natgillin/translations-raw huggingface dataset:
Nucala can only be obtained with a prescription and should be prescribed by a doctor experienced in identifying and treating severe eosinophilic asthma. 
Predpisovanje in izdaja zdravila Nucala je le na recept, predpiše pa ga lahko le zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem težke eozinofilne astme.
How is Nucala used? 
Kako se zdravilo Nucala uporablja?
The third study involved 135 mostly adult patients with eosinophilic asthma severe enough to need regular treatment by mouth with corticosteroids (potent anti-inflammatory medicines such as prednisone and prednisolone), and the main measure of effectiveness was how much the corticosteroid dose could be reduced using Nucala for 24 weeks compared with placebo. 
V tretjo študijo je bilo vključenih 135 bolnikov z dovolj težko eozinofilno astmo, da je bilo potrebno redno peroralno zdravljenje s kortikosteroidi (močnimi protivnetnimi zdravili, kot sta prednizon in prednizolon).
Reactions at the site of injection and back pain are common, affecting up to 1 patient in 10. 
Pogosti neželeni učinki, ki se lahko pojavijo pri največ 1 od 10 bolnikov, so reakcije na mestu injiciranja in bolečine v hrbtu.
Nucala contains the active substance mepolizumab. 
Vsebuje učinkovino mepolizumab.
This summary was last updated in September 2007. 
Ta povzetek je bil nazadnje posodobljen 09-2007.
In very rare cases depression may develop. 
V zelo redkih primerih se lahko razvije depresija.
Horses from four months of age should receive a second injection after four weeks. 
Konji, starejši od štirih tednov, morajo prejeti drugo injekcijo po štirih tednih.
All horses should be revaccinated every three months to maintain immunity. 
Za vzdrževanje imunosti je treba vse konje ponovno cepiti vsake tri mesece.
The effectiveness of Equilis StrepE has been studied in safety studies and one main field study. 
Učinkovitost zdravila Equilis StrepE so preučevali v študijah varnosti zdravila in v eni večji terenski študiji.
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) EQUILIS StrepE EPAR summary for the public 
EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) EQUILIS StrepE Povzetek EPAR za javnost
Other information about Equilis StrepE: 
Druge informacije o zdravilu Equilis StrepE:
The vaccine is given as a 0.2-ml injection into the inside of the upper lip. 
Cepivo se daje z 0,2 ml injekcijo v notranjo stran zgornje ustnice.
The horses had not had any disease including strangles in the past and had never been vaccinated. 
Konji niso v preteklosti imeli nobene bolezni, niti smolike, in niso bili nikoli cepljeni.
An increase in body temperature of up to 2°C may occur on the day of vaccination. 
Na dan cepljenja se lahko telesna temperatura poveča za največ 2 °C.
No adjuvant or preservative is included. 
Ne vsebuje adjuvansov ali sredstev za konzerviranje.
The highly contagious and common disease caused by this bacterium is commonly called ‘strangles'. 
Visoko nalezljiva in pogosta bolezen, ki jo povzroča ta bakterija, je običajno znana pod imenom „smolika“.
Equilis StrepE is a vaccine. 
Zdravilo Equilis StrepE je cepivo.
This is the first vaccine to be licensed for horses in the EU against strangles. 
To je prvo cepivo za konje, ki je v Evropski uniji odobreno proti smoliki.
In case of accidental self-injection, which can cause inflammation with severe pain and swelling, seek medical advice immediately and show the Package Leaflet or the label to the doctor, even if only a small amount has been injected. 
V primeru nenamernega samoinjiciranja, ki lahko povzroči vnetje s hudo bolečino in oteklino, nemudoma poiščite medicinsko pomoč in pokažite zdravniku Navodilo za uporabo ali nalepko, tudi če je bila injicirana zelo majhna količina.
In rare cases, loss of appetite, fever and shivering may be observed. 
V redkih primerih se lahko pojavijo izguba apetita, vročina in tresavica.
After injection, swelling will develop at the injection site within four hours and the injection site may become warm or painful. 
V štirih urah po injekciji se bo na mestu injiciranja pojavila oteklina, mesto injiciranja pa lahko postane toplo ali boleče.
This is a highly contagious disease and a common bacterial infection in horses. 
Gre za visoko nalezljivo in pogosto bakterijsko okužbo pri konjih.
When a horse is given the vaccine, the immune system recognises the bacteria as ‘foreign' and makes antibodies against them. 
Ko konj prejme cepivo, imunski sistem prepozna bakterije kot „tujke“ in proti njim razvije protitelesa.
