natgillin/translations-raw huggingface dataset:
Talk to your doctor or pharmacist before using Stelara. 
Pred začetkom uporabe zdravila Stelara se posvetujte z zdravnikom ali farmacevtom.
Each vial contains 45 mg ustekinumab in 0.5 mL of solution for injection. 
Ena viala vsebuje 45 mg ustekinumaba v 0,5 ml raztopine za injiciranje.
STELARA 45 mg solution for injection in pre-filled syringe EU/1/08/494/003 
STELARA 45 mg raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/08/494/003
Number of patients randomised 
Posebne skupine bolnikov
• the number of vials and strength is correct o If your dose is 45 mg or less, you will get one 45 mg vial of Stelara o If your dose is 90 mg you will get two 45 mg vials of Stelara and you will need to give yourself two injections. 
o Če je vaš odmerek 45 mg ali manjši, boste prejeli eno 45 mg vialo zdravila Stelara.
Histologic healing (defined as neutrophil infiltration in < 5% of crypts, no crypt destruction, and no erosions, ulcerations, or granulation tissue) was assessed at week 8 of UNIFI-I and Week 44 of UNIFI-M. At week 8, after a single intravenous induction dose, significantly greater proportions of patients in the recommended dose group achieved histologic healing (36%) compared with patients in the placebo group (22%). 
Histološka in histološko endoskopska zacelitev sluznice Histološko zacelitev sluznice (ki je definirana kot prisotnost nevtrofilne infiltracije v < 5% kript, odsotnost uničenja strukture kript, odsotnost erozij, ulceracij ali granulacijskega tkiva) so ocenjevali v 8. tednu študije UNIFI-I in v 44. tednu študije UNIFI-M.
Table 12: Summary of Key Efficacy Measures in UNIFI-M (week 44; 52 weeks from initiation of the induction dose) 
Preglednica12:Povzetek glavnih kazalcev učinkovitosti v študij UNIFI-M (po 44 tednih; 52tednov po začetnem indukcijskem odmerku) Placebo* N=175
STELARA 90 mg solution for injection in pre-filled syringe EU/1/08/494/004 
STELARA 90 mg raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/08/494/004
STELARA must not be given to patients with active tuberculosis (see section 4.3). 
Pred začetkom zdravljenja z zdravilom STELARA je treba bolnike pregledati in opraviti preiskave na prisotnost tuberkuloze, ker se zdravila STELARA ne sme dajati bolnikom z aktivno tuberkulozo (glejte poglavje 4.3).
Endoscopic normalization was defined as a Mayo endoscopic subscore of 0 and was observed as early as week 8 of UNIFI-I. At week 44 of UNIFI-M, it was achieved in 24% and 29% of patients treated with ustekinumab every 12 or 8weeks, respectively,as compared to18% of patients in the placebo group. 
V 44. tednu študije UNIFI-M jo je doseglo 24% bolnikov, ki so prejemali ustekinumab vsakih 12 tednov, in 29% tistih bolnikov, ki so prejemali ustekinumab vsakih 8 tednov, v primerjavi z 18% bolnikov iz skupine s placebom.
STELARA 90 mg solution for injection Solution for injection. 
STELARA 90 mg raztopina za injiciranje Raztopina za injiciranje.
Each pre-filled syringe contains 45 mg ustekinumab in 0.5 mL of solution for injection. 
Ena napolnjena injekcijska brizga vsebuje 45 mg ustekinumaba v 0,5 ml raztopine za injiciranje.
• Infections of the chest are uncommon (may affect up to 1 in 100 people) 
• Občasno se pojavijo okužbe spodnjih dihal (pojavijo se lahko pri največ 1 od
Fistula Response 
Simptomatska remisija
What Stelara is 
Kaj je zdravilo Stelara
• Shingles (a type of painful rash with blisters) are uncommon (may affect up to 1 in 100 people) 
• Občasno se pojavi pasavec (boleč izpuščaj v obliki mehurčkov - herpes zoster) (pojavi se lahko pri največ 1 od 100 bolnikov).
You must look out for signs of infection while you are using Stelara. 
