FrancophonIA/ELRC3.0 huggingface dataset:
English: Livensa releases testosterone through the skin into the bloodstream to produce testosterone levels that match the levels seen before removal of the womb and ovaries.
Maltese: Fin-nisa li jkunu tneħħewlhom l-utru u l-ovarji, l-ammont ta' testosteronu prodott jonqos bin-nofs. Livensa jirrilaxxa testosteronu minn ġolġilda għal ġod-demm biex jipproduċi livelli ta' testosteronu illi jkunu daqs il-livelli li kien hemm qabel it-tneħħija tal-utru u tal-ovarji.
English: When the results of the two studies were looked at together, the women who used Livensa had an average of 1.07 more satisfying sexual episodes than the women who used placebo over a four-week period.
Maltese: Meta r-riżultati taż-żewġ studji ġew analizzati flimkien, in-nisa li użaw Livensa kellhom medja ta' 1.07 episodji sesswali aktar sodisfaċenti min-nisa li ngħataw ilplaċebo matul perjodu ta' erba' ġimgħat.
English: Low testosterone levels have been linked to low sexual desire and to reduced sexual thoughts and arousal.
Maltese: Il-livelli baxxi ta' testosteronu għandhom rabta ma' xewqa sesswali baxxa u ma' tnaqqis fil-ħsibijiet u fl-eċitament sesswali.
English: The patch is applied to dry, clean skin on the lower abdomen (the tummy below the waist).
Maltese: Il-garża tiġi applikata fuq ġilda xotta u nadifa fuq in-naħa ta' isfel taż-żaqq ('l isfel mill-qadd).
English: EMA/671012/2010 EMEA/H/C/002303
Maltese: EMEA/H/C/002303
English: The full EPAR for Possia can be searched for on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: Wieħed jista' jfittex l-EPAR sħiħ għal Possia minn fuq is-sit elettroniku tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Possia is a medicine that contains the active substance ticagrelor.
Maltese: Possia huwa mediċina li fiha s-sustanza attiva ticagrelor.
English: In the main study, 9.3% of the patients taking Possia had another heart attack, stroke or died from a cardiovascular disease compared with 10.9% of patients taking clopidogrel.
Maltese: Fl-istudju ewlieni, 9.3% tal-pazjenti li jieħdu Possia kellhom attakk tal-qalb ieħor, puplesija jew mietu minħabba marda kardjovaskulari meta mqabbla ma' 10.9% li kienu qegħdin jieħdu clopidogrel.
English: This is a summary of the European public assessment report (EPAR) for Possia.
Maltese: Dan huwa sommarju tar-rapport ta' valutazzjoni pubblika Ewropew (EPAR) għal Possia.
English: The active substance in Possia, ticagrelor, is an inhibitor of platelet aggregation.
Maltese: Is-sustanza attiva fi Possia, ticagrelor, hija inibitur tal-aggregazzjoni tal-plejtlits.
English: The most common side effects with Possia (seen in between 1 and 10 patients in 100) are dyspnoea (difficulty breathing), epistaxis (nosebleeds), gastrointestinal haemorrhage (bleeding in the stomach or gut), bleeding in the skin or below the skin, bruising, and bleeding at the procedural site (where a blood vessel has been punctured).
Maltese: L-aktar effetti sekondarji komuni bi Possia (li dehru f'bejn pazjent 1 u 10 minn kull 100) huma dispnea (diffikultà fit-teħid tan-nifs), epistassi (demm mill-imnieħer), emorraġija gastrointestinali (fsada flistonku jew fl-organi ġewwiena tal-addome), fsada fil-ġilda jew taħt il-ġilda, tbenġil, u fsada fis-sit talproċedura (fejn tkun ittaqbet vina tad-demm).
English: What is the risk associated with Possia?
Maltese: X'inhu r-riskju assoċjat ma' Possia?
English: How does Possia work?
Maltese: Liema benefiċċju wera Possia waqt l-istudji ?
English: The effects of Possia were first tested in experimental models before being studied in humans.
Maltese: Għall-ewwel, l-effetti ta' Possia ġew ittestjati fuq mudelli esperimentali, imbagħad ġew studjati fuq ilbniedem.
English: Possia was compared with clopidogrel (another inhibitor of platelet aggregation) in a main study involving over 18,000 adults who had had a heart attack or had unstable angina.
