FrancophonIA/ELRC3.0 huggingface dataset:
English: Contains sodium and cyclodextrin.. See package leaflet for further information.
Slovenian: Vsebuje natrij in ciklodekstrin.
English: Do not take PREVYMIS if:
Slovenian: Ne jemljite zdravila PREVYMIS:
English: Sodium hydroxide (E524) Water for injections
Slovenian: 6.1 Seznam pomožnih snovi hidroksipropilbetadeks (ciklodekstrin) natrijev klorid natrijev hidroksid (E524)
English: --¹ not less than 10E6.0 CCID50
Slovenian: --¹ ne manj kot 10E6.0 CCID50
English: 1 oral applicator
Slovenian: 1 peroralni aplikator
English: 1 glass container + 1 oral applicator + 1 transfer adapter
Slovenian: 1 stekleni vsebnik + 1 peroralni aplikator + 1 nastavek za prenos
English: 1 squeezable tube multi-monodose (5 single dose) squeezable tube (polyethylene) presentation connected by a bar
Slovenian: Komplet več enoodmernih stisljivih tub (polietilen) (5 posameznih odmerkov), ki so povezane s ploščico
English: Therefore, patients must be monitored closely.
Slovenian: Zato morate bolnike skrbno nadzorovati.
English: No interaction studies have been performed.
Slovenian: Interakcijskih študij niso izvedli.
English: 1 mg corresponds to 18.2 EAU*.
Slovenian: 1 mg ustreza 18,2 EAU*.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Slovenian: Tega zdravila ne smete mešati z drugimi zdravili razen s tistimi, ki so omenjena v poglavju 6.6.
English: This leaflet was last revised in {MM/YYYY}
Slovenian: Navodilo je bilo nazadnje revidirano {MM/LLLL}
English: It will be given once a day, for up to 7 days.
Slovenian: Zdravilo boste prejemali enkrat na dan do 7 dni.
English: • swelling of the face, lips, tongue or throat
Slovenian: • otekanje obraza, ustnic, jezika ali grla
English: Tell your doctor immediately if you notice any of the following as you may need to stop treatment:
Slovenian: Svojega zdravnika nemudoma obvestite, če opazite karkoli od naslednjega, saj boste morda morali prekiniti zdravljenje:
English: These may be the first signs that a severe allergic reaction is happening.
Slovenian: To so lahko prvi znaki, da se je pri vas huda alergijska reakcija razvila.
English: As a protein the dose for the infant is expected to be very low.
Slovenian: Glede na proteinsko naravo, se pričakuje, da je odmerek za dojenčka zelo nizek.
English: These are rare (may affect up to 1 in 1,000 people).
Slovenian: Ti znaki so redki (lahko prizadenejo do 1 od 1.000 bolnikov).
English: Via Valcanello, 4 03012 Anagni (FR) Italy
Slovenian: Via Valcanello, 4 03012 Anagni (FR) Italija
English: Date of latest renewal: 23 February 2006
Slovenian: Datum zadnjega podaljšanja dovoljenja za promet: 23. februar 2006
English: Fasturtec is not directly effective in the treatment of these abnormalities.
Slovenian: Fasturtec ni neposredno učinkovit pri zdravljenju teh anomalij.
English: It is not known whether the chance of developing an allergic reaction is increased if treatment with Fasturtec is repeated.
Slovenian: Ni znano, če je možnost razvoja alergijskih reakcij povečana, če se zdravljenje z zdravilom Fasturtec ponovi.
English: The following information is intended for healthcare professionals only: See section 3 “How to use Fasturtec” and practical information on preparation and handling given below.
Slovenian: Naslednje informacije so namenjene samo zdravstvenemu osebju: Glejte poglavje 3 "Kako uporabljati zdravilo Fasturtec" in navodila za pripravo in ravnanje spodaj.
English: Your treatment with Fasturtec may need to be stopped, and you may need further treatment.
