natgillin/translations-raw huggingface dataset:
Renal and/or hepatic impairment
Zmanjšano delovanje ledvic in/ali jeter
Gastrointestinal (GI) perforation has been reported in siltuximab clinical trials although not in MCD trials.
V kliničnih študijah (vendar ne v študijah MCD) siltuksimaba so poročali o perforacijah gastrointestinalnega trakta.
Each 400 mg vial should be reconstituted with 20 mL of single-use water for injections to yield a 20 mg/mL solution.
Eno400 ml vialo je treba rekonstituirati z 20 ml vode za injekcije za enkratno uporabo, da nastane raztopina z 20 mg/ml.
Haemoglobin increase > 15 g/L (0.9 mmol/L) at Week 13/haemoglobin response-evaluable population Durable complete symptomatic responsed
(0,17; 1,13)c zvečanje koncentracije hemoglobina na > 15 g/l (0,9 mmol/l) po 13 tednih pri populaciji s podatkom o koncentraciji hemoglobina trajni popolni simptomatski odzivd
What you need to know before you are given SYLVANT You should not be given SYLVANT if:
Kaj morate vedeti, preden boste prejeli zdravilo SYLVANT Kako boste prejemali zdravilo SYLVANT
The percent change from baseline in MCD-related signs and symptoms and MCD-related overall symptom score at each cycle was calculated.
Izračunali so tudi odstotno spremembo ocene omenjenih znakov in simptomov od izhodiščne vrednosti in skupno oceno omenjenih simptomov pri vsakem krogu zdravljenja.
No major age-related differences in pharmacokinetics (PK) or in safety profile were observed in clinical studies.
V kliničnih študijah razlik v farmakokinetičnih in varnostnih lastnosti zdravila glede na starost bolnikov niso opazili.
HR 0.418
134 dni razmerje ogroženosti (HR) 0,418
Infusion bags (250 mL) must contain Dextrose 5% and must be made of polyvinyl chloride (PVC), or polyolefin (PO), or polypropylene (PP), or polyethylene (PE).
Za pripravo priporočamo iglo 21G dolžine 38 mm. Infuzijska vrečka (250 ml) mora vsebovati 5% raztopino glukoze, narejena pa mora biti iz polivinil klorida (PVC), poliolefina (PO), polipropilena (PP) ali polietilena (PE).
• stomach pain or discomfort, constipation, diarrhoea, heartburn, ulcers (sores) in the mouth,
• bolečine ali nelagodje v trebuhu, zaprtje, driska, zgaga, razjede v ustih, siljenje na bruhanje,
Use with caution in patients who may be at increased risk for GI perforation.
Pri bolnikih s povečanim tveganjem za perforacijo gastrointestinalnega trakta zdravilo uporabljajte previdno.
The population PK of siltuximab were analysed to evaluate the effects of demographic characteristics.
Za oceno vpliva demografskih lastnosti bolnikov so analizirali populacijsko farmakokinetiko siltuksimaba.
Therefore, prescribers should diligently monitor patients receiving treatment in order to detect serious infections.
Da bi lahko odkrili pojav resne okužbe, je treba zelo pozorno spremljati bolnike, ki prejemajo zdravilo.
Each 100 mg vial should be reconstituted with 5.2 mL of single-use water for injections to yield a 20 mg/mL solution.
Eno100 ml vialo je treba rekonstituirati s 5,2 ml vode za injekcije za enkratno uporabo, da nastane raztopina z 20 mg/ml.
Serious infections, including pneumonia and sepsis, were observed during clinical studies (see section 4.8).
kliničnih študijah so opažali pojav resnih okužb, med drugim pljučnice in sepse (glejte poglavje 4.8).
6.6 Special precautions for disposal and other handling
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Zdravilo je samo za enkratno uporabo.
For patients with baseline calculated creatinine clearance of 12 mL/min or greater, there was no meaningful effect on siltuximab PK. Four patients with severe renal impairment (creatinine clearance 12 to 30 mL/min) were included in the data set.
Podatki vključujejo tudi podatke štirih bolnikov s hudo ledvično okvaro (očistek kreatinina 12 do 30ml/min).
Siltuximab crossed the placenta during gestation whereby fetal serum concentrations of siltuximab at gestation day (GD) 140 were similar to maternal concentrations.
