natgillin/translations-raw huggingface dataset:
Weight decreased 
Skrajšanje časa izklopa
Bottles: 10 or 30 capsules. 
Pretisni omoti: 10 ali 30 kapsul.
Hepatic impairment 
bolečine v okončinah
Blisters: Store in the original blister in order to protect from moisture. 
Pretisni omoti: Shranjujte v originalni pretisnem omotu za zagotovitev zaščite pred vlago.
95% CI 
N Povprečje LS 95-odstotni IZ Vrednost p
EU/1/15/1066/001 10 hard capsules EU/1/15/1066/008 30 hard capsules 
EU/1/15/1066/008 30 trdih kapsul
Tel:+351 22 986 61 00 
4745-457 S. Mamede do Coronado Portugalska tel: +351 22 986 61 00 faks: +351 22 986 61 90
No dose adjustment is necessary in patients with mild hepatic impairment (Child-Pugh Class A). 
Pri bolnikih z blago okvaro jeter (stopnje A po Child-Pughu) odmerka ni treba prilagajati.
Constipation, Dry mouth, Vomiting 
- zamašeno uho - suho oko - boleč ali otekel trebuh
Name and address of the manufacturer responsible for batch release 
Ime in naslov izdelovalca, odgovornega za sproščanje serij Bial - Portela & Cª, S.A.
Keep the bottle tightly closed in order to protect from moisture 
POSEBNA NAVODILA ZA SHRANJEVANJE Plastenko shranjujte tesno zaprto za zagotovitev zaščite pred vlago.
EU/1/15/1066/009 10 hard capsules EU/1/15/1066/010 30 hard capsules 
EU/1/15/1066/010 30 trdih kapsul
OPC 25 mg 
Placebo OPC 25 mg
Ongentys 25 mg hard capsules 
IME ZDRAVILA Ongentys 25 mg trde kapsule
OPC 25 mg OPC 50 mg OPC 25 mg - placebo OPC 50 mg - placebo 
Placebo OPC 5 mg OPC 25 mg
Posology 
TRAKU
Ongentys 50 mg hard capsules 
IME ZDRAVILA Ongentys 50 mg trde kapsule
EU/1/15/1066/005 10 hard capsules EU/1/15/1066/006 30 hard capsules EU/1/15/1066/007 90 hard capsules 
EU/1/15/1066/007 90 trdih kapsul
Capsule shell 
90 trdih kapsul
EU/1/15/1066/002 10 hard capsules EU/1/15/1066/003 30 hard capsules EU/1/15/1066/004 90 hard capsules 
EU/1/15/1066/004 90 trdih kapsul
• Risk Management Plan (RMP) 
• Načrt zaobvladovanje tveganja (RMP)
Date of first authorisation: 24 February 2009 Date of latest renewal: 24 February 2014 
Datum prve odobritve: 24. februar 2009 Datum zadnjega podaljšanja: 24. februar 2014
Paresthesia, neuritis 
Parestezija, neuritis
Interference with serological testing: See section 4.5. 
Interferenca s serološkimi testi: glejte poglavje 4.5.
Store in refrigerator. 
Shranjujte v hladilniku.
The use of INTANZA should be based on official recommendations. 
Uporaba cepiva INTANZA mora temeljiti na uradnih priporočilih.
INTANZA is a vaccine. 
INTANZA je cepivo.
This vaccine is recommended to help to protect you against flu. 
Cepivo se priporoča za zaščito proti gripi.
Pharmacotherapeutic group: Influenza vaccines, ATC code: J07BB02 
Farmakoterapevtska skupina: Cepiva proti gripi, oznaka ATC: J07BB02.
Children and adolescents INTANZA is not recommended for use in children and adolescents below 18 years. 
Otroci in mladostniki Cepivo INTANZA ni priporočeno za uporabo pri otrocih in mladostnikih pod 18 let.
- Tell your doctor if you have been treated with medicines that may reduce your immune response such as corticosteroids (for example cortisone), medicines against cancer (chemotherapy), radiotherapy or other medicines affecting the immune system. 
- Obvestite svojega zdravnika, če ste se zdravili z zdravili, ki lahko zmanjšajo vaš imunski odziv, kot so kortikosteroidi (na primer kortizon), zdravila proti raku (kemoterapija), radioterapija ali druga zdravila, ki vplivajo na imunski sistem.
