FrancophonIA/ELRC3.0 huggingface dataset:
English: It is not intended to provide practical advice on how to use Vimizim.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Treatment with Vimizim should be supervised by a doctor experienced in MPS IVA or similar diseases.
Slovenian: Zdravljenje z zdravilom Vimizim mora nadzorovati zdravnik, ki ima izkušnje z zdravljenjem MPS IVA ali podobnih bolezni.
English: What is Vimizim and what is it used for?
Slovenian: Kaj je zdravilo Vimizim in za kaj se uporablja?
English: The CHMP concluded that, following 6 months of treatment, Vimizim was shown to be effective at improving the distance patients could walk in six minutes, and this was accompanied by other beneficial effects, including improved ability to carry out daily activities.
Slovenian: Odbor CHMP je zaključil, da se je zdravilo Vimizim po 6 mesecih zdravljenja izkazalo za učinkovito pri izboljšanju razdalje, ki so jo bolniki lahko prehodili v šestih minutah, poleg tega pa so opazili še druge koristne učinke, vključno z izboljšanjem sposobnosti opravljanja vsakodnevnih dejavnosti.
English: Before receiving Vimizim, the patient should be given a medicine to prevent an allergic reaction to Vimizim.
Slovenian: Preden bolnik prejme zdravilo Vimizim, mora dobiti zdravilo za preprečevanje alergijske reakcije na zdravilo Vimizim.
English: Vimizim has been investigated in one main study involving 176 patients with MPS IVA, which compared Vimizim with placebo (a dummy treatment).
Slovenian: Zdravilo Vimizim so raziskali v eni glavni študiji s 176 bolniki z MPS IVA, v kateri so zdravilo Vimizim primerjali s placebom (zdravilom brez zdravilne učinkovine).
English: The main measure of effectiveness was the change in the distance patients could walk in six minutes after 6 months of treatment.
Slovenian: Glavno merilo učinkovitosti je bila sprememba razdalje, ki so jo bolniki po 6 mesecih zdravljenja lahko prehodili v šestih minutah.
English: Study results also suggested that the medicine could improve how well patients breathe or climb stairs, and in children, how well they grew.
Slovenian: Rezultati študije so pokazali tudi, da lahko zdravilo pri bolnikih izboljša dihanje in zmožnost hoje po stopnicah ter izboljša rast pri otrocih.
English: Before treatment, the patients could walk on average just over 200 metres in six minutes.
Slovenian: Bolniki so pred zdravljenjem v povprečju lahko prehodili nekaj več kot 200 metrov v šestih minutah.
English: For more information about treatment with Vimizim, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Vimizim preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: The full EPAR and risk management plan summary for Vimizim can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Vimizim sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This disease is caused by the lack of an enzyme called N-acetylgalactosamine-6-sulfatase, which is needed to break down substances in the body called glycosaminoglycans (GAGs).
Slovenian: Bolezen povzroča pomanjkanje encima, imenovanega N-acetilgalaktozamin-6-sulfataza, ki je potreben za razgradnjo snovi v telesu, imenovanih glikozaminoglikani (GAG).
English: After 6 months, patients treated with the recommended dose of Vimizim could walk an extra 37 metres on average in six minutes, compared with an increase of 14 metres in patients receiving placebo.
Slovenian: Po 6 mesecih so bolniki, zdravljeni s priporočenim odmerkom zdravila Vimizim, v povprečju lahko prehodili dodatnih 37 metrov v šestih minutah, medtem ko se je pri bolnikih, ki so prejemali placebo, razdalja podaljšala za 14 metrov.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Vimizim, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Vimizim in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: Vimizim must not be used in patients who have experienced life-threatening allergic reactions to elosulfase alfa or any of the other ingredients in Vimizim.
Slovenian: Zdravilo Vimizim se ne sme uporabljati pri bolnikih, ki so imeli smrtno nevarne alergijske reakcije na elosulfazo alfa ali katero koli drugo sestavino zdravila Vimizim.