Siltuksimab je prehajal preko placente tako, da je bila (na 140. dan brejosti) koncentracija siltuksimaba pri plodu podobna kot pri samici.
You are severely allergic to siltuximab or any of the other ingredients of this medicine (listed in section 6).
Kaj morate vedeti, preden boste prejeli zdravilo SYLVANT Zdravila SYLVANT ne smete prejemati, če: imate hudo alergijo na siltuksimab ali katero koli drugo sestavino tega zdravila (navedeno v poglavju 6).
A total of 79 patients with symptomatic MCD were randomised and treated.
Skupno so randomizirali in zdravili 79 bolnikov s simptomatsko multicentrično Castlemanovo boleznijo.
Blood and lymphatic system disorders very common
Bolezni krvi in limfatičnega sistema zelo pogosti nevtropenija, trombocitopenija
Package leaflet: Information for the patient SYLVANT 100 mg powder for concentrate for solution for infusion siltuximab This medicine is subject to additional monitoring.
Navodilo za uporabo SYLVANT 100 mg prašek za koncentrat za raztopino za infundiranje siltuksimab Za to zdravilo se izvaja dodatno spremljanje varnosti.
Binding bioactive IL-6 by siltuximab may result in increased metabolism of CYP450 substrates, because CYP450 enzyme activity will normalise.
CYP450 normalizira, s tem pa se presnova substratov CYP450 poveča.
MCD-related signs and symptoms were prospectively collected.
Podatke o znakih in simptomih multicentrične Castlemanove bolezni so zbirali prospektivno.
Characteristics, section 4.2).
(glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
• you have high level of fats in your blood (hypertriglyceridaemia) - this is because SYLVANT may increase these levels.
• če imate zvečano koncentracijo maščob v krvi (hipertrigliceridemijo) - zdravilo SYLVANT
• The active substance is siltuximab.
• Učinkovina je siltuksimab.
Therefore, administering siltuximab with CYP450 substrates that have a narrow therapeutic index has the potential to change therapeutic effects and toxicity of these medicinal products due to alteration in the CYP450 pathways.
Opisani učinek na aktivnost CYP450 pri sočasnem odmerjanju siltuksimaba in substratov CYP450 z majhnim terapevtskim indeksom lahko vpliva na terapevtske učinke in toksično delovanje teh zdravil.
What SYLVANT is used for
Za kaj uporabljamo zdravilo SYLVANT
Table 2: Adverse reactions in siltuximab treated patients in MCD clinical studies a
Preglednica 2: Neželeni učinki pri bolnikih, ki so prejemali siltuksimab v študijah multicentrične Castlemanove boleznia
Elevations in triglycerides and cholesterol (lipid parameters) were observed in patients treated with SYLVANT (see section 4.8).
Pri bolnikih, ki so prejemali zdravilo SYLVANT, so opažali zvečanje koncentracij trigliceridov in holesterola (glejte poglavje 4.8).
The SYLVANT therapy should be withheld if the patient has a severe infection or any severe non-haematological toxicity and can be restarted at the same dose after recovery.
Zdravljenje z zdravilom SYLVANT je treba odložiti, če ima bolnik hudo okužbo ali kakršnokoli hudo poslabšanje krvne slike zaradi nehematološkega vzroka.
Haemoglobina
nazofaringitis
Similarly, in cultures of human Burkitt's B-lymphoma cells, the production of immunoglobulin M protein in response to IL-6 was dose-dependently inhibited by siltuximab.
Prav tako je siltuksimab v odvisnosti od odmerka zaviral z IL-6 stimulirano nastajanje proteina imunoglobulina M v kulturah celic B človeškega Burkittovega limfoma.
Analyses for both primary and secondary endpoints on various subgroups including age (< 65 years and ≥ 65 years); race (White and Non-White); region (North America, Europe, Middle East and Africa, and Asia Pacific); baseline corticosteroid use (yes and no); prior therapy (yes and no); and MCD histology (plasmatic and mixed histology) consistently showed that the treatment effect favoured the siltuximab arm except for the hyaline vascular subgroup in which no patient achieved the definition of the primary endpoint.
