FrancophonIA/ELRC3.0 huggingface dataset:
English: Protection starts 2 weeks after vaccination and lasts for 6 months.
Maltese: Il-protezzjoni tibda ġimagħtejn wara t-tilqim u ddum 6 xhur.
English: The injection of Bovalto Ibraxion may cause a temporary tissue reaction at the site of injection, which may last for three weeks and rarely up to five weeks.
Maltese: L-injezzjoni ta' Bovalto Ibraxion tista' tikkawża reazzjoni temporanja fit-tessut fis-sit tal-injezzjoni li tista' ddum sa tliet ġimgħat u rarament sa ħames ġimgħat.
English: Why is Bovalto Ibraxion approved?
Maltese: Għaliex ġie approvat Bovalto Ibraxion?
English: IBR virus infections affect the airways with nasal discharge, conjunctivitis (inflammation of the eye) and coughing.
Maltese: L-infezzjonijiet tal-virus tal-IBR jaffettwaw il-pajpijiet tan-nifs b'tisfija nażali, il-konġuntivite (infjammazzjoni tal-għajn) u s-sogħla.
English: Other information about Bovalto Ibraxion?
Maltese: Kif jintuża Bovalto Ibraxion?
English: Two injections are given 3 weeks apart to calves from age 2 weeks provided they have not acquired antibodies against IBR virus from the mother.
Maltese: Żewġ injezzjonijiet jingħataw 3 ġimgħat il-bogħod minn xulxin lill-għoġġiela minn ġimagħtejn 'il fuq sakemm ma jkunux wirtu antikorpi kontra l-virus tal-IBR mingħand ommijiethom.
English: If pain persists for more than 12 hours after medical examination, the doctor should be contacted again.
Maltese: Jekk l-uġigħ jippersisti għal aktar minn 12-il siegħa wara l-eżami mediku, it-tabib għandu jerġa' jiġi kkuntattjat.
English: Field studies were conducted in around 300 cattle of various ages in both an IBR contaminated and an IBR free environment.
Maltese: Studji fuq il-post twettqu fuq madwar 300 ifrat ta' etajiet varji kemm f'ambjent ikkontaminat bl-IBR kif ukoll f'ambjent ħieles mill-IBR.
English: What are the risks associated with Bovalto Ibraxion?
Maltese: X'riskji huma assoċjati ma' Bovalto Ibraxion?
English: The vaccine is given into the neck at the front of the shoulder.
Maltese: It-tilqima tingħata fl-għonq fuq in-naħa ta' quddiem tal-ispalla.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Bovalto Ibraxion's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) tal-Aġenzija kkonkluda li l-benefiċċji ta' Bovalto Ibraxion huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: The virus in the vaccine has also been modified to allow vaccinated animals to be distinguished from naturally infected animals so allowing better disease management.
Maltese: Il-virus fit-tilqima ġie modifikat ukoll sabiex jippermetti li l-annimali mlaqqma jintgħarfu mill-annimali infettati b'mod naturali u b'hekk jippermetti ġestjoni aħjar tal-marda.
English: When Bovalto Ibraxion is given to cattle the animals' immune system recognises the inactive virus as ‘foreign' and makes antibodies against it.
Maltese: Meta Bovalto Ibraxion jingħata lill-ifrat, is-sistema immunitarja tal-annimali tagħraf lill-virus inattiv bħala “barrani” u tipproduċi antikorpi kontrih.
English: Pfizer Animal Health 2000 Rockford Road Charles City, Iowa 50616 USA
Maltese: Pfizer Animal Health 2000 Rockford Road Charles City, Iowa 50616 L-Istati Uniti
English: For a full list of excipients, see section 6.1.
Maltese: Għal lista sħiħa ta' sustanzi mhux attivi, ara section 6.1.
