FrancophonIA/ELRC3.0 huggingface dataset:
English: After a single topical administration, the mean peak plasma concentration of 21.5 ng/ml (± 43.5) is reached in Tmax mean of 15.9 hours (1-48 hours).
Croatian: Nakon jedne topikalne primjene, srednja vrijednost najviših koncentracija u plazmi od 21,5 ng/ml (± 43,5) dostiže se pri srednjoj vrijednosti Tmax od 15,9 sati (1 - 48 sati).
English: The mean AUC0-24 was 100 ng*h/ml (± 51.7).
Croatian: Srednja vrijednost AUC0-24 bila je 100 ng*h/ml (±
English: Kidney disease may cause reduced clearance of mirtazapine, which may result in higher drug exposure.
Croatian: Bolest bubrega može uzrokovati smanjeno uklanjanje mirtazapina, što može dovesti do veće izloženosti VMP-u.
English: Mirataz 20 mg/g transdermal ointment for cats
Croatian: Mirataz 20 mg/g transdermalna mast za mačke
English: The veterinary medicinal product is a skin sensitiser.
Croatian: Veterinarsko-medicinski proizvod izaziva preosjetljivost kože.
English: Excipients: Butylhydroxytoluene (E321) 0.01 mg
Croatian: Butilhidroksitoluen (E321) 0,01 mg
English: After administration of the product to 8 cats at a dose of 0.5 mg/kg once daily for 14 days, mean peak plasma concentration of 39.6 ng/ml (± 9.72) is reached in Tmax mean of 2.13 hours (1-4 hours).
Croatian: Nakon primjene proizvoda na osam mačaka u dozi od 0,5 mg/kg jednom dnevno tijekom 14 dana, postignuta je srednja vrijednost najviših koncentracija u plazmi od 39,6 ng/ml (± 9,72) u srednjoj vrijednosti Tmax od 2,13 sata (1 - 4 sati).
English: Step 2: Twist cap on tube counter clockwise to open.
Croatian: Korak 2.: Za otvaranje zakrenuti zatvarač na tubi u smjeru suprotnom od kazaljke na satu.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE
Croatian: 13. RIJEČI „SAMO ZA PRIMJENU NA ŽIVOTINJAMA” I „UVJETI ILI OGRANIČENJA
English: The product may be harmful after ingestion.
Croatian: Proizvod može biti štetan ako se proguta.
English: Do not eat, drink or smoke while handling the veterinary medicinal product.
Croatian: Prilikom rukovanja veterinarsko-medicinskim proizvodom ne smije se jesti, piti ili pušiti.
English: The veterinary medicinal product is applied topically to the inner pinna (inner surface of the ear) once daily for 14 days, at the dosage of 0.1 g ointment /cat (2 mg mirtazapine /cat).
Croatian: Veterinarsko-medicinski proizvod primjenjuje se topikalno na unutarnji dio ušne školjke (unutarnja površinu uha) jednom dnevno tijekom 14 dana, u dozi od 0,1 g masti/mačka (2 mg mirtazapina/mačka).
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - 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).
Croatian: Učestalost nuspojava određena je prema sljedećim pravilima: - vrlo česte (više od 1 na 10 tretiranih životinja pokazuju nuspojavu(e) ) - česte (više od 1, ali manje od 10 životinja na 100 tretiranih životinja) - manje česte (više od 1,ali manje od 10 životinja na 1.000 tretiranih životinja)
English: Each dose of 0.1 g contains: Mirtazapine (as hemihydrate) 2 mg
Croatian: Svaka doza od 0,1 g sadrži: Mirtazapin (kao hemihidrat) 2 mg
English: 5 gram coated aluminium tube (coat: lacquer (internal)/ enamel (external) with a low-density polyethylene (LDPE) screw cap and crimp sealant.
Croatian: Obložena aluminijska tuba od 5 grama (premaz: lak (unutarnji)/emajl (vanjski)) sa zatvaračem na navoj od polietilena niske gustoće i zaštitnom kapicom.
English: Do not use in pregnant or lactating cats..
Croatian: Ne primjenjivati u gravidnih mačaka te mačaka u laktaciji.
English: Transdermal use.
Croatian: Transdermalna primjena.
English: Mirataz 20 mg/g transdermal ointment for cats mirtazapine
Croatian: Mirataz 20 mg/g transdermalna mast za mačke mirtazapin
English: Marketing authorisation holder: Aniserve GmbH Geyerspergerstr.
Croatian: Nositelj odobrenja za stavljanje u promet: Aniserve GmbH
English: Veterinary medicinal product subject to prescription.
