FrancophonIA/ELRC3.0 huggingface dataset:
English: How to take Clopidogrel Teva Pharma B.V.
Bulgarian: Kako jemati zdravilo Klopidogrel Teva Pharma B.V.
English: Rare side effects (may affect up to 1 in 1000 people):
Bulgarian: Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov):
English: There is no evidence that other medicinal products that reduce stomach acid such as H2 blockers (except cimetidine which is a CYP2C19 inhibitor) or antacids interfere with antiplatelet activity of clopidogrel.
Bulgarian: cimetidina, ki je CYP2C19 inhibitor) ali antacidi, ovirajo antitrombocitno delovanje klopidogrela.
English: Excipients
Bulgarian: ZUNANJA
English: Haematoma
Bulgarian: Dojenje
English: Very rare side effects (may affect up to 1 in 10,000 people):
Bulgarian: Zelo redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov):
English: If you become pregnant while taking Clopidogrel Teva Pharma B.V., consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.
Bulgarian: Če med zdravljenjem z zdravilom Klopidogrel Teva Pharma B.V. zanosite, se takoj posvetujte
English: NAME OF THE MEDICINAL PRODUCT Clopidogrel Teva Pharma B.V. 75 mg film-coated tablets
Bulgarian: IME ZDRAVILA Klopidogrel Teva Pharma B.V. 75 mg filmsko obložene tablete
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING BOTTLE LABEL (30 or 100 film-coated tablets)
Bulgarian: ETIKETA STEKLENIČKE (30 in 100 filmsko obloženih tablet)
English: If you forget to take a dose of Clopidogrel Teva Pharma B.V., but remember within 12 hours of the missed dose, take your tablet straight away and then take your next tablet at the usual time.
Bulgarian: spomnite do 12 ur od vašega običajnega časa jemanja, takoj vzemite tableto.
English: A crossover study in 40 healthy subjects, 10 each in the four CYP2C19 metaboliser groups (ultrarapid, extensive, intermediate and poor), evaluated pharmacokinetic and antiplatelet responses using 300 mg followed by 75 mg/day and 600 mg followed by 150 mg/day, each for a total of 5 days (steady state).
Bulgarian: Študija je ocenila farmakokinetiko in antiagregacijski odziv po uporabi odmerka 300 mg in potem 75 mg/dan ter 600 mg in potem 150 mg/dan, vsako od obeh shem skupaj 5 dni (stanje dinamičnega ravnovesja).
English: The mean bleeding time prolongation was also similar in the two groups.
Bulgarian: trombocitov podobno kot pri zdravih preiskovancih. Tudi povprečno podaljšanje časa krvavitve je bilo v obeh skupinah podobno.
English: Reduced levels of certain white blood cells which increases the risk of infection (neutropenia) Vertigo (dizziness accompanied by a whirling sensation) Bleeding inside the abdomen
Bulgarian: zmanjšanje števila belih krvnih celic, zaradi česar je tveganje za okužbo večje (nevtropenija),
English: For patients over 75 years of age clopidogrel should be initiated without a loading dose.
Bulgarian: ter z/brez uporabe trombolitikov. Pri bolnikih, ki so starejši od 75 let, je treba zdravljenje
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON of bottles (30 or 100 film-coated tablets)
Bulgarian: ŠKATLICA za stekleničke (30 ali 100 filmsko obloženih tablet)
English: Patients randomized in the ACTIVE program were those presenting with documented AF, i.e., either permanent AF or at least 2 episodes of intermittent AF in the past 6 months, and had at least one of the following risk factors: age ≥75 years or age 55 to 74 years and either diabetes mellitus requiring drug therapy, or documented previous MI or documented coronary artery disease; treated for systemic hypertension; prior stroke, transient ischaemic attack (TIA), or non-CNS systemic embolus; left ventricular dysfunction with left ventricular ejection fraction <45%; or documented peripheral vascular disease.
