natgillin/translations-raw huggingface dataset:
Marketing Authorisation Holder Genzyme Europe B.V.
Imetnik dovoljenja za promet z zdravilom Genzyme Europe B.V.
Very common: Fatigue, pyrexia, mucosal inflammation Common: Multi-organ failure, systemic inflammatory response syndrome*, pain, chills, irritability, oedema, peripheral oedema, feeling hot, feeling abnormal
Zelo pogosti: utrujenost, pireksija, vnetje sluznice Pogosti: odpoved več organov, sindrom sistemskega vnetnega odziva*, bolečina, mrzlica, razdražljivost, edem, periferni edem, občutek vročine, nenormalno počutje
Patients with cardiac disease and those taking medicinal products known to affect blood pressure or cardiac function should be closely monitored during treatment with clofarabine (see sections 4.5 and 4.8).
Bolnike s srčnimi boleznimi in bolnike, ki jemljejo zdravila, za katere je znano, da vplivajo na krvni tlak ali delovanje srca, je treba med zdravljenjem s klofarabinom skrbno spremljati (glejte poglavji 4.5 in 4.8).
The safety profile of clofarabine has not been established in patients with severe renal impairment or patients receiving renal replacement therapy (see section 4.3).
Varnostni profil klofarabina pri bolnikih s hudo okvaro ledvic oz. pri bolnikih, ki prejemajo ledvično nadomestno terapijo, ni bil določen (glejte poglavje 4.3).
Dose reduction for patients experiencing non-haematological toxicities Infectious events
Zmanjšanje odmerka pri bolnikih, pri katerih se pojavijo nehematološki toksični učinki Dogodki, povezani z okužbami
Common: Maculo-papular rash, petechiae, erythema, pruritic rash, skin exfoliation, generalised rash, alopecia, skin hyperpigmentation, generalised erythema, erythematous rash, dry skin, hyperhidrosis Frequency not known: Stevens Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN)
Pogosti: makulo-papularni izpuščaj, petehije, eritem, srbeči izpuščaji, luščenje kože, generalizirani osip, alopecija, hiperpigmentacija kože, splošni eritem, eritematozni izpuščaji, suha koža, čezmerno znojenje Pogostnost neznana: Stevens-Johnsonov sindrom (SJS), toksična epidermalna nekroliza (TEN)
Tell your doctor or carer immediately if you experience any of the following as you may need to stop treatment: - if you get a fever or high temperature - because clofarabine reduces the number of blood cells made in the bone marrow, you may be more likely to catch infections; - if you have breathing difficulties, rapid breathing, or breathlessness; - if you feel a change in your heart rate; - if you suffer from dizziness (light-headedness) or fainting - it may be a symptom of low blood pressure; - if you feel sick or have diarrhoea (loose bowels); - if your urine is darker than usual - it is important to drink plenty of water to avoid dehydration; - if you get a rash with blisters or mouth ulcers; - if you lose your appetite, have nausea (feeling sick), vomiting, diarrhea, dark-colored urine and light-coloured stools, stomach pain, jaundice (yellowing of the skin and eyes), or if you feel generally unwell, these could be symptoms of an inflammation of the liver (hepatitis), or liver damage (hepatic failure); - if you pass little or no urine, or experience drowsiness, nausea, vomiting, breathlessness, loss of appetite and / or weakness (these may be signs of acute kidney failure / kidney failure).
Zdravnika ali skrbnika takoj obvestite, če imate naslednje težave, ker boste morda morali prekiniti zdravljenje: - če imate vročino ali zvišano telesno temperaturo - ker klofarabin zmanjša število krvnih celic, ki nastajajo v kostnem mozgu, zato obstaja večja verjetnost, da boste zboleli za okužbo; - če imate težave pri dihanju, dihate hitro ali ste zasopli; - če čutite spremembo hitrosti bitja srca; - če imate omotico (vrtoglavico) ali omedlevico - to so lahko znaki nizkega krvnega tlaka; - če vam je slabo ali imate drisko; - če je vaš urin temnejši kot ponavadi - pomembno je, da pijete veliko vode, da bi preprečili dehidracijo; - če se pojavi izpuščaj z mehurji ali razjede ustne sluznice; če izgubite apetit, občutite slabost v želodcu (siljenje na bruhanje), bruhate, imate drisko, temen urin in svetlo blato, bolečine v trebuhu, zlatenico (porumenelost kože in očesnih beločnic), ali če se na splošno slabo počutite, so to lahko simptomi vnetja jeter (hepatitisa) ali okvare jeter (odpovedi jeter).
