FrancophonIA/ELRC3.0 huggingface dataset:
English: The development of the electronic Application Form (eAF) for human medicinal products will be completed in 2008 (EU telematics project); A system to support the use of the eAF standard will also be developed and maintained by the Agency in connection with the centralised procedure.
Slovenian: V letu 2008 bo dokončan razvoj elektronskega obrazca vloge (eAF) za zdravila v humani medicini (telematski projekt EU).
English: ref.: EMEA/MB/556125/2007
Slovenian: EMEA/172874/2008
English: Applications received (Input)
Slovenian: Vloge prejete/predvidene (vhodni podatek)
English: Direct telephone: (44-20) 75 23 71 07 Fax: (44-20) 74 18 85 95
Slovenian: Direktni telefon: (44-20) 75 23 71 07
English: European medicines network
Slovenian: 1.1 Evropska mreža zdravil
English: Contribution from EEA Community programmes Other
Slovenian: Programi Skupnosti
English: Veterinary marketing authorisation procedures
Slovenian: Postopki za izdajo dovoljenja za promet z zdravili v veterini
English: TOTAL EXPENDITURE
Slovenian: ODHODKI SKUPAJ
English: Annex 4 EMEA contact points Pharmacovigilance and product-quality-defect reporting
Slovenian: Priloga 4 Kontaktne osebe agencije EMEA
English: Centres for Pharmacovigilance and Pharmacoepidemiology (ENCePP).
Slovenian: pharmacovigilance@emea.europa.eu Za zadeve v zvezi s farmakovigilanco za
English: applications
Slovenian: Pristojbine
English: Currently available data are described in section 4.3, 4.4, 4.8, 5.1 and 5.2.
Slovenian: Trenutno dostopni podatki so opisani v poglavjih 4.3, 4.4, 4.8, 5.1 in 5.2.
English: THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE PROFESSIONALS ONLY
Slovenian: NASLEDNJE INFORMACIJE SO NAMENJENE IZKLJUČNO ZDRAVSTVENEMIM DELAVCEM:
English: Your doctor will advise on benefits and risks of this medicine.
Slovenian: Vaš zdravnik vas bo poučil o koristih in tveganjih, povezanih s tem zdravilom.
English: The long-term benefits and risks of this medicine in children and adolescents are not yet clear.
Slovenian: Dolgoročne koristi in tveganja za otroke in mladostnike v zvezi s tem zdravilom še niso jasni.
English: Cardioxane is also contraindicated in the following circumstances:
Slovenian: Zdravilo Cardioxane je kontraindicirano tudi v naslednjih primerih:
English: This product information is the outcome of the referral procedure to which this Commission decision relates.
Slovenian: Te informacije o zdravilu so rezultat napotitvenega postopka na katerega se nanaša odločitev Evropske komisije.
English: What you need to know before you are given Cardioxane You must not be given Cardioxane
Slovenian: Kaj morate vedeti, preden boste prejeli zdravilo Cardioxane
English: Annex III Amendments to the relevant sections of the Product information
Slovenian: Priloga III Dopolnitve ustreznih poglavij informacij o zdravilu
English: − If you are under 18 years old and your planned dose of anthracycline is considered low - talk to your doctor about this.
Slovenian: − Če ste mlajši od 18 let in načrtovani odmerek antraciklina velja za nizkega - o tem se posvetujte s svojim zdravnikom.
English: The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure with the following amendments (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below: A. Summary of Product Characteristics
Slovenian: Veljavni povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so zadnje različice, dogovorjene v postopku skupine za usklajevanje CMDh z naslednjimi dopolnili (vstavitev, zamenjava ali brisanje besedila, kot je ustrezno), da odražajo dogovorjeno besedilo, kot je navedeno v nadaljevanju:
English: The safety and efficacy of Cardioxane in children aged 0 to 18 years have not been established.
Slovenian: Varnost in učinkovitost zdravila Cardioxane pri otrocih, starih 0 do 18 let, še nista dokazani.
