natgillin/translations-raw huggingface dataset:
The duration of treatment depends on the type, duration and course of your complaints and is determined by your doctor.
Trajanje zdravljenja Trajanje zdravljenja je odvisno od vrste, trajanja in poteka vaše bolezni in ga določi vaš zdravnik.
The drops should be poured in a spoon or diluted in water, and taken orally.
Kapljice je treba nakapati na žlico ali razredčiti v vodi in jih vzeti peroralno.
UCB Pharma Ireland Limited, United Drug House, Magna Drive
UCB Pharma Irska Limited, United Drug House, Magna Drive
The decrease in cetirizine clearance in these elderly volunteers appeared to be related to their decreased renal function.
Manjši očistek cetirizina pri teh starejših prostovoljcih je bil videti povezan z zmanjšanim delovanjem ledvic.
Quinta da Fonte 2770-229 Paco de Arcos Portugal
Quinta da Fonte 2770-229 Paco de Arcos Portugalska
Due to the divergent national decisions taken by Member States concerning the authorisation of Zyrtec, a number of divergences exist in the product information and a referral was therefore triggered by the European Commission Article 30 of Directive 2001/83/EC as amended in order to harmonise the divergent Product Information texts across the EU.
Ker so države članice sprejele različne odločitve glede dovoljenj za promet z zdravilom Zyrtec, obstajajo razhajanja v informacijah o zdravilu, zato je Evropska komisija v skladu s členom 30 Direktive 2001/83/ES, kakor je bila spremenjena, sprožila napotitveni postopek za uskladitev različnih besedil v informacijah o zdravilu po vsej EU.
- the Summaries of Products Characteristic, labelling and package leaflet proposed by the Marketing Authorisation Holders have been assessed based on the documentation submitted and the scientific discussion within the Committee,
- da so bili povzetki glavnih značilnosti zdravila, označevanja in navodil za uporabo, ki so jih predlagali imetniki dovoljenj za promet z zdravilom, ocenjeni na podlagi predložene dokumentacije in znanstvene razprave v odboru;
The distribution of pharmacokinetic parameters such as peak plasma concentration (Cmax) and area under curve (AUC), is unimodal in human volunteers.
Porazdelitev farmakokinetičnih parametrov, kot sta največja plazemska koncentracija (Cmax) in površina pod krivuljo (AUC), je unimodalna pri ljudeh prostovoljcih.
The MAH agreed to the text proposed by the CHMP.
Imetnik dovoljenja za promet z zdravilom se je strinjal z besedilom, ki ga je predložil CHMP.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development.
Študije na živalih ne kažejo na neposredne ali posredne škodljive vplive na nosečnost, razvoj zarodka/plodu, porod in postnatalni razvoj.
In a 35-day study in children aged 5 to 12, no tolerance to the antihistaminic effect (suppression of wheal and flare) of cetirizine was found.
V 35-dnevni študiji pri otrocih, starih od 5 do 12 let, niso ugotovili tolerance za antihistaminski učinek (zmanjšanje otekline in rdečine) cetirizina.
The extent of bioavailability is similar when cetirizine is given as solutions, capsules or tablets.
Obseg biološke uporabnosti je podoben, če se cetirizin jemlje v obliki raztopine, kapsul ali tablet.
In 16 member states, treatment with cetirizine is also recommended in infants and toddlers aged 1 to 2 years.
V 16 državah članicah se zdravljenje s cetirizinom priporoča tudi pri dojenčkih in mlajših otrocih, starih od 1 do 2 let.
In infants and toddlers aged 6 to 24 months, it is reduced to 3.1 hours.
Pri dojenčkih, starih od 6 do 24 mesecev, je zmanjšana na 3,1 uro.
A harmonized wording for age groups and relevant posology was agreed upon:
Dogovorjeno je naslednje usklajeno besedilo za starostne skupine in ustrezno odmerjanje:
This medicine is available without prescription.
Zdravilo je na voljo brez recepta.
The extent of absorption of cetirizine is not reduced with food, although the rate of absorption is decreased.
Obseg absorpcije cetirizina se zaradi hrane ne zmanjša, čeprav se zmanjša hitrost absorpcije.
Since cetirizine is mainly eliminated via renal route (see section 5.2.
