FrancophonIA/ELRC3.0 huggingface dataset:
English: Strong inducers of CYP3A4 should be avoided, or selection of an alternate concomitant medicinal product, with no or minimal potential to induce CYP3A4 should be considered.
Maltese: Indutturi qawwija ta' CYP3A4 għandhom jiġu evitati, jew għandha tiġi kkunsidrata għażla ta' prodott mediċinali alternattiv fl-istess waqt, bi ftit jew bl-ebda potenzjal li jinduċi CYP3A4.
English: In clinical trials, a higher incidence of severe liver function test abnormalities and hepatic dysfunction was observed in Asian (in particular Japanese) patients treated with Stivarga, compared with Caucasians (see section 4.2).
Maltese: Fi provi kliniċi, ġiet osservata inċidenza ogħla ta' anormalitajiet severi fit-test talfunzjoni tal-fwied u disfunzjoni tal-fwied f'pazjenti Asjatiċi (b'mod partikulari Ġappuniżi) ikkurati b'Stivarga meta mqabbla ma' pazjenti Kawkasi (ara sezzjoni 4.2).
English: Headache Tremor Peripheral neuropathy
Maltese: Proporzjon normalizzat internazzjonali mhux normali
English: Re-occurrence
Maltese: Perċentwali
English: Clinical data indicate that regorafenib has no effect on digoxin pharmacokinetics, therefore can be given concomitantly with p-glycoprotein substrates, such as digoxin, without a clinically meaningful drug interaction.
Maltese: għalhekk jista' jingħata flimkien ma' sustrati ta' glikoproteina p, bħal digoxin, mingħajr interazzjoni klinikament sinifikanti.
English: Table 2: Recommended measures and dose modifications in case of drug-related liver function test abnormalities
Maltese: Tabella 2: Miżuri u modifikazzjonijiet tad-doża rrakkomandati f'każ ta' anormalitajiet fittestijiet tal-funzjoni tal-fwied relatati mal-mediċina
English: The safety profile of regorafenib in these studies was consistent with the safety results of a phase III B study conducted in 2872 patients with metastatic colorectal cancer whose disease had progressed after treatment with standard therapies.
Maltese: III B li twettaq fuq 2872 pazjent b'kanċer metastatiku tal-kolon u tar-rektum li l-marda tagħhom kienet avanzat wara trattament b'terapiji standard.
English: Inhibitors and inducers of BCRP and P-glycoprotein may interfere with the exposure of M-2 and M-5.
Maltese: Inibituri u indutturi ta' BCRP u ta' glikorpoteina P jistgħu jinterferu mal-esponiment għal M-2 u M-5.
English: Subgroup analysis results by historical KRAS mutational status showed a treatment effect for OS in favour of regorafenib over placebo for patients with KRAS wild-type tumours whereas a numerically lower effect was reported in patients with KRAS mutant tumours; the treatment effect for PFS favouring regorafenib was observed regardless of KRAS mutational status.
Maltese: KRAS tat-tip selvaġg, filwaqt li effett numerikament aktar baxx kien irrappurtat f'pazjenti b'tumuri bi KRAS mutant; l-effett tal-kura għallPFS li jiffavorixxi regorafenib kien osservat irrispettivament mill-istat ta' mutazzjoni ta' KRAS.
English: Systemic exposure of regorafenib at steady-state increases dose proportionally up to 60 mg and less than proportionally at doses greater than 60 mg. Accumulation of regorafenib at steady state results in about a 2-fold increase in plasma concentrations, which is consistent with the elimination half-life and dosing frequency.
Maltese: L-esponiment sistemiku għal regorafenib fi stat fiss jiżdied b'mod proporzjonali mad-doża sa 60 mg u inqas minn proporzjonali b'dożi akbar minn 60 mg.
English: Administration of rifampicin (600 mg for 9 days), a strong CYP3A4 inducer, with a single dose of regorafenib (160 mg on day 7) resulted in a reduction in AUC of regorafenib of approximately 50%, a 3- to 4-fold increase in mean exposure of the active metabolite M-5, and no change in exposure of active metabolite M-2.
Maltese: regorafenib (160 mg f'jum 5) wassal għal żieda ta' madwar 33% fl-esponiment medju (AUC) għal regorafenib , u għal tnaqqis ta' madwar 90% fl-esponiment medju għall-metaboliti attivi, M-2
English: Bayer Austria Ges.
