FrancophonIA/ELRC3.0 huggingface dataset:
English: Important information about some of the ingredients of Avalox This medicinal product contains 787mg (approximately 34mmol) sodium per dose.
Bulgarian: Αυτό το φαρµακευτικό προϊόν περιέχει 787 mg (περίπου 34mmol) νάτριο ανά δόση.
English: Lactation
Bulgarian: Γερµανία
English: The following solutions are incompatible with moxifloxacin solution for infusion: Sodium chloride 10% and 20% solutions
Bulgarian: Tα ακόλουθα διαλύµατα είναι µη συµβατά µε το διάλυµα moxifloxacin για έγχυση: Sodium chloride 10% και 20% διαλύµατα.
English: No prolongation of the QT interval was seen when a dose of 30 mg/kg was infused over 60 minutes.
Bulgarian: QT όταν η δόση των 30 mg/kg εγχυόταν για πάνω απο 60 λεπτά.
English: Anaemia
Bulgarian: Candidiasis
English: The relationship between moxifloxacin concentrations and change in QTc interval was investigated in CAP and cSSSI studies and the Phase III trials suggested similar results for moxifloxacin and the comparators.
Bulgarian: Σε in vivo δοκιµασίες δεν βρέθηκε απόδειξη γονοτοξικότητας παρά το γεγονός ότι χρησιµοποιήθηκαν πολύ υψηλές δόσεις moxifloxacin.
English: This medicinal product is authorised in the Member States of the EEA under the following names:
Bulgarian: Αύξηση της πήξης του αίµατος Αλλεργικές Αντιδράσεις Ασυνήθεις:
English: - If you develop a skin reaction or blistering and/or peeling of the skin and/or mucosal reactions (see section 4.
Bulgarian: - Εάν εµφανίσετε δερµατική αντίδραση ή φουσκάλες και /ή ξεφλούδισµα του δέρµατος και / ή βλεννογονικές αντιδράσεις (βλ.
English: Each bottle bag contains 400mg moxifloxacin (as hydrochloride).
Bulgarian: Μια φιάλη 250 ml περιέχει 400 mg moxifloxacin (ως hydrochloride).
English: Arthralgia Myalgia
Bulgarian: Γαλλία
English: Italy
Bulgarian: Αυστρία
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
Bulgarian: Παράρτηµα I - Να συµπληρωθεί σε εθνικό επίπεδο]
English: Allergic reaction (see section 4.4)
Bulgarian: Καρδιακή ανακοπή (βλ.παράγραφο 4.4)
English: Uncommon: Tingling sensation (pins and needles) and/or numbness, changes in taste (in very rare cases loss of taste), confusion and disorientation, sleep problems (predominately sleeplessness), shaking, sensation of dizziness (spinning or falling over), sleepiness
Bulgarian: απώλεια όσφρησης), παράξενα όνειρα, διαταραχή της ισορροπίας, και ανεπαρκής συγχρονισµός (λόγω της ζάλης), σπασµοί, διαταραχή της συγκέντρωσης, διαταραχή του λόγου, µερική ή ολική απώλεια της µνήµης
English: Oedema
Bulgarian: Ναυτία
English: In dogs, high oral doses (≥ 60 mg/kg) leading to plasma concentrations ≥ 20 mg/l caused changes in the electroretinogram and in isolated cases an atrophy of the retina.
Bulgarian: Σε σκύλους, υψηλές από του στόµατος δόσεις (≥60 mg/kg) που οδήγησαν σε συγκεντρώσεις πλάσµατος ≥ 20 mg/l, προκάλεσαν µεταβολές στο ηλεκτροαµφιβληστροειδογράφηµα και σε µεµονωµένες περιπτώσεις ατροφία του αµφιβληστροειδούς.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 bag of 250 ml contains 400 mg moxifloxacin (as hydrochloride).
Bulgarian: Μια φιάλη ή ένας σάκκος 250 ml περιέχει 400 mg moxifloxacin (ως hydrochloride).
English: Note: This SPC, labelling and package leaflet is the version valid at the time of Commission Decision.
Bulgarian: ρήξη των τενόντων, φλεγµονή των αρθρώσεων, µυϊκή ακαµψία, επιδείνωση των συµπτωµάτων της µυασθένιας gravis.
English: The CHMP considers that the benefit-risk relationship for IV/PO moxifloxacin in the management of cSSSI is only favourable with qualification of the indication for use.
