FrancophonIA/ELRC3.0 huggingface dataset:
English: A direct effect on PTSD while controlling for the effect on depression was not demonstrated.
Maltese: Ma ntweriex effett dirett fuq il-PTSD waqt il-kontroll għalleffett fuq id-depressjoni.
English: What Zoloft looks like and contents of the pack
Maltese: Id-dehra ta' Zoloft u l-kontenuti tal-pakkett [Timtela mill-pajjiż]
English: QUALITATIVE AND QUANTITATIVE COMPOSITION [To be completed nationally]
Maltese: U KWANTITATTIVA [Timtela mill-pajjiż]
English: The clinical programme for the indication social anxiety disorder consisted of two short term double blind, randomized, placebo controlled clinical trials and two long term efficacy and safety studies.
Maltese: Il-programm kliniku għall-indikazzjoni tad-disturb ta' ansjetà soċjali ikkonsista minn żewġ provi kliniċi double blind randomizzati, ikkontrollati bi plaċebo u żewġ studji dwar is-sigurtà u l-effikaċja għal perjodu ta' żmien twil.
English: Reversible, selective MAO-A inhibitor (moclobemide) Due to the risk of serotonin syndrome, the combination of sertraline with a reversible and selective MAOI, such as moclobemide, is not recommended.
Maltese: Minħabba r-riskju tas-sindromu tas-serotonina, l-użu ta' sertraline flimkien ma' MAOI selettiv u riverssibli, bħal moclobemide, mhux irrikmandat.
English: Clinical pharmacology studies have shown that sertraline has no effect on psychomotor performance.
Maltese: Studji kliniċi dwar il-farmakoloġija wrew li sertraline m'għandux effett fuq il-prestazzjoni psikomotorili.
English: The interference of depressive symptoms and their effect on PTSD is still a concern because this was not sufficiently controlled for.
Maltese: L-interferenza tas-sintomi ta' depressjoni u tal-effett tagħhom fuq il-PTSD għadha ta' tħassib minħabba li din ma ġietx ikkontrollata biżżejjed.
English: The data submitted to support the additional indication anxiety treatment indication proposed by the MAH consisted of various studies showing that the sertraline groups consistently had a greater reduction in the Ham-D Factor for anxiety and somatisation than the placebo group.
Maltese: Id-dejta sottomessa biex issostni l-indikazzjoni addizzjonali għat-trattament tal-ansjetà proposta mill-MAH kienet magħmula minn studji varji li juru li l-gruppi ta' sertraline b'mod konsistenti kellhom tnaqqis akbar fil-Fattur Ham-D għall-ansjetà u s-somatizzazzjoni mill-grupp tal-plaċebo.
English: Butylhydroxytoluene: can cause irritation of eyes, skin and mucous membranes.
Maltese: Butylhydroxytoluene: jista' jikkawża irritazzjoni fl-għajnejn, fil-ġilda u fil-membrani mukużi.
English: The MAH submitted data from a number of studies to support the proposed harmonised text for this section.
Maltese: Il-MAH issottometta dejta minn għadd ta' studji biex isostni t-test armonizzat propost għal din is-sezzjoni.
English: • If you have suffered from bleeding disorders or have been taking medicines which thin the blood (eg acetylsalicyclic acid (aspirin), or warfarin) or may increase the risk of bleeding.
Maltese: • Jekk batejt minn disturbi ta' fsada jew ħadt mediċini li jraqqu d-demm (eż. aċidu aċitilsaliċiliku (aspirina), jew warfarina) jew jistgħu iżidu ir-riskju ta' fsada.
English: Sodium chloride Potassium chloride Disodium phosphate dehydrate Potassium dihydrogen phosphate dl-α-tocopheryl acetate Light liquid paraffin Water for injections
Maltese: Sodium chloride Potassium chloride Disodium phosphate dehydrate Potassium dihydrogen phosphate dl-α-tocopheryl acetate Paraffuna kiwida ħafifa Ilma għall-injezzjonijiet
English: DATE OF REVISION OF THE TEXT {MM/YYYY}
Maltese: DATA TA' REVIŻJONI TAT-TEST {MM/YYYY}
English: Porcine circovirus type 2 ORF2 subunit antigen
Maltese: Porcine circovirus tip 2 ORF subjunit antiġen
English: MARKETING AUTHORISATION NUMBER(S) EU/2/015/187/001-004
Maltese: EU/2/015/187/001-004
English: PCV2 ORF2 subunit antigen ≥1436 AU
Maltese: PCV2 ORF subjunit antiġen ≥ 1436 AU1
English: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Maltese: Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer L-OLANDA
English: 8.3 mg Antigenic units as determined in the in vitro potency test (antigenic mass assay).
