FrancophonIA/ELRC3.0 huggingface dataset:
English: In a cardiovascular safety outcomes program of pooled data from three active comparator controlled trials, 17, 412 patients with OA or RA were treated with etoricoxib (60 mg or 90 mg) for a mean duration of approximately 18 months.
Maltese: Fi programm dwar ir-riżultati tas-sigurtà kardjovaskulari ta' tagħrif kondiviż minn tliet provi kkontrollati attivi ta' tqabbil, 17,412-il pazjent b'OA jew RA ġew ikkurati b'etoricoxib (60 mg jew 90 mg) għal tul ta' żmien medju ta' madwar 18-il xahar.
English: Uncommon: blood urea nitrogen increased, creatine phosphokinase increased, haematocrit decreased, haemoglobin decreased, hyperkalaemia, leukocytes decreased, platelets decreased, serum creatinine increased, uric acid increased.
Maltese: Mhux komuni: żieda fin-nitroġenu fl-urea tad-demm, żieda fil-creatine phosphokinase, tnaqqis ematokritiku, tnaqqis fl-emoglobina, iperkalamija, tnaqqis fil-lewkoċiti, tnaqqis fil-pjastrini, żieda filkreatinina tas-serum, żieda fl-aċidu uriku.
English: Arcoxia 30, 60, 90 ja 120 mg tabletti, kalvopäällysteinen
Maltese: Arcoxia 30, 60, 90 ja 120 mg tabletti, kalvopäällysteinen Turox 30, 60, 90 ja 120 mg tabletti, kalvopäällysteinen
English: Common (occurring in greater than 1 out of 100 and less than 1 out of 10 people) Weakness and fatigue, dizziness, headache, flu-like illness, diarrhoea, wind, nausea, indigestion (dyspepsia), stomach pain or discomfort, heartburn, changes in blood tests related to your liver, swelling of the legs and/or feet due to fluid retention (oedema), increased blood pressure, palpitations, bruising.
Maltese: Dgħjufija u għejja, sturdament, uġigħ ta' ras, mard simili għal dak ta' l-influwenza, dijarrea, gass, nawseja, indiġestjoni (dispepsija), uġigħ jew skumdità fl-istonku, ħruq ta' stonku, tibdil fit-testijiet tad-demm relatat mal-fwied tiegħek, nefħa fir-riġlejn u/jew fis-saqajn dovuta għal żamma ta' fluwidu (edema), pressjoni tad-demm ogħla, palpitazzjonijiet, tbenġil.
English: In rats and rabbits, there was a dose dependent increase in post implantation loss at exposures greater than or equal to 1.5 times the human exposure (see sections 4.3 and 4.6).
Maltese: F'firien u fniek, kien hemm żieda dipendenti fuq id-doża f'telf ta' wara l-impjantazzjoni f'espożizzjonijiet ikbar minn jew daqs 1.5 drabi l-espożizzjoni umana (ara sezzjonijiet 4.3 u 4.6).
English: In patients experiencing attacks of acute gouty arthritis, etoricoxib 120 mg once daily over an eight-day treatment period, relieved moderate to extreme joint pain and inflammation comparable to indomethacin 50 mg three times daily.
Maltese: F'pazjenti li esperjenzaw attakki ta' artrite tal-gotta akuta, etoricoxib 120 mg darba kuljum fuq perjodu ta' kura ta' 8 ijiem, serraħ minn uġigħ u infjammazzjoni fil-ġogi moderat għal sever komparabbli għal indomethacin 50 mg tliet darbiet kulujm.
English: Hepatocellular and thyroid follicular cell adenomas observed in rats are considered to be a consequence of rat-specific mechanism related to hepatic CYP enzyme induction.
Maltese: Adenomi epatoċellulari u taċ-ċelloli follikulari tat-tirojde osservati fil-firien huma meqjusin bħala konsegwenza ta' mekkaniżmu speċifiku għall-firien relatat ma' induzzjoni ta' enzim CYP tal-fwied.
