FrancophonIA/ELRC3.0 huggingface dataset:
English: Regarding treatment of interdigital necrobacillosis in cattle, the in vitro studies demonstrated that the MIC values (MIC50 <0.25-0.5 µg/ml) of most major pathogens strains causing interdigital necrobacillosis in cattle, with the exception of treponeme infections, can be reached in the subcutaneous fat after a single subcutaneous injection with tilmicosin at a dose of 10 mg/kg body weight.
Maltese: Rigward il-kura ta' nekrobaċillosi interdiġitali fl-ifrat, l-istudji in vitro wrew li l-valuri tal-MIC (MIC50 <0.25-0.5 µg/ml) tal-biċċa l-kbira tar-razez ewlenin ta' patoġeni li jikkawżaw in-nekrobaċillosi interdiġitali fl-ifrat, bl-eċċezzjoni tal-infezzjonijiet bi treponeme, jistgħu jintlaħqu fix-xaħam ta' taħt il-ġilda wara injezzjoni waħda taħt il-ġilda b'tilmicosin f'doża ta' 10 mg/kg tal-piż tal-ġisem.
English: The clinical studies used naturally infected cattle with interdigital necrobacillosis without a bacteriological diagnosis.
Maltese: L-istudji kliniċi użaw ifrat infettati b'mod naturali bin-nekrobaċillosi interdiġitali mingħajr dijanjosi batterjoloġika.
English: In cattle subcutaneous injections of 10, 30 and 50 mg/kg body weight, repeated three times with a 72 hours interval, did not cause death.
Maltese: Fil-baqar injezzjonijiet taħt il-ġilda ta' 10, 30 u 50 mg/kg ta' piż tal-ġisem, ripetuti tliet darbiet b'intervall ta' 72 siegħa, ma kkawżawx il-mewt.
English: The half-life following subcutaneous injection in cattle is 2-3 days.
Maltese: Il-half-life wara injezzjoni taħt il-ġilda fil-baqar hi ta' 2-3 ijiem.
English: Numerous studies revealed that 10 mg tilmicosin/kg body weight is effective against respiratory disease due to M. haemolytica and P. multocida in cattle and sheep.
Maltese: Bosta studji wrew li 10 mg tilmicosin/kg tal-piż tal-ġisem huwa effettiv kontra mard respiratorju kkawżat mill-M. haemolytica u l-P. multocida fl-ifrat u n-nagħaġ.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One ml contains:
Maltese: 1 ml fih:
English: Cattle, sheep rabbit
Maltese: Għal kura tal-annimali biss.
English: Belgium ELI LILLY BENELUX N.V. Division Elanco Animal Health
Maltese: ELI LILLY BENELUX N.V.
English: Treatment of interdigital necrobacillosis.
Maltese: Kura ta' nekrobaċillożi interdiġitali.
English: Sheep weighing 40 kg were more resistant and survived a subcutaneous dose of 150 mg/kg body weight, showing ataxia and lethargy.
Maltese: Nagħaġ li jiżnu 40 kg kienu aktar reżistenti u ssopravivew doża taħt il-ġilda ta' 150 mg/kg tal-piż tal-ġisem, filwaqt li wrew atassja u letarġija.
English: Cattle, sheep
Maltese: Baqar, nagħaġ, fniek
English: NOTE TO THE PHYSICIAN
Maltese: ANNESS I KARATTERISTIĊI
English: The MIC90 data from recently isolated European strains should be included in SPC section 5.1 Pharmacodynamic properties.
Maltese: Id-dejta dwar il-MIC90 mir-razez Ewropej iżolati dan l-aħħar għandha tiġi inkluża f'sezzjoni 5.1 tal-SPC ‘Kwalitajiet farmakodinamiċi'.
English: Do not administer intramuscularly.
Maltese: Ilma għall-injezzjonijiet
English: Sometimes (1 in 12) a pain reaction was seen after subcutaneous injection of tilmicosin.
Maltese: Xi drabi (1 minn 12) kienet osservata reazzjoni ta' wġigħ wara injezzjoni ta' tilmicosin taħt il-ġilda.
