natgillin/translations-raw huggingface dataset:
Compared with a fixed combination of beclometasone dipropionate and formoterol, Riarify reduced the rate of moderate/severe exacerbations over 52 weeks by 23% (rate: 0.41 versus 0.53 events per patient/year; p = 0.005).
V primerjavi s fiksno kombinacijo beklometazondipropionata in formoterola je zdravilo Riarify v 52 tednih zmanjšalo stopnjo zmernih/hudih poslabšanj za 23 % (razmerje: 0,41 v primerjavi z 0,53 dogodka na bolnika/leto; p = 0,005).
Pre-dose FEV1
FEV1 pred odmerkom
Just after starting to breathe in, press down firmly on the top of the pressurised container to release one puff.
Takoj potem, ko začnete vdihavati, čvrsto pritisnite na zgornji del tlačnega vsebnika,
Compared with tiotropium, Riarify reduced the rate of moderate/severe exacerbations over 52 weeks by 20% (rate: 0.46 versus 0.57 events per patient/year; p = 0.003).
V primerjavi s tiotropijem je zdravilo Riarify v 52 tednih zmanjšalo stopnjo zmernih/hudih poslabšanj za 20 % (razmerje: 0,46 v primerjavi z 0,57 dogodka na bolnika/leto; p = 0,003).
TRISTAR was a 26-week active-controlled open label study comparing Riarify with an extemporary combination made of a fixed combination of fluticasone/vilanterol 92/22 micrograms inhalation powder, one inhalation once daily plus tiotropium 18 micrograms inhalation powder, hard capsule, one inhalation once daily (1,157 randomised patients).
Riarify s kombinacijo, sestavljeno iz fiksne kombinacije flutikazona/vilanterola 92/22 mikrogramov prašek za inhaliranje, ena inhalacija enkrat na dan plus tiotropij 18 mikrogramov prašek za inhaliranje, trda kapsula, ena inhalacija enkrat na dan (1.157 randomiziranih bolnikov).
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS ALUMINIUM CONTAINER
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Patients who find it difficult to synchronise aerosol actuation with inspiration of breath may use the AeroChamber Plus spacer device, properly cleaned as described in the relevant leaflet.
Bolniki, ki s težavo uskladijo sprožitev aerosola z vdihavanjem, lahko uporabljajo nastavek
Excipients: anhydrous ethanol, hydrochloric acid; propellant: norflurane.
Pomožne snovi: brezvodni etanol, klorovodikova kislina, potisni plin norfluran.
Following inhalation, formoterol is absorbed from both the lung and the gastrointestinal tract.
Absorpcija in porazdelitev Po inhalaciji se formoterol absorbira iz pljuč in prebavil.
Riarify 87/5/9 micrograms pressurised inhalation, solution beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium
Riarify 87/5/9 mikrogramov inhalacijska raztopina pod tlakom beklometazondipropionat/formoterolijev fumarat dihidrat/glikopironij
• fungal infections of the mouth.
• glivične okužbe (ust).
The study compared data obtained after treatment with a single dose of Riarify (4 inhalations of 100/6/25 micrograms, a non-marketed formulation containing twice the approved strength of glycopyrronium) or a single dose of the extemporary combination of beclometasone dipropionate/formoterol (4 inhalations of 100/6 micrograms) plus glycopyrronium (4 inhalations of 25 micrograms).
100/6/25 mikrogramov, s formulacijo, ki je ni na trgu n ki vsebuje dvakratno odobreno jakost glikopironija) ali enkratnim odmerkom trojne kombinacije, ki je bila sestavljena iz fiksne kombinacije beklometazondipropionata in formoterola 100/6 mikrogramov (4 inhalacije po 100/6 mikrogramov)
Riarify significantly improved dyspnoea (measured as the Transition Dyspnoea Index - TDI - focal score) after 26 weeks of treatment compared with baseline (by 1.71 units; p < 0.001), but the adjusted mean difference versus a fixed combination of beclometasone dipropionate and formoterol was not statistically significant (0.21 units; p = 0.160).
p < 0,001), vendar prilagojena srednja razlika v primerjavi s fiksno kombinacijo beklometazondipropionata in formoterola ni bila statistično značilna (0,21 enot; p = 0,160).
