FrancophonIA/ELRC3.0 huggingface dataset:
English: There is no specific antidote to lurasidone, therefore, appropriate supportive measures should be instituted and close medical supervision and monitoring should continue until the patient recovers.
Slovenian: V primeru prevelikega odmerjanja je treba uvesti ustrezne podporne ukrepe in skrben zdravniški nadzor.
English: Coadministration of lurasidone with the strong CYP3A4 inducer rifampicin resulted in a 6-fold decrease in exposure of lurasidone.
Slovenian: Pri sočasni uporabi lurasidona in rifampicina, močnega induktorja CYP3A4, se je izpostavljenost lurasidonu zmanjšala za 6-krat.
English: White to off-white, film-coated round tablets of 8 mm debossed with ‘LB'
Slovenian: Bele ali skoraj bele, okrogle (premer 8 mm), filmsko obložene tablete z oznako “LB”.
English: Each 37 mg tablet contains lurasidone hydrochloride equivalent to 37.2 mg lurasidone.
Slovenian: Ena 37 mg tableta vsebuje lurasidonijev klorid v količini, ki ustreza 37,2 mg lurasidona.
English: If you have any of these conditions, please talk to your doctor as he/she may want to adjust your dose, monitor you more closely or stop treatment with Latuda.
Slovenian: Zdravnik bo morda moral prilagoditi odmerek, zdravljenje skrbno nadzirati, ali pa zdravljenje z zdravilom Latuda prekiniti.
English: Lurasidone should be used with caution in elderly patients with dementia who have risk factors for stroke.
Slovenian: Pri starostnikih z demenco, ki imajo dejavnike tveganja za možgansko kap, je lurasidon treba uporabljati previdno.
English: Baseline Mean (SD) LS Mean Change (SE) Treatment Difference vs. placebo
Slovenian: Izhodiščno povprečje (SD) Povprečna sprememba najmanjših kvadratov (SN) Razlika zdravljenja v primerjavi s placebom Ocena (SN) p-vrednost
English: • increase in creatinine (a marker of kidney function) seen in blood tests.
Slovenian: • krvne preiskave lahko pokažejo zvišanje ravni kreatinina (pokazatelj delovanja ledvic).
English: Hyperprolactinaemia Lurasidone elevates prolactin levels due to antagonism of dopamine D2 receptors.
Slovenian: Lurasidon zaradi antagonističnega delovanja na dopaminske D2 receptorje zviša vrednosti prolaktina.
English: Angelini Pharma Österreich GmbH
Slovenian: Austria/ Österreich Angelini Pharma Österreich GmbH Brigittenauer Lände 50-54
English: Each 74 mg tablet contains lurasidone hydrochloride equivalent to 74.5 mg lurasidone.
Slovenian: Ena 74 mg tableta vsebuje lurasidonijev klorid v količini, ki ustreza 74,5 mg lurasidona.
English: Cases of venous thromboembolism (VTE) have been reported with antipsychotic medicinal products.
Slovenian: Pri zdravljenju z antipsihotiki so poročali o primerih venske trombembolije.
English: (a) Olanzapine 15 mg in Study D1050231, quetiapine extended-release (XR) 600 mg in Study D1050233.
Slovenian: Izhodiščno povprečje (SD) Povprečna sprememba najmanjših kvadratov (SN) Razlika zdravljenja v primerjavi s placebom Ocena (SN) p-vrednost (a) olanzapin v odmerku 15 mg v študiji D1050231, kvetiapin s podaljšanim sproščanjem (XR) v odmerku 600 mg v študiji D1050233 N je število oseb na model ocene.
English: total score).
Slovenian: Analysis Set)
English: • a history of seizures (fits) or epilepsy
Slovenian: • če imate ali ste kdaj imeli težave z epileptičnimi napadi (krči) ali epilepsijo
English: There were no clinically relevant differences in the pharmacokinetics of lurasidone in a population pharmacokinetic analysis in patients with schizophrenia.
Slovenian: V populacijski farmakokinetični analizi pri bolnikih s shizofrenijo niso ugotovili klinično pomembnih razlik v farmakokinetiki lurasidona.
