natgillin/translations-raw huggingface dataset:
Revaccination: Revaccinate every three months to maintain immunity.
Revakcinacija: Revakciniramo vsake tri mesece, da ohranimo imunost.
This swelling resolves completely within 3 weeks and normally has no effect on the appetite of the vaccinated animal and causes no apparent discomfort.
V 3 tednih ta oteklina povsem mine in običajno ne vpliva na apetit cepljene živali niti ne povzroča vidnega nelagodja.
Special care must be taken when connecting the applicator to the needle to avoid needle-stick injuries.
Posebno je treba paziti pri nameščanju aplikatorja na iglo, da ne pride do vboda z iglo.
Allow the sterile solvent to reach room temperature (15-25 °C).
Počakajte, da se sterilni vehikel ogreje na sobno temperaturo (15-25 °C).
After reconstitution use within 4 hours.
Po rekonstituciji uporabite v 4 urah.
10 x 1 dose of vaccine 10 x 1 dose of solvent 10 applicators 10 syringes with needle
10 x 1 odmerek cepiva 10 x 1 odmerek vehikla 10 aplikatorjev 10 brizg z iglo
As the incidence of purpura haemorrhagica is very low, its occurrence cannot be ruled out completely.
Ker pa je hemoragična purpura zelo redka, njenega pojava ne moremo povsem izključiti.
The vaccine is intended for use in horses for which a risk of Streptococcus equi infection has been clearly identified, due to contact with horses from areas where this pathogen is known to be present, e.g. stables with horses that travel to shows and/or competitions in such areas, or stables that obtain or have livery horses from such areas.
Cepivo je namenjeno za uporabo pri konjih, pri katerih je nevarnost okužbe s Streptococcusom equi jasno razpoznana, ker so bili v stiku s konji iz območij, za katera je znano, da je na njih prisoten ta povzročitelj, npr. hlevi s konji, ki jih vozijo na razstave ali tekmovanja na takšna območja, ali hlevi, kjer sprejemajo ali imajo v oskrbi konje s takšnih območij.
Allow the reconstituted vaccine to sit for 1 minute and then carefully swirl the contents to mix.
Rekonstituirano cepivo naj 1 minuto počaka, potem pa vsebino previdno obračajte, da se zmeša.
For the full list of excipients, see section 6.1.
Pomožne snovi Za celoten seznam pomožnih snovi glejte poglavje 6.1.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Na voljo je malo podatkov o varnosti in učinkovitosti tega cepiva ob sočasni uporabi s katerim koli drugim zdravilom za uporabo v veterinarski medicini.
Lyophilisate for suspension for injection
Liofilizat za suspenzijo za injiciranje
6.5 Nature and composition of immediate packaging Each package of Equilis StrepE contains: 10 vials with lyophilisate and 10 vials of 0.5 ml solvent, each in 3 ml Type I glass vials closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap, 10 applicators, 10 syringes with needle.
Eno pakiranje Equilisa StrepE vsebuje: 10 vial z liofilizatom in 10 vial z 0,5 ml vehikla v 3mililitrskih vialah iz stekla tipa I, zaprtih z zamaški iz umetne gume in zaporka iz aluminija s šifro; 10
In case of accidental self-injection, seek medical advice immediately and show the package insert or the label to the physician even if only a very small amount is injected.
V primeru nenamernega samo-injiciranja se takoj posvetujte z zdravnikom in mu pokažite navodilo za uporabo ali ovojnino, tudi če je bila injicirana le zelo majhna količina.
Pharmacotherapeutic group: immunological for equidae, live bacterial vaccine, ATCvet code: QI05AE.
Farmakoterapevtska skupina: imunološko zdravilo za ekvide: živo bakterijsko cepivo Oznaka ATCvet: QI05AE
Withdraw 0.2 ml of the reconstituted vaccine into the syringe provided (see Figure 1) and connect the applicator to the needle (see Figure 2).
