FrancophonIA/ELRC3.0 huggingface dataset:
English: Carmustine Obvius 100 mg powder for concentrate for solution for infusion carmustine
Maltese: TAL-PRODOTT MEDIĊINALI Carmustine Obvius 100 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni carmustine
English: Renal toxicity.
Maltese: Tossiċità fil-kliewi.
English: Package leaflet: Information for the user Carmustine Obvius 100 mg powder and solvent for concentrate for solution for infusion carmustine
Maltese: Informazzjoni għall-utent Carmustine Obvius 100 mg trab u solvent għall-konċentrat għal soluzzjoni għall-infużjoni carmustine
English: Severe (end-stage) renal impairment.
Maltese: Indeboliment tal-kliewi sever (l-aħħar stadju).
English: Concomitant use with digoxin leads to delayed, moderate, suspected, decreased effect of digoxin (due to the decreased digoxin absorption).
Maltese: Digoxin L-użu fl-istess ħin mad-digoxin iwassal għal effett imnaqqas tad-digoxin imdewwem, moderat u suspettat (minħabba assorbiment tad-digoxin imnaqqas).
English: Males should be advised of potential risk of infertility and to seek fertility/family planning counselling prior to therapy with carmustine .
Maltese: L-irġiel għandhom jiġu infurmati dwar ir-riskju potenzjali tal-infertilità u jingħataw parir li jfittxu pariri dwar il-fertilità/l-ippjanar tal-familja qabel it-terapija b'carmustine.
English: The lyophilisate can appear as a fine powder, however handling can cause it to appear as a more heavy and lumpy lyophilisate than as a powdery lyophilisate due to the mechanical instability of the freeze drying cake.
Maltese: Illyophilisate jista' jidher bħala trab fin, madankollu l-immaniġġjar jista' jikkawża li dan jidher bħala lyophilisate aktar tqil u bil-boċċi aktar milli lyophilisate qisu terra minħabba l-instabbiltà mekkanika tal-freeze drying cake.
English: When placebo-controlled trials are available, adverse reactions are included if the incidence is ≥ 5% higher in the treatment group.
Maltese: Meta l-provi ta' kontroll bi plaċebo jkunu disponibbli, ir-reazzjonijiet avversi jiġu inklużi jekk l-inċidenza tkun ≥ 5% ogħla fil-grupp tat-trattament.
English: Carmustine Obvius 100 mg powder and solvent for concentrate for solution for infusion
Maltese: IL-PRODOTT MEDIĊINALI Carmustine Obvius 100 mg trab u solvent għall-konċentrat għal soluzzjoni għall-infużjoni
English: Symptoms may include: fluid accumulation in the abdomen, enlargement of spleen, severe bleeding of the oesophgus, yellow-coulouring of skin and whites of the eyes; - Breathing problems caused by interstitial fibrosis (with lower doses); - Kidney problems; - Gynecomastia (breast growth in males)
Maltese: Il-pazjenti kollha li kellhom anqas minn ħames snin waqt li kienu qed jingħataw it-trattament mietu b'fibrożi pulmonari; la d-doża ta' carmustine, la d-doża ta' vincristine addizzjonali u lanqas ir-radjazzjoni tax-xewka tad-dahar ma kellhom impatt fuq ir-riżultat fatali.
English: Monitoring and subsequent doses
Maltese: Monitoraġġ u dożi sussegwenti
English: As an alkylating agent, it can alkylate reactive sites on nucleoproteins, thus interfering with DNA and RNA synthesis and DNA repair.
Maltese: Bħala aġent alkylating, huwa jista' jeħel ma'siti reattivi (alkylating effect) fuq in-nukleoproteini,
English: Symptoms may include muscle weakness in one area, poor decision-making or concentration, involuntary twitching, trembling, difficulty speaking or swallowing, seizures; - Anorexia; - Constipation; - Diarrhoea; - Inflammation of the mouth and lips; - Reversible liver toxicity in high-dose therapy.