Slovenian: Zdravljenje z zdravilom Fasturtec bo morda treba prekiniti in morda boste potrebovali dodatno zdravljenje.
English: Special patient populations
Slovenian: Posebna populacija bolnikov
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Izdaja zdravila je le pod omejenimi pogoji in na recept (glejte Dodatek I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: Do not use this medicine if you notice that the solution is unclear and/or contains particles.
Slovenian: Ne uporabljajte tega zdravila, če opazite, da raztopina ni bistra ali da vsebuje delce.
English: After reconstitution or dilution an immediate use is recommended.
Slovenian: Po rekonstituciji ali redčenju priporočamo takojšnjo uporabo.
English: Clearance is increased (ca. 35%) in children and adolescents compared to adults, resulting in a lower systemic exposure.
Slovenian: Očistek pri otrocih in mladostnikih je v primerjavi z odraslimi povečan za približno 35%, kar se kaže v nižji sistemski izpostavljenosti.
English: Your dose will be calculated according to your body weight.
Slovenian: Vaš odmerek bodo izračunali na osnovi telesne mase.
English: Frequency not known (frequency cannot be estimated from the available data) - involuntary muscle movements (muscle contraction involuntary).
Slovenian: Neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov) - nehoteni mišični gibi (nehotena kontrakcija mišic).
English: Safety results on 246 patients were consistent with the adverse events profile in the overall population.
Slovenian: Rezultati o varnosti pri 246 bolnikih so se skladali s profilom neželenih učinkov v splošni populaciji.
English: * Anaphylactic shock including potential fatal outcome ** From post-marketing experience + Uncommon G3/4 ++ Common G3/4
Slovenian: * Anafilaktični šok, vključno s potencialnim smrtnim izidom ** Izkušnje v obdobju trženja + Občasni G3/4 ++ Pogosti G3/4
English: Frequencies are defined using the following MedDRA convention as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Slovenian: Navedba pogostnosti neželenih učinkov po MeDRA klasifikaciji: zelo pogosti (1/10); pogosti (1/100 to <1/10); občasni (1/1,000 to <1/100), redki (1/10,000 to <1/1,000); zelo redki (<1/10,000), neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti).
English: - Convulsion**
Slovenian: - konvulzije**
English: Fasturtec is injected slowly into a vein, which should take about 30 minutes.
Slovenian: Fasturtec vam bodo počasi injicirali v veno, kar bo trajalo približno 30 minut.
English: Sample handling:
Slovenian: Ravnanje z vzorci:
English: Fasturtec will be administered at the same time as other medicines that may also cause side effects.
Slovenian: Fasturtec boste prejemali sočasno kot druga zdravila, ki tudi lahko povzročijo neželene učinke.
English: No filter should be used for infusion.
Slovenian: Pri infuziji ne smete uporabljati filtra.
English: Metabolism
Slovenian: Metabolizem
English: 9 SPECIAL STORAGE CONDITIONS Store in a refrigerator
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v hladilniku
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23 February 2001
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 23. februar 2001
English: Rasburicase is a protein, and therefore: 1) not expected to bind to proteins, 2) expected that metabolic degradation will follow the pathways of other proteins, i.e. peptide hydrolysis, 3) unlikely to be candidate for drug-drug interactions.
Slovenian: Razburikaza je beljakovina, zato: 1) ne pričakujemo, da se bo vezala na beljakovine, 2) pričakujemo, da se bo metabolno razkrajala po isti poti kot ostale beljakovine, tj. s hidrolizo peptidov in 3) ni verjetno, da bi prišlo do interakcij z drugimi zdravili.
English: Blood must be collected into pre-chilled tubes containing heparin anticoagulant.
Slovenian: Kri morate zbrati v vnaprej ohlajene epruvete, ki vsebujejo heparin kot antikoagulant.
English: The safety results of patients treated with Fasturtec in Study EFC4978 were consistent with the adverse events profile observed in previous clinical studies with predominantly paediatric patients.
