FrancophonIA/ELRC3.0 huggingface dataset:
English: In 4 previous systemic pharmacokinetic studies in adult populations, travoprost free acid plasma concentrations ranged from BLQ to 52.0 pg/mL.
Maltese: F'4 studji farmakokinetiċi sistemiċi preċedenti f'popolazzjonijiet adulti, il-konċentrazzjonijiet talaċidu ħieles ta' travoprost fil-plażma varjaw minn BLQ sa 52.0 pg/mL.
English: TRAVATAN 40 micrograms/mL eye drops travoprost
Maltese: TRAVATAN 40 mikrogramma/mL qtar għall-għajnejn travoprost
English: Reproduction and development studies have demonstrated a potent effect on foetal loss with a high rate observed in rats and mice (180 pg/ml and 30 pg/ml plasma, respectively) at exposures 1.2 to 6 times the clinical exposure (up to 25 pg/ml).
Maltese: Studji dwar ir-riproduzzjoni u l-iżvilupp urew effett qawwi fuq it-telf tal-fetu, b'rata għolja osservata fil-firien u l-ġrieden (180 pg/ml u 30 pg/ml fil-plażma, rispettivament) f'esponimenti ta' 1.2 sa 6 darbiet l-esponiment kliniku (sa 25 pg/ml).
English: However, data in the age group 2 months to < 3 years (9 patients) is limited (see section 5.1).
Maltese: Madankollu, dejta fil-grupp ta' età minn xaharejn sa <3 snin (9 pazjenti) hija limitata (ara sezzjoni 5.1).
English: Excipient(s) with known effect:
Maltese: Effetti fl-għajn:
English: 4 mL oval Polypropylene (PP) or Low Density Polyethylene (LDPE) bottle and PP or LDPE dispensing plug with a PP screw cap, presented in an overwrap.
Maltese: Flixkun ovali ta' 4 mL magħmul minn Polypropylene (PP) jew Polyethylene ta' Densità baxxa (LDPE - Low Density Polyethylene) u tapp għall-għoti magħmul minn PP jew LDPE b'għatu bilkamin magħmul minn PP, ippreżentati f'pakkett ta' protezzjoni.
English: 1 mL of solution contains 40 micrograms of travoprost
Maltese: ML wieħed ta' soluzzjoni fih 40 mikrogramma travoprost
English: In pregnant rat, systemic administration of travoprost at doses more than 200 times the clinical dose during the period of organogenesis resulted in an increased incidence of malformations.
Maltese: F'firien tqal, lgħoti sistemiku ta' travoprost f'dożi aktar minn 200 darba d-doża klinika, waqt il-perjodu talorganoġenesi rriżulta f'żieda fl-inċidenza ta' malformazzjonijiet.
English: How to store TRAVATAN
Maltese: Tużax TRAVATAN
English: Table 1 Comparison of Mean IOP Change from Baseline (mmHg) at Week 12
Maltese: Tabella 1 Tqabbil tal-Bidla Medja fl-IOP mil-Linja Bażi (mmHg) f'Ġimgħa 12
English: Date of first authorisation: 27 November 2001 Date of latest renewal: 06 October 2006
Maltese: Data tal-aħħar tiġdid: 06 Ottubru 2006
English: Uncommon headache Rare dizziness, visual field defect, dysgeusia
Maltese: Mhux komuni uġigħ ta' ras Rari sturdament, difett fil-kamp tal-vista, disġewżja
English: In children < 3 years old that mainly suffer from PCG (primary congenital glaucoma), surgery (e.g. trabeculotomy/goniotomy) remains the first line treatment.
Maltese: Fi tfal b'età ta' <3 snin li fil-biċċa l-kbira jbatu minn PCG (glawkoma konġenitali primarja - primary congenital glaucoma), kirurġija (eż. trabekulotomija/goniotomija) tibqa' l-kura preferita.
English: TRAVATAN 40 micrograms/mL eye drops, solution travoprost
Maltese: TRAVATAN 40 mikrogramma/mL qtar għall-għajnejn, soluzzjoni travoprost
English: Prostaglandins and prostaglandin analogues are biologically active materials that may be absorbed through the skin.
