FrancophonIA/ELRC3.0 huggingface dataset:
English: Nevanac is an eye drop suspension that contains the active substance nepafenac (1 and 3 mg/ml).
Slovenian: Nevanac je suspenzija v obliki kapljic za oko, ki vsebuje zdravilno učinkovino nepafenak (1 in 3 mg/ml).
English: Nevanac must not be used in people who are hypersensitive (allergic) to nepafenac, to any of the other ingredients or to other NSAIDs.
Slovenian: Zdravila Nevanac ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) nepafenak ali katero koli drugo sestavino zdravila ali na druga nesteroidna protivnetna zdravila.
English: Like other NSAIDs, Nevanac must not be used in patients who have previously had an attack of asthma, hives or inflammation of the nasal passages when they take aspirin or other NSAIDs.
Slovenian: Podobno kot drugih nesteroidnih protivnetnih zdravil tudi zdravila Nevanac ne smejo uporabljati bolniki, ki so ob zaužitju aspirina ali drugih nesteroidnih protivnetnih zdravil že doživeli napad astme, dobili izpuščaje ali imeli vnetje nosne votline.
English: Nevanac is used in adults to prevent and treat the pain and inflammation that can occur after an operation to remove a cataract from the eye.
Slovenian: Zdravilo Nevanac se uporablja pri odraslih za preprečevanje in zdravljenje bolečin ter vnetij, ki se lahko pojavijo po operativni odstranitvi katarakte iz očesa.
English: Nevanac is also used to reduce the risk of macular oedema (swelling in the macula, the central part of the retina at the back of the eye) that can occur after cataract surgery in adult diabetes patients.
Slovenian: Zdravilo Nevanac se uporablja tudi za zmanjšanje tveganja makularnega edema (otekanja v rumeni pegi, osrednjem delu mrežnice v zadnjem delu očesa), ki se lahko pojavi po operaciji katarakte pri odraslih sladkornih bolnikih.
English: The most common side effects with Nevanac (seen in up to 1 in 100 patients) are inflammation of the surface of the eye, defects in the cornea, the sensation of a foreign body in the eye, and crust forming at edge on the eyelids.
Slovenian: Najpogostejši neželeni učinki zdravila Nevanac (opaženi pri več kot 1 bolniku od 10) so vnetje površine oči, okvare v roženici, občutek tujka v očesu in kraste, ki se naredijo na robovih vek.
English: Another three studies, in a total of 981 patients, compared Nevanac used three times a day, either with placebo, with ketorolac eye drops (another NSAID) or with both placebo and ketorolac.
Slovenian: V drugih treh študijah, ki so vključevale skupaj 981 bolnikov, so zdravilo Nevanac, uporabljeno trikrat na dan, primerjali s placebom, s kapljicami za oko, ki vsebujejo ketorolak (drugo nesteroidno protivnetno zdravilo), ali s placebom in ketorolakom.
English: In the study comparing Nevanac with ketorolac, around 65% of both groups of patients showed no or few signs of inflammation.
Slovenian: V študiji, v kateri so zdravilo Nevanac primerjali s ketorolakom, približno 65 % bolnikov iz obeh skupin ni imelo nobenih znakov vnetja ali pa je bilo teh znakov malo.
English: For reducing the risk of macular oedema, Nevanac has been compared with placebo in three main studies involving 1483 diabetes patients with retinopathy (damage to the retina) undergoing cataract surgery.
Slovenian: Pri zmanjšanju tveganja makularnega edema so zdravilo Nevanac primerjali s placebom v eni glavni študiji, v kateri je sodelovalo 1483 sladkornih bolnikov z retinopatijo (poškodbo mrežnice), ki so prestali operacijo katarakte.
English: For the prevention and treatment of pain and inflammation, Nevanac 1 mg/ml has been studied in four main studies involving a total of 1,201 patients undergoing cataract surgery.