The data below summarizes the frequencies of the adverse reactions that were recorded following vaccination during clinical trials and worldwide post-marketing experience, using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (<1/10,000), not known (cannot be estimated from available data). 
Spodnji podatki so povzetek pogostnosti neželenih učinkov, ki so jih zabeležili v kliničnih preizkušanjih po cepljenju in zajeli po svetu po prihodu cepiva na trg, po naslednjem dogovoru: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10); občasni (≥1/1000 do < 1/100); redki (≥ 1/10000 do < 1/1000); zelo redki (< 1/10000); neznani (se jih ne da oceniti na podlagi razpoložljivih podatkov).
Please read the instruction before use 
Pred uporabo preberite navodila
- You should tell your doctor before vaccination if you have a poor immune response (immunosuppression) due to disease or medicines, because the vaccine may not work very well in this case. 
- Obvestite zdravnika pred cepljenjem, če imate oslabljen imunski sistem (imunosupresija) zaradi bolezni ali zdravil, saj se lahko zgodi, da cepivo v tem primeru ne bo delovalo najbolje.
B/Brisbane/60/2008 - like strain (B/Brisbane/60/2008, wild type) .................... 15 micrograms HA** 
B/Brisbane/60/2008, divji tip, ki je podoben sevu B/Brisbane/60/2008 ............ 15 mikrogramov HA**
Sanofi Pasteur - Parc Industriel d'Incarville - 27100 Val-de-Reuil - France Sanofi Pasteur, Campus Mérieux - 1541, avenue Marcel Mérieux - 69280 Marcy l'Etoile - France For any information about this medicine, please contact the local representative of the Marketing 
Sanofi Pasteur - Parc Industriel d'Incarville - 27100 Val-de-Reuil - Francija Sanofi Pasteur, Campus Mérieux - 1541, avenue Marcel Mérieux - 69280 Marcy l'Etoile - Francija Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika
The safety of INTANZA has been assessed in 3 open-label randomised clinical trials, 3,372 vaccinees received an injection of INTANZA. 
Varnost cepiva INTANZA je bila ocenjena v 3 odprtih, randomiziranih kliničnih preskušanjih, v katerih je bilo 3.372 oseb cepljenih z zdravilom INTANZA.
Justification for not including Braille is accepted. 
Sprejeta je utemeljitev, da Braillova pisava ni potrebna.
What INTANZA is and what it is used for What you need to know before you use INTANZA 
Kaj je cepivo INTANZA in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili cepivo INTANZA
With the same hand, push very firmly with the thumb on the plunger to activate the needle shield. 
Z isto roko čvrsto pritisnite palec na bat, da aktivirate zaščito igle.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal. 
• Redno posodobljena poročila o varnosti zdravila (PSUR) Imetnik dovoljenja za promet z zdravilom mora redno posodobljena poročila o varnosti zdravila za to zdravilo predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem
Immunisation should be carried out by intradermal route. 
Imunizacija se izvaja intradermalno.
INTANZA may be given at the same time as other vaccines. 
Zdravilo INTANZA se lahko daje sočasno z drugimi cepivi.
In this comparative trial the geometric mean titres (GMTs), seroprotection rate*, seroconversion or significant increase rate** and the geometric mean titre ratio (GMTR) for anti-HA antibody (measured by HI) were assessed according to predefined criteria. 
V tem primerjalnem preskušanju so ocenili geometrično povprečje titra (GMTs), stopnjo serozaščite*, serokonverzijo ali značilne stopnje povečanja** in razmerje geometričnega povprečja titrov (GMTR) za protitelesa anti-HA (izmerjeno z uporabo metode HI) v skladu s predhodno opredeljenimi kriteriji.
INTANZA may contain residues of eggs such as ovalbumin and residues of neomycin, formaldehyde and octoxinol 9, which are used during the manufacturing process (see section 4.3). 
Cepivo INTANZA lahko vsebuje sledove jajc kot je ovalbumin ter sledove neomicina, formaldehida in oktoksinola 9, ki se uporabljajo v procesu izdelave zdravila (glejte poglavje 4.3).
