FrancophonIA/ELRC3.0 huggingface dataset:
English: What you need to know before you take Voriconazole Hikma
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Vorikonazol Hikma Ne jemljite zdravila Vorikonazol Hikma
English: If you stop taking Voriconazole Hikma
Slovenian: Če ste prenehali uporabljati zdravilo Vorikonazol Hikma:
English: Although not studied, voriconazole is likely to increase the plasma concentrations of ergot alkaloids and lead to ergotism.
Slovenian: Čeprav ni raziskano, lahko vorikonazol poveča koncentracijo alkaloidov ergot v plazmi in povzroči ergotizem.
English: • Tacrolimus (used in transplant patients)
Slovenian: • takrolimus (uporablja se pri bolnikih po presaditvah organov)
English: PHARMACOLOGICAL PROPERTIES
Slovenian: Splošne farmakokinetične značilnosti
English: • Oral contraceptives (if you take Voriconazole Hikma whilst using oral contraceptives, you may get side effects such as nausea and menstrual disorders)
Slovenian: • peroralne kontraceptive (če med jemanjem peroralnih kontraceptivov jemljete zdravilo Vorikonazol
English: Although not studied, voriconazole is likely to increase the plasma concentrations of sulfonylureas and cause hypoglycaemia.
Slovenian: Čeprav ni raziskano, lahko vorikonazol poveča koncentracijo sulfonilsečnin v plazmi in tako povzroči hipoglikemijo.
English: retinal haemorrhage optic nerve disorder7, papilloedema8, oculogyric crisis, diplopia, scleritis, blepharitis optic atrophy, corneal opacity
Slovenian: mrežnične krvavitve obolenje vidnega živca7, edem papile vidnega živca8, okulogirna kriza, diplopija, skleritis, blefaritis atrofija vidnega živca, zamotnitev roženice
English: In an oral multiple dose study, AUCτ was similar in subjects with moderate hepatic cirrhosis (Child-Pugh B) given a maintenance dose of 100 mg twice daily and subjects with normal hepatic function given 200 mg twice daily.
Slovenian: V študiji večkratnih peroralnih odmerkov je bila AUCτ pri preskušancih z zmerno cirozo jeter (ChildPugh B), ki so dobivali vzdrževalni odmerek 100 mg dvakrat na dan, podobna kot pri preskušancih z normalnim delovanjem jeter, ki so dobivali 200 mg dvakrat na dan. Farmakokinetičnih podatkov za bolnike s hudo cirozo jeter (Child-Pugh C) ni (glejte poglavji 4.2 in 4.4).
English: It is recommended that the standard loading dose regimens be used but that the maintenance dose be halved in patients with mild to moderate hepatic cirrhosis (Child-Pugh A and B) receiving voriconazole (see section
Slovenian: Pri bolnikih z blago do zmerno cirozo jeter (Child-Pugh A in B), ki dobivajo vorikonazol, je priporočljivo uporabiti standardno polnilno odmerjanje, vzdrževalni odmerek pa prepoloviti (glejte poglavje 5.2).
English: The medicines in the following list must not be taken during your Voriconazole Hikma treatment:
Slovenian: Med zdravljenjem z zdravilom Vorikonazol Hikma ne smete jemati zdravil, ki so na spodnjem seznamu:
English: • Pancreatitis which may present with severe abdominal pain
Slovenian: • vnetje trebušne slinavke, ki se lahko kaže kot hude bolečine v trebuhu
English: How to take Voriconazole Hikma
Slovenian: Kako jemati zdravilo Vorikonazol Hikma
English: • Constipation, indigestion, inflammation of the lips
Slovenian: • zaprtje, prebavne težave, vnetje ustnic
English: Short acting opiates (CYP3A4 substrate)
Slovenian: Kratkodelujoči opiati (substrat CYP3A4)
English: Other Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) (e.g., delavirdine, nevirapine)*
Slovenian: drugi nenukleozidni zaviralci reverzne transkriptaze (NNRTIs) (kot sta delavirdin, nevirapin)* [substrati CYP3A4, inhibitorji ali induktorji CYP450]
English: Ear and labyrinth disorders hypoacusis, vertigo, tinnitus
Slovenian: Ušesne bolezni, vključno z motnjami labirinta hipakuza, vrtoglavica, tinitus
English: Voriconazole should be administered with caution in patients with concomitant medication that is known to prolong QTc interval.