English: Staphylococcus aureus was not isolated in any preclinical study or clinical trial.
Maltese: L-iStaphylococcus aureus ma kien iżolat fl-ebda prova preklinika jew klinika.
English: Deaths of cattle have been observed following a single intravenous dose of 5 mg/kg body weight, and following the subcutaneous injection of doses of 150 mg/kg body weight at 72 hour intervals.
Maltese: Imwiet ta' baqar ġew osservati wara doża waħda ta' 5 mg/kg ta' piż tal-ġisem ġol-vini, u wara linjezzjoni ta' dożi ta' 150 mg/kg ta' piż tal-ġisem taħt il-ġilda f'intervalli ta' 72 siegħa.
English: Avoid introduction of contamination into vial during use.
Maltese: Evita l-introduzzjoni ta' kontaminazzjoni ġol-kunjett waqt l-użu.
English: Do not treat lamb weighing less than 15 kg, since there is a risk of overdosage toxicity.
Maltese: Tagħtix lil ħrief li jiżnu inqas minn 15 kg billi hemm riskju ta' tossiċità minn doża eċċessiva.
English: In pigs, tilmicosin-induced lethality is potentiated by adrenalin.
Maltese: Fil-qżieqeż, letalità indotta minn tilmicosin tiġi msaħħa minn adrenalin.
English: Do not administer to lambs weighing less than 15 kg.
Maltese: Tagħtix lil ħrief li jiżnu inqas minn 15 kg.
English: Therefore the following warning sentences should be added in SPC section 4.11 Withdrawal period(s): (i) “If the product is administered to cows during the dry period (in accordance with section 4.7 of the SPC), milk should not be used for human consumption until 36 days after calving” and (ii) “If the product is administered to ewes during the dry period (in accordance with section 4.7 of the SPC), milk should not be used for human consumption until 18 days after lambing”.
Maltese: Għalhekk, ilKumitat ħass li s-sentenza ta' twissija li ġejja għandha tiġi miżjuda fis-sezzjoni 4.11 ‘Perjodu ta' tiżmim' tal-SPC: “Jekk il-prodott jingħata lin-nagħaġ matul il-perjodu li fih ma jiġix prodott il-ħalib (skont is-sezzjoni 4.7 tal-SPC), il-ħalib m'għandux jintuża għall-konsum mill-bniedem sa 18-il jum wara t-twelid tal-ħrief”.
English: Use only according to the benefit/risk assessment by the responsible veterinarian.
Maltese: Uża biss skont kif il-veterinarju responsabbli iqis il-beneficcju/riskju tal-prodott.
English: Regarding the Haemophilus (Actinobacillus) and Mycoplasma the Committee considered that the data to substantiate these two pathogens were insufficient and the MAHs agreed to remove Haemophilus (Actinobacillus) and Mycoplasma from the respiratory indication for cattle.
Maltese: Rigward il-Haemophilus (Actinobacillus) u l-Mycoplasma, il-Kumitat ħass li d-dejta sabiex tissostanzja dawn iż-żewġ patoġeni ma kinitx suffiċjenti u d-detenturi tal-awtorizzazzjoni għattqegħid fis-suq qablu li jneħħu l-Haemophilus (Actinobacillus) u l-Mycoplasma mill-indikazzjoni respiratorja għall-ifrat.
English: Pharmacokinetic data showed that tilmicosin was well distributed into the skin of sheep following subcutaneous injection at doses of 5 mg/kg body weight or 10 mg/kg body weight.
Maltese: Dejta farmakokinetika wriet li tilmicosin kien distribwit sewwa fil-ġilda tan-nagħaġ wara injezzjoni taħt il-ġilda f'dożi ta' 5 mg/kg tal-piż tal-ġisem jew 10 mg/kg tal-piż tal-ġisem.
English: The posology is 10 mg tilmicosin per kg body weight which corresponds to 1 ml of product per 30 kg body weight.
Maltese: Il-pożoloġija hija ta' 10 mg tilmicosin għal kull kg tal-piż tal-ġisem li jikkorrispondi għal 1 ml tal-prodott għal kull 30 kg talpiż tal-ġisem.