Beclometasone dipropionate: pneumonia, oral fungal infections, lower respiratory tract infection fungal, dysphonia, throat irritation, hyperglycaemia, psychiatric disorders, cortisol decreased, blurred vision.
Med neželenimi učinki, ki so jih opazili, so naslednji običajno povezani z: beklometazondipropionatom: pljučnica, oralna glivična okužba, glivična okužba spodnjih dihal, disfonija, draženje žrela, hiperglikemija, psihiatrične motnje, zmanjšanje ravni kortizola, zamegljen vid;
After a glycopyrronium single i.v.
Po enkratni i.v.
The renal excretion of beclometasone dipropionate and its metabolites is negligible.
Izločanje beklometazondipropionata in njegovih presnovkov skozi ledvice je zanemarljivo.
Each delivered dose (the dose leaving the mouthpiece) contains 87 micrograms of beclometasone dipropionate, 5 micrograms of formoterol fumarate dihydrate and 9 micrograms of glycopyrronium (as 11 micrograms glycopyrronium bromide).
En dostavljen odmerek (odmerek, ki zapusti ustnik) vsebuje 87 mikrogramov beklometazondipropionata, 5 mikrogramov formoterolijevega fumarata dihidrata in 9 mikrogramov glikopironija (v obliki 11 mikrogramov glikopironijevega bromida).
• diarrhoea
• omrtvelost
Package leaflet: Information for the user Riarify 87 micrograms/5 micrograms/9 micrograms pressurised inhalation, solution beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium
Navodilo za uporabo Riarify 87 mikrogramov/5 mikrogramov/9 mikrogramov inhalacijska raztopina pod tlakom beklometazondipropionat/formoterolijev fumarat dihidrat/glikopironij
Riarify should be used with caution in patients with cardiac arrhythmias, especially third degree atrioventricular block and tachyarrhythmias (accelerated and/or irregular heart beat), idiopathic subvalvular aortic stenosis, hypertrophic obstructive cardiomyopathy, severe heart disease (particularly acute myocardial infarction, ischaemic heart disease, congestive heart failure), occlusive vascular diseases (particularly arteriosclerosis), arterial hypertension and aneurysm.
idiopatsko subvalvularno aortno stenozo, hipertrofično obstruktivno kardiomiopatijo, hudo boleznijo srca (zlasti akutni miokardni infarkt, ishemična bolezen srca, kongestivno srčno popuščanje),
Each metered dose (the dose leaving the valve) contains 100 micrograms of beclometasone dipropionate, 6 micrograms of formoterol fumarate dihydrate and 10 micrograms of glycopyrronium.
En odmerjen odmerek (odmerek, ki zapusti ventil) vsebuje 100 mikrogramov beklometazondipropionata, 6 mikrogramov formoterolijevega fumarata dihidrata in 10 mikrogramov glikopironija.
Ethanol anhydrous Hydrochloric acid Norflurane (propellant)
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi brezvodni etanol klorovodikova kislina norfluran (potisni plin)
The (R,R)- and (S,S)-enantiomers represented about 40% and 60% of unchanged active substance excreted in the urine, respectively.
Enantiomeri (R,R) in (S,S) predstavljata približno
Riarify 87/5/9 micrograms pressurised inhalation beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium Inhalation use
Riarify 87/5/9 mikrogramov inhalacijska raztopina pod tlakom beklometazondipropionat/formoterolijev fumarat dihidrat/glikopironij za inhaliranje
Wipe inside and outside of the mouthpiece and the inhaler with a clean, dry cloth or tissue.
Odstranite zaščitni pokrovček z ustnika tako, da jo snamete z inhalatorja Zunanjost in notranjost ustnika ter inhalator obrišite s čisto suho krpo ali papirnatim robčkom Pokrovček namestite nazaj na ustnik.
If you get any side effects talk to your doctor or pharmacist.
Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom ali farmacevtom.
Each metered dose (the dose leaving the valve) contains 100 micrograms of beclometasone dipropionate, 6 micrograms of formoterol fumarate dihydrate and 10 micrograms of glycopyrronium (as 12.5 micrograms of glycopyrronium bromide).
En odmerjen odmerek (odmerek, ki zapusti ventil) vsebuje 100 mikrogramov beklometazondipropionata, 6 mikrogramov formoterolijevega fumarata dihidrata in 10 mikrogramov glikopironija (v obliki 12,5 mikrograma glikopironijevega bromida).
