FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, patients treated with Protelos/Osseor should be screened and monitored regularly, every 6 to 12 months.
Maltese: Barra minn hekk, pazjenti kkurati bi Protelos / Osseor għandhom jiġu skrinjati u mmonitorjati regolarment, kull 6 sa 12-il xahar.
English: The PRAC's recommendations were then sent to the Committee for Medicinal Products for Human Use (CHMP) responsible for all questions concerning medicines for human use, which adopted the Agency's final opinion.
Maltese: Imbagħad ir-rakkomandazzjonijiet tal-PRAC intbagħtu lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) responsabbli għall-kwistjonijiet kollha li jikkonċernaw mediċini għall-użu mill-bniedem, li adotta l-opinjoni finali tal-Aġenzija.
English: • Protelos/Osseor will only be prescribed for preventing fractures in post-menopausal women and men with severe osteoporosis who have a high risk of fracture and cannot be treated with other medicines approved for osteoporosis.
Maltese: • Protelos/Osseor se jiġi preskritt biss għall-prevenzjoni ta' ksur f'nisa wara l-menopawsa u rġiel b'osteoporożi severa li għandhom riskju għoli ta' ksur u li ma jistgħux jiġu trattati b'mediċini oħrajn approvati għall-osteoporożi.
English: • Protelos/Osseor should only be used to treat severe osteoporosis in postmenopausal women and men at high risk of fracture, for whom treatment with other medicinal products approved for the treatment of osteoporosis is not possible due to, for example, contraindications or intolerance;
Maltese: • Protelos/Osseor għandu jintuża biss biex jikkura l-osteoporożi severa fin-nisa wara l-menopawsa u rġiel b'riskju għoli ta' ksur, li għalihom kura bi prodotti mediċinali oħra approvati għall-kura ta' osteoporożi mhix possibbli minħabba, pereżempju, kontraindikazzjonijiet jew intolleranza;
English: This final EMA recommendation on the use of Protelos/Osseor was based on an analysis of pooled data from randomised studies in around 7,500 post-menopausal women with osteoporosis.
Maltese: Din ir-rakkomandazzjoni finali tal-EMA dwar l-użu ta' Protelos/Osseor kienet ibbażata fuq analiżi ta' dejta miġbura minn studji li ntgħażlu b'mod każwali f'madwar 7,500 mara bl-osteoporożi wara lmenopawsa.
English: • Protelos/Osseor should be stopped if the patient develops ischaemic heart disease, peripheral arterial disease or cerebrovascular disease, or if hypertension is uncontrolled;
Maltese: • Protelos/Osseor għandu jitwaqqaf jekk il-pazjent jiżviluppa mard tal-qalb iskemiku, mard arterjali periferali jew mard ċerebrovaskulari, jew jekk il-pressjoni għolja ma tkunx ikkontrollata;
English: Available data do not show evidence of an increased cardiovascular risk in patients without established, current or past history of ischaemic heart disease, peripheral arterial disease or cerebrovascular disease, or in those without uncontrolled hypertension.
Maltese: Dejta disponibbli ma wrietx evidenza ta' riskju kardjovaskulari miżjud f'pazjenti mingħajr storja filpreżent jew fil-passat ta' mard tal-qalb iskemiku, mard arterjali periferali jew mard ċerebrovaskulari stabbilit, jew dawk li ma jbatux minn pressjoni għolja mhux ikkontrollata.
English: • Protelos/Osseor must not be used in patients with established, current or past history of ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease, or those with uncontrolled hypertension;
Maltese: • Protelos/Osseor ma għandux jintuża f'pazjenti li għandhom fil-passat jew fil-preżent kellhom storja ta' mard iskemiku tal-qalb stabbilit, mard arterjali periferali u/jew mard ċerebrovaskulari, jew dawk bi pressjoni għolja mhux ikkontrollata;
English: The patient's risk of developing cardiovascular disease should be evaluated before starting treatment and on a regular basis thereafter, generally every 6 to 12 months;
Maltese: Ir-riskju tal-pazjent li jiżviluppa mard kardjovaskulari għandu jiġi evalwat qabel ma tinbeda l-kura u fuq bażi regolari wara, ġeneralment kull 6 sa 12-il xahar;
English: • You should not take Protelos/Osseor if you have or have had heart or circulatory problems such as stroke, heart attack, or obstruction of the blood flow in the arteries.
