FrancophonIA/ELRC3.0 huggingface dataset:
English: Common side effects (may affect up to 1 in 10 people): - Reduction in blood cell counts (platelets, red or white blood cells), increase in white blood cell counts, changes in red blood cell counts (seen in blood tests) - Reduced magnesium, phosphate, potassium, calcium or sodium in the blood, fluid overload,
Croatian: - sniženje broja krvnih stanica (krvnih pločica, crvenih ili bijelih krvnih stanica), povećanje broja bijelih krvnih stanica, promjene broja crvenih krvnih stanica (vide se na krvnim pretragama)
English: abdominal pain, indigestion, constipation, passing wind, bloating, loose stools - Bile duct disorders, yellowing of the skin due to liver problems, liver tissue damage and inflammation of the liver - Itching, rash, hair loss, acne, increased sweating - Pain in joints, limbs, back and feet, muscle spasms - Insufficient function of the kidneys, reduced production of urine, impaired or painful urination - General weakness, fever, collection of fluid in your body, pain and discomfort, increase of the enzyme alkaline phosphatase in your blood, weight gain, feeling of temperature disturbed - Insufficient function of your transplanted organ
Croatian: - svrbež, osip, gubitak kose, akne, pojačano znojenje - bol u zglobovima, udovima, leđima i stopalima, mišićni grčevi - nedostatna funkcija bubrega, smanjeno stvaranje mokraće, narušeno ili bolno mokrenje
English: Blood trough levels of tacrolimus should also be closely monitored when clinical signs of toxicity or acute rejection are observed, following conversion between Modigraf granules to Prograf capsules, dose adjustments, changes in the immunosuppressive regimen, or co-administration of substances which may alter tacrolimus whole blood concentrations (see section 4.5).
Croatian: Modigraf granula na Prograf kapsule, nakon prilagodbe doze, nakon promjene imunosupresivnog režima ili kod istodobne primjene tvari koje mogu promijeniti koncentracije takrolimusa u punoj krvi
English: In paediatric patients converted to tacrolimus, an initial oral dose of 0.20 - 0.30 mg/kg/day should be administered in 2 divided doses (e.g. morning and evening).
Croatian: U odraslih bolesnika koji su prebačeni na Modigraf početnu peroralnu dozu od 0,15 mg/kg na dan treba primijeniti u 2 odvojene doze (npr. ujutro i navečer).
English: Cardiac disorders common:
Croatian: Srčani poremećaji Često:
English: Tacrolimus was started as continuous intravenous infusion at a dose of 0.025 mg/kg/day and oral tacrolimus was administered at a dose of 0.15 mg/kg/day with subsequent dose adjustments to target trough levels of 10 to 20 nanogram/ml.
Croatian: 0,025 mg/kg na dan, a peroralni takrolimus je primijenjen u dozi od 0,15 mg/kg na dan s naknadnim prilagodbama doze do ciljnih najnižih razina od 10 do 20 nanogram/ml.
English: Excretion
Croatian: Doziranje
English: Several cases of accidental overdose have been reported with tacrolimus; symptoms have included tremor, headache, nausea and vomiting, infections, urticaria, lethargy and increases in blood urea nitrogen, serum creatinine concentrations and alanine aminotransferase levels.
Croatian: Simptomi su uključivali tremor, glavobolju, mučninu i povraćanje, infekcije, urtikariju, letargiju i povećanje dušika iz ureje,
English: nervous system disorders, seizures, disturbances in consciousness, peripheral neuropathies, dizziness, paraesthesias and dysaesthesias, writing impaired uncommon:
Croatian: poremećaji živčanog sustava, napadaji, poremećaji svijesti, periferne neuropatije,
English: Hepatic impairment
Croatian: - mišićna slabost
English: renal failure, renal failure acute, nephropathy toxic, renal tubular necrosis, urinary abnormalities, oliguria, bladder and urethral symptoms uncommon:
Croatian: zatajenje bubrega, akutno zatajenje bubrega, toksična nefropatija, bubrežna tubularna nekroza, mokraćni poremećaji, oligurija, simptomi mokraćnog mjehura i mokraćne cijevi
English: If the clinical condition of the patient prevents oral dosing, an initial intravenous dose of 0.075 - 0.100 mg/kg/day (with Prograf 5 mg/ml concentrate for solution for infusion) should be administered as a continuous 24-hour infusion.