Maltese: Il-fatturi ta' riskju jinkludu t-tipjip, mard respiratorju, anormalitajiet radjugrafiċi eżistenti, radjazzjoni toraċika sekwenzjali jew fl-istess ħin, kif ukoll ilkombinazzjoni ma' sustanzi attivi oħrajn li jikkawżaw ħsara fil-pulmun.
English: Carmustine Obvius is a powder and solvent for concentrate for solution for infusion.
Maltese: Carmustine Obvius huwa trab u solvent għall-konċentrat għal soluzzjoni għall-infużjoni.
English: Posology and laboratory investigations
Maltese: U EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: Common Acute leukaemia, bone marrow dysplasia - following long-term use.
Maltese: Lewkimja akuta, displażija talmudullun - wara użu għal żmien twil.
English: - Excipients: - Powder: No excipients.
Maltese: - Eċċipjenti:
English: Melphalan Concomitant use with melphalan leads to increased risk of pulmonary toxicity.
Maltese: Carmustine Obvius ma għandux jintuża fit-tfal u fl-adolexxenti minħabba riskju kbir ta' tossiċità pulmonari.
English: In cases where the nadir after initial dose does not fall in the same row for leucocytes and platelets (e.g. leucocytes >4,000 and platelets <25,000) the value given the lowest percentage of prior dose should be used (e.g. platelets <25,000 then a maximum of 50% of prior dose should be given).
Maltese: F'każijiet fejn in-nadir wara d-doża inizjali ma jaqax fl-istess ringiela għal-lewkoċiti u lpjastrini (pereżempju, lewkoċiti >4,000 u pjastrini <25,000) għandu jintuża l-valur li jingħata laktar perċentwal baxx mid-doża ta' qabel (pereżempju, pjastrini <25,000 mela għandu jingħata massimu ta' 50 % mid-doża ta' qabel).
English: On one hand, their carbamoylating activity was reported to contribute to the cytotoxic properties of their parent drugs by inhibiting DNA repair enzymes.
Maltese: Billi tirrapporta l-effetti sekondarji tista' tgħin biex tiġi pprovduta aktar informazzjoni dwar is-sigurtà ta' din il-mediċina.
English: Ataxia, dizziness, headache.
Maltese: Ġeneralment jingħata, tal-anqas, kull sitt ġimgħat.
English: Nadir after prior dose
Maltese: Twissijiet u prekawzjonijiet
English: It is unknown whether carmustine/metabolites are excreted in human milk.
Maltese: Mhux magħruf jekk carmustine/metaboliti jiġux eliminati fil-ħalib tas-sider tal-bniedem.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Kanuma can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: Is-sommarju tal-opinjoni tal-Kumitat għall-Prodotti Mediċinali Orfni għal Kanuma jinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: In this study, 31% of the patients given Kanuma (11 out of 36) achieved normal levels of ALT enzymes, compared with 7% of the patients given placebo (2 out of 30).
Maltese: F'dan l-istudju, 31% tal-pazjenti li ngħataw Kanuma (11 minn 36) kisbu livelli normali ta' enzimi ALT, meta mqabbel ma' 7% tal-pazjenti li ngħataw plaċebo (2 minn 30).
English: Kanuma contains the active substance sebelipase alfa.
Maltese: Kanuma fih is-sustanza attiva sebelipase alfa.
English: This is a summary of the European public assessment report (EPAR) for Kanuma.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Kanuma.
English: The second study involved 66 patients (children and adults) and compared Kanuma with placebo (a dummy treatment).
Maltese: It-tieni studju involva 66 pazjent (tfal u adulti) u qabbel Kanuma ma' plaċebo (kura finta).
English: Other information about Kanuma
Maltese: Informazzjoni oħra dwar Kanuma
English: Why is Kanuma approved?
Maltese: Għaliex ġie approvat Kanuma?
English: Because the number of patients with lysosomal acid lipase deficiency is low, the disease is considered ‘rare', and Kanuma was designated an ‘orphan medicine' (a medicine used in rare diseases) on 17 December 2010.