Bulgarian: Αvelox περιέχει τη δραστική ουσία moxifloxacin, η οποία ανήκει σε µια οµάδα αντιβιοτικών που ονοµάζονται φθοροκινολόνες.
English: The Applicant proposed the insertion of a section on QTc interval in section 4.4, as well as the following box-warning at the beginning of section 4.4:
Bulgarian: Το κείµενο που προτάθηκε για την παράγραφο 4.4 συµπτύχθηκε ώστε να γίνει πιο σαφές.
English: If this becomes severe or persistent or you notice that your stool contains blood or mucus you should stop taking Avalox immediately and consult your doctor.
Bulgarian: Στα πρώτα σηµάδια πόνου ή φλεγµονής θα πρέπει να σταµατήσετε τη λήψη του Avelox, να ξεκουράσετε το προσβεβληµένο µέλος και να συµβουλευτείτε το γιατρό σας.
English: Ear Rare:
Bulgarian: Ιταλία:
English: France:
Bulgarian: Ισπανία:
English: “Complicated skin and skin structure infections only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of this infection (see section 4.4)”
Bulgarian: «Επιπλεγµένες λοιµώξεις του δέρµατος και των δοµών του δέρµατος µόνο όταν η χορήγηση αντιβακτηριακών φαρµάκων, τα οποία συνήθως συνιστώνται για την αρχική θεραπεία των εν λόγω λοιµώξεων, κρίνεται ακατάλληλη (βλέπε παράγραφο 4.4)»
English: - Moxifloxacin solution for infusion is for intravenous administration only.
Bulgarian: Η moxifloxacin αντενδείκνυται σε παιδιά και εφήβους σε ανάπτυξη.
English: Regarding section 5.2 of the SPC, the Applicant agreed to remove the CLSI disk diffusion and MIC breakpoint criteria for aerobic bacteria but retained the CLSI recommendations for anaerobes in the SPC, as there are no MIC breakpoints established by EUCAST making the CLSI standard the only reference available to guide physicians.
Bulgarian: - Η θεραπεία µε moxifloxacin µπορεί να αλληλεπιδράσει µε τον έλεγχο καλλιέργειας Mycobacterium spp.
English: The wording to be implemented was agreed by the CHMP and communicated to the Applicant.
Bulgarian: Το Avelox θα πρέπει πάντα να δίνεται από γιατρό ή νοσηλευτικό προσωπικό.
English: - Antibiotic associated diarrhoea (AAD) and antibiotic-associated colitis (AAC), including pseudomembranous colitis and Clostridium difficile-associated diarrhoea, has been reported in association with the use of broad spectrum antibiotics including moxifloxacin and may range in severity from mild diarrhoea to fatal colitis.
Bulgarian: - Έχει αναφερθεί διάρροια σχετιζόµενη µε αντιβιοτικά (AAD) και κολίτιδα σχετιζόµενη µε αντιβιοτικά (AAC), συµπεριλαµβανοµένης της ψευδοµεβρανώδους κολίτιδας και διάρροιας σχετιζόµενης µε Clostridium diffiicile, σε συσχέτιση µε τη χρήση αντιβιοτικών ευρέος φάσµατος συµπεριλαµβανοµένης της moxifloxacin και µπορεί να κυµαίνονται σε βαρύτητα από ήπια διάρροια µέχρι θανατηφόρα κολίτιδα.
English: Read all of this leaflet carefully before you start using this medicine.
Bulgarian: Διαβάστε προσεκτικά αυτό το φύλλο οδηγιών χρήσης προτού αρχίσετε να χρησιµοποιείτε αυτό το φάρµακο.
English: Uncommon:
Bulgarian: Φιλανδία:
English: Slovak Republic: Avelox Slovenia:
Bulgarian: Το Avelox ενδείκνυνται για τη θεραπεία:
English: The Applicant also claimed growing evidence that moxifloxacin has the best PK/PD profile to avoid the selection of resistance amongst the respiratory fluoroquinolones currently available in Europe.
Bulgarian: - Εάν έχετε κάποια αλλεργία (εάν έχετε υπερευαισθησία) στη δραστική ουσία moxifloxacin, σε κάποια άλλη αντιβακτηριακή κινολόνη ή σε οποιοδήποτε άλλο από τα συστατικά του Avelox
English: - If you have any further questions, ask your doctor or pharmacist.
Bulgarian: Να µην ψύχεται ή καταψύχεται.
