natgillin/translations-raw huggingface dataset:
− very rare (less than 1 animal in 10,000 animals, including isolated reports).
Vrlo rijetke (manje od 1 životinje od ukupno 10 000 životinja, uključujući izolirana izvješća).
NAO-1 stabiliser
NAO-1 stabilizator Voda za injekcije
Basic vaccination performed during an outbreak is not efficacious, because immunity is insufficient until basic vaccination has been completed.
Primarno cijepljenje tijekom izbijanja bolesti nije efikasno jer imunitet nije dovoljno razvijen sve dok se ne dovrši primarno cijepljenje.
The vaccine strain is resistant to aminoglycosides, sulphonamides, flumequine and trimetroprim-sulfa combinations.
Cjepni soj je otporan na aminoglikozide, sulfonamide, flumekvine, trimetroprim-sulfa kombinacije.
Solvent: This medicinal product does not require any special storage conditions.
Otapalo: Ovaj medicinski proizvod ne zahtjeva nikakve posebne uvijete čuvanja.
NAME OF THE VETERINARY MEDICINAL PRODUCT Equilis StrepE
NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA
The sensitivity of the vaccine strain to antibiotics is listed above (under section 4.4).
Osjetljivost cjepnog soja na antibiotike je naznačena gore (u odjeljku 4.4).
Purpura haemorrhagica has not been observed in any of the safety studies performed during development of Equilis StrepE.
Purpura haemorrhagica nije proučavana ni u jednom ispitivanju o neškodljivosti tijekom razvoja Equilis StrepE.
Further, an increase in rectal temperature up to 2 °C may occur on the day of vaccination.
Nadalje, povećanje rektalne temperature do 2°C može se javiti na dan cijepljenja.
It is recommended that all horses stabled together are vaccinated.
Preporuča se cijepljenje svih konja u istoj staji.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Nema dostupnih informacija o neškodljivosti i djelotvornosti kad se koristi s drugim veterinarskomedicinskim proizvodima.
Anti-inflammatory therapy is indicated even if only a very small amount of the product in injected.
Protuupalna terapija je indicirana ako je inicirana i vrlo malena količina ovog proizvoda.
Equilis StrepE - solvent
Equilis StrepE - otapalo
Do not mix with any other veterinary medicinal products except the solvent supplied for use with the vaccine.
Ne miješati s bilo kojim drugim veterinarsko-medicinskim proizvodom osim diluentom priloženim za primjenu s cjepivom.
Allow the sterile solvent to reach room temperature (15-25 °C).
Pričekati da otapalo postigne sobnu temperaturu ( 15-25°C).
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton box
PODACI NA VANJSKOM PAKOVANJU Kartonska kutija
Submucosal vaccination with 0.2 ml of reconstituted product.
Submukozno cijepljenje s 0,2 ml rekonstituiranog proizvoda.
After vaccination a diffusely swollen reaction, which may be warm or painful, develops at the injection site within 4 hours.
Nakon cijepljenja može se javiti difuzna oteklina, koja može biti topla i bolna, a razvija se na mjestu injekcije unutar 4 sata.
In rare cases, inappetence, fever, shivering and diffuse oedematous swellings (e.g. facial oedema, swollen muzzle/upper lip) may be observed.
U rjeđim slučajevima mogu se opaziti inapetencija, groznica, drhtanje i difuzne edemske otekline (npr. edem lica, natečena njuška/gornja usna ).
The reaction is maximal at 2-3 days post vaccination with a maximum area of 3 cm by 8 cm.
Ta reakcija traje najviše 2-3 dana nakon cijepljenja s najvećim područjem od 3
As the incidence of purpura haemorrhagica is very low, its occurrence cannot be ruled out completely.
Učestalost pojavljivanja purpura haemorrhagica je vrlo rijetka ali ne može biti isključena.
For immunisation of horses against Streptococcus equi to reduce clinical signs and occurrence of lymph node abscesses.