Maltese: Minħabba li l-għadd ta' pazjenti b'defiċjenza ta' lysosomal acid lipase huwa baxx, il-marda hija kkunsidrata ‘rari', u Kanuma kien ikklassifikat bħala ‘mediċina orfni' (mediċina użata f'mard rari) fis17 ta' Diċembru 2010.
English: What are the risks associated with Kanuma?
Maltese: X'inhuma r-riskji assoċjati ma' Kanuma?
English: The active substance in Kanuma, sebelipase alfa, is a copy of the enzyme that is lacking in patients with lysosomal acid lipase deficiency.
Maltese: Is-sustanza attiva f'Kanuma, sebelipase alfa, hija kopja tal-enzima li hija nieqsa f'pazjenti b'defiċjenza ta' lysosomal acid lipase.
English: Kanuma is available as a concentrate to be made into a solution for infusion (drip) into a vein.
Maltese: Kanuma huwa disponibbli bħala konċentrat li jiġi magħmul f'soluzzjoni għal infużjoni (dripp) ġol-vina.
English: The most serious side effects with Kanuma (seen in around 3 patients in 100) are signs and symptoms of severe allergic reactions.
Maltese: L-effetti sekondarji l-aktar serji b'Kanuma (li dehru f'madwar 3 minn kull 100 pazjent) huma sinjali u sintomi ta' reazzjonijiet allerġiċi severi.
English: The recommended dose is 1 mg per kilogram body weight given once every other week.
Maltese: Id-doża rakkomandata hija ta' 1 mg għal kull kilogramma ta' piż tal-ġisem li tingħata darba kull ġimagħtejn.
English: Kanuma is a medicine used to treat patients of all ages with lysosomal acid lipase deficiency.
Maltese: Kanuma huwa mediċina li tintuża fil-kura ta' pazjenti ta' kull età b'defiċjenza ta' lysosomal acid lipase.
English: These include chest discomfort, red eyes, eyelid swelling, difficulty breathing, itchy rash, hives, flushing, runny nose, rapid heartbeat and rapid breathing.
Maltese: Dawn jinkludu skumdità fis-sider, għajnejn ħomor, nefħa talkappell tal-għajn, diffikultà fin-nifs, raxx bil-ħakk, urtikarja, fawra, imnieħer iqattar, taħbit tal-qalb mgħaġġel u nifs mgħaġġel.
English: In patients who have rapidly progressing disease before 6 months of age, a dose of 1 mg/kg is given once a week instead of once every other week; in these patients the dose can be increased to 3 mg/kg once a week depending on the response to treatment.
Maltese: F'pazjenti li għandhom marda li tavvanza b'mod rapidu qabel l-età ta' 6 xhur, tingħata doża ta' 1 mg/kg darba fil-ġimgħa minnflok darba kull gimagħtejn; f'dawn il-pazjenti d-doża tista' tiżdied għal 3 mg/kg darba fil-ġimgħa skont ir-rispons għall-kura.
English: Kanuma has been studied in 2 main studies in patients with lysosomal acid lipase deficiency.
Maltese: Kanuma ġie studjat f'2 studji ewlenin f'pazjenti b'defiċjenza ta' lysosomal acid lipase.
English: The study showed that 6 out of the 9 infants given Kanuma survived to 1 year of age.
Maltese: L-istudju wera li 6 mid-9 trabi li ngħataw Kanuma baqgħu ħajjin sal-età ta' sena.
English: How does Kanuma work?
Maltese: Kif jaħdem Kanuma?
English: The first study involved 9 infants with growth failure or other evidence of rapidly progressing disease in their first 6 months of life.
Maltese: L-ewwel studju involva 9 trabi b'falliment fit-tkabbir jew evidenza oħra ta' marda li qiegħda tavvanza b'mod rapidu flewwel 6 xhur ta' ħajjithom.
English: In addition, the company that markets Kanuma is carrying out a study in infants with rapidly progressing disease and will set-up a registry of patients of all ages to obtain further information on the long-term benefits and safety of Kanuma, in particular on the risk of allergic reactions and the development of antibodies against the medicine.
