natgillin/translations-raw huggingface dataset:
< [To be completed nationally] >
[Izpolni država članica]
< {DD/MM/YYYY} > < {DD month YYYY} >
{DD/ MM/ LLLL} {DD mesec LLLL}
< {MM/YYYY} >
{MM/ LLLL}
15 LABELLING
15 OZNAČEVANJE
16 PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON BOX
16 PODATKI NA ZUNANJI OVOJNINI
Alendronate HEXAL and associated names (see Annex I) 10 mg tablets
Alendronat HEXAL in pripadajoča imena (glejte Dodatek I) 10 mg tablete [Glejte Dodatek I - Izpolni država članica]
Alendronic acid
Alendronska kislina
One tablet contains 10 mg alendronic acid (as sodium alendronate trihydrate).
Ena tableta vsebuje 10 mg alendronske kisline (v obliki natrijevega alendronata trihidrata).
14 tablets 28 tablets 56 tablets 98 tablets 112 tablets 50 x 1 (unit dose) tablet
14 tablet 28 tablet 56 tablet 98 tablet 112 tablet 50 x 1 (enkratni odmerek) tableta
Alendronate HEXAL should be swallowed whole Alendronate HEXAL must be taken on an empty stomach immediately on rising in the morning, with plain water only, at least 30 minutes before the first food, drink or other medication of the day!
Tablete Alendronat HEXAL je treba vzeti na prazen želodec takoj po jutranjem vstajanju izključno z navadno vodo, najmanj 30 minut pred zaužitjem prve hrane, pijače ali drugih zdravil v tem dnevu!
18 MINIMUM PARTICULARS TO APPEAR ON BLISTERS
18 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU
19 PACKAGE LEAFLET
19 NAVODILO ZA UPORABO
Alendronate HEXAL and associated names (see Annex I) 10 mg tablets [See Annex I - To be completed nationally]
Alendronat HEXAL in pripadajoča imena (glejte Dodatek I) 10 mg tablete
What is Alendronate HEXAL and what is it used for 2.
Kaj je zdravilo Alendronat HEXAL in za kaj ga uporabljamo 2.
Before you take Alendronate HEXAL 3.
Kaj morate vedeti, preden boste vzeli zdravilo Alendronat HEXAL 3.
How to take Alendronate HEXAL 4.
Kako jemati zdravilo Alendronat HEXAL 4.
How to store Alendronate HEXAL 6.
Shranjevanje zdravila Alendronat HEXAL 6.
Broken bones usually occur at the hip, spine, or wrist and can lead not only to pain but also to considerable problems like stooped posture (‘ dowager’ s hump’) and loss of mobility.
Največkrat se zlomijo kosti kolka, hrbtenice ali zapestja, ki ne povzročajo samo bolečin, temveč tudi precejšnje težave, kot so sključena drža (grba) in nezmožnost gibanja.
As well as your treatment with Alendronate HEXAL, your doctor may suggest you make changes to your lifestyle to help your condition, such as:
Te spremembe so:
Stopping smoking Smoking appears to increase the rate at which you lose bone and, therefore, may increase your risk of broken bones.
Prenehanje kajenja Kaže, da kajenje povečuje hitrost izgubljanja kostne mase in lahko zato zveča tveganje za zlome kosti.
Exercise Like muscles, bones need exercise to stay strong and healthy.
Telesna aktivnosti Tako kot za mišice je tudi za kosti potrebna telesna aktivnost, da ostanejo močne in zdrave.
BEFORE YOU TAKE ALENDRONATE HEXAL
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO ALENDRONAT HEXAL
21 Do not take Alendronate HEXAL
Ne jemljite zdravila Alendronat HEXAL
- if you are allergic (hypersensitive) to alendronate sodium trihydrate or any of the other
- če ste alergični na (preobčutljivi za) natrijev alendronat trihidrat ali katerokoli sestavino zdravila
ingredients of Alendronate HEXAL
Alendronat HEXAL,
- if you have certain problems with your gullet (oesophagus - the tube that connects your
- če imate določene težave s požiralnikom (požiralnik je cev, ki povezuje usta in želodec), kot sta
mouth with your stomach) such as narrowing or difficulty swallowing
zožitev ali oteženo požiranje,
- if you cannot stand or sit upright for at least 30 minutes
- če ne morete stati ali pokončno sedeti vsaj 30 minut,
- if your doctor has told you that you have low blood calcium
- če vam je zdravnik povedal, da imate nizko vrednost kalcija v krvi.
