natgillin/translations-raw huggingface dataset:
The company informed the CHMP that its current clinical trials will continue.
Družba je CHMP obvestila, da bo s kliničnimi študijami, ki jih trenutno izvaja, nadaljevala.
Briakinumab was designed to attach to a part of two ‘cytokines' (messenger molecules) in the immune system called interleukin-12 and interleukin-23.
Briakinumab se veže na del dveh „citokinov“ (sporočilnih molekul) v imunskem sistemu, imenovanih interlevkin-12 in interlevkin-23.
As the CHMP was evaluating the initial documentation provided by the company, it had not yet made the application?
Ker je CHMP ocenjeval začetno dokumentacijo, ki jo je predložila družba, še ni podal nobenih priporočil.
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 protitelo je protitelo (vrsta beljakovine), ki je bilo zasnovano tako, da prepozna posebno strukturo (imenovano antigen) v telesu in se veže nanjo.
By attaching to them, briakinumab was expected to block their activity, thereby reducing the activity of the immune system and the symptoms of the disease.
Briakinumab naj bi z vezavo nanju zavrl njuno delovanje ter tako zmanjšal aktivnost imunskega sistema in simptome bolezni.
These cytokines are involved in causing the inflammation and other processes that cause psoriasis.
Ta citokina sodelujeta pri povzročitvi vnetja in drugih postopkih, ki povzročijo psoriazo.
What were the reasons given by the company for withdrawing
Kakšni so bili razlogi družbe za umik vloge?
The active substance in Ozespa, briakinumab, is a monoclonal antibody.
Zdravilna učinkovina v zdravilu Ozespa, briakinumab, je monoklonsko protitelo.
What is Ozespa?
Kaj je zdravilo Ozespa?
What was the recommendation of the CHMP at that tim any recommendations.
Kakšno je bilo takrat priporočilo CHMP?
on is available b ‘All documents'.
Dopis, s katerim družba agencijo obvešča o umiku vloge, je na voljo pod zavihkom „All documents“ (Vsi dokumenti).
Ozespa is medicine that contains the ac for injection.
Ozespa je zdravilo, ki vsebuje zdravilno učinkovino briakinumab.
11, Abbott Laboratories Ltd officially notified the Committee for Medicinal Products thorisation for or the treatment of plaque psoriasis (a disease causing red, scaly patches on the skin).
Družba Abbott Laboratories Ltd je dne 14. januarja 2011 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Ozespa, namenjenim zdravljenju psoriaze s plaki (bolezni, ki povzroča rdeče, luskaste zaplate na koži).
What was Ozespa expected to be used for?
Za kaj naj bi se zdravilo Ozespa uporabljalo?
was the application when it was withdrawn?
Kako daleč je bil postopek ocenjevanja vloge ob njenem umiku?
How is Ozespa expected to work?
Kako naj bi zdravilo Ozespa delovalo?
Withdrawal of the marketing authorisation application for Ozespa (briakinumab) EMA/40202/2011
Umik vloge za dovoljenje za promet z zdravilom Ozespa (briakinumab)
Ozespa was expected to be used to treat moderate to severe plaque psoriasis respond to or cannot use other systemic (whole-body) treatments for psorias methotrexate and PUVA (psoralen ultraviolet-A).
Zdravilo Ozespa naj bi se uporabljalo za zdravljenje zmerne do hude psoriaze s plaki pri odraslih, ki se niso odzvali na drugo sistemsko zdravljenje psoriaze (zdravljenje, ki deluje na celotno telo) , vključno z zdravljenjem s ciklosporinom, metotreksatom in PUVA (psoralen in obsevanje z ultravijolično svetlobo A), oz. pri odraslih, ki drugega sistemskega zdravljenja ne morejo uporabljati.
How far into the evaluation initial documentation provided by the company.
To pomeni, da je CHMP še vedno ocenjeval začetno dokumentacijo, ki jo je predložila družba.
