natgillin/translations-raw huggingface dataset:
• You have a history of stomach bleeding or ulcers. • You are dehydrated, for example by a prolonged bout of vomiting or diarrhoea. • You have swelling due to fluid retention. • You have a history of heart failure, heart attack or any other form of heart disease. • You have a history of stroke or mini stroke. • You have a history of high blood pressure .< ARCOXIA > can increase blood pressure in some people, especially in high doses, and your doctor will want to check your blood pressure from time to time. • You have any history of liver or kidney disease. • You are being treated for an infection. < ARCOXIA > can mask or hide a fever, which is a sign of infection. • You are a woman trying to become pregnant. • You are elderly (i.e., over 65 years of age). • You have diabetes, high cholesterol, or are a smoker.
Zdravilo < ARCOXIA > lahko prikrije zvišano telesno temperaturo, ki je znak okužbe • nameravate zanositi. • ste starejši (tj. nad 65 let). • imate sladkorno bolezen, povišan holesterol ali kadite.
If you are not sure if any of the above apply to you, talk to your doctor before taking< ARCOXIA > to see if this medicine is suitable for you.
Če niste prepričani, ali kaj od naštetega velja za vas, se, preden začnete jemati zdravilo < ARCOXIA >, posvetujte z zdravnikom, da se prepričate, če je zdravilo primerno za vas.
< ARCOXIA > works equally well in older and younger adult patients.
Pri starejših odraslih bolnikih je zdravilo < ARCOXIA > enako učinkovito kot pri mlajših odraslih bolnikih.
If you are elderly (i. e., over 65 years of age), your doctor will want to appropriately keep a check on you.
Če ste starejši (tj. nad 65 let), vas bo vaš zdravnik temu primerno nadzoroval.
Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Uporaba drugih zdravil Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli drugo zdravilo, tudi če ste ga dobili brez recepta.
35 In particular if you are taking any of the following medicines, your doctor may want to monitor you to check that your medicines are working properly, once you start taking< ARCOXIA >:
Če trenutno jemljete majhne odmerke acetilsalicilne kisline za preprečevanje srčne ali možganske kapi, s tem ne prekinite, ne da bi se prej posvetovali s svojim zdravnikom.
If you are currently taking low-dose aspirin to prevent heart attacks or stroke, you should not stop taking aspirin until you talk to your doctor -do not take high dose aspirin or other anti-inflammatory medicines while taking< ARCOXIA >
Skupaj z zdravilom < ARCOXIA > ne smete jemati večjih odmerkov acetilsalicilne kisline ali drugih protivnetnih zdravil.
Pregnancy and breast-feeding< ARCOXIA > tablets must not be taken during pregnancy.
Nosečnost in dojenje Tablet zdravila < ARCOXIA > med nosečnostjo ne smete jemati.
If you are pregnant or think you could be pregnant, or if you are planning to become pregnant, do not take the tablets.
Če ste noseči, mislite, da bi lahko bili noseči ali če nameravate zanositi, tablet ne jemljite.
It is not known if< ARCOXIA > is excreted in human milk.
Ni znano, če se zdravilo < ARCOXIA > izloča v materino mleko.
If you are breast-feeding, or planning to breast- feed, consult your doctor before taking< ARCOXIA >.
Če dojite ali nameravate dojiti, se pred začetkom jemanja zdravila < ARCOXIA > posvetujte z zdravnikom.
If you are using< ARCOXIA >, you must not breast- feed.
Med jemanjem zdravila < ARCOXIA > ne smete dojiti.
Driving and using machines Dizziness and sleepiness have been reported in some patients taking< ARCOXIA >.
Vpliv na sposobnost upravljanja vozil in strojev Pri nekaterih bolnikih, ki so jemali zdravilo < ARCOXIA >, so poročali o vrtoglavici in dremavosti.
Do not drive if you experience dizziness or sleepiness.