Maltese: 8.3mg 1 Tajter ta' unit antiġeniċi miksub minn testijiet ta' potenza in vitro (antigenic mass assay)
English: dl-α-tocopheryl acetate
Maltese: dl-alpha - tocopherol acetate
English: Avoid multiple broaching.
Maltese: Evita li taqqab ħafna drabi.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Maltese: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni: - komuni ħafna (aktar minn wieħed f'10 annimali trattati li juru effetti mhux) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal trattati) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal trattati) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal trattati) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal trattati, inklużi rapporti iżolati).
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) PCV2 ORF2 subunit antigen
Maltese: TAS-SUSTANZA(i) ATTIVA(I) PCV2 ORF subjunit antiġen
English: Adjuvants: dl-α-tocopheryl acetate
Maltese: Sustanza mhux attiva: dl-alpha - tocopherol acetate
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis PCV ID
Maltese: Porcilis PCV ID
English: Pharmacotherapeutic group: immunologicals for Suidae, inactivated viral vaccines for pigs.
Maltese: Grupp farmako-terapewtiku: immunoloġiċi għall-Suidae, vaċċin virali inattivat għall-ħnieżer Kodici ATĊ veterinarja:
English: For intradermal use.
Maltese: Mhux applikabli.
English: In individual pigs the size may increase to 4 cm and redness may be observed.
Maltese: F`ċerti ħnieżer id-daqs jista' jikber sa 4 cm u ħmura tista tiġi osservata.
English: Cardboard box with 1 or 10 PET vials.
Maltese: Kaxxa tal-kartun b' 1 jew 10 kunjetti PET.
English: PET (polyethylene terephthalate) vial of 20 ml closed with a nitryl-based rubber stopper and sealed with an aluminium cap.
Maltese: Kunjett PET (polyethylene terephthalate) ta' 20ml magħluq b'tapp tal-gomma bbażat fuq n-nitryl u ssiġillat b'kappa tal-aluminju.
English: The animals return to normal within 1-2 days after the peak temperature is observed.
Maltese: C. l-annimali jirritornaw għan-normal fi żmien 1-2 ġranet wara li t-temperatura massima tkun osservata.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intradermal use
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI Użu minn ġol-ġilda.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis PCV ID emulsion for injection for pigs
Maltese: VETERINARJU Porcilis PCV ID emulsjoni għall-injezzjoni għall-ħnieżer
English: Pack size:
Maltese: Skema ta' vaċċinazzjoni:
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Intervet International B.V.5831 AN Boxmeer
Maltese: Intervet International B.V. 5831 AN Boxmeer L-OLANDA
English: STATEMENT OF ACTIVE SUBSTANCES One dose (0.2 ml) contains:
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Doża waħda (0.2ml) fiha:
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Maltese: L-addittivi (inkluż l-aġġuvanti) elenkati f‘sezzjoni 6.1 tas-Sommarju tal-karatteristiċi tal-prodott huma jew sustanzi ammissibbli li għalihom m'hemmx bżonn ta' limiti massimi ta' residwi kif indikat fittabella numru 1 tal-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010 huma kkunsidrati li ma jaqgħux fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009 meta wżati bħal f'dan il-prodott mediċinali veterinarju.
English: Safety and efficacy of Porcilis PCV ID have been demonstrated using the device IDAL.
Maltese: Is-sigurtà u l-effikaċja ta' Porcilis PCV ID ġie muri meta ntużal-apparat IDAL
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 0.2 ml contains:
Maltese: Kull doża ta' 0.2 ml fiha:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation:
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizazzjoni:
English: Interaction with other medicinal products and other forms of interaction Safety and efficacy data are available which demonstrate that this vaccine can be given with Porcilis M Hyo ID ONCE on the same day from 3 weeks of age, either at different sites (e.g. alternate sides of the neck), or at the same site providing that intradermal administration of each vaccine is separated by at least 3 cm.
