FrancophonIA/ELRC3.0 huggingface dataset:
English: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 47 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2009 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
Maltese: (44-20) 74 18 84 00 Fax (44-20) 74 18 84 47 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2009 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
English: Other information about Startvac:
Maltese: Informazzjoni oħra dwar Startvac:
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) STARTVAC EPAR summary for the public
Maltese: RAPPORT PUBBLIKU EWROPEW TA' VALUTAZZJONI (EPAR) STARTVAC Sommarju tal-EPAR għall-pubbliku
English: Startvac is an emulsion for injection that is available in vials (3, 10 and 50 ml).
Maltese: Startvac huwa emulsjoni għal injezzjoni li jiġi f'kunjetti (3, 10 u 50 ml).
English: It may also cause a temporary increase in body temperature.
Maltese: Din tista' tikkawża wkoll żieda temporanja fit-temperatura tal-ġisem.
English: Startvac contains liquid paraffin (a type of mineral oil).
Maltese: Startvac fih il-paraffina likwida (tip ta' żejt minerali).
English: It is given as three injections into the neck muscle: the first is given 45 days before the cow is expected to give birth, the second 35 days later, and the third after another 62 days.
Maltese: Dan jingħata bħala tliet injezzjonijiet fil-muskolu tal-għonq: l-ewwel waħda tingħata 45 jum qabel ma lbaqra tkun mistennija li twelled, it-tieni 35 jum wara, u t-tielet wara 62 jum ieħor.
English: Startvac contains killed forms of two bacteria that normally cause mastitis (Escherichia coli and Staphylococcus aureus).
Maltese: Startvac fih forom maqtula ta' żewġ batterji li normalment jikkawżaw il-mastite (Escherichia coli u Staphylococcus aureus).
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Startvac exceed the risks for herd immunisation of healthy cows and heifers, in dairy cattle herds with recurring mastitis problems, to reduce the incidence of sub-clinical mastitis and the incidence and severity of the clinical signs of clinical mastitis caused by Staphylococcus aureus, coliforms and coagulase-negative staphylococci, and recommended that Startvac be given a marketing authorisation.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' Startvac huma akbar mir-riskji għat-tilqim ta' merħliet ta' baqar u frat b'saħħithom, f'merħliet ta' baqar tal-ħalib bi problemi ta' mastite rikorrenti, sabiex titnaqqas l-inċidenza ta' mastite sub-klinika u l-inċidenza u s-severità tas-sinjali kliniċi ta' mastite klinika kkawżata minn Staphylococcus aureus, koliformi u stafilokokki koagulażi negattivi u rrakkomanda li Startvac jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: The benefit-risk balance may be found in module 6 of this EPAR.
Maltese: Il-bilanċ bejn il-benefiċċju u r-riskju jista' jinstab fil-modulu 6 ta' dan l-EPAR.
English: Why has Startvac been approved?
Maltese: Għaliex ġie approvat Startvac?
English: What is the risk associated with Startvac?
Maltese: X'inhu r-riskju assoċjat ma' Startvac?
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Startvac to Laboratorios Hipra, S.A. on 11 February 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea, għal Startvac lil Laboratorios Hipra, S.A nhar fi 11/02/2009.
English: What is Startvac?
Maltese: Kif jaħdem Startvac?
English: The strengthened immunity reduces the number of cows affected and the severity of clinical signs.
Maltese: L-immunità msaħħa tnaqqas in-numru ta' baqar affettwati u s-severità ta' sinjali kliniċi.
English: If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Maltese: Jekk tixtieq aktar informazzjoni abbażi tar-rakkomandazzjonijiet tas-CVMP, aqra d-Diskussjoni Xjentifika (ukoll parti millEPAR).
English: Startvac is a vaccine.
Maltese: Startvac huwa tilqima.
English: Startvac is a vaccine for cows that contains inactivated (killed) bacteria called Escherichia coli and Staphylococcus aureus.
Maltese: Startvac huwa tilqima għall-baqar li fih batterji inattivi (maqtula) msejħa Escherichia coli u
English: The vaccine also contains an ‘adjuvant' (liquid paraffin) to stimulate a better response.