Maltese: Prostaglandins u analogi ta' prostaglandin huma materjali bijoloġikament attivi li jistgħu jiġu assorbiti mill-ġilda.
English: TRAVATAN has been studied in patients with mild to severe hepatic impairment and in patients with mild to severe renal impairment (creatinine clearance as low as 14 ml/min).
Maltese: TRAVATAN kien studjat f'pazjenti b'indeboliment ħafif sa sever tal-fwied u f'pazjenti b'indeboliment ħafif sa sever tal-kliewi (tneħħija tal-krejatinina baxxa sa 14 ml/min).
English: Opened (2)
Maltese: Infetaħ (2):
English: TRAVATAN preserved with polyquaternium-1 induced minimal ocular surface toxicity, compared to eye drops preserved with benzalkonium chloride, on cultured human corneal cells and following topical ocular administration in rabbits.
Maltese: TRAVATAN ippreservat b'polyquaternium-1 ikkawża tossiċità minima fis-superfiċje okulari, meta mqabbel ma' qtar għall-għajnejn ippreservati b'benzalkonium chloride, fuq kolturi ta' ċelluli talkornea umana u wara għoti topika fl-għajn fil-fniek.
English: In clinical trials with TRAVATAN, the most common adverse reactions were ocular hypearemia and iris hyperpigmentation, occurring in approximately 20% and 6% of patients respectively.
Maltese: Fi provi kliniċi bi TRAVATAN, l-aktar reazzjonijiet avversi komuni kienu iperimija fl-għajn u iperpigmentazzjoni tal-ħabba tal-għajn, li jseħħu f'madwar 20% u 6% tal-pazjenti rispettivament.
English: TRAVATAN 40 micrograms/mL eye drops, solution.
Maltese: TRAVATAN 40 mikrogramma/mL qtar għall-għajnejn, soluzzjoni.
English: • If you have had cataract surgery, talk to your doctor before you use TRAVATAN.
Maltese: • Jekk kellek operazzjoni tal-katarretti, kellem lit-tabib tiegħek qabel tuża TRAVATAN.
English: Decrease of elevated intraocular pressure in adult patients with ocular hypertension or open-angle glaucoma (see section 5.1).
Maltese: Tnaqqis ta' pressjoni għolja fl-għajnejn f'pazjenti adulti bi pressjoni għolja tal-għajnejn jew bi glawkoma tat-tip open-angle (ara sezzjoni 5.1).
English: If more than one topical ophthalmic medicinal product is being used, the medicinal products must be administered at least 5 minutes apart (see section 4.5).
Maltese: Jekk ikun qed jintuża aktar minn prodott mediċinali topiku għall-għajnejn wieħed, il-prodotti mediċinali għandhom jingħataw b'interval ta' mill-inqas 5 minuti minn xulxin (ara sezzjoni 4.5).
English: Unilateral treatment can result in permanent heterochromia.
Maltese: Din il-bidla tista' tkun permanenti.
English: • TRAVATAN may increase the length, thickness, colour and/or number of your eyelashes.
Maltese: • TRAVATAN jista' jżid it-tul, il-ħxuna, il-kulur u/jew in-numru ta' xagħar ta' xfar għajnejk.
English: Travoprost, a prostaglandin F2 analogue, is a highly selective full agonist which has a high affinity for the prostaglandin FP receptor, and reduces the intraocular pressure by increasing the outflow of aqueous humour via trabecular meshwork and uveoscleral pathways.
Maltese: Travoprost, analogu ta' prostaglandin F2α, huwa agonist komplut li huwa selettiv ħafna u għandu affinità għolja għar-riċettur FP ta' prostaglandin u jnaqqas il-pressjoni fl-għajn billi jżid il-ħruġ talaqueous humour mix-xibka trabekulari u r-rotot uveosklerali.
