FrancophonIA/ELRC3.0 huggingface dataset:
English: Immediately after injection of OPTISON, 10 ml of sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution for injection should be injected at a rate of 1 ml/s.
Maltese: Eżatt wara l-injezzjoni ta' OPTISON, 10 ml ta' sodium chloride 9 mg/ml (0.9%) soluzzjoni għall-injezzjoni jew glucose 50 mg/ml (5%) soluzzjoni għall-injezzjoni għandhom jiġu injettati b'rata ta' 1 ml/s.
English: Pharma-Cos Limited Pharma-Cos House, C. Portanier Street MT-Santa Venera SVR 1732 Tel: + 35 6 2144 1870
Maltese: MT-Santa Venera SVR 1732 Tel: + 35 6 2144 1870
English: Finished product after rubber stopper perforation: 30 minutes.
Maltese: Prodott lest wara t-titqib tat-tapp tal-gomma: 30 minuta.
English: The microspheres have a mean diameter of 2.5 - 4.5 microns and concentrations of 5-8 x 108 microspheres/ml.
Maltese: Il-mikrosferi għandhom dijametru medju ta' 2.5 - 4.5 mikroni u koncentrazzjonijiet ta' 5-8 x 108 mikrosferi/ml. Mikrosferi ta' dan il-limitu ta' daqs jikkontribwixxu għall-effett tal-kuntrast billi jiġġeneraw ekujiet ħafna iktar qawwija.
English: Do not freeze.
Maltese: Aħżen wieqaf fi friġġ.
English: Doses administered in one study were 0.2 ml above 25 kg body weight and 0.1ml under 25 kg, and in a second study 0.5ml above 20 kg body weight and 0.3 ml under 20 kg, by bolus peripheral intravenous injection followed by a saline flush.
Maltese: 2ml għal piż tal-ġisem itqal minn 25kg u 0.1ml għal piż tal-ġisem eħfef minn 25kg, u f'tieni studju 0.5ml piż tal-ġisem itqal minn 20kg u 0.3ml għal piż tal-ġisem eħfef minn 20kg, b'injezzjoni ġol-vini periferali bolus wara flaxxjatura salina.
English: GE International Inc. Konstitucijos pr. 7 LT-09308 Vilnius Tel.: + 370 68 723 753
Maltese: 7 LT-09308 Vilnius Tel.:
English: Nervous system disorders
Maltese: Disturbi respiratorji,
English: Information obtained from a preclinical study in rats with 125I-labelled albumin microspheres indicated that microspheres were rapidly cleared from the circulation, and radio-labelled microspheres, albumin shells and 125I were taken up primarily in the liver.
Maltese: Linformazzjoni li nkisbet fi studju prekliniku fil-firien b'mikrosferi tal-albumina ttikkettjati b'mikrosferi b'I125 indikat li l-mikrosferi malajr tneħħew miċ-ċirkolazzjoni, u l-mikrosferi radju-tikkettati, il-qxur tal-albumina u I125 ittieħdu l-iktar mill-fwied.
English: In pregnant rabbits exposed to daily doses of 2.5 ml/kg (approximately 15 x the maximum recommended clinical dose) during organogenesis, maternal toxicity and embryo-foetal toxicity including a slight to extreme dilation of ventricles in the brain of developing rabbit embryos was observed.
Maltese: Fi fniek tqal li ġew esposti għal dożi ta' 2.5 ml/kg kuljum (bejn wieħed u ieħor 15-il darba iktar mid-doża massima klinika rrakkomandata) waqt l-organoġenesi, ġew osservati tossiċità fl-omm, tossicità għall-embriju u l-fetu inkluż ftuħ minn ftit sa estrem tal-ventrikoli tal-moħħ tal-embriji tal-fniek li qed jiżviluppaw.
English: Package leaflet: Information for the user OPTISON 0.19 mg/ml dispersion for injection Perflutren-containing microspheres
Maltese: Informazzjoni għall-utent OPTISON 0.19 mg/ml dispersjoni għall-injezzjoni
English: Allergic type symptoms (e.g. anaphylactoid reaction or -shock, face oedema, urticaria)
Maltese: Disturbi fis-sistema immuni Sintomi tat-tip allerġiku (eż. reazzjoni anafilaktojde jew - xokk, edema fil-wiċċ,
English: A separate syringe should be used.