The effects of Ozespa were first tested in experimental models before being stud The company presented the results of four main studies in 2,479 adults with psor compared with placebo (a dummy treatment), etanercept and methotrexate (o treat p effectiveness was the change in the symptom scores, as measured using two sta
Družba je predstavila rezultate štirih glavnih študij z 2479 odraslimi s psoriazo.
The main measure of ndard scales for psoriasis.
Glavno merilo učinkovitosti je bila sprememba simptomov, izmerjena z dvema standardnima lestvicama za psoriazo.
The final concentrations of the vaccines will therefore also differ.
Končne koncentracije cepiv se bodo zato tudi razlikovale.
Date of first authorisation: 12/11/2019
Datum pridobitve dovoljenja za promet:12/11/2019
Chickens and embryonated chicken eggs.
Piščanci in embrionirana kokošja jajca.
Do not use in flocks without MDAs against IBDV.
Ne uporabljajte v jatah brez MDA proti IBDV.
It is recommended to vaccinate all chickens on a site at the same time.
Priporočljivo je hkrati cepiti vse piščance na eni lokaciji.
In practice, studies in commercial broiler chickens have shown an onset of immunity from between 24 days of age and 28 days of age.
V praksi so študije pri komercialnih piščancih borjlerjih pokazale začetek imunosti med 24. in 28. dnem starosti.
ATCvet code: QI01AD09
Oznaka ATC vet: QI01AD09
Duration of immunity: up to 43 days of age.
Trajanje imunosti: do 43. dne starosti.
This depletion does not cause immunosuppression in chickens.
To izčrpavanje ne povzroči imunosupresije pri piščancih.
During this time, contact between the vaccinated chickens and any immunosuppressed or unvaccinated birds should be avoided.
V tem času je treba preprečiti stik med cepljenimi piščanci in vsemi imunosupresivnimi ali necepljenimi pticami.
Reconstitution of the vaccine:
Rekonstitucija cepiva:
Appropriate veterinary and husbandry measures should be taken to avoid spread of the vaccine strain to susceptible wild and domestic birds.
Sprejeti je treba ustrezne veterinarske in rejske ukrepe, da se prepreči širjenje seva cepiva na dovzetne divje in domače ptice.
For the reconstitution and administration of the vaccine, use sterile equipment free from any residues of chemical disinfectants.
Za rekonstitucijo in dajanje cepiva uporabite sterilno opremo brez kakršnih koli ostankov kemičnih razkužil.
Do not use in birds in lay or breeding birds, or within 4 weeks before the start of the laying period.
Ne uporabite pri pticah v obdobju nesnosti ali vzrejnih pticah ali 4 tedne pred začetkom obdobja nesnosti.
Vaccinated birds may excrete the vaccine strain up to 3 weeks following vaccine take.
Cepljene ptice lahko izločajo sev cepiva še do 3 tedne po cepljenju.
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.
SPC so bodisi dovoljene snovi, za katere tabela 1 priloge Uredbe Komisije (EU) št. 37/2010 določa, da MRL ni potreben ali pa, ne spadajo v področje uporabe Uredbe (ES) št. 470/2009, kadar so uporabljene tako kot v tem zdravilu za uporabo v veterinarski medicini.
Solvent for GUMBOHATCH
Vehikel za GUMBOHATCH
EU/2/19/245/001 (10 x 1,000 doses) EU/2/19/245/002 (10 x 2,000 doses) EU/2/19/245/003 (10 x 2,500 doses) EU/2/19/245/004 (10 x 4,000 doses) EU/2/19/245/005 (10 x 5,000 doses)
EU/2/19/245/001 (10 x 1000 odmerki) EU/2/19/245/002 (10 x 2000 odmerki) EU/2/19/245/003 (10 x 2500 odmerki) EU/2/19/245/004 (10 x 4000 odmerki) EU/2/19/245/005 (10 x 5000 odmerki)
This product should only be used after it has been demonstrated that very virulent IBDV strains are epidemiologically relevant in the area of vaccination.
Zdravilo se lahko uporablja le, ko je bilo dokazano, da so na področju cepljenja epidemiološko relevantni zelo virulentni sevi IBDV.
