FrancophonIA/ELRC3.0 huggingface dataset:
English: Product information for Noxafil (posaconazole) is to be updated to strengthen warnings that the two dose forms given by mouth cannot be simply interchanged at the same dose.
Maltese: L-informazzjoni tal-prodott għal Noxafil (posaconazole) għandha tiġi aġġornata biex issaħħaħ ittwissijiet li ż-żewġ forom tad-dożi mogħtija mill-ħalq ma jistgħux sempliċiment jiġu skambjati fl-istess doża.
English: and Prevotella spp.
Maltese: u Prevotella spp.
English: ATCvet code: QJ01DD90.
Maltese: QJ01DD90.
English: Date of last renewal: 26/05/2010.
Maltese: Data tal-aħħar tiġdid: 26/05/2010.
English: 1348 Louvain-la-Neuve
Maltese: 1348 Louvain-la-Neuve IL-BELĠJU
English: 2,000 µg/kg Fat 2,000 µg/kg Liver 6,000 µg/kg Kidney 100 µg/kg Milk
Maltese: 1000 µg/kg 2000 µg/kg 2000 µg/kg 6000 µg/kg 100 µg/kg
English: Figure 2).
Maltese: Stampa 2).
English: Bordetella bronchiseptica is inherently insensitive to ceftiofur in vitro.
Maltese: Bordetella bronchiseptica mhuwiex sensittiv għal ceftiofur in vitro.
English: Treatment of acute interdigital necrobacillosis (Panaritium, foot rot).
Maltese: Trattament tan-nekrobaċillożi interdiġitali akuta (Panaritium, foot rot).
English: Pregnancy and fertility:
Maltese: Tqala u fertilità:
English: Antiinfectious agents / Antibiotics
Maltese: Sustanzi kontra l infezzjonijiet / Antibijotiċi
English: Meat and offal: 9 days.
Maltese: Laħam u Ġewwieni: 9 ijiem.
English: Pasteurella multocida, Haemophilus parasuis and Streptococcus suis.
Maltese: Pasteurella multocida, Haemophilus parasuis, u Streptococcus suis.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19/05/2005.
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 19/05/2005.
English: Maximum concentrations in plasma (4.2±0.9 µg/ml) are reached at approximately 22 hours after administration.
Maltese: Livelli massimi fil-plażma (4.2 ± 0.9 µg/ml) jintlaħqu bejn wieħed u ieħor, 22 siegħa wara li jingħata.
English: Oily vehicle (vegetable origin).
Maltese: Veikolu żejtni (oriġini veġetali).
English: Protein binding of ceftiofur and its major metabolite is high, approximately 70% - 90%.
Maltese: Il-livell ta' abbinament ta' ceftiofur u tad-derivat attiv prinċipali tiegħu mal-proteini huwa għoli, bejn wieħed u ieħor 70%-90%.
English: Meat and offal: 71 days.
Maltese: Laħam u nterjuri: 71 jum.
English: Ceftiofur is a third generation cephalosporin antibiotic, which is active against many Gram-positive and Gram-negative pathogens.
Maltese: Ceftiofur huwa antibijotiku cephalosporin tat-tielet generazzjoni, li huwa attiv kontra ħafna mikrobi Gram-positive u Gram-negative.
English: • Treatment of bacterial respiratory disease associated with Actinobacillus pleuropneumoniae,
Maltese: • Trattament ta' mard respiratorju minn mikrobi assoċjati ma' Actinobacillus pleuropneumoniae,
English: • Administer in the posterior part of the ear base (see Figure 1).
Maltese: • Amministra fil-parti ta' wara tal-bażi tal-widna (ara Stampa 1).
English: Oily vehicle (vegetable origin): Triglycerides, medium chain Cottonseed oil.
Maltese: Veikolu żejtni (oriġini veġetali) Triglycerides, ta' tul medju Żejt taż-żerriegħa tal-qoton.
English: MRLs
Maltese: SC
English: Ceftiofur (as crystalline free acid)
Maltese: Ceftiofur (bħala aċidu ħieles mill-kristalli)
English: Excipient: Oily vehicle (vegetable origin).
Maltese: Ingredjenti oħra: Veikolu żejtni (oriġini veġetali).
English: Date of first authorisation: 08/10/2009.
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 08/10/2009.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One ml contains:
Maltese: U KWANTITATTIVA Millilitru wieħed fih:
English: Ceftiofur is particularly active against the following target pathogens causing respiratory and other diseases in pigs: Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis and Streptococcus suis.
