FrancophonIA/ELRC3.0 huggingface dataset:
English: INTANZA is as immunogenic as the comparator trivalent adjuvanted (MF-59 containing) vaccine in terms of GMT for each of the 3 influenza strains with the SRH method and for 2 strains with the HI method.
Slovenian: Cepivo INTANZA je tako imunogeno kot primerjalno trivalentno cepivo z adjuvansom (ki vsebuje MF-59) v smislu GMT za vsakega od 3 sevov gripe po metodi SRH in za 2 seva po
English: In a pivotal randomised comparative phase III trial, 2,606 subjects over 60 years of age received 0.1 ml of INTANZA by intradermal route and 1,089 subjects over 60 years of age received 0.5 ml of a trivalent inactivated influenza vaccine administered by intramuscular route.
Slovenian: V randomiziranih primerjalnih preskušanjih faze III je 2606 oseb, starih nad 60 let, prejelo 0,1 ml cepiva INTANZA intradermalno, 1089 oseb, starih nad 60 let, pa je prejelo 0,5 ml trivalentno inaktiviranega cepiva gripe po intramuskularni poti.
English: • As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of anaphylactic event following the administration of the vaccine.
Slovenian: • Tako kot pri vseh cepivih, ki jih injiciramo, morate imeti na voljo ustrezno zdravljenje in nadzor, za primer anafilaktične reakcije, ki lahko sledi cepljenju
English: INTANZA is at least as immunogenic as the comparator trivalent inactivated influenza vaccine administered by intramuscular route for each of the 3 influenza strains in subjects from 60 years of age and over.
Slovenian: Cepivo INTANZA je enako imunogeno kot primerjano trivalentno inaktivirano cepivo gripe, ki se daje intramuskularno, za vse 3 seve gripe pri osebah, starih nad 60 let.
English: Systemic safety profile of INTANZA is similar to the comparator vaccine, adjuvanted or nonadjuvanted, administered intramuscularly.
Slovenian: Sistemski profil varnosti cepiva INTANZA je podoben primerjanemu cepivu z adjuvansom ali brez, ki
English: Pack of 1 or 10 or 20 pre-filled syringe(s) with a Micro-Injection System
Slovenian: Pakiranje z 1 ali 10 ali 20 napolnjenimi brizgami s sistemom za mikro-injiciranje
English: In a randomised comparative phase III trial, 398 subjects over 65 years of age received 0.1 ml of INTANZA by intradermal route and 397 subjects over 65 years of age received 0.5 ml of a trivalent inactivated adjuvanted (MF-59 containing) influenza vaccine at the same dosage administered by intramuscular route.
Slovenian: V randomiziranem primerjalnem preskušanju faze III je 398 oseb, starih 65 in več let, prejelo 0,1 ml cepiva INTANZA intradermalno, 397 oseb, starih 65 let in več, pa je prejelo 0,5 ml trivalentnega inaktiviranega cepiva proti gripi z adjuvansom (ki vsebuje MF-59) v enakem odmerku
English: Immune system disorders
Slovenian: Sistem za mikroinjiciranje
English: A/Michigan/45/2015 (H1N1)pdm09 - like strain A/Hong Kong/4801/2014 (H3N2) - like strain
Slovenian: A/Michigan/45/2015 (H1N1)pdm09 - podoben sev
English: Injection is considered successful whether or not the presence of a
Slovenian: Injekcija je uspešna ne glede na prisotnost izpuščaja.
English: INTANZA 15 microgram/strain, suspension for injection Influenza vaccine (split virion, inactivated)
Slovenian: INTANZA 15 mikrogramov/sev, suspenzija za injiciranje Cepivo proti gripi z delci virionov, inaktivirano
English: divize vakcín sanofi-aventis, s.r.o.
Slovenian: Česká republika Sanofi Pasteur divize vakcín sanofi-aventis, s.r.o.
