FrancophonIA/ELRC3.0 huggingface dataset:
English: Ask your doctor or pharmacist for advice before taking any medicine.
Bulgarian: Spør lege eller apotek dersom du har noen spørsmål om bruken av dette legemidlet.
English: [Invented name] 400 mg film-coated tablets are indicated for the treatment of the following bacterial infections: - Acute exacerbation of chronic bronchitis - Community acquired pneumonia, except severe cases - Acute bacterial sinusitis (adequately diagnosed) - Mild to moderate pelvic inflammatory disease (i.e. infections of female upper genital tract, including salpingitis and endometritis), without an associated tubo-ovarian or pelvic abscess.
Bulgarian: [Legemidlets navn] 400 mg filmdrasjerte tabletter er indisert ved behandling av følgende bakterielle infeksjoner: - Akutt eksaserbasjon av kronisk bronkitt - Samfunnservervet pneumoni , unntatt alvorlige tilfeller - Akutt bakteriell sinusitt (korrekt diagnostisert) - Lett til moderat bekkenbetennelse (det vil si infeksjoner
English: The presence of the bulky bicycloamine substituent at the C-7 position prevents active efflux, associated with the norA or pmrA genes seen in certain Gram-positive bacteria.
Bulgarian: Nærværet av den store bicykloamingruppen i C7-posisjon beskytter mot aktiv effluks, relatert
English: - Quinolone antibiotics may make your skin become more sensitive to sunlight or UV light.
Bulgarian: - Kinolonantibiotika kan gjøre at huden
English: - Cases of fulminant hepatitis potentially leading to life-threatening liver failure have been reported with moxifloxacin (see section 4.8).
Bulgarian: Hvis hjertearrytmier opptrer under behandling med moxifloxacin bør behandlingen stoppes og EKG-undersøkelse gjennomføres. - Tilfeller av fulminant hepatitt, som kan føre til livstruende leversvikt, har vært rapportert for moxifloxacin (se pkt 4.8).
English: Interstitial fluid
Bulgarian: Interstitialvæske
English: [Invented name] 400 mg film-coated tablets are not recommended for use in monotherapy of mild to moderate pelvic inflammatory disease but should be given in combination with another appropriate antibacterial agent (e.g. a cephalosporin) due to increasing moxifloxacin resistance of Neisseria gonorrhoeae unless moxifloxacin-resistant Neisseria gonorrhoeae can be excluded (see sections 4.4 and 5.1).
Bulgarian: [Legemidlets navn] 400 mg filmdrasjerte tabletter anbefales ikke som monoterapi ved lett til moderat bekkenbetennelse, men bør gis i kombinasjon med andre passende antibakterielle midler (f.eks.
English: The benefit of moxifloxacin treatment especially in infections with a low degree of severity should be balanced with the information contained in the warnings and precautions section.
Bulgarian: Nytten av moxifloxacinbehandling, spesielt ved mindre alvorlige infeksjoner
English: AVELOX 400 mg filmsko obložene tablete
Bulgarian: 14 dager [Legemidlets navn] 400 mg filmdrasjerte tabletter er brukt
English: As necessary, expert advice should be sought where the local prevalence of resistance is such that utility of the agent in at least some types of infections is questionable.
Bulgarian: Ekspertråd bør innhentes når den lokale forekomsten av resistens er
English: Blister fluid
Bulgarian: Chalmydia trachomatis*
English: The CHMP considered that due to the emergence of fluoroquinolone-resistant N. gonorrhoeae strains moxifloxacin should not be used in empirical monotherapy of mild to moderate PID, unless a resistance against moxifloxacin can be ruled out.
Bulgarian: cefalosporiner) på grunn av økende moxifloxacinresistens hos Neisseria gonorrhoeae, hvis ikke moxifloxacinresistente Neisseria gonorrhoeae kan utelukkes (se pkt.
English: [Invented name] tablets are not sufficient for sole therapy of this kind of infections and therefore another antibiotic in addition to [Invented name] tablets should be prescribed by your doctor for the treatment of infections of the female upper genital tract (see section 2.