Common: Haematuria* Common: Renal failure, acute renal failure
Pogosti: hematurija* Pogosti: odpoved ledvic, akutna odpoved ledvic
Each vial contains 180 mg of salt (sodium chloride).
Ena viala vsebuje 180 mg soli (natrijevega klorida).
The no-observable effect level for maternal toxicity in rats was 18 mg/m 2/day and in rabbits was more than
Odmerek, pri katerem niso opazili toksičnih učinkov na mater, je bil pri podganah 18 mg/m2/dan, pri kuncih pa več kot 12 mg/m2/dan.
Evoltra should not be handled by pregnant women.
Nosečnice ne smejo delati z zdravilom Evoltra.
There is no experience in patients with hepatic impairment (serum bilirubin > 1.5 x ULN plus AST and ALT > 5 x ULN) and the liver is a potential target organ for toxicity.
Ni izkušenj z uporabo pri bolnikih z okvaro jeter (serumski bilirubin > 1,5 x ULN plus AST in ALT > 5 x ULN) in jetra so potencialni tarčni organ za toksične učinke.
Suppression of bone marrow should be anticipated.
Pričakovati je treba supresijo kostnega mozga.
There is no experience in patients with hepatic impairment (serum bilirubin > 1.5 x ULN plus AST and ALT > 5 x ULN) and the liver is a potential target organ for toxicity (see sections 4.3 and 4.4).
Ni izkušenj z uporabo pri bolnikih z okvarjenim delovanjem jeter (serumski bilirubin > 1,5 x ULN plus AST in ALT > 5 x ULN) in jetra so potencialna tarča za toksične učinke (glejte poglavji 4.3 in 4.4).
Forty-one patients of 115 (35.7%) experienced at least one renal and urinary disorders adverse event.
Pri enainštiridesetih bolnikih izmed 115 (35,7 %) so poročali o vsaj enem neželenem dogodku bolezni ledvic ali sečil.
Excipient with known effect Each 20 ml vial contains 180 mg of sodium chloride.
Pomožne snovi z znanim učinkom Ena 20 ml viala vsebuje 180 mg natrijevega klorida.
Any patient who experiences a severe toxicity on a third occasion, a severe toxicity that does not recover within 14 days (see above for exclusions), or a life-threatening or disabling toxicity (US NCI CTC Grade 4 toxicity) should be withdrawn from treatment with clofarabine (see section 4.4).
Pri bolnikih, pri katerih se tudi tretjič pojavijo hudi toksični učinki, ki se ne izboljšajo v 14 dneh (glejte izjeme zgoraj), ali življenje ogrožujoči ali onesposabljajoči toksični učinki (4. stopnje po CTC NCI v ZDA), je treba zdravljenje s klofarabinom prekiniti (glejte poglavje 4.4).
Driving and using machines Do not drive or use any tools or machines if you feel dizzy, light-headed or faint.
Vpliv na sposobnost upravljanja vozil in strojev Če imate omotico, vrtoglavico ali omedlevico, ne vozite avtomobila in ne upravljajte z orodji ali stroji.
Intravenous infusion of 52 mg/m clofarabine produced equivalent exposure across a wide range of weights.
Pri intravenskem infundiranju 52 mg klofarabina/m2 je bila izpostavljenost pri bolnikih z zelo različno telesno maso enaka.
Evoltra contains the active substance clofarabine.
Zdravilo Evoltra vsebuje zdravilno učinkovino klofarabin.
Common: Anorexia, decreased appetite, dehydration Frequency not known: hyponatremia
Pogosti: anoreksija, zmanjšan apetit, dehidracija
Patients who underwent transplant while in continued remission*
PRt bolniki s presaditvijo med trajajočo remisijo* PRt
Pharmacokinetics in patients aged between 2 to 19 years old with relapsed or refractory ALL or AML following administration of multiple doses of clofarabine by intravenous infusion
Farmakokinetika pri bolnikih, starih od 2 do 19 let s ponovljeno ali neodzivno ALL ali AML po intravenskem infundiranju več odmerkov klofarabina
The diluted concentrate is chemically and physically stable for 3 days at 2
Razredčeni koncentrat je kemijsko in fizikalno stabilen 3 dni pri 2 °C do 8 °C ter pri sobni temperaturi (do 25°C).
