natgillin/translations-raw huggingface dataset:
Plegridy continued to produce benefit in the second year of treatment.
Zdravilo Plegridy je še naprej prinašalo koristi v drugem letu zdravljenja.
Plegridy received a marketing authorisation valid throughout the EU on 18 July 2014.
Za zdravilo Plegridy je bilo 18. julija 2014 izdano dovoljenje za promet, veljavno po vsej EU.
The European Medicines Agency decided that Plegridy's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Plegridy večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Other information about Plegridy
Druge informacije o zdravilu Plegridy
This decreases the rate at which the medicine is removed from the body and allows it to be given less often.
To zmanjšuje hitrost izločanja zdravila iz telesa in omogoča manj pogosto dajanje zdravila.
This study was extended for two further years to investigate the long-term safety and efficacy of Plegridy, and available data from the extension phase at the time of approval were consistent with the results of the main study.
Ta študija je bila podaljšana za naslednji dve leti, da so proučili dolgoročno varnost in učinkovitost zdravila Plegridy, razpoložljivi podatki iz podaljšane faze pa so bili v času odobritve skladni z rezultati glavne študije.
Plegridy must not be used in patients who have severe depression or have thoughts of suicide.
Zdravilo Plegridy se ne sme uporabljati pri bolnikih, ki imajo hudo depresijo ali samomorilne misli.
As for all medicines, data on the use of Plegridy are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Plegridy stalno spremljajo.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Plegridy have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Plegridy upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Treatment should start with a dose of 63 micrograms, followed by a dose of 94 micrograms after two weeks, and then 125 micrograms every two weeks thereafter.
Zdravljenje je treba začeti v odmerku 63 mikrogramov, čemur po dveh tednih sledi 94-mikrogramski odmerek, nato pa se zdravljenje nadaljuje s 125-mikrogramskim odmerkom vsaka dva tedna.
What benefits of Plegridy have been shown in studies?
Kakšne koristi zdravila Plegridy so se pokazale v študijah?
Side effects reported with Plegridy are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Plegridy, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Why is Plegridy authorised in the EU?
Zakaj je bilo zdravilo Plegridy odobreno v EU?
Plegridy is available as a solution for injection in pre-filled pens or pre-filled syringes that contain 63, 94 or 125 micrograms peginterferon beta-1a.
Zdravilo Plegridy je na voljo v obliki raztopine za injiciranje v napolnjenih injekcijskih peresnikih ali napolnjenih injekcijskih brizgah, ki vsebujejo 63, 94 ali 125 mikrogramov peginterferona beta-1a.
The exact way that Plegridy works in MS is not yet known but it seems to calm down the immune system, and prevents relapses of MS.
Natančen način delovanja zdravila Plegridy pri multipli sklerozi ni še popolnoma znan, toda zdi se, da pomirja imunski sistem in preprečuje recidive multiple skleroze.
For more information about using Plegridy, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Plegridy glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Plegridy is a medicine used to treat multiple sclerosis (MS), a disease in which inflammation damages the protective insulation around nerves (demyelination) as well as the nerves themselves.
Plegridy je zdravilo, ki se uporablja za zdravljenje multiple skleroze, tj. bolezni, pri kateri vnetje poškoduje zaščitno ovojnico okoli živcev (demielinizacija) in živce same.
An overview of Plegridy and why it is authorised in the EU
Pregled zdravila Plegridy in zakaj je odobreno v EU
What are the risks associated with Plegridy?
Kakšna tveganja so povezana z zdravilom Plegridy?
The active substance in Plegridy is the protein interferon beta-1a, one of a group of interferons that can be naturally produced by the body to help it fight against viruses and other attacks.
Učinkovina v zdravilu Plegridy je beljakovina interferon beta-1a, ki je ena od skupin interferonov, ki jih lahko telo naravno ustvari v boju proti virusom in drugim napadom.
The most common side effects with Plegridy (which may affect more than 1 in 10 people) are headache, muscle pain, joint pain, influenza (flu)-like symptoms, pyrexia (fever), chills, asthenia (weakness), and erythema (reddening of the skin), pain or pruritus (itching) at the injection site.
Najpogostejši neželeni učinki zdravila Plegridy (ki se lahko pojavijo več kot 1 bolniku od 10) so glavobol, bolečine v mišicah, bolečine v sklepih, gripi podobni simptomi, pireksija (povišana telesna temperatura), mrzlica, astenija (šibkost) in eritem (pordelost kože), bolečina ali pruritus (srbenje) na mestu injiciranja.