The bacterium strain included in Equilis StrepE has had some genes removed, so that it grows less well inside the horse's body and is less likely to cause disease. 
Sevu bakterije, ki ga vsebuje zdravilo Equilis StrepE, so bili odstranjeni nekateri geni, zato v telesu konja slabše raste in obstaja manjša verjetnost, da bi povzročil bolezen.
The vaccine is provided together with the solvent, applicator and a syringe with needle. 
Cepivu so priloženi vehikel, aplikator in brizga z iglo.
The European Commission granted a marketing authorisation valid throughout the European Union for Equilis StrepE to Intervet International B.V. on 7 May 2004. 
Evropska komisija je dovoljenje za promet z zdravilom Equilis StrepE, veljavno po vsej Evropski uniji, odobrila družbi Intervet International B.V.
Equilis StrepE is available as a lyophilisate (freeze-dried pellet) which is made up into a suspension for injection. 
Zdravilo Equilis StrepE je na voljo kot liofilizat (peleta, posušena v zmrznjenem stanju) za pripravo suspenzije za injiciranje.
Equilis StrepE is only for use in healthy horses that are at risk of S. equi infection due to contact with horses from areas where the bacterium is known to be present. 
Zdravilo Equilis StrepE je namenjeno samo za uporabo pri zdravih konjih, pri katerih obstaja tveganje za okužbo s S. equi zaradi stika s konji z območij, na katerih je bakterija prisotna.
as the local and systemic reactions observed after single, repeated dose and overdose treatment were considered acceptable. 
mesecev, saj so bile reakcije na mestu injiciranja in reakcije telesa, ugotovljene po enkratnem in večkratnem cepljenju ter cepljenju s prevelikim odmerkom, ocenjene kot sprejemljive.
In strangles, the lymph nodes in the head can become large enough to block the airway, causing the horse to have difficulty breathing. 
Pri smoliki se lahko bezgavke v glavi tako povečajo, da blokirajo dihalno pot, konj pa ima zaradi tega težave z dihanjem.
The studies demonstrated that Equilis StrepE is effective in the active immunisation of horses from 4 months of age against Streptococcus equi to reduce clinical signs and occurrence of lymph node abscesses. 
Študije so pokazale, da je zdravilo Equilis StrepE učinkovito pri aktivni imunizaciji konj, starejših od 4 mesecev, proti Streptococcus equi za zmanjšanje kliničnih znakov in nastanka abscesov na bezgavkah.
The results of the safety trials demonstrate that Equilis StrepE is safe for horses from four months of age onwards, 
Rezultati študij varnosti zdravila so pokazali, da je Equilis StrepE varen za uporabo pri konjih, starejših od štirih
Equilis StrepE contains small amounts of a type of bacterium called S. equi. 
Zdravilo Equilis StrepE vsebuje majhne količine bakterije vrste S. equi.
Only healthy horses which are at risk of infection should be vaccinated. 
Cepivo je namenjeno samo zdravim konjem, pri katerih obstaja tveganje za pojav okužbe.
In the future, the immune system will be able to produce antibodies more quickly when it is again exposed to the bacteria. 
Ko bo imunski sistem naslednjič izpostavljen bakterijam, bo lahko hitreje izdelal protitelesa.
Equilis StrepE is a vaccine which contains the active substance live deletion mutant Streptococcus equi bacteria. 
Zdravilo Equilis StrepE je cepivo, ki vsebuje zdravilno učinkovino živi delecijski mutant bakterije Streptococcus equi.
What benefit has Equilis StrepE shown during the studies? 
Kakšne koristi je zdravilo Equilis StrepE izkazalo med raziskavami?
Equilis StrepE is used to vaccinate horses against the respiratory disease caused by the bacteria Streptococcus equi. 
Zdravilo Equilis StrepE se uporablja za cepljenje konjev proti dihalnih obolenjem, ki jih povzroča bakterija Streptococcus equi.
In very rare cases an abscess and discharge may develop at the injection site, and the lymph nodes in the head may enlarge, which may be painful for a short while. 
V zelo redkih primerih se lahko na mestu injiciranja pojavi absces in izcedek, lahko pa se tudi povečajo bezgavke v glavi, kar utegne povzročiti kratkotrajno bolečino.
What is the risk associated with Equilis StrepE? 
Kakšna tveganja so povezana z zdravilom Equilis StrepE?
Equilis StrepE reduces the clinical signs of disease and the occurrence of lymph node abscesses (collections of pus). 