Maltese: It-tilqima fiha wkoll ‘sustanza miżjuda' (paraffina likwida) biex tistimula rispons aħjar.
English: The studies showed that Startvac reduced the number of cows with mastitis due to Staphylococcus aureus and related bacteria and it reduced the severity of the symptoms in the cows that had mastitis.
Maltese: L-istudji wrew li Startvac naqqas in-numru ta' baqar bil-mastite minħabba Staphylococcus aureus u batterji relatati u naqqas is-severità tas-sintomi fil-baqar li kellhom il-mastite.
English: Page 2/2©EMEA 2009
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi: 11/02/2009.
English: Startvac is used to strengthen the immunity of whole herds of otherwise healthy dairy cows in herds that are known to have problems due to mastitis (inflammation of the udder due to infection).
Maltese: Startvac jintuża biex isaħħaħ l-immunità ta' merħliet sħaħ ta' baqar tal-ħalib li altrimenti huma b'saħħithom f'merħliet li huma magħrufin li għandhom problemi minħabba l-mastite (infjammazzjoni tal-beżżula minħabba infezzjoni).
English: Information on the prescription status of this product may be found on the label/outer package.
Maltese: L-informazzjoni dwar l-istejtus tal-preskrizzjoni ta' dan il-prodott tista' tinstab fuq it-tikketta/pakkett ta' barra.
English: The study compared cows that were given Startvac with those that were given placebo (a dummy vaccine) and looked at the number of cows with mastitis, the severity of mastitis symptoms, and milk production.
Maltese: L-istudju qabbel baqar li ngħataw Startvac ma' dawk li ngħataw plaċebo (tilqima finta) u ħares lejn in-numru ta' baqar bil-mastite, is-severità tas-sintomi tal-mastite, u l-produzzjoni tal-ħalib.
English: EMA/403781/2014 EMEA/H/C/1088
Maltese: EMEA/H/C/1088
English: It is available as orodispersible tablets (5, 7.5, 10, 15 and 20 mg).
Maltese: Jiġi bħala pilloli orodispersibbli (5, 7.5, 10, 15 u 20 mg).
English: Olazax Disperzi olanzapine
Maltese: Olazax Disperzi olanzapina
English: The full EPAR for Olazax Disperzi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The active substance in Olazax Disperzi, olanzapine, is an antipsychotic medicine.
Maltese: Is-sustanza attiva f'Olazax Disperzi , l-olanzapina, hija mediċina antipsikotika.
English: This is a summary of the European public assessment report (EPAR) for Olazax Disperzi.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Olazax Disperzi.
English: The recommended starting dose of Olazax Disperzi depends on the disease being treated: 10 mg per day is used in schizophrenia and in the prevention of manic episodes, and 15 mg per day in the treatment of manic episodes, unless it is used with other medicines, in which case the starting dose can be 10 mg per day.
Maltese: Doża ta' 10 mg kuljum tintuża għall-iskiżofrenija u fil-prevenzjoni ta' episodji manijaċi, u 15 mg kuljum filkura ta' episodji manijaċi, sakemm ma tintużax ma' mediċini oħra, f'liema każ id-doża inizjali tista' tkun ta' 10 mg kuljum.
English: Olazax Disperzi is a ‘generic medicine'.
Maltese: Olazax Disperzi huwa ‘mediċina ġenerika'.
English: This means that Olazax Disperzi is similar to ‘reference medicines' already authorised in the European Union (EU) called Zyprexa and Zyprexa Velotab.
Maltese: Dan ifisser li Olazax Disperzi huwa simili għall-‘mediċini ta' referenza' diġà awtorizzati fl-Unjoni Europea (UE) bl-isem ta' Zyprexa u Zyprexa Velotab.
English: Olazax Disperzi is also used to treat moderate to severe manic episodes (extremely high mood) in adults.
Maltese: Olazax Disperzi jintuża wkoll fil-kura ta' episodji moderati sa severi tal-manija (burdata tajba b'mod estrem) f'adulti.
English: The European Commission granted a marketing authorisation valid throughout the EU for Olazax Disperzi on 10 December 2009
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Olazax Disperzi fl-10 ta' Diċembru 2009.
