FrancophonIA/ELRC3.0 huggingface dataset:
English: The applicant, Virbac, submitted an application for a decentralised procedure for Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle.
Slovenian: Predlagatelj, družba Virbac, je predložil vlogo za decentralizirani postopek za zdravili Deltanil 10 mg/ml, raztopina za kožni poliv za govedo in ovce, in Deltanil 100 mg, raztopina za kožni nanos za govedo.
English: Based on the evaluation of the currently available data, the CVMP considered that the benefit-risk profile of Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle is positive.
Slovenian: Na podlagi ocene trenutno razpoložljivih podatkov je CVMP menil, da je razmerje med tveganji in koristmi za zdravili Deltanil 10 mg/ml, raztopina za kožni poliv za govedo in ovce, in Deltanil 100 mg, raztopina za kožni nanos za govedo, ugodno.
English: Opinion following an Article 33(4)1 referral for Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle
Slovenian: Mnenje v zvezi z napotitvijo v skladu s členom 33(4)1 za zdravili Deltanil 10 mg/ml, raztopino za kožni poliv za govedo in ovce, in Deltanil 100 mg, raztopino za kožni nanos za govedo
English: The procedure started on 5 May 2011.
Slovenian: Postopek se je začel 5. maja 2011.
English: The final opinion was converted into a Decision by the European Commission on 3 November 2011.
Slovenian: Končno mnenje se je 3. novembra 2011 spremenilo v odločbo Evropske komisije.
English: 1 Article 78 of Directive 2001/82/EC
Slovenian: 1 Člen 78 Direktive 2001/82/ES.
English: Opinion following an Article 78
Slovenian: Mnenje v zvezi s postopkom iz člena 78
English: The rapporteur and co-rapporteur appointed were Dr JeanClaude Rouby and Dr David Murphy, respectively.
Slovenian: Za poročevalca je bil imenovan dr. Jean-Claude Rouby, za soporočevalca pa dr. David Murphy.
English: A written explanation was provided by the representative of the marketing authorisation holder on 23 May 2011.
Slovenian: Predstavnik imetnika dovoljenja za promet z zdravilom je 23. maja 2011 predložil pisno obrazložitev.
English: HIPRABOVIS PNEUMOS Emulsion for injection for cattle and associated names
Slovenian: HIPRABOVIS PNEUMOS emulzija za injiciranje za govedo in povezana imena
English: Due to concerns regarding reports of anaphylactic-type events following use of HIPRABOVIS PNEUMOS Emulsion for injection for cattle, France suspended the marketing authorisation for the product on 6 April 2011 triggering a procedure under Article 78 of Directive 2001/82/EC.
Slovenian: Zaradi poročil o dogodkih anafilaktičnega tipa po uporabi zdravila HIPRABOVIS PNEUMOS emulzija za injiciranje za govedo je Francija 6. aprila 2011 začasno umaknila dovoljenje za promet z zdravilom in sprožila postopek v skladu s členom 78 Direktive 2001/82/ES.
English: HIPRABOVIS PNEUMOS Emulsion for injection for cattle is an inactivated vaccine for reduction of the clinical signs and lung lesions caused by Mannheimia haemolytica serotype A1 and Histophilus somni in calves from 2 months of age.
Slovenian: HIPRABOVIS PNEUMOS emulzija za injiciranje za govedo je inaktivirano cepivo za zmanjšanje kliničnih znakov in pljučnih lezij, ki jih povzročata Mannheimia haemolytica, serotip A1, in Histophilus somni pri teletih, starejših od dveh mesecev.
English: Based on the rapporteurs' assessment of the data available from pharmacovigilance reports and a laboratory study, the CVMP concluded that the underlying cause of the adverse events observed has yet to be determined; the data evaluated indicated an association between vaccination of cattle with HIPRABOVIS PNEUMOS Emulsion for injection for cattle and the occurrence of anaphylactic-type events; no corrective measures could be recommended; and the benefit-risk balance for the product was unfavourable.