Very common (may affect more than 1 in 10 people): anxiety, headache, fever, tiredness; feeling and being sick, diarrhoea (loose bowels); flushing, itching and inflamed skin, inflammation of mucus (moist) linings such as the mouth and other areas; you may have more infections than normal because Evoltra can lower the number of certain types of blood cells in your body; skin rashes which may be itchy, red, painful or peeling skin including palms of the hands and soles of the feet, or small reddish or purple spots underneath the skin.
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 oseb): tesnoba, glavobol, zvišana telesna temperatura, utrujenost; občutek slabosti in slabost, driska; oblivanje, srbeča in vneta koža, vnetje (vlažnega) roba sluznic, kot so usta in na drugih mestih; morda boste imeli več okužb kot navadno, ker zdravilo Evoltra lahko zmanjša število določenih vrst krvnih celic v telesu; kožni izpuščaji, ki so lahko srbeči, rdeči, boleči, ali luščenje kože na dlaneh in podplatih ali majhne rdečkaste ali vijolične pike pod kožo.
During the post-marketing period prolonged cytopaenias (thrombocytopaenia, anaemia, neutropaenia and leukopaenia) and bone marrow failure have been reported.
Med spremljanjem zdravila po dajanju le tega v promet so poročali o podaljšani citopeniji (trombocitopenija, anemija, nevtropenija in levkopenija) ter odpovedi kostnega mozga.
In the post-marketing period, following treatment with clofarabine, serious hepatotoxic adverse reactions of VOD in paediatric and adult patients have been associated with a fatal outcome.
Med spremljanjem zdravila po dajanju le tega v promet so pri pediatrični populaciji in pri odraslih po zdravljenju s klofarabinom poročali o hudih hepatotoksičnih dogodkih (VOD), povezanih s smrtnim izidom.
Each vial of Evoltra contains 180 mg of sodium chloride.
Ena viala zdravila Evoltra vsebuje 180 mg natrijevega klorida.
Evoltra 1 mg/ml concentrate for solution for infusion must be diluted prior to administration.
Zdravilo Evoltra 1 mg/ml koncentrat za raztopino za infundiranje je treba pred uporabo razredčiti.
*Each ml of concentrate contains 1 mg of clofarabine.
* Vsak ml koncentrata vsebuje 1 mg klofarabina.
Very common: Vomiting, nausea, diarrhoea Common: Mouth haemorrhage, gingival bleeding, haematemesis, abdominal pain, stomatitis, upper abdominal pain, proctalgia, mouth ulceration Frequency not known: Pancreatitis elevations in serum amylase and lipase, enterocolitis, neutropaenic colitis, caecitis
Zelo pogosti: bruhanje, navzea, diareja Pogosti: krvavitve v ustih, krvavitve iz dlesni, hematemeza, bolečina v trebuhu, stomatitis, bolečina v zgornjem delu trebuha, proktalgija, razjede v ustih Pogostnost neznana: pankreatitis, povečanje amilaze in lipaze v serumu, enterokolitis, nevtropenični kolitis, tiflitis
Therefore, a safe and effective dosage recommendation for patients < 1 year old has yet to be established.
Podatkov o farmakokinetiki, varnosti in učinkovitosti klofarabina pri dojenčkih ni. Varna in učinkovita priporočila za odmerjanje pri bolnikih starih < 1 leto je treba še ugotoviti.
breathlessness, cough; - vomiting blood, stomach ache, pain in the bottom; - bleeding inside the head, stomach, intestine or lungs, mouth or gums, mouth ulcers, inflamed mouth lining; - yellowing of the skin and eyes (also called jaundice), or other liver disorders; - bruising, hair loss, changes to skin colour, increased sweating, dry skin, or other skin problems; - pain in the chest wall or bones, neck or back pain, pain in limbs, muscles, or joints; - blood in urine; - failure of organs, pain, increased muscle tension, water retention and swelling in parts of the body, including the arms and legs, changes in mental state, feeling hot, cold or abnormal; - clofarabine may affect the levels of certain substances in the blood.