Take special care with Alendronate HEXAL Tell your doctor
Bodite posebno pozorni pri jemanju zdravila Alendronat HEXAL Zdravniku povejte
- if you suffer from kidney problems
- če imate težave z ledvicami,
- if you have any swallowing or digestive problems
- če imate kakšne težave pri požiranju ali s prebavo,
- if you have low blood calcium levels.
- če imate nizke vrednosti kalcija v krvi.
Irritation, inflammation or ulceration of the gullet (oesophagus - the tube that connects your mouth with your stomach) often with symptoms of chest pain, heartburn, or difficulty or pain upon swallowing may occur, especially if patients do not drink a full glass of water and/ or if they lie down less than 30 minutes after taking Alendronate HEXAL.
Pojavijo se lahko draženje, vnetje ali razjeda požiralnika (cevi, ki povezuje usta z želodcem), pogosto z znaki bolečine v prsnem košu, zgage ali težkega oz. bolečega požiranja, še posebno, če bolnik po zaužitju zdravila Alendronat HEXAL ne popije polnega kozarca vode in/ ali se uleže prej kot po 30 minutah po zaužitju zdravila.
Talk to your doctor before you take Alendronate HEXAL if you have or have had pain or swelling of your gums and/ or jaw, numbness of the jaw, if the jaw feels heavy or if you have lost a tooth.
Če imate ali ste imeli boleče ali otečene dlesni in/ ali čeljust, omrtvičeno čeljust, če imate občutek teže v čeljusti ali ste izgubili zob, se pred jemanjem zdravila Alendronat HEXAL posvetujte z zdravnikom.
Taking other medicines It is likely that calcium supplements, antacids, and some oral medicines will interfere with the absorption of Alendronate HEXAL if taken at the same time.
Jemanje drugih zdravil Verjetno je, da bodo dodatki kalcija, antacidi in nekatera peroralna zdravila motila absorpcijo Alendronata HEXAL, če jih boste vzeli istočasno.
Therefore, it is important that you follow the advice given in section 3. “ How to take Alendronate HEXAL”.
Zato je pomembno, da upoštevate navodila v poglavju 3. “ Kako jemati zdravilo Alendronat HEXAL ”.
Pregnancy and breast-feeding You should not take Alendronate HEXAL if you are or think you may be pregnant.
Nosečnost in dojenje Ne jemljite zdravila Alendronat HEXAL, če ste noseči ali če mislite, da bi lahko bili noseči.
HOW TO TAKE ALENDRONATE HEXAL
KAKO JEMATI ZDRAVILO ALENDRONAT HEXAL
Follow these instructions carefully to make sure you will benefit from Alendronate HEXAL.
Da vam bo zdravilo Alendronat HEXAL pomagalo, morate natančno upoštevati ta navodila.
It is very important to follow instructions 1), 2), 3) and 4) to help the Alendronate HEXAL reach your stomach quickly and help reduce the chance of irritating your gullet (oesophagus - the tube that connects your mouth with your stomach).
Zelo pomembno je, da upoštevate navodila 1), 2), 3) in 4), da bo lahko Alendronat HEXAL hitro prišel v želodec in da boste zmanjšali možnost draženja požiralnika (cevi, ki povezuje usta z želodcem).
3) Do not lie down - stay fully upright (sitting, standing or walking) - for at least 30 minutes after swallowing the tablet.
3) Ne uležite se – ostanite v popolnoma pokončnem položaju (sedite, stojte ali hodite) – še najmanj 30 minut potem, ko ste pogoltnili tableto.
If you forget to take Alendronate HEXAL If you miss a dose, just take one tablet on the morning after you remember.
Če ste pozabili vzeti zdravilo Alendronat HEXAL Če pozabite vzeti odmerek, vzemite eno tableto naslednje jutro, potem ko se spomnite.