Slovenian: Na podlagi poročevalčeve ocene podatkov, na voljo v poročilih o farmakovigilanci in laboratorijski študiji, je odbor CVMP sklenil, da je treba osnovni vzrok za neželene dogodke šele ugotoviti; ocenjeni podatki kažejo na povezavo med cepljenjem govedi z zdravilom HIPRABOVIS PNEUMOS emulzija za injiciranje za govedo in pojavnostjo dogodkov anafilaktičnega tipa; priporočiti ni mogoče nobenih popravnih ukrepov, razmerje med tveganji in koristmi pri tem zdravilu pa je bilo neugodno.
English: The Committee, adopted on 14 July 2011, an opinion recommending the suspension of the marketing authorisations for HIPRABOVIS PNEUMOS Emulsion for injection for cattle and associated names until the marketing authorisation holder proposes appropriate measures to mitigate the risk of occurrence of such adverse events and demonstrates a favourable benefit-risk balance for the product when used according to the recommendations of the summary of product characteristics The list of product names concerned is given in Annex I. The scientific conclusions and grounds for suspension of the marketing authorisations are provided in Annex II.
Slovenian: Komisija je 14. julija 2011 sprejela sklep, ki priporoča začasni umik dovoljenja za promet z zdravilom HIPRABOVIS PNEUMOS emulzija za injiciranje za govedo in povezana imena, dokler imetnik dovoljenja za promet z zdravilom ne priporoči ustreznih ukrepov za ublažitev tveganja pojava takih neželenih dogodkov ter dokaže ugodno razmerje med tveganji in koristmi pri zdravilu, če se uporablja skladno s priporočili v povzetku glavnih značilnosti zdravila.
English: procedure for
Slovenian: za zdravilo
English: Children and adolescents under 16 years of age.
Slovenian: Otroci in mladostniki, mlajši od 16 let.
English: The absolute bioavailability is approximately 100%.
Slovenian: Absolutna biološka uporabnost je približno 100 %.
English: Therefore, the dose for each indication is the maximum recommended dose:
Slovenian: Zato odmerek za posamezno indikacijo predstavlja maksimalni priporočeni odmerek:
English: This increase is not generally important for most patients.
Slovenian: To povečanje pri večini bolnikov večinoma ni pomembno.
English: The potential for human risk in pregnancy is unknown.
Slovenian: Možnost za tveganje pri človeku v nosečnosti ni znana.
English: 11415 Tallinn Estonia
Slovenian: 11415 Tallinn Estonija
English: Bottles: Keep the container tightly closed.
Slovenian: Plastenke: Vsebnik shranjujte tesno zaprt.
English: This should be considered when rapid symptomatic relief is needed.
Slovenian: To moramo upoštevati, kadar je potrebno hitro lajšanje simptomov.
English: Patients were treated for a median duration of 11 months.
Slovenian: Bolniki so se zdravili povprečno 11 mesecev.
English: [Very Common (>1/10) Common (>1/100, <1/10) Uncommon (>1/1000, <1/100) Rare (>1/10,000, <1/1,000) Very rare (<1/10,000) including isolated cases]
Slovenian: [Zelo pogosti (>1/10), pogosti (> 1/100, < 1/10), občasni (> 1/1000, < 1/100), redki (> 1/10.000, < 1/1.000), zelo redki (< 1/10.000 vključno s posameznimi primeri)]
English: <INVENTED NAME> tablets contain lactose.
Slovenian: Tablete < IZMIŠLJENO IME > vsebujejo laktozo.
English: However, current estimates are based on limited data and the extent of under-reporting is unquantifiable.
Slovenian: Vendarle pa sedanje ocene temeljijo na omejenih podatkih in pomanjkanja podatkov ni mogoče količinsko oceniti.
English: The onset of drug effect may be faster when <INVENTED NAME> is administered without food.
Slovenian: Učinek lahko nastopi hitreje, če < IZMIŠLJENO IME > vzamemo brez hrane.
English: There was an increase in digoxin Cmax (approximately 33%).
Slovenian: Prišlo je do povečanja Cmax digoksina (približno 33 %).
English: Less than 2% was recovered as unchanged drug.
Slovenian: Manj kot 2 % sta se izločila v obliki nespremenjene učinkovine.