- podplutbe, izguba las, spremembe barve kože, čezmerno potenje, suha koža ali druge težave s kožo; - bolečina v steni prsnega koša ali kosteh, bolečina v vratu ali hrbtu, bolečina v okončinah, mišicah ali sklepih; - kri v urinu; - odpoved organov, bolečina, povečana napetost mišic, zadrževanje vode in otekanje v nekaterih delih telesa, vključno z rokami in nogami, spremembe duševnega stanja, občutek vročine, mraza ali nenormalno počutje; - klofarabin lahko vpliva na ravni nekaterih snovi v krvi.
Increases in postimplantation loss, reduced foetal body weights and decreased litter sizes together with increases in the number of malformations (gross external, soft tissue) and skeletal alterations (including retarded ossification) were reported in rats receiving doses which produced approximately 2 to 3 fold the clinical exposure (54 mg/m2/day) and in rabbits receiving 12 mg/m 2/day clofarabine.
Pri podganah, ki so prejemale odmerke, ki so bili približno 2- do 3-krat večji od klinične izpostavljenosti (54 mg/m2/dan), ter pri kuncih, ki so prejemali 12 mg klofarabina/m2/dan, so poročali o povečanju postimplantacijske izgube, zmanjšanju telesne mase ploda in zmanjšanju velikosti mladičev, skupaj s povečanjem števila malformacij (zunanje, mehka tkiva) ter spremembami na skeletu (vključno z zaostalo osifikacijo).
Other medicines and Evoltra
Shranjevanje zdravila Evoltra
Evoltra 1 mg/ml concentrate for solution for infusion clofarabine
Evoltra 1 mg/ml koncentrat za raztopino za infindiranje klofarabin
Each 20 ml vial contains 20 mg of clofarabine
Ena 20 ml viala vsebuje 20 mg klofarabina
Plasma protein binding Serum albumin Elimination:  half-life of clofarabine
Vezava na beljakovine v plazmi Serumski albumin
Suggested dilution schedule based on the recommended dosage of 52 mg/m2/day clofarabine
Predlagane razredčitve za priporočeni odmerek 52 mg klofarabina/m2/dan Telesna površina (m2)
STATEMENT OF ACTIVE SUBSTANCE(S)
Stopnja skupne remisije (SR)
Twentythree patients out of 115 experienced a vascular disorder considered to be related to clofarabine, the most frequently reported being flushing (13 events; not serious) and hypotension (5 events; all of which were considered to be serious; see section 4.4).
Najpogosteje so poročali o oblivanju (13 dogodkov; niso bili resni) in hipotenziji (5 dogodkov; vsi so bili ocenjeni kot resni; glejte poglavje 4.4).
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
What Evoltra contains
Kaj vsebuje zdravilo Evoltra
• Recovery of peripheral counts (platelets  100 x 10
• periferna obnovitev števila krvnih celic (trombociti  100 x 109/l in ANC  1,0 x 109/l)
Patients who did not undergo transplant CR
bolniki brez presaditve
Each ml of concentrate contains 1 mg of clofarabine.
En ml koncentrata vsebuje 1 mg klofarabina.
Renal failure or acute renal failure have been observed as a consequence of infections, sepsis and tumour lysis syndrome (see section 4.8).
Kot posledico okužb, sepse in sindroma lize tumorja so opazili odpoved ledvic ali akutno odpoved ledvic (glejte poglavje 4.8).
The liver is a potential target organ for clofarabine toxicity and 25.2% of patients experienced at least one hepato-biliary disorders adverse event (see sections 4.3 and 4.4).
Pri 25,2 % bolnikov je prišlo do vsaj enega neželenega dogodka bolezni jeter, žolčnika in žolčevodov (glejte poglavji 4.3 in 4.4).
Clofarabine should be discontinued immediately if substantial increases in creatinine, liver enzymes and/or bilirubin are observed.
Če opazite znatno povečanje kreatinina, jetrnih encimov in/ali bilirubina, morate zdravljenje s klofarabinom takoj prekiniti.
Occurrences of enterocolitis, including neutropaenic colitis, caecitis, and C. difficile colitis have been reported during treatment with clofarabine.
Med zdravljenjem s klofarabinom so poročali o pojavih enterokolitisa, vključno z nevtropeničnim kolitisom, tifilitisom in kolitisom zaradi C. difficile.
