FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not use SIMBRINZA - if you are allergic to brinzolamide or brimonidine tartrate or any of the other ingredients of this medicine (listed in section 6) - if you are allergic to sulphonamides (examples include medicines used to treat diabetes and infections and also diuretics (water tablets)) - if you are taking a monoamine oxidase (MAO) inhibitors (examples include medicines to treat depression or Parkinson's disease) or certain antidepressants.
Slovenian: (navedeno v poglavju 6), - če ste alergični na sulfonamide (mednje sodijo na primer zdravila za zdravljenje sladkorne bolezni in okužb ter tudi diuretiki (tablete za odvajanje vode)), - če jemljete zaviralce monoaminooksidaze (MAO) (mednje sodijo na primer zdravila za zdravljenje depresije ali Parkinsonove bolezni) ali določene antidepresive; obvestite svojega zdravnika, če jemljete kateri koli antidepresiv, - če imate hude težave z ledvicami, - če je vaša kri preveč kisla (motnja, ki ji pravimo hiperkloremična acidoza), - pri dojenčkih in majhnih otrocih, mlajših od 2 let.
English: 2, hypoaesthesia eye
Slovenian: 2, hipestezija očesa
English: 2, upper respiratory tract congestion nasal congestion
Slovenian: 2, kongestija sluznice zgornjih dihal
English: Wearing contact lenses - SIMBRINZA contains benzalkonium chloride
Slovenian: Glejte poglavje ‘Nošenje kontaktnih leč - zdravilo SIMBRINZA vsebuje benzalkonijev klorid' v nadaljevanju.
English: 2, feeling abnormal
Slovenian: 2, nenavadno počutje občutek nemira
English: 1, visual acuity reduced
Slovenian: 1, izcedek iz očesa 1, zmanjšana ostrina vida
English: If you use more SIMBRINZA than you should
Slovenian: Če ste uporabili večji odmerek zdravila SIMBRINZA, kot bi smeli Sperite oko s toplo vodo.
English: SIMBRINZA 10 mg/ml + 2 mg/ml eye drops brinzolamide/brimonidine tartrate
Slovenian: SIMBRINZA 10 mg/ml + 2 mg/ml kapljice za oko brinzolamid/brimonidinijev tartrat okularna uporaba
English: 2, eye swelling 2, eyelid oedema
Slovenian: 2, edem vek 1, edem veznice suho oko
English: Uncommon: pain
Slovenian: Občasni: bolečine
English: Least squares means derived from a statistical model that accounts for study site, 9 AM baseline IOP stratum, and correlated IOP measurements within patient
Slovenian: Srednje vrednosti po metodi najmanjših kvadratov, izpeljane iz statističnega modela z upoštevanjem mesta izvajanja študije, začetnih vrednosti očesnega tlaka ob 9.00 uri zjutraj in ustreznih meritev očesnega tlaka pri posameznem bolniku
English: SIMBRINZA contains two active substances, brinzolamide and brimonidine tartrate.
Slovenian: Zdravilo SIMBRINZA vsebuje dve učinkovini, brinzolamid in brimonidinijev tartrat.
English: There is a potential for an additive effect on the known systemic effects of carbonic anhydrase inhibition in patients receiving an oral carbonic anhydrase inhibitor and topical brinzolamide.
Slovenian: Pri bolnikih, ki jemljejo peroralni zaviralec karboanhidraze ob topikalni uporabi brinzolamida, obstaja nevarnost za aditivno delovanje z znanimi sistemskimi učinki zaviralcev karboanhidraze.
English: 2, rash maculopapular pruritus generalised
Slovenian: 2, generalizirani pruritus
English: , heart rate irregular
Slovenian: , nepravilen srčni utrip
English: How to store SIMBRINZA
Slovenian: Shranjevanje zdravila SIMBRINZA
English: -8.1 (n=346) -8.2 (n=330)
Slovenian: -8,2 (n=330)
English: 1, meibomianitis
Slovenian: 1, omotica
English: When nasolacrimal occlusion is used and the eyelids are closed for 2 minutes, systemic absorption is reduced.
Slovenian: Sistemsko absorpcijo zdravila bolnik zmanjša z zaprtjem nazolakrimalnega kanala in vek za 2 minuti.
English: 2, throat irritation
Slovenian: 2, razdražljivost
English: -8.4 (n=394) -8.4 (n=384)
Slovenian: -8,4 (n=394)
English: 1, sneezing Not known: asthma Gastrointestinal disorders Common: dry mouth Uncommon: dyspepsia
Slovenian: 1, kapljanje izcedka po zadnji strani žrela kihanje Neznana: astma
English: Contact your doctor immediately if you develop extreme tiredness or dizziness.
