FrancophonIA/ELRC3.0 huggingface dataset:
English: Concerns were raised by CVMP regarding references highlighting emergence of resistant strains of M. synoviae both under experimental conditions (Le Carrou et al
Maltese: Tqajjem tħassib mis-CVMP rigward ir-referenzi li jenfasizzaw l-emerġenza ta' razez reżistenti ta' M. synoviae kemm taħt kundizzjonijiet sperimentali (Le Carrou et al
English: The product has been shown to be efficacious in the treatment of E. coli, Avibacterium paragallinarum, Pasteurella multocida, Mycoplasma gallisepticum and Mycoplasma synoviae in chickens; E. coli, Mycoplasma gallisepticum, Mycoplasma synoviae and Pasteurella multocida in turkeys.
Maltese: Il-prodott intwera li huwa effikaċi fit-trattament ta' E. coli, Avibacterium paragallinarum, Pasteurella multocida, Mycoplasma gallisepticum u Mycoplasma synoviae fit-tiġieġ; E. coli, Mycoplasma gallisepticum, Mycoplasma synoviae u Pasteurella multocida fid-dundjani.
English: Turkeys
Maltese: KARATTERISTIĊI
English: Discard unused material.
Maltese: Armi kull materjal mhux użat.
English: Enrofloxacin administered via drinking water to poultry is rapidly and very well absorbed with a bioavailability of approx. 90 %.
Maltese: Enrofloxacin mogħti mal-ilma tax-xorb lit-tjur jiġi assorbit malajr u tajjeb ħafna b'bijodisponibilità ta' madwar 90 %.
English: In this paper, clinical resistance was assessed against the Clinical Laboratory and Standards Institute (CLSI) breakpoint for ciprofloxacin of ≥ 4 mg/l.
Maltese: F'dan id-dokument, ir-reżistenza klinika kienet ivvalutata f'paragun mal-valur tal-limitu tal-Laboratorju Kliniku u l-Istitut tal-Istandards (CLSI) għal ciprofloxacin ta' ≥ 4 mg/l.
English: The challenge studies suggested that a dose of 10 mg/kg bodyweight would be more effective than the proposed 5 mg/kg bodyweight, especially when treating acute cases.
Maltese: L-istudji ta' stimulazzjoni ssuġġerew li doża ta' 10 mg/kg piż tal-ġisem tkun aktar effettiva mill-5 mg/kg piż tal-ġisem proposta, b'mod speċjali fit-trattament ta' każijiet akuti.
English: Baytril 10% oral solution and associated names contain 100 mg enrofloxacin per ml oral solution for use in drinking water.
Maltese: Baytril 10% soluzzjoni orali u ismijiet assoċjati fihom 100 mg enrofloxacin għal kull ml ta' soluzzjoni orali għall-użu fl-ilma tax-xorb.
English: Do not administer to layer replacement birds within 14 days of coming into lay.
Maltese: Tagħtix lil għasafar li jbidu ta' sostituzzjoni fi żmien 14-il jum minn meta jbidu.
English: Satisfactory data have been submitted to support the use of enrofloxacin at the proposed harmonised dose rate to treat Avibacterium paragallinarum, Pasteurella multocida, Mycoplasma gallisepticum and Mycoplasma synoviae in chickens; Mycoplasma gallisepticum, Mycoplasma synoviae and Pasteurella multocida in turkeys.
Maltese: Ġiet ippreżentata dejta sodisfaċenti b'appoġġ għall-użu ta' enrofloxacin fir-rata ta' doża armonizzata proposta għat-trattament ta' Avibacterium paragallinarum, Pasteurella multocida, Mycoplasma gallisepticum u Mycoplasma synoviae fit-tiġieġ;
English: Since enrofloxacin was first authorised for use in poultry, there has been widespread reduction in susceptibility of E. coli to fluoroquinolones and emergence of resistant organisms.
Maltese: Billi enrofloxacin l-ewwel li ġie awtorizzat għall-użu fit-tjur, kien hemm tnaqqis estensiv fis-suxxettibilità tal-E. coli għall-fluoroquinolones u t-tfaċċar ta' organiżmi reżistenti.
