FrancophonIA/ELRC3.0 huggingface dataset:
English: Brexidol 20mg Tablets
Maltese: Brexidol 20mg Pillola
English: Evidence from observational studies suggests that piroxicam may be associated with a high risk of serious gastrointestinal toxicity, relative to other NSAIDs.
Maltese: Evidenza minn studji ta' osservazzjoni jissuġġerixxu li piroxicam jista' jkun assoċjat ma' riskju għoli ta' tossiċità gastrointestinali serja, relattiv ma' NSAIDs oħra.
English: As such the below outlined recommendations only apply to systemic formulations of piroxicam:
Maltese: Fil-fatt ir-rakkomandazzjonijiet ta' hawn isfel japplikaw biss għal formulazzjonijiet sistemiċi ta' piroxicam:
English: Piroxicam Beral Dispersible 20 Mg, Comprimé
Maltese: Piroxicam Beral Dispersible 20
English: Via Palermo 26 A 43100, Parma Italy
Maltese: Via Palermo 26 A 43100, Parma L-Italja
English: 10 mg/cap Hard capsules
Maltese: 10 mg/kap Kapsuli iebsa
English: Laboratoires S.M.B S. S.A. Rue De La Pastorale 16/28 B-1080 Brussels Belgium
Maltese: S.A. Rue De La PastMill-ħalqe 16/28 B-1080 Brussels Il-Belġju
English: Boehringer Ingelheim International Gmbh Binger Straβe 173
Maltese: Boehringer InĠellheim International Gmbh Binger Straβe 173
English: Mobilat P Cream 5 mg/g
Maltese: Mobilat P Krema
English: Boehringer Ingelheim International Gmbh Binger Str 173
Maltese: Boehringer InĠellheim International Gmbh Binger Str 173
English: Cutaneous use
Maltese: Ġol-muskolu use
English: Anti-coagulants: NSAIDs, including piroxicam, may enhance the effects of anti-coagulants, such as warfarin.
Maltese: NSAIDs, li jinkludu piroxicam, jistgħu jawmentaw l-effetti ta' anti-koagulanti, bħal warfarin.
English: United Kingdom Tillomed Laboratories Limited
Maltese: Crescent Pharma Limited
English: 20 mg/cap Hard capsules
Maltese: 20 mg/kap Kapsuli iebsa
English: The decision to prescribe piroxicam should be based on an assessment of the individual patient's overall risks (see sections 4.3 and 4.4).”
Maltese: Id-deċiżjoni li jingħata piroxicam għandha tiġi ibbażata fuq stima tar-riskji globali tal-pazjenti individwali (ara sezzjonijiet 4.3 u 4.4).
English: Flexirox 20 Mg, Poudre Effervescente En Sachet-Dose
Maltese: Mg, Poudre Effervescente En Sachet-Dose
English: United Kingdom Waymade Plc Sovereign House
Maltese: Waymade Plc Sovereign House Miles Gray Road Basildon, Essex SS14
English: 3 Howard Road, Eaton Socon St. Neots, Cambs PE19 3ET United Kingdom
Maltese: Neots, Cambs PE19 3ET
English: 20 mg/sachet Grannules for oral solution
Maltese: 20 mg/qartas Granijiet għal soluzzjoni orali
English: The European Commission considered it to be in the interest of public health to perform a new benefit/risk assessment of piroxicam.
Maltese: Il-Kummissjoni Ewropea ħasset li huwa fl-interess tas-saħħa pubblika li twettaq evalwazzjoni ġdida tal-benefiċċju/riskju ta' piroxicam.
English: Olcam 20 Mg, Gélule 20 mg
Maltese: Mg, Gélule 20 mg
English: Patients taking concomitant oral corticosteroids, selective serotonin reuptake inhibitors (SSRIs) or anti-platelet agents such as low-dose acetylsalicylic acid are at increased risk of serious GI complications (see below and section 4.5).