Maltese: • Ma għandekx tieħu Protelos/Osseor jekk għandek jew kellek problemi tal-qalb jew problemi ċirkolatorji bħal puplesija, attakk tal-qalb, jew ostruzzjoni tal-fluss tad-demm fl-arterji.
English: The CHMP opinion was forwarded to the European Commission, which endorsed it and issued a final legally binding decision valid throughout the EU on 15 April 2014.
Maltese: Ir-rakkomandazzjonijiet tas-CHMP intbagħtu lill-Kummissjoni Ewropea, li approvathom u ħarġet deċiżjoni finali legalment vinkolanti valida fl-UE kollha.
English: The CHMP considered that the cardiovascular risk in patients taking Protelos/Osseor can be managed by restricting its use to patients with no history of heart and circulatory problems and limiting its use to those who cannot take other medicines approved for the treatment of osteoporosis.
Maltese: L-Aġenzija Ewropea għall-Mediċini kkonkludiet ir-reviżjoni tagħha ta' Protelos/Osseor u rrakkomandat iktar restrizzjonijiet fuq l-użu tal-mediċina lill-pazjenti li ma jistgħux jiġu kkurati b'mediċini oħrajn approvati għall-osteoporożi.
English: Both committees worked in close collaboration and the PRAC's recommendation was instrumental for us to fully assess the benefit-risk profile of the medicine', said Tomas Salmonson, chair of the CHMP.
Maltese: Biex wasal għall-konklużjonijiet tiegħu, is-CHMP innota li d-dejta ta' studju wriet effett benefiċjali filprevenzjoni ta' ksur, inkluż f'pazjenti b'riskju għoli ta' ksur.
English: The current recommendations add to EMA recommendations made in April 2013 not to use Protelos/Osseor in patients with known circulatory problems.
Maltese: Ir-rakkomandazzjonijiet attwali jżidu mar-rakkomandazzjonijiet tal-EMA li saru f'April 2013 biex ma jintużax Protelos/Osseor f'pazjenti bi problemi taċ-ċirkolazzjoni magħrufa.
English: The first stage of this review was conducted by the Pharmacovigilance Risk Assessment Committee (PRAC), the committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations.
Maltese: L-ewwel stadju ta' din ir-reviżjoni saret mill-Kumitat għall-Valutazzjoni tar-Riskji tal-Farmakoviġilanza (PRAC), il-kumitat responsabbli għall-evalwazzjoni ta' kwistjonijiet ta' sikurezza għall-mediċini talbniedem, li għamel sett ta' rakkomandazzjonijiet.
English: • Doctors should continue to base their decision to prescribe Protelos/Osseor on an assessment of the individual patient's risks.
Maltese: • It-tobba għandhom ikomplu jibbażaw id-deċiżjoni tagħhom li jippreskrivu Protelos/Osseor fuq valutazzjoni tar-riskji tal-pazjent individwali.
English: EMA/299177/2014 EMEA/V/C/002762
Maltese: EMEA/V/C/002762
English: Other information about Eryseng Parvo:
Maltese: Informazzjoni oħra dwar Eryseng Parvo:
English: For swine erysipelas, the first laboratory study showed that 90% (27 out of 30) of vaccinated pigs were protected against Erysipelothrix rhusiopathiae serotype 1 remaining free of specific skin lesions whilst 93% (28 out of 30) of vaccinated pigs were protected against Erysipelothrix rhusiopathiae serotype 2 remaining free of specific skin lesions.
Maltese: Għal erysipelas tal-majjali, l-ewwel studju fil-laboratorju wera li 90% (27 minn 30) tal-majjali mlaqqma kienu protetti kontra Erysipelothrix rhusiopathiae serotip1 u baqgħu liberi minn leżjonijiet talġilda speċifiċi filwaqt li 93% (28 minn 30) tal-majjali mlaqqma kienu protetti kontra Erysipelothrix rhusiopathiae serotip 2 u baqgħu liberi minn leżjonijiet tal-ġilda speċifiċi.
English: Eryseng Parvo contains an adjuvant (aluminium hydroxide, DEAE-dextran and ginseng) to enhance the immune response.
Maltese: Eryseng Parvo fih aġġuvant (aluminium hydroxide, DEAE-dextran u ginseng) biex itejjeb ir-rispons immunitarju.
