FrancophonIA/ELRC3.0 huggingface dataset:
English: The effervescent granules should be dissolved in a glass of cool water, and the resulting buffer solution should be mixed with the suspension.
Maltese: Ilgranuli effervexxenti għandhom jiddewwbu f'tazza ilma friska, u s-soluzzjoni buffer li tirriżulta għandha titħallat mas-suspensjoni.
English: 5 months
Maltese: 5 xhur
English: • Hives, itching
Maltese: TWISSIJA(IET) SPEĊJALI
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING DUKORAL - 20x1 dose package (inner carton for 20 vaccine vials)
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA DUKORAL - 20 x 1 pakkett ta' doża waħda (kartuna ta' ġewwa għal 20 flixkun tal-vaċċin)
English: • Swelling of the lymph glands
Maltese: • Nefħa tal-glandoli limfatiċi
English: Children 2 to below 6 years of age should receive 3 doses.
Maltese: Tfal ta' bejn 2 u inqas minn 6 snin, għandhom jingħataw 3 dożi.
English: The full EPAR for Zepatier 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: Zepatier is available as tablets which contain 50 mg elbasvir and 100 mg grazoprevir.
Maltese: Zepatier jiġi bħala pilloli li fihom 50 mg elbasvir u 100 mg grazoprevir.
English: Zepatier was well tolerated with a favourable safety profile.
Maltese: Zepatier ġie ttollerat tajjeb, bi profil ta' sigurtà favorevoli.
English: Elbasvir blocks the action of a protein called ‘NS5A', while grazoprevir blocks an enzyme called ‘NS3/4A protease'.
Maltese: Elbasvir jimblokka l-azzjoni ta' proteina li tissejjaħ ‘NS5A', waqt li grazoprevir jimblokka enzima msejħa 'NS3/4A protease'.
English: For patients with genotype 1a virus, 93% of patients (483 out of 519 patients) treated with Zepatier tested negative compared with 95% (55 out of 58 patients) on Zepatier with ribavirin.
Maltese: Għal pazjenti bil-virus b'ġenotip 1a, 93% tal-pazjenti (483 minn 519-il pazjent) li ġew ikkurati b'Zepatier ittestjaw negattivi meta mqabbla ma' 95% (55 minn 58 pazjent) li kienu fuq Zepatier ma' ribavirin.
English: Other information about Zepatier
Maltese: Informazzjoni oħra dwar Zepatier:
English: Why is Zepatier approved?
Maltese: Għaliex ġie approvat Zepatier?
English: For patients with genotype 4 virus, 94% of patients (61 out of 65 patients) treated with Zepatier tested negative compared with 100% (8 out of 8 patients) treated with Zepatier and ribavirin.
Maltese: Għal pazjenti bil-virus b'ġenotip 4, 94% tal-pazjenti (61 minn 65 pazjent) li ġew ikkurati b'Zepatier ittestjaw negattivi, meta mqabbla ma' 100% (8 minn 8 pazjenti) li ġew ikkurati b'Zepatier u ribavirin.
English: Zepatier is an antiviral medicine used to treat adults with chronic (long-term) hepatitis C, an infectious disease that affects the liver, caused by the hepatitis C virus.
Maltese: Zepatier huwa mediċina antivirali użata biex tikkura adulti b'epatite Ċ kronika (fit-tul), marda infettiva li taffettwa l-fwied, ikkawżata mill-virus tal-epatite Ċ.
English: The active substances in Zepatier, elbasvir and grazoprevir, block two proteins essential for the hepatitis C virus to multiply.
Maltese: Is-sustanzi attivi f'Zepatier, elbasvir u grazoprevir, jimblokkaw żewġ proteini li huma essenzjali sabiex il-virus tal-epatite Ċ jimmultiplika.
English: It must also not be used with the herbal remedy St. John's wort (used for depression and anxiety), or the epilepsy medicines carbamazepine and phenytoin because these medicines may affect the way Zepatier works.
