušča recikliranje oocist.