Amerika, regija Evropa, Bližnji Vzhod in Afrika ter Azijsko-pacifiška regija), izhodiščni uporabi kortikosteroidov (da in ne), predhodnem zdravljenju (da in ne) in histologiji multicentrične
SYLVANT 100 mg powder for concentrate for solution for infusion 8 mL Type 1 glass vial with an elastomeric closure and an aluminium seal with a flip-off button containing 100 mg of siltuximab.
8 ml viala iz stekla tipa 1 z elastomernim zamaškom in neprodušno aluminijasto zaporo s snemno zaporko, ki vsebuje 100 mg siltuksimaba.
Pharmacodynamic effects In vitro, siltuximab dose-dependently inhibited the growth of an IL-6-dependent murine plasmacytoma cell line in response to human IL-6.
In vitro je siltuksimab (odvisno od odmerka) zaviral z IL-6-stimulirano rast celične linije od IL-6 odvisnega glodalskega plazmacitoma.
Do not infuse SYLVANT concomitantly in the same intravenous line with other agents.
Z istim infuzijskim sistemom ne smete sočasno infundirati zdravila SYLVANT in drugih zdravil.
Unopened vial
1 viala
During intravenous infusion of SYLVANT, mild to moderate infusion reactions may improve following slowing of or stopping the infusion.
Zmanjšanje hitrosti ali prekinitev intravenskega infundiranja zdravila SYLVANT lahko ublaži blago do zmerno infuzijsko reakcijo.
How to store SYLVANT
Kako boste prejemali zdravilo SYLVANT
General disorders and administration site conditions very common
Splošne težave in spremembe na mestu aplikacije zelo pogosti lokaliziran edem
The most serious adverse reaction associated with the use of siltuximab was anaphylactic reaction.
Anafilaktična reakcija je najresnejši neželeni učinek uporabe siltuksimaba.
Siltuximab (9.2 and 46 mg/kg/week) did not produce any toxicity of the reproductive tract in cynomolgus monkeys.
Pri opicah cinomolgus siltuksimab (9,2 in 46 mg/kg/teden) ni deloval toksično na spolne organe.
Immunogenicity
• omotičnost
All clinical studies with SYLVANT excluded patients with clinically significant infections, including those known to be hepatitis B surface antigen positive.
Bolniki z resnimi okužbami (vključno z bolniki, ki so pozitivni na površinski antigen hepatitisa B) niso bili vključeni v klinične študije zdravila SYLVANT.
A slight reduction in T-cell dependent antibody response and a reduction in the size of the splenic germinal centers following Keyhole limpet hemocyanin (KLH) immunisation was observed which were considered to be pharmacological responses of IL-6 inhibition and not of toxicological significance.
Megathura crenulata (KLH - Keyhole Limpet Haemocyanin) so opazili rahlo zmanjšanje od celic-T odvisnega protitelesnega odziva in zmanjšanje velikosti germinalnih limfatičnih centrov v vranici.
• sore throat
• prehlad • vneto grlo
Promptly evaluate patients presenting with symptoms that may be associated with or suggestive of GI perforation.
Bolnike s simptomi, ki so lahko povezani s perforacijo gastrointestinalnega trakta je treba takoj obravnavati.
Oropharyngeal pain
Okvara ledvic
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM EUSA Pharma
Siltuximab is a chimeric (human-murine) immunoglobulin G1κ (IgG1κ) monoclonal antibody produced in a Chinese hamster ovary (CHO) cell line by recombinant DNA technology.
Situksimab je himerni (človeško-glodalski) imunoglobulin G1κ (IgG1κ).
From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes the risk of microbial contamination, the product should be used immediately.
Iz mikrobiološkega vidika je pripravljeno zdravilo treba porabiti takoj, razen če je bilo zdravilo odprto/pripravljeno in razredčeno v aseptičnih pogojih.
Table 3: Efficacy endpoints from study 1 Efficacy endpoints
Preglednica 3: Cilji opazovanja za oceno učinkovitosti v študiji 1 Cilji opazovanja za oceno učinkovitosti siltuksimab + BSC*
Signs of such a tear developing include stomach pain getting worse, feeling sick (nausea), change in bowel habits and fever - if you get any of these, contact your doctor right away.
Znaki pojava raztrganine so poslabšanje želodčnih bolečin, siljenje na bruhanje (navzea), spremembe odvajanja blata in zvišana telesna temperatura.