Maltese: Sverige Bayer AB
English: Placebo plus BSC§ (N=194)
Maltese: Plaċebo ma' BSC§
English: Therapies included treatment with fluoropyrimidine-based chemotherapy, an anti-VEGF therapy, and, if the patient was KRAS wild type, an anti-EGFR therapy.
Maltese: It-terapiji kienu jinkludu kura b'kimoterapija bbażata fuq fluoropyrimidine, terapija kontra VEGF, u jekk il-pazjent kellu KRAS tat-tip salvaġġ, terapija kontra EGFR.
English: Of these events, 35.6% in the Stivarga arm and 54.5% in the placebo arm have been reported as not recovered/not resolved.
Maltese: Minn dawn l-avvenimenti, 35.6% fil-grupp ta' Stivarga u 54.5% fil-grupp ta' plaċebo ġew irrappurtati bħala ma rkuprawx/m'għaddewx.
English: Randomisation was performed within 10 weeks after the last treatment with sorafenib.
Maltese: Randomisation saret fi żmien 10 ġimgħat wara l-aħħar trattament b'sorafenib.
English: Co-administration with neomycin, a poorly absorbed antimicrobial agent used for eradicating the gastrointestinal microflora (which may interfere with the enterohepatic circulation of regorafenib) had no effect on the regorafenib exposure, but there was an approximately 80% decrease in the exposure of the active metabolites M-2 and M-5 which showed in vitro and in vivo comparable pharmacological activity as regorafenib.
Maltese: L-għoti flimkien ma' neomycin, sustanza kontra l-mikrobi assorbita ħażin użata għall-eradikazzjoni tal-mikroflora gastro-intestinali (li tista' tinterferixxi maċ-ċirkolazzjoni entero-epatika ta' regorafenib) ma kellu l-ebda effett fuq l-esponiment għal regorafenib, iżda kien hemm tnaqqis ta' madwar 80% fl-esponiment għall-metaboliti attivi
English: Thrombocytopenia Neutropenia Lymphopenia Metabolism and nutrition disorders Hypocalcaemia Hypokalemia Hypophosphatemia
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija
English: The mean elimination half-life for the metabolite M-5 is approximately 60 hours (range from 40 to 100 hours).
Maltese: M-5 hija madwar 60 siegħa (firxa minn 40 sa 100 siegħa).
English: (thrombocytopenia) - reduction in the number of red blood cells (anaemia) - decreased appetite and food intake - high blood pressure (hypertension) - voice changes or hoarseness (dysphonia) - frequent or loose bowel movements (diarrhoea) - painful or dry mouth, painful tongue, mouth sores (stomatitis and/or mucosal inflammation) - feeling sick (nausea) - vomiting - high blood levels of bilirubin, a substance produced by the liver (hyperbilirubinaemia) - changes in enzymes produced by the liver, which may indicate that something is wrong with the liver (increase in transaminases) - redness, pain, blisters and swelling of the palms of the hands or soles of the feet (hand-foot skin reaction) - rash - weakness, lack of strength and energy, excessive tiredness and unusual sleepiness
Maltese: - jekk ikollok infezzjoni b'sinjali bħal deni għoli, sogħla qawwija bi jew mingħajr żieda filproduzzjoni tal-mukus (bżieq), uġigħ qawwi fil-griżmejn, qtugħ ta' nifs, ħruq/uġigħ meta tgħaddi l-awrina, tnixxija mhux tas-soltu mill-vaġina jew irritazzjoni, ħmura, nefħa u/jew uġigħ fi kwalunkwe parti tal-ġisem.
English: As medicinal products with anti-angiogenic properties may suppress or interfere with wound healing, temporary interruption of Stivarga is recommended for precautionary reasons in patients undergoing major surgical procedures.
Maltese: Peress li prodotti mediċinali bi kwalitajiet anti-anġjoġeniċi jistgħu jissopprimu jew jinterferixxu malfejqan tal-feriti, waqfien temporanju ta' Stivarga huwa rrakkomandat għal raġunijiet ta' prekawzjoni f'pazjenti li għaddejjin minn proċeduri kirurġiċi maġġuri.
English: Continue Stivarga treatment.
Maltese: Fi provi kliniċi,
English: The addition of Stivarga to BSC resulted in a statistically significant improvement in OS compared to placebo plus BSC with a hazard ratio of 0.624 [95% CI 0.498, 0.782], p=0.000017 stratified log rank test, and a median OS of 10.6 months vs. 7.8 months (see Table 7 and Figure 4).