Glede na to, da se cetirizin v glavnem izloča preko ledvic (glejte poglavje 5.2.)
In vitro receptor binding studies have shown no measurable affinity for other than H1receptors.
In vitro študije vezave na receptor niso pokazale merljive afinitete za druge receptorje razen za H1.
Content (concentration)
Pot uporabe zdravila vsebina (koncentracija)
Plasma protein binding of cetirizine is 93 ± 0.3 %.
Vezava cetirizina na plazemske beljakovine je 93 ± 0,3 %.
Cetirizine, a human metabolite of hydroxyzine, is a potent and selective antagonist of peripheral H1receptors.
Cetirizin, človeški presnovek hidroksizina, je močan in selektiven antagonist perifernih receptorjev H1.
Sanofi Aventis France 9 Boulevard Romain Rolland 75159 Paris Cedex 14 France
Sanofi Aventis Francija 9 Boulevard Romain Rolland 75159 Paris Cedex 14 Francija
The MAH also reviewed the remaining divergent contra-indications.
Imetnik dovoljenja za promet z zdravilom je preučil tudi preostale razhajajoče kontraindikacije.
The CLcr (ml/min) may be estimated from serum creatinine (mg/dl) determination using the following formula:
CLcr v ml/min je mogoče oceniti iz koncentracije kreatinina v serumu (mg/dl) po formuli:
UCB Pharma GmbH (AT) Jacquingasse,16-18/3.OG 1030 Wien
UCB Pharma GmbH (AT) Jacquingasse,16-18/3.OG 1030 Dunaj
In addition to the adverse effects reported during clinical studies and listed above, isolated cases of the following adverse drug reactions have been reported in post-marketing experience.
Poleg neželenih učinkov, o katerih so poročali med kliničnimi študijami in so navedeni zgoraj, so v okviru postmarketinških izkušenj poročali tudi o posameznih primerih sledečih neželenih učinkov.
However, as it is the case with all antihistamines, it is recommended to avoid concurrent consumption of alcohol.
Vendar pa se, kot pri vseh antihistaminikih, odsvetuje sočasno uživanje alkohola.
This is why the harmonized wording does not propose a weight - based posology, as weight is clearly not the only factor to define the dose.
Zato usklajeno besedilo ne predlaga odmerjanja na podlagi telesne mase, saj ta ne more biti edini dejavnik pri določanju odmerka.
McNeil Products Limited Foundation Park, Roxborough way, Maidenhead, Berkshire, SL6 3UG, UK
McNeil Products Limited Foundation Park, Roxborough way, Maidenhead, Berkshire, SL6 3UG, Velika Britanija
Cetirizine (n=1656)
cetirizin (n = 1656)
The use of the film-coated tablet formulation is not recommended in children aged less than 6 years since this formulation does not allow for appropriate dose adaptation.
Pri otrocih, mlajših od 6 let, ni priporočljiva uporaba filmsko obloženih tablet, ker ta oblika ne dopušča ustrezne prilagoditve odmerka.
Thermoformed transparent, colorless, physiologically inert PVC blister strip thermosealed by an aluminium foil covered by suitable lac; in a carton box.
Toplotno oblikovan, prozoren, brezbarven, fiziološko inerten PVC pretisni omot, toplotno zavarjen z aluminijasto folijo in prevlečen z ustreznim voskom; v kartonasti škatli.
Cetirizine does not modify the protein binding of warfarin.
Cetirizin ne spremeni vezave varfarina na beljakovine.
Cetirizine exhibits linear kinetics over the range of 5 to 60 mg.
Cetirizin ima linearno kinetiko v odmerkih od 5 do 60 mg.
LIST OF EXCIPIENTS Also contains lactose.
SEZNAM POMOŽNIH SNOVI Vsebuje laktozo.
The current paediatric indications are not disharmonised based on the indication itself but with regards to the definition of the paediatric age groups and with regards to the dosing for these groups.
Trenutne pediatrične indikacije se ne razlikujejo glede same indikacije, ampak glede opredelitve pediatričnih starostnih skupin ter predpisanih odmerkov za posamezno starostno skupino.
In a placebo-controlled study, cetirizine given at the high daily dose of 60 mg for seven days did not cause statistically significant prolongation of QT interval.