Če se pri vas pojavita vrtoglavica ali dremavost, ne smete voziti.
Important information about some of the ingredients of< ARCOXIA > < ARCOXIA > contains lactose.
Pomembne informacije o nekaterih sestavinah zdravila < ARCOXIA > Zdravilo < ARCOXIA > vsebuje laktozo.
HOW TO TAKE< ARCOXIA >
KAKO JEMATI ZDRAVILO < ARCOXIA >
Always take< ARCOXIA > exactly as your doctor has told you.
Pri jemanju zdravila < ARCOXIA > natančno upoštevajte zdravnikova navodila.
< ARCOXIA > Tablets should not be taken by children or adolescents under 16 years of age.
Otroci in mladostniki, mlajši od 16 let, ne smejo jemati zdravila < ARCOXIA >.
Take< ARCOXIA > Tablets by mouth once a day. < ARCOXIA > can be taken with or without food.
Tablete zdravila < ARCOXIA > lahko jemljete skupaj s hrano ali brez nje.
It is important that you use the lowest dose that controls your pain and you should not take< ARCOXIA > for longer than necessary.
Pomembno je, da jemljete najmanjši odmerek, ki vam ublaži bolečino, in da zdravila < ARCOXIA > ne jemljete dalj časa, kot je potrebno.
36 Osteoarthritis The recommended dose is 30 mg once a day, increase to a maximum of 60 mg once a day if needed.
Osteoartroza Priporočeni odmerek je 30 mg enkrat na dan, po potrebi se poveča na 60 mg enkrat na dan.
Rheumatoid arthritis The recommended dose is 90 mg once a day.
38 Revmatoidni artritis Priporočeni odmerek je 90 mg enkrat na dan.
Gout The recommended dose is 120 mg once a day which should only be used for the acute painful period, limited to a maximum of 8 days treatment.
Uporablja se lahko le pri akutni bolečini in največ 8 dni.
People with liver problems • If you have mild liver disease, you should not take more than 60 mg a day. • If you have moderate liver disease, you should not take more than 60 mg every other day or 30 mg a day.
Bolniki z boleznimi jeter Če imate blago bolezen jeter, ne smete jemati odmerka, večjega od 60 mg na dan. • Če imate zmerno bolezen jeter, ne smete jemati odmerka, večjega od 60 mg vsak drugi dan ali • 30 mg na dan.
If you take more< ARCOXIA > than you should You should never take more tablets than the doctor recommends.
Če ste vzeli večji odmerek zdravila < ARCOXIA >, kot bi smeli Nikoli ne vzemite več tablet, kot vam jih je predpisal zdravnik.
If you do take too many< ARCOXIA > tablets, you should seek medical attention immediately.
Če ste pomotoma vzeli prevelik odmerek zdravila < ARCOXIA >, nemudoma poiščite zdravniško pomoč.
If you forget to take< ARCOXIA > It is important to take< ARCOXIA > as your doctor has prescribed.
Če ste pozabili vzeti zdravilo < ARCOXIA > Pomembno je, da zdravilo < ARCOXIA > jemljete natančno po zdravnikovih navodilih.
Like all medicines ,< ARCOXIA > can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo < ARCOXIA > neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
If you develop any of these signs you should stop< ARCOXIA > and talk to your doctor immediately: • shortness of breath, chest pains, or ankle swelling appear or if they get worse • yellowing of the skin and eyes (jaundice) – these are signs of liver problems • severe or continual stomach pain or your stools become black • an allergic reaction- which can include skin problems such as ulcers or blistering, or swelling of the face, lips, tongue, or throat which may cause difficulty in breathing
Če se pri vas pojavi kateri od spodnjih znakov, prenehajte jemati zdravilo < ARCOXIA > in se takoj posvetujte z zdravnikom: • kratka sapa, bolečine v prsih ali otekanje gležnjev (če se pojavijo na novo ali se poslabšajo), • rumeno obarvanje kože in oči (zlatenica), kar kaže na bolezen jeter, • močne ali vztrajne bolečine v trebuhu ali črno blato, • alergijska reakcija – ki lahko vključuje težave s kožo, kot so razjede ali mehurji, ali otekanje obraza, ustnic, jezika ali žrela, kar lahko povzroči težave pri dihanju.