Maltese: Pazjenti li qed jieħdu ukoll kortikosterojdi orali, inibituri selettivi tat-teħid ta' serotonin (SSRIs) jew sustanzi kontra l-plejtlits bħal ma huwa acetylsalicylic acid f'doża baxxa huma f'riskju miżjud ta' kumplikazzjonijiet GI serji (ara hawn taħt u sezzjoni 4.5).
English: Kapsula
Maltese: Mg Kapseln
English: The CHMP also made recommendations for changes, or so called “key elements”, to be included in the product information of piroxicam, as well as for some other non-selective NSAIDs which were published on the EMEA website in September 2006 (Doc ref: EMEA/CHMP/381615/2006).
Maltese: Il-CHMP għamel ukoll rakkomandazzjonijiet għal bidliet, jew hekk imsejħa “elementi prinċipali”, li għandhom jiġu inklużi fl-informazzjoni dwar ilprodott ta' piroxicam, kif ukoll għal xi NSAIDs oħra mhux selettivi li ġew ippubblikati fuq il-websajt ta' l-EMEA f'Settembru 2006 (Dok ref: EMEA/CHMP/381615/2006).
English: Solution For Injection Intramuscular
Maltese: Mg Injektioslösung
English: If you are over 70 years old, or you are taking other medicines like corticosteroids or certain drugs for depression called selective serotonin reuptake inhibitors (SSRIs), or acetylsalicylic acid to prevent blood clotting, your doctor may like to prescribe you together with [Invented name] a medicine for protecting your stomach and intestines.
Maltese: Jekk għandek aktar minn 70 sena, jew jekk qed tieħu mediċini oħra bħal kortikosterojdi jew ċertu mediċini għad-depressjoni li jissejħu inibituri selettivi tat-teħid ta' serotonin (SSRIs), jew acetylsalicyclic acid li jipprevjeni t-tagħqid tad-demm, it-tabib tiegħek għandu mnejn ikun jixtieq jippreskrivi [Isem inventat] ma' mediċina oħra li tipproteġi l-istonku u l-imsaren tiegħek.
English: The use of topical NSAIDs is accompanied by a markedly reduced systemic exposure compared to systemic dosing and therefore a lower rate of systemic adverse events is expected with use of topical formulations.
Maltese: Lużu ta' NSAIDs topiċi huwa akkumpanjat minn esponiment sistemiku mnaqqas ħafna meta mqabbel ma' dożaġġ sistemiku u għalhekk hija mistennija rata aktar baxxa ta' episodji avversi sistemiċi bl-użu ta' formulazzjonijiet topiċi.
English: PiroxicamRatiopharm 20 Zäpfchen
Maltese: PiroxicamRatiopharm 20
English: The CHMP reviewed the data submitted by Marketing Authorisation Holders from clinical trials, epidemiological studies, and spontaneous reporting of adverse drug reactions.
Maltese: Il-CHMP evalwa l-informazzjoni sottomessa mid-Detenturi ta' l-Awtorizzazzjoni għat-Tqegħid fisSuq minn provi kliniċi, studji epidemjoloġiċi, u rappurtar spontanju ta' reazzjonijiet avversi talmediċina.
English: 0.5 % Gel
Maltese: 0.5 % Ġell
English: Boehringer Ingelheim International GmbH Binger Strasse 173
Maltese: Boehringer InĠellheim International GmbH Binger Strasse 173
English: Piroxicam 20mg Capsules
Maltese: Piroxicam 20mg Kapsulas
English: • If you are taking other NSAIDs, including COX-2 selective NSAIDs and acetyl-salicylic acid, a substance present in many medicines used to relieve pain and lower fever.
Maltese: • Jekk qed tieħu NSAIDs oħra, li jinkludu NSAIDs silettivi ta' COX-2 u acetyl-salicylic acid, sustanza li tinsab f'ħafna mediċini li jtaffu l-uġigħ u jnaqqsu d-deni.
English: − In view of the available data, the Committee concluded that there is an increased risk of gastrointestinal and serious skin reactions associated with systemic formulations of piroxicam when compared to other NSAIDs as a group.