English: In a clinical field study including severe cases, treatment with tilmicosin at doses of either 5 mg/kg body weight or 10 mg/kg body weight resulted in a better cure rate as compared to the positive control group (amoxicillin 15 mg/kg body weight).
Maltese: Fi studju kliniku fuq il-post li kien jinkludi każijiet severi, il-kura b'tilmicosin f'dożi ta' 5 mg/kg tal-piż tal-ġisem jew ta' 10 mg/kg tal-piż tal-ġisem wasslet għal rata ta' kura aħjar meta mqabbel mal-grupp ta' kontroll pożittiv (amoxicillin 15 mg/kg tal-piż tal-ġisem).
English: The only lesion observed at autopsy was a necrosis of the myocardium in the group treated with 50 mg/kg body weight.
Maltese: L-unika leżjoni osservata fl-awtopsja kienet nekrożi tal-mijokardju fil-grupp ikkurat b'50 mg/kg ta' piż tal-ġisem.
English: Overall summary of the scientific evaluation of Micotil 300 mg/ml Injectie and its associated names (see annex I)
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika ta' Micotil 300 mg/ml Injectie u ismijiet assoċjati (ara Anness I)
English: Pigs given 4.5 to 5.6 mg tilmicosin/kg body weight intravenously with no epinephrine all survived.
Maltese: Qżieqeż mogħtija 4.5-5.6 mg ta' tilmicosin/kg ta' piż tal-ġisem ġol-vina bla ebda epinephrine kollha baqgħu ħajjin.
English: The absence of bacteriological cure demonstration in the clinical study should be stated in the SPC in section 4.4 Special warnings for each target species.
Maltese: In-nuqqas ta' turija ta' kura batterjoloġika flistudju kliniku għandu jiġi ddikjarat fl-SPC fis-sezzjoni 4.4 ‘Twissijiet speċjali għal kull speċi li għaliha hu indikat il-prodott'.
English: Neonatal calves Feedlot cattle
Maltese: Għoġġiela tat-twelid Baqar feedlot
English: Bacteriology from nasal swabs and lung tissues in these studies revealed M. haemolytica and P. multocida as major causes of pneumonia in calves.
Maltese: Il-batterjoloġija minn swabs nażali u tessuti tal-pulmun f'dawn l-istudji wriet l-M. haemolytica u l-P. multocida bħala kawżi prinċipali tal-pulmonite fl-għoġġiela.
English: • the CVMP considered the scope of the referral was the harmonisation of the summary of product characteristics, labelling and package leaflet;
Maltese: • is-CVMP ikkunsidra li l-kamp ta' applikazzjoni tar-riferiment kien l-armonizzazzjoni tal karatteristiċi tal-prodott fil-qosor, it-tikkettar u l-fuljett ta' tagħrif;
English: Treatment of bovine respiratory disease associated with Mannheimia haemolytica and Pasteurella multocida.
Maltese: TAL-PRODOTT MEDIĊINALI VETERINARJU Biex timtela mill-pajjiż partikolari.
English: Cattle:
Maltese: Tqala:
English: Regarding treatment of foot rot in sheep associated with Dichelobacter nodosus and Fusobacterium necrophorum, the in vitro studies demonstrated that the MIC values (MIC50 <0.25-0.5 µg/ml) of several bacteria, causing foot rot in sheep, indicate sensitivity for tilmicosin, however some strains were resistant.
Maltese: Rigward il-kura ta' tmermir tas-saqajn fin-nagħaġ assoċjat mad-Dichelobacter nodosus u lFusobacterium necrophorum, l-istudji in vitro wrew li l-valuri tal-MIC (MIC50 <0.25-0.5 µg/ml) ta' diversi batterji, li jikkawżaw it-tmermir tas-saqajn fin-nagħaġ, jindikaw sensittività għal tilmicosin, madankollu xi razez kienu reżistenti.
English: Micotil 300 Injectie is a solution for injection containing tilmicosin with a strength of 300 mg per ml.
