natgillin/translations-raw huggingface dataset:
Peyona should only be used in a neonatal intensive care unit in which adequate facilities are available for patient surveillance and monitoring.
Zdravljenje z zdravilom Peyona mora potekati izključno na oddelku intenzivne nege za novorojenčke, kjer so na voljo ustrezni pripomočki za nadzor in spremljanje bolnika.
− infants whose mothers may have ingested large quantities of caffeine prior to delivery (see section
− dojenčkih, katerih matere so pred porodom zaužile velike količine kofeina (glejte poglavje 4.4)
The medicinal product must be used immediately after diluting by aseptic technique
Zdravilo je treba po redčenju z uporabo aseptične tehnike uporabiti takoj.
Endotracheal tube
endotrahealna cevka
If your newborn gets any side effects, talk to your baby's doctor.
Če opazite pri svojem novorojenčku kateri koli neželeni učinek, se posvetujte z otrokovim zdravnikom.
Effects described include central nervous system (CNS) stimulation such as convulsion, irritability, restlessness and jitteriness, cardiac effects such as tachycardia, arrhythmia, hypertension and increased stroke volume, metabolism and nutrition disorders such as hyperglycaemia.
Opisani učinki vključujejo spodbujanje osrednjega živčnega sistema (OŽS) kot so konvulzije, razdražljivost, nemir in živčnost, srčne učinke kot so tahikardija, aritmija,
Caffeine's main action is as a CNS stimulant.
Farmakodinamični učinki Glavni učinek kofeina je spodbujanje OŽC.
These active substances should not be used concurrently.
Teh zdravilnih učinkovin ne uporabljajte sočasno.
It may be needed that your baby's doctor decides to check the levels of caffeine in a blood test periodically throughout treatment to avoid toxicity.
Morda bo moral otrokov zdravnik v izogib toksičnosti ves čas zdravljenja s testi redno določati ravni kofeina v krvi.
MM/YYYY
{MM/LLLL}
After oral administration of 10 mg caffeine base/kg body weight to preterm newborn infants, the peak plasma caffeine concentration (Cmax) ranged from 6 to 10 mg/l and the mean time to reach peak concentration (tmax) ranged from 30 min to 2 h. The extent of absorption is not affected by formula feeding but tmax may be prolonged.
Po peroralnem dajanju 10 mg kofeina/kg telesne mase nedonošenega novorojenčka je bil razpon najvišje koncentracije kofeina v plazmi (Cmax) od 6 do 10 mg/l in razpon povprečnega časa do dosežene najvišje koncentracije (tmax) od 30 minut do 2 uri.
Ampoules of all parenteral solutions must be inspected visually for particulate matter prior to administration.
Vse ampule s parenteralno raztopino je treba pred uporabo vizualno pregledati zaradi delcev.
Rare
enkratno
Caffeine citrate should be administered with caution in preterm newborn infants with impaired renal or hepatic function.
Kofeinijev citrat je treba dajati previdno pri nedonošenih novorojenčkih z okvarjenim delovanjem ledvic ali jeter.
Type I clear glass 1 ml ampoule Type I clear glass 3 ml ampoule Pack size of 10 ampoules.
1 ml ampula iz prosojnega stekla vrste I 3 ml ampula iz prosojnega stekla vrste I
Dose of caffeine citrate (mg/kg body weight)
Odmerek kofeinijevega citrata (mg/kg telesne mase)
In newborn infants born to mothers who consumed large quantities of caffeine prior to delivery, baseline plasma caffeine concentrations should be measured prior to initiation of treatment with caffeine citrate, since caffeine readily crosses the placenta into the foetal circulation (see sections 4.2 and 5.2).
Pri novorojenčkih, rojenim materam, ki so pred porodom zaužile velike količine kofeina, je treba pred uvedbo zdravljenja s kofeinijevim citratom izmeriti izhodiščne koncentracije kofeina v plazmi, saj kofein hitro prehaja skozi placento v plodov obtok (glejte poglavji 4.2 in 5.2).
The active substance is caffeine citrate.
Zdravilna učinkovina je kofeinijev citrat.