S priloženo brizgo odvzemite 0,2 ml rekonstituiranega cepiva (glejte sliko 1) in na iglo namestite aplikator (glejte sliko 2).
Do not mix with any other veterinary medicinal products except the solvent supplied for use with the vaccine.
Ne mešajte z nobenim drugim zdravilom za uporabo v veterinarski medicini, razen z vehiklom, ki je priložen cepivu.
Accidental self-injection may result in an inflammatory reaction with severe pain and swelling.
Nenamerno samoinjiciranje lahko povzroči vnetno reakcijo s hudo bolečino in oteklino.
To stimulate immunity against Streptococcus equi.
Za vzbujanje imunosti proti Streptococcusu equi
The vaccine strain is sensitive to penicillins, tetracyclines, macrolides and lincomycin.
Cepni sev je občutljiv za peniciline, tetracikline, makrolide in linkomicin.
For any information about this veterinary medicinal product, please contact the marketing authorization holder.
Za vse nadaljnje informacije o tem zdravilu se obrnite na krajevno predstavništvo imetnika dovoljenja za promet z zdravilom.
In very rare cases an abscess may develop at the injection site or in the regional lymph nodes.
Zelo redko se lahko na mestu vboda ali v regionalnih limfnih vozlih razvije absces.
Equilis StrepE - solvent
Equilis StrepE - vehikel
The vaccine strain is resistant to aminoglycosides, sulphonamides, flumequine and trimetroprim-sulfa combinations.
Cepni sev je odporen proti aminoglikozidom, sulfonamidom, flumekvinu in kombinacijam trimetoprima in sulfametoksazola.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Evropske agencije za zdravila (European Medicines Agency) http://www.ema.europa.eu/.
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Rok uporabnosti zdravila za uporabo v veterinarski medicini v pakiranju za prodajo: 3 leta
Shedding of the vaccine strain from the injection site can be observed for a period of four days after vaccination.
Izločanje cepnega seva iz mesta injiciranja je mogoče opaziti štiri dni po cepljenju.
Solvent: This medicinal product does not require any special storage conditions.
Vehikel: Posebne razmere za shranjevanje niso potrebne.
PACKAGE SIZE 10 x 1 dose
10 x 1 odmerek
Shelf life after reconstitution according to directions: 4 hours.
Rok uporabnosti po rekonstituciji v skladu z navodili: 4 ure.
In addition to the clinical signs given under section 4.6, vaccination with a ten times overdose may induce an abscess in one of the submandibular lymph nodes.
Poleg kliničnih znakov, ki so opisani v poglavju 4.6, lahko cepljenje z 10-krat prevelikim odmerkom povzroči tudi absces submandibularnega limfnega vozla.
Ensure that the lyophilisate is completely reconstituted before use.
Pred uporabo preverite, da je liofilizat povsem rekonstituiran.
NAME OF THE VETERINARY MEDICINAL PRODUCT Equilis StrepE
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI
ADVICE ON CORRECT ADMINISTRATION
NASVET O PRAVILNI UPORABI ZRAVILA
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC BIOLOŠKE AKTIVNE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROSTITEV SERIJE
This medicinal product does not require any special storage conditions.
Posebne razmere za shranjevanje niso potrebne.
− common (more than 1 but less than 10 animals in 100 animals)
- pogosti (pojavijo se pri več kot 1 toda pri manj kot 10 živalih od 100 živali)
4.2 Indications for use, specifying the target species For immunisation of horses against Streptococcus equi to reduce clinical signs and occurrence of lymph node abscesses.
4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Imunizacija konjev proti Streptococcusu equi za zmanjšanje kliničnih znakov in nastanka abscesov limfnih vozlov.
The abscesses drain purulent material from 2 weeks after vaccination, but heal without intervention within a month thereafter.
Iz abscesa se 2 tedna po cepljenju izloča gnojen izcedek, nato se v enem mesecu brez intervencije zaceli.