Maltese: Interazzjoni ma' prodotti mediċinali oħra jew forom oħra ta' interazzjoni Hemm informazzjoni dwar is-sigurtà u l-effikaċja li turi li dan il-vaċċin veterinarju jista' jiġi amministrat ma Porcilis M Hyo ID ONCE fl-istess ġurnata minn eta` ta' 3 ġimgħat, jew f`post differenti (e.g. naħiet alternati tal-għonq), jew fl-istess post sakemm l-amministrazzjoni inta-dermali ta`kull vaċċin tkun separata mill lanqas bi 3 ċentimetri.
English: Ask your veterinary surgeon how to dispose of medicines no longer required.
Maltese: Staqsi lill-kirurgu veterinarju dwar kif l-aħjar li tarmi l-mediċini li ma jkunux aktar meħtieġa.
English: In individual pigs this temperature may increase up to 2 °C.
Maltese: F'xi ħnieżer individwali t-temperatura tista tiżdied sa 2
English: Pigs (for fattening).
Maltese: U LUŻU
English: The product stimulates the development of active immunity against porcine circovirus type 2 in pigs.
Maltese: Dan il-prodott jistimula l-iżvilupp tal-immunita` attiva kontra iċ-circovirus tip 2 fil-ħnieżer.
English: Safety and efficacy data are available which demonstrate that this vaccine can be given with Porcilis M Hyo ID ONCE on the same day from 3 weeks of age, either at different sites (e.g. alternate sides of the neck), or at the same site providing that intradermal administration of each vaccine is separated by at least 3 cm.
Maltese: Hemm informazzjoni dwar is-sigurtà u l-effikaċja li turi li dan il-vaċċin veterinarju jista' jiġi amministrat ma' Porcilis M Hyo ID ONCE fl-istess ġurnata minn eta` ta' 3 ġimgħat, jew f`post differenti (e.g. naħiet alternati tal-għonq), jew fl-istess post sakemm l-amministrazzjoni inta-dermali ta`kull vaċċin tkun separata mill lanqas bi 3 ċentimetri.
English: Glass vial (type I) of 10 ml closed with a nitryl-based rubber stopper and sealed with an aluminium cap.
Maltese: Kunjett tal-ħġieġ (tip I) ta' 10ml magħluq b'tapp tal-gomma bbażat fuq n-nitryl u s-siġillat b'kappa talaluminju.
English: BATCH NUMBER
Maltese: Mhux applikabli
English: 1Antigenic units as determined in the in vitro antigenic mass assay.
Maltese: 1 Tajter ta' unit antiġeniċi miksub minn testijiet ta' potenza in vitro (antigenic mass assay) Emulsjoni omoġenja bajda sa kważi bajda wara li tħawwadha.
English: EXP
Maltese: KUNJETTI
English: Light liquid paraffin
Maltese: Paraffina likwida ħafifa
English: Intradermal administration of 0.2 ml per animal, preferably at the sides of the neck, along the muscles of the back or in the hind leg using a multi-dose needle-free injection device for intradermal application of liquids suitable to deliver a “jet-stream” volume of vaccine (0.2ml ± 10%) through the epidermal layers of the skin.
Maltese: 2ml kull annimal preferibbilment fil-ġnub tal-għonq, mallmuskoli ta' wara jew fis-sieq ta' wara billi tuża apparat tal-injezzjoniet għall-ħafna dożi, mingħajr labar għall-applikazzjoni minn ġol-ġilda ta' likwidi, adattat li jagħti volum tal-vaċċin (0.
English: Zero days.
Maltese: IDAL® .
English: For the active immunisation of pigs to reduce viraemia, virus load in lungs and lymphoid tissues and virus shedding caused by PCV2 infection.
Maltese: Għal immunizzazzjoni attiva tal-ħnieżer tas-simna sabiex jitnaqqas l-ammont ta' virus fid-demm, lammont ta'virus fil-pulmuni u tessuti limfatiki u tferrix tal-virus ikkawżar minn infezzjonijiet talPCV2.
English: ROUTE(S) OF ADMINISTRATION Intradermal use
Maltese: MOD(I) TA' AMMINISTRAZZJONI Użu minn ġol-ġilda.
English: Name and address of the manufacturer responsible for batch release
Maltese: Isem u indirizz tal-manufattur responsabbli għall-ħruġ tal-lott
English: MedDRA Preferred Term (v.15.1)
Maltese: Terminu Ippreferut MedDRA (v.15.1)
English: - The active substance is brinzolamide.
