natgillin/translations-raw huggingface dataset:
For all products listed in Annex I, the existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below.
Obstoječe informacije o zdravilu je treba spremeniti (z vstavljanjem, zamenjavo ali izbrisom besedila) za vsa zdravila, navedena v Prilogi I,tako da odražajo spodaj navedeno dogovorjeno besedilo.
The risk of developing inhibitors is correlated to the exposure to Antihaemophilic Factor VIII, this risk being highest within the first 20 exposure days.
Tveganje za nastanek zaviralcev je povezano z izpostavljenostjo antihemofiličnemu faktorju VIIInajvečje je v prvih 20 dneh izpostavljenosti.
* Frequency is based on studies with all FVIII products which included patients with severe haemophilia A. PTPs = previously-treated patients, PUPs = previously-untreated patients”
• To sprotno opombo in pojasnitev kratice je treba navesti pod preglednico: *Pogostnost temelji na študijah z vsemi zdravili s FVIII, ki so vključevale bolnike s hudo hemofilijo A. PZB = predhodno zdravljeni bolniki, PNB = predhodno nezdravljeni bolniki«
• [[For products listed in Annex I for which a frequency for PUPs has not been implemented in section 4.8 of the SmPC] the wording should be revised as follows:] “For patients who have received previous treatment with Factor VIII (more than 150 days of treatment) inhibitor antibodies (see section 2) may form uncommonly (less than 1 in 100 patients).
• [[Za zdravila, navedena v Prilogi I, za katera v poglavju 4.8 povzetka glavnih značilnosti zdravila ni navedena pogostnost pri predhodno nezdravljenih bolnikih,] je treba besedilo spremeniti, kot sledi:] »Pri bolnikih, ki so se predhodno zdravili s faktorjem VIII (zdravljenje je trajalo več kot 150 dni), zaviralna protitelesa lahko nastanejo občasno (pri manj kot 1 od 100 bolnikov).
([For all products listed in Annex I] all existing information on inhibitor development should be replaced with the following)
([Za vsa zdravila, navedena v Prilogi I,] je treba vse obstoječe informacije o nastanku zaviralcev zamenjati z naslednjim besedilom)
([For all products listed in Annex I] the wording should be revised as follows: all existing information on inhibitor development should be replaced with the following)
([Za vsa zdravila, navedena v Prilogi I,] je treba besedilo spremeniti, kot sledi: vse obstoječe informacije o nastanku zaviralcev je treba zamenjati z naslednjim besedilom)
”Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with <product name> < see section 5.1>.
»Pri bolnikih s hemofilijo A, zdravljenih s faktorjem VIII, vključno z zdravilom <ime zdravila> , lahko pride do nastanka nevtralizirajočih protiteles (zaviralcev) <, glejte poglavje 5.1>.
Section 5.1 - Pharmacodynamic properties (In accordance with the PRAC recommendation, existing relevant text in section 5.1 of the SmPC in relation to inhibitor frequency for Recombinate should be deleted.)
(V skladu s priporočilom odbora PRAC je treba obstoječe ustrezno besedilo v poglavju 5.1 povzetka glavnih značilnosti zdravila glede pogostnosti zaviralcev pri zdravilu Recombinate izbrisati.)
[[For all products listed in Annex I] the wording should be revised as follows:] “The formation of inhibitors (antibodies) is a known complication that can occur during treatment with all Factor VIII medicines.
Poglavje 2 - Kaj morate vedeti, preden <boste vzeli> <boste uporabili> zdravilo X: [[Za vsa zdravila, navedena v Prilogi I,] je treba besedilo spremeniti, kot sledi:] »Nastanek zaviralcev (protiteles) je znan zaplet, ki se lahko pojavi med zdravljenjem z vsemi zdravili s faktorjem VIII.
