FrancophonIA/ELRC3.0 huggingface dataset:
English: PRAC also concluded that alemtuzumab is associated with immune-mediated diseases such as autoimmune hepatitis, haemophilia A and haemophagocytic lymphohistiocytosis (HLH), which can happen with a delay of months to years after the latest treatment.
Maltese: Il-PRAC ikkonkluda wkoll li alemtuzumab huwa assoċjat ma' mard medjat mis-sistema immuni bħal epatite awtoimmuni, emofilja A u limfoistjoċitożi emofagoċitika (HLH), li jistgħu jseħħu b'dewmien ta' xhur sa snin wara l-aħħar trattament.
English: PRAC also considered the views expressed by the neurology scientific advisory group.
Maltese: Il-PRAC ikkunsidra wkoll ilfehmiet espressi mill-grupp konsultattiv xjentifiku dwar in-newroloġija.
English: The relative young age of patients who died within a short period (30 days) from Lemtrada treatment is also noted.
Maltese: Hija nnutata wkoll l-età żgħira relattiva tal-pazjenti li mietu f'perjodu qasir (30 jum) minn trattament b'Lemdada.
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Maltese: Numru tal-MA Isem (ivvintat) Qawwa Għamla farmaċewtika
English: The full EPAR for Stribild 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: Other information about Stribild
Maltese: Informazzjoni oħra dwar Stribild
English: This summary was last updated in 10/2017.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'10-2017.
English: Stribild is available as tablets (150 mg elvitegravir/150 mg cobicistat /200 mg emtricitabine/245 mg tenofovir disoproxil).
Maltese: Stribild jiġi bħala pilloli (150 mg elvitegravir/150 mg cobicistat /200 mg emtricitabine/245 mg tenofovir disoproxil).
English: It is used to treat patients from 12 years of age and weighing at least 35 kg who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Maltese: Dan jintuża biex jikkura pazjenti mill-età ta' tnax-il sena u li jiżnu minn tal-inqas 35 kg u li huma infettati bil-virus tal-immunodefiċjenza umana tat-tip-1 (HIV-1, human immunodeficiency virus type 1), virus li jikkawża s-sindrome ta' immunodefiċjenza akkwiżita (AIDS, acquired immune deficiency syndrome).
English: A third study involving 50 adolescents aged 12 to 18 years who had not been previously treated for HIV-1 showed that Stribild was also effective in reducing viral load in this age group; 88% (44 of 50 patients) responded to treatment after 24 weeks, and the response persisted after 48 weeks.
Maltese: It-tielet studju li involva 50 adolexxent ta' età ta' 12 sa 18-il sena li ma ġewx ikkurati preċedentement għall-HIV-1 wera li Stribild kien ukoll effettiv biex inaqqas it-tagħbija virali f'dan il-grupp ta' età; 88 % (44 minn 50 pazjent) irrispondew għall-kura wara 24 ġimgħa, u r-rispons baqa' wara 48 ġimgħa.
English: This is a summary of the European public assessment report (EPAR) for Stribild.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Stribild.
English: Stribild is a medicine that contains the active substances elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil.
Maltese: Stribild huwa mediċina li fiha s-sustanzi attivi elvitegravir, cobicistat, emtricitabine u tenofovir disoproxil.
English: In the second study, involving 707 patients, Stribild was compared with a medicine containing efavirenz, emtricitabine and tenofovir disoproxil.
Maltese: Fit-tieni studji, li involva 707 pazjent, Stribild tqabbel ma' mediċina li fiha efavirenz, emtricitabine u tenofovir disoproxil.
English: Why is Stribild approved?
Maltese: Għaliex ġie approvat Stribild?
English: Stribild was investigated in two main studies involving 1,422 adult patients with HIV-1 who had not been treated before, where Stribild was compared with other HIV medicines.
Maltese: Stribild ġie investigat f'żewġ studji ewlenin li involvew 1,422 pazjent bl-HIV-1 li ma ġewx ikkurati qabel, fejn Stribild tqabbel ma' mediċini oħra konta l-HIV.
English: After 48 weeks, around 88% of patients treated with Stribild (305 out of 348) responded to treatment compared with around 84% of patients treated with the comparator medicine (296 out of 352).