English: To be completed nationally <Date of first authorisation:> <{DD/MM/YYYY}><{DD month YYYY}>.
Maltese: Trid timtela mill-pajjiż konċernat <Data tal-ewwel awtorizzazzjoni:> <{DD/MM/YYYY}><{DD month YYYY}>.
English: Chickens infected with Mycoplasma gallisepticum, Mycoplasma synoviae, Avibacterium paragallinarum, Pasteurella multocida, Escherichia coli;
Maltese: Tiġieġ infettati b' Mycoplasma gallisepticum, Mycoplasma synoviae, Avibacterium paragallinarum, Pasteurella multocida, Escherichia coli;
English: The marketing authorisation holders have conducted a basic PK/PD analysis regarding E. coli, but no consideration has been given to an antimutant dosing strategy or to the potential to select for resistant food-borne organisms of significance to public health (Campylobacter, Salmonella).
Maltese: Id-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq għamlu analiżi bażika tal-PK/PD rigward l-E. coli, iżda ma ngħatat l-ebda konsiderazzjoni lil strateġija ta' dożaġġ antimutant jew lill-potenzjal ta' għażla għal organiżmi reżistenti li jinġarru fl-ikel ta' sinfikat għas-saħħa pubblika (Campylobacter, Salmonella).
English: The paper states that the high values for 2005-6 were due to the high level of resistance in Spain (24%), which was not included in 1999-2000.
Maltese: Iddokument jiddikjara li l-valuri għoljin għall-2005-6 kienu dovuti għal-livell għoli ta' reżistenza fi Spanja (24%), li ma kienx inkluż fl-1999-2000.
English: Chickens, turkeys: 3 days Do not use in poultry producing eggs for human consumption
Maltese: Tiġieġ, Dundjani: 3 ijiem Tagħtix lil tjur li jipproduċu l-bajd għallkonsum mill-bniedem
English: Doses up to 100 mg/kg bodyweight during 5 days or 30 mg/kg bodyweight for 3 weeks were clinically well tolerated in broilers.
Maltese: Dożi sa 100 mg/kg piż tal-ġisem matul 5 ijiem jew 30 mg/kg piż tal-ġisem għal 3 ġimgħat kienu klinikament ittollerati sew fil-brojlers.
English: Enrofloxacin should be used where clinical experience, supported where possible by sensitivity testing of the causal organism, indicates enrofloxacin as the active substance of choice.
Maltese: Enrofloxacin għandu jintuża fejn l-esperjenza klinika, fejn possibbli appoġġjata minn ittestjar tassensittività tal-organiżmu kawżali, tindika enrofloxacin bħala s-sustanza attiva tal-għażla.
English: Target species, indications and posology
Maltese: 2.1. Speċijiet fil-mira, indikazzjonijiet u pożoloġija
English: The first time point at which all residues were below their respective maximum residue limits in the slower-growing birds was at 3 days after final treatment, one day after the faster-growing birds.
Maltese: L-ewwel punt ta' ħin li fih ir-residwi kollha kienu taħt il-limiti massimi ta' residwi tagħhom fit-tjur li jikbru aktar bil-mod kien wara 3 ijiem mit-trattament finali, jum wara t-tjur li jikbru aktar malajr.
English: Animal Health Division Energieweg 1
Maltese: Il-Pajjiżi l-Baxxi Bayer B.V. Animal Health Division Energieweg 1
English: The proposed SPC contains the warnings regarding prudent use of fluoroquinolones in food producing animals in line with the CVMP reflection paper 2006
Maltese: L-SPC propost fih it-twissijiet rigward l-użu prudenti ta' fluoroquinolones fl-annimali li jipproduċu l-ikel konformi mad-dokument ta' riflessjoni tal-2006 tas-CVMP
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal product, animal species, withdrawal period, marketing authorisation holders in the Member States
Maltese: Lista tal-ismijiet, għamliet farmaċewtiċi, qawwiet tal-prodotti mediċinali veterinarji, speċi tal-annimali, perjodu ta' tiżmim, detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq fl-Istati Membri
English: Turkeys infected with Mycoplasma gallisepticum, Mycoplasma synoviae, Pasteurella multocida, Escherichia coli.