Slovenian: Pri bolnikih, ki sočasno jemljejo zdravila, ki podaljšujejo interval QTc, je treba vorikonazol uporabljati previdno.
English: Tell your docotor if you experience this.
Slovenian: Če doživite te učinke, to povejte zdravniku.
English: *Oral dosage forms of voriconazole are available from other manufacturers **This also applies to patients aged 15 years and older.
Slovenian: *Peroralne oblike vorikonazola so na voljo s s strani drugih proizvajalcev.
English: Warfarin (30 mg single dose, coadministered with 300 mg BID voriconazole) [CYP2C9 substrate] Other oral coumarins (e.g., phenprocoumon, acenocoumarol) [CYP2C9 and CYP3A4 substrates]
Slovenian: Antikoagulanti varfarin (enkratni 30 mg odmerek, sočasno uporabljan s 300 mg vorikonazola BID) [substrat CYP2C9]
English: Oral bioavailability may, however, be limited in paediatric patients with malabsorption and very low body weight for their age.
Slovenian: Lahko pa je biološka uporabnost po peroralni uporabi omejena pri tistih pediatričnih bolnikih,
English: Electrolyte disturbances such as hypokalaemia, hypomagnesaemia and hypocalcaemia should be monitored and corrected, if necessary, prior to initiation and during voriconazole therapy (see section 4.4).
Slovenian: Pred začetkom in med zdravljenjem z vorikonazolom je treba spremljati in po potrebi korigirati elektrolitske motnje, kot so hipokaliemija, hipomagneziemija in hipokalciemija (glejte poglavje 4.4).
English: Monitoring for voriconazoleassociated adverse reactions is recommended if voriconazole is used sequentially after fluconazole.
Slovenian: Če se vorikonazol uporablja zaporedno za flukonazolom, je priporočljiv nadzor glede neželenih učinkov, povezanih z vorikonazolom.
English: Electrolyte disturbances such as hypokalaemia, hypomagnesaemia and hypocalcaemia should be monitored and corrected, if necessary, prior to initiation and during voriconazole therapy (see section 4.2).
Slovenian: Pred začetkom zdravljenja z vorikonazolom in med njim je treba spremljati in po potrebi korigirati elektrolitske motnje, kot so hipokaliemija, hipomagneziemija in hipokalciemija (glejte poglavje 4.2).
English: Acute renal failure has been observed in severely ill patients undergoing treatment with voriconazole.
Slovenian: Pri hudo bolnih bolnikih, zdravljenih z vorikonazolom, so poročali o akutni ledvični odpovedi.
English: Co-administration of voriconazole with everolimus is not recommended because voriconazole is expected to significantly increase everolimus concentrations.
Slovenian: Everolimus (substrat CYP3A4, substrat P-glikoproteina (P-gp)) Sočasna uporaba vorikonazola in everolimusa ni priporočena, saj se pričakuje, da vorikonazol pomembno zviša koncentracijo everolimusa.
English: Breakthrough IFI - Day 180 2 (1.6%)
Slovenian: Uspešnost na 180. dan* 55 (56,1%)
English: 8 mg/kg dose (number of vials)
Slovenian: odmerek 8 mg/kg (število vial)
English: [CYP3A4 substrates, inhibitors or CYP450 inducers]
Slovenian: [substrati in inhibitorji CYP3A4][CYP3A4 substrates and inhibitors]
English: In an independent published study, Sirolimus Cmax ↑ 6.6-fold Sirolimus AUC0-∞ ↑ 11-fold
Slovenian: v neodvisni objavljeni študiji, sirolimus Cmax ↑ 6,6-krat sirolimus AUC0-∞ ↑ 11-krat ciklosporin Cmax ↑ 13% ciklosporin AUCτ ↑ 70%
English: No dose adjustment
Slovenian: Prilagajanje odmerka ni potrebno.
English: Loading dose regimen (first 24 hours)
Slovenian: polnilni odmerek (prvih 24 ur)
English: 300 mg QD (co-administered with voriconazole 350 mg BID)*
Slovenian: 300 mg QD (sočasno uporabljan s 350 mg vorikonazola BID)
English: Uncommon: may affect up to 1 in 100 people
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov):
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 200 mg of voriconazole.
Slovenian: Ena viala vsebuje 200 mg vorikonazola.