Maltese: Ceftiofur għandu effett partikulari kontra il-mikrobi li ġejin li jikkawżaw mard respiratorju u mard ieħor fil-majjali: Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis u Streptococcus suis.
English: In cattle, although Naxcel has not been specifically tested for overdoses, no signs of systemic toxicity related to ceftiofur have been observed following 55 mg/kg parenteral daily overdoses of ceftiofur sodium for five days.
Maltese: Għalkemm Naxcel ma ġiex ittestjat speċifikament f'dożi eċċessivi, fil-baqar ma ġewx osservati sinjali ta' tossiċità sistemika relatati ma' ceftiofur wara dożaġġi eċċessivi b'injezzjoni ta' 55 mg/kg ceftiofur sodjum kuljum għal ħamest-ijiem.
English: Treatment of acute post-partum (puerperal) metritis in cases where treatment with another antimicrobial has failed.
Maltese: Trattament tal-metrite akuta post-partum (puerperal) fil-baqar, f'każijiet fejn trattament b'antibijotiku ieħor ikun falla.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Ceftiofur 100 mg/ml
Maltese: Ceftiofur 100 mg / ml
English: Approximately 60% and 15% of the dose are excreted in the urine and faeces, respectively, within 10 days after administration.
Maltese: Bejn wieħed u ieħor 60% u 15% tad-doża jitneħħew ma' l-urina u l-ħmieġ rispettivament, fi żmien 10 jiem wara li jingħata.
English: One ml contains:
Maltese: GĦAL:
English: In cattle, ceftiofur is active against the following micro-organisms which are involved in acute postpartum (puerperal) metritis: Escherichia coli, Arcanobacterium pyogenes and Fusobacterium necrophorum; and interdigital necrobacillosis: Bacteroides spp., Fusobacterium necrophorum, Porphyromonas spp.
Maltese: (puerperal): Escherichia coli, Arcanobacterium pyogenes u Fusobacterium necrophorum; u finnekrobaċillożi interdiġitali:
English: Opaque white to light brown suspension.
Maltese: Suspensjoni opaka bajda għal kannella ċar.
English: Total plasma concentrations above 0.2µg/ml and 1µg/ml of ceftiofur and its active metabolites are maintained for at least 7 and 4 days, respectively.
Maltese: Livelli totali filplażma ta'‘l fuq minn 0.2 µg/ml u 1 µg/ml ta' ceftiofur u d-derivati attivi tiegħu jinżammu fil-plażma għal tal-anqas 7 u 4 ijiem rispettivament.
English: Cardboard box with one type I glass vial of 50 ml or 100 ml with a chlorobutyl-isoprene rubber stopper and aluminium cap.
Maltese: Kaxxa tal-kartun li fiha hemm kunjett wieħed ta' 50 ml jew 100 ml, tal-ħġieġ ta' tip 1 b'tapp tarrabber chlorobutyl-isoprene u b'siġill ta' l-aluminju.
English: If clinical signs have not improved 48 hours after treatment, the diagnosis and treatment of the condition should be re-evaluated.
Maltese: Jekk 48 siegħa wara t-trattament is-sinjali kliniċi ma jitjiebux, id-djanjożi u t-trattament talkundizzjoni għandhom jiġu evalwati mill-ġdid.
English: Protein binding of ceftiofur and its major metabolite is approximately 70%.
Maltese: Il-livell ta' abbinar ta' ceftiofur u l-forma prinċipali tiegħu mal-proteini huwa ta' bejn wieħed u ieħor 70%.
English: Cattle.
Maltese: Majjali.
English: Pigs
Maltese: Muskolu
English: 100 mg. For the full list of excipients, see section 6.1.
Maltese: Għal-lista sħiħa tal-ingredjenti (mhux attivi), ara s-sezzjoni 6.1.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/05/053/001 (100 ml)
Maltese: EU/2/05/053/001 (100 ml)
English: Laboratory studies in rats revealed no teratogenic effects but maternotoxic (soft faeces) and foetotoxic (reduced foetal weight) effects were observed.
Maltese: Fiż-żewġ speċi ma kienux innotati effetti fuq l-imġieba riproduttiva.
English: Intramuscular use.
Maltese: Antibatteriċi għal użu sistemiku.
English: 5mg ceftiofur/kg bodyweight (equivalent to 1ml of Naxcel per 20kg bodyweight) administered once in the neck by intramuscular injection.