English: Rare iridocyclitis, ophthalmic herpes simplex, eye inflammation, photopsia, eczema eyelids, conjunctival oedema, halo vision, conjunctival follicles, hypoaesthesia eye, trichiasis, meibomianitis, anterior chamber pigmentation, mydriasis, asthenopia, eyelash hyperpigmentation, eyelash thickening
Maltese: Is-sejbiet huma relatati mal-attività agonista tar-riċettur FP ġewwa l-uteru u kien hemm mewt bikri tal-embriju, telf tal-embriju wara li ġie impjantat u effett tossiku fuq il-fetu.
English: Uncommon corneal erosion, uveitis, iritis, anterior chamber inflammation, keratitis, punctate keratitis, photophobia, eye discharge , blepharitis, erythema of eyelid, periorbital oedema, eyelids pruritus, visual acuity reduced, vision blurred, lacrimation increased, conjunctivitis, ectropion, cataract, eyelid margin crusting, growth of eyelashes
Maltese: Mhux komuni tħaffir tal-kornea, uveite, irite, infjammazzjoni talkompartiment anterjuri, keratite, keratite ittikkjata, fotofobija, tnixxija mill-għajn, blefarite, eritema tal-kappell tal-għajn, edima madwar l-għajn, ħakk fil-kpiepel tal-għajnejn, akutezza tal-vista mnaqqsa, vista mċajpra, żieda fid-dmugħ, konġuntivite, ektropjon, katarretti, qoxra fit-tarf tal-kappell talgħajn, tkabbir tax-xagħar ta' xfar l-għajnejn
English: Opened (3)
Maltese: Infetaħ (3):
English: General side effects: eye viral infection, dizziness, bad taste, irregular or decreased heart rate, increased or decreased blood pressure, shortness of breath, asthma, nasal allergy or inflammation, nasal dryness, voice changes, gastrointestinal discomfort or ulcer, constipation, dry mouth, redness or itching of the skin, rash, hair colour change, loss of eyelashes, joint pain, musculoskeletal pain, generalised weakness.
Maltese: Effetti sekondarji ġenerali: infezzjoni minn virus fl-għajn, sturdament, togħma ħażina, rata ta' taħbit tal-qalb irregolari jew imnaqqsa, żieda jew tnaqqis fil-pressjoni, qtugħ ta' nifs, ażżma, allerġija jew infjammazzjoni fl-imnieħer, nixfa fl-imnieħer, bidliet fil-vuċi, skonfort jew ulċera gastro-intestinali, stitikezza, ħalq xott, ħmura jew ħakk fil-ġilda, raxx, bidla fil-kulur tax-xagħar, telf tax-xagħar ta' xfar l-għajnejn, uġigħ fil-ġogi, uġigħ muskolu-skeletali, dgħufija ġeneralizzata.
English: Pharmacotherapeutic group: Ophthalmologicals-antiglaucoma preparations and miotics-prostaglandin analogues
Maltese: Bidliet madwar l-għajn u fil-kappell tal-għajn
English: Decrease of elevated intraocular pressure in paediatric patients aged 2 months to < 18 years with ocular hypertension or paediatric glaucoma (see section 5.1).
Maltese: Dejta dwar l-effikaċja u s-sigurtà fil-grupp ta' età minn xaharejn sa <3 snin (9 pazjenti) hija limitata (ara sezzjoni 5.1).
English: TRAVATAN can be used in paediatric patients from 2 months to < 18 years at the same posology as in adults.
Maltese: TRAVATAN jista' jintuża fi tfal b'età minn xaharejn sa <18-il sena bl-istess doża tal-adulti.
English: Uncommon palpitations Rare heart rate irregular, heart rate decreased Not known chest pain, bradycardia, tachycardia, arrhythmia
Maltese: Mhux magħrufa uġigħ fis-sider, bradikardija, takikardija, arritmija
English: The short-term safety profiles in the different paediatric subsets were also similar (see section 5.1).
Maltese: Il-profili tas-sigurtà għal żmien qasir fissottogruppi pedjatriċi differenti wkoll kienu simili (ara sezzjoni 5.1).
English: General side effects: depression, anxiety, insomnia, sensation of false movement, ringing in ears, chest pain, abnormal heart rhythm, increased heart beat, worsening of asthma, diarrhea, nose bleeds, abdominal pain, nausea, vomiting, itching, abnormal hair growth, painful or involuntary urination, increase in prostate cancer marker.