Maltese: John's wort (li jintuża għad-dipressjoni u l-ansjetà), jew mal-mediċini għall-epilessija, carbamazepine u phenytoin għaliex dawn il-mediċini jistgħu jaffetwaw il-mod ta' kif jaħdem Zepatier.
English: Zepatier has been shown to be highly effective in clearing the hepatitis C virus genotypes 1a, 1b and 4 from the blood of patients with or without compensated cirrhosis, including patients also infected with HIV or who have chronic kidney disease.
Maltese: Zepatier intwera li huwa effettiv ħafna biex ineħħi l-virus tal-epitate Ċ ġenotipi 1a, 1b u 4 mid-demm tal-pazjenti bi jew mingħajr ċirrożi kkumpensata, inkluż pazjenti li huma infettati bl-HIV jew li għandhom mard kroniku tal-kliewi.
English: Zepatier contains the active substances elbasvir and grazoprevir.
Maltese: Zepatier għandu s-sustanzi attivi elbasvir u grazoprevir
English: Zepatier with or without ribavirin has been investigated in eight main studies involving around 2,000 patients infected with hepatitis C virus of various genotypes whose liver was working normally or adequately.
Maltese: Zepatier b'ribavirin jew mingħajru ġie investigat fi tmien studji prinċipali li involvew lil madwar 2,000 pazjent infettat bil-virus tal-epitate Ċ ta' ġenotipi varji, li l-fwied tagħhom kien qiegħed jaħdem b'mod normali jew adegwat.
English: Looking at the results of the studies together, 96% of patients with genotype 1b virus (301 out of 312 patients) tested negative for the virus after 12 weeks of treatment with Zepatier.
Maltese: Meta wieħed iħares lejn ir-riżultati tal-istudji flimkien, 96% tal-pazjenti li kellhom il-virus ta' ġenotip 1b (301 minn 312-il pazjent) ittestjaw negattivi għall-virus wara 12-il ġimgħa ta' kura b'Zepatier.
English: Zepatier is recommended for use in patients infected with hepatitis C virus genotypes 1a, 1b and 4 who may or may not have compensated liver cirrhosis (scarring of the liver but the liver is still able to work adequately).
Maltese: Zepatier huwa rrakkomandat sabiex jintuża f'pazjenti li huma infettati bil-virus tal-epitate Ċ tal-ġenotip 1a, 1b u 4 li jista' jkollhom jew jista' ma jkollhomx ċirrożi (meta l-fwied ikollu feriti iżda xorta waħda jkun jista' jaħdem b'mod adegwat) ikkumpensata tal-fwied.
English: Zepatier must not be used in patients with moderately or severely reduced liver function (Child-Pugh class B or C cirrhosis).
Maltese: Zepatier m'għandux jittieħed minn pazjenti li jsofru minn indeboliment moderat jew sever fil-funzjoni tal-fwied (ċirrożi ta' Child-Pugh klassi B jew Ċ).
English: There are several varieties (called genotypes) of hepatitis C virus.
Maltese: Hemm bosta varjetajiet (li jissejħu ġenotipi) tal-virus tal-epitate Ċ.
English: Benefit was also seen in patients also infected with HIV or who had chronic (long-term) kidney disease.
Maltese: Il-benefiċċju deher ukoll f'pazjenti li kienu infettati wkoll bl-HIV jew li kellhom mard kroniku (fit-tul) filkliewi.
English: What measures are being taken to ensure the safe and effective use of Zepatier?
Maltese: X'miżuri qed jitteħdu biex jassiguraw l-użu sigur u effikaċi ta' Zepatier?
English: By blocking these proteins, Zepatier stops the hepatitis C virus from multiplying and infecting new cells.
Maltese: Billi jimblokka dawn il-proteini, Zepatier iwaqqaf il-virus tal-epatite Ċ milli jimmultiplika u jinfetta ċelluli ġodda.
English: What are the risks associated with Zepatier?
Maltese: X'inhuma r-riskji assoċjati ma' Zepatier?
