natgillin/translations-raw huggingface dataset:
Medically appropriate supervision should be maintained when using lumiracoxib in the elderly and in patients with mild renal, hepatic, or cardiac dysfunction.
Pri uporabi lumirakoksiba pri starejših bolnikih in pri bolnikih z blago disfunkcijo ledvic, jeter ali srca je potreben ustrezen medicinski nadzor.
No difference was observed in the extent of lumiracoxib protein binding in synovial fluid compared to plasma.
Razlik v obsegu vezave lumirakoksiba na beljakovine v sinovialni tekočini in v plazmi niso opazili.
Fluconazole: Co-administration of lumiracoxib with the potent CYP2C9 inhibitor fluconazole had no clinically relevant effect on the pharmacokinetics or the COX-2 selectivity of lumiracoxib.
Vpliv drugih zdravil na farmakokinetiko lumirakoksiba Flukonazol: Sočasna uporaba lumirakoksiba z močnim zaviralcem CYP2C9 flukonazolom ni klinično pomembno vplivala na farmakokinetiko ali selektivnost za COX-2 lumirakoksiba.
There is no additional benefit by increasing the dose to 400 mg daily.
Zvečanje odmerka na 400 mg na dan ne prinese dodatnih koristi.
Chromosome aberrations were induced in V79 cells at high, cytotoxic concentrations of lumiracoxib,
V celicah V79 so povzročili kromosomske aberacije z visokimi, citotoksičnimi koncentracijami lumirakoksiba, za katere menimo, da za ljudi nimajo biološkega pomena.
Lumiracoxib is an orally active, selective cyclooxygenase-2 (COX-2) inhibitor within the clinical dose range.
Lumirakoksib je znotraj območja kliničnih odmerkov peroralni selektivni zaviralec ciklooksigenaze-2 (COX-2).
Omeprazole: Omeprazole had no effect on the pharmacokinetics of lumiracoxib.
Omeprazol: Omeprazol ni vplival na farmakokinetiko lumirakoksiba.
Coating:
Prevleka:
Thus no alteration in oral contraceptive medication is necessary when lumiracoxib is co-administered.
Zato ob sočasni uporabi lumirakoksiba ni potrebno spreminjanje peroralnega kontraceptiva.
Uncommon: syncope, hypoaesthesia, migraine, paraesthesia, dysgeusia, vertigo, tinnitus
Redke: sinkopa, hipestezija, migrena, parestezije, disgevzija, vrtoglavica, tinitus.
Uncommon: palpitations, myocardial infarction* Rare: cardiac failure, atrioventricular block of first degree Vascular disorders
Redki: popuščanje srca, atrioventrikularni blok prve stopnje.
Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs and some selective COX-2 inhibitors during post-marketing surveillance.
Med postmarketinškim spremljanjem so v zvezi z uporabo NSAR in nekaterih selektivnih zaviralcev COX-2 zelo redko poročali o hudih kožnih reakcijah, od katerih so bile nekatere smrtne, med drugim o eksfoliativnem dermatitisu, Stevens-Johnsonovem sindromu in toksični epidermalni nekrolizi.
Clinical 5
Klinični vidik 5
The changes of the Product Information related to the CV can be summarised as follows: - Addition of a statement that decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient's overall risks.
Spremembe Informacij o zdravilu v zvezi s kardiovaskularnim sistemom lahko povzamemo, kot sledi: - dodana je izjava, da mora odločitev, da se predpiše selektiven zaviralec COX-2, temeljiti na vrednotenju celotnega tveganja posameznega bolnika; - dodana je izjava, da naj predpisovalci zdravila uporabljajo najnižji učinkovit odmerek za najkrajši možni čas trajanja ter da je potrebo za lajšanje bolečin potrebno pogosto ponovno oceniti.
There was no indication of genotoxic potential in three in vivo rat studies (micronucleus tests in bone marrow and liver and liver comet assay).