Maltese: Għandha tintuża siringa separata.
English: * Reactions for which no frequency rate can be provided due to lack of clinical trial data have been classified as “Not known”.
Maltese: * Reazzjonijiet li għalihom ma tista' tiġi pprovduta l-ebda rata ta' frekwenza minħabba nuqqas ta' dejta minn provi kliniċi ġew ikklassifikati bħala “Mhux magħrufa”.
English: The recommended dose is 0.5 ml - 3.0 ml per patient.
Maltese: 0.5 - 3.0 ml.
English: Via Galeno 36
Maltese: GE Healthcare S.r.l. Via Galeno 36
English: This study did not assess the effect of OPTISON on visualisation of cardiac or pulmonary structures.
Maltese: Dan l-istudju ma evalwax l-effett ta' OPTISON fuq il-viżwalizzazzjoni ta' strutturi kardijaċi jew pulmonari.
English: Uncommon side effects (affects 1 to 10 users in 1,000):
Maltese: Effetti sekondarji mhux komuni (jaffettwaw minn utent 1 sa 10 minn kull 1,000):
English: Šustekova 2
Maltese: ANNESS II
English: • Flushing (redness)
Maltese: • Fwawar (ħmura)
English: The approximate amount of perflutren gas in each ml of OPTISON is 0.19 mg - The other ingredients are human albumin, sodium chloride, N-acetyltryptophan, caprylic acid, sodium hydroxide and water for injections.
Maltese: - Is-sustanzi l-oħra huma albumina umana, sodium chloride, N-acetyltryptophan, caprylic acid,
English: SK-85104 Bratislava Tel.: + 421 2 5465 4841
Maltese: Tel.: + 421 2 5465 4841
English: • Tinnitus (noises in the ear)
Maltese: • Tinnite (żanżin fil-widnejn)
English: Posology
Maltese: MΑΡΟΥΣΙ
English: - Insert a 20 G plastic cannula in a large antecubital vein, preferably of the right arm.
Maltese: - Daħħal kannula tal-plastik 20 G f'vina kbira antekubitali, preferibbilment fid-driegħ tal-lemin.
English: OPTISON must not be mixed with other medicinal products.
Maltese: OPTISON m'għandux jitħallat ma' prodotti mediċinali oħrajn.
English: mmHg) and 11 with a normal PASP (≤35 mmHg; mean 29.3±4.6 mmHg; range 22.0-35.0 mmHg).
Maltese: medda 22.0-35.0 mmHg).
English: • Allergic type symptoms, for example, a severe allergic reaction or - shock (anaphylaxis), swelling of the face (face oedema), an itchy skin eruption (urticaria).
Maltese: • Sintomi tal-allerġija, pereżempju, reazzjoni allerġika severa jew xokk (anafilassi), nefħa talwiċċ (edema tal-wiċċ), fawra fuq il-ġilda bil-ħakk (urtikarja).
English: OPTISON is supplied as: 1 vial of 3 ml or 5 vials of 3 ml.
Maltese: OPTISON jiġi bħala: kunjett wieħed ta' 3 ml jew 5 kunjetti ta' 3 ml.
English: The approximate amount of perflutren gas in each ml of OPTISON is 0.19 mg.
Maltese: L-ammont ta' gass ta' perflutren f'kull ml ta' OPTISON huwa bejn wieħed u ieħor 0.19 mg.
English: Homogenous white suspension after resuspension.
Maltese: Hekk terġa' ssir mill-ġdid suspensjoni bajda omoġenja.
English: The reported adverse events following the use of OPTISON in Phase III human clinical studies have been mild to moderate with subsequent full recovery.
Maltese: L-avvenimenti avversi, li ġew irrapporati wara l-użu ta' OPTISON fi studji klinici ta' Fażi
English: No clinically important pulmonary haemodynamic, systemic haemodynamic, or ECG changes were observed.