V s placebom nadzorovani študiji cetirizin, ki so ga sedem dni dajali v odmerku 60 mg na dan, ni povzročil statistično pomembnega podaljšanja QT intervala.
The liquid formulations are primarily for children up to 12 years, the solid tablets are for children from 12 years on and for adults.
Tekoči pripravki so predvsem namenjeni zdravljenju otrok do 12 leta starosti, trde tablete pa za zdravljenje otrok, starejših od 12 let, in odraslih.
The MAH acknowledged that the indication section varies a lot from one Member State to the other but that the wording differences corresponded to three well-identified indications.
Imetnik dovoljenja za promet z zdravilom priznava, da se besedila z indikacijami med posameznimi državami članicami precej razlikujejo, vendar vse različice ustrezajo trem dobro opredeljenim indikacijam.
Studies in healthy volunteers show that cetirizine, at doses of 5 and 10 mg strongly inhibits the wheal and flare reactions induced by very high concentrations of histamine into the skin, but the correlation with efficacy is not established.
Študije na zdravih prostovoljcih so pokazale, da cetirizin v odmerkih po 5 in 10 mg močno zavira rdečino in oteklino povzročeno z zelo veliko koncentracijo histamina apliciranega v kožo, vendar povezava z učinkovitostjo ni dokazana.
Pregnancy and breast-feeding Ask your doctor for advice before taking any medicine.
Nosečnost in dojenje Posvetujte se z zdravnikom, preden vzamete katerokoli zdravilo.
Cetirizine does not undergo extensive first pass metabolism.
Cetirizin ni podvržen obsežnemu prvemu prehodu preko jeter.
If you are a sensitive patient, you may find that the simultaneous use of alcohol or other nervous depressant agents may additionally affect your attention and ability to react.
Če ste občutljivi, lahko pri vas sočasna uporaba alkohola ali drugih pomirjeval dodatno vpliva na pozornost in sposobnost reagiranja.
United Kingdom: Benadryl allergy oral syrup, Benadryl for children allergy solution, Zirtek allergy relief for children, Zirtek allergy solution, Benadryl allergy solution, Benadryl allergy oral solution
Velika Britanija: Benadryl allergy oral syrup, Benadryl for children allergy solution, Zirtek allergy relief for children, Zirtek allergy solution, Benadryl allergy solution, Benadryl allergy oral solution
Avenida de Barcelona, 239 08750 Molins de Rei (Barcelona) Spain
Avenida de Barcelona 239 08750 Molins de Rei (Barcelona) Španija
The MAH also reworded the entire section 4.8 Undesirable effects in accordance with current guidelines and with the QRD comments received.
Imetnik dovoljenja za promet z zdravilom je preoblikoval tudi celotni razdelek 4.8 Neželeni učinki v skladu s trenutnimi smernicami in prejetimi pripombami po pregledu kakovosti dokumentacije.
Depending on the member state, the posology is based on the weight or the age, or even a combination of both and a number of age groups and posology groups were identified.
V posameznih državah članicah je tako odmerjanje določeno glede na telesno maso ali starost otroka ali celo kombinacijo obeh dejavnikov, ugotovljene pa so številne starostne skupine ali skupine za odmerjanje.
Although statistically more common than under placebo, somnolence was mild to moderate in the majority of cases.
Čeprav je bila statistično somnolenca pri cetirizinu bolj pogosta kot pri placebu, je bila v večini primerov blaga do zmerna.
Uncommon: agitation
Občasni: agitacija
Adverse drug reactions (WHO-ART)
Neželeni učinki (WHO-ART)
UCB GmbH Alfred-Nobel-Str. 10 D-40789 Monheim Germany
UCB GmbH Alfred-Nobel-Str. 10 D-40789 Monheim Nemčija
UCB Nordic A/S Arne Jacobsens Allé 15 DK-2300 Kobenhavn S Denmark
UCB Nordic A/S Arne Jacobsens Allé 15 DK-2300 Kobenhavn S Danska
This study supports the safety of administering cetirizine to allergic patients with mild to moderate asthma.
Ta študija podpira varnost dajanja cetirizina bolnikom z alergijo in blago do zmerno astmo.
To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in ml/min is needed.
Za uporabo te preglednice je potrebno predhodno oceniti bolnikov očistek kreatinina (CLcr) v ml/min.