Priming the inhaler
Priprava inhalatorja
Tremor, dizziness, dysgeusia1, hypoaesthesia1
Bolezni živčevja glavobol pogosti tremor, omotica, disgevzija1, hipoestezija1
• fungal infections of the chest
• glivične okužbe žrela ali požiralnika;
• skin rash, hives, skin itching
• kožni izpuščaj, koprivnica, srbenje kože;
Testing your inhaler
Preverjanje inhalatorja
• pain in the back of the mouth and throat
• bolečina v zadnjem delu ust in žrelu; • vnetje in rdečina žrela;
Related to glycopyrronium
V povezavi z glikopironijem
Adrenal suppression1
občasni trombocitopenija1
How to store Riarify
Shranjevanje zdravila Riarify
It is important that you take your dose as advised by your doctor.
Če ste uporabili večji odmerek zdravila Riarify, kot bi smeli Pomembno je, da uporabite odmerek, ki vam ga je svetoval zdravnik.
After dispensing, the inhaler may be stored at a temperature up to 25°C for a maximum of 2 months.
Po izdaji lahko inhalator shranjujete največ 2 meseca pri temperaturi do 25 °C.
LIST OF EXCIPIENTS
ŠTEVEC ODMERKOV
For glycopyrronium, the maximum plasma concentration was similar after administration of the fixed or extemporary combination, while the systemic exposure was slightly higher after administration of Riarify than with the extemporary combination.
Za glikopironij je bila največja koncentracija v plazmi podobna po dajanju fiksne kombinacije ali trojne kombinacije, ki je bila sestavljena iz fiksne kombinacije beklometazondipropionata in formoterola plus glikopironija,
• medicines for treating Parkinson's disease (levodopa), to treat an underactive thyroid gland (levothyroxine), medicines containing oxytocin (which causes uterine contraction) and alcohol can increase the chances of formoterol side effects on the heart.
• zdravili za zdravljenje Parkinsonove bolezni (levodopa), zmanjšanega delovanja ščitnice (levotiroksin), zdravili, ki vsebujejo oksitocin (ta povzroči krčenje maternice), in alkoholom lahko poveča možnost, da formoterol povzroči neželene učinke na srce; • zaviralci monoaminoksidaze, vključno z zdravili, ki imajo podobne lastnosti kot furazolidon in prokarbazin in se uporabljajo za zdravljenje duševnih motenj, lahko povzroči zvišanje krvnega tlaka;
IMPORTANT: steps 2 to 5 should not be performed too quickly: Patients should remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free from dust and dirt or any other foreign objects.
Bolnik naj z ustnika sname zaščitni pokrovčekin preveri, ali je ustnik čist in brez prahu ali umazanije od drugih predmetov.
Glaucoma1, cataract1
neznana pogostnost glavkom1, katarakta1
• fungal infections of the vagina
• glivične okužbe nožnice;
Store at 25°C for a maximum of 2 months.
Shranjujte največ 2 meseca pri temperaturi 25 °C.
The daily dose of Riarify corresponds to a medium dose of inhaled corticosteroid; furthermore, these effects are much less likely to occur than with oral corticosteroids.
Dnevni odmerek zdravila Riarify ustreza srednjemu odmerku inhalacijskega kortikosteroida.
• if you have an eye problem called narrow-angle glaucoma.
• če imate težavo z očmi, imenovano glavkom z zaprtim zakotjem;
Use with a spacer
Pot uporabe
Among the observed adverse reactions the following are typically associated with:
Možni sistemski učinki vključujejo:
Store at 25°C for a maximum of 4 months.
Shranjujte največ 4 mesece pri temperaturi 25 °C.
• increased blood flow to some tissues in the body
• povečan pretok krvi v nekaterih tkivih telesa; • kašelj in produktivni kašelj;
• tiredness
• driska;
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN
Oedema peripheral1
občasni astenija redki periferni edem1
• swallowing difficulties
• težave s požiranjem;
Atrial fibrillation, electrocardiogram QT prolonged, tachycardia, tachyarrhythmia1, palpitations
Srčne bolezni atrijska fibrilacija, podaljšanje intervala QT na elektrokardiogramu, tahikardija, tahiaritmija1, palpitacije občasni angina pektoris (stabilna1 in nestabilna), ventrikularne ekstrasistole1, nodalni ritem, sinusna bradikardija redki
• tooth decay
• suha usta;
You should get a replacement when the counter or indicator shows the number 20.