English: Tinnitus
Bulgarian: Αντοχή
English: For more details see below and refer to sections 4.3 and 4.5.
Bulgarian: Για περισσότερες λεπτοµέρειες δείτε παρακάτω και αναφερθείτε στις παραγράφους 4.3 & 4.5.
English: gait disturbances, esp. due to dizziness or vertigo)
Bulgarian: Λοιπές πληροφορίες ) - Εάν είστε έγκυος ή θηλάζετε
English: LABELLING
Bulgarian: Αναιµία
English: Resistant
Bulgarian: Ισπανία
English: Rare:
Bulgarian: Τσεχία:
English: The CHMP did not agree with the Applicant's conclusions, although the boxed warning was considered appropriate.
Bulgarian: Η επίδραση του Avelox δεν επηρεάζεται από το φαγητό συµπεριλαµβανοµένων των γαλακτοκοµικών προϊόντων.
English: +Methicillin resistant S. aureus have a high probability of resistance to fluoroquinolones.
Bulgarian: + ο ανθεκτικός στη methicillin S.aureus έχει υψηλή πιθανότητα αντίστασης στις φθοροκινολόνες.
English: The CHMP was of the opinion that the use of IV moxifloxacin for treatment of CAP should be qualified by the same wording as the cSSSI indication.
Bulgarian: Η αντίσταση στις φθοροκινολόνες µπορεί να αυξηθεί µέσα από τις µεταλλάξεις της γυράσης του DNA και της τοποϊόµεράσης IV.
English: - If you are pregnant or breast-feeding.
Bulgarian: - Εάν είστε παιδί ή έφηβος σε ανάπτυξη
English: In addition, the Applicant was requested to commit to amend the SPC for the moxifloxacin tablets, in order to bring it in line with the IV formulation, and make it clear that the tablets may be used for cSSSI and CAP of any severity only when IV therapy has already resulted in substantial improvement in the patient's condition, such that a switch to oral treatment is considered appropriate.
Bulgarian: - Η moxifloxacin θα πρέπει να χρησιµοποιείται µε προσοχή σε ασθενείς µε µυασθένεια gravis διότι µπορεί να επιδεινωθούν τα συµπτώµατα.
English: Headache, dizziness
Bulgarian: ΛΗΞΗ
English: - This medicine has been prescribed for you.
Bulgarian: - Παιδιά και έφηβοι σε ανάπτυξη.
English: If you receive more Avalox than you should If you are concerned that you may have been received too much Avalox, contact your doctor immediately.
Bulgarian: Εάν ανησυχείτε ότι µπορεί να έχετε λάβει περισσότερο Avelox, επικοινωνήστε µε το γιατρό σας αµέσως.
English: Spain:
Bulgarian: Έκδοχα:
English: PACKAGE LEAFLET
Bulgarian: Ιρλανδία
English: In the interstitial fluid unbound concentration time profiles similar to those in plasma were found with unbound peak concentrations of 1.0 mg/l (geometric mean) reached approximately 1.8 h after an intravenous dose.
Bulgarian: Στο διάκενο του υγρού ο χρόνος ελεύθερης συγκέντρωσης κατανέµεται οµοίως µε εκείνη στο πλάσµα όπου βρέθηκε µε ελεύθερες µέγιστες συγκεντρώσεις 1.0mg/l ( γεωµερικός µέσος) επιτυγχάνοντας περίπου 1.8 h µετά απο ενδοφλέβια δόση.
English: Route of administration
Bulgarian: αύξηση της ευαισθησίας του δέρµατος
English: However, the CHMP maintained its position, stating that the clinical and microbiological responses point to a conclusion that moxifloxacin IV/PO is not among the optimal treatments for cSSSI.
Bulgarian: Εποµένως δεν παρατηρήθηκε κλινικά σχετιζόµενη αλληλεπίδραση µεταξύ της moxifloxacin και της γλιβενκλαµίδης.
English: Seizures incl.
Bulgarian: QTc.
English: Studies in rats (p.o. and i.v.)
Bulgarian: Τενοντίτις (βλ.παρ.4.4)
English: It was considered that the same restrictions should apply to the indications for both CAP and cSSTI as already adopted by CHMP for oral moxifloxacin to treat CAP. Intravenous moxifloxacin is almost always followed by oral treatment and as such the restriction for use of oral moxifloxacin should be reflected in the SPC of the intravenous product.
