natgillin/translations-raw huggingface dataset:
The concurrent use of Fluenz Tetra with antiviral agents that are active against influenza A and/or B viruses has not been evaluated. 
Sočasne uporabe cepiva Fluenz Tetra s protivirusnimi zdravili, ki delujejo proti virusom gripe A in/ali B niso ocenili.
Fluenz Tetra demonstrated immunologic non-inferiority to the two formulations of Fluenz as the upper bound for each of the four 95% CIs for the post-dose strain-specific GMT HAI antibody ratios was ≤ 1.5. 
Cepivo Fluenz Tetra je pokazalo imunsko neinferiornost na dve obliki cepiva Fluenz, saj je bila zgornja meja vseh štirih 95 % intervalov zaupanja pri razmerju GMT protiteles specifičnih za sev, ki zavirajo hemaglutinacijo po aplikaciji
Fluenz Tetra is manufactured according to the same process as Fluenz. 
Cepivo Fluenz Tetra je izdelano po enakem postopku kot cepivo Fluenz.
Fluenz safety 
Varnost cepiva Fluenz
6 to 35 M 1,041 
6 do 35 m 1.041
Keep the nasal applicator in the outer carton in order to protect from light. 
Nosnik shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
Limited available evidence suggests that the trivalent Fluenz is not excreted in breastmilk. 
Maloštevilni dokazi, ki so na voljo, kažejo, da se trivalentno cepivo Fluenz ne izloča v materino mleko.
B/Phuket/3073/2013 - like strain (B/Phuket/3073/2013, MEDI 254977) 
B/Phuket/3073/2013 - podoben sev (B/Phuket/3073/2013, MEDI 254977)
Fluenz Tetra will help to protect against the four virus strains contained in the vaccine, and other strains closely related to them. 
Cepivo Fluenz Tetra vam bo pomagalo pri zaščiti pred štirimi sevi virusa, ki jih cepivo vsebuje in drugimi podobnimi sevi.
Do not use salicylates in children and adolescents for 4 weeks after vaccination unless medically indicated as Reye's syndrome has been reported following the use of salicylates during wild-type influenza infection. 
Salicilatov se ne sme uporabljati še 4 tedne po cepljenju pri otrocih in mladostnikih, razen če je to medicinsko indicirano, ker so po uporabi salicilatov v času okužbe z gripo virusa divjega tipa poročali o Reyevem sindromu.
Fluenz demonstrated 64.4% (1.4, 88.8) fewer cases than injectable influenza vaccine in 476 infants and toddlers 6-23 months of age and 48.2% (12.7, 70.0) fewer cases in 1,609 children 24-71 months of age. 
S cepivom Fluenz je bilo 64,4 % (1,4; 88,8) manj primerov kot pri cepivu proti gripi, ki se injicira, pri 476 dojenčkih in malčkih starih od 6 - 23 mesecev in 48,2 % (12,7; 70,0) manj primerov pri 1.609 otrok starih od 24 - 71 mesecev.
5 single-use nasal applicators (0.2 ml each) 
5 nosnikov za enkratno uporabo (vsak po 0,2 ml)
The active substances are: Reassortant influenza virus* (live attenuated) of the following four strains**: 
Učinkovine so: Novi virus gripe* (živ oslabljen) naslednjih štirih sevov**:
It is not known whether Fluenz Tetra is excreted in human milk. 
Ni znano, ali se cepivo Fluenz Tetra izloča v materino mleko.
Europe, Asia/ Oceania, Latin America 
Evropa, Azija/ Oceanija, Južna Amerika
Fluenz demonstrated 55.7% (39.9, 67.6) fewer cases than injectable influenza vaccine in 3,686 infants and toddlers 6-23 months of age and 54.4% (41.8, 64.5) fewer cases in 4,166 children 24-59 months of age. 