Maltese: Effetti sekondarji ġenerali: depressjoni, ansjetà, insomnja, sensazzjoni ta' moviment falz, żarżir filwidnejn, uġigħ fis-sider, ritmu tal-qalb mhux normali, żieda fit-taħbit tal-qalb, aggravar tal-ażżma, dijarea, fsada mill-imnieħer, uġigħ addominali, dardir, rimettar, ħakk, tkabbir mhux normali taxxagħar, tgħaddi l-awrina bl-uġigħ jew b'mod involontarju, żieda fil-markatur tal-kanċer tal-prostata.
English: Uncommon skin hyperpigmentation (periocular), skin discolouration, hair texture abnormal, hypertrichosis
Maltese: Rari riattivazzjoni ta' ulċera peptika, disturb gastrointestinali, stitikezza, ħalq xott
English: The drop will go in here (picture 2)
Maltese: Il-qatra se tmur hawn (stampa 2)
English: (eye drops)
Maltese: (qtar għall-għajnejn).
English: Following topical ocular administration of TRAVATAN to healthy volunteers, low systemic exposure to active free acid was demonstrated.
Maltese: Wara li TRAVATAN ingħata b'mod topiku fl-għajnejn lill-voluntiera f'saħħithom, kien dimostrat esponiment sistemiku baxx għall-aċidu ħieles attiv.
English: TRAVATAN may gradually change the eye colour by increasing the number of melanosomes (pigment granules) in melanocytes.
Maltese: TRAVATAN b'mod gradwali jista' jbiddel il-kulur tal-għajn billi jżid in-numru ta' melanosomi (grani tal-pigment) fil-melanoċiti.
English: • If you are allergic to travoprost or any of the other ingredients of this medicine (listed in section 6).
Maltese: • Jekk inti allerġiku għal travoprost jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fis sezzjoni 6).
English: If you stop using TRAVATAN
Maltese: Mediċini oħra u TRAVATAN
English: A topical overdose is not likely to occur or to be associated with toxicity.
Maltese: Doża topika eċċessiva mhix probabbli li sseħħ jew li tkun assoċjata ma' tossiċità.
English: The effect on IOP was seen after the second week of treatment and was consistently maintained throughout the 12 week period of study for all age groups.
Maltese: L-effett fuq l-IOP kien osservat wara t-tieni ġimgħa ta' kura u nżamm b'mod konsistenti matul ilperijodu ta' 12-il ġimgħa tal-istudju għall-etajiet kollha.
English: Effects in the eye: corneal disorder, eye inflammation, iris inflammation, inflammation inside the eye, eye surface inflammation with/out surface damage, sensitivity to light, eye discharge, eyelid inflammation, eyelid redness, swelling around the eye, eyelid itching, blurred vision, increased tear production, infection or inflammation of the conjunctiva (conjunctivitis), abnormal turning outward of the lower eyelid, clouding of the eye, eyelid crusting, growth of eyelashes.
Maltese: Effetti fl-għajn: disturb fil-kornea, infjammazzjoni fl-għajn, infjammazzjoni tal-ħabba tal-għajn, infjammazzjoni ġewwa l-għajn, infjammazzjoni tas-superfiċje tal-għajn bi/bla ħsara fis-superfiċje, sensittività għad-dawl, tnixxija mill-għajn, infjammazzjoni tal-kappell tal-għajn, ħmura tal-kappell talgħajn, nefħa madwar l-għajn, ħakk fil-kappell tal-għajn, vista mċajpra, żieda fil-produzzjoni taddmugħ, infezzjoni jew infjammazzjoni tal-konġuntiva (konġuntivite), kappell t'isfel tal-għajn idur 'il barra b'mod mhux normali, għajn imċajpra, qxur fil-kappell tal-għajn, tkabbir tax-xagħar ta' xfar lgħajnejn.
English: What TRAVATAN looks like and contents of the pack TRAVATAN is a liquid (a clear, colourless solution) supplied in a pack containing a 4 ml plastic bottle with a screw cap. Each bottle contains 2.5 mL of travoprost eye drops and each bottle is placed in a pouch.