English: Breast enlargement**** Breast pain**** Galactorrhoea**** Erectile dysfunction**** Amenorrhoea**** Dysmenorrhoea****
Slovenian: Motnje reprodukcije in dojk zvišanje ravni prolaktina v krvi povečanje dojk**** bolečina v dojkah**** galaktoreja**** erektilna disfunkcija**** amenoreja**** dismenoreja****
English: 0.1 mg/kg/day lurasidone hydrochloride, respectively, or on early embryonic development at an oral dose of 15 mg/kg/day lurasidone hydrochloride.
Slovenian: Pri podganah lurasidon ni vplival na razmnoževanje samcev pri peroralnem odmerku lurasidonijevega klorida 150 mg in samic pri peroralnem odmerku lurasidonijevega klorida 0,1 mg/kg/dan ali na zgodnji embrionalni razvoj pri peroralnem odmerku lurasidonijevega klorida 15 mg/kg/dan.
English: Elderly patients with dementia Lurasidone has not been studied in elderly patients with dementia.
Slovenian: Pri starostnikih z demenco uporabe lurasidona niso raziskovali.
English: • prednisone (to treat inflammatory disease)
Slovenian: • prednizon (za zdravljenje vnetnih bolezni)
English: • verapamil (to treat high blood pressure or chest pain).
Slovenian: • flukonazol (za zdravljenje glivičnih okužb) • verapamil (za zdravljenje visokega krvnega tlaka ali bolečine v prsnem košu).
English: White to off-white, film-coated round tablets of 6 mm debossed with ‘LA'
Slovenian: Bele ali skoraj bele, okrogle (premer 6 mm), filmsko obložene tablete z oznako “LA”.
English: Latuda 18.5 mg film-coated tablets
Slovenian: IME ZDRAVILA Latuda 18,5 mg filmsko obložene tablete
English: There were no clinically relevant differences between genders in the pharmacokinetics of lurasidone in a population pharmacokinetic analysis in patients with schizophrenia.
Slovenian: V populacijski farmakokinetični analizi pri bolnikih s shizofrenijo med spoloma niso ugotovili klinično pomembnih razlik v farmakokinetiki lurasidona.
English: Pale green, film-coated oval tablets of 12 mm x 7 mm debossed with ‘LD'
Slovenian: Svetlozelene, ovalne (12 mm x 7 mm), filmsko obložene tablete z oznako “LD”.
English: Latuda film-coated tablets are available in pack sizes containing 14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1,
Slovenian: Latuda filmsko obložene tablete so na voljo v škatlah, ki vsebujejo 14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 90 x 1 ali 98 x 1 filmsko obloženo tableto v aluminij/aluminij perforiranih enoodmernih pretisnih omotih.
English: Tel: + 43 5 9606 0
Slovenian: Tel: + 43 5 9606 0 office@angelini.at
English: Extrapyramidal symptoms (EPS)
Slovenian: Ekstrapiramidni simptomi
English: The serum concentrations of lurasidone are increased in healthy subjects with Child-Pugh Class A, B and C hepatic impairment with an increased exposure of 1.5-, 1.7- and 3-fold respectively.
Slovenian: Pri zdravih osebah z okvaro jeter razreda A, B in C po Child-Pughovi klasifikaciji so bile koncentracije lurasidona v serumu povečane.
English: The recommended starting dose is 37 mg of lurasidone once daily.
Slovenian: Priporočeni začetni odmerek lurasidona je 37 mg enkrat na dan. Začetnega odmerka ni treba titrirati.
English: • sleep disorder
Slovenian: • prebavne motnje
English: Latuda 74 mg film-coated tablets lurasidone
Slovenian: Latuda 74 mg filmsko obložene tablete lurasidon
English: Lurasidone should be used cautiously in patients with a history of seizures or other conditions that potentially lower the seizure threshold.
Slovenian: Pri bolnikih z anamnezo epileptičnih napadov ali drugih stanj, ki bi lahko znižala prag za epileptične napade, je lurasidon treba uporabljati previdno.
English: • diarrhoea
Slovenian: • boleče uriniranje
English: Latuda 18.5 mg film-coated tablets lurasidone
Slovenian: Latuda 18,5 mg filmsko obložene tablete lurasidon
English: Contact your doctor if you have questions on this medicine.
Slovenian: Če imate o tem zdravilu kakršno koli vprašanje, se posvetujte z zdravnikom.