Maltese: Wara 48 ġimgħa, madwar 88 % tal-pazjenti li ġew ikkurati bi Stribild (305 minn 348) irrispondew għall-kura meta mqabbel ma' madwar 84 % tal-pazjenti li ġew ikkurati bil-mediċina bil-komparatur (296 minn 352).
English: After 48 weeks, around 90% of patients treated with Stribild (316 out of 353) responded to treatment compared with around 87% of patients treated with the comparator treatment (308 out of
Maltese: Wara 48 ġimgħa, madwar 90 % tal-pazjenti kkurati bi Stribild (316 minn 353) irrispondew għall-kura meta mqabbel ma' madwar 87 % tal-pazjenti kkurati bil-kura bil-komparatur (308 minn 355).
English: Tenofovir and emtricitabine are closely related types of antiviral agent called reverse transcriptase inhibitors.
Maltese: It-tenofovir u l-emtricitabine huma tipi ta' aġenti antivirali relatati mill-qrib li jissejħu inibituri tat-transkrittażi inversa.
English: The company that markets Stribild will ensure that all doctors who are expected to prescribe Stribild are provided with educational materials containing important safety information.
Maltese: Il-kumpanija li tqiegħed Stribild fis-suq se tiżgura li t-tobba kollha li mistennija jippreskrivu Stribild jiġu pprovduti b'materjal edukattiv li jkun fih informazzjoni importanti dwar is-sigurtà.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Stribild on 24/05/2013
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Stribild fl-24/05/2013.
English: Stribild contains four active substances.
Maltese: Stribild fih erba' sustanzi attivi.
English: In the first study, involving 715 patients, Stribild was compared with the combination of ritonavir, atazanavir plus a medicine containing emtricitabine and tenofovir disoproxil (which are also contained in Stribild).
Maltese: Fl-ewwel studju, li involva 715-il pazjent, Stribild tqabbel mal-kombinazzjoni ta' ritonavir, atazanavir flimkien ma' mediċina li fiha emtricitabine u tenofovir disoproxil (li jinsabu wkoll fi Stribild).
English: It blocks an HIV-1 enzyme called integrase, which is involved in thevirus's replication, thereby reducing the virus's ability to replicate normally and slowing down its spread.
Maltese: Dan jimblokka enzima tal-HIV-1 li tissejjaħ integrase, li hija involuta fir-replikazzjoni tal-virus, b'hekk titnaqqas l-abbiltà tal-virus li jirreplika ruħu b'mod normali u jitnaqqas it-tixrid tiegħu.
English: What are the risks associated with Stribild?
Maltese: X'inhuma r-riskji assoċjati ma' Stribild?
English: Patients whose viral load was reduced to less than 50 HIV-1 RNA copies/ml after 48 weeks of treatment were considered to have responded to treatment.
Maltese: HIV-1 RNA kopja/ml wara 48 ġimgħa ta' kura ġew kkunsidrati li kienu rrispondew għall-kura.
English: They block the activity of reverse transcriptase, an enzyme produced by HIV-1 that allows the virus to replicate itself in the body.
Maltese: Dawn jimblukkaw l-attività tat-transkrittażi inversa, enzima prodotta mill-HIV-1 li tippermetti lill-virus jirreplika ruħu fil-ġisem.
English: Tenofovir disoproxil is a ‘prodrug' of tenofovir, meaning that it is converted into the active substance tenofovir in the body.
Maltese: It-tenofovir disoproxil hija ‘promediċina' ta' tenofovir, li jfisser li tiġi kkonvertita fis-sustanza attiva tenofovir fil-ġisem.
English: How is Stribild used?
Maltese: Kif jaħdem Stribild?
English: By blocking reverse transcriptase as well as integrase, Stribild reduces the amount of HIV-1 in the blood and keeps it at a low level.
Maltese: Billi jimblokka t-transkrittażi inversa kif ukoll integrase, Stribild inaqqas lammont ta' HIV-1 fid-demm u jżommu f'livell baxx.
English: In patients taking some of the components of Stribild, certain rare but serious side effects have been seen including lactic acidosis (excess lactic acid in the blood) and severe kidney problems that may also affect bones.
Maltese: F'pazjenti li kienu qed jieħdu xi wħud mill-komponenti ta' Stribild, dehru ċerti effetti sekondarji rari iżda serji, inkluż aċidożi lattika (aċidu lattiku eċċessiv fiddemm) u problemi serji fil-kliewi li jistgħu jaffettwaw ukoll l-għadam.
