FrancophonIA/ELRC3.0 huggingface dataset:
English: Suramox 15% LA and its associated name Stabox 15% LA is presented as an injectable suspension containing amoxicillin, which is a β-lactam antibiotic, belonging to the group of penicillins intended for the treatment of respiratory infections caused by Pasteurella multocida and Mannheimia haemolytica in cattle and for the treatment of respiratory infections due to Pasteurella multocida in pigs.
Maltese: Suramox 15% LA u l-isem assoċjat tiegħu Stabox 15% LA hu ppreżentat bħala sospensjoni għallinjezzjoni li fiha amoxicillin, li hu antibijotiku β-lactam, li jagħmel parti mill-grupp ta' peniċillini intiżi għall-kura ta' infezzjonijet respiratorji kkawżati minn Pasteurella multocida u Mannheimia haemolytica fl-ifrat u għall-kura ta' infezzjonijiet respiratorji kkawżati mill-Pasteurella multocida filmajjali.
English: France2
Maltese: Franza2
English: Micronised amoxicillin
Maltese: Amoksiċillina mikronizzat
English: 50 days
Maltese: 50 ġurnata
English: Animals (2 male and 2 female) were slaughtered at 7, 14, 21 and 27 days after the final injection.
Maltese: L-annimali (2 irġiel u 2 nisa) nqatlu wara 7, 14, 21 u 27 jum mill-injezzjoni finali.
English: The bactericidal effect of amoxicillin is neutralised by simultaneous use of bacteriostatic acting pharmaceuticals (macrolides, sulphonamides and tetracyclines).
Maltese: L-effett batteriċidali ta' l-amoksiċillina hu newtralizzat mill-użu simultanju ta' aġenti farmaċewtiċi batterjostatiċi (makrolidi,sulfonamidi u tetraċiklini).
English: In the complementary studies animals that were younger and weighed much less (211 to 249; 206 to 228 kg) were used; otherwise the studies were conducted similarly to the pivotal study.
Maltese: Fl-istudji komplementari ntużaw annimali li kienu iżgħar u eħfef (bejn 211 u 249; bejn 206 u 228 kg); mill-bqija l-istudji tmexxew b'mod simili għall-istudju ewlieni.
English: The animals were slaughtered at 7, 14, 46 and 57 days after the final injection.
Maltese: L-annimali nqatlu wara 7, 14, 46 u 57 jum millinjezzjoni finali.
English: Stearic acid
Maltese: Aċidu steariku
English: - Milk:
Maltese: - Majjali:
English: Use in such cases only according to the benefit/risk assessment by the responsible veterinarian.
Maltese: F'każijiet bħal dawn uża biss skond il-valutazzjoni benefiċċju/riskju mill-veterinarju responsabbli.
English: Benzylpenicillin was considered by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) at its 36th meeting in 1990.
Maltese: Benzylpenicillin ġie kkunsidrat mill-Kumitat Espert Konġunt ta' l-FAO/WHO dwar l-Addittivi ta' lIkel (JECFA) fis-36 laqgħa tiegħu fl-1990.
English: Residues from the core injection site and its surrounding also remained below the limit of detection of muscle (2.1 µg/kg) in all samples after 80 days and three samples after 90 days with remaining one being below the limit of quantification (25 µg/kg).
Maltese: Ir-residwi mill-qalba tas-sit ta' l-injezzjoni u madwara baqgħu taħt il-limitu li jitkejjel fil-muskolu (2.1 µg/kg) fil-kampjuni kollha wara 80 jum u fi tliet kampjuni wara 90 jum u b'wieħed minnhom jibqa' taħt il-limitu tal-kwantifikazzjoni (25 µg/kg).
English: Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact.
Maltese: Peniċillini u ċefalosporini jistgħu jikkawżaw sensittività eċċessiva (allerġija) wara injezzjoni, inalazzjoni, inġestjoni jew kuntatt mal-ġilda.
English: However, an ADI for penicillins was not established.
Maltese: Madankollu ma ġiex stabilit ADI għall-peniċillini.
English: All samples were analysed for amoxicillin concentrations using a validated HPLC-MS/MS method with a limit of quantification of 25 µg/kg for all tissues.