Bulgarian: type antibiotika i tillegg til [Legemidlets navn] for behandling av infeksjoner øvre del av kvinners underliv (se pkt 2 ”Hva du må ta hensyn
English: Inherently resistant organisms
Bulgarian: Naturlig resistente arter
English: Therefore in such cases empirical moxifloxacin should be co-administered with another appropriate antibiotic (e.g. a cephalosporin) unless moxifloxacin-resistant Neisseria gonorrhoeae can be excluded.
Bulgarian: I slike tilfeller bør empirisk moxifloxacin bør gis i tillegg til et annet hensiktsmesig antibiotika (f.eks. celafosponrin) med mindre moxifloxacin-resistent Neisseria gonorrhoeae kan utelukkes. Dersom klinisk forbedring ikke oppnås etter 3 dagers behandling bør behandlingen revurderes. - På grunn av bruskskader hos voksende dyr (se pkt.
English: Site: Plasma ratio
Bulgarian: Konsentrasjon Vev/plasma forholdstall
English: Ethmoid sinus
Bulgarian: Etmoidalsinus
English: No adjustment of dosage is required in patients with mild to severely impaired renal function or in patients on chronic dialysis i.e. haemodialysis and continuous ambulatory peritoneal dialysis (see section 5.2 for more details).
Bulgarian: si hemodialyse og kontinuerlig ambulatorisk peritonealdialyse (se pkt.
English: Tissue
Bulgarian: Legemidler
English: You should avoid prolonged exposure to sunlight or strong sunlight and should not use a sunbed or any other UV lamp while taking [Invented name].
Bulgarian: sin blir mer følsom for sollys og UV-lys. Du bør unngå lengre
English: pseudomembranous colitis) has been reported in association with the use of broad spectrum antibiotics including moxifloxacin; therefore it is important to consider this diagnosis in patients who develop serious diarrhoea during or after the use of moxifloxacin.
Bulgarian: - Antibiotikarelatert kolitt (inkludert pseudomembranøs kolitt) har vært rapportert i forbindelse med bruk av bredspektrede antibiotika inklusive moxifluxacin.
English: Saliva
Bulgarian: Vev
English: 3.1 mg/l
Bulgarian: serumkonsentrasjon 3,1 mg/l
English: Community acquired pneumonia 10
Bulgarian: - Samfunnservervet pneumoni
English: Aerobic Gram-negative micro-organisms Haemophilus influenzae*
Bulgarian: Haemophilus influenzae*
English: Dosage (adults) One 400 mg film-coated tablet once daily.
Bulgarian: Én 400 mg tablett en gang daglig.
English: Use should be with caution in patients with CNS disorders which may predispose to seizures or lower the seizure threshold.
Bulgarian: Forsiktighet bør utvises hos pasienter med CNSforstyrrelser
English: S. pneumoniae
Bulgarian: pneumoniae
English: Invented name Name
Bulgarian: Inntak av [Legemidlets navn]
English: Strength
Bulgarian: PAKNINGSVEDLEGG
English: - Any medicine containing magnesium or aluminium such as antacids for indigestion, or any medicine containing iron or zinc, medicine containing didanosine or medicine containing sucralfate to treat gastrointestinal disorders can reduce the action of [Invented name] tablets.
Bulgarian: som inneholder magnesium eller aluminium, slik som antacida mot sure oppstøt, eller ethvert legemiddel
English: Unless otherwise indicated by your doctor the recommended durations of use of [Invented name] are: - Sudden worsening of chronic bronchitis (acute exacerbation of chronic bronchitis) 10 days - Infection of the lungs acquired (pneumonia) outside the hospital, except severe cases days - Acute infection of the sinuses (acute bacterial sinusitis) days - Mild to moderate infections of the female upper genital tract (pelvic inflammatory disease),
Bulgarian: Med mindre legen har fortalt deg noe annet, anbefales følgende behandlingstider: - Plutselig forverring av kronisk bronkitt (akutt eksaserbasjon av kronisk bronkitt) 5-10 dager - Infeksjoner
English: RECORDATI ESPAÑA, SL Crta.
