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In clinical trials, worsening of Parkinsonian symptomatology and hallucinations were reported very commonly and more frequently than with placebo (see section 4.8), and olanzapine was not more effective than placebo in the treatment of psychotic symptoms.
V klini nih preskušanjih so o poslabšanju parkinsonske simptomatike in halucinacijah poro ali zelo pogosto in pogosteje kot pri placebu (glejte poglavje 4. 8), olanzapin pa ni bil bolj u inkovit kot placebo pri zdravljenju psihoti nih simptomov.
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Amylase: in the clinical trial subset of 1,008 patients, asymptomatic increases in serum amylase levels greater than 1.5 times the upper limit of normal were seen in 10 % of patients treated with efavirenz and 6 % of patients treated with control regimens.
Amilaze: V klinični raziskavi so v podskupini 1 008 bolnikov asimptomatska zvišanja nivojev serumskih amilaz, večja kot 1, 5 kratna zgornja meja normalne vrednosti, opazili pri 10 % bolnikov, zdravljenih z efavirenzem, in pri 6 % bolnikov iz kontrolne skupine.
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9 Haemorrhage (see section 4.4): In clinical trials across all indications the overall incidence of NCI-CTC Grade 3-5 bleeding events ranged from 0.4 % to 5 % in Avastin treated patients, compared with up to 2.9 % of patients in chemotherapy control group.
Krvavitev (glejte poglavje 4. 4) V kliničnih preskušanjih vseh indikacij je celokupna incidenca krvavitev stopnje 3 do 5 po lestvici NCI- CTC znašala od 0, 4 do 5 % bolnikov, ki so se zdravili z zdravilom Avastin. V kontrolni skupini, ki je prejemala kemoterapijo, je ta odstotek znašal do 2, 9 %.
254 Prevajalska redakcija
izobraževanje
CELEX: 32003L0061
Community comparative tests and trials shall be carried out within the Community for the post-control of samples of fodder plant seed placed on the market under the provisions of this Directive, whether mandatory or discretionary, and taken during sampling.
V Skupnosti se primerjalni testi in poskusi Skupnosti izvajajo za naknadno kontrolo vzorcev semena krmnih rastlin, ki je dano v promet v okviru določb te direktive, ne glede na to, ali so določbe obvezne ali neobvezne, in je odvzeto med vzorčenjem.
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For combination with capecitabine, the most frequent treatment-related undesirable effects (≥ 5 %) reported in a phase III trial in breast cancer patients failing anthracycline treatment are presented (see capecitabine summary of product characteristics).
Pri kombinaciji s kapecitabinom so predstavljeni najpogostejši z zdravljenjem povezani neželeni učinki (≥ 5 %), o katerih so poročali v fazi III kliničnega preizkušanja pri bolnicah z rakom dojke z neuspelim zdravljenjem z antraciklini (prosimo, glejte povzetek glavnih značilnosti kapecitabina).
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The most commonly reported adverse reactions, occurring in more than 5 % of patients treated with Remeron in randomized placebo-controlled trials (see below) are somnolence, sedation, dry mouth, weight increased, increase in appetite, dizziness and fatigue.
Najpogoste so poročali o neželenih učinkih, ki so se pojavili pri več kot 5 % bolnikov, zdravljenih z zdravilom Remeron v randomiziranih s placebom nadzorovanih preskušanjih (glejte spodaj): somnolenca, sedacija, suha usta, povečana telesna masa, povečanje teka, omotica in utrujenost.
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The following groups were not well represented or excluded from clinical trials: patients with pelvic surgery, patients post-radiotherapy, patients with severe renal or hepatic impairment and patients with certain cardiovascular conditions (see section 4.3).
Naslednje skupine niso bile zadovoljivo zastopane ali so bile izključene iz kliničnih študij: bolniki po operacijah na medenici, po radioterapiji, s hudo ledvično ali jetrno okvaro in bolniki z nekaterimi kardiovaskularnimi motnjami (glejte poglavje 4. 3).
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Based on information from subsequent clinical trials, the use of Rapamune, mycophenolate mofetil, and corticosteroids, in combination with IL-2 receptor antibody (IL2R Ab) induction, is not recommended in the de novo renal transplant setting (see section 5.1).
