FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment with Orgalutran should be carried out by a doctor who has experience in this type of fertility treatment.
Bulgarian: Лечението с Orgalutran трябва да се извършва от лекар с опит в такъв вид лечение на проблемите на стерилитета.
English: Treatment should start on day 5 or 6 after the start of ovarian stimulation with follicle stimulating hormone (FSH) or corifollitropin alfa (a modified FSH).
Bulgarian: Лечението трябва да започне на петия или шестия ден след началото на яйчниковата стимулация с фоликулостимулиращ хормон (FSH) или корифолитропин алфа (модифициран FSH).
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Orgalutran.
Bulgarian: В него се разяснява оценката на Комитета по лекарствените продукти за хуманна употреба (CHMP) относно лекарството, на която Комитетът основава становище за издаване на разрешение за употреба и препоръки относно условията на употреба за Orgalutran.
English: Treatment with Orgalutran should be continued up to the day that there are enough large follicles (small sacs in the ovary that hold the eggs).
Bulgarian: Лечението с Orgalutran трябва да продължи докато се получат достатъчно големи фоликули (малки торбички в яйчника, в които се намират яйцеклетките).
English: In studies, the most common side effect with Orgalutran (seen in more than 1 patient in 10) was a skin reaction at the injection site, mainly redness with or without swelling.
Bulgarian: В проучванията най-честата нежелана реакция при Orgalutran (наблюдавана при повече от 1 на 10 пациенти) е реакция на мястото на инжектиране, основно зачервяване без подуване.
English: For the full list of restrictions, see the package leaflet.
Bulgarian: За пълния списък с ограниченията - вижте листовката.
English: During fertility treatment, ovarian stimulation is normally used to make the ovaries produce more than one egg.
Bulgarian: По време на лечение на проблеми с фертилитета яйчниковата стимулация обикновено се използва, за да се стимулират яйчниците да образуват повече от една яйцеклетки.
English: Orgalutran is preferably given into the upper leg.
Bulgarian: За предпочитане е Orgalutran да се прилага в бедрото.
English: The active substance in Orgalutran, ganirelix, blocks the receptors for a natural hormone called gonadotrophin-releasing hormone (GnRH).
Bulgarian: Активното вещество в Orgalutran, ганиреликс, блокира рецепторите на естествения хормон, гонадотропин освобождаващ хормон (GnRH).
English: What benefit has Orgalutran shown during the studies?
Bulgarian: Какви ползи от Orgalutran са установени в проучванията?
English: For more information about treatment with Orgalutran, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Bulgarian: За повече информация относно лечението с Orgalutran - прочетете листовката (също част от EPAR).
English: GnRH controls the secretion of another hormone called luteinising hormone (LH), which causes ovulation (the release of eggs during the menstrual cycle).
Bulgarian: GnRH контролира освобождаването на друг хормон, наречен лутеинизиращ хормон (LH), който предизвиква овулация (освобождаване на яйцеклетките по време на менструалния цикъл).
English: A few days later, a hormone called human chorionic gonadotrophin (hCG) is given to trigger ovulation, and the eggs are then harvested.
Bulgarian: Няколко дни по-късно се прилага хормон, наречен човешки хорион гонадотропин (ЧХГ), за да се предизвика овулация и тогава се изваждат яйцеклетките.
English: Orgalutran is used to prevent premature ovulation (early release of eggs from the ovary) in women having fertility treatment and who are having ovarian stimulation (stimulation of the ovaries so that they produce more eggs).
Bulgarian: Orgalutran се използва за предотвратяване на преждевременна овулация (ранно освобождаване на яйцеклетки от яйчника) при жени, които са подложени на лечение на стерилитет и които са в процес на яйчникова стимулация (стимулация на яйчниците за произвеждане на повече яйцеклетки).
English: Orgalutran is a solution for injection in a prefilled syringe.
Bulgarian: Orgalutran представлява инжекционен разтвор в предварително напълнена спринцовка.
English: Orgalutran should not be used in people who may be hypersensitive (allergic) to ganirelix, to any of the other ingredients, to GnRH or to other GnRH analogues (medicines that have a similar structure to GnRH and modify the activity of GnRH in the body).
