FrancophonIA/ELRC3.0 huggingface dataset:
English: • Reminder card with the following key messages: o Need to measure serum creatinine before treatment with Aclasta o Contraindication in patients with creatinine clearance < 35 ml/min o Contraindication in pregnancy and in breast-feeding women due to potential teratogenicity o Need to ensure appropriate hydration of the patient o Need to infuse Aclasta slowly over a period of no less than 15 minutes o One-yearly dosing regime o Adequate calcium and vitamin D intake are recommended in association with Aclasta administration.
Maltese: • Biljett biex ifakkar b'dawn il-messaġġi essenzjali: o Il-bżonn li titkejjel il-kreatinna fis-serum qabel trattament b'Aclasta o Il-kontraindikazzjoni f'pazjenti bi tneħħija tal-kreatinina ta' < 35 ml/min o Il-kontra-indikazzjoni f'nisa tqal u li qed ireddgħu minħabba li jista' jkun teratoġeniku o Il-bżonn li tiżgura l-idratazzjoni xierqa tal-pazjent o Il-bżonn li l-infużjoni ta' Aclasta tingħata bil-mod fuq perjodu ta' mhux anqas minn 15-il minuta o Il-frekwenza tad-doża li tingħata darba f'sena o Li ammonti xierqa ta' calcium u vitamina D huma rakkomandati li jittieħedu meta tingħata Aclasta o Il-bżonn ta' attività fiżika xierqa, li ma tpejjipx u dieta tajba għas-saħħa.
English: The Member States shall ensure that the Marketing Authorisation Holder (MAH) will provide all physicians who are expected to prescribe/use Aclasta in the authorised indications of treatment of osteoporosis in post-menopausal women and in men at increased risk of fracture, including those with a recent low-trauma hip fracture, and treatment of osteoporosis associated with long-term systemic glucocorticoid therapy in post-menopausal women and in men at increased risk of fracture with an updated physician information pack containing the following:
Maltese: L-Istati Membri għandhom jiżguraw li d-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) se jipprovdi lit-tobba kollha li huma mistennija jordnaw/jużaw Aclasta fl-indikazzjonijiet awtorizzati tal-kura ta' osteoporożi fin-nisa wara l-menopawsa u f'irġiel li għandhom riskju akbar ta' ksur, inklużi dawk li kellhom ksur tal-ġenbejn li ma joħloqx ħsara kbira, u kura ta' osteoporożi assoċjata ma' terapija sistemika bi glukokortikojdi għal perjodu twil ta' żmien f'nisa wara l-menopawsa u f'irġiel li għandhom riskju akbar ta' ksur b'pakkett ta' informazzjoni għat-tobba aġġornat li fih dawn li ġejjin:
English: • Physician educational material • Patient information pack
Maltese: • Materjal edukattiv għat-tobba
English: • Contraindication in patients with severe kidney problems
Maltese: • Il-kontraindikazzjoni f'pazjenti bi problemi severi fil-kliewi
English: • Key signs and symptoms of serious adverse events
Maltese: • Is-sinjali u s-sintomi essenzjali ta' każijiet avversi serji
English: • Need for adequate calcium & vitamin D supplementation, appropriate physical activity, non smoking and healthy diet
Maltese: • Il-bżonn ta' supplimentazzjoni xierqa bil-calcium u l-vitamina D, attività fiżika xierqa, li ma tpejjipx u dieta tajba għas-saħħa
English: • Package leaflet
Maltese: • Pakkett ta' informazzjoni għall-pazjent
English: The patient information pack should be provided and contain the following key messages:
Maltese: Il-pakkett ta' informazzjoni għall-pazjent għandu jingħata u għandu jkun fih il-messaġġi essenzjali li ġejjin:
English: Grounds for CHMP opinion
Maltese: Raġunijiet għal opinjoni tas-CHMP
English: On 25 January 2016 the Netherlands therefore triggered a referral under Article 31 of Directive 2001/83/EC, and requested the CHMP to assess the impact of the above concerns on the benefit-risk balance of metformin containing products and to issue an opinion on whether the relevant marketing authorisations should be maintained, varied, suspended or revoked.