The onset of immunity depends on the initial maternally derived antibodies (MDA) level of the batch of chickens and even then will be different for individual chickens.
Nastop imunosti je odvisen od začetne ravni maternalnih protiteles (MDA) v določeni seriji piščancev in tudi takrat bo imunost pri vsakem piščancu nastopila drugače.
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 OSTANKOV ZDRAVILA (MRL) Učinkovina, ki je v osnovi biološkega izvora namenjena vzbujanju aktivne imunosti, ne spada v področje uporabe Uredbe (ES) št. 470/2009.
The vaccine contains an intermediate-plus IBDV strain bound to specific IBDV immunoglobulins, forming an immune-complex which is administered through vaccination.
Cepivo vsebuje vmesni plus sev IBDV, vezan na specifične IBDV imunoglobuline, ki tvorijo imunski kompleks, ki ga vbrizgamo s cepljenjem.
Marketing authorisation holder and manufacturer responsible for batch release: Laboratorios Hipra, S.A.
Imetnik dovoljenja za promet z zdravilom in proizvajalec odgovoren za sproščanje serij: Laboratorios Hipra, S.A.
An automated egg injection machine can be used.
Uporablja se lahko avtomatične naprave za injiciranje v jajca.
Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the label.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki.
The instructions for the calibration and use of the equipment should be strictly followed in order to deliver the appropriate dose.
Za zagotovitev ustreznega odmerka je treba strogo upoštevati navodila za kalibracijo in uporabo opreme.
Mix the contents of the vial by gentle agitation until the contents are completely resuspended, then withdraw the suspension obtained and inject it into the solvent bag.
Vsebino viale mešajte z rahlim tresenjem, dokler vsebina ni popolnoma raztopljena, nato suspenzijo izvlecite in jo injicirajte v vrečko za vehikel.
Do not mix with any other veterinary medicinal product, except the solvent supplied for use with this veterinary medicinal product.
Ne mešajte z nobenim drugim zdravilom za uporabo v veterinarski medicini, razen z vehiklom, ki je priložen za uporabo s tem zdravilom.
Repeat step 2 to ensure that all the lyophilisate has been transferred into the solvent bag.
Ponovite 2. korak, da zagotovite, da se ves liofilizat prenese v vrečko za vehikel.
Onset of immunity: from 24 days of age.
Nastop imunosti: od 24. dne starosti.
Laboratorios Hipra, S.A. Carretera C-63 km 48.300 Polígono Industrial El Rieral Amer, 17170 Girona Spain
Laboratorios Hipra, S.A. Carretera C-63 km 48.300 Polígono Industrial El Rieral Amer, 17170 Girona Španija
Shelf life of the lyophilisate as packaged for sale: 21 months.
Rok uporabnosti liofilizata v pakiranju za prodajo: 21 mesecev.
Pharmacotherapeutic group: Immunologicals for aves, domestic fowl, live viral vaccines, avian infectious bursal disease virus (Gumboro disease).
Farmakoterapevtska skupina: Imunološka zdravila za ptice, domača perutnina (rod Gallus), živa virusna cepiva, virus bolezni Gumboro.
EXP {month/year} Once reconstituted use within 2 hours.
EXP {mesec/leto} Po rekonstituciji uporabite v 2 urah.
For subcutaneous administration:
Za subkutano injiciranje:
The safety of the veterinary medicinal product has not been established during lay.
Varnost zdravila v obdobju nesnosti ni bila ugotovljena.
Disodium phosphate dodecahydrate Potassium dihydrogen phosphate Potassium chloride Sodium chloride
L-histidin saharoza natrijev hidrogenfosfat dodekahidrat kalijev dihidrogenfosfat kalijev klorid natrijev klorid
Solvent: Polypropylene bags containing 200 ml, 400 ml, 800 ml or 1,000 ml.
Polipropilenske vrečke, ki vsebujejo 200 ml, 400 ml, 800 ml ali 1.000 ml.
Withdraw 2 ml of the solvent and inject into the vial containing the lyophilisate.
Izvlecite 2 ml vehikla in ga injicirajte v vialo, ki vsebuje liofilizat.