English: For the full list of all side effects reported with Zepatier, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Zepatier, ara l-fuljett ta' tagħrif.
English: The most common side effects with Zepatier (which may affect more than 1 in 10 people) are tiredness and headache.
Maltese: L-effetti sekondarji l-aktar komuni b'Zepatier (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10 persuni) huma għeja u wġigħ ta' ras.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom21 September 2018 EMA/632431/2018 EMEA/H/C/004656
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom21 ta' Settembru 2018 EMA/632431/2018 EMEA/H/C/004656
English: Entolimod TMC was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 11 January 2016, for the treatment of acute radiation syndrome.
Maltese: Entolimod TMC kien ikklassifikat bħala “mediċina orfni” (mediċina li tintuża f'mard rari) fil-11 ta' Jannar 2016 għall-kura tas-sindromu ta' radjazzjoni akuta.
English: What is Entolimod TMC?
Maltese: X'inhu Entolimod TMC?
English: The company also provided data from 2 studies in a total of 150 healthy participants.
Maltese: Il-kumpanija pprovdiet ukoll data minn żewġ studji f'total ta' 150 parteċipant b'saħħtu.
English: Entolimod TMC is a medicine that contains the active substance entolimod.
Maltese: Entolimod TMC huwa mediċina li fiha s-sustanza attiva entolimod.
English: Withdrawal of the marketing authorisation application for Entolimod TMC (entolimod) EMA/632431/2018
Maltese: EMA/632431/2018
English: On 31 July 2018, TMC Pharma Services Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wished to withdraw its application for a marketing authorisation for Entolimod TMC, intended to be used to reduce the risk of death following exposure to potentially lethal amounts of radiation.
Maltese: Fil-31 ta' Lulju 2018, TMC Pharma Services Ltd infurmat uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) li xtaqet tirtira l-applikazzjoni tagħha għall-awtorizzazzjoni għat-tqegħid fis-suq għal Entolimod TMC, maħsub li jintuża biex inaqqas ir-riskju ta' mewt wara esponiment għal ammonti potenzjalment letali ta' radjazzjoni.
English: Entolimod TMC works by attaching to a protein on the surface of cells known as toll-like receptor 5 (TLR5).
Maltese: Entolimod TMC jaħdem billi jeħel ma' proteina fuq il-wiċċ taċ-ċelloli magħrufa bħala riċettur 5 tat-tip Toll (TLR5).
English: The application was withdrawn after the CHMP had evaluated the initial documentation provided by the company and formulated a list of questions.
Maltese: L-applikazzjoni ġiet irtirata wara li s-CHMP evalwa d-dokumentazzjoni inizjali pprovduta mill-kumpanija u fformula lista ta' mistoqsijiet.
English: Because dangerous doses of radiation cannot be given to humans, the effects of Entolimod TMC against radiation were evaluated in a main study involving 179 macaque monkeys.
Maltese: Minħabba li dożi perikolużi ta' radjazzjoni ma jistgħux jingħataw lill-bnedmin, l-effetti ta' Entolimod TMC kontra r-radjazzjoni ġew evalwati fi studju ewlieni li involva 179 xadina macaque.
English: Withdrawal of the marketing authorisation application for Entolimod TMC (entolimod)
Maltese: L-irtirar tal-applikazzjoni għall-awtorizzazzjoni għat-tqegħid fis-suq għal Entolimod TMC (entolimod)
English: Exposure to high amounts of radiation can result in multiple organ failure and death.
Maltese: Esponiment għal ammonti kbar ta' radjazzjoni jista' jirriżulta f'insuffiċjenza multipla tal-organi u mewt.
English: Entolimod TMC was expected to be used to reduce the risk of death in adults and children from 2 years of age exposed to a high amount of radiation following a disaster such as a nuclear accident.
Maltese: Entolimod TMC kien mistenni li jintuża biex inaqqas ir-riskju ta' mewt f'adulti u tfal minn sentejn ‘il fuq li kienu esposti għal ammont kbir ta' radjazzjoni wara diżastru bħal inċident nukleari.