If you feel that the effect of Zyrtec is too weak or too strong, please consult your doctor.
Če menite, da je učinek zdravila Zyrtec prešibak ali premočan, se posvetujte s svojim zdravnikom.
Taking Zyrtec with food and drink Food does not affect noticeabily the absorbtion of cetirizine.
Jemanje zdravila Zyrtec skupaj s hrano in pijačo Hrana ne vpliva opazno na absorpcijo cetirizina.
The MAH was asked to revise section 4.5 Interaction with other medicinal products, as no pharmacokinetic interactions are awaited with this substance, since it is not metabolised and two third of the ingested dose are eliminated unchanged in urine.
Imetnik dovoljenja za promet z zdravilom je bil naprošen tudi za preoblikovanje razdelka 4.5 Medsebojno delovanje z drugimi zdravili, ker se ne pričakuje nobeno farmakokinetično medsebojno delovanje s to snovjo, saj se ta ne presnavlja, dve tretjini zaužitega odmerka pa se izločita nespremenjeni z urinom.
Walton Oaks Dorking Road, Walton on the Hill KT 20 7 NS, Surrey Great Britain
Walton Oaks Dorking Road, Walton on the Hill KT 20 7 NS, Surrey Velika Britanija
Patients intending to drive, engaging in potentially hazardous activities or operating machinery should not exceed the recommended dose and should take their response to the medicinal product into account.
Bolniki, ki nameravajo voziti, se ukvarjati s potencialno nevarnimi aktivnostmi ali upravljati s stroji, ne smejo preseči priporočenega odmerka in morajo upoštevati svoj odziv na zdravilo.
Objective tests as demonstrated by other studies have demonstrated that usual daily activities are unaffected at the recommended daily dose in healthy young volunteers.
Objektivni testi drugih študij so pokazali, da ob priporočenem dnevnem odmerku pri zdravih mladih prostovoljcih ni vpliva na vsakodnevne aktivnosti.
Hungary: Zyrtec filmtabletta, Zyrtec start filmtabletta Ireland: Zirtek tablets
Madžarska: Zyrtec filmtabletta, Zyrtec start filmtabletta Irska: Zirtek tablets
Double blind controlled clinical or pharmacoclinical trials comparing cetirizine to placebo or other antihistamines at the recommended dosage (10 mg daily for cetirizine), of which quantified safety data are available, included more than 3200 subjects exposed to cetirizine.
Dvojno slepa, nadzorovana klinična in farmakoklinična preskušanja, v katerih so primerjali cetirizin s placebom ali drugimi antihistaminiki v priporočenih odmerkih (za cetirizin 10 mg na dan), za katere so na razpolago izmerjeni podatki o varnosti, so zajela več kot 3200 ljudi, ki so dobivali cetirizin.
UCB GmbH Huttenstraße 205 D-50170 Kerpen Germany
UCB GmbH Huttenstraße 205 D-50170 Kerpen Nemčija
Pharmacotherapeutic group: Piperazine derivatives, ATC code: R06A E07
Farmakoterapevtska skupina: derivati piperazina, ATC oznaka: R06A E07
The systemic exposure with half doses is not documented and insufficient efficacy related to half doses may lead the patients to cumulate other treatments.
Sistemska izpostavljenost s prepolovljenimi odmerki ni dokumentirana, zaradi neučinkovitosti takšnega odmerjanja pa je možno, da bodo bolniki prejemali tudi druga zdravila.
UCB SA Pharma Secteur Chemin du Foriest, B-1420 Braine l´Alleud Belgium
UCB SA Pharma Secteur Chemin du Foriest, B-1420 Braine-l´Alleud Belgija
Greece: Ziptek
Grčija: Ziptek
When a treatment with cetirizine is stopped after repeated administration, the skin recovers its normal reactivity to histamine within 3 days.
Po prenehanju večkratnega dajanja cetirizina koža v treh dneh ponovno privzame svoje normalno reagiranje na histamin.
Clinical studies have produced no evidence of impaired attention, alertness and driving capabilities after taking Zyrtec at the recommended dose.
Klinične študije niso pokazale poslabšanja pozornosti, budnosti in sposobnosti za vožnjo po jemanju zdravila Zyrtec v priporočenih odmerkih.
