FrancophonIA/ELRC3.0 huggingface dataset:
English: A meta-analysis of patients with moderate to severe Alzheimer's disease (MMSE total scores <20) from the six phase III, placebo-controlled, 6-month studies (including monotherapy studies and studies with patients on a stable dose of acetylcholinesterase inhibitors) showed that there was a statistically significant effect in favour of memantine treatment for the cognitive, global, and functional domains.
Maltese: III kkontrollati bi plaċebo li damu 6 xhur (inklużi studji b'monoterapija u studji b'pazjenti fuq doża stabbli ta' inibituri ta' acetylcholinesterase) uriet li kien hemm effett statistikament sinifikanti favur il-kura b'memantine fil-qasam ta' l-għarfien, globali u funzjonali.
English: In man, about 80% of the circulating memantine-related material is present as the parent compound.
Maltese: Fil-bniedem, madwar 80% tal-materjal li għandu x'jaqsam ma' memantine li jkun fiċ-ċirkulazzjoni jinsab bħala s-sustanza mhux mibdula.
English: Lactose (120 mg/film-coated tablet) and soya lecithin (0.195 mg/film-coated tablet).
Maltese: Lactose (120 mg/pillola miksija b'rita) u soya lecithin (0.195 mg//pillola miksija b'rita).
English: INFORMATION IN BRAILLE Memantine ratiopharm 20 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Memantine ratiopharm 20 mg
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/836/022
Maltese: EU/1/13/836/021 EU/1/13/836/022
English: Lactose (160 mg/film-coated tablet) and soya lecithin (0.26 mg/film-coated tablet).
Maltese: Lactose (160 mg/pillola miksija b'rita) u soya lecithin (0.26 mg/pillola miksija b'rita).
English: In most clinical trials, patients with recent myocardial infarction, uncompensated congestive heart failure (NYHA III-IV), or uncontrolled hypertension were excluded.
Maltese: Fil-parti l-kbira tal-provi kliniċi, pazjenti li ftit qabel kellhom infart mijokardijaku, insuffiċjenza konġestiva tal-qalb mhux kompensata (NYHA III-IV), jew pressjoni għolja mhux ikkontrollata kienu esklużi.
English: Dizziness Balance disorders Gait abnormal Seizures
Maltese: Sturdament Disturbi tal-bilanċ Mixja anormali Aċċessjonijiet
English: The maximum daily dose is 20 mg per day.
Maltese: Id-doża massima ta' kuljum hi ta' 20 mg kuljum.
English: When patients were identified with concurrent worsening in all three domains, results showed a statistically significant effect of memantine in preventing worsening, as twice as many placebo-treated patients as memantine-treated patients showed worsening in all three domains (21% vs. 11%, p<0.0001).
Maltese: Meta pazjenti dehru li marru għall-agħar fit-tlett oqsma, ir-riżultati urew effett statistikament sinifikanti ta' memantine biex jevita li jmorru għall-agħar, darbtejn aktar mill-pazjenti ikkurati bi plaċebo hekk kif pazjenti kkurati b'memantine marru għall-agħar fit-tlett oqsma (21% vs. 11%, p0.
English: Memantine ratiopharm 5 mg Memantine ratiopharm 10 mg Memantine ratiopharm 15 mg Memantine ratiopharm 20 mg film-coated tablets memantine hydrochloride
Maltese: Memantine ratiopharm 5 mg Memantine ratiopharm 10 mg Memantine ratiopharm 15 mg Memantine ratiopharm 20 mg pilloli miksija b'rita memantine hydrochloride
English: Concomitant use of N-methyl-D-aspartate (NMDA)-antagonists such as amantadine, ketamine or dextromethorphan should be avoided.
Maltese: Għandu jkun evitat l-użu fl-istess ħin ta' antagonisti-N-methyl-D-aspartate (NMDA) bħal amantadine, ketamine jew dextromethorphan.
English: Also, urine pH may be elevated by states of renal tubulary acidosis (RTA) or severe infections of the urinary tract with Proteus bacteria.
Maltese: Minbarra hekk, il-pH ta' l-awrina tista' titla minħabba każijiet ta' aċidożi tubulari renali (RTA) jew infezzjonijiet severi tal-passaġġ tal-awrina b'Proteus bacteria.