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Slovenian: Informacije o zdravilu lahko pristojni organi držav članic naknadno posodobijo ob sodelovanju referenčne države članice, če je to potrebno, v skladu s postopki, določenimi v 4.
English: Children and adolescents up to 18 years of age (see sections 4.4 and 4.8).
Slovenian: 4.3 Kontraindikacije Otroci in mladostniki do 18 let (glejte poglavji 4.4. in 4.8.
English: Cardioxane is contraindicated in children and adolescents up aged 0 to 18 years of age who are planned to receive a cumulative dose of less than 300 mg/m2 of doxorubicin or the equivalent cumulative dose of another anthracycline.
Slovenian: Cardioxane je kontraindiciran pri otrocihin mladostnikih, starih od 0 do 18 let starosti, pri katerih se načrtuje prejemanje kumulativnega odmerka doksorubicina manjšega kot 300 mg/m2 ali enakovrednega kumulativnega odmerka drugega antraciklina.
English: Cardioxane is contraindicated in children and adolescents up to 18 years of age (see section 4.3).
Slovenian: Cardioxane je kontraindiciran pri otrocih in mladostnikih, starih do 18 let (glejte poglavje 4.3).
English: 4.3 Contraindications
Slovenian: A. Povzetek glavnih značilnosti zdravila
English: If you are allergic to:
Slovenian: če ste alergični na:
English: 12 months
Slovenian: 12 mesecev
English: Date of first authorisation: 12 December 2018
Slovenian: Datum prve odobritve: 12. december 2018
English: Not known (cannot be estimated from the available data):
Slovenian: Neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov):
English: In this age group, 235 paediatric subjects received one dose and 340 subjects received two doses.
Slovenian: V tej starostni skupini je 235 pediatričnih oseb prejelo en odmerek, 340 oseb pa je prejelo dva odmerka.
English: The available safety data in the paediatric population are presented below.
Slovenian: Razpoložljivi podatki o varnosti za pediatrično populacijo so predstavljeni v nadaljevanju.
English: Currently available safety and immunogenicity data are described in sections 4.8 and 5.1 but no recommendation on posology can be made.
Slovenian: Trenutno razpoložljivi podatki o varnosti in imunogenosti so opisani v poglavjih 4.8 in 5.1, vendar priporočil za odmerjanje ni mogoče dati.
English: The non-inferiority data observed are summarised in Table 2.
Slovenian: Ugotovljeni podatki o neinferiornosti so povzeti v preglednici 2.
English: (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100), not known (cannot be estimated from the available data).
Slovenian: (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: The following side effects have been reported during clinical trials and during general use:
Slovenian: O naslednjih neželenih učinkih so poročali med kliničnimi preskušanji in med splošno uporabo:
English: You can also report side effects directly via the national reporting system listed in Appendix V.* By reporting side effects, you can help provide more information on the safety of this medicine.
Slovenian: O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V.* S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
English: Read all of this leaflet carefully before you receive this medicine because it contains important information for you.
Slovenian: Pred začetkom uporabe zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Slovenian: Za boljšo sledljivost bioloških zdravil je treba jasno zabeležiti ime in številko serije apliciranega zdravila.
English: For instructions on the handling of the vaccine before administration, see section 6.6.
Slovenian: Za navodila glede ravnanja s cepivom pred apliciranjem glejte poglavje 6.6.
English: Adults and children from 9 years of age: One dose of 0.5 ml
Slovenian: Odrasli in otroci, stari 9 let ali več: en odmerek 0,5 ml
English: When a person is given the vaccine, the immune system (the body's natural defence system) will produce its own protection against the influenza virus.
Slovenian: Ko je oseba cepljena, bo imunski sistem (naravni obrambni sistem telesa) začel proizvajati lastno zaščito proti virusu gripe.
English: It is important that procedures are in place to avoid injury from faints.
Slovenian: Pomembno je, da poskrbite za ukrepe za preprečitev poškodb v primeru omedlevice.
