FrancophonIA/ELRC3.0 huggingface dataset:
English: PHARMACEUTICAL FORM AND CONTENTS 1 bottle with 250 ml solution for infusion Component of a multipack
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 1 steklenica z 250 ml raztopine za infundiranje Sestavni del več pakiranj
English: [Moxifloxacin] 400 mg solution for infusion is indicated for the treatment of: - Community acquired pneumonia - Complicated skin and structure infections
Slovenian: [Moksifloksacin] 400 mg raztopina za infundiranje je indicirana za zdravljenje:
English: The activity of moxifloxacin is not affected by mechanisms of resistance that are specific to antibacterial agents of other classes.
Slovenian: Mehanizmi odpornosti, ki so značilni za protimikrobna zdravila iz drugih skupin, ne vplivajo na protimikrobno aktivnost moksifloksacina.
English: For Octegra be aware of the following: - If you are taking other medicines that affect your heart during treatment with Octegra there is an increased risk for altering your heart rhythm.
Slovenian: Če med zdravljenjem z zdravilom Octegra jemljete druga zdravila, ki vplivajo na srce, obstaja povečano tveganje za spremembe srčnega ritma.
English: Uncommon ≥ 1/1,000 to
Slovenian: občasni > 1/1.000 do <
English: Moxifloxacin was non-carcinogenic in an initiation-promotion study in rats.
Slovenian: V iniciacijsko promocijski študiji na podganah niso ugotovili karcinogenega delovanja moksifloksacina.
English: A large number of cases showing an increase in oral anticoagulant activity have been reported in patients receiving antibacterial agents, especially fluoroquinolones, macrolides, tetracyclines, cotrimoxazole and some cephalosporins.
Slovenian: Spremembe internacionalnega normaliziranega razmerja (INR) Pri bolnikih, ki so dobivali antibiotike, predvsem fluorokinolone, makrolide, tetracikline, kotrimoksazol in nekatere cefalosporine, so poročali o velikem številu primerov pri katerih se je aktivnost peroralnega antikoagulanta zvečala.
English: Concomitant administration of moxifloxacin with ranitidine or probenecid did not alter renal clearance of the parent drug.
Slovenian: Sočasna uporaba moksifloksacina in ranitidina ali probenecida ne vpliva na ledvični očistek prvotne učinkovine.
English: There is no data available in lactating or nursing women.
Slovenian: Podatkov o uporabi moksifloksacina pri doječih ženskah ni na voljo.
English: - Cases of fulminant hepatitis potentially leading to liver failure (including fatal cases) have been reported with moxifloxacin (see section 4.8).
Slovenian: V povezavi z moksifloksacinom so poročali o primerih fulminantnega hepatitisa, ki lahko povzroči jetrno odpoved (vključno s smrtnimi primeri) (glejte poglavje 4.8).
English: No prolongation of the QT interval was seen when a dose of 30 mg/kg was infused over 60 minutes.
Slovenian: Če so odmerek 30 mg/kg infundirali v 60 minutah, niso opazili podaljšanja intervala QT.
English: Toxic effects on the CNS were observed in monkeys.
Slovenian: Pri opicah so opazili toksične učinke na osrednje živčevje.
English: Quinolones, including moxifloxacin, are known to cause lesions in the cartilage of the major diarthrodial joints in immature animals.
Slovenian: Znano je, da kinoloni povzročajo poškodbe sklepnega hrustanca v nosilnih sklepih nerazvitih živalskih mladičev.
English: PHARMACEUTICAL FORM AND CONTENTS 1 bag with 250 ml solution for infusion
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 1 vreča z 250 ml raztopine za infundiranje
English: Resistance to fluoroquinolones can arise through mutations in DNA gyrase and topoisomerase IV. Other mechanisms may include over-expression of efflux pumps, impermeability, and protein-mediated protection of DNA gyrase.
Slovenian: Drugi mehanizmi so lahko prekomerno izraženi mehanizmi prehoda, neprepustnost in zaščita giraze DNK s pomočjo proteinov.
