FrancophonIA/ELRC3.0 huggingface dataset:
English: The withdrawal period was supported by a residue depletion study where 20 cows received an infusion of one injector per quarter of Synulox Lactating Cow in all 4 quarters of the udder at 12-hour intervals following 3 consecutive milkings.
Maltese: Il-perjodu ta' irtirar kien appoġġat minn studju dwar it-tnaqqis tar-residwu fejn 20 baqra rċevew infużjoni ta' injezzjoni waħda kull ribbi ta' Synulox Lactating Cow fl-4 ribbi kollha tal-beżżula f'intervalli ta' 12-il siegħa wara tliet taħlibiet konsekuttivi.
English: Cattle Meat and offal: 4 days
Maltese: Laħam u Ġewwieni: 4 ijiem
English: The review of literature on the current level of resistance to amoxycillin/clavulanic acid among clinically significant mastitis pathogens indicates that resistance remains low.
Maltese: Ir-reviżjoni tal-letteratura dwar il-livell attwali ta' reżistenza għal amoxycillin/clavulanic acid fost ilpatoġeni klinikament sinifikanti tal-mastite tindika li r-reżistenza għadha baxxa.
English: Therefore a positive clinical anti-inflammatory impact of prednisolone remains questionable.
Maltese: Għalhekk l-impatt kliniku anti-infjammatorju pożittiv ta' prednisolone jibqa' wieħed diskutibbli.
English: Synulox Lactating Cow and associated names is a pale cream/buff coloured oily suspension containing clavulanic acid, amoxicillin and prednisolone in a base designed to disperse rapidly in milk.
Maltese: Synulox Lactating Cow u l-ismijiet assoċjati huwa sospensjoni żejtnija ta' lewn krema ċar/isfar skur li fiha clavulanic acid, amoxicillin u prednisolone f'bażi ddisinjata biex tinfirex malajr fil-ħalib.
English: The tissue samples were analysed for amoxicillin, clavulanic acid and prednisolone by the validated HPLC method.
Maltese: Il-kampjuni tat-tessut kienu analizzati għal amoxicillin, clavulanic acid u prednisolone permezz tal-metodu ta' HPLC ivvalidat.
English: In the second study 20 healthy lactating dairy cows were treated 3 times, by the intramammary route, with the test product at the dosage of 1 syringe infused into each quarter via the teat canal, immediately after milking, for 3 consecutive milkings.
Maltese: Fit-tieni studju 20 baqra tal-ħalib b'saħħithom li kienu qegħdin jreddgħu kienu kkurati 3 darbiet, permezz tar-rotta intramammarja, permezz tal-prodott tat-test f'dożaġġ ta' siringa 1 infuża f'kull ribbi permezz tal-kanal tar-ras tal-beżżula, immedjatament wara t-taħlib, għal 3 taħlibiet konsekuttivi.
English: Consequently the CVMP agreed on the following indications for the product: “For use in clinical cases of mastitis including cases associated with infections with the following pathogens: Staphylococci (including -lactamase producing strains) Streptococci (including S.agalactiae, S.dysgalactiae and S.uberis) Escherichia coli (including -lactamase producing strains)” As it is generally recommended to treat clinical mastitis in the first instance with a narrow spectrum antimicrobial and where possible after bacteriological diagnosis, recommendations on prudent use were proposed to be included in the SPC.
Maltese: Fuq il-bażi ta' dejta preċedenti u reċenti, l-inċidenza ta' patoġeni li jipproduċu β-lactamase, jiġifieri Staphylococcus aureus u Escherichia coli minn każijiet ta' mastite bovina, tista' tiġi kkunsidrata bħala waħda għolja f'ċerti reġjuni.
English: The overall review indicates that over the six years covered by the data from the Netherlands, there was no evidence of significant and consistent increases in MIC levels of amoxycillin/clavulanic acid and cephalosporins.
Maltese: Ir-reviżjoni ġenerali tindika li matul is-sitt snin koperti mid-dejta mill-Pajjiżi l-Baxxi, ma kienx hemm evidenza ta' żidiet sinifikanti u konsistenti fil-livelli tal-MIC ta' amoxycillin/clavulanic acid u cephalosporins.