English: Pfizer Limited Ramsgate Road Sandwich, Kent CT13 9NJ United Kingdom
Maltese: Pfizer Limited Ramsgate Road Sandwich, Kent CT13 9NJ Renju Unit
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Poulvac FluFend H5N3 RG
Maltese: VETERINARJU Poulvac FluFend H5N3 RG
English: White oil is a mineral hydrocarbon, Arlacel 83V is sorbitan sesquioleate, Tween 80 is polyoxyethylene sorbitan monooleate, sodium phosphate dibasic (E339) and potassium phosphate monobasic (E340) are substances with E numbers.
Maltese: Zejt abjad huwa idrokarburi minerali, Arlacel 83V huwa sesquioleate sorbitan, Tween 80 huwa sorbitan monuleat polyoxyethylene, sodju fosfat dibasiku (E339) u potassju fosfat monobażiċi (E340) huma sustanzi bin-numri E.
English: MANUFACTURER'S BATCH NUMBER Lot (Number)
Maltese: NUMRU TAL-LOTT TAL-MANIFATTUR Lott (Numru)
English: PACKAGE SIZE 500 ml
Maltese: DAQS TAL-PAKKETT 500 ml
English: Animal
Maltese: VETERINARJU
English: PACKAGE SIZE 1 x 500 ml 10 x 500 ml
Maltese: DAQS TAL-PAKKETT 1 x 500 ml
English: Mineral hydrocarbons, low to high viscosity including microcrystalline waxes, approximately C10-C60, aliphatic, branched aliphatic and alicyclic compounds
Maltese: Idrokarboni minerali, baxxa għal viskożità għolja li jinkludu xama 'mikrokristallina , madwar C10C60, alifatiċi, branched komposti alifatiċi u aliċikliċi
English: 6.1 List of excipients
Maltese: 6.1 Lista ta' sustanzi
English: Store and transport refrigerated (2ºC - 8ºC).
Maltese: Aħżen u ttrasporta ġo friġġ (2C - 8C).
English: Potassium phosphate monobasic
Maltese: Sodium chloride Sodium phosphate dibasic Potassium phosphate monobasic
English: Polyoxyethylen e sorbitan monooleate and trioleate
Maltese: Tween 80 (polyoxyethylen e sorbitan monooleate)
English: 1) There are important outstanding issues regarding the differences of production and control between the manufacturing sites (including the nature of the eggs used) and the lack of a validation study for the potency test on finished product (it appears that final product tests are only done at Weesp but in-process tests such as titration and HA quantification need to be equivalent too).
Maltese: 1) Hemm kwistjonijiet importanti li għadhom ma ġewx solvuti dwar id-differenzi fuq il-produzzjoni u l-kontroll bejn is-siti ta' produzzjoni (li jinkludu n-natura tal-bajd użati) u in-nuqqas ta' studju dwar il-validita' fuq it-test tal-qawwa tal-prodott finali (jidher li t-testijiet tal-prodott finali jsiru biss f'Weesp imma testijiet matul il-proċess bħal titrazzjoni u kwantifikazzjoni HA jeħtieġ li jkunu ekwivalenti wkoll).
English: QUALITY ASPECTS
Maltese: KOMPOŻIZZJONI KWALITATTIVA
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary Following the administration of a double dose in chickens and ducks, no adverse reactions other than those described in section 4.6 have been observed.
Maltese: 4.10 Doża eċċessiva (sintomi, proċeduri ta' emerġenza, antidoti)jekk ikun hemm bżonn Wara l-amministrazzjoni ta' doża doppja fit-tiġieġ u l-papri, l-ebda reazzjonijiet avversi għajr dawk deskritti f'sezzjoni 4.6 ma ġew osservati.
English: MARKETING AUTHORISATION NUMBER EU/2/06/060/001-002
Maltese: NUMRU/I TA' L-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/06/060/001-002
English: Chickens and ducks.
Maltese: Tiġieġ u papri.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/060/001-002
Maltese: NUMRU(I) TA' L-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/06/060/001-002
English: Ducks:
Maltese: Papri:
English: PHARMACEUTICAL FORM Emulsion for injection.
