FrancophonIA/ELRC3.0 huggingface dataset:
English: Co-medication is not advisable.
Maltese: M'hemmx esperjenza klinika fi tfal u adoloxxenti.
English: Losartan maintains glomerular filtration rate and reduces filtration fraction.
Maltese: Losartan iżomm ir-rata ta' filtrazzjoni glomerulari u jnaqqas il-porzjon ta' filtrazzjoni.
English: Digitalis glycosides
Maltese: Il-Belġju
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 100 mg losartan potassium and 12.5 mg hydrochlorothiazide.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha 100 mg losartan potassium u 12.5 mg hydrochlorothiazide.
English: The following side effects have been reported:
Maltese: Uġigħ ta' ras, sturdament Mhux komuni:
English: Concomitant treatment with cyclosporine may increase the risk of hyperuricaemia and gout-type complications.
Maltese: Trattament flimkien ma' cyclosporine jista' jżid ir-riskju għal iperurikemija u kumplikazzjonijiet tat-tip tal-gotta.
English: Increases in cholesterol and triglyceride levels may be associated with thiazide diuretic therapy.
Maltese: Żidied fil-livelli ta' kolesterol u trigliċeridi jistgħu jkunu assoċjati ma' terapija dijuretika ta' thiazides.
English: (ventricular tachycardia)-inducing medicinal products (including some antiarrhythmics), hypokalaemia being a predisposing factor to torsades de pointes (ventricular tachycardia):
Maltese: Distress respiratorju (li jinkludi pnewmonite u edema pulmonari) Disturbi gastro-intestinali:
English: • Weakness, tiredness, chest pain,
Maltese: • Debolezza, għeja, uġigħ fis-sider
English: Due to the divergent national decisions taken by Member States concerning the authorisation of the above-mentioned products (and its associated names), Denmark notified the CHMP/EMEA Secretariat of an official referral under Article 30 of Directive 2001/83/EC as amended in order to resolve divergences amongst the nationally authorised SPCs and thus to harmonise its divergent SPCs across the EU.
Maltese: Minħabba d-deċiżjonijiet nazzjonali diverġenti meħudin minn Stati Membri fir-rigward ta' l-awtorizzazzjoni tal-prodotti msemmijin hawn fuq (u l-ismijiet assoċjati tagħhom), id-Danimarka nnotifikat lis-Segretarjat tasCHMP/EMEA b'referenza uffiċjali skond l-Artikolu 30 tad-Direttiva 2001/83/KE kif emendata sabiex jiġu solvuti diverġenzi fost SPCs awtorizzati fuq livell nazzjonali u b'hekk biex jiġu armonizzati SPCs diverġenti tagħha fl-UE kollha.
English: Cozaar Comp 50 mg/12.5 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in packs of 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 98, or 280 tablets.
Maltese: Cozaar Comp 50 mg/12.5 mg - Folji tal-PVC/PE/PVDC b'għotjien b'fojl ta' l-aluminju f'pakketti ta' 4, 7, 10 pilloli, 14-il pillola, 20, 28, 30, 50, 56, 84, 98, jew 280 pillola.
English: WHAT COZAAR COMP IS AND WHAT IT IS USED FOR Cozaar Comp is a combination of an angiotensin II receptor antagonist (losartan) and a diuretic (hydrochlorothiazide).
Maltese: X'INHU COZAAR COMP U GĦALXIEX JINTUŻA Cozaar Comp hu kombinazzjoni ta' antagonist għar-riċettatur ta' angiotensin II (losartan) u fijuretiku (hydrochlorothiazide).
English: Cozaar Comp 100 mg/12.5 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in packs of 14, 15, 28, 30, 50, 56, 84, 90, 98, 280 tablets.
Maltese: Cozaar Comp 100 mg/12.5 mg - Folji tal-PVC/PE/PVDC b'għotjien b'fojl ta' l-aluminju f'pakketti ta' 14, 15-il pillola, 28, 30, 50, 56, 84, 90, 98, jew 280 pillola.