English: • increased blood prolactin, increased blood glucose (blood sugar), increase in some liver enzymes, seen in blood tests
Slovenian: (krvnega sladkorja) v krvi in zvišanje ravni nekaterih jetrnih encimov
English: Latuda 74 mg tablets lurasidone
Slovenian: IME ZDRAVILA Latuda 74 mg tablete lurasidon
English: • deliberate injury to oneself
Slovenian: • premišljeno samopoškodovanje
English: Reproductive system and breast disorders
Slovenian: Infekcijske in parazitske bolezni nazofaringitis
English: • irritation to lining of stomach
Slovenian: • bolečina v trebuhu
English: Latuda 37 mg tablets lurasidone
Slovenian: IME ZDRAVILA Latuda 37 mg tablete lurasidon
English: • diabetes or are prone to diabetes
Slovenian: • če imate sladkorno bolezen ali tveganje za razvoj sladkorne bolezni
English: Physicians should therefore weigh the risks versus the benefits when prescribing lurasidone to patients with Parkinson's disease.
Slovenian: Pri predpisovanju lurasidona bolnikom s Parkinsonovo boleznijo mora zdravnik presoditi o tveganjih v primerjavi s koristmi.
English: Sudden death attributable to underlying cardiovascular disease observed during the clinical development programme**** *Somnolence includes adverse reaction terms: hypersomnia, hypersomnolence, sedation, and somnolence **Parkinsonism includes adverse reaction terms: bradykinesia, cogwheel rigidity, drooling, extrapyramidal disorder, hypokinesia, muscle rigidity, parkinsonism, psychomotor retardation, and tremor ***Dystonia includes adverse reaction terms: dystonia, oculogyric crisis, oromandibular dystonia, tongue spasm, torticollis, and trismus.
Slovenian: **Izraz parkinsonizem vključuje naslednje neželene učinke: bradikinezijo, fenomen zobatega kolesa, slinjenje, ekstrapiramidne motnje, hipokinezijo, okorelost mišic, parkinsonizem, psihomotorično retardacijo in tremor.
English: (IC50>5.9 μM) of the enzymes cytochrome P450 (CYP)1A2, CYP2B6, CYP2C8, CYP2C9,
Slovenian: Lurasidon in vitro ni neposredno ali šibko zaviral (neposredno ali v odvisnosti od časa) (IC50 > 5,9 μM) encimov citokroma P450 (CYP)1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 in CYP3A4.
English: Viale Amelia 70
Slovenian: Italy/ Italia Angelini S.p.A Viale Amelia 70
English: • Rhabdomyolysis which is the breakdown of muscle fibres that leads to the release of muscle fibre contents (myoglobin) into the bloodstream, seen as muscle pain, being sick, being confused, an abnormal heart rate and rhythm, and possibly dark urine
Slovenian: • rabdomioliza, ki je razgradnja mišičnega tkiva, kar povzroči sproščanje vsebine mišičnih vlaken
English: • rigid posture
Slovenian: • okorela drža
English: Latuda 37 mg film-coated tablets lurasidone
Slovenian: Latuda 37 mg filmsko obložene tablete lurasidon
English: Latuda 74 mg film-coated tablets
Slovenian: IME ZDRAVILA Latuda 74 mg filmsko obložene tablete
English: CDRS-R Total Score
Slovenian: Primarni cilj: Skupna vrednost CDRS-R
English: Latuda 37 mg film-coated tablets
Slovenian: IME ZDRAVILA Latuda 37 mg filmsko obložene tablete
English: Renal impairment No dose adjustment of lurasidone is required in patients with mild renal impairment.
Slovenian: Pri bolnikih z blago okvaro ledvic odmerka lurasidona ni treba prilagajati.
English: System Organ Class
Slovenian: Povečanje telesne mase
English: • seizure (fits)
Slovenian: • epileptični napadi (krči)
English: • rufinamide (to treat seizures).
Slovenian: • rufinamid (za zdravljenje epileptičnih napadov).
English: • increase in creatine phosphokinase (an enzyme in muscles) seen in blood tests
Slovenian: • krvne preiskave lahko pokažejo zvišanje ravni kreatin-kinaze (mišični encim)
English: Baseline Mean (SD)
Slovenian: Izhodiščna srednja vrednost (SD)
English: Each film-coated tablet contains lurasidone hydrochloride equivalent to18.6 mg lurasidone.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje lurasidonijev klorid v količini, ki ustreza 18,6 mg lurasidona.