The following side effects can occur during treatment with< ARCOXIA >:
Med zdravljenjem z zdravilom < ARCOXIA > se lahko pojavijo naslednji neželeni učinki:
Common (occurring in greater than 1 out of 100 and less than 1 out of 10 people) Weakness and fatigue, dizziness, headache, flu-like illness, diarrhoea, wind, nausea, indigestion (dyspepsia), stomach pain or discomfort, heartburn, changes in blood tests related to your liver, swelling of the legs and/ or feet due to fluid retention (oedema), increased blood pressure, palpitations, bruising.
Pogosti (pojavijo se pri več kot 1 od 100 oseb in manj kot 1 od 10 oseb) Šibkost in utrujenost, omotica, glavobol, gripi podobna bolezen, driska, vetrovi, siljenje na bruhanje, slaba prebava (dispepsija), bolečina ali neugodje v trebuhu, zgaga, spremembe v krvnih testih za delovanje jeter, otekanje nog in/ ali stopal zaradi zadrževanja tekočine v telesu (edemi), povišan krvni tlak, neprijetni občutki ob hitrem ali močnem utripanju srca (palpitacije), modrice.
Uncommon (occurring in greater than 1 out of 1000 and less than 1 out of 100 people) Stomach or bowel bloating, chest pain, heart failure, heart attack, stroke, mini-stroke (transient ischaemic attack), abnormal heart rhythm (atrial fibrillation), upper respiratory infection, high levels of potassium in your blood, changes in blood or urine tests relating to your kidney, changes in your bowel habits including constipation, dry mouth, mouth ulcers, taste alteration, gastroenteritis, gastritis, stomach ulcer, being sick (vomiting), irritable bowel syndrome, inflammation of the esophagus, blurred vision, eye irritation and redness, nose bleed, ringing in the ears, vertigo, appetite increases or decreases, weight gain, muscle cramp/ spasm, muscle pain/ stiffness, inability to sleep, sleepiness, numbness or tingling, anxiety, depression, 37 decreases in mental sharpness, breathlessness, cough, swelling of the face, flushing, skin rash or itchy skin, urinary tract infection.
Občasni (pojavijo se pri več kot 1 od 1000 oseb in manj kot 1 od 100 oseb) Napihnjen trebuh, bolečina v prsnem košu, srčno popuščanje, srčni napad, kap, mala možganska kap (tranzitorna ishemična ataka), motnje srčnega ritma (atrijska fibrilacija), okužba zgornjih dihal, visoke vrednosti kalija v krvi, spremembe krvnih ali urinskih testov za delovanje ledvic, spremembe prebave, vključno z zaprtjem, suha usta, razjede v ustih, spremembe okušanja, vnetje želodca in črevesja, vnetje želodca, želodčna razjeda, slabost (bruhanje), sindrom razdraženega črevesja (sindrom iritabilnega kolona), vnetje požiralnika, zamegljen vid, draženje in rdečina oči, krvavitev iz nosu, zvonjenje v ušesih, vrtoglavica, povečanje ali zmanjšanje apetita, povečanje telesne mase, mišični krči/ spazmi, 39 mišična bolečina/ okorelost, nespečnost, zaspanost, odrevenelost ali mravljinčenje, tesnoba, depresija, zmanjšana sposobnost jasnega mišljenja, zasoplost, kašelj, otekanje obraza, zardevanje, kožni izpuščaj ali srbenje, okužba sečil.
Rare (occurring in greater than 1 out of 10,000 and less than 1 out of 1000 people) Low blood levels of sodium.