English: Excipient
Maltese: Anġjodema
English: Studies in rats indicate that losartan crosses the bloodbrain barrier poorly, if at all.
Maltese: Studji fuq il-firien indikaw li losartan jaqsam il-barriera tad-demm-moħħ b'mod fqir, jekk jaqsam.
English: Uncommon: Necrotizing angiitis (vasculitis, cutaneous vasculitis)
Maltese: Mhux komuni: Anġijite nekrotizzanti (vaskulite, vaskulite kutanea) Disturbi respiratorji, toraċiċi u medjastinali:
English: Pregnancy and Lactation should be contraindicated and the appropriate wording included in sections 4.3, 4.4 and 4.6 of the SPC, and the relevant sections of the Package Leaflet.
Maltese: It-Tqala u Treddigħ għandhom ikunu kontraindikati u lformolazzjoni addattata għandha tiġi inkluża fis-sezzjonijiet 4.3, 4.4 u 4.6 ta' l-SPC, u fis-sezzjonijiet relevanti tal-Fuljett ta' Tagħrif.
English: Thiazide therapy may impair glucose tolerance.
Maltese: It-terapija b'thiazides tista' timpedixxi t-tolleranza għal glukosju.
English: In controlled clinical trials for essential hypertension, dizziness was the only adverse experience reported as substance-related that occurred with an incidence greater than placebo in 1% or more of patients treated with losartan and hydrochlorothiazide.
Maltese: Fi provi kliniċi b'kontrolli għal pressjoni essenzjali għolja, l-isturdament kien l-uniku każ avvers rapportat bħala relatat mas-sustanza li seħħ b'inċidenza akbar minn plaċebo f'1% jew aktar ta' pazjenti trattati b'losartan u hydrochlorothiazide.
English: Angiotensin II binds to the AT1 receptor found in many tissues (e.g. vascular smooth muscle, adrenal gland, kidneys and the heart)
Maltese: Angiotensin II jintrabat mar-riċettatur AT1 li jinstab f'ħafna tessuti (eż. Il-muskoli vaskulari lixxi, il-glandoli adrenali, il-kliewi u l-qalb) u jissensitizza diversi azzjonijiet bijoloġiċi importanti li jinkludu t-tidjiq tal-vażi tad-demm u r-rilaxx ta' aldosterone.
English: Yellow, oval film-coated tablets marked 717 on one side and plain or scored on the other.
Maltese: Pilloli miksijin b'rita ta' lewn isfar u f'għamla ovali u mmarkati b'717 fuq naħa waħda u b'xaqq jew mingħajr xaqq fuq in-naħa l-oħra.
English: Calcium salts
Maltese: LORZAAR VARIPHARM
English: When pregnancy is diagnosed, treatment with Cozaar Comp should be stopped immediately and, if appropriate, alternative therapy should be started.
Maltese: Meta tqala tiġi dijanjonizzata, it-trattament b'Cozaar Comp għandu jitwaqqaf immedjatament, u jekk jixraq, terapija alternattiva għandha tinbeda.
English: Latent diabetes mellitus may become manifest during thiazide therapy.
Maltese: Dijabete melittus mistura tista' tiġi manifestata waqt terapija b'thiazides.
English: Cozaar Plus 100/12,5 100 mg losartan potassium12.5 mg hydrochlorothiazide
Maltese: COZAAR-COMP 100/12.5MG 100 mg losartan potassium
English: Unless continued Losartan/HTCZ therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Maltese: Għajr meta t-tkomplija ta' t-terapija b'losartan/HTCZ hija kkonsidrata essenzjali, pazjenti li qegħdin jippjanaw tqala għandhom jinqelbu fuq terapija alternattiva ta' kontra l-pressjoni għolja li għandha profil tas-sigurtà stabilit għal użu fi tqala.