English: The active substance in Vimizim, elosulfase alfa, is a copy of the human enzyme N-acetylgalactosamine-6-sulfatase.
Slovenian: Zdravilna učinkovina v zdravilu Vimizim, elosulfaza alfa, je kopija humanega encima N-acetilgalaktozamin-6-sulfataze.
English: Vimizim is available as a concentrate to be made into a solution for infusion (drip) into a vein.
Slovenian: Zdravilo Vimizim je na voljo v obliki koncentrata za pripravo raztopine za infundiranje (kapalno infuzijo) v veno.
English: For practical information about using Vimizim, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Vimizim naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Other information about Vimizim
Slovenian: Druge informacije o zdravilu Vimizim
English: For the full list of all side effects reported with Vimizim, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Vimizim, glejte navodilo za uporabo.
English: Vimizim is an enzyme replacement therapy.
Slovenian: Vimizim je zdravilo za encimsko nadomestno zdravljenje.
English: Vimizim is a medicine that contains the active substance elosulfase alfa.
Slovenian: Vimizim je zdravilo, ki vsebuje zdravilno učinkovino elosulfazo alfa.
English: How does Vimizim work?
Slovenian: Kako zdravilo Vimizim deluje?
English: How is Vimizim used?
Slovenian: Kako se zdravilo Vimizim uporablja?
English: Bioavailability was shown to be approximately 70%.
Slovenian: Ugotovljeno je bilo, da je biološka razpoložljivost približno 70 %.
English: Plasma protein binding is high (~99%).
Slovenian: Vezava na plazemske beljakovine je visoka (~ 99 %).
English: ATCvet code: QP53BX03.
Slovenian: Oznaka ATCvet: QP53BX03
English: Do not use in dogs or cats under 14 weeks of age.
Slovenian: Ne uporabite pri psih in mačkah, mlajših od 14 tednov.
English: Administer with food.
Slovenian: Dajajte s hrano.
English: The duration of efficacy may be reduced if the dose is administered on an empty stomach.
Slovenian: Trajanje učinkovitosti se lahko skrajša, če se odmerek daje na prazen želodec.
English: These effects are caused primarily by activation of nicotinic acetylcholine receptors (nAChRs).
Slovenian: Te učinke povzroča večinoma aktivacija nikotinskih acetilholinskih receptorjev (nAChRs).
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Slovenian: 4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) Antidota ni.
English: Use with caution in dogs and cats with pre-existing epilepsy.
Slovenian: Previdno uporabljajte pri psih in mačkah z obstoječo epilepsijo.
English: Furthermore, a reduction of food intake was observed in females, however a significant reduction in their bodyweight was not observed.
Slovenian: Poleg tega so pri samicah opazili zmanjšan vnos hrane, vendar pa bistvenega zmanjšanja njihove telesne mase niso opazili.
English: In case of adverse clinical signs, the animal should be treated symptomatically.
Slovenian: V primeru neželenih kliničnih znakov je treba žival zdraviti simptomatsko.
English: Pharmacotherapeutic group: other ectoparasiticides for systemic use.
Slovenian: FARMAKOLOŠKE LASTNOSTI Farmakoterapevtska skupina: drugi ektoparazitiki za sistemsko uporabo.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 11/02/2011.
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 11/02/2011
English: In very rare cases, blindness, impaired vision and other eye disorders were observed.
Slovenian: V zelo redkih primerih so opazili slepoto, slabovidnost in ostala obolenja oči.
English: Keep the blister in the outer carton to protect from light.
Slovenian: Pretisni omot shranjujte v zunanji ovojnini, za zaščito pred svetlobo.
English: Children should not come into contact with the veterinary medicinal product.
Slovenian: Otroci ne smejo priti v stik s tem zdravilom za uporabo v veterinarski medicini.
English: The veterinary medicinal product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).