Slovenian: Rezultati varnosti bolnikov, ki so prejemali zdravilo Fasturtec v študiji EFC4978, so bili skladni s profilom neželenih učinkov opaženih v prejšnjih kliničnih študijah s pretežno pediatričnimi bolniki.
English: - Severe hypersensitivity reactions
Slovenian: - hude preobčutljivostne reakcije
English: Your doctor may also test your blood to make sure that you do not develop any blood disorders.
Slovenian: Vaš zdravnik vam bo lahko opravil krvne preiskave tudi z namenom izključitve razvoja krvnih bolezni.
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Slovenian: V natisnjenem navodilu za uporabo zdravila morata biti navedena ime in naslov izdelovalca, odgovornega za sprostitev serije.
English: If you are given more Fasturtec than you should be If it does occur, the doctor will closely monitor the effects on your red blood cells and treat any symptoms that follow.
Slovenian: Če ste uporabili večji odmerek zdravila Fasturtec, kot bi smeli V primeru, da se to zgodi, bo zdravnik pazljivo nadziral vpliv zdravila na vaše rdeče krvne celice in zdravil morebitne simptome.
English: Pharmacotherapeutic group: Detoxifying agents for antineoplastic treatment, ATC code: V03AF07.
Slovenian: Farmakoterapevtska skupina: Zdravila za zaščito organizma pred toksičnostjo citostatikov, oznaka ATC: V03AF07.
English: Efficacy results on 229 evaluable patients showed an overall response rate (normalization of plasma uric acid levels) of 96.1%.
Slovenian: Rezultati o učinkovitosti pri 229 ocenljivih bolnikih so pokazali celoten delež odziva (normalizacijo koncentracije sečne kisline v plazmi) 96,1 %.
English: Because teratogenic effects of rasburicase cannot be ruled out, Fasturtec should only be used during pregnancy if strictly necessary.
Slovenian: Teratogenih učinkov razburikaze ni moč izključiti, zato naj se zdravilo Fasturtec v nosečnosti uporablja le, če je to nujno potrebno.
English: What Fasturtec is and what it is used for
Slovenian: Kaj je zdravilo Fasturtec in za kaj ga uporabljamo
English: - Diarrhoea + - Vomiting++ - Nausea++
Slovenian: - driska + - bruhanje++ - slabost++
English: • difficulty in breathing or swallowing
Slovenian: • težave pri dihanju ali požiranju
English: Sanofi Chimie Route d'Avignon 30390 Aramon France
Slovenian: Sanofi Chimie Route d'Avignon 30390 Aramon Francija
English: However, the in-use stability has been demonstrated for 24 hours between +2°C and 8°C.
Slovenian: Kljub temu so dokazali, da je pripravljena raztopina stabilna 24 ur pri temperaturi med 2 °C in 8 °C.
English: - Muscle contraction involuntary**
Slovenian: - nehotena kontrakcija mišic**
English: Pregnancy and breast-feeding Tell your doctor if you are, or think you may be pregnant, or if you are breast-feeding.
Slovenian: Nosečnost in dojenje Obvestite svojega zdravnika če ste ali mislite, da ste noseči ali čedojite.
English: Therefore the diluted solution should be infused immediately.
Slovenian: Zato morate razredčeno raztopino uporabiti takoj.
English: - Bronchospasm - Rhinitis
Slovenian: - bronhospazem - rinitis
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/.
English: During treatment with Fasturtec, the advantage of breastfeeding should be weighted against the potential risk for the infant.
Slovenian: Med zdravljenjem z zdravilom Fasturtec je potrebno preceniti prednost dojenja v primerjavi z možnim tveganjem za dojenčka.
English: Other medicines and Fasturtec
Slovenian: Druga zdravila in zdravilo Fasturtec
English: In adults (≥ the age of 18 years), age, gender, baseline liver enzymes and creatinine clearance did not impact the pharmacokinetics of rasburicase.