Maltese: Dundjani infettati b' Mycoplasma gallisepticum, Mycoplasma synoviae, Pasteurella multocida, Escherichia coli.
English: Fluoroquinolones should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other classes of antimicrobials.
Maltese: Il-fluoroquinolones għandhom jitħallew għat-trattament ta' kundizzjonijiet kliniċi li jkunu rrispondew b'mod inadegwat, jew li jkunu mistennija li jirrispondu b'mod inadegwat, għal klassijiet oħra ta' sustanzi antimikrobiċi.
English: However according to the EFSA/ECDC report (2012) resistance to ciprofloxacin in indicator E. coli isolates taken from chickens is described as moderate to high at a rate of 47%, although in this report, the resistance rate is based on epidemiological cut-off values for non-pathogenic strains.
Maltese: (2012) ir-reżistenza għal ciprofloxacin fl-iżolati indikaturi tal-E. coli meħuda mit-tiġieġ hija deskritta bħala moderata għal għolja f'rata ta' 47%, għalkemm f'dan ir-rapport, ir-rata ta' reżistenza hija bbażata fuq valuri ta' limitu epidemjoloġiċi minn razez mhux patoġeniċi.
English: There are not sufficient data available to set a scientifically-derived withdrawal period in rabbits, but the limited data available show that the first time point at which all residues were below the MRLs set by the CVMP was at 2 days after the final treatment.
Maltese: M'hemmx dejta suffiċjenti disponibbli biex jiġi stabbilit perjodu tal-irtirar miksub xjentifikament filfniek, iżda d-dejta limitata disponibbli turi li l-ewwel punt ta' ħin li fih ir-residwi kollha kienu taħt lMRLs stabbiliti mis-CVMP kien jumejn wara t-trattament finali.
English: Bayer plc
Maltese: PARIR SABIEX
English: Turkeys: Meat and offal: 3 days.
Maltese: Dundjani: Laħam u ġewwieni tal-annimali: 3 ijiem.
English: User safety warnings:
Maltese: Kodici ATĊ veterinarja:
English: Mode of action
Maltese: B'MOD KORRETT
English: Whereas
Maltese: A.
English: Therefore, and considering the context of this Article 34 referral which is to harmonise the SPCs, CVMP proposed to harmonise to the highest dose rate of enrofloxacin of 10 mg/kg for 3-5 days in both chickens and turkeys, which is also that approved in the majority of Member States.
Maltese: Għaldaqstant, u b'kunsiderazzjoni tal-kuntest ta' din ir-referenza talArtikolu 34 li huwa li l-SPCs jiġu armonizzati, is-CVMP ippropona li jarmonizza sal-ogħla rata ta' doża ta' 10 mg/kg enrofloxacin għal 3-5 ijiem kemm fit-tiġieġ kif ukoll fid-dundjani, li hija wkoll dik approvata fil-parti l-kbira tal-Istati Membri.
English: Those with known hypersensitivity to (fluoro)quinolones should avoid contact with this product.
Maltese: Nies li huma sensittivi għal (fluoro)quinolones għandhom jevitaw li jmissu ma' dan il-prodott.
English: A recent paper by de Jong et al quotes data from the European Antimicrobial Susceptibility Surveillance in Animals (EASSA) collected from EU countries.
Maltese: 4, 2012, jikkwota dejta mis-Sorveljanza Ewropea tas-Suxxettibbiltà Antimikrobjali fl-Annimali (EASSA) miġbura mill-pajjiżi tal-UE.
English: In vitro antibiotic susceptibility of Dutch Mycoplasma synoviae field isolates originating from joint lesions and the respiratory tract of commercial poultry.
Maltese: Olandiżi ta' Mycoplasma synoviae fuq il-post li joriġinaw minn feriti fil-ġogi u fl-apparat respiratorju ta' tjur kummerċjali.
English: Calculations in broiler chickens produce the highest exposure of the environment (PECsoil 887 µg/kg).
Maltese: Il-kalkolazzjonijiet fit-tiġieġ brojler jipproduċu l-ogħla esponiment talambjent (PECsoil 887 µg/kg).
