FrancophonIA/ELRC3.0 huggingface dataset:
English: How is Grastofil used?
Maltese: Grastofil?
English: For the full list of side effects and restrictions with Grastofil, see the package leaflet.
Maltese: Għallista sħiħa tal-effetti sekondarji u r-restrizzjonijiet bi Grastofil, ara l-fuljett ta' tagħrif.
English: Filgrastim works in the same way as naturally produced G-CSF by encouraging the bone marrow to produce more white blood cells.
Maltese: Filgrastim taħdem bl-istess mod ta' G-CSF li tiġi prodotta b'mod naturali billi tistimola lill-mudullun biex jipproduċi aktar ċelloli bojod tad-demm.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Grastofil has been shown to have a comparable quality, safety and effectiveness to Neupogen.
Maltese: L-Aġenzija Ewropea għall-Mediċini ddeċidiet li, b'mod konformi mar-rekwiżiti tal-UE għal mediċini bijosimili, Grastofil wera li għandu kwalità, sigurtà u effikaċja komparabbli għal Neupogen.
English: Ref.: EMEA/327260/2009 EMEA/H/C/230
Maltese: EMEA/268267/2009 EMEA/H/C/230
English: Integrilin eptifibatide EPAR summary for the public
Maltese: Integrilin eptifibatide Sommarju tal-EPAR għall-pubbliku
English: What is the risk associated with Integrilin?
Maltese: X'inhuma r-riskji marbuta ma' Integrilin?
English: Integrilin is a medicine that contains the active substance eptifibatide.
Maltese: Integrilin huwa mediċina li fiha s-sustanza attiva eptifibatide.
English: This is followed by a continuous infusion of 2.0 microgram/kg per minute which is continued for up to 72 hours, until the start of surgery, or until discharge from the hospital, whichever occurs first.
Maltese: Din hija segwita minn infużjoni kontinwa ta' 2.0 mikrogrammi/kg fil-minuta li tibqa' sejra sa 72 siegħa, sakemm jibda l-intervent kirurġiku, jew sakemm il-pazjent jintbagħat mill-isptar, skont liema minnhom isseħħ l-ewwel.
English: • patients who have already had a non-Q-wave myocardial infarction (a type of heart attack), with chest pain in the last 24 hours and with abnormalities on the electrocardiogram (ECG) or signs of heart problems in the blood.
Maltese: • pazjenti li diġà kellhom infart mijokardijaku mhux tal-mewġa Q (tip ta' attakk tal-qalb), b'uġigħ f'sidirhom fl-aħħar 24 siegħa u b'anomaliji fuq l-elettrokardjogramma (ECG) jew sinjali ta'
English: Integrilin is given with aspirin and unfractionated heparin (other medicines that prevent blood clots).
Maltese: Integrilin jingħata mal-aspirina u l-eparina mhux frazzjonata (mediċini oħra li jimpedixxu emboli).
English: If the patient undergoes a percutaneous coronary intervention (PCI or angioplasty, a surgical procedure that is used to unblock narrowed coronary arteries), the treatment can be continued for up to 24 hours after surgery, with a maximum treatment duration of 96 hours.
Maltese: Jekk il-pazjent jagħmel intervent perkutaneju koronarju (PCI jew anġioplastika, proċedura kirurġika li ssir biex tiżblokka arterji koronarji dojoq), it-trattament jista' jitkompla sa mhux aktar minn 24 siegħa wara l-intervent kirurġiku, sa massimu ta' dewmien tat-trattament ta' 96 siegħa.
English: The marketing authorisation was renewed on 1 July 2004 and on 1 July 2009.
Maltese: L-awtorizzazzjoni għat-tqegħid fis-suq ġiet imġedda fl-1 ta' Lulju 2004 u fl-1 ta' Lulju 2009.
English: The active substance in Integrilin, eptifibatide, stops the platelets aggregating by blocking a protein called glycoprotein IIb/III on their surface that helps make them sticky.
Maltese: Is-sustanza attiva f'Integrilin, eptifibatide, twaqqaf il-pjastrini milli jaggregaw billi timblokka proteina msejħa glikoproteina IIb/III preżenti fil-wiċċ tagħhom li tgħin sabiex jeħlu.
English: Integrilin is used to prevent a myocardial infarction (heart attack) in adults.