Inhibitor Development
Nastanek zaviralcev
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH
Novartis Hungária Kft. Pharma részlege
Madžarska Novartis Hungária Kft. Pharma részlege
Sandimmun 50 mg/ml concentrado para solución para perfusión
Sandimmun 50 mg/ml concentrado para solución para perfusión španija
Sandimmune, concentraat voor oplossing voor intraveneuze infusie 50 mg/ml
Sandimmune, concentraat voor oplossing voor intraveneuze infusie 50 mg/ml koncentrat za raztopino za intravensko infundiranje
Sandimmun 100 mg/ml Lösung zum Einnehmen
Sandimmun 100 mg/ml Lösung zum Einnehmen peroralna raztopina peroralna uporaba 100 mg/ml
Intravenous
ČLANICAH
250 mg/5 ml Concentrate for solution for infusion
250 mg/5 ml koncentrat za raztopino za infundiranje
No long-term data were submitted.
Predložili niso nobenih dolgoročnih podatkov.
This risk persists until significant remission occurs.
Takšno tveganje obstaja vse dokler ne pride do znatne remisije.
No specific antidote is known.
Specifičen antidot ni poznan.
In the older age groups no such increase was observed.
V starejših starostnih skupinah niso opažali takega povečanja.
• Undesirable effects
• Neželeni učinki
Common: decreased appetite.
Pogosti: zmanjšan apetit
4.7 Effects on Ability to Drive and Use Machines
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji
In addition, efficacy could not be demonstrated in this population.
Poleg tega v tej populaciji niso dokazali učinkovitosti.
It is recommended that paroxetine is administered once daily in the morning with food.
Priporočljivo je, da se paroksetin jemlje enkrat dnevno in sicer zjutraj skupaj s hrano.
Special Populations:
Posebne populacije:
None required re-start of the medication.
Pri nobenem ni bilo treba ponovno uvesti zdravila.
Further to a meeting of the Standing Committee the Commission requested the CHMP to review the new available data.
Na podlagi sestanka Stalnega odbora je Komisija zaprosila CHMP, da preuči nove razpoložljive podatke.
OVERALL CONCLUSION ON BENEFIT/RISK
SKUPNI ZAKLJUČEK O RAZMERJU MED KORISTMI IN TVEGANJI
<The tablet should be swallowed rather than chewed.> <Shake bottle before use.>
<Tableto je potrebno pogoltniti in ne žvečiti.> <Pred uporabo stekleničko pretresite.>
Long-term safety in children
Dolgoročna varnost pri otrocih
Paroxetine was first approved in 1990 as an antidepressant in the U.K.
Paroksetin so prvič odobrili leta 1990 kot antidepresiv v Veliki Britaniji.
Elderly patients may be at an increased risk.
Pri starejših bolnikih je tveganje lahko večje.
• Children aged below 7 years
• Otroci mlajši od 7 let
This is most likely to occur within the first few weeks of treatment.
Najbolj verjetno se to zgodi v prvih nekaj tednih zdravljenja.
Young adults should therefore be monitored carefully throughout treatment.
Mlajše odrasle je torej potrebno skrbno nadzorovati ves čas zdravljenja.
Although all three analyses derived their data from the same database, they differed in a certain extent from each other in terms of design, definitions, specific products that were compared and the time frame within which patients' data was examined.
Čeprav so vse tri analize temeljile na podatkih iz iste zbirke podatkov, so se v določeni meri medsebojno razlikovale glede zasnove, definicij in specifičnih izdelkov, ki so jih primerjale, ter časovnega okvira, v katerem so obravnavali podatke o bolnikih.
The main safety issues discussed were the risk of suicide and the risk of withdrawal reactions.
Poglavitni vprašanji varnosti, o katerih so razpravljali, sta tveganje za samomor in tveganje za odtegnitvene reakcije.
The CHMP, having considered the additional data that became available after the opinion of 22 April 2004, concluded that such data do not change its previous conclusions and recommendations.
CHMP je, upoštevajoč dodatne podatke, pridobljene po sprejemu mnenja z dne 22. aprila 2004, sklenil, da ti podatki ne spreminjajo njegovih prejšnjih sklepov in priporočil.
Long-term efficacy
Dolgoročna učinkovitost
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF PAROXETINE CONTAINING MEDICINAL PRODUCTS (see Annex I)
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVIL, KI VSEBUJEJO PAROKSETIN (glej Dodatek I)
The elimination half-life is variable but is generally about 1 day.