Maltese: Fil-25 ta' Jannar 2016, in-Netherlands għalhekk tat bidu għal riferiment skont l-Artikolu 31 tadDirettiva 2001/83/KE, u talbet lis-CHMP biex jivvaluta l-impatt fuq it-tħassib imsemmi hawn fuq dwar il-bilanċ bejn il-benefiċċju u r-riskju ta' prodotti li fihom metformin u biex tinħareġ opinjoni dwar jekk l-awtorizzazzjonijiet għat-tqegħid fis-suq rilevanti għandhomx jinżammu, jiġu varjati, jiġu sospiżi jew jiġu revokati.
English: Apart from lactic acidosis, the overall safety profile of metformin in patients with moderate renal impairment is similar to the safety profile in patients with normal renal function.
Maltese: Minbarra l-aċidożi lattika, il-profil ta' sigurtà globali ta' metformin f'pazjenti b'indeboliment tal-kliewi moderat huwa simili għall-profil ta' sigurtà f'pazjenti b'funzjoni tal-kliewi normali.
English: In conclusion, the possible elevated risk of lactic acidosis could be sufficiently minimised in patients with moderate renal impairment (GFR greater than 30 ml/min) with a clear dosing recommendation, additional monitoring of GFR levels before and during treatment, and updated warnings and precautions in the SmPC and package leaflet.
Maltese: Bħala konklużjoni, ir-riskju possibbli elevat ta' aċidożi lattika jista' jiġi minimizzat biżżejjed f'pazjenti b'indeboliment tal-kliewi moderat (GFR akbar minn 30 ml/min) b'rakkomandazzjoni ta' dożaġġ ċara, monitoraġġ addizzjonali tal-livelli GFR qabel u waqt il-kura, u twissijiiet u prekawzjonijiet aġġornati fl-SmPC u fil-fuljett ta' tagħrif.
English: Metformin, alone or in combination with other medicines, is considered the first choice in the treatment for Type 2 diabetes mellitus (T2DM) and it is widely used in the EU.
Maltese: Metformin, waħdu jew flimkien ma' mediċini oħra, huwa meqjus l-ewwel għażla fil-kura taddijabete mellitus tat-Tip 2 (T2DM) u jintuża m'mod komuni fl-UE.
English: • The CHMP was of the view that the risk of lactic acidosis can be minimised in patients with moderate renal impairment with clear dosing recommendations, additional monitoring of GFR levels before and during treatment and updated warnings and precautions in the Summary of Product Characteristics (SmPC) and Package Leaflet (PL).
Maltese: • Is-CHMP kien tal-fehma li r-riskju ta' aċidożi lattika jista' jitnaqqas f'pazjenti b'indeboliment tal-kliewi moderat b'rakkomandazzjonijiet ta' dożaġġ ċari, monitoraġġ addizzjonali tal-livelli ta' GFR qabel u waqt il-kura u twissijiet u prekawzjonijiet aġġornati fis-Sommarju talKaratteristiċi tal-Prodott (SmPC) u l-Fuljett ta' Tagħrif (PL).
English: Further information on Mektovi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: Aktar informazzjoni fuq Mektovi tista' tinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It contains the active substance binimetinib.
Maltese: Fih is-sustanza attiva binimetinib.
English: Mektovi is available as 15 mg tablets.
Maltese: Mektovi jiġi bħala pilloli ta' 15 mg.
English: Other information about Mektovi
Maltese: Informazzjoni oħra dwar Mektovi
English: The most common side effects with Mektovi and encorafenib taken together at the highest recommended doses are tiredness, nausea (feeling sick), diarrhoea, vomiting, retinal detachment (an eye problem that leads to poor vision), abdominal pain, joint pain, muscle pain and high levels of an enzyme called creatine kinase, which may indicate muscle problems.
Maltese: L-effetti sekondarji l-aktar komuni b'Mektovi u b'encorafenib meħuda flimkien fl-ogħla dożi rakkomandati huma għeja, nawsja (tħossok ma tiflaħx), dijarea, rimettar, distakkar tar-retina (problema fl-għajnejn li twassal għal vista batuta), uġigħ addominali, uġigħ fil-ġogi, uġigħ fil-muskoli u livelli għoljin ta' enzima msejħa kinażi tal-kreatina, li jistgħu jindikaw problemi fil-muskoli.
English: Up to 50% of patients with metastatic melanoma have a mutation in BRAF with the V600 mutation being the most common.
Maltese: Sa 50% tal-pazjenti b'melanoma metastatika jkollhom mutazzjoni fil-BRAF, u l-aktar mutazzjoni komuni hija l-V600.