English: Memantine ratiopharm is available in packs of 10, 14, 21, 28, 30, 42, 56, 98 and 100 film-coated tablets.
Maltese: Memantine ratiopharm hu disponibbli f'pakketti ta' 10, 14, 21, 28, 30, 42, 56, 98 u 100 pillola miksija b'rita.
English: Lactose (40 mg/film-coated tablet) and soya lecithin (0.065 mg/film-coated tablet).
Maltese: Lactose (40 mg/pillola miksija b'rita) u soya lecithin (0.065 mg//pillola miksija b'rita).
English: INFORMATION IN BRAILLE Memantine ratiopharm 5 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Memantine ratiopharm 5 mg
English: Lactose (80 mg/film-coated tablet) and soya lecithin (0.13 mg/film-coated tablet).
Maltese: Lactose (80 mg/pillola miksija b'rita) u soya lecithin (0.13 mg/pillola miksija b'rita).
English: Other Anti-dementia drugs, ATC code: N06DX01.
Maltese: N06DX01.
English: In patients with mild or moderate hepatic impaired function (Child-Pugh A and Child-Pugh B), no dose adjustment is needed.
Maltese: F'pazjenti b'indeboliment epatiku ħafif jew moderat (Child-Pugh A u Child-Pugh B) m'hemmx bżonn ta' tibdil fid-doża.
English: 20 mg film-coated tablets
Maltese: 20 mg pilloli miksija b'rita
English: INFORMATION IN BRAILLE Memantine ratiopharm 10 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Memantine ratiopharm 10 mg
English: INFORMATION IN BRAILLE Memantine ratiopharm 15 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Memantine ratiopharm 15 mg
English: 15 mg tablet week 4 and beyond 20 mg tablets once a day
Maltese: pillola ta' 15 mg minn ġimgħa 4 'l quddiem pillola ta' 20 mg darba kuljum
English: HDPE bottles
Maltese: Fliexken tal-HDPE
English: Blister packs
Maltese: Pakketti bil-folji
English: ● other NMDA-antagonists at the same time should be avoided.
Maltese: • antagonisti oħra ta' NMDA fl-istess ħin għandu jkun evitat.
English: The 20 mg film-coated tablets are white to off-white, capsule shaped, biconvex tablets with a break score on one side and debossed with “20” on the other side.
Maltese: Il-pilloli miksija b'rita ta' 20 mg huma pilloli bojod sa bojod jagħtu fil-griż, b'forma ta' kapsula, bikonvessi, b'xaqq minn fejn tista' taqsamhom fuq naħa waħda u mnaqqxa b'“20” fuq in-naħa l-oħra.
English: From Week 4 on:
Maltese: It-3 ġimgħa:
English: The 15 mg film-coated tablets are white to off-white, capsule shaped, biconvex tablets plain on one side and debossed with “15” on the other side.
Maltese: Il-pilloli miksija b'rita ta' 15 mg huma sa bojod jagħtu fil-griż, pilloli bojod b'forma ta' kapsula, bikonvessi, li ma fihom xejn fuq naħa waħda u mnaqqxa bi “15” fuq in-naħa l-oħra.
English: NAME OF THE MEDICINAL PRODUCT Memantine ratiopharm 10 mg tablets memantine hydrochloride
Maltese: Memantine ratiopharm 10 mg pilloli memantine hydrochloride
English: Headache Fatigue 1 Hallucinations have mainly been observed in patients with severe Alzheimer's disease.
Maltese: 1 Alluċinazzjonijiet dehru l-aktar f'pazjenti bil-marda ta' Alzheimer severa.
English: Each film-coated tablet contains 5 mg memantine hydrochloride equivalent to 4.15 mg memantine.
Maltese: Kull pillola miksija b'rita fiha 5 mg memantine hydrochloride ekwivalenti għal 4.15 mg memantine.
English: In patients with severe renal impairment (creatinine clearance 5-29 ml/min) daily dose should be 10 mg per day.
Maltese: F'pazjenti b'indeboliment renali sever (tneħħija tal-kreatinina 5 - 29 ml/min) id-doża għandha tkun 10 mg kuljum.