Wash and disinfect hands after handling vaccinated birds or their litter because the virus is excreted by vaccinated birds for up to 3 weeks.
Po ravnanju s cepljenimi pticami ali njihovim nastiljem si umijte in razkužite roke, saj cepljene ptice virus izločajo še do 3 tedne.
In case of adverse reactions following accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
V primeru neželenih učinkov po nenamerni samo-aplikaciji se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali ovojnino.
The reconstituted vaccine is a slightly reddish homogeneous suspension which should be used within 2 hours after reconstitution.
Rekonstituirano cepivo je rahlo rdečkasta homogena suspenzija, ki jo je treba uporabiti v 2
Solvent: Do not store above 25 ºC.
Vehikel: Ne shranjujte pri temperaturi nad 25 °C.
The vaccine (0.2 ml dose) must be injected under the skin of the neck of the 1-day-old broiler chicks.
Cepivo (0,2-mililitrski odmerek) je treba injicirati pod kožo na vratu enodnevnih pitovnih piščancev.
To stimulate active immunity against very virulent bursal disease viruses (Gumboro disease) in broiler chickens.
Za spodbujanje aktivne imunosti proti zelo virulentnim virusom bolezni Gumboro pri brojlerjih.
For active immunisation of 1-day-old broiler chicks and embryonated broiler chicken eggs to reduce clinical signs and lesions of the bursa of Fabricius caused by very virulent avian infectious bursal disease virus infection.
Za aktivno imunizacijo enodnevnih brojlerjev in embrioniranih kokošjih jajc z brojlerji, da se zmanjšajo klinični znaki in lezije burze Fabricij, ki jih povzroča okužba z zelo virulentnim virusom nalezljive ptičje bolezni Gumboro.
1,000 doses 2,000 doses 2,500 doses 4,000 doses 5,000 doses
1000 odmerki 2000 odmerki 2500 odmerki 4000 odmerki 5000 odmerki
Lyophilisate: brown reddish colour.
Liofilizat: rdečkasto rjave barve.
Each dose of reconstituted vaccine (0.05 ml for an in ovo dose or 0.2 ml for a subcutaneous dose) contains:
Vsak odmerek rekonstruiranega cepiva (0,05 ml za v jajčno celico ali 0,2 ml za subkutani odmerek) vsebuje:
In ovo and subcutaneous use.
V jajčno celico in subkutana uporaba.
Shelf life of the solvent as packaged for sale: 3 years.
Rok uporabnosti vehikla v pakiranju za prodajo: 3 leta.
An automated syringe can be used.
Uporabite lahko avtomatsko brizgo.
By the in ovo route: Administer one single injection of 0.05 ml of the reconstituted vaccine into each chicken egg at 18 days of embryonation.
Pri uporabi v jajčno celico: Vbrizgajte eno injekcijo z 0,05 ml rekonstituiranega cepiva v vsako piščančje jajce pri 18 dneh embrionizacije.
The vaccine (0.05 ml dose) must be injected into the amniotic sac of 18-day-old embryonated broiler chicken eggs.
Cepivo (0,05-mililitrski odmerek) je treba injicirati v amnijsko ovojnico 18 dni starih embrioniranih kokošjih jajc z brojlerji.
Rinse the vial with another 2 ml of the solvent/lyophilisate suspension obtained in step 1, and inject it back into the solvent bag.
Vialo sperite z dodatkom 2 ml suspenzije vehikla/liofilizata, pridobljenega v 1. koraku, in jo injicirajte nazaj v vrečko za vehikel.
Each dose (0.05 ml for in ovo or 0.2 ml for SC) contains: Live attenuated IBDV, strain 1052…………….. 101.48 - 102.63 PU* * PU: Potency Units
Vsak odmerek (0,05 ml za dajanje v jajčno celico ali 0,2 ml za subkutano dajanje) vsebuje: Živ, oslabljen IBDV, sev 1052................ 101,48 - 102,63 PU* * PU: Potency Units
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. PROIZVAJALCI BIOLOŠKE UČINKOVINE IN PROIZVAJALEC ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJ
For the full list of excipients, see section 6.1.