Slovenian: Učinkovitost zdravila Nevanac v odmerku 1 mg/ml pri preprečevanju in zdravljenju bolečine in vnetja je bila raziskana v štirih glavnih študijah, ki so vključevale skupaj 1 201 bolnika, pri katerem je bila opravljena operacija katarakte.
English: Nevanac contains benzalkonium chloride, which is known to discolour soft contact lenses.
Slovenian: Zdravilo Nevanac vsebuje benzalkonijev klorid, ki dokazano obarva mehke kontaktne leče.
English: The active substance in Nevanac, nepafenac, is a ‘prodrug' of amfenac.
Slovenian: Zdravilna učinkovina v zdravilu Nevanac, nepafenak, je „predzdravilo“ amfenaka.
English: For the full list of all side effects reported with Nevanac, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Nevanac, glejte navodilo za uporabo.
English: In the second and third study, 2.3% and 5.9% of patients taking Nevanac 3 mg/ml developed macular oedema, respectively, compared with between 17.3% and 14.3% of patients taking placebo.
Slovenian: V drugi in tretji študiji se je makularni edem razvil pri 2,3 % oziroma 5,9 % bolnikih, ki so jemali zdravilo Nevanac, v primerjavi s 17,3 % oziroma 14,3 % bolnikov, ki so jemali placebo.
English: In the study comparing different numbers of drops daily, the patients using Nevanac 1 mg/ml three times a day had the lowest failure rate.
Slovenian: V študiji, v kateri so primerjali različno število kapljic na dan, je bilo zdravljenje bolnikov, ki so uporabljali zdravilo Nevanac 1 mg/ml trikrat dnevno, najuspešnejše.
English: In the first study, 3.2% of patients taking Nevanac 1 mg/ml developed macular oedema (4 out of 125), compared with 16.7% of patients taking placebo (21 out of 126).
Slovenian: V prvi študiji se je makularni edem razvil pri 3,2 % (4 od 125) bolnikov, ki so jemali zdravilo Nevanac, v primerjavi s 16,7 % (21 od 126) bolnikov, ki so jemali placebo.
English: How has Nevanac been studied?
Slovenian: Kako je bilo zdravilo Nevanac raziskano?
English: In diabetes patients, Nevanac was more effective than placebo in reducing the risk of macular oedema.
Slovenian: Pri sladkornih bolnikih je bilo zdravilo Nevanac pri zmanjševanju tveganja makularnega edema učinkovitejše od placeba.
English: Nevanac was more effective than placebo and as effective as ketorolac in reducing signs of inflammation.
Slovenian: Zdravilo Nevanac je bilo pri zmanjševanju znakov vnetja učinkovitejše od placeba in enako učinkovito kot ketorolak.
English: This means that it is converted into amfenac in the eye. Amfenac is a non-steroidal anti-inflammatory drug (NSAID).
Slovenian: Amfenak je nesteroidno protivnetno zdravilo (NSAID).
English: One drop of Nevanac is given into the affected eye(s), either three times a day with the 1 mg/ml strength, or once a day if using the 3 mg/ml strength.
Slovenian: V prizadeto oko (obe očesi) se daje ena kapljica zdravila Nevanac trikrat na dan v odmerku 1 mg/ml ali enkrat na dan v odmerku 3 mg/ml.
English: One study compared Nevanac 1 mg/ml used once, twice or three times a day with placebo (dummy eye drops) in 220 patients.
Slovenian: V eni študiji so pri 220 bolnikih zdravilo Nevanac 1 mg/ml, uporabljeno enkrat, dvakrat ali trikrat na dan, primerjali s placebom (kapljicami za oko brez zdravilne učinkovine).
English: What is Nevanac used for?
Slovenian: Za kaj se zdravilo Nevanac uporablja?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nevanac have also been included in the summary of product characteristics and the package leaflet.