English: Hypersensitivity to the active substance, peanut or soya or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva, karawett jew sojja jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1.
English: There is a possible relationship between this accumulation and the vacuolisation observed in lungs.
Maltese: Hemm relazzjoni possibbli bejn din l-akkumulazzjoni u l-vakwolizzazzjoni osservata filpulmun.
English: What Memantine ratiopharm contains - The active substance is memantine hydrochloride.
Maltese: X'fih Memantine ratiopharm - Is-sustanza attiva hi memantine hydrochloride.
English: NAME OF THE MEDICINAL PRODUCT Memantine ratiopharm 20 mg tablets memantine hydrochloride
Maltese: Memantine ratiopharm 20 mg pilloli memantine hydrochloride
English: LIST OF EXCIPIENTS Contains lactose and soya lecithin.
Maltese: TA' EĊĊIPJENTI Fih lactose u soya lecithin.
English: At a dose of memantine of 20 mg per day the CSF levels match the ki-value (ki = inhibition constant) of memantine, which is 0.5 μmol in human frontal cortex.
Maltese: B'doża ta' 20 mg memantine kuljum il-livelli ta' CSF qablu mal-valur-ki (ki = kostanti ta' limpediment) ta' memantine, li hija 0.5 µmol fil-kortiċi anterjuri tal-bniedem.
English: Each film-coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine.
Maltese: Kull pillola fiha 10 mg ta' memantine hydrochloride, ekwivalenti għal 8.31 mg ta' memantine.
English: Each film-coated tablet contains 15 mg memantine hydrochloride equivalent to 12.46 mg memantine.
Maltese: Kull pillola miksija b'rita fiha 15 mg memantine hydrochloride ekwivalenti għal 12.46 mg memantine.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Memantine ratiopharm 10 mg
Maltese: U KWANTITATTIVA Memantine ratiopharm 10 mg
English: Each film-coated tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg memantine.
Maltese: Kull pillola fiha 20 mg ta' memantine hydrochloride, ekwivalenti għal 16.62 mg ta' memantine.
English: The 10 mg film-coated tablets are white to off-white, capsule shaped, biconvex tablets with a break score on one side and debossed with “10” on the other side.
Maltese: Pilloli bojod sa bojod jagħtu fil-griż, b'forma ta' kapsula, bikonvessi b'xaqq minn fejn tista' taqsam fuq naħa waħda u mnaqqxa b'“10” fuq in-naħa l-oħra.
English: Each film-coated tablet contains 5 mg of memantine hydrochloride equivalent to 4.15 mg memantine.
Maltese: Kull pillola miksija b'rita fiha 5 mg ta' memantine hydrochloride, ekwivalenti għal 4.15 mg ta' memantine.
English: Alkalisation of urine may result from drastic changes in diet, e.g. from a carnivore to a vegetarian diet, or from the massive ingestion of alkalising gastric buffers.
Maltese: L-awrina tista' ssir alkalina minn bidliet drastiċi fid-dieta, eż. minn dieta li tinkludi l-laħam għal waħda veġetarjana, jew it-teħid ta' ammonti kbar ta' sustanzi newtralizzanti (buffers) gastriċi alkalini.
English: Relative large overdoses (200 mg and 105 mg/day for 3 days, respectively) have been associated with either only symptoms of tiredness, weakness and/or diarrhoea or no symptoms.
Maltese: Dożi eċċessivi relattivament għoljin (200 mg u 105 mg kuljum għal tlitt ijiem, rispettivament) kienu assoċjati ma' sintomi ta' għeja biss, dgħjufija u/jew dijarea, jew ma ebda sintomu.
English: From the fourth week on, the usual dose is two tablets once a day (1x 20 mg).
Maltese: Mir-4 ġimgħa 'l quddiem, id-doża li ġeneralment tingħata hija ta' żewġ pilloli darba kuljum (1x 20 mg).