Eliminacijski razpolovni čas je variabilen, navadno pa je približno 1 dan.
• 6-monthly Periodic Safety Update Reports should be provided to the Reference Member States and/or National Competent Authorities for the next 2 years.
• Referenčnim državam članicam in/ali nacionalnim pristojnim oblastem je treba posredovati 6mesečna Redna poročila o varnosti (Periodic Safety Update Reports) za naslednji 2 leti.
Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100, <1/10), uncommon (≥ 1/1,000, <1/100), rare (≥ 1/10,000, <1/1,000), very rare (<1/10,000), including isolated reports.
Pogostnost je definirana kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100, < 1/10), občasni (≥ 1/1.000, < 1/100), redki (≥ 1/10.000, < 1/1.000), zelo redki (< 1/10.000), vključno s posamičnimi primeri.
This was supported by a 36 week maintenance study.
Študija je bila podprta z 36-tedensko vzdrževalno študijo.
Morning dosing with paroxetine does not have any detrimental effect on either the quality or duration of sleep.
Jutranje odmerjanje paroksetina nima škodljivega učinka niti na kakovost niti na trajanje spanja.
Special Patient Populations
Posebne populacije bolnikov
Increased hostility occurred particularly in children with obsessive compulsive disorder, and especially in younger children less than 12 years of age.
Okrepljena sovražnost je bila opažena predvsem pri otrocih z obsesivno-kompulzivno motnjo in še posebej pri otrocih mlajših od 12 let.
Conditions set out in Annex IV of the CHMP Opinion, including the submission of 6-monthly Periodic Safety Update Reports for the next two years.
Pogoji, navedeni v Dodatku IV Mnenja CHMP, vključno z oddajo rednih 6-mesečnih Periodičnih poročil o varnosti zdravila (Periodic Safety Update Reports- PSUR) za naslednji dve leti.
In a majority of instances the complications begin immediately or soon (<24 hours) after delivery.
V večini primerov so bili zapleti bodisi neposredno bodisi kmalu (< 24 ur) po porodu.
No signs of drug effects were observed in these infants.
Pri teh otrocih učinki zdravila niso bili opaženi.
In published studies, serum concentrations in breast-fed infants were undetectable (<2 ng/ml) or very low (<4 ng/ml).
V objavljenih študijah so bile koncentracije v serumu otrok, ki so bili dojeni nedokazljive (< 2 ng/ml) ali zelo nizke (< 4 ng/ml).
Treatment with paroxetine can be initiated:
Zdravljenje s paroksetinom se lahko uvede:
Supportive care with frequent monitoring of vital signs and careful observation is indicated.
Indicirana je podporna nega s pogostim nadziranjem vitalnih znakov in skrbnim opazovanjem.
These new data reviewed by CHMP included three studies (one published and two unpublished) based on the UK General Practice Research Database (GPRD).
Novi podatki, ki jih je pregledal CHMP, so vključevali tri študije (eno objavljeno in dve neobjavljeni), ki temeljijo na zbirki podatkov iz raziskav splošne medicine (General Practice Research Database, GPRD) iz Združenega kraljestva.
Children and Adolescents (7-17 years)
Otroci in mladostniki (stari od 7 do 17 let)
Most withdrawal symptoms were mild or moderate.
Večina odtegnitvenih simptomov je bila blaga ali zmerna.
There is also some evidence that paroxetine may be of therapeutic value in patients who have failed to respond to standard therapy.
Obstajajo tudi nekateri dokazi, da ima paroksetin lahko terapevtsko vrednost pri bolnikih, ki se na standardno zdravljenje niso odzvali.
These studies did not show a statistical significant elevation of suicide related events and self harm in young adults.
Te raziskave niso pokazale statistično značilnega povečanja dogodkov, povezanih s samomori, ter samopoškodovanj pri mladih odraslih.
Carcinogenesis: In two-year studies conducted in mice and rats, paroxetine had no tumorigenic effect.
Kancerogenost: V dveletnih študijah, ki so jih opravili na miših in podganah, paroksetin ni učinkoval tumorogeno.
