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triax system
51 Prevajalska redakcija
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Adverse reactions based on experience from clinical trials and postmarketing experience are presented below by system organ class and frequency of occurrence.
Neželene reakcije na podlagi izkušenj iz kliničnih preskušanj in na podlagi izkušenj po uvedbi zdravila na trg so v nadaljevanju predstavljene po skupinah organskih sistemov in pogostosti pojavljanja.
52 Prevajalska redakcija
izobraževanje
CELEX: 32001L0083
Pre-established, systematic written procedures for the organization, conduct, data collection, documentation and verification of clinical trials shall be required.
Zahtevajo se naprej pripravljeni, sistematično napisani postopki za organizacijo, izvajanje, zbiranje podatkov, dokumentacijo ter preverjanje kliničnih preskušanj.
53 Prevajalska redakcija
izobraževanje
CELEX: 31992R2913
Council Regulation (EEC) No 1970/88 of 30 June 1988 concerning triangular traffic under the outward processing relief arrangements and the standard exchange system (34);
Uredba Sveta (EGS) št. 1970/88 z dne 30. junija 1988 o tristranskem prometu v okviru postopka pasivnega oplemenitenja in sistema standardne zamenjave,
54 Prevajalska redakcija
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In addition, grade 3 or 4 adverse reactions possibly attributable to Fasturtec and reported in the clinical trials, are listed below, by system organ class and by frequency.
Spodaj so navedeni neželeni učinki 3. in 4. stopnje, ki bi jih lahko pripisali Fasturtecu in o katerih so poročali v kliničnih preskušanjih. Razdeljeni so po organskih sistemih in pogostosti.
55 Prevajalska redakcija
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Adverse reactions based on experience from clinical trials and postmarketing experience are presented in the following table by system organ class and frequency of occurrence.
Neeleni učinki na podlagi izkušenj iz kliničnih preskušanj in pomarketinških izkušenj so navedeni v naslednji tabeli po organskih sistemih in pogostnosti.
56 Prevajalska redakcija
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Adverse reactions reported during clinical trials or following the marketing use of IntronA alone or in combination with ribavirin System Organ Class Infections and infestations
Neželeni učinki, o katerih so poročali med kliničnimi preskušanji ali v okviru postmarketinških izkušenj z uporabo zdravila IntronA, samostojno ali v kombinaciji z ribavirinom Razporeditev po organskih sistemih Infekcijske in parazitske bolezni Zelo pogosti:
57 Prevajalska redakcija
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24 Adverse reactions based on experience from clinical trials and postmarketing experience are presented in the following table by system organ class and frequency of occurrence.
Neželeni učinki na podlagi izkušenj iz kliničnih preskušanj in pomarketinških izkušenj so navedeni v naslednji tabeli po organskih sistemih in pogostnosti.
58 Prevajalska redakcija
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The adverse drug reactions reported in the 2 trials by at least the 5 % of the patients are summarised and categorised according to the MedDRA system organ class in the table below:
Neželeni učinki, o katerih je pri obeh raziskavah poročalo najmanj 5 % bolnikov, so povzeti in kategorizirani v skladu z MedDRA klasifikacijo organskih sistemov v spodnji razpredelnici:
59 Prevajalska redakcija
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5 Undesirable effects reported in clinical trials or from the post-marketing experience are listed in the following table per body system and per frequency and this is for all age groups.
Neželeni učinki, o katerih so poročali v kliničnih študijah ali po začetku trženja cepiva, so prikazani spodaj. Navedeni so po lokalizaciji in po pogostnosti in vključujejo otroke vseh starostnih skupin.
60 Prevajalska redakcija
izobraževanje
CELEX: 21998A0710(01)
Candidate system configurations shall be studied to subsequently identify and initiate critical research and technology developments and carry out early trials of selected GNSS 2 concepts.
Preučiti je treba potencialne konfiguracije sistema, da bi pozneje lahko opredelili in začeli izvajati kritične raziskave in tehnološki razvoj ter opravili začetne preskuse izbranih konceptov GNSS 2.
61 Prevajalska redakcija
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Clinical trial data and post-marketing data Table 3 presents adverse reactions by system organ class and by frequency category based on experience with glimepiride and other sulphonylureas.