Slovenian: Če občutite skrajno utrujenost ali omotico, se nemudoma posvetujte s svojim zdravnikom.
English: Always use this medicine exactly as your doctor, optometrist (optician) or pharmacist has told you.
Slovenian: Pri uporabi tega zdravila natančno upoštevajte navodila zdravnika, optometrista (optika) ali farmacevta.
English: - If you get any side effects, talk to your doctor, optometrist (optician) or pharmacist.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, optometristom (optikom) ali farmacevtom.
English: 1, cough 2, epistaxis
Slovenian: 2, epistaksa
English: -8.5 (n=384) -8.3 (n=373)
Slovenian: -8,3 (n=373)
English: Hepatobiliary disorders Not known: liver function test abnormal Skin and subcutaneous tissue disorders
Slovenian: Neznana: nenormalni izvidi preiskav delovanja jeter
English: SIMBRINZA should not be used by women who are breast-feeding.
Slovenian: Tudi peroralno uporabljen brimonidin se izloča v materino mleko, zato zdravila SIMBRINZA ne smete uporabljati pri materah, ki dojijo.
English: -8.5 (n=384) -8.4 (n=377)
Slovenian: -8,4 (n=377)
English: Brinzolamide was not teratogenic in rats and rabbits, following systemic administration (oral gavage).
Slovenian: Po sistemski uporabi (peroralnem prisilnem hranjenju) brinzolamid ni bil teratogen pri podganah in kuncih.
English: 1, oesophagitis
Slovenian: 1, astenopija
English: The same types of adverse reactions that are attributable to sulphonamides may occur with topical administration.
Slovenian: Pri topikalni uporabi se lahko pojavijo enake vrste neželenih učinkov kot pri sulfonamidih.
English: Mean percent IOP reductions from baseline with SIMBRINZA ranged from 25 to 37%.The percentages of patients with an IOP measurement less than 18 mmHg were similar across study visits for the same time point through Month 6 in the SIMBRINZA and Brinzolamide + Brimonidine groups.
Slovenian: Odstotki bolnikov z izmerjenim očesnim tlakom manj kot 18 mmHg so bili podobni ob vseh obiskih v okviru študije za isto časovno točko do 6. meseca zdravljenja, tako v skupini, ki je prejemala zdravilo SIMBRINZA, kot v skupini, ki jeprejemala brinzolamid in brimonidin.
English: Bring the bottle tip close to the eye. Do this in front of a mirror if it helps.
Slovenian: Če vam to pomaga, uporabite ogledalo.
English: Symptoms of brimonidine overdose (including loss of consciousness, hypotension, hypotonia, bradycardia, hypothermia, cyanosis and apnoea) have been reported in neonates and infants receiving brimonidine eye drops as part of medical treatment of congenital glaucoma.
Slovenian: Pri novorojenčkih in majhnih otrocih, ki so prejemali brimonidin v kapljicah za oko v okviru medicinskega zdravljenja prirojenega glavkoma, so poročali o simptomih prevelikega odmerjanja brimonidina (vključno z izgubo zavesti, hipotenzijo, hipotonijo, bradikardijo, hipotermijo, cianozo in apnejo).
English: Ask your optometrist (optician) or pharmacist how to throw away medicines you no longer use.
Slovenian: O načinu odstranjevanja zdravila, ki ga ne uporabljate več, se posvetujte z optometristom (optikom) ali farmacevtom.
English: 2, nasal dryness postnasal drip
Slovenian: 2, draženje žrela suhost nosne sluznice
English: SIMBRINZA contains brinzolamide, a sulphonamide inhibitor of carbonic anhydrase and, although administered topically, is absorbed systemically.
Slovenian: Zdravilo SIMBRINZA vsebuje brinzolamid, ki je sulfonamidni zaviralec karboanhidraze in se tudi pri topikalni uporabi absorbira sistemsko.
English: If you get any side effects, talk to your doctor, optometrist (optician) or pharmacist.
Slovenian: Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom, optometristom (optikom) ali farmacevtom.
English: 2, abdominal discomfort diarrhoea
Slovenian: 2, neprijeten občutek v trebuhu diareja
English: - Keep this leaflet.
Slovenian: Odvijte zaporko na kapalnem vsebniku.
