natgillin/translations-raw huggingface dataset:
Parenteral medicinal SABA products should be contraindicated in patients at less than 22 weeks of gestation, in patients with pre-existing ischaemic heart disease or those patients with significant risk factors for ischaemic heart disease and in patients with threatened abortion during the first and second trimester of gestation.
Parenteralna zdravila, ki vsebujejo kratkodelujoče beta agoniste, je treba kontraindicirati pri bolnicah v manj kot 22. tednu nosečnosti, pri bolnicah z obstoječo ishemično boleznijo srca in bolnicah z izrazitimi dejavniki tveganja za ishemično bolezen srca ter pri bolnicah, ki jim grozi splav v prvem in drugem trimesečju nosečnosti.
For these indications which include short term management of uncomplicated tocolysis the PRAC recommended the parenteral products should only be administered for short term management (up to 48 hours) in patients between 22 and 37 weeks of gestation.
Pri teh indikacijah, ki vključujejo kratkotrajno vodenje nezapletene tokolize, je PRAC priporočil, naj se parenteralne oblike zdravil dajejo samo za kratkotrajno zdravljenje (največ 48 ur) pri bolnicah med 22. in 37. tednom nosečnosti.
Tachycardia, palpitations, and changes of blood pressure accounted for about 2/3 of the adverse events associated with the oral formulation.
Približno dve tretjini neželenih dogodkov, povezanih s peroralno obliko, so predstavljale tahikardija, palpitacije in spremembe krvnega tlaka.
For these indications which include short term management of uncomplicated tocolysis the PRAC recommended the parenteral products should only be administered for short term management (up to 48 hours) of the obstetric indications in patients between 22 and 37 weeks of gestation.
Pri teh indikacijah, ki vključujejo kratkotrajno vodenje nezapletene tokolize, je PRAC priporočil, naj se parenteralne oblike zdravil dajejo samo za kratkotrajno zdravljenje (največ 48 ur) indikacij v porodništvu pri bolnicah med 22. in 37. tednom nosečnosti.
Myocardial infarction or serious arrhythmias were not reported in the clinical trial reports available to the MAH.
V poročilih o kliničnih preskušanjih, s katerimi razpolaga imetnik dovoljenja za promet z zdravilom, ni poročil o srčnem infarktu ali resnih aritmijah.
• epilepsy.
• epilepsijo.
The studies lasted up to 12 weeks.
Študije so trajale do 12 tednov.
The main measure of effectiveness was the change in the number of seizures after 11 to 12 weeks;
Glavno merilo učinkovitosti je bila sprememba števila napadov po 11 do 12 tednih;
The European Commission granted a marketing authorisation valid throughout the European Union for Lyrica to Pfizer Limited on 6 July 2004.
Evropska komisija je dovoljenje za promet z zdravilom Lyrica, veljavno po vsej Evropski uniji, odobrila družbi Pfizer Limited dne 6. julija 2004.
Patients who have kidney problems need to take lower doses.
Bolniki, ki imajo težave z ledvicami, morajo jemati nižje odmerke.
It is available as capsules (white: 25, 50 and 150 mg; white and orange: 75, 225 and 300 mg; orange: 100 mg; light orange: 200 mg) and as an oral solution (20 mg/ml).
Na voljo je v obliki kapsul (belih: 25, 50 in 150 mg; belih in oranžnih: 75, 225 in 300 mg; oranžnih: 100 mg; svetlo oranžnih: 200 mg) ali kot peroralna raztopina (20 mg/ml).
This document is a summary of the European Public Assessment Report (EPAR) for Lyrica.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Lyrica.
Other information about Lyrica:
Druge informacije o zdravilu Lyrica:
Effectiveness was measured using a standard anxiety questionnaire after four to eight weeks.
Učinkovitost so merili s standardnim vprašalnikom za merjenje tesnobe po štirih do osmih tednih.