Bulgarian: som gis i dette avsnittet.
English: QT-prolongation is a known undesirable effect of moxifloxacin.
Bulgarian: ikke renal clearance av moxifloxacin.
English: Aerobic Gram-positive micro-organisms Gardnerella vaginalis
Bulgarian: Gardnerella vaginalis
English: Efficacy and safety of moxifloxacin in children and adolescents have not been established (see section 4.3).
Bulgarian: Sikkerhet og effekt av moxifloxacin hos barn og ungdom er
English: You should check with your doctor or pharmacist if you are not sure how to take [Invented name].
Bulgarian: Kontakt lege eller apotek hvis du er usikker.
English: Alveolar macrophages
Bulgarian: Alveolære makrofager
English: Moxifloxacin is mainly bound to serum albumin.
Bulgarian: Moxifloxacin distribueres meget raskt
English: Member State
Bulgarian: Pasienter
English: - If you are pregnant or breast-feeding.
Bulgarian: - Dersom du har epilepsi eller en sykdom
English: It is approved for the treatment of the following bacterial infections if they are caused by bacteria susceptible to moxifloxacin: - Acute exacerbation of chronic bronchitis - Community acquired pneumonia, except severe cases - Acute bacterial sinusitis (adequately diagnosed).
Bulgarian: [Legemidlets navn] brukes hos voksne for å behandle følgende bakterieinfeksjoner: - Plutselig forverring av kronisk bronkitt (akutt eksaserbasjon av kronisk bronkitt) - Infeksjoner
English: - If you suffer from epilepsy or a condition which makes you likely to have convulsions, consult your doctor before taking [Invented name].
Bulgarian: som gjør at du kan få kramper må du snakke med legen din før du begynner å ta [Legemidlets navn].
English: DE - Germany
Bulgarian: H.
English: [Invented name] is used in adults for treating the following bacterial infections: - Sudden worsening of chronic bronchitis (acute exacerbation of chronic bronchitis) - Infection of the lungs (pneumonia) acquired outside the hospital, except severe cases - Acute infection of the sinuses (acute bacterial sinusitis) - Mild to moderate infections of the female upper genital tract (pelvic inflammatory disease), including infections of the fallopian tubes and infections of the uterus mucous membrane.
Bulgarian: infeksjon i bihulene (akutt bakteriell sinusitt) - Lette til moderate infeksjoner i øvre del av kvinners underliv (bekkennbetennelse), inkludert infeksjoner
English: Bronchial mucosa
Bulgarian: Bronkialslimhinne
English: Please contact your doctor before you continue the treatment if you develop signs such as rapidly feeling unwell and/or being sick associated with yellowing of the whites of the eyes, dark urine, itching of the skin, a tendency to bleed or liver induced disease of the brain (symptoms of a reduced liver function or a rapid and severe inflammation of the liver).
Bulgarian: som plutselig sykdomsfølelse samtidig med at det hvite i øynene blir gult, mørk urin, kløe i huden, blødningstendenser eller
English: Introduction
Bulgarian: infusjon
English: Moxifloxacin should be used with caution in patients with ongoing proarrhythmic conditions, such as acute myocardial ischaemia or QT prolongation as this may lead to an increased risk for ventricular arrhythmias (incl.
Bulgarian: QT-forlengelse, da dette kan føre til en øket risiko for ventrikkulær arrytmi (inkludert torsade de pointes) og hjertestans (se også pkt.
English: Avelox 400 mg tabletten
Bulgarian: Etter en dose på 400 mg er AUC målt
English: Renal/hepatic impairment
Bulgarian: Nyre/leverfunksjonsnedsettelse
English: The European Commission granted a marketing authorisation valid throughout the EU for Filgrastim ratiopharm to ratiopharm GmbH on 15 September 2008.
Bulgarian: Европейската комисия издава разрешение за употреба, валидно в рамките на Европейския съюз, за Filgrastim ratiopharm на ratiopharm GmbH на 15 септември 2008 г.
English: Therefore, the CHMP's view was that, as for Neupogen, the benefit outweighs the identified risk.
