FrancophonIA/ELRC3.0 huggingface dataset:
English: Cholelithiasis Cholecystitis
Maltese: KLASSIFIKAZZJONI ĠENERALI
English: 1 ml solution for injection contains 6 mg liraglutide.
Maltese: 1 ml ta' soluzzjoni għall-injezzjoni fih 6 mg ta' liraglutide.
English: If pancreatitis is suspected, liraglutide should be discontinued; if acute pancreatitis is confirmed, liraglutide should not be restarted (see sections 4.8 and 5.1).
Maltese: Jekk ikun hemm suspett ta' pankreatite, liraglutide għandu jitwaqqaf; jekk tiġi kkonfermata pankreatite akuta, liraglutide m'għandux jerġa' jinbeda (taqsimiet 4.8 u 5.1).
English: The estimated hazard ratio was consistently below 1 for all 3 MACE components.
Maltese: L-istima tal-proporzjon ta' periklu kien konsistentament taħt il-1 għat-3 komponenti kollha tal-MACE.
English: 1all patients; 2previous OAD monotherapy; 3previous diet treated patients 5Victoza add-on to SGLT2i was investigated at all approved doses of SGLT2i 4the dosing of insulin glargine was open-labelled and was applied according to Guideline for titration of insulin glargine.
Maltese: Plaċebo *Superjorità (p<0.01) vs il-komparatur attiv; **Superjorità (p<0.0001) vs il-komparatur attiv; ***Superjorità (p<0.001) vs il-komparatur attiv, †Mhux inferjuri (p<0.0001) vs il-komparatur attiv 1il-pazjenti kollha; 2 monoterapija OAD preċedenti; 3pazjenti li qabel kienu ttrattati bid-dieta 5Victoza bħala żieda ma' SGLT2i ġie investigat f'kull doża approvata ta' SGLT2i 4id-dożaġġ tal-insulina glargine kien open-labelled u ġie mogħti skont il-Linja Gwida għall-aġġustament fid dożaġġ tal-insulina glargine.
English: Body weight loss was observed in both treatment arms (-4.3 kg with liraglutide and -3.7 kg with lixisenatide).
Maltese: 2%, p<0.0001).Tnaqqis fil-piż tal-ġisem ġie osservat fiżżewġ fergħat ta' trattament (-4.3 kg b'liraglutide u -3.7 kg b'lixisenatide).
English: Five double-blind, randomised, controlled clinical phase 3a adult trials were conducted to evaluate the effects of liraglutide on glycaemic control (Table 2).
Maltese: Saru ħames provi kliniċi double-blind, randomised, u kkontrollati ta' fażi 3a fl-adulti biex jevalwaw leffetti ta' liraglutide fuq il-kontroll gliċemiku (Tabella 2).
English: - Keep this leaflet.
Maltese: Sett sħiħ ta' analiżi
English: • Cardiovascular evaluation
Maltese: • Evalwazzjoni kardjovaskulari
English: Increased amylase* * From controlled phase 3b and 4 clinical trials only where they were measured.
Maltese: * Minn provi kliniċi kkontrollati ta' fażi 3b u 4, fejn ġew ikkalkulati biss.
English: Cardiac disorders
Maltese: Disturbi gastro intestinali
English: Improved first and second phase insulin secretion after 52 weeks treatment with liraglutide was demonstrated in a subset of patients with type 2 diabetes (n=29).
Maltese: Intwera titjib fis-sekrezzjoni tal-insulina fl-ewwel u fit-tieni fażi wara 52 ġimgħa ta' kura b' liraglutide f'sotto-grupp ta' pazjenti b'dijabete ta' tip 2 (n=29).
English: This is more likely to happen if you also take a sulfonylurea or insulin.
Maltese: tnaqqis fid-doża tas-sulfonylurea jew tal-insulina.
English: Overall, frequency, type and severity of adverse reactions in adolescents and children aged 10 years and above were comparable to that observed in the adult population.