English: Olazax Disperzi is a medicine containing the active substance olanzapine.
Maltese: Olazax Disperzi huwa mediċina li fiha s-sustanza attiva olanzapina.
English: The CHMP concluded that, in accordance with EU requirements, Olazax Disperzi has been shown to have comparable quality and to be bioequivalent to Zyprexa and Zyprexa Velotab.
Maltese: Is-CHMP ikkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, Olazax Disperzi wera li għandu kwalità komparabbli u huwa bijoekwivalenti għal Zyprexa u Zyprexa Velotab.
English: Because Olazax Disperzi is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicines, Zyprexa and Zyprexa Velotab.
Maltese: Peress li Olazax Disperzi huwa mediċina ġenerika, l-istudji fin-nies ġew limitati għal testitjiet biex jiddeterminaw il-bijoekwivalenza tiegħu mal-mediċini ta' referenza, Zyprexa u Zyprexa Velotab.
English: Why has Olazax Disperzi been approved?
Maltese: Għaliex ġie approvat Olazax Disperzi?
English: What is Olazax Disperzi?
Maltese: Kif jintuża Olazax Disperzi?
English: Other information about Olazax Disperzi
Maltese: Informazzjoni oħra dwar Olazax Disperzi
English: Because Olazax Disperzi is a generic medicine and is bioequivalent to the reference medicines, its benefit and risk are taken as being the same as the reference medicines.
Maltese: Peress li Olazax Disperzi huwa mediċina ġenerika u bijoekwivalenti għall-mediċini ta' referenza, ilbenefiċċju u r-riskju tiegħu huma meqjusa li huma l-istess għal dawk tal-mediċini ta' referenza.
English: Patients over 65 years of age and patients who reduced liver or kidney function may need a lower starting dose of 5 mg per day.
Maltese: Pazjenti li jkollhom iktar minn 65 sena u pazjenti li jkollhom tnaqqis fil-funzjoni tal-fwied jew tal-kliewi tagħhom jista' jkollhom bżonn ta' doża inizjali iktar baxxa ta' 5 mg kuljum.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/16/197/001
Maltese: FIS-SUQ EU/2/16/197/001
English: CANADA
Maltese: IL-KANADA
English: CLYNAV stimulates active immunity against salmonid alphavirus subtype 3 (SAV3).
Maltese: CLYNAV jistimula l-immunità attiva kontra salmonid alphavirus sottotip 3 (SAV3).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 27/06/2017
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizazzjoni: 27/06/2017
English: Name and address of the manufacturer of the biological active substance Elanco Canada Ltd
Maltese: Isem u indirizz tal-manifattur tas-sustanza bioloġika attiva Elanco Canada Ltd
English: Potassium dihydrogen phosphate Disodium hydrogen phosphate heptahydrate Sodium chloride
Maltese: Disodium hydrogen phosphate heptahydrate
English: ATCvet code: QI10AX.
Maltese: QI10AX
English: Atlantic salmon (Salmo salar).
Maltese: Salamun tal-Atlantiku (Salmo salar)
English: PACKAGE SIZE 250 ml
Maltese: EVA (250 ml)
English: CLYNAV contains a supercoiled DNA plasmid which expresses proteins of salmon alphavirus which induces a protective immune response in vaccinated Atlantic salmon.
Maltese: CLYNAV fih plasmid DNA supercoiled li jesprimi l-proteini tal-alphavirus tas-salamun li jinduċi rispons immuni protettiv fis-salamun imlaqqam tal-Atlantiku.
English: Store and transport refrigerated (2 °C - 8 °C).
Maltese: Aħżen u ttrasporta fil-friġġ(2 °C - 8 °C).
English: For the active immunisation of Atlantic salmon to reduce impaired daily weight gain, and reduce mortality, and cardiac, pancreatic and skeletal muscle lesions caused by pancreas disease following infection with salmonid alphavirus subtype 3 (SAV3).
Maltese: Għat-tilqima attiva tas-salamun tal-Atlantiku biex jitnaqqsu l-indeboliment fiż-żieda fil-piż ta' kuljum, u tnaqqas il-mortalità, u leżjonijiet tal-muskoli kardijaċi, tal-frixa u skeletriċi kkawżati minn mard talfrixa wara infezzjoni b'salmonid alphavirus sottotip 3 (SAV3).