Med uporabo zdravila Stelara morate biti pozorni na znake okužbe, ki vključujejo:
STELARA 130 mg concentrate for solution for infusion Ustekinumab 
STELARA 130 mg koncentrat za raztopino za injiciranje ustekinumab
A numerically lower number of subjects in the ustekinumab group (0.6%, 2/348) underwent UC disease related surgeries compared with subjects in the placebo group (1.7%, 3/175) through week 44. 
Do 44. tedna je bilo absolutno število bolnikov, ki so potrebovali kirurški poseg zaradi ulceroznega kolitisa, manjše v skupini, ki je prejemala ustekinumab (0,6%, 2/348) kot v skupini, ki je prejemala placebo (1,7%, 3/175).
• the number of vials and strength is correct o If your dose is 90 mg you will get one 90 mg vial of Stelara. 
o Če je vaš odmerek 90 mg, boste prejeli eno 90 mg vialo zdravila Stelara.
Each pre-filled syringe contains 45 mg of ustekinumab in 0.5 mL. 
Ena napolnjena injekcijska brizga vsebuje 45 mg ustekinumaba v 0,5 ml.
STELARA 45 mg solution for injection in pre-filled syringe Solution for injection. 
STELARA 45 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Raztopina za injiciranje.
Tell your doctor straight away if you notice any of these signs of infection. 
Če opazite katerega teh znakov okužbe, to nemudoma povejte zdravniku.
• Vaginal yeast infection 
• glivična okužba nožnice
This is because strong shaking may damage the medicine. 
• Vial zdravila Stelara ne smete stresati, ker bi lahko močno stresanje poškodovalo zdravilo.
In patients with psoriasis, steady-state serum concentrations of ustekinumab were achieved by week 28 after initial subcutaneous doses at Weeks 0 and 4 followed by doses every 12 weeks. 
Po dajanju začetnih subkutanih odmerkov v 0. in 4. tednu in kasnejšem prejemanju odmerkov na 12 tednov so bile serumske koncentracije ustekinumaba v stanju dinamičnega ravnovesja, pri bolnikih s psoriazo, dosežene do 28. tedna.
Pharmacotherapeutic group: Immunosuppressants, interleukin inhibitors, ATC code: L04AC05. 
Oznaka ATC: L04AC05
STELARA 45 mg solution for injection Solution for injection. 
STELARA 45 mg raztopina za injiciranje Raztopina za injiciranje.
medical or nursing staff may inject Stelara. 
Na začetku zdravljenja vam bo zdravilo Stelara lahko injiciralo medicinsko ali negovalno osebje.
Number of patients randomised PASI 50 response N (%) PASI 75 response N (%) PASI 90 response N (%) PGA of cleared or minimal N (%) Number of patients ≤ 100 kg 
90 mg število randomiziranih bolnikov odziv PASI 50 N (%) odziv PASI 75 N (%) odziv PASI 90 N (%) PGA pri bolnikih brez sprememb ali z minimalnimi spremembami N (%) število bolnikov z maso ≤ 100 kg odziv PASI 75 N (%) število bolnikov z maso > 100 kg odziv PASI 75 N (%)
STELARA 130 mg concentrate for solution for infusion ustekinumab 
STELARA 130 mg koncentrat za raztopino za infundiranje ustekinumab
The solution should be visually inspected for particulate matter or discoloration prior to subcutaneous administration. 
Pred subkutanim injiciranjem jo morate vizualno pregledati, ali vsebuje delce in ali je obarvana.
Common side effects (may affect up to 1 in 10 people): 
Pogosti: neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov):
The recommended dose of STELARA based on body weight is shown below (Tables 1 and 2). 
Pediatrični bolniki s psoriazo s plaki (stari 6 let in več) Priporočeni odmerek zdravila STELARA glede na telesno maso je prikazan v spodnjih preglednicah (Preglednici 1 in 2).
Tell your doctor right away if you develop symptoms such as cough, shortness of breath, and fever. 
Če se pri vas pojavijo simptomi, kot so kašelj, zadihanost in visoka telesna temperatura, takoj obvestite zdravnika.
Each pre-filled syringe contains 90 mg of ustekinumab in 1 mL. 