English: Av. Da Siderurgia Nacional 4745-457 S. Mamede do Coronado Portugal
Slovenian: Av. Da Siderurgia Nacional 4745-457 S. Mamede do Coronado Portugalska
English: Doses greater than those recommended for each indication have either not demonstrated additional efficacy or have not been studied.
Slovenian: Odmerki, večji od priporočenih za posamezno indikacijo, niso pokazali dodatne učinkovitosti ali pa njihove uporabe niso raziskali.
English: Therefore, the combination should be administered with caution, especially in the elderly.
Slovenian: Zato je treba kombinacijo uporabljati previdno, še posebej pri starejših bolnikih.
English: The relationship to treatment is not established.
Slovenian: Povezava z zdravljenjem ni bila dokazana.
English: To undertaking its risk management plan as communicated to the CHMP during May 2005 CHMP meeting and outlined in the assessment report response on 10 May 2005.
Slovenian: Da bo izvedel svoj načrt o obvladovanju tveganj, kot ga je sporočil CHMP-ju na sestanku maja 2005 in kot je opisan v odgovoru na poročilo o oceni z dne 10. maja 2005.
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Slovenian: Raziskave pri živalih so pokazale toksičnost za reprodukcijo (glejte 5.3).
English: Edificio Vasco da Gama, nº19, Porto Salvo 2770-192 Paço d´Arcos Portugal
Slovenian: Edificio Vasco da Gama, nº19, Porto Salvo 2770-192 Paço d´Arcos Portugalska
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES AND NORWAY AND ICELAND
Slovenian: DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK TER JAKOSTI ZDRAVILA, POT UPORABE IN IMETNIKOV DOVOLJENJA ZA PROMET V DRŽAVAH ČLANICAH TER NORVEŠKA IN ISLANDIJA
English: Puławska 303 02-785 Warszawa Poland
Slovenian: Puławska 303 02-785 Warszawa Poljska
English: The following additional safety results were observed in the study:
Slovenian: V raziskavi so prišli še do naslednjih ugotovitev v zvezi z varnostjo:
English: This USR was initiated on 16 February 2005 and finalised on 17 February 2005.
Slovenian: Nujen varnostni ukrep se je začel 16. februarja 2005 in zaključil 17. februarja 2005.
English: Very rare: confusion, hallucinations.
Slovenian: Zelo redke: zmedenost, halucinacije
English: 2003 PC Haarlem The Netherlands
Slovenian: 2003 PC Haarlem Nizozemska
English: Aluminum/aluminium blisters in packs containing 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 98 or 100 tablets.
Slovenian: Aluminij/aluminij pretisni omoti v škatlah, ki vsebujejo 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 98 ali 100 tablet.
English: Pain relief was observed as early as four hours after initiation of treatment.
Slovenian: Olajšanje bolečine so opazili že 4 ure po začetku zdravljenja.
English: The absolute risk increase for such events is unlikely to exceed 1% per year based on existing data (uncommon).
Slovenian: Glede na obstoječe podatke je malo verjetno, da absolutno povečanje tveganja teh dogodkov preseže 1 % na leto (občasni).
English: Hertfordshire EN11 9BU United Kingdom
Slovenian: Hertfordshire EN11 9BU Velika Britanija
English: Further to the assessment of:
Slovenian: po vrednotenju:
English: Congestive heart failure (NYHA II-IV).
Slovenian: Kongestivno srčno popuščanje (NYHA II-IV).
English: These beneficial effects were observed as early as the second day of therapy and maintained for up to 52 weeks.
Slovenian: Ti koristni učinki so se pojavili že drugi dan zdravljenja in so vztrajali do 52 tednov.
English: - Addition of a more detailed description of the first signs of skin reactions leading to discontinuation of the treatment.
Slovenian: - Dodan je podrobnejši opis začetnih znakov kožnih reakcij, zaradi katerih se zdravljenje prekine.
English: Patients with hypertension whose blood pressure has not been adequately controlled.
Slovenian: Bolniki z visokim krvnim tlakom, ki ni zadostno nadzorovan.
English: These data are not considered clinically significant.