English: These beneficial effects were observed as early as the second day of therapy and maintained for up to 52 weeks.
Maltese: Dawn l-effetti ta' benefiċċju ġew osservati sa mit-tieni jum ta' kura u nżammu sa 52 ġimgħa.
English: Elderly
Maltese: Ġenerali
English: The following undesirable effects were reported at an incidence greater than placebo in clinical trials in patients with OA, RA, chronic low back pain or ankylosing spondylitis treated with etoricoxib 30 mg, 60 mg or 90 mg for up to 12 weeks, or in the MEDAL Program studies, or in post-marketing experience:
Maltese: L-effetti mhux mixtieqa li ġejjin ġew irrapportati b'inċidenza ikbar minn dawk ta' plaċebo fi provi kliniċi f'pazjenti b'OA, RA, uġigħ fil-parti t'isfel tad-dahar jew b'ankylosing spondylitis ikkurati b'etoricoxib 30 mg, 60 mg jew 90 mg għal mhux aktar minn 12-il ġimgħa, jew fl-istudji tal-Programm MEDAL, jew f'esperjenza ta' wara t-tqegħid fis-suq:
English: Each film-coated tablet contains 30, 60, 90 or 120 mg of etoricoxib.
Maltese: Kull pillola miksija b'rita fiha 30, 60, 90 jew 120 mg ta' etoricoxib.
English: In patients with ankylosing spondylitis, etoricoxib 90 mg once daily provided significant improvements in spine pain, inflammation, stiffness and function.
Maltese: F'pazjenti b'ankylosing spondylitis, etoricoxib 90 mg darba kuljum ta titjib sinjifikanti fl-uġigħ ta' lispina, infjammazzjoni, ebusija u funzjoni.
English: Rheumatoid arthritis The recommended dose is 90 mg once daily.
Maltese: Artrite rewmatojde Id-doża rakkomandata hija 90 mg darba kuljum.
English: Pack sizes:
Maltese: Mekkaniżmu ta' Azzjoni
English: Etoricoxib, as with other medicinal products inhibiting prostaglandin synthesis, may cause uterine inertia and premature closure of the ductus arteriosus during the last trimester.
Maltese: Etoricoxib, bħal kull mediċina oħra li tinibixxi s-sinteżi ta' prostaglandin, jista' jikkawża inerzja ta' l-utru u għeluq prematur tad-ductus arteriosus matul l-aħħar tliet xhur tat-tqala.
English: Etoricoxib at 60 and 90 mg had no effect on methotrexate plasma concentrations or renal clearance.
Maltese: Etoricoxib f'60 u 90 mg ma kellu ebda effett fuq il-konċentrazzjonijiet tal-plasma jew fuq it-tneħħija mill-kliewi ta' methotrexate.
English: Uncommon: chest pain.
Maltese: Mhux komuni: uġigħ fis-sider.
English: Patients with a recent history of myocardial infarction, coronary artery bypass grafting or percutaneous coronary intervention within 6 months preceding enrollment were excluded.
Maltese: Pazjenti bi storja reċenti ta' infart mijokardijaku, grafting tal-bypass ta' l-arterja koronarja jew intervent koronarju perkutanju fi żmien 6 xhur qabel ir-reġistrazzjoni ġew esklużi.
English: Lactation
Maltese: KARTUNA
English: Use of gastroprotective agents and low dose aspirin were permitted in the studies.
Maltese: L-użu ta' sustanzi gastroprotettivi u aspirina ta' doża baxxa kien permess fl-istudji.
English: HOW TO STORE <ARCOXIA>
Maltese: X'fih <ARCOXIA>
English: In a study in healthy subjects, daily administration of etoricoxib 120 mg did not alter hepatic CYP3A4 activity as assessed by the erythromycin breath test.
Maltese: Fi studju f'suġġetti b'saħħithom, l-amministrazzjoni ta' kuljum ta' etoricoxib 120 mg ma bidlitx l-attività CYP3A4 epatika kif ivvalutata mit-test tan-nifs ta' erythromycin.