English: The company informed the CHMP that there are no ongoing clinical trials or compassionate use programmes with the medicine.
Maltese: Il-kumpanija għarrfet lis-CHMP li fil-preżent m'hemm ebda prova klinika jew programm ta' użu ta' kompassjoni bil-mediċina.
English: What was Entolimod TMC expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża Entolimod TMC?
English: how many of them survived high doses of radiation when given different doses of Entolimod TMC or placebo (a dummy treatment).
Maltese: Dawn l-istudji jeżaminaw l-effetti tal-mediċina fuq il-bnedmin u kif ilmediċina tkissret u tneħħiet mill-ġisem.
English: Inflicted injury
Maltese: Ferita imposta
English: (See Figure D).
Maltese: (Ara Figura D).
English: MedDRA System Organ Class
Maltese: MedDRA Sistema tal-Klassifika tal-Organi
English: Very rarely will the patch come off completely.
Maltese: Rarament ħafna l-garża tinqala' kompletament.
English: Ethanol (96 per cent) Glycerol
Maltese: Ethanol (96 fil-mija) Glycerol
English: Release Liner Siliconised polyester
Maltese: Polyester silikonizzat
English: Both patients recovered fully with symptomatic treatment.
Maltese: Iż-żewġ pazjenti rkupraw kompletament bi trattament sintomatiku.
English: Northern Ireland BT51 3RP
Maltese: L-Irlanda ta' Fuq BT51 3RP
English: Oxybutynin is a racemic (50:50) mixture of R- and S-isomers.
Maltese: Oxybutynin huwa taħlita raċemika (50:50) tal-isomeri R u S.
English: (N=400) Mean (SD) Median Mean (SD) Median
Maltese: (N=400) Medja (SD) Medjan Medja (SD) Medjan
English: Figure A:
Maltese: Figura A:
English: Physical activity subscale
Maltese: Subskala tal-attività fiżika
English: - Tricyclic antidepressants (used to treat depression).
Maltese: - Antidepressanti triċikliċi (użati għat-trattament tad-depressjoni).
English: Other adverse reactions reported were application site pruritus (Kentera 2.1%, placebo 0.8%), application site dermatitis (Kentera 1.8%, placebo 0.3%), dizziness (Kentera 1.5%, placebo 0.5%), headache (Kentera 1.5%, placebo 2.8%), constipation (Kentera 1.3%, placebo 1.0%), and pruritus (Kentera 1.3%, placebo 1.3%).
Maltese: Reazzjonijiet avversi oħra li ġew irrappurtati kienu prurite fis-sit tal-applikazzjoni (Kentera 2.1%, plaċebo 0.8%), dermatite fis-sit tal-applikazzjoni (Kentera 1.8%, plaċebo 0.3%), sturdament (Kentera 1.5%, plaċebo 0.5%), uġigħ ta' ras (Kentera 1.5%, plaċebo 2.8%), stitikezza (Kentera 1.3%, plaċebo 1.0%), u prurite (Kentera 1.3%, plaċebo 1.3%).
English: Backing film Clear polyester/ethylene-vinyl acetate (PET/EVA)
Maltese: Polyester/ethylene-vinyl acetate (PET/EVA) ċar
English: UAB Sicor Biotech filiāle Latvijā
Maltese: UAB "Sicor Biotech"
English: EU/1/03/270/004 30 sachets
Maltese: EU/1/03/270/004 30 qartas
English: The majority of patients were Caucasian (86.3%) and female (89.2%), with a mean age of 59.4 years (range: 18 to 88 years).
Maltese: Il-maġġoranza tal-pazjenti kienu Kawkażi (86.3%) u nisa (89.2%), b'età medja ta' 59.4 snin (firxa: 18 sa 88 sena).
English: Salomone Pharma Ltd Tel: +35 621 220 174
Maltese: V.J. Salomone Pharma Ltd Tel: +35 621 220 174
English: EU/1/03/270/004 <30 sachets>
Maltese: EU/1/03/270/004 <30 qartas >
English: Kentera delivers approximately 0.08 mg/kg/day.