Maltese: Iż-żieda ta' Stivarga ma' BSC wasslet għal titjib statistikament sinifikanti f'OS meta mqabbla mal plaċebo flimkien ma' BSC bi proporzjon ta' periklu ta' 0.624 [CI ta' 95% 0.498, 0.782], p=0.000017
English: Haemorrhage* Hypertension
Maltese: Astenja/ għeja Uġigħ
English: Posterior reversible encephalopathy syndrome (PRES) PRES has been reported in association with Stivarga treatment (see section 4.8).
Maltese: PRES kienet irrappurtata f'assoċjazzjoni ma' kura b'Stivarga (ara sezzjoni 4.8).
English: Pain
Maltese: Komuni
English: Whereas plasma concentrations of M-2 and M-5 after a single dose of regorafenib are much lower than those of parent compound, steady-state plasma concentrations of M-2 and M-5 are comparable to those of regorafenib.
Maltese: M-5 fil-plażma wara doża waħda ta' regorafenib huma ħafna aktar baxxi minn dawk tal-komponent oriġinali, il-konċentrazzjonijiet ta' M-2 u M-5 fi stat fiss fil-plażma huma komparabbli ma' dawk ta' regorafenib.
English: Important information about some of the ingredients of Stivarga
Maltese: * Proporzjoni ta' Periklu < 1 jiffavorixxi lil Stivarga
English: The safety and efficacy of regorafenib in patients below 18 years of age in the indication gastrointestinal stromal tumours (GIST) have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' regorafenib f'pazjenti b'età inqas minn 18-il sena fl-indikazzjoni ta' tumuri tal-stroma gastro-intestinali (GIST) għadhom ma ġewx determinati s'issa.
English: The clinical efficacy and safety of Stivarga have been evaluated in an international, multi-centre, randomised, double-blind, placebo-controlled phase III study (RESORCE) in patients with hepatocellular carcinoma who have been previously treated with sorafenib.
Maltese: III internazzjonali, b'aktar minn ċentru wieħed, randomised, double-blind u kkontrollat bil-plaċebo (RESORCE) f'pazjenti b'karċinoma epatoċellulari li kienu ttrattati minn qabel b'sorafenib.
English: The recommended dose of regorafenib is 160 mg (4 tablets of 40 mg) taken once daily for 3 weeks followed by 1 week off therapy.
Maltese: Id-doża rrakkomandata ta' regorafenib hija ta' 160 mg (4 pilloli ta' 40 mg) meħuda darba kuljum għal
English: Regorafenib is metabolized primarily in the liver by oxidative metabolism mediated by CYP3A4, as well as by glucuronidation mediated by UGT1A9.
Maltese: Bijotrasformazzjoni Regorafenib huwa metabolizzat primarjament fil-fwied permezz ta' metaboliżmu ossidattiv medjat minn CYP3A4, kif ukoll minn glukuronidazzjoni medjata minn UGT1A9.
English: A pre-planned interim analysis for efficacy was performed when 432 deaths had occurred.
Maltese: Saret analiżi interim ippjanata minn qabel tal-effikaċja wara li seħħew 432 mewt.
English: The Asian patients treated with Stivarga in clinical studies were primarily from East Asia (~90%).
Maltese: Il-pazjenti Asjatiċi kkurati b'Stivarga fl-istudji kliniċi kienu primarjament mill-Asja tal-Lvant (~90%).
English: (hypokalaemia, hypophosphatemia, hypocalcaemia, hyponatraemia and hypomagnesaemia) - high level of uric acid in the blood (hyperuricaemia) - loss of body fluids (dehydration) - headache - shaking (tremor) - disorder of the nerves which can cause a change in sensation, such as numbness, tingling,
Maltese: telithromycin) - mediċini tipikament użati għall-kura tal-epilessija (aċċessjonijiet) (eż. phenytoin, carbamazepine jew phenobarbital) - methotrexate, mediċina tipikament użata għall-kura tal-kanċer
English: Hepatobiliary disorders
Maltese: Il-metaboliti
English: weakness or pain (peripheral neuropathy) - taste disorders - dry mouth - heartburn (gastro-oesophageal reflux) - infection or irritation of the stomach and intestines (gastroenteritis) - hair loss (alopecia) - dry skin - rash with flaking or peeling of skin (exfoliative rash) - a sudden, involuntary contraction of a muscle (muscle spasms) - protein in the urine (proteinuria) - high levels of certain enzymes involved in digestion (increase in amylase and lipase) - abnormal blood clotting condition (abnormal International Normalized Ratio).