Slovenian: To zdravilo za uporabo v veterinarski medicini se lahko uporablja kot del strategije zdravljenja za obvladovanje alergijskega dermatitisa, ki ga povzročajo bolhe (flea allergy dermatitis - FAD).
English: Regular monthly treatments with Comfortis break the fleas' life cycle and may be needed to control the flea population in contaminated households.
Slovenian: Redna mesečna zdravljenja z zdravilom Comfortis prekinejo življenjski cikel bolhe in so morda potrebna za obvladovanje populacije bolh v kontaminiranem gospodinjstvu.
English: In the majority of cases, vomiting was transient, mild and did not require symptomatic treatment.
Slovenian: V večini primerov je bilo bruhanje prehodno in blago ter ga ni bilo treba simptomatsko zdraviti.
English: AUC and Cmax values were higher in fed than fasted cats.
Slovenian: Vrednosti AUC in Cmax so bile višje pri nahranjenih kot pa pri teščih mačkah.
English: Spinosad has been shown to be a substrate for P-glycoprotein (PgP).
Slovenian: Ugotovljeno je bilo, da je spinosad substrat za P-glikoprotein (PgP).
English: All dogs and cats within the household should be treated.
Slovenian: Zdraviti se mora vse pse in mačke v gospodinjstvu.
English: Spinosad could therefore interact with other PgP-substrates (for example, digoxin, doxorubicin) and possibly enhance adverse reactions from such molecules or compromise efficacy.
Slovenian: Spinosad bi lahko zato medsebojno deloval z drugimi PgP-substrati (na primer z digoksinom ali doksorubicinom) in morebiti okrepil neželene učinke teh molekul ali zmanjšal učinkovitost.
English: Spinosad therefore has a different mode of action to other flea control or insect control products.
Slovenian: Spinosad ima zato drugačen način delovanja kot druga sredstva za obvladovanje bolh ali izdelki za obvladovanje insektov.
English: The veterinary medicinal product may safely be given at monthly intervals at the recommended dose.
Slovenian: To zdravilo za uporabo v veterinarski medicini se lahko varno daje v mesečnih intervalih v priporočenem odmerku.
English: Do not use in case of known hypersensitivity to the active substance or to any of the excipients.
Slovenian: Ne uporabite v primeru preobčutljivosti na zdravilno učinkovino ali na katero koli pomožno snov.
English: The incidence of vomiting observed after the first and second treatments was higher (8%) in dogs dosed at the upper end of the dose band.
Slovenian: Pojavnost bruhanja, ki so jo opazili po prvem in drugem zdravljenju, je bila višja (8 %) pri psih, ki so prejeli odmerek na zgornji meji odmerjanja.
English: Fleas may persist for a period of time after administration of the product due to the emergence of adult fleas from pupae already in the environment.
Slovenian: Bolhe se lahko pojavijo tudi v obdobju po dajanju zdravila zaradi razvoja odraslih bolh iz ličink, ki so že v okolju.
English: It does not interact with known binding sites of other nicotinic or GABAergic insecticides such as neonicotinides (imidacloprid or nitenpyram), fiproles (fipronil), milbemycins, avermectins (e.g. selamectin) or cyclodienes, but through a novel insecticidal mechanism.
Slovenian: Ne deluje medsebojno z znanimi mesti vezave drugih nikotinskih ali GABA-ergičnih insekticidov, kot so neonikotinidi (imidakloprid ali nitenpiram), fiproli (fipronil), milbemicini, avermektini (npr. selamektin) ali ciklodieni, ampak s povsem novim insekticidnim mehanizmom.
English: The product starts killing fleas 30 minutes after administration; 100% of fleas are dead/moribund within 4 hours post-treatment in dogs, and in cats within 24 hours.
Slovenian: Zdravilo začne bolhe ubijati v 30 minutah po dajanju; 100 % bolh pogine/so v fazi poginjanja pri psih v 4 urah po dajanju zdravila, pri mačkah pa v 24 urah.
English: Seizures were rare adverse reactions.