S cepivom Fluenz je bilo 55,7 % (39,9; 67,6) manj primerov kot pri cepivu proti gripi, ki se injicira, pri 3.686 dojenčkih in malčkih starih od 6 - 23 mesecev in 54,4 % (41,8; 64,5) manj primerov pri 4.166 otrok starih od 24 - 59 mesecev.
Fluenz Tetra is supplied as a 0.2 ml suspension in a single-use nasal applicator (Type 1 glass), with nozzle (polypropylene with polyethylene transfer valve), nozzle tip-protector cap (synthetic rubber), plunger rod, plunger-stopper (butyl rubber) and a dose-divider clip. 
Cepivo Fluenz Tetra je na voljo kot 0,2 ml suspenzija v nosniku za enkratno uporabo (steklo tia 1), s šobo (polipropilen s polietilenskim ventilom za prenos), zaporko za zaščito konice šobe (sintetična guma), batom, batnim zamaškom (butil guma) in sponko za razdelitev odmerka.
In study participants who received 2 doses in year 1 and placebo in year 2, efficacy in year 2 was 56.2% (95% CI: 30.5, 72.7) and 44.8% (95% CI: 18.2, 62.9), respectively, in D153-P501, thus supporting the need for second-season revaccination. 
Pri preiskovancih v študiji, ki so 1. leto prejeli 2 odmerka in placebo 2. leto, je bila učinkovitost 2. leto 56,2 % (95-% IZ: 30,5; 72,7) oziroma 44,8 % (95-% IZ: 18,2; 62,9) pri študiji D153-P501, kar govori v prid potrebi po revakcinaciji v drugi sezoni.
The rate of wheezing was not increased in Fluenz recipients 24 months and older. 
Stopnja sopenja se pri prejemnikih cepiva Fluenz starih 24 mesecev ali več ni povišala.
Children and adolescents from 24 months: 0.2 ml (administered as 0.1 ml per nostril). 
Otroci in mladostniki stari 24 mesecev ali več: 0,2 ml (aplicirano po 0,1 ml v vsako nosnico).
Reduction in culture-confirmed influenza illness relative to injectable influenza vaccine. 
Zmanjšanje obolelosti za gripo, potrjene s kulturo, glede na cepivo proti gripi, ki se injicira.
When a person is given the vaccine, the immune system (the body's natural defence system) will produce its own protection against the influenza virus. 
Imunski sistem (naravni obrambni sistem telesa) osebe, ki prejme cepivo, začne izločati lastno zaščito proti virusu gripe.
In previously unvaccinated study participants who received one dose in year 1, efficacy was 57.7% (95% CI: 44.7, 67.9) and 56.3% (95% CI: 43.1, 66.7), respectively, thus supporting the need for two doses of vaccine in previously unvaccinated children. 
Pri preiskovancih v študiji, ki se pred tem niso cepili in so prejeli le en odmerek v 1. letu, je bila učinkovitost 57,7 % (95-% IZ: 44,7; 67,9) oziroma 56,3 % (95-% IZ: 43,1; 66,7), to govori v prid potrebi po dveh odmerkih cepiva pri predhodno necepljenih otrocih.
• Fluenz Tetra is administered as a divided dose in both nostrils as described below. 
• Cepivo Fluenz Tetra se aplicira kot razdeljen odmerek v obe nosnici kot je opisano spodaj.
A/Brisbane/02/2018 (H1N1)pdm09 - like strain (A/Switzerland/3330/2017, MEDI 307134) 
A/Brisbane/02/2018 (H1N1)pdm09 - podoben sev (A/Switzerland/3330/2017, MEDI 307134)
Children who have not previously had an influenza vaccine will receive a second, follow-up dose after an interval of at least 4 weeks. 
Otroci, ki se še nikoli niso cepili proti gripi, bodo najmanj po 4 tednih prejeli še drugi, vzdrževalni odmerek.
Do not administer Fluenz Tetra to children and adolescents receiving salicylate therapy (see section 4.3). 
Cepiva Fluenz Tetra se ne sme uporabiti pri otrocih in mladostnikih, ki se zdravijo s salicilati (glejte poglavje 4.3).