Maltese: Barra minn hekk, il-kumpanija li tqiegħed Kanuma fis-suq qiegħdha twettaq studju fit-trabi b'marda li qiegħda tavvanza b'mod rapidu u sejra toħloq reġistru għal pazjenti ta' kull età biex tikseb aktar informazzjoni dwar il-benefiċċji fit-tul u s-sigurtà ta' Kanuma, b'mod partikolari dwar ir-riskju ta' reazzjonijiet allerġiċi u l-iżvilupp ta' antikorpi kontra l-mediċina.
English: The main measure of effectiveness was the proportion of patients who achieved normal levels of a liver enzyme called ALT after 5 months of treatment.
Maltese: Il-kejl ewlieni tal-effikaċja kien il-proporzjon ta' pazjenti li kisbu livelli normali ta' enzima tal-fwied imsejħa ALT wara 5 xhur ta' kura.
English: The CHMP considered that Kanuma led to significant improvements in survival in infants, and was effective at improving symptoms of the disease in patients of all ages.
Maltese: Is-CHMP ikkunsidra li Kanuma wassal għal titjib sinifikanti fis-sopravivenza tattrabi, u kien effikaċi fit-titjib tas-sintomi tal-marda f'pazjenti ta' kull età.
English: A risk management plan has been developed to ensure that Kanuma is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Kanuma jintuża bl-aktar mod sigur possibbli.
English: The Committee noted the lack of any effective treatments for lysosomal acid lipase deficiency and the high mortality in infants with rapidly progressing disease.
Maltese: Il-Kumitat innota nnuqqas ta' kuri effikaċi għad-defiċjenza ta' lysosomal acid lipase u l-mortalità għolja fi trabi b'marda li tavvanza b'mod rapidu.
English: The full EPAR and risk management plan summary for Kanuma 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 Għal aktar informazzjoni rigward il-kura b'Kanuma, aqra l-fuljett ta' tagħrif (parti wkoll mill-EPAR) jew ikkuntattja lit-tabib jew spiżjar tiegħek.
English: The company will also provide educational material to all doctors expected to prescribe Kanuma, encouraging them to enroll patients in the registry and informing them of how to monitor patients for antibodies and manage patients who develop severe allergic reactions.
Maltese: L-iżvilupp ta' antikorpi kontra l-mediċina ġie wkoll rapportat speċjalment fi trabi.
English: Treatment should be given by a trained healthcare professional who can manage medical emergencies (such as a severe allergy).
Maltese: Il-kura għandha tingħata minn professjonist tal-kura tas-saħħa mħarreġ li jista' jimmaniġġja emerġenzi mediċi (bħal allerġija severa).
English: What measures are being taken to ensure the safe and effective use of Kanuma?
Maltese: X'miżuri qegħdin jitteħdu biex jiġi żgurat l-użu sigur u effettiv ta' Kanuma?
English: --1 Lipoteichoic acid (LTA) from Biofilm Adhesion Component (BAC) of Streptococcus uberis, strain 5616 ............................................................................................................. ≥ 1 RPU* *Relative Potency Units (ELISA)
Maltese: --1 Lipoteichoic acid (LTA) minn Komponent ta' Adeżjoni Biofilm (BAC) ta' Streptococcus uberis, razza 5616 ≥ 1 RPU* *Unitajiet tal-Potenza Relattiva (ELISA)
English: Cattle Intramuscular Vial (glass) 1 dose (2 ml)
Maltese: Kunjett (tal-ħġieġ)
English: Final study report by Q4 2021
Maltese: Rapport ta' studju finali sa Q4 2021
English: • Porphyria.
Maltese: • Porfirija.
English: Placebo (ITT, LOCF)
Maltese: Plaċebo (ITT, LOCF)
English: Avia Pharma AB
Maltese: Pharma AB
English: #Overall risk ratio.
Maltese: #Proporzjon ta' riskju globali.
English: 28 pessaries.
Maltese: Pessarju. 28 pessarju.
English: Common (≥ 1/100 to < 1/10)
Maltese: Komuni (≥ 1/100 sa <1/10)
English: Remove 1 applicator from the package.