5 mg/kg body weight Intravenous infusion (over 10 minutes) or by oral administration
5 mg/kg telesne mase intravenska infuzija (10-minutna) ali peroralno dajanje vsakih 24 ur*
In newborn infants born to mothers who consumed large quantities of caffeine prior to delivery, baseline plasma caffeine concentrations should be measured prior to initiation of treatment with caffeine citrate (see section 4.4).
Pri novorojenčkih, rojenih materam, ki so pred porodom zaužile veliko količino kofeina, je treba pred uvedbo zdravljenja s kofeinijevim citratom izmeriti izhodiščno vrednost koncentracije kofeina v plazmi (glejte poglavje 4.4).
These effects are not relevant with regard to short term administration in the preterm infant population (see section
Ti učinki niso pomembni zaradi kratkega obdobja dajanja v skupini nedonošenčkov (glejte poglavje 5.3).
Caffeine citrate readily dissociates in aqueous solution.
Kofeinijev citrat v vodni raztopini hitro disociira.
Contents of the pack and other information
Shranjevanje zdravila Peyona Vsebina pakiranja in dodatne informacije
The dose expressed as caffeine base is one-half the dose when expressed as caffeine citrate (20 mg caffeine citrate are equivalent to 10 mg caffeine base).
Odmerek, izražen kot kofein, je polovica odmerka, če je izražen kot kofeinijev citrat (20 mg kofeinijevega citrata je enakovredno 10 mg kofeina).
Peyona should be inspected visually for particulate matter and discoloration prior to administration.
Zdravilo Peyona je treba pred uporabo vizualno pregledati glede delcev in obarvanja.
Peyona is a solution for infusion and oral solution.
Zdravilo Peyona je raztopina za infundiranje in peroralna raztopina.
Loading dose 1.0 ml/kg body weight
1,0 ml/kg telesne mase
The solution must not be used if it is discoloured or foreign particulate matter is present.
Raztopine ne smete uporabljati, če je obarvana ali v njej plavajo delci.
- That Peyona is for the treatment of primary apnoea - That treatment with Peyona must be provided in a neonatal intensive care unit and initiated and supervised by a physician experienced in neonatal intensive care - Details of the loading and maintenance dosages and that caffeine may accumulate in premature newborn infants because of its long half-life.
- Zdravljenje z zdravilom Peyona je treba nuditi v enoti za intenzivno nego novorojenčkov, začeti in nadzorovati pa ga mora zdravnik, izkušen v intenzivni negi novorojenčkov.
− infants whose mothers consume caffeine while providing breast milk for feeding.
− dojenčki, katerih matere uživajo kofein in dajejo mleko za prehranjevanje Priporočljivo je izmeriti izhodiščne vrednosti kofeina pri:
Caffeine has a prolonged half-life in premature newborn infants and there is potential for accumulation which may necessitate monitoring infants treated for an extended period (see section
Razpolovna doba kofeina pri nedonošenčkih je podaljšana, zato obstaja možnost kopičenja, zaradi katerega je morda treba nadzirati dojenčke, ki zdravilo dobivajo dalj časa (glejte poglavje 5.2).
The following other side effects may also be considered serious by your baby's doctor in the context of the global clinical evaluation.
- resna bolezen črevesja s krvavim blatom (nekrotizirajoči enterokolitis) V kontekstu celotne klinične ocene lahko zdravnik tudi naslednje neželene učinke obravnava kot resne.
However, it is difficult to distinguish them from frequent complications occurring in premature babies and complications due to the disease.
Vendar pa je te neželene učinke težko ločiti od pogostih zapletov, ki se pojavljajo pri nedonošenčkih,
Peyona 20 mg/ml solution for infusion and oral solution Caffeine citrate (equivalent to 10 mg/ml of caffeine base) IV/oral use
Peyona 20 mg/ml raztopina za infundiranje in peroralna raztopina kofeinijev citrat (ustreza 10 mg/ml kofeina) i.v./peroralna uporaba
Hepatic cytochrome P450 1A2 (CYP1A2) is involved in caffeine biotransformation in older individuals.