English: • the active ingredients or any of the other ingredients of this medicine (listed in section 6)
Slovenian: • učinkovino(-e) ali katero koli sestavino tega zdravila (navedeno v poglavju 6),
English: Abbreviations: GMT = geometric mean titre; CI = confidence interval.
Slovenian: Okrajšave: GMT = geometrična sredina titra; IZ = interval zaupanja.
English: None of the ingredients in the vaccine can cause flu.
Slovenian: Nobena od sestavin cepiva ne more povzročiti gripe.
English: A protective immune response may not be elicited in all vaccine recipients.
Slovenian: Varovalni imunski odziv morda ne bo dosežen pri vseh prejemnikih cepiva.
English: No effects on breast fed newborn/infant are anticipated.
Slovenian: Učinkov na dojene novorojence/otroke se ne pričakuje.
English: Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient to prevent influenza.
Slovenian: Odziv protiteles pri bolnikih z endogeno ali iatrogeno imunosupresijo morda ne bo zadosten za preprečitev gripe.
English: Compared to adults 18 years of age and older, paediatric subjects generally reported higher rates of local and systemic adverse reactions.
Slovenian: V primerjavi z odraslimi osebami, starimi 18 let ali več, so pediatrični udeleženci na splošno poročali o višjih stopnjah lokalnih in sistemskih neželenih učinkov.
English: • You should tell your doctor if your immune system is impaired, or if you are undergoing treatment which affects the immune system, e.g. with medicine against cancer (chemotherapy) or corticosteroid medicines (see section “Other medicines and Flucelvax Tetra”).
Slovenian: • morate vi povedati zdravniku, če je vaš imunski sistem okvarjen ali prejemate zdravljenje, ki vpliva na imunski sistem, npr. zdravila proti raku (kemoterapija) ali kortikosteroidna zdravila (glejte poglavje 2, "Druga zdravila in cepivo Flucelvax Tetra");
English: • You should tell your doctor if you have an acute illness associated with fever.
Slovenian: • morate vi povedati zdravniku, če imate akutno bolezen, ki je povezana z zvišano telesno temperaturo.
English: For any information about this medicine, please contact the local representative of the Marketing Authorization Holder:
Slovenian: Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
English: Pharmacotherapeutic group: Influenza vaccine, ATC code: J07BB02
Slovenian: Farmakoterapevtska skupina: Cepiva proti gripi, oznaka ATC: J07BB02
English: Influenza cases were identified by active and passive surveillance of influenza-like illness (ILI).
Slovenian: Primere gripe so ugotavljali z aktivnim in pasivnim spremljanjem gripi podobne bolezni (ILIinfluenza-like illness).
English: A single syringe contains 0.5 ml of suspension for injection.
Slovenian: Ena brizga vsebuje 0,5 ml suspenzije za injiciranje.
English: Bold = Non-inferiority criterion met.
Slovenian: Krepki tisk = Izpolnjeno merilo neinferiornosti.
English: Children less than 9 years of age reported similar rates of adverse reactions compared to older children.
Slovenian: Otroci, mlajši od 9 let, so poročali o podobnih stopnjah neželenih učinkov kot starejši otroci.
English: Seqirus Vaccines Limited Gaskill Road, Speke L24 9GR Liverpool United Kingdom
Slovenian: Seqirus Vaccines Limited Gaskill Road, Speke L24 9GR Liverpool Velika Britanija
English: In some human studies, antibody titres of 1:40 or greater have been associated with protection from influenza illness in up to 50% of subjects.
Slovenian: V nekaterih študijah pri ljudeh so bili titri protiteles 1 : 40 ali višji povezani z zaščito pred gripo pri do 50 % udeležencev.
English: However, inactivated influenza vaccines can be used in all stages of pregnancy.
Slovenian: Vendar pa se inaktivirana cepiva proti gripi lahko uporablja v vseh fazah nosečnosti.