Sucrose
Barnahely
Haemoglobin increase > 15 g/L (0.9 mmol/L) at Week 13/haemoglobin response-evaluable population
zvečanje koncentracije hemoglobina na > 15 g/l (0,9 mmol/l) po 13 tednih pri populaciji s podatkom o koncentraciji hemoglobina trajanje tumorskega in simptomatskega odziva
Immune system disorders common
Bolezni imunskega sistema pogosti anafilaktična reakcija
Histidine hydrochloride monohydrate Polysorbate 80
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi histidin histidinijev klorid monohidrat polisorbat 80 saharoza
Data from all patients treated with siltuximab monotherapy (n = 370) form the overall basis of the safety evaluation.
Skupna baza podatkov za oceno varnosti zdravila vsebuje podatke vseh bolnikov, ki so prejemali siltuksimab v monoterapiji (n = 370).
SYLVANT 100 mg powder for concentrate SYLVANT 400 mg powder forconcentrate siltuximab
SYLVANT 100 mg prašek za koncentrat SYLVANT 400 mg prašek za koncentrat siltuksimab i.v.
SYLVANT 400 mg powder for concentrate for solution for infusion Each single-use vial contains 400 mg siltuximab powder for concentrate for solution for infusion.
SYLVANT 400 mg prašek za koncentrat za raztopino za infundiranje Ena viala za enkratno uporabo vsebuje 400 mg siltuksimaba v obliki praška za koncentrat za raztopino za infundiranje.
A statistically significant difference (61.3% vs. 0% respectively; p = 0.0002) in the haemoglobin response in the siltuximab arm compared with the placebo arm was observed.
Med skupino, ki je prejemala siltuximab in skupino, ki je prejemala placebo so opazili statistično značilno razliko v hemoglobinskem odzivu (61,3% v primerjavi z 0%; p = 0,0002).
Biomarkers
Biološki označevalci
A consistent treatment effect favouring siltuximab treated patients across all major secondary endpoints was shown in the hyaline vascular subgroup.
Izjema je bila podskupina s hialino vaskularnim histološkim podtipom v kateri v skupini s siltuksimabom noben bolnik ni dosegel primarnega cilja opazovanja V podskupini s hialino vaskularnim histološkim podtipom, ki je prejemala siltuksimab je analiza v vseh glavnih sekundarnih ciljih opazovanja pokazala enoten boljši učinek zdravljenja.
Hypercholesterolaemia
Bolezni jeter
• joint pain, arm or leg pain
• glavobol • bolečina v sklepih, rokah ali nogah
methods.
Sylvant.
Durable tumour & symptomatic response (independent review)
Primarni cilj za oceno učinkovitosti trajni tumorski in simptomatski odziv (po oceni neodvisnih ocenjevalcev)
Each single-use vial contains 400 mg siltuximab.
Ena viala za enkratno uporabo vsebuje 400 mg siltuksimaba.
Inspect the vials for particulate matter and discolouration prior to dose preparation.
Pred pripravljanjem odmerka preglejte viale, da ne vsebujejo trdnih delcev in njihova vsebina ni obarvana.
This medicinal product should be administered by qualified healthcare professionals and under appropriate medical supervision.
4.2 Odmerjanje in način uporabe Zdravilo lahko daje usposobljen zdravstveni delavec.
Subgroup analyses
KLINIČNI PODATKI
Each vial contains 100 mg of siltuximab.
Ena viala vsebuje 100 mg siltuksimaba.
Each single-use vial contains 100 mg siltuximab.
Ena viala za enkratno uporabo vsebuje 100 mg siltuksimaba.
Cross-study population PK analyses were performed using data from 378 patients with a variety of conditions who received single-agent siltuximab at doses ranging from 0.9 to 15 mg/kg.
Vsi bolniki so prejemali siltuksimab kot edino zdravilo v odmerkih od 0,9 do 15 mg/kg.
Vascular disorders very common
Žilne bolezni zelo pogosti hipertenzija
Each vial contains 400 mg of siltuximab.
Ena viala vsebuje 400 mg siltuksimaba.