Za imunizaciju konja protiv Streptoccoccus equi u svrhu smanjivanja kliničkih znakova i pojave apscesa limfnih čvorova.
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).
Povući 0,2 ml rekonstituiranog cjepiva u priloženu špricu (vidi sliku 1) i spojiti aplikator s iglom (vidi sliku 2).
Withdraw 0.2 ml of the reconstituted vaccine into the syringe provided with the vaccine (see Figure 1) and connect the applicator to the needle (see Figure 2).
Povući 0,2 ml rekonstituiranog cjepiva u priloženu špricu (vidi sliku 1) i spojiti aplikator s iglom ( vidi sliku 2).
Lyophilisate for suspension for injection
Liofilizat za suspenziju za injekciju
Intervet International B.V. Wim de Körverstraat 35 NL - 5831 AN Boxmeer The Netherlands
Wim de Korverstraat 35 NL-5831 AN Boxmeer The Netherlands
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.
Kao dodatak kliničkim znacima iznesenim pod brojem 4.6, cijepljenje s dozom deset puta većom od preporučene može uzrokovati apsces u jednom od submandibularnih limfnih čvorova.
Onset of immunity: 2 weeks after basic vaccination.
Početak imuniteta: 2 tjedna nakon prvog cijepljenja.
After reconstitution use within 4 hours.
EXP {mjesec/godina} Nakon rekonstitucije upotrijebiti unutar 4 sata.
QUALITATIVE AND QUANTITATIVE COMPOSITION Per dose of 0.2 ml vaccine:
Doza od 0,2 ml vakcine:
Shedding of the vaccine strain from the injection site can be observed for a period of four days after vaccination.
Curenje vakcinalnog soja na mjestu injektiranja može se primijetiti u periodu od četiri dana nakon cijepljenja.
A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Odluka o korištenju ovog cjepiva prije bilo kojeg drugog veterinarsko medicinskog proizvoda treba donositi, od slučaja do slučaja.
To the physician:
Za liječnika:
Basic vaccination: Horses from 4 months of age onwards receive two vaccinations of one dose with a 4 week interval.
Primarno cijepljenje: konji od 4 mjeseca starosti na dalje, primaju dva cijepljenja s jednom dozom u intervalu od 4 tjedna.
The abscesses drain purulent material from 2 weeks after vaccination, but heal without intervention within a month thereafter.
Iz apscesa se cijedi gnoj od 2 tjedna nakon cijepljenja a zaliječi se bez intervencije u roku od mjesec dana.
PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection Lyophilisate: off-white or cream-coloured pellet Solvent: clear colourless solution
Liofilizat i otapalo za suspenziju za injekciju Liofilizat: bjelkasta do krem peleta Otapalo: bistra bezbojna otopina
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).
Fiksirati glavu životinje, podignuti gornji dio usnice i umetnuti iglu unutar gornjeg dijela usnice sve dok aplikator nije položen na usnicu.
Aseptically reconstitute the lyophilisate with 0.3 ml of the sterile solvent provided.
Sterilno rekonstituirajte liofilizat s 0,3 ml priloženog sterilnog otapala.
Accidental self-injection may result in an inflammatory reaction with severe pain and swelling.
Slučajno samo-iniciranje može uzrokovati upalnu reakciju praćenu jakom boli i oteklinom.
Furthermore, an increase in rectal temperature up to 2.5 °C may occur on the day of vaccination.
Također može se javiti povećanje rektalne temperature do 2,5°C na dan cijepljenja.
Disposal: read package leaflet.
Zbrinjavanje: pročitati uputu o VMP.
This product contains a live auxotrophic deletion mutant Streptococcus equi vaccine strain with attenuated virulence.
Ovaj proizvod sadrži živi auksotrofan delecijski mutant Streptococcus equi cjepni soj smanjene virulencije.
Live deletion mutant Streptococcus equi strain TW928 109.0 to 109.4 cfu
Živi delecijski mutant Streptococcus equi, soj TW928 109,0 do 109,4 cfu1.