English: 2, rash
Slovenian: 1, kašelj
English: SIMBRINZA contains brinzolamide, an inhibitor of carbonic anhydrase, and although administered topically, is absorbed systemically.
Slovenian: Zdravilo SIMBRINZA vsebuje brinzolamid, ki je zaviralec karboanhidraze in se tudi pri topikalni uporabi absorbira sistemsko.
English: 2, scleral pigmentation
Slovenian: 2, pigmentacija beločnice subkonjunktivalna cista
English: 1, corneal oedema
Slovenian: 1, urtikarija
English: Serious adverse reactions following inadvertent ingestion with the brimonidine component of SIMBRINZA by paediatric subjects have been reported.
Slovenian: Po nenamernem zaužitju učinkovine brimonidin zdravila SIMBRINZA pri otrocih so poročali o pojavu resnih neželenih učinkov.
English: Propylene glycol
Slovenian: SIMBRINZA brinzolamid brimonidin
English: Immune system disorders Uncommon: hypersensitivity3 Psychiatric disorders
Slovenian: Občasni: zmanjšanje števila eritrocitov2, povečana vrednost klorida v krvi Bolezni imunskega sistema Občasni: preobčutljivost Psihiatrične motnje
English: The same types of adverse reactions that are attributable to oral carbonic inhibitors (i.e. acid-base disturbances) may occur with topical administration (see section 4.5).
Slovenian: Pri njegovi topikalni uporabi se lahko torej pojavijo enake vrste neželenih učinkov, kot se pojavljajo pri uporabi peroralnih zaviralcev karboanhidraze (t.j.
English: Zyllt can be given to the following groups of patients:
Slovenian: Zdravilo Zyllt se lahko daje naslednjim skupinam bolnikov:
English: This means that Zyllt is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Plavix.
English: The European Commission granted a marketing authorisation valid throughout the EU for Zyllt to Krka, d.d., Novo mesto on 28 September 2009.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Zyllt, veljavno po vsej Evropski uniji, odobrila družbi Krka, d.d., Novo mesto, dne 28. septembra.
English: The Committee recommended that Zyllt be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Zyllt odobri dovoljenje za promet.
English: What are the benefit and risk of Zyllt?
Slovenian: Kakšne so koristi in tveganja, povezana z zdravilom Zyllt?
English: Other information about Zyllt:
Slovenian: Druge informacije o zdravilu Zyllt:
English: The standard dose of Zyllt is one 75 mg tablet once a day, taken with or without food.
Slovenian: Običajni odmerek zdravila Zyllt je ena 75-miligramska tableta enkrat na dan, ki se vzame s hrano ali brez nje.
English: In acute coronary syndrome, Zyllt is used together with aspirin and treatment generally starts with a loading dose of four 75 mg tablets.
Slovenian: Pri akutnem koronarnem sindromu se zdravilo Zyllt uporablja skupaj z aspirinom, zdravljenje pa se na splošno začne z udarnim odmerkom štirih 75-miligramskih tablet.
English: Zyllt clopidogrel EPAR summary for the public
Slovenian: Zyllt klopidogrel Povzetek EPAR za javnost
English: Zyllt can be started between a few days and 35 days after the attack;
Slovenian: Zdravilo Zyllt se lahko začne jemati od nekaj dni po napadu do 35 dni po njem;
English: Zyllt is a ‘generic medicine'.
Slovenian: Zdravilo Zyllt je „generično zdravilo“.
English: Zyllt is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Slovenian: Zdravilo Zyllt se uporablja pri odraslih za preprečevanje aterotrombotičnih dogodkov (težav, ki jih povzročajo krvni strdki in otrdelost krvnih žil).
English: Because Zyllt is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Slovenian: Ker je zdravilo Zyllt generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Zyllt has been shown to have comparable quality and to be bioequivalent to Plavix.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v s skladu z zahtevami EU dokazano, da ima zdravilo Zyllt primerljivo raven kakovosti kot zdravilo Plavix ter mu je biološko enakovredno.
English: Zyllt can be started between seven days and six months after the stroke;
Slovenian: Zdravilo Zyllt se lahko začne jemati od sedem dni po napadu do šest mesecev po njem;
English: Zyllt can be used in patients who are having myocardial infarction with ‘ST segment elevation' (an abnormal reading on the electrocardiogram or ECG) when the doctor thinks that they would benefit from the treatment.
Slovenian: Zdravilo Zyllt se lahko uporablja pri bolnikih, ki so imeli srčni napad z „dvigom spojnice ST“ (nenormalni zapis na elektrokardiogramu ali EKG), če zdravnik meni, da bi jim zdravilo lahko pomagalo.