Maltese: 5 mg ceftiofur/kg piż (ekwivalenti għal 1 ml Naxcel għal kull 20 kg piż) mgħotija darba fl-għonq binjezzjoni fil-muskolu.
English: • Treatment of septicaemia, polyarthritis or polyserositis associated with Streptococcus suis infection.
Maltese: • Trattament ta' septisimja, poliartrite u poliserusite assoċjati ma' infezzjoni b' Streptococcus suis.
English: TARGET SPECIES Cattle.
Maltese: Kodici ATĊ veterinarja:
English: - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Maltese: - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal, inklużi rapporti iżolati).
English: It has an antimicrobial activity similar to that of ceftiofur against the target pathogens.
Maltese: Għandu effett kontra l-mikrobi simili għal dak ta' ceftiofur kontra l-mikrobi immirati.
English: For systemically administered broad spectrum cephalosporins (3
Maltese: Amministrazzjoni fil-bażi tal-widna:
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 are 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 tal-karatteristiċi tal-prodott fil-qosor huma jew 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 ikunsidrati li ma jaqgħux fi ħdan liskop tar-Regolament (KE) Nru 470/2009 meta wżati bħal f'dan il-prodott mediċinali veterinarju.
English: STATEMENT OF ACTIVE SUBSTANCES Ceftiofur (as crystalline free acid)
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA U SUSTANZI OĦRA Ceftiofur (bħala aċidu ħieles mill-kristalli)
English: MARKETING AUTHORISATION NUMBER (S) EU/2/05/053/001-002
Maltese: EU/2/05/053/001-002
English: Dose of 5 mg ceftiofur/kg bodyweight (equivalent to 1 ml of Naxcel per 20 kg bodyweight) administered once in the neck by intramuscular injection.
Maltese: Doża ta' 5 mg ceftiofur/kg piż (ekwivalenti għal 1 ml Naxcel għal kull 20 kg piż) mogħtija darba fl-għonq b-injezzjoni fil-muskolu.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular use.
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI Għal użu fil-muskolu.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s))
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)
English: rd and 4
Maltese: ANNESS III
English: Withdrawal period(s):
Maltese: Sustanza(i) Attiva(i):
English: The active substance in Naxcel is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Maltese: Is-sustanza attiva f'Naxcel 5 mg/ml soluzzjoni intramammarja għal baqar hija sustanza ammissibbli kif deskritt fit-tabella numru 1 fl-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010:
English: Use only according to the benefit-risk assessment by the responsible veterinarian.
Maltese: Uża biss skond il-valutazzjoni tal-benefiċċju u r-riskju tal-veterinarju responsabbli.
English: WITHDRAWAL PERIOD(S) Meat and offal: 71 days.
Maltese: Laħam u interjuri: 71 jum.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Naxcel 100 mg/ml suspension for injection for pigs ceftiofur
Maltese: VETERINARJU Naxcel 100 mg/ml suspensjoni għall-injezzjoni għal majjali ceftiofur
English: IM Read the package leaflet before use.
Maltese: Mhux id-daqs tal-pakketti kollha jistgħu qegħdin fis-suq.
English: Single subcutaneous injection of 6.6 mg ceftiofur/kg bw (equivalent to 1ml of Naxcel per 30 kg bw) administered at the base of the ear.
Maltese: Injezzjoni waħda ta' 6.6 mg ceftiofur/kg piż tal-ġisem (ekwivalenti għal 1 ml Naxcel għal kull 30 kg piż tal-ġisem) mgħotija darba taħt il-ġilda fil-bażi tal-widna.
English: Maximum concentrations in plasma (about 5 µg/ml) occurred from 12 hours following administration.
Maltese: Livelli massimi filplażma (bejn wieħed u ieħor 5 µg/ml) jintlaħqu minn 12-il siegħa wara li jingħata.
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary Owing to the low toxicity of ceftiofur in pigs overdoses do not typically lead to any clinical signs, other than transient local swellings as described in section 4.6 (Adverse reactions).
Maltese: Huwa rakkmandat li l-akbar volum li tinjetta jkun ta' 4 ml. 4.10 Doża eċċessiva (sintomi, proċeduri ta' emerġenza, antidoti), jekk ikun hemm bżonn Minħabba t-tossiċita' baxxa ta' ceftiofur fil-majjali, mhux soltu li dożi eċċessivi iwasslu għal sinjali cliniċi jekk mhux nefħiet lokaliżżati li jgħaddu kif spjegat f'sezzjoni 4.6 (Effetti mhux mixtieqa) . 4.11 Perjodu ta' tiżmim
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Naxcel 200 mg/ml suspension for injection for cattle ceftiofur
Maltese: VETERINARJU Naxcel 200 mg/ml suspensjoni għall-injezzjoni għall-baqar. ceftiofur
English: Pharmacotherapeutic group: Antibacterials for systemic use, third-generation cephalosporins.