Maltese: Kif jidher TRAVATAN u l-kontenut tal-pakkett TRAVATAN huwa likwidu (soluzzjoni ċara u mingħajr kulur) fornut f'pakkett li fih flixkun talplastik ta' 4 ml b'għatu bil-kamin.
English: Eye drops, solution.
Maltese: Qtar għall-għajnejn, soluzzjoni.
English: It is absorbed through the cornea where the isopropyl ester is hydrolysed to the active free acid.
Maltese: Jiġi assorbit minn ġol-kornea fejn isopropyl ester jiġi idrolizzat f'aċidu ħieles attiv.
English: Ear and labyrinth disorders Not known vertigo, tinnitus
Maltese: Użu fl-adulti, inkluż il-popolazzjoni anzjana
English: Uncommon cough, nasal congestion, throat irritation Rare dyspnoea, asthma, respiratory disorder, oropharyngeal pain, dysphonia, rhinitis allergic, nasal dryness
Maltese: Rari qtugħ ta' nifs, ażżma, disturb fir-respirazzjoni, uġigħ fil-farinġi u fil-larinġi, disfonija, rinite allerġika, imnieħer xott
English: An updated RMP should be submitted: - At the request of the European Medicines Agency; - Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Maltese: - Meta l-Aġenzija Ewropea għall-Mediċini titlob din l-informazzjoni; - Kull meta s-sistema tal-ġestjoni tar-riskju tiġi modifikata speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil bejn il-benefiċċju u r-riskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar-riskji).
English: Both side effects were observed with a higher incidence in children and adolescents compared to adults.
Maltese: Iż-żewġ effetti sekondarji kienu osservati b'inċidenza ogħla fit-tfal u l-adolexxenti meta mqabbla ma' adulti.
English: 1 x 50 doses 4 x 50 doses 1 x 200 doses
Maltese: 1 x 50 doża 4 x 50 doża 1 x 200 doża
English: 4.6 to 6.8
Maltese: 4.6 sa 6.8
English: 6.9 to 9.0
Maltese: 6.9 sa 9.0
English: The final concentration of the skimmed milk powder should be 5 g/litre.
Maltese: Il-konċentrazzjoni finali tat-trab tal-ħalib xkumat għandha tkun 5 g/litru.
English: Up to 4.5
Maltese: Sa 4.5
English: Prevtec Microbia GmbH Geyerspergerstrasse 27 80689 München GERMANY
Maltese: Prevtec Microbia GmbH Geyerspergerstrasse 27 80689 München Il-ĠERMANJA
English: As an example, for a 4-hour consumption of 22 litres and a dosing pump rate of 1%, the volume of the stock solution should be 22 litres x 0.01 = 220 ml.
Maltese: Bħala eżempju, għal konsum ta' 4 sigħat ta' 22 litru u rata tal-pompa tad-dożaġġ ta' 1%, il-volum tas-soluzzjoni ewlenija għandu jkun 22 litru x 0.01 = 220 ml.
English: Onset of immunity: 7 days after vaccination Duration of immunity: 21 days after vaccination
Maltese: Bidu tal-immunità: 7 ijiem wara t-tilqima Tul ta' immunità: 21 jum wara t-tilqima
English: Immunological properties:
Maltese: Proprjetajiet immunoloġiċi:
English: Lyophilisate for oral suspension.
Maltese: Lijofiliżat għal sospensjoni orali.
English: Live non-pathogenic Escherichia coli O8:K87
Maltese: Escherichia coli O8:K87
English: GERMANY
Maltese: SPANJA
English: Water consumption (litres) in a 4-hour time period 1 pig
Maltese: Konsum tal-ilma (litri) f'perjodu ta' 4 sigħat Ħanżir 1
English: Type I glass vial of 11 ml containing 50 doses and type II glass vial of 50 ml containing 200 doses with a chlorobutyl rubber stopper sealed with an aluminium cap.