Na podlagi podatkov iz poznejših kliničnih preskušanj se ne priporoča uporabe zdravila Rapamune, mofetilijevega mikofenolata in kortikosteroidov v kombinaciji z indukcijo protiteles proti receptorjem IL- 2 (IL2R Ab) pri ledvičnem presadku de novo (glejte poglavje 5. 1).
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In clinical trials, worsening of Parkinsonian symptomatology and hallucinations were reported very commonly and more frequently than with placebo (see section 4.8), and oral olanzapine was not more effective than placebo in the treatment of psychotic symptoms.
V kliničnih preskušanjih so o poslabšanju parkinsonske simptomatike in halucinacijah poročali zelo pogosto in pogosteje kot pri placebu (glejte poglavje 4. 8), peroralni olanzapin pa ni bil bolj učinkovit kot placebo pri zdravljenju psihotičnih simptomov.
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izobraževanje
CELEX: 32001L0020
the act by a competent authority of conducting an official review of documents, facilities, records, quality assurance arrangements, and any other resources that are deemed by the competent authority to be related to the clinical trial and that may be located at the site of the trial, at the sponsor's and/or contract research organisation's facilities, or at other establishments which the competent authority sees fit to inspect;
dejanje, ki ga opravi pristojni organ za uraden pregled dokumentov, prostorov, zapisov, sistemov za zagotavljanje kakovosti in katerih koli drugih sredstev, za katere pristojni organ meni, da so povezani s kliničnim preskušanjem, in ki se lahko nahajajo na kraju preskušanja, v prostorih naročnika in/ali pogodbene raziskovalne organizacije ali v drugih ustanovah, za katere se pristojnemu organu zdi ustrezno, da jih pregleda;
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CELEX: 32003L0061
Community comparative tests and trials shall be carried out within the Community for the post-control examination of samples of vegetable seed placed on the market under the provisions of this Directive, whether mandatory or discretionary, and taken during sampling.
V Skupnosti se primerjalni testi in poskusi Skupnosti izvajajo za naknadno kontrolo vzorcev semena zelenjadnic, ki je dano v promet v okviru določb te direktive, ne glede na to, ali so določbe obvezne ali neobvezne, in je odvzeto med vzorčenjem.
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This Marketing Authorisation is subject to conditions considered essential for the safe and effective use of the medicinal product, which are that a long-term, double-blind, placebo controlled trial should be conducted as a post-marketing commitment (see Annexe IV).
Dovoljenje za promet je odvisno od pogojev, za katere se šteje, da so bistveni za varno in učinkovito uporabo zdravila, to pomeni, da mora biti kot del postmarketinških obveznosti izvedeno dolgoročno, dvojno slepo, s placebom kontrolirano preizkušanje (glejte Dodatek IV).
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The results of a population pharmacokinetic analysis of these trials have demonstrated that pediatric patients with body weights ≤ 40 kg have a reduced systemic exposure (measured by Css) of A771726 relative to adult rheumatoid arthritis patients (see section 4.2).
Rezultati populacijske farmakokinetične analize teh preskušanj so pokazali, da je pri pediatričnih bolnikih s telesno maso ≤ 40 kg sistemska izpostavljenost A771726 (merjena s Css) manjša kot pri odraslih bolnikih z revmatoidnim artritisom (glejte poglavje 4. 2).
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izobraževanje
CELEX: 32003L0061
Community comparative tests and trials shall be carried out within the Community for the post-control of samples of seed of oil and fibre plants placed on the market under the provisions of this Directive, whether mandatory or discretionary, and taken during sampling.
V Skupnosti se primerjalni testi in poskusi Skupnosti izvajajo za naknadno kontrolo vzorcev semena oljnic in predivnic, ki je dano v promet v okviru določb te direktive, ne glede na to, ali so določbe obvezne ali neobvezne, in je odvzeto med vzorčenjem.
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Data from two randomised controlled clinical trials (157 and 14 insulin aspart-exposed pregnancies respectively) do not indicate any adverse effect of insulin aspart on pregnancy or on the health of the foetus/ newborn when compared to insulin human (see section 5.1).
