FrancophonIA/ELRC3.0 huggingface dataset:
English: After 4 weeks of treatment, their potassium level fell on average by 1.0 mmol/litre.
Maltese: Wara 4 ġimgħat ta' kura, bejn wieħed u ieħor, il-livell tal-potassju tagħhom waqa' b'1.0 mmol/litru.
English: Veltassa is a medicine used for treating adults with high levels of potassium in the blood (hyperkalaemia).
Maltese: Veltassa huwa mediċina li tintuża għall-kura tal-adulti b'livelli għoljin ta' potassju fid-demm (iperkalimja).
English: The most common side effects with Veltassa (which may affect more than 1 in 100 people) are those affecting the digestive system (constipation, diarrhoea, abdominal pain and wind) and blood tests showing low levels of magnesium in the blood.
Maltese: L-effetti sekondarji l-aktar komuni b'Veltassa (li jistgħu jaffettwaw aktar minn 1 minn kull 100) huma dawk li jaffettwaw is-sistema diġestiva (stitikezza, dijarea, uġigħ addominali u gass) u testijiet taddemm li juru livelli baxxi ta' manjeżju fid-demm.
English: EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku patiromer
English: After 4 weeks, the average potassium level did not change in patients who received Veltassa for 4 weeks but it went back up by an average of 0.7 mmol/litre in patients who received placebo.
Maltese: Wara 4 ġimgħat, il-livell medju tal-potassju ma nbidilx f'pazjenti li rċivew Veltassa għal 4 ġimgħat iżda dan reġa' tela' b'medja ta' 0.7 mmol/litru f'pazjenti li rċivew il-plaċebo.
English: This is a summary of the European public assessment report (EPAR) for Veltassa.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta
English: The maximum dose is 25.2 g once a day.
Maltese: 2 g darba kuljum.
English: Hyperkalaemia can cause serious heart problems and muscle weakness.
Maltese: L-iperkalimja tista' tikkawża problemi serji tal-qalb u dgħufija fil-muskoli.
English: What are the risks associated with Veltassa?
Maltese: X'inhuma r-riskji assoċjati ma' Veltassa?
English: The second part of the study compared Veltassa with placebo (a dummy treatment) in 107 patients whose potassium level had fallen with Veltassa treatment during the first part of the study.
Maltese: It-tieni parti tal-istudju qabblet Veltassa mal-plaċebo (kura finta) f'107 pazjenti li l-livell tal-potassju tagħhom kien waqa' bil-kura b'Veltassa matul l-ewwel parti tal-istudju.
English: One main study involving patients with chronic kidney disease who had hyperkalaemia found that Veltassa is effective in reducing potassium levels in the blood.
Maltese: Studju ewlieni wieħed li involva pazjenti b'marda tal-kliewi kronika li kellhom l-iperkalimja sab li Veltassa huwa effettiv biex inaqqas il-livelli ta' potassju fid-demm.
English: When Veltassa is taken by mouth, the active substance, patiromer, remains in the gut where it attaches tightly to potassium to form a compound that is then passed out in the stool.
Maltese: Meta Veltassa jittieħed mill-ħalq, is-sustanza attiva, patiromer, tibqa' fil-musrana fejn din teħel sewwa mal-potassju biex tifforma kompost li mbagħad jgħaddi fl-ippurgar.
English: For the full list of all side effects and restrictions with Veltassa, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u rrestrizzjonijiet kollha rrappurtati b'Veltassa, ara l-fuljett ta' tagħrif.
English: How does Veltassa work?
Maltese: Kif jintuża Veltassa?
English: The European Medicines Agency decided that Veltassa's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: L-Aġenzija Ewropea għall-Mediċini ddeċiediet li l-benefiċċji ta' Veltassa huma akbar mir-riskji tiegħu u rrakkomandat li jkun approvat għall-użu fl-UE.