Slovenian: V povzetek glavnih značilnosti zdravila in navodilo za uporabo so bili vključeni priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo tega zdravila upoštevati zdravstveni delavci in bolniki.
English: How does Nevanac work?
Slovenian: Kako zdravilo Nevanac deluje?
English: How is Nevanac used?
Slovenian: Kako se zdravilo Nevanac uporablja?
English: What is Nevanac?
Slovenian: Kaj je zdravilo Nevanac?
English: The usual dose is one tablet taken once a day with food.
Slovenian: Običajni odmerek je ena tableta, ki se jemlje enkrat na dan sočasno s hrano.
English: This means that it is similar to a ‘reference medicine' already authorised in the European Union (EU)
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Viread.
English: The full EPAR for Tenofovir disoproxil Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Dizoproksiltenofovirat Mylan je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It is used in patients with liver damage but whose liver is still working properly (compensated liver disease).
Slovenian: Uporablja se pri bolnikih z okvaro jeter, ki sicer še vedno ustrezno delujejo (kompenzirana jetrna bolezen).
English: The company that makes Tenofovir disoproxil Mylan will also ensure that all doctors who are expected to prescribe or use the medicine are provided with educational materials containing important safety information, particularly on the risks and precautions relating to kidney function and the bones.
Slovenian: Družba, ki izdeluje zdravilo Dizoproksiltenofovirat Mylan, bo zagotovila tudi, da bodo vsi zdravniki, ki naj bi predpisovali ali uporabljali to zdravilo, prejeli izobraževalno gradivo, ki bo vsebovalo pomembne varnostne informacije, zlasti o tveganjih in previdnostnih ukrepih, ki se nanašajo na delovanje ledvic in kosti.
English: This is a summary of the European public assessment report (EPAR) for Tenofovir disoproxil Mylan.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Dizoproksiltenofovirat Mylan.
English: In adults, it can also be used for those patients with liver damage whose liver is not working properly (decompensated liver disease) and those patients who do not respond to treatment with lamivudine (another medicine for hepatitis B).
Slovenian: Pri odraslih se lahko uporablja tudi pri tistih bolnikih z okvaro jeter, pri katerih ta ne delujejo ustrezno (dekompenzirana jetrna bolezen), in tistih, ki se ne odzivajo na zdravljenje z lamivudinom (drugim zdravilom za zdravljenje okužbe z virusom hepatitisa B).
English: Tenofovir disoproxil Mylan, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Slovenian: Zdravilo Dizoproksiltenofovirat Mylan v kombinaciji z drugimi protivirusnimi zdravili zniža količino virusa HIV v krvi in jo vzdržuje na nizki ravni.
English: The Committee recommended that Tenofovir disoproxil Mylan be approved for use in the EU.
Slovenian: Priporočil je, da se zdravilo Dizoproksiltenofovirat Mylan odobri za uporabo v EU.
English: Tenofovir is a nucleotide reverse-transcriptase inhibitor (NRTI).
Slovenian: Tenofovir je zaviralec nukleotidne reverzne transkriptaze (NRTI).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Tenofovir disoproxil Mylan has been shown to have comparable quality and to be bioequivalent to Viread.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Dizoproksiltenofovirat Mylan primerljivo raven kakovosti kot zdravilo Viread ter da mu je biološko enakovredno.
English: What measures are being taken to ensure the safe and effective use of Tenofovir disoproxil Mylan?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Dizoproksiltenofovirat Mylan?
English: Tenofovir disoproxil Mylan is used to treat adults and adolescents from 12 years of age infected with human immunodeficiency virus type 1 (HIV 1), a virus that causes acquired immune deficiency syndrome (AIDS).
Slovenian: Zdravilo Dizoproksiltenofovirat Mylan se uporablja za zdravljenje odraslih in mladostnikov, starejših od 12 let, ki so okuženi z virusom človeške imunske pomanjkljivosti tipa 1 (HIV 1), tj. virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
English: Because Tenofovir disoproxil Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Dizoproksiltenofovirat Mylan generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: Tenofovir disoproxil Mylan does not cure HIV infection or AIDS, but it may hold off damage to the immune system and the development of infections and diseases associated with AIDS.