Maltese: Bacteroides spp., Fusobacterium necrophorum, Porphyromonas spp.
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Single subcutaneous injection of 6.6 mg ceftiofur/kg bodyweight (equivalent to 1 ml of Naxcel per 30 kg bodyweight) administered at the base of the ear.
Maltese: 4.9 Ammont li jingħata u l-metodu ta' amministrazzjoni Injezzjoni waħda ta' 6.6 mg ceftiofur/kg piż tal-ġisem (ekwivalenti għal 1 ml Naxcel għal kull 30 kg piż tal-ġisem) mgħotija darba taħt il-ġilda fil-bażi tal-widna.
English: Whenever possible, cephalosporins should only be used based on susceptibility testing.
Maltese: Kull meta jkun possibbli kefalosporini għandhom jintużaw biss fuq bażi ta' testijiet tas-suxxettibilità.
English: PHARMACEUTICAL PARTICULARS
Maltese: Sustanzi b'attività farmakoloġika
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS One ml contains:
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA U SUSTANZI OĦRA Sustanza attiva:
English: In such cases, death has been attributed to intra-vascular administration of the product or anaphylaxis.
Maltese: U METODU TA' AMMINISTRAZZJONI Għal użu fil-muskolu.
English: Once broached, use within 28 days.
Maltese: DATA TA' SKADENZA Jiskadi {xahar / sena} La darba jinfetaħ uża fi żmien 28 jum.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Naxcel 100 mg/ml suspension for injection for pigs
Maltese: VETERINARJU Naxcel 100 mg/ml suspensjoni għall-injezzjoni għal majjali
English: People with known hypersensitivity to penicillins and cephalosporins should avoid contact with this veterinary medicinal product.
Maltese: Nies li huma ipersensittivi għal peniċillini u kefalosporini għandhom jevitaw li jmissu ma' dan ilprodott mediċinali veterinarju.
English: After administration, ceftiofur is quickly metabolised to desfuroylceftiofur, the principal active metabolite.
Maltese: KPQ, jista' jwassal għal żieda fir-reżistenza tal-mikrobi għal-ceftiofur.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Naxcel 200 mg/ml suspension for injection for cattle
Maltese: VETERINARJU Naxcel 200 mg/ml suspensjoni għall-injezzjoni għall-baqar
English: None.
Maltese: Baqar.
English: • Take appropriate precautions to avoid intra-arterial or intravenous injection, such as restraining appropriately the animal (chute or head restraint for example) and using appropriate needles [1 inch (2.54 cm) long, 16 gauge].
Maltese: • Ħu l-prekawzzjonijiet li hemm bżonn biex tevita injezzjoni fl-arterji jew fil-vini, billi ixxekkel lannimal kif jixraq (eżempju: rampa jew xkiel tar-ras) u użu ta' labar adattati [tul tal-pulzier (2.54
English: Treatment of septicaemia, polyarthritis or polyserositis associated with Streptococcus suis infection.
Maltese: Trattament ta' septisimja, poliartrite u poliserusite assoċjati ma' infezzjoni b' Streptococcus suis.
English: Laboratory studies in rats have shown no evidence of teratogenic effects but maternotoxic (soft faeces) and foetotoxic (reduced foetal weight) effects were observed.
Maltese: Studji fil-laboratorju fuq il-ġrieden ma pprovdewx evidenza ta' effetti teratoġeniċi, ħsara lill-fetu jew ħsara lill-omm.
English: Diagram of the head showing the direction for the base of the ear injections administered toward the animal's opposite eye.
Maltese: Stampa tar-ras li turi injezzjonijiet filbażi tal-widna amministrati fiddirezzjoni tal-għajn opposta.
English: Do not use in cases of hypersensitivity to ceftiofur or other beta-lactam antibiotics, or to any of the excipients.
Maltese: Tużax f'każijiet ta' ipersensittività għal ceftiofur jew antibiotiċi oħra tat-tip beta-lactam, jew għal ingredjenti oħra.
English: One hour after a single administration, plasma concentrations are above 1 µg/ml.
Maltese: Siegħa wara li jingħata darba, il-livelli fil-plażma huma ‘l fuq minn 1 µg/ml.