Ena napolnjena injekcijska brizga vsebuje 90 mg ustekinumaba v 1 ml raztopine.
Tell your doctor straight away if you notice any of the following signs. 
Če opazite katerega koli od teh znakov, se takoj posvetujte z zdravnikom.
Check the pre-filled syringe(s) to make sure 
Preverite napolnjeno injekcijsko brizgo in se prepričajte:
All patients were followed for efficacy for up to 52 weeks following first administration of study agent. 
Po prvem prejemu študijskega zdravila so pri vseh bolnikih spremljali učinkovitost zdravljenja do 52. tedna.
• The other ingredients are L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 
• Pomožne snovi so EDTA dinatrijeva sol dihidrat, L-histidin, L-histidinijev klorid monohidrat,
If you stop using Stelara It is not dangerous to stop using Stelara. 
Če ste prenehali uporabljati zdravilo Stelara
Prolonged vigorous shaking may damage the medicine. 
• Viale zdravila Stelara ne smete stresati, ker bi daljše močno stresanje lahko poškodovalo zdravilo.
• Wipe the injection site on the skin with an antiseptic wipe 
• Z antiseptičnim zložencem obrišite predel kože, kamor boste injicirali zdravilo.
There was significant improvement in DLQI scores in the ustekinumab groups as compared with placebo at week 24, which was maintained through weeks 52 and 100. 
V skupini, ki je prejemala ustekinumab, je bila po 24 tednih zdravljenja pomembno izboljšana tudi ocena dermatološkega indeksa kakovosti življenja (Dermatology Life Quality Index - DLQI), ki se je ohranila do 52. in do 100. tedna.
STELARA 45 mg solution for injection Ustekinumab 
STELARA 45 mg raztopina za injiciranje ustekinumab
You and your doctor should decide if you should breast-feed or use Stelara - do not do both. 
Skupaj se bosta odločila, ali boste dojili ali pa jemali zdravilo Stelara.
CorticosteroidFree Clinical Remission Durable Remission 
Ohranjena klinična remisija do 44. tedna Klinična remisija brez kortikosteroidov Dolgotrajna remisija Simptomatska remisija Kombinacija simptomatske remisije in zacelitve sluznice
PASI 50 response N (%) 
odziv ACR 50 N (%)
Recommended dose of Ustekinumab 
52. teden priporočeni odmerek ustekinumaba priporočeni odmerek ustekinumaba
• Used syringes should be placed in a puncture-resistant container, like a sharps container (see 
• Uporabljene brizge zavrzite v za to namenjene posode za odstranjevanje ostrih predmetov, ki so narejene tako, da preprečujejo vbod z iglo (glejte Sliko 8).
Malignancies 
Odmerek
STELARA 90 mg solution for injection in pre-filled syringe ustekinumab 
STELARA 90 mg raztopina za injiciranje v napolnjeni injekcijski brizgi ustekinumab
STELARA 90 mg solution for injection Ustekinumab 
STELARA 90 mg raztopina za injiciranje ustekinumab
However, abnormal regulation of IL 12 and IL 23 has been associated with immune mediated diseases, such as psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis. 
Imunske bolezni, kot so psoriaza, psoriatični artritis, Crohnova bolezen in ulcerozni kolitis, so povezane z nenormalno regulacijo IL-12 in IL-23.
ACR 50 response, N (%) ACR 70 response, N (%) Number of patients with ≥ 3% BSA PASI 75 response, N (%) PASI 90 response, N (%) Combined PASI 75 and ACR 20 response, N (%) 
odziv PASI 90 N (%) sestavljen odziv PASI 75 in ACR 20 N (%)
• Blocked or stuffy nose 
• zamašen nos
STELARA 45 mg solution for injection in pre-filled syringe Ustekinumab 
STELARA 45 mg raztopina za injiciranje v napolnjeni injekcijski brizgi ustekinumab
In patients who failed biological therapy 
Med bolniki, ki so nadaljevali z vzdrževalnim odmerjanjem,
Your doctor will check how well you are before treatment. 
Pred začetkom zdravljenja bo zdravnik ocenil vaše zdravstveno stanje.