English: Protein binding of voriconazole was not affected by impaired hepatic function.
Slovenian: Okvarjeno delovanje jeter ni vplivalo na vezavo vorikonazola na beljakovine.
English: Do not take Voriconazole Hikma: - If you are allergic to the active ingredient voriconazole or to sulfobutylether beta cyclodextrin sodium
Slovenian: - če ste alergični na vorikonazol ali na sulfobutileter betaciklodekstrin natrij (navedeno v poglavju 6).
English: subcutaneous tissue, mucosa and submucosal tissues, itchy or sore patches of thick, red skin with silvery scales of skin, irritation of the skin and mucous membranes, life-threatening skin condition that causes large portions of the epidermis, the skin's outermost layer, to detach from the layers of skin below
Slovenian: • alergijske kožne reakcije (včasih hude), vključno s hitrim otekanjem (edemom) usnjice, podkožnega tkiva, sluznice in podsluzničnih tkiv, srbeča ali boleča območja debele rdeče kože s srebrnkastimi luskami, draženje kože in sluznic, smrtno nevarno kožno stanje, pri katerem se veliki deli povrhnjice,
English: • Depressed function of the adrenal gland, underactive thyroid gland
Slovenian: • zmanjšano delovanje nadledvične žleze, premalo aktivna ščitnica
English: 9 mg/kg dose (number of vials)
Slovenian: odmerek 9 mg/kg (število vial)
English: Mode of action
Slovenian: Mehanizem delovanja
English: Concomitant use of voriconazole and phenytoin should be avoided unless the benefit outweighs the risk (see section 4.5).
Slovenian: Vorikonazola in fenitoina se ne sme uporabljati sočasno, razen če korist odtehta tveganje (glejte poglavje
English: How to store Voriconazole Hikma
Slovenian: Shranjevanje zdravila Vorikonazol Hikma
English: 6 mg/kg dose (number of vials)
Slovenian: odmerek 6 mg/kg (število vial)
English: Careful monitoring of full blood counts and adverse reactions to rifabutin (e.g., uveitis) is
Slovenian: Med sočasno uporabo rifabutina in vorikonazola je priporočljivo natančno nadziranje celotne krvne slike in neželenih učinkov rifabutina (npr. uveitisa).
English: Cardiovascular
Slovenian: Dojenje
English: Voriconazole (N=98)
Slovenian: Opazovani dogodki v študiji Vorikonazol (n=98)
English: Respiratory, thoracic and mediastinal disorders respiratory distress9
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora dihalna stiska9 akutni sindrom dihalne stiske, pljučni edem
English: 4 mg/kg dose (number of vials)
Slovenian: odmerek 4 mg/kg (število vial)
English: Voriconazole administration induced no impairment of male or female fertility in rats at exposures similar to those obtained in humans at therapeutic doses.
Slovenian: Uporaba vorikonazola pri izpostavljenosti, podobni tisti, ki je pri ljudeh dosežena s terapevtskimi odmerki, ni zmanjšala plodnosti pri podganjih samcih in samicah.
English: Voriconazole Cmax ↓ 4% Voriconazole AUCτ ↓ 32%
Slovenian: v primerjavi z vorikonazolom 200 mg BID, vorikonazol Cmax ↓ 4% vorikonazolAUCτ ↓ 32%
English: Efavirenz (CYP450 inducer; CYP3A4 inhibitor and substrate)
Slovenian: kontraindicirano (glejte poglavje efavirenz (nenukleozidni zaviralec reverzne transkriptaze) [induktor CYP450; zaviralec in substrat CYP3A4]
English: Sulphobutylether beta cyclodextrin sodium (SBECD)
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi sulfobutileter betaciklodekstrin natrij (SBECD)
English: Infusion-related reactions
Slovenian: Z infundiranjem povezane reakcije
English: Norethisterone/ethinylestradiol (1 mg/0.035 mg QD)
Slovenian: peroralni kontraceptivi * [substrat CYP3A4; inhibitor CYP2C19] noretisteron/etinilestradiol (1 mg/0,035 mg QD)
English: 3 mg/kg dose (number of vials)
Slovenian: odmerek 3 mg/kg (število vial)
English: Although not studied, voriconazole is likely to increase the plasma concentrations of vinca alkaloids and lead to neurotoxicity.