Bulgarian: Orgalutranе противопоказен за хора, които биха могли да проявят свръхчувствителност (алергични реакции) към ганиреликс, някоя от другите съставки, GnRH или други GnRH аналози (лекарства със сходна на GnRH структура, които модифицират действието на GnRH в организма).
English: For the full list of all side effects reported with Orgalutran, see the package leaflet.
Bulgarian: За пълния списък на всички наблюдавани при Orgalutran нежелани реакции - вижте листовката.
English: For further information on how to use Orgalutran, see the package leaflet.
Bulgarian: За допълнителна информация как да се използва Orgalutran - вижте листовката.
English: Orgalutran was compared with buserelin, leuprorelin, and triptorelin (GnRH agonists: another group of medicines used to prevent premature ovulation, which work by stimulating the receptor for GnRH to such an extent that the body stops making LH).
Bulgarian: Orgalutran е сравнен с бусерелин, леупрорелин и трипторелин (GnRH агонисти: друга група лекарства, използвани за предотвратяване на преждевременна овулация, които действат чрез стимулиране на рецептора на GnRH до такова ниво, че организмът спира да произвежда лутеинизиращ хормон).
English: What is the risk associated with Orgalutran?
Bulgarian: Какви са рисковете, свързани с Orgalutran?
English: By blocking the effect of GnRH, Orgalutran stops the production of LH, and therefore prevents premature ovulation.
Bulgarian: Като блокира действието на гонадотропин освобождаващия хормон, Orgalutran възпрепятства производството на лутеинизиращ хормон и така предотвратява преждевременна овулация.
English: How has Orgalutran been studied?
Bulgarian: Как е проучен Orgalutran?
English: What is Orgalutran used for?
Bulgarian: За какво се използва Orgalutran?
English: What is Orgalutran?
Bulgarian: Какво представлява Orgalutran?
English: How is Orgalutran used?
Bulgarian: Как се използва Orgalutran?
English: Why has Orgalutran been approved?
Bulgarian: Какви са основанията за одобряване на Orgalutran?
English: How does Orgalutran work?
Bulgarian: Как действа Orgalutran?
English: 1123 Budapest
Bulgarian: 1123 Budapest Ουγγαρία
English: Comercialização de Produtos Farmacêuticos Unipessoal, Lda.
Bulgarian: Farmacêuticos Unipessoal, Lda.
English: B-1050 Brussel Belgium
Bulgarian: B-1050 Brussel
English: Netherlands Bayer BV Energieweg 1
Bulgarian: Bayer BV Energieweg 1
English: 7 - 21 days
Bulgarian: 7 - 21 ηµέρες
English: H. influenzae and M. catarrhalis
Bulgarian: H.influenzae & M. Catarrhalis
English: 3641 RT Mijdrecht Netherlands
Bulgarian: 3641 RT Mijdrecht Ολλανδία
English: Moraxella (Branhamella) catarrhalis
Bulgarian: Μοraxella (Branhamella) catarrhalis
English: Berkshire RG14 1JA United Kingdom
Bulgarian: Berkshire RG14 1JA Ηνωµένο Βασίλειο
English: Bayer Austria GmbH Herbststraße 6-10 1160 Wien Austria
Bulgarian: Bayer Austria GmbH Herbststraße 6-10 1160 Wien Αυστρία
English: 151 25 Marousi - Athens Greece
Bulgarian: 151 25 MarousiAthens
English: Member State EU/EEA
Bulgarian: Κράτος Μέλος EU/EEA
English: Active ingredient: Moxifloxacin
Bulgarian: Δραστική ουσία: Moxifloxacin
English: Sodium bicarbonate 4.2% and 8.4% solutions
Bulgarian: Sodium bicarbonate 4.2% και 8.4% διαλύµατα
English: Streptococcus milleri group* (S. anginosus, S. constellatus and S. intermedius) Streptococcus pneumoniae*
Bulgarian: Streptococcus milleri group (S.anginosus, S.constellatus & S.intermedius)*
English: Common ≥ 1/100 to < 1/10
Bulgarian: Συνήθεις ≥1/100 έως <1/10
English: Refer to sections 4.3, 4.4 and 4.5.
Bulgarian: Βλέπε παράγραφο 4.3, 4.4 και 4.5.