Maltese: Ebda tibdil emodinamiku pulmonari, emodinamiku sistemiku jew fl-ECG klinikament importanti ma ġie osservat.
English: In the rabbit embryotoxicity study, a significant increase in the number of foetuses with dilated ventricles in the brain was observed (see section 4.6).
Maltese: Fi studju dwar it-tossiċità fl-embriji fil-fniek, ġie osservat tkattir sinifikanti tan-numri ta' feti li kellhom twessigħ fil-ventrikuli tal-moħħ (ara sezzjoni 4.6).
English: Currently available data are described in section 5.1 but no recommendation on a posology can be made.
Maltese: Dejta disponibbli hi deskritta fis-sezzjoni 5.1 imma l-ebda rakkomandazzjoni dwar il-pożoloġija ma tista' tingħata.
English: In clinical trials with OPTISON, undesirable effects were reported as adverse events with the following frequencies given in the table below: very common (≥1/10); common (≥1/100 to <1/10);
Maltese: Fi provi kliniċi b'OPTISON, l-effetti mhux mixtieqa ġew irrapportati bħala avvenimenti avversi bilfrekwenzi li ġejjin, mogħtija fit-Tabella t'hawn taħt: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna <1/10,000, mhux magħrufa (ma tistax tittieħed stima mid-dejta disponibbli).
English: spol.
Maltese: C.
English: Pulmonary hypertension with a systolic pulmonary artery pressure > 90 mm Hg.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis sezzjoni 6.1 Ipertensjoni pulmonarja bi pressjoni sistolika fl-arterji tal-pulmun > 90 mm Hg.
English: Rare severe allergic reactions (anaphylaxis) have been associated with the administration of human albumin products.
Maltese: F'każijiet rari, reazzjonijiet allerġiċi severi (anafilassi) ġew assoċjati mal-għoti ta' prodotti tal-albumina tal-bniedem.
English: Do not use OPTISON - if you are allergic (hypersensitive) to perflutren or any of the other ingredients of OPTISON (listed in section 6).
Maltese: Tużax OPTISON: - jekk inti allerġiku għal perflutren jew għal xi sustanza oħra ta' OPTISON (elenkati fis-sezzjoni 6).
English: The ultrasonic properties of microspheres containing perflutren are very different from that of soft tissue and will generate strong echoes.
Maltese: Il-karatteristiċi ultrasoniċi ta' mikrosferi li fihom perflutren huma differenti ħafna minn dawk ta' tessuti rotob u jiġġeneraw ekujiet qawwija.
English: Low mechanical index was used for ultrasound imaging.
Maltese: Għal immaġni b'ultrasound intuża indiċi mekkaniku baxx.
English: Eosinophilia
Maltese: Tfal u adolexxenti
English: Following intravenous injection of 0.21 to 0.33 ml/kg of OPTISON to healthy volunteers, the perflutren component of OPTISON was rapidly and nearly completely eliminated in less than 10 minutes with a dominating pulmonary elimination half-life of 1.3±0.7 minutes.
Maltese: Wara injezzjoni fil-vina ta' 0.21 sa 0.33 ml/kg ta' OPTISON lil voluntiera f'saħħithom, is-sustanza, perflutren ta' OPTISON tneħħiet malajr u kważi għal kollox f'inqas minn 10 minuti; b'half-life ta'
English: Ultrasound imaging must be performed during injection of OPTISON as optimal contrast effect is obtained immediately after administration.
Maltese: Għalhekk, għandha tingħata attenzjoni meta OPTISON jingħata lin-nisa li jkunu qed ireddgħu.
English: 10 000 Zagreb Tel: + 385 1 6170 280
Maltese: GE Healthcare d.o.o. Josipa Marohnića 1 10 000 Zagreb Tel: + 385 1 6170 280
English: Pregnancy
Maltese: Dispnea
English: Immediately after injection of OPTISON, 10 ml of sodium chloride 9 mg/ml solution for injection or glucose 50 mg/ml solution for injection should be injected at a rate of 1 ml/s to optimise the effect of the contrast agent.