Redki (pojavijo se pri več kot 1 od 10. 000 in manj kot 1 od 1000 oseb) Zmanjšanje vrednosti natrija v krvi.
Very Rare (occurring in less than 1 out of 10,000 people) Allergic reactions (which may be serious enough to require immediate medical attention) including hives, swelling of the face, lips, tongue, and/ or throat which may cause difficulty in breathing or swallowing, bronchospasm (wheezing or shortness of breath), severe skin reactions, inflammation of the stomach lining or stomach ulcers that can become serious and may lead to bleeding, liver problems, serious kidney problems, severe increase in blood pressure, confusion, seeing, feeling or hearing things that are not there (hallucinations).
Zelo redki (pojavijo se pri manj kot 1 od 10. 000 oseb) Alergijske reakcije (ki so lahko tako hude, da zahtevajo takojšnjo zdravniško pomoč), vključno s koprivnico, otekanjem obraza, ustnic, jezika in/ ali žrela, kar lahko povzroči težave pri dihanju ali požiranju, bronhospazem (sopenje ali kratka sapa), hude reakcije na koži, vnetje želodčne sluznice ali želodčne razjede, ki lahko postanejo hude in zakrvavijo, bolezni jeter, hude bolezni ledvic, hudo povišanje krvnega tlaka, zmedenost, videnje, čutenje ali slišanje stvari, ki jih ni (halucinacije).
HOW TO STORE< ARCOXIA >
SHRANJEVANJE ZDRAVILA < ARCOXIA >
Do not use< ARCOXIA > after the expiry date which is stated on the pack.
Zdravila < ARCOXIA > ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
Keep the container tightly closed in order to protect from moisture.
Plastenke shranjujte tesno zaprte za zagotovitev zaščite pred vlago.
Store in the original package in order to protect from moisture.
Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
What< ARCOXIA > contains
Kaj vsebuje zdravilo < ARCOXIA >
Each film coated tablet contains 30, 60, 90 or 120 mg of etoricoxib.
Ena filmsko obložena tableta vsebuje 30, 60, 90 120 mg etorikoksiba.
What< ARCOXIA > looks like and contents of the pack
Izgled zdravila < ARCOXIA > in vsebina pakiranja
< ARCOXIA > Tablets are available in four strengths:
Zdravilo < ARCOXIA > je na voljo v štirih jakostih:
30 mg blue-green, apple-shaped, biconvex film coated tablets marked ‘ ACX 30’ on one side and ‘ 101’ on the other.
30 mg filmsko obložene tablete so modro- zelene, na obeh straneh izbočene, v obliki jabolka, z oznako "ACX 30" na eni in oznako "101" na drugi strani.
38 60 mg dark green, apple-shaped, biconvex film coated tablets marked ‘ ARCOXIA 60’ on one side and ‘ 200’ on the other.
60 mg filmsko obložene tablete so temno zelene, na obeh straneh izbočene, v obliki jabolka, z oznako "ARCOXIA 60" na eni strani in oznako "200" na drugi strani.
90 mg white, apple-shaped, biconvex film coated tablets marked ‘ ARCOXIA 90’ on one side and ‘ 202’ on the other.
40 90 mg filmsko obložene tablete so bele, na obeh straneh izbočene, v obliki jabolka, z oznako "ARCOXIA 90" na eni strani in oznako "202" na drugi strani.
120 mg pale-green, apple-shaped, biconvex film coated tablets marked ‘ ARCOXIA 120’ on one side and ‘ 204’ on the other.
120 mg filmsko obložene tablete so svetlo zelene, na obeh straneh izbočene, v obliki jabolka, z oznako "ARCOXIA 120" na eni strani in oznako "204" na drugi strani.
Pack sizes of 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 98 or 100 tablets in blisters; or 30 and 90 tablets in bottles.
2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 98 ali 100 tablet v pretisnem omotu; ali 30 ali 90 tablet v plastenkah.