EU/1/08/505/004 - pack of 1 pre-filled syringe with a Micro-Injection System EU/1/08/505/005 - pack of 10 pre-filled syringes with a Micro-Injection System EU/1/08/505/006 - pack of 20 pre-filled syringes with a Micro-Injection System 
EU/1/08/505/004 - pakiranje z 1 napolnjeno brizgo s sistemom za mikro-injiciranje EU/1/08/505/005 - pakiranje z 10 napolnjenimi brizgami s sistemom za mikro-injiciranje EU/1/08/505/006 - pakiranje z 20 napolnjenimi brizgami s sistemom za mikro-injiciranje
** Seroconversion = negative pre-vaccination HI titre and post vaccination HI titre ≥ 40, Significant increase = positive pre-vaccination HI titre and at least a 4-fold increase in post-vaccination HI titre GMTR: Geometric mean titre ratio of individual (post-/pre-vaccination titre). 
** Serokonverzija = negativni titer HI pred cepljenjem in titer po cepljenju ≥ 40, značilno povečanje = pozitivni titri HI pred cepljenjem in vsaj 4-povečanje titra HI po cepljenju GMTR (geometric mean titer ratio): razmerje geometričnega povprečja titra posameznika (titri pred
Very limited data in immunocompromised patients are available for INTANZA. 
Na voljo je zelo malo podatkov o uporabi cepiva INTANZA pri imunokompromitiranih bolnikih.
What you need to know before you use INTANZA 
Kaj morate vedeti, preden boste uporabili cepivo INTANZA
*In some cases, local redness lasted up to 7 days. 
* V nekaterih primerih je lokalna pordelost trajala do 7 dni c. možni neželeni dogodki
What INTANZA is and what it is used for 
Kaj je cepivo INTANZA in za kaj ga uporabljamo
INTANZA 15 µg/strain 2017/2018 Influenza vaccine 
INTANZA 15 µg/sev 2017/2018
HOW TO USE INTANZA 
KAKO UPORABLJATI CEPIVO INTANZA
Allergic reactions including generalized skin reactions such as urticaria, anaphylactic reactions, angioedema, shock 
Alergijska reakcija, ki vključuje generalizirano kožno reakcijo kot je urtikaria, anafilaktično reakcijo, angioedem, šok
Sanofi Pasteur Europe, 2 Avenue Pont Pasteur, 69007 Lyon, France. 
Sanofi Pasteur Europe, 2 Avenue Pont Pasteur, 69007 Lyon, Francija.
INTANZA has no or negligible influence on the ability to drive and use machines. 
Cepivo INTANZA nima oziroma zanemarljivo vpliva na sposobnost vožnje in upravljanja s stroji.
What INTANZA looks like and contents of the pack 
Izgled cepiva INTANZA in vsebina pakiranja
In case of presence of liquid at the injection site after vaccine administration, re-vaccination is not required. 
V primeru, da je po cepljenju na mestu vboda prisotna tekočina, ponovno cepljenje ni potrebno.
INTANZA should under no circumstances be administered intravascularly. 
Cepivo INTANZA se pod nobenim pogojem ne sme dajati intravaskularno.
During clinical trials and after the vaccine came on the market, the following side effects were reported with the use of INTANZA. 
V kliničnih preizkusih in v obdobju po prihodu cepiva INTANZA na trg so poročali o sledečih neželenih učinkih
- Other vaccines: INTANZA can be given at the same time as other vaccines by using separate limbs. 
- Druga cepiva: cepivo INTANZA se lahko daje sočasno z drugimi cepivi, vendar v ločene okončine.
Do not use this vaccine after the expiry date which is stated on the carton after EXP. 
Cepiva INTANZA ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
INTANZA is not recommended for use in children and adolescents below 18 years due to insufficient data on safety and efficacy. 
Uporaba zdravila INTANZA zaradi pomanjkljivih podatkov o varnosti in učinkovitosti ni priporočljiva pri otrocih in mladostnikih, mlajših od 18 let.
Pre-filled syringe label text 
Besedilo na nalepki za napolnjeno brizgo
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 
D. POGOJI IN OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
Other vaccines or medicines and INTANZA Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. 
Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
Marketing Authorisation Holder: Sanofi Pasteur Europe, 2 Avenue Pont Pasteur, 69007 Lyon, 
Imetnik dovoljenja za promet: Sanofi Pasteur Europe, 2 Avenue Pont Pasteur, 69007 Lyon, Francija.
0.1 ml of suspension in a pre-filled syringe (glass) with a Micro-Injection System, with attached micro-needle, equipped with an elastomer plunger stopper (chlorobutyl), a tip cap (thermoplastic elastomer and polypropylene) and a needle shielding system. 