For immunisation of horses against Streptococcus equi to reduce clinical signs and occurrence of lymph node abscesses.
Imunizacija konjev proti Streptococcusu equi za zmanjšanje kliničnih znakov in nastanka abscesov limfnih vozlov.
Live deletion mutant Streptococcus equi strain TW928 109.0 to 109.4 cfu
Živi delecijski mutant seva Streptococcus equi TW928 109,0 do 109,4 CFU1
− very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)
- zelo pogosti (pojavijo se pri več kot 1 živali od 10 živali v teku enega zdravljenja)
However, the bacterial compounds of this product can cause an inflammatory reaction with intense and painful swelling after accidental injection.
Toda bakterijske spojine v proizvodu lahko v primeru nenamernega injiciranja povzročijo vnetno reakcijo z močno in bolečo oteklino.
THE WORDS "FOR ANIMAL TREATMENT ONLY"
BESEDILO ''SAMO ZA ŽIVALI''
Slight apathy may occasionally be observed one day after vaccination.
Občasno se lahko naslednji dan po cepljenju pojavi blaga apatija.
The vaccine organism may establish a small suppurative inflammation locally at the injection site, leading to a disruption of the overlaying lip mucosa and subsequent discharge fluid and inflammatory cells.
Na mestu vboda lahko cepni mikroorganizem povzroči manjše lokalno gnojno vnetje, zaradi katerega lahko pride do razkroja sluznice ustnice nad mestom vboda ter izločanja tekočine in vnetnih celic.
The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
(EU) št.37/2010 določa, da MRL ni potreben ali pa, kot so uporabljene v tem zdravilu za uporabo v veterinarski medicini, niso vključene v Uredbo(ES) št. 470/2009.
This product contains a live auxotrophic deletion mutant Streptococcus equi vaccine strain with attenuated virulence.
Zdravilo vsebuje živi avksotrofni delecijski mutant cepnega seva Streptococcusa equi z oslabljeno virulenco.
In rare cases, inappetence, fever, shivering and diffuse oedematous swellings (e.g. facial oedema, swollen muzzle/upper lip) may be observed.
Redko lahko zasledimo anoreksijo, vročino, tresenje in difuzne edematozne otekline (npr. facialni edem, otekel gobec/ gornja ustnica).
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 1 dose
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV
This product contains a live bacterial deletion mutant with a limited growth potential in mammalian tissue.
Zdravilo vsebuje živi bakterijski delecijski mutant z omejenim potencialom za rast v tkivu sesalcev.
It is able to multiply locally at the submucosal injection site during a short period and is shed into the oro-nasal cavity during a few days, but the vaccine strain does not survive on the oro-nasal mucosa and does not disseminate systemically at the recommended dose.
Na mestu submukoznega injiciranja se lahko krajši čas lokalno razmnožuje in nekaj dni širi v ustno in nosno votlino, vendar na sluznici ustne in nosne votline ne preživi in se pri uporabi priporočenega odmerka ne širi v organizem.
Restrain the animal's head, lift the upper lip and insert the needle into the inside of the upper lip until the applicator rests on the lip. Administer the whole contents of the syringe into the inside of the upper lip (see Figure 3).
Konju zadržite glavo, dvignite zgornjo ustnico in iglo vbodite na notranji strani zgornje ustnice tako globoko, da se aplikator dotakne njene površine.
Lyophilisate: Store in a refrigerator (2 °C - 8 °C).
Liofilizat: Shranjujte v hladilniku (2 °C-8 °C).
Vaccination scheme:
Revakcinacija:
Basic vaccination: Horses from 4 months of age onwards receive two vaccinations of one dose with a 4 week interval.
Shema cepljenja: Osnovno cepljenje: konje od 4 mesecev starosti dalje cepimo dvakrat s po enim odmerkom s 4
PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection Lyophilisate: off-white or cream-coloured pellet Solvent: clear colourless solution
Liofilizat in vehikel za suspenzijo za injiciranje Liofilizat: peleta belkaste ali krem barve Vehikel: bistra brezbarvna raztopina
Onset of immunity: 2 weeks after basic vaccination.