English: Resolution has been observed at 56 days post-injection.
Maltese: Kollox jerġa' jiġi għannormal sa 56 jum wara l-injezzjoni.
English: United Kingdom Schering Health Care Ltd The Brow
Maltese: Schering Health Care Ltd The Brow
English: Química Farmacéutica Bayer, S.L.
Maltese: Química Farmacéutica Bayer, S.L. Av.
English: Av. Baix Llobregat, 3-5 08970 Sant Joan Despí, Barcelona Spain
Maltese: Baix Llobregat, 3-5 08970 Sant Joan Despí, Barcelona Spanja
English: Viale Certosa 130 20156 Milano Italy
Maltese: Viale Certosa 130 20156
English: Bayer Santé 13, Rue Jean Jaurès 92807 Puteaux Cedex France
Maltese: Bayer Santé 13, Rue Jean Jaurès 92807 Puteaux Cedex Franża
English: Bayer Hellas AG 18-20 Sorou Str 15125 Amaroussion Athens Greece
Maltese: Bayer Hellas AG 18-20 Sorou Str 15125 Amaroussion Athens il-Greċja
English: 15125 Amaroussion Athens, Greece
Maltese: 15125 Amaroussion Athens, Il-Greċja
English: Bayer Schering Pharma Oy Pansiontie 47, FI-20210 Turku Finland
Maltese: Bayer Schering Pharma Oy Pansiontie 47, FI-20210
English: RH15 9NE
Maltese: West Sussex RH15 9NE
English: 143, Avenue Louise 1050 Brussel, Belgium
Maltese: 143, Avenue Louise 1050 Brussel, il-Belġju
English: Bayer Austria GmbH (Schering Austria GmbH) Herbststr.
Maltese: Bayer Austria GmbH (Schering Austria
English: The product is marketed in pack size of 3 x 21 film-coated tablets.
Maltese: Il-prodott jitqiegħed fis-suq f'pakketti ta' 3 x 21 pillola miksijin b'rita.
English: Pharmaceutical form Route of administration
Maltese: Għamla Farmaċewtika
English: The wallet with the inserted blister is assembled with a package leaflet (PL) and all components are wrapped together with clear, transparent cellophane wrapping to form the unit pack which prevents the loss of individual components.
Maltese: Il-portafoll bil-blister infilzat jiġi mmuntat b'fuljett ta' tagħrif (PL) u l-komponenti kollha jitgeżwru flimkien b'kisja ta' cellophane irqiq u trasparenti biex jifforma l-pakkett li jipprevjeni t-telf ta' komponenti individwali.
English: The Yasminelle blister is glued in a carton which is subsequently folded to a wallet configuration.
Maltese: Il-blister ta' Yasminelle huwa mwaħħal bil-kolla ma' kartuna li mbagħad tintlewa f'forma ta' portafoll.
English: Czech Republic Bayer Schering Pharma AG D-13342 Berlin
Maltese: Republika Ċeka Bayer Schering Pharma AG
English: The risk resulting from the separation of a package leaflet from cardboard wallets is comparable with the risk resulting from separation of blisters from conventional external packaging (cardboard box).
Maltese: Ir-riskju li jirriżulta mill-firda tal-fuljett ta' tagħrif mill-portafolli tal-kartun jista' jitqabbel mar-riskju li jirriżulta mill-firda tal-folji minn pakketti esterni konvenzjonali (kaxxi tal-kartun).
English: Although different observations in respect to readability of the Braille text through the cellophane wrapping have been made by blind users, it is assumed that before use of the product the cellophane wrapping will be removed and therefore blind person will be in a position to identify the product.
Maltese: Għalkemm saru osservazzjonijiet differenti dwar il-possibilità ta' qari tal-kitba bil-Braille mill-kisi tas- cellophane minn persuni għomja, wieħed jassumi li qabel ma xi ħadd juża l-prodott, dan ineħħi lkisi tas-cellophane u għalhekk il-persuna għamja tkun tista' tidentifika l-prodott.
English: Finally taking into account that the medicinal product is intended for long term use, the possible mistakes and misuse are further minimised.
Maltese: Finalment, meta wieħed jikkunsidra li l-prodott mediċinali huwa intiż għal użu fit-tul, il-possibilità ta' żbalji u użu ħażin tkompli tonqos.
English: Moreover cardboard wallets protect blisters against damage.
Maltese: Barra minn hekk ilportafolli tal-kartun jipproteġu l-folji mill-ħsara.