Number of 130 mg STELARA Vials 
Število vial zdravila STELARA 130 mg
OUTER CARTON (130 mg) 
BESEDILO NA ŠKATLI VIALE (130 mg)
Significantly greater proportions of patients were in clinical remission in both ustekinumab treated groups compared to the placebo group at week 44 (see Table 6). 
Po 44tednih so bili deleži bolnikov,ki so bili v kliničniremisiji, v obeh skupinah, ki sta prejemali ustekinumabstatistično značilno večji kot vskupini, ki je prejemalaplacebo (glejte Preglednico6).
Number of patients with ≥ 3% BSA psoriasis skin involvement at baseline 
Število bolnikov z ≥ 3% BSA (Body Surface Area; ocena prizadete telesne površine) na začetku zdravljenja
PASI 75 response N (%) Number of patients > 100 kg 
število bolnikov z maso ≤ 100 kg odziv PASI 75 N (%) število bolnikov z maso > 100 kg odziv PASI 75 N (%)
Placebo 
CDLQI
See the package leaflet for further information. 
Shranjevanje zdravila Stelara Vsebina pakiranja in dodatne informacije
The tablets must never be swallowed but should be placed under the tongue and allowed to dissolve, which usually takes five to 10 minutes. 
Tablete se ne sme pogoltniti, ampak jih je treba položiti pod jezik in počakati, da se raztopijo, kar navadno traja 5 do 10 minut.
The European Commission granted a marketing authorisation valid throughout the European Union for Suboxone on 26 September 2006. 
Evropska komisija je dovoljenje za promet z zdravilom Suboxone, veljavno po vsej Evropski uniji, izdala 26. septembra 2006.
The medicine can only be obtained by ‘special' prescription. 
Izdaja zdravila je le na „poseben“ recept.
What measures are being taken to ensure the safe and effective use of Suboxone? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Suboxone?
The doctor may increase the dose depending on the patient's response but the daily dose should not be higher than 24 mg buprenorphine. 
Zdravnik bo v skladu z bolnikovim odzivom odmerek morda povečal, vendar pa dnevni odmerek ne sme presegati 24 mg buprenorfina.
‘Sublingual' means that the tablet is placed under the tongue where it dissolves. 
„Podjezične“pomeni, da se tableto položi pod jezik, da se raztopi.
This document is a summary of the European public assessment report (EPAR) for Suboxone. 
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Suboxone.
Sublingual tablets containing buprenorphine alone have been available in the EU since the mid-1990's for the treatment of opioid addiction. 
Podjezične tablete, ki vsebujejo zgolj buprenorfin, so za zdravljenje zasvojenosti z opioidi v EU na voljo od sredine devetdesetih let prejšnjega stoletja.
Suboxone is used in adults and children over 15 years of age, who are also receiving medical, social and psychological support. 
Uporablja se za odrasle in otroke, starejše od 15 let, ki so deležni tudi medicinske, socialne in psihološke podpore.
Other information about Suboxone 
Druge informacije o zdravilu Suboxone
The recommended starting dose is one or two tablets of Suboxone 2 mg/0.5 mg. 
Priporočeni začetni odmerek je ena ali dve tableti zdravila Suboxone 2 mg/0,5 mg.
Once the patient has been stabilised, the maintenance dose may be reduced gradually and eventually treatment may be stopped. 
Ko je bolnikovo stanje stabilno, se lahko vzdrževalni odmerek postopoma zmanjša in zdravljenje zaključi.
A risk management plan has been developed to ensure that Suboxone is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila Suboxone je bil pripravljen načrt obvladovanja tveganj.
Suboxone buprenorphine / naloxone 
Suboxone buprenorfin/nalokson
The CHMP noted that the combination of an opioid analogue with an opioid antagonist is an established strategy for reducing the potential misuse of the medicine. 
CHMP je ugotovil, da je uporaba kombinacije opioidnega analoga in opioidnega antagonista uveljavljena strategija za zmanjšanje morebitne zlorabe zdravila.
The effectiveness of Suboxone treatment depends on the patient also receiving other medical, social and psychological support. 
