FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/11/713/011 EU/1/11/713/012 EU/1/11/713/013 EU/1/11/713/014 EU/1/11/713/015 EU/1/11/713/016 EU/1/11/713/017 EU/1/11/713/018 EU/1/11/713/019 EU/1/11/713/020 EU/1/11/713/042
Maltese: EU/1/11/713/017 EU/1/11/713/018 EU/1/11/713/019 EU/1/11/713/020 EU/1/11/713/042
English: The major metabolic pathway (24 % of the dose) is an enzymatic hydrolysis of the acetamide group.
Maltese: (24 % tad-doża) huwa permezz ta' idroliżi tal-grupp aċetamajd.
English: In this study, patients were prescribed 20 mg/kg, 25 mg/kg, 40 mg/kg or 50 mg/kg daily dose of oral solution based on their age titration schedule.
Maltese: mg/kg, 40 mg/kg jew 50 mg/kg ta' soluzzjoni orali bbażati fuq l-iskeda tat-titrazzjoni skond l-eta`.
English: A risk of birth defects for your unborn child cannot be completely excluded.
Maltese: Ir-riskju li jista' jkun hemm difetti għat-tarbija ġol-guf ma jistax jiġi kompletament eskluż.
English: The starting dose for a child or adolescent of 25 kg should be 250 mg twice daily with a maximum dose of 750 mg twice daily.
Maltese: Id-doża inizjali fit-tfal jew adodoloxxenti ta' 25 kg għandha tkun 250 mg darbtejn kuljum b'doża massima ta' 750 mg darbtejn kuljum.
English: Example: if your daily dose is 1,000 mg, you might take 2 tablets of 250 mg in the morning and 2 tablets of 250 mg in the evening.
Maltese: Jekk id-doża tiegħek hija 1,000 mg kuljum, jista' jkun li 2 pilloli ta' 250 mg filgħodu u 2
English: EU/1/11/713/028 30 tablets EU/1/11/713/029 100 tablets EU/1/11/713/030 200 tablets
Maltese: EU/1/11/713/028 30 pilloli EU/1/11/713/029 100 pilloli EU/1/11/713/030 200 pilloli
English: EU/1/11/713/008 30 tablets EU/1/11/713/009 100 tablets EU/1/11/713/010 200 tablets
Maltese: EU/1/11/713/008 30 pilloli EU/1/11/713/009 100 pilloli EU/1/11/713/010 200 pilloli
English: • skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (StevensJohnson syndrome), and a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis).
Maltese: raxx fil-ġilda, li jista' jifforma bżieżaq u li jidher qisu targi żgħar (tikek ċentrali skuri mdawwra b'erja iżjed pallida, b'ċirku skur mat-tarf) (erythema multiforme), raxx diffuz bilbżieżaq u ġilda li titqaxxar, partikolarrment madwar il-ħalq, mnieħer, għajnejn u l-ġenitali (sindrome ta' Stevens-Johnson), u forma iżjed severa li tikkawża ġilda li titqaxxar f'iżjed minn 30% tal-wiċċ tal-ġilda (nekroliżi tossiku epidermali). rabdomajoliżi (tkissir ta' tessut tal-muskoli) u żieda assoċjata mal-krejatina phosphokinase fid-demm.
English: • Levetiracetam Actavis is used as a chronic treatment.
Maltese: • Levetiracetam Actavis huwa wżat bħala trattament għal marda kronika.
English: 5 to 10 mg/kg (0.05 to 0.10 ml/kg) twice daily
Maltese: 5 sa 10 mg/kg (0.05 sa 0.10ml/kg) darbtejn kuljum
English: Choreoathetosis, dyskinesia, hyperkinesia, gait disturbance, encephalopathy
Maltese: diskinesija, iperkinesja, diffikultà filmixi,
English: Levetiracetam Actavis 750 mg film-coated tablets Oval, orange 19.0 x 9.3 mm marked with “L” on one side and “750” on the other side.