English: It may harm them,
Maltese: Insuffiċjenza kardijaka magħrufa,
English: Clinical effects
Maltese: Effetti kliniċi
English: EU/1/06/340/003 5 single-dose containers EU/1/06/340/004 30 single-dose containers EU/1/06/340/005 90 single-dose containers
Maltese: EU/1/06/340/003 5 kontenituri b'doża waħda EU/1/06/340/004 30 kontenitur b'doża waħda EU/1/06/340/005 90 kontenitur b'doża waħda
English: Alopecia2
Maltese: Alopeċja2
English: 10 single-dose containers.
Maltese: FIHA 10 KONTENITURI
English: Алерган България ЕООД Тел.
Maltese: България Алерган България ЕООД
English: Benzalkonium chloride has been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy.
Maltese: Kien irrappurtat li benzalkonium chloride, jikkawża punctate keratopathy u/jew keratopatija ulċerattiva tossika.
English: Table 2 System Organ Class
Maltese: Tabella 2 Sistema tal-klassifika tal-organi
English: It is a synthetic prostamide, structurally related to prostaglandin F2α (PGF2α) that does not act through any known prostaglandin receptors.
Maltese: Huwa prostamide sintetiku, strutturalment relatat ma' prostaglandin F2α (PGF2α), li ma jaħdimx permezz ta' xi riċettur ta'
English: Insomnia2, nightmare2
Maltese: Nuqqas ta' rqad2, ħmar il-lejl2
English: Chemical and physical in-use stability has been demonstrated for 28 days at 25°C.
Maltese: Kienet murija stabilità kimika u fiżika waqt l-użu għal 28 ġurnata f'temperatura ta' 25°C.
English: ANNEX II
Maltese: Tabella 1
English: Rhinitis2
Maltese: Rinite2
English: In fact, the upper limit of the 95% CI did not exceed 0.14 mm Hg at week 12.
Maltese: Fil-fatt, il-limitu ta' fuq ta' 95% CI ma qabiżx 0.14 mm Hg f'ġimgħa 12.
English: Metabolism and nutrition disorders hypoglycaemia1
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni ipogliċemija1
English: In all four cases, positive de-challenge and re-challenge were reported.
Maltese: Fl-erba' każijiet kollha, ġew irrappurtati de-challenge u re-challenge pożittivi.
English: Hallucination:
Maltese: Alluċinazzjoni:
English: In the publication: Nanda T, Rasool N, Callahan AB, Stamper RL, Odel JG. Ophthalmic Timolol Hallucinations: A Case Series and Review of the Literature.
Maltese: Nanda T, Rasool N, Callahan AB, Stamper RL, Odel JG.
English: • Depression; memory loss; hallucination
Maltese: • Depressjoni, telf ta' memorja; alluċinazzjoni
English: Investigations liver function tests (LFT) abnormal2
Maltese: Investigazzjoniet testijiet tal-funzjoni tal-fwied (LFT) b'riżultat anormali2
English: These doses are at least 7.5 times higher than the amount of bimatoprost in an accidental dose of the entire contents of a carton of GANFORT single-dose (90 single-dose containers x 0.4 mL; 36 mL) in a 10 kg child [(36 mL*0.3 mg/mL bimatoprost)/10 kg; 1.08 mg/kg].
Maltese: Dawn id-dożi huma mill-inqas 7.5 darbiet ogħla mill-ammont ta' bimatoprost f'doża aċċidentali tal-kontenut kollu ta' kartuna ta' GANFORT doża waħda (90 kontenitur b'doża waħda x 0.4 mL; 36 mL) f'tifel/tifla ta' 10 kg [(36 mL*0.3 mg/mL ta' bimatoprost)/10 kg; 1.08
English: • Reduced sexual urge; sexual dysfunction
Maltese: • Tnaqqis fl-aptit sesswali; disfunzjoni sesswali
English: • Cough, worsening of asthma, worsening of the lung disease called chronic obstructive pulmonary disease (COPD)
Maltese: • Sogħla, aggravament tal-ażżma, aggravament tal-marda tal-pulmun imsejħa marda pulmonari ostruttiva kronika (COPD)
English: Hepatic
Maltese: Epatiċi
English: Eye drops, solution, 3 x 3 ml
Maltese: U KONTENUT Qtar għall-għajnejn, soluzzjoni, 3 x 3 ml
English: Choroidal detachment
Maltese: Kundizzjonijiet oħra
English: <{MM/YYYY}> <{DD/MM/YYYY}> <{DD month YYYY}>
Maltese: M'għandek terfa' soluzzjoni mhux użata.