Croatian: Ako kliničko stanje bolesnika ne dopušta peroralnu primjenu, treba dati početnu intravensku dozu od 0,075 do 0,100 mg/kg na dan (s Prograf 5 mg/ml koncentratom za otopinu za infuziju) u obliku kontinuirane 24-satne infuzije.
English: Astellas Pharma Ltd. Tel: + 44 (0) 203 379 8700
Croatian: Tel: + 44 (0) 203 379 8700
English: Prophylaxis of kidney transplant rejection
Croatian: Profilaksa odbacivanja presatka bubrega
English: parenchymal lung disorders, dyspnoea, pleural effusion, cough, pharyngitis, nasal congestion and inflammations uncommon:
Croatian: poremećaji plućnog parenhima, dispneja, pleuralni izljev, kašalj, faringitis,
English: haemolytic uraemic syndrome, anuria very rare:
Croatian: hemolitičko-uremijski sindrom, anurija
English: Tacrolimus has been used with or without antibody induction in paediatric heart transplantation.
Croatian: U pedijatrijskih se bolesnika s presatkom srca takrolimus primjenjuje uz indukciju ili bez indukcije protutijela.
English: Therapeutic drug monitoring of mycophenolic acid may be appropriate when switching from ciclosporin to tacrolimus or vice versa.
Croatian: Pri prelasku s ciklosporina na takrolimus i obrnuto možda će biti potrebno terapijsko praćenje mikofenolatne kiseline.
English: Modigraf 1 mg granules for oral suspension tacrolimus oral use
Croatian: Modigraf 1 mg granule za oralnu suspenziju takrolimus kroz usta
English: If the clinical condition of the patient prevents oral dosing, an initial intravenous dose of 0.05 mg/kg/day (with Prograf 5 mg/ml concentrate for solution for infusion) should be administered as a continuous 24-hour infusion.
Croatian: Ako kliničko stanje bolesnika ne dopušta peroralnu primjenu, potrebno je dati početnu intravensku dozu od 0,05 mg/kg na dan (s Prograf 5 mg/ml koncentratom za otopinu za infuziju) u obliku kontinuirane 24-satne infuzije.
English: optic neuropathy Ear and labyrinth disorders common:
Croatian: Poremećaji uha i labirinta Često:
English: Astellas Pharma Kft. Tel.: + 36 1 577 8200
Croatian: Tel.: + 36 1 577 8200
English: CYP3A4 inducers potentially leading to decreased tacrolimus blood levels Clinically the following substances have been shown to decrease tacrolimus blood levels: Strong interactions have been observed with rifampicin, phenytoin or St. John's Wort (Hypericum perforatum) which may require increased tacrolimus doses in almost all patients.
Croatian: Inhibitori CYP3A4 koji mogu dovesti do povećanja koncentracije takrolimusa u krvi Klinički se pokazalo da sljedeće tvari povećavaju koncentracije takrolimusa u krvi:
English: Modigraf 0.2 mg granules for oral suspension tacrolimus oral use
Croatian: Modigraf 0,2 mg granule za oralnu suspenziju takrolimus kroz usta
English: Very common side effects (may affect more than 1 in 10 people): - Increased blood sugar, diabetes mellitus, increased potassium in the blood - Difficulty in sleeping - Trembling, headache - Increased blood pressure - Liver function tests abnormal - Diarrhoea, nausea - Kidney problems
Croatian: - povišen šećer u krvi, šećerna bolest, povišen kalij u krvi - poteškoće sa spavanjem
English: increased uric acid or lipids in the blood, decreased appetite, increased acidity of the blood,
Croatian: - sniženi magnezij, fosfat, kalij, kalcij ili natrij u krvi, preopterećenje tekućinom, povišena mokraćna kiselina ili lipidi u krvi, smanjen apetit, povećana kiselost krvi, druge promjene elektrolita u krvi (vide se na krvnim pretragama)
English: hypertension common:
Croatian: hipertenzija
English: Following your organ transplant (e.g. liver, kidney, heart), your body's immune system will try to reject the new organ.