English: Intravenous use 400 mg / 250 ml
Slovenian: 400 mg raztopina za infundiranje intravenska uporaba 400 mg / 250 ml
English: NAME OF THE MEDICINAL PRODUCT Octegra and associated names (see Annex I) 400 mg/250 ml solution for infusion [See Annex I - To be completed nationally] Moxifloxacin
Slovenian: Octegra in povezana imena (Glejte Dodatek I) 400 mg/250 ml raztopina za infundiranje [Glejte Dodatek I - Izpolni država članica] moksifloksacin
English: In the interstitial fluid unbound concentration time profiles similar to those in plasma were found with unbound peak concentrations of 1.0 mg/l (geometric mean) reached approximately 1.8 h after an intravenous dose.
Slovenian: Največja koncentracija nevezane učinkovine 1,0 mg/l (geometrijska sredina) je bila dosežena približno 1,8 ure po intravenski uporabi.
English: Superinfections due to resistant bacteria or fungi e.g. oral and vaginal candidiasis
Slovenian: zelo redki infekcijske in parazitske bolezni superinfekcije z odpornimi bakterijami ali glivicami (npr. kandidoza v ustih in vaginalna kandidoza)
English: very rarely life-threatening shock (e.g. difficulty in breathing, drop of blood pressure, fast pulse), swelling (incl.
Slovenian: huda, nenadna splošna alergijska reakcija, tudi zelo redko smrtno nevaren šok (npr. težave pri dihanju, zmanjšanje krvnega tlaka, hiter utrip), otekline (tudi potencialno smrtno nevarna oteklina v dihalnih poteh)
English: It was considered that the same restrictions should apply to the indications for both CAP and cSSTI as already adopted by CHMP for oral moxifloxacin to treat CAP. Intravenous moxifloxacin is almost always followed by oral treatment and as such the restriction for use of oral moxifloxacin should be reflected in the SPC of the intravenous product.
Slovenian: Menili so, da naj bi enake omejitve veljale za indikacije tako za izvenbolnišnično pridobljeno pljučnico kot tudi za zapletene okužbe kože in mehkih tkiv, kot jih je že določil CHMP za peroralni moksifloksacin za zdravljenje izvenbolnišnično pridobljene pljučnice.
English: CARTON FOR UNIT PACK AND LABEL - GLASS BOTTLE
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI ŠKATLA Z ENIM PAKIRANJEM IN NALEPKA - STEKLENICA
English: However, studies have shown that moxifloxacin has a lower risk to induce photosensitivity.
Slovenian: Ugotovili so, da kinoloni pri bolnikih povzročajo fotosenzitivne reakcije, vendar pa so s študijami dokazali, da je pri moksifloksacinu tveganje za nastanek fotosenzitivnosti manjše.
English: Netherlands Bayer HealthCare AG 51368 Leverkusen Germany
Slovenian: Nizozemska Bayer HealthCare AG 51368 Leverkusen
English: BEFORE YOU USE OCTEGRA
Slovenian: Pred prvo uporabo zdravila Octegra
English: NAME OF THE MEDICINAL PRODUCT Octegra and associated names (see Annex I) 400 mg/250 ml solution for infusion [See Annex I - To be completed nationally]
Slovenian: Octegra in povezana imena (Glejte Dodatek I) 400 mg/250 ml raztopina za infundiranje [Glejte Dodatek I - Izpolni država članica]
English: PHARMACEUTICAL FORM AND CONTENTS 5 bottles with 250 ml solution for infusion Multipack
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 5 steklenic z 250 ml raztopine za infundiranje Več pakiranj
English: - Quinolones have been shown to cause photosensitivity reactions in patients.
Slovenian: Znano je, da kinoloni povzročajo epileptične napade.
English: Species for which acquired resistance may be a problem Aerobic Gram-positive micro-organisms
Slovenian: Mycoplasma pneumoniae* vrste, pri katerih je pridobljena odpornost lahko vprašljiva aerobni, po Gramu pozitivni mikroorganizmi Enterococcus faecalis* aerobni, po Gramu negativni mikroorganizmi Enterobacter cloacae
English: Luxembourg Bayer HealthCare AG 51368 Leverkusen Germany
Slovenian: Luksemburg Bayer HealthCare AG 51368 Leverkusen
English: PK/PD
Slovenian: FK/FD (farmakokinetika/farmakodinamika)
English: Intra-arterial administration should be avoided since preclinical studies demonstrated peri-arterial tissue inflammation following infusion by this route.