Podatki dveh randomiziranih, kontroliranih kliničnih preskušanj (157 izpostavljenih nosečnosti v prvem, 14 izpostavljenih nosečnosti v drugem) ne kažejo neželenih učinkov insulina aspart na nosečnost ali na zdravje ploda/ novorojenčka v primerjavi s humanim insulinom (glejte poglavje 5. 1).
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In other clinical trials evaluating ZOSTAVAX in subjects 50 years of age or older, including a study of concomitantly administered inactivated influenza vaccine, the safety profile was generally similar to that seen in the Adverse Event Monitoring Substudy of the SPS.
V ostalih kliničnih preskušanjih cepiva ZOSTAVAX pri osebah, starih 50 let in več, vključno s študijo o sočasni uporabi cepiv proti gripi z inaktiviranimi virusi, je bil varnostni profil v splošnem podoben varnostnemu profilu v podštudiji spremljanja neželenih učinkov, ki je bila izvedena v okviru SPS.
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*In pooled clinical trials, the incidence of headache was 30.3 % with venlafaxine versus 31.3 % with placebo. **Cases of suicidal ideation and suicidal behaviours have been reported during venlafaxine therapy or early after treatment discontinuation (see section 4.4).
* V združenih kliničnih raziskavah je bila pojavnost glavobola pri venlafaksinu 30, 3 %, pri placebu pa 31, 3 %. ** Med zdravljenjem z venlafaksinom ali kmalu po prekinitvi zdravljenja so poročali o primerih samomorilne miselnosti in samomorilnega vedenja (glejte poglavje 4. 4).
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In placebo-controlled clinical trials, in comparison with patients treated with TNF blocking agents and placebo, patients who received combination TNF blocking agents with abatacept experienced an increase in overall infections and serious infections (see section 4.5).
V s placebom nadzorovanih kliničnih preskušanjih je bilo število vseh okužb in hudih okužb večje pri bolnikih, ki so prejemali zaviralce TNF v kombinaciji z abataceptom kot pri bolnikih, ki so prejemali zaviralce TNF in placebo (glejte poglavje 4. 5).
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The safety assessment is based on all data from 1,203 patients in the ongoing Phase III placebo-controlled trials DUET-1 and DUET-2 in antiretroviral treatment-experienced HIV-1 infected adult patients, 599 of whom received INTELENCE (200 mg b. i. d.) (see section 5.1).
Ocena varnosti zdravila temelji na vseh podatkih pri 1. 203 bolnikih iz s placebom nadzorovanih preskušanj III. faze DUET- 1 in DUET- 2, ki še potekajo. Gre za odrasle bolnike, okužene s HIV- 1, ki so že prejeli protiretrovirusno zdravljenje, od tega jih je 599 prejemalo zdravilo INTELENCE (200 mg b. i. d.) (glejte poglavje 5. 1).
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CELEX: 32002D0756
In the case of the assessment of seed potatoes under Directive 2000/29/EC, each sample to be submitted to the laboratory tests shall have been previously coded by the body responsible for carrying out the trials and tests under the responsibility of the Commission services.
Pri oceni semenskega krompirja na podlagi Direktive 2000/29/ES organ, odgovoren za izvajanje poskusov in testiranj pod odgovornostjo služb Komisije, prej označi vsak vzorec, ki se predloži v laboratorijsko testiranje.
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An increased incidence in bone fractures in women was seen in a pooled analysis of adverse event reports of bone fracture from randomised, controlled, double blind clinical trials in over 8100 pioglitazone and 7400 comparator treated patients, on treatment for up to 3.5 years.
V skupni analizi neželenih učinkov zlomov kosti iz randomiziranih, nadzorovanih, dvojno slepih kliničnih preskušanj pri več kot 8100 s pioglitazonom in 7400 s primerjalnim zdravilom zdravljenimi bolniki, ki so se zdravili do 3, 5 let, so opazili povečano incidenco zlomov kosti pri ženskah.
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izobraževanje
CELEX: 22002D0080
Commission Decision 2000/165/EC of 15 February 2000 setting out the arrangements for Community comparative trials and tests on seeds and propagating material of certain plants under Council Directives 66/401/EEC, 66/402/EEC, 66/403/EEC and 69/208/EEC (OJ L 52, 25.2.2000, p. 41).