English: ILI was defined according to Centers for Disease Control and Prevention (CDC) case definition, i.e., a fever (oral temperature ≥100.0°F / 38°C) and cough or sore throat.
Slovenian: ILI je bila opredeljena skladno z opredelitvijo primera Centrov za nadzor in preprečevanje bolezni (CDC - Centers for Disease Control and Prevention), t. j. zvišana telesna temperatura (oralna temperatura ≥ 100,0 °F/38 °C) in kašelj ali boleče grlo.
English: This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery.
Slovenian: Spremlja jo lahko več nevroloških znakov, kot so prehodna motnja vida, parestezija in tonično-klonični gibi okončin med okrevanjem.
English: Annual revaccination with current influenza vaccines is recommended because immunity declines during the year after vaccination and circulating strains of influenza virus may change from year to year.
Slovenian: Priporoča se vsakoletno cepljenje s trenutnim cepivi proti gripi, ker v letu po cepljenju imunost upade, sevi virusa gripe v obtoku pa se lahko vsako leto spreminjajo.
English: Comparison of immunogenicity of TIVc in the paediatric and adult population
Slovenian: Primerjava imunogenosti TIVc pri pediatrični in odrasli populaciji
English: The immune response to each of the vaccine antigens was assessed 21 days after vaccination.
Slovenian: Imunski odziv na vsakega od antigenov cepiva so ocenili 21 dni po cepljenju.
English: Similar rates of local and system adverse reactions were reported in the overall paediatric population 4 to < 18 years of age.
Slovenian: O podobnih stopnjah lokalnih in sistemskih neželenih učinkov so poročali v splošni pediatrični populaciji, starosti od 4 leta do <18 let.
English: These antibodies neutralise influenza viruses.
Slovenian: Ta protitelesa onemogočijo viruse gripe.
English: Tell your doctor immediately if you experience any of the following side effects - you may need medical attention:
Slovenian: Takoj povejte zdravniku, če opazite katerega koli od naslednjih neželenih učinkov; morda boste potrebovali medicinsko pomoč:
English: B * Simultaneous one-sided 97.5% confidence intervals for the vaccine efficacy of each influenza vaccine relative to placebo based on the Sidak-corrected score confidence intervals for the two relative risks.
Slovenian: * Sočasni enostranski 97,5-% intervali zaupanja za učinkovitost cepiva za vsako cepivo proti gripi v primerjavi s placebom, na osnovi intervalov zaupanja vrednosti s Sidakovim popravkom za relativni tveganji.
English: • difficulty in breathing, dizziness, a weak and rapid pulse and skin rash which are symptoms of an anaphylactic reaction (a very severe allergic reaction)
Slovenian: • težave pri dihanju, omotičnost, šibek in hiter srčni utrip ter kožni izpuščaj, ki so simptomi anafilaktične reakcije (zelo hude alergijske reakcije).
English: Influenza vaccinations can be used at any stage of pregnancy.
Slovenian: Cepiva proti gripi se lahko uporabljajo v vseh fazah nosečnosti.
English: % Lower Limit of OneSided 97.5% CI
Slovenian: % Spodnja meja enostranskega 97,5-% IZ
English: It should be noted that both V58P12 and V58P13 were performed in the 2007-2008 northern hemisphere influenza season.
Slovenian: da sta bili študiji V58P12 in V58P13 izvedeni na severni polobli med sezono gripe 2007-2008.
English: Ask you pharmacist how to throw away medicines you no longer use.
Slovenian: O načinu odstranjevanja zdravila, ki ga ne uporabljate več, se posvetujte s farmacevtom.
English: • You should tell your doctor if you have a bleeding problem or bruise easily.
Slovenian: • morate vi povedati zdravniku, če imate težave s krvavenjem ali hitro dobite modrice;
English: Furthermore, antibody to one antigenic variant of influenza virus might not protect against a new antigenic variant of the same type or subtype.
Slovenian: Poleg tega protitelo proti eni antigenski različici virusa gripe lahko ne obvaruje pred novo antigensko različico istega tipa ali podtipa.