English: The clinical consequences of these interactions have not been evaluated.
Maltese: Il-konsegwenzi kliniċi ta' dawn l-effetti ma ġewx evalwati.
English: Iodine Contrast Media
Maltese: Flixkun HDPE
English: In addition, a prevention indication for HCTZ alone, based on the LIFE data is not considered approvable.
Maltese: Barra minn hekk, indikazzjoni ta' prevenzjoni għal HCTZ waħdu, ibbażata fuq id-dejta LIFE mhijiex ikkunsidrata approvabbli.
English: The diuretic action of hydrochlorothiazide reduces plasma volume, increases plasma renin activity and increases aldosterone secretion, with consequent increases in urinary potassium and bicarbonate loss, and decreases in serum potassium.
Maltese: L-azzjoni dijuretika ta' hydrochlorothiazide tnaqqas il-volum ta' plażma, tgħolli l-attività ta' renin fil-plażma u żżid it-tnixxija ta' aldosterone, b'żidied sussegwenti fit-tnaqqis ta' potassju u bikarbonat fl-awrina, u tnaqqis tal-potassju fis-serum.
English: Cozaar Comp 100/12.5 (losartan 100 mg/ HCTZ 12.5 mg) is available for those patients titrated to 100 mg of Cozaar Comp who require additional blood pressure control.
Maltese: Cozaar Comp 100/12.5 (100 mg losartan/12.5 mg HCTZ) huwa disponibbli għal dawk il-pazjenti li ġew iddożati għal 100 mg ta' Cozaar li jeħtieġu kontroll addizzjonali għal pressjoni tad-demm tagħhom.
English: and elicits several important biological actions, including vasoconstriction and the release of aldosterone.Angiotensin II also stimulates smooth-muscle cell proliferation.
Maltese: Angiotensin II jissensitizza wkoll il-proliferazzjoni taċ-ċelloli lixxi tal-muskoli.
English: Losartan has been shown to have a mild and transient uricosuric effect.
Maltese: Dawn l-effetti huma ġeneralment riversibbli.
English: Common: Hyperkalaemia, mild reduction of haematocrit and haemoglobin Uncommon: Mild increase in urea and creatinine serum levels Very rare: Increase in hepatic enzymes and bilirubin.
Maltese: Mhux komuni: Żieda ħafifa fil-livelli ta' urea u kreatinina fis-serum Rari ħafna:
English: Hypertension Studies
Maltese: KLASSIFIKAZZJONI ĠENERALI
English: NAME OF THE MEDICINAL PRODUCT Cozaar Comp 100 mg/25 mg mg film-coated tablets Losartan and hydrochlorothiazide
Maltese: TAL-PRODOTT MEDIĊINALI Cozaar Comp 100 mg/25 mg mg pilloli miksijin b'rita Losartan u hydrochlorothiazide
English: Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins.
Maltese: L-assorbiment ta' hydrochlorothiazide jiġi impedut fil-preżenza ta' reżini ta' skambju anijoniċi.
English: As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function, including renal failure, have been reported (in particular, in patients whose renal function is dependent on the renin-angiotensin-aldosterone system, such as those with severe cardiac insufficiency or pre-existing renal dysfunction).
Maltese: Bħala konsegwenza ta' l-impediment tas-sistema renin-angiotensin, bidliet fil-funzjoni renali li jinkludi insuffiċjenza renali ġew irrapportati (b'mod partikolari f'pazjenti li l-funzjoni renali tagħhom tiddependi fuq is-sistema ta' renin angiotensin aldosterone bħal dawk li għandhom insuffiċjenza kardijaka severa jew disturbi fil-funzjonament renali li kienu jeżistu minn qabel).
English: • if you need to have an anaesthetic (even at the dentist) or before surgery, or if you are going to have tests to check your parathyroid function, you must tell the doctor or medical staff that you are taking Losartan potassium and Hydrochlorothiazide tablets.