English: RO-București 050451 Tel: + 40 21 331 6767
Slovenian: Tel: + 40 21 331 6767 office@angelini.ro
English: • back pain
Slovenian: • bolečine v hrbtu
English: • an increase in your weight
Slovenian: • povečanje telesne mase
English: • indigestion
Slovenian: • vrtoglavica
English: • decreased liver function
Slovenian: • če imate okvaro delovanja ledvic
English: No dose adjustment of lurasidone is required in patients with mild hepatic impairment.
Slovenian: Pri bolnikih z blago okvaro jeter odmerka lurasidona ni treba prilagajati.
English: • a history of blood clots, or if someone else in your family has a history of blood clots, as medicines for schizophrenia have been associated with formation of blood clots
Slovenian: • če imate ali ste kdaj imeli težave s krvnimi strdki ali pa takšne težave ima ali je imel kdo od vaših krvnih sorodnikov.
English: Each film-coated tablet contains lurasidone hydrochloride equivalent to 37.2 mg lurasidone.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje lurasidonijev klorid v količini, ki ustreza 37,2 mg lurasidona.
English: It is effective in a dose range of 37 to 148 mg once daily.
Slovenian: Zdravilo je učinkovito v razponu odmerkov od 37 do 148 mg enkrat na dan. Odmerek se lahko poveča na osnovi presoje zdravnika in opaženega kliničnega odziva.
English: Parkinsonism** Dizziness Dystonia*** Dyskinesia
Slovenian: omotica distonija*** diskinezija letargija disartrija tardivna diskinezija maligni nevroleptični sindrom konvulzije****
English: Rare cases of glucose related adverse reactions, e.g. increase in blood glucose, have been reported in clinical trials with lurasidone.
Slovenian: V kliničnih preskušanjih lurasidona so poročali o redkih primerih neželenih učinkov na raven glukoze, npr. zvišanju ravni glukoze krvi.
English: Each film-coated tablet contains lurasidone hydrochloride equivalent to 74.5 mg lurasidone.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje lurasidonijev klorid v količini, ki ustreza 74,5 mg lurasidona.
English: N=121 N=116
Slovenian: n=116
English: • The other ingredients are mannitol, pregelatinised starch, croscarmellose sodium, hypromellose,
Slovenian: *Izraz somnolenca vključuje naslednje neželene učinke: hipersomnijo, hipersomnolenco, sedacijo in somnolenco.
English: Weight gain has been observed with atypical antipsychotic use.
Slovenian: Pri uporabi atipičnih antipsihotikov so poročali o povečanju telesne mase.
English: Hypersensitivity
Slovenian: Hiperprolaktinemija
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja izpuščaj srbenje čezmerno znojenje angioedem
English: Tardive dyskinesia
Slovenian: • nerazločno govorjenje
English: office@angelini.bg
Slovenian: CGI-BP-S
English: General disorders and administration site conditions
Slovenian: Splošne težave in spremembe na mestu aplikacije utrujenost motnje drže
English: Medicinal product subject to medical prescription.
Slovenian: Odmerek bo določil zdravnik.
English: Adverse drug reactions (ADRs) based upon pooled data are shown by system, organ class and by preferred term are listed below.
Slovenian: Neželeni učinki, ki temeljijo na zbranih podatkih, so v nadaljevanju prikazani po organskih sistemih.
English: A.
Slovenian: Edition).
English: • slurred speech
Slovenian: • odpoved ledvic
English: MA (EU) Number Invented name Strength Pharmaceutical form Route of administration Immediate Packaging Package size
Slovenian: Izmišlje no ime Jakost Farmacevtska oblika
English: 1 x 1 tablet (unit dose)
Slovenian: Pot uporabe Stična ovojnina
English: Implementation of the agreement by the Member States (submission of the variation by the Marketing Authorisation Holder):
Slovenian: Izvajanje sporazuma s strani držav članic (predložitev spremembe s strani imetnika dovoljenja za promet z zdravilom):
English: 20 February 2014
Slovenian: 20. februar 2015
English: The procedure started on 20 September 2007.
Slovenian: Postopek se je začel 20. septembra 2007.