English: 30 mg blue-green, apple-shaped, biconvex film coated tablets marked ‘ACX 30' on one side and ‘101' on the other.
Maltese: 30 mg pilolli miksijin b'rita, ġejjin għat-tond miż-żewġ naħat, f'għamla ta' tuffieħa, blu-ħodor immarkati ‘ACX 30' fuq naħa u b'‘101' fuq in-naħa l-oħra.
English: The incidence of adverse experiences in EDGE and EDGE II and of adverse experiences considered serious or resulting in discontinuation in the MEDAL study was higher with etoricoxib than diclofenac.
Maltese: L-inċidenza ta' esperjenzi avversi f'EDGE u EDGE II u ta' esperjenzi avversi meqjusin serji jew li jirriżultaw fi twaqqif ta' l-istudju MEDAL kienu ogħla b'etoricoxib milli b'diclofenac.
English: Elderly: Pharmacokinetics in the elderly (65 years of age and older) are similar to those in the young.
Maltese: Il-farmakokinetiċi fl-anzjani (65 sena jew aktar) huma simili għal dawk fiż-żgħażagħ.
English: Arcoxia 30 mg, 60 mg, 90 mg och 120 mg filmdragerade tabletter United Kingdom ARCOXIA 30, 60, 90 or 120 mg film-coated tablets
Maltese: Arcoxia 30 mg, 60 mg, 90 mg, 120 mg-Filmtabletten Auxib 30 mg, 60 mg, 90, 120 mg-Filmtabletten
English: In the rat, gastrointestinal toxicity of etoricoxib increased with dose and exposure time.
Maltese: Fil-firien, it-tossiċità gastrointestinali ta' etoricoxib żdiedet mad-doża u mal-ħin ta' espożizzjoni.
English: 90 mg Tablets: White, apple-shaped, biconvex tablets <debossed ‘202' on one side and ‘ARCOXIA 90' on the other side>.
Maltese: Pilloli ġejjin għat-tond miż-żewġ naħat f'għamla ta' tuffieħa, bojod, <imnaqqxin b'‘202' fuq naħa u b'‘ARCOXIA 90' fuq in-naħa l-oħra>.
English: The rates of confirmed lower GI clinical events (small or large bowel perforation, obstruction, or hemorrhage, (POBs)) were not significantly different between etoricoxib and diclofenac.
Maltese: Ir-rati ta' episodji kliniċi GI baxxi kkonfermati (perforazzjoni żgħira jew kbira ta' l-imsaren, ostruzzjoni, jew emorraġija, (POBs)) ma kinux ferm differenti bejn etoricoxib u diclofenac.
English: If signs of hepatic insufficiency occur, or if persistently abnormal liver function tests (three times the upper limit of normal) are detected, etoricoxib should be discontinued.
Maltese: Jekk iseħħu sinjali ta' insuffiċjenza tal-fwed, jew jekk jirriżultaw testijiet tal-funzjoni tal-fwied mhux normali b'mod persistenti (tliet darbiet il-limitu ta' fuq tan-normal), etoricoxib għandu jitwaqqaf.
English: The use of etoricoxib, as with any medicinal product known to inhibit cyclooxygenase / prostaglandin synthesis, is not recommended in women attempting to conceive (see sections 4.6, 5.1, and 5.3).
Maltese: L-użu ta' etoricoxib, bħal b'kull prodott mediċinali ieħor magħruf li jinibixxi sinteżi ta' cyclooxygenase / prostaglandin, mhuwiex rakkomandat f'nisa li jkunu qegħdin jipprovaw ikollhom ittfal (ara sezzjonijiet 4.6, 5.1, u 5.3).
English: Data from clinical studies showed clinically meaningful treatment effect for the 90mg etoricoxib once daily dose for AS indications; however, some data are available to indicate that lower doses might also show effect.