Maltese: Levetiracetam Actavis 750 mg pilloli miksija b'rita huma ovali, orangjo, 19.0 x 9.3 mm imnaqqxa b'
English: EU/1/11/713/038 30 tablets EU/1/11/713/039 100 tablets EU/1/11/713/040 200 tablets
Maltese: EU/1/11/713/038 30 pilloli EU/1/11/713/039 100 pilloli EU/1/11/713/040 200 pilloli
English: No adverse reactions on male or female fertility or reproduction performance were observed in rats at doses up to 1,800 mg/kg/day (x 6 the MRHD on a mg/m2 or exposure basis) in parents and F1 generation.
Maltese: Ebda reazzjoni avversa fuq il-fertilita` maskili jew femminili jew abbilta` riproduttiva ma kienu osservati fil-firien f'dożi sa 1,800 mg/kg/day (x 6 l-MRHD fuq bażi ta' mg/m2 jew t'esponiment) fil ġenituri u l-ġenerazzjoni F1.
English: Levetiracetam Actavis 750 mg tablets are oval, orange, 19.0 x 9.3 mm marked with “L” on one side and “750” on the other side.
Maltese: Ovali, oranġjo, 19.0 x 9.3 mm imnaqqxa b' “L” fuq naħa u “750” fuq naħa oħra.
English: Perforated unit dose blisters: EU/1/11/713/042 60 x 1 tablets
Maltese: EU/1/11/713/042 60 x 1 pilloli
English: In infants and children aged 1 month to less than 4 years, irritability (very common, 11.7%) and coordination abnormal (common, 3.3%) were reported more frequently than in other age groups or in the overall safety profile.
Maltese: F'trabi u tfal t'eta` minn xahar sa inqas minn 4 snin, irritabilta` (komuni ħafna, 11.7%) u ko-ordinazzjoni abnormali (komuni,
English: Teл.
Maltese: totali.
English: Somnolence, headache
Maltese: Naġħas, uġigħ ta' ras
English: The tablet formulation is not adapted for use in infants and children under the age of 6 years.
Maltese: Il-formulazzjoni tal-pillola ma hijiex adattata għall-użu fit-trabi u tfal taħt l-età ta '6 snin.
English: One tablet of Levetiracetam Actavis 1,000 mg contains 1,000 mg of levetiracetam.
Maltese: Kull pillola ta' Levetiracetam Actavis 1,000 mg fiha 1,000 mg ta' levetiracetam.
English: EU/1/11/713/001 20 tablets EU/1/11/713/002 30 tablets EU/1/11/713/003 50 tablets EU/1/11/713/004 60 tablets EU/1/11/713/005 100 tablets EU/1/11/713/006 120 tablets EU/1/11/713/007 200 tablets
Maltese: EU/1/11/713/001 20 pilloli EU/1/11/713/002 30 pilloli EU/1/11/713/003 50 pilloli EU/1/11/713/004 60 pilloli EU/1/11/713/005 100 pilloli EU/1/11/713/006 120 pilloli EU/1/11/713/007 200 pilloli
English: 7 to 14 mg/kg (0.07 to 0.14 ml/kg) twice daily
Maltese: 7 sa 14 mg/kg (0.07 sa 0.14 ml/kg) darba kuljum (2) (4)
English: (4) Following dialysis, a 3.5 to 7 mg/kg (0.035 to 0.07 ml/kg) supplemental dose is recommended.
Maltese: Wara id-dijaliżi, hija rrikkmandata doża supplimentari ta' bejn 3.5 u 7 mg/kg (0.035 sa 0.07 ml/kg).
English: reduction from baseline in average daily partial onset seizure frequency) assessed by a blinded central reader using a 48-hour video EEG.
Maltese: Il-kejl primarju ta' effettivita` kienet ir-rata ta' pazjenti li rrispondew (persentaġġ tal-pazjenti b' ≥ 50 % tnaqqis mill-linja bażi fil-frekwenza tal-medda ta' aċċessjonijiet tat-tip partial onset f'ġurnata) mkejla b' blinded central reader bl'użu ta' vidjo EEG ta' 48 siegħa.