During the first year, patients treated with Plegridy every two or four weeks experienced fewer relapses on average than patients on placebo: 0.26 and 0.29 relapses versus 0.40, respectively.
V prvem letu so bolniki, ki so prejemali zdravilo Plegridy vsaka dva ali štiri tedne, povprečno doživeli manj recidivov kot bolniki, ki so prejemali placebo: 0,26 in 0,29 recidiva v primerjavi z 0,40 recidiva.
In MS, the immune system (the body's natural defences) malfunctions and attacks parts of the central nervous system (the brain, spinal cord and optic nerve [nerve that sends signals from the eye to the brain]), causing inflammation that damages the nerves and the insulation around them.
Pri multipli sklerozi imunski sistem telesa ne deluje pravilno in napade dele osrednjega živčnega sistema (možgane, hrbtenjačo in vidni živec [živec, ki pošilja signale iz očesa v možgane]), kar povzroča vnetje, ki poškoduje živce in ovojnico okoli njih.
When Plegridy was given every four weeks its beneficial effect was smaller, and it was not possible to identify a group of patients in whom this less frequent dosing was considered appropriate.
Kadar se je zdravilo Plegridy dajalo vsake štiri tedne, so bili njegovi koristni učinki manjši, prav tako pa ni bilo mogoče določiti skupin bolnikov, za katere naj bi bilo to manj pogosto odmerjanje primerno.
During the first year, patients were given Plegridy every two or four weeks, or placebo (a dummy treatment); during the second year, all patients were given Plegridy every two or four weeks.
V prvem letu so bolniki prejeli zdravilo Plegridy vsaka dva ali štiri tedne ali placebo (zdravilo brez učinkovine); v drugem letu so vsi bolniki zdravilo Plegridy prejemali vsaka dva ali štiri tedne.
The Agency considered that Plegridy given every two weeks has been shown to produce about a 30% reduction in the number of relapses in patients with relapsing-remitting MS compared with placebo, which is comparable to the effect of other MS medicines containing nonpegylated interferon beta, and is considered clinically relevant.
Menila je, da je bilo za zdravilo Plegridy, ki so ga bolniki jemali vsaka dva tedna, dokazano, da za okoli 30-odstotkov zmanjša število recidivov pri bolnikih z recidivno-remitentno multiplo sklerozo v primerjavi s placebom, kar je primerljivo z učinkom drugih zdravil za zdravljenje multiple skleroze, ki vsebujejo nepegilirani interferon beta, in se šteje za klinično pomembno.
Plegridy can only be obtained with a prescription and treatment should be started under the supervision of a doctor experienced in treating MS.
Predpisovanje in izdaja zdravila Plegridy je le na recept, zdravljenje z njim pa je treba uvesti pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem multiple skleroze.
With regards to the safety profile, the most common side effects observed during treatment with Plegridy are considered to be manageable and generally consistent with those seen with non-pegylated interferon products.
Z vidika varnostnega profila se šteje, da so najpogostejši neželeni učinki, opaženi med zdravljenjem z zdravilom Plegridy, obvladljivi in na splošno skladni z učinki, ki jih je mogoče opaziti pri nepegiliranih zdravilih, ki vsebujejo interferone.
What is Plegridy and what is it used for?
Kaj je zdravilo Plegridy in za kaj se uporablja?
The progression of disability was reduced in patients given Plegridy every two weeks but less clearly so in those given the medicine every four weeks.
Napredovanje invalidnosti je bilo manjše pri bolnikih, ki so prejemali zdravilo Plegridy vsaka dva tedna, vendar manj očitno pri bolnikih, ki so zdravilo prejemali vsake štiri tedne.
It is used specifically in adults with a type of MS known as relapsing-remitting MS, where the patient has flareups of symptoms (relapses) between periods of recovery (remissions).
Uporablja se zlasti pri odraslih bolnikih z vrsto multiple skleroze, imenovane recidivno-remitentna multipla skleroza, pri kateri ima bolnik napade (recidive) simptomov, ki jim sledijo obdobja izboljšanja (remisije).
Plegridy is given by injection under the skin of the abdomen, the arm or the thigh.
Zdravilo Plegridy se daje z injiciranjem v podkožje trebuha, nadlakti ali stegna.
For the full list of side effects and restrictions with Plegridy, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Plegridy glejte navodilo za uporabo.