Maltese: - raxx bil-qxur jew ġilda titqaxxar (raxx bil-qxur) - kontrazzjoni involontarju f'daqqa ta' muskolu (spażmi fil-muskoli) - proteini fl-awrina (proteinurja)
English: Film coat
Maltese: Disturbi filqalb
English: Environmental risk assessment studies have shown that regorafenib has the potential to be persistent, bioaccumulative and toxic to the environment and may pose a risk to the surface water and to the sediment compartment (see section 6.6).
Maltese: Studji dwar stima tar-riskju ambjentali wrew li regorafenib għandu l-potenzjal li jkun persistenti, bijoakkumulattiv u tossiku għall-ambjent u jista' joħloq riskju għall-ilma tal-wiċċ u għallkompartiment tas-sediment (ara sezzjoni 6.6).
English: - dry mouth - decreased appetite - high blood pressure (hypertension) - excessive tiredness (fatigue).
Maltese: - pressjoni għolja (ipertensjoni) - għeja eċċessiva (għeja).
English: The decision to resume treatment with Stivarga following major surgical intervention should be based on clinical judgment of adequate wound healing.
Maltese: Id-deċiżjoni li terġa' tinbeda kura b'Stivarga wara intervent kirurġiku maġġuri għandha tkun ibbażata fuq ġudizzju kliniku ta' fejqan adegwat tal ferita.
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitor; ATC Code: L01XE21
Maltese: ), metastasi (VEGFR3, PDGFR, FGFR) u immunità tat-tumur (CSF1R).
English: The full EPAR for Rydapt 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: acute myeloid leukaemia mastocytosis.
Maltese: lewkimja majelojde akuta mastoċitożi
English: Other information about Rydapt
Maltese: Informazzjoni oħra dwar Rydapt
English: The active substance in Rydapt, midostaurin, is a ‘tyrosine kinase inhibitor'.
Maltese: Is-sustanza attiva f' Rydapt, il-midostaurin, hija ‘inibitur tat-tirożina kinażi'.
English: Rydapt is available as capsules containing 25 mg of midostaurin.
Maltese: Rydapt jiġi bħala kapsuli li fihom 25 mg ta' midostaurin.
English: What are the risks associated with Rydapt?
Maltese: X' inhuma r-riskji assoċjati ma' Rydapt?
English: The commonest severe side effects were tiredness, sepsis (blood poisoning), pneumonia (lung infection), febrile neutropenia and diarrhoea.
Maltese: L-effetti sekondarji severi l-aktar komuni kienu għeja, sepsis (avvelenament tad-demm), pulmonite (infezzjoni fil-pulmun), newtropenija bid-deni u dijarea.
English: About 51% of those given Rydapt and 43% of those given placebo were still alive after 5 years.
Maltese: Madwar 51% ta' dawk li ngħataw Rydapt u 43% ta' dawk li ngħataw plaċebo kienu għadhom ħajjin wara 5 snin.
English: When looked at separately the response rate was highest (60%) in those with aggressive systemic mastocytosis.
Maltese: Meta jitqiesu b' mod separat, ir-rata ta' rispons kienet l-ogħla (60%) f' dawk b' mastoċitożi sistemika aggressiva.
English: This is a summary of the European public assessment report (EPAR) for Rydapt.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta᾽ valutazzjoni (EPAR) għal Rydapt.
English: The most frequent severe side effects were febrile neutropenia, lymphopenia (low counts of lymphocytes, a particular type of white blood cell), infections at the site of a catheter (a tube inserted in a vein), exfoliative dermatitis, high blood sugar and nausea (feeling sick).
Maltese: L-effetti sekondarji severi l-aktar frekwenti kienu newtropenija bid-deni, limfopenija (għadd baxx ta' limfotiċi, tip partikolari ta' ċellola bajda tad-demm), infezzjonijiet fejn tkun il-kateter (tubu inserit f' vina), dermatite bil-qxur, zokkor għoli fid-demm u nawżja (dardir).
English: Rydapt is also used on its own in adults with the following disorders of a type of white blood cell known as mast cell: aggressive systemic mastocytosis, systemic mastocytosis associated with a haematological neoplasm (blood cancer), and mast cell leukaemia.
Maltese: Rydapt jintuża wkoll waħdu f' adulti li għandhom id-disturbi li ġejjin ta' tip ta' ċellola bajda taddemm magħrufa bħala ċellola mast (mast cell): mastoċitożi sistemika aggressiva, mastoċitożi sistemika assoċjata ma' neoplażma ematoloġika (kanċer tad-demm), u lewkimja taċ-ċellola mast.