Maltese: Micotil 300 Injectie huwa soluzzjoni għall-injezzjoni li fiha tilmicosin b'qawwa ta' 300 mg għal kull ml.
English: In Staphylococcus aureus challenge study, tilmicosin treatment (10 mg/kg body weight as a single subcutaneous injection) in ewes resulted in significantly less mortality, and more normal udders at day 10 although milk samples were still bacteriologically positive in treated animals at day 10.
Maltese: Fi studju ta' esponiment għall-iStaphylococcus aureus, il-kura b'tilmicosin (10 mg/kg tal-piż tal-ġisem bħala injezzjoni waħda taħt il-ġilda) wasslet għal mortalità konsiderevolment aktar baxxa, u glandoli mammarji aktar normali f'jum 10 għalkemm f'jum 10 il-kampjuni tal-ħalib xorta kienu għadhom batterjoloġikament pożittivi fl-annimali kkurati.
English: No data to support the term “control” were provided.
Maltese: Ma ġiet ipprovduta l-ebda dejta sabiex tappoġġa t-terminu “kontroll”.
English: Deaths occurred after one single intravenous injection of 5 mg/kg body weight in cattle and 7.5 mg/kg in sheep body weight.
Maltese: Imwiet seħħew wara injezzjoni waħda ġol-vini ta' 5 mg/kg ta' piż tal-ġisem fil-baqar u 7.5 mg/kg ta' piż tal-ġisem fin-nagħaġ.
English: CMC Harmonisation
Maltese: Armonizzazzjoni tas-CMC
English: Protium was included in the list of products for Summary of Product Characteristics (SPC) harmonisation, drawn up by the CMD(h), in accordance with Article 30(2) of Directive 2001/83/EC, as amended.
Maltese: Protium ġie inkluż fil-lista ta' prodotti għall-armonizzazzjoni tas-Sommarju tal-Karatteristiċi tal-Prodott (Summary of Product Characteristics - SPC), imfassal mis-CMD(h), skont l-Artikolu 30(2) tadDirettiva 2001/83/KE, kif emendata.
English: Section 4.2 - Posology and method of administration
Maltese: Sezzjoni 4.2 - Pożoloġija u metodu ta' amministrazzjoni
English: • Gastric and duodenal ulcer
Maltese: • Ulċera gastrika u duwodenali
English: Pantoprazole is not registered in Iceland and Malta.
Maltese: Pantoprazole mhuwiex irreġistrat fl-Iżlanda u f'Malta.
English: Section 5 - Pharmacological properties
Maltese: Sezzjoni 5 - Kwalitajiet farmakoloġiċi
English: The MAH submitted the module 2.3 for pantoprazole gastro-resistant tablets 20 and 40mg dated March 2009 and for pantoprazole powder for solution for injection dated December 2008 as well as the module 3 for pantoprazole gastro-resistant tablets 20 and 40mg and for pantoprazole powder for solution for injection dated April 2009.
Maltese: L-MAH issottometta il-modulu 2.3 għall-pilloli gastro-reżistenti ta' pantoprazole ta' 20 u 40mg datat Marzu 2009 u għat-trab ta' pantoprazole għal soluzzjoni għall-injezzjoni datat Diċembru 2008 kif ukoll il-modulu 3 għall-pilloli gastro-reżistenti ta' pantoprazole ta' 20 u 40mg u għat-trab ta' pantoprazole għal soluzzjoni għall-injezzjoni datat April 2009.
English: The inclusion of substances for which an involvement of CYP 3A4 or CYP 2C19 is known (such as carbamazepine, diazepam, glibenclamide, and nifedipine) is justified.
Maltese: L-inklużjoni ta' sustanzi li għalihom involviment ta' CYP 3A4 jew CYP 2C19 huwa magħruf (bħal pereżempju carbamazepine, diazepam, glibenclamide, u nifedipine) hija ġustifikata.
English: In addition the indication for H. Pylori eradication was simplified.
Maltese: Pylori ġiet issimplifikata.