Regarding the dosing by age group, the MAH defended the same dosing for age group 12 to 18 as in adults because the increase in body weight is compensated by a decrease in clearance, allowing for an equivalent systemic exposure.
V zvezi z odmerjanjem glede na starostno skupino je imetnik dovoljenja za promet z zdravilom zagovarjal enako odmerjanje za starostno skupino od 12 do 18 let kot pri odraslih, saj se povečanje telesne mase nadomesti z manjšim izločanjem, kar omogoča enako sistemsko izpostavljenost.
The drug is indicated in adults and children aged 2 years and older in all the member states.
Zdravilo je v vseh državah članicah indicirano pri odraslih in otrocih, starih dve leti ali več.
Nevertheless, precaution is recommended if alcohol is taken concomitantly.
Vendar pa ob sočasnem uživanju alkohola priporočamo previdnost.
In adults, all three indications are treated by a 10 mg daily dose of cetirizine.
Pri odraslih se vse tri indikacije zdravijo z 10miligramskim dnevnim odmerkom cetirizina.
At therapeutic doses, no clinically significant interactions have been demonstrated with alcohol (for a blood alcohol level of 0.5 g/l).
Pri jemanju terapevtskih odmerkov se niso pokazale klinično pomembne interakcije z alkoholom (pri koncentraciji alkohola v krvi 0,5 g/l).
The MAH was also asked to provide data in support of the recommended dosing in patients with renal impairment and provide justifications for the benefit/risk ratio of halving the dose.
Imetnik dovoljenja za promet z zdravilom je bil tudi naprošen, da zagotovi podatke v podporo predlaganim odmerkom pri bolnikih z ledvičnimi obolenji ter utemelji razmerje med koristmi in tveganji v primeru prepolovitve odmerka.
Patients with hepatic impairment and renal impairment: dose adjustment is recommended (see Patients with moderate to severe renal impairment above).
Bolniki z jetrno in ledvično okvaro: odmerek je priporočljivo prilagoditi (glejte zgoraj »Bolniki z zmerno do hudo ledvično okvaro«).
Due to the pharmacokinetic, pharmacodynamic and tolerance profile of cetirizine, no interactions are expected with this antihistamine.
Zaradi farmakokinetičnega in farmakodinamičnega profila ter profila tolerance cetirizina, z njim ni pričakovati interakcij.
WHAT Zyrtec IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO ZYRTEC IN ZA KAJ GA UPORABLJAMO
Adults and adolescents above 12 years old:
Odrasli in mladostniki, starejši od 12 let:
[To be completed nationally]
[Dopolniti lokalno]
According to the guideline of the SPC, negative interactions should be mentioned in the SPC only if they are of clinical interest to the prescriber.
V skladu s smernicami za povzetek glavnih značilnosti zdravila je treba negativno medsebojno delovanje v povzetku navesti le, če so klinično pomembne za osebo, ki zdravilo predpisuje.
Caution should be exercised when prescribing to pregnant or breast feeding women because cetirizine passes into breast milk.
Pri predpisovanju zdravila nosečnicam ali doječim materam je potrebna previdnost, saj cetirizin prehaja v mleko.
For these less frequently reported undesirable effects, the estimated frequencies (uncommon: ≥1/1,000 to 1/100, rare: ≥1/10,000 to 1/1,000, very rare: 1/10,000) are made based on post-marketing experience.
Za te redkeje poročane neželene učinke, je ocena pogostnosti (občasni: ≥1/1.000 do <1/100, redki: ≥1/10.000 do <1/1.000, zelo redki: <1/10.000) narejena na osnovi postmarketinških izkušenj.
If you stop taking Zyrtec If you have any further questions on the use of this product, ask your doctor or pharmacist.
Če ste prenehali jemati zdravilo Zyrtec Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom ali s farmacevtom.
Clear and colorless liquid
Bistra in brezbarvna tekočina.
The drug is authorised for the symptomatic treatment of seasonal allergic rhinitis, perennial allergic rhinitis, and various types of pruritus and dermatological conditions from allergic origin, in particular chronic idiopathic urticaria.