Maltese: Integrilin jintuża sabiex jipprevjeni infart mijokardijaku (attak tal-qalb) fl-adulti.
English: • patients who have unstable angina (a severe type of chest pain that varies in intensity);
Maltese: • pazjenti li għandhom anġina mhux stabbli (tip gravi ta' wġigħ fis-sider li jvarja fl-intensità);
English: Integrilin is an inhibitor of platelet aggregation.
Maltese: Integrilin huwa impeditur tal-aggregazzjoni tal-pjastrini.
English: An additional study compared Integrilin with placebo in 2,000 patients who were having PTCA to remove a blood clot from the coronary arteries and insert a stent (a short tube that remains in the artery to stop it closing).
Maltese: Studju ieħor qabbel Integrilin ma' plaċebo f'2,000 pazjent li kellhom PTCA biex jitneħħa embolu mill-arterji koronarji u biex jiddaħħlilhom stent (tubu qasir li jibqa' fl-arterja biex iwaqqafha milli tingħalaq).
English: This includes patients who are having percutaneous transluminal coronary angiography (PTCA, a type of surgery to clear the arteries supplying the heart).
Maltese: Dan jinkludi pazjenti li għandhom anġioplastika koronarja transluminali perkutanea (PTCA, tip ta' intervent kirurġiku biex tnaddaf l-arterji li jissupplixxu l-qalb).
English: Integrilin has been compared with placebo (dummy treatment) in a study involving 11,000 patients who were in hospital and had signs that they may soon develop a heart attack, or who had already had a small heart attack.
Maltese: Integrilin tqabbel ma' plaċebo (trattament finta) fi studju li involva 11,000 pazjent li kienu l-isptar u kellhom sinjali li aktarx fiż-żmien qarib kien ser ikollhom attak tal-qalb, jew li diġà kellhom attakk talqalb ħafif.
English: How does Integrilin work?
Maltese: X'inhu Integrilin?
English: The full EPAR for Integrilin can be found here.
Maltese: Għaliex ġie approvat Integrilin?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Integrilin on 1 July 1999.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Integrilin fl-1 ta' Lulju 1999.
English: Patients who have moderate problems with their kidneys should receive a lower dose during the infusion.
Maltese: Il-pazjenti li għandhom problemi moderati fil-kliewi għandhom jingħataw dożijiet iktar baxxi waqt linfużjoni.
English: In the first study, Integrilin was more effective than placebo in preventing death or a heart attack during the 30 days after it was given.
Maltese: Fl-ewwel studju, Integrilin kien aktar effikaċi mill-plaċebo fil-prevenzjoni ta' mewt jew ta' attakk talqalb waqt it-30 jum ta' wara li ngħata.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Integrilin's benefits are greater than its risks when used to prevent early myocardial infarction.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Integrilin huma akbar mir-riskji tiegħu biex jimpedixxi infart mijokardijaku bikri.
English: For the full list of all side effects reported with Integrilin, see the Package Leaflet.
Maltese: Il-Kumitat irrakkomanda li Integrilin jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: HDPE bottle polypropylene measuring syringe
Maltese: Qawwa Għamla Farmaċewtika
English: Cattle: subcutaneous or intravenous use Pigs: intramuscular use Horses: intravenous use
Maltese: 1 kunjett Laħam u ġewwieni injezzjoni majjali taħt il-ġilda, Majjali: filmuskolu ta' l-annimali: 15-il jum; (Baqar) Laħam u ġewwieni ta' l-annimali: 5-il jum; (Majjali)
English: (Cattle), Meat and offal: 5 days.
Maltese: Laħam u ġewwieni ta' l-annimali: 5 ijiem.
English: EU (MA) Number
Maltese: Qratas (karta/PE/alu/PE
English: Meat and offal: 15 days (Cattle), Milk: 5 days
Maltese: 1.5 g 100 qratas Laħam u ġewwieni: 3 ijiem.
English: Further information on Anoro Ellipta 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: Umeclidinium is a muscarinic receptor antagonist.
Maltese: L-umeclidinium hija antagonista tar-riċettur muskariniku.
English: Anoro Ellipta contains the active substances umeclidinium bromide and vilanterol.
Maltese: Anoro Ellipta fih is-sustanzi attivi umeclidinium bromide u vilanterol.