Croatian: Vaš imunološki sustav pokušat će odbaciti novi organ.
English: other changes in the blood salts (seen in blood tests) - Anxiety symptoms, confusion and disorientation, depression, mood changes, nightmare,
Croatian: - simptomi tjeskobe, smetenost i dezorijentacija, depresija, promjene raspoloženja, noćne more, halucinacije, mentalni poremećaji
English: If the dose cannot be administered orally as a result of the clinical condition of the patient, intravenous therapy of 0.01 - 0.05 mg/kg/day (with Prograf 5 mg/ml concentrate for solution for infusion) should be initiated as a continuous 24-hour infusion.
Croatian: Ako kliničko stanje bolesnika ne dopušta peroralnu primjenu doze, potrebno je započeti intravensku terapiju dozom od 0,01 - 0,05 mg/kg na dan (s Prograf 5 mg/ml koncentratom za otopinu za infuziju) u obliku kontinuirane 24-satne infuzije.
English: Rare side effects (may affect up to 1 in 1,000 people): - Small bleedings in your skin due to blood clots - Increased muscle stiffness - Blindness, deafness - Collection of fluid around the heart - Acute breathlessness - Cyst formation in your pancreas - Problems with blood flow in the liver - Serious illness with blistering of skin, mouth, eyes and genitals; increased hairiness - Thirst, fall, feeling of tightness in your chest, decreased mobility, ulcer
Croatian: - ozbiljna bolest s mjehurima na koži, u ustima, na očima i spolnim organima; pojačana dlakavost - žeđ, pad, osjećaj stezanja u prsima, smanjena pokretljivost, čir
English: If the dose cannot be administered orally as a result of the clinical condition of the patient, intravenous therapy of 0.05 - 0.10 mg/kg/day (with Prograf 5 mg/ml concentrate for solution for infusion) should be initiated as a continuous 24-hour infusion.
Croatian: Ako kliničko stanje bolesnika ne dopušta peroralnu primjenu doze, potrebno je započeti intravensku terapiju dozom od 0,05 do 0,10 mg/kg na dan (s Prograf 5 mg/ml koncentratom za otopinu za infuziju) u obliku kontinuirane 24-satne infuzije.
English: hallucination, mental disorders - Fits, disturbances in consciousness, tingling and numbness (sometimes painful) in the hands and feet, dizziness, impaired writing ability, nervous system disorders - Blurred vision, increased sensitivity to light, eye disorders - Ringing sound in your ears - Reduced blood flow in the heart vessels, faster heartbeat - Bleeding, partial or complete blocking of blood vessels, reduced blood pressure - Shortness in breath, changes in the lung tissue, collection of liquid around the lung,
Croatian: - nepravilan rad srca, preskakanje srca, smanjena radna učinkovitost srca, poremećaj srčanog mišića, povećanje srčanog mišića, pojačano lupanje srca, poremećaj na EKG-u, poremećaj brzine rada srca i pulsa - krvni ugrušak u venama udova, šok
English: Tacrolimus trough levels should be measured prior to conversion and within 1 week after conversion.
Croatian: Prije prebacivanja i u roku od 1 tjedna nakon prebacivanja na drugu formulaciju treba izmjeriti najniže razine takrolimusa.
English: Consideration should be given to use of a behavioural modification programme.
Croatian: Treba razmotriti primjenu programa modifikacije ponašanja.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains:
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna tableta sadrži:
English: These signs are potentially treatment related.
Croatian: Ti su znakovi potencijalno povezani s terapijom.
English: The product may therefore result in an increase or decrease in aggression levels.
Croatian: Proizvod stoga može uzrokovati povećanje ili smanjenje razina agresije.
English: In comparison, none of the five enzymes increased with increasing doses of imepitoin.
Croatian: Za usporedbu, nijedan od tih pet enzima nije se povećao uz povećanje doza imepitoina.
English: This evaluation may include consideration of inciting factors or situations associated with previous aggressive episodes.
Croatian: Ta procjena može uključivati razmatranje poticajnih čimbenika ili situacija povezanih s prethodnim agresivnim epizodama.