V treh študijah in vivo na podganah (mikronukleusna testa v kostnem mozgu in jetrih in jetrni kometni preskus) niso našli znakov genotoksičnega potenciala.
Serious hypersensitivity reactions (such as anaphylaxis and angioedema) have been reported in patients receiving lumiracoxib.
Pri bolnikih, ki so prejemali lumirakoksib, so poročali o resnih preobčutljivostnih reakcijah (na primer anafilaksiji in angioedemu).
There was no statistically significant difference between lumiracoxib and NSAIDs for incidence of MI (clinical MI and silent MI).
MI dogodki v študiji TARGET (12-mesečna študija) Med lumirakoksibom in NSAR glede incidence MI (klinični MI in tihi MI) ni bilo statistično signifikantne razlike.
400 mg film-coated tablets: Ovaloid, red, tablets with “NVR” debossed on one side and “OD” on the other side.
400 mg filmsko obložene tablete: ovalne, rdeče, tablete, na eni strani je vtisnjen napis “NVR”, na drugi pa “OD”.
200 mg film-coated tablets: Ovaloid, red, tablets with “NVR” debossed on one side and “OC” on the other side.
200 mg filmsko obložene tablete: ovalne, rdeče, tablete, na eni strani je vtisnjen napis “NVR”, na drugi pa “OC”.
The changes of the Product Information related to the SCAR can be summarised as follows: - Addition of a warning to report that the onset of skin reactions occur in the majority of cases within the first month of treatment.
Spremembe Informacij o zdravilu, povezanih s hudimi kožnimi neželenimi reakcijami (Severe Cutaneous Adverse Reaction, SCAR), lahko povzamemo, kot sledi: - dodano je opozorilo k poročilu, da se kožne reakcije v večini primerov pojavijo v prvem mesecu zdravljenja; - dodano je opozorilo za bolnike z anamnezo alergije na katerokoli zdravilo; - dodano je opozorilo, ki poudarja, da so se pri uporabi zaviralcev Cox-2 pojavile usodno hude kožne reakcije; - dodan je podroben opis začetnih znakov kožnih reakcij, zaradi katerih se zdravljenje prekine.
Each 100 mg film-coated tablet contains 100 mg lumiracoxib.
Ena 100-miligramska filmsko obložena tableta vsebuje 100 mg lumirakoksiba.
Each 200 mg film-coated tablet contains 200 mg lumiracoxib.
Ena 200-miligramska filmsko obložena tableta vsebuje 200 mg lumirakoksiba.
Each 400 mg film-coated tablet contains 400 mg lumiracoxib.
Ena 400-miligramska filmsko obložena tableta vsebuje 400 mg lumirakoksiba.
100 mg film-coated tablets: Ovaloid, red, tablets with “NVR” debossed on one side and “OB” on the other side.
100 mg filmsko obložene tablete: ovalne, rdeče, tablete, na eni strani je vtisnjen napis “NVR”, na drugi pa “OB”.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 12th September 2003
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET
To develop and disseminate a Physician Decision Treatment Guide for prescribers of lumiracoxib.
Da bo za vse, ki predpisujejo lumirakoksib, pripravil in jim posredoval Vodnik za zdravnike o izbiri zdravljenja
Upper gastrointestinal complications [perforations, ulcers or bleedings (PUBs)], some of them resulting in a fatal outcome, have occurred in patients treated with lumiracoxib.
Pri bolnikih, zdravljenih z lumirakoksibom, so se pojavljali zapleti v zgornjih prebavilih [perforacije, ulkusi ali krvavitve (PUK)]; nekateri so imeli smrtni izid.
For systolic blood pressure, mean change from baseline were +0.4 mmHg for lumiracoxib and +2.1 mmHg for NSAIDs (p<0.0001).
Kardiorenalni učinki v študiji TARGET (12-mesečna študija) Za sistolični krvni tlak je bila povprečna sprememba od izhodne vrednosti +0,4 mmHg pri lumirakoksibu in +2,1 mmHg pri NSAR (p<0,0001).