Slovenian: Ti podatki ne veljajo za klinično pomembne.
English: The CHMP confirmed changes to the Product Information already introduced through a type II variation adopted in May 2005 further to the February USR and requested further changes.
Slovenian: CHMP je potrdil spremembe informacij o zdravilu, že vnešene z variacijo tipa II, sprejeto aprila 2005 po februarskem nujnem varnostnem ukrepu in zahteval še nadaljnje spremembe.
English: After the Commission Decision, the Member State competent authorities will update the product information as required.
Slovenian: Pristojne oblasti držav članic bodo podatke o izdelku posodobile v skladu z zahtevami, ko bo podana odločba Komisije.
English: Via Benedetto Croce, 37 I-56125 Pisa Italy
Slovenian: Via Benedetto Croce, 37 I-56125 Pisa Italija
English: The rate of absorption was affected, resulting in a 36% decrease in Cmax and an increase in Tmax by 2 hours.
Slovenian: Vplivalo je na hitrost absorpcije in povzročilo 36 % zmanjšanje Cmax in podaljšanje tmax za 2 uri.
English: To submit a descriptive study protocol to CHMP.
Slovenian: Da bo CHMP-ju predložil opisni protokol študije.
English: Safety and effectiveness of etoricoxib in paediatric patients have not been established.
Slovenian: Varnosti in učinkovitosti etorikoksiba pri pediatričnih bolnikih niso ugotavljali.
English: Film-coated tablet/tablet.
Slovenian: Filmsko obložena tableta.
English: The volume of distribution at steady state (Vdss) was approximately 120 l in humans.
Slovenian: Volumen porazdelitve v stanju dinamičnega ravnovesja (Vdss) je bil pri ljudeh približno 120 l.
English: Via G. Fabbroni, 6 I-00191 Roma Italy
Slovenian: Via G. Fabbroni, 6 I-00191 Roma Italija
English: Two isoforms, COX-1 and COX-2, have been identified.
Slovenian: Poznamo dve izoobliki, COX-1 in COX-2.
English: If blood pressure rises significantly, alternative treatment should be considered.
Slovenian: Če se krvni tlak pomembno zviša, je treba razmisliti o nadomestnem zdravljenju.
English: On 20 April 2005, Pfizer presented data on serious skin reactions for valdecoxib during a hearing.
Slovenian: Dne 20. aprila 2005 je Pfizer med zaslišanjem predstavil podatke o hudih kožnih reakcijah pri uporabi valdekoksiba.
English: Pregnancy and lactation (see sections 4.6 and 5.3).
Slovenian: Nosečnost in dojenje (glejte 4.6 in 5.3).
English: Further revisions to the SPC will be promptly communicated to HCPs and promptly incorporated into printed materials and product websites.
Slovenian: Nadaljnje revizije SPC-ja se nemudoma sporočijo poklicnim zdravstvenim delavcem (Health Care Professionals, HCP) in se takoj vnesejo v vse tiskano gradivo in objave na spletnih straneh.
English: Etoricoxib is an inhibitor of human sulfotransferase activity, particularly SULT1E1, and has been shown to increase the serum concentrations of ethinyl estradiol.
Slovenian: Etorikoksib je zaviralec aktivnosti človeške sulfotransferaze, zlasti SULT1E1, in pokazalo se je, da poveča serumske koncentracije etinilestradiola.
English: Cyclooxygenase is responsible for generation of prostaglandins.
Slovenian: Ciklooksigenaza je odgovorna za tvorbo prostaglandinov.
English: Patients appear to be at highest risk for these reactions early in the course of therapy, with the onset of the reaction occurring in the majority of cases within the first month of treatment.
Slovenian: Kaže, da je tveganje za te reakcije največje kmalu po začetku zdravljenja, v večini primerov z nastopom v prvem mesecu zdravljenja.
English: Therefore, this SPC may not necessarily represent the current text.
Slovenian: Zaradi tega ta Povzetek glavnih značilnosti zdravila ne predstavlja nujno sedanjega besedila.
English: These beneficial effects were maintained over the 12week treatment periods.
Slovenian: Ti koristni učinki so trajali celotno 12-tedensko obdobje zdravljenja.