Slovenian: Ker so v predkliničnih študijah dokazali vnetje periarterialnega tkiva, ki se je pojavilo, če so zdravilo infundirali intraarterialno, se je treba temu načinu dajanja izogibati.
English: frequency cannot be estimated from the available data
Slovenian: pojavijo se pri manj kot 1 bolniku od 100.000 bolnikov Neznana pogostnost: pogostnosti iz razpoložljivih podatkov ni mogoče oceniti
English: Use should be with caution in patients with CNS disorders which may predispose to seizures or lower the seizure threshold.
Slovenian: Bolniki z motnjami osrednjega živčevja jih morajo uporabljati previdno, saj lahko povzročijo epileptične napade ali znižajo prag njihovega pojava.
English: - Elderly patients with renal disorders should use moxifloxacin with caution if they are unable to maintain adequate fluid intake, because dehydration may increase the risk of renal failure.
Slovenian: Starejši bolniki z motnjami v delovanju ledvic, ki ne morejo skrbeti za zadosten vnos tekočine, morajo uporabljati moksifloksacin previdno.
English: Moxifloxacin IV for cSSSI was approved in 2005 in all countries that had already approved the intravenous formulation for use in CAP. No consensus was reached on Day 60 of the CMD(h) referral and the procedure was therefore referred to the CHMP.
Slovenian: Intravenozni moksifloksacin za zapletene okužbe kože in mehkih tkiv je bil leta 2005 odobren v vseh državah, ki so že odobrile intravenozno formulacijo za uporabo pri izvenbolnišnično pridobljeni pljučnici.
English: Pain or inflammation at injection site Uncommon: Inflammation of a vein
Slovenian: bolečina ali vnetje na mestu injiciranja
English: HOW TO STORE OCTEGRA
Slovenian: SHRANJEVANJE ZDRAVILA OCTEGRA
English: Very common: affects more than 1 user in 10
Slovenian: pojavijo se pri več kot 1 od 10 bolnikov
English: Changes in Laboratory Test Results Uncommon: Increased blood lipids (fats) Rare:
Slovenian: Spremembe laboratorijskih vrednosti Občasni:
English: - If you have a history of tendon disease or disorder which was related to treatment with quinolone antibiotics (see sections Take special care ... and 4.
Slovenian: Dodatne informacije) zdravila Octegra, - če ste noseči ali dojite, - če ste otrok ali mladostnik v obdobju rasti, če se je po zdravljenju s kinolonskimi antibiotiki pri vas že pojavil tendinitis ali poškodba kite (glejte poglavje Bodite posebno pozorni... in 4.
English: The CHMP was of the opinion that the use of IV moxifloxacin for treatment of CAP should be qualified by the same wording as the cSSSI indication.
Slovenian: Zdravljenje izvenbolnišnično pridobljene pljučnice CHMP je bil mnenja, da mora biti uporaba intravenoznega moksifloksacina za zdravljenje izvenbolnišnično pridobljene pljučnice opredeljena v istem besedilu kot indikacija za zapletene okužbe kože in mehkih tkiv.
English: Rupture of tendon, inflammation of joints, muscle rigidity, worsening of the symptoms of myasthenia gravis
Slovenian: bolečina in oteklina kit (vnetje kit; tendinitis), mišični krči, trzanje mišic Zelo redki: pretrganje kite, vnetje v sklepih, mišična rigidnost, poslabšanje znakov miastenije gravis
English: Severe, sudden generalised allergic reaction incl.
Slovenian: Alergijske reakcije Občasni:
English: The following solutions are incompatible with moxifloxacin solution for infusion: Sodium chloride 10% and 20% solutions
Slovenian: Naslednje raztopine so inkompatibilne z raztopino moksifloksacina za infundiranje: 10 % in 20 % raztopina natrijevega klorida 4,2 % in 8,4 % raztopina natrijevega karbonata
English: Injection and infusion site reactions
Slovenian: Infusionslösung
English: At the first sign of any pain or inflammation you should stop taking Octegra, rest the affected limb and consult your doctor immediately.
Slovenian: Takoj ko se pojavijo bolečine ali vnetje, je treba prenehati uporabljati zdravilo Octegra, prizadeti ud pa mora mirovati.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 bottle of 250 ml contains 400 mg moxifloxacin (as hydrochloride).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 steklenica (250 ml) vsebuje 400 mg moksifloksacina v obliki moksifloksacinijevega klorida.