In the overall population, the incidence of APTC events was 59/9117 patients (0.65%) for lumiracoxib versus 50/9127 patients (0.55%) for NSAIDs, with a HR of 1.14 [95% CI 0.781.66] p=0.5074.
V celotni populaciji je bila incidenca APTC dogodkov 59/9117 bolnikov (0,65 %) za lumirakoksib proti 50/9127 bolnikov (0,55 %) za NSAR, s HR 1,14 [95 % CI 0,78-1,66] p=0,5074.
Clinical 6
Klinični vidik 6
Thus no dose adjustment is necessary in patients with renal impairment.
Zato pri bolnikih z okvarami ledvic ni potrebno prilagajanje odmerjanja.
Cardiovascular effects
Učinki na jetra
Clinical 7
Klinični vidik 7
In clinical studies, few patients (<0.3%) treated with lumiracoxib developed perforations, obstruction or bleeds (POBs).
obstrukcije ali krvavitve (POK) pojavile pri majhnem številu bolnikov (<0,3 %), ki so bili zdravljeni z lumirakoksibom.
Musculoskeletal disorders Uncommon: joint swelling, muscle cramps, arthralgia
Bolezni mišično-skeletnega sistema Občasne: otekanje sklepov, mišični krči, artralgija.
Lumiracoxib was not teratogenic in reproduction toxicity studies conducted in rats and rabbits at doses representing systemic exposure 10.4 (rat) and 38 (rabbit) times greater than the human therapeutic level after a 200 mg dose.
V študijah toksičnosti za razmnoževanje, opravljenih na podganah in kuncih z odmerki, ki so predstavljali sistemsko izpostavljenost, ki je bila 10,4-krat (podgana) oziroma 38-krat (kunec) večja od terapevtske ravni pri človeku po 200-miligramskem odmerku, lumirakoksib ni bil teratogen.
Lumiracoxib did not affect blood pressure control in hypertensive patients, nor did it differ from placebo regarding newly occurring hypertension in clinical trials.
Prav tako se v kliničnih študijah ni razlikoval od placeba glede pojavnosti novo odkrite hipertenzije.
Common: influenza like symptoms, respiratory tract infection (e.g bronchitis), urinary tract infection Uncommon: candidiasis, ear infection, herpes simplex, tooth infection
Redke: kandidiaza, infekcije ušes, herpes simpleks, okužbe zob.
Elevations of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST), greater than three times the upper limit of normal (>3xULN) have been reported in placebo/active-controlled clinical studies in approximately 1.2% of patients in clinical trials up to one year with lumiracoxib 100 mg and 200 mg daily.
V s placebom in aktivno kontroliranih kliničnih študijah 100-miligramskih in 200-miligramskih dnevnih odmerkov lumirakoksiba, ki so trajale do enega leta, so pri približno 1,2 % bolnikov poročali o zvišanju alanin aminotransferaze (ALT) in/ali aspartat aminotransferaze (AST), ki je preseglo trikratnik zgornje meje normalnih vrednosti (>3xULN).
Common: fatigue, oedema (e.g lower limb) Uncommon: appetite increased or decreased, chest pain, rigors, thirst Rare: anaphylaxis
Občasne: zvečan ali zmanjšan apetit, bolečina v prsih, rigor, žeja.
In the low dose ASA group the incidence of POBs was 15/2167 patients (0.69%) for lumiracoxib versus 19/2159 patients (0.88%) for NSAIDs, with a HR of 0.79 [95% CI 0.401.55] (not statistically significant).
V skupini z ASA v majhnih odmerkih je bila incidenca POB 15/2167 bolnikov (0,69 %) za lumirakoksib proti 19/2159 bolnikov (0,88 %) za NSAR, HR 0,79 [95 % CI 0,40-1,55] (statistično nesignifikantno).
In the overall population, the incidence of POBs was 29/9117 patients (0.32%) for lumiracoxib versus 83/9127 patients (0.91%) for NSAIDs, with a HR of 0.34 [95% CI 0.22-0.52] p<0.0001.