Imunost se razvije dva tedna po osnovnem cepljenju.
QUALITATIVE AND QUANTITATIVE COMPOSITION Per dose of 0.2 ml vaccine:
V odmerku po 0,2 ml cepiva:
The vaccine strain is a deletion mutant with a limited growth potential in mammalian tissue.
Cepni sev je delecijski mutant z omejeno potencialno rastjo v tkivu sesalcev.
Anti-inflammatory therapy is indicated even if only a very small amount of the product in injected.
Čeprav je bila injicirana le zelo majhna količina proizvoda, je indicirana protivnetna terapija.
The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN ZAOSTANKOV ZDRAVILA (MRL) Učinkovina biološkega izvora, namenjena vzbujanju imunosti, ni vključena v Uredbo(ES) št.
Therefore only a single dose of vaccine is needed to restore immunity.
Imunski odziv na osnovno cepljenje se ohrani do šest mesecev, zato je za obnovitev imunosti potreben samo en odmerek cepiva.
DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION Submucosal vaccination of 0.2 ml of reconstituted product.
4.9 Odmerjanje in pot uporabe Submukozno cepljenje z 0,2 ml rekonstituiranega cepiva.
Furthermore, an increase in rectal temperature up to 2.5 °C may occur on the day of vaccination.
Na dan cepljenja se lahko za največ 2,5 °C poveča rektalna temperatura.
Aseptically reconstitute the freezedried vaccine with 0.3 ml of the sterile solvent provided.
Aseptično rekonstituirajte liofilizirano cepivo z 0,3 ml priloženega sterilnega vehikla.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCTS OR WASTE MATERIALS
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEPORABLJENEGA ZDRAVILA ALI ODPADNIH SNOVI
MARKETING AUTHORISATION HOLDER
DATUM PRIDOBITVE DOVOLJENJA ZA PROMET
Aseptically reconstitute the lyophilisate with 0.3 ml of the sterile solvent provided.
Liofilizat aseptično rekonstituirajte z 0,3 ml priloženega sterilnega vehikla.
THE WORDS "KEEP OUT OF THE SIGHT AND REACH OF CHILDREN"
BESEDILO ''ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM''
ROUTE OF ADMINISTRATION See package leaflet.
POT UPORABE ZDRAVILA Glejte priloženo navodilo.
After vaccination a diffusely swollen reaction, which may be warm or painful, develops at the injection site within 4 hours.
Po cepljenju se na mestu vboda v 4 urah pojavi reakcija v obliki difuzne otekline, ki je lahko topla ali boleča.
Use during pregnancy, lactation or lay: Do not use in pregnant or lactating mares.
4.7 Uporaba v obdobju brejosti, laktacije ali nesnosti Ne uporabite pri brejih kobilah ali kobilah v obdobju laktacije.
Further, an increase in rectal temperature up to 2 °C may occur on the day of vaccination.
Na dan cepljenja se lahko za največ 2 °C poveča rektalna temperatura.
QUANTITY OF THE ACTIVE SUBSTANCE Live Streptococcus equi.
Živi Streptococcus equi
STATEMENT OF ACTIVE AND OTHER SUBSTANCE 0.2 ml dose:
V odmerku po 0,2 ml:
NAME OF THE VETERINARY MEDICINAL PRODUCT Equilis StrepE, lyophilisate for suspension for injection, for horses
Equilis StrepE, liofilizat za suspenzijo za injiciranje, za konje
THE WORDS "KEEP OUT OF THE SIGHT AND REACH OF CHILDREN" Keep out of the sight and reach of children.
BESEDILO ''ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM'' Zdravilo shranjujte nedosegljivo otrokom.