(CYP1A2) sodeluje v biološki transformaciji kofeina pri starejših osebah.
Other causes of apnoea (e.g., central nervous system disorders, primary lung disease, anaemia, sepsis, metabolic disturbances, cardiovascular abnormalities, or obstructive apnoea) should be ruled out or properly treated prior to initiation of treatment with caffeine citrate.
Pred začetkom zdravljenja s kofeinijevim citratom je treba izključiti ali ustrezno zdraviti druge vzroke za apnejo (npr. bolezen osrednjega živčnega sistema, primarna bolezen pljuč, anemija, sepsa, motnje presnove,
As for all preterm infants, those treated with caffeine citrate should be carefully monitored for the development of necrotising enterocolitis (see section
Kot pri vseh nedonošenčkih je treba tudi pri tistih, zdravljenih s kofeinijevim citratom, skrbno nadzirati razvoj nekrotizirajočega enterokolitisa (glejte poglavje 4.4).
After opening the ampoules, the medicinal product should be used immediately.
Zdravilo je treba po odprtju ampule porabiti takoj.
Caffeine citrate can be administered by intravenous infusion and by the oral route.
Kofeinijev citrat se lahko daje kot intravenska infuzija ali peroralno.
Peyona 20 mg/ml solution for infusion and oral solution Caffeine citrate (equivalent to 10 mg/ml of caffeine base)
Peyona 20 mg/ml raztopina za infundiranje in peroralna raztopina kofeinijev citrat (ustreza 10 mg/ml kofeina)
Infants received 20 mg/kg caffeine citrate loading dose intravenously.
Dojenčkom so intravensko dali začetni odmerek 20 mg/kg kofeinijevega citrata.
Peyona 20 mg/ml solution for infusion and oral solution
Peyona 20 mg/ml raztopina za infundiranje in peroralna raztopina
Caffeine citrate can be either used without dilution or diluted in sterile solutions for infusion such as glucose 50 mg/ml (5%), or sodium chloride 9 mg/ml (0.9%) or calcium gluconate 100 mg/ml (10%) immediately after withdrawal from the ampoule (see section 6.6).
natrijev klorid 9 mg/ml (0,9 %) ali kalcijev glukonat 100 mg/ml (10 %) nemudoma po izvleku iz ampule (glejte poglavje 6.6).
No deaths associated with caffeine overdose have been reported in preterm infants.
Pri prevelikem odmerjanju kofeina nedonošenčkom niso poročali o smrtnih primerih.
Nervous system disorders Convulsion
raztopina za infundiranje peroralna raztopina
• If your newborn has a reduced weight gain or food intake • If you (the mother) consumed caffeine prior to delivery
• če ste vi (mati) pred porodom zaužili kofein
Non-clinical data revealed no major hazard for humans based on studies of repeated dose toxicity of caffeine.
5.3 Predklinični podatki o varnosti Predklinični podatki na osnovi študij toksičnosti pri ponavljajočih se odmerkih ne kažejo večjega tveganja za človeka.
Caffeine has been shown to increase heart rate, left ventricular output, and stroke volume in published studies.
V objavljenih študijah se je pokazalo, da kofein poveča hitrost srčnega utripa, iztis iz levega prekata in utripni volumen.
- If your newborn gets any side effects, talk to your baby's doctor.
- Če opazite kateri koli neželeni učinek, se posvetujte z otrokovim zdravnikom.
Hypoglycaemia, failure to thrive, feeding intolerance
Presnovne in prehranske motnje hiperglikemija pogosti hipoglikemija, nenapredovanje v rasti, neprenašanje hrane neznana
Inter-conversion between caffeine and theophylline occurs in preterm newborn infants.
Pri nedonošenih novorojenčkih se pojavi interkonverzija med kofeinom in teofilinom.
The citrate moiety is rapidly metabolized on infusion or ingestion.
Zdravilna učinkovina citrat se hitro presnovi po infundiranju ali zaužitju.