Maltese: Kunjett tal-ħġieġ ta' tip I ta' 11 ml li fih 50 doża u kunjett tal-ħġieġ ta' tip II ta' 50 ml li fih 200 doża b'tapp tal-lastiku chlorobutyl issiġillat b'kappa tal-aluminju.
English: (F4ac):.......................1.3x10
Maltese: ħajja u mhux patoġenika (F4ac):.......................1.3x10
English: Live non-pathogenic Escherichia coli O141:K94
Maltese: Escherichia coli O141:K94
English: Live E. coli O8:K87 (F4ac) and live E. coli O141:K94 (F18ac)
Maltese: E. coli O8:K87 ħajja (F4ac) u E. coli O141:K94 ħajja (F18ac).
English: (F18ac): ...............2.8x10
Maltese: ħajja u mhux patoġenika (F18ac): ...............2.8x10
English: Geyerspergerstr.
Maltese: Ħnieżer.
English: Overdose (symptoms, emergency procedures, antidotes), if necessary A rectal temperature up to 41.2 °C may occur in individual animals within the first 24 hours after administration of a 10-fold overdose.
Maltese: Doża eċċessiva (sintomi, proċeduri ta' emerġenza, antidoti), jekk meħtieġ Temperatura tar-rektum sa 41.2 °C tista' sseħħ f'annimali individwali fi żmien l-ewwel 24 siegħa wara amministrazzjoni ta'doża eċċessiva ta' 10 darbiet iżjed.
English: to 9.0x10
Maltese: sa 9.0x10
English: 200 pigs
Maltese: 200 ħanżir
English: Coliprotec F4/F18 lyophilisate for oral suspension for pigs
Maltese: Coliprotec F4/F18 lijofiliżat għal sospensjoni orali għall-ħnieżer
English: - reduce the incidence of moderate to severe post-weaning E. coli diarrhoea (PWD) in infected pigs; - reduce the faecal shedding of enterotoxigenic F4-positive and F18-positive E. coli from infected pigs.
Maltese: - tnaqqas l-inċidenza ta' dijarea tal-E. coli moderata sa severa wara t-treddigħ (PWD) fil-ħnieżer infettati; - tnaqqas it-tixrid mill-ippurgar ta' E. coli enterotossiġenika pożittiva għal F4 u pożittiva għal F18 minn ħnieżer infettati.
English: Shake well and transfer the suspension into a graduated container, mix again with water to complete to a total volume of 100 ml.
Maltese: Ħallat sew u ttrasferixxi s-sospensjoni f'kontenitur gradwat, erġa' ħallat mal-ilma biex timla sa volum total ta' 100 ml.
English: Shake well and transfer the suspension into a graduated container, mix again with water to complete to a total volume of 400 ml.
Maltese: Ħallat sew u ttrasferixxi s-sospensjoni f'kontenitur gradwat, erġa' ħallat mal-ilma biex timla sa volum total ta' 400 ml.
English: not attenuated CFU - colony forming units
Maltese: CFU = unitajiet li jiffurmaw kolonji
English: The vaccine confers cross protection against F18ab-positive E. coli, as demonstrated by challenge for both the 7-day onset of immunity and the 21-day duration of immunity.
Maltese: It-tilqima tagħti protezzjoni inkroċjata kontra E. coli F18ab-pożittiva, kif muri bi sfida kemm għall-bidu ta' 7 ijiem ta' immunità kif ukoll għat-tul ta' 21 jum ta' immunità.
English: Live non-pathogenic E. coli O141:K94 (F18ac):.................2.8x10
Maltese: E. coli O141:K94 ħajja u mhux patoġenika (F18ac): ...............2.8x10
English: to 3.0x10
Maltese: sa 3.0x10
English: Reconstitute the lyophilisate by adding 10 ml (50-dose presentation) or 20 ml (200-dose presentation) of water to the vial.
Maltese: Irrikostitwixxi l-lijofiliżat billi żżid 10 ml (preżentazzjoni ta' 50 doża) jew 20 ml (preżentazzjoni ta' 200 doża) tal-ilma fil-kunjett.