Maltese: − Fid-dawl ta' l-informazzjoni disponibbli, il-Kumitat ikkonkluda li hemm riskju akbar ta' reazzjonijiet gastro-intestinali u serji tal-ġilda assoċjati ma' formulazzjonijiet sistemiċi ta' piroxicam meta mqabbel ma' NSAIDs oħra bħala grupp.
English: 10 mg/1 g Gel
Maltese: 10 mg/1 g Ġell
English: Effervescent tablets
Maltese: Mg Pillola Effervexxenti
English: Liophilised
Maltese: Lijofilizzat
English: Dispersible Sécable
Maltese: Mg, Comprimé Dispersible Sécable
English: Zerospam20 mg/cap Hard capsules
Maltese: Zerospam20 mg/kap Kapsuli iebsa
English: − The CHMP considered that the benefit/risk balance for systemic formulations of piroxicam is positive in the treatment of symptomatic relief of osteoarthritis, rheumatoid arthritis or ankylosing spondylitis; however the CHMP considered that the benefit/risk balance of piroxicam in the treatment of acute conditions is negative and that these indications should be revoked.
Maltese: − Il-CHMP ikkunsidra li l-bilanċ bejn il-benefiċċju u r-riskju għal formulazzjonijiet sistemiċi ta' piroxicam huwa pożittiv fit-trattament ta' solliev sintomatiku ta' l-osteoartrite, l-artrite rewmatika jew l-ispondilite li tagħqad bl-ankilosi; madankollu l-CHMP ikkunsidra li l-bilanċ bejn il-benefiċċju u r-riskju ta' piroxicam fit-trattament ta' kondizzjonijiet akuti huwa negattiv u li dawn l-indikazzjonijiet għandhom jiġu revokati.
English: Eurogenerics N.V. Heizel Esplanade 22 B-1020 Brussels Belgium
Maltese: Il-Lussemburgu Eurogenerics S.A. Esplanade Heysel B 22
English: B-2610 Wilrijk Belgium
Maltese: B-1050 Brussels Il-Belġju
English: 20 Mg
Maltese: Mg 20 mg
English: Injekčný roztok parenteral use
Maltese: Injekčný roztok
English: With regards to topical formulations of piroxicam, the CHMP agreed that no restrictions were necessary.
Maltese: Dwar il-formulazzjonijiet topiċi ta' piroxicam, il-CHMP qabel li m'hemmx bżonn restrizzjonijiet.
English: Postfach 3380 D-89070 Ulm Germany
Maltese: 3 D-89079 Ulm
English: Bruxicam 0,5% 0.50% Eye Drops, Solution Ocular
Maltese: Bruxicam 0,5% 0.50% Soluzzjoni għat-taqtir ta' l-għajnejn
English: Po Box 217
Maltese: Pobox 21229
English: United Kingdom Neolab Limited 57 High Street
Maltese: Neolab Limited
English: If a gastrointestinal complication is suspected during treatment, piroxicam should be discontinued immediately and additional clinical evaluation and treatment should be considered.”
Maltese: Jekk kumplikazzjoni gastrointestinali hija issuspettata waqt it-trattament, piroxicam għandu jiġi imwaqqaf immedjatament u evalwazzjoni klinika addizzjonali u trattament addizzjonali għandhom jiġu ikkonsidrati.
English: 20124 Milano Italy
Maltese: 20100 Milano L-Italja
English: Jenapirox Tabs 20 Mg
Maltese: Jenapirox Tabs 20
English: The review found that limited epidemiological data and spontaneous adverse drug reaction data provided a signal of increased risk of gastrointestinal and skin reactions (including life-threatening bullous reactions) relative to other nonselective NSAIDs.
Maltese: Din l-evalwazzjoni ġiet finalizzata f'Ġunju 2006. Levalwazzjoni sabet li informazzjoni epidemjoloġika limitata u informazzjoni spontanja dwar irreazzjoni tal-mediċina pprovdiet sinjal ta' riskju akbar ta' reazzjonijiet gastro-intestinali u tal-ġilda (fosthom reazzjonijiet bullużi ta' periklu għall-ħajja) relattiv għal NSAIDs oħra mhux selettivi.