Croatian: Veterinarsko-medicinski proizvod izdaje se na veterinarski recept.
English: 0.1 g contains 2 mg mirtazapine (as hemihydrate)
Croatian: 0,1 g sadrži 2 mg mirtazapina (kao hemihidrat)
English: Transient increased hepatic alanine transferase can be observed uncommonly.
Croatian: U manje čestim slučajevima može se zamijetiti prolazno povišen jetreni enzim alanin aminotransferaza.
English: Transdermal ointment
Croatian: OBLIK Transdermalna mast
English: Tapioca starch polymethylsilsesquioxane
Croatian: Polimetil silseskvioksan iz škroba tapioke
English: Do not use in cats treated with monoamine oxidase inhibitors (MAOIs) or treated with an MAOI within 14 days prior to treatment with the veterinary medicinal product due to an increased risk of serotonin syndrome (see also “special warnings”).
Croatian: Ne primjenjivati u mačaka tretiranih inhibitorima monoaminoksidaze (MAOI) ili VMP-om iz skupine MAOI unutar razdoblja od 14 dana prije terapije veterinarsko-medicinskim proizvodom jer može doći do povećanog rizika od serotoninskog sindroma (vidjeti također „posebna upozorenja”).
English: LABELLING AND PACKAGE LEAFLET
Croatian: OZNAČAVANJE I UPUTA O VMP-u
English: Incompatibilities:
Croatian: Inkompatibilnosti: Nije primjenjivo.
English: Do not use in breeding, pregnant or lactating cats.
Croatian: Ne primjenjivati u rasplodnih i gravidnih mačaka te mačaka u laktaciji.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - 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).
Croatian: - rijetke (više od 1, ali manje od 10 životinja na 10.000 tretiranih životinja)
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release
Croatian: Naziv i adresa proizvođača odgovornog<ih> za puštanje serije u promet
English: 4.3 Contraindications
Croatian: „Kontraindikacije”).
English: Do not use in cats treated with cyproheptadine, tramadol or monoamine oxidase inhibitors (MAOIs) or treated with an MAOI within 14 days prior to treatment with the veterinary medicinal product as there may be an increased risk of serotonin syndrome (see section 4.8).
Croatian: (MAOI) ili VMP-om iz skupine MAOI unutar razdoblja od 14 dana prije terapije veterinarsko-medicinskim proizvodom jer može doći do povećanog rizika od serotoninskog sindroma (vidjeti odjeljak 4.8.).
English: Do not use in cats treated with cyproheptadine, tramadol or monoamine oxidase inhibitors (MAOIs) or treated with an MAOI within 14 days prior to treatment with the veterinary medicinal product as there may be an increased risk of serotonin syndrome (see section 4.3).
Croatian: (MAOI) ili VMP-om iz skupine MAOI unutar razdoblja od 14 dana prije terapije veterinarsko-medicinskim proizvodom jer može doći do povećanog rizika od serotoninskog sindroma (vidjeti odjeljak 4.3.).
English: Excipients: Butylhydroxytoluene (E321; as antioxidant) 0.01 mg
Croatian: Butilhidroksitoluen (E321, kao antioksidant) 0,01 mg Nemasna, homogena mast bijele do prljavo bijele boje.
English: The main measure of effectiveness was the change in symptoms.
Croatian: Glavno mjerilo učinkovitosti bilo je promjena simptoma.
English: Remsima (infliximab)
Croatian: Remsima (infliksimab)
English: It also allows patients the convenience of having their treatment at home.
Croatian: Također omogućava bolesnicima pogodnost liječenja kod kuće.
English: This overview was last updated in 11/2019.
Croatian: Pregled informacija posljednji je put ažuriran u 11. 2019.
English: Some side effects, including infections, may be more common in children than in adults.
Croatian: Neki simptomi, uključujući infekcije, mogu biti češći u djece nego u odraslih.
English: Further information on Remsima can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/remsima.
Croatian: Više informacija o lijeku Remsima dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/remsima.
English: It is usually used when other medicines or treatments have failed, in adults with the following immune-system diseases:
Croatian: Obično se primjenjuje kada drugi lijekovi ili terapije nisu bili uspješni, u odraslih osoba sa sljedećim bolestima imunosnog sustava:
English: What is Remsima and what is it used for?
Croatian: Što je Remsima i za što se koristi?
English: What measures are being taken to ensure the safe and effective use of Remsima?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Remsima?
English: This means that Remsima is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Croatian: To znači da je lijek Remsima visokog stupnja sličnosti s drugim biološkim lijekom („referentni lijek”) koji je već odobren u EU-u.