Maltese: Eżatt wara l-injezzjoni ta' OPTISON, 10 ml ta' sodium chloride 0.9 mg/ml soluzzjoni għall-injezzjoni jew glucose 50 mg/ml soluzzjoni għall-injezzjoni għandhom ikunu injettati b'rata ta' 1 ml/s biex ittejjeb l-effett tas-sustanza tal-kuntrast.
English: Warning: Never use any other type of route but the open flow connection.
Maltese: Qatt tuża mod ieħor jekk mhux il-konnessjoni bi fluss liberu (open flow connection).
English: • Ventricular tachycardia (a series of rapid heartbeats)
Maltese: • Takikardja ventrikulari (serje ta' taħbit mgħaġġel tal-qalb) Frekwenza mhux magħrufa (effetti sekondarji fejn ma tistax tittieħed stima mid-data disponibbli):
English: Reporting of suspected adverse reactions
Maltese: KONDIZZJONIJIET U REKWIŻITI OĦRA TALAWTORIZZAZZJONI GĦAT-TQEGĦ ID FIS-SUQ
English: Warm sensation Chest pain
Maltese: Mikrosferi li fihom perflutren
English: OPTISON is an ultrasound contrast agent that helps to obtain clearer pictures (scan) of the heart during an echocardiography (a procedure where an image of the heart is obtained by using ultrasound).
Maltese: OPTISON jiġi injettat waqt eżami bl-ultrasawnd biex ittabib ikun jista' jevalwa l-funzjoni ta' qalbek.
English: 18 G needle before withdrawing the suspension into the injection syringe.
Maltese: sodium hydroxide u ilma għall-injezzjonijiet.
English: The disposition and elimination of the albumin microspheres have not been studied in humans.
Maltese: Id-dispożizzjoni u l-eliminazzjoni tal-mikrosferi tal-albumina ma ġewx studjati fil-bniedem.
English: BATCH NUMBER Lot 14.
Maltese: eliminazzjoni mill-pulmun ta' 1.
English: • Feeling sick (nausea)
Maltese: • Uġigħ fis-sider
English: Storage at room temperature (up to 25ºC) for 1 day is acceptable.
Maltese: Il-ħażna f'temperatura tal-kamra (sa 25ºC) għal ġurnata hija aċċettabbli.
English: OPTISON is a transpulmonary echocardiographic contrast agent for use in patients with suspected or established cardiovascular disease to provide opacification of cardiac chambers, enhance left ventricular endocardial border delineation with resulting improvement in wall motion visualisation.
Maltese: Jekk tingħata OPTISON aktar milli suppost Ma ġewx irrapportati effetti li jistgħu jkunu dovuti għal doża eċċessiva.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON NAME OF THE MEDICINAL PRODUCT OPTISON 0.19 mg/ml dispersion for injection Perflutren-containing microspheres STATEMENT OF ACTIVE SUBSTANCE(S) 1 ml contains: Perflutren-containing microspheres 5 - 8 x 108, with a mean diameter range of 2.5 - 4.5 µm, equivalent to 0.19 mg perflutren gas per ml.
Maltese: Għalhekk, id-doża ta' OPTISON trid tinbidel b'mod individwali, għalkemm studji kliniċi wrew li doża inizjali ta' 0.5 - 3.0 ml għal kull pazjent tista' tiġi rrakkomandata biex tiċċajpar in-naħa xellugija tal-qalb.
English: In the Phase I trial, healthy volunteers have received up to 44.0 ml of OPTISON and experienced no significant adverse events.
Maltese: Fil-prova ta' Fażi I, voluntiera f'saħħithom irċevew sa 44.0
English: It is strongly recommended that every time you receive a dose of OPTISON the name and batch number of the product are recorded in order to maintain a record of the batches used.
Maltese: Din id-doża tista' tiġi ripetuta jekk ikun hemm bżonn.
English: Milk: 108 hours (4.5 days).
Maltese: Ħalib: 108 sigħat (4.5 ijiem).