Maltese: Dejta minn studji kliniċi wriet effett ta' kura klinikament sinifikattiva għad-doża ta' 90mg etoricoxib darba kuljum għal indikazzjonijiet AS; madankollu, hemm xi dejta disponibbli li tindika li dożi iktar baxxi jistgħu wkoll juru effett.
English: Patients enrolled in the Program had a wide range of cardiovascular and gastrointestinal risk factors at baseline.
Maltese: Pazjenti rreġistrati fil-Programm kellhom firxa wiesgħa ta' fatturi ta' riskju kardjovaskulari u gastrointestinali fil-linja bażi.
English: However no treatment-related external or skeletal foetal malformations were observed.
Maltese: Madankollu, ebda malformazzjoni fetali esterna jew skeletali relatata mal-kura ma ġiet osservata.
English: • If you have moderate liver disease, you should not take more than 60 mg every other day or 30 mg a day.
Maltese: • Jekk għandek marda tal-fwied moderata, ma għandekx tieħu aktar minn 60 mg kuljum darba iva u darba le jew 30 mg kuljum.
English: Elimination of etoricoxib occurs almost exclusively through metabolism followed by renal excretion.
Maltese: L-eliminazzjoni ta' etoricoxib isseħħ kważi esklussivament permezz ta' metaboliżmu segwit minn tneħħija mill-kliewi.
English: In patients with moderate hepatic dysfunction (Child-Pugh score 7-9), regardless of indication, the dose of 60 mg every other day should not be exceeded; administration of 30 mg once daily can also be considered.
Maltese: F'pazjenti b'malfunzjonament moderata tal-fwied (skor Child-Pugh ta' 7-9), minkejja l-indikazzjoni, id-doża ta' 60 mg jum iva u jum le ma għandhiex tinqabeż; għoti ta' 30 mg darba kuljum jista' jiġi kkunsidrat ukoll.
English: In clinical trials, etoricoxib was administered without regard to food intake.
Maltese: Fi provi kliniċi, etoricoxib ingħata mingħajr ma tqies it-teħid ta' l-ikel.
English: In two 12-week double-blind endoscopy studies, the cumulative incidence of gastroduodenal ulceration was significantly lower in patients treated with etoricoxib 120 mg once daily than in patients treated with either naproxen 500 mg twice daily or ibuprofen 800 mg three times daily.
Maltese: F'żewġ studji ta' endoskopija double-blind ta' 12-il ġimgħa, l-inċidenza kumulattiva ta' ulċerazzjoni gastroduwodenali kienet ferm inqas fil-pazjenti kkurati b'etoricoxib 120 mg darba kuljum milli f'pazjenti kkurati jew b'naproxen 500 mg darbtejn kuljum jew b'ibuprofen 800 mg tliet darbiet kuljum.
English: Caution should be exercised when co-administering etoricoxib with warfarin or other oral anticoagulants (see section 4.5).
Maltese: Pazjenti tfal Etoricoxib huwa kontra-indikat fi tfal u adoloxxenti taħt is-16-il sena (ara sezzjoni 4.3).
English: The full EPAR for Afstyla 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: The injection is given into a vein over several minutes.
Maltese: L-injezzjoni tingħata ġo vina tul bosta minuti.
English: Other information about Afstyla
Maltese: Informazzjoni oħra dwar Afstyla
English: It contains the active substance lonoctocog alfa.
Maltese: Hu fih issustanza attiva lonoctocog alfa.
English: They may include: angioedema (swelling of tissues under the skin), burning and stinging at the injection site, chills, flushing, itchy rash over the whole body, headache, hives, hypotension (low blood pressure), lethargy, nausea (feeling sick), restlessness, tachycardia (rapid heartbeat), tightness of the chest, tingling, vomiting and wheezing.