English: Dosing adjustment for adult and adolescents patients weighing more than 50 kg with impaired renal function
Maltese: Regolar tad-doża f'pazjenti adulti u addoloxxenti li jiżnu iżjed minn 50kg b' indeboliment fil-kliewi
English: • suicide attempt and suicidal ideation, mental disorder, abnormal behaviour, hallucination, anger,
Maltese: attentat ta' suwiċidju u ħsibijiet ta' suwiċidju, mġieba abnormali, alluċinazzjonijiet, rabja,
English: Suicide attempt, suicidal ideation, psychotic disorder, abnormal behaviour, hallucination, anger, confusional state , panic attack, affect lability/mood swings, agitation
Maltese: rabja, stat konfużjonali, attakk ta' paniku, tibdil flemozzjonijiet/tibdil fil-burdati, agitazzjoni
English: EU/1/11/713/021 20 tablets EU/1/11/713/022 30 tablets EU/1/11/713/023 50 tablets EU/1/11/713/024 60 tablets EU/1/11/713/025 100 tablets EU/1/11/713/026 120 tablets EU/1/11/713/027 200 tablets
Maltese: EU/1/11/713/021 20 pilloli EU/1/11/713/022 30 pilloli EU/1/11/713/023 50 pilloli EU/1/11/713/024 60 pilloli EU/1/11/713/025 100 pilloli EU/1/11/713/026 120 pilloli EU/1/11/713/027 200 pilloli
English: • swelling of the face, lips, tongue and throat (Quincke's oedema);
Maltese: • nefħa fil-wiċċ, fix-xofftejn, fl-ilsien u l-gerżuma (edema tal-Quincke);
English: • as an add-on to other antiepileptic medicines to treat:
Maltese: • biex jiżdied ma' mediċini oħra ta' kontra l-epilessija fit-trattament:
English: Perforated unit dose blisters: EU/1/11/713/043 60 x 1 tablets
Maltese: EU/1/11/713/043 60 x 1 pilloli
English: One tablet of Levetiracetam Actavis 750 mg contains 750 mg of levetiracetam.
Maltese: Kull pillola ta' Levetiracetam Actavis 750 mg fiha 750 mg ta' levetiracetam.
English: • abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea;
Maltese: uġigħ fl-addomenu, dijareja, dispepsja (indigistjoni), rimettar, dardir; raxx;
English: With continued long-term treatment, 28.6% of the patients were free of myoclonic seizures for at least 6 months and 21.0 % were free of myoclonic seizures for at least 1 year.
Maltese: tal-pazjenti ma kellhomx aċċessjonjiet mijokloniċi għal mill-inqas 6 xhur u 21.0 % ma kellhomx aċċessjonjiet mijokloniċi għal mill-inqas sena.
English: (1) An oral solution should be used for doses under 250 mg, for doses not multiple of 250 mg when dosing recommendation is not achievable by taking multiple tablets and for patients unable to swallow tablets.
Maltese: (1) Soluzzjoni orali għandha tintuża għal dożi inqas minn 250mg, għal dożi mhux multiplikati ta' 250 mg meta rakkomandazzjoni tad-dożaġġ ma jkunx jista' jinkiseb billi tieħu pilloli multiplikati u għallpazjenti li ma jistgħux jibilgħu pilloli.
English: EU/1/11/713/011 20 tablets EU/1/11/713/012 30 tablets EU/1/11/713/013 50 tablets EU/1/11/713/014 60 tablets EU/1/11/713/015 100 tablets EU/1/11/713/016 120 tablets EU/1/11/713/017 200 tablets
Maltese: EU/1/11/713/011 20 pilloli EU/1/11/713/012 30 pilloli EU/1/11/713/013 50 pilloli EU/1/11/713/014 60 pilloli EU/1/11/713/015 100 pilloli EU/1/11/713/016 120 pilloli EU/1/11/713/017 200 pilloli
English: EU/1/11/713/031 20 tablets EU/1/11/713/032 30 tablets EU/1/11/713/033 50 tablets EU/1/11/713/034 60 tablets EU/1/11/713/035 100 tablets EU/1/11/713/036 120 tablets EU/1/11/713/037 200 tablets
Maltese: EU/1/11/713/031 20 pilloli EU/1/11/713/032 30 pilloli EU/1/11/713/033 50 pilloli EU/1/11/713/034 60 pilloli EU/1/11/713/035 100 pilloli EU/1/11/713/036 120 pilloli EU/1/11/713/037 200 pilloli
English: The patients were randomized to carbamazepine CR 400--1,200 mg/day or levetiracetam 1,000--3,000 mg/day, the duration of the treatment was up to 121 weeks depending on the response.
