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Romanian to English: Product Information - Section 4.3 of Summary of Product Characteristics -Contraindications General field: Medical Detailed field: Medical: Pharmaceuticals
Source text - Romanian 4.3 Contraindicaţii
- Sindrom imunodeficitar.
- Pacienţi cu risc crescut de infecţii oportunistice, inclusiv pacienţi imunocompromişi (inclusiv
cei cărora li se administrează în prezent terapii imunosupresive sau cei imunocompromişi de
terapiile anterioare).
- Infecţii active severe, infecţii cronice active (hepatită, tuberculoză).
- Neoplazii active.
- Insuficienţă hepatică severă (Child-Pugh clasa C).
- Pacienți care în ultimele 6 luni au avut infarct miocardic (IM), angină pectorală instabilă,
accident vascular cerebral/atac ischemic tranzitor (AIT), insuficiență cardiacă decompensată
(care necesită tratament în spital) sau insuficiență cardiacă clasa III/IV New York Heart
Association (NYHA) (vezi pct. 4.4).
- Pacienți cu aritmii cardiace severe care necesită tratament antiaritmic cu medicamente
antiaritmice de clasa Ia sau III (vezi pct. 4.4).
- Pacienți cu bloc AV Mobitz II de gradul doi sau trei, sindromul sinusului bolnav sau care nu au
pacemaker (vezi pct. 4.4).
- Pacienți cu interval QTc la momentul inițial ≥500 msec (vezi pct. 4.4).
- În timpul sarcinii și la femeile cu potențial fertil care nu utilizează metode contraceptive eficace
(vezi pct. 4.4 și 4.6).
- Hipersensibilitate la substanţa activă sau la oricare dintre excipienţii enumeraţi la pct. 6.1.
Translation - English 4.3 Contraindications
- Immunodeficiency syndrome.
- Patients with increased risk for opportunistic infections, including immunocompromised
patients (including those currently receiving immunosuppressive therapies or those
immunocompromised by prior therapies).
- Severe active infections, active chronic infections (hepatitis, tuberculosis).
- Active malignancies.
- Severe liver impairment (Child-Pugh class C).
- Patients who in the previous 6 months had myocardial infarction (MI), unstable angina pectoris,
stroke/transient ischaemic attack (TIA), decompensated heart failure (requiring inpatient
treatment), or New York Heart Association (NYHA) class III/IV heart failure (see section 4.4).
- Patients with severe cardiac arrhythmias requiring anti-arrhythmic treatment with class Ia or
class III anti-arrhythmic medicinal products (see section 4.4).
- Patients with second-degree Mobitz type II atrioventricular (AV) block or third-degree AV
block, or sick-sinus syndrome, if they do not wear a pacemaker (see section 4.4).
- Patients with a baseline QTc interval ≥ 500 msec (see section 4.4).
- During pregnancy and in women of childbearing potential not using effective contraception (see
sections 4.4 and 4.6).
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
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Translation education
Master's degree - Moldova University
Experience
Years of experience: 18. Registered at ProZ.com: Mar 2020.
Keywords: Translation in my language pairs of pharmaceutical dossiers, business/official correspondence, product information for European Medicines Agency and for
European Union National Competent Authorities -following QRD templates for the CP, DCP or national templates -for Germany and France, medical device IFUs, clinical reports, patient information documents. Please send enquiries at [email protected]
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