English: Elderly: No dosage adjustment is necessary for elderly patients.
Slovenian: Starejši bolniki: Pri starejših bolnikih prilagajanje odmerkov ni potrebno.
English: ATC Code: MO1 AH05
Slovenian: Oznaka ATC: M01 AH05
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS PRESENTED BY THE EMEA
Slovenian: DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, PREDSTAVLJENI S STRANI EVROPSKE AGENCIJE ZA ZDRAVILA
English: Very rare: bronchospasm.
Slovenian: Zelo redke: bronhospazem.
English: The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient's overall risks (see sections 4.3, 4.4).
Slovenian: Odločitev da se predpiše selektivni zaviralec COX-2, mora temeljiti na oceni vseh tveganj za vsakega posameznega bolnika (glejte poglavji 4.3, 4.4).
English: Elderly: Pharmacokinetics in the elderly (65 years of age and older) are similar to those in the young.
Slovenian: Starejši bolniki: farmakokinetika pri starejših bolnikih (starih 65 let ali več) je podobna kot pri mlajših bolnikih.
English: Further to a request from the European Commission, the scope of the ongoing class was broadened review to include the assessment of serious skin reactions in addition to the cardiovascular safety aspects.
Slovenian: Na zahtevo Evropske komisije se je obseg revizije skupine zdravil v teku še razširil, tako da poleg vidikov kardiovaskularne varnosti zajema tudi vrednotenje hudih kožnih reakcij.
English: The MAH commits to inform the CHMP of the outcome of the MEDAL and EDGE II studies on cardiovascular and GI safety upon completion and will provide necessary updates as applicable.
Slovenian: Imetnik dovoljenja za promet se zavezuje, da bo obvestil CHMP o izidu študij MEDAL in EDGE II o kardiovaskularni in gastrointestinalni varnosti po njunem zaključku in ustrezno predložil potrebne posodobljene podatke.
English: Common: ALT increased, AST increased.
Slovenian: Pogoste: porast ALT, porast AST.
English: While this information may suggest an increase in dose, doses of etoricoxib greater than those listed for each indication have not been studied in combination with rifampicin and are therefore not recommended (see section 4.2).
Slovenian: Čeprav to lahko nakazuje povečanje odmerka, odmerkov etorikoksiba, večjih od tistih, navedenih za posamezno indikacijo, v kombinaciji z rifampicinom niso preučevali in jih zato ne priporočamo (glejte 4.2).
English: Paediatric patients: The pharmacokinetics of etoricoxib in paediatric patients (<12 years old) have not been studied.
Slovenian: Pediatrični bolniki: farmakokinetike etorikoksiba pri pediatričnih bolnikih (< 12 let) niso preučevali.
English: - Addition of a warning for patients with risk factors for heart disease, such as hypertension, hyperlipidaemia (high cholesterol levels), diabetes and smoking.
Slovenian: - Dodano je opozorilo za bolnike z dejavniki tveganja za srčne bolezni, kot so hipertenzija, hiperlipidemija (visoke ravni holesterola), sladkorna bolezen in kajenje.
English: The geometric mean area under the curve (AUC0-24hr) was 37.8 µg•hr/ml.
Slovenian: Geometrična sredina površine pod krivuljo (AUC0-24 ur) je znašala 37,8 µg•h/ml.
English: Very rare: urticaria, Stevens-Johnson syndrome, toxic epidermal necrolysis.
Slovenian: Zelo redke: urtikarija, Stevens-Johnson-ov sindrom, toksična epidermalna nekroliza.
English: NAME OF THE MEDICINAL PRODUCT <INVENTED NAME (see Annex 1)> 60 mg Film-coated Tablets/Tablets <INVENTED NAME (see Annex 1)> 90 mg Film-coated Tablets/Tablets <INVENTED NAME (see Annex 1)> 120 mg Film-coated Tablets/Tablets
Slovenian: IME ZDRAVILA < IZMIŠLJENO IME (glejte Priloga 1)> 60 mg filmsko obložene tablete < IZMIŠLJENO IME (glejte Priloga 1)> 90 mg filmsko obložene tablete < IZMIŠLJENO IME (glejte Priloga 1)> 120 mg filmsko obložene tablete
English: These principal metabolites either demonstrate no measurable activity or are only weakly active as COX-2 inhibitors.