English: Because of the nature of epilepsy, the pharmacological response to treatment may vary.
Croatian: Zbog prirode epilepsije, farmakološki odgovor na liječenje može varirati.
English: Any remaining half-tablet should be used for the next dose.
Croatian: Preostalu polovicu tablete treba primijeniti za sljedeću dozu.
English: No interaction with highly protein bound compounds is therefore expected.
Croatian: Stoga se ne očekuje interakcija sa spojevima s visokim vezanjem na proteine.
English: The required dose will vary between dogs and will depend on the severity of the disorder.
Croatian: Potrebna doza razlikovat će se među psima, a ovisit će o težini poremećaja.
English: Though efficacy may not be complete, imepitoin is considered to be a suitable treatment option in some dogs because of its safety profile.
Croatian: Iako djelotvornost možda nije potpuna, imepitoin se smatra prikladnom opcijom liječenja u nekih pasa zbog svog sigurnosnog profila.
English: Imepitoin is extensively metabolised prior to elimination.
Croatian: Imepitoin se opsežno metabolizira prije eliminacije.
English: See also section "Pregnancy and lactation".
Croatian: Vidjeti također dio "Graviditet i laktacija".
English: Idiopathic epilepsy
Croatian: Idiopatska epilepsija
English: Ask your veterinary surgeon how to dispose of medicines no longer required.
Croatian: Pitajte svog veterinara kako odlagati veterinarsko-medicinske proizvode koji vam više nisu potrebni.
English: Imepitoin has a relatively high volume of distribution (579 to 1548 ml/kg).
Croatian: Imepitoin ima relativno visoki volumen distribucije (od 579 do 1548 ml/kg).
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the bottle after EXP.
Croatian: Ne koristite ovaj veterinarsko-medicinski proizvod poslije isteka roka valjanosti koji je naznačen na kutiji i bočici poslije EXP.
English: Pharmacotherapeutic group: Antiepileptics, Other antiepileptics, imepitoin ATCvet code: QN03AX90
Croatian: FARMAKOLOŠKA SVOJSTVA Farmakoterapijska grupa: antiepileptici, drugi antiepileptici, imepitoin ATCvet kod: QN03AX90
English: Most events are transient, resolving during or shortly after the end of the treatment course.
Croatian: Većina je nuspojava prolazna i rješava se tijekom ili neposredno nakon završetka liječenja.
English: Metabolite profiles in urine and faeces revealed four major inactive metabolites which are formed by oxidative modification.
Croatian: Profili metabolita u mokraći i stolici pokazuju četiri glavna neaktivna metabolita koji nastaju oksidativnom modifikacijom.
English: 6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Croatian: 6.6 Posebne mjere opreza prilikom odlaganja neupotrebljenog veterinarsko-medicinskog proizvoda ili otpadnih materijala dobivenih primjenom tih proizvoda Bilo koji neupotrebljeni veterinarsko-medicinski proizvod ili otpadni materijali dobiveni primjenom tih veterinarsko-medicinskih proizvoda trebaju se odlagati u skladu s lokalnim propisima.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Croatian: Detaljne informacije o ovom veterinarsko-medicinskom proizvodu su dostupne na web stranici Europske agencije za lijekove http://www.ema.europa.eu/.
English: See also section "Overdose".
Croatian: Vidjeti također dio "Predoziranje".
English: The pharmacological response to imepitoin may vary and efficacy may not be complete.
Croatian: Mogući su različiti farmakološki odgovori na imepitoin, a djelotvornost možda neće biti potpuna.
English: When transition between different antiepileptic therapies is medically required, this should be done gradually and with appropriate clinical supervision.
Croatian: Kada je iz medicinskih razloga potrebno prijeći na neku drugu terapiju protiv epilepsije, to treba provoditi postupno i uz odgovarajući klinički nadzor.
English: 25% of dogs did not respond to the treatment with imepitoin (same or increased frequency of seizures).
Croatian: 25% pasa nije imalo odgovor na liječenje imepitoinom (ista ili povećana učestalost napadaja).
English: In more than half of the dogs that experienced ataxia during this clinical trial the signs resolved spontaneously within 24 hours in spite of continued treatment and in half of the remaining dogs within 48 hours.