English: Each inhalation provides 55 micrograms of umeclidinium (as umeclidinium bromide) and 22 micrograms of vilanterol.
Maltese: Kull inalazzjoni tipprovdi 55 mikrogramma ta' umeclidinium (bħala umeclidinium bromide) u 22 mikrogramma ta' vilanterol.
English: Vilanterol is a long-acting beta-2 adrenergic agonist.
Maltese: Il-vilanterol hija beta-2-agonista adrenerġika li taġixxi fit-tul.
English: The most common side effects with Anoro Ellipta (which may affect up to 1 in 10 people) are upper respiratory tract infections (nose and throat infection), urinary tract infections (infection of the structures that carry urine), pharyngitis (inflammation of the throat), sinusitis (inflammation of the sinuses), nasopharyngitis (inflammation of the nose and throat), headache, cough, oropharyngeal pain (pain in the mouth and throat), constipation and dry mouth.
Maltese: L-effetti sekondarji l-aktar komuni b'Anoro Ellipta (li jistgħu jaffettwaw sa persuna 1 minn kull 10) huma infezzjonijiet fl-apparat respiratorju ta' fuq (infezzjoni tal-imnieħer u tal-griżmejn), infezzjonijiet fl-apparat tal-awrina (infezzjoni tal-istrutturi li jġorru l-awrina), farinġite (infjammazzjoni tal-griżmejn), sinusite (infjammazzjoni tas-sinusis), nażofarinġite (infjammazzjoni tal-imnieħer u tal-griżmejn), uġigħ ta' ras, sogħla, uġigħ orofarinġeali (uġigħ fil-ħalq u l-griżmejn), stitikezza u ħalq xott.
English: Anoro Ellipta received a marketing authorisation valid throughout the EU on 8 May 2014.
Maltese: Anoro Ellipta rċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fit-8 ta' Mejju 2014.
English: Anoro Ellipta is a medicine used to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults.
Maltese: Anoro Ellipta huwa mediċina użata biex ittaffi s-sintomi tal-mard pulmonari ostruttiv kroniku (COPD) fladulti.
English: Previously known as Anoro.
Maltese: Preċedentement magħruf bħala Anoro.
English: Anoro Ellipta and a higher-dose combination of umeclidinium and vilanterol (113 micrograms/22 micrograms) were compared with placebo (a dummy treatment), vilanterol alone, umeclidinium alone or another COPD medicine called tiotropium in 5 main studies.
Maltese: Anoro Ellipta u kombinazzjoni ta' doża ogħla ta' umeclidinium u vilanterol (113-il mikrogramma/22 mikrogramma) tqabblu ma' plaċebo (kura finta), vilanterol waħdu, umeclidinium waħdu jew mediċina oħra tas-COPD msejħa tiotropium f'5 studji ewlenin.
English: It works by attaching to beta-2 adrenergic receptors found in the muscle cells of many organs including the airways in the lungs.
Maltese: Din taħdem billi teħel ma' riċetturi adrenerġiċi beta-2 li jinsabu fiċ-ċelloli tal-muskoli ta' bosta organi inkluż il-passaġġi tal-arja fil-pulmun.
English: Other information about Anoro Ellipta
Maltese: Informazzjoni oħra dwar Anoro Ellipta
English: In all 5 studies, involving over 5,600 patients, the main measure of effectiveness was based on changes in the patients' forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second).
Maltese: Fil-5 studji kollha, li involvew aktar minn 5,600 pazjent, il-kejl ewlieni tal-effikaċja kien ibbażat fuq ittibdil fil-volumi espiratorji furzati tal-pazjenti (FEV1, il-volum massimu ta' arja li persuna tista' toħroġ man-nifs f'sekonda).
English: Anoro Ellipta is used for maintenance (regular) treatment.
Maltese: Anoro Ellipta jintuża għall-kura ta' manutenzjoni (regolari).
English: Anoro Ellipta also increased FEV1 by an average of up to 95 ml more than vilanterol alone and by 52 ml more than umeclidinium bromide alone.
Maltese: Anoro Ellipta żied ukoll l-FEV1 b'medja sa 95 ml aktar minn vilanterol waħdu u bi 52 ml aktar minn umeclidinium bromide waħdu.
English: What are the risks associated with Anoro Ellipta?
Maltese: X'inhuma r-riskji assoċjati ma' Anoro Ellipta?