Maltese: B'mod ġenerali, il-frekwenza, it-tip u s-severità tar-reazzjonijiet avversi fl-adolexxenti u fit-tfal ta' 10 snin u 'l fuq kienu simili għal dawk osservati fil-popolazzjoni adulta.
English: Data from clinical trials showed that liraglutide is associated with delayed gastric emptying.
Maltese: Data minn provi kliniċi wriet li liraglutide huwa assoċjat ma' dewmien fit-tbattil tal-istonku.
English: Liraglutide exposure was reduced in patients with renal impairment compared to individuals with normal renal function.
Maltese: L-espożizzjoni ta' liraglutide tnaqqset f'pazjenti b'indeboliment tal-kliewi meta mqabbel ma' individwi b'funzjoni normali tal-kliewi.
English: A clinically relevant interaction with active substances with poor solubility or with narrow therapeutic index such as warfarin cannot be excluded.
Maltese: Ma tistax tiġi eskluża interazzjoni klinikament rilevanti ma' sustanzi attivi b'solubilità baxxa jew b'indiċi terapewtiku żgħir bħal warfarin.
English: There is no therapeutic experience in patients with congestive heart failure New York Heart Association (NYHA) class IV, and liraglutide is therefore not recommended for use in these patients.
Maltese: M'hemm l-ebda esperjenza terapewtika f'pazjenti b'insuffiċjenza konġestiva tal-qalb ta' klassi IV skont il-klassifika tan-New York Heart Association (NYHA) u għalhekk liraglutide mhuwiex irrakkomandat għall-użu f'dawn il-pazjenti.
English: Liraglutide did not change the overall exposure of griseofulvin following administration of a single dose of griseofulvin 500 mg. Griseofulvin Cmax increased by 37% while median tmax did not change.
Maltese: Is-Cmax ta' griseofulvin żdied b'37%, filwaqt li t-tmax medjan ma nbidilx.
English: Renal impairment Renal failure acute
Maltese: Insuffiċjenza renali akuta
English: • as monotherapy when metformin is considered inappropriate due to intolerance or contraindications
Maltese: • bħala monoterapija meta metformin huwa kkonsidrat li mhuwiex adattat minħabba xi intolleranza
English: Gastrointestina l disorders
Maltese: Rimettar Dispepsja
English: This medicine contains less than 1 mmol sodium (23 mg) per dose.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: The safety profile of liraglutide in combination with premix insulin was overall comparable to that observed for placebo in combination with premix insulin (see section 4.8).
Maltese: Il-profil ta' sigurtà ta' liraglutide flimkien ma' insulina mħallta minn qabel kienet fil-parti l-kbira simili għal dak osservat għal plaċebo flimkien ma' insulina mħallta minn qabel (ara taqsima 4.8).
English: When Victoza is added to a sulfonylurea or insulin, a reduction in the dose of sulfonylurea or insulin should be considered to reduce the risk of hypoglycaemia (see section 4.4).
Maltese: Meta Victoza jiżdied ma' sulfonylurea jew insulina, għandu jiġi kkunsidrat tnaqqis fid-doża tas sulfonylurea jew tal-insulina biex jitnaqqas ir-riskju ta' ipogliċemija (ara taqsima 4.4).
English: There was no clinically relevant effect on the overall exposure of either ethinyloestradiol or levonorgestrel.
Maltese: Ma kien hemm l-ebda effett klinikament rilevanti fuq l-espożizzjoni totali kemm ta' ethinyloestradiol kif ukoll ta' levonorgestrel.
English: You can keep the pen for 1 month when stored at a temperature below 30˚C or in a refrigerator (2˚C8˚C), away from the freezer compartment.
Maltese: Tista' żżomm il-pinna għal xahar meta tinħażen f'temperatura taħt 30˚C jew fi friġġ (2˚C-8˚C), 'il bogħod mill-kompartiment tal-friża.
English: * human glucagon-like peptide-1 (GLP-1) analogue produced by recombinant DNA technology in Saccharomyces cerevisiae.