Podatki iz kliničnih preskušanj in podatki po pridobitvi dovoljenja za promet V preglednici 3 so navedeni neželeni učinki glede na organski sistem in kategorijo pogostnosti na osnovi izkušenj z glimepiridom in drugimi sulfonilsečninami.
62 Prevajalska redakcija
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Table 2 Adverse reactions very commonly and commonly reported in paediatric clinical trials Very common (≥ 1/ 10) - Common (≥ 1/ 100, < 1/ 10) System Organ Class Infection and infestations
Preglednica 2. Neželeni učinki, o katerih so v pediatričnih kliničnih preskušanjih poročali zelo pogosto (≥ 1/ 10) ali pogosto (≥ 1/ 100, < 1/ 10) uk
63 Prevajalska redakcija
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Table 2 Adverse reactions very commonly and commonly reported in paediatric clinical trials  13 Very common (≥1/10) - Common (≥1/100, < 1/10) System Organ Class Infection and infestations
Preglednica 2. Neželeni učinki, o katerih so v pediatričnih kliničnih preskušanjih poročali zelo pogosto (≥ 1/ 10) ali pogosto (≥ 1/ 100, < 1/ 10) Razporeditev po organskih sistemih Infekcijske in parazitske bolezni Zelo pogosti:
64 Prevajalska redakcija
izobraževanje
CELEX: 31989D0531
whereas the reference laboratory must organize comparative trials, carry out further training of experts, and develop data and information systems for the use of the Commission and the Member States;
ker mora referenčni laboratorij organizirati primerjalne poskuse, izvajati izpopolnjevanje strokovnjakov ter razvijati podatkovne in informacijske sisteme, ki jih bodo uporabljali Komisija in države članice;
65 Prevajalska redakcija
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Adverse reactions reported in all clinical trials and occurring more frequently (p ≤ 0.05) with telmisartan plus hydrochlorothiazide than with placebo are shown below according to system organ class.
Neželeni učinki, o katerih so poročali v vseh kliničnih preskušanjih in so se pojavljali pogosteje (p ≤ 0, 05) pri telmisartanu in hidroklorotiazidu kot pri placebu, so našteti po organskih sistemih.
66 Prevajalska redakcija
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In the table below all medically important adverse reactions, which occurred in clinical trials at an incidence greater than placebo are listed by system organ class and frequency (very common (≥ 1/ 10),
V spodnji preglednici so po organskih sistemih in pogostnosti navedeni vsi medicinsko pomembni neželeni učinki, ki so se v kliničnih preizkušanjih pojavljali pogosteje kot pri uporabi placeba.
67 Prevajalska redakcija
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The posology proposed for children has been tested in clinical trials, but also results from dosing adaptations based on body weight and clearance that varies according to the maturation of the renal system.
19 Predlagano odmerjanje za otroke je bilo preverjeno v kliničnih preskušanjih, izhaja pa tudi iz prilagajanja odmerkov telesni masi in izločanju zdravila, kar je odvisno od zrelosti ledvičnega sistema.
68 Prevajalska redakcija
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The additional adverse reactions listed by system organ class and ranked by frequency in Table 2 were reported at incidence rates greater than placebo for subjects treated with celecoxib 400 mg to 800 mg daily in long-term polyp prevention trials of duration up to 3 years (the APC and PreSAP trials; see Section 5.1, Pharmacodynamic properties:
21 400 do 800 mg na dan v dolgoročnih preskušanjih preprečevanja polipov, ki so trajala do 3 leta (preskušanji APC in PreSAP; glejte poglavje 5. 1, Farmakodinamične lastnosti:
69 Prevajalska redakcija
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Overall survival outcome in the trials could not be satisfactorily explained by differences in the incidence of thrombosis and related complications between those given recombinant human M erythropoietin and those in the control group. A systematic review has also been performed involving more than 9000 cancer patients participating in 57 clinical trials.
Rezultata celotnega preživetja v teh preskušanjih ni mogoče zadovoljivo pojasniti z različno incidenco tromboze in sorodnih zapletov med bolniki, ki so dobivali rekombinantni humani lje eritropoetin, in bolniki v kontrolni skupini. vo Sistematično so pregledali tudi podatke o več kot 9000 bolnikih z rakom, ki so sodelovali v 57 kliničnih preskušanjih.
70 Prevajalska redakcija
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The adverse reactions considered at least possibly related to treatment with the components of Truvada from clinical trial and post-marketing experience are listed below by body system organ class and absolute frequency.