English: Synulox Lactating Cow was shown to be efficacious regarding the main mastitis pathogens: Staphylococci, Streptococci and Escherichia coli.
Maltese: Staphylococci, Streptococci u Escherichia coli.
English: INDICATIONS
Maltese: FILPAKKETT
English: By using the most conservative method of calculating the time to safe concentration and including the 5th milking in the calculations, a withdrawal period of 6.1 milkings or 73.4 hours was calculated which is rounded to 7 milkings or 84 hours.
Maltese: Permezz tal-użu tal-aktar metodu konservattiv ta' kalkolu tal-ħin għal konċentrazzjoni sigura u inkluża l-ħames taħliba fil-kalkoli, ġie kkalkolat perjodu ta' irtirar ta' 6.1 taħlibiet jew 73.4 siegħat li għad-dritt ġie miżjud għal 7 taħlibiet jew 84 siegħa.
English: Milk: 84 hours, i.e. 7 milking times with 2 times a day milking or 11 milking times with 3 times a day milking.
Maltese: Laħam u Ġewwieni ta' l-Annimali: 7 ġranet Ħalib: 84 siegħa, i.e. 7 ħalbiet b'żewġ ħalbiet kuljum jew 11-il ħalba b'tlett ħalbiet kuljum.
English: Active substances:
Maltese: Sustanza Attiva:
English: 50 doses (50 ml)
Maltese: 50 doża (50ml)
English: Aluminium hydroxide .................................................................................................................... 2.7 mg Saponin ........................................................................................................................................ 30 HU** (**) Haemolytic units
Maltese: Aluminium hydroxide .................................................................................................................... 2.7 mg Saponin ........................................................................................................................................ 30 HU** (**) unitajiet emolitiċi
English: MERIAL Animal Health Limited Biological Laboratory, Ash Road, Pirbright, Woking, Surrey GU24 0NQ United Kingdom
Maltese: MERIAL Animal Health Limited Biological Laboratory, Ash Road Pirbright, Woking, Surrey GU 24 ONQ United Kingdom
English: BATCH NUMBER Lot{number}
Maltese: NUMRU TAL-LOTT Lot {numru}
English: Sheep and cattle
Maltese: Nagħaġ u bovini
English: Aluminium hydroxide Purified saponin Silicon antifoam Phosphate buffer Glycine buffer Water for injection
Maltese: Aluminium hydroxide Saponin ippurifikat Silicon antifoam Fosfat buffer Glycine buffer Ilma għal injezzjoni
English: EU/2/09/094/001 EU/2/09/094/002 EU/2/09/094/003 EU/2/09/094/004 EU/2/09/094/005
Maltese: EU/2/09/094/001 EU/2/09/094/002 EU/2/09/094/003
English: EXP {month/year}
Maltese: EXP {xahar / sena}
English: Veterinary medicinal product subject to prescription.
Maltese: Prodott mediċinali veterinarju bi preskrizzjoni.
English: Pharmacotherapeutic group: bluetongue virus vaccine, ATCvet code: QI04AA02 (sheep) and QI02AA08 (cattle).
Maltese: Grupp Farmako-terapewtiku: virus tal-bluetongue serotip 8, Kodiċi ATC veterinarja Q104AA02 (nagħaġ) u Q102AA08 (bovini).
English: Avoid multiple vial broaching.
Maltese: Evita ftuħ ta' ħafna fliexken.
English: Bluetongue virus serotype 8 antigen ........................................................................... ≥ 2.1 log10 pixels* (*) Antigen content (VP2 protein) by immuno-assay Adjuvants:
Maltese: Antiġen tal-virus tal-Bluetongue tas-serotip 8 ........................................................... > 2.1 log10 pixels * (*) Kontenut tal-antiġen(proteina VP2) bl-immuno-assay Sustanzi mhux attivi:
English: Active immunisation of sheep and cattle to prevent viraemia* and to reduce clinical signs caused by Bluetongue virus serotype 8 (BTV 8).