0,1 ml suspenzije v napolnjeni brizgi (steklo) s sistemom za mikro-injiciranje, s pritrjeno mikro-iglo, opremljeno z batom iz elastomera (klorobutil), s pokrovom konice (termoplastični elastomer in polipropilen) in sistemom za zaščito igle.
INTANZA is given as an injection into the upper layer of the skin (preferably the muscle of the upper 
Cepivo INTANZA se daje v obliki injekcije v zgornjo plast kože (po možnosti v mišico nadlakti).
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. 
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
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. 
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.
• 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. 
• Tako kot pri vseh cepivih, ki jih injiciramo, morate imeti na voljo ustrezno zdravljenje in nadzor, za primer anafilaktične reakcije, ki lahko sledi cepljenju
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. 
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.
Systemic safety profile of INTANZA is similar to the comparator vaccine, adjuvanted or nonadjuvanted, administered intramuscularly. 
Sistemski profil varnosti cepiva INTANZA je podoben primerjanemu cepivu z adjuvansom ali brez, ki
Pack of 1 or 10 or 20 pre-filled syringe(s) with a Micro-Injection System 
Pakiranje z 1 ali 10 ali 20 napolnjenimi brizgami s sistemom za mikro-injiciranje
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. 
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
Immune system disorders 
Sistem za mikroinjiciranje
A/Michigan/45/2015 (H1N1)pdm09 - like strain A/Hong Kong/4801/2014 (H3N2) - like strain 
A/Michigan/45/2015 (H1N1)pdm09 - podoben sev
Injection is considered successful whether or not the presence of a 
Injekcija je uspešna ne glede na prisotnost izpuščaja.
INTANZA 15 microgram/strain, suspension for injection Influenza vaccine (split virion, inactivated) 
INTANZA 15 mikrogramov/sev, suspenzija za injiciranje Cepivo proti gripi z delci virionov, inaktivirano
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 
- 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,
Influenza virus (inactivated, split) of the following strains*: 
Virusi influence (inaktivirani, razcepljeni) naslednjih sevov*:
This vaccine has no or negligible influence on the ability to drive and use machines. 
Vpliv na sposobnost vožnje in upravljanja s stroji Cepivo INTANZA nima oziroma zanemarljivo vpliva na sposobnost vožnje in upravljanja s stroji.
Rare reactions (may affect up to 1 in 1000 people) - Tingling or numbness, inflammation of nerves, itching and rash. 
Redki (lahko prizadanejo do 1 med 1000 cepljenimi) - Ščemenje ali odrevenelost, vnetje živcev, srbenje in izpuščaj
INTANZA 15 microgram/strain suspension for injection Influenza vaccine (split virion, inactivated) 
INTANZA 15 mikrogramov/sev suspenzija za injiciranje Cepivo proti gripi z delci virionov, inaktivirano
Influenza virus (inactivated, split) of the following strains: 
Virusi influence (inaktivirani, razcepljeni) naslednjih sevov:
INTANZA will help to protect you against the three strains of virus contained in the vaccine, or other strains closely related to them. 
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.
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 
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).
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. 
Sistem za mikro-injiciranje za intradermalno injekcijo je sestavljen iz napolnjene brizge z mikro-iglo (1,5 mm) in s sistemom za zaščito igle.
Common Uncommon Rare 
Občasni Redki
After repetitive yearly injections the safety profile of INTANZA is similar to the previous injections. 
Po ponovnem vsakoletnem cepljenju je bil profil varnosti cepiva INTANZA podoben prejšnjim b. povzetek tabelarno prikazanih neželenih učinkov
You hear a click and a shield comes out to cover the needle. 
Ko bo zaščita izskočila in pokrila iglo, boste zaslišali klik.
Neuralgia, febrile convulsions, neurological disorders, such as encephalomyelitis and Guillain-Barré 
Bolezni živčevja nevralgija, febrilne konvulzije, nevrološke motnje kot je encefalomielitis in Guillain-Barréjev sindrom vaskulitis, v zelo redkih primerih povezan s prehodno prizadetostjo ledvic
Based on the experience with trivalent inactivated influenza vaccines administered by intramuscular or deep subcutaneous injection, the following events may be reported: 
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
Uncommon reactions (may affect up to 1 in 100 people) - Tiredness, joint pain and increased sweating. 