Bulgarian: sistemske hipertenzije; predhodno možgansko kap, tranzitorno ishemično atako (TIA) ali sistemski embolus (ne v osrednjem živčevju); disfunkcijo levega prekata z iztisnim deležem levega prekata (LVEF) < 45 %; ali dokumentirano bolezen perifernih žil. Povprečna ocena CHADS2 je bila 2,0 (razpon: od 0 do 6).
English: If you are breastfeeding or planning to breastfeed, talk to your doctor before taking this medicine.
Bulgarian: Če dojite ali nameravate dojiti, se pred jemanjem
English: In particular, in a post-hoc analysis in 2,172 patients (17% of the total CURE population) who underwent stent placement (Stent-CURE), the data showed that clopidogrel compared to placebo, demonstrated a significant RRR of 26.2% favouring clopidogrel for the co-primary endpoint (CV death, MI, stroke) and also a significant RRR of 23.9% for the second co-primary endpoint (CV death, MI, stroke or refractory ischaemia).
Bulgarian: Zlasti post-hoc analiza podatkov 2172 bolnikov (17 % celotne populacije CURE), ki so jim namestili žilno opornico (Stent-CURE), je ob klopidogrelu v primerjavi
English: The benefit of the combination of clopidogrel with ASA beyond four weeks has not been studied in this setting (see section 5.1).
Bulgarian: s kombinacijo klopidrogela in ASA, ki bi bilo daljše od štirih tednov, v tem okviru
English: In CURE, 823 (6.6%) patients received concomitant GPIIb/IIIa receptor antagonist therapy.
Bulgarian: V študiji CURE je 823 (6,6 %) bolnikov sočasno prejemalo
English: - Perforated blisters contain 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 film-coated tablet.
Bulgarian: - Perforirani pretisni omoti vsebujejo 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 ali 100x1 filmsko obložena tableta.
English: - If you have any side effects, including any side effects not listed in this leaflet, talk your doctor or pharmacist.
Bulgarian: - Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
English: Posology: • Adults and older people
Bulgarian: Otroci in mladostniki Ne dajajte
English: The number of patients experiencing the primary endpoint [cardiovascular (CV) death, myocardial infarction (MI), or stroke] was 582 (9.3%) in the clopidogrel-treated group and 719 (11.4%) in the placebo-treated group, a 20% relative risk reduction (95% CI of 10%-28%; p=0.00009) for the clopidogrel-treated group (17% relative risk reduction when patients were treated conservatively, 29% when they underwent percutaneous transluminal coronary angioplasty (PTCA) with or without stent and 10% when they underwent coronary artery bypass graft (CABG)).
Bulgarian: s klopidogrelom (17 % zmanjšanje relativnega tveganja, če so bili bolniki zdravljeni konzervativno, 29 % kadar je bila izvedena perkutana transluminalna koronarna angioplastika (PTKA) z ali brez stenta in 10 %, če je bila izvedena premostitvena operacija koronarnih arterij (POKA)).
English: • Swelling in the mouth or skin disorders such as rashes, itching and blistering of the skin.
Bulgarian: otekanje ust ali bolezni kože, kot so izpuščaj, srbenje in mehurji na koži. To so lahko znaki alergijske reakcije.
English: The active thiol metabolite which has been isolated in vitro, binds rapidly and irreversibly to platelet receptors, thus inhibiting platelet aggregation.
Bulgarian: in ireverzibilno veže na trombocitne receptorje in tako zavre agregacijo trombocitov.
English: These results indicate that clopidogrel can be administered with pantoprazole.
Bulgarian: Podatki se nanašajo na klopidogrel
English: However, clopidogrel and ASA have been administered together for up to one year (see section
Bulgarian: in acetilsalicilno kislino sočasno uporabljali do enega leta (glejte poglavje 5.1).
English: In patients with atrial fibrillation, clopidogrel should be given as a single daily dose of 75 mg. ASA (75-100 mg daily) should be initiated and continued in combination with clopidogrel (see section 5.1).