Also, the Agency considered Plegridy to be of greater benefit to patients when given every two weeks as compared to less frequent injections tested in the study.
Prav tako je ugotovila, da imajo bolniki več koristi od zdravila Plegridy, če se jemlje vsaka dva tedna, v primerjavi z manj pogostimi injiciranji, ki so jih preskusili v študiji.
Plegridy contains the active substance peginterferon beta-1a.
Zdravilo Plegridy vsebuje učinkovino peginterferon beta-1a.
How is Plegridy used?
Kako se zdravilo Plegridy uporablja?
Patients can inject Plegridy themselves, provided that they have been trained.
Bolniki si lahko po ustreznem usposabljanju zdravilo Plegridy injicirajo sami.
How does Plegridy work?
Kako deluje zdravilo Plegridy?
this interferon has been ‘pegylated' (attached to a chemical called polyethylene glycol).
V zdravilu Plegridy je ta interferon pegiliran (vezan na snov, imenovano polietilenglikol).
The main measure of effectiveness was the number of relapses that patients experienced over one year but the study also looked at other measures including how fast the patients' disability progressed.
Glavno merilo učinkovitosti je bilo število recidivov, ki so jih bolniki doživeli v enem letu.
Plegridy has been shown to reduce the rate of relapses in patients with relapsing-remitting MS in a main study which lasted two years and involved 1,516 patients.
V glavni študiji, ki je trajala dve leti in je vključevala 1 516 bolnikov, se je izkazalo, da zdravilo Plegridy zmanjšuje hitrost recidivov pri bolnikih z recidivno-remitentno multiplo sklerozo.
However, the chance of a hazard occurring has been estimated very low.
Vendar pa je možnost, da bi se ta nevarnost pojavila, ocenjena kot zelo majhna.
Keep out of the sight and reach of children.
Shranjujte izven pogleda in dosega otrok.
These measures should help to protect the environment.
Na ta način boste pomagali obvarovati okolje.
Date of last renewal: 13/06/2019.
Zadnji datum podaljšanja: 13/06/2019.
When spray devices are used it is advisable to consult the technical staff of the distributors before using this technique.
Kadar uporabljate naprave za razprševanje, je priporočljivo, da se posvetujete s tehničnim osebjem dobaviteljev, preden uporabite to tehniko.
According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Skladno z 71. členom Direktive 2001/82/ES Evropskega parlamenta in Sveta z vsemi dopolnitvami in spremembami lahko država članica, skladno z nacionalno zakonodajo, prepove izdelavo, uvoz/vnos, posedovanje, prodajo, oskrbo in/ali uporabo imunoloških zdravil za uporabo v veterinarski medicini na svojem celotnem ozemlju ali delu ozemlja, če ugotovi da:
ATCvet code: QI01AD07.
Oznaka ATC vet: QI01AD07
Simultaneous use of both vaccines increases the risk of recombination of viruses and potential emergence of new variants.
Sočasna uporaba obeh cepiv poveča tveganje ponovne kombinacije virusov in morebiten pojav novih različic.
3) One drop containing one dose should be applied into one nostril or one eye.
3) Eno kapljico, ki vsebuje en odmerek, je treba dati v eno nosnico ali eno oko.
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.
Aktivna učinkovina biološkega izvora, namenjena vzbujanju aktivne imunosti, ni vključena v Uredbo(ES) št. 470/2009.
1) Reconstitute the lyophilisate using water of good quality (e.g. free from chlorine and/or disinfectants).
1) Liofilizat rekonstituirajte z vodo dobre kakovosti (npr. brez klora in/ali dezinficiensov).
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 Evropske agencije za zdravila (European Medicines Agency) (http://www.ema.europa.eu/).
All chickens on the site should be vaccinated at the same time.
Vse piščance na lokaciji je treba cepiti istočasno.
During this time, the contact of immunosuppressed and unvaccinated chickens with vaccinated chickens should be avoided.
V tem času je treba preprečiti stik imunosupresivnih in necepljenih piščancev s cepljenimi.
The premises must be cleaned and disinfected after each production round.
Prostori morajo biti očiščeni in dezinficirani po vsaki proizvodni enoti.
Wash and disinfect hands and equipment after vaccination to avoid the spread of the virus.
Po cepljenju si operite in dezinficirajte roke in opremo, da se virus ne bi širil.
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 are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Pomožne snovi (vključno z dodatki), navedene v poglavju 6.1 SPC, so bodisi dovoljene snovi, za katere tabela 1 priloge Uredbe Komisije (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.