English: The second laboratory study showed 93% (14 out of 15) pigs were protected against challenge with Erysipelothrix rhusiopathiae serotypes 1 and 2.
Maltese: It-tieni studju fil-laboratorju wera li 93% (14 minn 15) tal-majjali kienu protetti kontra sfida b'Erysipelothrix rhusiopathiae serotip 1 u 2.
English: The parvovirus study showed that Eryseng Parvo protected 100% of the foetuses whilst 89% of foetuses were mummified in the control group.
Maltese: L-istudju tal-parvovirus wera li Eryseng Parvo pproteġa 100% tal-feti filwaqt li 89% tal-feti ġew immummifikati fil-grupp ta' kontroll.
English: Porcine parvovirosis and swine erysipelas vaccine (inactivated)
Maltese: Parvovirus tal-majjali u vaċċin erysipelas tal-majjali (inattivati)
English: It contains a strain of porcine parvovirus called NADL-2 and a strain of Erysipelothrix rhusiopathiae called R32E11.
Maltese: Fih razza ta' parvovirus tal-majjali msejħa NADL-2 u razza ta' Erysipelothrix rhusiopathiae imsejħa R32E11.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Eryseng Parvo on 8 July 2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Eryseng Parvo fit-8 ta' Lulju 2014.
English: Eryseng Parvo is also used to protect male and female pigs against swine erysipelas caused by Erysipelothrix rhusiopathiae, serotype 1 and serotype 2.
Maltese: Eryseng Parvo jintuża wkoll biex jipproteġi majjali irġiel u nisa kontra erysipelas tal-majjali ikkawżata mill-batterji Erysipelothrix rhusiopathiae, serotip 1 u serotip 2.
English: For porcine parvovirus a laboratory study was conducted involving three groups of 11 gilts (female pigs that have not yet had piglets) vaccinated with different concentrations of porcine parvovirus.
Maltese: Għal parvovirus tal-majjali, sar studju f'laboratorju li involva tliet gruppi ta' 11-il majjala mgħammra (majjali nisa li għad ma kellhomx qżieqeż) imlaqqma b'konċentrazzjonijiet differenti ta' parvovirus talmajjali.
English: Pigs were challenged with parvovirus at day 40 of pregnancy and then euthanized (humanely killed) at day 90 of pregnancy.
Maltese: Il-majjali ġew sfidati bil-parvovirus fl-40 jum ta' tqala u imbagħad ġew ewtanizzati (maqtula mingħajr uġigħ) fid-90 jum ta' tqala.
English: Eryseng Parvo is used to protect embryonic and foetal (unborn) piglets against porcine parvovirus infection via the placenta.
Maltese: Eryseng Parvo jintuża biex jipproteġi qżieqeż ebrijoniċi u fetali (mhux imwielda) kontra infezzjoni ta' parvovirus tal-majjali mill-plaċenta.
English: The first study involved 40 pigs; 30 pigs were vaccinated with two doses, separated by three weeks, while a control group of 10 pigs received placebo (dummy treatment).
Maltese: L-ewwel studju involva 40 majjal; 30 majjal ġew imlaqqma b'żewġ dożi, b'intervall ta' tliet ġimgħat bejniethom, filwaqt li grupp ta' kontroll ta' 10 majjali irċieva plaċebo (trattament finta).
English: What is Eryseng Parvo?
Maltese: Għal xiex jintuża Eryseng Parvo?
English: All pigs were challenged 22 days after the second vaccination dose with injections of the bacteria Erysipelothrix rhusiopathiae serotypes 1 and 2.
Maltese: Il-majjali kollha ġew sfidati 22 jum wara t-tieni doża ta' tilqim b'injezzjonijiet ta' batterju Erysipelothrix rhusiopathiae serotip 1 u 2.
English: What is the risk associated with Eryseng Parvo?
Maltese: X'riskji huma assoċjati ma' Eryseng Parvo?
English: What is the withdrawal period?
Maltese: Kemm huwa twil il-perjodu ta' tiżmim?
English: The most common side effect (seen in more than 1 in 10 pigs) with Eryseng Parvo is mild to moderate inflammation at the injection site which typically resolves within four days but in some cases may persist for up to 12 days post-vaccination.