V celotni populaciji je bila incidenca POB 29/9117 bolnikov (0,32 %) za lumirakoksib proti 83/9127 bolnikov (0,91 %) za NSAR, s HR 0,34 [95 % CI 0,22-0,52] p<0,0001.
In the overall population, the incidence of MIs was 23/9117 patients (0.25%) for lumiracoxib versus 17/9127 patients (0.19%) for NSAIDs, with a HR of 1.31 [95% CI 0.70-2.45] p=0.4012.
V celotni populaciji je bila incidenca MI 23/9117 bolnikov (0,25 %) za lumirakoksib proti 17/9127 bolnikov (0,19 %) za NSAR, s HR 1,31 [95 % CI 0,70-2,45] p=0,4012.
In humans, lumiracoxib undergoes extensive hepatic metabolism.
Pri ljudeh se lumirakoksib intenzivno presnavlja v jetrih.
Uncommon: conjunctivitis, dry eye, visual disturbance (e.g. blurred vision) Rare: keratitis
Občasne: konjunktivitis, suho oko, motnje vida (n.pr.
Film-coated tablets 200 mg:
200 mg filmsko obložene tablete:
In the low-dose ASA group, the incidence of APTC events was 24/2167 patients (1.11%) for lumiracoxib versus 23/2159 patients (1.07%) for NSAIDs, with a hazard ratio (HR) of 1.04 [95% CI 0.59-1.84] p=0.8918.
V skupini z ASA v majhnih odmerkih je bila incidenca APTC dogodkov 24/2167 bolnikov (1,11 %) za lumirakoksib proti 23/2159 bolnikov (1,07 %) za NSAR, s kvocientom tveganja (HR) 1,04 [95 % CI 0,59-1,84] p=0,8918.
When compared separately to ibuprofen and naproxen, the HR were 0.75 [95% CI 0.20-2.79] p=0.6669 and 2.37 [95% CI 0.74-7.55] p=0.1454, respectively.
Ko so ga ločeno primerjali z ibuprofenom in naproksenom, je bil HR 0,75 [95 % CI 0,20-2,79] p=0,6669 oziroma 2,37 [95 % CI 0,74-7,55] p=0,1454.
One hour after oral administration of
Eno uro po peroralni aplikaciji lumirakoksiba, označenega s
In the population not using low-dose aspirin, the incidence of MI events was 14/6950 patients (0.20%) for lumiracoxib versus 9/6968 patients (0.13%) for NSAIDs, with a HR of 1.47 [95% CI 0.63-3.39] p=0.3706.
V skupini, ki ni jemala aspirina v majhnih odmerkih, je bila incidenca MI dogodkov 14/6950 bolnikov (0,20 %) za lumirakoksib proti 9/6968 bolnikov (0,13 %) za NSAR, s HR 1,47 [95 % CI 0,63-3,39] p=0,3706.
In the population not using low-dose aspirin, the incidence of APTC events was 35/6950 patients (0.50%) for lumiracoxib versus 27/6968 patients (0.39%) for NSAIDs, with a HR of 1.22 [95% CI 0.74-2.02] p=0.4343.
V skupini, ki ni jemala aspirina v majhnih odmerkih, je bila incidenca APTC dogodkov 35/6950 bolnikov (0,50 %) za lumirakoksib proti 27/6968 bolnikov (0,39 %) za NSAR, s HR 1,22 [95 % CI 0,74-2,02] p=0,4343.
A significant difference in GI safety between selective COX-2 inhibitors + acetylsalicylic acid vs. NSAIDs + acetylsalicylic acid has not been demonstrated in long-term clinical trials (see section 5.1).
V dolgoročnih kliničnih raziskavah se ni pokazala signifikantna razlika glede varnosti prebavil ob kombinaciji selektivnih COX-2 zaviralcev in acetilsalicilne kisline v primerjavi s kombinacijo NSAR in acetilsalicilna kislina.