Maltese: Kentera jagħti madwar 0.08 mg/kg/jum.
English: Placebo)
Maltese: Plaċebo)
English: Date of first authorisation: 15/06/2004 Date of latest renewal: 30/04/2009
Maltese: Data tal-aħħar tiġdid: 30/04/2009
English: - Quinidine (used to treat abnormal heart rhythms).
Maltese: - Quinidine (użat għat-trattament ta' ritmi anormali tal-qalb).
English: BT51 3RP Northern Ireland
Maltese: BT51 3RP L-Irlanda ta' Fuq
English: - Phenothiazines, butyrophenone or clozapine (used to treat mental illness).
Maltese: - Phenothiazines, butyrophenone jew clozapine (użati għat-trattament ta' mard mentali).
English: Oxybutynin may antagonize prokinetic therapies.
Maltese: Oxybutynin jista' jantagonizza terapiji prokinetiċi.
English: Pharmacovigilance System:
Maltese: Sistema ta' Farmakoviġilanza:
English: After 30 doses, discard the Kentera pump.
Maltese: Wara 30 doża, armi l-pompa ta' Kentera.
English: Discard the protective liners.
Maltese: - Armi l-kisi protettiv.
English: - Erythromycin a macrolide antibiotic (used to treat bacterial infections).
Maltese: - Erythromycin antibijotiku makrolide (użat għat-trattament ta' infezzjonijiet batterjali).
English: Other commonly occurring adverse drug reactions reported were dry mouth (8.6%), constipation (3.9%), diarrhoea (3.2%), headache (3.0%), dizziness (2.3%) and blurred vision (2.3%).
Maltese: Reazzjonijet avversi tal-mediċina oħra li seħħew b'mod komuni kienu ħalq xott (8.6%), stitikezza (3.9%), dijarea (3.2%), uġigħ ta' ras (3.0%), sturdament (2.3%), u vista mċajpra (2.3%).
English: The most commonly reported adverse reaction was dry mouth (Kentera 6.9%, placebo 2.8%).
Maltese: L-aktar reazzjonijiet avversi rrappurtati b'mod komuni kienu ħalq xott (Kentera 6.9%, plaċebo 2.8%).
English: Only apply Kentera to intact skin.
Maltese: Applika Kentera fuq ġilda intatta biss.
English: P-value (Kentera vs.
Maltese: (Kentera vs.
English: Excipients: ethanol (96%), glycerol, hydroxypropylcellulose, sodium hydroxide (for pH adjustment), and purified water.
Maltese: Sustanzi mhux attivi: ethanol (96%), glycerol, hydroxypropylcellulose, sodium hydroxide (għal aġġustament tal-pH), u ilma ppurifikat.
English: The free base form of oxybutynin is pharmacologically equivalent to oxybutynin hydrochloride.
Maltese: Il-forma bażi libera ta' oxybutynin hija farmakoloġikament ekwivalenti għal oxybutynin hydrochloride.
English: Abdominal discomfort, dyspepsia
Maltese: Skumdità addominali, dispepsja
English: The safety of Kentera was evaluated in patients with urge urinary incontinence in a randomised, double-blind, placebo-controlled, parallel group Phase 3 study that included 789 patients (with 389 patients receiving Kentera and 400 patients receiving placebo).
Maltese: Is-sigurtà ta' Kentera ġiet evalwata f'pazjenti b'inkontinenza urinarja impulsiva fi studju ta' Fażi 3 randomised, double-blind, ikkontrollat bi plaċebo, bi grupp parallel li kien jinkludi 789 pazjent (bi 389 pazjent jirċievu Kentera u 400 pazjent jirċievu plaċebo).
English: Each patch of 39 cm2 contains 36 mg of oxybutynin.
Maltese: Kull garża ta' 39 cm2 fiha 36 mg ta' oxybutynin.
English: - The active substance is oxybutynin.