Zdravilo Equilis StrepE zmanjšuje klinične znake bolezni in nastanek abscesov (ognojkov) na bezgavkah.
The reaction is greatest at two to three days after injection, but the area affected should not be larger than 3 by 8 cm. 
Reakcija je najhujša dva do tri dni po injiciranju, vendar pa prizadeto območje običajno ni večje od 3 krat 8 cm. Oteklina običajno izgine v treh tednih in ne vpliva na apetit cepljenega konja, niti mu ne povzroča nelagodja.
Why has Equilis StrepE been approved? 
Zakaj je bilo zdravilo Equilis StrepE odobreno?
Fewer of the horses receiving Equilis StrepE had symptoms of strangles. 
Po prejemu zdravila Equilis StrepE je imelo manj konjev simptome smolike.
How has Equilis StrepE been studied? 
Kako je bilo zdravilo Equilis StrepE raziskano?
They also had fewer abscesses and fewer lymph nodes affected. 
Prav tako se je zmanjšal delež abscesov in obolelih bezgavk.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Equilis StrepE exceed the risks for immunisation of horses against S. equi to reduce clinical signs and occurrence of lymph node abscesses, and recommended that Equilis StrepE be given a marketing authorisation. 
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je sklenil, da so koristi zdravila Equilis StrepE pri imunizaciji konj proti S. equi za zmanjšanje kliničnih znakov in nastanka abscesov na bezgavkah večje od z njim povezanih tveganj.
How does Equilis StrepE work? 
Kako zdravilo Equilis StrepE deluje?
What is Equilis StrepE used for? 
Za kaj se zdravilo Equilis StrepE uporablja?
What is Equilis StrepE? 
Kaj je zdravilo Equilis StrepE?
* Antibody micro agglutination-lytic reaction 
*reakcija mikroaglutinacije-lize protiteles.
EU (MA) number 
EU (MA) številka Izmišljeno ime Jakost Farmacevtska oblika
Leptospira interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae strain MSLB 1089 
--1 Leptospira interrogans serološka skupina Icterohaemorrhagiae serovar Icterohaemorrhagiae, sev MSLB 1089
Packag e size 
Pakiranje Vsebina Velikost pakiranja
Strengt h 
Način uporabe
The company presented results of studies on the quality, safety and effectiveness of the medicine. 
Družba je predložila rezultate študij o kakovosti, varnosti in učinkovitosti zdravila.
The study measured the number of patients who responded to treatment. 
Merilo učinkovitosti študije je bilo število bolnikov, ki so se odzvali na zdravljenje.
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom structure (called an antigen) that is found on certain cells in the body. 
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom antigen), ki je prisotna na določenih celicah v telesu, in se veže nanjo.
This means that it was intended to be highly similar to a biological medicine (the ‘reference medicine') already authorised in the European Union called Herceptin. 
To pomeni, da naj bi bilo podobno biološkemu zdravilu („referenčnemu zdravilu“), ki je v Evropski uniji že odobreno, in sicer zdravilu Herceptin.
Trastuzumab has been designed to attach to HER2. 
Trastuzumab je bil zasnovan za vezavo na HER2.
Two studies were carried out in healthy volunteers to investigate whether Ogivri produces the same levels of the active substance in the body as the reference medicine Herceptin and therefore has the same effect. 
Opravljeni sta bili dve študiji na zdravih prostovoljcih, da bi proučili, ali zdravilo Ogivri tvori enake ravni zdravilne učinkovine v telesu kot referenčno zdravilo Herceptin in ima tako enak učinek.
Withdrawal of the marketing authorisation application for Ogivri (trastuzumab) EMA/564631/2017 
Umik vloge za pridobitev dovoljenja za promet z zdravilom Ogivri (trastuzumab) EMA/564631/2017
In a third study, Ogivri in combination with a taxane was compared with Herceptin used in combination with a taxane in 500 patients with metastatic breast cancer whose tumour cells overexpressed HER2. 
V tretji študiji so zdravilo Ogivri v kombinaciji s taksanom primerjali z zdravilom Herceptin v kombinaciji s taksanom pri 500 bolnikih z metastatskim rakom dojk, pri katerih so tumorske celice čezmerno izražale HER2.
On 3 August 2017, Mylan S.A.S. 
Družba Mylan S.A.S.
Ogivri is a medicine that contains the active substance trastuzumab. 
Ogivri je zdravilo, ki vsebuje zdravilno učinkovino trastuzumab.
HER2 is overexpressed in about a quarter of breast cancers and a fifth of gastric cancers. 