Slovenian: Zdravilo Dizoproksiltenofovirat Mylan ne ozdravi okužbe z virusom HIV ali aidsa, vendar pa lahko upočasni slabšanje imunskega sistema ter prepreči razvoj okužb in bolezni, povezanih z aidsom.
English: Tenofovir disoproxil Mylan is also used to treat chronic (long-term) hepatitis B virus infection in adults and adolescents from 12 years of age.
Slovenian: Dizoproksiltenofovirat Mylan se uporablja tudi za zdravljenje kronične (dolgotrajne) okužbe z virusom hepatitisa B pri odraslih in mladostnikih, starejših od 12 let.
English: For patients who have taken medicines to treat HIV infection before, doctors should only prescribe Tenofovir disoproxil Mylan once they have looked at the antiviral medicines the patient has taken before or the likelihood of the virus's response to antiviral medicines.
Slovenian: Bolnikom, ki so predhodno že jemali zdravila za zdravljenje okužbe z virusom HIV, smejo zdravniki predpisati zdravilo Dizoproksiltenofovirat Mylan šele potem, ko se seznanijo s protivirusnimi zdravili, ki jih je bolnik jemal pred tem, oziroma ko ocenijo, kakšna je verjetnost, da se bo virus odzval na protivirusna zdravila.
English: Tenofovir also interferes with the action of an enzyme produced by the hepatitis-B virus called ‘DNA polymerase', which is involved in the formation of viral DNA.
Slovenian: Tenofovir prav tako ovira delovanje encima, ki ga proizvaja virus hepatitisa B, imenovan „DNK-polimeraza“, ki je vključen v proces nastajanja virusne DNK.
English: In HIV infection, it blocks the activity of reverse transcriptase, an enzyme produced by HIV that allows it to reproduce itself in the cells it has infected.
Slovenian: Pri okužbi z virusom HIV zavira dejavnost reverzne transkriptaze, tj. encima, ki ga tvori virus HIV in ki mu omogoča razmnoževanje v okuženih celicah.
English: Tenofovir disoproxil Mylan can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of HIV infection or chronic hepatitis B. Tenofovir disoproxil Mylan is available as tablets (245 mg) to be taken by mouth.
Slovenian: Predpisovanje in izdaja zdravila Dizoproksiltenofovirat Mylan je le na recept, zdravljenje z njim pa mora uvesti zdravnik, ki ima izkušnje z zdravljenjem okužbe z virusom HIV ali kroničnega hepatitisa B. Zdravilo Dizoproksiltenofovirat Mylan je na voljo v obliki tablet (245 mg), ki se jemljejo peroralno.
English: Tenofovir disoproxil Mylan stops the virus making DNA and prevents it from multiplying and spreading.
Slovenian: Zdravilo Dizoproksiltenofovirat Mylan ustavi tvorbo DNK v virusu in tako prepreči njegovo razmnoževanje in širjenje.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tenofovir disoproxil Mylan have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Dizoproksiltenofovirat Mylan upoštevati zdravstveni delavci in bolniki, so prav tako vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: For more information about treatment with Tenofovir disoproxil Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Dizoproksiltenofovirat Mylan preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: What are the benefits and risks of Tenofovir disoproxil Mylan?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Dizoproksiltenofovirat Mylan?
English: Because Tenofovir disoproxil Mylan is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Viread.
Slovenian: Ker je zdravilo Dizoproksiltenofovirat Mylan generično zdravilo, so bile študije pri ljudeh omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Viread.