English: Remsima received a marketing authorisation valid throughout the EU on 10 September 2013.
Croatian: Lijek Remsima dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 10. rujna 2013.
English: Remsima is a ‘biosimilar' medicine.
Croatian: Remsima je „biosličan lijek”.
English: An overview of Remsima and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Remsima i zašto je odobren u EU-u
English: In addition, Remsima and Remicade given by infusion into a vein were compared in one main study involving 606 adults with rheumatoid arthritis.
Croatian: Nadalje, Remsima i Remicade davani infuzijom u venu bili su uspoređeni u jednom glavnom ispitivanju koje je obuhvatilo 606 odraslih osoba s reumatoidnim artritisom.
English: Side effects reported with Remsima are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Remsima pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: The most common side effects with Remsima (which may affect more than 1 in 10 people) are viral infections (such as flu or cold sores), headache, upper respiratory-tract infection (nose and throat infections), sinusitis (inflammation of the sinuses), nausea (feeling sick), abdominal pain (stomach ache), infusion-related reactions and pain.
Croatian: Najčešće su nuspojave lijeka Remsima (koje se mogu javiti u više od 1 na 10 osoba) virusne infekcije (kao što su gripa i herpes), glavobolja, infekcije gornjih dišnih puteva (infekcija nosa i grla), sinusitis (upala sinusa), mučnina, abdominalna bol (bol u trbuhu), reakcije i bol povezani s infuzijom.
English: Remsima is given as an infusion into a vein lasting one or two hours.
Croatian: Remsima se daje infuzijom u venu u trajanju od jednog ili dva sata.
English: After 30 weeks of treatment, Remsima was as effective as Remicade with around 60% of patients responding to treatment with either medicine.
Croatian: Nakon 30 tjedana liječenja, lijek Remsima bio je jednako učinkovit kao i Remicade, s približno 60% bolesnika koji su reagirali na terapiju jednim ili drugim lijekom.
English: Remsima is also used in patients aged between 6 and 17 years with severe, active Crohn's disease or severely active ulcerative colitis, when they have not responded to or cannot take other medicines or treatments.
Croatian: Remsima se primjenjuje i u bolesnika u dobi između 6 i 17 godina s teškom, aktivnom Crohnovom bolešću ili vrlo aktivnim ulceroznim kolitisom, kada u bolesnika nije postignuta reakcija drugim lijekovima ili terapijama, odnosno kada ih bolesnici ne mogu primati.
English: Remsima must not be used in patients with tuberculosis, other severe infections, or moderate or severe heart failure (an inability of the heart to pump enough blood around the body).
Croatian: Remsima se ne smije primjenjivati u bolesnika s tuberkulozom, drugim teškim infekcijama i umjerenim ili teškim zatajenjem srca (nemogućnost srca da pumpa dovoljne količine krvi u tijelu).
English: How often the treatment is repeated depends on which disease is being treated, and on the patient's response to the medicine.
Croatian: Učestalost ponavljanja terapije ovisi o vrsti bolesti koja se liječi i o odgovoru bolesnika na lijek.
English: By blocking TNF-alpha, infliximab improves the inflammation and other symptoms of the diseases.
Croatian: Inhibirajući djelovanje glasnika TNF-alfa infliksimab smanjuje upalu i druge simptome tih bolesti.
English: Infliximab has been designed to attach to a chemical messenger in the body called tumour necrosis factor-alpha (TNF-alpha).
Croatian: Infliksimab je namijenjen vezivanju na kemijski glasnik u tijelu pod nazivom faktor nekroze tumora alfa (TNF-alfa).
English: Why is Remsima authorised in the EU?
Croatian: Zašto je lijek Remsima odobren u EU-u?
English: The company that markets Remsima will provide a card to patients that includes information about the medicine and can be used to record tests they have taken.
Croatian: Tvrtka koja stavlja lijek Remsima u promet pobrinut će se da bolesnici dobiju karticu koja uključuje informacije o lijeku i može se upotrijebiti za bilježenje testova koje su proveli.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Remsima has a highly similar structure, purity and biological activity to Remicade and is distributed in the body in the same way.
Croatian: Europska agencija za lijekove zaključila je kako je, u skladu sa zahtjevima EU-a za bioslične lijekove, utvrđeno da lijek Remsima ima vrlo sličnu strukturu, čistoću i biološku aktivnost kao i Remicade te se u tijelu raspoređuje na isti način.
English: Remsima can only be obtained with a prescription and treatment should be started and supervised by a specialised doctor who has experience in the diagnosis and treatment of the diseases that Remsima can be used to treat.