Bulgarian: Θα πρέπει να αποφεύγετε την παρατεταµένη έκθεση στο φως του ήλιου ή σε δυνατό φως του ήλιου και δεν θα πρέπει να χρησιµοποιείτε κρεβάτια µε λάµπες τεχνητού µαυρίσµατος ή κάποια άλλη λάµπα υπεριώδους ακτινοβολίας κατά τη διάρκεια λήψης του Avelox.
English: The CHMP considers that the totality of the safety data relating to use of moxifloxacin (IV and oral and IV/PO) should be taken into account together when assessing the overall benefit-risk and therefore, the safety profile described for oral administration applies to intravenous administration, with the additional expectation that the difference in PK and in patient and infection characteristics for those in need of initial IV treatment is likely to increase any risks associated with systemic administration.
Bulgarian: Σε ό,τι αφορά τις αιτούµενες ενδείξεις δεν υπάρχει κανένα αναµενόµενο πλεονέκτηµα της µοξιφλοξασίνης έναντι των εγκεκριµένων φθοριοκινολονών, εκτός από τη σιπροφλοξασίνη στην πνευµονία της κοινότητας (λόγω της εγγενούς χαµηλής δραστηριότητας της σιπροφλοξασίνης έναντι του S. pneumoniae).
English: Local reactions at the injection site are common and normally resolve within 4 weeks.
Bulgarian: Локалните реакции на мястото на инжектиране са чести и обикновено отшумяват в рамките на 4 седмици.
English: Cattle may show a temporary increase in body temperature (no more than 2.7 °C) in the 48 hours following vaccination.
Bulgarian: При ваксинираните говеда е възможно временно повишение на телесната температура (с не повече от 2,7℃) до 48 часа след ваксинацията.
English: The European Medicines Agency (EMA) reviewed additional information submitted according to an agreed timetable on the quality, safety and efficacy of the vaccine.
Bulgarian: Всяка година Европейската агенция по лекарствата (ЕМА) разгледа допълнителната информация в съответствие с договорен график за качеството, безопасността и ефикасността на ваксината.
English: Local reactions may increase slightly following the second dose, in this case lasting up to 15 days.
Bulgarian: Локалните реакции могат леко да се усилят след втората доза и ако случаят е такъв, продължават до 15 дни.
English: The first injection is given from three months of age and the second injection is given three weeks later.
Bulgarian: Първата инжекция се поставя след тримесечна възраст, а втората - три седмици по-късно.
English: The virus exists in several forms (serotypes) throughout the world; the types used in Zulvac 1+8 Bovis are serotypes 1 and 8.
Bulgarian: Вирусът съществува в редица форми (серотип) по света; типовете, използвани в Zulvac 1+8 Bovis , са серотип 1 и 8.
English: The vaccine is used to prevent viraemia (the presence of viruses in the blood) in cattle from three months of age.
Bulgarian: Ваксината се използва за предотвратяване на виремия (наличие на вируса в кръвта) при говеда на възраст над три месеца.
English: A field study was also conducted investigating the safety of the vaccine in dairy cows, including pregnant and lactating cows.
Bulgarian: Проведено е също полево проучване, което изследва безопасността на ваксината при млечни крави, включително бременни и лактиращи крави.
English: The field study showed that the vaccine can be used safely in pregnant and lactating cows.
Bulgarian: Полевото проучване показва, че ваксината може да се използва безопасно при бременни и лактиращи крави.
English: Another laboratory study in cattle looked at how long the vaccine was able to protect against bluetongue infection.
Bulgarian: Друго лабораторно проучване при говеда разглежда колко време ваксината е в състояние да предпазва срещу инфекция с вируса на син език.
English: This means that it was not possible at the time of the initial authorisation to obtain complete information about Zulvac 1+8 Bovis.
Bulgarian: Това означава, че при първоначалното лицензиране не е било възможно да бъде получена пълна информация за Zulvac 1+8 Bovis.
English: immune system recognises the viruses as ‘foreign' and makes antibodies against them.
Bulgarian: При прилагане на ваксината имунната система на говедата разпознава вирусите като „чужди“ и произвежда антитела срещу тях.
English: The withdrawal period for Zulvac 1 + 8 Bovis for meat and milk is zero days.
Bulgarian: Карентният срок за Zulvac 1 + 8 Bovis за месо и мляко е нула дни.
English: The studies showed that the vaccine is safe and that it prevents viraemia caused by bluetongue virus serotypes 1 and 8 in cattle from three months of age.