Maltese: Il-kampjuni kollha ġew analizzati għall-konċentrazzjoni ta' amoxicillin bl-użu ta' metodu ta' HPLC-MS/MS validat b'limitu ta' kwantifikazzjoni ta' 25 µg/kg għat-tessuti kollha.
English: Pigs: Treatment of respiratory infections due to Pasteurella multocida.
Maltese: Majjali: Kura ta' nfezzjonijiet respiratorji kawżati minn Pasteurella multoċida.
English: Spain
Maltese: Spanja1
English: The statistical approach could not be used for the calculation of the withdrawal period as the test for log-linearity (F-test) was not met and therefore the ‘alternative approach' as set out in the CVMP guideline (EMEA/CVMP/036/95-Final) was used.
Maltese: L-istrateġija statistika ma setgħetx tintuża għall-kalkulazzjoni tal-perjodu ta' irtirar għax it-test tal-loglinearity (F-test) ma ntlaħaqx u għalhekk intużat l-‘istrateġija alternattiva' kif stipulata fil-linja gwida tas-CVMP (EMEA/CVMP/036/95-Finali).
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF RESIDUE DATA FOR SURAMOX 15% LA AND ITS ASSOCIATED NAME STABOX 15% LA, SUBMITTED TO THE CVMP AS A FOLLOW-UP OF AN ARTICLE 35 REFERRAL, FOR LIFTING THE SUSPENSION OF THE MARKETING AUTHORISATIONS
Maltese: TAD-DATA DWAR RESIDWI GĦAL SURAMOX 15% LA U L-ISEM ASSOĊJAT TIEGĦU STABOX 15% LA, SOTTOMESSA LIS-CVMP BIEX ISEGWI RIFERIMENT TAĦT L-ARTIKOLU 35, GĦAT-TNEĦĦIJA TAS-SOSPENSJONI TA' L-AWTORIZZAZZJONIJIET GĦATTQEGĦID FIS-SUQ
English: Another possible mode of resistance to β-lactam antibiotics can be associated with chromosomal mutations in bacteria resulting either in modification of the penicillin binding proteins (PBPs) or in modification of the cellular permeability to β-lactams.
Maltese: Mod ieħor possibbli ta' reżistenza għall-antibijotiċi β-lactam jista' jkun assoċjat b'tibdiliet kromosonali fil-batterji li jirriżultaw jew f'modifikazzjoni tal-proteini magħquda bil-peniċillina (PBPs) jew f'modifikazzjoni tal-permeabbiltà ċellulari għal β-lactams.
English: Amoxicillin was previously evaluated by the CVMP together with other penicillins, in order to establish maximum residue limits (MRLs).
Maltese: Amoxicillin kien preċedentament ivvalutat mis-CVMP flimkien ma' peniċillini oħra, biex jiġu iffissati l-limiti massimi ta' residwi (MRLs).
English: In setting maximum residue limits (MRLs) for the penicillins, the CVMP adopted the same approach as the Joint FAO/WHO Expert Committee on Food Additives (JECFA).
Maltese: Waqt li ffissa l-limiti massimi ta' residwu (MRLs) għall-peniċillini, is-CVMP adotta l-istess strateġija bħall-Kumitat Espert Konġunt ta' l-FAO/WHO dwar l-Addittivi ta' l-Ikel (JECFA).
English: At the injection site residues above the muscle MRLs were found in at least one core sample at the last time point tested (27 days) and as a result three other residues studies measuring residue levels at 30, 36, 38 and 46 days were carried out.
Maltese: Fis-sit ta' l-injezzjoni, instabu residwi għola mill-MRLs tal-muskolu f'għallinqas kampjun wieħed mill-qalba fl-aħħar punt ta' żmien ittestjat (27 jum) u minħabba f'hekk saru tliet studji oħra dwar residwi li kejlu l-livelli ta' residwu fit-30, 36, 38 u 46 jum.