In the population not using low-dose aspirin, the incidence of POBs was 14/6950 patients (0.2%) for lumiracoxib versus 64/6968 patients (0.92%) for NSAIDs, with a hazard ratio (HR) of 0.21 [95% CI 0.12-0.37] p<0.0001.
Pri populaciji, ki ni jemala aspirina v majhnih odmerkih, je bila incidenca POB 14/6950 bolnikov (0,2 %) za lumirakoksib proti 64/6968 bolnikov (0,92 %) za NSAR, s kvocientom tveganja (HR) 0,21 [95 % CI 0,12-0,37] p<0,0001.
In the low-dose ASA group, the incidence of MI events was 9/2167 patients (0.42%) for lumiracoxib versus 8/2159 patients (0.37%) for NSAIDs, with a HR of 1.14 [95% CI 0.44-2.95] p=0.7899.
V skupini z ASA v majhnih odmerkih je bila incidenca MI dogodkov 9/2167 bolnikov (0,42 %) za lumirakoksib proti 8/2159 bolnikov (0,37 %) za NSAR, s HR 1,14 [95 % CI 0,44-2,95]
When compared separately to ibuprofen and naproxen, the HR were 0.47 [95% CI 0.04-5.14] p=0.5328 and 1.36 [95% CI 0.47-3.93] p=0.5658, respectively.
Ko so ga ločeno primerjali z ibuprofenom in naproksenom, je bil HR 0,47 [95 % CI 0,04-5,14] p=0,5328 in 1,36 [95 % CI 0,47-3,93] p=0,5658.
Film-coated tablets 400 mg:
400 mg filmsko obložene tablete:
When compared separately to ibuprofen and naproxen, the HR were 0.56 [95% CI 0.20-1.54] p=0.2603 and 1.42 [95% CI 0.70-2.90] p=0.3368, respectively.
Ko so ga ločeno primerjali z ibuprofenom in naproksenom, je bil HR 0,56 [95 % CI 0,20-1,54] p=0,2603 oziroma 1,42 [95 % CI 0,70-2,90] p=0,3368.
When compared separately to ibuprofen and naproxen, the HR were 0.66 [95% CI 0.21-2.09] p=0.4833 and 1.77 [95% CI 0.82-3.84] p=0.1471, respectively.
Ko so ga ločeno primerjali z ibuprofenom in naproksenom, je bil HR 0,66 [95 % CI 0,21-2,09] p=0,4833 oziroma 1,77 [95 % CI 0,82-3,84] p=0,1471.
When compared separately to ibuprofen and naproxen, the HR were 0.76 [95% CI 0.41-1.40] p=0.3775 and 1.46 [95% CI 0.89-2.37] p=0.1313, respectively.
Ko so ga ločeno primerjali z ibuprofenom in naproksenom, je bil HR 0,76 [95 % CI 0,41-1,40] p=0,3775 oziroma 1,46 [95 % CI 0,89-2,37] p=0,1313.
Lumiracoxib crosses the placenta in rats and rabbits.
Lumirakoksib pri podganah in kuncih prehaja placento.
When compared separately to ibuprofen and naproxen, the HR were 0.94 [95% CI 0.44-2.04] p=0.8842 and 1.49 [95% CI 0.76-2.92] p=0.2417, respectively.
Ko so ga ločeno primerjali z ibuprofenom in naproksenom, je bil HR 0,94 [95 % CI 0,44-2,04] p=0,8842 oziroma 1,49 [95 % CI 0,76-2,92] p=0,2417.
Hepatic effects
Učinki na ledvica
Renal function should be monitored when lumiracoxib and either of these drugs is used in combination.
Kadar uporabljamo v kombinaciji lumirakoksib in katero od teh dveh zdravil, moramo spremljati delovanje ledvic.
No dose adjustment is necessary in patients known to be CYP2C9 poor metabolisers.
Pri osebah z upočasnjeno presnovo CYP2C9 ni potrebno prilagajanje odmerjanja.
Film-coated tablets 100 mg:
100 mg filmsko obložene tablete:
Lumiracoxib is eliminated predominantly via hepatic metabolism.