English: Post box 7123
Maltese: Id-Danimarka Merial Post box 7123
English: Merial Italia S.p.A. Viale Luigi Bodio, 37/b 20158 Milano Italy
Maltese: Viale Luigi Bodio, 37/b 20158 Milano Italy
English: Intervet Ireland Ltd. Magna Drive Magna Business Park Citywest Road Dublin 24
Maltese: Magna Drive Magna Business Park Citywest Road Dublin 24
English: Tissue samples were analysed using a HPLC-MS/MS analytical method.
Maltese: Il-kampjuni tat-tessut ġew analizzati bl-użu ta' metodu analitiku HPLC-MS/MS.
English: Norbrook Laboratories Limited
Maltese: Norbrook Laboratories Limited Station Works
English: Intervet UK Ltd Walton Manor Walton
Maltese: Ir-Renju Unit Intervet UK Ltd Walton Manor
English: 5831 AN Boxmeer
Maltese: Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
English: Sandringham House Harlow Business Park Harlow Essex CM19 5TG United Kingdom
Maltese: Sandringham House Harlow Business Park Harlow
English: When the products are administered at the recommended doses, the available data supported:
Maltese: Meta l-prodotti jingħataw bid-dożi rakkomandati, id-data disponibbli appoġġjat:
English: 3 CVMP note for guidance for the determination of withdrawal periods for milk (EMEA/CVMP/473/98) - link 4 CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95) - link
Maltese: 3 CVMP note for guidance for the determination of withdrawal periods for milk (EMEA/CVMP/473/98) - link 4 CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95) - link għandha tingħata kunsiderazzjoni lil residwi f'annimali ta' produzzjoni baxxa.
English: Belgium Intervet International B.V. Wim de Körverstraat 35
Maltese: Intervet International B.V.
English: Merial Animal Health Limited,
Maltese: Ir-Renju Unit Merial Animal Health Limited, PO Box 327
English: A GLP-compliant residue depletion study in sheep was submitted, conducted with the veterinary medicinal product ‘Nilzan Drench Plus', a combination product containing oxyclozanide (3.1% w/v) and levamisole (1.5% w/v).
Maltese: Ġie ppreżentat studju dwar it-tnaqqis tar-residwi konformi mal-GLP fin-nagħaġ, li sar bil-prodott mediċinali veterinarju “Nilzan Drench Plus”, prodott kkombinat li fih oxyclozanide (3.1% w/v) u levamisole (1.5% w/v).
English: Applicant/Marketing authorisation holder
Maltese: Applikant/Detentur talawtorizzazzjoni għat-tqegħid fis-suq
English: Merial GmbH Am Söldnermoos 6 85399 Hallbergmoos Germany
Maltese: 85399 Hallbergmoos Germany
English: Belgium Chanelle Pharmaceuticals Manufacturing Ltd.
Maltese: Il-Bulgarija Chanelle Pharmaceuticals Manufacturing Ltd.
English: The highest residues levels (2 µg/kg i.e. 1/5 of the MRL) were observed in one cow at the second milking.
Maltese: L-ogħla livelli ta' residwi (2 µg/kg jiġifieri 1/5 tal-MRL) ġew osservati f'baqra waħda fit-tieni taħliba.
English: List of the names, pharmaceutical form, strength of the veterinary medicinal products, animal species, route of administration, applicants/marketing authorisation holders in the Member States
Maltese: Lista ta' ismijiet, għamla farmaċewtika, qawwa tal-prodotti mediċinali veterinarji, speċijiet ta' annimali, mnejn jingħata, l-applikanti/id-detenturi tal-awtorizzazzjoni għat-tqegħid fissuq fl-Istati Membri
English: Ceva Sante Animale 10 Avenue de la Ballastiere 33500 Libourne Cedex France
Maltese: Il-Bulgarija Ceva Sante Animale 10 Avenue de la Ballastiere 33500 Libourne Cedex France
English: Merial Norden A/S Slotsmarken 13 Horshlom 2970 Denmark
Maltese: In-Norveġja Merial Norden A/S Slotsmarken 13
English: In these 3 cows the maximum levels were 11.4, 20.26 and 23.2 µg/kg at 24 and 48 hours after administration and residue levels decreased to below the MRL by the 6th, 7th or 8th milking after administration, although the last
Maltese: F'dawn it-3 baqar, il-livelli massimi kienu 11.4, 20.26 u 23.2 µg/kg fis-siegħa 24 u fis-siegħa 48 wara l-għoti u l-livelli tar-residwi naqsu għal taħt l-MRL sas-6, is-7 jew it-8 taħliba wara l-għoti, għalkemm laħħar kampjun ippreżenta livell ta' 10.