English: Memantine ratiopharm 5 mg film-coated tablets Memantine ratiopharm 10 mg film-coated tablets Memantine ratiopharm 15 mg film-coated tablets Memantine ratiopharm 20 mg film-coated tablets memantine hydrochloride
Maltese: Memantine ratiopharm 5 mg pilloli miksijin b'rita Memantine ratiopharm 10 mg pilloli miksijin b'rita Memantine ratiopharm 15 mg pilloli miksijin b'rita Memantine ratiopharm 20 mg pilloli miksijin b'rita memantine hydrochloride
English: Each film-coated tablet contains 15 mg of memantine hydrochloride equivalent to 12.46 mg memantine.
Maltese: Kull pillola miksija b'rita fiha 15 mg ta' memantine hydrochloride, ekwivalenti għal 12.46 mg ta' memantine.
English: Venous thrombosis/thromboembolism
Maltese: Pressjoni għolja Trombożi fil-vini/tromboemboliżmu
English: If tolerated well after at least 7 days of treatment, the dose could be increased up to 20 mg/day according to standard titration scheme.
Maltese: Jekk tiġi ttollerata tajjeb wara mill-inqas sebat ijiem ta' kura, id-doża tista' tiżdied sa 20 mg kuljum skont skema ta' titrazzjoni standard.
English: one and a half 10 mg tablets week 4 and beyond two 10 mg tablets once a day
Maltese: pillola u nofs ta' 10 mg minn ġimgħa 4 'l quddiem żewġ pillolli ta' 10 mg darba kuljum
English: Women taking Memantine ratiopharm should not breast-feed.
Maltese: Kompli ħu Memantine ratiopharm sakemm tibqa' tikseb benefiċċju.
English: Marketing Authorisation Holder ratiopharm GmbH Graf-Arco-Straße 3
Maltese: Graf-Arco-Straße 3
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/836/023
Maltese: EU/1/13/836/016
English: Take one 10 mg tablet once a day (white to off-white, capsule shaped, biconvex, with a break score on one side and debossed with “10” on the other side) for 7 days.
Maltese: Ħu pillola miksija b'rita waħda ta' 10 mg darba kuljum (pillola bajda sa bajda tagħti fil-griż, b'forma ta' kapsula, bikonvessa, b'xaqq minn fejn tista' taqsam fuq naħa waħda u mnaqqxa b'“10” fuq in-naħa l-oħra) għal sebat ijiem.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Memantine ratiopharm 5 mg
Maltese: U KWANTITATTIVA Memantine ratiopharm 5 mg
English: White to off-white, capsule shaped, biconvex tablets with a break score on one side and debossed with “20” on the other side.
Maltese: Pilloli bojod sa bojod jagħtu fil-griż, b'forma ta' kapsula, bikonvessi b'xaqq minn fejn tista' taqsam fuq naħa waħda u mnaqqxa b'“20” fuq in-naħa l-oħra.
English: PHARMACEUTICAL FORM Film-coated tablet (tablet)
Maltese: Insuffiċjenza kardijaka u emboli tad-demm fil-vini (trombożi/tromboemboliżmu)
English: The patient received symptomatic treatment and plasmapheresis.
Maltese: Il-pazjent ingħata kura għas-sintomi u plażmafereżi.
English: Elevated liver function test Hepatitis
Maltese: Test tal-funzjoni tal-fwied għoli Epatite
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/836/012
Maltese: EU/1/13/836/015
English: Take one 20 mg tablet once day (white to off-white, capsule shaped, biconvex, with a break score on one side and debossed with “20” on the other side) for 7 days.
Maltese: Ħu pillola miksija b'rita waħda darba kuljum ta' 20 mg (pillola bajda sa bajda tagħti fil-griż, b'forma ta' kapsula, bikonvessa, b'xaqq minn fejn tista' taqsam fuq naħa waħda u mnaqqxa b'“20” fuq in-naħa l-oħra) għal sebat ijiem.
English: In a clinical study in young healthy subjects, no relevant effect of memantine on the pharmacokinetics of galantamine was observed.
Maltese: Fi studju kliniku li sar fuq pazjenti żgħażagħ b'saħħithom ma kienx hemm effett rilevanti ta' memantine fuq il-farmakokinetika ta' galantamine.
English: Concomitant administration of memantine with the antispasmodic agents, dantrolene or baclofen, can modify their effects and a dose adjustment may be necessary.