Maltese: Pinna mimlija għal-lest fiha 18 mg ta' liraglutide f'3 ml. * analogu ta' glucagon-like peptide-1 (GLP-1) uman magħmul minn teknoloġija tad-DNA rikombinanti f'Saccharomyces cerevisiae.
English: You may get hypoglycaemia (low blood sugar) when using Victoza together with a sulfonylurea or insulin, as sulfonylureas and insulin increase the risk of hypoglycaemia.
Maltese: Jista' jkollok ipogliċemija (livell baxx ta' zokkor fid-demm) meta tuża Victoza flimkien ma' xi sulfonylurea jew insulina għax is-sulfonylureas u l-insulina jżidu r-riskju ta' ipogliċemija.
English: Very few episodes (0.001 events/patient year) were observed with administration of liraglutide in combination with oral antidiabetics other than sulfonylureas.
Maltese: Ħlief mas-sulfonylureas, kienu ftit ħafna lepisodji (0.001 avvenimenti/pazjent fis-sena) li ġew osservati meta liraglutide ingħata flimkien mal antidijabetiċi orali.
English: Severe and persistent pain in the abdomen (stomach area) which might reach through to your back, as well as nausea and vomiting, as it could be a sign of an inflamed pancreas (pancreatitis).
Maltese: Uġigħ persistenti u sever fl-addome (fil-parti tal-istonku) li jista' jilħaq għal dahrek, kif ukoll dardir u rimettar, għax jista' jkun sinjal ta' infjammazzjoni fil-frixa (pankreatite).
English: The urine and faeces radioactivity was mainly excreted during the first 68 days, and corresponded to three minor metabolites, respectively.
Maltese: Ir-radjuattività tal-awrina u l-ippurgar tneħħiet primarjament matul l-ewwel 6-8 ijiem u kienet tikkorrispondi għal tliet metaboliti minuri, rispettivament.
English: Liraglutide did not change the overall exposure of paracetamol following a single dose of 1000 mg. Paracetamol Cmax was decreased by 31% and median tmax was delayed up to 15 min. No dose adjustment for concomitant use of paracetamol is required.
Maltese: Liraglutide ma bidilx l-espożizzjoni totali ta' paracetamol wara doża waħda ta' 1000 mg.
English: Vomiting Dyspepsia Abdominal pain upper
Maltese: ISTRUZZJONIJIET BIEX TUŻA L-PINNA VICTOZA
English: The full EPAR for Capecitabine Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This summary was last updated in 03-2012.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'03-2012.
English: Capecitabine Accord is a ‘hybrid generic medicine'.
Maltese: Capecitabine Accord huwa ‘medeċina ġenerika ibrida'.
English: 5-FU is an analogue of pyrimidine.
Maltese: 5-FU huwa analogu tal-pyrimidine.
English: It is available as tablets (150, 300 and 500 mg).
Maltese: Huwa disponibbli f'pilloli (150, 300 u 500 mg).
English: Pyrimidine is part of the genetic material of cells (DNA and RNA).
Maltese: Pyrimidine hija parti mill-materjal ġenetiku taċ-ċelloli (DNA u RNA).
English: EPAR summary for the public capecitabine
Maltese: Sommarju tal-EPAR għall-pubbliku capecitabine
English: This is a summary of the European public assessment report (EPAR) for Capecitabine Accord.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Capecitabine Accord.
English: In the body, 5-FU takes the place of pyrimidine and interferes with the enzymes involved in making new DNA.
Maltese: Fil-ġisem, 5-FU jieħu post il-pyrimidine u jfixkel l-enzimi involuti fil-formazzjoni ta' DNA ġdid.
English: Capecitabine Accord is a medicine that contains the active substance capecitabine.
Maltese: Capecitabine Accord huwa mediċina li fih is-sustanza attiva capecitabine.