Croatian: U više od polovice pasa koji su doživjeli ataksiju tijekom tog kliničkog ispitivanja znakovi su spontano prestali u roku od 24 sata unatoč nastavljenom liječenju, a u pola od preostalih pasa u roku od 48 sati.
English: Should seizures not be adequately controlled, further diagnostic measures and other antiepileptic treatment should be considered.
Croatian: Ako se ne postigne odgovarajuća kontrola napadaja, potrebno je razmotriti dodatne dijagnostičke mjere i druge terapije protiv epilepsije.
English: Increasing doses of phenobarbital were associated with increasing levels of the liver enzymes ALT, AP, AST, GGT, and GLDH.
Croatian: Veće doze fenobarbitala bile su povezane s višim razinama jetrenih enzima ALT, AP, AST, GGT i GLDH.
English: In epileptic dogs, aggression has been uncommonly reported, and increased sensitivity to sound and anxiety have been rarely reported in the field.
Croatian: U epileptičnih pasa s terena se manje često prijavljuje agresija, a povećana osjetljivost na zvuk i anksioznost prijavljuju se rijetko.
English: Imepitoin is a centrally acting substance with anxiolytic and antiepileptic properties which crosses the blood brain barrier without involvement of active transport or active clearance, resulting in immediate equilibrium between plasma and brain.
Croatian: Imepitoin je proizvod sa centralnim djelovanjem te s anksiolitičkim i antiepileptičkim svojstvima koji prolazi kroz krvno-moždanu barijeru bez uključivanja aktivnog transporta ili aktivnog klirensa, a rezultat je neposredna ravnoteža između plazme i mozga.
English: Here it acts as a low affinity partial agonist of the benzodiazepine receptor.
Croatian: Pri tome djeluje kao parcijalni agonist benzodiazepinskog receptora niskog afiniteta.
English: The anxiolytic effect of imepitoin is mediated via the GABAA receptor.
Croatian: Anksiolitički učinak imepitoina posredovan je receptorom GABAA.
English: Bodyweight (kg)
Croatian: Tjelesna masa (kg)
English: Pharmacokinetic studies indicate that imepitoin is well absorbed (> 92%) after oral administration and that no pronounced first pass effect occurs.
Croatian: Farmakokinetička ispitivanja pokazuju da se imepitoin dobro apsorbira (> 92%) nakon peroralne primjene i da nema izraženog učinka prvog prolaza.
English: They may also be present during the preictal or postictal period or as behaviour changes which occur as part of the disease itself.
Croatian: Mogu biti prisutni u preiktalnom ili postiktalnom razdoblju ili kao promjene u ponašanju koje se javljaju kao dio bolesti.
English: Ingestion of this product may cause dizziness, lethargy and nausea.
Croatian: Gutanje ovog proizvoda može uzrokovati vrtoglavicu, letargiju i mučninu.
English: However, the upper limit of the confidence interval for creatinine remained within the reference range at all visits.
Croatian: Međutim, gornja granica intervala pouzdanosti za kreatinin ostala je u rasponu referentnih vrijednosti u svim pregledima.
English: To prevent accidental ingestion of tablets, the cap of the bottle should be replaced immediately after withdrawing the required number of tablets for one administration.
Croatian: Da bi se spriječilo nehotično gutanje tableta, zatvarač boce treba zatvoriti čim se izvadi broj tableta potreban za jednu primjenu.
English: Imepitoin also inhibits seizures via potentiation of the GABAA receptor-mediated inhibitory effects on the neurons and in addition, imepitoin has a weak calcium channel blocking effect which may contribute to its anticonvulsive properties.
Croatian: Imepitoin također inhibira napadaje pojačavanjem inhibicijskih učinaka na neurone posredovanih receptorima GABAA i osim toga, imepitoin ima slabi učinak blokiranja kalcijevih kanala što može pridonijeti njegovim svojstvima djelovanja protiv konvulzija.
English: Noise phobia
Croatian: Fobija od buke
English: The in-vivo plasma protein binding of imepitoin in dogs is low (60 to 70%).