English: The average increase in FEV1 with Anoro Ellipta was 60, 90 and 112 ml more than with tiotropium after 24 weeks of treatment in the three studies where Anoro Ellipta was compared with tiotropium.
Maltese: Iż-żieda medja fil-FEV1 b'Anoro Ellipta kienet 60, 90 u 112-il ml aktar milli bi tiotropium wara 24 ġimgħa ta' kura fit-tliet studji fejn Anoro Ellipta tqabbel ma' tiotropium.
English: As for all medicines, data on the use of Anoro Ellipta are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Anoro Ellipta hija ssorveljata kontinwament.
English: The active substances in Anoro Ellipta, umeclidinium and vilanterol, work in different ways to widen the airways and improve breathing in COPD.
Maltese: Is-sustanzi attivi f'Anoro Ellipta, l-umeclidinium u l-vilanterol, jaħdmu b'modi differenti biex iwessgħu lpassaġġi tal-arja u jtejbu t-teħid tan-nifs fis-COPD.
English: Results showed that Anoro Ellipta improved lung function by an average FEV1 of 167 ml more than placebo after 24 weeks of treatment.
Maltese: Ir-riżultati wrew li Anoro Ellipta tejjeb il-funzjoni tal-pulmun b'FEV1 medju ta' 167 ml aktar minn plaċebo wara 24 ġimgħa ta' kura.
English: How is Anoro Ellipta used?
Maltese: Kif jaħdem Anoro Ellipta?
English: Anoro Ellipta can only be obtained with a prescription.
Maltese: Aktar informazzjoni fuq Anoro Ellipta tinstab fis-sit elettroniku tal-Aġenzija:
English: Pack size bottle (HDPE)
Maltese: 14-il pillola flixkun (HDPE)
English: (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging
Maltese: Qawwa Għamla farmaċewtika
English: Further information on Briviact 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: Briviact
Maltese: Nubriveo
English: Briviact contains the active substance brivaracetam.
Maltese: Briviact fih is-sustanza attiva brivaraketam.
English: Briviact is available as tablets (10, 25, 50, 75 and 100 mg), an oral solution (10 mg/ml) and a solution for injection or infusion (drip) into a vein (10 mg/ml), which is used when the medicine cannot be given by mouth.
Maltese: Briviact huwa disponibbli bħala pilloli (10, 25, 50, 75 u 100 mg), soluzzjoni orali (10 mg/ml) u soluzzjoni għal injezzjoni jew infużjoni (dripp) fil-vina (10 mg/ml), li tintuża meta l-mediċina ma tkunx tista' tingħata mill-ħalq.
English: Briviact received a marketing authorisation valid throughout the EU on 14 January 2016.
Maltese: Briviact irċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fl-14 ta' Jannar 2016.
English: (brivaracetam)
Maltese: Briviact1 (brivaracetam)
English: This compares with 20% in those adding placebo.
Maltese: Dan jikkumpara ma' 20 % ta' dawk li żiedu l-plaċebo.
English: This was shown in three main studies involving a total of 1,558 patients aged 16 years and above.
Maltese: Dan intwera fi tliet studji ewlenin li involvew total ta' 1,558 pazjent minn 16-il sena 'l fuq.
English: Taking the studies together, the frequency of seizures was at least halved in 34 to 38% of those adding Briviact at doses from 25 to 100 mg twice a day.
Maltese: Meta l-istudji jittieħdu flimkien, il-frekwenza ta' attakki ta' puplesija tnaqqset mill-inqas bin-nofs fi 34 sa 38 % ta' dawk li jżidu Briviact b'dożi minn 25 sa 100 mg darbtejn kuljum.
English: As for all medicines, data on the use of Briviact are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Briviact hija ssorveljata kontinwament.
English: What are the risks associated with Briviact?
Maltese: X'inhuma r-riskji assoċjati ma' Briviact?
English: The recommended starting dose in adults and younger patients weighing more than 50 kg is either 25 mg twice a day or 50 mg twice a day, depending on the patient's condition.
Maltese: Id-doża rakkomandata tal-bidu fl-adulti u f'pazjenti iżgħar li jiżnu aktar minn 50 kg hija jew 25 mg darbtejn kuljum jew 50 mg darbtejn kuljum, jiddependi mill-kundizzjoni tal-pazjent.