Slovenian: Pri odrasih (starejših od 18 let), starost, spol, bazalni jetrni encimi in očistek kreatinina niso vplivali na farmakokinetiko razburikaze.
English: *One enzyme activity unit (EAU) corresponds to the enzyme activity that converts 1 µmol of uric acid into allantoin per minute under the operating conditions described: +30 °C ± 1 °C TEA pH 8.9 buffer.
Slovenian: *Ena enota aktivnosti encima (Enzyme Activity Unit - EAU) ustreza encimski aktivnosti, ki spremeni 1 µmol sečne kisline v alantoin na minuto pri določenih pogojih: +30 °C ± 1 °C pufra TEA, pH 8,9.
English: Special populations Renally or hepatically impaired patients: No dose adjustment is necessary.
Slovenian: Posebna populacija Bolniki z okvaro ledvic ali jeter: Prilagoditev odmerka ni potrebna.
English: Plasma samples should immediately be prepared by centrifugation in a pre-cooled centrifuge (4°C).
Slovenian: Vzorce plazme morate takoj pripraviti s centrifugiranjem v vnaprej ohlajeni centrifugi (4 °C).
English: - Allergy/ allergic reactions (rashes and urticaria)
Slovenian: - alergijske reakcije (izpuščaji in urtikarija)
English: At present, there is insufficient data available on patients being retreated to recommend multiple treatment courses.
Slovenian: Za zdaj je premalo podatkov o bolnikih, ki so jih zdravili ponovno, da bi priporočili ponavljajoče se zdravljenje.
English: To ensure accurate measurement of uric acid plasma level during treatment with Fasturtec, a strict sample handling procedure must be followed (see section 6.6).
Slovenian: Da bi zagotovili točne meritve ravni sečne kisline v plazmi med zdravljenjem z zdravilom Fasturtec, se morate strogo držati postopka ravnanja z vzorci (glejte poglavje 6.6).
English: Minimal accumulation of rasburicase (<1.3 fold) was observed between days 1 and 5 of dosing.
Slovenian: Minimalno kopičenje razburikaze (<1,3 kratno) so opazili med 1. in 5. dnevom odmerjanja.
English: The solvent is a colourless and clear liquid.
Slovenian: Vehikel je brezbarvna in bistra tekočina.
English: Please tell your doctor if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
English: Inspect visually prior to use.
Slovenian: Pred uporabo si oglejte raztopino.
English: Fasturtec is to be used immediately prior to and during the initiation of chemotherapy only, as at the present, there is insufficient data to recommend multiple treatment courses.
Slovenian: Fasturtec uporabljajte le tik pred kemoterapijo ali med njenim začetkom, kajti do zdaj ni dovolj podatkov, da bi priporočili več ponovitev zdravljenja.
English: Clinical experience with Fasturtec demonstrates that patients should be closely monitored for the onset of allergic-type undesirable effects, especially severe hypersensitivity reactions including anaphylaxis (see section 4.8).
Slovenian: Klinične izkušnje z zdravilom Fasturtec kažejo, da morate bolnike pozorno nadzorovati, da bi opazili začetek alergijskih neželenih učinkov, zlasti hudih preobčutljivostnih reakcij, vključno z anafilakso (glejte poglavje 4.8).
English: Therefore the reconstituted solution should be diluted under controlled and validated aseptic conditions.
Slovenian: Zato morate rekonstituirano raztopino razredčiti v validiranih aseptičnih pogojih.
English: (methaemoglobinaemia) - fits (convulsion).
Slovenian: (methemoglobinemija) - krči (konvulzije).
English: (frequency not known) which may be fatal - low blood pressure (hypotension) - wheezing or difficulty in breathing (bronchospasm) - blood disorders such as a disorder of the blood in which red blood cells are abnormally broken down (haemolysis), destroyed (haemolytic anaemia), or abnormal blood pigment levels
Slovenian: (pogostnost neznana), ki je lahko smrtno nevaren - znižan krvni pritisk (hipotenzija) - sopenje ali težave pri dihanju (bronhospazem) - krvne bolezni, kot je bolezen krvi, pri kateri pride do nenormalne razgradnje rdečih krvnih celic
English: In order to prevent possible haemolytic anaemia induced by hydrogen peroxide, rasburicase is contraindicated in patients with these disorders.