English: What are the risks associated with Mektovi?
Maltese: X'inhuma r-riskji assoċjati ma' Mektovi?
English: In melanoma tumours with the BRAF V600 mutation, an abnormal form of the protein BRAF is present, which switches on another protein called MEK involved in stimulating cell division.
Maltese: F'tumuri ta' melanoma bil-mutazzjoni BRAF V600, hija preżenti forma mhux normali tal-proteina BRAF, li tattiva proteina oħra msejħa MEK involuta fl-istimulazzjoni tad-diviżjoni taċ-ċelluli.
English: As for all medicines, data on the use of Mektovi are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Mektovi hija ssorveljata kontinwament.
English: Mektovi is used in combination with another medicine, encorafenib (Braftovi), and is only for patients whose cancer cells have a specific mutation (change) in their genes called 'BRAF V600'.
Maltese: Mektovi jintuża flimkien ma' mediċina oħra, encorafenib (Braftovi), u huwa biss għall-pazjenti li ċċelluli tal-kanċer tagħhom ikollhom mutazzjoni speċifika (bidla) fil-ġeni tagħhom imsejħa ‘BRAF V600'.
English: Patients normally take 45 mg (3 tablets) by mouth twice a day but can have the dose reduced or treatment stopped temporarily if they experience troublesome side effects.
Maltese: Normalment il-pazjenti jieħdu 45 mg (3 pilloli) mill-ħalq darbtejn kuljum, iżda d-doża tagħhom tista' titnaqqas jew il-kura tagħhom titwaqqaf temporanjament jekk jesperjenzaw effetti sekondarji inkwetanti.
English: A study of 577 patients with melanoma with the BRAF V600 mutation that had spread or could not be removed surgically showed that Mektovi with encorafenib prolongs the length of time patients live without their disease getting worse.
Maltese: Studju ta' 577 pazjent b'melanoma bil-mutazzjoni BRAF V600 li kienet infirxet jew li ma setgħetx titneħħa kirurġikament wera li Mektovi flimkien ma' encorafenib itawwal it-tul ta' żmien li l-pazjenti jgħixu mingħajr mal-marda tagħhom tmur għall-agħar.
English: Mektovi is a medicine for treating melanoma (a skin cancer) that has spread or cannot be removed by surgery.
Maltese: Mektovi huwa mediċina għall-kura ta' melanoma (kanċer tal-ġilda) li tkun infirxet jew li ma tistax titneħħa permezz ta' kirurġija.
English: The side effects seen with Mektovi are similar to those seen with other medicines in the same class and are considered manageable.
Maltese: L-effetti sekondarji li dehru b'Mektovi huma simili għal dawk li jidhru b'mediċini oħra fl-istess klassi u huma meqjusa ġestibbli.
English: This compared with over 9.5 months for patients who took encorafenib alone and just over 7 months for patients taking a different medicine called vemurafenib.
Maltese: Dan tqabbel ma' aktar minn 9.5 xhur għall-pazjenti li ħadu encorafenib waħdu u ftit aktar minn 7 xhur għall-pazjenti li kienu qed jieħdu mediċina differenti msejħa vemurafenib.
English: How does Mektovi work?
Maltese: Kif jintuża Mektovi?
English: The active substance in Mektovi, binimetinib, works by blocking MEK directly and by preventing its activation by BRAF thereby slowing down the growth and spread of the cancer.
Maltese: Is-sustanza attiva f'Mektovi, il-binimetinib, taħdem billi timblokka l-MEK direttament u billi twaqqaf l-attivazzjoni tagħha mill-BRAF u b'hekk jitnaqqsu t-tkabbir u t-tifrix tal-kanċer.
English: What measures are being taken to ensure the safe and effective use of Mektovi?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Mektovi?
English: 500 ml (2000 doses)
Maltese: 500ml (2000 doża)
English: Active substance
Maltese: Sustanza Attiva
English: to Council Directive 95/2/EC2.
Maltese: Direttiva tal-Kunsill 95/2/EC2).