English: − piroxicam should not be used for treatment of any acute condition due to the long half life of 50 hours and the safety profile, since equally effective and safer therapies are available;
Maltese: − piroxicam m'għandux jintuża għat-trattament ta' xi kondizzjoni akuta minħabba l-half life twila ta' 50 siegħa u l-profil tas-sigurtà, billi huma disponibbli terapiji effettivi daqsu u aktar siguri;
English: Sopharma Ad
Maltese: Użu orali
English: 17, Boulevards De La Plaine B-1050 Bruxelles Belgium
Maltese: Il-Lussemburgu Pfizer S.A. 17, Boulevards De La Plaine B-1050 Bruxelles Il-Belġju
English: Feldene Dispersible 20 Mg, Comprimé Sécable
Maltese: Feldene Dispersible 20
English: Piroxicam Acis 20mg Tabs
Maltese: Piroxicam Acis 20mg Pillolas
English: The risk for developing serious GI complications increases with age.
Maltese: Ir-riskju li jiżviluppaw kumplikazzjonijiet GI serji jiżdied ma' l-età.
English: 20 mg/ml, 1ml Solution for injection Intramuscular use
Maltese: 20 mg/ml, 1ml Soluzzjoni għall-injezzjoni
English: Gottlieb-Daimler-Strasse 19 891 50 Laichingen Germany
Maltese: Gottlieb-Daimler-Strasse 19
English: Pfizer Aps Lautrupvang 8 Dk-2750 Ballerup Denmark
Maltese: Dk-2750 Ballerup Id-Danimarka
English: Piroxicam Sandoz 20 Mg Zetpil
Maltese: Piroxicam Sandoz 20 20 mg
English: United Kingdom Actavis Uk Limited Whiddon Vally
Maltese: Actavis Uk Limited Whiddon Vally Barnstaple Devon Ex32 8ns Ir-Renju Unit
English: Ampoule
Maltese: Ampulla
English: Piroxicam 10mg Capsules
Maltese: Piroxicam 10mg Kapsulas
English: This communication should inform healthcare professionals of the risks of gastrointestinal and skin reactions associated with piroxicam and should be in line with the DHPC endorsed by the CHMP.
Maltese: reazzjonijiet gastro-intestinali u tal-ġilda assoċjati ma' piroxicam u għandha tkun konformi mad-DHPC approvata mill-CHMP.
English: Barnstaple
Maltese: GENEPHARM
English: Teva Generics Belgium N.V. Laarstraat 16
Maltese: Teva Generics Belgium N.V.
English: Capsules
Maltese: Mg Kapsulas
English: Piroxicam Albic 20 Mg
Maltese: Piroxicam Albic 20
English: Piroxicam Al 20 Zäpfchen
Maltese: Piroxicam Palbian 20
English: Piroxicam Innotech International 20 Mg, Gélule
Maltese: Piroxicam Innotech International 20
English: Rationpharm Gmbh
Maltese: Jinfirex fuq
English: Docpharma N.V. Ambachtenlaan B-3001 Heverlee Belgium
Maltese: Docpharma N.V. Ambachtenlaan
English: Ointment
Maltese: Zäpfchen
English: Oral powder
Maltese: Trab Orali
English: “As with other NSAIDs, the use of piroxicam together with acetyl-salicylic acid or concomitant use with other NSAIDs, including other piroxicam formulations, must be avoided, since data are inadequate to show that such combinations produce greater improvement than that achieved with piroxicam alone; moreover, the potential for adverse reactions is enhanced (see section 4.4).
Maltese: Bħal b'NSAIDs oħra, l-użu ta' piroxicam flimkien ma'acetyl-salicylic acid jew użu konkomitanti ma' NSAIDs oħra, inklużi formulazzjonijiet ta' piroxicam oħra, għandhom jiġu evitati, peress li d-dejta mhix adegwata biex turi li kumbinazzjonijiet bħal dawn jipproduċu titjib akbar milli dak miksub b'piroxicam waħdu; barra minn hekk, il-potenzjal għal reazzjonijiet avversi huwa awmentat (ara sezjoni 4.4).