Maltese: Possia tqabbel ma' clopidogrel (inibitur ieħor ta' aggregazzjoni tal-plejtlits) fi studju prinċipali li jinvolvi aktar minn 18,000 adult li sofrew attakk tal-qalb jew li kellhom anġina instabbli.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Possia to AstraZeneca on 03 December 2010.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea għal Possia lil AstraZeneca fil-03 ta' Diċembru 2010.
English: It must also not be used in patients taking other medicines which have a strong blocking effect on one of the liver enzymes (CYP3A4).
Maltese: Ma għandux jintuża f'pazjenti li jkunu qegħdin jieħdu mediċini oħrajn li għandhom effett ta' imblukkar qawwi fuq wieħed mill-enzimi tal-fwied (CYP3A4).
English: Ticagrelor stops the platelets aggregating by blocking the action of a substance called ADP when it attaches to the surface of the platelets.
Maltese: Ticagrelor iwaqqaf ilplejtlits milli jeħlu ma' xulxin billi jimblokka l-azzjoni ta' sustanza msejħa ADP meta teħel mal-wiċċ talplejtlits.
English: Other information about Possia
Maltese: Kif jintuża Possia?
English: The CHMP noted that the main study showed that, compared with clopidogrel, Possia reduces the risk of heart attacks and cardiovascular deaths.
Maltese: Is-CHMP innota li l-istudju ewlieni wera li, meta mqabbel ma' clopidogrel, Possia inaqqas ir-riskju ta' attakki tal-qalb u ta' mewt kardjovaskulari.
English: This stops the platelets becoming ‘sticky', reducing the risk of a blood clot forming and helping to prevent a stroke or another heart attack.
Maltese: Madankollu Possia ma kienx aktar effikaċi minn clopidogrel biex inaqqas ir-riskju ta' puplesija.
English: For the full list of all side effects reported with Possia, see the
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrapportati bi Possia, ara l-fuljett ta' tagħrif.
English: Possia is used together with aspirin to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries) such as heart attacks or strokes.
Maltese: Possia jintuża flimkien mal-aspirina biex jimpedixxi episodji aterotrombotiċi (problemi kkawżati minn għaqid tad-demm u minn ebusija tal-arterji) bħal attakki tal-qalb jew puplesiji.
English: The full EPAR for Terrosa 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: Terrosa contains the active substance teriparatide.
Maltese: Terrosa fih is-sustanza attiva teriparatide.
English: Terrosa is a ‘biosimilar medicine'.
Maltese: Terrosa hija ‘mediċina bijosimili'.
English: Terrosa is available as a solution for injection in cartridges (containing 600 micrograms of teriparatide) intended to be used with ServoPen Fix system.
Maltese: Terrosa huwa disponibbli bħala soluzzjoni għall-injezzjoni fi skrataċ (li fihom 600 mikrogramma ta' teriparatide) maħsuba biex jintużaw mas-sistema ServoPen Fix.
English: Other information about Terrosa
Maltese: Informazzjoni oħra dwar Terrosa
English: Why is Terrosa approved?
Maltese: Għaliex ġie approvat Terrosa?
English: This is a summary of the European public assessment report (EPAR) for Terrosa.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Terrosa.
English: The active substance in Terrosa, teriparatide, is identical to part of the human parathyroid hormone.
Maltese: Is-sustanza attiva f'Terrosa, teriparatide, hija identika għal parti mill-ormon tal-paratirojde uman.
English: The reference medicine for Terrosa is Forsteo.
Maltese: Il-mediċina ta' referenza għal Terrosa hija Forsteo.
English: For more information on biosimilar medicines, see the question-and-answer document here.
Maltese: Għal aktar informazzjoni dwar il-mediċini bijosimili, ara ddokument mistoqsija u tweġiba hawn.
English: Laboratory studies comparing Terrosa with Forsteo have shown that the active substance in Terrosa is highly similar to that in Forsteo in terms of structure, purity and biological activity.
Maltese: Studji fil-laboratorju li qabblu Terrosa ma' Forsteo wrew li s-sustanza attiva f'Terrosa hija simili ħafna għal dik f'Forsteo f'termini ta' struttura, purità u attività bijoloġika.
English: What are the risks associated with Terrosa?