Spodaj so po organskih sistemih in absolutni pogostosti navedene neželene reakcije, ki so vsaj možno povezane z zdravljenjem z učinkovinami zdravila Truvada na podlagi kliničnih preskušanj in izkušenj po izdaji v promet.
71 Prevajalska redakcija
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Based on limited data from 2 clinical trials that enrolled VZV-seronegative or low seropositive subjects (27 subjects 30 years of age or older received live attenuated zoster vaccine), injection site and systemic adverse experiences were generally similar to those reported by other subjects who received ZOSTAVAX in clinical trials, with 2 of the 27 subjects reporting fever.
Na podlagi maloštevilnih podatkov iz 2 kliničnih preskušanj, ki sta vključevali VZV- seronegativne osebe ali osebe z nizko VZV- seropozitivnostjo (27 oseb, starih 30 let ali več, je prejelo živo, atenuirano cepivo proti herpesu zostru) so bili mesto injiciranja in sistemski neželeni učinki na splošno podobni tistim, o katerih so poročali pri drugih osebah, ki so prejele cepivo ZOSTAVAX v kliničnih preskušanjih, pri čemer so pri dveh od 27 osebah poročali o zvišani telesni temperaturi.
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However, these were not evident from clinical trials with Optimark.  Central nervous system disorders In patients suffering from epilepsy or brain lesions the likelihood of convulsions during the examination may be increased.
Vendar pa teh reakcij v kliničnih preskušanjih z zdravilom Optimark ni bilo.  Bolezni osrednjega živčevja Pri bolnikih z epilepsijo ali lezijami v možganih se lahko verjetnost konvulzij med preiskavo poveča.
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15 Data from a placebo-controlled clinical trial did not establish efficacy of Xigris in paediatric patients suffering from severe sepsis, acute infection, systemic inflammation and respiratory and cardiovascular organ dysfunction.
Rezultati s placebom nadzorovanega kliničnega preskušanja niso pokazali učinkovitosti zdravila Xigris pri pediatričnih bolnikih s hudo sepso, akutno infekcijo, sistemskim vnetjem in motenim
74 Prevajalska redakcija
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Adverse reactions seen in all trials are listed below according to MedDRA system organ class and in decreasing frequency which is defined as follows: Very Common (> 1/ 10); Common (> 1/ 100 to < 1/10); Uncommon (> 1/1000 to < 1/100).
Neželeni učinki iz vseh raziskav so navedeni spodaj in so razdeljeni po organskih sistemih po MedDRA in pogostosti, na naslednji način: zelo pogosti (> 1/ 10); pogosti (> 1/ 100 do < 1/ 10); občasni (> 1/ 1000 do < 1/ 100).
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Treatment Related Undesirable Effects Reported in Multiple Myeloma Clinical Trial (Caelyx 30 mg/ m2 in combination with bortezomib every 3 weeks) by Severity, MedDRA System Organ Class and Preferred Term Very Common (≥ 1/ 10); Common (≥ 1/ 100, < 1/ 10); Uncommon (≥ 1/ 1,000, < 1/ 100) CIOMS III AE by body system
Z zdravljenjem povezani neželeni učinki, ki so jih prijavili v kliničnem preskušanju pri bolnikih z multiplim mielomom (zdravljenih z zdravilom Caelyx 30 mg/ m2 v kombinaciji z bortezomibom na vsake 3 tedne), razvrščeni po jakosti ter po organskih sistemih v skladu z MedDRA- o in navedeni po najprimernejšem izrazu iz MedDRA- e Zelo pogosti (≥ 1/ 10), pogosti (≥ 1/ 100, < 1/ 10), občasni (≥ 1/ 1. 000, < 1/ 100) CIOMS III Neželeni učinki,
76 Prevajalska redakcija
izobraževanje
CELEX: 32000R2235
Without prejudice to further revisions and a more comprehensive reform of the system of quotas, the measures referred to in the above three recitals should be introduced for a trial period expiring one year from the date of entry into force of this Regulation.
Brez poseganja v kasnejše revizije in temeljitejšo reformo sistema kvot je treba ukrepe iz treh zgornjih uvodnih navedb uvesti za poskusno dobo, ki poteče eno leto po začetku veljavnosti te uredbe.