Slovenian: Čeprav ni raziskano, lahko vorikonazol poveča koncentracijo alkaloidov rožnatega zimzelena v plazmi in povzroči nevrotoksične učinke.
English: Long acting opiates (CYP3A4 substrate)
Slovenian: Dolgodelujoči opiati (substrat CYP3A4)
English: Voriconazole Cmax ↑ 23% Voriconazole AUCτ ↓ 7%
Slovenian: v primerjavi z vorikonazolom 200 mg BID, vorikonazol Cmax ↑ 23% vorikonazol AUCτ ↓ 7%
English: (listed in section 6).
Slovenian: (npr. uveitis)
English: Common: may affect up to 1 in 10 people
Slovenian: Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov):
English: Monitoring for adverse reactions related to oral contraceptives, in addition to those for voriconazole, is recommended.
Slovenian: Poleg nadzora neželenih učinkov vorikonazola je priporočljiv nadzor neželenih učinkov peroralnih kontraceptivov.
English: What Voriconazole Hikma contains - The active substance is voriconazole.
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Vorikonazol Hikma - Zdravilna učinkovina je vorikonazol.
English: Frequent monitoring for adverse reactions and toxicity related to methadone, including QTc prolongation, is recommended when co-administered with voriconazole since methadone levels increased following coadministration of voriconazole.
Slovenian: Ker se raven metadona ob sočasni uporabi z vorikonazolom poveča, je priporočljivo pogosto nadziranje neželenih učinkov in toksičnosti metadona, vključno s podaljšanjem QTc.
English: Efavirenz 300 mg QD, coadministered with voriconazole 400 mg BID)*
Slovenian: efavirenz 400 mg QD, sočasno uporabljan z 200 mg vorikonazola BID *
English: 6 mg/kg every 12 hours for the first 24 hours
Slovenian: 6 mg/kg vsakih 12 ur v prvih 24 urah odmerek po prvih 24 urah (vzdrževalni odmerek)
English: The reconstituted solution can be diluted with:
Slovenian: 60,0 ml (3) Pripravljeno (rekonstituirano) raztopino je mogoče redčiti z:
English: No significant differences in Cmax and AUCτ were observed between healthy elderly females (≥ 65 years) and healthy young females (18-45 years).
Slovenian: in zdravimi mladimi ženskami (18- 45 let) niso ugotovili pomembnih razlik v C max in AUCτ.
English: • invasive aspergillosis (a type of fungal infection due to Aspergillus sp.),
Slovenian: Uporablja se za zdravljenje bolnikov (odraslih in otrok, starih 2 leti ali več): • z invazivno aspergilozo (vrsta glivične okužbe, ki jo povzročajo vrste Aspergillus),
English: Survived to day 180
Slovenian: Preživetje do 180. dneva Razvoj dokazane ali verjetne IGO do 180. dneva
English: Frequent monitoring for adverse reactions and toxicity related to
Slovenian: Priporočljiv je pogost nadzor neželenih učinkov in toksičnosti NSAID.
English: Study Endpoints
Slovenian: Mejne vrednosti
English: • Omeprazole (used for treating ulcers)
Slovenian: • omeprazol (uporablja se za zdravljenje želodčnih razjed)
English: Please advise your doctor if you have any stomach pains or if your stools have a different consistency.
Slovenian: Če se vam pojavijo bolečine v želodcu ali se spremeni čvrstost blata, morate to povedati zdravniku.
English: After dilution:
Slovenian: Po redčenju:
English: 6 mg/kg every 12 hours 400 mg every 12 hours 200 mg every 12 hours
Slovenian: 400 mg vsakih 12 ur
English: Prevention of fungal infections in high risk bone marrow transplant recipients This medicinal product should only be used under the supervision of a doctor.
Slovenian: Preprečevanje glivičnih okužb pri prejemnikih presadka kostnega mozga, pri katerih obstaja veliko tveganje.
English: Results are presented in Table 9.
Slovenian: Rezultati so predstavljeni v tabeli 9.
English: Side effects that have been reported during marketed use include:
Slovenian: Neželeni učinki, o katerih so poročali v obdobju trženja, vključujejo:
English: The use of this vaccine should be in accordance with official recommendations.
Slovenian: Cepivo je treba uporabljati v skladu z uradnimi priporočili.