A priming response is maintained for up to six months after basic vaccination.
Osnovna imunost traje do 6 mjeseci nakon primarnog cijepljenja.
THE WORDS "FOR ANIMAL TREATMENT ONLY" For animal treatment only.
RIJEČI “ SAMO ZA PRIMJENU NA ŽIVOTINJAMA” Samo za primjenu na životinjama.
This product contains a live bacterial deletion mutant with a limited growth potential in mammalian tissue.
Ovaj proizvod sadrži živi bakterijski delecijski mutant s mogućnošću ograničenog rasta u tkivu sisavaca.
SPECIAL STORAGE CONDITIONS Keep out of the sight and reach of children.
11. POSEBNE MJERE PREDOSTROŽNOSTI ZA ČUVANJE Čuvati izvan dosega i pogleda djece.
The onset of immunity is established as two weeks after vaccination.
Početak imuniteta se javlja 2 tjedna nakon cijepljenja.
The vaccine strain is a deletion mutant with a limited growth potential in mammalian tissue.
Cjepni soj je delecijski mutant s ograničenim potencijalom rasta u tkivu sisavaca.
THE WORDS "KEEP OUT OF THE SIGHT AND REACH OF CHILDREN" Keep out of the sight and reach of children.
I POGLEDA DJECE” Čuvati izvan dosega i pogleda djece.
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.
Vakcinalni organizmi mogu uzrokovati malu gnojnu lokalnu upalu na mjestu injekcije što uzrokuje oštećenje sluznice te posljedični iscjedak.
Do not use in pregnant or lactating mares.
Ne upotrebljavati kod gravidnih kobila ili kobila u laktaciji.
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 1 dose
SADRŽAJ: TEŽINA, VOLUMEN I BROJ DOZA
Name and address of the manufacturer of the biological active substance Intervet International B.V.
Naziv i adresa proizvođača biološke aktivne tvari: Intervet International B.V.
− rare (more than 1 but less than 10 animals in 10,000 animals)
Rijetke (više od 1 ali manje od 10 od ukupno 10 000 životinja)
ROUTE OF ADMINISTRATION For submucosal use.
Za submukoznu primjenu.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Lyophilisate vial
OSNOVNI DJELOVI NAPISANI NA MALIM JEDINICAMA UNUTARNJIH PAKOVANJA
THE WORDS "KEEP OUT OF THE SIGHT AND REACH OF CHILDREN"
Čuvati izvan pogleda i dosega djece.
10 x 1 dose of vaccine 10 x 1 dose of solvent 10 applicators 10 syringes with needle
10 x 1 doza vakcine 10 x 1 doza otapala
Slight enlargements, which may be transient painful, of the retropharyngeal and mandibular lymph nodes may occur for a few days after vaccination.
Lagano povećanje, koje može biti prolazno bolno, retrofaringealnih i mandibularnih limfnih čvorova,
Lyophilisate: Store in a refrigerator (2 °C - 8 °C).
Liofilizat: Čuvati u hladnjaku (2°C-8°C).
PACKAGE SIZE 10 x 1 dose
VELIČINA PAKOVANJA 10 x 1 doza vakcine 10 x 1 doza otapala
− uncommon (more than 1 but less than 10 animals in 1,000 animals)
Manje česte (više od 1 ali manje od 10 od ukupno 1000 životinja)
The frequency of adverse reactions is defined using the following convention:
Učestalost nuspojava je određena prema sljedećim pravilima:
QUANTITY OF THE ACTIVE SUBSTANCE Live Streptococcus equi.
Živi Streptococcus equi.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
6.6 Posebne mjere predostrožnosti za odlaganje neupotrebljenog veterinarsko-medicinskog proizvoda ili otpadnih materijala dobivenih primjenom tih proizvoda
Marketing authorization holder and manufacturer responsible for batch release: Intervet International B.V.