Marketing Authorisation Holder and Manufacturer [See Annex 1-To be filled in nationally] {Name and address} {tel} {fax} {e-mail}
[Glejte Dodatek I – Izpolni država članica] {Ime in naslov} {tel.} {fax} {e- mail}
This medicinal product is authorized in the Member States of the EEA under the following names:
To zdravilo ima dovoljenje za promet v državah članicah EGP pod naslednjimi imeni:
Cyprus Denmark Estonia Finland France Germany Greece Hungary Iceland Ireland Italy Latvia Lithuania Luxembourg Malta Netherlands Norway Poland Portugal Romania Slovakia Slovenia Spain
Avstrija Belgija Bolgarija Češka Ciper Danska Estonija Finska Francija Nemčija Grčija Madžarska Islandija Irska Italija Latvija Litva Luksemburg Malta Nizozemska Norveška Poljska Portugalska Romunija Slovaška Slovenija Španija Švedska Velika Britanija
Arcoxia 30 mg, 60 mg, 90 mg, 120 mg-Filmtabletten Arcoxia 30 mg, 60 mg, 90 mg, 120 mg, comprimés pelliculés ARCOXIA ARCOXIA 30 mg, 60 mg, 90 mg, 120 mg Arcoxia 30, 60, 90, 120 mg Arcoxia Arcoxia Arcoxia 30, 60, 90 ja 120 mg tabletti, kalvopäällysteinen Arcoxia 30 mg, comprimé pelliculé ARCOXIA 30/ 60/ 90/ 120 mg Filmtabletten ARCOXIA 30mg, 60mg, 90mg,120mg film-coated tablets Arcoxia 30 mg, 60 mg, 90 mg, 120 mg filmtabletta Arcoxia Arcoxia 30, 60, 90 or 120 mg film-coated tablets Arcoxia 30, 60, 90, 120 mg compresse rivestite con film Arcoxia 30 mg, 60 mg, 90 mg un 120 mg apvalkotā s tablets Arcoxia 30, 60, 90, 120 mg plė vele dengtos tabletė s Arcoxia 30 mg, 60 mg, 90 mg, 120 mg, comprimés pelliculés ARCOXIA 30, 60, 90 or 120 mg film-coated tablets Arcoxia 30 mg, 60 mg, 90 mg, 120 mg Arcoxia ARCOXIA 30 mg, 60 mg, 90 mg, 120 mg tabletki powlekane ARCOXIA 30 mg, 60 mg, 90 mg, 120 mg comprimidos revestidos por película ARCOXIA 60 mg, 90 mg, 120 mg, comprimate filmate ARCOXIA 30 mg, 60 mg, 90 mg, 120 mg Arcoxia 30/ 60/ 90/ 120 mg filmsko oblož ene tablete Arcoxia 30, 60, 90 y 120 mg comprimidos recubiertos con película
Arcoxia 30 mg, 60 mg, 90 mg, 120 mg- Filmtabletten Arcoxia 30 mg, 60 mg, 90 mg, 120 mg, comprimés pelliculés ARCOXIA ARCOXIA 30 mg, 60 mg, 90 mg, 120 mg Arcoxia 30, 60, 90, 120 mg Arcoxia Arcoxia Arcoxia 30, 60, 90 ja 120 mg tabletti, kalvopäällysteinen Arcoxia 30 mg comprimé pelliculé ARCOXIA 30/ 60/ 90/ 120 mg Filmtabletten ARCOXIA 30mg, 60mg, 90mg, 120mg film- coated tablets Arcoxia 30 mg, 60 mg, 90 mg, 120 mg filmtabletta Arcoxia Arcoxia 30, 60, 90 or 120 mg film- coated tablets Arcoxia 30, 60, 90, 120 mg compresse rivestite con film Arcoxia 30 mg, 60 mg, 90 mg un 120 mg apvalkotās tablets Arcoxia 30, 60, 90, 120 mg plėvele dengtos tabletės Arcoxia 30 mg, 60 mg, 90 mg, 120 mg, comprimés pelliculés ARCOXIA 30, 60, 90 or 120 mg film- coated tablets Arcoxia 30 mg, 60 mg, 90 mg, 120 mg Arcoxia ARCOXIA 30 mg, 60 mg, 90 mg, 120 mg tabletki powlekane ARCOXIA 30 mg, 60 mg, 90 mg, 120 mg comprimidos revestidos por película ARCOXIA 60 mg, 90 mg, 120 mg, comprimate filmate ARCOXIA 30 mg, 60 mg, 90 mg, 120 mg Arcoxia 30/ 60/ 90/ 120 mg filmsko obložene tablete Arcoxia 30, 60, 90 y 120 mg comprimidos recubiertos con película Arcoxia 30 mg, 60 mg, 90 mg och 120 mg filmdragerade tabletter ARCOXIA 30, 60, 90 or 120 mg film- coated tablets
Sweden United Kingdom
Navodilo je bilo odobreno:
40 ANNEX IV
(MM/ LLLL).