English: Transient changes in swimming behaviour, pigmentation and inappetence are very common and can be observed for up to 2, 7 and 9 days, respectively.
Maltese: Bidliet temporanji fl-imġiba fl-għawm, pigmentazzjoni u nuqqas ta' aptit huma komuni ħafna, u jistgħu jiġu osservati għal sa 2, 7 u 9 ijiem, rispettivament.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each 0.05 ml dose contains:
Maltese: Kull doża ta' 0.05 ml fiha:
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Maltese: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni: - komuni ħafna (aktar minn wieħed f'10 annimali li juru effetti mhux mixtieqa matul il-perjodu ta' kura waħda) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal) - mhux komuni (aktar minn wieħed iżda inqas minn 10 annimali f'1,000 annimal) - rari (aktar minn wieħed iżda inqas minn 10 annimali f'10,000 annimal) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal, inklużi rapporti iżolati).
English: Manufacturer responsible for batch release: Lohmann Animal Health GmbH Heinz-Lohmann-Straβe 4, 27472 Cuxhaven
Maltese: Manifattur responsabbli għall-ħrug tal-lott: Lohmann Animal Health GmbH Heinz-Lohmann-Straβe 4, 27472 Cuxhaven
English: Lohmann Animal Health GmbH Heinz-Lohmann-Straβe 4, 27472 Cuxhaven
Maltese: Lohmann Animal Health GmbH Heinz-Lohmann-Straβe 4, 27472
English: Active substance: pUK-SPDV-poly2#1 DNA plasmid coding for salmon pancreas disease virus proteins: 5.1 - 9.4 μg.
Maltese: Sustanza attiva: pUK-SPDV-poly2#1 DNA kodifikazzjoni tal-plasmid għall-proteini tal-virus tal-marda tal-frixa tassalamun; 5.1 - 9.4 μg
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals ) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Maltese: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni: - komuni ħafna (iktar minn 1 minn kull 10 annimali li juru r- reazzjoni(jiet) avversa matul il-kors ta' kura waħda) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal) - mhux komuni (aktar minn wieħed iżda inqas minn 10 annimali f'1,000 annimal) - rari (aktar minn wieħed iżda inqas minn 10 annimali f'10,000 annimal) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal, inklużi rapporti iżolati).
English: Pharmacotherapeutic group: Immunologicals for Atlantic salmon.
Maltese: Mediċini immunoloġiċi għas-Salamun Atlantiku.
English: In the absence of compatibility studies, this veterinary medicinal product must not be mixed with any other veterinary medicinal products.
Maltese: Fin-nuqqas ta' studji dwar kompatibilità, dan il-prodott mediċinali veterinarju ma jistax jintuża flimkien ma prodotti mediċinali veterinarji oħra.
English: Needle injuries at the site of injection are common following administration of the vaccine which can persist in up to 5% of fish for at least 90 days, and can be seen both macroscopically and microscopically.
Maltese: Korrimenti bil-labra fis-sit tal-injezzjoni huma komuni wara l-għoti tat-tilqima, u jistgħu jippersistu f'sa 5% tal-ħut għal mill-inqas 90 jum, u dan jista' jiġi osservat kemm makroskopikament u kemm mikroskopikament.
English: 250 ml sterile, flexible, ethyl vinyl acetate (EVA) bags with a locking snap down port. A sterile and individually packaged transfer tube set is included in the final product packaging.
Maltese: Borża ta' ethyl vinyl acetate (EVA) ta' 250 ml, sterili, flessibbli, b'locking snap down port.
English: Duration of immunity is approximately 3 months after vaccination (demonstrated under laboratory conditions at a water temperature of 12 ±2 °C).
Maltese: It-tul tal-immunità hu madwar 3 xhur wara t-tilqima (murija taħt kundizzjonijiet tal-laboratorju f'temperatura tal-ilma ta' 12 ±2°C).
English: No effects other than those described in section 4.6 have been observed following the administration of an overdose.
