natgillin/translations-raw huggingface dataset:
This is because you might also be allergic to this medicine.
46 Če ste negotovi v zvezi z uporabo zdravila, se posvetujte z zdravnikom ali s farmacevtom.
47 Cefuroxime axetil tablets will not affect your ability to drive or operate machinery.
47 Vpliv na sposobnost upravljanja vozil in strojev
Children between the ages of 5 and 12
Otroci od 5 do 12 let
For acute otitis media:
48 Akutno vnetje srednjega ušesa:
48 1 tablet of Cefuroximaxetil 250 twice a day for 5-10 days.
1 tableta zdravila Aksetilcefuroksimat 250 dvakrat na dan 5- 10 dni.
Skin rash with or without severe itching and wheal formation (urticaria) Renal and urinary problems:
Kožni izpuščaj s hudo srbečico ali brez nje ter koprivnica.
Nervous system disorders: headaches, dizziness Kidneys and urinary tract: blood in the urine, fever and pain in the side (acute interstitial nephritis)
49 Bolezni živčevja: glavoboli, omotica Ledvice in sečila: kri v urinu, povišana telesna temperature in bolečine v boku (akutni intersticijski nefritis)
49 Rare side effects (affecting less than 1 in 1000 people) include:
Redki neželeni učinki (prizadenejo manj kot 1 od 1000 ljudi) vključujejo:
Keep Cefuroximaxetil in the original packaging..
Shranjujte v originalni ovojnini..
Cefuroximaxetil 125 contains 150.36 mg of
Aksetilcefuroksimat 250 vsebuje 300, 72 mg
Cefuroximaxetil 250 contains 300.72 mg of Cefuroximaxetil per tablet equivalent to 250 mg of cefuroxime.
aksetilcefuroksimata na tableto, kar ustreza 250 mg cefuroksima.
- The other ingredients (excipients) are in the tablet core: sodium laurylsulphate, copovidone,
- Pomožne snovi so v jedru tablete: natrijev lavrilsulfat, kopovidon, premreženi natrijev
croscarmellose sodium (E468), magnesium stearate (E470B), anhydrous colloidal silicon dioxide (E551), mannitol (E421), microcrystalline cellulose (E 460), crospovidone (E1202)and talc (E553B); in the tablet coating: mannitol (E421), soluble (potato) starch, talc (E553B), titanium dioxide (E171) and aspartame (E951).
karmelozat (E468), magnezijev stearat (E 470B), brezvodni koloidni silicijev dioksid (E551), granulirani manitol (E421), mikrokristalna celuloza (E460), krospovidon (E1202), smukec (E553B); v oblogi tablete: manitol (E421), topni škrob (krompirjev), smukec (E553B), titanov dioksid (E171), aspartam (E951).
50 Cefuroximaxetil tablets are coated.
50 Izgled zdravila Aksetilcefuroksimat in vsebina pakiranja
Cefuroximaxetil 250 are white to slightly yellowish capsule-shaped tablets with a break-line on both sides.
Aksetilcefuroksimat 250 so bele do rahlo rumenkaste tablete, ki imajo obliko podobno kapsuli, z zarezo na obeh straneh.
Cefuroximaxetil 250 mg coated tablets are available in carton boxes with blister(s) tear-off or strips containing 8, 10, 12, 14 and 24 tablets.
Aksetilcefuroksimat 250 mg obložene tablete so na voljo v kartonski škatli s pretisnim( i) omotom( i) ali z dvojnimi trakovi, ki vsebujejo 8, 10, 12, 14 in 24 tablet.
Xorimax 250 mg potahované tablety
Češka Xorimax 250 mg potahované tablety
51 United Kingdom
51 Velika Britanija
52 PACKAGE LEAFLET:
52 NAVODILO ZA UPORABO
This is because you might also be allergic to this medicine.
53 Če ste negotovi v zvezi z uporabo zdravila, se posvetujte z zdravnikom ali s farmacevtom.
