natgillin/translations-raw huggingface dataset:
Elevated liver enzymes Skin and subcutaneous tissue disorders: Common Skin reactions (for example oral, ungual and cutaneous pigmentation) and oral mucositis. 
Občasni: navzea Neznana pogostnost: prebavne motnje, bruhanje, gastrointestinalna razjeda, huda hipomagneziemija Bolezni jeter, žolčnika in žolčevodov Redki: zvišane vrednosti jetrnih encimov Bolezni kože in podkožja: Pogosti: kožne reakcije (na primer pigmentacija ust, nohtov in kože) in oralni mukozitis.
2D barcode carrying the unique identifier included 
EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako
Siklos 1000 mg film-coated tablets Each film-coated tablet contains 1,000 mg of hydroxycarbamide. 
Siklos 1000 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 1000 mg hidroksikarbamida.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BOTTLE 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
If you get any side effects, talk to your doctor or, pharmacist or nurse. 
Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom farmacevtom ali medicinsko sestro.
Cytotoxic: handle tablets with care. 
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Citotoksično: s tabletami ravnajte skrbno.
You must not breast-feed while taking Siklos. 
Če jemljete zdravilo Siklos, ne smete dojiti.
PHARMACEUTICAL FORM AND CONTENTS 
FARMACEVTSKA OBLIKA IN VSEBINA 30 tablet
Siklos should be used with caution in patients with mild to moderate renal impairment (see section 
Pri bolnikih z blago ali zmerno ledvično okvaro je treba zdravilo Siklos uporabljati previdno (glejte poglavje 4.2).
Talk to your doctor or pharmacist or nurse before taking Siklos 
Pred začetkom jemanja zdravila Siklos se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro
During treatment with Siklos, blood counts must be monitored every two weeks at treatment initiation (i.e. for the first two months) and if the daily dose of hydroxycarbamide is up to 35 mg/kg b.w. 
prva dva meseca) in, če dnevni odmerek hidroksikarbamida znaša do 35 mg/kg TM, kontrolirati krvno sliko na vsaka dva tedna.
Platelets 
PLASTENKA
EU/1/07/397/002 60 tablets EU/1/07/397/003 90 tablets EU/1/07/397/004 120 tablets 
EU/1/07/397/004 120 tablet
Low blood cell counts (myelosuppression), enlargement of red blood cells, decreased resistance to infections. 
Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov): Zelo nizko število krvnih celic (mielosupresija), povečanje velikosti rdečih krvničk , zmanjšanje odpornosti proti okužbam.
Siklos 100 mg film-coated tablets Each film-coated tablet contains 100 mg of hydroxycarbamide. 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Siklos 100 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 100 mg hidroksikarbamida.
Wounds on the legs (leg ulcers), and modification of liver function. 
Redki neželeni učinki (pojavijo lahko pri največ 1 od 1.000 bolnikov): Rane na nogah (ulkusi na nogah), spremembe jetrne funkcije.
Siklos 1000 mg film-coated tablets hydroxycarbamide 
Siklos 1000 mg filmsko obložene tablete hidroksikarbamid
Siklos 100 mg film-coated tablets hydroxycarbamide 
Siklos 100 mg filmsko obložene tablete hidroksikarbamid
There are no data that support specific guidance for dose adjustment in patients with hepatic impairment, but, due to safety considerations, Siklos is contraindicated in patients with severe hepatic impairment (see section 4.3). 
Zaradi skrbi glede varnosti je Siklos kontraindiciran pri bolnikih s hudo jetrno okvaro (glejte poglavje 4.3).
6.6 Special precautions for disposal and other handling 
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Siklos je zdravilo, s katerim je treba previdno ravnati.
Check with your doctor or pharmacist if you are not sure. 
Če niste prepričani, se posvetujte z zdravnikom ali farmacevtom.