English: Capecitabine Accord is taken twice a day at doses between 625 and 1,250 mg per square metre body surface area (calculated using the patient's height and weight).
Maltese: Capecitabine Accord jittieħed darbtejn kuljum f'dożi bejn 625 u 1,250 mg għal kull metru kwadru talwiċċ tal-ġisem (ikkalkulat permezz tat-tul u l-piż tal-pazjent).
English: While the reference medicine, Xeloda, is available as 150 and 500 mg tables, Capecitabine Accord is also available as 300 mg tablets.
Maltese: Filwaqt li l-mediċina ta' referenza, Xeloda, hija disponibbli f'pilloli ta' 150 u 500 mg, Capecitabine Accord huwa disponibbli wkoll f'pilloli ta' 300 mg.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Capecitabine Accord on 20 April 2012.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Capecitabine Accord f' 20 ta' April 2012
English: It is taken as tablets, while 5-FU normally needs to be injected.
Maltese: Huwa jittieħed f'għamla ta' pilloli, filwaqt li 5-FU normalment ikollu jiġi injettat.
English: Other information about Capecitabine Accord
Maltese: Informazzjoni oħra dwar Capecitabine Accord
English: The CHMP concluded that, in accordance with EU requirements, Capecitabine Accord has been shown to have comparable quality and to be bioequivalent to Xeloda.
Maltese: Is-CHMP kkonkluda li, f'konformità mar-rekwiżiti tal-UE, Capecitabine Accord wera li għandu kwalità komparabbli u li huwa bijoekwivalenti għal Xeloda.
English: The company provided data from studies to determine that it is bioequivalent to the reference medicine, Xeloda.
Maltese: Il-kumpannija pprovdiet dejta minn studji sabiex tiġi determinata l-bijoekwivalenza tiegħu għallmediċina ta' referenza, Xeloda.
English: The active substance in Capecitabine Accord, capecitabine, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells) that belongs to the group ‘anti-metabolites'.
Maltese: Is-sustanza attiva f'Capecitabine Accord, capecitabine, hija mediċina ċitotossika (mediċina li toqtol ċelloli li jkunu qegħdin jinqasmu, bħaċ-ċelloli tal-kanċer) li tifforma parti mill-grupp ta' ‘antimetaboliti'.
English: Capecitabine is a ‘prodrug' that is converted to 5-fluorouracil (5-FU) in the body, but more is converted in tumour cells than in normal tissues.
Maltese: Capecitabine hija ‘promediċina' li hija kkonvertita f' 5-fluorouracil (5-FU) fil-ġisem, iżda ammont akbar minnha huwa kkonvertit f'ċelloli tat-tumur milli f'tessuti normali.
English: Capecitabine Accord is an anticancer medicine.
Maltese: Capecitabine Accord huwa mediċina ta' kontra l-kanċer.
English: What is Capecitabine Accord?
Maltese: Kif jaħdem Capecitabine Accord?
English: Capecitabine Accord is used with other anticancer medicines, including a platinum-containing anticancer medicine such as cisplatin;
Maltese: • kanċer gastriku (tal-istonku) avvanzat. Capecitabine Accord jintuża flimkien ma' mediċini oħrajn ta' kontra l-kanċer, inkluża mediċina ta' kontra l-kanċer li fiha l-platinu bħal pereżempju cisplatin;
English: Because Capecitabine Accord is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Capecitabine Accord huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u rriskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: This means that it is similar to a ‘reference medicine' containing the same active substance, but available at a new strength in addition to existing strengths.
Maltese: Dan ifisser li hija simili għal ‘mediċina ta' referenza' li fiha l-istess sustanza attiva, iżda disponibbli f'qawwa ġdida minbarra l-qawwiet eżistenti.
English: • metastatic colorectal cancer (cancer of the large bowel that has spread to other parts of the body).
Maltese: • kanċer kolorettali metastatiku (kanċer tal-musrana l-kbira li jkun infirex għal partijiet oħra talġisem).