English: How is Rydapt used?
Maltese: Kif jaħdem Rydapt?
English: In patients with an FLT3 mutation, an abnormal form of the FLT3 tyrosine kinase stimulates the survival and growth of AML cells.
Maltese: F' pazjenti b' mutazzjoni talFLT3, forma anormali tat-tirożina kinażi
English: Rydapt is a cancer medicine used to treat adults with newly diagnosed acute myeloid leukaemia (AML), a cancer of white blood cells.
Maltese: Rydapt huwa mediċina kontra l-kanċer li tintuża biex tikkura adulti li tkun għadha kif saritilhom iddijanjożi tal-lewkimja tal-majelojde akuta (AML, acute myeloid leukaemia), kanċer taċ-ċelloli bojod tad-demm.
English: Why is Rydapt approved?
Maltese: Għaliex ġie approvat Rydapt?
English: One main study, involving 717 such patients, compared Rydapt with placebo (a dummy treatment) initially as an addition to other cancer medicines, followed by treatment with Rydapt or placebo alone in those whose disease responded.
Maltese: Studju ewlieni wieħed, li kien jinvolvi 717-il pazjent bħal dawn, qabbel Rydapt ma' plaċebo (kura finta) inizjalment bħala żieda ma' mediċini oħra kontra l-kanċer, segwit minn kura b' Rydapt jew plaċebo waħedhom f' dawk li l-marda tagħhom irrispondiet.
English: The usual starting dose is 50 mg (two capsules) twice a day for AML, on days 8 to 21 of a 28-day treatment cycle, and then every day once the disease has responded.
Maltese: Id-doża tal-bidu tas-soltu hija 50 mg (żewġ kapsuli) darbtejn kuljum għal AML, fil-jum 8 sal-21 ta' ċiklu ta'
English: Rydapt also blocks a mutated form of another enzyme, KIT kinase, which plays an important role in stimulating the abnormal growth of mast cells in patients with mast cell disorders.
Maltese: Rydapt jimblokka wkoll forma mutata ta' enzima oħra, KIT kinażi, li għandha rwol importanti fl-istimolu tat-tkabbir anormali taċ-ċelloli mast f' pazjenti b' disturbi taċċellola mast.
English: Overall, using the most stringent, up-to-date criteria, the disease responded to treatment in about 28% of patients (32 of 113).
Maltese: B' mod ġenerali, bl-użu tal-kriterji l-aktar stretti u aġġornati, il-marda rrispondiet għall-kura f' madwar 28% tal-pazjenti (32 minn 113).
English: Rydapt is only given when the AML has a particular genetic change called an FLT3 mutation.
Maltese: Rydapt jingħata biss meta AML ikollha bidla ġenetika partikolari li tissejjaħ mutazzjoni tal-FLT3.
English: Because the number of patients with these diseases is low, they are considered ‘rare', and Rydapt was designated an ‘orphan medicine' (a medicine used in rare diseases) on various dates (see below).
Maltese: Peress li n-numru ta' pazjenti li jbatu minn dan il-mard huwa baxx, huma kkunsidrati ‘rari', u Rydapt ġie kklassifikat bħala ‘mediċina orfni' (mediċina li tintuża f' mard rari) f' diversi dati (ara hawn taħt).
English: When used for mast cell disorders, the commonest side effects (affecting one third or more of all patients) were nausea, vomiting, diarrhoea, peripheral oedema (swelling of the ankles and feet) and tiredness.
Maltese: Meta użat għal disturbi fiċ-ċellola mast, l-effetti sekondarji l-aktar komuni (li jaffettwaw terz jew aktar tal-pazjenti kollha) kienu nawżja, remettar, dijarea, edema periferika (nefħa tal-għekiesi u s-saqajn) u għeja.
English: When used to treat AML, the most common side effects with Rydapt (which may affect more than 1 in 10 people) are febrile neutropenia (fever and low white blood cell count, seen in nearly all patients), exfoliative dermatitis (inflamed, peeling skin), vomiting, headache, petechiae (tiny blood spots under the skin) and fever.
Maltese: Meta użat biex jikkura AML, l-effetti sekondarji l-aktar komuni b' Rydapt (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma newtropenija bid-deni (deni u għadd baxx ta' ċelloli tad-demm bojod, osservati kważi fil-pazjenti kollha), dermatite bil-qxur (ġilda infjammata, titqaxxar), remettar, uġigħ ta' ras, tbenġil (ponot żgħar tad-demm taħt il-ġilda) u deni.