Bleeding 
trombociti
Gastrointestinal disorders: Uncommon: 
sistemski in kožni eritematozni lupus Neznana pogostnost: suha koža
Nervous system disorders: Common: 
Motnje reprodukcije in dojk:
Rash, melanonychia, alopecia 
Občasni: izpuščaj, melanonihija, alopecija Redki: ulkusi na nogah Zelo redka pogostnost:
UNIQUE IDENTIFIER- HUMAN READABLE DATA 
EDINSTVENA OZNAKA - V BERLJIVI OBLIKI PC:
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, imetnikov dovoljenja za promet z zdravilom v državah članicah
Spain 
Italija
MA (EU) Number Name 
Številka (EU) dovoljenja za pormet
powder: 2500 IU; solvent: 3.2 ml 
prašek: 2500 i.e.; vehikel: 3,2 ml
1 powder vial + 1 solvent vial + 1 vial adapter 
1 viala s praškom + 1 viala z vehiklom + 1 adapter za vialo
EU/1/12/775/001 NovoThirteen 2500 IU Powder and solvent for solution for injection 
EU/1/12/775/001 NovoThirteen 2500 i.e. prašek in vehikel za raztopino za injiciranje za intravensko uporabo prašek : viala (steklo); vehikel: viala (steklo)
Implementation of the agreement by the Member States (submission of the variation by the Marketing Authorisation Holder): 
Izvajanje dogovora s strani držav članic (predložitev spremembe s strani imetnika dovoljenja za promet z zdravilom):
Adoption of CMDh agreement: 
Sprejetje dogovora skupine CMDh:
Transmission to National Competent Authorities of the translations of the annexes to the agreement: 
Posredovanje prevodov prilog k dogovoru pristojnim nacionalnim organom:
September 2013 CMDh meeting 
Zasedanje skupine CMDh septembra 2013
EU - number 
EU številka
Strength Pharmaceutical form 
Farmacevtsk a oblika
It was to be available as 200 mg capsules. 
Naj voljo naj bi bilo v obliki 200-miligramskih kapsul.
In addition, the CHMP had concerns about the documentation submitted in support of the effectiveness and safety of the medicine. 
Poleg tega je CHMP izrazil tudi zadržke glede dokumentacije, predložene v podporo učinkovitosti in varnosti zdravila.
The Committee had concerns over the quality of the medicine (in particular on the choice of the starting material to make the medicine and the presence of impurities). 
Odbor je izrazil zadržke glede kakovosti zdravila (zlasti glede izbire vhodne snovi za izdelavo zdravila in prisotnosti nečistot).
The summary of the opinion of the Committee for Orphan Medicinal Products for Ketoconazole AIDSCFM can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation. 
Povzetek mnenja Odbora za zdravila sirote o zdravilu Ketoconazole AID-SCFM je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
In its letter notifying the Agency of the withdrawal of application, the applicant stated that it was withdrawing the application since it would require a further time extension to provide the responses to the CHMP's questions. 
Predlagatelj je v dopisu, s katerim agencijo obvešča o umiku vloge, navedel, da se je za umik vloge odločil zato, ker bi potreboval dodatno podaljšanje roka za predložitev odgovorov na vprašanja CHMP.
Blocking cortisol production will help to reduce cortisol levels in the body, thereby relieving the symptoms of the disease. 
Z zaviranjem tvorbe kortizola pomaga znižati ravni kortizola v telesu in tako lajša simptome bolezni.
On 23 February 2015, Agenzia Industrie Difesa - Stabilimento Chimico Farmaceutico Militare officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Ketoconazole AID-SCFM, for the treatment of Cushing's syndrome. 
Družba Agenzia Industrie Difesa - Stabilimento Chimico Farmaceutico Militare je dne 23. februarja 2015 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Ketoconazole AID-SCFM, namenjenim zdravljenju Cushingovega sindroma.
Ketoconazole AID-SCFM was expected to be used to treat adults with Cushing's syndrome for whom surgery was not an option or had failed. 
Zdravilo Ketoconazole AID-SCFM naj bi se uporabljalo za zdravljenje odraslih s Cushingovim sindromom, pri katerih kirurški poseg ni mogoč ali ni bil uspešen.
The active substance in Ketoconazole AID-SCFM, ketoconazole, blocks the activity of a group of enzymes involved in the production of cortisol by the adrenal glands, such as 17 alpha-hydroxylase or 11b-hydroxylase. 
Zdravilna učinkovina v zdravilu Ketoconazole AID-SCFM, ketokonazol, zavira delovanje skupine encimov, ki sodelujejo pri nastajanju kortizola v nadledvičnih žlezah, kot sta 17-alfa-hidroksilaza in 11beta-hidroksilaza.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Ketoconazole AID-SCFM did not outweigh its risks. 