54 Cefuroxime axetil tablets will not affect your ability to drive or operate machinery.
54 Vpliv na sposobnost upravljanja vozil in strojev
For acute otitis media:
55 Akutno vnetje srednjega ušesa:
55 1 tablet of Cefuroximaxetil 250 twice a day for 5-10 days.
1 tableta zdravila Aksetilcefuroksimat 250 dvakrat na dan 5- 10 dni.
Uncommon side effects (affecting less than 1 in 100 people) include:
56 Občasni neželeni učinki (prizadenejo manj kot 1 od 100 ljudi) vključujejo:
56 Rare side effects (affecting less than 1 in 1000 people) include:
Redki neželeni učinki (prizadenejo manj kot 1 od 1000 ljudi) vključujejo:
Cefuroximaxetil 125 contains 150.36 mg of
Aksetilcefuroksimat 500 vsebuje 601, 44 mg
Cefuroximaxetil 500 contains 601.44 mg of Cefuroximaxetil per tablet (equivalent to 500 mg of cefuroxime).
aksetilcefuroksimata na tableto, kar ustreza 500 mg cefuroksima.
57 Cefuroximaxetil tablets are coated.
57 Izgled zdravila Aksetilcefuroksimat in vsebina pakiranja
Cefuroximaxetil 500 are white to slightly yellowish capsule-shaped tablets.
Aksetilcefuroksimat 500 so bele do rahlo rumenkaste tablete, ki imajo obliko podobno kapsuli.
Cefuroximaxetil 500 mg coated tablets are available in carton boxes with blister(s) tear-off or strips containing 8, 10, 12, 14, 20 and 24 tablets.
Aksetilcefuroksimat 500 mg obložene tablete so na voljo v kartonski škatli s pretisnim( i) omotom( i) ali z dvojnimi trakovi, ki vsebujejo 8, 10, 12, 14, 20 in 24 tablet.
Xorimax 500 mg potahované tablety
Češka Xorimax 500 mg potahované tablety
Estonia
Estonija Grčija Madžarska
Xorimax 500 mg bevont tabletta
Xorimax 500 mg dengtos tabletės
Portugal
Portugalska Slovaška
Slovak Republic
Španija
58 To be completed nationally
58
28 November 2005 EMEA/ CHMP/ 323166/ 2005 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 31 REFERRAL
28. november 2005 EMEA/ CHMP/ 383030/ 2005 MNENJE ODBORA ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI (CHMP) V ZVEZI Z NAPOTITVIJO IZ ČLENA 31
CELECOXIB
CELEKOKSIB
The COX-2 inhibitors celecoxib, etoricoxib, lumiracoxib, parecoxib, rofecoxib and valdecoxib comprise a relatively new group of substances whose common pharmacological action is the selective inhibition of cyclooxygenase-2.
Zaviralci COX- 2, celekoksib, etorikoksib, lumirakoksib, parekoksib, rofekoksib in valdekoksib sestavljajo relativno novo skupino snovi, katerih skupno farmakološko delovanje je selektivno zaviranje ciklooksigenaze- 2.
COX-2 inhibitors have been introduced in medical practice for treatment of patients with chronic inflammatory degenerative diseases such as rheumatoid arthritis and osteoarthritis.
Zaviralci COX- 2 so bili v zdravniško prakso uvedeni za zdravljenje bolnikov s kroničnimi vnetnimi boleznimi kot so revmatoidni artritis in osteoartritis.
These data resulted in the worldwide withdrawal of rofecoxib (Vioxx) from the market on 30 September 2004 by the Marketing Authorisation Holder and raised questions regarding the cardiovascular safety of other Cox-2 inhibitors.
Zaradi teh podatkov je imetnik dovoljenja za promet dne 30. septembra 2004 z vseh svetovnih tržišč umaknil rofekoksib (Vioxx), pojavila pa so se tudi vprašanja o kardiovaskularni varnosti drugih zaviralcev Cox- 2.