Maltese: Neħħi applikatur 1 mill pakkett.
English: Abnormal Pap smear
Maltese: Pap smear anormali
English: Hard fat (adeps solidus).
Maltese: Xaħam iebes (adeps solidus)
English: Endoceutics S.A. Rue Belliard 40 1040 Brussels Belgium
Maltese: Endoceutics S.A. Rue Belliard 40
English: Substantial improvement Intrarosa Placebo Intrarosa Placebo Intrarosa Placebo
Maltese: Titjib sostanzjali Intrarosa Plaċebo Intrarosa Plaċebo Intrarosa Plaċebo
English: Sverige/Svíþjóð/Ruosti Tlf/Sími/Tlf/Puh/Tel: + 46 (0) 8 544 900 22
Maltese: Tlf/Sími/Tlf/Puh/Tel: + 46 (0) 8 544 900 22
English: Coronary artery disease (CAD)/ Hypertension
Maltese: Mard tal-arterja koronarja (CAD, Coronary artery disease)/ Ipertensjoni
English: • you are seriously overweight (BMI >30 kg/m2);
Maltese: • ikollok piż żejjed b'mod serju (BMI >30 kg/m2);
English: - The active substance is prasterone.
Maltese: - Is-sustanza attiva hi prasterone.
English: Tecnimede - Sociedade Técnico-Medicinal, S.A. Tel: + 351 210 414 100 dmed.fv@tecnimede.pt
Maltese: Tel: + 351 210 414 100 dmed.fv@tecnimede.pt
English: Pessary.
Maltese: Pessarju.
English: Endometrial safety
Maltese: Sigurtà endometrijali
English: Abnormal Pap smear (mostly ASCUS or LGSIL)
Maltese: Pap smear anormali (l-aktar ASCUS jew LGSIL)
English: Cmax (ng/mL) AUC0-24 (ng⋅h/mL)
Maltese: Cmax (ng/mL) AUC0-24
English: Pessary 28 pessaries and 6 applicators.
Maltese: Pessarju 28 pessarju u 6 applikaturi.
English: Applicator made of LDPE and 1% colorant (Titanium dioxide).
Maltese: L-applikatur huwa magħmul minn LDPE u 1 % kolorant (Titanium dioxide ).
English: Date of first authorisation: 08 january 2018
Maltese: Data tal-ewwel awtorizzazzjoni: 08 jannar 2018
English: Placebo (N=9)
Maltese: Plaċebo (N=9)
English: • you have systemic lupus erythematosus (SLE);
Maltese: • għandek lupus erythematosus sistemiku (systemic lupus erythematosus, SLE);
English: INFORMATION IN BRAILLE UNIQUE IDENTIFIER - 2D BARCODE UNIQUE IDENTIFIER - HUMAN READABLE DATA
Maltese: INFORMAZZJONI BIL-BRAILLE IDENTIFIKATUR UNIKU - BARCODE 2D IDENTIFIKATUR UNIKU - DATA LI TINQARA MILL-BNIEDEM
English: Vaginal use.
Maltese: Mhux applikabbli.
English: Intrarosa 6.5 mg pessary.
Maltese: Intrarosa 6.5 mg pessarju.
English: Results of the WHI studies are presented:
Maltese: WHI huma ppreżentati:
English: • Generally recognised risk factors for VTE include, use of oestrogens, older age, major surgery, prolonged immobilisation, obesity (BMI > 30 kg/m2), pregnancy/postpartum period, systemic lupus erythematosus (SLE), and cancer.
Maltese: • Fatturi ta' riskju rikonoxxuti b'mod ġenerali għall-VTE jinkludu, l-użu ta' estroġeni, età akbar, kirurġija maġġuri, immobilizzazzjoni mdewma, obeżità (BMI > 30 kg/m2), perjodu tat-tqala/wara l-ħlas, lupus erythematosus sistemiku (SLE, systemic lupus erythematosus), u kanċer.