English: Stribild does not cure HIV-1 infection or AIDS, but it may hold off damage to the immune system and the development of infections and diseases associated with AIDS.
Maltese: Stribild ma jikkurax l-infezzjoni tal-HIV-1 jew l-AIDS, iżda jista' jittardja l-ħsara lis-sistema immunitarja, u l-iżvilupp ta' infezzjonijiet u mard assoċjat mal-AIDS.
English: This will cover information on the risk of kidney disease in adults and adolescents and the measures to reduce this risk, including appropriate screening and monitoring of patients.
Maltese: Dan se jkopri informazzjoni dwar ir-riskju ta' mard fil-kliewi fl-adulti u fl-adolexxenti u l-miżuri biex dan ir-riskju jitnaqqas, inkluż skrinjar u monitoraġġ xieraq tal-pazjenti.
English: Stribild must not be used with several other medicines as it may interact with them, thereby reducing the effectiveness of treatment or increasing the risk of side effects.
Maltese: Stribild m'għandux jintuża flimkien ma' diversi mediċini oħra peress li jista' jinteraġixxi magħhom, u b'hekk titnaqqas l-effikaċja tal-kura jew jiżdied ir-riskju ta' effetti sekondarji.
English: The Agency also noted the risk of side effects affecting the kidneys, and recommended that kidney function should be carefully assessed before patients start taking Stribild and should be monitored during treatment.
Maltese: L-Aġenzija nnutat ukoll ir-riskju ta' effetti sekondarji li jaffettwaw il kliewi, u rrakkomandat li l-funzjoni tal-kliewi għandha tiġi vvalutata bir-reqqa qabel il-pazjenti jibdew jieħdu Stribild u għandhom jiġu mmonitorjati waqt il-kura.
English: Ref. EMEA/CHMP/259505/2009 EMEA/H/A-29/1062
Maltese: EMEA/CHMP/259505/2009 EMEA/H/A-29/1062
English: Co-Rapporteur:
Maltese: Ko-rapporteur:
English: Dr Michal Pirożynski (Poland)
Maltese: Prof Michal Pirożynski (Il-Polonja)
English: 25 September 2008
Maltese: 25 ta' Settembru 2008
English: Dr Barbara Van Zwieten-Boot (the Netherlands)
Maltese: Prof Barbara Van Zwieten-Boot (l-Olanda)
English: 1 Article 29 of Directive 2001/83/EC as amended, referral on the grounds of potential serious risk to public health
Maltese: 1 Artikolu 29 tad-Direttiva 2001/83/KE kif emendata, referenza abbażi ta' riskju potenzjali serju għas-saħħa pubblika
English: What is Budesonide Sandoz?
Maltese: X'inhu Budesonide Sandoz?
English: The review was carried out under an ‘Article 29' referral1.
Maltese: Ir-reviżjoni saret skont referenza ‘tal-Artikolu 29'
English: Based on evaluation of the currently available data, including the studies carried out to compare the way Budesonide Sandoz is handled by the body to that of Rhinocort, and the scientific discussion within the Committee, the CHMP concluded that the benefits of Budesonide Sandoz outweigh its risks, and that therefore the marketing authorisation for Budesonide Sandoz should be granted in all concerned Member States for patients aged from 6 years.
Maltese: Abbażi tal-valutazzjoni tad-dejta disponnibbli bħalissa, inklużi l-istudji mwettqa biex iqabblu l-mod kif il-ġisem jirreaġixxi ma' Budesonide Sandoz u ma' Rhinocort, u d-diskussjoni xjentifika fi ħdan ilKumitat, is-CHMP ikkonkluda li l-benefiċċji ta' Budesonide Sandoz huma ikbar mir-riskji tiegħu, u li għalhekk l-awtorizzazzjoni għat-tqegħid fis-suq għal Budesonide Sandoz għandha tingħata fl-Istati Membri kollha kkonċernati, għal pazjenti ‘l fuq minn 6 snin.
English: Budesonide Sandoz is almost identical to another medicine authorised in the European Union, Rhinocort.
Maltese: Budesonide Sandoz huwa kważi identiku għal mediċina oħra awtorizzata fl-Unjoni Ewropea, Rhinocort.