English: Capecitabine Accord tablets should be swallowed with water within the 30 minutes after a meal.
Maltese: Il-pilloli Capecitabine Accord għandhom jinbelgħu mal-ilma sa mhux aktar tard minn 30 minuta wara l-ikel.
English: Treatment is continued for six months after colon surgery.
Maltese: Il-kura titkompla għal sitt xhur wara l-kirurġija tal-kolon.
English: Why has Capecitabine Accord been approved?
Maltese: Għaliex ġie approvat Capecitabine Accord?
English: Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
Maltese: Żewġ mediċini huma bijoekwivalenti meta jipproduċu l-istess livelli ta' sustanza attiva fil-ġisem.
English: Capecitabine Accord should only be prescribed by a doctor who is qualified in the use of anticancer medicines.
Maltese: Capecitabine Accord għandu jingħata biss b'riċetta ta' tabib li jkun ikkwalifikat fl-użu ta' mediċini kontra l-kanċer.
English: Capecitabine Accord is used with docetaxel (another anticancer medicine) after treatment with anthracyclines (another type of anticancer medicine) has failed.
Maltese: wara li l-kura bl-antraċiklini (tip ieħor ta' mediċina kontra l-kanċer) ma tkunx irnexxiet.
English: The doctor will calculate the number of 150, 300 and 500 mg tablets the patient needs to take.
Maltese: It-tabib jikkalkula l-għadd ta' pilloli ta' 150, 300 u 500 mg li l-pazjent ikun jeħtieġ jieħu.
English: What are the benefits and risks of Capecitabine Accord?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Capecitabine Accord?
English: How is Capecitabine Accord used?
Maltese: Għalxiex jintuża Capecitabine Accord?
English: How has Capecitabine Accord been studied?
Maltese: Kif ġie studjat Capecitabine Accord?
English: Norway
Maltese: NO - In-Norveġja
English: Netherlands
Maltese: NL - L-Olanda
English: Bulgaria
Maltese: BG - Il-Bulgarija
English: Iceland
Maltese: IS - L-islanda
English: Ireland
Maltese: IE - L-Irlanda
English: Slovak Republic
Maltese: SK - Is-Slovakkja
English: Portugal
Maltese: PT - Il-Portugall
English: Poland
Maltese: PL - Il-Polonja
English: Romania
Maltese: RO - Ir-Rumanija
English: France
Maltese: FR - Franza
English: Finland
Maltese: FI - Il-Finlandja
English: Italy
Maltese: MEMBRI
English: Czech Republic
Maltese: CZ - Ir-Repubblika
English: Flutiform® 250/10 µg 250mcg/10mcg
Maltese: Flutiform® 250/10 µg
English: ANNEX I
Maltese: SE - L-Isvezja
English: 140 (2 x 70) tablets (multipack)
Maltese: 140 (2 x 70) pillola (pakkett multiplu)
English: MA (EU) number (Invented) name
Maltese: Numru tal-MA (UE)
English: Pharmaceutical Form
Maltese: Għamla farmaċewtika
English: Strength
Maltese: Qawwa
English: Immediate Packaging
Maltese: Daqs tal-pakkett
English: Active substance:
Maltese: U KWANTITATTIVA Sustanza Attiva:
English: Discussion
Maltese: Diskussjoni
English: 3991 RA Houten
Maltese: 3991 RA Houten The Netherlands
English: Pulmotil AC sol. ad us. vet.
Maltese: ad us. vet.
English: ATC vet code: QJ01FA91
Maltese: QJ01FA91
English: SPC harmonisation:
Maltese: Armonizzazzjoni tal-SPC:
English: PACKAGE SIZE 240 ml
Maltese: DAQS TAL-PAKKETT 240 ml
English: The Netherlands Eli Lilly Nederland B.V. Elanco Animal Health Grootslag 1-5
Maltese: Eli Lilly Nederland B.V. Elanco Animal Health Grootslag 1-5
English: 4.6 Adverse reactions (frequency and seriousness)
Maltese: 4.6 Effetti mhux mixtieqa (frekwenza u gravità)
English: Pharmacotherapeutic Group: antibacterials for systemic use, macrolides.