English: Piroxicam Beral 20 Mg, Suppositoire
Maltese: Piroxicam Beral 20 20 mg
English: Lyophilisat
Maltese: Bruschettini
English: Feldene 10 Mg, Gélule
Maltese: Feldene 10 Mg,
English: Tabs rapid
Maltese: Mg Tabs
English: Piroxicam Stada 10mg Tabs
Maltese: Piroxicam Stada 10mg Pillolas
English: Nycomed Nederland B.V. Nikkelstraat 5
Maltese: Nycomed Il-Belġju N.V. Gentsesteenweg 615
English: Undesirable effects may be minimised by using the minimum effective dose for the shortest duration necessary to control symptoms.
Maltese: Effetti mhux mixtieqa għandhom jiġu minimizzati permezz ta' l-użu tad-doża minima effettiva għall-iqsar tul ta' żmien neċessarju biex tikontrolla s-sintomi.
English: Brexin 20 Mg, Comprimé Sécable
Maltese: Mg, Comprimé Sécable
English: Brexidol 20mg Effervescent Tablets
Maltese: Brexidol 20mg Pillola Effervexxenti
English: Piroxicam-Sandoz Parenteral 20 Mg Injektionslösung
Maltese: Piroxicam-Sandoz Parenteral 20
English: Your doctor will prescribe piroxicam to you only when you have had unsatisfactory relief of symptoms with other non-steroidal anti-inflammatory medicines (NSAIDs).”
Maltese: It-tabib tiegħek ser jiktiblek riċetta għal piroxicam biss meta ma ma jibdiex ikollok solljev sodisfaċenti tas-sintomi b'mediċini anti-infjammatorji mhux sterojdi oħra (NSAIDs).
English: 20MG/ML Solution for injection Intramuscular use
Maltese: 20MG/ML Soluzzjoni għall-injezzjoni
English: Tabs
Maltese: Stada Tabs
English: Merck Dura Gmbh Alsfelder Str. 19 D-64289 Darmstadt Germany
Maltese: D-64289 Darmstadt Il-Ġermanja
English: • Patient history of gastrointestinal disorders that predispose to bleeding disorders such as ulcerative colitis, Crohn's disease, gastrointestinal cancers or diverticulitis.
Maltese: • Pazjent b'passat mediku ta' disturbi gastrointestinali li jippredisponu għal disturbi ta' fsada bħal ma huma kolite ulċerattiva, marda ta' Crohn, kanċer gastrointestinali jew divertikulite.
English: Dispersible tablet
Maltese: Mg Comprimidos Dispersíveis
English: The clinical benefit and tolerability should be re-evaluated periodically and treatment should be immediately discontinued at the first appearance of cutaneous reactions or relevant gastrointestinal events.”
Maltese: Il-benefiċċju u tolerabilità klinika għandhom ikun evalwati mill-ġdid perjodikament u t-trattament għandu jitwaqqaf immedjatament ma' l-ewwel dehra ta' reazzjonijiet tal-ġilda jew reazzjonijiet gastrointestinali relevanti.
English: Tad Pharma Gmbh Heinz-Lohmann-Str. 5 D-27472 Cuxhaven
Maltese: D-27472 Cuxhaven Il-Ġermanja
English: Gastro resistant tablet Oral
Maltese: Mg, Lyophilisat Oral
English: Walton-0n-The-Hill
Maltese: Fl-għajnejn
English: Effervescent Tablet
Maltese: Mg Tabletten
English: Acute Gout
Maltese: Użu gor-rektum
English: MA (EU) Number Name
Maltese: Numru ta' l-EU Isem inventat
English: Pack size
Maltese: Mnejn jingħata Il-pakkett Daqs talpakkett
English: Other information about Privigen
Maltese: Informazzjoni oħra dwar Privigen
English: Further information can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Privigen.
Maltese: Aktar informazzjoni tista' tinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/medicines/human/EPAR/Privigen.