Zdravilo je bilo odobreno za simptomatsko zdravljenje sezonskega alergijskega rinitisa, trajnega alergijskega rinitisa ter različnih vrst pruritisa in dermatoloških stanj alergijskega izvora, zlasti kronične idiopatične urtikarije.
In addition, the MAH agreed to include a warning for the drop formulation, stating that the confirmation of the diagnosis by a practitioner specialized in allergy should be sought before starting a treatment with cetirizine in children under the age of 2, as symptoms of viral infections of the upper respiratory system are misinterpreted as allergic in this age group.
Poleg tega je imetnik dovoljenja za promet z zdravilom soglašal tudi, da se vključi opozorilo o kapljičnih pripravkih, ki navaja, da mora pred začetkom zdravljenja s cetirizinom pri otrocih, mlajših od dveh let, diagnozo potrdi alergolog, saj se pri tej starostni skupini simptomi virusne okužbe zgornjega dihalnega sistema lahko napačno razlagajo kot alergijsko obolenje.
), in cases no alternative treatment can be used,the dosing intervals must be individualized according to renal function.
in če ni na voljo nobenega alternativnega zdravljenja, se mora odmerni interval prilagoditi posamezniku glede na ledvično funkcijo.
Spain: Alerlisin, Virlix, Reactine, Zyrtec comprimidos recubiertos con pelicula, Alerrid 10 mg comprimidos recubiertos con pelicula
Španija: Alerlisin, Virlix, Reactine, Zyrtec comprimidos recubiertos con pelicula, Alerrid 10 mg comprimidos recubiertos con pelicula
Patients with moderate renal impairment had a 3-fold increase in half-life and 70 % decrease in clearance compared to healthy volunteers.
Pri bolnikih z zmerno ledvično okvaro je bila razpolovna doba trikrat večja, očistek pa 70 % manjši kot pri zdravih prostovoljcih.
You should not take Zyrtec during breast feeding because cetirizine passes into breast milk.
Med dojenjem zdravila Zyrtec ne smete jemati, ker cetirizin prehaja v materino mleko.
The sentence will therefore be adapted to: “In paediatric patients suffering from renal impairment, the dose will have to be adjusted on an individual basis taking into account the renal clearance of the patient, his age, and his body weight”
Tako se bo stavek spremenil v: „Pri pediatričnih bolnikih z ledvičnim obolenjem bo treba odmerek prilagoditi za vsakega posameznika posebej, ob upoštevanju bolnikovega ledvičnega izločanja, njegove starosti in telesne mase.“
The MAH provided extensive testing data from the review of therapeutic trials and the corresponding clinical study reports in support of these indications and proposed the removal of the other indications such as atopic dermatitis, prevention of asthma, mosquito bites as the clinical evidences available to support these indications was considered insufficient.
Imetnik dovoljenja za promet z zdravilom je v podporo tem indikacijam zagotovil obsežne podatke testiranj iz pregleda terapevtskih preskušanj in ustreznih poročil iz kliničnih študij ter predlagal odstranitev drugih indikacij, kot so atopični dermatitis, preprečevanje astme, piki komarjev, saj klinični dokazi, ki so na voljo v podporo teh indikacij, ne zadostujejo.
The MAH however informed the CHMP that due to the need for translating the old terms into the new ones, the process must start by a recoding of the source documents.
Imetnik dovoljenja za promet z zdravilom je CHMP obvestil, da se mora zaradi prevajanja starih izrazov v nove postopek začeti s ponovnim šifriranjem izvornih dokumentov.
The CHMP acknowledged the problem of translating from old to new formats and the MAH's division of events into frequencies observed in clinical trials and frequencies estimated from post marketing experience could be agreed upon.
CHMP je priznal težave s prevajanjem iz starih oblik v nove, soglašal pa bi lahko tudi o razdelitvi pojavov na pogostnosti, opažene v kliničnih preskušanjih, in pogostnosti, ocenjene na podlagi izkušenj po izdaji dovoljenja za promet, ki jo je opravil imetnik dovoljenja za promet z zdravilom.
If you forget to take Zyrtec Do not take a double dose to make up for forgotten dose.
Če ste pozabili vzeti zdravilo Zyrtec Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
- Immune system disorders: rare: allergic reactions, some severe (very rare)
- Bolezni imunskega sistema: redki: alergijske reakcije, nekatere hude (zelo redko).