Slovenian: Da bi preprečili morebitno hemolitično anemijo zaradi vodikovega peroksida, je razburikaza kontraindicirana pri bolnikih s temi okvarami.
English: The recommended dose is 0.20 mg per kg of body weight per day in both children and adults.
Slovenian: Priporočen odmerek je 0,20 mg na kg telesne mase na dan, tako pri otrocih, kot pri odraslih.
English: There are no data from the use of rasburicase in pregnant women.
Slovenian: Podatkov o uporabi razburikaze pri nosečnicah ni.
English: In humans, uric acid is the final step in the catabolic pathway of purines.
Slovenian: Pri človeku je sečna kislina zadnja stopnja katabolne poti purinov.
English: - Hypotension
Slovenian: - hipotenzija
English: In case of disorders of the blood in which red blood cells are abnormally broken down (haemolysis) or abnormal blood pigment levels (methaemoglobinaemia), your doctor will immediately and permanently discontinue treatment with Fasturtec.
Slovenian: V primeru bolezni krvi, pri katerih pride do nenormalne razgradnje rdečih krvnih celic (hemoliza) ali nenormalnih vrednosti krvnih barvil (methemoglobinemija), vam bo vaš zdravnik nemudoma in za stalno ukinil zdravljenje z zdravilom Fasturtec.
English: Adverse reactions possibly attributable to Fasturtec and reported in the clinical trials, are listed below, by system organ class and by frequency.
Slovenian: Neželeni učinki , ki bi jih lahko pripisali zdravilu Fasturtec in o katerih so poročali v kliničnih preskušanjih, so glede na organske sisteme in pogostnost navedeni spodaj.
English: • coughing or wheezing
Slovenian: • kašelj ali piskanje
English: NAME OF THE MARKETING AUTHORISATION HOLDER sanofi-aventis groupe
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM sanofi-aventis groupe
English: Tell your doctor if you have ever had any allergic type reactions due to other medicines; Fasturtec can cause allergic-type reactions, such as severe anaphylaxis including anaphylactic shock (sudden lifethreatening or fatal allergic reactions).
Slovenian: Obvestite svojega zdravnika, če ste kadarkoli ob uporabi drugih zdravil imeli kakršnokoli alergijsko reakcijo: zdravilo Fasturtec lahko izzove alergijske reakcije, kot je anafilaksija, vključno z anafilaktičnim šokom (nenadna, življensko nevarna ali smrtna alergijska reakcija).
English: How to use Fasturtec
Slovenian: Kako uporabljati zdravilo Fasturtec
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost za zdravilno učinkovino ali katerokoli izmed pomožnih snovi navedeno v poglavju 6.1.
English: What you need to know before you are given Fasturtec
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Fasturtec
English: The most commonly reported adverse reactions were nausea, vomiting, headache, fever, and diarrhea.
Slovenian: Najbolj pogosto poročani neželeni učinki so bili: slabost, bruhanje, glavobol, povišana telesna temperatura in driska.
English: Time to first confirmation of normal levels of uric acid in hyperuricaemic patients is four hours for Fasturtec and 24 hours for allopurinol.
Slovenian: Čas, potreben za doseganje normalnih ravni sečne kisline pri bolnikih s hiperurikemijo, je pri zdravilu Fasturec 4 ure in pri alopurinolu 24 ur.
English: The solvent contains no preservative.
Slovenian: Raztopina ne vsebuje konzervansov.
English: In turn, this allows efficient excretion of the serum phosphate load preventing further deterioration of renal function from calcium/phosphorus precipitation.
Slovenian: To omogoča učinkovito izločanje serumskih fosfatov, kar preprečuje nadaljnje poslabšanje delovanja ledvic zaradi obarjanja kalcija in fosforja.