Bulgarian: Проучванията показват, че ваксината е безопасна и предотвратява виремия, причинена от вируса на син език, серотип 1 и 8, при говеда на възраст над три месеца.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zulvac 1+8 Bovis on 08/03/2012.
Bulgarian: Европейската комисия издава лиценз за употреба, валиден в Европейския съюз, за Zulvac 1+8 Bovis на 8 март 2012 г.
English: Zulvac 1+8 Bovis was initially authorised under ‘exceptional circumstances'.
Bulgarian: Първоначално Zulvac 1+8 Bovis е одобрен при „извънредни обстоятелства“.
English: The studies looked at the strength of vaccine required to protect against bluetongue infection, and at the safety of the vaccine.
Bulgarian: Проучванията разглеждат количеството на активната субстанция във ваксината, необходимо за осигуряване на защита срещу инфекция с вируса на син език, и безопасността на ваксината.
English: Zulvac 1+8 Bovis was studied in calves in four main studies carried out in a laboratory.
Bulgarian: Zulvac 1+8 Bovis е проучен при телета в четири основни проучвания, проведени в лабораторни условия.
English: The CVMP concluded that the benefits of Zulvac 1+8 Bovis exceed the risks for prevention of viraemia caused by bluetongue virus serotypes 1 and 8 in cattle from three months of age and recommended that Zulvac 1+8 Bovis be given a marketing authorisation.
Bulgarian: CVMP заключава, че ползите от Zulvac 1+8 Bovis превишават рисковете за предпазване от виремия, причинена от вируси на болестта „син език“, серотип 1 и 8, при говеда на възраст над три месеца и препоръчва на Zulvac 1+8 Bovis да се издаде лиценз за употреба.
English: Zulvac 1+8 Bovis is a vaccine that contains inactivated (killed) bluetongue serotypes 1 and 8 viruses as the active substance.
Bulgarian: Zulvac 1+8 Bovis е ваксина, която съдържа инактивиран (убит) вирус на болестта „син език“, серотип 1 и 8, като активна субстанция.
English: Zulvac 1+8 Bovis is a vaccine.
Bulgarian: Zulvac 1+8 Bovis е ваксина.
English: Zulvac 1+8 Bovis contains bluetongue viruses that have been inactivated so that they cannot cause the disease.
Bulgarian: Zulvac 1+8 Bovis съдържа инактивирани вируси на син език, които не могат да причинят заболяването.
English: Zulvac 1+8 Bovis is used in cattle to protect them against bluetongue disease, an infection caused by the bluetongue virus which is transmitted by midges.
Bulgarian: Zulvac 1+ 8 Bovis се прилага при говеда за защита от болестта „син език“ - инфекция, която се причинява от вируса на син език и се предава от хапещи насекоми.
English: In 2013 the CVMP considered that the submitted data were adequate for the authorisation of Zulvac 1+8 Bovis to convert to a normal status.
Bulgarian: През 2013 г. CVMP реши, че предоставената информация е достатъчна за отмяна на „извънредните обстоятелства“ по отношение на лиценза за употреба на Zulvac 1+8 Bovis.
English: Other information about Zulvac 1+8 Bovis:
Bulgarian: Допълнителна информация за Zulvac 1+8 Bovis:
English: What benefit has Zulvac 1+8 Bovis shown during the studies?
Bulgarian: Какви ползи от Zulvac 1+8 Bovis са установени в проучванията?
English: What is the risk associated with Zulvac 1+8 Bovis?
Bulgarian: Какви са рисковете, свързани с Zulvac 1+8 Bovis?
English: What is Zulvac 1+8 Bovis?
Bulgarian: Какво представлява Zulvac 1+8 Bovis?
English: How has Zulvac 1+8 Bovis been studied?
Bulgarian: Как е проучен Zulvac 1+8 Bovis?
English: How does Zulvac 1+8 Bovis work?
Bulgarian: Как действа Zulvac 1+8 Bovis?
English: What is Zulvac 1+8 Bovis used for?
Bulgarian: За какво се използва Zulvac 1+8 Bovis?
English: Why has Zulvac 1+8 Bovis been approved?
Bulgarian: Какви са основанията за одобряване на Zulvac 1+8 Bovis?
English: Doses are calculated using the patient's weight.
Bulgarian: Дозите се изчисляват въз основа на теглото на пациента.
English: Belatacept has been designed to attach to two of these molecules called CD80 and CD86.