English: (Invented) name Strength
Maltese: Numru ta' l-EU Isem (inventat)
English: Route of administration Immediate Packaging Content (concentration) Pack size
Maltese: Kontenut (konċentrazzjoni)
English: Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands
Maltese: Indirizz uffiċjali Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● In-Netherlands
English: Afoxolaner Merial (afoxolaner) EMA/206832/2019
Maltese: Afoxolaner Merial () EMA/206832/2019
English: Further information on Afoxolaner Merial can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/afoxolaner-merial.
Maltese: ema.europa.eu/medicines/veterinary/EPAR/afoxolaner-merial.
English: Afoxolaner Merial received a marketing authorisation valid throughout the EU on 20 May 2019.
Maltese: Afoxolaner Merial ngħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fl-20 ta' Mejju 2019.
English: Afoxolaner Merial reduced the number of live mites by 97% 56 days after starting treatment and by 98% 84 days after starting treatment.
Maltese: Afoxolaner Merial naqqas l-għadd ta' dud ħaj b'97 % 56 jum wara lbidu tal-kura u bi 98 % 84 jum wara l-bidu tal-kura.
English: Afoxolaner Merial (afoxolaner)
Maltese: Afoxolaner Merial ()
English: Afoxolaner Merial contains the active substance afoxolaner.
Maltese: Afoxolaner Merial fih is-sustanza attiva afossolaner.
English: Other information about Afoxolaner Merial
Maltese: Informazzjoni oħra dwar Afoxolaner Merial
English: Afoxolaner Merial reduced the number of fleas and ticks by at least 98% and was at least as effective as a spot-on medicine containing pyriprole (another medicine against fleas and ticks).
Maltese: Afoxolaner Merial naqqas l-għadd ta' briegħed u qurdien b'mill-inqas 98 % u kien tal-inqas effettiv daqs mediċina għall-użu lokalizzat li fiha l-piriprol (mediċina oħra kontra l-briegħed u l-qurdien).
English: Afoxolaner Merial reduced the number of live mites by 96% 28 days after starting treatment and by 100% 56 days after starting treatment.
Maltese: Afoxolaner Merial naqqas l-għadd ta' dud ħaj b'96 % 28 jum wara l-bidu tal-kura u b'100 % 56 jum wara l-bidu tal-kura.
English: Afoxolaner Merial is a veterinary medicine used to treat infestations with fleas and ticks, as well as demodectic and sarcoptic mange (skin infestations caused by two different types of mites) in dogs.
Maltese: Afoxolaner Merial huwa mediċina veterinarja li tintuża biex tikkura infestazzjonijiet bil-briegħed u bilqurdien, kif ukoll skabbja demodektika u sarkoptika (infestazzjonijiet fil-ġilda kkawżati minn żewġ tipi differenti ta' dud) fil-klieb.
English: The company that makes NexGard has agreed that its scientific data can be used for Afoxolaner Merial (‘informed consent').
Maltese: Il-kumpanija li tipproduċi NexGard qablet li d-data xjentifika tiegħu tista' tintuża għal Afoxolaner Merial (“kunsens infurmat”).
English: Afoxolaner Merial kills fleas within 8 hours and ticks within 48 hours.
Maltese: Afoxolaner Merial joqtol il-briegħed fi żmien 8 sigħat u l-qurdien fi żmien 48 siegħa.
English: The active substance in Afoxolaner Merial, afoxolaner, acts as an ‘ectoparasiticide'.
Maltese: Is-sustanza attiva f'Afoxolaner Merial, l-afossolaner, taġixxi bħala ‘ektoparassitiċida'.
English: After being given, its actions last for at least 5 weeks against fleas and up to one month against ticks.
Maltese: Wara li jingħata, lazzjonijiet tiegħu jdumu mill-inqas 5 ġimgħat kontra l-briegħed u sa mhux aktar minn xahar kontra lqurdien.
English: It may be used as part of the management of flea allergy dermatitis (an allergic reaction to flea bites).