Maltese: GĦAMLA FARMAĊEWTIKA Emulsjoni għall-injezzjoni.
English: 3 weeks of age or older: 0.5 ml intramuscularly in the breast muscle.
Maltese: Età ta' 3 ġimgħat jew aktar: 0.5 ml intramuskolari fil-muskolu tas-sider.
English: MRLs Target
Maltese: L-ebda MRL
English: Inactivated recombinant avian influenza virus of H5N3 subtype (strain rg-A/ck/VN/C58/04)
Maltese: Virus rikombinat inattivat ta' l-influwenza avjana ta' sottotip H5N3 (strejn rg-A/ck/VN/C58/04)
English: Inactivated recombinant avian influenza virus of H5N3 subtype (strain rg-A/ck/VN/C58/04) ) > 1:40 HI Units
Maltese: Virus rikombinat inattivat ta' l-influwenza avjana . ta' sottotip H5N3 (strejn rg-A/ck/VN/C58/04) > 1: 40 HI Units
English: Ducks
Maltese: Mhux
English: Inactivated recombinant avian influenza virus of H5N3 subtype (strain rg-A/ck/VN/C58/04) > 1:40 HI units per dose
Maltese: Virus rikombinant inattivat ta' l-influwenza avjana tas-sottotip H5N3 (strejn rg-A/ck/VN/C58/04) > 1: 40 HI units f'doża
English: To the user:
Maltese: Aġġuvanti:
English: At one day old: 0.2 ml subcutaneously in the neck.
Maltese: F'età ta' jum wieħed: 0.2 ml taħt il-ġilda fl-għonq.
English: MRLs Target tissues
Maltese: L-ebda MRL meħtieġa
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Poulvac FluFend H5N3 RG emulsion for injection for chickens and ducks
Maltese: Poulvac FluFend H5N3 RG Emulsjoni għall-injezzjoni għat-tiġieġ u Papri
English: The following constituents of Poulvac FluFend H5N3 RG are included in Table 1 (Allowed substances) of the annex to Commission Regulation (EU) No 37/2010 as follows:
Maltese: Dawn il-kostitwenti ta 'Poulvac RG FluFend H5N3 huma inklużi fitTabella 1 (sustanzi Permissibbli) tal-Anness għar-Regolament (UE) Nru 37/2010 kif ġej:
English: Water in oil adjuvant
Maltese: Żejt abjad
English: Ducks: Reduction of clinical signs and virus excretion after challenge.
Maltese: Papri: Tnaqqis ta' sinjali kliniċi u eskrezzjoni tal-virus wara sfida immunloġika bil-prodott.
English: Duration of immunity in ducks : 14 weeks after the second injection.
Maltese: It-tul ta' l-immunità fil-papri: 14-il ġimgħa wara t-tieni njezzjoni.
English: PHARMACEUTICAL FORM Emulsion for injection
Maltese: GĦAMLA FARMAĊEWTIKA Emulsjoni għall-injezzjoni
English: For active immunisation of chickens and ducks against avian influenza virus type A, subtype H5.
Maltese: Għal imuniżżazzjoni attiva ta' tiġieġ u papri kontra l-virus ta' l-influwenza avjana ta' tip A, sottotip H5.
English: The import, sale, supply and/or use of Poulvac FluFend H5N3 RG is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy.
Maltese: L-importazzjoni, il-bejgħ, il-provvista u/jew l-użu ta' Poulvac FluFend H5N3 RG huma pprojbiti jew jistgħu jkunu pprojbiti f'ċertu Stati Membri jew ġo parti mit-territorju tagħhom minħabba l-politika nazzjonali tagħhom dwar is-saħħa ta' l-annimali.
English: Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.
Maltese: Attenzjoni kiruġika, esperta, u FIL-PRONT, hi meħtieġa li tista' tinkludi inċiżjoni u irrigazzjoni bikrija tal-parti injettata, speċjalment jekk ikun hemm involviment tal-laħam tas-saba' jew l-għerq.
English: Onset of immunity: 3 weeks after the second injection.