Maltese: Il-pazjenti kienu maqsuma mingħajr ma ġew magħżula biex jieħdu jew carbamazepine CR 400-1,200 mg/ġurnata jew levetiracetam 1,000-3,000 mg/ġurnata, b'trattament li dam sa 121 ġimgħa skond kemm kien ir-rispons.
English: 250 to 500 mg twice daily
Maltese: 250 sa 500 mg darbtejn kuljum 500 sa 1,000 mg darba kuljum
English: Perforated unit dose blisters: EU/1/11/713/041 60 x 1 tablets
Maltese: EU/1/11/713/041 60 x 1 pilloli
English: Levetiracetam and related analogs show a rank order of affinity for binding to the synaptic vesicle protein 2A which correlates with the potency of their anti-seizure protection in the mouse audiogenic model of epilepsy.
Maltese: Dan it-tagħrif jissuġġerixxi li l-interazzjoni bejn levtiracetam u l-proteina talbużżieqa tas-sinapsi 2A donnhom jikkontribwixxu għall-mekkaniżmu t'azzjoni kontra l-epilessija tal-prodott mediċinali.
English: Convulsion, balance disorder, dizziness, lethargy, tremor
Maltese: Uġigħ fl-addomenu, dijarreja, dispepsja, rimettar, dardir
English: Monotherapy for adults and adolescents from 16 years of age The recommended starting dose is 250 mg twice daily which should be increased to an initial therapeutic dose of 500 mg twice daily after two weeks.
Maltese: Monoterapija għal adulti u adoloxxenti minn 16-il sena ‘l fuq Id-doża rikkmandata tal-bidu hi ta' 250 mg darbtejn kuljum li għandha tiżdied għal doża terapewtika inizjal i ta' 500 mg darbtejn kuljum wara ġimgħatejn.
English: At 3,600 mg/kg/day, in only one of the 2 EFD studies, there was a slight decrease in foetal weight associated with a marginal increase in skeletal variations/minor anomalies.
Maltese: B' 3,600 mg/kg/ġurnata, f'studju wieħed miż-żewġt studji EFD, kien hemm tnaqqis żgħir fil-piz talfetu marbut ma' żieda marġinali f'varjazzjonijiet skeletali/ abnormalitajiet minuri.
English: The possible side effects of an overdose of levetiracetam are sleepiness, agitation, aggression, decrease of alertness, inhibition of breathing and coma.
Maltese: Wara dożi eċċessivi ta' levetiracetam, ġew osservati effetti ta' ħedla, aġitazzjoni, aggressjoni, tnaqqis fil-livell ta' kuxjenza, livell baxx tar-rifless respiratorju, u koma.
English: One tablet of Levetiracetam Actavis 250 mg contains 250 mg of levetiracetam.
Maltese: Kull pillola ta' Levetiracetam Actavis 250 mg fiha 250 mg ta' levetiracetam.
English: Dose in infants (1 month to 23 months), children (2 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg:
Maltese: Dożaġġ fit-trabi ( xhar sa 23 xahar), fit-tfal (2 sa 11 -il sena) u addoloxxenti (12 sa 17 -il sena) li jiżnu inqas minn 50 kg:
English: As with all antiepileptic medicines, sudden discontinuation of levetiracetam should be avoided as this may lead to breakthrough seizures that could have serious consequences for the woman and the unborn child. Monotherapy should be preferred whenever possible because therapy with multiple antiepileptic medicines AEDs could be associated with a higher risk of congenital malformations than monotherapy, depending on the associated antiepileptics.
Maltese: Għandha tingħata preferenza lil monoterapija kull meta dan huwa possibbli għaliex terapija b'diversi mediċini kontra l-epilessija tista' tkun assoċjata ma' riskju ogħla ta' malformazzjonijiet konġenitali minn monoterapija, skont liema mediċini kontra l-epilessija jingħataw flimkien.