Maltese: X'inhuma r-riskji assoċjati ma' Terrosa?
English: Terrosa must not be used in patients who have other bone diseases such as Paget's disease, bone cancer or bone metastases (cancer that has spread to the bone), patients who have had radiation therapy of the skeleton, or patients who have hypercalcaemia (high blood calcium levels), unexplained high levels of alkaline phosphatase (an enzyme) or severe kidney disease.
Maltese: Terrosa ma għandux jintuża fuq pazjenti li jkollhom mard ieħor tal-għadam bħall-marda tal-Paget, kanċer tal-għadam jew metastażi tal-għadam (kanċer li jkun infirex għall-għadam), fuq pazjenti li kellhom terapija ta' radjazzjoni tal-iskeletru, jew fuq pazjenti b'iperkalċemija (livelli għoljin ta' kalċju fid-demm), b'livelli għoljin mingħajr raġuni ta' alkaline phosphatase (enzima), jew b'mard serju talkliewi.
English: The recommended dose is 20 micrograms of Terrosa given once a day as an injection under the skin of the thigh or abdomen (belly).
Maltese: Id-doża rakkomandata hija ta' 20 mikrogramma ta' Terrosa li tingħata darba kuljum bħala injezzjoni taħt il-ġilda fil-koxxa jew fladdome (iż-żaqq).
English: Further, Terrosa and Forsteo produced similar effects on calcium levels in the blood.
Maltese: Barra minn hekk, Terrosa u Forsteo pproduċew effetti simili fuq il-livelli tal-kalċju fid-demm.
English: This means that Terrosa is highly similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU).
Maltese: Dan ifisser li Terrosa huwa simili għal mediċina bijoloġika (magħrufa wkoll bħala l-‘mediċina ta' referenza') li diġà hija awtorizzata fl-Unjoni Ewropea (UE).
English: A study in 54 healthy women has shown that the same doses of the two medicines given by injection under the skin produced similar levels of the active substance teriparatide in the body.
Maltese: Studju fuq 54 mara b'saħħithom wera li listess dożi taż-żewġ mediċini mogħtija permezz ta' injezzjoni taħt il-ġilda pproduċew livelli simili tassustanza attiva teriparatide fil-ġisem.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) considered evidence showing that Terrosa has a highly similar structure, purity and biological activity to Forsteo and is distributed in the body in the same way.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) qies evidenza li turi li Terrosa għandu struttura, purità u attività bijoloġika simili ħafna għal Forsteo u jiġi distribwit bl-istess mod filġisem.
English: This was considered sufficient to conclude that Terrosa will behave in the same way in terms of effectiveness and safety.
Maltese: Dan tqies bħala suffiċjenti biex jiġi konkluż li Terrosa ser jaġixxi bl-istess mod f'termini ta' effikaċja u sigurtà.
English: Terrosa is a medicine used for the treatment of osteoporosis (a disease that makes bones fragile) in:
Maltese: Terrosa jintuża għall-kura tal-osteoporożi (marda li tagħmel l-għadam fraġli) fil-gruppi li ġejjin:
English: For the full list of all side effects reported with Terrosa, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrapportati b'Terrosa, ara lfuljett ta' tagħrif.
English: What measures are being taken to ensure the safe and effective use of Terrosa?
Maltese: X'miżuri qegħdin jitteħdu biex jiġi żgurat l-użu sigur u effettiv ta' Terrosa?
English: The full EPAR for Opgenra 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: Eptotermin alfa has been authorised in the European Union (EU) since May 2001 in Osigraft.
Maltese: Eptotermina alfa ġiet awtorizzata fl-Unjoni Ewropea (UE) minn Mejju 2001 f'Osigraft.
English: EPAR summary for the public eptotermin alfa
Maltese: Sommarju tal-EPAR għall-pubbliku eptotermina alfa
English: • patients who have received a medicine containing BMP in the past;
Maltese: • pazjenti li fil-passat kienu rċievew mediċina li fiha BMP;
English: • patients who have an active infection at the operation site or have had repeated infections;
Maltese: • pazjenti li għandhom infezzjoni attiva fis-sit tal-operazzjoni jew li kellhom infezzjonijiet ripetuti;
English: Eptotermin alfa is produced by a method known as ‘recombinant DNA technology': it is made by cells that have received a gene (DNA), which makes them able to produce eptotermin alfa.