Maltese: - Is-sustanza attiva hija oxybutynin.
English: - Pull the patch out.
Maltese: skart likwidu.
English: Placebo (N=400)
Maltese: (N=400)
English: Frequencies are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).
Maltese: Il-frekwenzi huma definiti bħala: komuni ħafna (≥1/10), komuni (>1/100 sa <1/10), mhux komuni (>1/1,000 sa <1/100), rari (>1/10,000 sa <1/1,000), rari ħafna (<1/10,000).
English: Patients treated with Kentera experienced a highly statistically significant decrease in the number of urinary incontinence episodes per day from baseline to endpoint (the primary efficacy endpoint) compared with placebo (p<0.0001), as well as for the secondary endpoints: a decrease in the average daily urinary frequency (p=0.0017), and an increase in the average urine volume per void (p=0.0018).
Maltese: Il-pazjenti li rċevew trattament b'Kentera esperjenzaw tnaqqis statistikament sinifikanti ferm fin-numru ta' episodji ta' inkontinenza urinarja kuljum mil-linja bażi sal-punt finali (il-punt finali primarju tal effikaċja) meta mqabbla ma' plaċebo (p<0.0001), kif ukoll għall-punti finali sekondarji: tnaqqis filfrekwenza urinarja medja ta' kuljum (p=0.0017), u żieda fil-volum medju ta' awrina kull tbattil (p=0.0018).
English: Figure D:
Maltese: Figura D:
English: Acrylic copolymer adhesive solution containing 2-ethylhexyl acrylate N-vinyl pyrrolidone and hexamethyleneglycol dimethacrylate polymer domains
Maltese: Soluzzjoni adeżiva ta' acrylic copolymer li fiha d-dominji 2-ethylhexyl acrylate N-vinyl pyrrolidone u hexamethyleneglycol dimethacrylate polymer.
English: Figure B:
Maltese: Figura B:
English: Incidence
Maltese: EFFETTI
English: The active substance is oxybutynin.
Maltese: Is-sustanza attiva hija oxybutynin.
English: Impaired metabolism
Maltese: Metaboliżmu indebolit
English: Urinary void volume (ml) Baseline
Maltese: Volum ta' tbattil urinarju (mL)
English: See Figure B.
Maltese: Ara Figura B.
English: The sachet is constructed from a multi-layer foil based laminate pouch material (polymethacrylate/acrylonitrile copolymer/adhesive/aluminum/low density polyethylene/paper).
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Il-qartas huwa magħmul minn materjal laminat tal-borża b'diversi saffi abbażi ta' fojl (polymethacrylate/acrylonitrile copolymer/adeżiv/aluminju/polyethylene b'densità baxxa/karta).
English: The expression of CYP3A and CYP3A4 may vary by as much as 40 fold due to genetic polymorphism.
Maltese: L-espressjoni ta' CYP3A u CYP3A4 tista' tvarja b'sa 40 darba minħabba l-polimorfiżmu ġenetiku.
English: The Phase 3 study was a randomised, double-blind, placebo-controlled, parallel group study that included 789 patients.
Maltese: L-istudju ta' Fażi 3 kien studju randomised, double-blind, ikkontrollat bi plaċebo, bi grupp parallel li kien jinkludi 789 pazjent.
English: - The other ingredients are: ethanol (96%), glycerol, hydroxypropylcellulose, sodium hydroxide (for pH adjustment), and purified water.
Maltese: - Is-sustanzi l-oħra huma: ethanol (96%), glycerol, hydroxypropylcellulose, sodium hydroxide (għall aġġustament tal-pH), u ilma ppurifikat.
English: The volume of distribution was estimated to be 193 l after intravenous administration of 5 mg oxybutynin hydrochloride.
Maltese: Il-volum taddistribuzzjoni kien stmat li huwa 193 l wara l-għoti ġol-vini ta' 5 mg ta' oxybutynin hydrochloride.