English: Station Works Camlough Road Newry, Co. Down BT35 6JP
Maltese: Down BT35 6JP
English: Recalculated fat data (at 2, 4 and 7 days after administration) were analysed using the EMA statistical software (WT 1.4).
Maltese: Id-data dwar ix-xaħam ikkalkulata mill-ġdid (fil-jiem 2, 4 u 7 wara l-għoti) ġiet analizzata bl-użu tas-softwer statistiku tal-EMA (WT 1.4).
English: Four treated animals (two of each sex) were slaughtered at 5, 10 15 and 21 days after administration.
Maltese: Inqatlu erba' annimali ikkurati (tnejn minn kull sess) fil-jiem 5, 10, 15 u 21 wara l-għoti.
English: The second study was conducted in 2013 with a generic product containing oxyclozanide 34 mg/ml (marketed under the names Chanil 34 mg/ml oral suspension for cattle and Rumenil 34 mg/ml oral suspension for cattle).
Maltese: It-tieni studju sar fl-2013 bi prodott ġeneriku li fih oxyclozanide 34 mg/ml (imqiegħed fis-suq taħt lismijiet Chanil 34 mg/ml sospensjoni orali għall-frat u Rumenil 34 mg/ml sospensjoni orali għall-frat).
English: • a cattle milk withdrawal period of 108 hours (4.5 days),
Maltese: • perjodu tal-irtirar tal-ħalib tal-frat ta' 108 sigħat (4.5 ijiem),
English: The veterinary medicinal products Zanil and associated names, and generic products thereof are oral suspensions containing 34 mg oxyclozanide per ml.
Maltese: Il-prodotti mediċinali veterinarji Zanil u ismijiet assoċjati, u l-prodotti ġeneriċi tiegħu huma sospensjonijiet orali li fihom 34 mg oxyclozanide għal kull ml.
English: Sheep:
Maltese: Mogħoż:
English: Four treated animals (two of each sex) were slaughtered at 2, 4, 7 and 10 days after administration.
Maltese: Inqatlu erba' annimali kkurati (tnejn minn kull sess) fil-jiem 2, 4, 7 u 10 wara l-għoti.
English: Therefore, on 1 September 2016, France initiated a procedure under Article 35 of Directive 2001/82/EC, for the veterinary medicinal products Zanil and associated names, and generic products thereof.
Maltese: Għalhekk, fl-1 ta' Settembru 2016, Franza bdiet proċedura skont l-Artikolu 35 tadDirettiva 2001/82/KE, għall-prodotti mediċinali veterinarji Zanil u isimijiet assoċjati, u l-prodotti ġeneriċi tiegħu.
English: The product ‘Nilzan Drench Plus' was administered orally to sheep at the single recommended dose of 15 mg oxyclozanide per kg body weight and 7.5 mg levamisole per kg body weight.
Maltese: Il-prodott “Nilzan Drench Plus” ingħata mill-ħalq lin-nagħaġ bid-doża rakkomandata waħda ta' 15 mg oxyclozanide għal kull kg tal-piż tal-ġisem u 7.5 mg levamisole għal kull kg tal-piż tal-ġisem.
English: The untreated control animals (one of each sex) were slaughtered at 5 and 21 days.
Maltese: L-animali ta' kontroll mhux ikkurati (wieħed minn kull sess) inqatlu fil-jiem 5 u 21.
English: Milk residues were assayed using a HPLC-MS/MS analytical method before treatment and at 12 hour intervals up to 72 hours after administration.
Maltese: Ir-residwi tal-ħalib ġew assaġġjati bl-użu ta' metodu analitiku HPLC-MS/MS qabel il-kura u f'intervalli ta' 12-il siegħa sa 72 siegħa wara l-għoti.