Maltese: Bidu ta' immunità: 3 ġimgħat wara t-tieni injezzjoni.
English: Marker
Maltese: Papri
English: Pharmacologically active substance
Maltese: Sustanza(i) farmakoloġikam ent attiva(i)
English: a) the administration of the veterinary medicinal product to animals will interfere with the implementation of national programmes for the diagnosis, control and eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals b) the disease to which the veterinary medicinal product is intended to confer immunity is largely absent from the territory.
Maltese: a) l-amministrazzjoni tal-prodott mediċinali veterinarju lill-annimali tinterferixxi ma' limplimentazzjoni ta' programmi nazzjonali għad-dijanjosi, il-kontroll u l-eradikazzjoni tal-mard ta' l-annimali, jew tikkawża diffikultajiet fiċ-ċertifikazzjoni ta' l-assenza tal-kontaminazzjoni f'annimali ħajjin jew fl-ikel jew prodotti oħrajn miġjuba minn annimali ttrattati;
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
Maltese: TAS-SUSTANZA(I) BIOLOĠIKA(ĊI) ATTIVA(I)
English: INDICATIONS
Maltese: MANIFATTURI
English: One dose of 0.5 ml contains:
Maltese: Doża waħda ta' 0.5 ml fiha:
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: Isem u indirizz tal-manufattur(i) tas-sustanza(i) bioloġika(ċi) attiva(i)
English: To induce serological response against N3 neuraminidase which can act as a marker to Differentiate Infected from Vaccinated Animals (DIVA strategy).
Maltese: Biex tinduċi reazzjoni seroloġika kontra N3 neuraminidase li jistà jservi bħala marker biex Tagħraf Annimali Infettati minn Dawk Imlaqqma (strateġija DIVA).
English: To stimulate active immunity in chickens and ducks against avian influenza virus, H5 subtype.
Maltese: Biex tistimula l-immunità attiva fit-tiġieġ u l-papri kontra l-virus ta' l-influenza avjana, sottotip H5.
English: Sodium chloride
Maltese: Sodium chloride Mhux appklikabbli
English: Revaccinate after 3 weeks.
Maltese: U S-SIDIEN TA' L-AWTORIZZAZZJONI
English: Sorbitan sesquioleate
Maltese: Arlacel 83V (sorbitan sesquioleate)
English: To the physician:
Maltese: Grupp farmako-terapewtiku:
English: Revaccinate after 3 weeks: 0.5 ml subcutaneously in the neck The vaccination schedule should be completed at least 4 weeks before the start of laying.
Maltese: Laqqam mill-ġdid wara 3 ġimgħat: 0.5 ml taħt il-ġilda fl-għonq L-iskeda tat-tilqim għandha tkun kompluta ta' l-anqas 4 ġimgħat qabel ma jibdew ibidu.
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, Member States prohibit or may prohibit the import, sale, supply and/or use of the veterinary medicinal product on the whole or part of their territory if it is established that:
Maltese: Skond l-Artikolu 71 tad-Direttiva 2001/82/KEE tal-Parlament Ewropew u tal-Kunsill, l-Istati Membri jipprojbixxu jew jistgħu jipprojbixxu l-importazzjoni, il-bejgħ, il-forniment u/jew l-użu tal-prodott mediċinali veterinarju fit-territorju sħiħ tagħhom jew parti minnu jekk jiġi stabbilit illi:
English: Reduction of mortality and virus excretion after challenge.
Maltese: Tnaqqis ta' mortalità u eskrezzjoni tal-virus wara sfida immunoloġika bil-prodott.
English: Reduction of clinical signs and virus excretion after challenge.
Maltese: Tnaqqis ta' sinjali kliniċi u eskrezzjoni ta' virus wara sfida immunoloġika bil-prodott.
English: Pharmacotherapeutic group: Inactivated recombinant vaccine, ATC vet code: QI01AA23
Maltese: Vaċċin rikombinanti inattivat, Kodiċi ATĊ veterinarja:
English: Τηλ.