English: - If your eyesight becomes impaired or if you have any other eye disturbances whilst taking Octegra, consult an eye specialist immediately.
Slovenian: Če se pri vas med uporabo zdravila Octegra pojavijo kakršnekoli motnje vida ali očesne spremembe, se takoj posvetujte z oftalmologom.
English: very rarely lifethreatening shock (see section 4.4) Allergic oedema / angiooedema (incl.
Slovenian: zelo redki bolezni imunskega sistema alergijska reakcija (glejte poglavje anafilaksa (tudi zelo redko smrtno nevaren šok, glejte poglavje alergijski edem/angioedem (tudi edem grla, ki je lahko smrtno nevaren, glejte poglavje 4.4)
English: Muscle rigidity Exacerbation of symptoms of myasthenia gravis (see section 4.4)
Slovenian: zelo redki bolezni mišičnoskeletnega sistema in vezivnega tkiva artralgija mialgija tendinitis (glejte poglavje 4.4) mišični krči trzanje mišic ruptura kite (glejte poglavje artritis mišična rigidnost poslabšanje simptomov miastenije gravis (glejte poglavje 4.4)
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 bag of 250 ml contains 400 mg moxifloxacin (as hydrochloride).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 vreča (250 ml) vsebuje 400 mg moksifloksacina v obliki moksifloksacinijevega klorida.
English: Uncommon: Feeling unwell (predominantly weakness or tiredness), aches and pains such as back, chest,
Slovenian: slabo počutje (predvsem slabotnost ali utrujenost), boleča stanja (bolečine v hrbtu, prsnem košu, medenici in udih), znojenje
English: Difficulty in swallowing, inflammation of the mouth, severe diarrhoea containing blood and/or mucus (antibiotic associated colitis incl.
Slovenian: težave pri požiranju, vnetje v ustih, huda driska, ki vsebuje kri in/ali sluz (kolitis, povezan z antibiotičnim zdravljenjem, tudi psevdomembranski kolitis), ki se v zelo redkih primerih lahko razvije v smrtno nevarne zaplete
English: Streptococcus pyogenes* (Group A)
Slovenian: Streptococcus pyogenes* (skupina A) aerobni, po Gramu negativni mikroorganizmi Haemophilus influenzae*
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 bottle or 1 bag of 250 ml contains 400 mg moxifloxacin (as hydrochloride).
Slovenian: 1 steklenica ali 1 vreča (250 ml) vsebuje 400 mg moksifloksacina v obliki moksifloksacinijevega klorida.
English: electrical recording of the heart) changes.
Slovenian: upočasnjeno prevajanje električnih signalov).
English: Please contact your doctor before you continue the treatment if you suddenly start to feel unwell or notice yellowing of the whites of the eyes, dark urine, itching of the skin, a tendency to bleed or disturbances of thought or wakefulness.
Slovenian: Če se nenadoma slabo počutite ali opazite porumenele beločnice, temen urin, srbenje kože, nagnjenost h krvavitvam ali ste nezbrani in dremavi, prosimo, da se pred nadaljevanjem zdravljenja posvetujete z zdravnikom.
English: There was an increase in the incidence of abortions in monkeys and rabbits at human therapeutic plasma concentrations.
Slovenian: Če je bila terapevtska plazemska koncentracija enaka kot pri človeku, se je pri opicah in kuncih povečala pogostost splavov.
English: Cardiac and vascular disorders
Slovenian: Motnje v delovanju ledvic/jeter
English: Aerobic Gram-positive micro-organisms
Slovenian: splošno občutljive vrste aerobni, po Gramu pozitivni mikroorganizmi Staphylococcus aureus*+
English: Uncommon: affects 1 to 10 users in 1,000 Rare:
Slovenian: pojavijo se pri 1 do 10 bolnikih od 1.000 bolnikov
English: Octegra can be administered via a T-tube together with the following solutions:
Slovenian: Zdravilo Octegra je indicirano za zdravljenje:
English: Changes in INR
Slovenian: DODATEK III
English: Commonly susceptible species
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA
English: Muscular and Joint System Uncommon: Joint pain, muscle pain Rare:
Slovenian: Mišični in vezivni sistem Občasni:
English: Most importantly, response rates in staphylococcal infections were comparable between treatments as were responses for the relatively small number of Group A streptococcal infections.