English: Bimatoprost penetrates the human cornea and sclera well in vitro.
Maltese: Bimatoprost jippenetra sew fil-kornea umana u fl-isklera in vitro.
English: Other medicines and GANFORT
Maltese: Mediċini oħra u GANFORT
English: GANFORT medicinal product
Maltese: Prodott mediċinali GANFORT
English: • The active substances are bimatoprost 0.3 mg/ml and timolol 5 mg/ml corresponding to timolol maleate 6.8 mg/ml.
Maltese: • Is-sustanzi attivi huma bimatoprost. 0.3 mg/ml u timolol 5 mg/ml li jikkorrispondi għal timolol maleate 6.8 mg/ml.
English: 1adverse reactions only observed with Ganfort single-dose formulation 2adverse reactions only observed with Ganfort multi-dose formulation
Maltese: 1reazzjonijiet avversi osservati biss bil-formulazzjoni ta' doża waħda ta' Ganfort 2reazzjonijiet avversi osservati biss bil-formulazzjoni ta' doża multipla ta' Ganfort
English: Respiratory, thoracic and mediastinal disorders
Maltese: Disturbi respiratorji, toraċiċi u Komuni
English: GANFORT contains Benzalkonium chloride
Maltese: GANFORT fih benzalkonium chloride
English: Ganfort contains a preservative called benzalkonium chloride.
Maltese: GANFORT fih preservattiv imsejjaħ benzalkonium chloride.
English: To reduce the systemic absorption, see section 4.2.
Maltese: Biex tnaqqas l assorbiment sistemiku, ara sezzjoni 4.2.
English: Tel: +386 (0) 590 848 40
Maltese: Ewopharma d.o.o. Tel: +386 (0) 590 848 40
English: GANFORT has not been studied in patients with inflammatory ocular conditions, neovascular, inflammatory, angle-closure glaucoma, congenital glaucoma or narrow-angle glaucoma.
Maltese: glawkoma neovaskolari, infjammatorja, angle-closure, konġenitali jew narrow-angle.
English: Each ml of solution contains 0.05 mg of benzalkonium chloride.
Maltese: Kull ml ta' soluzzjoni fih 0.05 mg ta' benzalkonium chloride.
English: Table 1 System Organ Class
Maltese: Tabella 2 Sistema tal-Klassifika tal-Organi
English: Carton containing 5 single-dose containers in an aluminium foil pouch.
Maltese: Kartuna li jkun fiha 5 kontenituri b'doża waħda f'borża tal-fojl tal-aluminju.
English: GANFORT single-dose
Maltese: GANFORT doża waħda
English: Opened (3)
Maltese: NUMRU(I)
English: The following pack sizes are available:
Maltese: Id-daqsijiet li ġejjin tal-pakketti huma disponibbli:
English: There is a potential for additive effects resulting in hypotension, and/or marked bradycardia when ophthalmic beta-blocker solution is administered concomitantly with oral calcium channel blockers, guanethidine, beta-adrenergic blocking agents, parasympathomimetics, anti-arrhythmics (including amiodarone) and digitalis glycosides.
Maltese: Hemm il-potenzjal għal effetti additivi li jirriżultaw fi pressjoni baxxa, u/jew bradikardija qawwija meta soluzzjoni ta' imblokkaturi beta oftalmiċi tingħata flimkien ma' imblokkaturi tal-kanal tal-kalċju mill-ħalq, guanethidine, sustanzi beta-adrenerġiċi li jimblukkaw, parasimpatomimetiċi, prodotti kontra l-arritmija (li jinkudu amiodarone) u digitalis glycosides.