Bulgarian: ASA (75-100 mg na dan) je treba uvesti in nadaljevati v kombinaciji
English: 3542 DR Utrecht The Netherlands
Bulgarian: Teva Pharma B.V. Computerweg 10 3542 DR Utrecht Nizozemska
English: EFFECTIVE USE OF THE MEDICINAL PRODUCT
Bulgarian: Podrobne informacije o zdravilu
English: - Peelable perforated blisters contain 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 film-coated tablet.
Bulgarian: - Perforirani pretisni omoti, ki se odlepijo, vsebujejo 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 ali 100x1 filmsko obložena tableta.
English: If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Clopidogrel Teva Pharma B.V. once at the start of treatment.
Bulgarian: srčna kap), vam lahko zdravnik na začetku zdravljenja da enkrat 300 mg zdravila Klopidogrel Teva Pharma B.V. Nato je običajni odmerek ena 75-mg tableta zdravila Klopidogrel Teva Pharma B.V. na dan.
English: The 2x2 factorial design COMMIT trial included 45,852 patients presenting within 24 hours of the onset of the symptoms of suspected MI with supporting ECG abnormalities (i.e. ST elevation, ST depression or left bundle-branch block).
Bulgarian: V študijo COMMIT z 2x2 faktorsko raziskovalno zasnovo je bilo vključenih 45.852 bolnikov v 24 urah po nastopu
English: Tel/Tél: +32 3 820 73 73
Bulgarian: Teva Pharma Belgium N.V./S.A. Tel/Tél: +32 3 820 73 73
English: Gastrointestinal and retroperitoneal haemorrhage with fatal outcome, pancreatitis, colitis (including ulcerative or lymphocytic colitis), stomatitis
Bulgarian: Bolezni prebavil krvavitev v retroperitonealna krvavitev krvavitev v prebavila in retroperitonealna krvavitev s smrtnim izidom, pankreatitis, kolitis (vključno z ulceroznim ali limfocitnim
English: Major bleeding was mostly of extracranial origin in both groups (5.3% in the clopidogrel + ASA group; 3.5% in the placebo +ASA group), mainly from the gastrointestinal tract (3.5% vs. 1.8%).
Bulgarian: Hujše krvavitve so bile v obeh skupinah večinoma ekstrakranialne (5,3 % v skupini
English: There was no significant difference between groups in the primary composite endpoint of death, shunt thrombosis or cardiac-related intervention prior to 120 days of age following an event considered of thrombotic nature (89 [19.1%] for the clopidogrel group and 90 [20.5%] for the placebo group) (see section 4.2).
Bulgarian: spoja ali srčno intervencijo pred starostjo 120 dni po dogodku, za katerega je bilo ocenjeno, da je trombotične narave: v skupini
English: Common
Bulgarian: s skupino
English: The number of patients who reached the primary endpoint (time to first occurrence of stroke, MI, non-CNS systemic embolism or vascular death) was 832 (22.1%) in the group treated with clopidogrel + ASA and 924 (24.4%) in the placebo + ASA group (relative risk reduction of 11.1%; 95% CI of 2.4% to 19.1%; p=0.013), primarily due to a large reduction in the incidence of strokes.
Bulgarian: s klopidogrelom, in 719 (11,4 %) v skupini, ki je prejemala placebo, to je 20 % zmanjšanje relativnega tveganja (95 % IZ od 10 % - 28 %; p=0,00009) v skupini, zdravljeni
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 75 mg clopidogrel (as hydrobromide)
Bulgarian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena filmsko obložena tableta vsebuje 75 mg klopidogrela (v obliki bromida).
English: + ASA treatment group compared to the placebo + ASA group (1.4% versus 0.8%, respectively).
Bulgarian: s placebom + acetilsalicilno kislino (0,8 %). Med skupinama ni bilo
English: • Medicines used to break down blood clots (e.g. alteplase and streptokinase).
Bulgarian: • zdravila, ki razgrajujejo krvne strdke (npr.
English: Nervous system disorders
Bulgarian: Organski sistem Pogosti
English: A pharmacodynamic interaction between clopidogrel and acetylsalicylic acid is possible, leading to increased risk of bleeding.
Bulgarian: in acetilsalicilno kislino je možna in lahko poveča tveganje za pojav krvavitev.