English: 53100 Siena, Italy
Slovenian: 53100 Siena, Italija
English: Paediatric population (under 2 years of age)
Slovenian: Pediatrična populacija (mlajši od 2 let)
English: If a severe allergic reaction occurs tell your doctor straight away or go immediately/ take your child to the nearest Accident and Emergency department because urgent medical help may be needed.
Slovenian: Če pride do hude alergijske reakcije, takoj obvestite zdravnika ali pojdite takoj/otroka odpeljite do najbližjega urgentnega oddelka, saj bo morda potrebna nujna medicinska pomoč.
English: Since there was no direct impact on the seroprotection rate, the clinical consequences are presently unknown.
Slovenian: Ker neposrednega vpliva na stopnjo serozaščite ni bilo, klinične posledice trenutno niso znane.
English: The hSBA was the original correlate of protection against meningococcal disease.
Slovenian: hSBA je bil izvorni korelat zaščite proti meningokokni bolezni.
English: 5 micrograms
Slovenian: 5 mikrogramov
English: This may temporarily affect the ability to drive or use machines.
Slovenian: To lahko začasno vpliva na sposobnost vožnje ali upravljanja strojev.
English: The presence of a minor infection is not a contraindication.
Slovenian: Prisotnost blage okužbe ni kontraindikacija.
English: Immunogenicity was assessed in a subset of 150 subjects in each vaccine group.
Slovenian: Imunogenost so ocenili v podskupini 150 oseb v vsaki cepljeni skupini.
English: It is possible that the effectiveness of Menveo could be reduced in such individuals.
Slovenian: Možno je, da je učinkovitost cepiva Menveo pri takih posameznikih manjša.
English: The incidence and severity of any, local, systemic, and other reactions were generally similar in the Menveo groups across all studies and within the adolescent and adult age groups.
Slovenian: Incidenca in resnost vsakršnih - lokalnih, sistemskih in drugih reakcij - sta bili na splošno podobni v vseh skupinah, ki so dobile cepivo Menveo v vseh študijah in znotraj skupine mladostnikov in odraslih oseb.
English: Your doctor or nurse will take care to ensure the vaccine is not given into a blood vessel and will make sure that it is injected into muscle and not into the skin.
Slovenian: Zdravnik ali medicinska sestra bo poskrbel, da se cepivo ne da v krvno žilo in se prepričal, da se injicira v mišico in ne v kožo.
English: What Menveo is and what it is used for
Slovenian: Kaj je cepivo Menveo in za kaj ga uporabljamo
English: Date of latest renewal: 04 December 2014
Slovenian: Datum prve odobritve: 15. marec 2010 Datum zadnjega podaljšanja: 04. december 2014
English: 1 month post-vaccination
Slovenian: 1 mesec po cepljenju
English: The vaccine works by causing your body to make its own protection (antibodies) against these bacteria.
Slovenian: Cepivo deluje tako, da spodbudi telo k lastni zaščiti (tvorbi protiteles) proti tem bakterijam.
English: The need for and timing of a booster dose in subjects previously vaccinated with Menveo is to be defined based on national recommendations.
Slovenian: Potrebo po poživitvenem odmerku in časovno opredelitev pri osebah, ki so bile predhodno cepljene s cepivom Menveo, je treba določiti na osnovi nacionalnih priporočil.
English: It is important that procedures are in place to avoid injury from fainting.
Slovenian: Pomembno je, da so na voljo ukrepi za preprečevanje telesnih poškodb zaradi omedlevice.
English: 21 months 3 years 5 years
Slovenian: 21 mesecev 3 leta 5 let
English: For information on the reconstitution of the vaccine see the section for medical or healthcare professionals at the end of this leaflet.
Slovenian: Za informacije o rekonstituciji cepiva glejte poglavje namenjeno zdravstvenemu osebju na koncu tega navodila.
English: Bellaria-Rosia 53018 Sovicille (SI) Italy
Slovenian: Bellaria-Rosia 53018 Sovicille (SI) Italija
English: Post-marketing experience (all age groups)
Slovenian: Izkušnje v obdobju trženja (vse starostne skupine) Bolezni imunskega sistema
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before this medicine is given.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden vas cepijo s tem cepivom.
English: Long-term antibody persistence data following vaccination with Menveo are available up to 5 years after vaccination (see section 4.4 and 5.1).