Maltese: L-ebda effetti, ħlief dawk deskritti f'sezzjoni 4.6 ma ġew osservati wara l-għoti ta' doża eċċessiva.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Each 0.05 ml dose contains: pUK-SPDV-poly2#1 DNA plasmid coding for salmon pancreas disease virus proteins: 5.1 - 9.4 μg.
Maltese: Kull doża ta' 0.05 mL fiha; pUK-SPDV-poly2#1 DNA kodifikazzjoni tal-plasmid għall-proteini tal-virus tal-marda tal-frixa tassalamun; 5.1 - 9.4 μg
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 250 ml
Maltese: PIŻ, VOLUM JEW NUMRU TA' DOŻI 250 ml
English: Based on a 25 g fish weight a standard 0.5 mm diameter 3mm depth needle is recommended to be used routinely.
Maltese: Ibbażat fuq piż ta' ħuta ta' 25 g, labra standard b'dijametru ta' 0.5 mm u fond ta' 3 mm hi rakkomandata biex tintuża b'mod regolari.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT CLYNAV solution for injection for Atlantic salmon
Maltese: VETERINARJU CLYNAV soluzzjoni għall-injezzjoni għas-Salamun tal-Atlantiku
English: The effect of vaccine on reproductive performance has not been investigated.
Maltese: L-effett tat-tilqima fuq il-prestazzjoni riproduttiva ma ġiex investigat.
English: TARGET SPECIES Atlantic salmon (Salmo salar).
Maltese: HUWA INDIKAT IL-PRODOTT Salamun tal-Atlantiku (Salmo salar)
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Maltese: L-addittivi elenkati f'sezzjoni 6.1 tas-Sommarju tal-karatteristiċi tal-prodott huma sustanzi ammissibbli li għalihom m'hemmx bżonn ta' limiti massimi ta' residwi kif indikat fit-tabella numru 1 tal-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010 jew huma kkunsidrati li ma jaqgħux fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009 meta wżati bħal f'dan il-prodott mediċinali veterinarju.
English: Intramuscular use.
Maltese: U/JEW UŻU Mhux applikabbli.
English: Detailed information on this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Maltese: Informazzjoni dettaljata dwar dan il-prodott tinstab fuq il-websajt ta' l-Aġenzija Ewropea dwar ilMediċini (http://www.ema.europa.eu/).
English: Transfer tubing kit instructions: using the spiked end, screw the transfer tubing set onto the fill port of the ethyl vinyl acetate (EVA) bag with a ¼ turn in order to secure the line in place.
Maltese: Istruzzjonijiet tal-kit tat-tubing tat-trasferiment: bl-użu tat-tarf bil-ponta, waħħal is-sett tat-tubing tattrasferiment fuq il-fill port tal-ethyl vinyl acetate (EVA), billi ddawwar ¼ ta' tidwira sabiex twaħħal il-linja fil-post.
English: Do not use in clinically diseased groups of fish.
Maltese: Tużax fi gruppi ta' ħut klinikament morda.
English: 4.11 Withdrawal period(s) Zero degree days.
Maltese: 4.11 Perjodu ta' tiżmim Żero gradi-ġranet.
English: Anaesthetise the fish to immobilise them, and administer 0.05 ml of the vaccine by intramuscular injection in the area immediately anterior and lateral to the dorsal fin in the epaxial muscle.
Maltese: Anestetizza l-ħut biex timmobilizzahom u agħti 0.05 ml permezz ta' injezzjoni ġol-muskoli fiż-żona immedjatament anterjuri u laterali tal-ġewnaħ tad-dahar fil-muskolu epassjali.
English: Pack size:
Maltese: Daqs tal-pakkett:
English: Onset of immunity occurs within 399 degree days (mean water temperature in °C multiplied by number of holding days) following vaccination.
Maltese: Il-bidu tal-immunità jseħħ fi żmien 399 jum ta' gradi (medja tat-temperatura tal-ilma f'°C immultiplikata bin-numru ta' jiem ta' tiżmim) wara t-tilqima.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
Maltese: TAS-SUSTANZA(i) ATTIVA(I)
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only.