English: Micronised amoxicillin (as trihydrate) 150.0 mg/ml Excipient: Benzyl alcohol 35.0 mg/ml
Maltese: Alkoħol benżil 35.0 mg/ml
English: The statistical approach, although preferred, could not be used for the calculation of the withdrawal period at the injection site given the non homogeneous nature of the studies as shown by the weight differences as well as the way residue levels were determined (3 samples versus just one), and therefore the ‘alternative approach' as set out in the CVMP Note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95) was used.
Maltese: L-istrateġija statistika, għalkemm preferuta, ma setgħetx tintuża għall-kalkolu tal-perjodu ta' irtirar fissit ta' l-injezzjoni minħabba n-natura mhux omoġenja ta' l-istudji kif muri mid-differenzi fil-piż kif ukoll il-mod kif ġew determinati l-livelli ta' residwi (3 kampjuni kontra wieħed), u għalhekk intużat l‘istrateġija alternativa' li ġiet stipulata fin-Nota ta' gwida tas-CVMP dwar l-istrateġija għallarmonizzazzjoni tal-perjodi ta' irtirar (EMEA/CVMP/036/95).
English: Suramox 15% LA, suspension for injection Amoxicillin
Maltese: Suramox 15% LA, suspensjoni għal injezzjoni Amoksiċillina
English: Box of 125 ml bottle Box of 250 ml bottle Box of 500 ml bottle
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA KAXXA ta' 125, 250 jew 500 ml
English: 1ère Avenue - 2065 m - L.I.D.
Maltese: 1ère Avenue - 2065 m - L.I.D. 06516 CARROS CEDEX FRANZA
English: MANUFACTURER'S BATCH NUMBER <Batch> <Lot> <BN> {number}
Maltese: NUMRU TAL-LOTT TAL-MANIFATTUR <Lott> <lott> <Numru tal-lott> {numru}
English: Its structure contains the β-lactam ring and thiazolidine ring common to all penicillins.
Maltese: L-istruttura tikkuntieni ċ-ċirku βlactam u ċ-ċirku tiażolidine komuni għall-peniċillini kollha.
English: Having considered the new residue depletion data provided for the lifting of the suspension of the marketing authorisations for Suramox 15% LA and its associated name Stabox 15% LA concerning the establishment of withdrawal periods for cattle and pigs, the CVMP concluded that:
Maltese: Wara li kkunsidra d-data ġdida dwar it-tnaqqis tar-residwu pprovvduta għat-tneħħija tas-sospensjoni ta' l-awtorizzazzjonijiet għat-tqegħid fis-suq għal Suramox 15% LA u l-isem assoċjat tiegħu Stabox 15% LA dwar l-iffissar ta' perjodi ta' irtirar għall-ifrat u l-majjali, is-CVMP ikkonkluda li:
English: Cattle: Treatment of respiratory infections due to Pasteurella multocida and Mannheimia haemolytica.
Maltese: Kura ta' nfezzjonijiet respiratorji kawżati minn Pasteurella multoċida u Mannheimia emolitika.
English: The results from the study were used to design the pivotal residue study to include time points at 7, 14, 21 and 27 days after the last injection.
Maltese: Ir-riżultati minn dan l-istudju ntużaw fit-tfassil ta' l-istudju ewlieni dwar residwu biex jiġu inklużi l-punti taż-żmien fis-7, 14, 21 u 27 jum wara l-aħħar injezzjoni.
English: PACKAGE LEAFLET Suramox 15% LA, suspension for injection
Maltese: FIL-PAKKETT Suramox 15% LA, suspensjoni għal injezzjoni
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES Bottle of 125, 250 or 500 ml.
Maltese: KONTENUT BĦALA/SKOND IL-PIŻ, IL-VOLUM JEW IN-NUMRU TA' DOŻI Flixkun ta' 125, 250 jew 500 ml.
English: The animals were given 15 mg amoxicillin/kg bw corresponding to 1ml/10 kg bw which required 4 injections, three of which were the maximum volumes (20 ml) and the remaining given in the fourth injection.
Maltese: L-annimali ngħataw 15-il mg amoxicillin/kg piż li jikkorrespondu għal 1ml/10 kg piż li ħtieġu 4 injezzjonijiet, li tlieta minnhom ingħataw f'volumi massimi (20 ml) u l-bqija ngħatat fir-raba' injezzjoni.