Slovenian: Konvulzije so bile redek neželeni učinek.
English: If fleas reappear in the fourth week, the treatment interval can be shortened by up to 3 days in dogs.
Slovenian: Če se bolhe četrti teden ponovno pojavijo, lahko interval dajanja pri psih skrajšate za do 3 dni.
English: Treatment and prevention of flea infestations (Ctenocephalides felis).
Slovenian: Zdravljenje in preprečevanje infestacij z bolhami (Ctenocephalides felis).
English: The recommended dosage regimen should be followed.
Slovenian: Upoštevajte priporočeno tabelo odmerjanja.
English: However there was no evidence in the clinical observations and clinical chemistry parameters that indicated any loss in organ function.
Slovenian: Vendar klinična opažanja in klinični kemijski parametri niso pokazali slabšega delovanja organov.
English: The veterinary medicinal product should be administered with food or immediately after feeding.
Slovenian: Zdravilo za uporabo v veterinarski medicini se daje s hrano ali takoj po obroku.
English: As the safety of this for suckling puppies and kittens has not been established, the product should only be used during pregnancy and lactation according to the benefit/risk assessment by the responsible veterinarian.
Slovenian: Ker ni dokazov o varnosti za pasje in mačje mladiče, ki se dojijo, se lahko to zdravilo med brejostjo ali laktacijo uporablja le v skladu z oceno razmerja korist/tveganje odgovornega veterinarja.
English: At doses of approximately 2.5 times the recommended dose, spinosad caused vomiting in the vast majority of dogs.
Slovenian: Pri odmerkih, ki so približno 2,5-krat večji od priporočenega, je spinosad povzročil bruhanje pri veliki večini psov.
English: The use of the product in smaller dogs and smaller cats is therefore not recommended.
Slovenian: Zato uporaba tega zdravila pri manjših psih in mačkah ni priporočljiva.
English: Other commonly observed adverse reactions in cats were diarrhoea and anorexia.
Slovenian: Druga neželena učinka, ki so ju pri mačkah pogosto opazili, sta bili driska in anoreksija.
English: Cardboard box containing blister, each containing 3 or 6 chewable tablets.
Slovenian: Kartonska škatla vsebuje pretisni omot s 3 ali 6 žvečljivimi tabletami.
English: PACKAGE SIZE 3 tablets
Slovenian: VELIKOST PAKIRANJA 3 tablete
English: There is no antidote available.
Slovenian: Antidota ni.
English: In cats, the full 4 week gap between treatments should be maintained, even if fleas reappear (due to an occasional slightly reduced persistent efficacy) before the end of the 4 weeks.
Slovenian: Pri mačkah je treba upoštevati 4-tedenski razmik med zdravljenji, tudi če se bolhe znova pojavijo (zaradi občasne rahlo zmanjšane učinkovitosti) pred potekom 4 tednov.
English: The preventive effect against re-infestations is a result of the activity against adult fleas and the reduction in their production of eggs.
Slovenian: Preprečevalni učinek proti ponovnim infestacijam je rezultat delovanja proti odraslim bolham in manjšega nastajanja jajčec.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton after EXP.
Slovenian: Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na zunanji ovojnini, za oznako »EXP«.
English: Fleas from pets often infest the animal's basket, bedding and regular resting areas such as carpets and soft furnishings, which should be treated in case of massive infestation and at the beginning of the treatment with a suitable insecticide and vacuumed regularly.
Slovenian: Bolhe domačih živali pogosto infestirajo košaro, ležišče in prostore, kjer žival redno počiva, kot so preproge in oblazinjena pohištva; te morate v primeru hude infestacije in ob začetku zdravljenja obdelati z ustreznim insekticidom in jih redno sesati.
English: If vomiting occurs within an hour of administration and the tablet is visible, re-dose the animal with another full dose to ensure maximum effectiveness of the product.
Slovenian: Če v eni uri po dajanju zdravila pride do bruhanja in v njem opazite tableto, dajte živali še enkrat polni odmerek, da zagotovite največjo učinkovitost zdravila.