Slovenian: Najpomembneje pa je, da so bile stopnje odzivnosti pri stafilokoknih okužbah med posameznimi oblikami zdravljenja primerljive in da je bila primerljiva tudi odzivnost pri relativno majhnem številu okužb s streptokokom skupine A. Na splošno je CHMP menil, da podatki glede učinkovitosti intravenoznega/peroralnega zdravljenja z moksifloksacinom niso pretirano prepričljivi, to dejstvo pa je treba upoštevati pri varnostnem profilu, kot je razloženo spodaj.
English: HOW TO USE OCTEGRA
Slovenian: Med uporabo zdravila Octegra
English: Increase of a special liver enzyme in the blood (transaminases) Uncommon: Impaired liver function (incl.
Slovenian: zvečane vrednosti posebnih jetrnih encimov v krvi (transaminaze)
English: Bullous skin reactions like Stevens-Johnson syndrome or toxic epidermal necrolysis (potentially lifethreatening, see section 4.4)
Slovenian: fulminantni hepatitis, ki lahko povzroči življenjsko ogrožajočo jetrno odpoved (vključno s smrtnimi primeri) (glejte poglavje bolezni kože in podkožja srbenje izpuščaji koprivnica suha koža bulozne kožne spremembe, npr. StevensJohnsonov sindrom ali toksična epidermalna nekroliza, ki je lahko smrtno nevarna (glejte poglavje 4.4)
English: - Keep this leaflet.
Slovenian: Bodite posebno pozorni...).
English: Infusion site Common:
Slovenian: Prebavni sistem Pogosti:
English: Before you use Octegra..., Take special care ...).
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Octegra...)
English: Patients should be advised to contact their doctor prior to continuing treatment if signs and symptoms of fulminant hepatic disease develop such as rapidly developing asthenia associated with jaundice, dark urine, bleeding tendency or hepatic encephalopathy.
Slovenian: Če se razvijejo znaki in simptomi fulminantne jetrne bolezni (npr. hitro nastajanje astenije, zlatenica, temen seč, nagnjenost h krvavitvam ali jetrna encefalopatija), je treba bolnikom svetovati, da se pred nadaljevanjem zdravljenja posvetujejo z zdravnikom.
English: In conclusion, the CHMP considered that the use of IV moxifloxacin for treatment of community-acquired pneumonia (CAP) or complicated skin and soft tissue infections (cSSTI) should be qualified as follows:
Slovenian: PODLAGA ZA POZITIVNO MNENJE IN DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODIL ZA UPORABO V zaključku je CHMP menil, da mora biti uporaba intravenoznega moksifloksacina za zdravljenje izvenbolnišnično pridobljene pljučnice ali zapletenih okužb kože in mehkih tkiv opredeljena na naslednji način:
English: - If you are elderly with existing kidney problems take care that your fluid intake is sufficient because dehydration may increase the risk of kidney failure - Octegra may occasionally cause pain and inflammation of your tendons, particularly if you are elderly or if you are currently being treated with corticosteroids.
Slovenian: Če ste starejši in imate težave z ledvicami, poskrbite za zadosten vnos tekočine, kajti dehidracija lahko poveča tveganje za ledvično odpoved.
English: QT prolongation (see section 4.4) Palpitations Tachycardia Atrial fibrillation Angina pectoris Vasodilatation
Slovenian: zelo redki srčno-žilne bolezni podaljšan interval QT pri bolnikih s hipokaliemijo (glejte poglavje podaljšan interval QT (glejte poglavje 4.4) palpitacije tahikardija atrijska fibrilacija angina pektoris vazodilatacija ventrikularna tahiaritmija sinkopa (nenadna kratkotrajna nezavest) hipertenzija hipotenzija nespecifične aritmije torsade de pointes (glejte poglavje 4.4) srčni zastoj (glejte poglavje bolezni dihal, prsnega koša in mediastinalnega prostora dispneja (tudi astma)
English: Oedema
Slovenian: Presnova
English: Musculoskeletal, connective tissue and bone disorders
Slovenian: izvenbolnišnično pridobljene pljučnice zapletenih okužb kože in mehkih tkiv
English: Octegra 400 mg / 250 ml Infusionslösung
Slovenian: Octegra 400 mg / 250 ml
English: Recovery of the dose (unchanged drug and metabolites) totalled to approximately 98% after intravenous administration of the drug.