English: Ref. EMEA/CHMP/384879/2008
Slovenian: : EMEA/CHMP/554691/2008
English: A Decision was issued by the European Commission on 7 October 2008.
Slovenian: Evropska komisija je odločbo izdala 7. oktobra 2008.
English: London, 8 October 2008 Doc.
Slovenian: London, 8. oktober 2008 Sklic dok.
English: The Marketing Authorisation Holder provided supplementary information on 28 January 2008 and 28 April 2008.
Slovenian: Imetnik dovoljenja za promet z zdravilom je priskrbel dodatne informacije 28. januarja 2008 in 28. aprila 2008.
English: Risperdal Consta and associated names is an anti-psychotic, indicated for the maintenance treatment of schizophrenia in patients currently stabilised with oral antipsychotics.
Slovenian: Zdravilo Risperdal Consta in z njim povezana imena je antipsihotično zdravilo, indicirano za vzdrževalno zdravljenje shizofrenije pri bolnikih, katerih stanje je trenutno stabilizirano s peroralnimi antipsihotiki.
English: It is available as prolonged release powder and solvent for suspension for intramuscular use.
Slovenian: Zdravilo je na voljo v obliki praška s podaljšanim sproščanjem in vehikla za suspenzijo za intramuskularno uporabo.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Risperdal Consta and associated names International Non-Proprietary Name (INN): risperidone
Slovenian: ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI (CHMP) MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 30 ZA Risperdal Consta in z njim povezana imena Mednarodno nelastniško ime (INN): risperidon
English: The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) of Risperdal Consta and associated names approved across EU Member States, with respect to the indication, the special warnings and precautions for use and the interaction with other medicinal products and other forms of interaction.
Slovenian: Osnova za napotitev so bile razlike med povzetki glavnih značilnosti zdravila Risperdal Consta in z njim povezanih imen v državah članicah EU pri indikacijah, posebnih opozorilih in previdnostnih ukrepih ter medsebojnem delovanju z drugimi zdravili in drugih vrstah interakcij.
English: On 24 July 2007 the European Commission presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, as amended, in order to harmonise the nationally authorised Summaries of Product Characteristics (SPC), Labelling and Package Leaflet of the medicinal product Risperdal Consta and associated names.
Slovenian: Evropska komisija je dne 24. julija 2007 agenciji EMEA predložila napotitev v skladu s členom 30 Direktive 2001/83/ES, kakor je bila spremenjena, da bi uskladila nacionalno odobrene povzetke glavnih značilnosti zdravila, označevanje in navodilo za uporabo zdravila Risperdal Consta in z njim povezana imena.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amended SPC, Labelling and Package Leaflet in Annex III.
Slovenian: Seznam zadevnih imen zdravil je naveden v Dodatku I. Znanstveni zaključki so navedeni v Dodatku II, skupaj s spremenjenim povzetkom glavnih značilnosti zdravila, označevanjem in navodilom za uporabo v Dodatku III.
English: During its July 2008 meeting, the CHMP, in the light of the overall submitted data and the scientific discussion within the Committee, was of the opinion that the proposal for the harmonisation of the SPC, Labelling and Package Leaflet was acceptable and that they should be amended.
Slovenian: CHMP je med zasedanjem julija 2008 glede na vse predložene podatke in znanstveno razpravo v Odboru sprejel mnenje, da je predlog za uskladitev povzetkov glavnih značilnosti zdravila, označevanja in navodila za uporabo sprejemljiv in da bi bilo treba navedene dokumente spremeniti.
English: This medicinal product belongs to the list of products identified in 2007 for SPC harmonisation.
Slovenian: To zdravilo spada na seznam zdravil, katerih povzetke glavnih značilnosti zdravila je treba po ugotovitvah iz leta 2007 uskladiti.
English: The CHMP gave a positive opinion on 24 July 2008 recommending the harmonisation of the SPC, Labelling and Package Leaflet for Risperdal Consta and associated names.
Slovenian: V CHMP so podali pozitivno mnenje 24. julija 2008, s katerim so priporočili uskladitev povzetkov glavnih značilnosti zdravila, označevanja in navodila za uporabo za zdravilo Risperdal Consta in z njim povezana imena.
English: Most of them received only one infusion.
Slovenian: Večina od njih je prejela samo eno infuzijo.
English: The majority of patients were female.
Slovenian: Večina bolnikov je bila ženskega spola.