Bulgarian: Поради това CHMP счита, че както при Neupogen ползите са по-големи от установените рискове.
English: This means that Filgrastim ratiopharm is similar to a biological medicine that is already authorised in the European Union (EU) and contains the same active substance (also known as the ‘reference medicine').
Bulgarian: Това означава, че Filgrastim ratiopharm е подобен на друго биологично лекарство, вече одобрено в Европейския съюз (ЕС), и съдържа същото активно вещество (известно още като „референтно лекарство“).
English: Other side effects may be seen in more than 1 patient in 10, depending on the condition that Filgrastim ratiopharm is being used for.
Bulgarian: Възможни са други нежелани реакции при повече от 1 на 10 пациенти в зависимост от състоянието, за което се използва Filgrastim ratiopharm.
English: During the first 21-day chemotherapy cycle, patients treated with either Filgrastim ratiopharm or Neupogen had severe neutropenia for an average of 1.1 days, compared with 3.8 days in those receiving placebo.
Bulgarian: През първия 21-дневен цикъл на химиотерапия пациентите, лекувани с Filgrastim ratiopharm или Neupogen, имат тежка неутропения за средно 1,1 дни спрямо 3,8 дни при получаващите плацебо.
English: The active substance in Filgrastim ratiopharm, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G-CSF).
Bulgarian: Активното вещество в Filgrastim ratiopharm, филграстим, е много подобно на човешкия протеин, наречен гранулоцит-колониостимулиращ фактор (G-CSF).
English: The Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements, Filgrastim ratiopharm has been shown to have a comparable quality, safety and efficacy profile to Neupogen.
Bulgarian: Комитетът по лекарствените продукти за хуманна употреба (CHMP) решава, че в съответствие с изискванията на ЕС, е доказано, че Filgrastim ratiopharm има същия профил на качество, безопасност и ефикасност като Neupogen.
English: • to treat persistent neutropenia in patients with advanced human immunodeficiency virus (HIV) infection, to reduce the risk of bacterial infections when other treatments are not appropriate.
Bulgarian: за лечение на персистираща неутропения при пациенти с напреднала инфекция на човешки имунодефицитен вирус (HIV) за намаляване на риска от бактериални инфекции, когато други лечения са неподходящи.
English: The most common side effect with Filgrastim ratiopharm (seen in more than 1 patient in 10) is musculoskeletal pain (pain in the muscles and bones).
Bulgarian: Най-честата нежелана реакция при Filgrastim ratiopharm (наблюдавана при повече от 1 на 10 пациенти) е мускулно-скелетна болка (болки в мускулите и костите).
English: Filgrastim ratiopharm was compared to Neupogen and to placebo (a dummy treatment) in one main study involving 348 patients with breast cancer.
Bulgarian: Filgrastim ratiopharm е сравнен с Neupogen и с плацебо (сляпо лечение) в едно основно проучване, обхващащо 348 пациенти с рак на млечната жлеза.
English: The full EPAR for Filgrastim ratiopharm can be found here.
Bulgarian: Пълният текст на EPAR относно Filgrastim ratiopharm може да се намери тук.
English: Filgrastim ratiopharm can also be used in patients who are about to donate blood stem cells for transplant, to help release these cells from the bone marrow.
Bulgarian: Filgrastim ratiopharm може да се използва също при пациенти, на които предстои да дарят кръвни стволови клетки за трансплантация, за да се подпомогне освобождаването на клетките от костния мозък.
English: Filgrastim ratiopharm is usually given in a specialised treatment centre, although patients who receive it by injection under the skin may inject themselves once they have been trained appropriately.
Bulgarian: Filgrastim ratiopharm обикновено се дава в специализирани онкологични центрове, въпреки че пациентите, които приемат лекарството чрез подкожно инжектиране, могат да се инжектират сами след получаване на съответното обучение.
English: Filgrastim ratiopharm is used to stimulate the production of white blood cells in the following
Bulgarian: Filgrastim ratiopharm се използва за стимулиране на производството на бели кръвни клетки при
English: The replacement acts in same way as naturally produced G-CSF by encouraging the bone marrow to produce more white blood cells.