Odločba Komisije 2000/165/ES z dne 15. februarja 2000 o postopkih za primerjalne poskuse in testiranje semen in razmnoževalnega materiala nekaterih rastlin Skupnosti po direktivah Sveta 66/401/EGS, 66/402/EGS, 66/403/EGS in 69/208/EGS (UL L 52, 25.2.2000, str. 41).
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izobraževanje
CELEX: 31993L0071
For herbicides and for other plant protection products for which adverse effects, however transitory, are seen during the trials, performed in accordance to point 6.2, the margins of selectivity on target crops must be established, using twice the recommended rate of application.
Za herbicide in za druga fitofarmacevtska sredstva, pri katerih se med izvajanjem testov v skladu s točko 6.2. ugotovijo kakršnikoli neželeni učinki, čeprav prehodni, je treba določiti meje selektivnosti na ciljnih posevkih z dvakrat višjim odmerkom od priporočenega.
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Others An increased incidence in bone fractures in women was seen in a pooled analysis of adverse event reports of bone fracture from randomised, controlled, double blind clinical trials in over 8100 pioglitazone and 7400 comparator treated patients, on treatment for up to 3.5 years.
Drugo V skupni analizi neželenih učinkov zlomov kosti iz randomiziranih, nadzorovanih, dvojno slepih kliničnih preskušanj pri več kot 8100 s pioglitazonom in 7400 s primerjalnim zdravilom zdravljenimi bolniki, ki so se zdravili do 3, 5 let, so opazili povečano incidenco zlomov kosti pri ženskah.
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In 865 patients with leukaemia treated with dasatinib in Phase II clinical trials, the mean changes from baseline in QTc interval using Fridericia 's method (QTcF) were 4 - 6 msec; the upper 95 % confidence intervals for all mean changes from baseline were < 7 msec (see section 4.8).
Med kliničnimi preskušanji II. faze pri 865 bolnikih z levkemijo, zdravljenih z dasatinibom, so bile srednje vrednosti sprememb intervala QTc (z metodo po Fridericiju; QTcF) v primerjavi z izhodiščem 4 - 6 milisekund; zgornja meja 95 % intervala zaupanja je bila pri vseh srednjih vrednostih sprememb v primerjavi z izhodiščem manjša od 7 milisekund (glejte poglavje 4. 8).
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izobraževanje
CELEX: 32002D0756
Commission Decision of 16 September 2002 setting out the arrangements for Community comparative trials and tests on seeds and propagating material of certain plants under Council Directives 66/401/EEC, 66/402/EEC, 68/193/EEC, 92/33/EEC, 2002/54/EC, 2002/55/EC, 2002/56/EC and 2002/57/EC
ODLOČBA KOMISIJE z dne 16. septembra 2002 o ureditvah Skupnosti za primerjalne poskuse in testiranja semen in razmnoževalnega materiala nekaterih rastlin na podlagi Direktiv Sveta 66/401/EGS, 66/402/EGS, 68/193/EGS, 92/33/EGS, 2002/54/ES, 2002/55/ES, 2002/56/ES in 2002/57/ES
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izobraževanje
CELEX: 32003L0061
In accordance with the procedure referred to in Article 25(2), the Commission may prohibit, in whole or in part, the marketing of seed potatoes harvested in a particular area of the Community if the progeny of officially drawn samples of basic seed potatoes or certified seed potatoes harvested in that particular area and grown in one or more Community tests and trials has for three successive years fallen appreciably below the minimum conditions laid down in Annex I(1)(c), (2)(c), (3) and (4).
Komisija lahko trženje semenskega krompirja, ki je bil proizveden na določenem ozemlju Skupnosti, v celoti ali delno prepove v skladu s postopkom iz člena 25(2), če je potomstvo vzorcev, ki so bili uradno odvzeti iz osnovnega semenskega krompirja ali certificiranega semenskega krompirja, proizvedenega na tem ozemlju, in posejani v okviru enkratnih ali večkratnih primerjalnih testov in poskusov Skupnosti, v treh zaporednih letih znatno zaostalo za minimalnimi pogoji, določenimi v Prilogi I(1)(c), (2)(c), (3) in (4).