English: Reactions of not known frequency (frequency cannot be estimated from the available data) - Allergic reactions including skin reactions that may spread throughout the body such as hives, severe allergic reactions (anaphylactic reactions), swollen face, tongue or pharynx, difficulty to swallow, hives and difficulties to breathe (angioedema), failure of the circulatory system
Slovenian: - Alergijske reakcije, vključno kožne reakcije, ki se lahko razširijo po vsem telesu kot izpuščaji, hude alergijske reakcije (anafilaktične reakcije) otekel obraz, jezik ali žrelo, težave pri požiranju,
English: Influenza virus (inactivated, split) of the following strains*:
Slovenian: Virusi influence (inaktivirani, razcepljeni) naslednjih sevov*:
English: This vaccine has no or negligible influence on the ability to drive and use machines.
Slovenian: Vpliv na sposobnost vožnje in upravljanja s stroji Cepivo INTANZA nima oziroma zanemarljivo vpliva na sposobnost vožnje in upravljanja s stroji.
English: Rare reactions (may affect up to 1 in 1000 people) - Tingling or numbness, inflammation of nerves, itching and rash.
Slovenian: Redki (lahko prizadanejo do 1 med 1000 cepljenimi) - Ščemenje ali odrevenelost, vnetje živcev, srbenje in izpuščaj
English: INTANZA 15 microgram/strain suspension for injection Influenza vaccine (split virion, inactivated)
Slovenian: INTANZA 15 mikrogramov/sev suspenzija za injiciranje Cepivo proti gripi z delci virionov, inaktivirano
English: Influenza virus (inactivated, split) of the following strains:
Slovenian: Virusi influence (inaktivirani, razcepljeni) naslednjih sevov:
English: INTANZA will help to protect you against the three strains of virus contained in the vaccine, or other strains closely related to them.
Slovenian: Po injiciranju cepiva INTANZA razvije imunski sistem (naravna obramba telesa) zaščito proti okužbi Cepivo INTANZA pomaga pri zaščiti pred tremi sevi virusov, ki so zajeti v cepivu, in drugimi sevi, ki so tesno povezani z njimi.
English: As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine (see
Slovenian: Tako kot pri vseh cepivih, ki jih injiciramo, morate imeti na voljo ustrezno zdravljenje in nadzor, za primer anafilaktične reakcije, ki lahko sledi cepljenju (glejte poglavje 4.8).
English: The Micro-Injection System for intradermal injection consists of a pre-filled syringe with a micro-needle (1.5 mm) and a needle shielding system.
Slovenian: Sistem za mikro-injiciranje za intradermalno injekcijo je sestavljen iz napolnjene brizge z mikro-iglo (1,5 mm) in s sistemom za zaščito igle.
English: Common Uncommon Rare
Slovenian: Občasni Redki
English: After repetitive yearly injections the safety profile of INTANZA is similar to the previous injections.
Slovenian: Po ponovnem vsakoletnem cepljenju je bil profil varnosti cepiva INTANZA podoben prejšnjim b. povzetek tabelarno prikazanih neželenih učinkov
English: You hear a click and a shield comes out to cover the needle.
Slovenian: Ko bo zaščita izskočila in pokrila iglo, boste zaslišali klik.
English: Neuralgia, febrile convulsions, neurological disorders, such as encephalomyelitis and Guillain-Barré
Slovenian: Bolezni živčevja nevralgija, febrilne konvulzije, nevrološke motnje kot je encefalomielitis in Guillain-Barréjev sindrom vaskulitis, v zelo redkih primerih povezan s prehodno prizadetostjo ledvic
English: Based on the experience with trivalent inactivated influenza vaccines administered by intramuscular or deep subcutaneous injection, the following events may be reported:
Slovenian: Na podlagi izkušenj s trivalentnimi inaktiviranimi cepivi proti gripi, ki se dajejo v obliki intramuskularne ali globoke subkutane injekcije, bi lahko poročali o sledečih neželenih dogodkih: Bolezni krvi in limfatičnega sistema prehodna trombocitopenija, prehodna limfadenopatija
English: Uncommon reactions (may affect up to 1 in 100 people) - Tiredness, joint pain and increased sweating.