English: Because Zyllt is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Slovenian: Ker je zdravilo Zyllt generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Plavix.
English: Zyllt is a medicine that contains the active substance clopidogrel.
Slovenian: Zyllt je zdravilo, ki vsebuje zdravilno učinkovino klopidogrel.
English: Why has Zyllt been approved?
Slovenian: Zakaj je bilo zdravilo Zyllt odobreno?
English: It can also be used in patients who do not have this abnormal reading on the ECG, if they have unstable angina (a severe type of chest pain) or have had a ‘non-Q-wave' myocardial infarction.
Slovenian: Lahko se uporablja tudi pri bolnikih, pri katerih ni nenormalnega zapisa na EKG, če imajo nestabilno angino (hudo obliko bolečine v prsih) ali so imeli miokardni infarkt brez zobca Q. Zdravilo se dobi samo na recept.
English: The active substance in Zyllt, clopidogrel, is an inhibitor of platelet aggregation.
Slovenian: Zdravilna učinkovina v zdravilu Zyllt, klopidogrel, je zaviralec agregacije trombocitov.
English: The full EPAR for Zyllt can be found here.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Zyllt je na voljo tukaj.
English: What is Zyllt used for?
Slovenian: Za kaj se zdravilo Zyllt uporablja?
English: How does Zyllt work?
Slovenian: Kako zdravilo Zyllt deluje?
English: What is Zyllt?
Slovenian: Kaj je zdravilo Zyllt?
English: How has Zyllt been studied?
Slovenian: Kako je bilo zdravilo Zyllt raziskano?
English: How is Zyllt used?
Slovenian: Kako se zdravilo Zyllt uporablja?
English: It is used in adults who have essential hypertension (high blood pressure) that is not adequately controlled by telmisartan alone.
Slovenian: Uporablja se pri odraslih, ki imajo esencialno hipertenzijo (visok krvni tlak) in pri katerih samo s telmisartanom krvnega tlaka ni mogoče ustrezno uravnavati.
English: The full EPAR for Actelsar HCT 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 Actelsar HCT je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What measures are being taken to ensure the safe and effective use of Actelsar HCT?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Actelsar HCT?
English: telmisartan / hydrochlorothiazide
Slovenian: telmisartan/hidroklorotiazid
English: This is a summary of the European public assessment report (EPAR) for Actelsar HCT.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Actelsar HCT.
English: This means that Actelsar HCT is similar to a ‘reference medicine' already authorised in the European Union (EU) called MicardisPlus.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu MicardisPlus.
English: The Committee recommended that Actelsar HCT be approved for use in the EU.
Slovenian: Priporočil je, da se zdravilo Actelsar HCT odobri za uporabo v EU.
English: Telmisartan is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Slovenian: Telmisartan je antagonist receptorjev angiotenzina II, kar pomeni, da v telesu prepreči delovanje hormona, imenovanega angiotenzin II.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Actelsar HCT on 13 March 2013.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Actelsar HCT, veljavno po vsej Evropski uniji, odobrila dne 13. marca 2013.
English: Actelsar HCT is a ‘generic medicine'.
Slovenian: Zdravilo Actelsar HCT je „generično zdravilo“.
English: Because Actelsar HCT 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 Actelsar HCT generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: What are the benefits and risks of Actelsar HCT?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Actelsar HCT?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Actelsar HCT has been shown to have comparable quality and to be bioequivalent to MicardisPlus.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP), ki deluje pri agenciji, je zaključil, da je bilo v s skladu z zahtevami EU dokazano, da ima zdravilo Actelsar HCT primerljivo raven kakovosti kot zdravilo MicardisPlus ter da mu je biološko enakovredno.
English: Actelsar HCT is available as tablets (40 mg or 80 mg telmisartan and 12.5 mg hydrochlorothiazide; 80 mg telmisartan and 25 mg hydrochlorothiazide) to be taken by mouth once a day with liquid.
Slovenian: Zdravilo Actelsar HCT je na voljo v obliki tablet (40 mg ali 80 mg telmisartana in 12,5 mg hidroklorotiazida; 80 mg telmisartana in 25 mg hidroklorotiazida), ki se zaužijejo peroralno enkrat dnevno skupaj s tekočino.
English: For more information about treatment with Actelsar HCT, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Actelsar HCT preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: It is not intended to provide practical advice on how to use Actelsar HCT.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Actelsar HCT, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V povzetek glavnih značilnosti zdravila in navodilo za uporabo za zdravilo Actelsar HCT so bile vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: Because Actelsar HCT is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, MicardisPlus.