English: Light liquid paraffin, Polysorbate 80, Sorbitan oleate, phosphate buffered aqueous solution 6.2 Incompatibilities
Maltese: Paraffina likwida ħafifa, Polisorbejt 80, Sorbitan olejt, phosphate buffered aqueous solution 6.2 Inkompatibilitajiet
English: Intervet International Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Maltese: Wim de Körverstraat 35, 5831 AN Boxmeer The Netherlands
English: 1 OJ No L272 of 25.10.1996, p. 2 OJ No L 61 of 18.3.1995, p. 1
Maltese: .1996, p. 2 ²OJ Nru L61 tat 18.3.1995, p. 1
English: EXPIRY DATE (Month/Year) ……/…..
Maltese: DATA TA' SKADENZA (xahar / sena) ...../.........
English: Light liquid paraffin: 107.21 mg
Maltese: Paraffina likwida ħafifa: 107.21mg
English: For a list of excipients, see section 6.1
Maltese: Għal-lista sħiħa ta' eċċipjenti, ara s-sezzjoni 6.1.
English: Pharmacologically active substance Animal Species
Maltese: Sustanza farmakoloġikament attiva
English: Use sterile vaccination equipment.
Maltese: Uża apparat sterili għal vaċċin.
English: Mineral hydrocarbons, low to high viscosity including microcristalline waxes, approximately C10-C60; aliphatic, branched aliphatic and alicyclic compounds.
Maltese: Hidro-karboni minerali, xemgħa ta' viżkosita baxxa sa għolja inkluż mikro kristallina, madwar C10 - C60;
English: Pharmacotherapeutic group: Inactivated bacterial vaccine ATCvet code: QI 01AB07
Maltese: Grupp Farmako-terapewtiku: vaċċin magħmul minn bakterjum inattivat Kodici ATĊ veterinarja QI 01 AB07
English: • Sorbitan oleate (E 494), Potassium dihydrogen phosphate (E 340), Disodium hydrogen phosphate (E 339) and Potassium chloride (E 508) are approved as additives in foodstuffs for human consumption and therefore covered by Annex II of Council Regulation (EEC) No. 2377/90 for substances with an E- number1 (with the exception of preservatives listed in part C of Annex III
Maltese: • Sorbitan olejt (E494), Potassium dihydrogen phosphate (E340), Disodium hydrogen phosphate (E339) u l-klorid tal-potassjum (E 508) huma approvati bħala addittivi f'ikel għal konsum uman u għaldaqstant mdaħħla f'Anness
English: * inducing a mean titre in the chickens of the potency test of at least 11.2 (log2).
Maltese: * Tinduċi titru medju ta' mill-anqas 11.2 (log2) għat-test ta'potenza fil-tigieg.
English: EU/2/02/036/002 (500 ml)
Maltese: EU/2/02/036/002 (500mls)
English: 1 PET vial with 250 ml (1000 doses) 1 PET vial with 500 ml (2000 doses)
Maltese: Fjal wieħed tal-PET b'250ml (1000 doża) Fjal wieħed tal-PET b'500ml (2000 doża)
English: MANUFACTURER'S BATCH NUMBER Lot: ……
Maltese: NUMRU TAL-LOTT TAL-MANIFATTUR Lott: ......
English: Excipients Traces of formaldehyde
Maltese: Traċċi ta' formaldeħajd
English: INDICATION(S)
Maltese: <MANIFATTUR(I)
English: Occasionally hardened minor local swellings (0.5 - 2.0 cm) were observed which disappeared within 21 days after vaccination.
Maltese: Okkażjonalment nefħiet żgħar (0.5 - 2.0), lokaliżżati u iebsin ġew osservati li iżda sparixxew wara 21 ġurnata ta' vaċċinazzjoni.
English: Per dose of 0.25 ml:
Maltese: Kull doża ta' 0.25ml
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Nobilis OR inac emulsion for injection for chickens
Maltese: VETERINARJU Nobilis OR inac emulsjoni għal injezzjoni
English: Chickens
Maltese: Tigieg
English: Inactivated whole cell suspension of Ornithobacterium rhinotracheale serotype A strain B3263/91 1 x 107 cells *
Maltese: Suspensjoni ta ċelloli li fiha Ornithobacterium rhinotracheale serotip A, strejn B3263/91 1 x 107
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Per dose of 0.25 ml:
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA U SUSTANZI OĦRA Kull doża ta' 0.25ml:
English: 6.5 Nature and composition of immediate packaging Carton box with one Polyethylene Terephthalate (PET) vial of 250 ml (1000 doses) or 500 ml (2000 doses), closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap. 6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
Maltese: In-natura u l-għamla ta' l-ewwel ippakkjar Kaxxa tal-kartun li fiha fjala waħda ta' Polyethylene Terephthalate (PET) ta' 250ml (1000 doża) jew 500ml (2000 doża), magħluqa b'tapp tal-gomma u ssiġillati b'kappa tal-aluminjum b'kodiċi fuqha.