Maltese: Dawn jistgħu jinkludu: anġjoedema (nefħa tat-tessuti li jinsabu taħt il-ġilda), ħruq u tingiż fil-post tal-injezzjoni, tkexkix ta' bard, fwawar, raxx bil-ħakk mal-ġisem kollu, uġigħ ta' ras, ħorriqija, ipotensjoni (pressjoni tad-demm baxxa), letarġija, nawsja (tħossok ma tiflaħx), irrikwetezza, takikardija (taħbit tal-qalb mgħaġġel), tagħfis fis-sider, tagħrix, rimettar u tħarħir.
English: This is a summary of the European public assessment report (EPAR) for Afstyla.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Afstyla.
English: Afstyla was rated as ‘excellent' or ‘good' at treating 96% of the 347 bleeding episodes recorded during the study; 96% of bleeding episodes resolved with one or two injections of Afstyla.
Maltese: Afsyla ġie kklassifikat bħala ”eċċellenti” jew ”tajjeb” fit-trattament ta' 96 % minn 347 episodju ta' fsada li ġew irreġistrati matul l-istudju; 96 % tal-episodji ta' fsada li ġew riżolti b'injezzjoni waħda jew b'żewġ injezzjonijiet ta' Afstyla.
English: Among those patients who received Afstyla to prevent bleeding, an average of 1.14 bleeding episodes per year was recorded for each patient which was lower than the 19.64 episodes per year in patients not receiving Afstyla for prevention.
Maltese: Fost dawk il-pazjenti li rċevew Afstyla għall-prevenzjoni ta' fsada, ġiet irreġistrata medja ta' 1.14 episodju ta' fsada fis-sena għal kull pazjent u dan kien inqas minn 19.64 episodju fis-sena f'pazjenti li ma rċevewx Afstyla għall-prevenzjoni.
English: What are the risks associated with Afstyla?
Maltese: X'inhuma r-riskji assoċjati ma' Afstyla?
English: Afstyla was rated as ‘excellent' or ‘good' at treating 92% of the bleeding episodes.
Maltese: Afstyla ġie kklassifikat bħala ”eċċellenti” jew ”tajjeb” fit-trattament ta' 92 % ta' episodji ta' fsada.
English: A total of 848 bleeding episodes were recorded during the study, 94% of which resolved with one or two injections of Afstyla.
Maltese: Matul l-istudju, ġie rreġistrat total ta' 848 episodju ta' ħruġ ta' demm, b'94 % minnhom li ġew riżolti b'injezzjoni waħda jew żewġ injezzjonijiet ta' Afstyla.
English: Why is Afstyla approved?
Maltese: Għaliex ġie approvat Afstyla?
English: Among those patients who received Afstyla to prevent bleeding, the average number of bleeding episodes per year was 2.30 for patients receiving Afstyla three times a week, and 4.37 for those receiving Afstyla twice a week.
Maltese: Fost dawk il-pazjenti li rċivew Afstyla għall-prevenzjoni ta' fsada, l-għadd medju ta' episodji ta' fsada fis-sena kien ta' 2.30 għal pazjenti li rċivew Afstyla tliet darbiet fil-ġimgħa, u ta' 4.37 għal dawk li rċivew Afstyla darbtejn filġimgħa.
English: The active substance in Afstyla, lonoctocog alfa, is a shorter version of human factor VIII that works in the body in the same way as human factor VIII.
Maltese: Is-sustanza attiva f'Afstyla, lonoctocog alfa, hi verżjoni iqsar tal-fattur VIII uman li taħdem fil-ġisem bl-istess mod ta' kif jaħdem il-fattur VIII uman.
English: The first study involved 173 patients aged 12 years and above.
Maltese: L-ewwel studju involva 173 pazjent li kellhom 12-il sena jew aktar.
English: How does Afstyla work?
Maltese: Kif jaħdem Afstyla?
English: Afstyla is a medicine used for the treatment and prevention of bleeding in patients with haemophilia A (an inherited bleeding disorder caused by lack of a clotting protein called factor VIII).
