FrancophonIA/ELRC3.0 huggingface dataset:
English: The efficacy and safety of the veterinary medicinal product has not been established in cats weighing less than 2.1 kg or more than 7.0 kg (see “Dosage for each species, route(s) and method of administration”).
Slovenian: Učinkovitost in varnost zdravila pri mačkah, težkih manj kot 2,1 kg ali več kot 7,0 kg, nista bili ugotovljeni (glejte poglavje „Odmerki za posamezne živalske vrste ter pot(i) in način uporabe zdravila“).
English: In case of oral ingestion, in addition to effects cited above (except local reactions), salivation and tremors may rarely occur.
Slovenian: V primeru zaužitja zdravila se lahko poleg zgoraj navedenih učinkov (razen lokalnih reakcij) v redkih primerih pojavita tudi povečano slinjenje in tresenje.
English: In the target animal safety study, where cats received a higher dose (2.8 to 5.4 mg) than the label dose (2 mg) once daily for 42 days, steady state was achieved within 14 days.
Slovenian: V študiji varnosti pri ciljnih živalih, kjer so mačke 42 dni enkrat dnevno prejemale večji odmerek (od 2,8 do 5,4 mg) od priporočenega (2 mg), je bilo stanje dinamičnega ravnovesja doseženo v 14 dneh.
English: This line coincides with the appropriate length of ointment to be applied:
Slovenian: Ta črta predstavlja ustrezno dolžino črte mazila, ki ga morate nanesti:
English: The line below coincides with the appropriate length of ointment to be applied:
Slovenian: Spodnja črta predstavlja ustrezno dolžino črte mazila, ki ga morate nanesti:
English: Step 3: Apply even pressure on tube and squeeze a 3.8 cm line of ointment onto your index finger using the measured line on the bottle or in this leaflet as a guide.
Slovenian: 3. korak: Z enakomernim stiskanjem tube iztisnite 3,8 cm dolgo črto mazila na svoj kazalec.
English: In a crossover study conducted with the product at 0.5 mg/kg in eight cats to determine the relative bioavailability of oral and transdermal 2% mirtazapine, the mean terminal half-life (25.6 ± 5.5 hours) with topical administration was over 2X longer than the mean terminal half-life (8.63 ±3.9 hours) with oral administration.
Slovenian: V navzkrižni študiji, opravljeni z zdravilom v odmerku 0,5 mg/kg pri osmih mačkah z namenom določitve relativne biološke uporabnosti peroralnega in transdermalnega odmerka 2-odstotnega mirtazapina, je bila povprečna končna razpolovna doba (25,6 ± 5,5 ure) po lokalnem dajanju več kot 2krat daljša od povprečne končne razpolovne dobe (8,63 ± 3,9 ure) po peroralnem dajanju.
English: For bodyweight gain in cats experiencing poor appetite and weight loss resulting from chronic medical conditions (see “other information”).
Slovenian: Za povečanje telesne mase pri mačkah, ki imajo slab apetit in hujšajo zaradi kroničnih bolezenskih stanj (glejte poglavje „Druge informacije“).
English: Application site reaction(s) (erythema, crust/scab, residue, scaling/dryness, flaking, head shaking, dermatitis or irritation, alopecia, and pruritus) and behavioural changes (increased vocalisation, hyperactivity, disoriented state or ataxia, lethargy/weakness, attention seeking and aggression) occurred very commonly in safety and clinical studies.
Slovenian: V varnostnih in kliničnih študijah so se zelo pogosto pojavljale reakcije na mestu aplikacije (eritem, krusta/krasta, ostanki, mekinasta koža/suhost, luščenje, tresenje glave, dermatitis ali draženje, alopecija in srbenje) in vedenjske spremembe (povečano oglašanje, hiperaktivnost, dezorientiranost ali ataksija, letargija/šibkost, iskanje pozornosti in agresivnost).
English: Step 4: Using your finger, gently rub ointment on inside surface of cat's ear (pinna) spreading it evenly over the surface.
Slovenian: 4. korak: S prstom nežno vtrite mazilo v notranjo površino mačkinega uhlja
English: In the case of contact with the skin, wash thoroughly with soap and warm water.
Slovenian: V primeru stika s kožo prizadeti predel temeljito umijte z milom in toplo vodo.