English: 3.5 to 10.5 mg/kg (0.035 to 0.105 ml/kg) twice daily
Maltese: 5 mg/kg (0.035 sa 0.105ml/kg) darbtejn kuljum
English: Each film-coated tablet contains 500 mg levetiracetam.
Maltese: Kull pillola miksija b'rita fiha 500 mg levetiracetam.
English: How to take Levetiracetam Actavis
Maltese: X'fih Levetiracetam Actavis
English: In paediatric patients (1 month to less than 4 years of age), levetiracetam efficacy was established in a double-blind, placebo-controlled study, which included 116 patients and had a treatment duration of 5 days.
Maltese: F'pazjenti pedjatriċi (t'eta` ta' xahar sa inqas minn 4 snin), l-effikaċja ta' levetiracetam kienet stabbilita f'studju kkontrollat mill-plaċebo u double-blind li inkludew 116-il pazjent u kellu tul ta'
English: Pack sizes:
Maltese: Tel.:
English: • amnesia (loss of memory), memory impairment (forgetfulness), abnormal coordination/ataxia
Maltese: amneżija (telf ta' memorja),impediment tal- memorja (tinsa), ko-ordinazzjoni abnormali/ataxja (impediment fil-movimenti ko-ordinati), paraesteżja (tingiż), disturbi fl attenzjoni (telf ta'konċentrazzjoni); diplopja (viżjoni dopplja), viżjoni mċajpra;
English: There have been isolated reports of decreased levetiracetam efficacy when the osmotic laxative macrogol has been concomitantly administered with oral levetiracetam.
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET RIGWARD LUŻU SIGUR U EFFETTIV TAL-PRODOTT MEDIĊINALI
English: Levetiracetam Actavis 1,000 mg film-coated tablets Oval, white, 19.0 x 10.0 mm marked with “L” on one side and “1000” on the other side.
Maltese: Levetiracetam Actavis 1,000 mg pilloli miksija b'rita huma ovali, bojod, 19.0
English: Severe
Maltese: Severa
English: End-stage renal disease patients undergoing dialysis (1)
Maltese: Pazjenti fl-aħħar stadji talmarda tal-kliewi li jagħmlu ddijaliżi (1)
English: Completed suicide, personality disorder, thinking abnormal, delirium
Maltese: ħsibijiet abnormali, delirju
English: The renal clearance of levetiracetam and ucb L057 is 0.6 and 4.2 ml/min/kg respectively indicating that levetiracetam is excreted by glomerular filtration with subsequent tubular reabsorption and that the primary metabolite is also excreted by active tubular secretion in addition to glomerular filtration.
Maltese: It-tneħħija ta' levetiracetam fit-tfal kienet 30 % iżjed minn dik f'adulti li jbatu mill-epilessija meta ġiet ikkonsidrata d-differenza fil-piż. Levetiracetam kien assorbit malajr f'tfal b'epilessija (4 sa 12 -il sena) wara li ingħataw doża orali repetuta (20 sa 60 mg/kg/day).
English: Abdominal pain, diarrhoea, dyspepsia, vomiting, nausea
Maltese: Aċċessjoni, mard talbilanċ, sturdament, telqa, rogħda
English: (5) Following dialysis, a 5 to 10 mg/kg (0.05 to 0.10 ml/kg) supplemental dose is recommended.
Maltese: Wara id-dijaliżi, hija rrikkmandata doża supplimentari ta' bejn 5 u 10 mg/kg (0.05 sa 0.10 ml/kg).
English: The CLcr in ml/min may be estimated from serum creatinine (mg/dl) determination, for adults and adolescents weighing 50 kg or more, using the following formula:
Maltese: Din ir-rata tista' tigi kkalkulata mill-livell ta' krejatinina fis-serum (mg/dl), għal adulti u addoloxenti ta' 50 kg jew aktar, billi tuża din il-formula: [140 -eta` (snin)] x piż (kg)
English: Rare: may affect up to 1 in 1,000 people
Maltese: Rari: jista' jaffettwa sa 1 f'1,000 persuna infezzjonijiet; tnaqqis fin-numru tat-tipi kollha ta' ċelloli tad-demm;
English: These data are supplemented with the use of levetiracetam in corresponding open-label extension studies, as well as post-marketing experience.