How to store Peyona
Shranjevanje zdravila Peyona
Side effects where the frequency cannot be estimated from the available data - serious intestinal disease with bloody stools (necrotising enterocolitis)
Neželeni učinki, pri katerih pogostnosti ni mogoče oceniti iz razpoložljivih podatkov
Adverse Reaction
- alergijske reakcije
Package leaflet: Information for the user Peyona 20 mg/ml solution for infusion and oral solution caffeine citrate
Navodilo za uporabo Peyona 20 mg/ml raztopina za infundiranje in peroralna raztopina kofeinijev citrat
Each 3 ml ampoule contains 60 mg caffeine citrate (equivalent to 30 mg of caffeine base).
Ena 3 ml ampula vsebuje 60 mg kofeinijevega citrata (kar ustreza 30 mg kofeina).
In that case, infants received a second loading dose of 20 mg/kg caffeine citrate after treatment day 1 and before treatment day 8.
V tem primeru so dojenčki prejeli drugi začetni odmerek 20 mg/kg kofeinijevega citrata po
Ear and labyrinth disorders Deafness
Ušesne bolezni, vključno z motnjami labirinta gluhost neznana
A maintenance daily dose of 5 mg/kg caffeine citrate was then administered either intravenously or orally (through a feeding tube) for up to 10-12 days.
Nato so bodisi intravensko bodisi peroralno (skozi prehranjevalno cevko) do 1012 dni dobivali vzdrževalni odmerek 5 mg/kg kofeinijevega citrata.
In a post authorisation safety study, the frequency of adverse reactions in a small number of very premature infants with renal/hepatic imparment appeared to be higher as compared to premature infants without organ impairment (see sections 4.4 and 4.8).
Študija o varnosti zdravila po pridobitvi dovoljenja za promet kaže, da je pogostnost neželenih učinkov, pri majhnem številu zelo zgodaj rojenih nedonošenčkov z okvaro jeter/ledvic višja, v primerjavi z nedonošenčki brez okvare organa
Keep out of the sightand reach of children.
Zdravilo shranjujte nedosegljivo otrokom!
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS AMPOULE LABEL
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
Irritability, jitteriness, restlessness, brain injury
- spodbujanje osrednjega živčnega sistema, kot so razdražljivost, živčnost in nemir; možganske poškodbe - gluhost
PHARMACEUTICAL PARTICULARS 6.1 List of excipients
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi monohidrat citronske kisline natrijev citrat voda za injekcije
Infusion site phlebitis, infusion site inflammation
Splošne težave in spremembe na mestu aplikacije flebitis na mestu infundiranja, vnetje na mestu infundiranja pogosti
Each ml contains 20 mg caffeine citrate (equivalent to 10 mg caffeine).
En ml vsebuje 20 mg kofeinijevega citrata (kar ustreza 10 mg kofeina).
Treatment of primary apnoea of premature newborns.
Zdravljenje primarne apneje pri nedonošenčkih.
Each 1 ml ampoule contains 20 mg caffeine citrate (equivalent to 10 mg of caffeine base).
Ena 1 ml ampula vsebuje 20 mg kofeinijevega citrata (kar ustreza 10 mg kofeina).
• If your newborn suffers from seizures
• če ima novorojenček epileptične napade
Any unused portions must be discarded.
Ves preostali del zdravila je treba zavreči.
Common reported side effects (may affect up to 1 in 10 people) - local inflammatory reactions at the infusion site - cardiac disorders such as fast heart beat (tachycardia) - changes of sugar in blood or serum (hyperglycaemia)
- okužba krvnega obtoka (sepsa) - spremenjena raven sladkorja v krvi ali serumu (hipoglikemija), nenapredovanje v rasti,
Continued treatment is needed to maintain the beneficial effects and may lead to further improvement.
Nadaljevanje zdravljenja je potrebno za vzdrževanje koristnega učinka zdravila in lahko privede do nadaljnjega izboljšanja.
When this enzyme is blocked, the growth of hair is slowed down.
Če je encim blokiran, je rast dlak upočasnjena.
The European Commission granted a marketing authorisation valid throughout the European Union, for Vaniqa on 20 March 2001.