English: The decrease was associated with a 39% (loading dose) and 21% (maintenance dose) reduction of inhibition of platelet aggregation.
Bulgarian: 21 % (vzdrževalni odmerek).
English: There was an excess of intracranial bleeding in the clopidogrel
Bulgarian: V študiji CURE število velikih krvavitev s klopidogrelom
English: Common side effects (may affect up to 1 in 10 people):
Bulgarian: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov):
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON of peelable blisters (14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 film-coated tablet)
Bulgarian: ZUNANJA OVOJNINA - pretisni omoti, ki se odlepijo (14x1, 28x1, 30x1, 50x1, 84x1, 90x1 ali 100x1 filmsko obložena tableta)
English: Neutropenia, including severe neutropenia
Bulgarian: izpuščaj, srbenje, nenormalen občutek za dotik,
English: • If you think any of these apply to you, or if you are in any doubt at all, consult your doctor before taking Clopidogrel Teva Pharma B.V.
Bulgarian: Če menite, da se karkoli od navedenega nanaša na vas ali če ste kakorkoli v dvomih, se posvetujte
English: Clopidogrel is a prodrug, one of whose metabolites is an inhibitor of platelet aggregation.
Bulgarian: in eden njegovih presnovkov zavira agregacijo trombocitov.
English: Clopidogrel Teva Pharma B.V. contains hydrogenated castor oil.
Bulgarian: Zdravilo Klopidogrel Teva Pharma B.V. vsebuje tudi hidrogenirano ricinusovo olje Ta lahko povzroči želodčne težave in drisko.
English: After a single oral dose of 75 mg, clopidogrel has a half-life of approximately 6 hours.
Bulgarian: Po večkratnem odmerjanju 75 mg klopidogrela na dan 10 dni pri bolnikih
English: Headache and dizziness
Bulgarian: glavobol in omotica,
English: In CHARISMA and one cohort study (Simon), an increased event rate was observed only in poor metabolisers when compared to extensive metabolisers.
Bulgarian: so večji delež dogodkov ugotovili samo pri slabih metabolizatorjih v primerjavi z dobrimi.
English: Intracranial bleeding (some cases were reported with fatal outcome), headache, paraesthesia, dizziness
Bulgarian: s smrtnim izidom), glavobol, parestezije, omotica motnje okušanja
English: In a randomised, double-blind, parallel-group study (CLARINET), 906 paediatric patients (neonates and infants) with cyanotic congenital heart disease palliated with a systemic-to-pulmonary arterial shunt were randomised to receive clopidogrel 0.2 mg/kg (n=467) or placebo (n=439) along with concomitant background therapy up to the time of second stage surgery.
Bulgarian: Bolnike so randomizirali na prejemanje klopidogrela 0,2 mg/kg (n = 467) ali placeba (n = 439) obenem s sočasnim osnovnim zdravljenjem do tedaj, ko je bila opravljena operacija druge stopnje.
English: Although the administration of clopidogrel 75 mg/day did not modify the pharmacokinetics of S-warfarin or International Normalised Ratio (INR) in patients receiving long-term warfarin therapy, coadministration of clopidogrel with warfarin increases the risk of bleeding because of independent effects on hemostasis.
Bulgarian: Uporaba 75 mg klopidogrela na dan ni spremenila farmakokinetike S-varfarina ali
English: How to store Clopidogrel Teva Pharma B.V.
Bulgarian: Shranjavenja zdravila Klopidogrel Teva Pharma B.V.
English: Vascular disorders
Bulgarian: s premeno trombocitov.
English: CLINICAL PARTICULARS
Bulgarian: Terapevtske izkušnje
English: Discard 30 days after first opening 100 tablets HDPE bottle: Discard 100 days after first opening
Bulgarian: 30 filmsko obloženih tablet 100 filmsko obloženih tablet peroralna uporaba Pred uporabo preberite priloženo navodilo.
English: Clopidogrel Teva Pharma B.V contains clopidogrel and belongs to a group of medicines called “platelet aggregation inhibitors.” It works by stopping certain particles in your blood (“platelets”) from sticking together to form blood clots which can block blood flow to important parts of your body including your heart and your brain.