Maltese: - Is-sustanza attiva hi brinzolamide.
English: (picture 2)
Maltese: (stampa 2).
English: Opened (1): Opened (2): Opened (3):
Maltese: Infetaħ (1): Infetaħ (2): Infetaħ (3):
English: Uncommon: cardio-respiratory distress, bradycardia, palpitations
Maltese: Mhux Komuni: problemi kardjo-respiratorji, bradikardija, palpitazzjonijiet
English: B-2870 Puurs
Maltese: B-2870 Puurs Il-Belġju
English: Carbonic anhydrase activity was approximately 40-70% of predose levels.
Maltese: L-attivita ta' carbonic anhydrase bejn wieħed u ieħor kienet ta' 40-70% tal-livelli ta' qabel id-doża.
English: Each ml of suspension contains 0.1 mg benzalkonium chloride.
Maltese: Kull ml ta' suspensjoni fiha 0.1 mg benzalkonium chloride.
English: SIA Novartis Baltics Eesti filiaal Tel: +372 66 30 810
Maltese: SIA Novartis Baltics Eesti filiaa Tel: +372 66 30 810
English: Date of first authorisation: 9 March 2000 Date of latest renewal: 29 January 2010
Maltese: Data tal-ewwl awtorizzazzjoni: 9 ta' Marzu 2000
English: At steady-state, brinzolamide and its metabolite RBC concentrations ranged from 22.0 to 46.1 and 17.1 to 88.6 µM, respectively.
Maltese: Fi stat fiss, ilkonċentrazzjonijiet ta' brinzolamide u tal-prodott tal-metaboliżmu tiegħu varjaw minn 22.0 sa 46.1 u 17.1 sa 88.6 µM rispettivament.
English: This medicine contains 3.35 µg benzalkonium chloride per drop (= 1 dose) which is equivalent to 0.01% or 0.1 mg/ml.
Maltese: Din il-mediċina fiha 3.35 µg ta' benzalkonium chloride f'kull taqtira (= doża) li hu ekwivalenti għal 0.01 % jew 0.1 mg/ml.
English: An additional decrease in mean diurnal IOP of 3.2 to 3.4 mmHg for the brinzolamide group and 3.2 to 4.2 mmHg for the timolol group were observed.
Maltese: Kien osservat tnaqqis addizzjonali fil-medja ta' IOP ta' matul il-ġurnata ta' 3.2 sa 3.4 mmHg għall-grupp ta' brinzolamide u ta' 3.2 sa 4.2 mmHg għall-grupp ta' timolol.
English: The following adverse reactions have been reported with brinzolamide 10mg/ml eye drops, suspension and 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 <1/1000), very rare (<1/10,000), or not known (cannot be estimated from the available data).
Maltese: Ir-reazzjonijiet avversi li ġejjin kienu rrappurtati bi brinzolamide 10mg/ml qtar għall-għajnejn, suspensjoni u huma ikklassifikati 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 <1/1000), rari ħafna (<1/10,000), jew mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Brinzolamide, an inhibitor of carbonic anhydrase II (CA-II), the predominant iso-enzyme in the eye, with an in vitro IC50 of 3.2 nM and a Ki of 0.13 nM against CA-II.
Maltese: Brinzolamide, inibitur ta' carbonic anhydrase II (CA-II), li huwa l-iżo-enżima prinċipali fl-għajn, b' IC50 in-vitro ta' 3.2 nM u Ki ta 0.13 nM kontra il-CA-II.
English: Contains benzalkonium chloride, mannitol (E421), carbomer 974P, tyloxapol, edetate disodium, sodium chloride, hydrochloric acid/sodium hydroxide (to adjust pH) and purified water.
Maltese: Fih benzalkonium chloride, mannitol (E421), carbomer 974P, tyloxapol, edetate, sodium, sodium chloride, hydrochloric acid/sodium hydroxide (biex jikontrolaw il-pH) u ilma pur.
English: The cytochrome P-450 isozymes responsible for metabolism of brinzolamide include CYP3A4 (main), CYP2A6, CYP2C8 and CYP2C9.
Maltese: L-iżozimi taċ-ċitokromju P-450 li jieħdu sehem fil-metaboliżmu ta' brinzolamide jinkludu CYP3A4 il-prinċipali), CYP2A6, CYP2C8 u CYP2C9.
English: Eye drops, suspension.