Return to taking one tablet daily.
Nadaljujte z jemanjem ene tablete na dan.
The following terms are used to describe how often side effects have been reported.
23 Pri opisu, kako pogosto so poročali o neželenih učinkih, se uporabljajo naslednji izrazi.
23 Very common: ≥ 1/ 10 Common: ≥ 1/ 100 - < 1/ 10 Uncommon: ≥ 1/ 1,000 - < 1/ 100 Rare: ≥ 1/ 10,000 - < 1/ 1,000 Very rare: < 1/ 10,000, not known (cannot be estimated from the available data)
Zelo pogosti (≥1/ 10) Pogosti (> 1/ 100 - < 1/ 10) Občasni (≥1/ 1. 000 - < 1/ 100) Redki (≥1/ 10. 000 - < 1/ 1. 000) Zelo redki (< 1/ 10. 000), neznana (ni mogoče oceniti iz razpoložljivih podatkov)
Common: headache abdominal pain uncomfortable feeling in the stomach or belching after eating constipation full or bloated feeling in the stomach diarrhoea flatulence heartburn difficulty swallowing pain upon swallowing ulceration of the gullet (oesophagus - the tube that connects your mouth with your stomach) which can cause chest pain, heartburn or difficulty or pain upon swallowing bone, muscle and/ or joint pain
Pogosti: glavobol bolečina v trebuhu neprijeten občutek v želodcu ali riganje po jedi zaprtje občutek polnega ali napihnjenega želodca driska vetrovi zgaga težave pri požiranju bolečine pri požiranju razjede požiralnika (požiralnik je cev, ki povezuje usta z želodcem), ki lahko povzročijo bolečine v prsnem košu, zgago ali težko/ boleče požiranje bolečine v kosteh, mišicah in/ ali sklepih
Uncommon Nausea Vomiting irritation or inflammation of the gullet (oesophagus - the tube that connects your mouth with your stomach) or stomach black or tarlike stools rash itching redness of the skin
Občasni: slabost bruhanje draženje ali vnetje požiralnika (požiralnik je cev, ki povezuje usta z želodcem) ali želodca; črno ali katranu podobno blato izpuščaj srbečica pordela koža
Severe bone, muscle and/ or joint pain rash made worse by sunlight, transient flu-like symptoms, such as aching muscles, generally feeling unwell and sometimes with fever usually at the start of treatment hypersensitivity reactions including nettle rash and angio-oedema symptoms of low blood calcium levels including muscle cramps or spasms and/ or tingling sensation in the fingers or around the mouth
Redki: zamegljen vid, bolečina ali rdečina v očesu zožitev požiralnika (požiralnik je cev, ki povezuje usta z želodcem); razjede v ustih zaradi žvečenja ali sesanja tablet; želodčne ali peptične razjede (včasih hude ali s krvavitvijo), za katere pa ni znano, ali jih je povzročil Alendronat HEXAL; hude bolečine v kosteh, mišicah in/ ali sklepih izpuščaj, ki ga poslabša izpostavljenost sončni svetlobi, prehodni gripi podobni simptomi, kot so bolečine v mišicah, splošno slabo počutje, včasih z zvišano telesno temperaturo, običajno ob začetku zdravljenja; preobčutljivostne reakcije, vključno s koprivnico in angioedemom; simptomi nizke ravni kalcija v krvi, vključno z mišičnimi krči ali spazmami in/ ali mravljinčenjem v prstih ali okoli ust
dizziness swelling in the hands or legs lack or loss of strength osteonecrosis (death of bone tissue) 24 joint swelling
omotica otekanje rok in nog pomanjkanje ali izguba moči ostenekroza (odmrtje kostnega tkiva) otekanje sklepov
It will help if you make a note of what you experienced, when it started and how long it lasted.
24 Dobro je, da si zabeležite, kaj se vam je zgodilo, kdaj se je pojavilo in kako dolgo je trajalo.
HOW TO STORE ALENDRONATE HEXAL
SHRANJEVANJE ZDRAVILA ALENDRONAT HEXAL
Store in the original package in order to protect from moisture.
Shranjujte v originalni ovojnini za zagotovitev zaščite pred vlago:
What Alendronate HEXAL contains The active substance is alendronate sodium trihydrate.