English: Budesonide Sandoz is an anti-inflammatory medicine.
Maltese: Budesonide Sandoz hu mediċina antinfjammatorja.
English: Questions and answers on the referral for Budesonide Sandoz nasal suspension with 32 or 64 microgram per spray
Maltese: Mistoqsija u tweġiba dwar ir-referenza għal Budesonide Sandoz sospensjoni tal-imnieħer b'32 jew 64 mikrogramma għal kull sprejjatura
English: 19 February 2009
Maltese: 19 ta' Frar 2009
English: This is a procedure when one Member State (the ‘reference Member State', in this instance Germany) assesses a medicine 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', in this instance the Czech Republic, Denmark, France, the Netherlands, Norway, Sweden and the United Kingdom).
Maltese: Din hija proċedura meta Stat Membru (l-‘Istat Membru ta' referenza', f'dan il-każ il-Ġermanja) jevalwa mediċina bil-għan li jagħti awtorizzazzjoni għat-tqegħid fis-suq li tkun valida f'dan il-pajjiż kif ukoll fi Stati Membri oħra (l-‘Istati Membri konċernati', f'dan il-każ ir-Repubblika Ċeka, id-Danimarka, Franza, l-Olanda, in-Norveġja, l-Iżvezja u r-Renju Unit).
English: The only difference is that it contains very small amounts of ascorbic acid (an antioxidant).
Maltese: L-unika differenza hija li fih ammonti żgħar ħafna ta' aċidu assorbiku (antiosidant).
English: It is used to treat and prevent the symptoms of seasonal allergic rhinitis (allergy to pollen, also known as hayfever) and perennial allergic rhinitis (when the allergy is due to other triggers, such as house dust or animals).
Maltese: Jintuża biex jitratta u jipprevjeni s-sintomi tarrinite allerġika staġjonali (allerġija għall-polline, magħrufa ukoll bħala riħ tal-ħuxlief) u tar-rinite allerġika perenni (meta l-allerġija tiġi kkawżata minn fatturi oħra, bħal trab fid-djar jew l-annimali).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Budesonide Sandoz outweigh its risks, and the marketing authorisation can be granted in Germany and in the following Member States of the European Union, the Czech Republic, Denmark, France, the Netherlands, Norway, Sweden and the United Kingdom.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li lbenefiċċji ta' Budesonide Sandoz huma ikbar mir-riskji tiegħu, u l-awtorizzazzjoni għat-tqegħid fissuq tista' tingħata fil-Ġermanja u fl-Istati Membri tal-Unjoni Ewropea li ġejjin, ir-Repubblika Ċeka, id-Danimarka, Franza, l-Olanda, in-Norveġja, l-Iżvezja u r-Renju Unit.
English: Sandoz Pharmaceuticals GmbH submitted Budesonide Sandoz to the German medicines regulatory agency for a decentralised procedure.
Maltese: GmbH ippreżenta Budesonide Sandoz lill-aġenzija Ġermaniża li tirregola lmediċini għal proċedura diċentralizzata.
English: The European Medicines Agency (EMEA) has completed an arbitration procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Budesonide Sandoz.
Maltese: L-Aġenzija Ewropea għall-Mediċini (EMEA) temmet proċedura ta' arbitraġġ wara nuqqas ta' qbil fost l-Istati Membri tal-Unjoni Ewropea fir-rigward tal-awtorizzazzjoni tal-mediċina Budesonide Sandoz.
English: London, 3 June 2009
Maltese: Londra, 3 ta' Ġunju 2009 Dok. ta' Ref.
English: Why was Budesonide Sandoz reviewed?
Maltese: Għaliex ġie rivedut Budesonide Sandoz?
English: Company responses provided on: 24 December 2008 Opinion date:
Maltese: Data tal-opinjoni:
English: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea.europa.eu http://www.emea.europa.eu
Maltese: Madankollu, l-istati membri ma rnexxielhomx jilħqu qbil u l-aġenzija Ġermaniża li tirregola lmediċini rreferiet il-kwistjoni lis-CHMP għall-arbitraġġ fl-4 ta' Awwissu 2008.
English: The full EPAR for Kentera 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: This summary was last updated in 06-2011.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'06-2011.
English: EPAR summary for the public oxybutynin
Maltese: Sommarju tal-EPAR għall-pubbliku ossibutinina
English: The active substance in Kentera, oxybutynin, is an anticholinergic medicine.