English: The majority of studies were retrospective.
Slovenian: Večina študija je bila retrospektivnih.
English: Published literature was also provided.
Slovenian: Predložena je bila tudi objavljena literatura.
English: In about 80% of the cases, the outcome of pregnancy was unknown.
Slovenian: Pri približno 80 % primerov izid nosečnosti ni bil znan.
English: Therefore, no conclusions on safety can be drawn from these studies alone.
Slovenian: Zaključkov o varnosti zato samo iz teh študij ni mogoče izpeljati.
English: These reactions may be damaging, uncomfortable, or occasionally fatal.
Slovenian: Te reakcije so lahko škodljive, neprijetne in v nekaterih primerih smrtne.
English: Risk minimisation measures and other pharmacovigilance activities
Slovenian: Ukrepi za zmanjšanje tveganja in druge dejavnosti farmakovigilance
English: The following analyses were performed on spontaneous or solicited cases, medically confirmed or not, recorded until 15 December 2011.
Slovenian: Naslednje analize so izvedli na spontanih ali spodbujenih primerih, medicinsko potrjenih ali ne, ki so jih zabeležili do 15. decembra 2011.
English: Twenty-two clinical studies were submitted.
Slovenian: Predloženih je bilo dvaindvajset kliničnih študij.
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC for intravenous iron containing medicinal products.
Slovenian: • Odbor je obravnaval napotitev v skladu s členom 31 Direktive 2001/83/ES za intravenska zdravila, ki vsebujejo železo;
English: This recommendation was also advised by the PRAC during the consultation requested by the CHMP.
Slovenian: To priporočilo je med posvetovanjem na zahtevo CHMP izdal tudi PRAC.
English: Overall summary of the scientific evaluation of intravenous iron containing medicinal products (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja intravenskih zdravil, ki vsebujejo železo (glejte Prilogo I)
English: A total of 33 publications reporting on the safety of LMWID were identified.
Slovenian: Upoštevanih je bilo skupno 33 publikacij, ki so poročale o varnosti LMWID.
English: The majority of cases were reported as serious (366/587; 62%).
Slovenian: Večina primerov je bila zabeleženih kot resnih (366/587; 62 %).
English: For some cases (108 out of 168) the time-to-onset of the reaction was reported.
Slovenian: Pri nekaterih primerih (108 od 168) so poročali o času do pojava reakcije.
English: Predisposition to an allergy or known asthma may result in a more severe reaction.
Slovenian: Nagnjenost k alergijam ali znana astma lahko povzročita resnejšo reakcijo.
English: All studies have been performed applying a protocol not including a test dose.
Slovenian: Vse študije so bile izvedene z uporabo protokola brez testnega odmerka.
English: Data provided regarding safety in pregnancy and intestinal absorption disorder was very limited.
Slovenian: Predloženi podatki glede varnosti v nosečnosti in motnje absorpcije v črevesju so bili zelo omejeni.
English: Anti-allergic treatment was reported for 94/168 cases.
Slovenian: O antialergijskem zdravljenju so poročali pri 94 od 168 primerov.
English: The test-dose does not seem to prevent the occurrence of severe reactions.
Slovenian: Zdi se, da testni odmerek ne prepreči pojava resnih reakcij.
English: Test dose
Slovenian: Testni odmerek
English: Among all studies provided, only one life-threatening reaction was reported (Michael, et al 2002).
Slovenian: Pri vseh predloženih študijah so poročali o samo eni življenjsko ogrožajoči reakciji (Michael, in sod.
English: Cytotoxicity is mediated throughout the formation of reactive oxygen species (ROS).
Slovenian: Citotoksičnost se posreduje skozi celoten postopek oblikovanja reaktivnih kisikovih zvrsti (reactive oxygen species − ROS).
English: This corresponds to a hypersensitivity events frequency rate of 0.060%, which is lower than the frequency rate found in clinical trials.
Slovenian: To ustreza 0,060-odstotni stopnji pogostnosti preobčutljivostnih dogodkov, kar je nižje od stopnje pogostnosti v kliničnih preskušanjih.
English: Two of these 3 anaphylactoid reactions occurred in patients with Crohn's disease.
Slovenian: Dve od teh 3 anafilaktoidnih reakcij sta se pojavili pri bolnikih s Crohnovo boleznijo.