English: For practical information about using Tenofovir disoproxil Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Dizoproksiltenofovirat Mylan naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Tenofovir disoproxil Mylan tenofovir disoproxil
Slovenian: Dizoproksiltenofovirat Mylan dizoproksiltenofovirat
English: Other information about Tenofovir disoproxil Mylan
Slovenian: Druge informacije o zdravilu Dizoproksiltenofovirat Mylan
English: What is Tenofovir disoproxil Mylan and what is it used for?
Slovenian: Kaj je zdravilo Dizoproksiltenofovirat Mylan in za kaj se uporablja?
English: The active substance in this medicine, tenofovir disoproxil, is a ‘prodrug' that is converted into tenofovir in the body.
Slovenian: Zdravilna učinkovina zdravila Dizoproksiltenofovirat Mylan, dizoproksiltenofovirat, je „predzdravilo“, ki se v telesu pretvori v tenofovir.
English: Why is Tenofovir disoproxil Mylan approved?
Slovenian: Zakaj je bilo zdravilo Dizoproksiltenofovirat Mylan odobreno?
English: Tenofovir disoproxil Mylan contains the active substance tenofovir disoproxil.
Slovenian: Zdravilo Dizoproksiltenofovirat Mylan vsebuje zdravilno učinkovino dizoproksiltenofovirat.
English: It is not intended to provide practical advice on how to use Tenofovir disoproxil Mylan.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: How is Tenofovir disoproxil Mylan used?
Slovenian: Kako se zdravilo Dizoproksiltenofovirat Mylan uporablja?
English: How has Tenofovir disoproxil Mylan been studied?
Slovenian: Kako je bilo zdravilo Dizoproksiltenofovirat Mylan raziskano?
English: Tenofovir disoproxil Mylan is used in combination with other HIV medicines.
Slovenian: Uporablja se v kombinaciji z drugimi zdravili za zdravljenje okužbe z virusom HIV.
English: How does Tenofovir disoproxil Mylan work?
Slovenian: Kako zdravilo Dizoproksiltenofovirat Mylan deluje?
English: Strength Pharmaceutical Form
Slovenian: Farmacevtska oblika Način uporabe
English: If you forget to take a dose, take it as soon as you remember, unless it is nearly time for your next dose.
Slovenian: Če pozabite vzeti odmerek, ga vzemite takoj, ko se spomnite, razen če ni že blizu čas za naslednjega.
English: Children and adolescents Arava is not recommended for use in children and adolescents below 18 years of age.
Slovenian: Otroci in mladostniki Uporaba zdravila Arava ni priporočljiva pri otrocih in mladostnikih, ki so mlajši od 18 let.
English: Date of first authorisation: 02 September 1999 Date of latest renewal: 02 September 2009
Slovenian: Datum zadnjega podaljšanja: 02 september 2009
English: Arava with food, drink and alcohol
Slovenian: Zdravilo Arava skupaj s hrano, pijačo in alkoholom
English: Arava may be taken with or without food.
Slovenian: Zdravilo Arava lahko jemljete s hrano ali brez nje.
English: What Arava is and what it is used for
Slovenian: Kaj je zdravilo Arava in za kaj ga uporabljamo
English: Arava belongs to a group of medicines called anti-rheumatic medicines.
Slovenian: Zdravilo Arava spada v skupino zdravil, ki jih imenujemo antirevmatična zdravila.
English: You will normally take Arava over long periods of time.
Slovenian: Običajno boste zdravilo Arava jemali dolgo časa.
English: This may be reduced to a few weeks by taking certain medicines which speed up removal of Arava from your body.
Slovenian: To obdobje je mogoče skrajšati na nekaj tednov z jemanjem določenih zdravil, ki pospešijo odstranjevanje zdravila Arava iz telesa.
English: If you are pregnant or become pregnant while taking Arava, the risk of having a baby with serious birth defects is increased.
Slovenian: Če ste noseči ali zanosite med jemanjem zdravila Arava, je povečano tveganje, da se rodi otrok z resnimi prirojenimi okvarami.