English: What measures are being taken to ensure the safe and effective use of Rydapt?
Maltese: X' miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Rydapt?
English: By blocking the abnormal FLT3 enzyme, Rydapt helps to bring about the death of the abnormal cells and control the spread of the cancer.
Maltese: FLT3 tistimula s-sopravivenza u t-tkabbir taċ-ċelloli AML. Permezz tal-imblukkar tal-enzima anormali FLT3, Rydapt jgħin biex jinqatlu ċ-ċelloli anormali u tiġi kkontrollata l-firxa tal-kanċer.
English: 15 micrograms HA** B/Brisbane/60/2008 - like strain (B/Brisbane/60/2008, wild type) ............................................ 15 micrograms HA**
Maltese: X-263B) ..... 15 mikrogrammi HA** B/Brisbane/60/2008 - bħal razza (B/Brisbane/60/2008, tat-tip selvaġġ) ....................................... 15 mikrogrammi HA**
English: --1 Influenza virus (inactivated, split) of the following strains*:
Maltese: --1 Virus tal-influenza (inattivat, maqsum) tas-strains li hawn*:
English: A/California/7/2009 (H1N1)pdm09 - like strain (A/California/7/2009, NYMC X-179A) ....... 15 micrograms HA** A/Hong Kong/4801/2014 (H3N2) - like strain (A/Hong Kong/4801/2014, NYMC X-263B) .
Maltese: X-179A) ........... 15 mikrogrammi HA** A/Hong Kong/4801/2014 (H3N2) - bħal razza (A/Hong Kong/4801/2014, NYMC
English: Per 0.1 ml dose * propagated in fertilised hens' eggs from healthy chicken flocks ** haemagglutinin l t o r
Maltese: Kull doża ta' 0.1 ml * ippropogat fil-bajd fertilizzat tat-tiġieġ minn gruppi ta' tiġieġ f'saħħithom ** emagglutinin t x
English: 1 pre-filled syringe
Maltese: Qawwa Għamla farmaċewtika
English: PritorPlus telmisartan / hydrochlorothiazide
Maltese: PritorPlus telmisartan / idroklorotijażide
English: It is available as tablets (40 or 80 mg telmisartan and 12.5 mg hydrochlorothiazide; 80 mg telmisartan and 25 mg hydrochlorothiazide).
Maltese: Jiġi bħala pilloli (40 mg jew 80 mg telmisartan u 12.5 mg idroklorotija ide; 80 mg telmisartan u 25 mg idroklorotijażide).
English: This is a summary of the European public assessment report (EPAR) for PritorPlus.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' Valutazzjoni (EPAR) għal PritorPlus.
English: PritorPlus has been studied in five main studies involving a total of 2,985 patients with mild to moderate hypertension.
Maltese: PritorPlus ġie studjat f'ħames studji ewlenin li involvew total ta' 2,985 pazjent li jbatu minn ipertensjoni minn ħafifa għal moderata.
English: The European Commission granted a marketing authorisation valid throughout the European Union for PritorPlus on 22 April 2002.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal PritorPlus valida fl-Unjoni Ewropea kollha fit-22 ta' April 2002.
English: The most common side effect with PritorPlus (seen in between 1 and 10 patients in 100) is dizziness.
Maltese: L-effett sekondarju l-aktar komuni bi PritorPlus (li deher f'bejn pazjent wieħed u 10 minn kull 100) huwa l-isturdament.
English: In four of these studies, PritorPlus was compared with placebo (a dummy treatment) and with telmisartan taken alone in a total of 2,272 patients.
Maltese: F'erbgħa fost dawn l-istudji, PritorPlus tqabbel mal-plaċebo (kura finta) u mat-telmisartan meħud waħdu f'total ta' 2,272 pazjent.
English: Why has PritorPlus been approved?
Maltese: Għaliex ġie approvat PritorPlus?
English: PritorPlus contains two active substances, telmisartan and hydrochlorothiazide.
Maltese: PritorPlus fih żewġ sustanzi attivi, it-telmisartan u l-idroklorotijażide.
English: What is PritorPlus?
Maltese: X'inhu PritorPlus?
English: A risk management plan has been developed to ensure that PritorPlus is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiżgura li PritorPlus jintuża bl-aktar mod sigur possibbli.