Maltese: Staqsi lil veterinarju tiegħek dwar kif l-aħjar li tarmi l-mediċini li ma jkunux aktar meħtieġa.
English: No effects other than those described in section 6 have been observed following the administration of an overdose.
Maltese: L-ebda effetti, ħlief dawk deskritti f'sezzjoni 6 ma ġew osservati wara l-għoti ta' doża eċċessiva.
English: {Name and Address} <{tel}> <{fax}> <{e-mail}>
Maltese: {Isem u indirizz} <{tel}> <{fax}> <{e-mail}>
English: Geriatric patients should receive a dose selected according to the severity of the infection and the patient's creatinine clearance.
Maltese: Geriatric patients should receive a dose selected according to as low as possible depending on the severity of their infection illness and their the patient's creatinine clearance.
English: B - 1050 Bruxelles-Brussel Belgium
Maltese: B - 1050 Bruxelles-Brussel Il-Belġju
English: Articular tolerability:
Maltese: Tollerabilità artikulari:
English: 2794-003 Carnaxide Portugal
Maltese: 2794-003 Carnaxide Il-Portugall
English: Bayer Santé 13, rue Jean Jaurès 92807 Puteaux Cedex France
Maltese: Bayer Santé 13, rue Jean Jaurès 92807 Puteaux Cedex Franza
English: The absolute bioavailability is approximately 70-80%.
Maltese: Il-bijodisponibiltà assoluta hija madwar 70-80%.
English: Bayer Hungária Kft. H-1123 Budapest Alkotás u. 50.
Maltese: H-1123 Budapest Alkotás u. 50.
English: Viale Certosa 130 I-20156 Milan Italy
Maltese: Viale Certosa 130 I-20156 Milan L-Italja
English: PK/PD relationship:
Maltese: Relazzjoni PK/PD:
English: Bayer Austria GmbH Herbststraße 6-10 1160 Wien Austria
Maltese: Bayer Austria GmbH Herbststraße 6-10 1160
English: 18-20 Sorou Street, 15125 Marousi, Athens, Greece
Maltese: 18-20 Sorou Street, 15125 Marousi, Athens, IlGreċja
English: Ciprofloxacin Metabolites (M1-M4)
Maltese: Ciprofloxacin Metaboliti (M1-M4)
English: Cytochrome P450
Maltese: Citokromju P450
English: Haemophilus influenzae and Moraxella catarrhalis
Maltese: Haemophilus influenzae u Moraxella catarrhalis
English: Musculoskeletal System
Maltese: Sistema Muskolu-skeletrali
English: Microorganisms
Maltese: Mikro-organiżmi
English: 08970 Sant Joan Despí Barcelona
Maltese: Baix Llobregat, 3-5 08970 Sant Joan Despí Barcelona
English: Anaerobic micro-organisms Mobiluncus
Maltese: Mikro-organiżmi anaerobiċi Mobiluncus
English: Serum Creatinine [µmol/L]
Maltese: Krejatinina fis-Serum [µmol/L]
English: Belgium BAYER SA-NV Avenue Louise 143
Maltese: BAYER SA-NV Avenue Louise 143
English: Low concentrations of four metabolites have been reported, which were identified as: desethyleneciprofloxacin (M 1), sulphociprofloxacin (M 2), oxociprofloxacin (M 3) and formylciprofloxacin (M 4).
Maltese: Kienu irrapportati konċentrazzjonijiet baxxi ta' erba' metaboliti, li kienu identifikati bħala: desethyleneciprofloxacin (M 1), sulphociprofloxacin (M 2), oxociprofloxacin (M 3) u formylciprofloxacin (M 4).
English: • infections of the testicles
Maltese: • infezzjonijiet fit-testikoli
English: The AUC values were 17.4 mg*h/L (range 11.8-32.0 mg*h/L) and 16.5 mg*h/L (range 11.0-23.8 mg*h/L) in the respective age groups.
Maltese: Il-valuri ta' l-AUC kienu 17.4 mg*h/L (firxa 11.8-32.0 mg*h/L) u 16.5 mg*h/L (firxa 11.0-23.8 mg*h/L) fil-gruppi ta' età rispettiva.