Further to discussions at the CHMP October 2004 plenary meeting, the European Commission recommended that this public health issue on all aspects of cardiovascular safety including thrombotic events and cardio-renal events should be the subject of Community referrals under Article 31 of Directive 2001/ 83/ EC, as amended regarding decentrally authorised products containing celecoxib, etoricoxib and lumiracoxib and subject to a review procedure under Article 18 of Council Regulation (EEC) No 2309/ 93, as amended regarding the centrally authorised products containing celecoxib (Onsenal), parecoxib (Dynastat/ Rayzon) and valdecoxib (Bextra/ Valdyn).
2309/ 93, kot je bila spremenjena, v zvezi z zdravili, odobrenimi po centraliziranem postopku, ki vsebujejo celekoksib (Onsenal), parekoksib (Dynastat/ Rayzon) in valdekoksib (Bextra/ Valdyn).
Therefore, on 20 April 2005 further to a request from the EC, the CHMP broadened the scope of the procedure under Article 31 of Directive 2001/ 83/ EC, as amended and the review procedure under Article 18 of Council Regulation (EEC) No 2309/ 93, to include the assessment of serious skin reactions in the ongoing class review in addition to the cardiovascular safety aspects.
2309/ 93, razširil tako, da se v revizijo razreda zdravil v teku poleg vidikov kardiovaskularne varnosti vključi tudi vrednotenje hudih kožnih reakcij.
The Marketing Authorisation Holder of celecoxib provided written explanations by 10 January, 26 January and 10 May 2005.
Imetnik dovoljenja za promet s celekoksibom je pisna pojasnila predložil do 10. januarja in 26. januarja in 10. maja 2005.
Oral explanations were given by the Marketing Authorisation Holder on 18 January 2005, 15 February 2005 and 25 May 2005.
Ustno obrazložitev je imetnik dovoljenja za promet podal 18. januarja 2005, 15. februarja in 25. maja 2005.
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea. eu. int http: / /www. emea. eu. int  EMEA 2005 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Upon consideration of all available data, the CHMP adopted an opinion for celecoxib on 23 June 2005 recommending the maintenance of the Marketing Authorisations for celecoxib containing medicinal products in the indications stated in the Summary of Product Characteristics as set out in Annex III.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 86 68 E- mail: mail@ emea. eu. int http: // www. emea. eu. int EMEA 2005 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Po upoštevanju vseh razpoložljivih podatkov je CHMP dne 23. junija 2005 sprejel mnenje za celekoksib, v katerem priporoča ohranitev dovoljenj za promet za zdravila, ki vsebujejo celekoksib, za indikacije, navedene v Povzetku glavnih značilnosti zdravila, kot je opredeljeno v Dodatku III.
The list of 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 amended Summary of Product Characteristics in Annex III.
Znanstveni zaključki so podani v Dodatku II, skupaj s spremenjenim Povzetkom glavnih značilnosti zdravila v Dodatku III.
On the basis of the CHMP Opinion, the European Commission issued a Decision on 28 November 2005.
Na podlagi mnenja CHMP je Evropska komisija izdala odločbo dne 28. novembra 2005.
The information given in this document and Annexes reflect only the CHMP Opinion dated 23 June 2005.
Informacije, podane v tem dokumentu in Dodatkih odražajo samo mnenje CHMP z dne 23. junija 2005.