English: • Symptomatic gastro-oesophageal reflux disease
Maltese: • Marda tar-rifluss gastro-esofagali sintomatika
English: • Eradication of Helicobacter pylori (H. pylori) in combination with appropriate antibiotic therapy in patients with H. pylori associated ulcers
Maltese: • Eradikazzjoni ta' Helicobacter pylori (H. pylori) flimkien ma' terapija bl-antibijotiċi approprjata f'pazjenti li għandhom ulċeri assoċjati ma' H. pylori
English: Section 4.9 - Overdose
Maltese: Sezzjoni 4.9 - Doża żejda
English: The CHMP adopted four harmonised therapeutic indications for the 40 mg gastro-resistant tablets.
Maltese: Is-CHMP adotta erba' indikazzjonijiet terapewtiċi armonizzati għall-pilloli gastro-reżistenti ta' 40 mg.
English: In conclusion, the CHMP adopted a harmonised text for section 4.4.
Maltese: Bħala konklużjoni, is-CHMP adotta test armonizzat għas-sezzjoni 4.4.
English: and even up to 320 mg/d, p.o. for years in single patients and 240 mg i.v.
Maltese: u anke sa 320 mg/d, p.o. għal bosta snin f'pazjenti individwali u 240 mg i.v. kienu tollerati sewwa.
English: Section 4.8 - Undesirable effects
Maltese: Sezzjoni 4.8 - Effetti mhux mextieqa
English: No marketing authorisations exist for Pantoprazole i.v., powder for solution for injection, in Bulgaria, Estonia, Latvia and Lithuania.
Maltese: Ma jeżistu l-ebda awtorizzazzjonijiet ta' tqegħid fis-suq għal Pantoprazole i.v., trab għal soluzzjoni għall-injezzjoni, fil-Bulgarija, fl-Estonja, fil-Latvja u fil-Litwanja.
English: Warnings related to prevention of gastroduodenal ulcers induced by NSAIDs were added.
Maltese: Twissijiet relatati mal-prevenzjoni ta' ulċeri gastroduwodenali kkawżati minn NSAIDs ġew miżjuda.
English: Similarly, the dossier for the Drug Product (gastro-resistant tablets) was harmonised.
Maltese: B'mod simili, l-inkartament għall-Prodott mediċinali (pilloli gastro-reżistenti) ġie armonizzat.
English: For duodenal ulcer, gastric ulcer, moderate and severe reflux oesophagitis, open-label studies have shown that pantoprazole 40 mg/d, p.o. is comparably effective and safe to pantoprazole 40 mg/d, i.v.
Maltese: Għal ulċera duwodenali, ulċera gastrika, esofaġite tar-rifluss moderata u severa, studji open-label urew li pantoprazole 40 mg/d, p.o. huwa effikaċi u sigur b'mod simili ma' pantoprazole 40 mg/d, i.v. filfejqan ta' esofaġite tar-rifluss, u li l-formulazzjonijiet ta' 40 mg pantoprazole p.o. u i.v. huma ekwivalenti fl-abbiltà tagħhom biex inaqqsu t-tnixxija tal-aċidu gastriku.
English: The MAH discussed the concomitant use of PPIs and clopidogrel, noting a trend towards a potential clinical interaction between PPIs and clopidogrel.
Maltese: L-MAH iddiskuta l-użu konkomitatanti ta' PPIs u clopidogrel, u nnota tendenza lejn interezzjoni klinika potenzjali bejn PPIs u clopidogrel.
English: • Reflux oesophagitis
Maltese: • Esofaġite tar-rifluss
English: For the pantoprazole 20 mg tablets, the CHMP noted the MAH proposal and adopted a harmonised text.
Maltese: Għall-pilloli ta' pantoprazole 20 mg, is-CHMP ħa nota tal-proposta tal-MAH u adotta test armonizzat.
English: Indications proposed for pantoprazole 40 mg i.v.
Maltese: Indkazzjonijiet proposti għal pantoprazole 40 mg i.v.:
English: The EWP-CVS concluded that there was no evidence supporting an interaction between pantoprazole and clopidogrel.
Maltese: L-EWPCVS ikkonkluda li ma kien hemm l-ebda evidenza li kienet tappoġġa interazzjoni bejn pantoprazole u clopidogrel.