SYLVANT 100 mg powder for concentrate for solution for infusion SYLVANT 400 mg powder for concentrate for solution for infusion siltuximab
SYLVANT 100 mg prašek za koncentrat za raztopino za infundiranje SYLVANT 400 mg prašek za koncentrat za raztopino za infundiranje siltuksimab
SYLVANT 100 mg powder for concentrate for solution for infusion SYLVANT 400 mg powder for concentrate for solution for infusion
SYLVANT 100 mg prašek za koncentrat za raztopino za infundiranje SYLVANT 400 mg prašek za koncentrat za raztopino za infundiranje
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist, or nurse before you are given SYLVANT.
Če karkoli od zgoraj navedenega velja za vas (tudi če o tem niste prepričani), se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, preden prejmete zdravilo SYLVANT.
• weight gain.
največja vrednost)
Hypertriglyceridaemia, hyperuricaemia common
Presnovne in prehranske motnje zelo pogosti hipertrigliceridemija, hiperurikemija pogosti hiperholesterolemija
≥ 50 x 109/L
≥ 50 x 109/l hemoglobina
- Keep this leaflet.
Nežno premešajte.
Table 2 reflects the frequencies of identified adverse reactions in the 87 MCD patients (Study 1, Study 2 and Study 3) treated at the recommended dosage of 11 mg/kg every 3 weeks (details provided in section 5.1).
Bolniki so prejemali priporočeni odmerek 11 mg/kg vsake 3 tedne (podrobnosti so navedene v poglavju 5.1).
No evidence of altered safety or efficacy was identified in the patients who developed antibodies to siltuximab.
Pri bolnikih s protitelesi proti siltuksimabu niso odkrili sprememb v varnosti ali učinkovitosti.
Tell your doctor straight away if you notice the following side effects, as he or she may need to stop your treatment:
Drugi neželeni učinki so lahko: Če opazite katerega od naslednjih neželenih učinkov se pogovorite z zdravnikom ali medicinsko sestro:
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le na posebni recept.
Infections and infestations very common
Bolezni sečil zelo pogosti okvara ledvic
The following factors had no clinical effect on the clearance of siltuximab: gender, age, and ethnicity.
Spol, starost in etnična pripadnost nimajo kliničnega učinka na očistek siltuksimaba.
(MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8)
Zdravilo SYLVANT je indicirano za zdravljenje odraslih bolnikov z multicentrično Castlemanovo boleznijo (MCD - multicentric Castleman's disease), ki niso okuženi z virusom humane imunske pomanjkljivosti (so HIV negativni) in niso okuženi s humanim herpesvirusom-8 (so HHV-8
Elderly
VIALA
Do not use if visibly opaque or if foreign particles and/or solution discolouration are present.
Če vsebina ni prozorna ali je obarvana in/ali če vsebuje tujke, je ne smete uporabiti.
Each vial should be reconstituted with 5.2 mL of single-use water for injections to yield a 20 mg/mL solution.
Eno vialo je treba rekonstituirati s 5,2 ml vode za injekcije za enkratno uporabo, da nastane raztopina z
In mice dosed subcutaneously with an anti-mouse IL-6 monoclonal antibody,
Pri miših, ki so jim subkutano dajali monoklonsko protitelo proti mišjemu IL-6, niso opazili vpliva na plodnost niti pri samcih niti pri samicah.
• rash, itchy skin rash (eczema)
• izpuščaj, srbeč kožni izpuščaj (ekcem)
During or following infusion, treatment should be discontinued in patients who have severe infusion related hypersensitivity reactions (e.g., anaphylaxis).
Pri bolnikih, ki imajo hudo preobčutljivostno reakcijo na infuzijo (npr. anafilaksijo), je treba odmerjanje zdravila SYLVANT ukiniti med infundiranjem ali po njem.
Talk to your doctor, pharmacist, or nurse before you are given SYLVANT if:
Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila SYLVANT, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro: • če imate trenutno kakšno okužbo - zdravilo SYLVANT lahko zmanjša vaše zaznavanje, da ste okuženi, oziroma obrambno sposobnost v primeru okužbe in lahko pride do poslabšanja okužbe
3 years
Zaprta viala 3 leta
This summary was last updated in April 2015.
Povzetek je bil nazadnje posodobljen aprila 2015.
Most of these dogs also received additional treatment.
Večina teh psov je bila deležna tudi dodatnega zdravljenja.
Other information about Cerenia:
Druge informacije o zdravilu Cerenia:
The European Commission granted a marketing authorisation valid throughout the European Union, for Cerenia on 29/09/2006.