Bulgarian: Zdravilo Klopidogrel Teva Pharma B.V. klopidogrel in spada v skupino zdravil imenovano »zaviralci agregacije trombocitov«.
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription
Bulgarian: V natisnjenem navodilu za uporabo zdravila mora biti navedeno
English: Clopidogrel Teva Pharma B.V. with food and drink You can take Clopidogrel Teva Pharma B.V. with or without food.
Bulgarian: Zdravilo Klopidogrel Teva Pharma B.V. lahko jemljete
English: The CURE study included 12,562 patients with non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), and presenting within 24 hours of onset of the most recent episode of chest pain or symptoms consistent with ischaemia.
Bulgarian: Q zobca) do 24 ur po zadnji epizodi bolečine v prsih ali simptomih, skladnih z ishemijo.
English: Due to the irreversible binding, platelets exposed are affected for the remainder of their lifespan (approximately 7-10 days) and recovery of normal platelet function occurs at a rate consistent with platelet turnover.
Bulgarian: trombocite ohrani vso njihovo preostalo življenjsko dobo (približno 7-10 dni)
English: The number of patients experiencing the co-primary endpoint (CV death, MI, stroke or refractory ischaemia) was 1,035 (16.5%) in the clopidogrel-treated group and 1,187 (18.8%) in the placebo-treated group, a 14% relative risk reduction (95% CI of 6%-21%, p=0.0005) for the clopidogrel-treated group.
Bulgarian: s placebom, to je 14 % zmanjšanje relativnega tveganja (95 % IZ od 6 % -21 %, p=0,0005) za skupino, zdravljeno
English: Eye bleeding (conjunctival, ocular, retinal)
Bulgarian: sindrom preobčutljivosti (sindrom DIHS, DrugInduced
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER (14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 film-coated tablets)
Bulgarian: ŠKATLICA za pretisne omote (14x1, 28x1, 30x1, 50x1, 84x1, 90x1 ali 100x1 filmsko obložena tableta)
English: Further information on RoActemra can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/RoActemra.
Bulgarian: Допълнителна информация за RoActemra можете да намерите на уебсайта на Агенцията: ema.europa.eu/medicines/human/EPAR/RoActemra.
English: What measures are being taken to ensure the safe and effective use of RoActemra?
Bulgarian: Какви мерки се предприемат, за да се гарантира безопасната и ефективна употреба на RoActemra?
English: The pack will also include a patient alert card with key safety information for patients.
Bulgarian: Пакетът ще включва също сигнална карта за пациента с важна информация за пациентите относно безопасността.
English: All patients were also treated with a corticosteroid, which was stopped after reducing the dose gradually over 6 or 12 months.
Bulgarian: Всички пациенти са лекувани и с кортикостероид, приемът на който се прекратява след постепенно намаляване на дозата в продължение на 6 или 12 месеца.
English: The European Medicines Agency decided that RoActemra's benefits are greater than its risks and it can be authorised for use in the EU.
Bulgarian: Европейската агенция по лекарствата реши, че ползите от употребата на RoActemra са по-големи от рисковете и този продукт може да бъде разрешен за употреба в ЕС.
English: As for all medicines, data on the use of RoActemra are continuously monitored.
Bulgarian: Както при всички лекарства, данните във връзка с употребата на RoActemra непрекъснато се проследяват.
English: For more information about using RoActemra, see the package leaflet or contact your doctor or pharmacist.
Bulgarian: За повече информация относно употребата на RoActemra вижте листовката или се свържете с Вашия лекар или фармацевт.
English: By preventing interleukin-6 attaching to its receptors, tocilizumab reduces the inflammation and other symptoms of these diseases.
Bulgarian: Като предотвратява свързването на интерлевкин-6 с неговите рецептори, тоцилизумаб намалява възпалението и другите симптоми на тези заболявания.
English: RoActemra must not be used in patients who have an active, severe infection.