Slovenian: Občasni (lahko prizadanejo do 1 med 100 cepljenimi) - Utrujenost, bolečine v sklepih in povečano znojenje.
English: What INTANZA contains
Slovenian: Kaj vsebuje cepivo INTANZA
English: Sweating Pruritus, rash
Slovenian: Znojenje Pruritus, izpuščaj
English: A/Wisconsin/
Slovenian: A/H1N1
English: INTANZA is a suspension for injection in a pre-filled syringe of 0.1 ml with a Micro-Injection
Slovenian: Zdravilo INTANZA je suspenzija za injiciranje v napolnjenih injekcijskih brizgah z 0,1 ml s sistemom za mikro-injiciranje, pakirana po 1, 10 ali 20 enot.
English: Remove the needle cap from the Micro-Injection
Slovenian: Pokrov igle odstranite s
English: The active substances are Influenza virus (inactivated split) of the following strains*:
Slovenian: Zdravilne učinkovine so virusi gripe (inaktivirani, z delci virionov) naslednjih sevov*:
English: A/Michigan/45/2015 (H1N1)pdm09 - like strain (A/Michigan/45/2015, NYMC X-275) ............................................................................................................................. 15 micrograms HA**
Slovenian: A/Michigan/45/2015, NYMC X-275, ki je podoben sevu A/Michigan/45/2015 (H1N1)pdm09 ............................................................................................................................. 15 mikrogramov HA**
English: - Feeling generally unwell, fever (38.0°C or higher) and shivering.
Slovenian: Pogosti (lahko prizadanejo do 1 med 10 cepljenimi) - Modrica na mestu injiciranja - Splošno počutje nelagodja, povišana telesna temperatura (38,0°C ali več) in tresenje.
English: INTANZA is administered to you by your doctor or nurse.
Slovenian: Pred začetkom uporabe cepiva INTANZA se posvetujte s svojim zdravnikom, farmacevtom ali z medicinsko sestro.
English: A/Hong Kong/4801/2014 (H3N2) - like strain (A/Hong Kong/4801/2014, NYMC X-263B) ............................................................................................................................. 15 micrograms HA**
Slovenian: A/Hong Kong/4801/2014, NYMC X-263B, ki je podoben sevu A/Hong Kong/4801/2014 (H3N2) ............................................................................................................................. 15 mikrogramov HA**
English: Transient thrombocytopenia, transient lymphadenopathy
Slovenian: Artralgija pruritus, bolečina ehimoza
English: In case of presence of liquid at the injection site after vaccine administration, re-vaccination is not
Slovenian: V primeru, da je po cepljenju na mestu vboda prisotna tekočina, ponovno
English: Sanofi-Aventis Estonia OÜ Tel.: +372 627 3488
Slovenian: Sanofi Aventis Latvia SIA Vakcīnu nodaļa Tel.: +371 67114978
English: Very common
Slovenian: Prirobni ca
English: 15 µg haemagglutinin per strain per 0.1 ml dose
Slovenian: 15 mikrogramov hemaglutinina na sev na 0,1 ml na odmerek natrijev klorid, kalijev klorid, natrijev hidrogenfosfat dihidrat, kalijev dihidrogen fosfat, voda za
English: Oral use bottle (HDPE)
Slovenian: 40 mg filmsko obložena tableta peroralna uporaba plastenka (HDPE) 180 tablet
English: It is given once a day for five days.
Slovenian: Zdravilo se daje enkrat dnevno pet dni.
English: It is available in a 10 ml bottle.
Slovenian: Na voljo je v 10-mililitrski steklenički.
English: This summary was last updated in November 2008.
Slovenian: Povzetek je bil nazadnje posodobljen 11-2008.
English: This is usually temporary and happens primarily in older dogs.
Slovenian: Ta je običajno začasna in se pojavi predvsem pri starejših psih.
English: One large field trial was conducted in different centres throughout Europe.
Slovenian: Eno večje preskušanje na terenu je bilo izvedeno v različnih središčih v Evropi.