** Enote za nevtralizacijo virusa (Virus Neutralisation Units) Za celoten seznam pomožnih snovi, glejte poglavje 6.1.
Disposal: read package leaflet supplied with the lyophilisate vial.
Odstranjevanje: preberite navodilo za uporabo, priloženo viali z liofilizatom.
Solvent: clear colourless solution.
Vehikel: bistra brezbarvna raztopina.
By the subcutaneous route: Administer one single injection of 0.2 ml of the reconstituted vaccine to each chick at 1 day of age.
Pri subkutani uporabi: Vbrizgajte eno injekcijo z 0,2 ml rekonstituiranega cepiva vsakemu enodnevnemu piščancu.
It is important to note that the volumes of solvent which must be used to reconstitute the vaccine are different depending on whether the vaccine will be administered in ovo to embryonated eggs, or by subcutaneous injection to 1-day-old chicks.
razlikujejo glede na to, ali se bo cepivo dajalo v jajčno celico v embrionirana jajca ali subkutano z injekcijo enodnevnim piščancem.
In laboratory studies, lymphocyte depletion was very common, followed by a lymphocyte repopulation and regeneration of the bursa of Fabricius.
V laboratorijskih študijah je bilo izčrpanje limfocitov zelo pogosto, čemur sta sledila repopulacija limfocitov in regeneracija Fabricijeve burze.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard boxes (lyophilisate vials)
PODATKI NA ZUNANJI OVOJNINI Kartonske škatle (viale liofilizata)
la Selva, 135 Amer, 17170 Girona Spain
la Selva, 135 Amer, 17170 Girona Španija
GUMBOHATCH lyophilisate for suspension for injection for chickens
GUMBOHATCH liofilizat za suspenzijo za injiciranje za piščance
The efficacy of the vaccine has been demonstrated in broilers having an average MDA level from 4,500 to 5,100 ELISA units at hatching.
Učinkovitost cepiva je bila dokazana pri brojlerjih, ki imajo ob izvalitvi povprečno raven MDA med
In laboratory studies, lymphocyte depletion was very common after vaccine take, which was followed by a lymphocyte repopulation and regeneration of the bursa of Fabricius.
V laboratorijskih študijah je bilo po cepljenju izčrpavanje limfocitov zelo pogosto, nato sta sledila repopulacija limfocitov in regeneracija Fabricijeve burze.
la Selva, 135 Amer, 17170 (Girona) Spain
la Selva, 135 Amer, 17170 (Girona) Španija
Live attenuated infectious bursal disease virus (IBDV), strain 1052……….. 101.48 - 102.63 PU* * PU: Potency Units
Živ, oslabljen, virus bolezni Gumboro (IBDV), sev 1052........ 101,48 - 102,63 PU* * PU: Potency Units - enote za izražanje jakosti
After the administration of a 10-fold overdose, a mild exudate and slight congestion in the bursa of Fabricius were very commonly observed.
Po dajanju 10-kratnega prevelikega odmerka so zelo pogosto opazili blag izloček in rahlo kongestijo v Fabricijevi burzi
Lyophilisate for suspension for injection.
Liofilizat za suspenzijo za injiciranje.
IBDV-specific antibody solution………………………………2.7x106 VNU** of IgY per vial **VNU: Virus Neutralisation Units
IBDV - raztopina specifičnih protiteles…………………….. 2,7 x 106 VNU** IgY na vialo
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Lyophilisate vial
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
Method of administration:
Način uporabe zdravila:
GUMBOHATCH lyophilisate and solvent for suspension for injection for chickens
GUMBOHATCH liofilizat in vehikel za suspenzijo za injiciranje za piščance
In ovo or subcutaneous use.
V jajčno celico ali podkožno dajanje.
Type I glass vials closed with Type I bromobutyl stoppers and sealed with aluminium caps containing 1,000 doses, 2,000 doses, 2,500 doses, 4,000 doses or 5,000 doses of the freeze-dried vaccine.
ki vsebujejo 1.000 odmerkov, 2.000 odmerkov, 2.500 odmerkov, 4.000 odmerkov ali 5.000 odmerkov liofiliziranega cepiva.