English: Currently, triple therapy for seven days is still a valid and cost effective duration of treatment.
Maltese: Attwalment, it-terapija trippla għal sebat ijiem għada tul ta' trattament validu u kost-effettiv.
English: For the pantoprazole 40 mg tablet formulation, the CHMP noted the MAH proposal and adopted a harmonised text.
Maltese: Għall-formulazzjoni tal-pilloli ta' pantoprazole 40 mg, is-CHMP ħa nota tal-proposta tal-MAH u adotta test armonizzat.
English: monograph.
Maltese: IPPREŻENTATI
English: The dossier for the Drug Substance was harmonised and the CHMP noted the Ph. Eur.
Maltese: L-inkartament għas-Sustanza mediċinali ġie armonizzat u s-CHMP ħa nota tal-monografu Ph. Eur.
English: Currently, ulcers related to H. Pylori infection can be healed and prevented from recurring and in NSAIDs naïve patients with H. Pylori infection, pantoprazole is better than placebo in preventing peptic ulcer and upper gastrointestinal bleeding at six months.
Maltese: Attwalment, l-ulċeri relatati ma' infezzjoni ta' H. Pylori jistgħu jiġu mfejqa u jiġu impediti milli jerġgħu jfeġġu u fl-NSAIDs il-pazjenti naïve b'infezzjoni H. Pylori, pantoprazole huwa aħjar minn plaċebo għall-prevenzjoni tal-ulċeri peptiċi u fsad gastrointestinali fil-parti ta' fuq wara sitt xhur.
English: The specific mention of levonorgestrel and ethinyl oestradiol is justified as a general extrapolation to the whole group of oral contraceptives cannot be made.
Maltese: L-aċċenn speċifiku ta' levonorgestrel u ethinyl oestradiol huwa ġġustifikat għaliex estrapolazzjoni ġenerali għall-grupp sħiħ ta' kontraċettivi orali ma tistax issir.
English: Protium (pantoprazole) is a proton-pump inhibitor and is used to treat gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and injury of the food pipe (oesophagus).
Maltese: Protium (pantoprazole) huwa inibitur proton-pump u jintuża għat-trattament tal-marda tar-rifluss gastro-esofagali (gastroesophageal reflux disease - GERD), kundizzjoni fejn fluss lura ta' aċidu millistonku jikkawża ħruq ta' stonku u ħsara tal-pajp tal-ikel (l-esofagu).
English: The CHMP requested the input of the cardiovascular subgroup of the Efficacy Working Party (EWP-CVS) on this issue.
Maltese: Is-CHMP talab għad-dħul tas-sottogrupp kardjovaskulari talGrupp ta' Ħidma fuq l-Effikaċja (Efficacy Working Party - EWP-CVS) fuq din il-kwistjoni.
English: 20 mg gastro-resistant tablets
Maltese: Pilloli gastro-reżistenti ta' 20 mg
English: 40 mg gastro-resistant tablets
Maltese: Pilloli gastro-reżistenti ta' 40 mg
English: • Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions
Maltese: • Is-Sindrome ta' Zollinger-Ellison u kundizzjonijiet patoloġiċi ta' tnixxija żejda oħra
English: In particular, the interaction between atazanavir and others PPIs has been moved to Sections 4.4 and 4.5.
Maltese: B'mod partikolari, l-interazzjoni bejn atazanavir u PPIs oħra ġiet imressqa għas-Sezzjonijiet 4.4 u 4.5.
English: For the treatment of mild reflux disease and associated symptoms, several studies in adult patients with mild GERD have shown pantoprazole to be superior to placebo and ranitidine for the relief from the key GERD symptoms (heartburn, acid regurgitation, pain on swallowing) and healing of lesions and comparable to omeprazole and lansoprazole regarding the rate of symptom relief and healing in patients with mild GERD.