Maltese: Din id-dejta hija miżjudha b'użu ta' levetiracetam f' studji li jikkorrespondu ta' estenzjoni open-label, flimkien ma' esperjenza ta' wara t-tqegħid fis-suq.
English: Each tablet contains 250 mg levetiracetam.
Maltese: pilloli ta' 250 mg filgħaxija.
English: Ref. EMEA/554626/2009 EMEA/H/C/1025
Maltese: EMA/554626/2009 EMEA/H/C/1025
English: London, 24 September 2009 Doc.
Maltese: Londra, 24 ta' Settembru 2009 Dok. ta' Ref.
English: What is Ramvocid?
Maltese: X'inhu Ramvocid?
English: These include Staphylococcus aureus (including ‘methicillin-resistant' forms known as ‘MRSA') and Streptococcus pyogenes.
Maltese: Dawn jinkludu Staphylococcus aureus (inklużi forom ‘reżistenti għal methicillin' magħrufa bħala ‘MRSA') u Streptococcus pyogenes.
English: The active substance in Ramvocid, oritavancin, is an antibiotic that belongs to the group ‘lipoglycopeptides'.
Maltese: Is-sustanza attiva f'Ramvocid, oritavancin, huwa antibijotiku li jappartjeni għall-grupp tal‘lipoglikopeptidi'.
English: Patients were given either Ramvocid for seven days or vancomycin with or without cephalexin (other antibiotic medicines) for between 10 and 14 days.
Maltese: Pazjenti ngħataw jew Ramvocid għal sebgħat ijiem jew vancomycin bi jew mingħajr cephalexin (mediċini antibijotiċi oħra) għal bejn 10 u 14-il ġurnata.
English: On 20 August 2009, Targanta Netherlands B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Ramvocid, for the treatment of complicated skin and soft tissue infections caused by Gram-positive bacteria.
Maltese: Fl-20 ta' Awwissu 2000, Targanta Netherlands B.V. innotifikat uffiċjalment lill-Kumitat għallProdotti Mediċinali għall-Użu mill-Bniedem (CHMP) li tixtieq tirtira l-applikazzjoni tagħha għallawtorizzazzjoni għat-tqegħid fis-suq ta' Ramvocid, għat-trattament ta' infezzjonijiet kkumplikati talġilda u tat-tessuti rotob ikkawżati mill-batterji Gram-pożittivi.
English: How is Ramvocid expected to work?
Maltese: Għal xiex kien mistenni li jintuża Ramvocid?
English: The company presented results from one main study involving 1,267 patients with complicated skin and soft tissue infections.
Maltese: Il-kumpanija ppreżentat ir-riżultati ta' studju ewlieni li kien jinvolvi 1,267 pazjent b'infezzjonijiet ikkumplikati fil-ġilda u fit-tessut artab.
English: Questions and answers on the withdrawal of the marketing authorisation application for Ramvocid oritavancin
Maltese: Mistoqsija u tweġiba dwar l-irtirar tal-applikazzjoni għat-tqegħid fis-suq għal Ramvocid oritavancin
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Ramvocid could not have been approved for the treatment of complicated skin and soft tissue infections caused by Gram-positive bacteria.
Maltese: Skont l-analiżi tad-dejta u t-tweġiba tal-kumpanija għal-lista ta' mistoqsijiet tas-CHMP, fi żmien lirtirar, is-CHMP kellu xi tħassib u kellu opinjoni proviżorja li Ramvocid ma setax jiġi approvat għattrattament ta' infezzjonijiet ikkumplikati tal-ġilda u t-tessut artab ikkawwżati mill-batterji Grampożittivi.
English: Ramvocid is a powder to be made up into a solution for infusion (drip into a vein).
Maltese: Ramvocid huwa trab li jsir soluzzjoni għall-infużjoni (dripp fil-vina).