Bulgarian: Замяната действа по същия начин както при естествено произвеждания G-CSF - като се стимулира костният мозък да произвежда повече
English: The study looked at the duration of severe neutropenia during the patients' first cycle of cytotoxic chemotherapy.
Bulgarian: В проучването се изследва продължителността на тежката неутропения през първия цикъл от цитотоксичната
English: It contains the active
Bulgarian: В него се разяснява как
English: • to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell) and the occurrence of febrile neutropenia (neutropenia with fever) in patients receiving chemotherapy (cancer treatment) that is cytotoxic (cell-killing);
Bulgarian: за намаляване продължителността на неутропенията (ниски стойности на неутрофилите, тип бели кръвни клетки) и честотата на фебрилната неутропения (неутропения с повишена температура) при пациенти, получаващи цитотоксична (убива клетките) химиотерапия
English: Other information about Filgrastim ratiopharm:
Bulgarian: Допълнителна информация за Filgrastim ratiopharm:
English: To study the safety of Filgrastim ratiopharm, two further studies were carried out in patients with lung cancer and with non-Hodgkin's lymphoma.
Bulgarian: За проучване на безопасността на Filgrastim ratiopharm са проведени две допълнителни проучвания при пациенти с рак на белите дробове и неходжкинов лимфом.
English: • to reduce the duration of neutropenia in patients undergoing treatment to destroy the bone marrow cells before a bone marrow transplant (such as in some patients with leukaemia) if they are at a risk of long-term, severe neutropenia;
Bulgarian: за намаляване продължителността на неутропенията при пациенти, подложени на лечение за унищожаване на клетки от костния мозък, последвано от костномозъчна трансплантация (например при някои пациенти с левкемия), ако пациентите са с риск за продължителна
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) FILGRASTIM RATIOPHARM
Bulgarian: ЗА ОБЩЕСТВЕНА ОЦЕНКА (EPAR) FILGRASTIM RATIOPHARM
English: Treatment with Filgrastim ratiopharm and Neupogen brought about similar reductions in duration of severe neutropenia.
Bulgarian: При лечението с Filgrastim ratiopharm и Neupogen се постига подобно намаляване на продължителността на тежката неутропения.
English: Filgrastim ratiopharm was studied to show that it is comparable to the reference medicine, Neupogen.
Bulgarian: Filgrastim ratiopharm е проучен с цел да се покаже, че е равностоен на референтното лекарство
English: What benefit has Filgrastim ratiopharm shown during the studies?
Bulgarian: Какви ползи от Filgrastim ratiopharm са установени в проучванията?
English: Filgrastim ratiopharm is a ‘biosimilar' medicine.
Bulgarian: Filgrastim ratiopharm e „биоподобно“ лекарство.
English: For more information on biosimilar medicines, see the question-and-answer
Bulgarian: За повече информация за биоподобните
English: Filgrastim ratiopharm should not be used in people who may be hypersensitive (allergic) to filgrastim
Bulgarian: Filgrastim ratiopharm е противопоказен за лица, които биха могли да проявят свръхчувствителност (алергични реакции) към филграстим или някоя от другите съставки.
English: The reference medicine for Filgrastim ratiopharm is Neupogen.
Bulgarian: Референтното лекарство за Filgrastim ratiopharm е Neupogen.
English: Filgrastim ratiopharm is given by injection under the skin or infusion into a vein.
Bulgarian: Filgrastim ratiopharm се прилага с подкожна инжекция или инфузия във вена.
English: Filgrastim ratiopharm is a solution for injection or for infusion (drip into a vein).
Bulgarian: Filgrastim ratiopharm е инжекционен или инфузионен разтвор (въвежда се капково във вена).
English: The Committee recommended that Filgrastim ratiopharm be given marketing
Bulgarian: Комитетът препоръчва на Filgrastim ratiopharm
English: For the full list of all side effects reported with Filgrastim ratiopharm, see the Package Leaflet.
Bulgarian: За пълния списък на всички наблюдавани при Filgrastim
English: How does Filgrastim ratiopharm work?