Slovenian: Ker je zdravilo Actelsar HCT generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu MicardisPlus.
English: Other information about Actelsar HCT
Slovenian: Druge informacije o zdravilu Actelsar HCT
English: Therefore, the CHMP's view was that, as for MicardisPlus, the benefit outweighs the identified risk.
Slovenian: Zato je menil, da njegove koristi, tako kot pri zdravilu MicardisPlus, odtehtajo znana tveganja.
English: What is Actelsar HCT and what is it used for?
Slovenian: Kaj je zdravilo Actelsar HCT in za kaj se uporablja?
English: Actelsar HCT is a medicine that contains two active substances, telmisartan and hydrochlorothiazide.
Slovenian: Actelsar HCT je zdravilo, ki vsebuje dve zdravilni učinkovini, telmisartan in hidroklorotiazid.
English: The dose of Actelsar HCT to be used depends on the dose of telmisartan that the patient was taking before: patients who were receiving 40 mg telmisartan should take the 40/12.5 mg tablets, and patients who were receiving 80 mg telmisartan should take the 80/12.5 mg tablets.
Slovenian: Odmerek zdravila Actelsar HCT je odvisen od odmerka telmisartana, ki ga je bolnik jemal pred tem: bolniki, ki so prejemali 40 mg telmisartana, morajo jemati tablete po 40/12,5 mg, tisti, ki pa so prejemali 80 mg telmisartana, pa morajo jemati tablete po 80/12,5 mg. Tablete po 80/25 mg se dajejo bolnikom, pri katerih se krvni tlak ne uravna z jemanjem tablet po 80/12,5 mg ali pri katerih se je krvni tlak stabiliziral z uporabo dveh zdravilnih učinkovin, ki so ju jemali ločeno, preden so prešli na zdravilo Actelsar HCT.
English: For practical information about using Actelsar HCT, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Actelsar HTC naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Why is Actelsar HCT approved?
Slovenian: Zakaj je bilo zdravilo Actelsar HCT odobreno?
English: Actelsar HCT contains two active substances, telmisartan and hydrochlorothiazide.
Slovenian: Zdravilo Actelsar HCT vsebuje dve zdravilni učinkovini, telmisartan in hidroklorotiazid.
English: How has Actelsar HCT been studied?
Slovenian: Kako je bilo zdravilo Actelsar HCT raziskano?
English: How is Actelsar HCT used?
Slovenian: Kako se zdravilo Actelsar HCT uporablja?
English: How does Actelsar HCT work?
Slovenian: Kako zdravilo Actelsar HCT deluje?
English: Below is a brief description of the studies and their results:
Slovenian: V nadaljevanju je kratek opis študij in njihovih rezultatov.
English: Further information on Humira can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/humira.
Slovenian: Nadaljnje informacije o zdravilu Humira so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/humira.
English: Some rare but serious side effects have been reported, including serious infections.
Slovenian: Poročali so o nekaterih redkih, a resnih neželenih učinkih, ki so vključevali tudi hude okužbe.
English: What measures are being taken to ensure the safe and effective use of Humira?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Humira?
English: Humira received a marketing authorisation valid throughout the EU on 8 September 2003.
Slovenian: Za zdravilo Humira je bilo 8. septembra 2003 izdano dovoljenje za promet, veljavno po vsej Evropski uniji.
English: However, these are considered to be manageable and specific recommendations are given to help doctors manage these risks.
Slovenian: Vendar se ti štejejo za obvladljive, zato morajo zdravniki prejeti posebna priporočila za obvladovanje teh tveganj.
English: Humira is given as an injection under the skin, usually every 2 weeks.
Slovenian: Zdravilo Humira se injicira pod kožo, običajno vsaka dva tedna.
English: As for all medicines, data on the use of Humira are continuously monitored.
Slovenian: Kot velja pri vseh zdravilih, se podatki o uporabi zdravila Humira stalno spremljajo.
English: Why is Humira authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Humira odobreno v EU?
English: The European Medicines Agency decided that Humira's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Humira večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: What are the risks associated with Humira?
Slovenian: Kakšna tveganja so povezana z zdravilom Humira?
English: Other information about Humira
Slovenian: Druge informacije o zdravilu Humira
English: What is Humira and what is it used for?
Slovenian: Kaj je zdravilo Humira in za kaj se uporablja?