Uncommon: transient increases or decreases in blood pressure.
Občasni: prehodno povišan ali znižan krvni tlak
In general, improvement in patients starts after one week but may only become evident from the second week of therapy.
Na splošno pride pri bolnikih do izboljšanja že po enem tednu, vendar pa je izboljšanje lahko vidno šele po drugem tednu zdravljenja.
Hostility events were more clearly seen in the OCD studies than in the depression studies.
Sovražne dogodke so bolj očitno opažali v študijah OCD kot v študijah depresije.
[To be completed nationally]
[potrebno dopolniti lokalno]
Subsequently paroxetine has been approved for the treatment of various psychiatric disorders in all EU Member States.
Kasneje je bil odobren za zdravljenje različnih duševnih motenj v vseh državah članicah EU.
• Pharmacodynamic Properties Inclusion of information concerning long-term efficacy of paroxetine and dose response studies.
• Farmakodinamične lastnosti Vključitev podatkov o dolgoročni učinkovitosti paroksetina ter študijah odziva na odmerek.
Summary of Product Characteristics set out in Annex III of the CHMP Opinion with emphasis to the following:
Povzetkom glavnih značilnosti zdravila v Dodatku III Mnenja CHMP s poudarkom na sledečem:
The latter effects were likely related to maternal toxicity and are not considered a direct effect on the foetus/neonate.
Zadnji učinek je bil verjetno povezan z maternalno toksičnostjo in se ne smatra kot neposreden učinek na fetuse/novorojence.
Depression is associated with an increased risk of suicidal thoughts, self harm and suicide.
Depresija je povezana z večjim tveganjem za samomorilne misli, samouničevalnost in samomor.
QUALITATIVE AND QUANTITATIVE COMPOSITION <Each <tablet><coated tablet><film-coated tablet> contains <10 mg><20 mg><30 mg><40 mg> paroxetine <Each ml of <oral solution><oral suspension> contains <2 mg> paroxetine [To be completed nationally]
KAKOVOSTNA IN KOLIČINSKA SESTAVA <Vsaka <tableta> <obložena tableta> <filmsko obložena tableta> vsebuje <10 mg> <20 mg> <30 mg> <40 mg> paroksetina <Vsak ml <peroralne raztopine> <peroralne suspenzije> vsebuje <2 mg> paroksetina [potrebno dopolniti lokalno]
Although the majority of the symptoms reported in the clinical trials were not serious and not described as severe, subsequently there was evidence from spontaneous reports that some patients experienced serious and severe symptoms on stopping paroxetine.
Čeprav večina simptomov, o katerih so poročali v kliničnih preskušanjih, ni bila resnih in jih niso opisovali kot hude, so se kasneje pojavili dokazi iz spontanih poročil, da so nekateri bolniki ob ukinitvi paroksetina doživeli resne in hude simptome.
ANNEX 1 LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
DODATEK 1 SEZNAM IZMIŠLJENIH IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVIL, NAČINA UPORABE IN IMETNIKOV DOVOLJENJ ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
They usually occur within the first few days of discontinuing treatment, but there have been very rare reports of such symptoms in patients who have inadvertently missed a dose.
Običajno se pojavijo v prvih nekaj dneh po prekinitvi zdravljenja, zelo redko pa so o takšnih simptomih poročali pri bolnikih, ki so pozabili vzeti odmerek.
These symptoms could be due to either serotonergic effects or withdrawal symptoms.
Ti simptomi so lahko posledica serotoninergičnih učinkov ali odtegnitvenih simptomov.
It is general clinical experience with all antidepressant therapies that the risk of suicide may increase in the early stages of recovery.
Splošna klinična izkušnja pri zdravljenju z vsemi antidepresivi je, da se tveganje za samomor lahko v zgodnji fazi izboljšanja poveča.
Efficacy in adults
Učinkovitost pri odraslih
Hexal Hungária Kft. Tímár u.20.
Madžarska Hexal Hungária Kft. Tímár u.20.
Various analyses suggested that the risk of these outcomes was between 1.5 and 3.2 times greater with paroxetine compared to placebo.