77 Prevajalska redakcija
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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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15 Systemic sclerosis with digital ulcer disease Two randomised, double-blind, multi-centre, placebo-controlled trials have been conducted in 122 (Study AC-052-401, RAPIDS-1) and 190 (Study AC-052-331, RAPIDS-2) adult patients with systemic sclerosis and digital ulcer disease (either ongoing digital ulcers or a history of digital ulcers within the last year).
Sistemska skleroza z boleznijo razjed prstov Opravili so dve randomizirani dvojno slepi multicentrični s placebom nadzorovani študiji in sicer pri 122 (študija AC- 052- 401, RAPIDS- 1) in 190 (študija AC- 052- 331, RAPIDS- 2) odraslih bolnikih s sistemsko sklerozo in boleznijo razjed prstov (bodisi dolgotrajnimi razjedami prstov ali z anamnezo razjed prstov v zadnjem letu).
79 Prevajalska redakcija
izobraževanje
CELEX: 32004R0128
The trial results were examined for evidence of individual systematic error (p < 0,025) using Cochran's and Grubb's tests successively, by procedures described in the internationally agreed Protocol for the Design, Conduct and Interpretation of Method-Performance Studies.
Poskusni rezultati so bili pregledani, da bi evidentirali individualno sistematsko napako (p < 0,025) z zaporedno uporabo Cochranovega testa in Grubbovega testa, s postopki, opisanimi v mednarodno sprejetem Protokolu za projektiranje, izvedbo in interpretacijo študij izvajanja metode.
80 Prevajalska redakcija
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Nervous system symptoms: in clinical controlled trials, frequently reported adverse reactions in patients receiving 600 mg efavirenz with other antiretroviral agents included, but were not limited to: dizziness, insomnia, somnolence, impaired concentration and abnormal dreaming.
Simptomi živčnega sistema: V kontroliranih kliničnih raziskavah so bili pogosto poročani neželeni učinki pri bolnikih, ki so prejemali 600 mg efavirenza skupaj z drugimi protiretrovirusnimi učinkovinami: omotica, nespečnost, zaspanost, motena koncentracija in nenormalne sanje.
81 Prevajalska redakcija
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In other clinical trials with acquired antithrombin deficient cardiac surgery patients (n=118) and healthy volunteers (n=102), undesirable effects reported to be related to treatment with ATryn that were observed more than once are listed by System Organ Class in the table below.
Pri drugih klinicnih preskušanjih na bolnikih po operaciji srca in pomanjkanjem antitrombina (n =118) in zdravih prostovoljcih (n =102) so neželeni ucinki, povezani z zdravljenjem z zdravilom ATryn, ki so jih opazili vec kot enkrat, navedeni po razvrstitvi telesnega sistema organov v spodnji preglednici.
82 Prevajalska redakcija
izobraževanje
CELEX: 31998R2831
Whereas the trial period for the cumulative recovery system (CRS) for determining the full import duties on husked rice falling within CN code 1006 20 introduced by Commission Regulation (EC) No 703/97 (3), as amended by Regulation (EC) No 1470/98 (4), expires on 31 December 1998;
ker se poskusna doba za kumulativni sistem povračil (KSP) za določanje polnih uvoznih dajatev na oluščeni riž s tarifno oznako KN 1006 20, ki jo je uvedla Uredba Komisije (ES) št. 703/97 [3], kakor je bila spremenjena z Uredbo (ES) št. 1470/98 [4], izteče 31. decembra 1998;
83 Prevajalska redakcija
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In a systematic review of 30 randomized controlled trials, unopposed moderate or high dose oestrogen therapy, when compared to placebo, was associated with a significant increase in rates of endometrial hyperplasia with increasing rates at longer duration of treatment (Lethaby et al.
V sistematskem pregledu 30 randomiziranih in kontroliranih preskušanj so zmerne ali velike odmerke estrogena, ki ni modificiran z učinki progestogena, v primerjavi s placebom povezali z znatnim povečanjem ravni hiperplazije endometrija, te ravni pa so se še povečale s trajanjem zdravljenja (Lethaby et al.