Zato je CHMP v času umika menil, da koristi zdravila Ketoconazole AID-SCFM ne odtehtajo z njim povezanih tveganj.
Ketoconazole AID-SCFM was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 9 August 2012 for Cushing's syndrome. 
Zdravilo Ketoconazole AID-SCFM je bilo dne 9. avgusta 2012 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni) za Cushingov sindrom.
Ketoconazole AID-SCFM is a medicine that contains the active substance ketoconazole. 
Ketoconazole AID-SCFM je zdravilo, ki vsebuje zdravilno učinkovino ketokonazol.
Ketoconazole can also block the production of other hormones produced by the adrenal gland which are often raised in Cushing's syndrome. 
Poleg tega lahko ketokonazol zavira tudi tvorbo drugih hormonov, ki jih proizvajata nadledvični žlezi in katerih ravni so pri Cushingovem sindromu pogosto povišane.
Based on the initial review of the data, at the time of the withdrawal, the CHMP had several concerns and was of the provisional opinion that Ketoconazole AID-SCFM could not have been approved for the treatment of Cushing's syndrome. 
Na podlagi začetnega pregleda podatkov je CHMP v času umika izrazil več zadržkov in je začasno menil, da zdravila Ketoconazole AID-SCFM ni mogoče odobriti za zdravljenje Cushingovega sindroma.
The company also cited commercial reasons, since another medicine containing ketoconazole for Cushing's syndrome was recently authorised in the EU. 
Poleg tega je družba navedla tudi poslovne razloge, ki izhajajo iz dejstva, da je bilo nedavno v EU za zdravljenje Cushingovega sindroma že odobreno drugo zdravilo, ki vsebuje ketokonazol.
Because ketoconazole is a well-known substance and its use in Cushing's syndrome is well established, the applicant presented data from the published literature to support its application for Ketoconazole AID-SCFM. 
Ketokonazol je dobro znana učinkovina, katere uporaba pri Cushingovem sindromu je dobro uveljavljena, zato je predlagatelj v podporo vlogi za pridobitev dovoljenja za promet z zdravilom Ketoconazole AID-SCFM predložil podatke iz objavljene literature.
Another medicine containing ketoconazole (Ketoconazole HRA) was recently approved in the EU to treat Cushing's syndrome. 
Nedavno je bilo v EU za zdravljenje Cushingovega sindroma že odobreno drugo zdravilo, ki vsebuje ketokonazol (Ketoconazole HRA).
What is Ketoconazole AID-SCFM? 
Kaj je zdravilo Ketoconazole AID-SCFM?
What was Ketoconazole AID-SCFM expected to be used for? 
Za kaj naj bi se zdravilo Ketoconazole AID-SCFM uporabljalo?
How is Ketoconazole AID-SCFM expected to work? 
Kako naj bi zdravilo Ketoconazole AID-SCFM delovalo?
Take it as soon as you remember. 
Vzemite ga takoj, ko se spomnite.
Adults and the elderly: 
Odrasli in starejši:
TAKE SPECIAL CARE WITH… 
BODITE POSEBNO POZORNI…
Tell your doctor immediately.” 
Nemudoma obvestite zdravnika.''
TAKING OTHER MEDICINES 
JEMANJE DRUGIH ZDRAVIL
The administration to patients older than 80 years should be avoided. 
Zdravljenja bolnikov, ki so starejši od 80 let, se moramo izogibati.
Age over 70 years is associated with high risk of complications. 
Starost nad 70 let povezujejo z velikim tveganjem zapletov.
This review, which concluded in October 2005, did not reveal any new safety concerns for the class of NSAIDs as a whole. 
Ta pregled, ki je bil zaključen oktobra 2005, ni razkril novih pomislekov glede varnosti razreda NSAID-ov kot celote.
4.5 Interaction with other Medicinal Products and other forms of Interaction 
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
It does not cure arthritis and will help you only as long as you continue to take it. 
Artritisa ne ozdravi in vam bo pomagal le, dokler ga boste jemali.
The benefit and tolerability of treatment should be reviewed within 14 days. 