English: Thoroughly wash hands immediately after administration of the veterinary medicinal product or in case of skin contact with the product or the treated cat.
Slovenian: Takoj po uporabi zdravila ali v primeru kožnega stika z zdravilom ali zdravljeno mačko si temeljito umijte roke.
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).
Slovenian: Po enkratnem lokalnem dajanju dosežemo povprečno najvišjo koncentracijo v plazmi 21,5 ng/ml (± 43,5) pri srednji vrednosti Tmax 15,9 ure (1-48 ur).
English: Aniserve GmbH Geyerspergerstr.
Slovenian: Klifovet AG Geyerspergerstr.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY”
Slovenian: BESEDILO „SAMO ZA ŽIVALI“ Samo za živali.
English: Mirtazapine-induced weight gain may be secondary to changes in leptin and the tumour necrosis factor (TNF).
Slovenian: Z mirtazapinom inducirano povečanje telesne mase je lahko posledica sprememb ravni leptina in faktorja tumorske nekroze (TNF).
English: Mirataz 20 mg/g transdermal ointment for cats
Slovenian: Mirataz 20 mg/g transdermalno mazilo za mačke
English: The veterinary medicinal product is a skin sensitiser.
Slovenian: Zdravilo povzroča preobčutljivost kože.
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).
Slovenian: Po dajanju zdravila 8 mačkam v odmerku 0,5 mg/kg enkrat dnevno 14 dni je bila dosežena povprečna najvišja koncentracija v plazmi 39,6 ng/ml (± 9,72) pri srednji vrednosti Tmax 2,13 ure (1-4 ure).
English: If desired, the inner surface of the cat's ear may be cleaned by wiping with a dry tissue or cloth immediately prior to the next scheduled dose.
Slovenian: Tik pred naslednjim načrtovanim odmerkom se lahko notranjo površino mačkinega uhlja očisti s suhim zložencem ali krpo.
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).
Slovenian: Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali) - pogosti (pri več kot 1, toda manj kot 10 živalih od 100 zdravljenih živali) - občasni (pri več kot 1, toda manj kot 10 živalih od 1.000 zdravljenih živali)
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).
Slovenian: Zdravilo se nanaša lokalno na notranjo površino uhlja, enkrat dnevno v obdobju 14 dni, v odmerku 0,1 g mazila/mačko (2 mg mirtazapina/mačko).
English: 5 gram coated aluminium tube (coat: lacquer (internal)/ enamel (external) with a low-density polyethylene (LDPE) screw cap and crimp sealant.
Slovenian: Tuba s 5 g prevlečena z aluminijem (prevleka: lak (notranja stran)/emajl (zunanja stran)) z navojno zaporko iz polietilena z nizko gostoto (LDPE) in tesnilno maso pregiba.
English: Vomiting, polyuria associated with reduced urine specific gravity, elevated blood urea nitrogen (BUN) and dehydration were commonly observed in safety and clinical studies.
Slovenian: V varnostnih in kliničnih študijah so pogosto opazili bruhanje, poliurijo, povezano z zmanjšano specifično težo urina, zvišano raven dušika sečnine v krvi (BUN) in dehidracijo.
English: 0.1 g contains 2 mg mirtazapine (as hemihydrate)
Slovenian: 0,1 g vsebuje 2 mg mirtazapina (v obliki hemihidrata)
English: Transient increased hepatic alanine transferase can be observed uncommonly.
Slovenian: Občasno lahko opazimo prehodno povečano raven jetrne alanin-transferaze.
English: Mirataz 20 mg/g transdermal ointment for cats mirtazapine
Slovenian: Mirataz 20 mg/g transdermalno mazilo za mačke mirtazapin
English: The only effect tested under field practice was on bodyweight: client-owned cats presented with a weight loss ≥ 5%, deemed clinically significant by the investigator, gained a statistically significant (p<0.0001) amount of weight, after 14 days of product administration (3.39% weight gain or average of 130 grams) compared to those cats administered placebo (0.09% weight gain or average of 10 grams).