Lyrica is used to treat adults with the following conditions:
Zdravilo Lyrica se uporablja za zdravljenje odraslih z naslednjimi boleznimi:
The CHMP decided that Lyrica's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Lyrica večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The effectiveness of Lyrica was measured using a standard pain questionnaire;
Učinkovitost zdravila Lyrica so merili s standardnim vprašalnikom za točkovanje bolečine;
The recommended starting dose of Lyrica is 150 mg per day, divided into two or three doses.
Priporočeni začetni odmerek zdravila Lyrica je 150 mg na dan, ki se porazdeli na dva ali tri odmerke.
What benefit has Lyrica shown during the studies?
Kakšne koristi je zdravilo Lyrica izkazalo med študijami?
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 Lyrica.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Lyrica, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
The most common side effects with Lyrica (seen in more than 1 patient in 10) are dizziness and somnolence (sleepiness).
Najpogostejša neželena učinka zdravila Lyrica (opažena pri več kot 1 bolniku od 10) sta omotica in zaspanost.
Lyrica is used as an ‘add-on' to existing treatment in patients who have partial seizures (epileptic fits starting in one specific part of the brain) that cannot be controlled with their current treatment;
Zdravilo Lyrica se uporablja kot dodatek k obstoječim zdravljenjem pri bolnikih s parcialnimi napadi (epileptični napadi, ki izvirajo iz določenega dela možganov), ki jih ni mogoče nadzorovati s trenutnim zdravljenjem;
Lyrica has been compared with placebo (a dummy treatment) in 22 studies:
Zdravilo Lyrica so primerjali s placebom (zdravilom brez zdravilne učinkovine) v 22 študijah:
Lyrica should not be used in people who may be hypersensitive (allergic) to pregabalin or any of the other ingredients.
Zdravila Lyrica ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) pregabalin ali katero koli drugo sestavino zdravila.
A further study was carried out in 137 patients with central neuropathic pain due to a spinal cord injury.
Nadaljnja študija je bila izvedena s približno 137 bolniki z osrednjo nevropatsko bolečino, ki je bila posledica poškodbe hrbtenjače.
In neuropathic pain, Lyrica was more effective than placebo in decreasing pain.
Pri nevropatski bolečini je bilo zdravilo Lyrica učinkovitejše od placeba pri zmanjšanju bolečine.
• neuropathic pain (pain due to nerve damage).
• nevropatsko bolečino (bolečino zaradi poškodbe živcev).
What is the risk associated with Lyrica?
Kakšna tveganja so povezana z zdravilom Lyrica?
Lyrica can be used in peripheral neuropathic pain, such as the pain experienced by diabetic patients or by patients who have had herpes zoster (shingles), and central neuropathic pain, such as the pain experienced by patients who have had a spinal cord injury;
Zdravilo Lyrica se lahko uporablja pri periferni nevropatski bolečini, kot je bolečina pri bolnikih s sladkorno boleznijo, ali pri bolnikih, ki so imeli herpes zoster (pasovec), in osrednji nevropatski bolečini, kot je bolečina pri bolnikih s poškodbo hrbtenjače;
After three to seven days, the dose can be increased to 300 mg per day.
Po treh do sedmih dneh se lahko odmerek poveča na 300 mg na dan. Količina odmerkov se lahko poveča do dvakrat, dokler ni dosežen najučinkovitejši odmerek.
• for peripheral neuropathic pain, there were ten studies involving over 3,000 patients, about half of whom had diabetic neuropathy and half of whom had pain following shingles.
• v desetih študijah so proučevali periferno nevropatsko bolečino pri več kot 3 000 bolnikih, od katerih jih je približno polovica imela diabetično nevropatijo, druga polovica pa bolečine po pasovcu.
Stopping treatment with Lyrica should also be done gradually, over at least a week.
Največji odmerek je 600 mg na dan. Tudi prenehanje zdravljenja z zdravilom Lyrica mora potekati postopno, in sicer mora trajati najmanj en teden.