V 14 dneh je treba preveriti korist in prenašanje zdravljenja.
• “If any of these applies to you, you should not be given piroxicam. 
• ''Če karkoli od naštetega velja za vas, piroksikama ne smete jemati.
Medicines can sometimes interfere with each other. 
Pri nekaterih zdravilih lahko pride do medsebojnega delovanja.
Piroxicam is authorised in the European Union following national marketing procedures. 
Piroksikam je v Evropski uniji odobren na podlagi nacionalnih postopkov za pridobitev dovoljenja za promet.
Further to a request from the European Commission the CHMP reviewed safety data on non-selective NSAIDs. 
Na podlagi zahteve Evropske komisije je CHMP preučil podatke o varnosti neselektivnih NSAID-ov.
Do not double the dose. 
Odmerka ne podvojite.
The CHMP agreed that the recommendations of article 5(3) of regulation (EC) no 726/2004 issued in October 2006 and published on the EMEA website (Doc. 
CHMP se je strinjal, da priporočila iz člena 5(3) Uredbe (ES) št. 726/2004, izdane oktobra 2006 in objavljene na spletni strani EMEA (ref. št. dok.
If continued treatment is considered necessary, this should be accompanied by frequent review. 
Če ga je treba nadaljevati, ga moramo spremljati s pogostimi pregledi.
If it is almost time for your next dose, do not take the dose you have missed, just take the next dose at the correct time. 
Če je že skoraj čas za naslednji odmerek, pozabljeni odmerek izpustite in vzemite naslednjega ob pravem času.
With regards to topical formulations of piroxicam, the CHMP agreed that no restrictions were necessary. 
Glede topičnih formulacij piroksikama se je CHMP strinjal, da omejitve niso potrebne.
• Concomitant use with anticoagulants. 
• sočasna uporaba z antikoagulansi,
The European Commission requested the CHMP to give its opinion on whether the marketing authorisations for medicinal products containing piroxicam should be maintained, varied, suspended or revoked. 
Evropska komisija je CHMP zaprosila za mnenje o tem, ali je treba dovoljenja za promet z zdravili, ki vsebujejo piroksikam, ohraniti, spremeniti, umakniti ali razveljaviti.
3740 Ah Baarn Baarnsche Dijk 1 3741 Ln Baarn The Netherlands 
3740 Ah Baarn Baarnsche Dijk 1 3741 Ln Baarn Nizozemska
National Competent Authorities (NCA) shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders: 
Pristojni nacionalni organi morajo zagotoviti, da imetnik dovoljenja za promet z zdravilom izpolni naslednje pogoje:
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF PIROXICAM CONTAINING MEDICINAL PRODUCTS (see Annex I) 
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVIL, VSEBUJOČIH PIROKSIKAM (glejte Dodatek I)
Ref. EMEA/413136/2006) remain valid for piroxicam containing medicinal products. 
EMEA/413136/2006) ostanejo v veljavi za zdravila, ki vsebujejo piroksikam.
If you are older than 70 years your doctor may prescribe a lower daily dose and reduce the duration of treatment. 
Če ste starejši od 70 let, vam lahko zdravnik predpiše manjši dnevni odmerek in skrajša trajanje zdravljenja.
Si-8501 Novo Mesto Slovenia 
Si-8501 Novo Mesto Slovenija
Capsule, soft 
Kapsula, soft
Your doctor may limit your use of piroxicam or other medicines, or you may need to take a different medicine. 
Zdravnik vam bo morda zmanjšal uporabo piroksikama ali drugih zdravil ali pa boste morali jemati drugačno zdravilo.
B-8620 Nieuwpoort Belgium 
B-8620 Nieuwpoort Belgija
As such the below outlined recommendations only apply to systemic formulations of piroxicam: 
Spodaj navedena priporočila kot takšna veljajo samo za sistemske formulacije piroksikama:
These recommendations build on the previous key elements published for piroxicam in September 2006 and must be implemented in the product information. 
Ta priporočila so zasnovana na predhodnih ključnih elementih, ki so bili objavljeni za piroksikam septembra 2006 in jih je treba vključiti v informacije o zdravilu.
Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment. 