Maltese: Afstyla hu mediċina li tintuża għat-trattament u l-prevenzjoni tal-ħruġ ta' demm f'pazjenti b'emofilja A (disturb ta' fsada li jintiret ikkawżat min-nuqqas ta' proteina ta' għaqid imsejħa fattur VIII).
English: Hypersensitivity (allergic) reactions are common with Afstyla, affecting up to 1 in 10 people.
Maltese: Reazzjonijiet ta' sensittività eċċessiva (allerġiċi) huma komuni bl-użu ta' Afstyla u jistgħu jaffettwaw lil aktar minn persuna 1 minn kull 10.
English: For the full list of all side effects and restrictions, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha u r-restrizzjonijiet, ara l-fuljett ta' tagħrif.
English: Regarding safety, the reported side effects are in line with those expected for a factor VIII product, although hypersensitivity reactions occurred more frequently with Afstyla.
Maltese: Rigward is-sigurtà, l-effetti sekondarji rrapppurtati huma f'konformità ma' dawk mistennija għall-prodott talfattur VIII, għalkemm b'Afstyla, ir-reazzjonijiet ta' sensittività eċċessiva seħħew b'mod aktar frekwenti.
English: Afstyla has been shown to be effective in both preventing and treating bleeding episodes.
Maltese: Afstyla ntwera li hu effettiv kemm fil-prevenzjoni kif ukoll fit-trattament ta' episodji ta' fsada.
English: In the 16 surgical procedures that occurred during the study, Afstyla was rated as ‘excellent' or ‘good' in preventing bleeding episodes when used two to three times a week.
Maltese: Fis-16-il operazzjoni li twettqu matul l-istudju, Afstyla ġie kklassifikat bħala ”eċċellenti” jew ”tajjeb” fil-prevenzjoni ta' episodji ta' fsada meta ntuża darbtejn sa tliet darbiet filġimgħa.
English: Afstyla has been shown to be effective at preventing and treating bleeding episodes in two main studies in patients with severe haemophilia A who were previously treated with other factor VIII products.
Maltese: F'żewġ studji ewlenin f'pazjenti b'emofilja A severa li diġà kienu ġew ittrattati bi prodotti ta' fattur VIII oħra, intwera li Afstyla hu effettiv fil-prevenzjoni u t-trattament ta' episodji ta' fsada.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Afstyla's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Afstyla huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: 10 March 2011
Maltese: 10 ta' Marzu 2011
English: What is Tienam?
Maltese: X'inhu Tienam?
English: • intra- and post-partum infections,
Maltese: • infezzjonijiet intra u post-partum,
English: The CHMP harmonised the posology (the dose and frequency of dosing) in adults.
Maltese: Is-CHMP armonizza l-pożoloġija (id-doża u l-frekwenza ta' dożaġġ) fl-adulti.
English: • complicated urinary tract infections,
Maltese: • infezzjonijiet ikkumplikati tal-apparat urinarju,
English: Tienam contains two active substances: imipenem, which is an antibiotic belonging to the carbapenem family, and cilastatin, which is a ‘dehydropeptidase inhibitor'.
Maltese: Tienam fih żewġ sustanzi attivi: imipenem, li huwa antibijotiku li jagħmel parti mill-familja ta' carbapenem, u cilastatin, li huwa ‘inibitur ta' dehydropeptidase'.
English: It has been used to treat infections of the lungs, the urinary tract (structures that carry urine), the abdomen, skin and the reproductive system.
Maltese: Intuża fil-kura ta' infezzjonijiet tal-pulmuni, l-apparat urinarju (strutturi li jġorru l-awrina), l-addome, il-ġilda u s-sistema riproduttiva.
English: The medicine is available in all EU Member States under the trade name Tienam, as well under other trade names: Conet, Imipem, Primaxin, Tenacid and Zienam.
Maltese: Il-mediċina hija disponibbli fl-Istati Membri kollha tal-UE taħt l-isem kummerċjali Tienam, kif ukoll taħt ismijiet kummerċjali oħra: Conet, Imipem, Primaxin, Tenacid u Zienam.