84 Prevajalska redakcija
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Data from a placebo-controlled clinical trial which was stopped for futility after 477 patients 0 to 17 years-old had received the study treatment did not establish efficacy of Xigris in paediatric patients and showed a higher rate of central nervous system bleeding in the Xigris versus
Rezultati s placebom nadzorovanega kliničnega preskušanja, ki so ga zaradi neuspešnosti prekinili, potem, ko je študijsko zdravljenje prejelo 477 bolnikov, starih 0 do 17 let, niso pokazali učinkovitosti zdravila Xigris pri pediatričnih bolnikih in so pokazali višjo stopnjo krvavitve v osrednje živčevje v skupini bolnikov, ki so dobivali zdravilo Xigris, v primerjavi s skupino, ki je 14 dobivala placebo.
85 Prevajalska redakcija
izobraževanje
CELEX: 31999D0404
The Institute will systematically invite EU representatives to its seminars and similar events, including the summer course to be organised on a trial basis in 1999 pursuant to a WEU Council decision regarding the gradual development of the Institute into a European Security and Defence Academy.
Inštitut bo predstavnike EU sistematično vabil na svoje seminarje in podobne dogodke, vključno s poletnim tečajem, ki bo v letu 1999 prirejen poskusno, v skladu s sklepom Sveta ZEU o postopnem razvoju Inštituta v Akademijo za evropsko varnost in obrambo.
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izobraževanje
CELEX: 22003A0719(01)
MINDFUL of the guarantees under their respective legal systems which provide for the right to a fair trial to an extradited person, including the right to adjudication by an impartial tribunal established pursuant to law, DESIRING to conclude an Agreement relating to the extradition of offenders,
ZAVEDAJOČ SE, da njuna pravna sistema zagotavljata pravico do poštenega sojenja izročeni osebi, vključno s pravico do sojenja pred nepristranskim sodiščem, ustanovljenim v skladu z zakonom, Z ŽELJO skleniti sporazum o izročanju storilcev kaznivih dejanj -
87 Prevajalska redakcija
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Table 6 Treatment Related Undesirable Effects Reported in Ovarian Cancer Clinical Trials (50 mg/ m2 every 4 weeks) (Caelyx-treated patients) by Severity, MedDRA System Organ Class and Preferred Term Very Common (≥ 1/ 10); Common (≥ 1/ 100, < 1/ 10); Uncommon (≥ 1/ 1,000, < 1/ 100) CIOMS III
Neželeni učinki, povezani z zdravljenjem, o katerih so poročali v kliničnih preskušanjih pri bolnicah z rakom jajčnikov (50 mg/ m2 vsake 4 tedne) (bolnice, zdravljene z zdravilom Caelyx), razporejeni po resnosti in organskih sistemih v skladu z najprimernejšimi izrazi po MedDRA- i Zelo pogosti (≥ 1/ 10); pogosti (≥ 1/ 100, < 1/ 10); občasni (≥ 1/ 1. 000, < 1/ 100) CIOMS III Neželeni učinki po
88 Prevajalska redakcija
izobraževanje
CELEX: 31993R2454
For the purposes of Article 62 (2) of the Code, the documents to accompany the declaration shall be those provided for in Article 220; where the triangular traffic system is used the declaration shall also be accompanied by the INF sheet, except where Article 605 applies, in accordance with Article 604.
Za uporabo člena 62(2) zakonika so dokumenti, ki se morajo priložiti deklaraciji za vnos v postopek, tisti, ki so predvideni v členu 220, in v primeru uporabe tristranskega prometa, razen v primeru uporabe člena 605, je to list INF 5 pod pogoji, predvidenimi v členu 604.
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In the table below all medically important adverse reactions, which occurred in clinical trials at an incidence greater than placebo are listed by system organ class and frequency (very common (≥ 1/ 10), common (≥ 1/ 100 to < 1/ 10), uncommon (≥ 1/ 1,000 to < 1/ 100), rare (≥ 1/ 10,000 to < 1/ 1,000).
V spodnji preglednici so po organskih sistemih in pogostnosti navedeni vsi medicinsko pomembni neželeni učinki, ki so se v kliničnih preizkušanjih pojavljali pogosteje kot pri uporabi placeba. Pogostnosti so opredeljene na naslednji način: zelo pogosti (> 1/ 10), pogosti (> 1/ 100, < 1/ 10), občasni (> 1/ 1. 000, < 1/ 100) in redki (> 1/ 10. 000, < 1/ 1. 000).