Croatian: U pasa je in vivo nisko vezanje proteina na plazmu (60 do 70%).
English: Anxiolytic drugs acting at the benzodiazepine receptor site, such as imepitoin, may lead to disinhibition of fear-based behaviours.
Croatian: Anksiolitici koji djeluju na mjestu benzodiazepinskog receptora, kao što je imepitoin, mogu dovesti do dezinhibicije ponašanja uvjetovanih strahom.
English: At such doses, the symptoms are not usually life threatening and generally resolve within 24 hours if symptomatic treatment is given.
Croatian: Uz takve doze simptomi obično nisu opasni po život i najčešće nestaju unutar 24 sata ako se primijeni simptomatsko liječenje.
English: Clinical trials in epilepsy
Croatian: Klinička ispitivanja na slučajevima epilepsije
English: Bottle of 30, 100 or 250 tablets.
Croatian: Boca sa 30, 100 ili 250 tableta
English: Longer treatment durations for noise phobia should be at the benefit-risk assessment of the veterinarian.
Croatian: Dulja trajanja liječenja fobije od buke trebaju se temeljiti na veterinarovoj procjeni koristi i rizika.
English: Imepitoin is rapidly cleared from blood (Cl = 260 to 568 ml/hours/kg) with an elimination half-life of approximately 1.5 to 2 hours.
Croatian: Imepitoin se brzo uklanja iz krvi (Cl = 260 do 568 ml/h/kg) uz poluvijek eliminacije od približno
English: The safety of the veterinary medicinal product has not been tested in dogs weighing less than 2 kg or in dogs with safety concerns such as renal, liver, cardiac, gastrointestinal or other disease.
Croatian: Neškodljivost veterinarsko-medicinskog proizvoda nije testirana u pasa koji teže manje od 2 kg ili u pasa u kojih je neškodljivost primjene proizvoda upitna zbog bolesti bubrega, jetre, srca, probavnog sustava ili neke druge bolesti.
English: For the reduction of the frequency of generalised seizures due to idiopathic epilepsy in dogs for use after careful evaluation of alternative treatment options.
Croatian: Za smanjivanje učestalosti generaliziranih napadaja zbog idiopatske epilepsije u pasa i primjenu nakon pažljive procjene drugih mogućnosti liječenja.
English: EU/2/12/147/001 100 tablets (100 mg) EU/2/12/147/002 250 tablets (100 mg) EU/2/12/147/003 100 tablets (400 mg) EU/2/12/147/004 250 tablets (400 mg) EU/2/12/147/005 30 tablets (400 mg) EU/2/12/147/006 30 tablets (100 mg)
Croatian: EU/2/12/147/001 100 tableta (100 mg) EU/2/12/147/002 250 tableta (100 mg) EU/2/12/147/003 100 tableta (400 mg) EU/2/12/147/004 250 tableta (400 mg) EU/2/12/147/005 30 tableta (400 mg) EU/2/12/147/006 30 tableta (100 mg)
English: The efficacy of the veterinary medicinal product in dogs with status epilepticus and cluster seizures has not been investigated.
Croatian: Djelotvornost ovog veterinarsko-medicinskog proizvoda u pasa s epileptičkim statusom i serijskim napadajima nije ispitana.
English: For the reduction of anxiety and fear associated with noise phobia in dogs.
Croatian: Za smanjivanje anksioznosti i straha povezanih s fobijom od buke u pasa.
English: Dose linearity occurs over the therapeutic dose range of imepitoin.
Croatian: Linearnost doze javlja se u terapijskom rasponu doza imepitoina.
English: Co-administration of imepitoin tablets with food, reduces the total AUC by 30% but produces no significant change in Tmax and Cmax.
Croatian: Istovremena primjena tableta imepitoina s hranom smanjuje ukupnu površinu ispod krivulje (AUC) za 30% ali ne uzrokuje značajnu promjenu u vrijednostima Tmax i Cmax.
English: Prior to initiating treatment in these cases, behaviour therapy or referral to a behaviour specialist should be considered.
Croatian: Prije početka liječenja u tim slučajevima treba razmotriti bihevioralnu terapiju ili upućivanje bihevioralnom specijalistu.