Maltese: Jista' jintuża bħala parti mill-ġestjoni ta' dermatite allerġika mill-briegħed (reazzjoni allerġika għall-gdim tal-briegħed).
English: A second EU field study involved 31 dogs with demodectic mange which were treated monthly on 3 occasions with Afoxolaner Merial.
Maltese: It-tieni studju tal-UE fuq il-post involva 31 kelb bi skabbja demodektika li ġew ikkurati kull xahar fi tliet okkażjonijiet b'Afoxolaner Merial.
English: What are the risks associated with Afoxolaner Merial?
Maltese: X'inhuma r-riskji assoċjati ma' Afoxolaner Merial?
English: In an EU field study involving 146 dogs with flea and/or tick infestations, a single treatment with Afoxolaner Merial was effective in treating flea and tick infestations in dogs for up to 30 days after treatment.
Maltese: Fi studju tal-UE fuq il-post li kien jinvolvi 146 kelb b'infestazzjonijiet tal-briegħed u/jew tal-qurdien, kura waħda b'Afoxolaner Merial kienet effettiva fil-kura tal-infestazzjonijiet tal-briegħed u tal-qurdien fil-klieb sa 30 jum wara l-kura.
English: This authorisation was based on the authorisation granted to NexGard in 2014 (‘informed consent').
Maltese: Din l-awtorizzazzjoni kienet ibbażata fuq l-awtorizzazzjoni mogħtija għal NexGard fl-2014 (“kunsens infurmat”).
English: Why is Afoxolaner Merial authorised in the EU?
Maltese: Għalfejn Afoxolaner Merial huwa awtorizzat fl-UE?
English: produce the substance gamma-aminobutyric acid (GABA) to regulate the nervous system.
Maltese: Timblokka l-moviment normali tal-partikoli ċċarġjati tal-klorur (joni) ġewwa u barra ċ-ċelloli tannervituri, speċjalment dawk in-nervituri li jipproduċu s-sustanza ta' aċidu gamma-aminobutirriku (GABA) biex tirregola s-sistema nervuża.
English: A third EU field study involved 38 dogs with sarcoptic mange which were treated monthly for two months with Afoxolaner Merial.
Maltese: It-tielet studju tal-UE fuq il-post involva 38 kelb bi skabbja sarkoptika li ġew ikkurati kull xahar għal xahrejn b'Afoxolaner Merial.
English: Afoxolaner Merial is available as chewable tablets in four different strengths for use in dogs of different weights.
Maltese: Afoxolaner Merial jiġi bħala pilloli li jintmagħdu f'erba' qawwiet differenti għall-użu fi klieb ta' piżijiet differenti.
English: The blister with the remaining chewable tablets should be returned into the carton.
Maltese: Il-folja bil-pilloli li jintmagħdu li jibqa' għandha terġa' titpoġġa fil-kartuna.
English: This results in uncontrolled activity of the nervous system and the paralysis and death of fleas, ticks and mites.
Maltese: Dan iwassal għal attività mhux ikkontrollata tas-sistema nervuża u l-paraliżi u mewt tal-briegħed, il-qurdien u d-dud.
English: How is Afoxolaner Merial used?
Maltese: Kif jaħdem Afoxolaner Merial?
English: This medicine is the same as NexGard, which is already authorised in the European Union (EU).
Maltese: Din il-mediċina hija l-istess bħal NexGard, li diġà hija awtorizzata fl-Unjoni Ewropea (UE).
English: Treatment should be repeated at monthly intervals during the flea or tick seasons, monthly for demodectic mange until the mange is successfully treated (as confirmed by two negative skin scrapings one month apart) and monthly for two months for sarcoptic mange, or longer if treatment is unsuccessful as indicated by clinical signs and skin scrapings.