Slovenian: Edini učinek, preskušen v terenski praksi, je bil učinek na telesno maso: lastniške mačke, katerih izguba telesne mase je znašala ≥ 5 %, ki jo je raziskovalec ocenil kot klinično pomembno, so po 14 dneh uporabe zdravila pridobile statistično pomembno (p < 0,0001) telesno maso (3,39odstotno povečanje telesne mase ali povprečno 130 gramov) v primerjavi z mačkami, ki so prejemale placebo (0,09odstotno povečanje telesne mase ali povprečno 10 gramov).
English: The tube must be placed in the child-proof container after application, which must be closed immediately.
Slovenian: Tubo po nanosu zdravila vstavite v vsebnik z zaporko, varno za otroke, in vsebnik takoj zaprite.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Slovenian: NAVEDBA UČINKOVIN(E) IN DRUGE(IH) SESTAVIN Učinkovina:
English: EXP {month/year} Once opened use within 30 days.
Slovenian: Načeto zdravilo uporabite v 30 dneh.
English: If contact with your skin occurs wash with soap and water.
Slovenian: Če vaša koža pride v stik z zdravilom, prizadeti predel umijte z milom in vodo.
English: Impermeable disposable protective gloves should be provided at the point of sale with the product and must be worn when handling and administering the veterinary medicinal product.
Slovenian: Rokavice je treba nositi pri ravnanju z zdravilom in njegovem dajanju.
English: Do not leave the tube out of its child-proof container except during the application phase.
Slovenian: Ko tube ne uporabljate, je ne puščajte zunaj njenega vsebnika z zaporko, varno za otroke.
English: Children must not be present when applying the treatment to the cat.
Slovenian: Pri nanosu zdravila na mačko otroci ne smejo biti prisotni.
English: The efficacy and safety of the veterinary medicinal product has not been established in cats weighing less than 2.1 kg or more than 7.0 kg (see also section 4.9).
Slovenian: Učinkovitost in varnost zdravila pri mačkah, težkih manj kot 2,1 kg ali več kot 7,0 kg, nista bili ugotovljeni
English: Inhibition of 5-HT2 and histamine H1 receptors may account for the orexigenic effects of the molecule.
Slovenian: Oreksigen učinek molekule lahko povzroči zaviranje receptorjev 5-HT2 in histaminskih receptorjev H1.
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 “Contraindications”).
Slovenian: Ne uporabite pri mačkah, ki se zdravijo s ciproheptadinom, tramadolom ali zaviralci monoaminooksidaze (MAOI) ali so bile z MAOI zdravljene v zadnjih 14 dneh, ker lahko pride do povečanega tveganja za serotoninski sindrom (glejte poglavje „Kontraindikacije“).
English: Do not use in breeding, pregnant or lactating cats.
Slovenian: Ne uporabite pri vzrejnih živalih ali v obdobju brejosti in laktacije.
English: Step 2: Twist cap on tube counter clockwise to open.
Slovenian: 2. korak: Odprite zaporko na tubi tako, da jo zavrtite v nasprotni smeri urinega kazalca.
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”).
Slovenian: Ne uporabite pri mačkah, ki se zdravijo z zaviralci monoaminooksidaze (MAOI) ali so bile z MAOI zdravljene v zadnjih 14 dneh, ker lahko pride do povečanega tveganja za serotoninski sindrom (glejte poglavje „Posebna opozorila“).
English: Marketing authorisation holder: Aniserve GmbH Geyerspergerstr.
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Aniserve GmbH
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release
Slovenian: Ime in naslov proizvajalca (proizvajalcev) zdravila, odgovornega (odgovornih) za sproščanje serij Klifovet AG
English: The product may be harmful after ingestion.
Slovenian: Zdravilo ima lahko škodljive učinke pri zaužitju.
English: Diethylene glycol monoethyl ether Caprylocaproyl polyoxyglycerides Oleyl alcohol
Slovenian: 6.1 Seznam pomožnih snovi makrogol 400 makrogol 3350 dietilenglikolmonoetileter polioksigliceridi kaprilat kaprinat oleilalkohol butilhidroksitoluen (E321) dimetikon polimetil silseskvioksan iz škroba tapioke
English: Excipients: Butylhydroxytoluene (E321; as antioxidant) 0.01 mg
Slovenian: Vsak odmerek 0,1 g vsebuje: mirtazapin (v obliki hemihidrata) 2 mg Pomožne snovi: butilhidroksitoluen (E321; kot antioksidant) 0,01 mg Nemastno, homogeno, belo do umazano belo mazilo.