English: Psychiatric disorders depression1, memory loss1, hallucination 1
Maltese: Disturbi psikjatriċi depressjoni1, telf ta' memorja1, alluċinazzjoni1
English: Nervous system disorders syncope1, cerebrovascular accident1, increase in signs and symptoms of myasthenia gravis1, paraesthesia1, cerebral ischaemia1
Maltese: Disturbi fis-sistema nervuża sinkope1, inċident ċerebrovaskulari1, żieda fis sinjali u s-sintomi ta' mijastenija gravis1, parestesija1, iskemija ċerebrali1
English: The frequency of possible adverse reactions listed below is defined using the following convention:
Maltese: Il-frekwenza tal-effetti avversi possibbli elenkata hawn taħt hi definita bl-użu tal-konvenzjoni li ġejja:
English: Mean Cmax and AUC 0-24hrs values were similar on days 7 and 14 at approximately 0.08 ng/ml and 0.09 ng•hr/ml respectively, indicating that a steady drug concentration was reached during the first week of ocular dosing.
Maltese: Il-medja tal-valuri ta' Cmax u AUC 0-24siegħa kienu simili fis-7 u l-14-il ġurnata f'ammonti ta' madwar 0.08 ng/ml u 0.09 ng•siegħa/ml rispettivament, u dan jindika li konċentrazzjoni fissa tal-mediċina ntlaħqet matul l-ewwel ġimgħa ta' l-għotja fl-għajn.
English: The preservative in GANFORT, benzalkonium chloride, may cause eye irritation.
Maltese: Il-preservattiv f'GANFORT, benzalkonium chloride, jista' jikkawża iritazzjoni ta' l-għajnejn.
English: Eye drops, solution, 3 ml
Maltese: U KONTENUT Qtar għall-għajnejn, soluzzjoni, 3 ml
English: Potentiated systemic beta-blockade (e.g. decreased heart rate, depression) has been reported during combined treatment with CYP2D6 inhibitors (e.g. quinidine, fluoxetine, paroxetine) and timolol.
Maltese: Imblokk beta sistemiku msaħħaħ (eż. tnaqqis fir-rata ta' taħbit tal-qalb, dipressjoni) ġie rrappurtat matul il-kura kombinata b'inibituri ta' CYP2D6 (eż. quinidine, fluoxetine, paroxetine) u timolol.
English: If GANFORT single-dose is accidentally ingested, the following information may be useful: in 2-week oral mice and rats studies, doses of bimatoprost up to 100 mg/kg/day did not produce any toxicity; this corresponds to a human equivalent dose of 8.1 and 16.2 mg/kg, respectively.
Maltese: Jekk GANFORT doża waħda jinbela' aċċidentalment, l-informazzjoni li ġejja tista' tkun utli: fi studji orali li damu ġimagħtejn li saru fuq il-ġrieden u l-firien, dożi ta' bimatoprost sa 100 mg/kg/jum ma pproduċew l-ebda tossiċità; dan jikkorrispondi għal doża fil-bniedem ekwivalenti għal 8.1 u 16.2
English: Benzalkonium chloride, sodium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate, hydrochloric acid or sodium hydroxide (to adjust pH) and purified water.
Maltese: Benzalkonium chloride, sodium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate, hydrochloric acid jew sodium hydroxide (biex tadatta l-pH) u ilma ppurifikat.
English: 1 adverse reactions observed with Timolol 2 adverse reactions observed with Bimatoprost
Maltese: 1 reazzjonijiet avversi osservati b'Timolol 2 reazzjonijiet avversi osservati b'Bimatoprost
English: Pharmacotherapeutic group: Ophthalmological,- beta-blocking agents - ATC code: S01ED51
Maltese: Oftalmoloġiku, - sustanzi ta' imblokkaturi beta - Kodiċi ATC:
English: Potentiated systemic beta-blockade (e.g., decreased heart rate, depression) has been reported during combined treatment with CYP2D6 inhibitors (e.g. quinidine, fluoxetine, paroxetine) and timolol.