English: Belgium Bayer SA-NV Avenue Louise 143
Bulgarian: Λουξεµβούργο Bayer SA-NV Avenue Louise 143
English: Blackthorn Road Dublin 18
Bulgarian: Bayer Limited The Atrium Blackthorn Road, Dublin 18
English: Rare ≥ 1/10,000 to
Bulgarian: Σπάνιες ≥1/10.000 έως
English: Prevotella spp.
Bulgarian: Prevotella spp "Άλλοι" µικροοργανισµοί
English: The mean apparent total body clearance following a 400 mg dose ranges from 179 to 246 ml/min.
Bulgarian: Η µέση εµφανής ολική κάθαρση σώµατος µετά από δόση 400 mg κυµαίνεται από 179 έως 246 ml/min.
English: The CHMP maintained its previous position.
Bulgarian: Η CHMP διατήρησε την πρότερη θέση της.
English: DATE OF REVISION OF THE TEXT
Bulgarian: - Κλινικά σηµαντική βραδυκαρδία
English: EUCAST clinical MIC breakpoints for moxifloxacin (31.01.2006): Organism
Bulgarian: EUCAST κλινικά όρια MIC για τη moxifloxacin (31-01-2006):
English: {Name and address} <{tel}> <{fax}> <{e-mail}>
Bulgarian: Γενικές διαταραχές και καταστάσεις της οδού χορήγησης
English: Bayer Hellas S.A.
Bulgarian: Bayer Hellas S.A. Sorou 18-20
English: For a full list of excipients, see section 6.1.
Bulgarian: Για την πλήρη λίστα των εκδόχων, βλ.παράγραφο 6.1
English: The following wording was adopted:
Bulgarian: Διαταραχές του ανοσοποιητικού συστήµατος
English: [To be completed nationally] [See Annex I - To be completed nationally]
Bulgarian: [Να συµπληρωθεί σε εθνικό επίπεδο] [Βλ. Παράρτηµα I - Να συµπληρωθεί σε εθνικό επίπεδο]
English: [To be completed nationally]
Bulgarian: [Nα συµπληρωθεί σε εθνικό επίπεδο]
English: Infused at a constant flow rate over 60 minutes.
Bulgarian: Εγχύεται σε σταθερή διάρκεια ροής πάνω από 60 λεπτά.
English: 1 ml contains 1.6 mg moxifloxacin as hydrochloride.
Bulgarian: 1 ml περιέχει 1.6 mg moxifloxacin ως hydrochloride
English: As renal function decreases, concentrations of the M2 metabolite (glucuronide) increase by up to a factor of 2.5 (with a creatinine clearance of < 30 ml/min/1.73 m2).
Bulgarian: Όσο ελαττώνεται η νεφρική λειτουργία, οι συγκεντρώσεις του µεταβολίτη Μ2 (γλυκουρονίδιο) αυξάνονται έως 2.5 φορές (µε κάθαρση κρεατινίνης < 30 ml/min/1.73 m2).
English: Pharmacokinetics are linear in the range of 50 - 1200 mg single oral dose, up to 600 mg single intravenous dose and up to 600 mg once daily dosing over 10 days.
Bulgarian: Η φαρµακοκινητική είναι γραµµική στο εύρος των 50 - 1200 mg, εφάπαξ από του στόµατος δόσεως, µέχρι 600 mg εφάπαξ ενδοφλέβιας δόσεως και µέχρι 600 mg µία φορά την ηµέρα κατά τη διάρκεια 10 ηµερών.
English: Headache Dizziness
Bulgarian: ΚΛΙΝΙΚΑ ΣΤΟΙΧΕΙΑ
English: Moxifloxacin is eliminated from plasma with a mean terminal half life of approximately 12 hours.
Bulgarian: Η moxifloxacin αποβάλλεται από το πλάσµα µε µέση περίοδο ηµίσειας ζωής περίπου 12 ώρες.
English: The following solutions were incompatible with Avalox: Sodium chloride 10% and 20% solutions, Sodium bicarbonate 4.2% and 8.4% solutions
Bulgarian: διάλυµα για έγχυση: Sodium chloride 10% και 20% διαλύµατα, Sodium bicarbonate 4.2% και 8.4% διαλύµατα
English: After a single 400 mg intravenous 1 hour infusion peak plasma concentrations of approximately 4.1 mg/l were observed at the end of the infusion corresponding to a mean increase of approximately 26% relative to those seen after oral administration (3.1 mg/l).