English: Fasciola hepatica (common name: liver fluke), is the causative agent of fasciolosis, one of the most economically important helminth diseases of livestock worldwide.
Maltese: Fasciola hepatica (isem komuni: parassita tal-fwied), huwa l-aġent li jikkawża l-fasciolosis, waħda millaktar mard mid-dud ekonomikament importanti tal-bhejjem fid-dinja kollha.
English: For cattle the recommended dose is 10 mg oxyclozanide per kg body weight (equivalent to 3 ml of product per 10 kg body weight) with a maximum dose of 3.5 g of oxyclozanide per animal (equivalent to 105 ml of product per animal).
Maltese: Għall-frat, id-doża rakkomandata hija ta' 10 mg oxyclozanide għal kull kg tal-piż tal-ġisem (ekwivalenti għal 3 ml ta' prodott għal kull 10 kg tal-piż tal-ġisem) b'doża massima ta' 3.5 g ta' oxyclozanide għal kull annimal (ekwivalenti għal 105 ml ta' prodott għal kull annimal).
English: 1 CVMP European Public MRL Assessment Report for oxyclozanide (EMEA/MRL/889/03-FINAL) - link
Maltese: 1 CVMP European Public MRL Assessment Report for oxyclozanide (EMEA/MRL/889/03-FINAL) - link dehru fl-istudju b'“Nilzan Drench Plus” fil-jum 21 ġew ikkunsidrati li huma valuri erratiċi u ġew esklużi mill-analiżi.
English: Assumptions of log-linearity, homogeneity of variances and normality of residuals were confirmed and a withdrawal period of 12.78 days, was calculated.
Maltese: Il-preżunzjonijiet tal-loglinearità, l-omoġeneità tal-varjanzi u n-normalità tar-residwali ġew ikkonfermati u ġie kkalkulat perjodu tal-irtirar ta' 12.78 jiem.
English: Milk residues were assayed using a HPLC-MS/MS analytical method before the treatment and at 12 hours intervals up to 168 hours after administration.
Maltese: Ir-residwi tal-ħalib ġew assaġġjati bl-użu ta' metodu analitiku HPLC-MS/MS qabel il-kura u f'intervalli ta' 12-il siegħa sa 168 siegħa wara l-għoti.
English: The untreated control animals (one of each sex) were slaughtered at 2 and 10 days.
Maltese: L-animali ta' kontroll mhux ikkurati (wieħed minn kull sess) inqatlu fil-jiem 2 u 10.
English: For sheep and goats the recommended dose is 15 mg oxyclozanide per kg body weight (equivalent to 4.4 ml of product per 10 kg body weight) with a maximum dose of 0.68 g of oxyclozanide per animal (equivalent to 20 ml of product per animal).
Maltese: Għan-nagħaġ u għall-mogħoż, iddoża rakkomandata hija ta' 15 mg oxyclozanide għal kull kg tal-piż tal-ġisem (ekwivalenti għal 4.4 ml ta' prodott għal kull 10 kg tal-piż tal-ġisem) b'doża massima ta' 0.68 g ta' oxyclozanide għal kull annimal (ekwivalenti għal 20 ml ta' prodott għal kull annimal).
English: The product was administered to 22 cows at the single maximum recommended dose volume of 105 ml of product per animal and in accordance with the VICH Guideline 48.
Maltese: Il-prodott ingħata lil 22 baqra bil-volum ta' doża rakkomandat massimu wieħed ta' 105 ml ta' prodott għal kull annimal u skont il-Linja gwida 48 ta' VICH.
English: Oxyclozanide is a salicylanilide anthelmintic, used for the treatment of fasciolosis in cattle, sheep and goats and also for elimination of gravid tapeworm segments (Moniezia spp).
Maltese: Oxyclozanide huwa antelmintiku tassalicylanilide, li jintuża għall-kura tal-fasciolosis fil-frat, fin-nagħaġ u fil-mogħoż u wkoll għalleliminazzjoni ta' segments ta' duda tqila (Moniezia spp).