Evropska komisija je dovoljenje za promet z zdravilom Cerenia, veljavno po vsej Evropski uniji, izdala 29. septembra 2006.
Cerenia is a medicine that contains the active substance maropitant.
Cerenia je zdravilo, ki vsebuje zdravilno učinkovino maropitant.
Information on the prescription status of this product can be found on the label/outer package.
Podatki o predpisovanju tega zdravila so navedeni na nalepki/zunanji ovojnini.
A large number of studies with Cerenia were carried out either in laboratory dogs and cats or in animal patients at veterinary practices in several European countries and in the USA.
Z zdravilom Cerenia so bile opravljene številne študije, bodisi na laboratorijskih psih in mačkah bodisi na bolnih živalih v veterinarskih ordinacijah v številnih evropskih državah in ZDA.
Other reported side effects were decreased activity levels and tiredness.
Drugi neželeni učinki, o katerih so poročali, so bili zmanjšana telesna aktivnost in utrujenost.
What benefit has Cerenia shown during the studies?
Kakšne koristi je zdravilo Cerenia izkazalo v študijah?
It is available as tablets (16, 24, 60 and 160 mg) for dogs, and as a solution for injection (10 mg/ml) under the skin or into a vein for dogs and cats.
Na voljo je v obliki tablet (16, 24, 60 in 160 mg) za pse in kot raztopina za injiciranje v podkožje ali v žilo (10 mg/ml) za pse in mačke.
Handling Cerenia does not represent a particular risk for people.However, maropitant can produce short lived eye irritation and in the case of accidental eye exposure, the eyes should be flushed with plenty of water and medical attention sought.
Dajanje zdravila Cerenia ne predstavlja posebnega tveganja za ljudi, vendar lahko maropitant povzroči kratkotrajno draženje oči.V primeru nenamernega izpostavljanja oči zdravilu jih je treba sprati z veliko vode in poiskati zdravniško pomoč.
Only one out of 16 dogs given Cerenia vomited after receiving morphine, whilst 14 out of 15 dogs given placebo vomited, and in this group, nine of the dogs that vomited did so more than once.
Samo eden od 16 psov, ki so prejeli zdravilo Cerenia, je bruhal, potem ko so mu dali morfin, od 15 psov, ki so prejeli placebo, pa jih je bruhalo 14, pri čemer je v tej skupini devet psov bruhalo več kot enkrat.
The measures of effectiveness were evidence of retching, vomiting, intensity of nausea and improvements in the speed of recovery by for example measuring time to sit up and stand.
Merila učinkovitosti so bili znaki siljenja na bruhanje, bruhanje, intenzivnost slabosti in hitrejše okrevanje, ki so ga na primer merili s časom, ki so ga psi potrebovali, da so se usedli ali vstali.
Also, the treatment of vomiting should only be together with other supportive measures or other veterinary therapy while addressing the underlying causes of the vomiting.
Zdravljenje bruhanja je treba poleg tega izvajati samo skupaj z drugimi podpornimi ukrepi ali drugim veterinarskim zdravljenjem, pri čemer se je treba posvetiti izvirnim vzrokom bruhanja.
The benefit-risk balance can be found in the scientific discussion module of this EPAR.
Razmerje med koristmi in tveganji je na voljo v modulu znanstvene razprave tega evropskega javnega poročila o oceni zdravila (EPAR).
Cerenia was generally well tolerated.
Zdravilo Cerenia so živali na splošno dobro prenašale.
Why has Cerenia been approved?
Zakaj je bilo zdravilo Cerenia odobreno?
What is the risk associated with Cerenia?
Kakšna tveganja so povezana z uporabo zdravila Cerenia?
Since maropitant could affect heart activity, Cerenia should be used with caution in animals with certain heart conditions.
Ker bi maropitant lahko vplival na delovanje srca, je treba pri živalih, ki imajo nekatera srčna obolenja, zdravilo uporabljati previdno.
The active substance in Cerenia, maropitant, is broken down in the liver and therefore it is recommended to be used with caution in animals with liver disease.
Zdravilna učinkovina v zdravilu Cerenia, maropitant, se razgrajuje v jetrih, zato je priporočljivo, da se pri živalih z obolenji jeter uporablja previdno.