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Cerebrovascular adverse reactions An approximately 3-fold increased risk of cerebrovascular adverse reactions have been seen in randomised placebo-controlled clinical trials in the dementia population with some atypical antipsychotics, including risperidone, aripiprazole, and olanzapine.
Možganskožilni neželeni učinki V randomiziranih, s placebom kontroliranih kliničnih preskušanjih so pri skupini bolnikov z demenco ugotovili približno za 3- krat povečano tveganje za možganskožilne neželene učinke pri nekaterih atipičnih antipsihotikih, vključno z risperidonom, aripiprazolom in olanzapinom.
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These medicinal products include astemizole, terfenadine, oral midazolam (for caution on parenterally administered midazolam, see section 4.5), triazolam, cisapride, pimozide, amiodarone, ergot alkaloids (e. g. ergotamine, dihydroergotamine, ergonovine and methylergonovine) and vardenafil.
Zdravila, ki so kontraindicirana prav zaradi pričakovane izrazitosti interakcije in potenciala za resne neželene učinke, so navedena v poglavju 4. 3.
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In addition, in a double-blind placebo-controlled trial in adult patients receiving background methotrexate, patients treated with Enbrel and anakinra were observed to have a higher rate of serious infections (7 %) and neutropenia than patients treated with Enbrel (see sections 4.4 and 4.8).
Poleg tega so v dvojno slepem, s placebom kontroliranem preizkušanju pri odraslih bolnikih, ki so prejemali metotreksat, opazili, da so imeli bolniki, zdravljeni z zdravilom Enbrel in anakinro, pogostejše resne okužbe (7 %) in nevtropenijo kot bolniki, zdravljeni z zdravilom Enbrel (glejte poglavji 4. 4 in 4. 8).
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izobraževanje
CELEX: 32003L0061
Community comparative tests and trials shall be carried out within the Community for the post-control of samples of seed potatoes placed on the market under the provisions of this Directive, whether mandatory or discretionary, including those relating to plant health and taken during sampling.
V Skupnosti se primerjalni testi in poskusi Skupnosti izvajajo za naknadno kontrolo vzorcev semenskega krompirja, ki je dan v promet v okviru določb te direktive, ne glede na to, ali so določbe obvezne ali neobvezne, vključno s tistimi, ki se nanašajo na zdravstveno varstvo rastlin, in je odvzet med vzorčenjem.
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Co-administration with the following medicinal products that are substrates for CYP3A4 and which have narrow therapeutic windows is contraindicated (see section 4.3 and below): terfenadine, astemizole, cisapride, amiodarone, quinidine, ergot derivatives, pimozide, oral midazolam and triazolam.
Sočasno jemanje sledečih zdravil, ki so substrati za CYP3A4 in ki imajo ozko terapevtsko okno, je kontraindicirano (glejte poglavje 4. 3 in spodnje besedilo): terfenadin, astemizol, cisaprid, amiodaron, kvinidin, derivati ergot, pimozid, triazolam, peroralni midazolam.
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Limited data from clinical trials do not indicate a significantly increased risk of adverse reactions to zidovudine with co-trimoxazole (see interaction information above relating to lamivudine and cotrimoxazole) aerosolised pentamidine, pyrimethamine and acyclovir at doses used in prophylaxis.
Sicer skopi podatki iz kliničnih študij ne kažejo na pomembno povečanje tveganja za neželene reakcije na zidovudin pri uporabi kotrimoksazola (glejte tudi zgoraj navedene podatke o interakcijah, ki se nanašajo na lamivudin in kotrimoksazol), pentamidina v aerosolu, pirimetamina in aciklovirja pri profilaktičnih odmerkih.
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These medicinal products include astemizole, terfenadine, oral midazolam (for 24 caution on parenterally administered midazolam, see section 4.5), triazolam, cisapride, pimozide, amiodarone, ergot alkaloids (e. g. ergotamine, dihydroergotamine and ergonovine and methylergonovine) and vardenafil.
Med takšna zdravila spadajo astemizol, terfenadin, peroralni midazolam (za previdnost pri uporabi parenteralnega midazolama glejte poglavje 4. 5), triazolam, cisaprid, pimozid, amiodaron in alkaloidi ergot (npr. ergotamin, dihidroergotamin, ergonovin in metilergonovin) in vardenafil.