Nositelj odobrenja i proizvođač odgovoran za puštanje serije u promet: Intervet International B.V.
To stimulate immunity against Streptococcus equi.
ATCvet kod: QI05AE Za stimulaciju imuniteta protiv Streptococcus equi.
EXPIRY DATE EXP: {month/year}
ROK VALJANOSTI Exp: {mjesec/godina}
CONTENTS BY WEIGHT, BY VOLUME OR BYNUMBER OF DOSES 1 dose
SADRŽAJ: TEŽINA, VOLUMEN IL BROJ DOZA 10 x 1 doza
Pharmacotherapeutic group: immunological for equidae, live bacterial vaccine, ATCvet code: QI05AE.
IMUNOLOŠKA SVOJSTVA Farmakoterapijska skupina: imunološki proizvod za kopitare, živo bakterijsko cjepivo,
− very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)
Vrlo česte (više od 1 na 10 životinja pokazale su nuspojave tijekom jednog liječenja) Česte (više od jedne ali manje od 10 od ukupno 100 životinja)
NAME OF THE DILUENT
SAŽETAK OPISA SVOJSTAVA
A slight cloudy discharge commonly occurs from the mucosal injection site at 3 or 4 days post vaccination.
Mutni iscjedak javlja se na injekcionom mjestu na sluznici 3-4 dana nakon cijepljenja.
SPECIAL STORAGE CONDITIONS Store in a refrigerator (2 °C - 8 °C).
11. POSEBNI UVIJETI ČUVANJA Čuvati u hladnjaku (2°C-8°C).
PARTICULARS TO APPEAR ON THE INNER BOX WITH LYOPHILISATE
OSNOVNI DJELOVI NAPISANI NA MALIM JEDINICAMA UNUTARNJIH PAKOVANJA Bočica za liofilizat
EXPIRY DATE EXP {month/year}
ROK VALJANOSTI Exp {mjesec/godina}
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.
Sposoban je multiplicirati se lokalno na mjestu submukozne injekcije kroz kratak period te se širiti u oronazalnu šupljinu kroz par dana.
PACKAGE LEAFLET FOR: Equilis StrepE, lyophilisate and solvent for suspension for injection, for horses
Equilis StrepE liofilizat i otapalo za suspenziju za injekciju, za konje
Use during pregnancy, lactation or lay: Do not use in pregnant or lactating mares.
Primjena tijekom graviditeta, laktacije ili nesenja
NAME OF THE VETERINARY MEDICINAL PRODUCT Equilis StrepE, lyophilisate for suspension for injection, for horses
Equilis StrepE liofilizat za suspenziju za injekciju, za konje
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Intervet International B.V.
15. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET Intervet International B.V.
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 dissiminate systemically at the recommended dose.
Cjepni soj ne preživljava u sluznici oronazale šupljine niti se širi sistemski ako se koristi u preporučenoj dozi.
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
UVIJETI ILI OGRANIČENJA ODOBRENJA ZA STAVLJANJE U PROMET U POGLEDU OPSKRBE I PRIMJENE
NAME OF THE VETERINARY MEDICINAL PRODUCT Equilis StrepE, lyophilisate and solvent for suspension for injection
Equilis StrepE liofilizat i otapalo za suspenziju za injekciju
Name and address of the manufacturer responsible for batch release Intervet International B.V.
Naziv i adresa proizvođača odgovornog za puštanje serije u promet: Intervet International BV
Lyophilisate: off-white or cream coloured pellet Solvent: clear colourless solution
Liofilizat: bjelkasta do krem peleta.
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.
adsorbirani na aluminijev fosfat (0,17 mg Al adsorbirani na amorfni aluminijev hidroksifosfat sulfat (0,15 mg Al 3 proizveden tehnologijom rekombinantne DNK u stanicama kvasca (Saccharomyces cerevisiae) 4 umnožen u Vero stanicama ili ekvivalentna količina antigena utvrđena odgovarajućom imunokemijskom metodom.