Read the package leaflet supplied with the lyophilisate vial before use.
Pred uporabo preberite navodilo za uporabo, priloženo viali liofilizata.
* PU: Potency Units
** Enote za nevtralizacijo virusa (Virus Neutralisation Units)
Calculate and prepare the required volume of the vaccine as per the table below:
Izračunajte in pripravite potrebno količino cepiva, kot je prikazano v spodnji tabeli: Redčenje za subkutano injiciranje (0,2 ml na odmerek):
In ovo or SC use.
V jajčno celico ali SC dajanje.
Cardboard box with 10 lyophilisate vials containing 2,500 doses.
Kartonska škatla z 10 vialami z liofilizatom po 2.500 odmerkov.
Cardboard box with 10 bags containing 1,000 ml solvent.
Kartonska škatla z 10 vrečkami, ki vsebujejo 1.000 ml vehikla.
SPECIAL PRECAUTIONS FOR THE DISPOSAL, OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
ZDRAVILA ALI ODPADNIH SNOVI, ČE OBSTAJAJO
Cardboard box with 10 bags containing 200 ml solvent.
Kartonska škatla z 10 vrečkami, ki vsebujejo 200 ml vehikla.
Cardboard box with 10 bags containing 800 ml solvent.
Kartonska škatla z 10 vrečkami, ki vsebujejo 800 ml vehikla.
Cardboard box with 10 bags containing 400 ml solvent.
Kartonska škatla z 10 vrečkami, ki vsebujejo 400 ml vehikla.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard boxes (solvent bags)
Kartonske škatle (vrečke za vehikel)
Cardboard box with 10 lyophilisate vials containing 5,000 doses.
Kartonska škatla z 10 vialami z liofilizatom po 5.000 odmerkov.
Cardboard box with 10 lyophilisate vials containing 1,000 doses.
Kartonska škatla z 10 vialami z liofilizatom po 1.000 odmerkov.
Cardboard box with 10 lyophilisate vials containing 4,000 doses.
Kartonska škatla z 10 vialami z liofilizatom po 4.000 odmerkov.
Cardboard box with 10 lyophilisate vials containing 2,000 doses.
Kartonska škatla z 10 vialami z liofilizatom po 2.000 odmerkov.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
PROIZVAJALEC ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJ, ČE STA RAZLIČNA
<Batch><Lot> {number}
Lot {številka}
Excipients:
Odmerjanje:
C. STATEMENT OF THE MRLs
(MRL)
Wash and disinfect hands and equipment after use.
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo: Po uporabi si umijte in razkužite roke in opremo.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEPORABLJENEGA
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Solvent bag
PODATKI NA STIČNI OZ. PRIMARNI OVOJNINI Vrečka za vehikel
L-histidine
OVOJNINAH
Solvent volume to be used:
Število in vsebina vial s cepivom: Volumen vehikla, ki ga je treba uporabiti:
Solution for injection/infusion
Raztopina za injiciranje/infundiranje
The European Commission granted a marketing authorisation valid throughout the European Union for Eviplera on 28 November 2011.
Evropska komisija je dovoljenje za promet z zdravilom Eviplera, veljavno po vsej Evropski uniji, izdala 28. novembra 2011.
The recommended dose is one tablet once a day and it must be taken with food.
Priporočeni odmerek je ena tableta enkrat na dan, ki se mora vzeti s hrano.
All three active substances are already available in separate medicines in the EU.
Vse tri zdravilne učinkovine so kot ločena zdravila že na voljo v Evropski uniji.
The full EPAR for Eviplera 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) za zdravilo Eviplera je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
What measures are being taken to ensure the safe and effective use of Eviplera?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Eviplera have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo zdravstveni delavci in bolniki upoštevati za varno in učinkovito uporabo zdravila Eviplera, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
For more information about treatment with Eviplera, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Eviplera preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
This is a summary of the European public assessment report (EPAR) for Eviplera.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Eviplera.