In epilepsy, Lyrica reduced the number of seizures: about 45% of the patients taking 600 mg Lyrica a day and about 35% of those taking 300 mg Lyrica a day had a reduction in seizures of 50% or more.
Pri epilepsiji se je ob jemanju zdravila Lyrica zmanjšalo število napadov: pri približno 45 % bolnikov, ki so jemali 600 mg zdravila Lyrica, in pri približno 35 % bolnikov, ki so dnevno jemali 300 mg zdravila Lyrica, se je število napadov zmanjšalo za 50 % ali več.
For the full list of all side effects reported with Lyrica, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Lyrica, glejte navodilo za uporabo.
• for generalised anxiety disorder, there were eight studies involving over 3,000 patients.
• v osmih študijah so proučevali generalizirano anksiozno motnjo pri več kot 3 000 bolnikih.
Why has Lyrica been approved?
Zakaj je bilo zdravilo Lyrica odobreno?
For more information about treatment with Lyrica, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Lyrica preberite navodilo za uporabo (ki je prav tako del EPAR).
• for epilepsy, there were three studies involving over 1,000 patients.
• V treh študijah so proučevali več kot 1 000 bolnikov z epilepsijo.
In generalised anxiety disorder, Lyrica was more effective than placebo: 52% of the patients taking Lyrica had an improvement of 50% or more, compared with 38% of the patients taking placebo.
Pri generalizirani anksiozni motnji je bilo zdravilo Lyrica učinkovitejše od placeba: pri 52 % bolnikov, ki so jemali zdravilo Lyrica, je bilo izboljšanje 50- ali večodstotno v primerjavi z 38 % bolnikov, ki so jemali placebo.
The full EPAR for Lyrica can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Lyrica je na voljo tukaj.
What is Lyrica used for?
Za kaj se zdravilo Lyrica uporablja?
In central neuropathic pain, 22% of patients treated with Lyrica had a decrease in pain scores of 50% or more, compared with 8% of the patients treated with placebo.
Pri osrednji nevropatski bolečini je bilo pri 22 % bolnikov, zdravljenih z zdravilom Lyrica, doseženo izboljšanje točkovanja bolečine za 50 % ali več v primerjavi z 8 % bolnikov, ki so se zdravili s placebom.
How does Lyrica work?
Kako zdravilo Lyrica deluje?
In peripheral neuropathic pain, 35% of the patients treated with Lyrica had a decrease in pain scores of 50% or more, compared with 18% of the patients treated with placebo.
Pri periferni nevropatski bolečini je bilo pri 35 % bolnikov, zdravljenih z zdravilom Lyrica, doseženo izboljšanje točkovanja bolečine za 50 % ali več v primerjavi z 18 % bolnikov, ki so se zdravili s placebom.
How has Lyrica been studied?
Kako je bilo zdravilo Lyrica raziskano?
How is Lyrica used?
Kako se zdravilo Lyrica uporablja?
The company presented results of five key studies from the published literature.
Družba je predstavila rezultate petih glavnih študij iz objavljene literature.
If necessary, the dose can be divided between both sides of the mouth.
Po potrebi se lahko odmerek porazdeli med obe strani ust.
The European Commission granted a marketing authorisation valid throughout the European Union for Buccolam on 5 September 2011.
Evropska komisija je dovoljenje za promet z zdravilom Buccolam, veljavno po vsej Evropski uniji, odobrila dne 5. septembra 2011.
Each syringe contains 2.5 mg, 5 mg, 7.5 mg or 10 mg of midazolam.
Ena brizga vsebuje 2,5 mg, 5 mg, 7,5 mg ali 10 mg midazolama.
The full EPAR for Buccolam can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Buccolam je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The recommended dose ranges from 2.5.mg to 10 mg, depending on the child's age.