Maltese: Sena.
English: Avoid stress in the birds around the time of vaccination.
Maltese: Evita stress fit-tjur fiż-żmien tal-vaċċinazzjoni.
English: Excipients:
Maltese: Tiġieġ:
English: 6.5 Nature and composition of immediate packaging 500 ml of vaccine in high-density polyethylene bottles, closed with a nitrile rubber stopper and aluminium cap.
Maltese: 500 ml ta' vaċċin fi fliexken tal-polyethylene ta' densità għolja, magħluqin f'tapp tal-lastku nitrile u b'għatu ta' l-aluminju.
English: STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS One dose of 0.5 ml contains:
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA U SUSTANZI OĦRA Doża waħda ta' 0.5 ml fiha:
English: Any person intending to import, sell, supply and/or use Poulvac FluFend H5N3 RG must consult the relevant Member States competent authority on the current vaccination policies prior to the import, sale, supply and/or use.
Maltese: Kull persuna li bi ħsiebha timporta, tbiegħ, tipprovdi u/jew tuża Poulvac FluFend H5N3 RG għandha tikkonsulta l-Awtorità Kompetenti ta' l-Istat Membru dwar il-programmi ta' tilqim kurrenti qabel l-importazzjoni, bejġh, provista u/jew użu.
English: • Invasive candidiasis.
Maltese: • Kandidjażi invażiva.
English: QUALITY - MODULE 3
Maltese: - MODULU 3
English: Kent
Maltese: Billi
English: Diflucan has been included in the list of products for Summary of Product Characteristics (SPC) harmonisation in accordance with Article 30(2) of Directive 2001/83/EC, as amended.
Maltese: Diflucan ġie inkluż fil-lista ta' prodotti għall-armonizzazzjoni tas-Sommarju tal-Karatteristiċi talProdott (SPC) skont l-Artikolu 30(2) tad-Direttiva 2001/83/KE, kif emendata.
English: Section 5.1 - Pharmacodynamic properties
Maltese: Sezzjoni 5.1 - Karatteristiċi farmakodinamiċi
English: Additional data were available from a compassionate use study (EU, 2006).
Maltese: Dejta addizzjonali kienet disponibbli minn studju dwar l-użu kompassjonali (EU, 2006).
English: Cryptococcal infections in children
Maltese: Infezzjonijiet kriptokokkali fit-tfal
English: Scientific conclusions
Maltese: KWALITÀ
English: Cryptococcosis is a defining opportunistic infection for AIDS.
Maltese: Il-kriptokokkożi hi infezzjoni opportunistika ta' definizzjoni għall-AIDS.
English: • Cryptococcal meningitis (see section 4.4).
Maltese: • Meninġite kriptokokkali (ara s-sezzjoni 4.4).
English: Cryptococcal meningitis is caused by the fungus Cryptococcus neoformans.
Maltese: Il-meninġite kriptokokkali hija kkawżata mill-fungus Cryptococcus neoformans.
English: Fluconazole also exhibits activity in vitro against Cryptococcus species.
Maltese: Fluconazole tesebixxi wkoll attività in vitro kontra l-ispeċi Cryptococcus.
English: Diflucan (fluconazole) is indicated in the following fungal infections (see section 5.1).
Maltese: Diflucan (fluconazole) huwa indikat fl-infezzjonijiet fungali li ġejjin (ara s-sezzjoni 5.1).
English: Diflucan (fluconazole) is indicated in the following fungal infections in adults (see section 5.1):
Maltese: Diflucan (fluconazole) huwa indikat fl-infezzjonijiet fungali fl-adulti li ġejjin (ara s-sezzjoni 5.1):
English: The indication of relapse prevention in immunocompromised (HIV and cancer) patients was investigated.
Maltese: L-indikazzjoni ta' prevenzjoni mir-rikaduta f'pazjenti immunokompromessi (HIV u kanċer) ġiet investigata.
English: Based on the review of data the CHMP adopted a harmonised Module 3.