Maltese: L-effett sekondarju l-aktar komuni (li deher f'iktar minn ħanżir 1 minn kull 10) b'Eryseng Parvo huwa infjammazzjoni ħafifa sa moderata fil-post tal-injezzjoni, li tipikament titlaq fi żmien erbat ijiem iżda f'xi każijiet tista' tibqa' għal 12-il jum wara t-tilqima.
English: In the future, if the animals are exposed to porcine parvovirus and Erysipelothrix rhusiopathiae bacteria, the immune system will be able to respond more quickly.
Maltese: Fil-futur, jekk l-annimali jiġu esposti għal parvovirus tal-majjali u batterji Erysipelothrix rhusiopathiae, is-sistema immunitarja se tkun tista' tirrispondi iktar malajr.
English: When Eryseng Parvo is given to pigs the animals' immune system recognises the virus and bacteria as ‘foreign' and makes antibodies against them.
Maltese: Eryseng Parvo huwa vaċċin veterinarju li fih parvovirus tal-majjali u batterji Erysipelothrix rhusiopathiae inattivati (maqtula).
English: The benefit-risk balance may be found in the scientific discussion module of this EPAR.
Maltese: Il-bilanċ benefiċċju-riskju jista' jinsab fil-modulu ta' diskussjoni xjentifika ta' dan l-EPAR.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Eryseng Parvo exceed the risks for the approved indication and recommended that Eryseng Parvo be given a marketing authorisation.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' Eryseng Parvo huma akbar mir-riskji għall-indikazzjoni approvata u rrakkomanda li Eryseng Parvo jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: There was also an unvaccinated control group.
Maltese: Kien hemm ukoll grupp tal-kontroll mhux imlaqqam.
English: The measure of effectiveness was absence of porcine parvovirus and anti-porcine parvovirus antibodies in the foetuses.
Maltese: Il-kejl tal-effikaċja kien l-assenza tal-parvovirus tal-majjali u l-antikorpi kontra lparvovirus tal-majjali fil-feti.
English: The pigs were challenged a further six months later with injections of the bacteria Erysipelothrix rhusiopathiae serotypes 1 and 2 and the measure of effectiveness was the percentage of pigs protected by vaccination.
Maltese: Ilmajjali ġew sfidati sitt xhur wara aktar tard b'injezzjonijiet ta' batterju Erysipelothrix rhusiopathiae serotip 1 u 2 u l-kejl tal-effikaċja kien il-perċentwal ta' majjali protetti bit-tilqima.
English: Porcine parvovirus causes infertility, still births and small litters in sows (female pigs that have had piglets).
Maltese: Parvovirus tal-majjali tikkawża infertilità, twelid ta' feti mejtin u btan żgħar fil-majjali nisa (majjali nisa li kellhom il-qżieqeż).
English: How has Eryseng Parvo been studied?
Maltese: Kif ġie studjat Eryseng Parvo?
English: This will help protect them against porcine parvovirus and swine erysipelas.
Maltese: Dan se jgħin jipproteġihom kontra parvovirus tal-majjali u erysipelas tal-majjali.
English: How does Eryseng Parvo work?
Maltese: Eryseng Parvo huwa vaċċin.
English: Swine erysipelas is a bacterial disease of pigs characterised by sudden death, fever associated with diamond skin lesions, arthritis and by abortion in pregnant sows.
Maltese: Erysipelas tal-majjali hija marda batterika tal-majjali kkaratterizzata minn mewta għall-għarrieda, deni assoċjat ma' leżjonijiet tal-ġilda f'forma ta' djamanti, artrite u b'abort f'majjali nisa tqal.
English: The full EPAR for Velmetia 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: Velmetia sitagliptin / metformin hydrochloride
Maltese: Velmetia sitagliptina / metformina idrokloridrat
English: This is a summary of the European public assessment report (EPAR) for Velmetia.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Velmetia.
English: Why has Velmetia been approved?
Maltese: Għaliex ġie approvat Velmetia?
English: The most common side effect with Velmetia (seen in between 1 and 10 patients in 100) is nausea (feeling sick).
Maltese: L-effett sekondarju l-aktar komuni b'Velmetia (li deher f'bejn pazjent 1 u 10 minn 100) huwa nawżja (dardir).
English: • in patients who are not satisfactorily controlled on metformin (an antidiabetes medicine) used on its own;
Maltese: • f'pazjenti li mhumiex ikkontrollati b'mod sodisfaċenti bil-metformina biss (mediċina kontra ddijabete);
English: The European Commission granted a marketing authorisation valid throughout the EU for Velmetia on 16 July 2008.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Velmetia fis16 ta' Lulju 2008.