Maltese: Imblokk beta sistemiku msaħħaħ (eż., tnaqqis fir-rata ta' taħbit tal-qalb, dipressjoni) ġie rrappurtat matul il-kura kombinata b'inibituri ta' CYP2D6 (eż. quinidine, fluoxetine, paroxetine) u timolol.
English: Bimatoprost is eliminated primarily by renal excretion, up to 67% of an intravenous dose administered to healthy volunteers was excreted in the urine, 25% of the dose was excreted via the faeces.
Maltese: Bimatoprost jiġi eliminat primarjament mill-kliewi, sa 67% mid-doża mogħtija mill-vina lil voluntiera f'saħħithom kienet imneħħija fl-awrina, 25% tad-doża tneħħiet fl-ippurgar.
English: Eye disorders decreased corneal sensitivity1, diplopia1, ptosis1, choroidal detachment following filtration surgery (see section 4.4)1, keratitis1, blepharospasm2, retinal haemorrhage2, uveitis2,
Maltese: Disturbi fl-għajnejn tnaqqis fis-sensittività tal-kornea1, diplopja1, ptosi1, qtugħ korojdjali wara operazzjoni tal-filtrazzjoni (ara sezzjoni 4.4)1, keratite1,
English: Date of first authorisation 19 May 2006 Date of latest renewal 23 June 2011
Maltese: Data tal-aħħar tiġdid: 23 ta' Ġunju, 2011
English: Immune system disorders systemic allergic reactions including anaphylaxis1
Maltese: Disturbi fis-sistema immuni reazzjonijiet allerġiċi sistemiċi li jinkludu anafilassi1
English: Summary of the safety profile
Maltese: GANFORT Sommarju tal-profil tas-sigurtà
English: Gastrointestinal disorders nausea1,2, diarrhoea1, dyspepsia1, dry mouth1, abdominal pain1, vomiting1
Maltese: Disturbi gastrointestinali nawseja1,2, dijarea1, dispepsja1, ħalq xott1, uġigħ fl-addome1, rimettar1
English: This dose expressed as mg/m2 is at least 70-times higher than the accidental dose of one bottle of GANFORT in a 10 kg child.
Maltese: Din id-doża espressa f'mg/m2 hi ta' mill-anqas 70 darba aktar mid-doża aċċidentali ta' flixkun ta' GANFORT f'tarbija li tiżen 10 kg.
English: Surgical anaesthesia β-blocking ophthalmological preparations may block systemic β-agonist effects e.g. of adrenaline.
Maltese: Preparazzjonijiet oftalmoloġiċi β li jimblokkaw jistgħu jimblokkaw l-effetti sistemiċi ta' β-agonist, eż. tal-adrenalina.
English: Like other topically applied ophthalmic drugs, GANFORT (bimatoprost/timolol) is absorbed into the systemic circulation.
Maltese: Bħal mediċini oftalmiċi oħrajn li jiġu applikati b'mod topiku, GANFORT (bimatoprost/timolol) jiġi assorbit ġoċ-ċirkolazzjoni sistemika.
English: Dysgeusia2
Maltese: taħt il-ġilda
English: Symptoms of systemic timolol overdose include: bradycardia, hypotension, bronchospasm, headache, dizziness, shortness of breath, and cardiac arrest.
Maltese: Sintomi ta' doża eċċessiva ta' timolol jinkludu: bradikardija, pressjoni baxxa, bronkospażmi, uġigħ ta' ras, sturdament, qtugħ ta' nifs, u waqfien tal-qalb.
English: After once daily ocular administration of one drop of 0.03% bimatoprost to both eyes for two weeks, blood concentrations peaked within 10 minutes after dosing and declined to below the lower limit of detection (0.025 ng/ml) within 1.5 hours after dosing.
Maltese: Wara li tqattret qatra waħda ta' 0.03% bimatoprost kuljum fiż-żewġ għajnejn għal ħmistax, il-konċentrazzjonijiet fid-demm laħqu l-massimu fi żmien 10 minuti wara l-għotja tad-doża u naqsu sa taħt l-inqas limitu ta' osservazzjoni (0.025 ng/ml) fi żmien 1.5 sigħat wara l-għotja tad-doża.