Maltese: • jekk hemm bżonn li tingħata loppju (anke għand id-dentist) jew qabel intervent kirurġiku, jew jekk għandek tieħu xi testijiet biex tiċċekkja l-funzjoni tal-paratajrojd, għandek tgħid lit-tabib jew l-personel mediku li qed tieħu l-pilloli Losartan u Hydrochlorothiazide.
English: • if you take diuretics (water pills)
Maltese: • jekk qed tieħu d-dijuretiċi (pilloli ta' l-ilma)
English: Respiratory, thoracic and mediastinal disorders
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Komuni:
English: • Lactation (see section 4.6)
Maltese: Sezzjoni 4.4
English: Both biliary and urinary excretion contribute to the elimination of losartan and its metabolites.
Maltese: Kemm l-eliminazzjoni mill-marrara u dik urinarja jikkontribwixxu għall-eliminazzjoni ta' losartan u l-metabolit tiegħu.
English: • if you are diabetic
Maltese: • jekk int dijabetiku
English: NAME OF THE MEDICINAL PRODUCT Cozaar Comp 100 mg/12.5 mg mg film-coated tablets Losartan and hydrochlorothiazide
Maltese: TAL-PRODOTT MEDIĊINALI Cozaar Comp 100 mg/12.5 mg mg pilloli miksijin b'rita Losartan u hydrochlorothiazide
English: Special precautionary measures (e.g. blood tests) may be appropriate if you take potassium supplements, potassium-containing salt substitutes or potassium-sparing medicines, other diuretics (“water tablets”), some laxatives, medicines for the treatment of gout, medicines to control heart rhythm or for diabetes (oral agents or insulins).
Maltese: Miżuri prekawzjonarji speċjali (eż. testijiet tad-demm) jistgħu jkunu xierqa jekk qed tieħu supplimenti tal-potassju, sostituti tal-melħ li fihom il-potassju jew mediċini li ma jħallux t-tnixxija ta' potassju, dijuretiċi oħra (“pilloli ta' l-ilma”) xi purganti, mediċini għat-trattament tal-gotta, mediċini li jikkontrollaw ir-ritmu tal-qalb, jew għad-dijabete (mediċini orali jew insulina).
English: Each tablet contains 100 mg of losartan (as potassium salt) and 12.5 mg of hydrochlorothiazide (HCTZ) as the active ingredients.
Maltese: Kull pillola fiha 100 mg losartan (bħala mluħa ta' potassju) u 12.5 mg hydrochlorothiazide (HCTZ) bħala s-sustanzi attivi.
English: NAME OF THE MEDICINAL PRODUCT Cozaar Comp 50 mg/12.5 mg mg film-coated tablets Losartan and hydrochlorothiazide
Maltese: TAL-PRODOTT MEDIĊINALI Cozaar Comp 50 mg/ 12.5 mg mg pilloli miksijin b'rita Losartan u hydrochlorothiazide
English: As with other drugs that affect the renin-angiotensin-aldosterone system, increases in blood urea and serum creatinine have also been reported in patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney; these changes in renal function may be reversible upon discontinuation of therapy.
Maltese: Bħal fil-każ ta' mediċini oħra li jaffettwaw is-sistema renin-angiotensin-aldosterone, żieda ta' l-urea fid-demm u fil-kreatinina fis-serum ġew irrapportati wkoll f'pazjenti bi stenosi bilaterali ta' l-arterja renali jew stenosi ta' l-arterja għal kilwa waħda.
English: Therefore, serum lithium levels should be monitored carefully if lithium salts are to be coadministered with angiotensin II receptor antagonists.
Maltese: Għalhekk livelli ta' litju fis-serum għandhom jiġu monitorati bir-reqqa jekk mluħa tal-litju jingħataw flimkien ma' riċettaturi antagonisti ta' angiotensin II.