English: The tube must be stored in the child resistant bottle with cap and returned to the bottle and capped immediately after every use.
Slovenian: Po vsaki uporabi jo morate vrniti v plastenko in nanjo nemudoma namestiti zaporko.
English: Plastic bottle
Slovenian: PODATKI NA ZUNANJI OVOJNINI Plastenka
English: Avoid contact with the treated animal for the first 12 hours after each daily application and until the application site is dry.
Slovenian: Prvih 12 ur po vsakem nanosu, in dokler mesto nanosa ni suho, se izogibajte stiku z zdravljeno živaljo.
English: Klifovet AG Geyerspergerstrasse 27 80689 Muenchen Germany
Slovenian: Geyerspergerstrasse 27
English: Tube
Slovenian: ZDRAVILA
English: For bodyweight gain in cats experiencing poor appetite and weight loss resulting from chronic medical conditions (see section 5.1).
Slovenian: Za povečanje telesne mase pri mačkah, ki imajo slab apetit in hujšajo zaradi kroničnih bolezenskih stanj
English: Do not use in pregnant or lactating cats..
Slovenian: Ne uporabite v obdobju brejosti in laktacije.
English: Butylhydroxytoluene (E321) Dimethicone
Slovenian: mirtazapin (v obliki hemihidrata) 2 mg Pomožne snovi: butilhidroksitoluen (E321)
English: To apply the veterinary medicinal product:
Slovenian: Postopek nanosa zdravila:
English: Transdermal ointment
Slovenian: OVOJNINAH Tuba
English: Macrogol 400
Slovenian: 0,01 mg
English: THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN”
Slovenian: BESEDILO „ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM“ Zdravilo shranjujte nedosegljivo otrokom.
English: BATCH NUMBER
Slovenian: ŠTEVILKA SERIJE Lot {številka}
English: This overview was last updated in 11/2019.
Slovenian: Povzetek je bil nazadnje posodobljen 11-2019.
English: The main measure of effectiveness was the change in symptoms.
Slovenian: Glavno merilo učinkovitosti je bila sprememba simptomov.
English: Remsima (infliximab)
Slovenian: Remsima (infliksimab)
English: Further information on Remsima can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/remsima.
Slovenian: Nadaljnje informacije za zdravilo Remsima so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/remsima.
English: What measures are being taken to ensure the safe and effective use of Remsima?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Remsima?
English: Some side effects, including infections, may be more common in children than in adults.
Slovenian: Nekateri neželeni učinki, vključno z okužbami, utegnejo biti pogostejši pri otrocih kot pri odraslih.
English: This means that Remsima is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Slovenian: To pomeni, da je zelo podobno drugemu biološkemu zdravilu („referenčnemu zdravilu“), ki je že odobreno v EU.
English: Remsima received a marketing authorisation valid throughout the EU on 10 September 2013.
Slovenian: Za zdravilo Remsima je bilo 10. septembra 2013 izdano dovoljenje za promet, veljavno po vsej EU.
English: How often the treatment is repeated depends on which disease is being treated, and on the patient's response to the medicine.
Slovenian: Kako pogosto je treba zdravljenje ponavljati, je odvisno od bolezni, ki se zdravi, in od bolnikovega odziva na zdravilo.
English: Why is Remsima authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Remsima odobreno v EU?
English: An overview of Remsima and why it is authorised in the EU
Slovenian: Pregled zdravila Remsima in zakaj je odobreno v EU
English: What benefits of Remsima have been shown in studies?
Slovenian: Kakšne koristi zdravila Remsima so se pokazale v študijah?
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.
Slovenian: Zdravilo Remsima se uporablja tudi pri bolnikih v starosti med šest in 17 let z resno, aktivno Crohnovo boleznijo ali resnim, aktivnim ulceroznim kolitisom, kadar se na drugo zdravljenje ali zdravila niso odzvali ali kadar jih ne smejo prejemati.
English: It also allows patients the convenience of having their treatment at home.
Slovenian: Tako lahko bolniki zdravljenje izvajajo tudi v domačem okolju.
English: What is Remsima and what is it used for?
Slovenian: Kaj je zdravilo Remsima in za kaj se uporablja?
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.