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
SEZNAM IMEN, FARMACEVTSKIH OBLIK TER JAKOSTI ZDRAVILA, POT UPORABE IN IMETNIKOV DOVOLJENJA ZA PROMET V DRŽAVAH CLANICAH TER NORVEŠKA IN ISLANDIJA
1 Member State
1 Država clanica
Invented name
Zašciteno ime
Seidengasse 33-35 1071 Wien Austria
Seidengasse 33- 35 1071 Wien Austrija
Capsules
Kapsula
Oral
Peroralna uporaba
Pharmacia NV/ SA Rijksweg 12 B-2870 Puurs Belgium
Pharmacia NV/ SA Rijksweg 12 B- 2870 Puurs Belgija
2 Member State
2 Država clanica
5a-B Pargas Str P. O. Box 22002 1515 Lefkosia Cyprus
5a- B Pargas Str P. O. Box 22002 1515 Lefkosia Ciper
Czech Republic
Ceška
Davy Avenue Know Hill Milton Keynes MK5 8PH United Kingdom
Davy Avenue Know Hill Milton Keynes MK5 8PH Velika Britanija
3 Member State
3 Država clanica
Corporation Eesti Pirita tee 20 10127 Tallinn Estonia
Corporation Eesti Pirita tee 20 10127 Tallinn Estonija
Pfizer Oy Tietokuja 4 00330 Helsinki Finland
Pfizer Oy Tietokuja 4 00330 Helsinki Finska
Pfizer Oy Tietokuja 4
Pfizer Oy Tietokuja 4 00330 Helsinki Finska
4 Member State
4 Država clanica
Pfizer Holding France 23-25, avenue du Docteur Lannelongue 75668 Paris Cedex 14 France
Pfizer Holding France 23- 25, avenue du Docteur Lannelongue 75668 Paris Cedex 14 Francija
Cardel 23-25, avenue du Docteur Lannelongue 75668 Paris Cedex 14 France
Cardel 23- 25, avenue du Docteur Lannelongue 75668 Paris Cedex 14 Francija
1 76139 Karlsruhe Germany
1 76139 Karlsruhe Nemcija
5 Member State
5 Država clanica
5, Alketou Street 116 33 Athens Greece
5, Alketou Street 116 33 Athens Grcija
MOM Park ” F” Épület H-1123 Budapest
MOM Park ” F ” Épület H- 1123 Budapest Madžarska
Strength
Islandija
Iceland
Danska
Pharmacia Ireland Limited Airways Industrial Estate Dublin 17 Ireland
Pharmacia Ireland Limited Airways Industrial Estate Dublin 17 Irska
Italy
Via Robert Koch, 1- 2 20152 Milano Italija
Strength
Italija
Strada Statale 156 KM 50 04010 Borgo San Michele Latina Italy
Strada Statale 156 KM 50 04010 Borgo San Michele Latina Italija
Strength
Latvija
Latvia
Jakost
Pharmacia NV/ SA Rijksweg 12 2870 Puurs Belgium
Pharmacia NV/ SA Rijksweg 12 2870 Puurs Belgija
Pfizer AS Postboks 3 1324 Lysaker Norway
Pfizer AS Postboks 3 1324 Lysaker Norveška
Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom
Ramsgate Road Sandwich Kent CT13 9NJ Velika Britanija
Strength
Poljska
Lagoas Park, Edifício n. º 10 2740-244 Porto Salvo Portugal
Lagoas Park, Edifício n. º 10 2740- 244 Porto Salvo Portugalska
Manuel Ribeiro de Pavia, n. º1 - Venda Nova 2700-547 Amadora Portugal
Manuel Ribeiro de Pavia, n. º1 - Venda Nova 2700- 547 Amadora Portugalska
Pfizer Europe MA EEIG Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom
Pfizer Europe MA EEIG Ramsgate Road Sandwich Kent CT13 9NJ Velika Britanija
Capsules
Kapsula, trda
Avenida de Europa, 20-B Parque Empresarial La Moraleja 28108 Alcobendas, Madrid Spain
Avenida de Europa, 20- B Parque Empresarial La Moraleja 28108 Alcobendas, Madrid Španija
Box 501 183 25 Täby Sweden
Box 501 183 25 Täby Švedska
Pfizer bv Rivium Westlaan 142 2909 LD Capelle a/ d IJssel The Netherlands
Pfizer bv Rivium Westlaan 142 2909 LD Capelle a/ d IJssel Nizozemska
14 Member State
Velika Britanija
UK
Jakost
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS PRESENTED BY THE EMEA
ZNANSTVENI ZAKLJUCKI IN PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNACILNOSTI ZDRAVILA, PREDSTAVLJENI S STRANI EVROPSKE AGENCIJE ZA ZDRAVILA
16 SCIENTIFIC CONCLUSIONS FOR THE AMENDMENT OF THE MARKETING AUTHORISATION
16 ZNANSTVENI ZAKLJUCKI ZA DOPOLNILO DOVOLJENJA ZA PROMET
In September 2004, the Marketing Authorisation Holder (MAH) of rofecoxib (a selective Cox-2- inhibitor) informed the EMEA that new clinical trial (APPROVe) data for rofecoxib have revealed a risk of thrombotic cardiovascular (CV) events.