Maltese: Fuq il-bażi tar-reviżjoni tad-dejta, is-CHMP adotta Modulu 3 armonizzat.
English: Fluconazole is effective as a treatment against fungal infections in adults across the dose range recommended in national SPCs (50-400 mg daily).
Maltese: Fluconazole hija effettiva bħala kura kontra infezzjonijiet fungali fl-adulti tul il-medda ta' dożi rrakkomandati fl-SPCs nazzjonali (50-400 mg kuljum).
English: 50 mg, 100 mg, 150 mg and 200 mg capsule, 5 mg/mL syrup, 50 mg/5mL or 200 mg/5 mL powder for oral suspension, 2 mg/mL solution for infusion.
Maltese: Kapsula ta' 50 mg, 100 mg, 150 mg u 200 mg, xiropp ta' 5 mg/mL, trab ta' 50 mg/5mL jew 200 mg/5 mL għal sospensjoni orali, soluzzjoni ta' 2 mg/mL għall-infużjoni.
English: Fluconazole displays antifungal activity against most clinically common Candida species.
Maltese: Fluconazole turi attività antifungali kontra l-ispeċi Candida l-aktar klinikament komuni.
English: As fluconazole is a potent CYP2C9 inhibitor and a moderate CYP3A4 inhibitor and fluconazole is also an inhibitor of CYP2C19, treated patients who are concomitantly treated with medicinal products with a narrow therapeutic window metabolised through CYP2C9, CYP2C19 and CYP3A4, should be monitored.
Maltese: Minħabba li fluconazole hi inibitur qawwi ta' CYP2C9 u inibitur moderat ta' CYP3A4 u fluconazole hi wkoll inibitur ta' CYP2C19, il-pazjenti kkurati li huma kkurati b'mod konkomittanti ma' prodotti mediċinali b'tieqa terapewtika dejqa metabolizzati permezz ta' CYP2C9, CYP2C19 u CYP3A4, għandhom jiġu sorveljati.
English: In the final approved text of the section 4.2 of the SPC the doses in the paediatric population have been divided in age groups of Infant, toddler and children (28 days to 11 years old), adolescents (12 years to 17 years old) and term newborn infants (0 to 27 days old).
Maltese: Fit-test finali approvat tas-sezzjoni 4.2 tal-SPC, id-dożi fil-popolazzjoni pedjatrika nqasmu fi gruppi tal-etajiet ta' Trabi, tfal żgħar u tfal (28 ġurnata sa 11-il sena), adoloxxenti (12-il sena sa 17-il sena) u trabi tat-twelid li twieldu fi żmienhom (età minn 0 sa 27 jum).
English: Fluconazole is available also for intravenous (IV) use in the 2 mg/mL saline solution formulation.
Maltese: Fluconazole hi disponibbli wkoll għal użu ġol-vina (IV) fil-formulazzjoni ta' soluzzjoni salina ta' 2 mg/mL.
English: Section 4.8 - Undesirable effects
Maltese: Sezzjoni 4.8 - Effetti mhux mixtieqa
English: Fluconazole specifically inhibits the fungal ergosterol synthesis and the mycotic cytochrome P-450 mediated enzymes.
Maltese: Fluconazole speċifikament tinibixxi s-sinteżi ergosteroli fungali u l-enzima medjata taċ-ċitokromju mikotiku P-450.
English: For the 150 mg, one capsule presentation
Maltese: Għad-doża ta' 150 mg, fi preżentazzjoni ta' kapsula waħda
English: Candidemia occurs in up to 12% of HIV-infected children with chronically indwelling central venous catheters for total parental nutrition or intravenous antibiotics.
Maltese: Il-kandidemja sseħħ f'sa 12% tat-tfal infettati bl-HIV b'katiters venużi ċentrali kronikament impjantati għan-nutrizzjoni parentali totali jew għall-antibijotiċi ġol-vini.
English: A harmonised Module 3 was also adopted.
Maltese: Il-Modulu 3 armonizzat ġie adottat ukoll.