English: In lactating bitches, spinosad is excreted in the colostrum/milk.
Slovenian: Pri doječih psicah se spinosad izloča v kolostrum/mleko.
English: The recommended dosage regimen should be followed (see section 4.10 for information regarding overdose).
Slovenian: Upoštevajte priporočeno tabelo odmerjanja (za informacije o prekomernem odmerjanju glejte poglavje
English: Vomiting is most likely caused by a local effect on the small intestines.
Slovenian: Bruhanje najverjetneje povzroči lokalni učinek na tanko črevo.
English: Cat bodyweight (kg)
Slovenian: Telesna masa mačke (kg)
English: MANUFACTURER'S BATCH NUMBER Lot
Slovenian: IZDELOVALČEVA ŠTEVILKA SERIJE
English: In pregnant dogs (bitches), the safety of spinosad has not been sufficiently established.
Slovenian: Pri brejih psicah varnost spinosada ni bila dokazana v zadostni meri.
English: The preventive effect against re-infestations is a result of the adulticidal activity and the reduction in egg production and persists for up to 4 weeks after a single administration of the product.
Slovenian: Preprečevalni učinek proti ponovnim infestacijam je rezultat adulticidnega delovanja in manjšega nastajanja jajčec, ki traja še do 4 tedne po enkratni uporabi tega zdravila.
English: Insecticidal activity against new infestations persists for up to 4 weeks.
Slovenian: Insekticidna aktivnost pred ponovno infestacijo traja do 4 tedne.
English: The safety of the product in male dogs and male cats used for breeding has not been determined.
Slovenian: Varnost zdravila pri pasjih in mačjih samcih, namenjenih za vzrejo, ni bila ugotovljena.
English: Phospholipidosis (vacuolation of the cells of the liver, adrenal gland and lung) also occurred.
Slovenian: Pojavila se je tudi fosfolipidoza (vakuolizacija celic jeter, nadledvične žleze in pljuč).
English: Phospholipidosis (vacuolation of lymphoid tissue) also occurred; although this was not related to clinical signs in dogs treated up to 6 months.
Slovenian: Pojavila se je tudi fosfolipidoza (vakuolizacija limfoidnega tkiva), čeprav to ni bilo povezano s kliničnimi znaki pri psih,
English: In cats, the full 4 week gap between treatments should be maintained, even if fleas reappear before the end of the 4 weeks.
Slovenian: Pri mačkah je treba upoštevati 4-tedenski razmik med zdravljenji, tudi če se bolhe znova pojavijo pred potekom 4 tednov.
English: Spinosad comprises spinosyn A and spinosyn D. The insecticidal activity of spinosad is characterised by nervous excitation leading to muscle contractions and tremors, prostration, paralysis and rapid death of the flea.
Slovenian: Spinosad je sestavljen iz spinosina A in spinosina D. Za insekticidno aktivnost spinosada je značilno živčno vzdraženje, ki povzroči krčenje mišic in tremorje, izčrpanost, paralizo in hitro smrt bolh.
English: In adult cats, the AUC increased over 3 consecutive months of dosing with 75 mg spinosad/kg bodyweight, after which steady state was achieved; however, no clinical impact occurred as a result of this.
Slovenian: Pri odraslih mačkah se je vrednost AUC v treh zaporednih mesecih zdravljenja z odmerkom 75 mg/kg telesne mase povišala, potem pa stabilizirala, vendar to ni imelo nobenega kliničnega učinka.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/10/115/016 (90 mg, 3 tablets)
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/10/115/016 (90 mg, 3 tablete) EU/2/10/115/017 (90 mg, 6 tablet)
English: 6.5 Nature and composition of immediate packaging Clear PCTFE/PE/PVC blister sealed with aluminium foil containing 3 or 6 chewable tablets in cardboard box.