Bulgarian: RoActemra не трябва да се прилага при пациенти, които имат активна тежка инфекция.
English: Other information about RoActemra:
Bulgarian: Допълнителна информация за RoActemra:
English: RoActemra is a medicine used to treat:
Bulgarian: RoActemra е лекарство, което се използва за лечение на:
English: The main measure of effectiveness was based on the number of patients whose CRS resolved within 14 days of the first dose of RoActemra, and who needed no more than two doses of the medicine, and no additional treatment other than corticosteroid medicines.
Bulgarian: Основната мярка на ефективност се основава на броя на пациентите, при които CRS е овладян в рамките на 14 дни след прилагане на първата доза RoActemra и които не се нуждаят от повече от две дози от лекарството, нито от допълнително лечение, освен кортикостероидни лекарства.
English: Almost 4,000 patients from these 5 studies went on to enter studies looking at the long-term effects of RoActemra treatment and results showed that response to RoActemra is maintained for at least 2 years.
Bulgarian: Приблизително 4 000 пациенти от тези 5 проучвания впоследствие се включват в проучвания, в които се разглеждат дългосрочните ефекти на лечението с RoActemra, и резултатите показват, че повлияването се запазва най-малко 2 години.
English: The company that markets RoActemra must supply all doctors expected to prescribe the medicine with an educational pack containing important information on the safety and correct use of RoActemra.
Bulgarian: Фирмата, която предлага RoActemra, трябва да предостави на всички лекари, които се очаква да предписват лекарството, образователен пакет с важна информация относно безопасността и правилната употреба на RoActemra.
English: Doctors should monitor patients carefully for signs of infection during treatment, and should prescribe RoActemra with caution in patients who have had recurring or long-term infections, or diseases that could increase the risk of infections, such as diverticulitis or diabetes.
Bulgarian: Лекарите трябва внимателно да наблюдават пациентите за симптоми на инфекция по време на лечението и да предписват RoActemra с повишено внимание при пациенти с рецидивиращи или хронични инфекции или заболявания, които повишават риска от инфекции, например дивертикулит или диабет.
English: Patients were allowed to continue treatment with methotrexate during the study.
Bulgarian: По време на проучването на пациентите се разрешава да продължат лечението с метотрексат.
English: RoActemra can also be used in adults and children from 2 years of age for the treatment of severe or life-threatening cytokine release syndrome (CRS, a condition that can cause nausea, vomiting, pain and low blood pressure).
Bulgarian: RoActemra може да се използва и при възрастни и деца на възраст над 2 години за лечение на остър или животозастрашаващ синдром на освобождаване на цитокини (CRS, състояние, което може да причини гадене, повръщане, болка и ниско кръвно налягане).
English: Tocilizumab attaches to the receptor for a messenger molecule or ‘cytokine' called interleukin-6.
Bulgarian: Тоцилизумаб се свързва с рецептора за молекула посредник или „цитокин“, наречена интерлевкин-6.
English: The most serious side effects are serious infections, complications of diverticulitis (a disease affecting the gut) and hypersensitivity (allergic) reactions.
Bulgarian: Найсериозните нежелани реакции са тежки инфекции, усложнения на дивертикулит (заболяване, засягащо червата) и реакции на свръхчувствителност (алергични реакции).
English: An overview of RoActemra and why it is authorised in the EU
Bulgarian: Общ преглед на RoActemra и защо е разрешен за употреба в ЕС
English: RoActemra is also used to treat adults with giant cell arteritis, a disease in which arteries, usually of the head, are swollen.
Bulgarian: RoActemra се използва и за лечение на възрастни с гигантоклетъчен артерит - заболяване, при което артериите, обикновено тези в главата, се подуват.
English: Why is RoActemra authorised in the EU?
Bulgarian: Защо RoActemra е разрешен за употреба в ЕС?
English: Side effects reported with RoActemra are carefully evaluated and any necessary action taken to protect patients.
Bulgarian: Съобщените нежелани реакции, свързани с употребата на RoActemra, внимателно се оценяват и се предприемат всички необходими мерки за защита на пациентите.