English: Privigen (human normal immunoglobulin)
Maltese: Privigen (immunoglobulina normali umana)
English: Privigen received a marketing authorisation valid throughout the EU on 25 April 2008.
Maltese: Privigen ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fil-25 ta' April 2008.
English: What are the risks associated with Privigen?
Maltese: X'inhuma r-riskji assoċjati ma' Privigen?
English: These comprise patients with primary immune thrombocytopenia (ITP), who do not have enough platelets (components in the blood that help it to clot) and who are at high risk of bleeding; patients with Guillain-Barré syndrome or chronic inflammatory demyelinating polyneuropathy (CIDP), inflammatory disorders of the nerves that result in muscle weakness and numbness; patients with Kawasaki disease, a disease mainly seen in children which causes inflammation of blood vessels; and patients with multifocal motor neuropathy (MMN), nerve damage which causes weakness of the arms and legs.
Maltese: Dawn jinkludu pazjenti b'tromboċitopenija immunitarja primarja (ITP), li ma jkollhomx biżżejjed pjastrini (komponenti fid-demm li jgħinuh jagħqad) u li jkunu f'riskju għoli li jkollhom fsada; pazjenti li jbatu mis-sindrome Guillain-Barré jew polinewropatija demjelinata infjammatorja kronika (chronic inflammatory demyelinating polyneuropathy, (CIDP)), disturbi infjammatorji tan-nervituri li jirriżultaw fi dgħjufija u tnemnim tal-muskoli; pazjenti bil-marda Kawasaki, marda li tidher prinċipalment fit-tfal li tikkawża infjammazzjoni tal-vażi; u pazjenti b'newropatija motorja multifokali (multifocal motor neuropathy (MMN)), ħsara fin-nervituri li tikkawża dgħjufija fid-dirgħajn u fir-riġlejn.
English: The active substance in Privigen, human normal immunoglobulin, is a highly purified protein extracted from human plasma (part of the blood).
Maltese: Is-sustanza attiva fi Privigen, l-immunoglobulina normali umana, hija proteina ppurifikata ħafna estratta mill-plażma (parti mid-demm) umana.
English: In this study, 46 (81%) of the 57 patients had a platelet count above 50 million platelets per millilitre at least once during the study.
Maltese: F'dan l-istudju, 46 (81 %) mis-57 pazjent kellhom għadd ta' pjastrini ta' iktar minn 50 miljun pjastrina għal kull millilitru mill-inqas darba waqt l-istudju.
English: The patients had an average of 0.08 serious infections per year.
Maltese: Il-pazjenti kellhom medja ta' 0.08 infezzjonijiet serji fis-sena.
English: How is Privigen used?
Maltese: Kif jaħdem Privigen?
English: The medicine is available as a solution for infusion (drip) into a vein.
Maltese: Il-mediċina tiġi bħala soluzzjoni għall-infużjoni (dripp) ġol-vina.
English: The most common side effects with Privigen (seen in more than 1 patient in 10) are headache, nausea, pain (including in the back, neck, limbs, joints and face), fever, chills and a flu-like illness.
Maltese: L-effetti sekondarji l-aktar komuni bi Privigen (li dehru f'aktar minn pazjent 1 minn kull 10) huma wġigħ ta' ras, nawżja, uġigħ (inkluż fid-dahar, fl-għonq, fid-dirgħajn u r-riġlejn, fil-ġogi u fil-wiċċ), deni, dehxiet ta' bard u mard li jixbah lill-influwenza.
English: Severe haemolysis has previously been reported to be slightly more frequent with Privigen than with some other products containing the same active substance.
Maltese: Emoliżi severa preċedentement ġiet irrapportata li hija kemxejn aktar frekwenti bi Privigen milli b'xi prodotti oħra li jkun fihom l-istess sustanza attiva.
English: Privigen must not be used in patients with hyperprolinaemia type I or II (a genetic disorder causing high levels of the amino acid proline in the blood).
Maltese: Privigen m'għandux jintuża f'pazjenti bliperprolinemja tat-tip I jew II (disturb ġenetiku li jikkawża livelli għoljin ta' aminoaċidu prolina fiddemm).