Maltese: Immunizzazzjoni attiva ta' nagħaġ u bovini għall- prevenzjoni kontra viremja*, u għat-tnaqqis ta' sinjali kliniċi ikkawżati mill-virus tal-bluetongue serotip 8 (BTV8).
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each dose of 1 ml of vaccine contains: BTV8 antigen............................................... ≥ 2.1 log10 pixels* Aluminium hydroxide, Saponin, qs 1 dose (*) (*) see package leaflet
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA U SUSTANZI OĦRA Kull doża ta' millilitru ta' vaċċin fiha antiġen BTV 8 ................................................. > 2.1log10 pixels* Aluminju hydroxide Saponin qs doża (*) (*) Ara l-fuljett ta' tagħrif
English: TARGET SPECIES Sheep and cattle.
Maltese: HUWA INDIKAT IL-PRODOTT Nagħaġ u bovini.
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI SC
English: - 2nd injection: after 3-4 weeks.
Maltese: - It-tieni injezzjoni: wara 3-4 ġimgħat.
English: A transient increase in body temperature, normally not exceeding an average of 1.1 °C, may occur within 24 hours after vaccination.
Maltese: Sa' 24 siegħa mit-tilqima, jista' jkun hemm żieda transitorja fit-temperatura, normalment ta' mhux aktar minn medja ta' 1.1 °C.
English: 1 bottle of 10 doses (1 x 10 ml) 1 bottle of 50 doses (1 x 50 ml) 10 bottles of 50 doses (10 x 50 ml) 1 bottle of 100 doses (1 x 100 ml) 10 bottles of 100 doses (10 x 100 ml)
Maltese: Kaxxa ta' flixkun ta' 10 dożi (1 x 10 ml) Kaxxa ta' flixkun ta' 50 doża (1 x 50 ml) Kaxxa ta 10 fliexken ta' 50 doża (10 x 50 ml) Kaxxa ta' flixkun ta' 100 doża (1 x 100 ml) Kaxxa ta' 10 fliexken ta' 100 doża (10 x 100 ml)
English: NAME OF THE VETERINARY MEDICINAL PRODUCT BTVPUR AlSap 8 suspension for injection
Maltese: VETERINARJU BTVPUR AlSap 8 suspensjoni għall-injezzjoni.
English: The vaccine contains inactivated bluetongue virus serotype 8 with aluminium hydroxide and saponin adjuvants.
Maltese: Il-vaċċin fih il-virus inattivat tal-Bluetongue serotip 8 bis-sustanzi mhux attivi aluminium hydroxide u saponin.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) BTV 8 antigen ...................................................................................................... ≥ 2.1 log10 pixels/dose
Maltese: TAS-SUSTANZA ATTIVA / SUSTANZI ATTIVI BTV 8 antiġen ....................................................................................................... > 2.1log10 pixels/doża
English: 4.11 Withdrawal period Zero days.
Maltese: 4.11 Perjodu ta' Tiżmim Xejn.
English: Vaccination may be followed by a small local swelling at the injection site (at most 32 cm²) for a short period (at most 14 days).
Maltese: Wara t-tilqim jista' jkun hemm nefħa żgħira fil-post tal-injezzjoni (massimu ta' 32 cm²) għal żmien qasir (massimu ta' 14-il ġurnata).
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each dose of 1 ml of vaccine contains Bluetongue virus serotype 8 antigen ................. ≥ 2.1 log10 pixels
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA U SUSTANZI OĦRA Kull doża ta' millilitru ta' vaċċin fiha antiġen tal-virus tal-Bluetongue tas-serotip 8 ................................................................................................................... ≥ 2.1log10 pixels
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediku veterinarju tinstab fuq il-websajt tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: *below the level of detection by the validated RT-PCR method at 3.14 log10 RNA copies/ml, indicating no infectious virus transmission
Maltese: *taħt il-livell li jista' jitkejjel bil-metodu ikkonfermat RT/PCR 3.14log10
English: PACKAGE LEAFLET FOR: BTVPUR AlSap 8 suspension for injection
Maltese: FIL-PAKKETT BTVPUR AlSap 8 suspensjoni għall-injezzjoni.