Slovenian: Po intravenski uporabi se je izločilo približno 98 % učinkovine (nespremenjena učinkovina in presnovki).
English: Do not take Octegra if you are pregnant or breast-feeding.
Slovenian: Če ste noseči ali dojite, ne uporabljajte zdravila Octegra.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI OMOT IN VREČA
English: The following undesirable effects have a higher frequency category in the subgroup of IV treated patients with or without subsequent oral therapy:
Slovenian: zdravljenih bolnikov (ki so imeli sekvenčno zdravljenje ali pa ne), pojavili pogosteje:
English: pain in back, chest, pelvic and extremities) Sweating
Slovenian: slabost, bruhanje, bolečina v želodcu in trebuhu, driska
English: Ventricular tachyarrhythmias Syncope (i.e., acute and short lasting loss of consciousness) Hypertension Hypotension
Slovenian: presnovne in prehranske motnje hiperlipidemija hiperglikemija hiperurikemija psihiatrične motnje anksioznost psihomotorična hiperaktivnost agitacija čustvena labilnost depresija (v zelo redkih primerih potencialno samoogrožajoče vedenje) halucinacije depersonalizacija psihotične reakcije (potencialno samoogrožajoče vedenje)
English: before the corresponding lists of source countries.
Slovenian: pred ustreznimi seznami držav izvora.
English: routes should be provided as soon as it is available
Slovenian: dajanju je treba predložiti takoj, ko bodo na voljo.
English: II.C.2 Not listed in a Pharmacopoeia
Slovenian: II.C.2 Niso navedene v farmakopeji
English: An up-to-date certificate of suitability should be provided for Rousselot Acid hide gelatin (European origin)
Slovenian: Predložiti je treba veljaven certifikat o ustreznosti za Rousselot Acid hide gelatin (evropski izvor)
English: Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu
Slovenian: Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency, EMEA) http://www.emea.europa.eu/
English: A clear justification should be given in support of the proposed pass level of an HI serum titre of 6.0 log2.
Slovenian: Podana mora biti jasna utemeljitev predlagane mejne vrednosti titra HI v serumu 6,0 log2.
English: Tryptose: The Applicant should provide a list of any changes to the source countries for the pigs used as a source of the porcine starting material in tryptose.
Slovenian: Triptoza: Predlagatelj mora predložiti seznam vseh sprememb držav izvora za prašiče, uporabljenih kot vir prašičje vhodne snovi v triptozi.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/07/073/001-004
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/07/073/001-004
English: A dose of 1 ml is advised.
Slovenian: Priporočeni odmerek je 1 ml.
English: Specific Measures concerning the prevention of the transmission of animal spongiform encephalopathies
Slovenian: Posebni ukrepi, ki se nanašajo na preprečitev prenosa živalske spongiformne encefalopatije
English: The applicant is required to submit 3-montly Periodic Update Safety reports for the first 2 years following the initial use in the field and is additionally required to present a protocol that would ensure adequate recording and reporting of field data in relation to suspected adverse reactions including suspected lack of efficacy.
Slovenian: Predlagatelj mora predložiti 3-mesečna periodična poročila o varnosti za prvi 2 leti po prvi uporabi na terenu in protokol, ki zagotavlja ustrezno zapisovanje podatkov in poročanje o podatkih s terena o sumu na neželene učinke, tudi sumu na odsotnost učinkovitosti.
English: PET vials: 2 years
Slovenian: Viale iz PET: 2 leti
English: Any person intending to import, sell, supply and/or use Nobilis Influenza H7N1 must consult the relevant Member State's competent authority on the current vaccination policies prior to the import, sale, supply and/or use.
Slovenian: Vsakdo, ki namerava uvažati, prodajati, oskrbovati in/ali uporabljati Nobilis Influenza H7N1, se mora posvetovati s pristojnimi organi posamezne države članice o veljavnih programih cepljenja še pred uvozom, prodajo, oskrbo in/ali uporabo.