Maltese: Is-sustanza attiva f'Kentera, l-ossibutinina, hija mediċina antikolinerġika.
English: This is a summary of the European public assessment report (EPAR) for Kentera.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Kentera.
English: Kentera is a medicine that contains the active substance oxybutynin.
Maltese: Kentera huwa mediċina li fih s-sustanza attiva ossibutinina.
English: In the other, they were compared with tolterodine capsules (another medicine used to treat urge incontinence) in 361 patients.
Maltese: Fl-istudju l-ieħor, Kentera tqabbel ma' kapsuli tat-tolterodina (mediċina oħra użata fittrattament ta' inkontinenza minn urġenza) fi 361 pazjent.
English: Why has Kentera been approved?
Maltese: Għaliex ġie approvat Kentera?
English: In the study on the gel, after 12 weeks the average number of daily incontinence episodes, which was initially at 5.4, was reduced by 2.7 episodes per day in patients receiving Kentera gel compared with a drop on average of 2 episodes per day in patients receiving placebo.
Maltese: Fl-istudju li sar bil-ġell, wara 12-il ġimgħa l-għadd medju ta' episodji ta' inkontinenza kuljum, li fil-bidu kien 5.4, tnaqqas bi 2.7 episodji fil-pazjenti li kienu qed jieħdu Kentera fl-għamla tal-ġell apparagun mat-tnaqqis medju ta' 2 episodji kuljum f'pazjenti li kienu ngħataw plaċebo.
English: Kentera is used to treat urge incontinence (sudden lack of control over urination), increased urinary frequency (need to urinate frequently) and urgency (sudden urge to pass urine) in adults with an overactive bladder (when the bladder muscles contract suddenly).
Maltese: Kentera jintuża għat-trattament tal-inkontinenza urinarja minn urġenza (nuqqas ta' kontroll għal għarrieda fuq ir-rilaxx tal-urina), taż-żieda fil-frekwenza urinarja (ħtieġa frekwenti li tingħamel lawrina) u tal-urġenza urinarja (ħtieġa għal għarrieda li tingħamel l-awrina) f'adulti li jkollhom ilbużżieqa tal-urina iperattiva (meta l-muskoli tal-bużżieqa jinġibdu għal għarrieda).
English: It blocks some receptors in the body called muscarinic M1 and M3 receptors.
Maltese: Din timblokka r-riċetturi filġisem imsejħa riċetturi muskariniċi M1 u M3.
English: In one study, they were compared with placebo (a dummy treatment) in 520 patients.
Maltese: Fi studju minnhom, Kentera tqabbel ma' plaċebo (trattament finta) f'520 pazjent.
English: It must not be used in patients with urinary retention (difficulty in passing urine), severe gastro-intestinal conditions (problems with the stomach and gut), uncontrolled narrow-angle glaucoma (increased eye pressure even with treatment) or myasthenia gravis (a disease of the nerves and muscles causing muscle weakness), or in patients at risk of these conditions.
Maltese: M'għandux jintuża f'pazjenti b'żamma urinarja (diffikultà fil-ħruġ talawrina), b'kundizzjonijiet gastrointestinali gravi (problemi bl-istonku u fl-intestin), bi glawkoma b'angolu dejjaq mhux ikkontrollata (żieda fil-pressjoni fl-għajnejn reżistenti għat-trattament) jew mijastenija gravi (marda fin-nervituri u fil-muskoli li tikkawża dgħufija fil-muskoli) jew f'pazjenti f'riskju li jiżviluppawlhom dawn il-kundizzjonijiet.
English: Kentera was more effective than placebo.
Maltese: Kentera kien iktar effikaċi mill-plaċebo.
English: What is Kentera?
Maltese: X'inhu Kentera?
English: Kentera gel was compared with placebo in one main study in 789 patients with overactive bladders.
Maltese: Fi studju prinċipali Kentera tqabbel ma' plaċebo fi 789 pazjent li kellhom il-bużżieqa tal-urina iperattiva.
English: After 12 weeks, the average number of incontinence episodes per week had decreased by 19 (about three per day) with Kentera patches, compared with a decrease of 15 episodes with placebo.