English: Cmax (pg/mL) AUC0-24 (pg⋅h/mL)
Maltese: Cmax (pg/mL) AUC0-24
English: Prasterone is metabolised into estrogenic compounds.
Maltese: Prasterone jiġi metabolizzat fil-komposti estroġeniċi.
English: WHI studies combined - Additional risk of ischaemic stroke*4 over 5 years' use
Maltese: WHI flimkien - Riskju addizzjonali ta' puplesija iskemika*4 matul użu ta' 5 snin
English: Intrarosa 6.5 mg pessary prasterone
Maltese: Intrarosa 6.5 mg pessarju prasterone
English: - Probable dementia over the age of 65 (see section 4.4).
Maltese: - Dimenzja probabbli f'età akbar minn 65 sena (ara sezzjoni 4.4).
English: Note: Intrarosa is not a contraceptive.
Maltese: Nota: Intrarosa mhuwiex kontraċettiv.
English: A meta-analysis from 52 epidemiological studies reported an increased risk of ovarian cancer in women currently using HRT compared to women who have never used HRT (RR 1.43, 95% CI 1.311.56).
Maltese: Meta-analiżi minn 52 studju epidemjoloġiku rrappurtat riskju miżjud tal-kanċer tal-ovarji fin-nisa li bħalissa qed jużaw l-HRT meta mqabbla ma' nisa li qatt ma użaw HRT (RR 1.43, 95% CI 1.31-1.56).
English: Other medicines and Intrarosa
Maltese: Mediċini oħra u Intrarosa
English: How to store Intrarosa 6.
Maltese: Kif taħżen Intrarosa 6.
English: • Estrogen is a metabolite of prasterone.
Maltese: • L-estroġenu huwa metabolit ta' prasterone.
English: Intrarosa contains the active substance prasterone.
Maltese: Intrarosa fih is-sustanza attiva prasterone.
English: Table 3: Cmax and AUC0-24 of Prasterone, Testosterone, and Estradiol on Day 7 Following Daily Administration of Placebo or Intrarosa (mean ± S.D.)
Maltese: Tabella 3: Cmax u AUC0-24 ta' prasterone, Testosterone, u Estradiol f'Jum 7 Wara Għoti Kuljum tal-Plaċebo jew Intrarosa (medja± S.D.)
English: Table 1 shows the mean change in severity score in MBS dyspareunia after 12 weeks with associated statistical testing for the difference vs. placebo for Trial 1 (ERC-231) and Trial 2 (ERC-238).
Maltese: turi l-bidla medja fil-punteġġ tas-severità fl-MBS disparewnja wara 12-il ġimgħa b'ittestjar statistiku assoċjat għad-differenza vs. plaċebo għal Prova 1 (ERC-231) u Prova 2 (ERC-238).
English: - Skin and subcutaneous disorders: chloasma, erythema multiforme, erythema nodosum, vascular purpura.
Maltese: - Disturbi fil-ġilda u ta' taħt il-ġilda: kloażma, eritema multiforme, eritema nodosum, purpura vaskulari.
English: Oral oestrogen-only*3
Maltese: Estroġenu orali biss*3
English: − Rinse the 2 pieces for 30 seconds under running water;
Maltese: − Laħlaħ iż-żewġ biċċiet għal 30 sekonda taħt ilma ġieri;
English: • Hypersensitivity to the active substance or to the excipient listed in section 6.1;
Maltese: • Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1;
English: Additional cases per 1000 HRT users over 5 years (95%CI)
Maltese: 1000 utent ta' HRT matul 5 snin (95 % CI)
English: Risk ratio & 95%CI#
Maltese: Proporzjon ta' riskju u 95%CI#
English: • Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction);
Maltese: • Marda tromboembolika arterjali attiva jew reċenti (eż. anġina, infart mijokardiku);
English: • Untreated endometrial hyperplasia;
Maltese: • Iperplażja endometrijali mhux ikkurata;
English: Figure 1: Serum Concentrations of Prasterone (A), Testosterone (B), and Estradiol (C) Measured Over a 24h Period on Day 7 Following Daily Administration of Placebo or Intrarosa (mean ± S.D.)