Maltese: Għat-trattament tal-marda tar-rifluss mhux severa u s-sintomi assoċjati, bosta studji f'pazjenti adulti b'GERD mhux severa wrew li pantoprazole huwa superjuri għal plaċebo u ranitidine għas-solliev tas-sintomi ewlenin tal-GERD (ħruq ta' stonku, regurġitazzjoni talaċidu, uġigħ meta wieħed jibla') u biex ifiequ l-feriti u jista' jitqabbel ma' omeprazole u lansoprazole regward ir-rata tas-soliev tas-sintomi u l-fejqan f'pazjenti b'GERD mhux severa.
English: The dose, schedule and duration of treatment are in line with the clinical practices.
Maltese: Iddoża, il-programm u t-tul tat-trattament huma konformi mal-prattiċi kliniċi.
English: The inclusion of the substances diclofenac, naproxen, and piroxicam is justified by their recommended co-prescription according to the NSAID related ulcer prevention indication and are mentioned separately.
Maltese: L-inklużjoni tas-sustanzi diclofenac, naproxen, u piroxicam hija ġustifikata permezz tal-ko-riċetta rakkomandata tagħhom skont l-indikazzjoni għallprevenzjoni tal-ulċeri relatati mal-NSAID u huma msemmija b'mod separat.
English: In all other EU countries and Norway pantoprazole 20 mg and 40 mg, gastro-resistant tablets, are registered.
Maltese: Fil-pajjiżi kollha l-oħra tal-UE u fin-Norveġja l-pilloli ta' pantoprazole 20 mg and 40 mg gastroreżistenti, huma rreġistrati.
English: The CHMP noted the MAH proposal and adopted a harmonised text for this section.
Maltese: Is-CHMP ħa nota tal-proposta tal-MAH u adotta test armonizzat għal din is-sezzjoni.
English: The CHMP noted the MAH proposal for this section.
Maltese: Is-CHMP ħa nota tal-proposta tal-MAH għal din is-sezzjoni.
English: The trials showed that pantoprazole is superior to ranitidine and comparable to omeprazole in ulcer healing while the meta-analysis suggests that first-line drug therapy for patients diagnosed with gastric ulcer should preferably be PPI, rather than a H2 antagonist.
Maltese: Il-provi wrew li pantoprazole huwa superjuri għal ranitidine u simili għal omeprazole għall-fejqan tal-ulċeri filwaqt li l-meta-analiżi tissuġġerixxi li t-terapija tal-bidu bil-mediċini għallpazjenti li ġew iddijanjostikati b'ulċera gastrika preferibbilment għandha tkun PPI, milli antagonist ta' H2.
English: In conclusion, based on the data provided by the MAH and the existing clinical evidence the CHMP adopted three harmonised therapeutic indications for the 20 mg gastro-resistant tablets.
Maltese: Bħala konklużjoni, fuq il-bażi tad-dejta pprovduta mill-MAH u l-evidenza klinika eżistenti s-CHMP adotta tliet indikazzjonijiet terapewtiċi armonizzati għall-pilloli gastro-reżistenti ta' 20 mg.
English: In particular, a description of the metabolic pathway which adequately reflects what is known about pantoprazole metabolism and a text on antibiotics interactions were adopted.
Maltese: B'mod partikolari, deskrizzjoni tal-passaġġ metaboliku li tirrifletti b'mod adegwat dak li huwa magħruf dwar il-metaboliżmu ta' pantoprazole u test dwar l-interazzjonijiet mal-antibijotiċi ġew adottati.
English: Pantoprazole 20 mg gastro-resistant tablets
Maltese: Pilloli gastro-reżistenti ta' pantoprazole ta' 20 mg
English: Since efficacy of low dose (20 mg) pantoprazole in triple therapy for the eradication of H. pylori has not been investigated, the use of Protium is considered contraindicated and the dose needed to eradicate this infection (40 mg twice daily) cannot be administrated to these patients.
Maltese: Peress li l-effikaċja ta' doża baxxa (20 mg) ta' pantoprazole fit-terapija trippla għalleradikazzjoni ta' H. pylori ma' ġietx investigata, l-użu ta' Protium huwa kkunsidrat kontraindikat u ddoża meħtieġa biex tiġi eradikata din l-infezzjoni (40 mg darbtejn kuljum) ma tistax tingħata lil dawn il-pazjenti.