Bulgarian: Белатацепт е разработен да се свързва с две от тези молекули, наречени CD80 и CD86.
English: The full EPAR for Nulojix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Bulgarian: Пълният текст на EPAR относно Nulojix може да се намери на уебсайта на Агенцията: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The studies also looked at the number of organ rejections that occurred within one year of the transplant.
Bulgarian: Проучванията разглеждат и броя на отхвърлените органи, възникнали в рамките на една година от трансплантацията.
English: Further doses are given at the end of weeks 8 and 12.
Bulgarian: В края на 8-а и 12-а седмица се дават допълнителни дози.
English: This happens when certain molecules attach to receptors on the surface of the T cells.
Bulgarian: Това става, когато определени молекули се свързват с рецептори на повърхността на Т-клетките.
English: In the initial phase it is given at a dose of 10 mg per kilogram body weight on day 1 (day of transplantation or the day before) and then again on days 5, 14 and 28.
Bulgarian: В началната фаза лекарството се прилага в доза от 10 mg на килограм телесно тегло на ден 1 (деня на трансплантацията или деня преди нейното провеждане) и след това отново в дни 5, 14 и 28.
English: This is a summary of the European public assessment report (EPAR) for Nulojix.
Bulgarian: Настоящият документ представлява резюме на Европейския публичен оценъчен доклад (EPAR) за Nulojix.
English: A risk management plan has been developed to ensure that Nulojix is used as safely as possible.
Bulgarian: Разработен е план за управление на риска, за да се гарантира, че Nulojix се използва възможно най-безопасно.
English: For more information about treatment with Nulojix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Bulgarian: За повече информация относно лечението с Nulojix прочетете листовката (също част от EPAR) или се обърнете към Вашия лекар или фармацевт.
English: It contains the active substance belatacept.
Bulgarian: Съдържа активното вещество белатацепт (belatacept).
English: What measures are being taken to ensure the safe and effective use of Nulojix?
Bulgarian: Какви мерки се предприемат, за да се гарантира безопасната и ефективна употреба на Nulojix?
English: The main measures of effectiveness were the proportion of patients who survived with their transplanted kidneys intact and how well their kidneys functioned.
Bulgarian: Основните мерки за ефективност са делът на пациентите, които преживяват със запазени трансплантирани бъбреци, както и колко добре функционират бъбреците им.
English: It suppresses the activity of ‘T cells', immune system cells that can become involved in organ rejection.
Bulgarian: То потиска активността на „Т-клетките“, клетки на имунната система, които могат да участват в отхвърлянето на органа.
English: The CHMP therefore concluded that Nulojix's benefits are greater than its risks and recommended that it be given marketing authorisation.
Bulgarian: Следователно CHMP заключи, че ползите от Nulojix са по-големи от рисковете, и препоръча да се издаде разрешение за употреба.
English: In addition, the company that makes Nulojix will include an alert card in each medicine's pack to increase awareness of the benefits and risks with Nulojix.
Bulgarian: В допълнение фирмата производител на Nulojix ще осигури сигнална карта във всяка опаковка на лекарството, за да повиши осведомеността относно ползите и рисковете, свързани с Nulojix.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Nulojix, including the appropriate precautions to be followed by healthcare professionals and patients.
Bulgarian: Въз основа на този план информацията за безопасността е включена в кратката характеристика на продукта и в листовката за Nulojix, включително подходящи предпазни мерки за здравните специалисти и пациентите.
English: After the initial phase, which lasts three months, Nulojix is given at a maintenance dose of 5 mg/kg every four weeks starting from the end of the week 16.
Bulgarian: След първоначалната фаза, чиято продължителност е три месеца, Nulojix се прилага в поддържаща доза от 5 mg/kg през четири седмици, като се започва от края на 16-а седмица.
English: This is because patients treated with Nulojix who have had no previous exposure to the virus are at higher risk of getting a type of cancer known as post-transplant lymphoproliferative disorder.
Bulgarian: Това е така, защото пациентите, лекувани с Nulojix, които не са имали предишна експозиция на вируса, са изложени на по-висок риск от развитие на вид рак, известен като посттрансплантационно лимфопролиферативно нарушение.
English: T cells must be ‘activated' before they work.
Bulgarian: Преди да се задействат, Т-клетките трябва да бъдат „активирани“.
English: Other information about Nulojix
Bulgarian: Допълнителна информация за Nulojix