Kaj vsebuje zdravilo Alendronat HEXAL Zdravilna učinkovina je natrijev alendronat trihidrat.
The tablets are supplied in triplex blister (PVC/ PE/ PVDC/ AL) packs containing 14, 28, 56, 98, 112 and 50 x 1 (unit dose).
Tablete so na voljo v pakiranjih s tremi pretisnimi omoti (PVC/ PE/ PVDC/ AL), ki vsebujejo po 14, 28, 56, 98, 112 in 50 x 1 (enkratni odmerek) tablet.
Marketing Authorisation Holder and Manufacturer< [See Annex I - To be completed nationally] >
Imetnik dovoljenja za promet z zdravilom in izdelovalec [Glejte Dodatek I - Izpolni država članica]
This medicinal product is authorised in the Member States of the EEA under the following names: >
Zdravilo je v državah članicah EGP pridobilo dovoljenje za promet z naslednjimi imeni:
London, 13 April 2007 EMEA/ CHMP/ 75285/ 2007
London, 13. april 2007 EMEA/ CHMP/ 75285/ 2007
OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Alendronate HEXAL and associated names International Non-Proprietary Name (INN): alendronic acid (as sodium alendronate trihydrate)
Alendronat HEXAL in z njim povezana imena Mednarodno nelastniško ime (INN): alendronska kislina (kot natrijev alendronat trihidrat)
Hexal A/ S submitted applications for mutual recognition of Alendronate HEXAL and associated names, 10 mg tablets on the basis of the marketing authorisation granted by Sweden on 3 December 2004.
Podjetje Hexal A/ S je predložilo vlogo za medsebojno priznavanje zdravila Alendronat HEXAL in z njim povezanih imen, 10 mg tablet na podlagi dovoljenja za promet, ki ga je odobrila Švedska dne 3. decembra 2004.
In the repeat use of the Mutual Recognition procedure, which started on 11 October 2005, the application was submitted to the Concerned Member States (CMS):
Pri ponovni uporabi postopka medsebojnega priznavanja, ki se je začel 11. oktobra 2005, je bila vloga predložena zadevnim državam članicam:
Belgium, Greece and Denmark.
Belgiji, Grčiji in Danski.
The Rapporteur was Dr.
Poročevalec je bil dr.
Tomas Salmonson and Co-Rapporteur(s) was Dr.
Tomas Salmonson, soporočevalec pa dr.
The CHMP considered that the benefit/ risk ratio was considered to be favourable in the following indication: “ Treatment of osteoporosis in men at increased risk of fracture.
„ Zdravljenje osteoporoze pri moških s povišanim tveganjem za zlome.
A reduction in the incidence of vertebral, but not of non-vertebral fractures has been demonstrated”.
Dokazano je bilo zmanjšanje pogostosti vretenčnih zlomov, ne pa tudi nevretenčnih zlomov “.
The list of the product names concerned is given in Annex I.
Seznam zadevnih imen proizvodov je naveden v Dodatku I.
The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics in Annex III.
Znanstveni zaključki so podani v Dodatku II skupaj s Povzetkom glavnih značilnosti zdravila v Dodatku III.
1 Article 29(4) of Directive 2001/ 83/ EC, as amended.
1 Člen 29( 4) Direktive 2001/ 83/ ES, kot je bila spremenjena.
London, 14 July 2008 EMEA/ CHMP/ 151554/ 2008
London, 14. julij 2008 EMEA/ CHMP/ 151554/ 2008
OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Alvesco and associated names
MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 29( 4) 1 ZA Alvesco in z njim povezana imena
International Non-Proprietary Name (INN): ciclesonide
Mednarodno nelastniško ime (INN): ciklesonid
The Reference Member State was United Kingdom and the Concerned Member States were:
Referenčna država članica je bilo Združeno kraljestvo, zadevne države članice pa so bile:
First wave:
Prvi val:
Belgium, Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Hungary, Iceland, Ireland, Latvia, Lithuania, Luxembourg, The Netherlands, Norway, Poland, Slovak Republic, Slovenia and Sweden Repeat use:
Ponovna uporaba:
Austria, Bulgaria, Cyprus, Spain, France, Italy, Malta and Portugal
Avstrija, Bolgarija, Ciper, Španija, Francija, Italija, Malta in Portugalska.