Administration of a higher than recommended dose of Fluenz Tetra was reported rarely and the adverse reaction profile was comparable to that observed with the recommended dose of Fluenz Tetra. 
V redkih primerih so poročali o uporabi odmerka cepiva Fluenz Tetra, večjega od priporočenega, in profil neželenih učinkov je bil primerljiv kot pri uporabi priporočenega odmerka cepiva Fluenz Tetra.
For nasal use only. 
Samo za nazalno uporabo.
B/Colorado/06/2017 - like strain (B/Colorado/06/2017, MEDI 293454) 
B/Colorado/06/2017 - podoben sev (B/Colorado/06/2017, MEDI 293454)
Fluenz has demonstrated superiority in 3 active-controlled studies with injectable influenza vaccine. 
Cepivo Fluenz je bilo v 3 aktivno kontroliranih študijah s cepivom gripe, ki se injicira, superiorno.
Fluenz Tetra should under no circumstances be injected. 
Cepiva Fluenz Tetra se ne sme v nobenem primeru injicirati.
SINGLE-USE NASAL APPLICATOR 
NOSNIK ZA ENKRATNO UPORABO
This vaccine is presented as a nasal spray suspension in a single-use nasal applicator (0.2 ml) in a pack size of 1 and 10. 
Cepivo je v obliki pršila za nos, suspenzije, ki se nahaja v nosniku za enkratno uporabo (0,2 ml) v velikosti pakiranja 1 in 10.
..................................................................................................................per 0.2 ml dose 
........................................................................................................na 0,2 ml odmerek
• if you are in close contact with someone with a severely weakened immune system 
• če ste v tesnem stiku z nekom, ki ima hudo oslabljen imunski sistem (na primer bolnik s presajenim kostnim mozgom, ki mora biti izoliran).
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
Fluenz efficacy 
Učinkovitost cepiva Fluenz
A/Kansas/14/2017 (H3N2) - like strain (A/Kansas/14/2017, MEDI 308763) 
A/Kansas/14/2017 (H3N2) - podoben sev (A/Kansas/14/2017, MEDI 308763)
Additional experience has occurred with marketed use of Fluenz. 
V času trženja cepiva Fluenz so se pridobile dodatne izkušnje.
This vaccine complies with the WHO (World Health Organisation) recommendations (Northern Hemisphere) and EU decision for the 2019/2020 season. 
Cepivo ustreza priporočilom Svetovne zdravstvene organizacije (severna polobla) in odločbi EU za sezono 2019/2020.
PACK SIZE OF 1 SINGLE-USE NASAL APPLICATOR PACK SIZE OF 1 SINGLE-USE NASAL APPLICATOR (IN A TRI-FOLD CARTON) PACK SIZE OF 10 SINGLE-USE NASAL APPLICATORS (IN TRAYS) PACK SIZE OF 10 SINGLE-USE NASAL APPLICATORS 
VELIKOST PAKIRANJA 1 NOSNIKA ZA ENKRATNO UPORABO VELIKOST PAKIRANJA 1 NOSNIKA ZA ENKRATNO UPORABO (V KARTONU S TREMI PREGIBI)
This vaccine complies with the WHO recommendations (Northern Hemisphere) and EU decision for the 2019/2020 season. 
Cepivo ustreza priporočilom SZO (Svetovne zdravstvene organizacije) (severna polobla) in odločbi EU za sezono 2019/2020.
PACK SIZE OF 5 SINGLE-USE NASAL APPLICATORS 
VELIKOST PAKIRANJA 5 NOSNIKOV ZA ENKRATNO UPORABO
• nose bleed 
• krvavitve iz nosu
Fluenz Tetra nasal spray suspension Influenza vaccine (live attenuated, nasal) 2019/2020 season 
Fluenz Tetra pršilo za nos, suspenzija cepivo proti gripi (z živimi oslabljenimi virusi, nosno) sezona 2019/2020
Very rare reports of Guillain-Barré syndrome and exacerbation of symptoms of Leigh syndrome (mitochondrial encephalomyopathy) have also been observed in the post-marketing setting with Fluenz. 