Evoltra 1 mg/ml concentrate for solution for infusion
IME ZDRAVILA Evoltra 1 mg/ml koncentrat za raztopino za infundiranje
Special precautions for administration
Posebni pogoji za ravnanje
Τηλ: +30 210 900 1600
Sanofi-Aventis AEBE Τηλ: +30 210 900 1600
What Evoltra looks like and contents of the pack Evoltra is a concentrate for solution for infusion.
Zdravilo Evoltra je koncentrat za raztopino za infundiranje.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 20 mg/20 ml
Severe bone marrow suppression, including neutropaenia, anaemia and thrombocytopaenia have been observed in patients treated with clofarabine.
Pri bolnikih, ki so jih zdravili s klofarabinom, so opazili hudo supresijo kostnega mozga, vključno z nevtropenijo, anemijo in trombocitopenijo.
Neoplasms benign and malignant (including cysts and polyps) and Immune systems disorders Administration of clofarabine results in a rapid reduction in peripheral leukaemia cells.
Benigne in maligne novotvorbe (vključno s cistami in polipi) in bolezni imunskega sistema
The active substance is clofarabine.
Zdravilna učinkovina je klofarabin.
Children and adolescents (≥ 1 year old) The recommended dose in monotherapy is 52 mg/m of body surface area administered by intravenous infusion over 2 hours daily for 5 consecutive days.
Priporočeni odmerek za monoterapijo je 52 mg/m2 telesne površine, dane v obliki intravenske infuzije;
CR
DR
Further to that the results of the SALT study became available.
Po tem so postali razpoložljivi tudi rezultati študije SALT.
This referral procedure was concluded in 2004 (European Commission decision issued on 26 April 2004) and the product information was subsequently updated.
Napotitveni postopek je bil zaključen leta 2004 (Evropska komisija je izdala odločbo dne 26. aprila 2004), informacije o zdravilu pa so bile naknadno posodobljene.
This signal could possibly be due to environmental, genetic factors involved and it remains to be explained.
Ta znak bi bil morda lahko posledica okoljskih ali genskih dejavnikov in ga je treba še pojasniti.
Nimesulide-containing medicinal products for systemic use are currently authorised in 17 Member States on prescription only and marketed in 15 Member States (Bulgaria, Czech Republic, Cyprus, France, Greece, Hungary, Italy, Latvia, Lithuania, Malta, Poland, Portugal, Romania, Slovakia and Slovenia).
Zdravila, ki vsebujejo nimesulid za sistemsko uporabo, so trenutno odobrena v 17 državah članicah samo na recept, tržijo pa se v 15 državah članicah (Bolgarija, Češka, Ciper, Francija, Grčija, Madžarska, Italija, Latvija, Litva, Malta, Poljska, Portugalska, Romunija, Slovaška in Slovenija).
In the remaining Member States the exposure appears relatively stable over time.
V ostalih državah je izpostavljenost v tem času relativno stabilna.
However, it must be noted that no direct comparisons are available, and confidence intervals are overlapping considerably.
Treba je tudi upoštevati, da ni na voljo nobenih neposrednih primerjav, intervali zaupanja pa se pomembno prekrivajo.
It was noted that the majority of hepatic disorders (56%) occurred after two weeks of treatment.
Ugotovljeno je bilo, da se je večina jetrnih motenj (56 %) pojavila dva tedna po zdravljenju.
Patient's exposure has been decreasing over the recent years following the outcomes of the previous reviews under Article 31 and Article 107.
Izpostavljenost bolnikov se je v zadnjih letih po izidih preteklih pregledov v skladu s členom 31 in členom 107 zmanjševala.
Nevertheless, the SALT study did confirm the signal seen in Ireland which was not seen in any other country involved in the study.
Kljub temu pa je študija SALT potrdila opozorilni znak, ki so ga opazili na Irskem in ni bil opažen v nobeni drugi državi, ki je bila vključena v študijo.
The absolute risk for acute liver failure indicated for transplantation is 5.64 [2.43-11.11] per million person-years and 5.90 per billion DDDs (defined daily doses).
Absolutno tveganje za akutno odpoved jeter, pri kateri je potrebna presaditev, je 5,64 [2,4311,11] na milijon oseb/let in 5,90 na milijardo DDO (določenih dnevnih odmerkov).