English: How has Velmetia been studied?
Maltese: Kif ġie studjat Velmetia?
English: Velmetia should be taken with food to avoid any stomach problems caused by metformin.
Maltese: Velmetia għandu jittieħed mal-ikel sabiex jiġu evitati problemi tal-istonku kkawżati minn metformina.
English: What is Velmetia?
Maltese: X'inhu Velmetia?
English: Velmetia is a medicine that contains two active substances, sitagliptin and metformin hydrochloride.
Maltese: Velmetia huwa mediċina li fiha żewġ sustanzi attivi sitagliptina u metformina idrokloridrat.
English: The active substances in Velmetia, sitagliptin and metformin hydrochloride, each have a different mode of action.
Maltese: Is-sustanzi attivi f'Velmetia, is-sitagliptina u l-metformina idrokloridrat, kull waħda għandha azzjoni differenti.
English: If Velmetia is taken with a sulphonylurea or insulin, the dose of the sulphonylurea or insulin may need to be lowered, to avoid hypoglycaemia (low blood sugar levels).
Maltese: sulfonilurea jew l-insulina, id-doża ta' sulfonilurea jew l-insulina jista' jkun meħtieġ li tiġi mnaqqsa sabiex tiġi evitata ipogliċemija (livelli baxxi ta' zokkor fid-demm).
English: • in combination with a sulphonylurea, a PPAR-gamma agonist such as a thiazolidinedione, or insulin
Maltese: • flimkien ma' sulfonilurea, agonista PPAR gamma, bħal thiazolidinedione jew insulina (tipi oħra ta' mediċina kontra d-dijabete) f'pazjenti li mhumiex kontrollati b'mod sodisfaċenti b'din il-mediċina u metformina.
English: Velmetia is taken twice a day.
Maltese: Velmetia jittieħed darbtejn kuljum.
English: What is the risk associated with Velmetia?
Maltese: X'inhu r-riskju assoċjat ma' Velmetia?
English: Sitagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon.
Maltese: Is-sitagliptina tnaqqas ukoll l-ammont ta' glukożju magħmul mill-fwied, billi tgħolli l-livelli tal-insulina u tnaqqas il-livelli tal-ormon glukagonu.
English: The company carried out additional studies to show that the active substances in Velmetia are absorbed by the body in the same way as the two medicines given separately.
Maltese: Il-kumpanija għamlet iktar studji sabiex turi li s-sustanzi attivi f'Velmetia jiġu assorbiti mill-ġisem blistess mod bħaż-żewġ mediċini mogħtija separatament.
English: This study also compared the effects of adding sitagliptin or placebo.
Maltese: Dan l-istudju qabbel ukoll l-effetti taż-żieda ta' sitagliptina jew plaċebo.
English: The first included 1,091 patients who were not satisfactorily controlled on diet and exercise alone and compared the effect of Velmetia with that of metformin or sitagliptin alone.
Maltese: Fl-ewwel wieħed ħadu sehem 1,091 pazjent li ma kinux kontrollati b'mod sodisfaċenti bid-dieta u bl-eżerċizzju biss u dan qabbel l-effett ta' Velmetia ma' dak tal-metformina jew tas-sitagliptina biss.
English: Ref.: EMEA/264546/2009 EMEA/H/C/770
Maltese: EMEA/264546/2009 EMEA/H/C/770
English: This summary was last updated in 05-2009.
Maltese: Dan is-sommarju kien aġġornat l-aħħar fi: 05-2009.
English: The active substance in Avamys, fluticasone furoate, is a corticosteroid.
Maltese: Is-sustanza attiva f'Avamys, fluticasone furoate hija kortikosterojde.
English: Each symptom was measured on a scale from 0 to 3, with a maximum total score of
Maltese: Kull sintomu tkejjel fuq skala bejn 0 u 3, b'total massimu ta' 12.
English: In the studies of seasonal allergic rhinitis in patients aged 12 years or over, Avamys reduced symptom scores from around 9 points at the start of the study by between 3.6 and 5.4 points over two weeks, compared with a reduction of 2.3 to 3.7 points with placebo.