Maltese: Wara 12-il ġimgħa, l-għadd medju ta' episodji ta' inkontinenza fil-ġimgħa kien naqas bi 19 (madwar tlieta kuljum) b'Kentera, apparagun ma' tnaqqis bi 15-il episodju rreġistrat bil-plaċebo.
English: What is the risk associated with Kentera?
Maltese: X'inhuwa r-riskju assoċjat ma' Kentera?
English: Kentera transdermal patches were studied in a total of 881 patients, mostly elderly women, with overactive bladders in two main studies.
Maltese: Kentera ġie studjat f'żewġ studji ewlenin f'total ta' 881 pazjent, fil-biċċa l-kbira nisa anzjani, li kellhom il-bużżieqa tal-urina iperattiva.
English: Kentera patches were as effective as tolterodine, with both treatments decreasing the number of episodes by about three per day.
Maltese: Kentera kien effikaċi daqs it-tolterodina, tant li ż-żewġ trattamenti naqqsu lgħadd ta' episodji bi tlieta kuljum.
English: The most common side effects with Kentera patches (seen in more than 1 patient in 10) are application site reactions (including itching around the site of patch application).
Maltese: L-effetti sekondarji l-iktar komuni b'Kentera (li dehru f'iktar minn pazjent wieħed minn kull 10) huma reazzjonijiet fis-sit tal-applikazzjoni (inkluż ħakk madwar is-sit tal-applikazzjoni tar-roqgħa).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Kentera on 15 June 2004.
Maltese: Il-Kummissjoni Ewropea tat l-awtorizzazzjoni għat-tqegħid fis-suq għal Kentera valida fl-Unjoni Ewropea kollha fil-15 ta' Ġunju 2004.
English: Oxybutynin has been available as a tablet for the treatment of overactive bladder since the 1970s.
Maltese: L-ossibutinina ilha disponibbli f'pillola għat-trattament tal-bżieżaq tal-urina iperattivi mis-snin sebgħin.
English: For the full list of all side effects reported with Kentera, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrapportati b'Kentera, ara l-fuljett ta' tagħrif.
English: How does Kentera work?
Maltese: Għal xiex jintuża Kentera?
English: For the gel, the recommended daily dose is 4 mg of oxybutynin once a day, which corresponds to one gram of gel delivered using a metering pump or to the content of one sachet.
Maltese: Meta jintuża l-ġell, id-doża rrakomandata għal kuljum hija 4 mg tal-ossibutinina darba kuljum, li ssarraf fi gramma ġell mogħtija bil-pompa tad-dożaġġi jew fil-kontenut ta' borża waħda.
English: The patch should be applied to dry, intact skin on the abdomen (tummy), hip, or buttock immediately after it is removed from the protective sachet.
Maltese: Il-ġell jiġi applikat fuq ġilda xotta, nadifa fuq l-addome (żaqq), il-parti fuqanija tad-driegħ, l-ispallejn jew ilkoxxa.
English: The CHMP had first evaluated Kentera transdermal patches and concluded that their effectiveness was similar to that of the oxybutynin tablets already on the market and that the benefits outweighed the risks.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) ikkonkluda li l-effikaċja ta' Kentera kienet simili għal dik tal-pilloli tal-ossibutinina li diġà kienu tqiegħdu fis-suq u li l-benefiċċji tiegħu huma akbar mir-riskji tiegħu.
English: During its assessment of the application for Kentera gel, the CHMP concluded that its effectiveness was similar to that of the previously approved patches.
Maltese: Matul il-valutazzjoni tal-applikazzjoni ta' Kentera fl-għamla ta' ġell, is-CHMP ikkonkluda li l-effikaċja tiegħu kienet simili għal dik tal-irqajja' li diġà kienu ġew approvati.
English: How has Kentera been studied?
Maltese: Kif ġie studjat Kentera?
English: It is available as a transdermal patch (a patch that delivers a medicine across the skin) and as a gel in a sachet or a metering pump.
Maltese: Jiġi f'roqgħa transdermali (roqgħa li tagħti mediċina minn ġol-ġilda) u f'ġell ġo borża jew f'pompa tad-dożaġġi.
English: - Restriction of the maximum dose to 3 mg/day.
Maltese: - Restrizzjoni tad-doża massima għal 3 mg/kuljum.
English: SCIENTIFIC CONCLUSIONS
Maltese: IPPREŻENTATI