Bulgarian: Μετά από µία εφάπαξ δόση 400 mg ενδοφλεβίως, µίας ώρας έγχυσης, οι µέγιστες συγκεντρώσεις του πλάσµατος, περίπου 4,1 mg/l, παρατηρήθηκαν στο τέλος της έγχυσης, ανταποκρινόµενες σε µέση αύξηση περίπου 26% σε σχέση µε αυτές που παρατηρήθηκαν µετά από του στόµατος χορήγηση ( 3.1 mg/l).
English: - This medicinal product contains 787 mg (approximately 34 mmol) sodium per dose.
Bulgarian: - Αυτό το φαρµακευτικό προϊόν περιέχει 787 mg (περίπου 34 mmol) νάτριο ανά δόση.
English: The steady-state volume of distribution (Vss) is approximately 2 l/kg.
Bulgarian: Ο όγκος κατανοµής σε σταθεροποιηµένη κατάσταση (Vss) είναι περίπου 2 l/kg.
English: Rua Quinta do Pinheiro, 5 2794-003 Carnaxide Portugal
Bulgarian: Rua Quinta do Pinheiro, 5
English: Read the package leaflet before use.
Bulgarian: Πρέπει να ξεκινήσει γενική συµπτωµατική αγωγή.
English: Haemophilus influenzae*
Bulgarian: Aερόβιοι αρνητικοί κατά Gram µικροοργανισµοί Haemophilus influenzae*
English: 1 ml contains 1.6 mg moxifloxacin (as hydrochloride).
Bulgarian: 1 ml περιέχει 1.6 mg moxifloxacin (ως hydrochloride).
English: Sodium content: 34 mmol/250 ml
Bulgarian: 34 mmol/250 ml
English: In vitro and ex vivo experiments showed a protein binding of approximately 40 - 42% independent of the concentration of the drug.
Bulgarian: In vitro και ex vivo πειράµατα έδειξαν δέσµευση µε πρωτεΐνες περίπου 40 - 42%, ανεξάρτητα από τη συγκέντρωση του φαρµάκου.
English: In this leaflet:
Bulgarian: Αυτί Σπάνιες:
English: Látvia
Bulgarian: Όρια
English: See also sections 4.3 and 4.5.
Bulgarian: Δείτε επίσης παραγράφους 4.3 και 4.5.
English: Avelox United Kingdom: Avelox
Bulgarian: Εάν παραλείψετε τη δόση του AVELOX
English: Maximum concentrations of 5.4 mg/kg and 20.7 mg/l (geometric mean) were reached in bronchial mucosa and epithelial lining fluid, respectively, 2.2 h after an oral dose.
Bulgarian: Οι µέγιστες συγκεντρώσεις των 5.4 mg/kg και 20.7mg/l (γεωµετρικός µέσος) έφτασαν στο βρογχικό βλεννογόνο και στο επιθύλιο εσωτερικό υγρό αντίστοιχα 2.2h µετά απο µια απο του στόµατος δόση.
English: 5 years Use immediately after first opening and/or dilution.
Bulgarian: 5 χρόνια Χρησιµοποιείστε αµέσως µετά το πρώτο άνοιγµα και / ή τη διάλυση.
English: fatal cases, see section 4.4)
Bulgarian: παράγραφο 4.4)
English: Germany Bayer Vital GmbH Kaiser Wilhelm Allee 51368 Leverkusen Germany
Bulgarian: Bayer Vital GmbH Kaiser Wilhelm Allee 51368 Leverkusen Γερµανία
English: 4.9 Overdose
Bulgarian: 4.9 Υπερδοσολογία
English: Uncommon ≥ 1/1,000 to
Bulgarian: Ασυνήθεις ≥1/1.000 έως <1/100
English: affects 1 to 10 users in 10,000
Bulgarian: επηρεάζουν απο 1 εως 10 χρήστες στους 10,000
English: Staphylococcus aureus*+
Bulgarian: Τα συνήθως ευαίσθητα είδη Αερόβιοι θετικοί κατά Gram µικροοργανισµοί Staphylococcus aureus *+
English: Concomitant administration of charcoal with a dose of 400 mg oral or intravenous moxifloxacin will reduce systemic availability of the drug by more than 80% or 20% respectively.