English: Invented Name Strength
Maltese: ANNESS I LISTA TA`
English: ANNEX II SCIENTIFIC CONCLUSIONS
Maltese: ANNESS II KONLUŻJONIJIET XJENTIFIĊI
English: Horizon, Honey Lane Hurley, SL66RJ United Kingdom
Maltese: Horizon, Honey Lane Hurley, SL66RJ
English: #, Blepharitis
Maltese: #, Blefarite
English: • Haemoglobin ≥ 8 g/dL
Maltese: • L-emoglobina  8 g/dL
English: Table 12: Efficacy results from study IFM-2005-01 Endpoints
Maltese: Tabella 12: Riżultati ta' effikaċja minn studju IFM-2005-01
English: Overall response (CR+CRu+PR)
Maltese: Rispons globali (CR+CRu+PR)
English: Manufacturer Hospira UK Ltd.
Maltese: Hospira UK Ltd.
English: p-value d < 0.001
Maltese: valur d p < 0.001
English: CI=Confidence Interval
Maltese: CI = Intervall ta' Kunfidenza
English: Tel: +420-283-004-11
Maltese: s r.o. Tel: +420-283-004-11
English: Table 8 has been generated using Version 16 of the MedDRA.
Maltese: Tabella 8 ġiet iġġenerata bl-użu ta' Verżjoni 16 ta' MedDRA.
English: p-value g=0.275
Maltese: valur gp=0.275
English: Pruritus*, Dermatitis*, Rash*
Maltese: Ħakk*, Dermatite*, Raxx*
English: NOS=not otherwise specified * Grouping of more than one MedDRA preferred term.
Maltese: NOS = (not otherwise specified) mhux speċifikat mod ieħor * Aggruppament ta' aktar minn terminu wieħed ippreferut ta' MedDRA. #
English: > 1.0 x -1.5 x ULN Any
Maltese: > 1.0 x -1.5 x ULN
English: The active substance is bortezomib.
Maltese: Is-sustanza attiva hi bortezomib.
English: Table 13: Efficacy results from study MMY-3010 Endpoints
Maltese: Tabella 13: Riżultati t'effikaċja minn studju MMY-3010
English: Higher incidences were also noted for infections with Grade ≥ 3 neutropenia (24% versus 19% in Block 1 and 22% versus 11% in Block 2), increased ALT (17% versus 8% in Block 2), hypokalaemia (18% versus 6% in Block 1 and 21% versus 12% in Block 2) and hyponatraemia (12% versus 5% in Block 1 and 4% versus 0 in Block 2).
Maltese: Inċidenzi ogħla ġew ukoll innutati għal infezzjonijiet b'newropatija bi grad ≥ 3 (24 % kontra 19 % fi Blokk 1 u 22 % kontra 11 % fi Blokk 2), żieda fl-ALT (17 % kontra 8 % fi Blokk 2), ipokalemija (18 % kontra 6 % fi Blokk 1 u 21 % kontra 12 % fi Blokk 2) u iponatremijaa (12 % kontra 5 % fi Blokk 1 u 4 % kontra 0 fi Blokk 2).
English: The analysis demonstrated improved ORR (CR+PR) (odds ratio 3.769; 95% CI 2.045-6.947; p < 0.001), PFS (hazard ratio 0.511;95% CI 0.309-0.845; p=0.008), TTP (hazard ratio 0.385; 95% CI 0.212-0.698; p=0.001) for bortezomib in combination with dexamethasone over bortezomib monotherapy.
Maltese: L-analiżi wriet titjieb fl-ORR (CR+PR) (proporzjon farradi 3.769; 95% CI 2.045-6.947; p<0.001), PFS (proporzjon ta' periklu 0.511; 95% CI 0.309-0.845; p=0.008), TTP (proporzjon ta' periklu 0.385; 95% CI 0.212-0.698; p=0.001) għal bortezomib f'kombinazzjoni ma' dexamethasone fuq il-monoterpija bi bortezomib.
English: • Dosing Slide Rule
Maltese: • Slide Rule tad-dożaġġ
English: 39 ml/min/1.73 m 2, n=9), and Severe (CrCL < 20 ml/min/1.73 m 2, n=3).
Maltese: (CrCL=20-39 ml/min/1.73 m 2, n=9), u Qawwi (CrCL < 20 ml/min/1.73 m 2, n=3).
English: Musculoskeletal pain*
Maltese: Uġigħ muskoloskeletriku*
English: Combination with dexamethasone
Maltese: Kombinazzjoni b'dexamethasone