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Limited data from clinical trials do not indicate a significantly increased risk of adverse reactions to zidovudine with co- trimoxazole (see interaction information above relating to lamivudine and co-trimoxazole), aerosolised pentamidine, pyrimethamine and acyclovir at doses used in prophylaxis.
Skopi podatki iz kliničnih preskušanj ne kažejo na pomembnejše povečanje tveganja za pojav neželenih učinkov zidovudina pri sočasni uporabi kotrimoksazola (za podatke o interakcijah med lamivudinom in kotrimoksazolom glejte zgoraj), pentamidina v obliki aerosola, pirimetamina in aciklovirja v profilaktičnih odmerkih.
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These protocol mandated clinical sign assessments indicate that local skin reactions including erythema (61%), erosion (30%), excoriation/flaking/scaling (23%) and oedema (14%) were common in these placebo controlled clinical trials with imiquimod cream applied three times weekly (see section 4.4).
Ta predpisana vrednotenja kliničnih znakov so pokazala, da so bile lokalne reakcije na koži, vključno z rdečico (61 %), erozijo (30 %), lupljenjem/ luskavostjo (23 %) in oteklino (14 %), pogoste v teh s placebom nadzorovanih preskušanjih, kjer je bila imikvimod krema nanešena trikrat tedensko (glejte poglavje 4. 4).
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Similar changes were seen in metformin (haemoglobin 3 - 4 % and haematocrit 3.6 – 4.1 % relative reductions) and to a lesser extent sulphonylurea and insulin (haemoglobin 1 – 2 % and haematocrit 1 – 3.2 % relative reductions) treated patients in comparative controlled trials with pioglitazone.
Podobne spremembe so opažali v primerjalnih kontroliranih preskušanjih s pioglitazonom pri bolnikih, zdravljenih z metforminom (hemoglobin 3– 4 % in hematokrit 3, 6– 4, 1 % relativna znižanja), in v manjšem obsegu pri bolnikih, zdravljenih s sulfonilsečnino in insulinom (hemoglobin 1– 2 % in hematokrit 1– 3, 2 % relativna znižanja).
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Adults The most frequently (seen in 1 % of patients) reported adverse reactions associated with the use of olanzapine in clinical trials were somnolence, weight gain, eosinophilia, elevated prolactin, cholesterol, glucose and triglyceride levels (see section 4.4), glucosuria, increased appetite, dizziness, akathisia, parkinsonism (see section 4.4), dyskinesia, orthostatic hypotension, anticholinergic effects,
Odrasli Najpogosteje poro ani (opažene pri ≥ 1 % bolnikov) neželeni u inki, povezani z uporabo olanzapina v klini nih preskušanjih, so bili zaspanost, pove anje telesne mase, eozinofilija, zvišane ravni prolaktina, holesterola, glukoze in trigliceridov (glejte poglavje 4. 4), glikozurija, pove an apetit, omotica, akatizija, parkinsonizem (glejte poglavje 4. 4), diskinezija, ortostatska hipotenzija, antiholinergi ni u inki, prehodna asimptomatska zvišanja jetrnih transaminaz (glejte poglave 4. 4), izpuš aj, astenija, utrujenost in edem.
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Adults The most frequently (seen in ≥ 1 % of patients) reported adverse reactions associated with the use of olanzapine in clinical trials were somnolence, weight gain, eosinophilia, elevated prolactin, cholesterol, glucose and triglyceride levels (see section 4.4), glucosuria, increased appetite, dizziness, akathisia, parkinsonism (see section 4.4), dyskinesia, orthostatic hypotension, anticholinergic effects, transient asymptomatic elevations of hepatic transaminases (see section 4.4), rash, asthenia, fatigue and oedema.
Odrasli Najpogosteje poročani (opažene pri ≥ 1 % bolnikov) neželeni učinki, povezani z uporabo olanzapina v kliničnih preskušanjih, so bili zaspanost, povečanje telesne mase, eozinofilija, zvišane ravni prolaktina, holesterola, glukoze in trigliceridov (glejte poglavje 4. 4), glikozurija, povečan apetit, omotica, akatizija, parkinsonizem (glejte poglavje 4. 4), diskinezija, ortostatska hipotenzija, antiholinergični učinki, prehodna asimptomatska zvišanja jetrnih transaminaz (glejte poglave 4. 4), izpuščaj, astenija, utrujenost in edem.