Croatian: Lijek Remsima izdaje se samo na recept, a liječenje je potrebno započeti i provoditi pod nadzorom liječnika specijalista s iskustvom u dijagnosticiranju i liječenju bolesti za koje se može primjenjivati lijek Remsima.
English: The reference medicine for Remsima is Remicade.
Croatian: Referentni lijek za Remsima je Remicade.
English: Other information about Remsima
Croatian: Ostale informacije o lijeku Remsima
English: Because Remsima is a biosimilar medicine, the studies on effectiveness and safety of infliximab carried out with Remicade do not all need to be repeated for Remsima.
Croatian: Budući da je lijek Remsima biosličan lijek, ispitivanja učinkovitosti i sigurnosti primjene infliksimaba provedena za lijek Remicade nije potrebno ponavljati za lijek Remsima.
English: In addition, studies in rheumatoid arthritis and ankylosing spondylitis have shown that the safety and effectiveness of Remsima are equivalent to those of Remicade in the conditions.
Croatian: Nadalje, ispitivanja reumatoidnog artritisa i ankilozantnog spondilitisa pokazala su da su sigurnost i učinkovitost lijeka Remsima jednake onima lijeka Remicade u tim uvjetima.
English: Remsima must not be used in patients who have experienced hypersensitivity (allergy) to infliximab in the past, or who are hypersensitive (allergic) to mouse proteins or any of the other ingredients of Remsima.
Croatian: Remsima se ne smije primjenjivati u bolesnika koji su u prošlosti pokazali preosjetljivost (alergiju) na infliksimab ili koji su preosjetljivi (alergični) na bjelančevine mišjeg podrijetla ili bilo koji drugi sastojak lijeka Remsima.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Remsima have also been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Remsima nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: Remsima is an anti-inflammatory medicine that contains the active substance infliximab.
Croatian: Remsima je protuupalni lijek koji sadrži djelatnu tvar infliksimab.
English: What are the risks associated with Remsima?
Croatian: Koji su rizici povezani s lijekom Remsima?
English: After 22 weeks, the reduction of symptoms was comparable for treatment given by infusion into a vein and by injection under the skin.
Croatian: Nakon 22 tjedna smanjenje simptoma bilo je slično u oba načina primjene; za terapiju davanu infuzijom u venu i ubrizgavanjem pod kožu.
English: For more information about using Remsima, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Remsima pročitajte uputu o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: Patients received Remsima by infusion twice, two weeks apart and subsequent treatments were given either by infusion or injection under the skin.
Croatian: Bolesnici su primili lijek Remsima infuzijom dva puta u razmaku od dva tjedna, a kasnije terapije davane su ili infuzijom ili ubrizgavanjem pod kožu.
English: To reduce the risk of infusion-related reactions, patients may be given other medicines before or during treatment with Remsima or the infusion may be slowed down.
Croatian: Kako bi se smanjio rizik od reakcija povezanih s infuzijom, prije ili nakon terapije lijekom Remsima bolesnicima se mogu dati drugi lijekovi ili se infuzija može usporiti.
English: • Crohn's disease (a disease causing inflammation of the digestive tract), when the disease is moderate to severe or fistulising (with the formation of fistulas, abnormal passageways between the gut and other organs);
Croatian: • Crohnovom bolešću (bolešću koja uzrokuje upalu probavnog sustava) ako je bolest umjerena do teška ili fistulirajuća (stvaraju se fistule, neprirodni otvori između crijeva i drugih organa)
English: A study was also carried out in 250 patients with ankylosing spondylitis to show that Remsima given by infusion into a vein produces levels of the active substance in the body that are comparable to the reference medicine, Remicade.
Croatian: Ispitivanje je provedeno i u 250 bolesnika s ankilozantnim spondilitisom kako bi se pokazalo da lijek Remsima davan infuzijom u venu stvara razine djelatne tvari u tijelu koje su slične referentnom lijeku Remicade.
English: Remsima given by injection under the skin for rheumatoid arthritis is as effective as Remsima given by infusion and the safety profile is acceptable.
Croatian: Lijek Remsima davan injekcijom pod kožu za liječenje reumatoidnog artritisa jednako je učinkovit kao Remsima davan infuzijom i sigurnosni je profil prihvatljiv.
English: Remsima is available as a powder to be made up into a solution for infusion (drip) into a vein.
Croatian: Remsima je dostupan kao prašak za pripremu otopine za infuziju (ukapavanje) u venu.
English: The active substance in Remsima, infliximab, is a monoclonal antibody, a type of protein that has been designed to recognise and attach to a specific structure (called an antigen) in the body.