Po začetku trženja cepiva Fluenz so opazili zelo redka poročila o Guillain-Barréjevem sindromu in poslabšanju simptomov Leigh-sindroma (mitohondrijska encefalomiopatija).
Respiratory, thoracic and mediastinal disorders Very common: Nasal congestion/rhinorrhoea 
Bolezni dihal, prsnega koša in mediastinalnega prostora Zelo pogosti: zamašen nos/rinoreja Občasni: epistaksa
The suspension should be colourless to pale yellow, clear to opalescent. 
Suspenzija mora biti brezbarvna do bledorumena in bistra do opalescentna.
If any of these apply, tell your doctor, nurse or pharmacist before vaccination. 
Če karkoli od tega velja za vas, obvestite zdravnika, farmacevta ali medicinsko sestro pred cepljenjem.
Other possible side effects of Fluenz Tetra 
Drugi možni neželeni učinki cepiva Fluenz Tetra
No clinically meaningful changes in immune responses to measles, mumps, varicella, orally-administered poliovirus or Fluenz have been observed. 
Klinično pomembnih sprememb odziva imunskega sistema na cepivo proti ošpicam, mumpsu, noricam in na peroralno cepivo proti otroški paralizi ali cepivo Fluenz niso opazili.
• Refer to the Fluenz Tetra administration diagram (Figure 1) for step-by-step administration instructions. 
• Za navodila za aplikacijo cepiva Fluenz Tetra po korakih glejte postopek aplikacije (slika 1).
The safety experience with trivalent Fluenz is relevant to the use of Fluenz Tetra because Fluenz Tetra (influenza vaccine-live attenuated, nasal) is identical to Fluenz with the only difference being the addition of a fourth strain (a second B strain) to Fluenz Tetra. 
Izkušnje o varnosti s trivalentnim cepivom Fluenz so pomembne za uporabo cepiva Fluenz Tetra, saj je Fluenz Tetra (cepivo proti gripi - z živimi oslabljenimi virusi, nosno) identično cepivu Fluenz, pri čemer je edina razlika dodatek četrtega seva (drugi B sev) v cepivu Fluenz Tetra.
The patient can breathe normally while the vaccine is being administered - there is no need to actively inhale or sniff. 
Oseba lahko med dajanjem cepiva normalno diha - ni potrebe za aktivno inhaliranje ali vdihavanje skozi nosnici.
You can breathe normally while you are given Fluenz Tetra. 
Med prejemanjem cepiva Fluenz Tetra lahko normalno dihate.
Peak incidence of vaccine virus recovery occurred 2-3 days post-vaccination in Fluenz clinical studies. 
V kliničnih študijah cepiva Fluenz je bila največja incidenca rekuperacije virusa iz cepiva 2 - 3 dni po cepljenju.
• The patient can breathe normally while the vaccine is being administered - there is no need to actively inhale or sniff. 
• Oseba lahko med dajanjem cepiva normalno diha - ni potrebe za aktivno inhaliranje ali vdihavanje skozi nosnici.
This observation with trivalent Fluenz is relevant to the use of Fluenz Tetra because Fluenz Tetra (influenza vaccine-liveattenuated, nasal) is identical to Fluenz with the only difference being the addition of a fourth strain (a second B strain) to Fluenz Tetra. 
Ta sprememba pri trivalentnem cepivu Fluenz je pomembna za uporabo cepiva Fluenz Tetra, saj je Fluenz Tetra (cepivo proti gripi - z živimi oslabljenimi virusi, nosno) identično cepivu Fluenz, pri čemer je edina razlika dodatek četrtega seva (drugi B sev) v cepivu Fluenz Tetra.
Non-clinical data reveal no special hazard for humans based on conventional non-clinical studies of repeated dose toxicity, reproduction and developmental toxicity, local tolerance and neurovirulence. 