Evropska komisija je dovoljenje za promet z zdravilom Vaniqa, veljavno po vsej Evropski uniji, odobrila dne 20 marca 2001.
The effectiveness of the treatment was assessed at the end of the study by a doctor who graded the hirsutism as ‘clear/almost clear', ‘marked improvement', ‘improved' or ‘no improvement/worse', 48 hours after women had shaved the treated areas of the face and under the chin.
Učinkovitost zdravljenja je na koncu študije ocenil zdravnik, ki je stopnjo hirsutizma opredelil kot „čisto/skoraj čisto“, „očitno izboljšanje“, „izboljšanje“ ali „ni izboljšanja/slabše“, 48 ur po tem, ko so si ženske obrile zdravljene predele obraza in brado.
In both studies, significant improvement was seen with Vaniqa compared with placebo.
V obeh študijah je bilo pri uporabi zdravila Vaniqa v primerjavi s placebom vidno znatno izboljšanje.
The full EPAR for Vaniqa can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Vaniqa je na voljo spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
What measures are being taken to ensure the safe use of Vaniqa?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Vaniqa?
Improvement was seen as early as eight weeks after starting treatment.
Izboljšanje je bilo vidno že osem tednov po začetku zdravljenja.
Vaniqa is used for the treatment of facial hirsutism in women.
Zdravilo Vaniqa se uporablja za zdravljenje obraznega hirsutizma pri ženskah.
For more information about treatment with Vaniqa, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Vaniqa preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
This is a summary of the European public assessment report (EPAR) for Vaniqa.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Vaniqa.
Improvements may be noticed within eight weeks of starting treatment.
Izboljšanje se lahko pokaže v osmih tednih od začetka zdravljenja.
Vaniqa has been studied in two clinical trials involving 596 women treated for up to 24 weeks with Vaniqa or placebo (a dummy treatment, in this case the cream without any active substance).
Učinkovitost zdravila Vaniqa so raziskovali v dveh kliničnih preskušanjih, v katerih je sodelovalo 596 žensk, ki so jih do 24 tednov zdravili z zdravilom Vaniqa ali placebom (zdravilom brez zdravilne učinkovine, v tem primeru s kremo brez zdravilne učinkovine).
When the results were combined, a successful outcome (graded as ‘clear/almost clear' or ‘marked improvement') was seen in 35% of the women treated with Vaniqa, compared with 9% of those treated with placebo.
Po primerjavi vseh rezultatov je bilo zdravljenje uspešno (opredeljeno kot „čisto/skoraj čisto“ ali „očitno izboljšanje“) pri 35 % žensk, zdravljenih z zdravilom Vaniqa, v primerjavi z 9 % tistih, ki so prejemale placebo.
What benefit has Vaniqa shown during the studies?
Kakšne koristi je zdravilo Vaniqa izkazalo med študijami?
Vaniqa is a white cream that contains the active substance eflornithine (115 mg).
Zdravilo Vaniqa je krema bele barve, ki vsebuje zdravilno učinkovino eflornitin (115 mg).
Vaniqa should not be used in people who may be hypersensitive (allergic) to eflornithine or any of the other ingredients.
Zdravila Vaniqa ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) eflornitin ali katero koli drugo sestavino zdravila.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Vaniqa.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Vaniqa, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Facial hirsutism is excessive growth on the face of coarse hair, often in a male pattern.
Obrazni hirsutizem je prekomerna poraščenost po obrazu, pogosto na podoben način kot pri moških.
This enzyme is found in the bulb of the hair follicle where it controls hair production.
Ta encim se nahaja v čebulici mešička, kjer nadzira izgradnjo dlak.
The most common side effect with Vaniqa (seen in more than 1 patient in 10) is acne.
Najpogostejši neželeni učinek zdravila Vaniqa (opažen pri več kot 1 bolnici izmed 10) so akne.
Other information about Vaniqa
Druge informacije o zdravilu Vaniqa:
The CHMP decided that Vaniqa's benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Vaniqa večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The active substance in Vaniqa, eflornithine, works by blocking the action of an enzyme called ornithine decarboxylase.