Maltese: Qtar għall-għajnejn, suspensjoni.
English: The inhibition of total RBC CA activity at steady state was approximately 70-75%.
Maltese: L-inibizzjoni totali tal-attivita tar-RBC CA fl-istat fiss kien ta' bejn wieħed u ieħor 70-75%.
English: • Hyperchloraemic acidosis.
Maltese: • Aċidozi iperklorimika.
English: • Known hypersensitivity to sulphonamides (see also section 4.4).
Maltese: • Sensittività eċċessiva magħrufa għal sulfonamides (ara wkoll sezzjoni 4.4).
English: Brinzolamide and N-desethylbrinzolamide are the predominant components in the urine along with trace levels (<1%) of the N-desmethoxypropyl and O-desmethyl metabolites.
Maltese: Il-komponenti prinċipali fl-awrina huma brinzolamide u N-desethylbrinzolamide, bi traċċi (<1%) ta' N-desmethoxypropyl u O-desmethyl bħala prodotti tal-metaboliżmu.
English: Hydrochloric acid/sodium hydroxide (to adjust pH) Purified water
Maltese: Hydochloric acid/sodium hydroxide (biex jikkontrollaw il-pH), Ilma pur.
English: Binding to plasma proteins is not extensive (about 60%).
Maltese: Ma' tantx jeħel mal-proteini tal-plażma (bejn wieħed u ieħor 60%).
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: • Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkata fis sezzjoni 6.1.
English: CARTON FOR SINGLE BOTTLE, 5 ml, 10 ml + CARTON FOR 3 x 5 ml BOTTLES
Maltese: KARTUNA TA' FLIXKUN WIEĦED, 5 ml, 10 ml + KARTUNA TA' TLIET FLIXKEN ta' 5 ml
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskolu-skeletriċi u tattessut konnettiv
English: It is expected that inhibitors of CYP3A4 such as ketoconazole, itraconazole, clotrimazole, ritonavir and troleandomycin will inhibit the metabolism of brinzolamide by CYP3A4.
Maltese: Huwa mistenni li l-inibituri ta' CYP3A4 bħalma huma ketoconazole, itraconazole, clortrimazole, ritonavir u troleandomycin jimpedixxu il-metaboliżmu ta' brinzolamide li jseħħ permezz ta' CYP3A4.
English: Benzalkonium chloride, which is commonly used as a preservative in ophthalmic products, has been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy.
Maltese: Benzalkonium chloride li ġeneralment jintuża bħala preservativ fil-prodotti tal-għajnejn, gie rrapurtat li jista' jikkawza keratopatija ttikkjata, u/jew keratopatija ulċerattiva tossika.
English: It could infect the drops
Maltese: Infezzjonijiet u infestazzjonijiet
English: In clinical studies involving 2732 patients treated with AZOPT as monotherapy or adjunctive therapy to timolol maleate 5 mg/ml, the most frequently reported treatment-related adverse reactions were: dysgeusia (6.0%) (bitter or unusual taste, see description below) and temporary blurred vision (5.4%) upon instillation, lasting from a few seconds to a few minutes (see also section 4.7).
Maltese: Fi studji kliniċi li saru fuq 2732 pazjent li ġew ikkurati b'AZOPT bħala monoterapija jew bħala terapija flimkien ma' 5 mg/ml timolol maleate, ir-reazzjonijiet avversi relatati mal-kura, li kienu laktar komuni kienu: disġewżja (6.0%) (togħma morra jew mhux tas-soltu, ara id-deskrizzjoni hawn taħt) u vista mċajpra għal żmien qasir (5.4%) malli tqattar, li damet minn ftit sekondi sa ftit minuti (ara wkoll sezzjoni 4.7).
English: Dose-related decreases in foetal weights were observed in pups of dams receiving brinzolamide orally ranging from a slight decrease (about 5-6%) at 2 mg/kg/day to nearly 14% at 18 mg/kg/day.
Maltese: Dan it-tnaqqis kien ivarja bejn tnaqqis żgħir (bejn 5-6%) b'doża ta' 2 mg/kg/ġurnata sa kważi 14% b'doża ta 18 mg/kg/ġurnata.
English: Uncommon: erectile dysfunction
Maltese: Komuni: disġewżja
English: 5 ml 10 ml 3 x 5ml
Maltese: 3 x 5 ml
English: - The other ingredients are benzalkonium chloride, carbomer 974P, edetate disodium, mannitol (E421), purified water, sodium chloride, tyloxapol.