Lumirakoksib se odstranjuje iz telesa pretežno s presnovo v jetrih.
The pharmacokinetics of lumiracoxib have not been studied in patients with severe hepatic impairment (Child-Pugh >9).
Pri bolnikih s hudim obolenjem jeter ocena >9 po Child-Pughovi lestvici) farmakokinetike lumirakoksiba niso proučevali.
However, there is no lactose in {Invented Name} 400 mg film-coated tablets.
{IZMIŠLJENO IME} 400 mg filmsko obložene tablete ne vsebujejo laktoze.
Renal and urinary disorders Uncommon: dysuria, urinary frequency, cystitis Rare: chromaturia, renal failure
Občasne: dizurija, pogosto uriniranje, cistitis.
Skin and subcutaneous tissue disorders Uncommon: contusion, exanthem, pruritus, rash, urticaria Rare: angioedema
Občasne: kontuzija, eksantem, pruritus, izpuščaj, urtikarija.
Scientific conclusions and grounds for refusal presented by the European Medicines Agency
Znanstveni zaključki in razlogi za zavrnitev, ki jih je navedla Evropska agencija za zdravila
Sweden and Poland considered that the granting of the marketing authorisation constitutes a potential serious risk to public health.
Švedska in Poljska sta menili, da lahko izdaja dovoljenja za promet z zdravilom pomeni resno tveganje za javno zdravje.
The populations studied have been healthy adult volunteers as well as children and renal impairment patients.
V študije so bile vključene populacije zdravih odraslih prostovoljcev ter otrok in bolnikov z okvaro ledvic.
Overall summary of the scientific evaluation of Loraxin and associated names (see Annex I)
Splošni povzetek znanstvenega vrednotenja zdravila Loraxin in povezanih imen (glej Prilogo I)
The MAH also presented their grounds at an oral explanation on 16 October 2012.
Imetnik dovoljenja za promet z zdravilom je predstavil svoje utemeljitve tudi med ustno razlago 16. oktobra 2012.
More importantly, the sensitivity of the assay was considered to be insufficient to detect low concentrations of the parent compound (and the main metabolite desloratadine).
Še pomembneje pa je, da občutljivost analize ni veljala za zadostno za zaznavanje nizkih koncentracij izhodne sestavine (in glavnega metabolita dezloratadina).
List of the names, pharmaceutical form, strength of the medicinal products, route of administration, applicants /marketing authorisation holders in the Member States
Seznam imen, farmacevtske oblike, jakosti zdravila, načina uporabe, predlagatelja, imetnika dovoljenja za promet z zdravilom v državah članicah
Conditions for the lifting of the marketing authorisation suspension
Pogoji za odpravo začasnega umika dovoljenja za promet z zdravilom
For the majority of the clinical studies referenced in the submitted literature, the product was not clearly defined.
V večini kliničnih študij, ki so bile navedene v predloženi literaturi, zdravilo ni bilo jasno opredeljeno.
However, it is noted that the CHMP is a scientific committee and that while it operates within the legal framework, it cannot discuss the specific merits of procedural and legal aspects of administrative procedures laid down in the legislation.
Opozoriti pa je treba, da je CHMP znanstveni odbor in da sicer deluje v zakonskih okvirih, vendar ne more obravnavati posameznih vsebinskih vprašanj glede postopkovnih in pravnih vidikov upravnih postopkov, določenih v zakonodaji.
A judgement must be made whether the product studied can be considered as similar to the product for which application for marketing authorisation has been made in spite of existing differences”.
Presoditi je treba, ali se preiskovano zdravilo lahko šteje kot podobno zdravilu, za katero je že bila predložena vloga za pridobitev dovoljenja za promet z zdravilom, kljub obstoječim razlikam.”
Following the adoption of the CHMP opinion and recommendations during the June 2012 CHMP meeting, a request for re-examination was received from the MAH Vitabalans Oy on 6 July 2012 and the detailed grounds were submitted on 31 August 2012.