Predklinični podatki na osnovi običajnih študij predklinične varnosti, toksičnosti pri ponavljajočih se odmerkih, vpliva na sposobnost razmnoževanja in razvoja, lokalnega prenašanja in nevrovirulence ne kažejo posebnega tveganja za človeka.
Overdose with Fluenz Tetra is unlikely due to its presentation as a pre-filled sprayer. 
Preveliko odmerjanje cepiva Fluenz Tetra zaradi njegove oblike v napolnjenem razpršilniku ni verjetno.
Immunocompromised 
Imunska oslabelost
There was no evidence of significant maternal adverse outcomes in 138 pregnant women who had a record of receiving trivalent Fluenz in a US-based health insurance claims database. 
Po podatkih ameriške baze odškodninskih zahtevkov zdravstvenega zavarovanja pri 138 nosečnicah, ki so prejemale trivalentno cepivo Fluenz, ni bilo dokazov o posebnih neželenih izidih nosečnosti za mater.
AV006 USA 15 to 71 M 1,259 
ZDA 15 do 71 m 1.259
What Fluenz Tetra looks like and contents of the pack 
Izgled cepiva Fluenz Tetra in vsebina pakiranja
Fluenz Tetra nasal spray suspension Influenza vaccine (live attenuated, nasal) 
Fluenz Tetra pršilo za nos, suspenzija cepivo proti gripi (z živimi oslabljenimi virusi, nosno)
Talk to your doctor, nurse or pharmacist before vaccination: 
Pred cepljenjem se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom:
Spray in other nostril Place the tip just inside the other nostril and with a single motion, depress plunger as rapidly as possible to deliver remaining vaccine. 
Konico namestite nekoliko v drugo nosnico in z enkratnim pritiskom pritisnite na bat tako hitro, kot lahko, da vnesete preostanek cepiva.
Contains also: sucrose, dipotassium phosphate, potassium dihydrogen phosphate, gelatin (porcine, Type A), arginine hydrochloride, monosodium glutamate monohydrate, water for injections. 
Vsebuje tudi: saharozo, kalijev hidrogenfosfat, kalijev dihidrogenfosfat, želatino (svinjsko, tipa A), argininijev klorid, natrijev glutamat monohidrat, vodo za injekcije.
Fluenz Tetra must not be injected. 
Cepiva Fluenz Tetra se ne sme injicirati.
General disorders and administration site conditions Very common: Malaise 
Splošne težave in spremembe na mestu aplikacije Zelo pogosti: slabost
- If you have any further questions, ask your doctor, nurse or pharmacist. 
- Če imate dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Tell your doctor straight away or seek urgent medical care if you experience any of the effects above. 
Če opazite kateri koli zgoraj naštet neželeni učinek, nemudoma obvestite zdravnika ali poiščite nujno medicinsko pomoč.
Figure 1 Fluenz Tetra Administration 
Slika 1 Aplikacija cepiva Fluenz Tetra
The suspension is colourless to pale yellow, clear to slightly cloudy. 
Suspenzija je brezbarvna do bledorumena, bistra do nekoliko motna.
The co-administration of trivalent Fluenz with the live attenuated vaccines: measles, mumps, rubella, varicella and orally-administered poliovirus has been studied. 
Preučili so sočasno uporabo trivalentnega cepiva Fluenz z živimi oslabljenimi cepivi proti ošpicam, mumpsu, rdečkam, noricam in peroralnim cepivom proti otroški paralizi.
• After administering half of the dose in one nostril, administer the other half of the dose in the other nostril immediately or shortly thereafter. 
• Kmalu ali takoj po aplikaciji polovice odmerka v eno nosnico aplicirajte drugo polovico v drugo nosnico.
• Fluenz Tetra is administered as a divided dose in both nostrils. 
• Cepivo Fluenz Tetra se aplicira kot razdeljen odmerek v obe nosnici.
Check expiry date Product must be used before date on applicator label. 