Maltese: Eptotermina alfa tiġi prodotta b'metodu magħruf bħala ‘teknoloġija rikombinanti tad-DNA': hija magħmula minn ċelluli li jkunu rċievew ġene (DNA), li jagħmilhom kapaċi jipproduċu eptotermina alfa.
English: After two years, treatment with Opgenra was successful in 39% of the patients, compared with 49% with autograft.
Maltese: Wara sentejn, il-kura b'Opgenra kienet ta' suċċess f'39% tal-pazjenti, meta mqabbla ma' 49% b'awtograft.
English: This can cause pain, instability, and problems due to pressure on the nerves, including tingling, numbness, weakness and difficulty controlling certain muscles.
Maltese: Dan jista' jikkaġuna wġigħ, instabilità, u problemi minħabba tagħfis fuq in-nervituri, inkluż tnemnim, tirżiħ, djugħfija u diffikultà fil-kontroll ta' ċerti muskoli.
English: Opgenra is a medicine that contains the active substance eptotermin alfa.
Maltese: Opgenra huwa mediċina li fiha s-sustanza attiva eptotermina alfa.
English: It is a copy of a protein called osteogenic protein 1, also known as bone morphogenic protein 7 (BMP-7), which is produced naturally by the body and helps the formation of new bone tissue.
Maltese: Hija kopja ta' proteina msejħa proteina osteoġenika 1, magħrufa wkoll bħala proteina morfoġenika tal-għadam 7 (BMP-7), li hija magħmula b'mod naturali mill-ġisem u tgħin fil-formazzjoni ta' tessut ġdid tal-għadam.
English: • patients with an auto-immune disease (a disease caused by the body's own defence system attacking normal tissue);
Maltese: • pazjenti b'mard awtoimmuni (mard ikkaġunat mis-sistema difensiva tal-ġisem innifsu li tattakka t tessut normali);
English: The replacement eptotermin alfa acts in the same way as naturally produced BMP-7.
Maltese: L-eptotermina alfa sostituta taġixxi bl-istess mod bħal BMP-7 magħmul b'mod naturali.
English: What is the risk associated with Opgenra?
Maltese: X'inhu r-riskju assoċjat ma' Opgenra?
English: Opgenra has been studied in one main study involving 336 patients who needed spinal fusion surgery for spondylolisthesis.
Maltese: Opgenra ġiet studjata fi studju ewlieni li involva 336 pazjent li kellhom bżonn kirurġija ta' fużjoni tassinsla għall-ispondilolisteżi.
English: This is a summary of the European public assessment report (EPAR) for Opgenra.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Opgenra.
English: The company that makes Opgenra will provide educational packs and training DVDs for surgeons in each Member State.
Maltese: Il-kumpanija li tagħmel Opgenra se jipprovdi pakketti edukattivi u DVDs ta' taħriġ għall-kirurgi f'kull Stat Membru.
English: The company also presented evidence from the published scientific literature on patients treated in the United States of America (USA), where the medicine has been approved as a medical device for spine fusion since 2004.
Maltese: Il-kumpanija ppreżentat ukoll evidenza mil-letteratura xjentifika ppubblikata fuq pazjenti kkurati flIstati Uniti tal-Amerika (USA), fejn il-mediċina ġiet approvata bħala apparat mediku għall-fużjoni tassinsla mill-2004.
English: Other information about Opgenra
Maltese: Informazzjoni oħra dwar Opgenra:
English: What benefit has Opgenra shown during the studies?
Maltese: Liema benefiċċju wera Opgenra waqt l-istudji mwettqa?
English: In addition, some side effects are seen in between 1 and 10 patients in 100 following spine surgery itself, including infection after the operation, wound dehiscence (opening of the wound), secretion (seepage) and erythema (redness of the skin).
Maltese: Barra minn hekk, xi effetti sekondarji jidhru f'bejn pazjent 1 u 10 minn kull 100 wara kirurġija fuq l-ispina nfisha, inklużi infezzjoni wara l-operazzjoni, deixxenza (ftuħ) talferita, tnixxija u eritema (ħmura tal-ġilda).
English: The active substance in Opgenra, eptotermin alfa, acts on the bone.
Maltese: Is-sustanza attiva f'Opgenra, eptotermina alfa, taġixxi fuq l-għadam.