Maltese: Grupp Farmako-terapewtiku: antibatteriċi għal użu sistemiku, makrolidi.
English: 4.11 Withdrawal period(s)
Maltese: 4.11 Perjodu(i) ta' Rtirar
English: 6.2 Incompatibilities None known.
Maltese: .2 Inkompatibilitajiet
English: INDICATION(S)
Maltese: NUMRU(I)
English: Elanco Animal Health
Maltese: Départament Elanco Santé Animale
English: Propyl gallate
Maltese: Ilma ppurifikat
English: This antibacterial activity is predominantly against Gram-positive microorganism with activity against certain gram-negative ones and Mycoplasma of a bovine, porcine, ovine and avian origin.
Maltese: Din l-attività antibatterika hija l-aktar kontra mikrorganiżmi Gram-pożittivi b'attività kontra ċerti mikrorganiżmi gram-negattivi oħrajn u Mikoplażma ta' oriġini bovina, porċina, ovina u avjarja.
English: Excipients: Propyl gallate, Disodium edetate.
Maltese: Gallat tal-propil (propyl gallate), edetat disodiku (disodium edetate).
English: Luxembourg Eli Lilly Benelux N.V. Elanco Animal Health Rue del'Etuve 52-Bte 1Stoofstraat 52
Maltese: Il-Lussemburgu Eli Lilly Benelux N.V. Elanco Animal Health Rue del'Etuve 52-Bte 1Stoofstraat 52
English: Belgium Eli Lilly Benelux N.V. Elanco Animal Health Rue del'Etuve 52-Bte 1Stoofstraat 52
Maltese: Eli Lilly Benelux N.V. Elanco Animal Health Rue del'Etuve 52-Bte 1Stoofstraat 52
English: 5.1 Pharmacodynamic properties
Maltese: 5.1 Kwalitajiet farmakodinamiċi
English: Calves (non ruminant)
Maltese: Għoġiela (mhux ruminanti)
English: Pigs - 14 days
Maltese: Ħnieżer - 14-il jum
English: Cross-resistance between tilmicosin and other macrolides and lincomycin has been observed.
Maltese: Ġiet osservata kontroreżistenza bejn tilmikosina u makrolidi oħrajn u linkomiċina (lincomycin).
English: Personal protective equipment should be worn.
Maltese: Għandu jintlibes tagħmir ta' protezzjoni personali.
English: PHARMACEUTICAL PARTICULARS
Maltese: TAL-PRODOTTI MEDIĊINALI
English: For a full list of excipients, see section 6.1.
Maltese: Għal-lista sħiħa tal-ingredjenti mhux attivi, ara s-sezzjoni 6.1.
English: Tilmicosin (as phosphate) 250 mg/ml Excipients:
Maltese: Tilmikosina (tilmicosin, bħala fosfat) 250 mg/ml Sustanzi mhux attivi:
English: Whereas
Maltese: ISEM
English: MANUFACTURER'S BATCH NUMBER Lot
Maltese: NUMRU TAL-LOTT TAL-MANIFATTUR Lott
English: Eli Lilly Italia Elanco Animal Health Via A. Gramsci, 731-733 50019 Sesto Fiorentino Florence
Maltese: Gramsci, 731-733 50019 Sesto Fiorentino Florence
English: The Marketing Authorisation Holders submitted at the request of CVMP: - an exhaustive list of differences between the SPCs of the product authorized in the member states; - a proposal for a harmonised product information (SPC, labelling and package leaflet), taking into account the latest guidance; - the available relevant data substantiating such proposed harmonised product information.