English: Privigen must not be used in people who are hypersensitive (allergic) to normal human immunoglobulin or any of the other ingredients, or in patients who are allergic to other types of immunoglobulins, especially where they have deficiency (very low levels) of immunoglobulin A (IgA) and they have antibodies against IgA.
Maltese: Privigen m'għandux jintuża minn persuni li jkunu ipersensittivi (allerġiċi) għall-immunoglobulina normali umana jew għal kwalunkwe wieħed mill-ingredjenti l-oħra, jew f'pazjenti li jkunu allerġiċi għal tipi oħra ta' immunoglobulini, speċjalment meta jkollhom defiċjenza (livelli baxxi ħafna) ta' immunoglobulina A (IgA) u jkollhom antikorpi kontra l-IgA.
English: The second study looked at using Privigen in 57 patients with ITP.
Maltese: It-tieni studju ħares lejn l-użu ta' Privigen f'57 pazjent bl-ITP.
English: The average improvement was about 1.4 points.
Maltese: It-titjib medju kien madwar 1.4 punti.
English: For the full list of all side effects with Privigen, see the package leaflet.
Maltese: Għal-lista sħiħa ta' effetti sekondarji rrappurtati bi Privigen, ara lfuljett ta' tagħrif.
English: Privigen is a medicine used to support the immune system (the body's natural defences) in two main groups of patients:
Maltese: Privigen huwa mediċina użata biex issostni s-sistema immunitarja (id-difiżi naturali tal-ġisem) f'żewġ gruppi ewlenin ta' pazjenti:
English: • Patients who are at risk of infection because they do not have enough antibodies (also called immunoglobulins, proteins in the blood that help the body to fight disease).
Maltese: • Pazjenti li huma f'riskju ta' infezzjoni minħabba li ma jkollhomx biżżejjed antikorpi (li jissejħu wkoll immunoglobulini, proteini fid-demm li jgħinu lill-ġisem biex jiġġieled il-mard).
English: These also include people who have developed a lack of antibodies after birth (secondary immunodeficiency syndrome, SID), who have low levels of certain antibodies (called IgG) and who suffer from infections that are severe, keep coming back, and are not cured by medicines used to treat infections.
Maltese: Dawn jinkludu wkoll persuni li żviluppaw nuqqas ta' antikorpi wara t-twelid (sindrome talimmunodefiċjenza sekondarja, SID), li jkollhom livelli baxxi ta' ċerti antikorpi (imsejħa IgG) u li jbatu minn infezzjonijiet li huma severi, jibqgħu jfeġġu, u ma jiġux ikkurati b'mediċini użati għallkura ta' infezzjonijiet.
English: As for all medicines, data on the use of Privigen are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Privigen hija ssorveljata kontinwament.
English: In this third study, 17 (61%) of the 28 patients responded to treatment with an improvement of at least one point on the disability scale.
Maltese: F'dan it-tielet studju, 17 (61 %) mit-28 pazjent irrispondew għall-kura b'titjib ta' mill-inqas punt wieħed fuq l-iskala ta' diżabilità.
English: Haemolysis (breakdown of red blood cells) is an uncommon side effect in patients given human normal immunoglobulin (occurring with less than 1 dose in 100).
Maltese: Emoliżi (it-tkissir ta' ċelloli ħomor tad-demm) hija effett sekondarju mhux komuni f'pazjenti li jingħataw l-immunoglobulina normali umana (li sseħħ f'inqas minn doża waħda minn kull 100).
English: This confirmed that Privigen is effective in immunomodulation.
Maltese: Dan ikkonferma li Privigen huwa effikaċi fl-immunomodulazzjoni.
English: Privigen was given on two consecutive days.
Maltese: Privigen ma tqabbel mal-ebda kura oħra fl-istudji.
English: Privigen works by restoring abnormally low IgG levels to their normal range in the blood.
Maltese: Privigen ingħata għal jumejn konsekuttivi.
English: Side effects reported with Privigen are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati bi Privigen huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.