English: On this basis MRLs for amoxicillin and other penicillins were proposed by the CVMP, and amoxicillin is currently entered in Annex I of Council Regulation (EEC) No 2377/90, in accordance with the following table:
Maltese: Abbażi ta' dan ġew proposti MRLs għal amoxicillin u peniċillini oħra mis-CVMP, u amoxicillin bħalissa hu inkluż fl-Anness I tar-Regolament tal-Kunsill (KEE) Nru 2377/90, skond din it-tabella:
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Micronised amoxicillin (as trihydrate) 150.0 mg/ml
Maltese: TAS-SUSTANZA ATTIVA / SUSTANZI ATTIVI Amoksiċillina mikronizzat (bħala tri-idrat) 150.
English: Target tissue
Maltese: MRLs Tessut filmira
English: Aluminium stearate Propylene glycol dicaprylate/dicaprate
Maltese: SPEĊI GĦAL LIEMA HUWA INDIKAT IL-PRODOTT
English: • time points where residues at the injection sites were below the muscle MRL were identified for both cattle and pigs;
Maltese: • għall-ifrat u l-majjali ġew identifikati punti ta' żmien li fihom ir-reżidwi fis-siti ta' l-injezzjoni kienu inqas mill-MRL tal-muskoli;
English: • A meat withdrawal period can be set in both cattle and pigs using the ‘Alternative approach' as stated in the CVMP Note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95);
Maltese: • jista' jiġi stabbilit perjodu ta' irtirar għal-laħam kemm għall-ifrat kif ukoll għall-majjali bl-użu ta' ‘Strateġija alternattiva' kif jingħad fin-Nota ta' gwida tas-CVMP dwar l-istrateġija għallarmonizzazzjoni tal-perjodi ta' irtirar (EMEA/CVMP/036/95);
English: With the exception of one animal after 36 days which had high residues (core sample 339.4 µg/kg), residue levels were below the MRL after 30, 38 and 46 days.
Maltese: Ħlief għal annimal wieħed li wara 36 jum kellu residwi għoljin (kampjun mill-qalba 339.4 µg/kg), il-livelli ta' residwu kienu inqas millMRL wara 30, 38 u 46 jum.
English: Muscle Fat
Maltese: TAGĦRIF
English: Using the ‘alternative approach' as stated in CVMP Note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95) a withdrawal period of 16 days is obtained after adding 10 % ‘uncertainty factor'.
Maltese: Bl-użu ta' l-‘istrateġija alternattiva' kif imsemmi fin-Nota ta' gwida tasCVMP dwar l-istrateġija għall-armonizzazzjoni tal-perjodi ta' irtirar (EMEA/CVMP/036/95) jinkiseb perjodu ta' irtirar ta' 16-il jum wara ż-żieda ta' ‘fattur ta' inċertezza' ta' 10 %.
English: Cattle and pigs: Administer 15 mg amoxicillin (as trihydrate) per kg bodyweight equivalent to 1 ml per 10 kg, twice at 48 hours interval.
Maltese: Frat u majjali: Amministra 15 mg amoksiċillina (bħala tri-idrat) għal kull kilogramm piż tal-ġisem ekwivalenti għal 1 ml għal kull 10 kg, darbtejn f'intervall ta' 48 siegħa.
English: • the new residue depletion studies in both cattle and pigs are of an acceptable standard and in large part in accordance with CVMP guideline on injection site residues (EMEA/CVMP/542/03);
Maltese: • l-istudji l-ġodda ta' tnaqqis tar-residwu kemm fl-ifrat u kemm fil-majjali huma ta' standard aċċettabbli u fil-biċċa l-kbira konformi mal-linja gwida tas-CVMP dwar ir-residwi fis-sit ta' linjezzjoni (EMEA/CVMP/542/03);
English: - Pigs:
Maltese: Frat:
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Suramox 15% LA, suspension for injection
Maltese: VETERINARJU Suramox 15% LA, suspensjoni għal injezzjoni
English: After a single intramuscular administration of the product at 15 mg/kg to cattle, mean amoxicillin plasma peak concentration of 2.93 µg/ml is reached 1.64 hours after dosing.