English: CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 250 ml (1000 doses)
Maltese: PIŻ, VOLUM JEW NUMRU TA' DOŻI 250ml (1000 doża)
English: CONTRAINDICATIONS Do not use for birds in lay
Maltese: KONTRAINDIKAZZJONIJIET Tużax fi tjur waqt żmien il-bajd
English: Vaccination scheme:
Maltese: Skema ta' Vaċċinazzjoni:
English: METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous injection in the neck or intramuscular injection in the breast of one dose of 0.25 ml.
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI Injezzjoni taħt il-ġilda jew fil-muskolu ta' doża waħda ta'0.25ml
English: Under field conditions, sporadic local and systemic clinical reactions have been reported.
Maltese: F'kundizzjonijiet fil-beraħ, reazzjonijiet kliniċi sistemiċi ġew irrappurtati.
English: Light liquid paraffin:
Maltese: Għat-Tabib:
English: ACTIVE SUBSTANCE(S) Inactivated whole cell suspension of O. rhinotracheale Light liquid paraffin
Maltese: TAS-SUSTANZA ATTIVA / SUSTANZI ATTIVI Suspensjoni ta' ċelloli sħaħ t' Ornithobacterium rhinotracheale Paraffina likwida ħafifa
English: For animal treatment only -to be supplied only on veterinary prescription.
Maltese: Prott veterinarju li għandu jiġi mogħti biss bi preskrizzjoni veterinarja.
English: Name and address of the manufacturer of the biological active substance
Maltese: Isem u indirizz tal-manufattur(i) tas-sustanza bioloġika attiva
English: No other undesirable effects have been observed after administration of a double dose when compared with a single dose of vaccine.
Maltese: Ma ġewx osservati effetti mhux mixtieqa wara amministrazzjoni ta' doża doppja meta kkomparat ma doża waħda tal-vaċċin.
English: The second injection has to be administered at least 6 weeks later at an age of 14 - 18 weeks.
Maltese: It-tieni injezzjoni għandha tingħata tal-inqas 6 ġimgħat wara f'eta ta' 14 - 18 -il ġimgħa.
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-għotja tal-prodott mediċinali veterinarju lill-annimali tinterferixxi ma' l-implimentazzjoni ta' programmi nazzjonali għad-djanjosi, 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 akkwistati minn annimali ttrattati;
English: To the user:
Maltese: Żmien ta' tiżmim:
English: Polysorbate 80
Maltese: Mhux applikabbli
English: Allow vaccine to reach room temperature (15-25°C) before using the vaccine.
Maltese: Ħallil-vaċċin jilħaq it-temperatura tal-kamra (15 - 25oC) qabel tużah.
English: The first injection can be administered at an age of 6 - 12 weeks.
Maltese: L-ewwel injezzjoni tista tingħata f'eta ta' 6 - 12 -il ġimgħa.
English: Do not mix with any other vaccine/immunological product.
Maltese: Tħallatx ma tilqim jew prodotti immunoloġiċi oħra.
English: Nobilis OR inac emulsion for injection for chickens
Maltese: Nobivac OR inac emulsjoni għal injezzjoni
English: SPECIAL STORAGE CONDITIONS Store and transport at 2 - 8°C.
Maltese: KONDIZZJONIJIET SPEĊJALI DWAR KIF GĦANDU JINĦAŻEN Aħżen u ttrasporta f'temperaturi ta' 2°C - 8°C Tiffriżax
English: Store and transport at 2 - 8°C.
Maltese: Aħżen fil-friġġ (2°C - 8°C) Tiffriżax
English: The product contains the inactivated whole cells of Ornithobacterium rhinotracheale serotype A, strain B3263/91 mixed with an oil adjuvant.