Slovenian: Ta glavna presnovka nimata merljive aktivnosti ali le šibko zavirata COX-2.
English: None of these metabolites inhibit COX-1.
Slovenian: Noben od teh presnovkov ne zavira COX-1.
English: Hemodialysis contributed negligibly to elimination (dialysis clearance approximately 50 ml/min).
Slovenian: Hemodializa je k izločanju prispevala le neznatno (očistek dialize približno 50 ml/min).
English: - Addition of a warning for prescribers to consider discontinuation of therapy if during treatment, patients deteriorate in any of the organ system functions described.
Slovenian: - Dodano je opozorilo za predpisovalce zdravila, naj preučijo možnost prekinitve zdravljenja, če se med zdravljenjem bolniku poslabša katerakoli opisana funkcija organskih sistemov.
English: The CHMP agreed that an Urgent Safety Restriction (USR) on cardiovascular safety was needed to introduce new contraindications and strengthen warnings and information on side effects in the SPC.
Slovenian: CHMP je soglasno ugotovil, da je potreben nujen varnostni ukrep (Urgent Safety Restriction, USR) v zvezi s kardiovaskularno varnostjo, da se dodajo nove kontraindikacije in okrepijo opozorila in podatki o neželenih učinkih v Povzetku glavnih značilnosti zdravila (SPC).
English: Severe hepatic dysfunction (serum albumin <25 g/l or Child-Pugh score ≥10).
Slovenian: Huda motnja delovanja jeter (serumski albumin < 25 g/l ali lestvica po Child-Pughu ≥ 10).
English: In the event of overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the GI tract, employ clinical monitoring, and institute supportive therapy, if required.
Slovenian: Če pride do zaužitja prevelikega odmerka, so primerni običajni podporni ukrepi, npr. odstranitev neabsorbiranega zdravila iz prebavil ter uvedba kliničnega nadzora in podpornega zdravljenja, če je to potrebno.
English: Between November 2004 and June 2005, the MAH made oral explanations to the CHMP on cardiovascular and skin safety aspects for etoricoxib on 18 January and 15 February 2005.
Slovenian: Med novembrom 2004 in junijem 2005 je imetnik dovoljenja za promet 18. januarja in 15. februarja 2005 pred CHMP ustno obrazložil kardiovaskularne in kožne varnostne vidike za etorikoksib.
English: Etoricoxib is contraindicated in pregnancy (see section 4.3).
Slovenian: Etorikoksib je kontraindiciran v nosečnosti (glejte 4.3).
English: White, round, HDPE bottles with a white, polypropylene closure containing 30 or 90 tablets.
Slovenian: Bele, okrogle HDPE plastenke z belim polipropilenskim zamaškom s 30 ali 90 tabletami.
English: Very rare: renal insufficiency, including renal failure, usually reversible upon discontinuation of treatment (see section 4.4).
Slovenian: Zelo redke: ledvična okvara, vključno z ledvično odpovedjo, običajno reverzibilno po ukinitvi zdravljenja (glejte poglavje 4.4).
English: Use of gastroprotective agents and low dose aspirin were permitted in the study.
Slovenian: Uporaba gastroprotektivnih zdravil in majhnih odmerkov acetilsalicilne kisline je bila v raziskavi dovoljena.
English: 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.
Slovenian: Spremembe informacij o zdravilu v zvezi s kardiovaskularnim sistemom lahko povzamemo kot sledi: - Dodana je izjava, da mora odločitev da se predpiše selektivni zaviralec COX-2 temeljiti na oceni vseh tveganj za vsakega posameznega bolnika.
English: (See section 4.2 ‘Paediatric use'.)
Slovenian: (Glejte 4.2 Pediatrični bolniki.)
English: The gastrointestinal and cardiovascular safety data are summarized below.
Slovenian: Podatki o varnosti za prebavila in podatki o srčno-žilni varnosti so zbrani spodaj.