PARTICULARS TO APPEAR ON THE INNER BOX WITH LYOPHILISATE
Za dajanje submukozno na notranjo stran zgornje ustnice
Lyophilisate: off-white or cream coloured pellet Solvent: clear colourless solution
1 Colony forming units - kolonijske enote Liofilizat: peleta belkaste ali krem barve Vehikel: bistra brezbarvna raztopina
PACKAGE LEAFLET FOR: Equilis StrepE, lyophilisate and solvent for suspension for injection, for horses
Equilis StrepE, liofilizat in vehikel za suspenzijo za injiciranje, za konje
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST REVISED Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani
ROUTE OF ADMINISTRATION For submucosal use.
Za submukozno uporabo
Marketing authorization holder and manufacturer responsible for batch release: Intervet International B.V.
Imetnik dovoljenja za promet z zdravilom in izdelovalec, odgovoren za sprostitev serije Intervet International B.V.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS
6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi
Slight enlargements, which may be transient painful, of the retropharyngeal and mandibular lymph nodes may occur for a few days after vaccination.
Nekaj dni po cepljenju so lahko blago povečani retrofaringealni in mandibularni limfni vozli, kar lahko spremlja prehodna bolečina.
− rare (more than 1 but less than 10 animals in 10,000 animals)
- občasni (pojavijo se pri več kot1živali toda pri manj kot 10 živalih od 1.000 živali) - redki (pojavijo se pri več kot1živali toda pri manj kot 10 živalih od 10.000 živali) - zelo redki (pojavijo se pri manj kot 1 živali od 10.000 živali, vključujoč posamezne primere).
For animal treatment only.
Samo na veterinarski recept.
Name and address of the manufacturer of the biological active substance Intervet International B.V.
Ime in naslov izdelovalca biološke aktivne učinkovine
BATCH NUMBER Lot {number}
IZDELOVALČEVA ŠTEVILKA SERIJE Lot {številka}
EXPIRY DATE EXP: {month/year}
DATUM IZTEKA ROKA UPORABNOSTI EXP: {mesec/leto}
A slight cloudy discharge commonly occurs from the mucosal injection site at 3 or 4 days post vaccination.
Običajno se 3 do 4 dni po cepljenju na mestu vboda pojavi blag moten izcedek.
In addition to the clinical signs given under section 6, vaccination with a ten times overdose may induce an abscess in one of the submandibular lymph nodes.
Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) Poleg kliničnih znakov, ki so opisani v poglavju 6, lahko cepljenje z 10-krat prevelikim odmerkom povzroči tudi absces na katerem od submandibularnih limfnih vozlov.
NAME OF THE DILUENT
Viala z vehikom
SPECIAL STORAGE CONDITIONS Keep out of the sight and reach of children.
Zdravilo shranjujte nedosegljivo otrokom.
EXPIRY DATE EXP {month/year}
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA Exp {mesec/leto}
EXPIRY DATE Exp {month/year}
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP{mesec/leto}
6.1 List of excipients
6.5 Vrsta ovojnine in vsebina
Fimbriae Types 2 and 3 (FIM)
fimbrije tipa 2 in 3 (FIM)
3 micrograms Conjugated to meningococcal protein2 50 micrograms adsorbed on aluminium phosphate (0.17 mg Al adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.15 mg Al 3 produced in yeast (Saccharomyces cerevisiae) cells by recombinant DNA technology 4 produced in Vero cells or equivalent antigenic quantity determined by a suitable immunochemical method.
adsorbiran na aluminijev fosfat (0,17 mg Al adsorbiran na amorfni aluminijev hidroksifosfat sulfat (0,15 mg Al 3 pridobljen v celicah kvasovke (Saccharomyces cerevisiae) s tehnologijo rekombinantne DNA 4 pridobljen v celicah Vero ali enakovredna količina antigenov, določena z ustrezno imunokemijsko metodo.