Septembra 2004 je imetnik dovoljenja za promet z rofekoksibom (selektivnim zaviralcem Cox- 2) obvestil Evropsko agencijo za zdravila, da so podatki iz novega klinicnega preizkušanja (APPROVe) rofekoksiba pokazali tveganje za tromboticne kardiovaskularne dogodke.
These data resulted in the worldwide withdrawal of Vioxx (rofecoxib) from the market on 30 September 2004 by the MAH and raised questions regarding the cardiovascular safety of other Cox-2 inhibitors.
Zaradi teh podatkov je imetnik dovoljenja za promet dne 30. septembra 2004 z vseh svetovnih tržišc umaknil zdravilo Vioxx (rofekoksib), pojavila pa so se tudi vprašanja glede kardiovaskularne varnosti drugih zaviralcev Cox- 2.
Further to discussions at the CHMP October 2004 plenary meeting, the European Commission recommended that this public health issue on all aspects of cardiovascular safety including thrombotic events and cardio-renal events is the subject of Community referrals under Article 31 of Directive 2001/ 83/ EC, as amended regarding decentrally authorised products containing celecoxib, etoricoxib and lumiracoxib and subject to a review procedure under Article 18 of Council Regulation (EEC) No 2309/ 93, as amended regarding the centrally authorised products containing celecoxib (Onsenal), parecoxib (Dynastat/ Rayzon) and valdecoxib (Bextra/ Valdyn), which were started in November 2004.
Postopka sta se zacela novembra 2004.
In April 2005, the FDA (Food and Drug Administration) and the EMEA requested that Pfizer voluntarily withdraw Bextra (valdecoxib) from the market and Pfizer agreed to suspend sale and marketing of Bextra worldwide pending further discussions on the unfavorable risk versus benefit due to data on serious skin reactions.
Podjetje je soglašalo tudi, da po vsem svetu ustavi prodajo in trženje zdravila Bextra do nadaljnje razprave o neugodnem razmerju med tveganjem in koristjo v zvezi s podatki o hudih kožnih reakcijah.
§ Further to the assessment of:
§ po vrednotenju:
- the new data provided on rofecoxib by the APPROVe clinical study, which revealed a risk
- novih podatkov, ki jih je za rofekoksib prispevala klinicna raziskava APPROVe in ki kažejo
of thrombotic CV events,
tveganje za tromboticne kardiovaskularne dogodke,
- the data on celecoxib presented in the APC study, which suggested a dose-related
- podatkov za celekoksib iz raziskave APC, ki so nakazali povecanje tveganja hudih
- the data on valdecoxib and parecoxib presented in the CABG (Coronary Artery Bypass
- podatkov za valdekoksib in parekoksib iz raziskav CABG (Coronary Artery Bypass Graft) in
Graft) and in the CABG II studies, which showed a higher rate of serious CV thromboembolic events in the parecoxib/ valdecoxib treatment arm compared to the group of patients receiving placebo,
CABG II, ki kažejo višjo stopnjo hudih kardiovaskularnih tromboembolijskih dogodkov v skupinah bolnikov, ki so se zdravili s parekoksibom/ valdekoksibom, v primerjavi s skupino bolnikov, ki je prejemala placebo,
- the data on etoricoxib in the EDGE study and pooled analyses of other clinical trials,
- podatkov za etorikoksib iz raziskave EDGE ter analiz združenih podatkov iz drugih klinicnih
which suggested an association with a higher thrombotic risk than naproxen,
preizkušanj, ki nakazujejo povezavo z vecjim tveganjem za tromboticne dogodke v primerjavi z naproksenom,
- the data on lumiracoxib in the Target study, which suggested a small increase in
- podatkov za lumirakoksib iz raziskave Target, ki nakazujejo majhno povecanje tromboticnih
thrombotic events (especially myocardial infarction) versus naproxen, all available data show an increased risk of CV adverse reactions for Cox-2 inhibitors as a class and agreed that there is an association between duration and dose of intake and the probability of suffering a CV reaction.