Različne analize so pokazale, da je tveganje za te izide 1,5- do 3,2-krat večje pri paroksetinu v primerjavi s placebom.
Significant and relevant results were obtained in some of these studies.
V nekaterih od teh študij so dobili značilne in pomembne rezultate.
New data available after the CHMP Opinion of 22 April 2004: GPRD studies
Novi podatki, pridobljeni po sprejemu mnenja Odbora za zdravila za uporabo v humani medicini (CHMP) dne 22. aprila 2004: GPRD-raziskave
Paroxetine should only be used during pregnancy when strictly indicated.
Paroksetin se sme med nosečnostjo uporabljati le v primeru striktne indikacije.
Nevertheless, paroxetine should not be used during lactation unless the expected benefits to the mother justify the potential risks for the infant.
Kljub temu pa se paroksetin med dojenjem ne sme uporabljati, uporablja se lahko le v primeru, ko pričakovana korist za mater opravičuje možno tveganje za otroka.
Although paroxetine does not increase the mental and motor skill impairments caused by alcohol, the concomitant use of paroxetine and alcohol is not advised.
Čeprav paroksetin ne povečuje okvare duševnih in motoričnih sposobnosti, ki jih povzroča alkohol, sočasne uporabe paroksetina in alkohola ne priporočamo.
The recommended daily dose of paroxetine is 40mg/day for OCD and panic disorder and 20mg/day for the other indications.
Priporočeni dnevni odmerek paroksetina je 40 mg/dan za OCD in panično motnjo ter 20 mg/dan za druge indikacije.
Paroxetine is associated with withdrawal reactions which can be severe in intensity and prolonged in duration.
Paroksetin je povezan z odtegnitvenimi reakcijami, ki so lahko močno intenzivne in dolgo trajajo.
Paroxetine should not be used in the treatment of children and adolescents under the age of 18 years.
Paroksetin se ne sme uporabljati za zdravljenje otrok in mladostnikov mlajših od 18 let.
Suicide/suicidal ideation
Samomor/samomorilna miselnost
During the decision-making process for the article 31 referral on paroxetine subsequent to the CHMP opinion of 22 April 2004, UK informed the European Commission that three new studies with direct relevance to this issue had become available.
Med procesom odločanja v okviru obravnave učinkovine paroksetin v skladu s 31. členom, ki je sledilo mnenju CHMP z dne 22. aprila 2004, je Združeno kraljestvo obvestilo Evropsko komisijo, da so bili dani na razpolago rezultati treh novih raziskav, ki se neposredno tičejo obravnavane tematike.
Currently paroxetine is not authorised for use in children and adolescents in any EU Member State.
Trenutno paroksetina ni dovoljeno uporabljati pri otrocih in mladostnikih v nobeni od držav članic EU.
As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs.
Ker je možno, da med prvimi nekaj tedni zdravljenja ne pride do izboljšanja, je potrebno bolnike skrbno nadzorovati vse dokler ne pride do izboljšanja.
Women planning a pregnancy and those becoming pregnant during therapy should be asked to consult their physician.
Ženske, ki nameravajo zanositi in ženske, ki med zdravljenjem zanosijo se morajo posvetovati z zdravnikom.
In view of the above the CHMP confirmed its previous conclusions in relation to the risk of suicidal behaviour in patients using paroxetine.
Z ozirom na zgoraj navedeno je CHMP potrdil svoje prejšnje sklepe glede tveganja za samomorilno vedenje pri bolnikih, ki uporabljajo paroksetin.
• Member States should ensure that appropriate pharmaceutical forms / strengths can be made available in order to facilitate up and down titration in accordance to the posology recommendations stated in the SPC attached to Annex III of this Opinion.
• Države članice morajo zagotoviti razpoložljivost ustreznih farmacevtskih oblik / jakosti, da pospešimo višanja in nižanja odmerkov v skladu s priporočili za odmerjanje, navedenimi v SPC, priloženemu Dodatku III tega Mnenja.
Tecnimede - Sociedade TécnicoMedicinal, S.A.