90 Prevajalska redakcija
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terfenadine and astemizole (commonly used to treat allergy symptoms), pimozide (for psychiatric problems), cisapride (for heart burn or problems with the digestive system), ergot alkaloids (used to treat migraine attacks), triazolam and oral (taken by mouth) midazolam (used to help you sleep and/or relieve anxiety),
terfenadin in astemizol (pogosto uporabljana za zdravljenje alergijskih simptomov), pimozid (za psihiatrične težave), cisaprid (za zgago ali težave s prebavili), ergot alkaloidi (za zdravljenje migrenskih napadov), triazolam in peroralni (ki se jemlje skozi usta) midazolam (za pomoč pri težavah s spanjem in/ ali ublažitev tesnobe),
91 Prevajalska redakcija
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Clinically meaningful adverse reactions of moderate to severe intensity occurring in less than 1 % (< 1/ 100) of adult patients in all Phase II and III trials treated with the 500 mg/ 200 mg tipranavir/ ritonavir dose (n=1397) are listed below by system organ class and frequency according to the following categories:
Klinično pomembni zmerno hudi do hudi neželeni učinki, ki so se pojavili pri manj kot 1 % (< 1/ 100) odraslih bolnikov v vseh preskušanjih II. in III. faze, zdravljenih z odmerki po 500 mg/ 200 mg tipranavirja/ ritonavirja (n = 1397), so našteti po organskih sistemih in pogostnosti v naslednjih kategorijah:
92 Prevajalska redakcija
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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).
93 Prevajalska redakcija
izobraževanje
CELEX: 32001L0083
A clinical trial is any systematic study of medicinal products in human subjects whether in patients or non-patient volunteers in order to discover or verify the effects of and/or identify any adverse reaction to investigational products, and/or study their absorption, distribution, metabolism and excretion in order to ascertain the efficacy and safety of the products.
Klinično preskušanje je vsaka sistematična študija zdravil na ljudeh, bolnikih ali zdravih prostovoljcih, ki ima namen odkriti ali potrditi učinke in/ali ugotoviti katere koli neželene učinke zdravil v preskušanju, in/ali raziskati absorpcijo, porazdelitev, presnovo in izločanje zdravila v preskušanju, da se preveri učinkovitost in varnost zdravil.
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Numbers of patients with the following conditions who were exposed to SonoVue in the clinical trials were limited, and therefore, caution is advisable when administering the product to patients with: acute endocarditis, prosthetic valves, acute systemic inflammation and/ or sepsis, hyperactive coagulation states and/ or recent thromboembolism, and end-stage renal or hepatic disease.
Zato svetujemo previdnost pri dajanju zdravila bolnikom z: akutnim endokarditisom, umetnimi zaklopkami, akutnim sistemskim vnetjem in/ ali sepso, s hiperaktivnimi motnjami koagulacije in/ ali nedavno tromboembolijo in odpovedjo jeter ali ledvic.
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RS
EMEA
Adverse drug reactions (ADRs) reported from clinical trials to be related to Fabrazyme administered at a dose of 1mg/ kg in a total of 168 patients (154 males and 14 females) treated with Fabrazyme for a minimum of one infusion up to a maximum of 5 years are listed by System Organ Class and frequency (very common ≥ 1/ 10; common ≥ 1/ 100 to < 1/ 10 and uncommon ≥ 1/ 1000 to < 1/ 100) in the table below.
Neželeni učinki zdravila ((ADR – Adverse Drug Reaction), poročani med kliničnim preskušanjem v povezavi z zdravilom Fabrazyme pri odmerku 1 mg/ kg pri skupaj 168 bolnikih (154 moških in 14 žensk), zdravljenih z najmanj eno infuzijo zdravila Fabrazyme do največ 5 let, so navedeni v spodnji preglednici po organskih sistemih in po pogostnosti (zelo pogosti: > 1/ 10, pogosti: ≥ 1/ 100 do < 1/ 10 in občasni: ≥ 1/ 1. 000 do < 1/ 100).
96 Prevajalska redakcija
RS
EMEA
In one of these trials, a randomized, multicenter study, 882 infants were assigned in a 3:1 ratio to receive either PROCOMVAX or Merck Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (Merck PRP-OMPC Vaccine) plus Merck Hepatitis B (Recombinant) Vaccine at 2, 4, and 12-15 months of age, with the children monitored daily for five days after each injection for local reactions and systemic complaints.