50 (5x10) pre-filled syringes (multipack)
50 (5 x 10) napunjenih štrcaljki (višestruko pakiranje)
Poliovirus (Inactivated)4: Type 1 (Mahoney)
Virus poliomijelitisa (inaktiviran) 4 Tip 1 (Mahoney)
--1 One dose (0.5 ml) contains: Diphtheria Toxoid1:
--1 Jedna doza (0,5 ml) sadrži: Toksoid difterije 1
Tetanus Toxoid1:
Toksoid tetanusa 1
Hepatitis B surface antigen2,3:
Površinski antigen virusa hepatitisa B 2,3
Bordetella pertussis antigens1: Pertussis Toxoid (PT)
Antigene bakterije Bordetella pertussis1 Toksoid hripavca (PT)
Haemophilus influenzae type b polysaccharide (Polyribosylribitol Phosphate)
Polisaharid bakterije Haemophilus influenzae tip b
Filamentous Haemagglutinin (FHA) 20 micrograms Pertactin (PRN)
Pertaktin (PRN)
All patients are monitored for any reactions during the infusion and for at least one to two hours after the end of the infusion.
Svi bolesnici nadziru se na bilo koje reakcije tijekom infuzije i tijekom najmanje jednog do dva sata nakon dovršetka infuzije.
What is Entyvio and what is it used for?
Što je Entyvio i za što se koristi?
Further information can be found in the summary of the risk management plan.
Više informacija možete naći u sažetku plana upravljanja rizicima.
A risk management plan has been developed to ensure that Entyvio is used as safely as possible.
Razvijen je plan upravljanja rizikom kako bi se osiguralo da se Entyvio koristi što je sigurnije moguće.
The European Commission granted a marketing authorisation valid throughout the European Union for Entyvio on 22 May 2014.
Europska komisija izdala je odobrenje za stavljanje u promet koje za Entyvio vrijedi na prostoru Europske unije od 22. svibnja 2014.
Entyvio is given as an infusion that lasts 30 minutes.
Entyvio se daje u obliku infuzije koja traje najmanje 30 minuta.
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.
Cjelovito Europsko javno izvješće o ocjeni dokumentacije za lijek Entyvio (EPAR), kao i plan upravljanja rizicima mogu se naći na internetskim stranicama 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.
Preporučena doza je 300 mg na dan u nultom, drugom i šestom tjednu i potom svakih osam tjedana nakon toga u bolesnika koji odgovaraju na liječenje.
Other information about Entyvio
Druge informacije o lijeku Entyvio
What measures are being taken to ensure the safe and effective use of Entyvio?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Entyvio?
A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) in the body.
Monoklonsko protutijelo je protutijelo (vrsta proteina) koje je osmišljeno za prepoznavanje i vezivanje na specifičnu strukturu (zvanu antigen) u tijelu.
Entyvio was also shown to be more effective than placebo at improving symptoms of Crohn's disease.
Entyvio se također pokazao djelotvornijim od placeba u poboljšavanju simptoma Crohnove bolesti.
Why is Entyvio approved?
Zašto je Entyvio odobren?
This is a summary of the European public assessment report (EPAR) for Entyvio.
Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Entyvio.
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.
Tvrtka će također osigurati edukacijske materijale za sve zdravstvene djelatnike za koje se očekuje da će propisivati Entyvio kako bi ih se podsjetilo na potrebu praćenja bolesnika na znakove neurološke bolesti ili PML-a, a posebice onih liječenih biološkim lijekovima koji mogu uzrokovati PML.
Entyvio is produced by a method known as ‘recombinant DNA technology'; it is made by cells into which a gene (DNA) has been introduced that makes them able to produce vedolizumab.
Entyvio se proizvodi metodom poznatom pod nazivom „tehnologija rekombinantne DNK”; nastaje u stanicama u koje se uvodi gen (DNK), što ih čini sposobnim za proizvodnju vedolizumaba.
It is not intended to provide practical advice on how to use Entyvio.