These Member States and the applicant / MAH were not able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State.
Te države članice in predlagatelj/ imetnik dovoljenja za promet z zdravilom niso mogli doseči soglasja glede medsebojnega priznavanja dovoljenja za promet, ki ga je odobrila referenčna država članica.
Significant difference have been identified with regard to the currently approved posology for the control of exacerbations in severe asthma, and the need for a study comparing 160 µg, 320 µg and 640 µg/ daily to demonstrate a reduction in the frequency of exacerbations in patients with severe asthma at the higher doses.
Bistvene razlike so se pokazale v zvezi s trenutno odobrenim odmerjanjem za nadzorovanje poslabšanj pri hudi astmi ter zaradi potrebe po študiji, ki bi primerjala dnevne odmerke 160 µg, 320 µg in 640 µg z namenom dokazati zmanjšano pogostnost poslabšanj pri bolnikih s hudo astmo pri zdravljenju z večjimi odmerki.
The arbitration procedure started on 15 November 2007 with the adoption of a list of questions.
Poročevalec je bil dr.
During their March 2008 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/ risk ratio is favourable for Alvesco and associated names, that the objections raised by France should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
CHMP je na svojem zasedanju v maju 2008 na podlagi vseh posredovanih podatkov in znanstvene razprave v odboru soglasno sprejel mnenje, da je razmerje med koristmi in tveganji pri uporabi zdravila Alvesco in z njim povezanih imen pozitivno, ter da zadržki Francije ne bi smeli preprečiti odobritve dovoljenja za promet z zdravilom ter da je potrebno povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo referenčne države članice ustrezno spremeniti.
A positive opinion was adopted by consensus on 19 March 2008.
Pozitivno mnenje je bilo soglasno sprejeto dne 19. marca 2008.
In particular, the proposed wording for Section 4.2 at the end of CMDh procedure was amended to reflect that in severe asthmatics, a 12 week study provided by the applicant/ MAH has shown that a dose of 640µg/ d (given 320µg/ d twice daily) demonstrated a reduction in the frequency of exacerbations but without an improvement in lung function.
Usklajevalna skupina za postopek medsebojnega priznavanja in decentralizirani postopek za zdravila v humani medicini (CMDh) je ob zaključku postopka spremenila predlagano spremembo besedila v poglavju 4. 2 tako, da poglavje sedaj vsebuje opombo, da so rezultati 12- tedenske študije za hudo astmo pokazali, da dnevni odmerek 640 µg (dan v odmerku 320 µg dvakrat na dan) sicer kaže manjšo pojavnost poslabšanj stanja, vendar pa ne izboljšuje delovanja pljuč.
The applicant/ MAH also accepted an updated wording for Section 5.1, which includes more detail on Study M1-140, at the end of the CMDh procedure, and a fully updated Package Leaflet.
Predlagatelj/ imetnik dovoljenja za promet je ob zaključku postopka usklajevalne skupine CMDh potrdil tudi posodobljeno besedilo za poglavje 5. 1, ki vključuje podrobnejši opis študije M1- 140 ter popolnoma posodobljena navodila za uporabo.
Additionally, the applicant/ MAH was requested to commit to obtaining scientific advice in relation to exploring a suitable study design, and executing such study(ies) to provide further information on the use of the higher dose of Alvesco in the control of severe asthma.
Poleg tega so predlagatelja/ imetnika dovoljenja za promet z zdravilom pozvali, da si zagotovi ustrezno znanstveno svetovanje na področju načrtovanja in izvedbe študije (študij), ki bodo zagotovile nadaljnje informacije o uporabi večjih odmerkov zdravila Alvesco pri zdravljenju hude astme.
In light of this, the applicant/ MAH proposed a study which would resolve the outstanding question on the long term use of 320 µg and 640 µg daily.
Predlagatelj/ imetnik dovoljenja za promet je tako predlagal študijo, ki bi odgovorila na odprta vprašanja o dolgoročni uporabi dnevnega odmerka 320 µg in 640 µg.