All containers used for reconstitution should be clean and free from any traces of detergent or disinfectant.
Vsi vsebniki, ki jih uporabite za rekonstitucijo, morajo biti čisti in brez kakršnihkoli sledov detergenta ali dezinficiensa.
Do not mix with any other veterinary medicinal product, except Nobilis IB Ma5 or Solvent Oculo/Nasal recommended for use with the veterinary medicinal product.
Ne mešajte z nobenim drugim zdravilom za uporabo v veterinarski medicini, razen s cepivom Nobilis IB Ma5 ali vehiklom Oculo/Nasal, priporočenim za uporabo z zdravilom za uporabo v veterinarski medicini.
Marketing authorisation holder and manufacturer responsible for batch release: Intervet International B.V.
Imetnik dovoljenja za promet z zdravilom in proizvajalec, odgovoren za sproščanje serij: Intervet International B.V.
3) Mix thoroughly with a clean stirrer, ensuring that all vaccine is dissolved.
3) Dobro mešajte s čistim mešalom, da se vso cepivo raztopi.
In case of coarse spray, personal protective equipment consisting of masks with eye protection should be worn when handling the veterinary medicinal product.
Pri dajanju s veliko kapljičastim pršilom je treba nositi osebno zaščitno opremo, ki sestoji iz maske z zaščito za oči, kadar delate z zdravilom za uporabo v veterinarski medicini.
EXP Once reconstituted use within 2 hours.
EXP Rekonstituirano zdravilo uporabite v 2 urah.
Do not use the product if the contents are brownish and stick to the container as this indicates that the integrity of the container has been breached.
Ne uporabite cepiva, če je vsebina rjavkasta ali se lepi na merico, ker to kaže, da je bila integriteta merice kršena.
The safety parameters of the mixed vaccines are not different from those described for the vaccines administered separately.
Parametri varnosti mešanih cepiv se ne razlikujejo od parametrov, ki opisani za cepiva, ki se dajejo ločeno.
Pharmacotherapeutic group: Immunologicals for aves, domestic fowl, live viral vaccine.
Farmakoterapevtska skupina: Imunološka zdravila za ptice, domačo perutnino, živo virusno cepivo.
50% egg infective dose For the full list of excipients, see section 6.1.
1 50-odstotni infektivni odmerek za embrionirana kokošja jajca Za celoten seznam pomožnih snovi glejte poglavje 6.1.
4) Offer to birds immediately.
4) Takoj dajte piščancem.
Cups may contain 3 spheres to up to 400 spheres depending on the required dosages and production yields.
Merice lahko vsebujejo 3 kroglice do 400 kroglic, odvisno od zahtevanega odmerjanja in proizvodnih izplenov.
10 x 1,000 doses 10 x 2,500 doses 10 x 5,000 doses 10 x 10,000 doses
10 x 1.000 odmerkov 10 x 2.500 odmerkov 10 x 5.000 odmerkov 10 x 10.000 odmerkov
50% egg infective dose.
50-odstotni infektivni odmerek za embrionirana kokošja jajca.
EID50/dose
EID50/odmerek
Each dose of reconstituted vaccine contains:
KAKOVOSTNA IN KOLIČINSKA SESTAVA En odmerek rekonstituiranega cepiva vsebuje:
Special warnings for each target species: Vaccinate healthy animals only.
Posebna opozorila za vsako živalsko vrsto: Cepite smo zdrave živali.
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).
Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (pojavijo se pri več kot 1 od 10 zdravljenih živali) - pogosti (pojavijo se pri več kot 1 toda pri manj kot 10 živalih od 100 zdravljenih živali) - občasni (pojavijo se pri več kot 1 živali toda pri manj kot 10 živalih od 1000 zdravljenih živali) - redki (pojavijo se pri več kot 1 toda pri manj kot 10 živalih od 10.000 zdravljenih živali) - zelo redki (pojavijo se pri manj kot 1 živali od 10.000 zdravljenih živali, vključujoč posamezne primere)
After reconstitution the suspension looks clear.
Po rekonstituciji je suspenzija bistra.
Shelf life of the lyophilisate as packaged for sale: 24 months.
Rok uporabnosti liofilizata v pakiranju za prodajo: 24 mesecev.
Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with Nobilis IB Ma5 for spray or oculonasal application.
Na voljo so podatki o varnosti in učinkovitosti, ki kažejo, da se to cepivo lahko meša in daje s cepivom Nobilis IB Ma5 za pršenje ali okulonazalno dajanje.