Portugalska Tecnimede - Sociedade TécnicoMedicinal, S.A.
However, in a significant proportion of individuals they may be severe in intensity and of prolonged duration (2-3 months or more).
Vendar pa so pri pomembnem deležu bolnikov ti lahko resne jakosti in podaljšanega trajanja (2-3 mesece ali dlje).
These studies investigated the risk of suicidal behaviours (including completed suicides, suicide attempts and suicidal ideation) associated with the use of various antidepressants.
Te raziskave so proučevale tveganje za samomorilno vedenje (vključno z izvedenimi samomori, poskusi samomora in samomorilnim razmišljanjem), povezano z uporabo različnih antidepresivov.
The activating properties are not "amphetamine-like" in nature.
Te lastnosti po svoji naravi niso "podobne lastnostim amfetamina".
In patients who develop these symptoms, increasing the dose may be detrimental.
Pri bolnikih pri katerih se pojavijo ti simptomi je povečevanje odmerka lahko škodljivo.
PHARMACEUTICAL PARTICULARS 6.1 List of Excipients [To be completed nationally] 6.2 Incompatibilities [To be completed nationally] 6.3 Shelf-life [To be completed nationally] 6.4 Special precautions for storage [To be completed nationally] 6.5 Nature and contents of container [To be completed nationally]
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi [potrebno dopolniti lokalno] 6.2 Inkompatibilnosti [potrebno dopolniti lokalno] 6.3 Rok uporabnosti [potrebno dopolniti lokalno] 6.4 Posebna navodila za shranjevanje [potrebno dopolniti lokalno] 6.5 Vrsta ovojnine in vsebina [potrebno dopolniti lokalno] 6.6 Navodila za pripravo in ravnanje z zdravilom [potrebno dopolniti lokalno]
From the assessed data there was no indication of a signal of dependence with paroxetine.
V ocenjenih podatkih ni bilo indikacije za znake odvisnosti pri paroksetinu.
The CHMP noted that long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking.
V CHMP so opazili, da manjkajo podatki o varnosti na dolgi rok pri otrocih in mladostnikih v zvezi z rastjo, odraščanjem, kognitivnim in vedenjskim razvojem.
Rates in patients with other disorders for which paroxetine is indicated are similarly low.
Stopnje pri bolnikih z drugimi motnjami, za katere je paroksetin indiciran, so podobno nizke.
The treatment should consist of those general measures employed in the management of overdose with any antidepressant.
Zdravljenje mora obsegati tiste splošne ukrepe, ki se uporabljajo pri prevelikem odmerjanju katerega koli antidepresiva.
The CHMP considered that despite some problems in the studies, mainly related to the fact that many patients suffered from co-morbid depression, there is evidence to support the efficacy in this indication, however the long-term efficacy has not been sufficiently demonstrated.
V CHMP so menili, da kljub določenim težavam v študijah, povezanih zlasti z dejstvom, da je imelo veliko bolnikov komorbidno depresijo, obstajajo podatki, ki potrjujejo učinkovitost pri tej indikaciji, vendar pa dolgoročna učinkovitost ni bila zadostno dokazana.
The issue of suicidal behaviour among patients treated with paroxetine has been addressed in the past in literature and at national level in some Member States.
V preteklosti so se problema samomorilnega vedenja med bolniki, zdravljenimi s paroksetinom,v nekaterih državah članicah lotili v literaturi in na nacionalni ravni.
Toxicology studies have been conducted in rhesus monkeys and albino rats; in both, the metabolic pathway is similar to that described for humans.
Toksikološke študije so bile opravljene na opicah rhesus in na albino podganah; pri obeh vrstah je pot presnove podobna kot pri ljudeh.
The CHMP discussed in particular whether higher doses may be necessary for some patients and can be justified by the available data.
V CHMP so razpravljali zlasti o tem, ali so pri določenih bolnikih morda potrebni višji odmerki in ali razpoložljivi podatki to opravičujejo.
Immune system disorders Very rare: allergic reactions (including urticaria and angioedema).
Bolezni imunskega sistema Zelo redki: alergijske reakcije (vključno z urtikarijo in angioedemom)