Maltese: Wara amministrazzjoni intramuskolari waħda tal-prodott b'doża ta' 15mg għal kull 1kg lill-ifrat, ilkonċentrazzjoni massima fil-plażma medja ta' 2.93 µg għal kull milligram tintlaħaq 1.64 siegħa wara l-amministrazzjoni tad-doża.
English: In both species the product is administered intramuscularly at a dose rate of 15 mg amoxicillin/kg bw (equivalent to 1 ml of Suramox 15% LA/10 kg bw) twice at 48 hours interval.
Maltese: Fiż-żewġ speċi, il-prodott jingħata fil-muskolu b'rata ta' 15-il mg amoxicillin għal kull kilogramma piż (ekwivalenti għal 1 ml ta' Suramox 15% LA għal kull 10 kg piż) darbtejn b'48 siegħa bejniethom.
English: After a single intramuscular administration of the product at 15 mg/kg to pigs, mean amoxicillin plasma peak concentration of 3.78 µg/ml is reached 0.77 hours after dosing.
Maltese: Wara amministrazzjoni intramuskolari waħda tal-prodott b'doża ta' 15mg għal kull 1kg lil majjali, ilkonċentrazzjoni massima fil-plażma medja ta' 3.78 µg għal kull milligram tintlaħaq 0.77 siegħa wara l-amministrazzjoni tad-doża.
English: Studies performed in laboratory animals (rat, rabbit), did not show a teratogenic, embryotoxic or maternotoxic effect of amoxicillin.
Maltese: Studji magħmulin fl-annimali tal-laboratorju (far, fenek), ma wrewx effetti teratoġeniċi, embijotossiċi jew meternotossiċi ta' amoksiċillina.
English: (as trihydrate) Excipient:
Maltese: Preżentazzjoni tal-prodott:
English: 50 days - Milk: 2.5 days BATCH NUMBER <Batch> <Lot> <BN> {number} EXPIRY DATE <EXP {month/year}> Shelf-life after first opening the container: 28 days.
Maltese: NUMRU TAL-LOTT <Lott> <lott> <Numru tal-lott> {numru} DATA TA' SKADENZA <Jiskadi {xahar / sena}> Iż-żmien kemm idum tajjeb il-prodott wara li jinfetaħ il-kontenitur għall-ewwel darba: 28 ġurnata.
English: β-lactam antibiotics prevent the bacterial cell wall synthesis by interfering with the final stage of peptidoglycan synthesis.
Maltese: L-antibijotiċi β-lactam jimpedixxu s-sintesi tal-ħajt taċ-ċellula batterjali billi jindaħħlu ma' l-aħħar fażi tas-sintesi peptidoglikan.
English: 6.5 Nature and composition of immediate packaging Polyethylene terephtalate (PET) bottles with rubber closures and aluminium capsules Product presentations:
Maltese: Fliexken tal-Polietilene tereftalat (PET) b'tappijiet tal-gomma u kapsuli ta' l-aluminju.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Maltese: Għal kura ta' l-annimali biss - għandu jingħata biss bi preskrizzjoni veterinarja
English: Strict aseptic precautions should be observed.
Maltese: Prekawzjonijiet stretti asettiċi għandhom jiġu osservati..
English: Residue levels in fat, liver, kidney and non-injection site muscle were below the limit of quantification from the first time point (7 days) with the exception of one kidney sample that contained residues at the level of the limit of quantification (25 µg/kg).
Maltese: Illivelli ta' residwu fix-xaħam, fil-fwied, fil-kliewi u f'muskoli li fihom ma ngħatatx injezzjoni kienu inqas mill-limitu ta' kwantifikazzjoni mill-ewwel punt ta' żmien (sebat ijiem) ħlief għal kampjun wieħed mill-kliewi li kien fih residwi fil-livell tal-limitu ta' kwantifikazzjoni (25 µg/kg).
English: Pharmacotherapeutic group: Penicillins with extended spectrum ATCVet code: QJ01CA04
Maltese: 4.7 Użu fit-Tqala, fit-Treddiegħ u meta jbidu l-bajd
English: By their nature such chromosomal mutations tend to be relatively slow in developing and occur primarily by vertical transmission.