Slovenian: Najpogostejši neželeni učinki zdravila Remsima (ki se lahko pojavijo pri več kot 1 od 10 bolnikov) so virusne okužbe (na primer gripa ali herpes), glavobol, okužbe zgornjih dihal (okužbe nosu in žrela), sinusitis (vnetje sinusov), navzeja (slabost), bolečine v trebuhu, reakcije, povezane z infuzijo, in bolečine.
English: By blocking TNF-alpha, infliximab improves the inflammation and other symptoms of the diseases.
Slovenian: Z zaviranjem TNF-alfa infliksimab izboljša vnetna stanja in druge simptome obolenj.
English: Other information about Remsima
Slovenian: Druge informacije o zdravilu Remsima
English: As for all medicines, data on the use of Remsima are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Remsima stalno spremljajo.
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).
Slovenian: Zdravilo Remsima se ne sme uporabljati pri bolnikih s tuberkulozo, drugimi hudimi okužbami ali zmernim do hudim srčnim popuščanjem (nezmožnostjo srca, da črpa dovolj krvi po telesu).
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.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Remsima upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Side effects reported with Remsima are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Remsima, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: For more information about using Remsima, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Remsima glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: After 30 weeks of treatment, Remsima was as effective as Remicade with around 60% of patients responding to treatment with either medicine.
Slovenian: Po 30 tednih zdravljenja je bilo zdravilo Remsima enako učinkovito kot zdravilo Remicade, pri čemer se je približno 60 % bolnikov odzvalo na zdravljenje z enim od omenjenih zdravil.
English: All patients are monitored for any reactions during the infusion and for at least one to two hours afterwards.
Slovenian: Pri vseh bolnikih je treba preverjati, ali med infundiranjem in še najmanj eno do dve uri po njem ni prišlo do pojava kakršnih koli reakcij.
English: Remsima is used with methotrexate (another medicine that acts on the immune system);
Slovenian: Zdravilo Remsima se uporablja skupaj z metotreksatom (drugim zdravilom, ki učinkuje na imunski sistem);
English: After 22 weeks, the reduction of symptoms was comparable for treatment given by infusion into a vein and by injection under the skin.
Slovenian: Po 22 tednih je bilo zmanjšanje simptomov primerljivo z zdravljenjem, ki se daje z infuzijo v veno in z injekcijo v podkožje.
English: What are the risks associated with Remsima?
Slovenian: Kakšna tveganja so povezana z zdravilom Remsima?
English: Infliximab has been designed to attach to a chemical messenger in the body called tumour necrosis factor-alpha (TNF-alpha).
Slovenian: Infliksimab je bil zasnovan tako, da se v telesu veže na kemijskega prenašalca, imenovanega tumorje nekrozitirajoči faktor-alfa (TNF-alfa).
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.
Slovenian: Zdravila Remsima ne smejo uporabljati bolniki, pri katerih je v preteklosti prišlo do preobčutljivosti (alergije) na infliksimab, ali bolniki, ki so preobčutljivi za (alergični na) mišje beljakovine ali katero koli drugo sestavino zdravila Remsima.
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.
Slovenian: Vsi ti podatki so bili ocenjeni kot zadostni za zaključek, da se bo zdravilo Remsima pri odobrenih uporabah z vidika učinkovitosti in varnosti vedlo enako kot zdravilo Remicade.
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.
Slovenian: Varnost zdravila Remsima je bila ocenjena, na podlagi vseh izvedenih študij pa so bili neželeni učinki zdravila ocenjeni kot primerljivi z neželenimi učinki referenčnega zdravila Remicade.
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.
Slovenian: Učinkovina v zdravilu Remsima, infliksimab, je monoklonsko protitelo, tj. vrsta beljakovine, ki je bila zasnovana tako, da prepozna določeno strukturo (imenovano antigen) v telesu in se veže nanjo.
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.
Slovenian: Podjetje, ki trži zdravilo Remsima, bo priskrbelo kartico za bolnike z informacijami o zdravilu in s pomočjo katere se lahko vodi evidenca o preskušanjih, ki so jih opravili.
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.
Slovenian: Zdravilo Remsima je „podobno biološko zdravilo“, zato vseh študij o učinkovitosti in varnosti infliksimaba, izvedenih z zdravilom Remicade, z zdravilom Remsima ni treba ponavljati.