dogodkov (zlasti miokardnega infarkta) v primerjavi z naproksenom,
§ Further to the assessment of the data on serious skin reactions, celecoxib is associated with very rare occurrence of serious skin reactions, as evidenced in clinical studies and post-
17 vsi dostopni podatki kažejo povecano tveganje neželenih kardiovaskularnih reakcij pri skupini zaviralcev Cox- 2 in soglašal, da obstaja povezava med trajanjem jemanja in odmerki ter verjetnostjo pojava kardiovaskularne reakcije.
17 marketing surveillance, which analysis revealed several risk factors for the occurrence of these serious skin reactions with celecoxib.
§ Po vrednotenju podatkov o hudih kožnih reakcijah je celekoksib povezan z zelo redkimi pojavi hudih kožnih reakcij, kot je razvidno iz klinicnih študij in postmarketinškega nadzora, katerih analiza je pokazala vec dejavnikov tveganja za pojav hudih kožnih reakcij s celekoksibom.
- Addition of a statement that decision to prescribe a selective COX-2 inhibitor should be based
- dodana je izjava, da mora odlocitev o uvedbi selektivnega zaviralca COX- 2 temeljiti na
on an assessment of the individual patient's overall risks.
vrednotenju celotnega tveganja za posameznega bolnika.
- In the posology section it is recommended to use of the lowest effective dose, for the shortest
- v poglavju o odmerjanju je priporoceno, naj se uporablja najnižji ucinkovit odmerek za najkrajši
possible duration, and that the need for pain relief should be re-evaluated frequently.
cas delovanja ter da je potrebo po lajšanju bolecin potrebno pogosto ponovno oceniti.
- Addition of the contraindications Established ischaemic heart disease and/ or cerebrovascular
- dodani sta kontraindikaciji Potrjena ishemicna srcna bolezen in/ ali cerebrovaskularno obolenje
disease and Peripheral arterial disease.
ter Periferna arterijska bolezen.
- Addition of brief information of the CV findings in PreSAP (Efficacy and safety of celecoxib
- dodana je kratka informacija o kardiovaskularnih izsledkih v PreSAP (Ucinkovitost in varnost
(SC-58635) in the prevention of colorectal sporadic adenomatous polyps) and APC (Prevention of sporadic colorectal adenomas with celecoxib); to include more stringent wording regarding CV risk groups.
celekoksiba (SC- 58635) pri preprecevanju posameznih kolorektalnih adenomnih polipov) in APC (Preprecevanje posameznih kolorektalnih adenomov s celekoksibom); vkljuciti strožje besedilo v zvezi s skupinami za kardiovaskularna tveganja.
- Addition of a warning for patients with risk factors for heart disease, such as hypertension,
- dodano je opozorilo za bolnike z dejavniki tveganja za srcne bolezni, kot so hipertenzija,
hyperlipidaemia (high cholesterol levels), diabetes and smoking.
hiperlipidemija (visoke ravni holesterola), sladkorna bolezen in kajenje.