Maltese: Meta memantine jingħata flimkien ma' mediċini antispasmodiċi, dantolene jew baclofen, jista' jibdlilhom l-effetti tagħhom u jista' jkun hemm bżonn ta' bidla fid-doża.
English: Moderate to severe Alzheimer's disease usually causes impairment of driving performance and compromises the ability to use machinery.
Maltese: Il-marda ta' Alzheimer moderata għal severa normalment ma tħallix persuna ssuq tajjeb u l-ħila ta' l-użu ta' makkinarji tiġi kompromessa.
English: What Memantine ratiopharm looks like and contents of the pack White to off-white, capsule shaped, biconvex tablets with a break score on one side and debossed with “20” on the other side.
Maltese: Kif jidher Memantine ratiopharm u l-kontenut tal-pakkett Pilloli bojod sa bojod jagħtu fil-griż, forma ta' kapsula, bikonvessi, b'xaqq fuq naħa waħda minn fejn jistgħu jinqasmu u mnaqqxa b'“20” fuq in-naħa l-oħra.
English: What Memantine ratiopharm looks like and contents of the pack The 5 mg film-coated tablets are white to off-white, capsule shaped, biconvex tablets plain on one side and debossed with “5” on the other side.
Maltese: Kif jidher Memantine ratiopharm u l-kontenut tal-pakkett Pilloli bojod sa bojod jagħtu fil-griż, forma ta' kapsula, bikonvessi, b'xaqq fuq naħa waħda minn fejn jistgħu jinqasmu u mnaqqxa b'“10” fuq in-naħa l-oħra.
English: Drug hypersensitivity
Maltese: Psikoanalettiċi.
English: Pharmacotherapeutic group: Psychoanaleptics.
Maltese: • Infjammazzjoni tal-frixa, infjammazzjoni tal-fwied (epatite) u reazzjonijiet psikotiċi
English: In patients with mildly impaired renal function (creatinine clearance 50-80 ml/min) no dose adjustment is required.
Maltese: F'pazjenti b'funzjoni renali indebolita b'mod ħafif (tneħħija tal-kreatinina 50 - 80 ml/min) m'hemmx bżonn li tinbidel id-doża.
English: Administration
Maltese: MANIFATTURI
English: NAME OF THE MEDICINAL PRODUCT Memantine ratiopharm 5 mg film-coated tablets memantine hydrochloride
Maltese: Memantine ratiopharm 5 mg pilloli miksija b'rita memantine hydrochloride
English: In the most extreme case of overdose, the patient survived the oral intake of a total of 2000 mg memantine with effects on the central nervous system (coma for 10 days, and later diplopia and agitation).
Maltese: Fl-aktar każ estrem ta' doża eċċessiva, il-pazjent irnexxielu jibqa' ħaj meta ħa b'mod orali 2000 mg memantine b'effetti fuq is-sistema nervuża ċentrali (koma għal għaxart ijiem, u wara kellu diplopja u aġitazzjoni).
English: Strength
Maltese: Ippakkjar
English: EU (MA) number Invented name
Maltese: Numru tal-UE
English: Pharmaceutical form
Maltese: Qawwa Għamla Farmaċewtika
English: Active constituents %w/w:
Maltese: Komponenti attivi %w/w:
English: - Salmonellosis.
Maltese: - Salmonellożi.
English: Therapeutic indication:
Maltese: Indikazzjoni terapewtika:
English: Boehringer-Ingelheim Limited and Fort Dodge Animal Health responded separately.
Maltese: Boehringer-Ingelheim Limited u Fort Dodge Animal Health irrispondew separatament.
English: Iceland MTnr 880040
Maltese: L-Iżlanda MTnr 880040
English: Norbrook Laboratories Limited represented Scanvet Animal Health A/S.
Maltese: Norbrook Laboratories Limited irrappreżentaw lil Scanvet Animal Health A/S.
English: 1 g contains:
Maltese: 1 g fiha:
English: Netherlands NL 5055
Maltese: L-Olanda NL 5055
English: Netherlands NL 10437
Maltese: L-Olanda NL 10437
English: and Staphylococcus aureus.