English: When implanted, eptotermin alfa stimulates the formation of new bone.
Maltese: Meta tkun impjantata, eptotermina alfa tistimula l-formazzjoni ta' għadam ġdid.
English: What is Opgenra?
Maltese: X'inhu Opgenra?
English: How has Opgenra been studied?
Maltese: Kif ġie studjat Opgenra?
English: Osigraft is used to repair fractures (breaks) of the tibia (shin bone).
Maltese: Osigraft jintuża biex isewwi fratturi (ksur) tat-tibja (l-għadma tal-qasba tas-sieq).
English: The CHMP decided that Opgenra's benefits are greater than its risks for posterolateral lumbar spinal fusion in adult patients with spondylolisthesis where autograft has failed or is contra-indicated.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Opgenra huma ikbar mir-riskji f'pazjenti adulti bi spondilolisteżi fejn awtograft ma kienx irnexxa jew huwa kontraindikat.
English: It is supplied as two vials, one containing eptotermin alfa and another containing a substance called carmellose.
Maltese: Jiġi bħala żewġ kunjetti, wieħed li fih eptotermina alfa u ieħor li fih sustanza msejħa karmelloża (carmellose).
English: The most common side effects with Opgenra (seen in between 1 and 10 patients in 100) are heterotopic bone formation (bone formation outside the fusion area) and pseudoarthrosis (failure of the spine to fuse).
Maltese: L-iktar effetti sekondarji komuni b'Opgenra (li dehru f'bejn pazjent 1 u 10 minn kull 100) huma formazzjoni ta' għadam eterotopiku (formazzjoni ta' għadam barra ż-żona ta' fużjoni) u psewdoartrożi
English: Opgenra is used in adults with spondylolisthesis.
Maltese: Opgenra jintuża fl-adulti bl-ispondilolisteżi.
English: How is Opgenra used?
Maltese: Għalxiex jintuża Opgenra?
English: The effects of Opgenra were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Opgenra għall-ewwel ġew ittestjati fuq mudelli sperimentali qabel ma ġew studjati fuq ilbniedem.
English: Why has Opgenra been approved?
Maltese: Għaliex ġie approvat Opgenra?
English: Treatment was defined as ‘successful' when bone could be seen between the affected vertebrae on X-rays, and the patient had shown improvement in disability, with no need for further treatment of the spine, no serious side effects and no worsening of the symptoms caused by pressure on the nerves.
Maltese: It-trattament ġie definit bħala ‘ta' suċċess' meta seta' jidher l-għadam bejn il-vertebri effettwati fuq ir-raġġi-X, u l-pazjent wera titjib fid-diżabilità, mingħajr ħtieġa ta' iktar trattament tas-sinsla, l-ebda effetti sekondarji serji u l-ebda aggravar tas-sintomi kkaġunati mit-tagħfis fuq in-nervituri.
English: Opgenra is only used by a surgeon who is appropriately qualified.
Maltese: Il-kejl ewlieni tal-effikaċja kien innumru ta' pazjenti li l-kirurġija tagħhom kienet ta' suċċess wara sentejn.
English: The two powders are made up into a ‘suspension' (a liquid with solid particles in it) with a putty-like consistency, which is implanted in the body.
Maltese: Iż-żewġ trabijiet jitħalltu f'‘sospensjoni' (likwidu li fih partikuli solidi ġewwa fih) b'konsistenza qisha tajn, li tiġi impjantata filġisem.
English: • patients with cancer or being treated for cancer;
Maltese: • pazjenti bil-kanċer jew li qed jiġu kkurati għall-kanċer;
English: The study compared surgery using Opgenra and surgery using bone autografts.
Maltese: L-istudju qabbel kirurġija bl-użu ta' Opgenra u kirurġija bl-użu ta' awtografts tal-għadam.