Učinkovitost zdravila Suboxone je odvisna od tega, ali je bolnik deležen tudi medicinske, socialne in psihološke podpore.
Suboxone must not be used in patients with severe respiratory insufficiency (difficulty breathing) or severe liver problems. 
Zdravilo Suboxone se ne sme uporabljati pri bolnikih s hudo respiratorno insuficienco (težavami z dihanjem) ali hudimi obolenji jeter.
The Committee decided that Suboxone's benefits are greater than its risks and recommended that it be given marketing authorisation. 
Zaključil je, da so koristi zdravila Suboxone večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Patients also used a specially designed questionnaire to record their cravings, and the change in the questionnaire score before and at the end of the study was measured. 
Bolniki so izpolnjevali tudi posebne vprašalnike za beleženje želje po drogi, s katerimi so merili spremembo rezultatov pred študijo in ob koncu študije.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Suboxone, including the appropriate precautions to be followed by healthcare professionals and patients. 
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Suboxone. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
What benefit has Suboxone shown during the studies? 
Kakšne koristi je zdravilo Suboxone izkazalo med študijami?
Suboxone must be used under the supervision of a doctor who has experience in the management of opioid addiction. 
Zdravilo Suboxone se mora uporabljati pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem zasvojenosti z opioidi.
It must also not be used in patients with acute alcohol intoxication (excessive alcohol consumption), delirium tremens (a condition caused by alcohol withdrawal) or together with medicines known as opioid antagonists used for the treatment of alcohol or opioid dependence. 
Prav tako se ne sme uporabljati pri bolnikih, ki imajo težave z akutnim alkoholizmom (prekomernim uživanjem alkohola) ali delirium tremens (stanjem, povzročenim z odtegnitvijo od alkohola) ali skupaj z zdravili, znanimi kot opioidni antagonisti, ki se uporabljajo za zdravljenje odvisnosti od alkohola ali drog.
It is available as sublingual tablets containing 2 mg buprenorphine and 0.5 mg naloxone, 8 mg buprenorphine and 2 mg naloxone, or 16 mg buprenorphine and 4 mg naloxone. 
Na voljo je v obliki podjezičnih tablet, ki vsebujejo bodisi 2 mg buprenorfina in 0,5 mg naloksona, 8 mg buprenorfina in 2 mg naloksona ali 16 mg buprenorfina in 4 mg naloksona.
The way Suboxone is used depends on the patient's status: type of addiction, state of withdrawal, and whether the patient is already using another substitution treatment such as methadone before starting Suboxone. 
Način uporabe zdravila Suboxone je odvisen od vrste zasvojenosti, stanja odtegnitve in od tega, ali je bolnik pred začetkom zdravljenja z zdravilom Suboxone že jemal kakšno drugo nadomestno zdravljenje, npr. metadon.
What is the risk associated with Suboxone? 
Kakšna tveganja so povezana z zdravilom Suboxone?
The most common side effects with Suboxone (seen in more than 1 patient in 10) are insomnia (difficulty sleeping), constipation, nausea (feeling sick), sweating, headache and withdrawal syndrome. 
Najpogostejši neželeni učinki zdravila Suboxone (opaženi pri več kot 1 bolniku od 10) so nespečnost, zaprtje, slabost, potenje, glavobol in odtegnitveni sindrom.
Suboxone is used to treat dependence on opioid (narcotic) drugs such as heroin or morphine in drug addicts who have agreed to be treated for their addiction. 
Zdravilo Suboxone se uporablja za zdravljenje odvisnosti od opioidnih (narkotičnih) drog, kot sta heroin ali morfij, pri odvisnikih, ki so privolili v zdravljenje.
The craving score, which was between 62.4 and 65.6 before treatment, decreased at the end of the study to 29.8 with Suboxone, compared with 55.1 with placebo. 
Rezultat glede želje po drogi je pred zdravljenjem znašal med 62,4 in 65,6, ob koncu študije pa 29,8 ob jemanju zdravila Suboxone in 55,1 ob jemanju placeba.
Suboxone was as effective as buprenorphine on its own and more effective than placebo: 17.8% of the patients who received Suboxone had a urine sample that tested negative at the end of the study, compared with 5.8% of the patients receiving placebo. 