Croatian: Infliksimab, djelatna tvar u lijeku Remsima, monoklonsko je protutijelo, vrsta bjelančevina koja prepoznaje i vezuje se na određenu strukturu (antigen) u tijelu.
English: As for all medicines, data on the use of Remsima are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Remsima kontinuirano se prate.
English: The safety of Remsima has been evaluated, and on the basis of all the studies carried out, the side effects of the medicine are considered to be comparable to those of the reference medicine Remicade.
Croatian: Na temelju procjene sigurnosti primjene lijeka Remsima i svih provedenih ispitivanja, nuspojave lijeka smatraju se usporedivima s onima za referentni lijek Remicade.
English: What benefits of Remsima have been shown in studies?
Croatian: Koje su koristi od lijeka Remsima utvrđene u ispitivanjima?
English: This messenger is involved in causing inflammation and is found at high levels in patients with the diseases that Remsima is used to treat.
Croatian: Taj glasnik sudjeluje u nastanku upale te se u visokim razinama nalazi u osoba oboljelih od bolesti koje su na terapiji lijekom Remsima.
English: Patients received either Remsima or Remicade in addition to methotrexate for 30 weeks.
Croatian: Bolesnici su tijekom 30 tjedana primali lijek Remsima ili Remicade uz metotreksat.
English: For treatment of rheumatoid arthritis, Remsima is also available as a solution for injection under the skin in a pre-filled syringe or pen.
Croatian: Za liječenje reumatoidnog artritisa lijek Remsima dostupan je i kao otopina za potkožnu injekciju u napunjenoj štrcaljki ili brizgalici.
English: • psoriasis (a disease causing red, scaly patches on the skin).
Croatian: • psorijazom (bolešću koja uzrokuje crvene, ljuskave mrlje na koži).
English: • ankylosing spondylitis (a disease causing inflammation and pain in the joints of the spine);
Croatian: • ankilozantnim spondilitisom (bolešću koja uzrokuje upalu i bol zglobova kralježnice)
English: Laboratory studies comparing Remsima with Remicade have shown that the active substance in Remsima is highly similar to that in Remicade in terms of structure, purity and biological activity.
Croatian: Laboratorijska ispitivanja u kojima su uspoređivani lijekovi Remsima i Remicade pokazala su da je u pogledu strukture, čistoće i biološke aktivnosti djelatna tvar u lijeku Remsima vrlo slična djelatnoj tvari u lijeku Remicade.
English: Patients can inject Remsima themselves once they have been trained.
Croatian: Bolesnici mogu sami ubrizgavati lijek Remsima kada ih se za to osposobi.
English: All these data were considered sufficient to conclude that Remsima will behave in the same way as Remicade in terms of effectiveness and safety in its authorised uses.
Croatian: Svi ti podatci smatraju se dovoljnima za donošenje zaključka da će u pogledu učinkovitosti i sigurnosti primjene Remsima u odobrenim primjenama djelovati jednako kao Remicade . Stoga je stav Agencije da korist od lijeka Remsima, kao i od lijeka Remicade, nadmašuje identificirani rizik te da lijek može biti odobren za primjenu u EU-u.
English: All patients are monitored for any reactions during the infusion and for at least one to two hours afterwards.
Croatian: Tijekom infuzije i najmanje jedan do dva sata nakon toga, svi su bolesnici pod nadzorom radi moguće pojave reakcija.
English: How does Remsima work?
Croatian: Kako se Remsima primjenjuje?
English: • psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints);
Croatian: • psorijatičnim artritisom (bolešću koja uzrokuje crvene, ljuskave mrlje na koži i upalu zglobova)
English: Remsima is used with methotrexate (another medicine that acts on the immune system);
Croatian: • reumatoidnim artritisom (bolešću koja uzrokuje upalu zglobova); tada se Remsima primjenjuje s metotreksatom (još jednim lijekom koji djeluje na imunosni sustav)
English: • ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut);
Croatian: • ulceroznim kolitisom (bolešću koja uzrokuje upalu i čireve na stijenci crijeva)
English: How is Remsima used?
Croatian: Kako djeluje Remsima?
English: For the full list of all side effects of Remsima, see the package leaflet.
Croatian: Potpuni popis zabilježenih nuspojava povezanih s lijekom Remsima potražite u uputi o lijeku.
English: For rheumatoid arthritis, after two treatments with infliximab have been given by infusion, Remsima can be given by injection under the skin for subsequent treatments.
Croatian: Za liječenje reumatoidnog artritisa, nakon dviju infuzija infliksimaba