Poliovirus (Inactivated)4: Type 1 (Mahoney)
poliovirus (inaktiviran)4 tip 1 (sev Mahoney)
Hepatitis B surface antigen2,3:
površinski antigen hepatitisa B2,3
50 (5x10) pre-filled syringes (multipack)
50 (5 x 10) napolnjenih injekcijskih brizg (združeno pakiranje)
--1 One dose (0.5 ml) contains: Diphtheria Toxoid1:
--1 En odmerek (0,5 ml) vsebuje: toksoid davice1
Tetanus Toxoid1:
toksoid tetanusa1
Bordetella pertussis antigens1: Pertussis Toxoid (PT)
antigene Bordetella pertussis1 toksoid bakterije oslovskega kašlja (PT)
Filamentous Haemagglutinin (FHA) 20 micrograms Pertactin (PRN)
pertaktin (PRN)
The European Commission granted a marketing authorisation valid throughout the European Union for Entyvio on 22 May 2014.
Evropska komisija je dovoljenje za promet z zdravilom Entyvio, veljavno po vsej Evropski uniji, izdala 22. maja 2014.
What measures are being taken to ensure the safe and effective use of Entyvio?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Entyvio?
What is Entyvio and what is it used for?
Kaj je zdravilo Entyvio in za kaj se uporablja?
Furthermore, the risks are considered manageable, despite the lack of long-term safety data, if recommendations in place are followed.
Poleg tega so bila tveganja kljub pomanjkanju podatkov o dolgoročni varnosti ocenjena kot obvladljiva, če se upoštevajo sprejeta priporočila.
The full EPAR and risk management plan summary for Entyvio can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Entyvio sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The recommended dose is 300 mg given at weeks zero, two and six, and then every eight weeks after that in patients who respond.
Priporočeni odmerek je 300 mg, ki se daje na ničti, drugi in šesti teden ter nato pri bolnikih z odzivom na vsakih osem tednov.
This is a summary of the European public assessment report (EPAR) for Entyvio.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Entyvio.
It is not intended to provide practical advice on how to use Entyvio.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Entyvio was also shown to be more effective than placebo at improving symptoms of Crohn's disease.
Prav tako se je zdravilo Entyvio izkazalo za učinkovitejše od placeba pri izboljšanju simptomov Crohnove bolezni.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Entyvio's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Entyvio večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
Entyvio is given as an infusion that lasts 30 minutes.
Zdravilo Entyvio se daje z infuzijo, ki traja najmanj 30 minut.
Patients who receive Entyvio must be given a special alert card that summarises the safety information about the medicine.
Bolniki, ki prejemajo zdravilo Entyvio, morajo prejeti posebno opozorilno kartico, na kateri so povzete informacije o varnosti zdravila.
The company will also provide educational material to all healthcare professionals expected to prescribe Entyvio to remind them of the need to monitor patients for signs of neurological disease or PML, in particular those treated with certain biological medicines which may potentially cause PML.
Poleg tega bo družba zagotovila izobraževalno gradivo za vse zdravstvene delavce, ki naj bi predpisovali zdravilo Entyvio, da jih bo opozorila na potrebo po spremljanju bolnikov glede znakov nevroloških bolezni in PML, zlasti tistih, ki se zdravijo z določenimi biološkimi zdravili, ki lahko povzročijo PML.
Why is Entyvio approved?
Zakaj je bilo zdravilo Entyvio odobreno?
A risk management plan has been developed to ensure that Entyvio is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Entyvio je bil pripravljen načrt obvladovanja tveganj.
Other information about Entyvio
Druge informacije o zdravilu Entyvio
In ulcerative colitis and Crohn's disease these cells are involved in causing inflammation in the gut.
Pri ulceroznem kolitisu in Crohnovi bolezni te celice sodelujejo pri povzročanju vnetja v črevesju.
Vedolizumab has been designed to attach to ‘alfa-4-beta-7 integrin', a protein mostly found on the surface of certain white blood cells in the gut.
Vedolizumab je bil zasnovan tako, da se veže na „integrin alfa-4beta-7“, beljakovino, ki je najpogosteje prisotna na površini določenih belih krvnih celic v črevesju.