Slovenian: Podatki o dolgotrajni prisotnosti protiteles po cepljenju s cepivom Menveo so na voljo za obdobje do 5 let po cepljenju (glejte poglavji 4.4 in 5.1).
English: In non-clinical studies, Menveo had no direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
Slovenian: V nekliničnih študijah ni imelo cepivo Menveo niti neposrednih niti posrednih škodljivih učinkov na nosečnost, razvoj embria/fetusa, porod ali postnatalni razvoj.
English: - receive treatment that blocks the part of the immune system known as complement activation, such as eculizumab.
Slovenian: - prejemate zdravila, ki blokirajo del imunskega sistema, imenovan aktivacija komplementa, na primer ekulizumab.
English: The most common local and systemic adverse reactions observed in clinical trials were pain at the injection site and headache.
Slovenian: Najpogostejši lokalni in sistemski neželeni učinek, ki so ju opazili v kliničnih preskušanjih, sta bila bolečina na mestu injiciranja in glavobol.
English: Not known (cannot be estimated from the available data) Adverse reactions from clinical trials
Slovenian: Neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov) Neželeni učinki v kliničnih preskušanjih
English: Tell your doctor or nurse if you have experienced this kind of reaction previously.
Slovenian: Zdravnika ali medicinsko sestro obvestite, če ste takšno reakcijo že kdaj imeli.
English: 21 months
Slovenian: 21 mesecev
English: However, a mild fever or upper respiratory infection (for example cold) itself is not a reason to delay vaccination.
Slovenian: Malo zvišana telesna temperatura ali blaga okužba zgornjih dihal (na primer prehlad) nista vzrok za preložitev cepljenja.
English: The risk-benefit ratio for persons at risk of haematoma following intramuscular injection must be evaluated by health care professionals.
Slovenian: Razmerje med koristjo in tveganjem za osebe, pri katerih obstaja tveganje za nastanek hematoma po intramuskularnem injiciranju, mora ovrednotiti zdravstveni delavec.
English: Menveo cannot cause bacterial meningitis.
Slovenian: Cepivo Menveo ne more povzročiti bakterijskega meningitisa.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Slovenian: Cepiva ne smemo mešati z drugimi zdravili razen s tistimi, ki so omenjena v poglavju 6.6. 6.3 Rok uporabnosti
English: Pharmacotherapeutic group: Meningococcal vaccines, ATC code: J07AH08.
Slovenian: Farmakoterapevtska skupina: Cepiva proti meningokokom, oznaka ATC: J07AH08.
English: Before the injection of any vaccine, the person responsible for administration must take all precautions known for the prevention of allergic or any other reactions including thorough medical history and current health status.
Slovenian: Pred injiciranjem kateregakoli cepiva mora odgovorna oseba zagotoviti vse potrebno za preprečitev alergijskih ali drugih reakcij, vključno z ocenitvijo anamneze in trenutnega zdravstvenega stanja.
English: Frequencies are defined as follows:
Slovenian: Pogostnosti neželenih učinkov so opredeljene kot sledi:
English: For children (from 2 years of age), adolescents and adults: a single (0.5 ml) injection will be given.
Slovenian: Za otroke (od 2 let starosti), mladostnike in odrasle: daje se enkratna injekcija (0,5 ml).
English: 6-10 years
Slovenian: 6-10 let
English: There was no evidence of an increased rate of reactogenicity or change in the safety profile of the vaccines in either study.
Slovenian: V nobeni študiji ni bilo dokazov o zvišani stopnji reaktogenosti ali o spremembi profila varnosti cepiv.
English: Dizziness has been very rarely reported following vaccination.
Slovenian: Zelo redko so poročali o omotičnosti po cepljenju.
English: Menveo was non-inferior on these endpoints for serogroup C (Table 2).
Slovenian: Cepivo Menveo na teh končnih točkah ni bilo inferiorno za seroskupino C (Tabela 2).
English: However, chemical and physical stability after reconstitution was demonstrated for 8 hours below 25°C.
Slovenian: Dokazana je bila kemijska in fizikalna stabilnost cepiva po rekonstituciji 8 ur pri temperaturi do 25 °C.
English: A randomised, observer-blind study was conducted in children 12 to 59 months of age in Finland and Poland (V59P7).
Slovenian: Randomizirano, opazovalno slepo študijo so opravili pri otrocih, starih 12 do 59 mesecev na Finskem in Poljskem (V59P7).