Bulgarian: Как действа Filgrastim ratiopharm?
English: • to increase levels of neutrophils and reduce the risk of infections in patients with neutropenia who have a history of severe, repeated infections;
Bulgarian: за повишаване броя на неутрофилите и намаляване риска от инфекции при пациенти с
English: How has Filgrastim ratiopharm been studied?
Bulgarian: Как да използвате Filgrastim ratiopharm?
English: Moreover, the safety profile of clopidogrel in this subgroup of patients did not raise any particular concern.
Bulgarian: Освен това, профилът на безопасност на клопидогрел при тази подгрупа пациенти не предизвика някакъв особен проблем.
English: TTP is a potentially fatal condition requiring prompt treatment including plasmapheresis.
Bulgarian: ТТП е потенциално фатално състояние, изискващо бързо лечение, включително плазмафереза.
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Bulgarian: Експерименталните проучвания при животни не показват преки или непреки вредни ефекти по отношение на бременността, ембрионалното/фетално развитие, раждането или постнаталното развитие (вж. точка 5.3).
English: As a precautionary measure, breast-feeding should not be continued during treatment with Clopidogrel Zentiva.
Bulgarian: Като предпазна мярка, кърменето не трябва да продължава по време на лечението с Clopidogrel Zentiva.
English: Consequently, a direct effect (slight toxicity), or an indirect effect (low palatability) cannot be excluded.
Bulgarian: Следователно не може да се изключи пряк (слаба токсичност) или косвен ефект (леко вкусово усещане).
English: It is preferable not to take this product during pregnancy.
Bulgarian: За предпочитане е да не се приема този лекарствен продукт по време на бременност и кърмене.
English: This was associated with a reduction of the mean inhibition of platelet aggregation by 15% and 11%, respectively.
Bulgarian: Това е свързано с понижение на средното инхибиране на тромбоцитната агрегация съответно с 15% и 11%.
English: Adverse reactions that occurred either during clinical studies or that were spontaneously reported are presented in the table below.
Bulgarian: Нежеланите лекарствени реакции, настъпили по време на клиничните проучвания или съобщени спонтанно, са представени в таблицата по-долу.
English: When given to lactating rats, clopidogrel caused a slight delay in the development of the offspring.
Bulgarian: Когато се прилага при лактиращи плъхове, клопидогрел предизвиква слабо забавяне на развитието на поколението.
English: The clinically relevant adverse reactions observed in the CAPRIE, CURE, CLARITY, COMMIT and ACTIVE-A studies are discussed below.
Bulgarian: Клинично значимите нежелани лекарствени реакции, наблюдавани в проучванията CAPRIE, CURE, CLARITY, COMMIT и ACTIVE-A са обсъдени по-долу.
English: The other ingredients are (see section 2 ‘Clopidogrel Zentiva contains lactose' and ‘Clopidogrel Zentiva contains hydrogenated castor oil'):
Bulgarian: Другите съставки са (вижте точка 2 ‘Clopidogrel Zentiva съдържа лактоза' и ‘Clopidogrel Zentiva съдържа хидрогенирано рициново масло'):
English: For the 7, 14, 28 and 84 tablets pack sizes, you can check the day on which you last took a tablet of Clopidogrel Zentiva by referring to the calendar printed on the blister.
Bulgarian: При опаковките от 7, 14, 28 и 84 таблетки, можете да проверявате деня, в който последно сте приели таблетка Clopidogrel Zentiva по календара, отпечатан върху блистера.
English: The co-primary endpoints were death from any cause and the first occurrence of re-infarction, stroke or death.
Bulgarian: Съпътстващите първични крайни точки са били смърт по всякаква причина и първа поява на ре-инфаркт, инсулт или смърт.
English: Other medicines and Clopidogrel Zentiva
Bulgarian: Други лекарства и Clopidogrel Zentiva
English: Clopidogrel was found to have no effect on the fertility of male and female rats and was not teratogenic in either rats or rabbits.
Bulgarian: Клопидрогел не влияе върху фертилитета на мъжки и женски плъхове и няма тератогенен ефект при плъхове или зайци.