- Addition of a warning for prescribers to consider discontinuation of therapy if during
- dodano je opozorilo za predpisovalce zdravila, naj preucijo možnost prekinitve zdravljenja, ce se
treatment, patients deteriorate in any of the organ system functions described.
med zdravljenjem bolniku poslabša katerakoli opisana funkcija organskih sistemov.
- Addition of a warning for prescribers to exercise caution when prescribing NSAIDs, including
- dodano je opozorilo za predpisovalce zdravila, naj bodo previdni pri predpisovanju neselektivnih
celecoxib, in combination with ACE inhibitors or angiotensin II receptor antagonists.
nesteroidnih protivnetnih zdravil (non- steroidal anti- inflammatory drugs, NSAIDs), vkljucno s celekoksibom, v kombinaciji z zaviralci ACE ali antagonisti receptorjev angiotenzina II.
- Addition of a warning to report that the onset of skin reactions occur in the majority of cases
- dodano je opozorilo k porocilu, da se kožne reakcije v vecini primerov pojavijo v prvem mesecu
within the first month of treatment.
zdravljenja.
- Strengthening of a warning to highlight that fatal serious skin reactions have now occurred
- okrepljeno je opozorilo, ki poudarja, da so se pri uporabi celekoksiba pojavile hude kožne reakcije
with celecoxib.
s smrtnim izidom.
- Addition of a more detailed description of the first signs of skin reactions leading to
- dodan je podrobnejši opis zacetnih znakov kožnih reakcij, zaradi katerih se zdravljenje prekine.
- is of the Opinion that the benefit/ risk balance of medicinal products containing celecoxib in
- mnenja, da razmerje med koristjo in tveganjem za zdravila, ki vsebujejo celekoksib za
the agreed indications remains favourable and the Marketing Authorisations should be maintained according to revised Summaries of Product Characteristics (attached in Annex III of the CHMP Opinion),
dogovorjene indikacije, ostaja ugodno in da se dovoljenja za promet ohranijo v skladu s popravljenimi Povzetki glavnih znacilnosti zdravil (priloženih mnenju CHMP v Dodatku III),
- concluded that the cardiovascular safety and serious skin reactions should be continuously
- zakljucil, da je treba kardiovaskularno varnost in hude kožne reakcije neprekinjeno in natancno
and carefully monitored and assessed,
spremljati in vrednotiti,
- recommended to initiate a long term study to investigate the safety of celecoxib relative to non
- priporocil lansiranje dolgorocne študije, ki bi raziskovala varnost celekoksiba v primerjavi z
selective NSAIDs.
neselektivnimi nesteroidnimi protivnetnimi zdravili,
- recommended follow up measures to further investigate the safety of celecoxib.
- priporocil nadaljnje ukrepe za dodatno raziskovanje varnosti celekoksiba.
SUMMARY OF THE PRODUCT CHARACTERISTICS
POVZETEK TEMELJNIH ZNACILNOSTI ZDRAVILA
This SPC is the one that was Annexed to the Commission Decision on this Article 31 referral for celecoxib containing medicinal products.
Ta Povzetek glavnih znacilnosti zdravila je bil priložen k odlocbi Komisije v zvezi s tem postopkom, ki je bil sprožen v skladu s clenom 31, za zdravila, ki vsebujejo celekoksib.
19 1 NAME OF THE MEDICINAL PRODUCT
IME ZDRAVILA
{INVENTED NAME, see Annex I} 200 mg capsule, hard.
IZMIŠLJENO IME® 100 mg trde kapsule IZMIŠLJENO IME® 200 mg trde kapsule
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
KAKOVOSTNA IN KOLICINSKA SESTAVA
Each capsule contains 100 mg or 200 mg celecoxib.
Vsaka trda kapsula vsebuje 100 mg oziroma 200 mg celekoksiba.
Opaque, white with two blue bands marked 7767 and 100 (INVENTED NAME 100 mg).
Trda kapsula Motno bele kapsule z modro crto in oznakama 7767 in 100.
4 CLINICAL PARTICULARS
KLINICNI PODATKI