Bulgarian: Ταυτόχρονη χορήγηση ενεργού άνθρακα µε από του στόµατος ή ενδοφλέβια δόση 400 mg moxifloxacin, θα µειώσει τη συστηµατική διαθεσιµότητα του φαρµάκου περισσότερο από 80% ή 20% αντίστοιχα.
English: INFORMATION IN BRAILLE Justification for not including Braille accepted
Bulgarian: Η αιτιολόγηση για να µην περιληφθεί η γραφή Braille είναι αποδεκτή
English: After intravenous administration of moxifloxacin to dogs (30 mg/kg infused over 15, 30 or 60 minutes) the degree of QT prolongation was clearly depending on the infusion rate, i.e. the shorter the infusion time the more pronounced the prolongation of the QT interval.
Bulgarian: Μετά από ενδοφλέβια χορήγηση της Moxifloxacin σε σκύλους (30 mg/kg εγχυόµενα για πάνω από 15, 30 ή 60 λέπτά) ο βαθµός της επιµήκυνσης του διαστήµατος
English: The pharmacokinetic properties of moxifloxacin are not significantly different in patients with renal impairment (including creatinine clearance > 20 ml/min/1.73 m2).
Bulgarian: Οι φαρµακοκινητικές ιδιότητες της moxifloxacin δεν µεταβάλλονται σηµαντικά σε ασθενείς µε νεφρική δυσλειτουργία (συµπεριλαµβανοµένης κάθαρσης κρεατινίνης > 20 ml/min/1.73 m2).
English: Luxembourg:
Bulgarian: Αυστρία:
English: Moxifloxacin resistance rate of > 50% have been reported for methicillin resistant S. aureus.
Bulgarian: Έχει αναφερθεί απο για τον ανθεκτικό στην methicilllin S.aureus ότι το ποσοστό αντίστασης στη moxifloxacin είναι > 50%.
English: Infusion site Common:
Bulgarian: Ιρλανδία:
English: Common:
Bulgarian: Σπάνιες:
English: Avalox 400mg/250ml Solution for Infusion
Bulgarian: 400mg/250ml Solution for infusion
English: Contains sodium chloride, hydrochloric acid (for pH-adjustment), sodium hydroxide (for pHadjustment) and water for injections.
Bulgarian: Περιέχει sodium chloride, hydrochloric acid (για ρύθµιση του pH), sodium hydroxide (για ρύθµιση του pH), και water for injections.
English: 250 ml pack available in cartons of 5 and 12 bags.
Bulgarian: Διαθέσιµη συσκευασία των 250 ml σε κουτιά των 5 και 12 σάκων.
English: affects 1 to 10 users in 100
Bulgarian: επηρεάζουν απο 1 εως 10 χρήστες στους 100
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, APPLICANT(S) / MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES
Bulgarian: Μεταβολές του δέρµατος και των βλεννογονικών µεµβρανών (επώδυνες φυσαλίδες σε στόµα / µύτη ή σε πεός / κόλπο), πιθανώς απειλητικού για τη ζωή (Stevens - Johnson σύνδροµο, τοξική επιδερµική νεκρόλυση)
English: Sweden Bayer HealthCare AG Kaiser Wilhelm Allee 51368 Leverkusen Germany
Bulgarian: Λιθουανία Bayer HealthCare AG Kaiser Wilhelm Allee 51368 Leverkusen
English: The corresponding peak concentration in alveolar macrophages amounted to 56.7 mg/kg.
Bulgarian: Η αντίστοιχη µέγιστη συγκέντρωση στα φατνιακά µακροφάγα ανέρχεται σε 56.7mg/kg.
English: QT prolongation in patients with hypokalaemia (see section 4.4)
Bulgarian: Επιµήκυνση του διαστήµατος QT (βλ.παρ.4.4)
English: Bayer HealthCare AG Kaiser Wilhelm Allee 51368 Leverkusen Germany
Bulgarian: Bayer HealthCare AG Kaiser Wilhelm Allee 51368 Leverkusen Γερµανία
English: SUMMARY OF PRODUCT CHARACTERISTICS
Bulgarian: BayHealthComercialização de Produtos
English: This leaflet was last approved in {MM/YYYY}.