English: Arava tablets are for oral use.
Slovenian: Tablete Arava so za peroralno uporabo.
English: Other medicines and Arava
Slovenian: Druga zdravila in zdravilo Arava
English: In either case it should be confirmed by a blood test that Arava has been sufficiently removed from your body and you should then wait for at least another month before you become pregnant.
Slovenian: V obeh primerih je treba s krvno preiskavo potrditi, da se je zdravilo Arava dovolj odstranilo iz telesa, potem pa morate počakati vsaj še en mesec, preden zanosite.
English: Your doctor will also check your blood pressure regularly as Arava can cause an increase in blood pressure.
Slovenian: Prav tako vam bo vaš zdravnik redno meril krvni tlak, saj ga zdravilo Arava lahko zviša.
English: There have been reports of chronic overdose in patients taking Arava at daily doses up to five times the recommended daily dose, and reports of acute overdose in adults and children.
Slovenian: Obstajajo poročila o kroničnem prevelikem odmerjanju pri bolnikih, ki so jemali zdravilo Arava v dnevnih odmerkih, do petkrat večjih od priporočenega dnevnega odmerka, in poročila o akutnem prevelikem odmerjanju pri odraslih in otrocih.
English: Your doctor will carry out blood tests at regular intervals, before and during treatment with Arava, to monitor your blood cells and liver.
Slovenian: Vaš zdravnik vam bo pred in med zdravljenjem z zdravilom Arava v rednih presledkih opravljal preiskave krvi, da bo kontroliral vaše krvne celice in jetra.
English: Talc(E553b)
Slovenian: Smukec (E553b)
English: If you forget to take Arava
Slovenian: Če ste pozabili vzeti zdravilo Arava
English: • Physician Leaflet The Physician Leaflet should contain the following key messages:
Slovenian: • Navodilo za zdravnika Navodilo za zdravnika mora vsebovati naslednje informacije:
English: The Marketing Authorisation Holder (MAH) shall ensure that all physicians who are expected to prescribe/use Arava are provided with a physician educational pack containing the following:
Slovenian: Imetnik dovoljenja za promet bo poskrbel, da bodo vsi zdravniki, ki nameravajo predpisovati zdravilo Arava dobili izobraževalno gradivo, ki vsebuje:
English: Arava is used to treat adult patients with active rheumatoid arthritis or with active psoriatic arthritis.
Slovenian: Zdravilo Arava se uporablja za zdravljenje odraslih bolnikov z aktivnim revmatoidnim artritisom ali aktivnim psoriatičnim artritisom.
English: Women of childbearing potential must not take Arava without using reliable contraceptive measures.
Slovenian: Ženske v rodni dobi ne smejo jemati zdravila Arava, če ne uporabljajo zanesljive kontracepcijske zaščite.
English: Results of animal fertility studies have shown no effect on male and female fertility, but adverse effects on male reproductive organs were observed in repeated dose toxicity studies (see section 5.3).
Slovenian: Študije na živalih niso pokazale vpliva na plodnost samcev in samic, o neželenih učinkih na moških reproduktivnih organih pa so poročali v študijah toksičnosti ponavljajočih se odmerkov (glejte poglavje 5.3).
English: Arava is not recommended for use in patients below 18 years since efficacy and safety in juvenile rheumatoid arthritis (JRA) have not been established (see sections 5.1 and 5.2).
Slovenian: Zdravila Arava ni priporočljivo uporabljati za bolnike do 18. leta starosti, ker učinkovitost in varnost pri juvenilnem revmatoidnem artritisu (JRA) nista ugotovljeni (glejte poglavje 5.1 in 5.2).
English: Certain vaccinations should not be given while taking Arava, and for a certain amount of time after stopping treatment.
Slovenian: Določenih cepiv se med uporabo zdravila Arava in določen čas po koncu tega zdravljenja ne sme uporabljati.