Preverite rok uporabnosti Cepivo uporabite pred datumom na nalepki nosnika.
Improved Efficacy (95% CI) Matched strains 
Izboljšana učinkovitost (95-% IZ) Ujemajoči se sevi
If you have any further questions on this vaccine, ask your doctor, nurse or pharmacist. 
Če imate dodatna vprašanja o uporabi cepiva, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
For administration in the other nostril, pinch and remove the dose-divider clip from plunger. 
Odstranite sponko za razdelitev odmerka Za vnos v drugo nosnico odščipnite in odstranite sponko za razdelitev odmerka z bata.
The other ingredients are sucrose, dipotassium phosphate, potassium dihydrogen phosphate, gelatin (porcine, Type A), arginine hydrochloride, monosodium glutamate monohydrate and water for injections. 
Pomožne snovi so saharoza, kalijev hidrogenfosfat, kalijev dihidrogenfosfat, želatina (svinjska, tipa A), argininijev klorid, natrijev glutamat monohidrat in voda za injekcije.
You will not be given Fluenz Tetra: 
Cepiva Fluenz Tetra ne boste prejeli
If any of these apply, tell your doctor, nurse or pharmacist. 
Če karkoli od tega velja za vas, obvestite zdravnika, farmacevta ali medicinsko sestro.
Nasal spray, suspension 1 single-use nasal applicator (0.2 ml) 10 single-use nasal applicators (0.2 ml each) 
1 nosnik za enkratno uporabo (0,2 ml) 10 nosnikov za enkratno uporabo (vsak po 0,2 ml)
- If any of the side effects gets serious, talk to your doctor, nurse or pharmacist. 
- Če katerikoli neželeni učinek postane resen, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Dipotassium phosphate Potassium dihydrogen phosphate Gelatin (porcine, Type A) Arginine hydrochloride Monosodium glutamate monohydrate Water for injections 
6.1 Seznam pomožnih snovi saharoza kalijev hidrogenfosfat kalijev dihidrogenfosfat želatina (svinjska, tip A) argininijev klorid natrijev glutamat monohidrat voda za injekcije
Do not inject Fluenz Tetra. 
Cepiva Fluenz Tetra ne injicirajte.
No data exist regarding the safety of intranasal administration of Fluenz Tetra in children with unrepaired craniofacial malformations. 
O intranazalnem dajanju cepiva Fluenz Tetra otrokom z nepopravljenimi kraniofacialnimi deformacijami ni podatkov.
Fluenz Tetra will be given as a spray in each nostril. 
Cepivo Fluenz Tetra se daje v obliki pršila v vsako nosnico.
Fluenz Tetra is administered as a divided dose in both nostrils. 
Cepivo Fluenz Tetra se daje kot razdeljen odmerek v obe nosnici.
Immunisation must be carried out by nasal administration. 
Imunizacija se opravi z nazalno uporabo.
After administering half of the dose in one nostril, administer the other half of the dose in the other nostril immediately or shortly thereafter. 
Kmalu ali takoj po aplikaciji polovice odmerka v eno nosnico, dajte drugo polovico v drugo nosnico.
Fluenz Tetra immunogenicity 
Imunogenost cepiva Fluenz Tetra
Improved Efficacy (95% CI) All strains regardless of match 
Izboljšana učinkovitost (95-% IZ) Vsi sevi neodvisno od ujemanja
How to store Fluenz Tetra 
Kako uporabljati cepivo Fluenz Tetra
Fluenz Tetra must only be used as a nasal spray. 
Cepivo Fluenz Tetra se lahko uporablja le v obliki pršila za nos.
Remove dose-divider clip 
Sponka za razdelitev odmerka
How Fluenz Tetra works 
Kako učinkuje cepivo Fluenz Tetra
Efficacy (95% CI) Matched strains 
Učinkovitost (95-% IZ) Ujemajoči se sevi
Efficacy (95% CI) All strains regardless of match 
Učinkovitost (95-% IZ) Vsi sevi neodvisno od ujemanja
Fluenz Tetra is for nasal use only. 