Maltese: Il-kura għandha tiġi ripetuta f'intervalli ta' kull xahar matul l-istaġuni tal-briegħed jew talqurdien, kull xahar għall-iskabbja demodektika sakemm l-iskabbja tkun ikkurata b'suċċess (kif ikkonfermat minn żewġ biċċiet ta' ġilda negattivi kull xahar bejn kura u oħra) u kull xahar għal xahrejn għall-iskabbja sarkoptika, jew għal aktar jekk il-kura ma tirnexxix kif indikat mis-sinjali kliniċi u millbiċċiet tal-ġilda.
English: The effectiveness of Afoxolaner Merial was investigated in both laboratory and field studies.
Maltese: L-effikaċja ta' Afoxolaner Merial ġiet investigata kemm fi studji tal-laboratorju kif ukoll fuq il-post.
English: List of the names, pharmaceutical form, strengths of the medicinal product, route of administration, applicants / marketing authorisation holder in the Member States
Maltese: Lista tal-ismijiet, għamla farmaċewtika, qawwiet tal-prodotti mediċinali, mnejn jingħata, applikanti / detenturi tal-awtorizzazzjoni għat-tqegħid fissuq fl-istati membri
English: SE = Standard Error; CI = Confidence Interval;
Maltese: SE = Errur Standard; CI = Intervall ta' Kunfidenza;
English: The active substance is travoprost 40 micrograms/ml.
Maltese: Is-sustanza attiva hi travoprost 40 mikrogramma/ml.
English: ATC code: S01E E04
Maltese: S01E E04
English: Mean difference is Travoprost - Timolol.
Maltese: Differenza medja hija Travoprost - Timolol.
English: Alcon Cusí, S.A., Camil Fabra 58, 08320 El Masnou, Barcelona, Spain
Maltese: Alcon Cusí, S.A., Camil Fabra 58, 08320 El Masnou, Barcelona, Spanja
English: The marketing authorisation holder Novartis Europharm Limited Vista Building
Maltese: Detentur tal-Awtorizzazzjoni għat-tqegħid fis-Suq Novartis Europharm Limited Vista Building
English: In a similar 3 month study in adult patients, these events occurred at an incidence of 11.4% and 0.0%, respectively.
Maltese: Fi studju simili ta' 3 xhur f'pazjenti adulti, dawn l-avvenimenti seħħew b'inċidenza ta' 11.4% u 0.0%, rispettivament.
English: Rare musculoskeletal pain, arthralgia
Maltese: Rari uġigħ muskoluskeletriku, artralġja
English: Mean IOP reductions in the travoprost and timolol groups were similar (see Table 1).
Maltese: Tnaqqis medju fl-IOP fil-gruppi ta' travoprost u timolol kien simili (ara Tabella 1).
English: Aqueous humour concentrations declined with a half-life of approximately 1.5 hours.
Maltese: Konċentrazzjonijiet flaqueous humour naqsu b'half life ta' bejn wieħed u ieħor 1.5 sigħat.
English: B-2870 Puurs Belgium or
Maltese: B-2870 Puurs Il-Belġju jew
English: In the age groups 3 to < 12 years (n=36) and 12 to < 18 years (n=26), mean IOP reduction at Week 12 in the travoprost group was similar to that in the timolol group.
Maltese: Fil-gruppi ta' età minn 3 snin sa <12-il sena (n=36) u 12 sa <18-il sena (n=26), tnaqqis medju fl-IOP f'Ġimgħa 12 fil-grupp ta' travoprost kien simili għal dak fil-grupp ta' timolol.
English: The following adverse reactions are classified according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to<1/1,000), very rare <1/10,000), or not known (frequency cannot be estimated from the available data).
Maltese: Ir-reazzjonijiet avversi li ġejjin huma kklassifikati skont il-konvenzjoni li ġejja: 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), jew mhux magħrufa (il-frekwenza ma tistax tiġi stmata mid-dejta disponibbli).