Slovenian: Prozoren PCTFE/PE/PVC pretisni omot, zatesnjen z aluminijasto folijo, ki vsebuje 3 ali 6 žvečljivih tablet, pakiran v kartonski škatli.
English: In dogs, spinosad is excreted in the colostrum and milk of lactating bitches and it is therefore assumed that spinosad is excreted in the colostrum and milk of lactating queens.
Slovenian: Pri psih se spinosad izloča v kolostrum in mleko doječih psic, zato se domneva, da se izloča tudi v kolostrum in mleko doječih mačk.
English: Laboratory studies in rats and rabbits have not produced any evidence of any effect on the reproductive capacity in males and females.
Slovenian: Z laboratorijskimi študijami na podganah in kuncih ni bil dokazan vpliv na sposobnost razmnoževanja pri samcih in samicah.
English: Accurate dosing is not possible in dogs weighing less than 1.3 kg and in cats weighing less than 1.2 kg.
Slovenian: Pri psih s telesno maso manj kot 1,3 kg in mačkah s telesno maso manj kot 1,2 kg natančno odmerjanje ni mogoče.
English: Therefore, it is recommended to treat cats with food as this maximises the opportunity for fleas to ingest lethal amounts of spinosad.
Slovenian: Zato se priporoča dajanje zdravila mački skupaj s hrano, saj to poveča možnost, da bolhe zaužijejo smrtne količine spinosada.
English: This activity persists for up to 4 weeks after a single administration of the product.
Slovenian: Ta učinek traja še do 4 tedne po enkratni uporabi tega zdravila.
English: Comfortis 1040 mg chewable tablets for dogs
Slovenian: Comfortis 1040 mg žvečljive tablete za pse
English: Mild elevations of ALT (alanine aminotransferase) occurred in all dogs treated with Comfortis, although values returned to their baseline by day 24.
Slovenian: Pri vseh psih, zdravljenih z zdravilom Comfortis, je prišlo do blagega dviga ALT (alanin aminotransferaze), čeprav so se vrednosti ALT vrnile na izhodiščne do 24. dne.
English: Microcrystalline cellulose Artificial beef flavour Hydroxypropylcellulose Colloidal silicon, anhydrous Croscarmellose sodium Magnesium stearate
Slovenian: Celuloza, mikrokristalna Umetna aroma govedine Hidroksipropilceluloza Silicijev dioksid, koloidni, brezvodni Natrijev karmelozat, premreženi Magnezijev stearat
English: Therefore, it is recommended to treat dogs with food as this maximises the opportunity for fleas to ingest lethal amounts of spinosad.
Slovenian: Zato se priporoča dajanje zdravila psu skupaj s hrano, saj to poveča možnost, da bolhe zaužijejo smrtne količine spinosada.
English: Post marketing reports, following the concomitant use of Comfortis with ‘off label' high dose ivermectin indicate that dogs have experienced trembling/twitching, salivation/drooling, seizures, ataxia, mydriasis, blindness and disorientation.
Slovenian: Poročila iz obdobja trženja zdravila kažejo, da je pri psih ob sočasni uporabi zdravila Comfortis in visokih odmerkov ivermektina, ki niso odobreni, prišlo do tresenja/trzanja, salivacije/slinjenja, konvulzij, ataksije, midriaze, slepote in dezorientacije.
English: Comfortis tablets are chewable and palatable for dogs.
Slovenian: Zdravilo Comfortis so žvečljive in okusne tablete za pse.
English: Seek veterinary advice regarding information on the optimal time to start treatment with this product.
Slovenian: Glede optimalnega časa uvedbe zdravljenja s tem zdravilom se posvetujte z veterinarjem.
English: Lethargy, loss of condition and salivation were uncommon.
Slovenian: Letargija, izguba kondicije in slinjenje so se pojavili občasno.
English: At doses in excess of the recommended dose vomiting becomes a very common event.
Slovenian: Pri odmerkih, ki so večji od priporočenega, je bruhanje zelo pogost pojav.