Maltese: Suspensjoni ta ċelloli sħaħ inattivati ta' Ornithobacterium rhinotracheale serotip A, strejn B3263/91 1 x 107 ċelloli*.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/02/036/001-002
Maltese: NUMRU(I) TA' L-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/02/036/001-002
English: EU Number EU/2/02/036/001 (250 ml) EU/2/02/036/002 (500 ml)
Maltese: EU/2/02/036/001-002 (500mls)
English: For passive immunisation of broilers induced by active immunisation of female broiler breeders to reduce infection with Ornithobacterium rhinotracheale serotype A when this agent is involved.
Maltese: Għal immunizzazzjoni passiva ta' tigieg indotta b'immunizzazzjoni attiva f'tiġieġ tas-simna għarrazza sabiex titnaqqas l-infezzjoni bl-Ornithobacterium rhinotracheale serotip A, meta huwa involut dan l-aġent.
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Single dose of 0.25 ml.
Maltese: U METODU TA' AMMINISTRAZZJONI Doża waħda ta' 0.25ml,
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Maltese: MANIFATTUR TAS-SUSTANZA BIOLOĠIKA ATTIVA U SID LAWTORIZZAZZJONI TAL-MANIFATTURA RESPONSABBLI
English: The vaccine is to stimulate active immunity in broiler breeders in order to provide passive immunity to the progeny against Ornithobacterium rhinotracheale serotype A.
Maltese: Il-prodott jistimula immunita attiva f'tiġieġ tas-simna għar-razza sabiex jipprovdu immunita passiva lil tagħhom kontra Ornithobacterium rhinotracheale serotip A.
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: ATTIVA(I) U> SID/S-SIDIEN TA' L-AWTORIZZAZZJONI TAL-MANIFATTURA RESPONSABBLI
English: Inactivated whole cell suspension of Ornithobacterium rhinotracheale serotype A, strain B3263/91 1 x 107 cells * * inducing a mean titre in the chickens of the potency test of at least 11.2 (log2).
Maltese: Suspensjoni ta ċelloli li fiha Ornithobacterium rhinotracheale serotip A, strejn B3263/91 1 x 107 ċelloli*.
English: In laboratory studies, a local transient swelling was found at post mortem examination in up to 40% of the birds for at least 14 days after subcutaneous vaccination.
Maltese: Fi studji fil-laboratorju, nefħa lokaliżżata u li tmur instabet f'eżamijiet post-mortem f'madwar 40% tat-tjur għalmadwar 14 -il ġurnata wara titqiba taħt il-ġilda.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/02/036/001 (250 ml)
Maltese: NUMRU/I TA' L-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/02/036/001 (250mls)
English: Any person intending to import, sell, supply and/or use the product 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 turi l-intenzjoni li timporta, tbiegħ, tipprovdi u/jew tuża l-prodott għandha tikkonsulta ma' l-Awtorità Kompetenti ta' l-Istat Membru dwar il-programmi ta' tilqim kurrenti qabel timporta, tbiegħ, tipprovdi u/jew tuża.
English: 4.1 Target species
Maltese: 4.5 Prekawzjonijiet Speċjali għall-Użu
English: Pack size blister (PVC/PE/PVDC/alu)
Maltese: Daqs tal-pakkett folja (PVC/PE/PVDC/alu)
English: 30 mg Film-coated tablet Oral use
Maltese: 30 mg Pillola miksija b'rita
English: Further information on Invirase can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Invirase is available as capsules (200 mg) and tablets (500 mg).
Maltese: Invirase jiġi bħala kapsuli (200 mg) u pilloli (500 mg).
English: This overview was last updated in 03-2018.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'03-2018.
English: Other information about Invirase
Maltese: Informazzjoni oħra dwar Invirase
English: Invirase contains the active substance saquinavir.
Maltese: Invirase fih is-sustanza attiva saquinavir.
English: Invirase is an antiviral medicine used to treat adults infected with the human immunodeficiency virus type 1 (HIV 1), a virus that causes acquired immune deficiency syndrome (AIDS).
Maltese: Invirase huwa mediċina antivirali li tintuża biex tikkura adulti infettati bil-virus tal-immunodefiċjenza umana tat-tip 1 (HIV 1), virus li jikkawża s-sindrome tal-immunodefiċjenza akkwiżita (AIDS).
English: • rifampicin (used to treat tuberculosis);
Maltese: • rifampicin (użat biex jikkura tuberkulożi).
English: The active substance in Invirase, saquinavir, is a ‘protease inhibitor'.
Maltese: Is-sustanza attiva f'Invirase, saquinavir, hija “inibitur tal-proteażi”.