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Safety was assessed in a controlled clinical trial enrolling renal transplant patients  18 years of age considered of high-immunologic risk, defined as a history of one or more acute allograft rejection episodes and/ or the presence of chronic allograft nephropathy on a renal biopsy (see section 5.1).
Varnost so ocenjevali v kontroliranem kliničnem preskusu, v katerega so bili vključeni bolniki, mlajši od 18 let, po presaditvi ledvic, z velikim imunološkim tveganjem, kar pomeni z anamnezo ene ali več akutnih epizod zavrnitve alografta in/ ali prisotnost kronične nefropatije alografta ob ledvični biopsiji (glejte poglavje 5. 1).
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The following clinical safety features (hepatotoxicity, hyperlipidaemia, bleeding events, rash) were seen at higher frequency among APTIVUS/ ritonavir treated patients when compared with the comparator arm treated patients in the RESIST trials, or have been observed with APTIVUS/ ritonavir administration.
14 Naslednje klinične varnostne lastnosti (hepatotoksičnost, hiperlipidemija, krvavitve, izpuščaj) so v preskušanjih RESIST zasledili pogosteje pri bolnikih, ki so prejemali zdravilo APTIVUS ob ritonavirju, kot pri primerjalni skupini ali med dajanjem zdravila APTIVUS in ritonavirja.
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Haematologic laboratory abnormalities observed during the first 20 weeks of the trial included anemia (26 % of patients experienced a hemoglobin level of < 10 g/ dL), neutropenia (30 % experienced an ANC < 750/ mm3), and thrombocytopenia (13 % experienced a platelet count < 50,000/ mm3) (see section 4.4).
Hematološke laboratorijske nenormalnosti, ki so jih opazili prvih 20 tednov preskušanja so vključevale anemijo (26 % bolnikov je imelo hemoglobin < 10 g/ dl), nevtropenijo (30 % je imelo ANC < 750/ mm3) in trombocitopenijo (13 % je imelo število trombocitov < 50. 000/ mm3) (glejte poglavje 4. 4).
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In small short-term clinical trials, approximately 12.5 % of paediatric patients were observed to experience drug related adverse effects, the majority of which were local, nonserious ocular effects such as conjunctival hyperaemia, eye irritation, eye discharge, and lacrimation increased (see section 5.1).
V majhnih, kratkotrajnih kliničnih preskušanjih so opazili, da ima približno 12, 5 % pediatričnih bolnikov z zdravilom povezane neželene učinke, ki so večinoma lokalni učinki na očeh, ki niso opredeljeni kot resni,, na primer hiperemija veznice, draženje očesa, izcedek iz očesa in povečano solzenje (glejte poglavje 5. 1).
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In a double-blind, placebo-controlled, randomized clinical trial, in which ZOSTAVAX was administered to 100 subjects 50 years of age or older with a history of herpes zoster (HZ) prior to vaccination, the safety profile was generally similar to that seen in the Adverse Event Monitoring Substudy of the SPS.
V dvojno slepem, s placebom nadzorovanem, randomiziranem kliničnem preskušanju, v katerem je cepivo ZOSTAVAX prejelo 100 oseb, starih 50 let ali več, z anamnezo o herpesu zostru (HZ) pred cepljenjem, je bil varnostni profil v splošnem podoben varnostnemu profilu v podštudiji spremljanja neželenih učinkov, ki je bila izvedena v okviru SPS.
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Mean sirolimus whole blood trough levels from the same phase III trial were 7.2 ng/ ml (4.0 to 11 ng/ ml, expressed as chromatographic assay values; n=226) for the 2 mg per day dose and 14 ng/ ml (8.0 to 22 ng/ ml, expressed as chromatographic assay values; n=219) for the 5 mg per day dose (see section 4.2).