Maltese: u Staphylococcus aureus.
English: Netherlands NL 10351
Maltese: L-Olanda NL 10351
English: For the submission of responses Schering-Plough Limited (UK) represented Schering-Plough NV/SA (Belgium), Schering-Plough A/S (Denmark), AST Beheer BV and AST Farma BV.
Maltese: Għas-sottomissjoni tat-tweġibiet, Schering-Plough Limited (tar-Renju Unit) irrappreżentaw lil Schering-Plough NV/SA (tal-Belġju), Schering-Plough A/S (tad-Danimarka), AST Beheer BV u AST Farma BV.
English: The daily dose is 0.09 g oral paste (5 mg trimetoprim + 25 mg sulfadiazin) per kg body weight.
Maltese: Id-doża ta' kuljum hija 0.09 g ta' pejst orali (5 mg trimetoprim + 25 mg sulfadiazin) għal kull kg ta' piż tal-ġisem.
English: - Infected wounds and cellulitis.
Maltese: - Feriti infettati u ċellulite.
English: 45g/500 kg horse alternatively 52g / 600kg (equal to 30 mg/kg of the combined active substances) 1-2 times a day.
Maltese: 45g/żiemel ta' 500 kg inkella 52g / 600kg (ugwali għal 30 mg/kg tal-komponenti attivi kombinati) minn darba għal darbtejn kuljum.
English: Schering Plough A/S (Denmark)
Maltese: Schering Plough A/S (IdDanimarka)
English: Trimethoprim 2 mg
Maltese: Sulfadiazine 10 mg
English: Each 4.31g dose contains:
Maltese: Kull doża ta' 4.31g fiha:
English: UK Vm 00201/4064
Maltese: Ir-Renju Unit Vm 00201/4064
English: Trimethoprim 66,7 mg Sulfadiazine 333,3 mg horses Respiratory tract infections associated with Streptococcus spp.
Maltese: Trimethoprim 66,7 mg Sulfadiazine 333,3 mg żwiemel Infezzjonijiet fl-apparat respiratorju assoċjati ma' Streptococcus spp.
English: - Antibacterial medication in surgical cases where asepsis cannot be guaranteed.
Maltese: - Medikazzjoni antibatterika f'każijiet kirurġiċi fejn l-asepsi ma tistax tkun garantita.
English: On 11 July 2007, France presented to the EMEA a referral of TRIBRISSEN ORAL PASTE FOR HORSES (including associated names) and authorised products for which this product served as a reference product, under Article 35 of Directive 2001/82/EC, as amended.
Maltese: Fil-11 ta' Lulju ta' l-2007, Franza ppreżentat lill-EMEA referenza ta' TRIBRISSEN ORAL PASTE FOR HORSES (flimkien ma' ismijiet assoċjati) u prodotti awtorizzati li għalihom dan il-prodott serva bħala prodott ta' referenza, skond l-Artikolu 35 tad-Direttiva 2001/82/KE, kif emendata.
English: (Belgium)
Maltese: Belġju)
English: Schering Plough N.V./S.A.
Maltese: Schering Plough N.V.
English: Kingdom Vm 02000/4098
Maltese: Ir-Renju Unit Vm 02000/4098
English: Sulfatrim Oral Doser
Maltese: AST Beheer BV Sulfatrim Oral Doser
English: Preferably, horses should be treated initially with an initial injection of Tribrissen Injection 48% or Trivetrin Injection followed by daily administration of Tribrissen Oral Paste.
Maltese: Preferibbilment, iż-żwiemel għandhom jiġu injettati b'injezzjoni inizjali ta' Tribrissen Injection 48% jew b'Trivetrin Injection segwiti minn amministrazzjoni ta' kuljum ta' Tribrissen Oral Paste.
English: Kingdom Vm 00015/4028
Maltese: Ir-Renju Unit Vm 00015/4028
English: ScheringPlough Limited (UK)
Maltese: Schering-Plough Limited (ir-Renju Unit)
English: ScheringPlough A/S (Denmark)
Maltese: Schering-Plough A/S (IdDanimarka)
English: The marketing authorisations for Tribrissen (Denmark), Tribrissen vet oraalipasta (Finland), Tribrissen vet Oralpasta til hest (Norway) were withdrawn during the referral procedure at the request of the marketing authorisation holder.