English: The CHMP was concerned that the company had not provided enough evidence to support the use of Ramvocid to treat complicated skin and soft tissue infections at the dose proposed, particularly in patients with MRSA.
Maltese: Is-CHMP kien imħasseb li l-kumpanija ma kinitx ipprovdiet biżżejjed evidenza għas-sostenn tal-użu ta' Ramvocid fit-trattament ta' infezzjonijiet ikkumplikati tal-ġilda u tat-tessut artab fid-doża proposta, partikularment fil-pazjenti b'MRSA.
English: The effects of Ramvocid were first tested in experimental models before being studied in humans.
Maltese: Għall-ewwel, l-effetti ta' Ramvocid ġew ittestjati f'mudelli sperimentali qabel ma ġew studjati fuq ilbniedem.
English: Based on the review of the initial documentation, the CHMP prepares a list of questions at day 120, which is sent to the company.
Maltese: Fuq il-bażi tar-reviżjoni tad-dokumentazzjoni inizjali, is-CHMP jħejji lista ta' mistoqsijiet fil-120 jum, li mbagħad tintbagħat lill-kumpanija.
English: Ramvocid was to be used when the infection was caused by a group of bacteria known as ‘Grampositive' bacteria.
Maltese: Ramvocid kellu jintuża meta l-infezzjoni kkawżata minn grupp ta' batterji magħrufa bħala batterji ‘Gram-pożittivi'.
English: The rapporteur and co-rapporteur appointed were: Dr Cornelia Ibrahim and Prof. Christian Friis, respectively.
Maltese: Ir-rapporteur u l-ko-rapporteur maħturin kienu: Dr Cornelia Ibrahim u Prof. Christian Friis, rispettivament.
English: CVMP revised guideline on the SPC for antimicrobial products (EMEA/CVMP/SAGAM/383441/2005)http://www.ema.europa.eu/pdfs/vet/sagam/38344105enfin.pdf
Maltese: http://www.ema.europa.eu/pdfs/vet/sagam/38344105enfin.pdf
English: Doxycycline is a tetracycline derivative with uses similar to those of tetracycline antibiotics.
Maltese: Doxycycline huwa derivat tat-tetraċiklin b'użu simili għal dak tal-antibijotiċi tetraċiklini.
English: Written explanations were provided by the applicants/marketing authorisation holders on 21 April 2009 and 16 September 2009.
Maltese: Spjegazzjonijiet bil-miktub ġew provduti millapplikanti/detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq fil-21 ta' April 2009 u fis-16 ta'Settembru
English: Opinion following an Article 35F F referral for all strengths of water soluble powders and oral solutions containing doxycycline hyclate indicated for use in poultry and intended for administration via drinking water EMA/190025/2010
Maltese: Opinjoni wara referenza skont l-Artikolu 35F F għall-qawwiet kollha tat-trab li jinħall flilma u soluzzjonijiet orali li fihom doxycycline hyclate indikat għall-użu fit-tjur u maħsub biex jingħata permezz tal-ilma tax-xorb EMA/434457/2010
English: and oral solutions containing doxycycline hyclate indicated for use in poultry and intended for administration via drinking water in order to amend the SPC, labelling and package leaflet to include appropriate standard prudent use statements in line with recommendations of the CVMP revised guideline on the SPC for antimicrobial products2 and to include additional information regarding the correct administration of the concerned products.
Maltese: varjazzjonijiet fl-awtorizzazzjonijiet għat-tqegħid fis-suq għall-qawwiet kollha ta' trab li jinħall fl-ilma u soluzzjonijiet orali li fihom doxycycline hyclate għall-użu fit-tjur u maħsubin biex jingħataw permezz tal-ilma tax-xorb sabiex jiġu emendati l-SPC, it-tikketta u l-fuljett ta' tagħrif sabiex jinkludu stqarrijiet standard xierqa dwar użu prudenti skont ir-rakkomandazzjonijiet tal-linja gwida tas-CVMP dwar l-SPC għal prodotti mikrobjali2 u sabiex jinkludu informazzjoni addizzjonali dwar l-għoti korrett tal-prodotti kkonċernati.