Maltese: - Is-sustanzi mhux attivi l-oħra huma huma benzalkonium chloride, carbomer 974P, edetate disodium, mannitol (E421), ilma ppurifikat, sodium chloride, tyloxapol.
English: Subjects with moderate renal impairment (creatinine clearance of 30-60 ml/minute) were administered 1 mg of brinzolamide twice daily orally for up to 54 weeks.
Maltese: Persuni li jbgħatu minn indeboliment moderat fil-kliewi (tneħħija tal-krejatinina ta' 30-60 ml/minuta) ġew mogħtija 1 mg ta' brinzolamide mill-ħalq darbtejn kuljum għall-54 ġimgħa.
English: Each ml of suspension contains 10 mg brinzolamide.
Maltese: Kull ml ta' suspensjoni fiha 10 mg brinzolamide.
English: Not Known: hypersensitivity
Maltese: Mhux Komuni: sensittività eċċessiva
English: AZOPT 10 mg/ml eye drops, suspension brinzolamide
Maltese: AZOPT 10 mg/ml qtar għall-għajnejn, suspensjoni brinzolamide
English: AZOPT may cause the same allergy.
Maltese: jikkawża l-istess tip ta' allerġija.
English: AZOPT contains benzalkonium chloride
Maltese: AZOPT fih benzalkonium chloride
English: Gastrointestinal, nervous system, haematological, renal and metabolic effects are generally associated with systemic carbonic anhydrase inhibitors.
Maltese: Effetti gastrointestinali, fis-sistema nervuża, ematoloġiċi, fil-kliewi u fil-metaboliżmu, ġeneralment huma assoċjati ma' inibituri sistemiċi ta' carbonic anhydrase.
English: Use with caution in patients with risk of renal impairment because the possible risk of metabolic acidosis (see section 4.2).
Maltese: Uża b'attenzjoni f'pazjenti b'riskju ta' indeboliment renali minħabba r-riskju possibbli ta' aċidożi metabolika (ara sezzjoni 4.2).
English: Uncommon: apathy, depression, depressed mood, libido decreased, nightmare, nervousness Rare: insomnia
Maltese: Mhux Komuni: apatija, depressjoni, burdata depressa, tnaqqis fil-libido, inkubi, nervi
English: In an oral pharmacokinetic study, healthy volunteers received 1 mg capsules of brinzolamide twice daily for up to 32 weeks and RBC CA activity was measured to assess the degree of systemic CA inhibition.
Maltese: Fi studju farmakokinetiku, li sar, numru ta' volontiera b'saħħithom ġew mogħtija mil-ħalq kapsuli ta' 1 mg brinzolamide darbtejn kuljum għal 32 gimgħa u l-attivita tal-RBC CA kienet imkejjla biex jiġi determinat l-ammont ta' inibizzjoni tal-CA sistemiku.
English: The following pack sizes are available: outer cartons containing 1 x 5 ml, 3 x 5 ml and 1 x 10 ml bottles.
Maltese: Il-prodott jiġi f'dawn il-pakketti: kaxxa li fiha flixkun x 5 ml, 3 fliexken x 5 ml u flixkun x 10 ml.
English: • open-angle glaucoma as monotherapy in adult patients unresponsive to beta-blockers or in adult patients in whom betablockers are contraindicated, or as adjunctive therapy to beta-blockers or prostaglandin analogues (see also section 5.1).
Maltese: • glawkoma tat-tip ‘open-angle' bħala monoterapija f'pazjenti adulti li mhux qed jirrispondu għall-kura bil-beta-blokers jew f'pazjenti adulti fejn il-beta-blokers huma kontra-indikati, jew bħala kura flimkien ma' beta-blokers jew analogi ta' prostaglandin (ara wkoll sezzjoni 5.1).
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 normali l-livelli ta' l-aċidità (livelli tal-pH).
English: Not Known: liver function test abnormal
Maltese: Mhux Komuni: funzjoni erettili mhux normali
English: N-Desethylbrinzolamide accumulated in RBCs to steady state within 2028 weeks reaching concentrations ranging from 6-30 µM.
Maltese: N-desethylbrinzolamide akkumula fir-RBCs wara 20-28 gimgħa u laħaq konċentrazzjonijiet fi stat fiss ta' 6-30 µM.