English: Additional adverse drug reactions reported in paediatric patients in the 3 month paediatric study (n=77) compared to a similar trial in adults (n=185) included erythema of eyelid, keratitis, lacrimation increased, and photophobia all reported as single events with an incidence of 1.3% versus 0.0% seen in adults.
Maltese: Reazzjonijiet avversi tal-mediċina addizzjonali rrappurtati f'pazjenti pedjatriċi fl-istudju pedjatriku ta' 3 xhur (n=77) imqabbla ma' prova simili fl-adulti (n=185) inkludew eritema tal-kappell tal-għajn, keratite, żieda fid-dmugħ, u fotofobija kollha rrappurtati bħala avvenimenti singoli b'inċidenza ta' 1.3% kontra 0.0% osservata fl-adulti.
English: Pack sizes: 1 or 3 bottles.
Maltese: Daqsijiet tal-pakketti: 1 jew 3 fliexken.
English: Each mL of solution contains polyquaternium-1 (POLYQUAD) 10 microgram, propylene glycol 7.5 mg, polyoxyethylene hydrogenated castor oil 40 (HCO-40) 2 mg (see section 4.4.)
Maltese: Kull mL ta' soluzzjoni fih polyquaternium-1 (POLYQUAD) 10 mikrogrammi, propylene glycol 7.5 mg, polyoxyethylene hydrogenated castor oil 40 (HCO-40)
English: Mean IOP reduction at Week 12 in the 2 months to < 3 years of age group was 1.8 mmHg in the travoprost group and 7.3 mmHg in the timolol group.
Maltese: Tnaqqis medju fl-IOP f'Ġimgħa 12 fil-grupp ta' età ta' xaharejn sa <3 snin kien ta' 1.8 mmHg fil-grupp ta' travoprost u 7.3 mmHg fil-grupp ta' timolol.
English: Patients received either travoprost 0.004% once daily or timolol 0.5% (or 0.25% for subjects younger than 3 years old) twice daily.
Maltese: Il-pazjenti rċevew travoprost 0.004% darba kuljum jew timolol 0.5% (jew 0.25% għal individwi iżgħar minn 3 snin) darbtejn kuljum.
English: There are no data on the effects of TRAVATAN on human fertility.
Maltese: M'hemm l-ebda dejta dwar l-effetti ta' TRAVATAN fuq il-fertilità umana.
English: Specific in vitro interaction studies were performed with TRAVATAN and medicinal products containing thiomersal.
Maltese: Saru studji speċifici in vitro dwar l-interazzjonijiet bi TRAVATAN u prodotti mediċinali li fihom thiomersal.
English: Not known depression, anxiety, insomnia
Maltese: Mhux magħrufa depressjoni, ansjetà, insomnja
English: Manufacturer S.A. Alcon-Couvreur N.V. Rijksweg 14
Maltese: S.A. Alcon-Couvreur N.V.
English: Sodium hydroxide and/or hydrochloric acid (for pH-adjustment) Purified water
Maltese: Sodium hydroxide u/jew hydochloric acid (għall-aġġustament tal-pH) Ilma ppurifikat
English: Macular oedema has been reported during treatment with prostaglandin F2a analogues.
Maltese: Edima makulari kienet irrappurtata waqt kura b'analogi ta' prostaglandin F2a.
English: The most frequent adverse reactions reported in the paediatric population were ocular hyperaemia (16.9%) and growth of eyelashes (6.5%).
Maltese: L-aktar reazzjonijiet avversi frekwenti rrappurtati fil-popolazzjoni pedjatrika kienu iperimija fl-għajnejn (16.9%) u tkabbir taxxagħar ta' xfar l-għajnejn (6.5%).