English: Other information about Briviact
Maltese: Informazzjoni oħra dwar Briviact
English: Clinical studies have shown add-on treatment with Briviact to be more effective than placebo for controlling partial-onset seizures in adults and children from 4 years of age.
Maltese: Studji kliniċi wrew li l-kura bl-inklużjoni ta' Briviact tkun aktar effettiva mill-plaċebo sabiex tikkontrolla l-attakki ta' puplesija ta' bidu parzjali f'adulti u adolexxenti minn 4 snin 'il fuq.
English: The dose can then be adjusted according to the patient's needs up to a maximum of 100 mg or 2 mg per kg respectively, twice a day.
Maltese: Id-doża tista' mbagħad tiġi aġġustata skont il-bżonnijiet talpazjent sa massimu ta' 100 mg jew 2 mg kull kg rispettivament, darbtejn kuljum.
English: Briviact is more effective than placebo (a dummy treatment) at reducing seizures.
Maltese: Briviact huwa aktar effettiv mill-plaċebo (kura finta) għat-tnaqqis tal-attakki ta' puplesija.
English: Most side effects of Briviact were of mild or moderate severity and were considered manageable.
Maltese: Ħafna mill-effetti sekondarji ta' Briviact kienu ta' severità ħafifa jew moderata u tqiesu bħala kontrollabbli.
English: Briviact must not be used in patients who are hypersensitive (allergic) to brivaracetam, to other pyrrolidone derivatives (substances that are chemically similar to brivaracetam), or to any of the other ingredients.
Maltese: Briviact ma għandux jintuża f'pazjenti li huma ipersensittivi (allerġiċi) għal brivaracetam, għal derivattivi pirrolidoniċi oħrajn (sustanzi li huma kimikament simili għal brivaracetam), jew għal xi wieħed mill-ingredjenti l-oħra.
English: In Italy: Nubriveo
Maltese: Fl-Italja:
English: The exact way in which brivaracetam, the active substance in Briviact, works is not clear but it attaches to a protein called synaptic vesicle protein 2A, which is involved in the release of chemical messengers from nerve cells.
Maltese: Il-mod preċiż kif jaħdem brivaracetam, is-sustanza attiva fi Briviact, għadu mhux ċar iżda jidher li dan jaqbad ma' proteina msejħa proteina vexxikola sinattika 2A, li hija involuta fir-rilaxx ta' messaġġieri kimiċi min
English: Supportive studies showed that the doses recommended for children produced similar amounts of the medicine in the body to those seen with recommended doses in adults.
Maltese: Studji ta' sostenn urew li d-dożi rakkomandati għat-tfal ipproduċew ammonti simili tal-mediċina filġisem għal dawk li dehru b'dożi rakkomandati fl-adulti.
English: Briviact is an epilepsy medicine used as an add-on to other epilepsy medicines to treat partial-onset seizures (epileptic fits starting in one specific part of the brain).
Maltese: Briviact hija mediċina tal-epilessija użata bħala żieda ma' mediċini tal-epilessija oħrajn għall-kura talattakki ta' puplesija ta' bidu parzjali (attakki ta' puplesija epilettiċi li jibdew f'parti speċifika tal-moħħ).
English: Side effects reported with Briviact are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati bi Briviact huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: The most common side effects with Briviact (which may affect more than 1 in 10 people) are somnolence (sleepiness) and dizziness.
Maltese: L-effetti sekondarji l-aktar komuni ta' Briviact (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma s-sonnolenza (tħossok bi ngħas) u l-isturdament.
English: Epilepsy is caused by excessive electrical activity in certain areas of the brain.
Maltese: L-epilessija hija kkawżata minn attività elettrika eċċessiva f'ċerti partijiet tal-moħħ.
English: In those weighing less than 50 kg the dose is based on body weight and the usual starting dose is 0.5 mg per kg body weight twice a day.
Maltese: F'dawk li jiżnu anqas minn 50 kg, id-doża hija bbażata fuq il-piż tal-ġisem u d-doża tal-bidu normali hija 0.5 mg għal kull kg ta' piż tal-ġisem darbejn kuljum.
English: How does Briviact work?
Maltese: Kif jaħdem Briviact?