Maltese: Bin-natura tagħhom tibdiliet kromosonali bħal dawn għandhom tendenza li jiżviluppaw relattivament bil-mod u jseħħu primarjament b'trasmissjoni vertikali.
English: The three complementary studies were conducted similarly to the pivotal study but in one of the complementary studies animals were younger and weighing much less (53 to 59 kg) than the ones used in the other studies were used but they did all receive at least the maximum injection volume (5 ml).
Maltese: It-tliet studji komplimentari twettqu b'mod simili għall-istudju ewlieni iżda f'wieħed mill-istudji komplimentari l-annimali kienu iżgħar u eħfef (bejn 53 u 59 kg) minn dawk użati fl-istudji l-oħra iżda kollha rċevew ta' l-anqas il-volum massimu ta' l-injezzjoni (5 ml).
English: 6.1 List of excipients
Maltese: FARMAĊEWTIKU 6.1 Lista ta' ingredjenti mhux attivi
English: Considering that there is data at an additional time point (90 days) where residues were below the limit of quantification the addition of a 10 % ‘uncertainty factor' was accepted.
Maltese: Minħabba li hemm data f'punt ta' żmien addizzjonali (90 jum) fejn ir-residwi kienu inqas mil-limitu ta' kwantifikazzjoni, ġie aċċettat il-‘fattur ta' inċertezza' ta' 10%.
English: The animals were given 15 mg amoxicillin/kg bw corresponding to 1ml/10 kg/bw which required 2 injections, one of which was the maximum volume (5 ml) and the remaining given in the second injection.
Maltese: L-annimali ngħataw 15-il mg amoxicillin/kg piż li jikkorrespondu għal 1ml/10 kg piż li ħtieġu żewġ injezzjonijiet, li waħda minnhom kellha l-volum massimu (5 ml) u l-bqija ngħata fit-tieni injezzjoni.
English: They inhibit the activity of transpeptidase enzymes which catalyse crosslinkage of the glycopeptide polymer units that form the cell wall.
Maltese: Reazzjonijiet ta' sensittività eċċessiva mhux relatati mad-doża għandhom ikunu osservati.
English: In the pivotal residue study, heavy animals (body weight: 66 - 84.5 kg) were used (eight male and eight female).
Maltese: Fl-istudju ewlieni dwar residwi, intużaw annimali tqal (piż: 66 - 84.5
English: This leads to a withdrawal period of 50 days.
Maltese: Huwa għalhekk stabbilit perjodu ta' irtirar ta' 50 jum għall-majjali.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains:
Maltese: 0 mg/ml Sustanza mhux attiva:
English: In the pivotal residue study, heavy animals (body weight: 600 to 692 kg) were used (eight males and eight females).
Maltese: Fl-istudju ewlieni dwar residwi, intużaw annimali tqal (piż: bejn 600 u 692 kg) (tmienja rġiel u tmienja nisa).
English: Residue levels in skin+fat, liver and non-injection site muscle were below their respective MRLs from the first time point (7 days) tested and for kidneys from the second time point (14 days).
Maltese: Il-livelli ta' residwu fil-ġilda u x-xaħam, fil-fwied u fil-muskoli li fihom ma ngħatatx injezzjoni kienu inqas mill-MRLs rispettivi mill-ewwel punt ta' żmien ittestjat (sebat ijiem) u għall-kliewi mit-tieni punt ta' żmien (14-il jum).
English: 1 Marketing Authorisation not granted Reference Member State for the Mutual recognition Procedure
Maltese: 1 Awtorizzazzjoni għal tqegħid fis-suq mhux mogħtija Stat Membru ta' Riferenza għall-Proċedura ta' Rikonoxximent Reċiproku
English: A. fumigatus A. flavus A. terreus A. niger
Maltese: A. flavus A. terreus A. niger
English: 2, rue Louis Pasteur F-14200 Hérouville St Clair France
Maltese: 2, rue Louis Pasteur F-14200 Hérouville St Clair Franza
English: SP Europe Rue de Stalle, 73 B-1180 Bruxelles Belgium
Maltese: SP Europe Rue de Stalle, 73 B-1180 Bruxelles Il-Belġju
English: MARKETING AUTHORISATION NUMBER(S) EU/1/05/321/001
Maltese: FIS-SUQ EU/1/05/321/001
English: PHARMACEUTICAL FORM Oral suspension
Maltese: 3. GĦAMLA FARMAĊEWTIKA Suspensjoni orali
English: B-1180 Bruxelles Belgium
Maltese: B-1180 Bruxelles
English: 400 mg (10 ml) twice a day.