HER2 je čezmerno izražen pri približno četrtini rakov dojk in petini rakov želodca.
It was to be available as a powder to be made up into a solution for infusion (drip) into a vein. 
Na voljo naj bi bilo v obliki praška za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
Ogivri was expected to be used to treat early and metastatic breast cancer and metastatic gastric (stomach) cancer. 
Pričakovalo se je, da se bo zdravilo Ogivri uporabljalo za zdravljenje zgodnjega metastatskega raka dojk in metastatskega raka želodca.
By attaching to HER2, trastuzumab activates cells of the immune system, which then kill the tumour cells. 
Ob vezavi na HER2 aktivira celice imunskega sistema, ki nato uničijo tumorske celice.
The active substance in Ogivri and Herceptin, trastuzumab, is a monoclonal antibody. 
Zdravilna učinkovina v zdravilih Ogivri in Herceptin, trastuzumab, je monoklonsko protitelo.
A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific 
To je protitelo (vrsta beljakovine), ki je zasnovano tako, da prepozna posebno strukturo (imenovano
Ogivri was developed as a ‘biosimilar' medicine. 
Zdravilo Ogivri je bilo razvito kot „podobno biološko zdravilo“.
What was Ogivri expected to be used for? 
Za kaj naj bi se zdravilo Ogivri uporabljalo?
The CHMP's main concern was the lack of a valid certificate confirming that the manufacturing facility of the product complies with good manufacturing practice (GMP) requirements. 
Glavni zadržek odbora CHMP je bil odsotnost veljavnega potrdila o tem, da proizvodni obrat, v katerem proizvajajo zdravilo, deluje v skladu z zahtevami dobre proizvodne prakse.
Based on the review of the data at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Ogivri could not have been approved for the treatment of breast cancer and gastric cancer. 
Odbor CHMP je na podlagi pregleda podatkov ob umiku vloge izrazil določene zadržke in je začasno menil, da zdravila Ogivri ni mogoče odobriti za zdravljenje raka dojk in raka želodca.
Withdrawal of the marketing authorisation application for Ogivri (trastuzumab) 
Umik vloge za pridobitev dovoljenja za promet z zdravilom Ogivri (trastuzumab)
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the company had not provided enough documentation to support the application for Ogivri. 
Zato je ob umiku vloge menil, da družba ni predložila zadostne dokumentacije v podporo vlogi za zdravilo Ogivri.
The company informed the CHMP that the withdrawal does not impact ongoing clinical trials with Ogivri. 
Družba je odbor CHMP obvestila, da zavrnitev nima vpliva na klinična preskušanja, ki trenutno potekajo z zdravilom Ogivri.
In its letter notifying the Agency of the withdrawal of the application, the company stated that it was withdrawing the application because a GMP certificate for the manufacturing site of the product could not be obtained in the time available. 
Družba je v dopisu, s katerim je agencijo obvestila o umiku vloge, navedla, da umika vlogo, ker potrdila o dobri proizvodni praksi za proizvodni obrat, v katerem proizvajajo zdravilo Ogivri, ne more pridobiti v razpoložljivem času.
How does Ogivri work? 
Kako zdravilo Ogivri deluje?
officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Ogivri, for the treatment of breast cancer and gastric cancer. 
je 3. avgusta 2017 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Ogivri, namenjenim zdravljenju raka dojk in raka želodca.
What is Ogivri? 
Kaj je zdravilo Ogivri?
Ogivri was to be used only when the cancer has been shown to ‘overexpress HER2': this means that the cancer produces a protein called HER2 in large quantities on the surface of the tumour cells, which makes the tumour cells grow more quickly. 
To pomeni, da na površini tumorskih celic v večjih količinah nastaja beljakovina, imenovana HER2, zato tumorske celice hitreje rastejo.
Trastuzumab also stops HER2 producing signals that cause the tumour cells to grow. 
S tem prepreči, da bi beljakovina HER2 tvorila signale, ki spodbujajo rast tumorskih celic.
On 23 June 2005, the CHMP concluded that: 
Dne 23. junija je CHMP zaključil da:
- recommended follow up measures to further investigate the safety of celecoxib. 
- priporočil nadaljnje ukrepe za dodatno raziskovanje varnosti celekoksiba.
SCIENTIFIC CONCLUSIONS FOR AMENDMENT OF THE PRODUCT INFORMATION 
ZNANSTVENI ZAKLJUČKI ZA DOPOLNILO DOVOLJENJA ZA PROMET
The CHMP confirmed changes to the Product Information already introduced through the annual reassessment adopted in April 2005 further to the February USR and requested further changes. 