Bulgarian: Δεν πρέπει να το δώσετε σε άλλους.
English: See also section 4.3.
Bulgarian: Δείτε επίσης την παράγραφο 4.3.
English: Not known:
Bulgarian: ‘Αγνωστες:
English: After intravenous administration findings indicative of systemic toxicity were most pronounced when moxifloxacin was given by bolus injection (45 mg/kg) but they were not observed when moxifloxacin (40 mg/kg) was given as slow infusion over 50 minutes.
Bulgarian: Μετά από ενδοφλέβια χορήγηση, ευρήµατα ενδεικτικά συστηµατικής τοξικότητας ήταν πιο έντονα όταν η moxifloxacin χορηγούνταν µε bolus εγχύσεις ( 45 mg/kg) αλλά δεν παρατηρήθηκαν όταν η Moxifloxacin (40 mg/kg) χορηγούνταν µε αργή έγχυση για πάνω απο 50 λεπτά.
English: Moxifloxacin IV for cSSSI was approved in 2005 in all countries that had already approved the intravenous formulation for use in CAP. No consensus was reached on Day 60 of the CMD(h) referral and the procedure was therefore referred to the CHMP.
Bulgarian: Η moxifloxacin δεν έχει κλινικά σηµαντική αλληλεπίδραση µε τη τροφή, συµπεριλαµβανοµένων των γαλακτοκοµικών προϊόντων.
English: Under these circumstances, it is difficult to evaluate whether the infection or the treatment caused the INR (international normalised ratio) disorder.
Bulgarian: Υπó αυτές τις συνθήκες, είναι δύσκολο να εκτιµηθεί εάν είναι η λοίµωξη ή η θεραπεία που προκαλεί τη διαταραχή του INR (Ιnternational Normalised Ratio).
English: Unspecified arrhythmias Torsade de Pointes (see section 4.4) Cardiac arrest (see section 4.4)
Bulgarian: Δίκην ριπιδίου κοιλιακή ταχυκαρδία (torsade de points βλ.παραγραφο4.4)
English: Following a 400 mg intravenous infusion recovery of unchanged drug from urine was approximately 22% and from faeces approximately 26%.
Bulgarian: Ακολουθόντας µια ενδοφλέβια έγχυση 400 mg η ανάκτηση αναλλοίωτου φαρµάκου από τα ούρα ήταν περίπου 22% και από τα κόπρανα περίπου 26%.
English: United Kingdom
Bulgarian: ανοσµία)
English: Kidney
Bulgarian: Bayer
English: The Applicant attended an oral explanation at the May 2009 CHMP, during which the Applicant argumentation and data previously submitted in the context of the written responses was re-iterated.
Bulgarian: Εάν η θεραπεία µε αυτό το φάρµακο σταµατήσει νωρίτερα, µπορεί να µην ολοκληρωθεί η θεραπεία της λοίµωξής σας.
English: Changes in INR
Bulgarian: Αλλαγές του INR
English: - The other ingredients are sodium chloride, hydrochloric acid (for pH-adjustment), sodium hydroxide (for pH-adjustment) and water for injections
Bulgarian: - Τα υπόλοιπα έκδοχα είναι: Sodium chloride, hydrochloric acid (για ρύθµιση του pH), sodium hydroxide (για ρύθµιση του pH) και water for injections
English: Bullous skin reactions like Stevens-Johnson syndrome or toxic epidermal necrolysis (potentially lifethreatening, see section 4.4)
Bulgarian: Ξηροδερµία σύνδροµο StevensJohnson ή τοξική επιδερµική νεκρόλυση (πιθανώς απειλητικές για τη ζωή, βλ.παρ.4.4)
English: Hydrochloric acid (for pH-adjustment) Sodium hydroxide (for pH-adjustment) Water for injections
Bulgarian: Περιέχει sodium chloride, hydrochloric acid (για ρύθµιση του pH), sodium hydroxide (για ρύθµιση του pH) και water for injections
English: Animal studies have shown reproductive toxicity (see section 5.3).
Bulgarian: Μελέτες σε ζώα έχουν δείξει αναπαραγωγική τοξικότητα (βλ.παρ. 5.3).