Občasni (lahko prizadanejo do 1 med 100 cepljenimi) - Utrujenost, bolečine v sklepih in povečano znojenje.
What INTANZA contains 
Kaj vsebuje cepivo INTANZA
Sweating Pruritus, rash 
Znojenje Pruritus, izpuščaj
A/Wisconsin/ 
A/H1N1
INTANZA is a suspension for injection in a pre-filled syringe of 0.1 ml with a Micro-Injection 
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.
Remove the needle cap from the Micro-Injection 
Pokrov igle odstranite s
The active substances are Influenza virus (inactivated split) of the following strains*: 
Zdravilne učinkovine so virusi gripe (inaktivirani, z delci virionov) naslednjih sevov*:
A/Michigan/45/2015 (H1N1)pdm09 - like strain (A/Michigan/45/2015, NYMC X-275) ............................................................................................................................. 15 micrograms HA** 
A/Michigan/45/2015, NYMC X-275, ki je podoben sevu A/Michigan/45/2015 (H1N1)pdm09 ............................................................................................................................. 15 mikrogramov HA**
- Feeling generally unwell, fever (38.0°C or higher) and shivering. 
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.
INTANZA is administered to you by your doctor or nurse. 
Pred začetkom uporabe cepiva INTANZA se posvetujte s svojim zdravnikom, farmacevtom ali z medicinsko sestro.
A/Hong Kong/4801/2014 (H3N2) - like strain (A/Hong Kong/4801/2014, NYMC X-263B) ............................................................................................................................. 15 micrograms HA** 
A/Hong Kong/4801/2014, NYMC X-263B, ki je podoben sevu A/Hong Kong/4801/2014 (H3N2) ............................................................................................................................. 15 mikrogramov HA**
Transient thrombocytopenia, transient lymphadenopathy 
Artralgija pruritus, bolečina ehimoza
In case of presence of liquid at the injection site after vaccine administration, re-vaccination is not 
V primeru, da je po cepljenju na mestu vboda prisotna tekočina, ponovno
Very common 
Prirobni ca
15 µg haemagglutinin per strain per 0.1 ml dose 
15 mikrogramov hemaglutinina na sev na 0,1 ml na odmerek natrijev klorid, kalijev klorid, natrijev hidrogenfosfat dihidrat, kalijev dihidrogen fosfat, voda za
Oral use bottle (HDPE) 
40 mg filmsko obložena tableta peroralna uporaba plastenka (HDPE) 180 tablet
It is given once a day for five days. 
Zdravilo se daje enkrat dnevno pet dni.
It is available in a 10 ml bottle. 
Na voljo je v 10-mililitrski steklenički.
This summary was last updated in November 2008. 
Povzetek je bil nazadnje posodobljen 11-2008.
This is usually temporary and happens primarily in older dogs. 
Ta je običajno začasna in se pojavi predvsem pri starejših psih.
One large field trial was conducted in different centres throughout Europe. 
Eno večje preskušanje na terenu je bilo izvedeno v različnih središčih v Evropi.
Other information about Easotic: 
Druge informacije o zdravilu Easotic:
The European Commission granted a marketing authorisation valid throughout the European Union, for Easotic to Virbac S.A. on 20/11/2008. 
Evropska komisija je dovoljenje za promet z zdravilom Easotic, veljavno po vsej Evropski uniji, odobrila družbi Virbac S.A. dne 20. novembra 2008.
The dose is 1 ml, which is given directly into the ear by one activation of the pump supplied with the bottle. 
Odmerek je 1 ml, ki se daje neposredno v uho z eno aktivacijo črpalke, ki je priložena steklenički.
Mild reddening of the ear has been seen in around 2% of dogs. 
Opažena je bila blaga pordelost ušesa pri okoli 2 % psov.
The inside of the ear should be cleaned and dried before treatment and any excess hair cut away. 
Notranjost ušesa je treba pred zdravljenjem očistiti in osušiti, odvečno dlako pa je treba odrezati.
The medicine was well tolerated. 
Zdravilo so psi dobro prenašali.
It acts by preventing bacteria making proteins. 
Deluje tako, da bakterijam preprečuje proizvodnjo beljakovin.
What benefit has Easotic shown during the studies? 
Kakšne koristi je zdravilo Easotic izkazalo med študijami?
What is the risk associated with Easotic? 
Kakšna tveganja so povezana z zdravilom Easotic?