Maltese: Figura 1: Konċentrazzjonijiet fis-Seru ta' prasterone (A), Testosterone (B), u Estradiol (Ċ) Imkejla fuq Perjodu ta' 24 siegħa f'Jum 7 Wara Għoti Kuljum tal-Plaċebo jew Intrarosa (medja±
English: • probable memory loss if HRT is started over the age of 65.
Maltese: • telf probabbli tal-memorja jekk tinbeda HRT f'età ta' aktar minn 65 sena.
English: • stroke;
Maltese: sturdament);
English: Symptoms (subjective measures)
Maltese: Sintomi (kejl suġġettiv)
English: (Intrarosa: n= 81) (Placebo: n= 77)
Maltese: (Intrarosa: n= 81)
English: In a study conducted in postmenopausal women, administration of the Intrarosa pessary once daily for 7 days resulted in a mean prasterone Cmax and area under the curve from 0 to 24 hours (AUC0-24) at day 7 of 4.4 ng/mL and 56.2 ng h/mL, respectively, which were significantly higher than those in the group treated with placebo (Table 3; Figure 1).
Maltese: Fi studju li sar f'nisa ta' wara l-menopawża, l-għoti tal-pessarju ta' Intrarosa darba kuljum għal 7 ijiem irriżulta f'Cmax ta' prasterone medja u erja taħt il-kurva minn 0 sa 24 siegħa (AUC0-24) f'jum 7 ta' 4.4 ng/mL u 56.2 ng h/mL, rispettivament, li kienu b'mod sinikanti ogħla minn dawk fil-grupp ikkurat bil-plaċebo (Tabella 3; Figura 1).
English: • Remove the applicator.
Maltese: • Neħħi l-applikatur.
English: Manufacturer
Maltese: APPLIKATUR
English: Cases of hypertension have been reported in clinical trials with an uncommon frequency and similar incidence rates were observed in both groups (6.5 mg prasterone and placebo).
Maltese: Ġew irrappurtati każijiet ta' ipertensjoni fil-provi kliniċi bi frekwenza mhux komuni u ġew osservati rati ta' inċidenza fiż-żewġ gruppi (6.5 mg prasterone u plaċebo).
English: Systemic oestrogen-only therapy is associated with an up to 1.5-fold increase in risk of ischaemic stroke.
Maltese: Terapija sistemika b'estroġenu biss hija assoċjata ma' żieda sa 1.5 darbiet fir-riskju ta' puplesija iskemika.
English: • Known or suspected oestrogen-dependent malignant tumours (e.g endometrial cancer);
Maltese: • Tumuri malinni magħrufa jew suspettati dipendenti mill-estroġenu (eż. kanċer endometrijali);
English: At baseline, women had ≤ 5.0% superficial cells in the vaginal smear, a vaginal pH ˃ 5.0 and they had identified dyspareunia (moderate to severe) as their most bothersome symptom (MBS) of VVA.
Maltese: Fil-linja bażi, in-nisa kellhom ≤ 5.0 % ċelluli superfiċjali fis-smear vaġinali, pH vaġinali ta' ˃ 5.0 u kellhom disparewnja identifikata (moderata sa severa) bħala s-sintomu l-aktar fastidjuż (MBS,
English: Efficacy data were obtained from two US and Canadian randomised, double-blind, placebo-controlled, multicentre, pivotal phase III trials (ERC-231/Trial 1 and ERC-238/Trial 2) performed in postmenopausal women aged 40 to 80 years (mean age = 58.6 years in Trial 1 and 59.5 years in Trial 2) with vulvar and vaginal atrophy (VVA ).
Maltese: randomizzati, double-blind, ikkontrollati bi plaċebo, multiċentriċi (ERC-231/Prova 1 u ERC238/Prova 2) li saru f'nisa ta' wara l-menopawża li kellhom bejn 40 u 80 sena (età medjana
English: (Intrarosa: n= 325) (Placebo: n= 157)
Maltese: (Intrarosa: n= 325)