English: CARTON FOR SINGLE BOTTLE 2.5 ml + CARTON FOR 3x2.5 ml BOTTLES
Maltese: KARTUNA TA' FLIXKUN WIEĦED ta' 2.5 ml + KARTUNA TA' 3 FLIEXKEN ta' 2.5 ml
English: Rare dermatitis allergic, dermatitis contact, erythema, rash, hair colour changes, madarosis
Maltese: Rari dermatite allerġika, dermatite tal-kuntatt, eritema, raxx, bidla fil-kulur tax-xagħar, telf tax-xagħar talħuġbejn
English: Uncommon hypersensitivity, seasonal allergy
Maltese: Mhux komuni sensittività eċċessiva, allerġija tal-istaġun
English: The systemic metabolic pathways parallel those of endogenous prostaglandin F2 which are characterised by reduction of the 13-14 double bond, oxidation of the 15-hydroxyl and -oxidative cleavages of the upper side chain.
Maltese: Ir-rotot metaboliċi fil-ġisem jixbhu lil dawk ta' prostaglandin F2α endoġenu u huma kkaratterizzati minn tnaqqis tad-double bond 13-14, u ossidazzjoni tal-qsim 15-hydroxy u β-oxidative tal-katina tat-tarf tan-naħa ta' fuq.
English: Tiny amounts of hydrochloric acid or sodium hydroxide are added to keep acidity levels (pH levels) normal.
Maltese: Jiġu miżjuda ammonti żgħar ta' hydrochloric acid jew sodium hydroxide biex iżommu l-livelli tal-aċidità (livelli tal-pH) normali.
English: In a clinical trial, patients with open-angle glaucoma or ocular hypertension who were treated with TRAVATAN (polyquaternium-preserved) dosed once-daily in the evening demonstrated 8 to 9 mmHg reductions (approximately 33%) in intraocular pressure from 24 to 26 mmHg baseline.
Maltese: Fi prova klinika, f'pazjenti bi glawkoma open angle jew pressjoni għolja fl-għajn li kienu kkurati bi TRAVATAN (ippreservat b'polyquaternium) iddożat darba kuljum filgħaxija wrew tnaqqis ta' 8 sa 9 mmHg (madwar 33%) fil-pressjoni ta' ġewwa l-għajn minn linja bażi ta' 24 sa 26 mmHg.
English: TRAVATAN contains hydrogenated castor oil and propylene glycol which may cause skin reactions and irritation.
Maltese: TRAVATAN fih hydrogenated castor oil u propylene glycol, li jistgħu jikkawżaw reazzjonijiet u irritazzjoni fil-ġilda.
English: Each mL of solution contains 40 micrograms of travoprost.
Maltese: Kull mL ta' soluzzjoni fih 40 mikrogramma travoprost.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: Data on adjunctive administration of TRAVATAN with timolol 0.5% and limited data with brimonidine 0.2% were collected during clinical trials that showed an additive effect of TRAVATAN with these glaucoma medications.
Maltese: Dejta dwar l-għoti ta' TRAVATAN flimkien ma' 0.5% timolol u dejta limitata dwar l-użu ta' TRAVATAN ma' 0.2% brimonidine kienet miġbura waqt provi kliniċi li wriet effett addittiv ta' TRAVATAN ma' dawn il-mediċini għall-kura tal-glawkoma.
English: Peak active free acid plasma concentrations of 25 pg/mL or less were observed between 10 and 30 minutes post-dose.
Maltese: Konċentrazzjonijiet massimi ta' aċidu ħieles attiv fil-plażma ta' 25 pg/mL jew inqas kienu osservati minn 10 minuti sa 30 minuta wara li ngħatat iddoża.
English: The other ingredients are Polyquaternium-1, polyoxyethylene hydrogenated castor oil 40, propylene glycol, sodium chloride, boric acid, mannitol and purified water.
Maltese: Is-sustanzi mhux attivi l-oħra huma Polyquaternium-1, polyoxyethylene hydrogenated castor oil 40, propylene glycol, sodium chloride, boric acid, mannitol, u ilma ppurifikat.
English: TRAVATAN contains polyoxyethylene hydrogenated castor oil 40 which may cause skin reactions.