Maltese: 400 mg (10 ml) darbtejn kuljum.
English: SI-1000 Ljubljana Tel: + 386 01 3001070
Maltese: Ljubljana Tel: + 386 01 3001070
English: Common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000)
Maltese: Każijiet avversi relatati mal-kura (TRAE) skond is-sistema tal-ġisem u l-frekwenza Komuni (≥1/100, <1/10); Mhux komuni (≥1/1,000, <1/100); rari (≥1/10,000, <1/1,000)
English: blurred vision diplopia, scotoma
Maltese: vista mċajpra diplopja, skotoma
English: rash mouth ulceration, alopecia Stevens Johnson syndrome, vesicular rash
Maltese: raxx ulċeri fil-ħalq, alopeċja sindrome ta' Stevens Johnson, raxx vessikulari
English: „Н.Й.Вапцаров” 53А, ет.
Maltese: Ийст Парк Трейд Център Бул. „Н.Й.Вапцаров” 53А, ет.
English: Posaconazole has been shown in vitro to be active against the following microorganisms: Aspergillus species (Aspergillus fumigatus, A. flavus, A. terreus, A. nidulans, A. niger, A. ustus), Candida species (Candida albicans, C. glabrata, C. krusei, C. parapsilosis, C. tropicalis, C. dubliniensis, C. famata, C. inconspicua, C. lipolytica, C. norvegensis, C. pseudotropicalis), Coccidioides immitis, Fonsecaea pedrosoi, and species of Fusarium, Rhizomucor, Mucor, and Rhizopus.
Maltese: Intwera li posaconazole huwa effettiv in vitro kontra l-mikro-organiżmi li ġejjin:Speċi ta' Aspergillus (Aspergillus fumigatus, A. flavus, A. terreus, A. nidulans, A. niger, A. ustus), speċi ta' Candida (Candida albicans, C. glabrata, C. krusei, C. parapsilosis, C. tropicalis, C. dubliniensis, C. famata, C. inconspicua, C. lipolytica, C. norvegensis, C. pseudotropicalis), Coccidioides immitis, Fonsecaea pedrosoi, u speċi ta' Fusarium, Rhizomucor, Mucor, u Rhizopus.
English: Psychiatric disorders Rare:
Maltese: Disturbi psikjatriċi Rari:
English: • Rifabutin and rifampicin (used to treat certain infections).
Maltese: • Rifabutin u rifampicin (jintużaw għall-kura ta' ċerti infezzjonijiet).
English: electrolyte imbalance, anorexia hyperglycaemia
Maltese: skwilibriju fl-elettroliti, anoressija ipergliċemija
English: psychotic disorder, depression
Maltese: disturb psikotiku, dipressjoni
English: The other ingredients in the suspension are polysorbate 80, simeticone, sodium benzoate (E211), sodium citrate dihydrate, citric acid monohydrate, glycerol, xanthan gum, liquid glucose, titanium dioxide (E171), artificial cherry flavour containing benzyl alcohol and propylene glycol, and purified water.
Maltese: Is-sustanzi l-oħra huma polysorbate 80, simeticone, sodium benzoate (E211), sodium citrate dihydrate, citric acid monohydrate, glycerol, xanthan gum, glucose likwidu, titanium dioxide (E171), togħma artifiċjali taċ-ċirasa li fiha benzyl alcohol u propylene glycol, u ilma purifikat.
English: pulmonary hypertension, interstitial pneumonia, pneumonitis
Maltese: ipertensjoni pulmonari, pulmonite fl-interstizzju, infezzjoni fil-pulmun