Priporočeni odmerek znaša od 2,5 mg do 10 mg glede na starost otroka.
With regard to side effects, the medicine may cause respiratory depression, as is the case with other comparable medicines, but is generally well tolerated.
Kar zadeva stranske učinke, lahko zdravilo povzroča respiratorno depresijo tako kot druga primerljiva zdravila, vendar ga bolniki na splošno dobro prenašajo.
Neurotransmitters such as GABA are chemicals that allow nerve cells to communicate with each other.
Živčni prenašalci, kot je GABA, so kemične snovi, ki živčnim celicam omogočajo medsebojno komunikacijo.
Convulsions are caused by excessive electrical activity in the brain.
Konvulzije povzroča prekomerna električna aktivnost v možganih.
This is a summary of the European public assessment report (EPAR) for Buccolam.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Buccolam.
For more information about treatment with Buccolam, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Buccolam preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
Carers should only administer one dose.
Negovalci smejo dati samo en odmerek.
In the four studies, oromucosal midazolam was effective in stopping a seizure within 10 minutes in 65 to 78% of children compared with 41 to 85% of children who received rectal diazepam.
V štirih študijah je bil oralni midazolam pri zaustavitvi epileptičnega napada v 10 minutah učinkovit pri 65 do 78 % otrok v primerjavi z 41 do 85 % otrok, ki so prejeli rektalni diazepam.
Buccolam is given in the side of the child's mouth.
Zdravilo Buccolam se daje na eno stran otrokovih ust.
The full amount of the appropriate prefilled syringe should be given slowly into the space between the gum and the cheek.
Celotni odmerek ustrezne napolnjene brizge se mora vbrizgati počasi v prostor med dlesnijo in licem.
The Committee therefore decided that Buccolam's benefits are greater than its risks and recommended that it be given marketing authorisation.
Zato je Odbor zaključil, da so koristi zdravila Buccolam večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
Buccolam has the advantage of being quicker and easier to administer than rectal or intravenous medicines.
Prednost zdravila Buccolam je hitrejša in enostavnejša uporaba v primerjavi z rektalnimi ali intravenskimi zdravili.
Based on the results of the studies presented, the CHMP concluded that Buccolam is at least as effective as existing treatments for stopping acute prolonged, convulsive seizures in children.
Na podlagi rezultatov predstavljenih študij je CHMP zaključil, da je zdravilo Buccolam vsaj tako učinkovito kot obstoječa zdravljenja za zaustavljanje akutnih, dalj časa trajajočih epileptičnih napadov pri otrocih.
What benefit has Buccolam shown during the studies?
Kakšne koristi je zdravilo Buccolam izkazalo med študijami?
Although intravenous medicines may take less time to start working once injected, it takes time to gain access to the veins, especially in children.
Čeprav lahko intravenska zdravila začnejo delovati v krajšem času po injiciranju, pa je za zagotovitev dostopa do ven, zlasti pri otrocih, potreben dodaten čas.
If the seizure has not stopped within 10 minutes of giving Buccolam, they should seek medical help immediately.
Če epileptični napad v 10 minutah po prejemu zdravila Buccolam ne mine, je treba nemudoma poiskati zdravniško pomoč.
When given by carers or parents Buccolam should only be used when the child has already been diagnosed with epilepsy.
Kadar zdravilo Buccolam dajejo negovalci ali starši, se lahko uporablja samo, ko je pri otroku epilepsija že ugotovljena.
When comparing buccal midazolam with intravenous diazepam, the results were also very similar.
Tudi pri primerjavi bukalnega midazolama z intravenskim diazepamom so bili rezultati zelo podobni.
Buccolam is used to stop prolonged, acute (sudden) convulsive seizures in children and adolescents (from 3 months to less than 18 years of age).
Zdravilo Buccolam se uporablja za zaustavitev dalj časa trajajočih, akutnih (nenadnih) epileptičnih napadov pri otrocih in mladostnikih (starih več kot tri mesece in manj kot 18 let).