CHMP je na sestanku junija 2012 sprejel mnenje in priporočila, 6. julija 2012 pa je prejel zahtevek imetnika dovoljenja za promet z zdravilom Vitabalans Oy za ponovni pregled, podrobni razlogi so bili predloženi 31. avgusta 2012.
For the suspension to be lifted the Marketing Authorisation Holder would need to provide the National Competent Authorities with the following:
Imetnik dovoljenja za promet z zdravilom mora za odpravo umika dovoljenja nacionalnim pristojnim organom zagotoviti:
In view of this lack of evidence the committee found merit on the concerns raised by the member states on the potential serious risk to public health.
Odbor je zaradi pomanjkanja dokazov ugotovil, da so pomisleki glede morebitnega resnega tveganja za javno zdravje, ki sta jih izrazili državi članici, upravičeni.
The lower limit of detection in the analytical method used was 0.2 ng/ml, and due to this, over 50% of the plasma samples loratadine/desloratadine concentrations were below the lower limit of quantification and could not be determined.
Pri uporabljeni analitični metodi se je uporabljala spodnja meja zaznavanja 0,2 ng/ml, zaradi česar je bilo več kot 50 % koncentracij loratadina/dezloratadina v vzorcih plazme pod spodnjo mejo določanja in jih ni bilo mogoče opredeliti.
Loratadine is a second-generation long-acting, non-sedating antihistamine with no significant antimuscarinic activity.
Loratadin je dolgodelujoč, nesedativen antihistaminik druge generacije, ki nima pomembnega antimuskarinskega delovanja.
However one of the reports does not contain any data regarding PK/PD (or dose-response) relationships.
Eno od poročil pa ne vsebuje nobenih podatkov o farmakokinetičnih/farmakodinamičnih odnosih (povezavi med odmerkom in odzivom).
These studies include loratadine products in several strengths from 5 mg up to 40 mg.
Te študije vključujejo zdravila z loratadinom različnih jakosti, od 5 mg do 40 mg.
The intended daily dosage of Loraxin is 10 mg.
Predviden dnevni odmerek Loraxina je 10 mg.
This study was a two period cross-over bioequivalence study with only 40 subjects (in total 80 separate drug intake events).
To je bila navzkrižna študija biološke enakovrednosti, ki se je izvajala s samo 40 poskusnimi osebami v dveh časovnih intervalih (skupaj 80 posamičnih vnosov zdravila).
Loratadine was first authorised as Claritine 10mg tablet in Belgium, since 1987.
Prvo dovoljenje za loratadin je bilo izdano za tablete Claritine 10 mg leta 1987 v Belgiji.
Although the 90% confidence interval of the AUCt (0.884-1.035) and Cmax (0.822-0.989) of the metabolite desloratadine were within the acceptance interval, the CHMP considered that the pharmacokinetic data did not support the submitted bibliographic data since the evaluation of bioequivalence should in principle be based upon measured concentrations of the parent compound (in this case loratadine and not desloratadine).
Čeprav je bil 90-odstotni interval zaupanja za AUCt (0,884-1,035) in Cmax (0,822-0,989) metabolita dezloratadina znotraj razpona sprejemljivosti, je CHMP menil, da farmakokinetični podatki ne podpirajo predloženih bibliografskih podatkov, saj bi moralo vrednotenje biološke enakovrednosti načeloma temeljiti na merjenih koncentracijah izhodne sestavine (v tem primeru loratadina in ne dezloratadina).
As a result, procedural and legal considerations are outside the remit of the CHMP, and therefore the re-examination of the referral procedure under Article 29(4) of Directive 2001/83/EC focussed only on the scientific points addressed in the grounds for reexamination.
Ker CHMP torej ni pristojen za postopkovne in pravne obravnave, je bilo ponovno odločanje o napotitvenem postopku v skladu s členom 29(4) Direktive 2001/83/ES usmerjeno samo na nekatere znanstvene vidike iz utemeljitve za ponovni pregled.