English: Paediatric population (9 to less than 18 years of age)
Slovenian: Pediatrična populacija (od 9 let do manj kot 18 let)
English: Your doctor may decide to delay your vaccination until your fever is gone.
Slovenian: Zdravnik se bo morda odločil, da vaše cepljenje preloži, dokler zvišana telesna temperatura ne mine;
English: Tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby.
Slovenian: Če ste noseči, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom.
English: Hardening or swelling at the site of the injection, headache, muscle pain, and fatigue were common in the elderly.
Slovenian: Neželeni učinki otrditev ali otekanje na mestu injiciranja, glavobol, bolečine v mišicah in utrujenost so bili pri starejših pogosti.
English: a The comparator vaccine for noninferiority comparisons for A/H1N1, A/H3N2 and B1 is TIV1c, for B2 it is
Slovenian: a Primerjalno cepivo za primerjave neinferiornosti za A/H1N1, A/H3N2 in B1 je TIV1c, za B2 pa TIV2c.
English: • beta-propiolactone, cetyltrimethylammonium bromide, or polysorbate 80, which are trace residues from the manufacturing process.
Slovenian: • beta-propiolakton, cetiltrimetilamonijev bromid ali polisorbat 80, ki so ostanki v sledeh, ki nastanejo med postopkom izdelave.
English: • Fainting can occur following, or even before, any needle injection, therefore tell the doctor or nurse if you fainted with a previous injection.
Slovenian: • pri vsakem injiciranju z injekcijsko iglo ali celo pred njim lahko pride do omedlevice, zato morate vi povedati zdravniku, če ste že kdaj omedleli pri injiciranju.
English: In this study, 1159 paediatric subjects received Flucelvax Tetra (584 subjects aged > 9 to < 18 years; 575 subjects aged > 4 to < 9 years).
Slovenian: V tej študiji je 1.159 pediatričnih oseb prejelo cepivo Flucelvax Tetra (584 oseb, starih > 9 let do < 18 let, in 575 oseb, starih > 4 leta do < 9 let).
English: Male fertility has not been assessed in animals.
Slovenian: Plodnost samcev pri živalih ni bila ocenjena.
English: Flucelvax Tetra is manufactured using Madin Darby Canine Kidney (MDCK) cells.
Slovenian: Cepivo Flucelvax Tetra je izdelano z uporabo celic pasjih ledvic Madin Darby Canine Kidney (MDCK).
English: Tell your doctor immediately or go to the casualty department at your nearest hospital if you experience the following side effect - you may need urgent medical attention or hospitalisation:
Slovenian: Takoj povejte zdravniku ali pojdite v ambulanto za nujne primere v najbližjo bolnišnico, če opazite naslednje neželene učinke; morda boste potrebovali nujno medicinsko pomoč ali se boste morali zdraviti v bolnišnici:
English: Flucelvax Tetra should be used in accordance with official recommendations.
Slovenian: Cepivo Flucelvax Tetra je treba uporabljati v skladu z uradnimi priporočili.
English: After an episode of ILI, nose and throat swab samples were collected for analysis.
Slovenian: Po epizodi ILI so zbrali brise nosu in grla za analizo.
English: Flucelvax Tetra is a vaccine against flu (influenza).
Slovenian: Flucelvax Tetra je cepivo proti gripi (influenci).
English: Hypersensitivity to the active substance, to any of the excipients listed in section 6.1, or to possible trace residues such as beta-propiolactone, cetyltrimethylammonium bromide, and polysorbate 80.
Slovenian: Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1, ali na morebitne ostanke snovi v sledeh, kot so beta-propiolakton, cetiltrimetilamonijev bromid in polisorbat 80.
English: Appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Slovenian: Vedno morata biti na voljo ustrezno zdravljenje in zdravstveni nadzor za primer redke anafilaktične reakcije po uporabi cepiva.
English: Children 9 to less than 18 years of age received a single dose of Flucelvax Tetra.