Zdravilna učinkovina zdravila Vaniqa, eflornitin, deluje tako, da zavira delovanje encima, imenovanega ornitin dekarboksilaza.
It is applied in a thin layer and rubbed in thoroughly.
Nanesti jo je treba v tankem sloju in jo dobro vtreti v kožo.
Women using Vaniqa may still need to use other means to remove hair (plucking, shaving).
Za nekatere ženske je lahko poleg zdravila Vaniqa še naprej potrebna uporaba drugih metod odstranjevanja dlak (puljenje, britje).
For the full list of all the side effects reported with Vaniqa, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Vaniqa, glejte navodilo za uporabo.
What is the risk associated with Vaniqa?
Kakšna tveganja so povezana z zdravilom Vaniqa?
Vaniqa is applied to clean and dry affected areas of the face and under the chin twice a day (at least eight hours apart).
Zdravilo Vaniqa se dvakrat na dan (v vsaj osemurnih presledkih) nanese na čisto in suho kožo prizadetih predelov obraza in brade.
What is Vaniqa used for?
Za kaj se zdravilo Vaniqa uporablja?
How does Vaniqa work?
Kako zdravilo Vaniqa deluje?
How has Vaniqa been studied?
Kako je bilo zdravilo Vaniqa raziskano?
What is Vaniqa?
Kaj je zdravilo Vaniqa?
Vaniqa should be stopped if no improvements are noticed within four months of starting treatment.
Če po štirih mesecih zdravljenja ni opaziti izboljšanja stanja, je treba zdravljenje z zdravilom Vaniqa prekiniti.
How is Vaniqa used?
Kako se zdravilo Vaniqa uporablja?
3 x 30 tablets
Filmsko obložena tableta Peroralna uporaba plastenka (HDPE) 3 x 30 tablet
30 tablets
Filmsko obložena tableta Peroralna uporaba plastenka (HDPE) 30 tablet
This summary was last updated in July 2013.
Povzetek je bil nazadnje posodobljen julija 2013.
The success rates in the second study were similar.
Stopnje uspešnosti v drugi študiji so bile podobne.
Treatment may then be continued at the same dose given once a day.
Zdravljenje se lahko nato nadaljuje z enakim odmerkom enkrat dnevno.
Oclaticinib
Apoquel oklacitinib
Treatment should be started at a dose of 0.4 - 0.6 mg per kilogram bodyweight twice a day for up to two weeks.
Zdravljenje je treba začeti z odmerkom 0,4−0,6 mg na kilogram telesne mase dvakrat dnevno, do dva tedna.
One study involved 220 dogs and the second involved 299 dogs.
V eno študijo je bilo vključenih 220 psov, v drugo pa 299.
Other information about Apoquel:
Druge informacije o zdravilu Apoquel:
Hands should be washed after handling the tablets.
Po ravnanju s tabletami si je treba umiti roke.
The European Commission granted a marketing authorisation valid throughout the European Union, for Apoquel on 12/09/2013.
Evropska komisija je dovoljenje za promet z zdravilom Apoquel, veljavno po vsej Evropski uniji, odobrila dne 12. septembra 2013.
Apoquel tablets are available in three different strengths (3.5 mg, 5.4 mg and 16 mg) to cover a range of dog weights.
Tablete zdravila Apoquel so na voljo v treh različnih jakostih (3,5 mg, 5,4 mg in 16 mg), s katerimi se pokrije razpon različnih telesnih mas psov.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Apoquel exceed the risks for the approved indications and recommended that Apoquel be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Apoquel večje od z njim povezanih tveganj za odobrene indikacije, in priporočil, da se zanj odobri dovoljenje za promet.
The active substance in Apoquel, oclacitinib, is an immunomodulator (a medicine that changes the activity of the immune system) that works by blocking the action of enzymes known as Janus kinases.
Zdravilna učinkovina v zdravilu Apoquel, oklacitinib, je imunomodulator (zdravilo, ki spremeni aktivnost imunskega sistema), ki deluje tako, da preprečuje delovanje encimov, imenovanih Janusove kinaze.