English: INFORMATION IN BRAILLE PROTELOS 2 g
Maltese: INFORMAZZJONI BIL-BRAILLE PROTELOS 2 g
English: Relative Risk Reduction vs. placebo (95%CI), p value
Maltese: PROTELOS It-tnaqqis fir-Riskju Relattiv vs. plaċebo (95%CI), valur p
English: EU/1/04/288/001 EU/1/04/288/002 EU/1/04/288/003 EU/1/04/288/004 EU/1/04/288/005
Maltese: EU/1/04/288/001 EU/1/04/288/002 EU/1/04/288/003 EU/1/04/288/004
English: Its plasma clearance is about 12 ml/min (CV 22%) and its renal clearance about 7 ml/min (CV 28%).
Maltese: L-eliminazzjoni mill-plażma huwa ta' bejn wieħed u ieħor 12 ml/min (CV 22%) u l eliminazzjoni tal-kliewi huwa ta' bejn wieħed u ieħor 7 ml/min (CV 28%).
English: Musculo-skeletal fraction > 3 times the upper limit of the normal range.
Maltese: Ksur Muskoloskeletali > 3 darbiet iktar mill-ogħla limitu tal-livell normali.
English: PROTELOS contains aspartame:
Maltese: PROTELOS fih aspartame
English: Over 12 months, a statistically significant increase in mean lumbar spine BMD, main efficacy criteria (E (SE) = 5.32% (0.75); 95%CI = [3.86 ; 6.79]; p<0,001), similar to that observed in the pivotal antifracture phase III studies carried-out inpostmenopausal women, was observed.
Maltese: Fuq 12-il xahar, ġiet osservata żieda statistikament sinifikanti fil-BMD lumbari medju, il-kriterji medji tal-effikaċja (E (SE) = 5.32% (0.75); 95%CI = [3.86 ; 6.79]; p<0.001), simili għal dik osservata fl istudji ta' fażi
English: България Сервие Медикал ЕООД
Maltese: Сервие Медикал ЕООД Тел.:
English: In pooled randomised placebo-controlled studies of post-menopausal osteoporotic patients, a significant increase of myocardial infarction has been observed in PROTELOS treated patients as compared to placebo (1.7% versus 1.1 %), with a relative risk of 1.6 (95% CI = [1.07 ; 2.38]).
Maltese: Fi studji miġburin ta' pazjenti osteoporotiċi ta' wara l-menopawsa randomizzati u kkontrollati bi plaċebo, ġiet osservata żieda sinifikanti ta' infart mijokarijaku f'pazjenti kkurati bi PROTELOS meta mqabbel ma' plaċebo (1.7% meta mqabbel 1.1%), b'riskju relattiv ta' 1.6 (95% CI = [1.07 ; 2.38]).
English: Adverse reactions, defined as adverse events considered at least possibly attributable to strontium ranelate treatment in phase III studies are listed below using the following convention (frequencies versus placebo): very common (>1/10); common (>1/100, <1/10); uncommon (>1/1,000, <1/100); rare (>1/10,000, <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Maltese: III huma dawn li ġejjin bl-użu ta' din il-konvenzjoni (frekwenza versus plaċebo): komuni ħafna (>1/10), komuni (>1/100, <1/10); mhux komuni (>1/1,000, <1/100); rari (>1,10,000, <1/1,000); rari ħafna (<1/10,000); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: PROTELOS 2 g granules for oral suspension Strontium ranelate
Maltese: PROTELOS 2 g granijiet għal sospensjoni orali strontium ranelate
English: In pooled placebo-controlled studies of post-menopausal osteoporotic patients, strontium ranelate treated patients (N=3803, 11270 patient years of treatment) compared to placebo (N=3769, 11250 patient years of treatment)
Maltese: F'pajjiżi Asjatiċi, irrapportati bħala rari d Fi studji kkontrollati bi plaċebo miġburin ta' pazjenti osteoporotiċi ta' wara l-menopawsa, pazjenti kkurati bi strontium ranelate (N=3803, 11270 pazjent snin ta' kura) meta mqabbel ma' plaċebo (N=3769, 11250 pazjent snin ta' kura)
English: EU/1/04/288/005 84 sachets (3 packs of 28) EU/1/04/288/006 100 sachets
Maltese: EU/1/04/288/004 56 qartas EU/1/04/288/005 84 qartas EU/1/04/288/006 100 qartas