The CHMP reviewed the data submitted by the marketing authorisation holders from clinical and non-clinical studies, epidemiological studies and spontaneous reports.
CHMP je preučil podatke, ki so jih predložili imetniki dovoljenj za promet z zdravili, iz kliničnih in nekliničnih študij, epidemioloških študij in spontanih poročil.
In this regard the SALT study was a key piece of data expected to provide further insight.
V tem smislu naj bi študija SALT zagotovila ključne podatke za nadaljnji vpogled.
Overall summary of the scientific evaluation of nimesulide-containing medicinal products for systemic use (see Annex I)
Splošni povzetek znanstvenega vrednotenja zdravil za sistemsko uporabo, ki vsebujejo nimesulid (glejte Dodatek I)
The absolute risk for hospital admission for hepatoxicity is approximately 30-35 per 100,000 person-years and the absolute risk for abnormal liver function tests is approximately 1%.
Absolutno tveganje za sprejem v bolnišnico zaradi toksičnosti jeter je med 30-35 na 100 000 oseb/let, absolutno tveganje za neobičajne vrednosti preiskav jetrne funkcije pa je približno 1 %.
Restriction of the maximum dose to 100 mg twice daily (with withdrawal of the marketing authorisations for the 200 mg), restriction of the therapeutic indications to the three above mentioned and warnings, precaution for use and contraindications were introduced.
Omejitev največjega odmerka na 100 mg dvakrat na dan (z umikom dovoljenj za promet z zdravilom za odmerek 200 mg), omejitev terapevtskih indikacij na tri zgoraj navedene, sprejeta pa so bila opozorila, previdnostni ukrepi pri uporabi in kontraindikacije.
Nimesulide is a non-steroidal anti-inflammatory drug (NSAID) with preferred COX-2 inhibition authorised in Europe since 1985.
Nimesulid je nesteroidno protivnetno zdravilo (NSAID), selektivni zaviralec COX-2, ki je v Evropi odobreno od leta 1985.
On 19 January 2010, the European Commission triggered a referral under Article 31 of Directive 2001/83/EC requesting the CHMP to give its opinion on whether the marketing authorisations for medicinal products containing nimesulide for systemic use should be maintained, varied, suspended or withdrawn.
Evropska komisija je dne 19. januarja 2010 sprožila napotitev v skladu s členom 31 Direktive 2001/83/ES, s katero je CHMP zaprosila, naj poda mnenje, ali naj se dovoljenja za promet z zdravili, ki vsebujejo nimesulid za sistemsko uporabo, ohranijo, spremenijo, začasno umaknejo ali prekličejo.
Poland, France and Greece.
Največja izpostavljenost je opažena v Italiji, na Poljskem, v Franciji in Grčiji.
It is noted that 23% of the hepatic cases reported for nimesulide involved patients treated for more chronic indications.
Ugotovljeno je bilo, da so v 23 % primerov v zvezi z jetri, o katerih so poročali pri uporabi nimesulida, bolnike zdravili za bolj kronične indikacije.
• The Committee considered the referral made under article 31 of Directive 2001/83/EC, for medicinal products containing nimesulide for systemic use.
• Odbor je obravnaval napotitev v skladu s členom 31 Direktive 2001/83/ES za zdravila, ki vsebujejo nimesulid za sistemsko uporabo.
Nimesulide efficacy in the treatment of pain associated with several inflammatory and painful disorders has been shown in mostly short-term studies (up to four weeks) with limited numbers of patients.
Učinkovitost nimesulida pri zdravljenju bolečine, povezane z različnimi vnetji in bolečimi motnjami, je bila dokazana v večinoma kratkotrajnih študijah (do štiri tedne) z omejenim številom bolnikov.
It is indicated as second line treatment for acute pain, symptomatic treatment of painful osteoarthritis and primary dysmenorrhoea.
Indicirano je kot zdravilo drugega izbora za zdravljenje akutne bolečine, simptomatično zdravljenje bolečega osteoartritisa in primarne dismenoreje.
• The Committee considered all the available data submitted on the safety and the efficacy of nimesulide-containing products for systemic use.
• Odbor je upošteval vse razpoložljive podatke, predložene glede varnosti in učinkovitosti zdravil, ki vsebujejo nimesulid, za sistemsko uporabo.