English: Each dose of vaccine contains: Live non-pathogenic E. coli O8:K87 (F4ac):.......................1.3x10
Maltese: Kull doża ta' tilqima fiha: E. coli O8:K87 ħajja u mhux patoġenika (F4ac):.......................1.3x10
English: Administer a single dose of vaccine from 18 days of age.
Maltese: Agħti doża singola ta' tilqima mill-età ta' 18-il jum.
English: Antibodies triggered by the vaccine provide cross-reactivity against F4ab and F4ad-positive E. coli strains.
Maltese: L-antikorpi mqanqlin mill-vaċċin jipprovdu reattività inkroċjata kontra r-razez ta' E.coli F4ab u F4ad-pożittivi.
English: A rectal temperature up to 41.2 °C may occur in individual animals within the first 24 hours after administration of a 10-fold overdose.
Maltese: Temperatura tar-rektum sa 41.2 °C tista' sseħħ f'annimali individwali fi żmien l-ewwel 24 siegħa wara amministrazzjoni ta' doża eċċessiva ta' 10 darbiet iżjed.
English: Manufacturer responsible for batch release: Klifovet AG
Maltese: Klifovet AG
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals.
Maltese: Tħallatx ma' ebda prodott mediċinali veterinarju ieħor.
English: Live non-pathogenic E. coli O8:K87 (F4ac):
Maltese: E. coli O8:K87 ħajja mhux patoġenika (F4ac):
English: The vaccine induces an intestinal immunity and a serological response against F4-positive and F18positive E. coli in pigs.
Maltese: It-tilqima toħloq immunità intestinali u rispons seroloġiku kontra E. coli pożittiva għal F4 u pożittiva għal F18 fil-ħnieżer.
English: For active immunisation of pigs from 18 days of age against enterotoxigenic F4-positive and F18positive Escherichia coli in order to:
Maltese: Għal immunizzazzjoni attiva għall-ħnieżer minn età ta' 18-il jum kontra E.coli enterotossiġenika pożittiva għal F4 u pożittiva għal F18 sabiex:
English: To stimulate active immunity against enterotoxigenic F4-positive and F18-positive E. coli in pigs.
Maltese: Biex tistimula l-immunità attiva kontra E.coli pożittiva għal F4 u għal F 18 enterotossiġeniku filħnieżer.
English: Cardboard box of one vial of 50 or 200 doses.
Maltese: Kaxxa tal-kartun ta' kunjett wieħed ta' 50 jew 200 doża.
English: Live non-pathogenic E. coli O141:K94 (F18ac):
Maltese: E. coli O141:K94 ħajja mhux patoġenika (F18ac):
English: Shake well and use within 4 hours.
Maltese: Ħallat sew u uża fi żmien 4 sigħat.
English: - For administration through water lines using a dosing pump (proportioner), dilute the reconstituted vaccine in the needed volume of the dosing pump stock solution.
Maltese: - Għal amministrazzjoni minn linji tal-ilma bl-użu ta' pompa tad-dożaġġ (proportioner), iddilwixxi t-tilqima rikostitwita fil-volum meħtieġ għas-soluzzjoni ewlenija tal-pompa tad-dożi.
English: White or whitish powder.
Maltese: Għall-kura tal-annimali biss.
English: Name and address of the manufacturer responsible for batch release:
Maltese: Isem u indirizz tal-manifattur responsabbli mill-ħruġ tal-lott:
English: 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Maltese: .6 Prekawzjonijiet speċjali għar-rimi tal-prodotti mediċinali veterinarji mhux użati jew materjal ieħor għar-rimi li huwa derivat minn dawn il-prodotti
English: Pharmacotherapeutic group: Immunologicals for Suidae; live bacterial vaccine.
Maltese: Immunoloġiċi għal Suidae; tilqima ta' batterji ħajjin.
English: All materials used in preparing and administering the vaccine must be free of antimicrobials, detergent or disinfectant residues to prevent inactivation.
Maltese: Il-materjali kollha użati fil-preparazzjoni u fl-amministrazzjoni tat-tilqima għandhom ikunu mingħajr residwi ta' antimikrobiċi, deterġenti jew diżinfettanti biex tiġi evitata inattivazzjoni.