Maltese: Id-Detenturi tal-Awtorizzazzjoni għat-Tqegħid fis-Suq issottomettew fuq talba tas-CVMP: - lista eżawrjenti tad-differenzi bejn l-SPCs tal-prodott awtorizzat fl-Istati Membri; - proposta għal informazzjoni armonizzata tal-prodott (SPC, tikkettar u fuljett ta' tagħrif), li tikkunsidra l-aħħar gwida; - id-dejta rilevanti disponibbli li tissostanzja tali informazzjoni armonizzata tal-prodott proposta.
English: 4.9 Amounts to be administered and administration route
Maltese: .9 Doża rakkomandata u l-metodu ta' amministrazzjoni
English: The Netherlands
Maltese: L-Olanda
English: Chickens (broilers) Pigs
Maltese: Tiġieġ (brojlers) Ħnieżer
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Maltese: 4.10 Doża eċċessiva (sintomi, proċeduri ta' emerġenza, antidoti) jekk ikun hemm bżonn
English: Disodium edetate.
Maltese: Edetat disodiku (disodium edetate).
English: 48 hours after the start of treatment, the tilmicosin concentrations in lung and alveolar tissue were 2.3 µg/g and 3.29 µg/g respectively.
Maltese: 48 siegħa wara l-bidu tal-kura, il-konċentrazzjonijiet ta' tilmikosina fittessut tal-pulmun u f'dak alveolari kienu 2.3 µg/g u 3.29 µg/g rispettivament.
English: Pigs: After oral administration of 200 mg tilmicosin/l drinking water, the average active substance concentrations detected in lung tissue, alveolar macrophages and bronchial epithelium 5 days after the start of treatment were 1.44 µg/ml, 3.8 µg/ml and 7.4 µg/g respectively.
Maltese: Wara amministrazzjoni orali ta' 200 mg tilmikosina/l ta' ilma tax-xorb, il-konċentrazzjonijiet tas-sustanza attiva li nstabu fit-tessut tal-pulmun, fil-makrofaġi alveolari u fl-epitelju bronkjali 5 ijiem wara l-bidu tal-kura kienu ta' 1.44 µg/ml, 3.8 µg/ml u 7.4 µg/g rispettivament.
English: Turkeys: After oral administration of 75 mg tilmicosin/l drinking water, the average active substance concentrations detected in lung tissue, air sac tissue and plasma 5 days after the start of treatment were 1.89 µg/ml, 3.71 µg/ml and 0.02 µg/g respectively.
Maltese: Dundjani: Wara amministrazzjoni orali ta' 75 mg tilmikosina/l ta' ilma tax-xorb, il-konċentrazzjonijiet medji tas-sustanza attiva li nstabu fit-tessut tal-pulmun, fit-tessut tal-borża tal-arja u fil-plażma 5 ijiem wara l-bidu tal-kura kienu 1.89 µg/ml, 3.71 µg/ml u 0.02 µg/g rispettivament.
English: 6.1 List of excipients Disodium edetate
Maltese: Edetat disodiku (disodium edetate)
English: Introduction
Maltese: LISTA
English: Phosphoric acid (for pH adjustment) Purified water
Maltese: Aċidu fosforiku (għall-aġġustament tal-pH)
English: The primary container is a polyethylene naphthalate amber coloured bottle containing 240 ml or 960 ml of Pulmotil AC, with a polypropylene screw top and polyethylene/aluminium/polyethylene terephthalate seal.
Maltese: Il-kontenitur primarju huwa flixkun kulur l-ambra tal-polyethylene naphthalate li fih 240 ml jew 960 ml ta' Pulmotil AC, b'tapp bil-kamin tal-polipropilene u siġill tal-polietilene/aluminju/polietilene tereftalat.
English: Pigs: 14 days Chickens: 12 days Turkeys: 19 days Calves: 42 days
Maltese: Ħnieżer: 14-il jum Tiġieġ: 12-il jum Dundjani: 19-il jum Għoġiela: 42 jum
English: SPECIAL STORAGE CONDITIONS Do not store above 30 °C.
Maltese: Taħżinx f'temperaturi ogħla minn 30˚ C.