Kaže, da je tveganje za takšne reakcije največje v zgodnjem obdobju zdravljenja in da se pri večini bolnikov reakcije pojavijo prvi mesec zdravljenja.
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES AND NORWAY AND ICELAND 
DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE, IMETNIKOV DOVOLJENJA ZA PROMET V DRŽAVAH ČLANICAH, NORVEŠKI IN ISLANDIJI
− The CHMP considered the referral made under article 31of Directive 2001/83/EC, as amended, for medicinal products containing piroxicam. 
− CHMP je obravnaval napotitev v skladu s členom 31 Direktive 2001/83/ES, kot je bila spremenjena, za zdravila, ki vsebujejo piroksikam.
Sector 2, Bucuresti Romania 
Sector 2, Bucuresti Romunija
Posology relating to the indications as outlined in section 4.1 should read as follows: 
Besedilo o odmerjanju, ki se nanaša na indikacije, naštete v poglavju 4.1, se mora glasiti:
− further risk minimisation measures include limitation of the dose of piroxicam to 20 mg per day, and recommendations to treat patients for the shortest time possible to relieve symptoms with review within 14 days. 
− nadaljnji ukrepi za zmanjšanje tveganja vključujejo omejitev odmerka piroksikama na 20 mg dnevno in priporočila, naj zdravljenje bolnikov traja najkrajši možni čas, potreben za lajšanje simptomov, s preverjanjem najpozneje v 14 dneh.
Your doctor will give you a regular check-up to make sure you are taking the optimal dose of piroxicam. 
Zdravnik vas bo redno pregledoval, da bi zagotovil, da jemljete optimalni odmerek piroksikama.
Maramures Romania 
Maramures Romunija
“Skin reactions 
''Kožne reakcije
Tallinna Farmaatsiatehase As 33 Tondi Street Ee - 11316, Tallinn Estonia 
Tallinna Farmaatsiatehase As 33 Tondi Street Ee - 11316, Tallinn Estonija
Carretera De Barcelona 2 46132 Almacera Spain 
Carretera De Barcelona 2 46132 Almacera Španija
25125 Brescia Italy 
25125 Brescia Italija
You should not take this medicine if you are older than 80 years. 
Če ste starejši od 80 let, tega zdravila ne smete jemati.
The risk for developing serious GI complications increases with age. 
Tveganje razvoja resnih zapletov v prebavilih se s starostjo veča.
Therefore, the European Commission sent a notification that was received by the EMEA on 2 August 2006 and a referral under Article 31 of Directive 2001/83/EC, as amended was started on 21 September 2006. 
Iz tega razloga je Evropska komisija poslala obvestilo, ki ga je EMEA prejela 2. avgusta 2006, v skladu s katerim je bil 21. septembra 2006 sprožen napotitveni postopek v skladu s členom 31 Direktive 2001/83/ES, kot je bila spremenjena.
2300 Ak Leiden The Netherlands 
2300 Ak Leiden Nizozemska
00-895 Warszawa Poland 
00-895 Warszawa Poljska
Kraanlei 27-29 B-900 Gent Belgium 
Kraanlei 27-29 B-900 Gent Belgija
WHAT IS PIROXICAM [Invented name] AND WHAT IT IS USED FOR 
KAJ JE PIROKSIKAM (izmišljeno ime) IN ZA KAJ GA UPORABLJAMO
Due to its safety profile (see sections 4.2, 4.3 and 4.4), piroxicam is not a first line option should an NSAID be indicated. 
Piroksikam zaradi svojega varnostnega profila (glejte poglavja 4.2, 4.3 in 4.4) ni zdravilo prve izbire, kadar je indiciran nesteroidni antirevmatik.
The decision to prescribe piroxicam should be based on an assessment of the individual patient's overall risks (see sections 4.3 and 4.4).” 
Odločitev o zdravljenju s piroksikamom mora temeljiti na oceni splošnega tveganja pri posameznem bolniku (glejte poglavji 4.3 in 4.4).''
De Europa, 20 B 28108 Alcobendas Madrid Spain 
De Europa, 20 B 28108 Alcobendas Madrid Španija
Human studies have shown that concomitant use of piroxicam and acetyl-salicylic acid reduces the plasma piroxicam concentration to about 80% of the usual value 
Raziskave pri ljudeh so pokazale, da se pri sočasni uporabi piroksikama in acetilsalicilne kisline koncentracija piroksikama v plazmi zmanjša na približno 80 % običajne vrednosti.