English: The CHMP adopted a List of Questions, to be addressed by the Applicant.
Bulgarian: Εάν ανησυχείτε ότι µπορεί να παραλείψατε µια δόση Avelox, επικοινωνήστε µε το γιατρό σας αµέσως.
English: Therefore co-administration of moxifloxacin with any of the following medicinal products is contraindicated (see also section 4.3): - antiarrhythmics class IA (e.g. quinidine, hydroquinidine, disopyramide) - antiarrhythmics class III (e.g. amiodarone, sotalol, dofetilide, ibutilide) - neuroleptics (e.g. phenothiazines, pimozide, sertindole, haloperidol, sultopride) - tricyclic antidepressive agents - certain antimicrobial agents (sparfloxacin, erythromycin IV, pentamidine, antimalarials particularly halofantrine) - certain antihistaminics (terfenadine, astemizole, mizolastine) - others (cisapride, vincamine IV, bepridil, diphemanil).
Bulgarian: ιδιαίτερα halofantrine) - ορισµένα αντιισταµινικά (τερφεναδίνη, αστεµιζόλη, µιζολαστίνη) - άλλα (σιζαπρίδη, vincamine iv., bepridil, diphemanil).
English: Nausea
Bulgarian: Έµετος
English: Applicant
Bulgarian: Εµβοή
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 bottle of 250 ml contains 400 mg moxifloxacin (as hydrochloride).
Bulgarian: ΣΥΝΘΕΣΗ ΣΕ ΔΡΑΣΤΙΚΗ(ΕΣ) ΟΥΣΙΑ(ΕΣ) 1 σάκκος 250 ml περιέχει 400 mg moxifloxacin (ως hydrochloride).
English: In skin blister fluid concentrations of 1.75 mg/l were observed 10 h after intravenous administration.
Bulgarian: Σε φυσαλλιδώδες δέρµα παρατηρήθηκαν οι συγκεντρώσεις υγρού 1,75Mg/l 10 h µετά την ενδοφλέβια χορήγηση.
English: administration is only slightly higher than that observed after oral administration (35 mg·h/l) in accordance with the absolute bioavailability of approximately 91%.
Bulgarian: Η τιµή της AUC που είναι περίπου 39 mg.h /l µετά από ενδοφλέβια χορήγηση είναι µόνο ελαφρώς υψηλότερη από αυτή που παρατηρήθηκε µετά από του στόµατος χορήγηση ( 35 mg.h/l) σε συµφωνία µε την απόλυτη βιοδιαθεσιµότητα, που είναι περίπου 91%.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF AVALOX AND ASSOCIATED NAMES (SEE ANNEX I)
Bulgarian: Μυϊκή ακαµψία Παρόξυνση των συµπτωµάτων της µυασθένειας gravis (βλ.παρ.4.4)
English: The Applicant discussed the many factors that affect the QT interval and stated that while prolongation of the QTc interval is commonly used as a surrogate marker for the risk of developing ventricular arrhythmias such as Torsade de Pointes (TdP), there is no consensus on the degree of QT prolongation that is considered clinically significant.
Bulgarian: QTc χρησιµοποιείται ευρέως ως υποκατάστατος δείκτης για τον κίνδυνο ανάπτυξης κοιλιακής αρρυθµίας, όπως ταχυκαρδίες δίκην ριπιδίου (TdP), δεν υπάρχει συναίνεση για τον βαθµό επιµήκυνσης του διαστήµατος QT που κρίνεται κλινικά σηµαντικός.
English: Pharmacotherapeutic group: Quinolone antibacterials, fluoroquinolones, ATC code: J01MA14
Bulgarian: Φαρµακοθεραπευτική κατηγορία: αντιβακτηριακές κινολόνες, Φθοροκινολόνες, Κωδικός ATC: J01MA14
English: Moxifloxacin IV for CAP was approved through MRP in two subsequent waves, in 2002 and 2004.
Bulgarian: Η ενδοφλέβια χορήγηση µοξιφλοξασίνης για την πνευµονία της κοινότητας έλαβε έγκριση µέσω διαδικασίας αµοιβαίας αναγνώρισης σε δύο διαδοχικές φάσεις, το 2002 και το 2004.