English: During treatment with Fasturtec, your doctor will carry out blood tests to check the levels of uric acid and decide how long you will be treated for.
Slovenian: Med zdravljenjem z zdravilom Fasturtec vam bo vaš zdravnik s krvnimi preiskavami preveril raven sečne kisline in določil čas trajanja vašega zdravljenja.
English: Administration of rasburicase does not require any change in the timing or schedule of initiation of cytoreductive chemotherapy.
Slovenian: Zaradi uporabe razburikaze ni potrebno spreminjati urnika ali načrta začetka citoreduktivne kemoterapije.
English: Infusion: The final solution should be infused over 30 minutes.
Slovenian: Infuzija: Infuzija končne raztopine mora trajati 30 minut.
English: It is unknown whether rasburicase is excreted in human milk.
Slovenian: Ni znano, ali se razburikaza izloča v materinem mleku.
English: In case of severe allergic reaction, treatment should immediately and permanently be discontinued and appropriate therapy initiated.
Slovenian: V primeru hude alergijske reakcije morate takoj prekiniti zdravljenje z zdravilom Fasturtec in začeti z ustreznim zdravljenjem alergijskih reakcij.
English: EXP Use immediately after reconstitution or dilution
Slovenian: Uporabite takoj po rekonstituciji ali redčenju
English: The pharmacokinetics of rasburicase were evaluated in both paediatric and adult patients with leukaemia, lymphoma or other haematological malignancies.
Slovenian: Farmakokinetiko razburikaze so vrednotili tako pri pediatričnih, kot pri odraslih bolnikih z levkemijo, limfomom ali drugimi hematološkimi obolenji.
English: Rasburicase like other proteins, has the potential to induce allergic responses in humans, such as anaphylaxis, including anaphylactic shock, with potential fatal outcome.
Slovenian: Tako kot drugi proteini, tudi razburikaza lahko povzroči alergijske reakcije pri človeku, kot je anafilaksija, vključno z anafilaktičnim šokom, s potencialno smrtnim izidom.
English: Fasturtec is to be given to you before or during the start of your course of chemotherapy.
Slovenian: Fasturtec vam bodo dali tik pred kemoterapijo ali med njenim začetkom.
English: Fasturtec is not recommended in women of childbearing potential not using contraception.
Slovenian: Uporaba zdravila Fasturtec se ne priporoča plodnim ženskam, ki ne uporabljajo kontracepcije.
English: Fertility There are no data regarding the effect of rasburicase on fertility.
Slovenian: Plodnost Podatkov o učinku razburikaze na plodnost ni.
English: Store in the original package in order to protect from light
Slovenian: Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo
English: Not known
Slovenian: Neznani
English: Do not use Fasturtec if you: - are allergic (hypersensitive) to rasburicase, other uricases or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne uporabljajte zdravila Fasturtec, če ste: - alergični na (preobčutljivi za) razburikazo, druge urikaze ali katerokoli sestavino tega zdravila
English: The use of several vials may be necessary to obtain the quantity of rasburicase required for one administration.
Slovenian: Morda boste morali uporabiti več vial, da bi dobili količino razburikaze, potrebne za en odmerek.
English: Rasburicase is a tetrameric protein with identical subunits of a molecular mass of about 34 kDa.
Slovenian: Razburikaza je tetramerni protein z identičnimi podenotami in molekulsko maso približno 34 kDa.
English: Finally, plasma must be maintained in an ice/water bath and analysed for uric acid within 4 hours.
Slovenian: Končno, plazmo morate hraniti v posodici z ledom in vodo ter analizirati količino sečne kisline v 4 urah.
English: Rare (may affect up to 1 in 1,000 people): - runny or blocked nose, sneezing, facial pressure or pain (rhinitis).
Slovenian: Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov): - izcedek iz nosu ali zamašen nos, kihanje, pritisk na obraz ali bolečina (rinitis).