English: The company that markets these medicines is Merck, Sharp & Dohme.
Maltese: Il-kumpanija li tqiegħed dawn il-mediċini fis-suq hija Merck, Sharp & Dohme.
English: On 18 May 2009, the Dutch medicines regulatory agency referred the matter to the CHMP in order to harmonise the marketing authorisations for Tienam in the EU.
Maltese: Fit-18 ta' Mejju 2009, l-aġenzija regolatorja tal-mediċina Olandiża rriferiet il-kwistjoni lis-CHMP sabiex jarmonizza l-awtorizzazzjonijiet għat-tqegħid fis-suq għal Tienam fl-UE.
English: A company applied in the Netherlands for a generic version of Tienam in a decentralised procedure involving 16 Member States.
Maltese: Kumpanija applikat fil-Pajjiżi l-Baxxi għal verżjoni ġenerika ta' Tienam fi proċedura deċentralizzata li tinvolvi 16-il Stat Membru.
English: The CHMP also removed the use of Tienam in the prevention of infections.
Maltese: Is-CHMP neħħa wkoll l-użu ta' Tienam fil-prevenzjoni tal-infezzjonijiet .
English: When Tienam is absorbed in the body, the imipenem component kills the bacteria that are causing the infection, while the cilastatin component blocks the dehypropeptidase enzyme in the kidney that normally breaks down imipenem.
Maltese: Meta Tienam jiġi assorbit fil-ġisem, ilkomponent ta' imipenem joqtol lill-batterji li jkunu qegħdin jikkawżaw l-infezzjoni, filwaqt li lkomponent ta' cilastatin jimblokka l-enzima dehypropeptidase fil-kliewi li normalment tkisser lil imipenem.
English: The CHMP recommended that Tienam should not be used in some indications, such as meningitis, osteomyelitis (infection of the bones) and lung infection in cystic fibrosis patients.
Maltese: Is-CHMP irrakkomanda li Tienam ma għandux jintuża f'ċerti indikazzjonijiet, bħall-meninġite, lostjomelite (infezzjoni tal-għadam) u fl-infezzjoni tal-pulmun f'pazjenti bil-fibrożi ċistika.
English: Why was Tienam reviewed?
Maltese: Għaliex ġie rivedut Tienam?
English: The European Medicines Agency has completed a review of Tienam.
Maltese: L-Aġenzija Ewropea tal-Mediċini temmet reviżjoni ta' Tienam.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Tienam in the European Union (EU).
Maltese: Il-Kumitat għall-Prodotti Mediċinali għallUżu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li jeħtieġ li l-informazzjoni dwar il-preskrizzjoni ta' Tienam tiġi armonizzata fl-Unjoni Ewropea (UE).
English: During a decentralised procedure, the application submitted by the company is assessed by one Member State (the ‘reference Member State', in this instance the Netherlands), with a view of granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States').
Maltese: Matul proċedura deċentralizzata, l-applikazzjoni sottomessa mill-kumpanija tiġi vvalutata minn Stat Membru wieħed (l-‘Istat Membru ta' referenza', f'dan il-każ il-Pajjiżi l-Baxxi), bil-għan li tingħata awtorizzazzjoni għat-tqegħid fis-suq li tkun valida f'dan il-pajjiż kif ukoll fl-Istati Membri l-oħra (l-‘Istati Membri kkonċernati').
English: • complicated skin and soft-tissue infections,
Maltese: • infezzjonijiet ikkumplikati tal-ġilda u tat-tessut artab,
English: Tienam is an antibiotic used in complicated infections, generally in hospital.
Maltese: Tienam huwa antibijotiku li jintuża fl-infezzjonijiet ikkumplikati, ġeneralment l-isptar.
English: MA (EU) Number (Invented) name Strength Pharmaceutical form
Maltese: Numru tal-MA (EU) Isem (Ivvintat) Qawwa Għamla
English: Route of administration
Maltese: 7 pilloli