4.4 Special Warnings and Special Precautions for Use 
4.4 Posebna opozorila in previdnostni ukrepi
3508 Limassol Cyprus 
3508 Limassol Ciper
Via Aurelia, 58 00165 Roma Italy 
Via Aurelia, 58 00165 Roma Italija
− piroxicam should not be used for treatment of any acute condition due to the long half life of 50 hours and the safety profile, since equally effective and safer therapies are available; 
− piroksikam se zaradi dolgega razpolovnega časa 50 ur in varnostnega profila ne sme uporabljati za zdravljenje akutnih stanj, saj so na voljo enako učinkovita, a varnejša zdravila;
Biomedica-Chemica G. Lyra 25, Kato Kifissia Greece 
Biomedica-Chemica G. Lyra 25, Kato Kifissia Grčija
If you have any further questions on the use of this product, ask your doctor.” 
Če imate dodatna vprašanja o uporabi zdravila, se posvetujte s svojim zdravnikom.
V.Emanuele, 73 88074 Crotone (Kr) Italy 
V.Emanuele, 73 88074 Crotone (Kr) Italija
As a consequence, the CHMP has recommended to maintain the Marketing Authorisations for all medicinal products referred to in Annex I of the Opinion and to amend the relevant sections of the Summary of Product Characteristics and Package Leaflet of systemic formulations of piroxicam, as set out in Annex III of the Opinion in accordance with Article 31(2) of Directive 2001/83/EC, as amended. 
Posledično je CHMP priporočil ohranitev dovoljenj za promet za vsa zdravila iz Dodatka I k Mnenju ter spremembo ustreznih poglavij Povzetka glavnih značilnosti zdravila in Navodil za uporabo za sistemske formulacije piroksikama, kot je določeno v Dodatku III k Mnenju v skladu s členom 31(2) Direktive 2001/83/ES, kot je bila spremenjena.
20041 Agrate Brianza (Mi) Italy 
20041 Agrate Brianza (Mi) Italija
Karib House 63-65 Imperial Way Cr9 4qy Croydon, Surrey United Kingdom 
Karib House 63-65 Imperial Way Cr9 4qy Croydon, Surrey Velika Britanija
However a need to further evaluate the benefit/risk balance of some non-selective NSAIDs including piroxicam was identified. 
Ugotovljena pa je bila tudi potreba po nadaljnji presoji razmerja med koristmi in tveganji za nekatere neselektivne NSAID-e, vključno s piroksikamom.
Areta 31620 Huarte Pamplona Spain 
Areta 31620 Huarte Pamplona Španija
89143 Blaubeuren Germany 
89143 Blaubeuren Nemčija
Beverley, E Yorks HU17 0LD 
Beverley, E Yorks HU17 0LD Velika Britanija
16147 Genova Italy 
16147 Genova Italija
Make sure you have told your doctor about any other medicines that you are taking, including those that you have bought without a prescription.” 
Zdravnika obvestite o vseh drugih zdravilih, ki jih jemljete, tudi če ste jih kupili brez recept..''
B-2610 Wilrijk Belgium 
B-2610 Wilrijk Belgija
• If you are taking anticoagulants, such as warfarin, to prevent blood clots. 
• če jemljete antikoagulanse, na primer varfarin, za preprečevanje nastajanja krvnih strdkov;
48 81379, München 
48 81379, München Nemčija
If you have or had any medical problems or any allergies or if you are not sure as to whether you can use piroxicam tell your doctor before using this medicine. 
Če imate ali ste imeli kakršnekoli zdravstvene težave ali alergije ali ne veste, če lahko jemljete piroksikam, se posvetujte z zdravnikom.
The use of topical NSAIDs is accompanied by a markedly reduced systemic exposure compared to systemic dosing and therefore a lower rate of systemic adverse events is expected with use of topical formulations. 
Uporabo topičnih NSAID-ov spremlja izrazito manjša sistemska izpostavljenost v primerjavi s sistemskim odmerjanjem, zato se pri uporabi topičnih formulacij pričakuje nižja stopnja sistemskih neželenih učinkov.