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 Buccolam.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Buccolam, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
It must not be used in patients with myasthenia gravis (a disease causing muscle weakness), severe respiratory insufficiency (lung conditions that cause difficulty breathing), sleep apnoea syndrome (frequent interruption of breathing during sleep) or severe liver problems.
Ne smejo ga uporabljati bolniki z miastenijo gravis (bolezen, ki povzroča oslabelost mišic), hudo respiratorno insuficienco (bolezni pljuč, ki povzročajo težave z dihanjem), sindromom apneje v spanju (pogoste prekinitve dihanja med spanjem) ali hudimi težavi z jetri.
In infants from 3 months to less than 6 months Buccolam should only be used within a hospital and where equipment is available for resuscitation and monitoring of the patient due to an increased risk respiratory depression (inhibition of breathing).
Pri dojenčkih, starih od tri do šest mesecev, se lahko zdravilo Buccolam uporablja samo v bolnišnicah, kjer je na voljo oprema za oživljanje in je možno spremljanje bolnika zaradi povečanega tveganja za respiratorno depresijo (oviranje dihanja).
Other information about Buccolam
Druge informacije o zdravilu Buccolam:
What is the risk associated with Buccolam?
Kakšna tveganja so povezana z zdravilom Buccolam?
EPAR summary for the public midazolam
Povzetek EPAR za javnost
Buccolam must not be used in people who may be hypersensitive (allergic) to midazolam, benzodiazepines or any of the other ingredients.
Zdravila Buccolam ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) midazolam, benzodiazepine ali katerokoli drugo sestavino zdravila.
The most common side effects with Buccolam (seen in more than 1 patient in 10) are sedation, somnolence (sleepiness), depressed levels of consciousness, respiratory depression and nausea (feeling sick) and vomiting.
Najpogostejši neželeni učinki zdravila Buccolam (opaženi pri več kot 1 bolniku od 10) so sedacija, somnolenca (zaspanost), zmanjšana stopnja zavedanja, respiratorna depresija, slabost in bruhanje.
Buccolam attaches to the receptors for the neurotransmitter GABA in the brain and activates them.
Zdravilo Buccolam se veže na receptorje živčnega prenašalca GABA v možganih in jih aktivira.
These studies looked at children with acute convulsions and compared the effects of oromucosal midazolam with those of diazepam (another benzodiazepine) when given intravenously (into a vein) or rectally (into the rectum).
V teh študijah so proučevali otroke z akutnimi konvulzijami in primerjali učinke oralne uporabe midazolama z učinki diazepama (druge benzodiazepin) pri intravenski (dajanje v veno) ali rektalni (dajanje v danko) uporabi.
Reports from the published literature confirmed that oromucosal midazolam is effective in stopping seizures in children.
Poročila iz objavljene literature potrjujejo, da je oralni midazolam učinkovit pri zaustavljanju epileptičnih napadov pri otrocih.
Buccolam is a medicine that contains the active substance midazolam.
Buccolam je zdravilo, ki vsebuje zdravilno učinkovino midazolam.
It is available as ‘oromucosal solution' (a solution given in the side of the mouth, into the space between the gum and the cheek) in prefilled syringes.
Na voljo je v obliki „oralne raztopine“ (raztopine, ki se daje na eno stran ust v prostor med dlesnijo in licem) v napolnjenih brizgah.
In the brain, GABA is involved in reducing the electrical activity.
GABA v možganih vpliva na zmanjšanje električne aktivnosti.
The active substance in Buccolam is midazolam, a benzodiazepine, which acts as an anti-convulsant medicine.
Zdravilna učinkovina v zdravilu Buccolam, midazolam, je benzodiazepin, ki deluje kot antikonvulziv.
For the full list of all side effects reported with Buccolam, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Buccolam, glejte navodilo za uporabo.