English: Periodic monitoring of serum potassium and ECG is recommended when Losartan/hydrochlorothiazide is administered with medicinal products affected by serum potassium disturbances (e.g. digitalis glycosides and antiarrhythmics) and with the following torsades de pointes
Maltese: L-użu f'pazjenti b'indeboliment epatiku Losartan/HCTZ huwa kontra-indikat f'pazjenti li għandhom indeboliment epatiku sever (ara sezzjoni
English: In controlled clinical studies, once-daily administration of Losartan to patients with mild to moderate essential hypertension produced statistically significant reductions in systolic and diastolic blood pressure.
Maltese: Fi studji kliniċi b'kontrolli, l-għoti darba fil-ġimgħa ta' Losartan lil pazjenti bi pressjoni essenzjali għolja minn ħafifa sa moderata ikkaġuna tnaqqis statistikament sinifikanti fil-pressjoni tad-demm sistolika u dijastolika.
English: The reason for this broader indication is that the LIFE study was not a placebo-controlled study, studying the effect on stroke only compared to placebo, but an actively controlled study, comparing a losartan based with an atenolol based antihypertensive treatment using a primary composite endpoint of CV death, stroke and MI.
Maltese: Fi studju speċifikament ippjanat biex janalizza l-inċidenza ta' sogħla f'pazjenti trattati b'losartan meta mqabbla ma' pazjenti trattati b'impedituri ACE, l-inċidenza ta' sogħla rapportata minn pazjenti li qed jirċievu losartan jew hydrochlorothiazide kienet simili u kienet sinifikament inqas milli f'pazjenti trattati b'impeditur ACE.
English: • Jaundice (yellowing of the eyes and skin), inflammation of the pancreas,
Maltese: • Suffejra (tisfir ta' l-għajnejn u l-ġilda), infjammazzjoni tal-frixa,
English: Route of administration
Maltese: Quinte da Fonte
English: Because of the potential for adverse effects on the nursing infant, Cozaar Comp is contraindicated during breast-feeding (see section 4.3).
Maltese: Minħabba l-potenzjal għal effetti avversi fuq it-trabi mredda', Cozaar Comp hu kontra-indikat waqt it-treddigħ (ara sezzjoni 4.3).
English: Cozaar Comp 100 mg/25 mg> - PVC/PE/PVDC blister packages with aluminum foil lidding in packs of 7, 14, 28, 30, 50, 56, 84, 90, 98, or 280 tablets.
Maltese: Cozaar Comp 100 mg/25 mg - Folji tal-PVC/PE/PVDC b'għotjien b'fojl ta' l-aluminju f'pakketti ta' 7 pilloli, 14-il pillola, 28, 30, 50, 56, 98, jew 280 pillola.
English: Hypotension and Intravascular volume depletion
Maltese: Pressjoni Baxxa u żvojtar ta' volumi intravaskulari:
English: Neither losartan nor the active metabolite can be removed by hemodialysis.
Maltese: La losartan u lanqas il-metabolit attiv ma jistgħu jiġu eliminati f'emodijaliżi.
English: • Increased potassium levels (which can cause an abnormal heart rhythm), decreased haemoglobin levels.
Maltese: • Livell ta' potassju ogħla (li jista' jikkawża ritmu abnormali tal-qalb), livelli ta' emoglobina mnaqqsa.
English: The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis.
Maltese: L-aktar sinjali u sintomi komuni osservati huma dawk ikkawżati bi żvojtar elettrolitiku (ipokalemija, ipokloremja, iponatremja) u diżidrazzjoni li tirrużulta minn dijuresi eċċessiva.
English: Cozaar Comp Forte 100 mg/25 mg filmdragerade tabletter United Kingdom COZAAR-COMP 50/12.5MG FILM COATED TABLETS United Kingdom COZAAR-COMP 100/25MG FILM COATED TABLETS United Kingdom COZAAR-Comp
Maltese: Għal pazjenti li ma jirrispondux b'mod adegwat għal Cozaar Comp 50 mg/12.5 mg, id-doża tista' tiżdied għal pillola ta' Cozaar Comp 100 mg/25 mg (100 mg losartan/25 mg HCTZ) darba kuljum.