Maltese: FL-istudji tar-rinite allerġika staġjonali f'pazjenti minn tnax-il sena 'l fuq, Avamys naqqas il-punteġġ ta' sintomi minn madwar 9 fil-bidu tal-istudju għal bejn 3.6 u 5.4 fuq perjodu ta' ġimagħtejn, meta mqabbel ma' tnaqqis ta' 2.3 u 3.7 bi plaċebo.
English: Avamys fluticasone furoate EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku
English: The European Commission granted a marketing authorisation valid throughout the European Union for Avamys to Glaxo Group Ltd on 11 January 2008.
Maltese: Il-Kummissjoni Ewropea tat l-awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea kollha, għal Avamys lil Glaxo Group Ltd fil-11 ta' Jannar 2008.
English: Avamys was compared with placebo (a dummy treatment) in six main studies involving almost 2,500 patients.
Maltese: Avamys tqabbel ma' plaċebo (trattament finta) f'sitt studji ewlenin li involvew kważi 2,500 pazjent.
English: What is Avamys?
Maltese: X'inhu Avamys?
English: In the study of perennial allergic rhinitis, Avamys had reduced scores by 3.6 points after four weeks, compared with a reduction of 2.8 points with placebo.
Maltese: Fl-istudji ta' rinite allerġika perenni, Avamys naqqas l-ammonti bi 3.6 punti wara erba' ġimgħat, meta mqabbel ma' tnaqqis ta' 2.8 punti bi plaċebo.
English: Avamys is a nasal spray that contains the active substance fluticasone furoate.
Maltese: Avamys huwa sprej tal-imnieħer li fih is-sustanza attiva fluticasone furoate.
English: Why has Avamys been approved?
Maltese: Għaliex ġie approvat Avamys?
English: It works in a similar way to naturally occurring corticosteroid hormones, reducing the activity of the immune system by attaching to receptors in various types of immune cell.
Maltese: Taħdem b'mod simili għallormoni kortikosterojdi preżenti fin-natura, billi ddgħajjef l-attività tas-sistema immunitarja billi teħel ma' riċetturi f'diversi tipi ta' ċelloli immuni.
English: The most common side effect with Avamys (seen in more than 1 patient in 10) is epistaxis (nosebleeds).
Maltese: L-iktar effett sekondarju komuni b'Avamys (li deher f'iktar minn pazjent 1 minn kull 10) hu epistassi (fġir l-imnieħer).
English: The other two studies were carried out in children aged between two and 11 years: the first involved 558 children with perennial allergic rhinitis and the second involved 554 children with seasonal allergic rhinitis.
Maltese: L-ewwel studju sar fuq 558 tifel u tifla b'rinite allerġija perenni u t-tieni fuq 554 tifel u tifla b'rinite allerġija staġjonali.
English: Avamys is used to treat the symptoms of allergic rhinitis.
Maltese: Avamys jintuża għat-trattament tas-sintomi ta' rinite allerġika.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Avamys's benefits are greater than its risks for the treatment of the symptoms of allergic rhinitis in patients aged six years or over.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Avamys huma akbar mir-riskji tiegħu għat-trattament ta' sintomi ta' rinite allerġika f'pazjenti minn sitt snin 'il fuq.
English: However, it was not possible to determine if Avamys worked in children below the age of six years, because there were too few children below this age included the studies.
Maltese: Madankollu, ma kienx possibbli li jkun determinat jekk Avamys ħadimx fi tfal iżgħar minn sitt snin, minħabba li kienx hemm biżżejjed tfal iżgħar minn din l-età inklużi fl-istudji.
English: What is the risk associated with Avamys?
Maltese: X'inhu r-riskju assoċjat ma' Avamys?
English: The effects of Avamys were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Avamys għall-ewwel ġew ittestjati f'mudelli sperimentali qabel ma ġew studjati filbniedem.
English: The first four studies looked at Avamys used in patients aged 12 years or over: three were short-term studies lasting two weeks and involved a total of 886 patients with seasonal allergic rhinitis
Maltese: Tliet studji twettqu fuq żmien qasir ta' ġimagħtejn u kienu jinvolvu 886 pazjent b'rinite allerġika (riħ tal-ħuxliefhay fever), filwaqt li r-raba' studju dam erba' ġimgħat u kien jinvolvi 302 pazjenti b'allerġiji perenni (mhux skont l-istaġun), bħal allerġiji għall-annimali.