V eni od teh raziskav, ki je bila randomizirana in multicentrična, so 882 dojenčkov v razmerju 3: 1 razvrstili tako, da so prejemali PROCOMVAX ali pa Merckovo konjugirano cepivo proti hemofilusu b (meningokokni beljakovinski konjugat) (cepivo Merck PRP - OMPC) in Merckovo (rekombinantno) cepivo proti hepatitisu B. Otroke so cepili v starosti 2., 4. in od 12. do 15. meseca in jih glede lokalnih reakcij in sistemskih težav spremljali pet dni po vsaki injekciji.
97 Prevajalska redakcija
RS
EMEA
Gastrointestinal and renal effects consistent with dehydration were also observed in the monkey at the highest dose (systemic exposure levels equivalent to or greater than clinical exposure). The nonclinical toxicity profile of mycophenolate mofetil appears to be consistent with adverse events observed in human clinical trials which now provide safety data of more relevance to the patient population (see section 4.8).
Učinki na gastrointestinalni in renalni sistem skupaj z dehidracijo so bili opaženi tudi pri opicah, ki so prejele najvišje odmerke (sistemska izpostavljenost je bila enaka ali večja od klinične izpostavljenosti). Neklinični profil toksičnosti mofetilmikofenolata je v skladu z neželenimi učinki, ki so jih opazili pri kliničnih študijah pri ljudeh, ki so z varnostnega vidika pomembnejši (glej poglavje 4. 8).
98 Prevajalska redakcija
izobraževanje
CELEX: 32003L0094
During the final control of the finished product before its release for sale or distribution or for use in clinical trials, the quality control system shall take into account, in addition to analytical results, essential information such as the production conditions, the results of in-process controls, the examination of the manufacturing documents and the conformity of the product to its specifications, including the final finished pack.
Med končno kontrolo končnega izdelka pred sproščanjem v promet, distribucijo ali uporabo za klinična preskušanja, sistem zagotavljanja kakovosti poleg analiznih rezultatov upošteva bistvene podatke, kot so proizvodni pogoji, rezultati medprocesnih kontrol, pregled proizvodne dokumentacije in skladnost izdelka z njegovimi specifikacijami, vključno z zunanjo ovojnino.
99 Prevajalska redakcija
RS
EMEA
The requested additional analyses of the EPC trial data confirm an increased risk for deaths coded as heart failures (however, with no overall excess risk in the cardiovascular system), an increased risk of urogenital symptoms (including gynaecomastia and breast pain) mainly during the first year of intake, and further indicate the absence of an adverse effect on thromboembolic events during the follow-up (supported by a pattern of events inconsistent with hormonal effects).
Zahtevane dodatne analize podatkov preizkušanj EPC potrjujejo povečano tveganje smrti, označenih kot odpovedi srca (vendar brez celotnega prekomernega tveganja v kardiovaskularnem sistemu), povečano tveganje pojava urogenitalnih simptomov (vključno z ginekomastijo in bolečinami v prsih) predvsem med prvim letom jemanja, poleg tega pa še odsotnost neželenega učinka na tromboembolične dogodke med spremljanjem po koncu študije (podpira ga vzorec dogodkov, ki niso skladni z učinki hormonov).
100 Prevajalska redakcija
RS
EMEA
These active substances include e.g. antiarrhythmics (amiodarone, bepridil, quinidine, systemic lidocaine), antihistamines (astemizole, terfenadine), ergot derivatives (e.g. dihydroergotamine, ergonovine, ergotamine, methylergonovine), gastrointestinal motility agents (cisapride), neuroleptics (pimozide, sertindole), sedatives/hypnotics [triazolam, midazolam administered orally (for caution on parenterally administered midazolam, see section 4.5)] and HMG-CoA reductase inhibitors (simvastatin and lovastatin) (see section 4.5).
Med te učinkovine sodijo npr. antiaritmiki (amiodaron, bepridil, kinidin, sistemsko dani lidokain), antihistaminiki (astemizol, terfenadin), alkaloidi ergot (npr. dihidroergotamin, ergonovin, ergotamin in metilergonovin), učinkovine, ki vplivajo na motiliteto prebavnega trakta (cisaprid), nevroleptiki (pimozid, sertindol), sedativi/ hipnotiki [ triazolam, midazolam apliciran peroralno (za opozorila pri parenteralni aplikaciji midazolama glejte poglavje 4. 5) ] in inhibitorji HMG- CoA reduktaze (simvastatin in lovastatin) (glejte poglavje 4. 5).
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