Povprečna najnižja koncentracija sirolimusa v polni krvi je bila v isti študiji III. faze 7, 2 ng/ ml (od 4 do 11 ng/ ml, izraženo kot vrednosti kromatografskega preskusa; n = 226) ob odmerku 2 mg/ dan in 14 ng/ ml (od 8, 0 do 22 ng/ ml, izraženo kot vrednosti kromatografskega preskusa; n = 219) ob odmerku 5 mg/ dan (glejte poglavje 4. 2).
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CRIXIVAN with or without ritonavir should not be administered concurrently with amiodarone, terfenadine, cisapride, astemizole, alprazolam, triazolam, midazolam administered orally (for caution on parenterally administered midazolam, see Table 1 and 2 below), pimozide, ergot derivatives, simvastatin or lovastatin.
Zdravilo CRIXIVAN se v kombinaciji z ritonavirjem ali brez njega ne sme dajati sočasno z amiodaronom, terfenadinom, cisapridom, astemizolom, alprazolamom, triazolamom, peroralnim midazolamom (za previdnost pri parenteralnem midazolamu glejte tabeli 1 in 2), pimozidom, derivati rženega rožička, simvastatinom ali lovastatinom.
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In a comparative trial in subjects aged 1-11 years, the incidences of local and general solicited symptoms in the Ambirix group were similar to those seen with the three-dose combined vaccine containing 360 ELISA Units of formalin inactivated hepatitis A virus and 10 micrograms of recombinant hepatitis B surface antigen.
V primerjalnem preskušanju pri osebah, starih od 1 do 11 let, je bila incidenca lokalnih in generaliziranih simptomov v skupini, ki je prejemala Ambirix, podobna tisti po prejemu treh odmerkov kombiniranega cepiva z vsebnostjo 360 ELISA enot s formalinom inaktiviranega virusa hepatitisa A in 10 mikrogramov rekombinantnega površinskega antigena virusa hepatitisa B.
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These medicinal products include amiodarone, bepridil, quinidine, systemic lidocaine, astemizole, terfenadine, midazolam administered orally, triazolam, cisapride, pimozide, sertindole, simvastatin, lovastatin and the ergot alkaloids (e. g. ergotamine, dihydroergotamine, ergonovine and methylergonovine) (see section 4.3).
Med ta zdravila sodijo amiodaron, bepridil, kinidin, sistemsko dani lidokain, astemizol, terfenadin, midazolam apliciran peroralno, triazolam, cisaprid, pimozid, sertindol, simvastatin, lovastatin in alkaloidi ergot (npr. ergotamin, dihidroergotamin, ergonovin in metilergonovin) (glejte poglavje 4. 3).
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ADRs are added to the appropriate frequency grouping (Very common or Common) according to the highest incidence seen in any of the major clinical trials and are only added when they were seen in addition to those seen with Xeloda monotherapy or seen at a higher frequency grouping compared to Xeloda monotherapy (see Table 4).
Neželene učinke so v skupine (zelo pogosto ali pogosto) razvrstili glede na največjo incidenco, ki so jo opazili v katerem izmed glavnih kliničnih preskušanj. Dodani so samo, če so jih opazili poleg neželenih učinkov, opaženih pri samostojnem zdravljenju z zdravilom Xeloda, ali pa so jih opazili pogosteje (spadajo v višjo skupino po pogostnosti) kot pri samostojnem zdravljenju z zdravilom Xeloda (glejte preglednico 4).
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In each of two randomised, placebo-controlled trials, PROWESS and ADDRESS (see section 5.1), 28- day and in-hospital mortality were higher in patients treated with drotrecogin alfa (activated) compared to placebo for the sub-population of patients with single organ dysfunction and recent surgery (n=98 in PROWESS and n=636 in ADDRESS).
V vsakem od dveh randomiziranih s placebom kontroliranih preskušanj, PROWESS in ADDRESS (glejte poglavje 5. 1), sta bili 28- dnevna umrljivost in umrljivost v času hospitalizacije višji pri bolnikih, zdravljenih z drotrekoginom alfa (aktiviranim), v primerjavi s placebom, pri podskupini bolnikov z okvarjenim delovanjem enega organa in nedavnim operacijskim posegom (n = 98 v preskušanju PROWESS in n = 636 v preskušanju ADDRESS).
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