English: • Dermatomycosis including tinea pedis, tinea corporis, tinea cruris, tinea versicolor and dermal candida infections when systemic therapy is indicated.
Maltese: • Dermatomikożi li tinkludi tinea pedis, tinea corporis, tinea cruris, tinea versicolor u infezzjonijiet ta' kandida tal-ġilda meta tkun indikata terapija sistemika.
English: In general the Core Safety Profile, dated 2 April 2009 was considered.
Maltese: B'mod ġenerali, ġie kkunsidrat il-Profil tas-Sigurtà Ewlieni, datat it-2 ta' April 2009.
English: Risk factors for oesophageal candidiasis in children with HIV infection include low CD4 count (<100 cells/mm3), high viral load, and neutropenia (<500 cells/mm3).
Maltese: Il-fatturi ta' riskju għall-kandidjażi fl-esofagu fi tfal bl-infezzjoni HIV jinkludu numru baxx ta' CD4 (<100 ċellula/mm3), kwantità virali għolja, u newtropenja (<500 ċellola/mm3).
English: Section 4.1 - Therapeutic Indications
Maltese: Sezzjoni 4.1 - Indikazzjonijiet terapewtiċi
English: Mucosal candidiasis (Oropharyngeal and oesophageal) in children
Maltese: Kandidjażi mukosali (Orofarinġali u fl-esofagu) fit-tfal
English: Dermatomycoses include Tinea pedis, Tinea corporis, Tinea cruris, Tinea versicolor, Tinea unguinium (onychomycosis) and dermal Candida infections.
Maltese: Id-dermatomikożi tinkludi t-Tinea pedis, it-Tinea corporis, it-Tinea cruris, it-Tinea versicolor, it-Tinea unguinium (onikomikożi) u infezzjonijiet Candida tal-ġilda.
English: The original applications for the prevention of fungal infections indication included seven comparative clinical studies in which 755 patients received oral fluconazole, 383 patients placebo and 374 patients oral comparative agents.
Maltese: Lapplikazzjonijiet oriġinali għall-indikazzjoni ta' prevenzjoni ta' infezzjonijiet fungali inkludew seba' studji kliniċi komparattivi li fihom, 755 pazjent irċievew fluconazole orali, 383 pazjent irċievew plaċebo u 374 pazjent irċievew sustanzi orali komparattivi.
English: Oropharyngeal candidiasis (OPC) continues to be one of the most frequent opportunistic infections in HIV-infected children during the Highly Active Anti-Retroviral Therapy (HAART) era (28% of children), with an incidence rate of 0.93 per 100 child-years.
Maltese: Kandidjażi orofarinġali (OPC) għadha waħda mill-iktar infezzjonijiet opportunistiċi frekwenti (28% tat-tfal) fi tfal infettati bl-HIV matul il-perjodu tal-Highly Active Anti-Retroviral Therapy (HAART), b'rata ta' inċidenza ta' 0.93 għal kull 100 sena tat-tfal.
English: Paediatric Use
Maltese: Użu Pedjatriku
English: Several different dosing regimens were employed, 100 mg/day, 200 mg/day and 200 mg three times/week.
Maltese: Ingħataw diversi dożaġġi differenti, 100 mg/kuljum, 200 mg/kuljum u 200 mg tliet darbiet/ġimgħa.
English: Fluconazole is available for oral use in the 50 mg, 100 mg, 150 mg and 200 mg capsule formulation, in the 5 mg/mL syrup formulation, and in the 50 mg or 200 mg/5 mL powder for oral suspension on reconstitution with water formulation.
Maltese: Fluconazole hija disponibbli għal użu orali fil-formulazzjoni kapsulari ta' 50 mg, 100 mg, 150 mg u ta' 200 mg, fil-formulazzjoni ta' xiropp ta' 5 mg/mL, u bħala trab ta' 50 mg jew 200 mg/5 mL għal sospensjoni orali b'rikostruzzjoni bil-formolazzjoni tal-ilma.