English: MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: MANIFATTURITAS-SUSTANZA BIJOLOĠIKA ATTIVA U LMANIFATTUR RESPONSABBLI
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required.
Maltese: L-ingredjenti l-oħra (inklużi l-adjuvanti)elenkati f'sezzjoni 6.1 tal-SPC huma sustanzi permessili għalihom it-Tabella 1tal-Anness tar-Regolament tal-Kummissjoni (KE) Nru 37/2010 tindika li l-ebda MRL mhu meħtieġ.
English: Bluetongue virus serotype 8 antigen ........................................................................... ≥ 2.1 log10 pixels* Aluminium hydroxide .................................................................................................................... 2.7 mg Saponin ........................................................................................................................................ 30 HU** (*) antigen content (VP2 protein) by immuno-assay (**) Haemolytic units
Maltese: Antiġen tal-virus tal-Bluetongue tas-serotip 8 ............................................................ ≥ 2.1log10 pixels* Aluminju hydroxide ......................................................................................................................
English: Shelf life of the veterinary medicinal product as package for sale (50-ml and 100-ml bottles): 2 years.
Maltese: Żmien li l-prodott mediċinali veterinarju jista' jinżamm fuq l-ixkaffa ppakkjat għall-bejgħ (fliexken ta' 50 ml u 100 ml): sentejn.
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal product on the whole or part of their territory if it is established that:
Maltese: Skont l-Artikolu 71 tad-Direttiva 2001/82/KEE tal-Parlament Ewropew u tal-Kunsill, l-Istati Membri jistgħu, skont il-leġislazzjoni nazzjonali tagħhom,jipprojbixxu l-manifattura, l-importazzjoni, ilpussess, il-bejgħ, il-forniment u/jew l-użu ta' prodott immunoloġiku mediċinali veterinarju fitterritorju sħiħ tagħhom jew parti minnu jekk jiġi stabbilit illi:
English: ADVICE ON CORRECT ADMINISTRATION
Maltese: MOD1 TA' AMMINISTRAZZJONI
English: Any person intending to import, sell, supply and/or use BTVPUR AlSap 8 must consult the relevant Member State's 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, tbigħ, tipprovdi u/jew tuża BTVPUR AlSap 8 għandha tikkonsulta mal-Awtorità Kompetenti tal-Istat Membru dwar ilprogrammi ta' tilqim kurrenti qabel timporta, tbigħ, tipprovdi u/jew tuża.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 10 doses (10 ml)
Maltese: PIŻ, VOLUM JEW NUMRU TA' DOŻI 10 dożi (10ml)
English: None
Maltese: IEĦOR
English: 4.2 Indications for use, specifying the target species Active immunisation of sheep and cattle to prevent viraemia* and to reduce clinical signs caused by bluetongue virus serotype 8.
Maltese: Immunizzazzjoni attiva ta' nagħaġ u bovini għall-prevenzjoni kontra viremja*, u għat-tnaqqis ta' sinjali kliniċi kkawżati mill-virus tal-bluetongue serotip 8.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/09/094/001
Maltese: TAL-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/09/094/001
English: For a full list of excipients, see section 6.1.
Maltese: Għal-lista sħiħa tal-ingredjenti (mhux attivi), ara s-sezzjoni 6.1.
English: Box of 1 bottle of 10 ml Box of 1 bottle of 50 ml, Box of 10 bottles of 50 ml, Box of 1 bottle of 100 ml, Box of 10 bottles of 100 ml
Maltese: Kaxxa ta' flixkun ta' 10 ml Kaxxa ta' flixkun ta' 50 ml Kaxxa ta' 10 fliexken ta' 50 ml Kaxxa ta' flixkun ta' 100 ml Kaxxa ta' 10 fliexken ta' 100 ml
English: Shelf life of the veterinary medicinal product as package for sale (10-ml bottle): 18 months.
Maltese: Żmien li l-prodott mediċinali veterinarju jista' jinżamm fuq l-ixkaffa ppakkjat għall-bejgħ (flixkun ta' 10 ml): 18-il xahar.
English: The level of efficacy for other species may differ from that observed in sheep and cattle.
Maltese: Il-livell ta' effikaċja għal speċi oħra jista' jkun differenti minn dak osservat fin-nagħaġ u fil-bovini.
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Maltese: Is-sustanza attiva, peress li hija kostitwent ta' oriġini bijoloġika intiża biex tipproduċi immunità attiva, mhiex fl-iskop tar-Regolament tal-Kunsill (KE) 470/2009.
English: No adverse reactions except those mentioned in section 4.6 were observed after the administration of a double- dose of the vaccine.
Maltese: L-ebda reazzjoni avversa, ħlief dawk imsemmiija fis-sezzjoni 4.6, ma ntweriet wara li ngħatat doża doppja tat-tilqima.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous use
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI Taħt il-ġilda
English: Box of 1 bottle of 10 doses (1 x 10 ml).
Maltese: Flixkun tal-ħġieġ Tip 1, ta' 10 ml bit-tapp tal-lastku Kaxxa ta' flixkun wieħed ta' 10 dożi (1 x 10 ml)
English: It induces an active and specific immunity against bluetongue virus serotype 8 in the vaccinated animal.
Maltese: Il-vaċċin jinduċi immunità attiva u speċifika kontra l-virus tal-Bluetongue serotip 8 fl-annimal vaċċinat.
English: Actos pioglitazone
Maltese: Actos pijoglitażonu
English: The full EPAR for Actos can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ għal Actos jinstab fis-sit elettroniku tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Other information about Actos:
Maltese: Informazzjoni oħra dwar Actos:
English: Actos is a medicine that contains the active substance pioglitazone.
Maltese: Actos huwa mediċina li fiha s-sustanza attiva pijoglitażonu.
English: This is a summary of the European public assessment report (EPAR) for Actos.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Actos.
English: The recommended starting dose of Actos is 15 or 30 mg once a day.
Maltese: Id-doża tal-bidu rakkomandata ta' Actos hija 15 jew 30 mg darba kuljum.
English: Actos has been compared with placebo (a dummy treatment), metformin and gliclazide (a sulphonylurea) in a number of studies.
Maltese: Actos tqabbel ma' plaċebo (kura finta), mal-metformina u mal-gliċlażide (tip ta' sulfonilurea) f'numru ta' studji.
English: What is the risk associated with Actos?
Maltese: X'inhu r-riskju assoċjat ma' Actos?
English: Actos led to a decrease in the level of HbA1c, indicating that blood glucose levels had been reduced at doses of 15, 30 and 45 mg. Actos on its own was shown to be as effective as metformin and gliclazide.
Maltese: Actos wassal għal tnaqqis fil-livell tal-HbA1c, li jindika li l-livelli tal-glukożju fid-demm ikunu tnaqqsu għal dożi ta' 15, 30 u 45 mg.
English: The company that markets Actos will produce educational material for doctors prescribing the medicine, which will cover the possible risk of heart failure and bladder cancer with treatments that contain pioglitazone, the criteria for selecting patients and the need to review treatment regularly and stop treatment if patients are no longer benefiting.
Maltese: Il-kumpanija li tqiegħed Actos fis-suq se tipproduċi materjal edukattiv għat-tobba li jippreskrivu lmediċina, li se jkopri r-riskju possibbli ta' insuffiċjenza tal-qalb u kanċer fil-bużżieqa tal-urina bil-kuri li fihom il-pijoglitażonu, il-kriterji għall-għażla tal-pazjenti u l-ħtieġa ta' rieżami regolari tal-kura u li lkura titwaqqaf jekk il-pazjenti ma jibqgħux jibbenefikaw aktar minnha.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Actos on 13 October 2000.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Actos fit-13 ta' Ottubru 2000.
English: Some studies also looked at combining Actos with a sulphonylurea, insulin or metformin, or with the combination of metformin and a sulphonylurea.
Maltese: Xi studji stħarrġu wkoll il-kombinazzjoni ta' Actos mas-sulfonilurea, mal-insulina jew malmetformina, jew mal-kombinazzjoni tal-metformina u s-sulfonilurea.
English: The most common side effects with Actos (seen in between 1 and 10 patients in 100) are upper respiratory tract infection (colds), hypoaesthesia (reduced sense of touch), visual disturbance, bone fractures and increased weight.
Maltese: L-effetti sekondarji l-aktar komuni b'Actos (li dehru f'bejn pazjent 1 u 10 minn 100) huma infezzjonijiet fil-passaġġ tan-nifs tan-naħa ta' fuq (irjiħat), ipostesija (tnaqqis fis-sensittività tal-mess), disturbi viżivi, ksur fl-għadam u żieda fil-piż.
English: • on its own in patients for whom metformin (another diabetes medicine) is not suitable;
Maltese: • waħdu f'pazjenti li ma jistgħux jieħdu l-metformina (mediċina antidijabetika oħra);
English: What is Actos?
Maltese: X'inhu Actos?
English: If Actos is used in combination with other diabetes medicines, other side effects may occur.
Maltese: Jekk Actos jintuża f'kombinazzjoni ma' mediċini antidijabetiċi oħra, jistgħu jiżviluppaw effetti sekondarji oħrajn.
English: How has Actos been studied?
Maltese: Kif ġie studjat Actos?
English: Actos also improved the glucose control obtained in type 2 diabetes when it was added to existing treatment with a sulphonylurea, insulin or metformin, or the combination of metformin and a sulphonylurea.
Maltese: Actos tejjeb ukoll il-kontroll tal-glukożju miksub fid-dijabete tat-tip 2 meta żdied mal-kura eżistenti bis-sulfonilurea, l-insulina jew il-metformina, jew mal-kombinazzjoni tal-meformina u ssulfonilurea.
English: The active substance in Actos, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Maltese: Is-sustanza attiva f'Actos, il-pijoglitażonu, tagħmel iċ-ċelloli (tax-xaħam, tal-muskoli u tal-fwied) aktar sensittivi għall-insulina, li jfisser li l-ġisem jibda jagħmel użu aħjar mill-insulina li jipproduċi.
English: • together with both metformin and a sulphonylurea in patients who are not satisfactorily controlled despite treatment with two medicines by mouth;
Maltese: • f'kombinazzjoni kemm mal-metformina kif ukoll mas-sulfonilurea f'pazjenti li ma jkunux ikkontrollati b'mod sodisfaċenti minkejja kura b'żewġ mediċini mill-ħalq;
English: What measures are being taken to ensure the safe and effective use of Actos?
Maltese: X'miżuri qed jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Actos?
English: The CHMP decided that Actos's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Actos huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: The studies measured the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Maltese: L-istudji kejlu llivell ta' sustanza fid-demm magħrufa bħala emoglobina glikosilata (HbA1c), li tagħti indikazzjoni ta' kemm ikun ikkontrollat tajjeb il-glukożju fid-demm.
English: How does Actos work?
Maltese: Kif jintuża Actos?
English: Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Maltese: Id-dijabete tat-tip 2 hija marda li fiha l-frixa ma tipproduċix biżżejjed insulina biex tikkontrolla l-livell ta' glukożju fid-demm jew meta l-ġisem ma jkunx kapaċi juża l-insulina b'mod effikaċi.
English: What benefit has Actos shown during the studies?
Maltese: X'benefiċċju wera Actos matul l-istudji?
English: This dose may need to be increased after one or two weeks to up to 45 mg once a day if better blood glucose (sugar) control is needed.
Maltese: Jista' jkun meħtieġ li din iddoża tiżdied wara ġimgħa jew ġimagħtejn sa 45 mg darba kuljum jekk ikun meħtieġ kontroll aħjar fuq il-glukożju (zokkor) fid-demm.
English: For the full list of all side effects reported with Actos, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrapportati b'Actos, ara l-fuljett ta' tagħrif.
English: Actos is used to treat type 2 diabetes in adults (aged 18 years or over), particularly those who are overweight.
Maltese: Actos jintuża għall-kura tad-dijabete tat-tip 2 f'adulti (minn 18-il sena 'l fuq), b'mod partikolari dawk b'piż eċċessiv.
English: Tenofovir is a nucleotide reverse transcriptase inhibitor.
Maltese: It-tenofovir hija inibitur nukleosidiku tat-transkrittażi inversa.