Maltese: TRAVATAN fih polyoxyethylene hydrogenated castor oil 40 li jista' jikkawża reazzjonijiet fil-ġilda.
English: A pharmacokinetic study in paediatric patients aged 2 months to < 18 years demonstrated very low plasma exposure to travoprost free acid, with concentrations ranging from below the 10 pg/mL assay limt of quantitation (BLQ) to 54.5 pg/mL.
Maltese: Studju farmakokinetiku f'pazjenti pedjatriċi b'età minn xaharejn sa <18-il sena wera esponiment baxx ħafna fil-plażma għal aċidu ħieles ta' travoprost, b'konċentrazzjonijiet li jvarjaw minn taħt il-limitu ta' kwantifikazzjoni tal-analiżi (BLQ - assay limit of quantitation) ta' 10 pg/mL sa 54.5 pg/mL.
English: IOP reductions for this group were based on only 6 patients in the timolol group and 9 patients in the travoprost group where 4 patients in the travoprost group versus 0 patients in the timolol group had no relevant mean IOP reduction at Week 12.
Maltese: Tnaqqis fl-IOP għal dan il-grupp kien bbażat biss fuq 6 pazjenti filgrupp ta' timolol u 9 pazjenti fil-grupp ta' travoprost fejn 4 pazjenti fil-grupp ta' travoprost kontra 0 pazjenti fil-grupp ta' timolol ma kellhom l-ebda tnaqqis medju rilevanti fl-IOP f'Ġimgħa 12.
English: Not known: frequency cannot be estimated from the available data
Maltese: Mhux magħrufa: frekwenza ma tistax tiġi stmata mid-dejta disponibbli
English: This may reduce the systemic absorption of medicinal products administered via the ocular route and result in a decrease in systemic adverse reactions.
Maltese: Dan jista' jnaqqas l-assorbiment sistemiku tal-prodotti mediċinali mogħtija millgħajn u jirriżulta fi tnaqqis tar-reazzjonijiet avversi sistemiċi.
English: 3 x 2.5 mL - PP Bottle
Maltese: 3 x 2.5 mL - Flixkun magħmul minn PP
English: The efficacy of TRAVATAN in paediatric patients from 2 months to less than 18 years of age was demonstrated in a 12-week, double-masked clinical study of travoprost compared with timolol in 152 patients diagnosed with ocular hypertension or paediatric glaucoma.
Maltese: L-effikaċja ta' TRAVATAN f'pazjenti pedjatriċi b'età minn xaharejn sa inqas minn 18-il sena intweriet fi studju kliniku double-masked ta' 12-il ġimgħa ta' travoprost imqabbel ma' timolol f'152 pazjent dijanjostikati bi pressjoni għolja fl-għajnejn jew bi glawkoma pedjatrika.
English: Estimates based on least squares means derived from a statistical model that accounts for correlated IOP measurements within patient where primary diagnosis and baseline IOP stratum are in the model.
Maltese: Stimi bbażati fuq least squares means derivati minn mudell statistiku li jispjega l-kejl korrelatat tal-IOP fil-pazjent fejn dijanjosi primarja u stratum tal-IOP fil-linja bażi huma fil-mudell.
English: 1 x 2.5 mL - PP Bottle
Maltese: 1 x 2.5 mL - Flixkun magħmul minn PP
English: In a 3 month phase 3 study and a 7 days pharmacokinetic study, involving 102 paediatric patients exposed to TRAVATAN, the types and characteristics of adverse reactions reported were similar to what has been observed in adult patients.
Maltese: Fi studju ta' fażi 3 li dam 3 xhur u studju farmakokinetiku ta' sebgħat ijiem, li kienu jinvolvu 102 pazjenti pedjatriċi esposti għal TRAVATAN, it-tipi u l-karatteristiċi ta' reazzjonijiet avversi rrappurtati kienu simili għal dawk osservati f'pazjenti adulti.