Zdravilo Suboxone je bilo kot samostojno zdravilo enako učinkovito kot buprenorfin in učinkovitejše od placeba: negativen rezultat preiskave urina ob koncu študije je imelo 17,8 % bolnikov, ki so jemali zdravilo Suboxone, in 5,8 % bolnikov, ki so jemali placebo.
For the full list of all side effects reported with Suboxone, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Suboxone, glejte navodilo za uporabo.
In patients who have mild to moderately reduced liver function lower starting doses are recommended. 
Pri bolnikih z delno ali srednje okrnjenim delovanjem jeter se priporočajo nižji začetni odmerki.
Suboxone contains two active substances: buprenorphine, a partial opioid agonist (it acts like an opioid drug), and naloxone, an opioid antagonists (it counteracts the effects of opioid drugs). 
Zdravilo Suboxone vsebuje dve zdravilni učinkovini: buprenorfin, ki je opioidni agonist (deluje kot opioidna droga), in nalokson, ki je opioidni antagonist (izniči učinke opioidnih drog).
It is recommended that the patient's liver be checked before starting treatment with Suboxone and should also be monitored regularly during treatment. 
Pred začetkom zdravljenja z zdravilom Suboxone je priporočljivo opraviti preiskave delovanja bolnikovih jeter, redno pa je treba pregledovati njihovo delovanje tudi med samim zdravljenjem.
One main study compared Suboxone with buprenorphine on its own or with placebo (a dummy treatment) in 326 heroin-dependent patients for four weeks, and measured the percentage of patients who had no trace of opioids in their urine at the end of the study. 
V eni glavni študiji so pri 326 odvisnikih od heroina v obdobju štirih tednov zdravilo Suboxone primerjali z buprenorfinom kot samostojnim zdravilom ali s placebom in merili delež bolnikov, pri katerih ob koncu študije ni bilo mogoče zaznati nobenih sledi opioidov v urinu.
Why has Suboxone been approved? 
Zakaj je bilo zdravilo Suboxone odobreno?
The full EPAR for Suboxone can be searched for on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports For more information about treatment with Suboxone, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Suboxone je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Suboxone is a medicine that contains two active substances, buprenorphine and naloxone. 
Zdravilo Suboxone vsebuje dve zdravilni učinkovini: buprenorfin in nalokson.
How has Suboxone been studied? 
Kako je bilo zdravilo Suboxone raziskano?
What is Suboxone? 
Kaj je zdravilo Suboxone?
What is Suboxone used for? 
Za kaj se zdravilo Suboxone uporablja?
How does Suboxone work? 
Kako zdravilo Suboxone deluje?
How is Suboxone used? 
Kako se zdravilo Suboxone uporablja?
This summary was last updated in 08-2008. 
Povzetek je bil nazadnje posodobljen 8-2008.
The marketing authorisation was renewed on 22 September 2003 and on 22 September 2008. 
Dovoljenje za promet z zdravilom je bilo obnovljeno dne 22. septembra 2003 in 22. septembra 2008.
Other information about Comtan: 
Druge informacije o zdravilu Comtan:
The European Commission granted a marketing authorisation valid throughout the European Union for Comtan to Novartis Europharm Limited on 22 September 1998. 
Evropska komisija je dovoljenje za promet z zdravilom Comtan, veljavno po vsej Evropski uniji, odobrila družbi Novartis Europharm Limted dne 22. septembra 1998.
The Committee recommended that Comtan be given marketing authorisation. 
Odbor je priporočil, da se za zdravilo Comtan odobri dovoljenje za promet.
It should not be used with combinations that are ‘modified release' (when the levodopa is released slowly over a few hours). 
Ne sme se ga uporabljati skupaj v kombinacijah s „prilagojenim sproščanjem“ (kjer se levodopa počasi sprošča v obdobju več ur).
Comtan is used to treat patients with Parkinson's disease. 
Zdravilo Comtan se uporablja za zdravljenje bolnikov s Parkinsonovo boleznijo.
What benefit has Comtan shown during the studies? 
Kakšne koristi je zdravilo Comtan izkazalo med študijami?