English: Other information about Easotic:
Slovenian: Druge informacije o zdravilu Easotic:
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Easotic to Virbac S.A. on 20/11/2008.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Easotic, veljavno po vsej Evropski uniji, odobrila družbi Virbac S.A. dne 20. novembra 2008.
English: The dose is 1 ml, which is given directly into the ear by one activation of the pump supplied with the bottle.
Slovenian: Odmerek je 1 ml, ki se daje neposredno v uho z eno aktivacijo črpalke, ki je priložena steklenički.
English: Mild reddening of the ear has been seen in around 2% of dogs.
Slovenian: Opažena je bila blaga pordelost ušesa pri okoli 2 % psov.
English: The inside of the ear should be cleaned and dried before treatment and any excess hair cut away.
Slovenian: Notranjost ušesa je treba pred zdravljenjem očistiti in osušiti, odvečno dlako pa je treba odrezati.
English: The medicine was well tolerated.
Slovenian: Zdravilo so psi dobro prenašali.
English: It acts by preventing bacteria making proteins.
Slovenian: Deluje tako, da bakterijam preprečuje proizvodnjo beljakovin.
English: What benefit has Easotic shown during the studies?
Slovenian: Kakšne koristi je zdravilo Easotic izkazalo med študijami?
English: What is the risk associated with Easotic?
Slovenian: Kakšna tveganja so povezana z zdravilom Easotic?
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) EASOTIC EPAR summary for the public
Slovenian: EMEA/V/C/140 EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) EASOTIC Povzetek EPAR za javnost
English: Easotic has been studied in dogs in both laboratory and field trials.
Slovenian: Zdravilo Easotic je bilo preučeno na psih v laboratoriju in v preskušanjih na terenu.
English: The use of ear preparations may be associated with damage to hearing.
Slovenian: Uporaba pripravkov za ušesa je lahko povezana z okvaro sluha.
English: This stops the bacteria growing, resulting in their death.
Slovenian: To prepreči rast bakterij in povzroči, da odmrejo.
English: If accidental skin or eye contact occurs, wash immediately with lots of water.
Slovenian: Če pride do nenamernega stika s kožo ali očmi, nemudoma izperite z obilico vode.
English: Gentamicin sulphate is an antibiotic that belongs to the group aminoglycosides.
Slovenian: Gentamicinijev sulfat je antibiotik, ki spada v skupino aminoglikozidov.
English: Miconazole nitrate is an antifungal that works by preventing the formation of ergosterol, which is an important part of fungal cell walls.
Slovenian: Mikonazolijev nitrat je protiglivično sredstvo, ki deluje tako, da preprečuje nastajanje ergosterola, ki je pomemben del glivičnih celičnih sten.
English: Two of the active substances in Easotic, miconazole nitrate and gentamicin sulphate, work against the cause of the infection, while the third one, hydrocortisone aceponate, works on the inflammation.
Slovenian: Dve zdravilni učinkovini v zdravilu Easotic, mikonazolijev nitrat in gentamicinijev sulfat, delujeta proti vzroku okužbe, medtem ko tretja, hidrokortizon aceponat, deluje proti vnetju.
English: Easotic contains three active substances: hydrocortisone aceponate, miconazole nitrate and gentamicin sulphate.
Slovenian: Zdravilo Easotic vsebuje tri zdravilne učinkovine: hidrokortizon aceponat, mikonazololijev nitrat in gentamicinijev sulfat.
English: Easotic is used to treat dogs that suffer from acute or recurrent episodes of ear infections (otitis externa).
Slovenian: Zdravilo Easotic se uporablja za zdravljenje psov, ki trpijo zaradi akutnih ali ponavljajočih epizod vnetja ušesa (otitis externa).
English: Hydrocortisone aceponate is a glucocorticosteroid, which is a type of substance that helps to reduce inflammation and itching.
Slovenian: Hidrokortizon aceponat je glukokortikosteroid, vrsta snovi, ki pomaga zmanjšati vnetje in srbenje.
English: Easotic must not be used in dogs that may be allergic to the active substances or any of the other ingredients, if the eardrum is perforated, at the same time as other medicines that can harm the ear, or in dogs with a parasite infection called generalised demodecosis (mange).