41 CONDITIONS OF THE MARKETING AUTHORISATION
41 DODATEK IV
who prescribe etoricoxib according to national practice.
POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM
42
42 POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM
London, 23 October 2008 EMEA/ 438258/ 2008
London, 23. oktober 2008 EMEA/ CHMP/ 619546/ 2008
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 6 (12) REFERRAL
ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI (CHMP) MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 6( 12) ZA
Arcoxia
zdravilo Arcoxia
International non-proprietary name (INN): etoricoxib
Mednarodno nelastniško ime (INN): etorikoksib
Etoricoxib is a selective inhibitor of COX-2 (cyclooxygenase 2) indicated in the symptomatic relief of osteoarthritis (OA, 30-60mg once daily (od)), rheumatoid arthritis (RA, 90mg od) and the pain and signs of inflammation associated with acute gouty arthritis (120mg od).
Etorikoksib je selektivni zaviralec COX- 2 (ciklooksigenaze- 2), indiciran za simptomatsko lajšanje osteoartritisa (30– 60 mg enkrat dnevno), revmatoidnega artritisa (90 mg enkrat dnevno) ter bolečin in vnetij, povezanih z akutnim protinskim artritisom (120 mg enkrat dnevno).
This referral procedure relates to a request for arbitration concerning a type II variation for a new indication to include treatment of ankylosing spondylitis (AS), at a recommended daily dose of 90mg.
Ta napotitveni postopek se nanaša na vlogo za arbitražo v zvezi s spremembo tipa II glede nove indikacije, da bi se vključilo zdravljenje ankilozirajočega spondilitisa s priporočenim dnevnim 90 - miligramskim odmerkom.
At the end of the mutual recognition procedure, there was a discrepancy between different European Union (EU) Member States regarding the safety of etoricoxib at the 90mg dose in the new proposed indication.
Ob koncu postopka medsebojnega priznavanja se je med različnimi državami članicami Evropske unije (EU) pojavila neskladnost glede varnosti etorikoksiba v 90- miligramskem odmerku v novi predlagani indikaciji.
The main unresolved areas of concern identified by France were concerns regarding long term safety of a daily dose of 90mg etoricoxib in the view of possible increased cardiovascular (CV) risk related to the use of the 90mg dose in the ankylosing spondylitis (AS) indication.
Glavna nerešena vprašanja, ki jih je izpostavila Francija, so se nanašala na varnost dolgotrajne uporabe 90- miligramskega dnevnega odmerka etorikoksiba zaradi možnega povečanega tveganja za srce in ožilje, povezanega z uporabo 90- miligramskega odmerka pri indikaciji ankilozirajočega spondilitisa.
France considered that a review of the benefit/ risk profile of Arcoxia was needed.
Francija je ocenila, da je potrebna presoja profila razmerja med koristmi in tveganjem zdravila Arcoxia.