Ko števec ali kazalnik odmerkov pokaže številko 20, morate dobiti nov inhalator.
EXPIRY DATE
Datum izdaje:
Hyperaemia1, flushing1, hypertension
Žilne bolezni hiperemija1, vročinski oblivi1, hipertenzija občasni ekstravazacija krvi redki
Hypokalaemia may increase the disposition towards arrhythmias in patients who are treated with digitalis glycosides.
Pri bolnikih, zdravljenih z digitalisovimi glikozidi, lahko hipokaliemija poveča nagnjenost k motnjam srčnega ritma.
Compared with tiotropium, Riarify improved pre-dose FEV1 by 51 mL after 26 weeks of treatment and by 61 mL after 52 weeks of treatment.
26-tedenskem zdravljenju in za 61 ml po 52-tedenskem zdravljenju.
• inflammation of the kidneys.
• vnetje ledvic.
The combination of Riarify with some other COPD medicines or medicines such as diuretics (medicines that make the body lose water, to treat heart disease or high blood pressure), can cause a sharp fall in your blood level of potassium.
Kombinacija zdravila Riarify z nekaterimi drugimi zdravili za KOPB ali zdravili, kot so npr. diuretiki (zdravili za odvajanje vode,
• dizziness
• drhtenje;
B. PACKAGE LEAFLET
Zunanja ovojnina skupnega pakiranja
Related to beclometasone dipropionate
V povezavi z beklometazondipropionatom
• sensation of a missed heart beat, unusually slow heart beat
• občutek izpuščenega srčnega utripa,
Pressurised inhalation, solution (pressurised inhalation).
inhalacijska raztopina pod tlakom Brezbarvna do rumenkasta raztopina.
Vascular disorders
KAZALNIK ODMERKOV
The elimination half-life of grapiprant is approximately 4.6 to 5.67 hours.
Razpolovni čas izločanja grapipranta je približno 4,6 do 5,67 ure.
The tablet can be divided into equal halves.
Tableto je mogoče razdeliti na dve enaki polovici.
A clinical response to treatment is usually seen within 7 days.
Klinični odziv na zdravljenje se običajno pokaže v 7 dneh.
This difference in favour of Galliprant was statistically significant (p-value= 0.0008).
Ta razlika v korist zdravila Galliprant je bila statistično značilna (vrednost p = 0,0008).
26 Rue de la Chapelle 68330 Huningue France
26 Rue de la Chapelle 68330 Huningue Francija
Duration of treatment will depend on the response observed to treatment.
Trajanje zdravljenja je odvisno od opaženega odziva na zdravljenje.
100 mg For the full list of excipients, see section 6.1.
100 mg Za celoten seznam pomožnih snovi glejte poglavje 6.1.
Approximately 70-80% of the administered dose is excreted within 48-72 h with the majority of the dose excreted unchanged.
Približno 70-80 % uporabljenega odmerka se izloči v 4872 urah, pri čemer se večina odmerka izloči v nespremenjeni obliki.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 09/01/2018
Datum pridobitve dovoljenja za promet: 09/01/2018
No gender related differences in absorption are observed.
Razlik v absorpciji, povezanih s spolom živali, niso opazili.
If you notice any side effects, even those not already listed in this package leaflet or you think the medicine has not worked, please inform your veterinary surgeon.
Če opazite kakršne koli neželene učinke, tudi tiste, ki niso navedeni v tem navodilu za uporabo, ali mislite, da zdravilo ni delovalo, obvestite svojega veterinarja.
Administer this veterinary medicinal product on an empty stomach (e.g. in the morning) and at least one hour before the next meal, once daily at a target dose of 2 mg per kg body weight.
Zdravilo dajte na prazen želodec (npr. zjutraj) in vsaj eno uro pred naslednjim obrokom, enkrat dnevno v priporočenem odmerku 2 mg na kilogram telesne mase.
The safety of the veterinary medicinal product has not been established in dogs under 9 months of age and in dogs weighing less than 3.6 kg.
Varnost tega zdravila pri psih, mlajših od 9 mesecev in psih, ki tehtajo manj kot 3,6 kg, ni bila ugotovljena.
One bottle per cardboard box.