Why has Buccolam been approved?
Zakaj je bilo zdravilo Buccolam odobreno?
By activating its receptors, Buccolam increases GABA's effects, which will stop a convulsion.
Z aktiviranjem receptorjev zdravilo Buccolam poveča učinke živčnega prenašalca GABA, kar zaustavi epileptični napad.
The fifth study compared buccal midazolam with intravenous diazepam, where the measure of effectiveness was the treatment's ability to stop the seizure within 5 minutes.
V peti študiji so bukalni midazolam primerjali z intravenskim diazepamom, pri čemer je bilo glavno merilo učinkovitosti sposobnost zdravila, da v 5 minutah zaustavi epileptični napad.
In four of these studies, oromucosal midazolam was compared with rectal diazepam and the measure of effectiveness was the treatment's ability to stop the seizure within 10 minutes.
V štirih od teh študij so oralni midazolam primerjali z rektalnim diazepamom, merilo učinkovitosti pa je bila sposobnost zdravila, da v 10 minutah zaustavi epileptični napad.
What is Buccolam used for?
Za kaj se zdravilo Buccolam uporablja?
How has Buccolam been studied?
Kako je bilo zdravilo Buccolam raziskano?
What is Buccolam?
Kaj je zdravilo Buccolam?
How does Buccolam work?
Kako zdravilo Buccolam deluje?
How is Buccolam used?
Kako se zdravilo Buccolam uporablja?
Strength Pharmaceutical Form
Izmišljeno ime Jakost Farmacevtska oblika Pot uporabe Ovojnina
l t o r
Velikost pakiranja o ā t
The studies looked at measurements of pain and disease activity after 13 weeks of treatment.
V študijah so proučevali merjenje bolečine in bolezenske aktivnosti po 13 tednih zdravljenja.
It was to be available as filmcoated tablets.
Na voljo naj bi bilo v obliki filmsko obloženih tablet.
The Committee was not convinced that screening patients for the DQA1*0102 gene variant sufficiently reduced this risk.
Odbor ni bil prepričan, da pregledovanje bolnikov za odkrivanje genske različice DQA1*0102 zadostno zmanjšuje to tveganje.
Two of the studies involved 3,235 patients with knee osteoarthritis while the third study involved 1,262 patients with hip osteoarthritis.
V dveh študijah je sodelovalo 3 235 bolnikov z osteoartritisom kolena, v tretji študiji pa 1 262 bolnikov z osteoartritisom kolka.
The effects of Joicela were first tested in experimental models before being studied in humans.
Učinki zdravila Joicela so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
What is Joicela?
Kaj je zdravilo Joicela?
The company informed the CHMP that no clinical trials or compassionate use programmes are currently on-going with Joicela.
Družba je obvestila CHMP, da se trenutno ne izvajajo nobena klinična preskušanja ali programi sočutne uporabe zdravila Joicela.
DQA1*0102 is thought to increase the risk of liver toxicity in patients taking Joicela.
DQA1*0102 domnevno povečuje tveganje toksičnosti za jetra pri bolnikih, ki jemljejo zdravilo Joicela.
At the time of the withdrawal, the CHMP was of the view that the benefits of Joicela did not outweigh its risks, particularly its risk of liver toxicity.
V času umika je CHMP menil, da koristi zdravila Joicela ne odtehtajo z njim povezanih tveganj, zlasti tveganja toksičnosti za jetra.
By reducing the production of prostaglandins, Joicela helps to reduce the symptoms of inflammation, such as pain, seen in osteoarthritis.
Z zmanjševanjem proizvajanja prostaglandinov, zdravilo Joicela lajša simptome vnetja, kot je bolečina, opažena pri osteoartritisu.
Withdrawal of the marketing authorisation application for Joicela (lumiracoxib)
Umik vloge za pridobitev dovoljenja za promet z zdravilom Joicela (lumirakoksib)