Cepivo Fluenz Tetra JE SAMO ZA NAZALNO UPORABO.
Fluenz Tetra IS FOR NASAL USE ONLY. 
Cepivo Fluenz Tetra je samo za nazalno uporabo.
Medicinal products subject to medical prescription. 
Predpisovanje in izdaja zdravil je le na recept.
Age Range 
Starostni razpon
Skin and subcutaneous tissue disorders Uncommon: Rash 
Bolezni kože in podkožja Občasni: izpuščaj
What Fluenz Tetra contains 
Kaj vsebuje cepivo Fluenz Tetra
6 to 71 M 2,085 2002-2003 
D153-P514 Evropa 6 do 71 m 2.085 2002 - 2003
- Keep this leaflet. 
Napršite v drugo nosnico
The review was initiated on the basis of unresolved safety and efficacy concerns. 
Pregled je bil sprožen zaradi nerešenih vprašanj glede varnosti in učinkovitosti.
Prozac and associated names 
Prozac in z njim povezana imena
The final opinion was converted into a Decision by the European Commission on 21 August 2006. 
Končno mnenje je bilo spremenjeno v Odločbo Evropske komisije dne 21. avgusta 2006.
International Non-Proprietary Name (INN): Fluoxetine 
Mednarodno nelastniško ime (INN): Fluoksetin
London, 21 August 2006 EMEA/311654/2006 
London, 21. avgusta 2006 EMEA/311654/2006
The referral procedure started on 26 May 2005. 
Napotitveni postopek se je začel 26. maja 2005.
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 6(12) REFERRAL 
ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI (CHMP) MNENJE V ZVEZI Z NAPOTITVIJO IZ ČLENA 6(12)
* Notes: The information given in this document and Annexes reflect only the CHMP Opinion dated 1 June 2006. 
* Opombe: Informacije, podane v tem dokumentu in Dodatkih, odražajo samo mnenje CHMP z dne 1. junija 2006.
The Rapporteur and Co-Rapporteur appointed were: Dr Barbara van Zwieten-Boot and Dr Tomas Salmonson, respectively. 
Za poročevalca je bila imenovana dr. Barbara van Zwieten-Boot in za soporočevalca dr. Tomas Salmonson.
Fluoxetine is a selective inhibitor of serotonin reuptake. 
Fluoksetin je selektivni zaviralec ponovnega prevzema serotonina.
Written explanations were provided by the Marketing Authorisation Holders on 29 August 2005, 6 January 2006, 3 April 2006 and 11 May 2006. 
Imetniki dovoljenj za promet z zdravilom so pisna pojasnila predložili 29. avgusta 2005, 6. januarja 2006, 3. aprila 2006 in 11. maja 2006.
Based on evaluation of the currently available data and the Rapporteurs' assessment reports, the CHMP considered that the benefits of Prozac are greater than its potential risks in this population and therefore adopted an opinion on 1 June 2006 recommending the following extension of the indication: 
Na podlagi vrednotenja trenutno razpoložljivih podatkov in poročevalčevega poročila o oceni je CHMP menil, da so pri tej populaciji koristi zdravila Prozac večje od z njim povezanih morebitnih tveganj in je zato dne 1. junija 2006 sprejel mnenje, v katerem priporoča naslednjo razširitev indikacije:
On 2 May 2005, France referred the matter to the EMEA under Article 6(12) of Commission Regulation EC No 1084/2003. 
Francija je dne 2. maja 2005 Evropski agenciji za zdravila (EMEA) predložila napotitev v skladu s členom 6(12) Uredbe Komisije (ES) št. 1084/2003.
Prozac is authorised in most EU Member States for the treatment of major depressive episodes, obsessive-compulsive disorder and bulimia nervosa in adults. 
Prozac je odobren v večini držav članic EU za zdravljenje hudih epizod depresije, obsesivnokompulzivnih motenj in bulimije nervoze pri odraslih.