Ena plastenka v kartonski škatli.
EU/2/17/221/001 (20 mg, 7 tablets, 20 ml bottle) EU/2/17/221/002 (20 mg, 30 tablets, 20 ml bottle) EU/2/17/221/003 (60 mg, 7 tablets, 20 ml bottle) EU/2/17/221/004 (60 mg, 30 tablets, 35 ml bottle) EU/2/17/221/005 (100 mg, 7 tablets, 35 ml bottle) EU/2/17/221/006 (100 mg, 30 tablets, 60 ml bottle)
EU/2/17/221/001 (20 mg, 7 tablet, 20 ml plastenka) EU/2/17/221/002 (20 mg, 30 tablet, 20 ml plastenka) EU/2/17/221/003 (60 mg, 7 tablet, 20 ml plastenka) EU/2/17/221/004 (60 mg, 30 tablet, 35 ml plastenka) EU/2/17/221/005 (100 mg, 7 tablet, 35 ml plastenka) EU/2/17/221/006 (100 mg, 30 tablet, 60 ml plastenka)
As field studies were limited to 28 days, longer-term treatment should be considered carefully and regular monitoring undertaken by the veterinarian.
Ker je bila izvedba terenskih študij omejena na 28 dni, dlje trajajoče zdravljenje zahteva skrben razmislek in redno spremljanje s strani veterinarja.
If no clinical improvement is apparent after 14 days, treatment with Galliprant should be discontinued and different treatment options should be explored in consultation with the veterinarian.
Če po 14 dneh ne pride do kliničnega izboljšanja, je treba zdravljenje z zdravilom Galliprant ukiniti in v posvetu z veterinarjem proučiti druge možnosti zdravljenja.
SPECIAL STORAGE CONDITIONS Do not store above 30 °C.
POSEBNA NAVODILA ZA SHRANJEVANJE Ne shranjujte pri temperaturi nad 30 °C.
In case of overdose, symptomatic treatment should be initiated.
V primeru prevelikega odmerjanja je treba uvesti simptomatsko zdravljenje.
The veterinary medicinal product is available in the following pack sizes:
Zdravilo je na voljo v naslednjih velikostih pakiranja:
If signs of sulphonamide hypersensitivity occur, treatment should be discontinued.
Če se pojavijo znaki preobčutljivosti na sulfonamide, je treba zdravljenje ukiniti.
The mean percentage of unbound grapiprant was 4.35% and 5.01% at a grapiprant concentration of 200 ng/ml and 1000 ng/ml.
Povprečen odstotek nevezanega grapipranta je bil 4,35 % oziroma 5,01 % pri koncentraciji grapipranta 200 ng/ml oziroma 1000 ng/ml.
Do not use in case of hypersensitivity to the active substance or any of the excipients.
Ne uporabite v primerih preobčutljivosti na učinkovino ali na katero koli pomožno snov.
QM01AX92
Oznaka ATC vet: QM01AX92
Maximum grapiprant concentrations are observed in serum within one hour of dosing in the fasted state.
Najvišje koncentracije grapipranta v serumu nastopijo v eni uri po odmerjanju na tešče.
It is not known whether dogs with a history of hypersensitivity to sulphonamides will exhibit hypersensitivity to grapiprant.
Ni znano, ali psi z anamnezo preobčutljivosti na sulfonamide izkazujejo preobčutljivost na grapiprant.
Drug compatibility should be monitored in animals requiring adjunctive therapy.
Pri živalih, ki potrebujejo dodatno zdravljenje, je treba spremljati kompatibilnost zdravil.
Four metabolites are identified and the metabolic pathways include Ndeamination to form the major metabolite in faeces (7.2%) and urine (3.4%).
Ugotovljeni so štirje presnovki, presnovne poti pa vključujejo N-deaminacijo, pri kateri nastaja glavni presnovek v blatu (7,2 %) in urinu (3,4 %).
The concurrent use of grapiprant with other anti-inflammatory agents has not been studied and should be avoided.
Sočasna uporaba grapipranta z drugimi protivnetnimi zdravili ni bila proučena in se ji je treba izogibati.
Intake of the tablet with food reduces the oral bioavailability, i.e. the oral bioavailability of grapiprant when taken in the fasted state was 89% and when taken with food it was 33%, with mean Cmax and AUC grapiprant values reduced 4-fold and 2-fold, respectively.