Slovenian: Zdravilo Easotic se ne sme uporabljati pri psih, ki utegnejo biti alergični na zdravilne učinkovine ali katero koli drugo sestavino zdravila, če je ušesni bobnič predrt, sočasno z drugimi zdravili, ki lahko poškodujejo uho, ali pri psih s parazitsko okužbo, imenovano generalizirana demodikoza (garje).
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Easotic exceed the risks for the treatment of acute otitis externa, and acute exacerbation of recurrent otitis externa associated with bacteria susceptible to gentamicin and fungi susceptible to miconazole in particular Malassezia pachydermatis, and recommended that Easotic be given a marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Easotic pri zdravljenju akutnega vnetja ušes in akutnih izbruhov ponavljajočega vnetja ušes, povezanih z bakterijami, občutljivimi na gentamicin, in glivicami, občutljivimi na mikonazol, zlasti Malassezia pachydermatisin, večje od z njim povezanih tveganj, ter priporočil, da se za zdravilo Easotic odobri dovoljenje za promet.
English: In the study, the effectiveness of Easotic was compared with that of ear drops containing three similar active substances in dogs with acute or recurrent bacterial or fungal ear infections.
Slovenian: V študiji so učinkovitost zdravila Easotic primerjali z učinkovitostjo kapljic za uho, ki vsebujejo tri podobne zdravilne učinkovine, pri psih z akutnimi ali ponavljajočimi se bakterijskimi ali glivičnimi vnetji ušes.
English: When used at the recommended dose for five days, Easotic was as effective as the comparator medicine in improving the symptoms of ear infection (redness, swelling, ear discharge and discomfort).
Slovenian: Zdravilo Easotic je bilo v priporočenem odmerku in po petdnevnem zdravljenju enako učinkovito kot primerjalno zdravilo pri izboljševanju simptomov (pordelost, otekanje, izcedek iz ušesa, nelagodnost) vnetij ušesa.
English: Why has Easotic been approved?
Slovenian: Zakaj je bilo zdravilo Easotic odobreno?
English: For a full list of all side-effects reported with Easotic, see the Package Leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Easotic, glejte navodilo za uporabo.
English: What is Easotic used for?
Slovenian: Za kaj se zdravilo Easotic uporablja?
English: It is an ear drop suspension for dogs, that is white in colour.
Slovenian: Zdravilo so kapljice za uho v obliki suspenzije bele barve za pse.
English: If a person accidentally takes the medicine or eye irritation occurs, seek medical advice immediately and show the package leaflet or the label to a doctor.
Slovenian: Če pride do nenamernega zaužitja zdravila pri človeku, se nemudoma posvetujte z zdravnikom in mu pokažite navodilo za uporabo ali ovojnino.
English: How has Easotic been studied?
Slovenian: Kako je bilo zdravilo Easotic raziskano?
English: How does Easotic work?
Slovenian: Kako zdravilo Easotic deluje?
English: They often lead to the ear(s) being inflamed (red, swollen and itchy).
Slovenian: Vnetja ušes pri psih lahko povzročijo bakterije ali glivice, zaradi česar se uho(ušesa) vname(jo) (postanejo rdeča, zatečena in srbeča).
English: What is Easotic?
Slovenian: Kaj je zdravilo Easotic?
English: List of the name, pharmaceutical form, strength of the medicinal product, route of administration, marketing authorisation holder in the Member States
Slovenian: Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila in imetnikov dovoljenj za promet z zdravilom v državah članicah
English: Austria implant, pre-filled syringe subcutaneous use
Slovenian: Avstrija implantat, napolnjena injekcijska brizga
English: Further information on NexGard can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/NexGard.
Slovenian: Nadaljnje informacije o zdravilu NexGard so na voljo na spletni strani agencije: ema.europa.eu/medicines/veterinary/EPAR/NexGard.
English: The European Medicines Agency decided that NexGard's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila NexGard večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: NexGard received a marketing authorisation valid throughout the EU on 11 February 2014.