English: Uncommon:
Maltese: Investigazzjonijiet Komuni:
English: Because of their effects on calcium metabolism, thiazides may interfere with tests for parathyroid function (see section 4.4).
Maltese: Interazzjonijiet tal-mediċina/testijiet tal-laboratorju Minħabba l-effetti tagħhom fuq il-metaboliżmu tal-kalċju, thiazides jistgħu jinterferixxu ma' testijiet għal funzjoni tal-paratirojde (ara sezzjoni 4.4).
English: Following oral administration in patients with mild to moderate alcoholic cirrhosis of the liver, plasma concentrations of losartan and its active metabolite were, respectively, 5-fold and 1.7-fold greater than those seen in young male volunteers.
Maltese: Wara l-għoti mill-ħalq f'pazjenti b'ċirrosi alkoħolika fil-fwied minn ħafifa sa moderata, il-konċentrazzjonijiet fil-plażma ta' losartan u l-metabolit attiv tiegħu kienu 5 darbiet u 1.7 darbiet ogħla minn dawk li dehru f'voluntieri rġiel żgħażagħ.
English: Each tablet contains 100 mg of losartan (as potassium salt) and 25 mg of hydrochlorothiazide (HCTZ) as the active ingredients.
Maltese: Kull pillola fiha 100 mg losartan (bħala mluħa ta' potassju) u 25 mg hydrochlorothiazide (HCTZ) bħala s-sustanzi attivi.
English: Cozaar Comp is supplied in the following pack sizes:
Maltese: Twissijiet speċjali u prekawzjonijiet għall-użu:
English: Hepato-biliary disorders Rare: Hepatitis
Maltese: Disturbi fil-fwied u fil-marrara Rari:
English: • Cough, upper airway infection, congestion in the nose, sinusitis, sinus disorder,
Maltese: • Sogħla, infezzjoni fil-passaġġ ta' fuq, imnieħer imblukkat, sinusite, disturbi fis-sinus
English: As observed in studies with losartan alone, adverse foetal and neonatal effects, including renal toxicity and foetal death, occurred when pregnant rate were treated with the losartan/hydrochlorothiazide combination during late gestation and/or lactation.
Maltese: Kif kien osservat fi studji b'losartan waħdu, effetti avversi fetali u fi trabi għadhom jitwieldu, li jinkludu tossiċita renali u mewt fetali, seħħew meta meta firien tqal kienu trattati bil-kombinazzjoni ta' losartan/hydrochlorothiazide fl-aħħar tat-tqala u/jew t-treddigħ.
English: • Acute retinopathies of vascular origin
Maltese: • retinopatiji akuti ta 'oriġini vaskulari
English: • Symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia)
Maltese: • Kura ta' sintomi ta' indeboliment konjittiv u deboliment ewrosensorjali patoloġiku kronika fl-anzjani (eskluż il- marda tal- Alzheimer u d-dimenzja oħra)
English: 4.1 Therapeutic indications
Maltese: 4.1 Indikazzjonijiet Terapewtiċi
English: • Ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin
Maltese: • trattament anċillari ta' nuqqas ta' akutezza viżwali u disturbi fil-vista' preżumibbilment ta' oriġini vaskulari
English: Annex III Amendments to relevant sections of the summaries of product characteristics and package leaflets
Maltese: Anness III Emendi għas-sezzjonijiet relevanti tas-sommarji tal-karatteristiċi talprodott u fuljetti tal-pakkett
English: All references to the above mentioned indications should be deleted from the remaining relevant sections of the summaries of product characteristics.
Maltese: Ir-referenzi kollha għall-indikazzjonijiet imsemmijin hawn fuq għandhom jiġu mħassra mit-taqsimiet rilevanti li jkun fadal tas-sommarji tal-karatteristiċi tal-prodott.