Zaužitje tablete s hrano zmanjša peroralno biološko razpoložljivost, t. j. peroralna biološka razpoložljivost grapipranta je bila pri dajanju na tešče 89 %, pri dajanju s hrano pa 33 %, pri čemer sta se vrednosti Cmax in AUC grapipranta znižali za 4-krat oziroma 2-krat.
After a single oral dose of 2 mg grapiprant/kg, Cma x and AUC values of 1.21 µg/ml and 2.71 µg.h/ml were reached in the fasted state.
Po enkratnem peroralnem odmerku 2 mg grapipranta/kg v stanju teščosti sta bili doseženi vrednosti Cmax 1,21 µg/ml in AUC 2,71 µg.h/ml.
Do not use this veterinary medicinal product after the expiry date, which is stated on the carton and bottle after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na škatli in plastenki za oznako »EXP«.
Faecal excretion accounted for roughly 65% of the dose whereas approximately 20% of the dose was excreted through urine.
Približno 65 % odmerka se je izločilo z blatom, približno 20 % pa z urinom.
Dose range (mg/kg bw)
Razpon odmerka (mg/kg t. m.)
The pharmacological activity of the metabolites is not known.
Farmakološka aktivnost teh presnovkov ni znana.
In dogs, grapiprant is a major excretion product in bile, faeces and urine.
Pri psih je grapiprant glavni produkt izločanja v žolču, blatu in urinu.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 7 tablets
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV 7 tablet
- 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).
- pogosti (pri več kot 1, toda manj kot 10 živalih od 100 zdravljenih živali) - občasni (pri več kot 1, toda manj kot 10 živalih od 1.000 zdravljenih živali) - redki (pri več kot 1, toda manj kot 10 živalih od 10.000 zdravljenih živali)
Prior treatment with other anti-inflammatory substances may result in additional or increased severity of adverse effects and accordingly a treatment-free period with such drugs should be observed before the commencement of treatment with this veterinary medicinal product.
Predhodno zdravljenje z drugimi protivnetnimi zdravili lahko privede do dodatnih neželenih učinkov ali povečane resnosti neželenih učinkov, zato mora po zdravljenju s tovrstnimi zdravili in pred začetkom zdravljenja s tem zdravilom preteči interval brez zdravljenja.
The specific effects of the binding of prostaglandin E2 to the EP4 receptor include vasodilation, increased vascular permeability, angiogenesis and production of pro‐inflammatory mediators.
Specifični učinki vezave prostaglandina E2 na receptor EP4 vključujejo vazodilacijo, povečano žilno prepustnost, angiogenezo in tvorbo vnetnih mediatorjev.
Commonly used protein-bound veterinary medicinal products include cardiac, anticonvulsant and behavioural medications.
Pogosto uporabljana zdravila, ki se vežejo na beljakovine, vključujejo zdravila za srce, antiepileptike in zdravila za vedenjske motnje.
The concomitant use of protein-bound veterinary medicinal products with grapiprant has not been studied.
Sočasna uporaba grapipranta in zdravil, ki se vežejo na beljakovine, ni bila proučena.
MARKETING AUTHORISATION NUMBER(S) EU/2/17/221/006 (100 mg, 30 tablets, 60 ml bottle)
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/17/221/006 (100 mg, 30 tablet, 60 ml plastenka)
Grapiprant is readily and rapidly absorbed from the gastrointestinal tract in dogs.
Grapiprant se zlahka in zelo hitro absorbira iz prebavil psov.
One white HDPE bottle with a child-resistant cap containing 7 or 30 tablets (20 mg, 60 mg or 100 mg tablets).
Ena bela plastenka iz HDPE z za otroke varno zaporko, ki vsebuje 7 ali 30 tablet (20 mg, 60 mg ali 100 mg tablete).
In clinical studies, the following mild and generally transient adverse reactions have been observed: vomiting, soft-formed faeces, diarrhoea and inappetence.
V kliničnih študijah so opazili naslednje blage in na splošno prehodne neželene učinke: bruhanje, zmehčano blato, diarejo in neješčnost.
4.2 Indications for use, specifying the target species For the treatment of pain associated with mild to moderate osteoarthritis in dogs.
4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Za zdravljenje bolečine, povezane z blagim do zmernim osteoartritisom pri psih.