English: Other causes of frequent urination
Maltese: Frekwenza urinarja ta' kuljum
English: Rash, dry skin, rash pruritic
Maltese: Raxx, ġilda xotta, raxx pruritiku
English: Approximately 75% of patients had no prior pharmacological treatment for incontinence.
Maltese: Madwar 75% tal-pazjenti ma kellhom l-ebda trattament farmakoloġiku preċedenti għall-inkontinenza.
English: Thereafter, steady concentrations are maintained for up to 96 hours.
Maltese: Minn hemm 'l quddiem, konċentrazzjonijiet kostanti jinżammu sa 96 siegħa.
English: STORING KENTERA
Maltese: Jekk tieqaf tuża Kentera
English: The most commonly reported adverse drug reactions were application site reactions, occurring in 23.1% of patients.
Maltese: L-aktar reazzjonijet avversi tal-mediċina rrapurtati b'mod komuni kienu reazzjoni fil-parti tal applikazzjoni li seħħew fi 23.1% tal-pazjenti.
English: Metabolites include phenylcyclohexylglycolic acid, which is pharmacologically inactive, and N-desethyloxybutynin, which is pharmacologically active.
Maltese: Il-metaboliti jinkludu phenylcyclohexylglycolic acid, li huwa farmakoloġikament inattiv, u N-desethyloxybutynin, li huwa farmakoloġikament attiv.
English: The anticholinergic activity of oxybutynin is increased by concurrent use of other anticholinergics or medicinal products with anticholinergic activity, such as amantadine and other anticholinergic antiparkinsonian medicinal products (e.g. biperiden, levodopa), antihistamines, antipsychotics (e.g. phenothiazines, butyrophenones, clozapine), quinidine, tricyclic antidepressants, atropine and related compounds like atropinic antispasmodics, and dipyridamole.
Maltese: L-attività antikolinerġika ta' oxybutynin tiżdied bl-użu flimkien ma' antikolinerġiċi oħra jew ma' prodotti mediċinali b'attività antikolinerġika, bħal amantadine u prodotti mediċinali antikolinerġiċi oħra antiparkinsonjani (eż. biperiden, levodopa), antistamini, antipsikotiċi (eż. phenothiazines, butyrophenones, clozapine), quinidine, antidepressanti triċikliċi, atropine u taħlitiet relatati bħallantispasmodiċi atropiniċi, u dipyridamole.
English: Select an approved site for the application of Kentera.
Maltese: Agħżel sit approvat għall-applikazzjoni ta' Kentera.
English: Atrial fibrillation, atrial flutter, sinus arrhythmia
Maltese: Fibrillazzjoni atrijali, aġitazzjoni atrijali, arritmija tas-sinus
English: Also in conditions such as ulcerative colitis, and intestinal atony.
Maltese: Ukoll f'kondizzjonijiet bħal kolite ulċerattiva, u ‘atonija intestinali'.
English: Electrocardiogram abnormal, electrocardiogram change, blood chloride increased
Maltese: Elettrokardjogramma anormali, bidla fl elettrokardjogramma, żieda ta' chloride fid-demm
English: Hydroxypropylcellulose Sodium hydroxide (for pH-adjustment) Purified water
Maltese: Sodium hydroxide (għall-aġġustament tal-pH)
English: Kentera 90.7 mg/g gel
Maltese: Kentera 90.7 mg/g ġel
English: The R-isomer of oxybutynin shows greater selectivity for the M1 and M3 muscarinic subtypes (predominant in bladder detrusor muscle and parotid gland) compared to the M2 subtype (predominant in cardiac tissue).
Maltese: Attività anti-muskarinika tinsab l-aktar flisomeru R. L-isomeru R ta' oxybutynin juri selettività akbar għas-sub-tipi muskariniċi M1 u M3 (predominanti fil-muskolu detrusor tal-bużżieqa tal-awrina u fil-glandola parotid) meta mqabbla mas-subtip M2 (predominanti f'tessut kardijaku).
English: Kentera 90.7 mg/g gel oxybutynin
Maltese: Kentera 90.7 mg/g ġel oxybutynin