The list of the product names concerned is given in Annex I.
Seznam zadevnih imen zdravila je naveden v Dodatku I.
The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics in Annex III.
Znanstveni zaključki so podani v Dodatku II, skupaj s povzetkom glavnih značilnosti zdravila v Dodatku III.
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS / 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
Route of adminitration
Pot uporabe zdravila
2 France
Francija
3 Latvia
Latvija
Portugal Slovakia
Slovaška
Merck Sharp & Dohme inovativna zdravila d. o. o.
Merck Sharp & Dohme, inovativna zdravila d. o. o.
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) 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).
Etoricoxib was included in previous CHMP referrals on the safety of COX-2 selective inhibitors in which concluded in 2004 and 2005.
Etorikoksib je bil vključen v predhodna napotitvena postopka Odbora za zdravila za uporabo v humani medicini (CHMP) o varnosti selektivnih zaviralcev COX- 2, ki sta bila zaključena leta 2004 oziroma 2005.
Both referral procedures pertained to the safety of the COX-2 inhibitor products, including etoricoxib, with a particular focus on gastrointestinal (GI) and cardiovascular (CV) safety.
Oba napotitvena postopka sta se nanašala na varnost zdravil z zaviralci COX- 2, vključno z etorikoksibom, s posebnim poudarkom na gastrointestinalni in kardiovaskularni varnosti.
These led to updates of the product information to include class warnings on the risk of CV thrombotic, GI and severe skin reactions with COX-2 selective inhibitors.
To je pripeljalo do posodobitve informacij o zdravilu, ki so sedaj vsebovale skupinska opozorila o tveganju za trombotične reakcije srca in ožilja ter hude reakcije prebavil in kože zaradi selektivnih zaviralcev COX- 2.
In addition to class warnings and contraindications, introduced for all COX-2 selective inhibitors, a contraindication in patients with hypertension whose blood pressure is not adequately controlled was included specifically for etoricoxib because of evidence of higher rates of cardiorenal events than other COX-2 inhibitor products.
Poleg skupinskih opozoril in kontraindikacij, uvedenih za vse selektivne zaviralce COX- 2, se je pri bolnikih s povečanim krvnim tlakom, ki ni ustrezno nadzorovan, za etorikoksib zaradi dokazov o višjih stopnjah kardiorenalnih dogodkov v primerjavi z drugimi zdravili s selektivnimi zaviralci COX - 2 dodala posebna kontraindikacija.
In March 2006, the marketing authorisation holders (MAH) for Arcoxia (etoricoxib) submitted an application to extend the licensed indication to include treatment of ankylosing spondylitis (AS), at a recommended daily dose of 90mg.
Imetniki dovoljenj za promet z zdravilom Arcoxia (etorikoksib) so marca 2006 predložili vlogo za razširitev odobrene indikacije, da bi se vključilo zdravljenje ankilozirajočega spondilitisa s priporočenim dnevnim 90- miligramskim odmerkom.
Following concerns of a possible increased cardiovascular (CV) risk related to the use of the 90mg dose of etoricoxib, France considered that a review of the benefit/ risk profile of Arcoxia was needed.
Zaradi možnosti povečanega tveganja za srce in ožilje z uporabo 90- miligramskega odmerka etorikoksiba je Francija ocenila, da je potrebna ponovna presoja varnostnega profila razmerja med koristmi in tveganjem pri uporabi zdravila Arcoxia.
Therefore, France sent a notification that was received by the EMEA on 19 September 2007 and a referral under Article 6 (12) of Commission Regulation EC No 1084/ 2003 was started on 20 September 2007.
1084/ 2003 pa se je začel 20. septembra 2007.
Healthcare professionals were to be reminded of these measures through a communication letter (DHCP).
Zdravstveni delavci bodo o teh ukrepih opozorjeni s posebnim dopisom „ Spoštovani zdravstveni delavec “ (DHCP).
Data from clinical studies showed clinically meaningful treatment effect for the 90mg etoricoxib once daily dose for AS indications; however, some data are available to indicate that lower doses might also show effect.
Podatki iz kliničnih študij so kazali 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.