The arbitration procedure was discussed by the CHMP at its plenary meeting in September 2007 and a Rapporteur (Dr.
Arbitražni postopek je CHMP obravnaval na svojem plenarnem zasedanju septembra 2007, imenovana pa sta bila tudi poročevalec (dr.
Karl Broich) and Co-Rapporteur (Dr.
Karl Broich) in soporočevalec (dr.
During the February 2008 plenary meeting Dr.
Med plenarnim zasedanjem februarja 2008 je bil za soporočevalca imenovan dr.
Rafe Survana was appointed Co-Rapporteur, replacing Dr.
Rafe Survana, ki je zamenjal dr.
Matthew Thatcher.
Matthewa Thatcherja.
There was little direct comparative safety data for individual non-steroidal anti-inflammatory drugs (NSAIDs) other than diclofenac and naproxen.
Podatki so potrdili podobno trombotično kardiovaskularno ogroženost kot pri uporabi učinkovine diklofenak in nekoliko večjo varnost glede ogroženosti zgornjih prebavil v primerjavi z učinkovinama naproksen in diklofenak (vendar nobene manjše ogroženosti za spodnja prebavila).
It was therefore difficult to determine risks for etoricoxib compared with ibuprofen, ketoprofen or other less-commonly used NSAIDs.
Obstaja zelo malo neposrednih primerjalnih podatkov o varnosti posameznih nesteroidnih protivnetnih zdravil, razen za diklofenak in naproksen.
The CHMP therefore recommended the strengthening of the contraindication in hypertensive patients and alerts prescribers that blood pressure needs to be monitored, especially
Zato je težko določiti tveganja v zvezi z etorikoksibom v primerjavi z ibuprofenom, ketoprofenom ali drugimi, manj pogosto uporabljenimi nesteroidnimi protivnetnimi zdravili.
Reproduction is authorised provided the source is acknowledged. within 2 weeks of treatment initiation.
Podatki o uporabi zdravila so pokazali, da so nekatere bolnike s povišanim krvnim tlakom začeli zdraviti z etorikoksibom.
Healthcare professionals were to be reminded of these measures through a communication letter (Dear Healthcare Professional Letter).
Zdravstveni delavci bodo o teh ukrepih opozorjeni s posebnim dopisom („ Spoštovani zdravstveni delavec “).
Data from clinical studies showed clinically meaningful treatment effect for the 90mg etoricoxib once daily dose for AS indication; however, some data are available to indicate that lower doses might also show effect.
Podatki iz kliničnih študij so pokazali klinično pomembne učinke zdravljenja z 90- miligramskim odmerkom etorikoksiba enkrat dnevno pri indikacijah ankilozirajočega spondilitisa, na voljo pa so tudi podatki, ki kažejo, da so lahko tudi manjši odmerki učinkoviti.
The CHMP therefore recommended that dose finding studies should be explored to conclude if treatment with 60mg once daily would also be adequate for some patients.
Zato CHMP priporoča, da se študije o odmerjanju posebej proučijo za ugotovitev, ali bi zdravljenje s 60- miligramskim odmerkom enkrat dnevno zadostovalo za določene bolnike.
The scientific conclusions are provided in Annex II, the amended product information in Annex III and the conditions of the marketing authorisation in Annex IV.
Znanstveni zaključki so podani v Dodatku II, spremenjene informacije o zdravilu v Dodatku III, pogoji dovoljenja za promet z zdravilom pa v Dodatku IV.
∗ Notes: the information given in this document and its annexes reflects only the CHMP opinion dated 26 June 2008.
Informacije, podane v tem dokumentu in dodatkih, odražajo zgolj mnenje CHMP z dne 26. junija 2008.
The Member States’ competent authorities will continue to keep the product under regular review.
Pristojni organi držav članic bodo zdravilo še naprej redno nadzorovali.
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH Država članica Avstrija