Maltese: L-awtorizzazzjonijiet għat-tqegħid fis-suq għal Tribrissen (tad-Danimarka), Tribrissen vet oraalipasta (tal-Finlandja), Tribrissen vet Oralpasta til hest (tan-Norveġja) tneħħew matul il-proċedura ta' referenza fuq talba tad-detentur ta' l-awtorizzazzjoni għat-tqegħid fis-suq.
English: − Wound infections.
Maltese: − Infezzjonijiet minn feriti.
English: Next to an oral treatment during 5 days or until 2 days after the symptoms have disappeared, an intra-uterine treatment will be administered with 10 ml Tribrissen 48%, diluted in an isotonic solution of 100 ml during 3 days.
Maltese: Wara trattament orali matul 5 ijiem jew wara li jkunu għaddew jumejn mingħajr sintomi, jingħata trattament flutru b'10 ml Tribrissen 48%, maħlul f'soluzzjoni isotonika ta' 100 ml matul 3 ijiem.
English: Since the procedure concerns a range of products, the assessment has been limited to specific parts of the authorisations in accordance with Article 35(2) of Directive 2001/82/EC, as amended.
Maltese: Billi l-proċedura għandha x'taqsam ma' varjetà ta' prodotti, il-valutazzjoni kienet limitata għal partijiet speċifiċi ta' l-awtorizzazzjonijiet skond l-Artikolu 35(2) tad-Direttiva 2001/82/KE, kif emendata.
English: Each 45 g syringe contains:
Maltese: Kull siringa ta' 45 g fiha:
English: For the treatment of Salmonellosis, it is necessary to administer a double dose at 60 mg/kg/day.
Maltese: Doża rrakkomandata salmonellożi, jeħtieġ li tingħata doża doppja, jiġifieri, 60 mg/kg kuljum.
English: Trimethoprim 5.8 %w/w Sulfadiazine 28.83 %w/w horses Norodine Equine Paste is indicated in the treatment of bacterial infections In horses caused by sensitive microorganisms including: - Escherichia coli - Staphylococcus spp.
Maltese: .8 %piż/piż Sulfadiazine 28.83 %w/w żwiemel Norodine Equine Paste huwa indikat fit-trattament ta' infezzjonijiet batteriċi fiż-żwiemel ikkawżati minn mikrorganiżmi sensittivi fosthom: - Escherichia coli - Staphylococcus spp.
English: Belgium 282IS20F7
Maltese: Il-Belġju 282IS20F7 Schering Plough N.V./S.A. (Il
English: Member State / Marketing Authorisation Number
Maltese: Stat Membru / Numru ta' l-Awtorizzazzjoni tal
English: 2.3 Periodic Safety Update Reports
Maltese: 2.3 Rapporti Perjodiċi ta' Aġġornamenti dwar is-Sigurtà
English: Trimethoprim 58 mg/g Sulfadiazine 288,3 mg/g horses Infections in horses caused by micro-organisms sensitive to trimethoprim + sulphonamide
Maltese: Trimethoprim 58 mg/g Sulfadiazine 288,3 mg/g żwiemel Infezzjonijiet fiż-żwiemel ikkawżati minn mikrorganiżmi sensittivi għal trimethoprim + sulphonamide
English: The equivalent of one syringe is to treat 50 kg of body weight, from 50 kg to 500 kg.
Maltese: L-ekwivalenti ta' siringa waħda għandu jittratta 50 kg ta' piż tal-ġisem, minn 50 kg sa 500 kg.
English: Trimethoprim 58,00 mg, sulfadiazine 288,30 mg horses Infections in horses caused by micro-organisms sensitive to trimethoprim + sulphonamide
Maltese: Trimethoprim 58,00 mg, sulfadiazine 288,30 mg żwiemel Infezzjonijiet fiż-żwiemel ikkawżati minn mikrorganiżmi sensittivi għal trimethoprim + sulphonamide
English: Per 30 mg paste:
Maltese: Għal kull 30 mg ta' pejst: