FrancophonIA/ELRC3.0 huggingface dataset:
English: Historically, seasonal flu vaccines have contained three strains of influenza: one influenza A-H1N1 virus, one influenza A-H3N2 virus, and one influenza B virus.
Maltese: Storikament, il-vaċċini tal-influwenza staġjonali fihom tliet razez tal-influwenza: virus wiħed tal-influwenza A-H1N1, virus wieħed tal-influwenza A-H3N2, u virus wieħed tal-influwenza B.
English: Other information about Fluenz Tetra
Maltese: Informazzjoni oħra dwar Fluenz Tetra
English: Fluenz Tetra influenza vaccine (live attenuated, nasal)
Maltese: Fluenz Tetra vaċċin kontra l-influwenza (ħaj attenwat, nażali)
English: Fluenz Tetra will contain live attenuated (weakened) influenza A and B virus strains (type A-H1N1, type A-H3N2, and two type B strains) based on the official recommendation for the annual flu season.
Maltese: Fluenz Tetra ser ikun fih razez ta' virusis tal-influwenza A u B ħajjin attenwati (imdgħajfa) (tip A-H1N1, tip A-H3N2, u żewġ razez tip B) abbażi tar-rakkomandazzjoni uffiċjali għallistaġun tal-influwenza annwali.
English: Fluenz Tetra is a vaccine.
Maltese: Fluenz Tetra huwa vaċċin.
English: The study assessed the ability of the vaccines to stimulate an immune response against influenza, by measuring the production of protective antibodies.
Maltese: L-istudju vvaluta l-kapaċità tal-vaċċini li jistimulaw rispons immunitarju kontra l-influwenza, billi jkejlu l-produzzjoni ta' antikorpi protettivi.
English: Why is Fluenz Tetra approved?
Maltese: Għal xiex ġie approvat Fluenz Tetra?
English: The inclusion of both influenza B viruses in Fluenz Tetra can provide a broader protection against influenza B.
Maltese: L-inkużjoni taż-żewġ virusis talinfluwenza B fi Fluenz Tetra tista' tipprovdi protezzjoni akbar kontra l-influwenza B.
English: It must also not be given to children with a weakened immune system due to conditions such as blood disorders, symptomatic HIV infection, cancer or certain medical treatments, nor to children who are receiving treatment with salicylates (painkillers such as aspirin).
Maltese: Lanqas m'għandu jingħata lil tfal b'sistema immunitarja mdgħajfa minħabba kondizzjonijiet bħal disturbi fid-demm, infezzjoni HIV sintomatika, kanċer jew ċerti kuri mediċi, u lanqas lit-tfal li qegħdin jirċievu kura b'saliċilati (analġesiċi bħall-aspirina).
English: The recommended dose is one nasal spray (0.1 ml) per nostril.
Maltese: Id-doża rrakkomandata hija ta' sprejjatura nażali waħda (0.1 ml) f'kull minħar.
English: The safety profile of Fluenz Tetra is similar to Fluenz and was considered acceptable.
Maltese: Il-profil ta' sigurtà ta' Fluenz Tetra huwa simili għal Fluenz u kien ikkunsidrat aċċettabbli.
English: Fluenz Tetra must not be used in children who are hypersensitive (allergic) to the active substances or any of the other ingredients, to gentamicin (a type of antibiotic), or to eggs or egg proteins.
Maltese: Fluenz Tetra m'għandux jintuża fi tfal li huma ipersensittivi (allerġiċi) għas-sustanzi attivi jew għal xi waħda mis-sustanzi l-oħra, għal gentamicin (tip ta' antibijotiku), jew għall-bajd jew il-proteini tal-bajd.
English: Fluenz Tetra is a vaccine used to protect children from 2 to less than 18 years of age against influenza (flu).
Maltese: Fluenz Tetra huwa vaċċin użat biex jipproteġi t-tfal li għandhon sentejn sa anqas minn 18-il sena kontra l-influwenza.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Fluenz Tetra on 4 December 2013.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Fluenz Tetra valida fl-Unjoni Ewropea kollha fl-4 ta' Diċembru 2013.
English: Of these studies the main study involved over 2,000 children aged 2 to 17 years who were vaccinated with either Fluenz Tetra or one of two Fluenz vaccines containing either one of the two influenza B strains which are also contained in Fluenz Tetra.
Maltese: Minn dawn l-istudji, l-istudju ewlieni involva aktar minn 2,000 tifel u tifla li għandhom bejn sentejn u 17-il sena li kienu mlaqqma bi Fluenz Tetra jew b'wieħed miż-żewġ vaċċini ta' Fluenz li fihom waħda miż-żewġ razez ta' influwenza B li jinsabu wkoll fi Fluenz Tetra.
English: What are the risks associated with Fluenz Tetra?
Maltese: X'inhuma r-riskji assoċjati ma' Fluenz Tetra?
English: How does Fluenz Tetra work?
Maltese: Kif jintuża Fluenz Tetra?
English: Fluenz Tetra is available as a nasal spray.
Maltese: Fluenz Tetra jiġi bħala sprej nażali.
English: The most common side effects with Fluenz Tetra (seen in more than 1 patient in 10) are reduced appetite, headache, blocked or runny nose and malaise (feeling unwell).
Maltese: L-effetti sekondarji l-aktar komuni bi Fluenz Tetra (li dehru f'aktar minn pazjent 1 minn 10) huma nuqqas ta' aptit, uġigħ ta' ras, imnieħer imblokkat jew riħ u ma tħossokx f'siktek.
English: The study showed that patients vaccinated with Fluenz Tetra had immune responses against each of the four vaccine virus strains that were comparable to the immune responses stimulated by the Fluenz vaccines.
Maltese: Listudju wera li l-pazjenti mlaqqma bi Fluenz Tetra kellhom risponsi immunitarji kontra kull wieħed millerba' razez ta' virusis tal-vaċċin li kienu paragunabbli mar-risponsi immunitarji stimulati mill-vaċċini ta' Fluenz.
English: The company provided three studies that compared Fluenz Tetra with Fluenz, an authorised influenza vaccine that contains three of the four strains of influenza in Fluenz Tetra and whose effectiveness is already established.
Maltese: Għal-lista sħiħa taleffetti sekondarji kollha rrapportati bi Fluenz Tetra, ara l-fuljett ta' tagħrif.
English: It is not intended to provide practical advice on how to use Fluenz Tetra.
Maltese: Dan mhux intiż biex jipprovdi konsultazzjoni prattika dwar l-użu ta' Fluenz Tetra.
English: 250 mg Tablet bottle
Maltese: 250 mg Pillola
English: Immediate Packaging Pack size
Maltese: Il-pakkett li jmiss mal-prodott Daqs tal-pakkett
English: Date of first authorisation: 29 October 2004 Date of last renewal: 23 November 2009
Maltese: Data tal-aħħar tiġdid: 23 ta 'Novembru 2009
English: 30 µg/kg 30 µg/kg 10 µg/kg 25 µg/kg
Maltese: 30mikrogramma /kilogramma 30mikrogramma /kilogramma 10mikrogramma /kilogramma 25mikrogramma /kilogramma
English: The active substance, halofuginone, is an antiprotozoal agent of the quinazolinone derivatives group (nitrogenous polyheterocycles).
Maltese: Is-sustanza attiva halofuginone, hija aġent anti-protożoiku li ġej mill-grupp tal-Quinazolinone (nitrogenous polyheterocycles).
English: Intervet Productions SA Rue de Lyons F-27460 Igoville France
Maltese: Rue de Lyons F-27460
English: Benzoic acid (E 210)
Maltese: Lactic acid (E 270)
English: The concentrations to inhibit 50 % and 90 % of the parasites, in an in vitro test system, are IC50 < 0.1 µg/ml and IC90 of 4.5 µg/ml respectively.
Maltese: Ilkon`entrazzjoni sabiex tinpedixxi 50% u 90% tal-parassiti f'testijiet li saru in vitro huwa ta' IC50 < 0.1 mikrogrammi/ml u IC90 ta' 4.5 mikrogrammi/ml rispettivament.
English: Manufacturer responsible for batch release: Intervet Productions S.A.
Maltese: Intervet Productions S.A.
English: Tartrazine (E 102)
Maltese: Tartariżin ( E102)
English: Antiparasitic agents/Agents acting against protozoa
Maltese: Aġenti Antiparas / Aġenti li jaġixx kontra protozoa
English: None.
Maltese: NON
English: Pharmaco-logically active substance
Maltese: Sustanza farmakoloġik ament attiva
English: The apparent volume of distribution is 10 l/kg.
Maltese: Il-volum apparenti ta'distrubuzzjoni huwa ta' 10 litri/kilogramma.
English: <Batch> <Lot> <BN> number.
Maltese: <Lott> <lott> <Numru tal-lott> {numru}
English: Liver Kidney Muscle Fat
Maltese: Fwied Kliewi Muskoli
English: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Maltese: Intervet International B.V Wim de Korverstraat 35 5831 AN Boxmeer Olanda
English: The active substance in HALOCUR is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Maltese: Is-sustanza attiva f'HALOCUR hija sustanza permessa kif deskritt fit-tabella 1 tal-anness għarRegolament tal-Kummissjoni (UE) Nru 37/2010:
English: The maximum concentration in plasma Cmax is 4 ng/ml.
Maltese: L-għola kon`entrazzjoni fil-plasma (Cmax ) hija ta' 4 nanogrammi/millilitru.
English: HALOCUR contains 0.5 mg/ml halofuginone base (as lactate salt).
Maltese: HALOCUR fiha 0.5 mg/ml halofuginone bazi (bhala melh tal- lactate).
English: Halofuginone Bovine
Maltese: BOVINI
English: Halofuginone lactate (RU 38788) is a salt whose antiprotozoal properties and efficacy against Cryptosporidium parvum have been demonstrated both in in vitro conditions and in artificial and natural infections.
Maltese: Halofunginone lactate (RU38788) hija kimika li ġiet murija li għandha l-effett li toqtol il-protożoi tat-tip Cryptosoridium parvum kemm in vitro, kif ukoll f'infezzjonijiet artifi`jali u naturali.Is-sustanza għandha effett li twaqqaf it-tkabbir tal-kriptosporidja parvum.
English: 35 kg < calves ≤ 45 kg: 8 ml of HALOCUR once a day during 7 consecutive days
Maltese: • 35kg < għoġġiela ≤ 45kg : 8 ml HALOCUR darba kuljum għal sebat ijiem konsekuttivi.
English: Halofuginone
Maltese: Igoville
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Maltese: FARMAĊEWTIKU 6.1 Lista ta' ingredjenti Aċidu Benżoiku ( E210)
English: The dosage is: 100 µg of halofuginone base / kg body weight (BW) / once a day for 7 consecutive days, i.e. 2 ml of HALOCUR / 10 kg BW / once a day for 7 consecutive days.
Maltese: Id-doża hija ta' : 100 mikrogramma ta' bażi ta' ħalofuġinone/kg piż ħaj/ darba kuljum għal sebat ijiem konsekuttivi, i.e. 2ml ta' HALOCUR/10kg piż ħaj/ darba kuljum għal sebat ijiem konsekuttivi.
English: Halofuginone base (as lactate salt)
Maltese: Bażi ta' Ħalofuġinon (bħala lactate)
English: Prevention of diarrhoea due to diagnosed Cryptosporidium parvum, in farms with history of cryptosporidiosis.
Maltese: • Prevenzjoni kontra dijareja ikkawżata minn Cryptosoridium pavarum,f'irziezet li għandhom storja ta' kriptosporidjosi.
English: Pharmacotherapeutic group: Quinazolinone derivate ATCvet code: QP51AX08
Maltese: QP51AX08
English: 5831 AN Boxmeer The Netherlands
Maltese: Wim de Körverstraat 35 5831 AN Boxmeer Olanda
English: 500 ml bottle containing 490 ml of oral solution 1000 ml bottle containing 980 ml of oral solution
Maltese: Flixkun ta' 500ml li fih 490ml tal-prodott/ Flixkun ta' 1000ml li fih 980ml tal-prodott.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.emea.europa.eu/.
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediku veterinarju tinstab fuq il-websajt ta' l-Aġenzija Ewropea għall-Mediċini http://www.emea.europa.eu/.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance:
Maltese: Sustanza Attiva/i:
English: For treatment of anorexic calves, the product should be administered in half a litre of an electrolyte solution.
Maltese: Jekk se titratta għoġġiela bi stonku mqalleb, amministra l-prodott ma taħlita ta' nofs litru elektrolajts.
English: Animal species MRLs
Maltese: MRL
English: Marker residue
Maltese: Mhux applikabli
English: Symptoms of toxicity include diarrhoea, visible blood in faeces, decline in milk consumption, dehydration, apathy and prostration.
Maltese: Sintomi ta' tossi`ita' jinkludu: dijareja, demm fil-ħmieġ, tnaqqis fl-aptit, l-annimal jixxotta, telqa u għejja.
English: Repetitive contact with the product may lead to skin allergies.
Maltese: Kuntatt kontinwu jew ripetittiv mal-prodott jista' jikkawża allerġiji.
English: The terminal elimination half-life is 11.7 hours after intravenous administration and 30.84 hours after single oral administration.
Maltese: Il-ħin sabiex nofs il-prodott ikun eliminat huwa ta' 11.7 siegħat wara somministrazzjoni fil-vina u ta' 30.84 siegħat meta jingħata f'doża waħda fil-ħalq.
English: The plasmatic concentrations of halofuginone after repeated oral administrations are comparable to the pharmacokinetic pattern after single oral treatment.
Maltese: Ilkon`entrazzjoni ta'ħalofuġinon fil-plasma wara doża amministrata ripetutament mill-ħalq hija simili għall-profil farmokinetiku ta' doża waħda.
English: 45 kg < calves < 60 kg: 12 ml of HALOCUR once a day during 7 consecutive days For smaller or higher weights, a precise calculation should be performed (2 ml/10 kg BW).
Maltese: • 45kg < għoġġiela < 60kg : 12 ml HALOCUR darba kuljum għal sebat ijiem konsekuttivi.
English: High-density polyethylene portable bottle of 500 ml containing 490 ml of the oral solution.
Maltese: Flixken tal-poli-etilin ta' densita għolja tal-500ml li jkun fihom 490 ml tal-prodott.
English: Excipients:
Maltese: ĠINON
English: The excipients 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-eċċipjenti elenkati fit-taqsima 6.1 tal-SPC huma sustanzi permessi li għalihom it-tabella 1 tal-anness għar-Regolament tal-Kummissjoni (UE) Nru 37/2010 tindika li l-ebda MRLs mhumiex meħtieġa.
English: Reduction of diarrhoea due to diagnosed Cryptosporidium parvum.
Maltese: Tnaqqis ta' in`idenza ta' dijareja ikkawżata minn Cryptosoridium pavarum.
English: It is mainly active on the free stages of the parasite (sporozoïte, merozoïte).
Maltese: L-aktar li huwa effettiv huwa fl-istadju liberu tal-parassita (sporozojte, merozojte).
English: Once the first calf has been treated, all the forthcoming new-born calves must be systematically treated as long as the risk for diarrhoea due to C. parvum persists.
Maltese: Jekk għoġol ġie trattat b'dan il-prodott, kull ġħoġol li jitwieled wara irid jibqa' jiġi trattat sakemm il periklu ta' dijareja minn C.parvum jippersisti fir-razzett.
English: Meat and offal: 13 days.
Maltese: PERJODU/I TA' TIŻMIM Laħam u Interjur :13 -il ġurnata
English: The time necessary to obtain the maximum concentration Tmax is 11 hours.
Maltese: L-għola kon`entrazzjoni tintlaħaq (Tmax) fi 11-il siegħa.
English: Unchanged Halofuginone is the major component in the tissues.
Maltese: }alofuġinone mhux modifikat, huwa l-akbar komponent li wieħed isib fit-tessuti.
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 )
Maltese: - komuni ħafna (aktar minn wieħed f'10 annimali trattati li juru effetti mhux mixtieqa) - 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)
English: If eye irritation persists, seek medical advice.
Maltese: Jekk l irritazzjoni tal-għajnejn tippersisti, ara tabib.
English: - 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: - rari ħafna (inqas minn annimal wieħed f'10,000 annimal trattati, inklużi rapporti iżolati).
English: High-density polyethylene portable bottle of 1000 ml containing 980 ml of the oral solution.
Maltese: Flixken tal-poli-etilin ta' densita għolja tal-1000ml li jkun fihom 980ml tal-prodott.
English: Halofuginone base
Maltese: Dispożizzjoniji et oħrajn
English: An increase in the level of diarrhoea has been observed in treated animals in very rare cases.
Maltese: Zieda fil-livell ta 'dijarea ġiet osservata fl-annimali trattati, f'każijiet rari ħafna..
English: MA (EU) number (Invented) name
Maltese: No Numru tal-MA (EU)
English: Immediate Packaging Content (concentratio n)
Maltese: Kontenut (konċentrazzjoni)
English: 1 blister (7 tablets)
Maltese: 1 folja (7 pilloli)
English: Cats
Maltese: Majjali
English: Subcutaneous use
Maltese: Żwiemel
English: Subcutaneous or intravenous use (dogs), subcutaneous use (cats)
Maltese: Użu għal taħt il-ġilda jew ġol-vini (klieb), użu għal taħt il-ġilda (qtates)
English: Intramuscular use (pigs)
Maltese: Ħalib: 5 ijiem (baqar)
English: Dogs and cats
Maltese: Klieb u Qtates
English: 20 February 2014 EMA/108603/2014
Maltese: EMA/108603/2014
English: 2 More information can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Referrals/Tredaptive, Pelzont and Trevaclyn.
Maltese: ema.europa.eu/Find medicine/Human medicines/Referrals/Tredaptive, Pelzont and Trevaclyn.
English: Contact our press officers Monika Benstetter or Martin Harvey
Maltese: Ikkuntattja lill-uffiċjali għall-istampa tagħna Monika Benstetter jew Martin Harvey
English: CMDh endorses PRAC recommendation
Maltese: Is-CMDh japprova r-rakkomandazzjoni tal-PRAC
English: The review of nicotinic acid and its related substances acipimox and xantinol nicotinate was initiated on 27 February 2013 at the request of the Danish Health and Medicines Authority, under Article 31 of Directive 2001/83/EC.
Maltese: Ir-reviżjoni tal-aċidu nikotiniku u s-sustanzi relatati tiegħu acipimox u xantinol nicotinate inbdiet fis27 ta' Frar 2013 fuq talba mill-Awtorità Daniża tas-Saħħa u l-Mediċini, skont l-Artikolu 31 tadDirettiva 2001/83/KE.
English: In the EU, acipimox-containing medicines are currently marketed in Austria, Belgium, Denmark, Hungary, Italy, Luxembourg, the Netherlands and the United Kingdom.
Maltese: Fl-UE, il-mediċini li fihom acipimox bħalissa qegħdin jiġu kkummerċjalizzati fl-Awstrija, il-Belġju, id-Danimarka, l-Ungerija, l-Italja, ilLussemburgu, il-Pajjiżi l-Baxxi u r-Renju Unit.
English: After looking at the available data on acipimox, including evidence from the literature, spontaneous reports of adverse effects and advice from a group of experts in the treatment of lipid disorders, as well as data from HPS2-THRIVE, the PRAC concluded that acipimox continues to have a role as an additional or alternative treatment to reduce triglycerides in those forms of hyperlipoproteinaemia that involve high triglyceride levels (with or without increased cholesterol), in patients in whom lifestyle changes and use of other medicines such as fibrates and statins are not adequate.
Maltese: Wara li eżamina d-dejta disponibbli dwar acipimox, inkluż l-evidenza mid-dokumentazzjoni, ir-rapporti spontanji tal-effetti avversi u parir minn grupp ta' esperti fil-kura tad-disturbi fil-lipidi, kif ukoll id-dejta minn HPS2-THRIVE, il-PRAC ikkonkluda li acipmox għad għandu rwol bħala kura addizzjonali jew alternattiva biex inaqqas it-trigliċeridi f'dawk il-forom ta' iperlipoproteinemija li jinvolvu livelli ta' trigliċeridi għoljin (b'żieda fil-kolesterol jew le), f'pazjenti li l-istil ta' ħajja tagħhom jinbidel u l-użu ta' mediċini oħra bħal fibrati u statini mhumiex adegwati.
English: • Acipimox was considered to be efficacious in reducing triglyceride levels in patients with hypertriglyceridaemia (Fredrickson type IV hyperlipoproteinaemia) and significantly superior to placebo in patients with hypercholesterolaemia and hypertriglyceridaemia (Fredrickson type IIb hyperlipoproteinaemia).
Maltese: • Acipimox kien meqjus li kien effikaċi fit-tnaqqis tal-livelli tat-trigliċeridi f'pazjenti b'ipertrigliċeridemija (iperlipoproteinemija tat-tip IV skont il-klassifika ta' Fredrickson) u superjuri b'mod sinifikanti għal plaċebo f'pazjenti b'iperkolesterolemija u ipertrigliċeridemija (iperlipoproteinemija tat-tip IIb skont il-klassifika ta' Fredrickson).
English: Flushing, rash and gastrointestinal effects (nausea, dyspepsia, diarrhoea and upper abdominal pain) are the most frequently reported adverse effects for acipimox and are listed in the acipimox product information, together with pruritus, erythema, urticaria and angioedema.
Maltese: Fwawar, raxx u effetti gastrointestinali (dardir, dispepsja, dijarea u uġigħ addominali finnaħa ta' fuq) huma l-aktar effetti avversi rrapportati b'mod frekwenti għal acipimox u huma elenkati fl-informazzjoni dwar il-prodott ta' acipimox, flimkien ma' ħakk, eritema, urtikarja u anġjoedema.
English: In July 2013 it was established that nicotinic acid and the related substance xantinol nicotinate were not currently marketed in the EU to treat lipid disorders (xantinol nicotinate is authorised in some EU countries for oral use as a vasodilator, a medicine that widens the blood vessels used to treat blood circulation problems) and the review was therefore restricted to acipimox only.
Maltese: F'Lulju 2013 ġie stabbilit li l-aċidu nikotiniku u s-sustanza relatata nicotinate xantinol dak iż-żmien ma kinux qed jiġu kkummerċjalizzati fl-UE biex jikkuraw disturbi fil-lipidi (xantinol nicotinate huwa awtorizzat f'xi pajjiżi tal-UE għall-użu orali bħala vażodilatatur, mediċina li twessa' l-arterji tad-demm użata biex tikkura problemi ta' ċirkolazzjoni tad-demm) u għalhekk irreviżjoni ġiet limitata għal acipimox biss.
English: 1 The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
Maltese: 1 Is-CMDh, korp li jirrappreżenta l-Istati Membri tal-UE, huwa responsabbli biex jiżgura standards armonizzati dwar issigurtà għall-mediċini awtorizzati permezz tal-proċeduri nazzjonali madwar l-UE kollha.
English: The review of acipimox was based on the limited available efficacy and safety data on acipimox as well as data from the scientific literature relating to the structurally related compound nicotinic acid.
Maltese: Ir-reviżjoni ta' acipimox kienet ibbażata fuq id-dejta limitata disponibbli dwar l-effikaċja u s-sigurtà dwar acipomox kif ukoll id-dejta mid-dokumentazzjoni xjentifika relatata mal-kompost strutturalment relatat ta' aċidu nikotiniku.
English: More about the procedure
Maltese: B3).
English: In addition, the PRAC consulted an ad-hoc expert group of European experts on the use of acipimox.
Maltese: Barra minn hekk, il-PRAC ikkonsulta ma' grupp ta' esperti ad-hoc ta' esperti Ewropej dwar l-użu ta' acipimox.
English: The study showed that adding this combination to treatment with statins (another class of medicines used to treat lipid disorders) did not lead to additional benefits in reducing the risk of major vascular events such as heart attack and stroke, but did result in a higher frequency of non-fatal but serious side effects.
Maltese: L-istudju wera li ż-żieda ta' din il-kombinazzjoni mal-kura bi statini (klassi oħra ta' mediċini użati għall-kura tad-disturbi fil-lipidi) ma waslitx għal benefiċċji addizzjonali fit-tnaqqis tar-riskju ta' avvenimenti vaskulari kbar bħal attakk tal-qalb u puplesija, iżda rriżultat fi frekwenza ogħla ta' effetti sekondarji serji iżda mhux fatali.
English: These recommendations were originally made by the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) at its meeting of 5-8 November 2013.
Maltese: Dawn ir-rakkomandazzjoni kienu oriġinarjament saru mill-Kumitat Konsultattiv dwar il-Valutazzjoni tarRiskji tal-Farmakoviġilanza (PRAC) tal-Aġenzija Ewropea għall-Mediċini fil-laqgħa tiegħu tal-58 ta' Novembru 2013.
English: • Acipimox is indicated for the treatment of hypertriglyceridaemia with or without hypercholesterolaemia (Fredrickson type IIb or type IV hyperlipoproteinaemia).
Maltese: • Acipimox huwa indikat għall-kura ta' ipertrigliċeridimja b'iperkolesterolimja jew mingħajrha (iperlipoproteinemija tat-tip IIb jew tat-tip IV skont il-klassifika ta' Fredrickson).
English: This was endorsed by the CMDh.
Maltese: Dan kien awtorizzat mis-CMDh.
English: Nicotinic acid is a naturally occurring substance used in low doses as a vitamin (known as niacin or vitamin B3).
Maltese: L-aċidu nikotiniku hija sustanza li tinstab b' mod naturali li tintuża f'dożi aktar baxxi bħala vitamina (magħrufa bħala niacin jew vitamina