Slovenian: Otroci, stari od 9 let do manj kot 18 let, so prejeli en odmerek cepiva Flucelvax Tetra.
English: Seqirus Netherlands B.V. Нидерландия Тел.
Slovenian: Seqirus Netherlands B.V.
English: As with all vaccines, Flucelvax Tetra may not fully protect all persons who are vaccinated.
Slovenian: Kot pri vseh cepivih, tudi pri cepivu Flucelvax Tetra velja, da morda ne bo zagotovilo popolne zaščite vsem ljudem, ki so cepljeni.
English: Flucelvax Tetra has no or negligible influence on the ability to drive and use machines.
Slovenian: Cepivo Flucelvax Tetra nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: Fever (≥ 38°C)
Slovenian: (≥38 °C)
English: Flucelvax Tetra provides active immunisation against four influenza virus strains (two A subtypes and two B types) contained in the vaccine.
Slovenian: Cepivo Flucelvax Tetra daje aktivno imunizacijo proti štirim sevom virusa gripe (dva podtipa A in dva podtipa B), ki jih vsebuje.
English: 475 Green Oaks Parkway
Slovenian: 475 Green Oaks Parkway Holly Springs NC 27540
English: The preferred site for injection is the deltoid muscle of the upper arm.
Slovenian: Preferenčno mesto za injiciranje je deltoidna mišica nadlahti.
English: After shaking, the normal appearance of the vaccine is a clear to slightly opalescent suspension.
Slovenian: Normalen videz cepiva po pretresanju je bistra do rahlo opalescentna suspenzija.
English: V58P13 (Subjects 18 to < 50 years)
Slovenian: V58P13 (osebe, stare od 18 let do < 50 let)
English: A total of 11,404 subjects were enrolled to receive TIVc (N = 3828), Agrippal (N = 3676) or placebo (N = 3900) in a 1:1:1 ratio.
Slovenian: Skupno je bilo vključenih 11.404 oseb, ki so prejele cepivo TIVc (N = 3.828), cepivo Agrippal (N = 3.676) ali placebo (N = 3.900), in sicer v razmerju 1 : 1 : 1.
English: Table 5: GMTs and seroconversion rates in adult and paediatric subjects vaccinated with TIVc (V58P12 and V58P13)
Slovenian: Preglednica 5: GMT in stopnje serokonverzije pri odraslih in pediatričnih osebah, cepljenih s cepivom TIVc (V58P12 in V58P13)
English: Immune responses following vaccination with TIVc in the paediatric population (9 to < 18 years) were similar to those observed in the adult population in study V58P13 (see Table 5) in whom efficacy was demonstrated (results on vaccine efficacy are presented in Table 3).
Slovenian: Imunski odzivi po cepljenju s cepivom TIVc pri pediatrični populaciji (od 9 let do < 18 let) so bili podobni tistim, ki so jih opazili pri odrasli populaciji v študiji V58P13 (glejte preglednico 5), pri kateri so dokazali učinkovitost (rezultati učinkovitosti cepiva so prikazani v preglednici 3).
English: There was no evidence that the addition of the second influenza B strain resulted in immune interference to other strains included in the vaccine.
Slovenian: Ni bilo dokazov, da bi dodatek drugega seva virusa gripe B povzročil imunsko interferenco z drugimi sevi, vključenimi v cepivo.
English: • Your doctor or nurse will make sure that appropriate medical treatment and supervision is readily available in case of a rare anaphylactic reaction (a very severe allergic reaction with symptoms such as difficulty in breathing, dizziness, a weak and rapid pulse and skin rash) following the administration.
Slovenian: PREDEN prejmete cepivo: • bosta zdravnik ali medicinska sestra zagotovila, da bosta na voljo ustrezno zdravljenje in zdravstveni nadzor za primer redke anafilaktične reakcije (zelo hude alergijske reakcije s simptomi, kot so težave pri dihanju, omotičnost, šibek in hiter srčni utrip ter kožni izpuščaj) po uporabi.