Slovenian: Zdravilo NexGard je pridobilo dovoljenje za promet, veljavno po vsej Evropski uniji, 11. februarja 2014.
English: People handling the medicine should wash their hands after handling the product.
Slovenian: Osebe, ki rokujejo z zdravilom, si morajo po rokovanju z zdravilom umiti roke.
English: The effectiveness of NexGard was investigated in both laboratory and field studies.
Slovenian: Učinkovitost zdravila Nexgard so proučevali v laboratorijskih in terenskih študijah.
English: NexGard (afoxolaner) EMA/783550/2013
Slovenian: NexGard (afoksolaner) EMA/783550/2013
English: Because parasites must start feeding on the dog in order to be killed by the medicine, there may be a risk of transmission of diseases with which they may be infected.
Slovenian: Ker se morajo bolhe in klopi začeti hraniti s krvjo psa, da bi jih zdravilo lahko uničilo, obstaja tveganje za prenos bolezni, s katerimi so ti zajedavci lahko okuženi.
English: It blocks the normal movement of charged chloride particles (ions) in and out of nerve cells, especially those associated with gamma-aminobutyric acid (GABA), a substance which conveys messages between nerves (neurotransmitter).
Slovenian: Zavira normalno prehajanje nabitih kloridnih delcev (ionov) v živčne celice in iz njih, in sicer zlasti tistih, ki so povezani z gamaaminomasleno kislino (GABA), tj. snovjo, ki prenaša sporočila med živci (živčna prenašalca).
English: NexGard (afoxolaner)
Slovenian: NexGard (afoksolaner)
English: Afoxolaner kills parasites by causing an over-stimulation of their nervous system.
Slovenian: Afoksolaner zajedavce ubije tako, da v pretirano stimulira njihov živčni sistem.
English: Why is NexGard authorised in the EU?
Slovenian: Zakaj je zdravilo NexGard odobreno v EU?
English: In order for the active substance to have an effect, fleas and ticks must attach to the skin and commence feeding on the dog's blood.
Slovenian: Da bi bili bolhe in klopi izpostavljeni učinkovini, se morajo pritrditi na kožo in se začeti hraniti s krvjo psa.
English: NexGard kills fleas within 8 hours and ticks within 48 hours.
Slovenian: Zdravilo NexGard bolhe ubije v osmih urah, klope pa v 48 urah.
English: For more information about using NexGard, see the package leaflet or contact your veterinarian or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila NexGard glejte navodilo za uporabo ali se posvetujte z veterinarjem ali farmacevtom.
English: It may be used as part of the management of flea allergy dermatitis (an allergic reaction to flea bites).
Slovenian: Uporablja se lahko kot del zdravljenja alergijskega dermatitisa, ki ga povzročajo bolhe (alergijska reakcija na ugrize bolh).
English: Other information about NexGard
Slovenian: Druge informacije o zdravilu NexGard:
English: An overview of NexGard and why it is authorised in the EU
Slovenian: Pregled zdravila NexGard in zakaj je odobreno v EU
English: NexGard reduced the number of fleas and ticks by at least 98% and was at least as effective as a spoton medicine containing pyriprole (another medicine against fleas and ticks).
Slovenian: Zdravilo NexGard je zmanjšalo število bolh in klopov za vsaj 98 % in je bilo vsaj tako učinkovito kot zdravilo za kožni nanos, ki vsebuje piriprol (drugo zdravilo proti bolham in klopom).
English: NexGard reduced the number of live mites by 97% 56 days after starting treatment and by 98% 84 days after starting treatment.
Slovenian: Zdravilo Nexgard je število živih garjavcev zmanjšalo za 97 % 56 dni po začetku zdravljenja in za 98 % 84 dni po začetku zdravljenja.
English: NexGard reduced the number of live mites by 96% 28 days after starting treatment and by 100% 56 days after starting treatment.
Slovenian: Zdravilo NexGard je število živih garjavcev zmanjšalo za 96 % 28 dni po začetku zdravljenja in za 100 % 56 dni po začetku zdravljenja.