English: 2 vials + 1 infusion set + 2 transfer devices + 1 short catheter
Maltese: Kunjett (ħġieġ) 2 kunjetti + 1 sett ta' linfużjoni + 2 strumenti tattrasferiment + 1 kateter qasir
English: 1 vial + 1 infusion set +1 transfer device + 1 short catheter
Maltese: Kunjett (ħġieġ) 1 kunjett + 1 sett ta' linfużjoni + 1 strument tattrasferiment + 1 kateter qasir
English: (Invented) name
Maltese: Numru ta' l-EU Isem inventat Qawwa
English: The PRAC, as a consequence, concluded that pursuant to Article 116 of Directive 2001/83/EC
Maltese: Konsegwentement, il-PRAC, ikkonkluda li skont l-Artikolu 116 tad-Direttiva 2001/83/KE
English: Safety data from spontaneous reports
Maltese: Data ta' sigurtà minn rapporti spontanji
English: 1999, Study report [NP07224]
Maltese: Rapport ta' studju, 1999 [NP07224]
English: The estimated total exposure to fusafungine was of 727 patients.
Maltese: L-esponiment totali stmat ta' fusafungine kien ta' 727 pazjent.
English: Fusafungine is a depsipeptide antibacterial produced by Fusarium lateritium strain 437.
Maltese: Fusafungine huwa depsipeptid antibatterjali prodott mir-razza 437 ta' Fusarium lateritium.
English: • dyspnoea - 16.4% of hypersensitivity ADRs (15.0 % with regard to serious ADRs),
Maltese: • dispnea - 16.4% ta' ADRs ta' sensittività eċċessiva (15.
English: • angioedema - 3.8% (7.7%).
Maltese: • anġjodema - 3.8% (7.7%).
English: • bronchospasm - 3.9% (8.1%),
Maltese: • bronkospażmu - 3.9% (8.1%),
English: The MAH discussed fusafungine primarily as an antibiotic.
Maltese: Il-MAH iddiskuta fusafungine primarjament bħala antibijotiku.
English: • urticaria - 4.5% (4.6%),
Maltese: • urtikarja - 4.5% (4.6%),
English: • rash - 4.7% (2.1%),
Maltese: • raxx - 4.7% (2.1%),
English: Value of Locabiotal Aerosol in rhinosinusitis Rhinology
Maltese: Intérêt de Locabiotal Pressurisé dans les rhinosinusites.
English: • pruritus - 5.8% (4.8%),
Maltese: • prurite - 5.8% (4.8%),
English: The first Marketing Authorisation (MA) in the EU was granted in 05 April 1963.
Maltese: L-ewwel Awtorizzazzjoni għat-Tqegħid fis-Suq (MA) fl-UE ngħatat fil-5 ta' April 1963.
English: The 717 spontaneous cases of allergic reactions include a total of 1,065 ADRs referring to allergic reactions.
Maltese: Is-717-il każ spontanju ta' reazzjoni allerġika inkluda total ta' 1,065
English: 2002, Study report [NP08516] 8 Grouin J.M, 2003, Treatment of acute infectious rhinopharyngitis with fusafungine (1.0 mg x 4 daily): a pooled analysis of three double blind placebo-controlled parallel group studies.
Maltese: Rapport ta' studju, 2002 [NP08516] 8 Grouin J.M, 2003, Treatment of acute infectious rhinopharyngitis with fusafungine (1.0 mg x 4 daily): a pooled analysis of three double blind placebo-controlled parallel group studies.
English: Safety data from clinical trials
Maltese: Data ta' sigurtà minn provi kliniċi
English: The MAH submitted in vitro data regarding the anti-inflammatory activity of fusafungine suggesting that the mechanism of action of anti-inflammatory activity of fusafungine is complex (such as inhibition of release of ICAM-1, IL-1β, IL-6, IL-8, and TNF-α by human alveolar macrophages).
Maltese: Il-MAH ippreżenta data in vitro rigward l-attività anti-infjammatorja ta' fusafungine li tissuġġerixxi li lmekkaniżmu ta' azzjoni tal-attività anti-infjammatorja huwa kumpless (bħall-inibizzjoni tar-rilaxx ta' ICAM-1, IL-1β, IL-6, IL-8, u TNF-α permezz ta' makrofaġi alveolari tal-bniedem).
English: 2000, Study report [NP07760] 3 Bouter K. 7-day treatment of acute infectious rhinopharyngitis with fusafungine (1.0 mg x 4 daily): a double-blind placebo-controlled parallel-group study.
Maltese: Rapport ta' studju, 2000 [NP07760] 3 Bouter K. 7-day treatment of acute infectious rhinopharyngitis with fusafungine (1.0 mg x 4 daily): a double-blind placebo-controlled parallel-group study.