English: [the below currently approved indications should be deleted (specific wording of the indication may vary from product to product)]
Maltese: [L-Indikazzjonijiet li bħalissa huma approvati hawn taħt għandhom jitħassru (il-formulazzjoni speċifika tal-indikazzjoni tista' tvarja minn prodott għall-prodott)]
English: All references to the above mentioned indications should be deleted from the relevant sections of the package leaflets.
Maltese: Ir-referenzi kollha għall-indikazzjonijiet imsemmijin hawn fuq għandhom jiġu mħassra mit-taqsimiet rilevanti tal-fuljetti tal-pakkett.
English: The full EPAR for Intrarosa 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: Intrarosa is available as a 6.5 mg pessary.
Maltese: Intrarosa jiġi bħala pessarju ta' 6.5 mg.
English: The medicine has an acceptable safety profile.
Maltese: Il-mediċina għandha profil tas-sigurtà aċċettabbli.
English: The pain reduced by 1.3 and 1.4 points with Intrarosa compared with 0.9 and 1.1 points with placebo.
Maltese: L-uġigħ tnaqqas b'1.3 u 1.4 punti b'Intrarosa meta mqabbel ma' 0.9 u 1.1 punti bil-plaċebo.
English: Other information about Intrarosa
Maltese: Informazzjoni oħra dwar Intrarosa
English: Intrarosa must not be used in patients with the following conditions: genital bleeding where the cause has not been diagnosed, known or suspected breast cancer or oestrogen-dependent cancer, previous breast cancer, untreated endometrial hyperplasia (thickening of the lining of the womb), acute (shortterm) liver disease, previous liver disease where liver function tests are still abnormal, previous or current venous thromboembolism (formation of blood clots in the veins), thrombophilic disorders (abnormal blood clotting), active or recent arterial thromboembolic disease (disease caused by blood clots in the arteries), porphyria (inability to break down chemicals called porphyrins).
Maltese: Intrarosa m'għandux jintuża f'pazjenti bil-kondizzjonijiet li ġejjin: fsada ġenitali fejn il-kawża ma ġietx dijanjostika, kanċer tas-sider jew kanċer dipendenti fuq l-estroġenu magħruf jew suspettat, kanċer tas-sider preċedenti, iperplażja endometrijali mhux ikkurata (ħxuna tal-kisja tal-utru), marda tal-fwied akuta (ta' perjodu qasir), marda tal-fwied preċedenti fejn it-testijiet tal-funzjoni tal-fwied għadhom anormali, tromboemboliżmu venuż preċedenti jew attwali (l-iffurmar ta' emboli tad-demm fil-vini), disturbi trombofiliċi (koagulazzjoni tad-demm anormali), marda tromboembolika arterjali attiva jew riċenti (marda kkawżata minn emboli tad-demm fl-arterji), porfirija (nuqqas ta' ħila biex tkisser ilkimiċi msejħa porfirini).
English: Why is Intrarosa approved?
Maltese: Għaliex ġie approvat Intrarosa?
English: Intrarosa contains the active substance prasterone, also known as dehydroepiandrosterone (DHEA).
Maltese: Intrarosa fih is-sustanza attiva, prasterone, magħrufa wkoll bħala dehydroepiandrosterone (DHEA).
English: There was also a decrease in the number of parabasal cells (which normally increase with atrophy) of 42% and 47% with Intrarosa compared with 2% and 12% with placebo.
Maltese: Kien hemm ukoll tnaqqis fin-numru ta' ċelloli parabażali (li normalment jiżdiedu bl-atrofija) ta' 42 % u 47 % b'Intrarosa meta mqabbel ma' 2 % u 12 % malplaċebo.
English: This is a summary of the European public assessment report (EPAR) for Intrarosa.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Intrarosa.
English: What are the risks associated with Intrarosa?
Maltese: X'inhuma r-riskji assoċjati ma' Intrarosa?