The safety and efficacy of the veterinary medicinal product has not been established during lay.
Varnost in učinkovitost zdravila za uporabo v veterinarski medicini ni bila ugotovljena v obdobju nesnosti.
STORAGE CONDITIONS
POGOJI SHRANJEVANJA
Name and address of the manufacturers of the biological active substance
Ime in naslov proizvajalcev biološke učinkovine
Vaccinated chickens may excrete the vaccine strain up to 20 days following vaccination.
Cepljeni piščanci lahko izločajo cepni sev do 20 dni po cepljenju.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product mentioned above.
Ni podatkov o varnosti in učinkovitosti tega cepiva , kadar se uporabi s katerimkoli drugim zdravilom za uporabo v veterinarski medicini razen z omenjenim zgoraj.
Shelf life after reconstitution according to directions: 2 hours.
Rok uporabnosti po rekonstituciji v skladu z navodili: 2 uri.
Duration of immunity: 8 weeks.
Trajanje imunosti: 8 tednov.
The vaccine has been demonstrated to provide protection against QX-like variant.
Pokazalo se je, da cepivo zagotavlja zaščito proti različici podobni QX .
Store in a refrigerator (2 C - 8 C).
Shranjujte v hladilniku (2 C - 8 C).
Do not use this veterinary medicinal product after the expiry date which is stated on the label.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini.
Lyophilisate: Store in a refrigerator (2 C - 8 C).
Liofilizat: Shranjujte v hladilniku (2C - 8C).
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Če opazite kakršne koli resne stranske učinke ali druge učinke, ki niso omenjeni v tem navodilu za uporabo, obvestite svojega veterinarja.
Sealed aluminium laminate cup with a polypropylene (cup) and polypropylene/polyethylene (lid) contact layer containing 1,000; 2,500; 5,000 or 10,000 doses.
Zavarjena merica iz aluminijevega laminata s polipropilenskim (merica) in polipropilensko polietilenskim (pokrovček) stičnim slojem, ki vsebuje 1.000, 2.500, 5.000 ali 10.000 odmerkov.
Ensure that the nasal drop is inhaled before freeing the bird.
Prepričajte se, da je piščanec kapljico vdihnil, preden ga izpustite.
Do not freeze.
Cepivo ne sme zmrzniti.
1) The contents of a cup (1,000 doses only) can be added to Solvent Oculo/Nasal using the included adapter and administered after connecting the included dropper.
1) Vsebino merice (samo 1.000 odmerkov) lahko dodate vehiklu Oculo/Nasal s pomočjo priloženega adapterja in jo daste živalim, ko ste namestili priloženo kapalko.
For active immunisation of chickens in order to reduce respiratory signs of avian infectious bronchitis caused by QX-like variants of infectious bronchitis virus (IBV).
Za aktivno imunizacijo piščancev z namenom zmanjšanja respiratornih znakov kužnega bronhitisa perutnine, ki ga povzročajo variantni sevi podobni QX virusa kužnega bronhitisa (IBV).
Ask your veterinary surgeon how to dispose of medicines no longer required.
ZDRAVILA ALI ODPADNIH SNOVI, ČE OBSTAJAJO Vprašajte svojega veterinarja, kako odstraniti zdravila, ki jih več ne potrebujete.
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. PROIZVAJALCI BIOLOŠKE UČINKOVINE IN PROIZVAJALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
Chickens should be vaccinated against other prevalent IBV serotypes (e.g. Massachusetts) according to the local IB vaccination programme.
Piščance je treba cepiti proti drugim razširjenim serotipom virusa infekcioznega bronhitisa (npr. Massachusetts) v skladu z lokalnim programom cepljenja proti infekcioznemu bronhitisu.
Lyophilisate for oculonasal suspension
Liofilizat za okulonazalno suspenzijo
Apply coarse spray ≥250 microns.
Uporabite razpršilnik z večjimi kapljicami ≥250 mikronov.
The vaccine virus is capable of spreading to in contact birds for a minimum of 20 days after vaccination and appropriate care should be taken to separate vaccinated from non-vaccinated chickens.
Cepni virus se lahko razširi na živali v stiku najmanj 20 dni po cepljenju in treba je ustrezno poskrbeti, da so cepljeni piščanci ločeni od necepljenih.
Shelf life of the solvent as packaged for sale: 4 years.
Rok uporabnosti vehikla v pakiranju za prodajo: 4 leta.