CHMP je potrdil spremembe informacij o zdravilu, že vnešene med rednim letnim ponovnim vrednotenjem, sprejete aprila 2005 po februarskem nujnem varnostnem ukrepu in zahteval še nadaljnje
On 20 April 2005, Pfizer presented data on serious skin reactions for valdecoxib during a hearing. 
Dne 20. aprila 2005 je Pfizer med zaslišanjem predstavil podatke o hudih kožnih reakcijah pri uporabi
- Addition of a more detailed description of the first signs of skin reactions leading to 
- dodan je podrobnejši opis začetnih znakov kožnih reakcij, zaradi katerih se zdravljenje
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 and the Package Leaflet (PL). 
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).
Further to a request from the European Commission, the scope of the ongoing class review was broadened to include the assessment of serious skin reactions in addition to the cardiovascular safety 
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.
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 tržišč umaknil zdravilo Vioxx (rofekoksib), pojavila pa so se tudi vprašanja glede kardiovaskularne varnosti drugih zaviralcev Cox-2.
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 postmarketing 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 kliničnih študij in postmarketinškega nadzora, katerih analiza je pokazala več dejavnikov tveganja za pojav hudih kožnih reakcij s celekoksibom.
Between November 2004 and June 2005, the MAH made oral explanations to the CHMP on cardiovascular and skin safety aspects for Onsenal on 18 January, 15 February, and 25 May 2005. 
Med novembrom 2004 in junijem 2005 je imetnik dovoljenja za promet 18. januarja, 15. februarja in 25 maja 2005 pred CHMP ustno obrazložil kardiovaskularne in kožne varnostne vidike za celekoksib.
During the CHMP meeting of February 2005, discussions on cardiovascular safety took place. 
CHMP je o kardiovaskularni varnosti razpravljal na svoji seji februarja 2005.
In September 2004, the Marketing Authorisation Holder (MAH) of rofecoxib (a selective Cox-2inhibitor) 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 kliničnega preizkušanja (APPROVe) rofekoksiba pokazali tveganje za trombotične kardiovaskularne dogodke.
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. 
V zvezi z razpravo Odbora za zdravila za uporabo v humani medicini (CHMP) na plenarni seji oktobra 2004 je Evropska komisija priporočila, da se za to javno zdravstveno vprašanje o vseh vidikih kardiovaskularne varnosti, vključno s trombotičnimi dogodki in kardiorenalnimi dogodki, sproži napotitveni postopek Skupnosti v skladu z 31. členom Direktive 2001/83/ES z vsemi dodatki za zdravila, odobrena po decentraliziranem postopku, in vsebujejo celekoksib, etorikoksib in lumirakoksib ter revizijski postopek v skladu z 18. členom Uredbe Sveta (EGS) št. 2309/93 z vsemi dodatki za zdravila, odobrena po centraliziranem postopku, in vsebujejo celekoksib (Onsenal), parekoksib (Dynastat/Rayzon) in valdekoksib (Bextra/Valdyn).
- is of the Opinion that the benefit/risk balance of Onsenal in Familial Adenomatous Polyposis (FAP) remains favourable and the Marketing Authorisations should be maintained according to revised Summaries of Product Characteristics and Package Leaflet (attached in Annex I and IIIB, respectively of the CHMP Opinion), - concluded that the cardiovascular safety and serious skin reactions should be continuously and 
- mnenja, da razmerje med koristjo in tveganjem za zdravilo Onsenal pri familiarni adenomatozni polipozi (FAP) ostaja ugodno in da se dovoljenja za promet ohranijo v skladu s popravljenimi Povzetki glavnih značilnosti zdravil (priloženih mnenju CHMP v Dodatku III), - zaključil, da je treba kardiovaskularno varnost in hude kožne reakcije neprekinjeno in
GROUNDS FOR AMENDMENT OF PRODUCT INFORMATION 
PODLAGA ZA DOPOLNILO DOVOLJENJA ZA PROMET
- Addition of a warning for patients with a history of any drug allergy, - Strengthening of a warning to highlight that fatal serious skin reactions have now occurred 
- dodano je opozorilo za bolnike z anamnezo alergije na katerokoli zdravilo, - okrepljeno je opozorilo, ki poudarja, da so se pri uporabi celekoksiba pojavile hude kožne
This USR was initiated on 16 February 2005 and finalised on 
Nujen varnostni ukrep se je začel 16. februarja 2005 in zaključil 17. februarja 2005.