Svrha sažetka nije davati praktične savjete o korištenju lijeka Entyvio.
Entyvio was shown to be more effective than placebo: 47% (106 out of 225) of patients who received Entyvio showed an improvement in symptoms, compared with 26% (38 out of 149) of patients who received placebo.
Entyvio se pokazao znatno djelotvornijim od placeba: 47 % (106 od 225) bolesnika koji su primali Entyvio pokazalo je poboljšanje simptoma u usporedbi s 26 % (38 od 149) bolesnika koji su primali placebo.
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 osmišljen za vezivanje na „alfa-4-beta-7 integrin”, protein koji se uglavnom nalazi na površini leukocita u utrobi.
Patients who receive Entyvio must be given a special alert card that summarises the safety information about the medicine.
Bolesnici koji primaju Entyvio moraju dobiti posebnu karticu s upozorenjem koja sažima sigurnosne informacije o lijeku.
In Crohn's disease, the CHMP considered that although the time required for improvement of symptoms may be longer and the size of the effect limited when compared with anti-TNF-alfa therapy, Entyvio still offers a benefit for patients because of its different mechanism of action and safety profile.
Kod Crohnove bolesti CHMP je smatrao da iako vrijeme potrebno za poboljšavanje simptoma može biti dulje, a učinak ograničen u usporedbi s anti-TNF-alfa terapijom, lijek Entyvio još uvijek nudi koristi za bolesnike zbog svog različitog mehanizma djelovanja i sigurnosnog profila.
Entyvio must not be used in people with active serious infections such as tuberculosis, sepsis (infection in the blood), listeriosis (infection with bacteria called Listeria) or opportunistic infections (those seen in patients with a weakened immune system) such as progressive multifocal leukoencephalopathy (PML, a rare brain infection that usually leads to severe disability or death).
Entyvio se ne smije koristiti u osoba s aktivnim, ozbiljnim infekcijama poput tuberkuloze, sepse (infekcije krvi), listerioze (infekcije bakterijom zvanom Listeria) ili oportunističkim infekcijama (onim uočenim u bolesnika s oslabljenim imunološkim sustavom) poput progresivne multižarišne leukoencefalopatije (PML, rijetka infekcija mozga koja obično uzrokuje tešku onesposobljenost ili smrt).
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Entyvio, including the appropriate precautions to be followed by healthcare professionals and patients.
Na temelju tog plana sigurnosne informacije uključene su u sažetak opisa svojstava lijeka i u uputu o lijeku za Entyvio, uključujući i odgovarajuće mjere opreza kojih se trebaju pridržavati zdravstveni djelatnici i bolesnici.
By blocking alfa-4-beta-7 integrin, vedolizumab reduces the inflammation in the gut and the symptoms of these diseases.
Blokadom alfa-4-beta-7 integrina vedolizumab smanjuje upalu u utrobi i simptome tih bolesti.
Furthermore, the risks are considered manageable, despite the lack of long-term safety data, if recommendations in place are followed.
Nadalje, unatoč nedostatku dugoročnih podataka o sigurnosti, rizici se smatraju prihvatljivima ako se bolesnici pridržavaju određenih preporuka.
Patients received either Entyvio or placebo (a dummy treatment) and the main measure of effectiveness was the proportion of patients whose symptoms improved after 6 weeks of treatment.
Bolesnici su primili ili Entyvio ili placebo (slijepo liječenje), a glavna mjera djelotvornosti bio je omjer bolesnika čiji su se simptomi poboljšali nakon 6 tjedana liječenja.
The most common side effects with Entyvio (which may affect more than 1 in 10 people) are nasopharyngitis (inflammation of the nose and throat such as a cold), headache and arthralgia (joint pain).
Najčešće nuspojave lijeka Entyvio (koje mogu zahvatiti više od 1 na 10 osoba) bile su nazofaringitis (upala nosa i grla poput prehlade), glavobolja i artralgija (bol u zglobovima).