FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common side effects with Unituxin (seen in more than 30% of patients) are: pain affecting any part of the body, hypotension (low blood pressure), hypersensitivity (allergic reactions), fever, urticaria (hives), capillary leak syndrome (a condition whereby fluid leaks from the blood vessels causing swelling and a fall in blood pressure), anaemia (low red blood cell counts), low platelet counts, low sodium and potassium levels, raised liver enzymes and low levels of white blood cells.
Maltese: L-effetti sekondarji l-aktar komuni b'Unituxin (li dehru f'aktar minn 30% tal-pazjenti) huma: uġigħ li jolqot xi parti tal-ġisem, ipotensjoni (pressjoni baxxa tad-demm), ipersensittività (reazzjonijiet allerġiċi), deni, urtikarja (ħorriqija), sindromu ta' tnixxija kapillari (kundizzjoni li permezz tagħha lfluwidu jnixxi mill-vini li tikkawża nefħa u tnaqqis fil-pressjoni tad-demm), anemija (għadd baxx ta' ċelloli tad-demm ħomor), għadd baxx ta' pjastrini, livelli tas-sodju u tal-potassju baxx, żieda fl-enzimi tal-fwied u livelli baxxi ta' ċelloli tad-demm bojod.
English: The full EPAR and risk management plan summary for Unituxin 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: Unituxin is given in combination with 3 other medicines: GM-CSF, interleukin-2 and isotretinoin.
Maltese: 3 mediċini oħrajn: isotretinoin, GM-CSF u interleukin-2.
English: After around 3 years, 80% of patients receiving Unituxin were alive compared with 67% of patients receiving isotretinoin alone.
Maltese: Wara madwar 3 snin, 80 % talpazjenti li kienu qegħdin jirċievu Unituxin kienu għadhom ħajjin meta mqabbel ma' 67 % tal-pazjenti li kienu qegħdin jirċievu isotretinoin waħdu.
English: This is a summary of the European public assessment report (EPAR) for Unituxin.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Unituxin.
English: Why is Unituxin approved?
Maltese: Għaliex ġie approvat Unituxin?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Unituxin on 14 August 2015.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Unituxin valida fl-Unjoni Ewropea kollha fl-14 ta' Awwissu 2015.
English: Because the number of patients with neuroblastoma is low, the disease is considered ‘rare', and Unituxin was designated an ‘orphan medicine' (a medicine used in rare diseases) on 21 June 2011.
Maltese: Billi l-għadd ta' pazjenti b'newroblastoma huwa wieħed baxx, il-marda titqies “rari” u fil21 ta' Ġunju 2011 Unituxin ġie kklassifikat bħala “mediċina orfni” (mediċina użata f'mard rari) fil-21 ta' Ġunju 2011.
English: Other information about Unituxin
Maltese: Informazzjoni oħra dwar Unituxin
English: A main study conducted in 230 patients with high-risk neuroblastoma showed that Unituxin (given with isotretinoin, GM-CSF and interleukin-2) was more effective than isotretinoin alone at keeping patients alive and preventing the re-emergence of their cancer.
Maltese: Studju ewlieni mwettaq f'230 pazjent b'newroblastoma ta' riskju għoli wera li Unituxin (meta jingħata ma' isotretinoin, GM-CSF u interleukin-2) kien aktar effikaċi minn isotretinoin waħdu biex iżomm ilpazjenti ħajjin u fil-prevenzjoni tal-feġġa mill-ġdid tal-kanċer tagħhom.
English: What are the risks associated with Unituxin?
Maltese: X'inhuma r-riskji assoċjati ma' Unituxin?
English: Unituxin is given as an infusion (drip) into a vein.
Maltese: Unituxin jingħata bħala infużjoni (dripp) ġol-vina.
English: The active substance in Unituxin, dinutuximab, is a monoclonal antibody, designed to recognise and attach to a substance present at high levels in neuroblastoma cancer cells known as ganglioside GD2.
Maltese: Il-pazjenti b'newroblastoma ta' riskju għoli jeħtieġu terapija aggressiva, li ta' spiss ma tkunx biżżejjed biex tipprevjeni l-kanċer milli jerġa' jitfaċċa.
English: In addition, the company that markets Unituxin will carry out two studies to get more information about the safety of the medicine, including its long-term safety.
Maltese: Barra minn hekk, il-kumpanija li tqiegħed Unituxin fis-suq ser twettaq żewġ studji biex tikseb aktar informazzjoni dwar is-sigurtà tal-mediċina, inkluż is-sigurtà fit-tul tagħha.
English: Unituxin is a cancer medicine used to treat neuroblastoma, a nerve cell cancer, in children aged 12 months to 17 years.
Maltese: Unituxin huwa mediċina kontra l-kanċer użata biex tikkura newroblastoma, kanċer taċ-ċelloli tannervituri, fi tfal li għandhom bejn 12-il xahar u 17-il sena.
English: Unituxin is used to treat children with ‘high-risk' neuroblastoma, the form of the cancer that has a high chance of returning.
Maltese: Unituxin jintuża biex jikkura tfal b'newroblastoma ta' "riskju għoli", il-forma ta' kanċer li għandha probabbiltà kbira li terġa' titfaċċa.
English: Children treated with Unituxin will first have responded to chemotherapy and then received an additional treatment to clear out their bone marrow (myeloablative therapy) and a stemcell transplantation.
Maltese: It-tfal ikkurati b'Unituxin l-ewwel ser ikunu rrispondew għallkimoterapija u mbagħad ikunu rċevew kura addizzjonali biex inaddfu l-mudullun tagħhom (kura majeloablativa) u trapjant taċ-ċelloli staminali.
English: This overview was last updated in April 2019.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'April 2019.
English: Further information on Suvaxyn PRRS MLV can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/suvaxyn-prrs-mlv.
Maltese: ema.europa.eu/medicines/veterinary/EPAR/suvaxyn-prrs-mlv.
English: The most common side effects with Suvaxyn PRRS MLV are a short lived increase in body temperature (0.5-0.8 °C on average), which may affect more than 1 in 10 pigs within 4 days of vaccination, and local reactions in the form of swellings which resolve without treatment in 5 to 9 days.
Maltese: L-effetti sekondarji l-aktar komuni b'Suvaxyn PRRS MLV huma żieda li ma ddumx fit-temperatura tal-ġisem (medja ta' 0.5-0.8 °C), li tista' taffettwa aktar minn ħanżir 1 minn kull 10 fi żmien 4 ijiem mit-tilqim, u reazzjonijiet lokali fil-forma ta' nefħiet li jmorru mingħajr kura fi żmien 5 sa 9 ijiem.
English: Protection starts to be effective 21 days after vaccination and lasts for 26 weeks after vaccination.
Maltese: Il-protezzjoni tibda tkun effettiva 21 jum wara li jingħata t-tilqim u ddum għal 26 ġimgħa wara t-tilqim.
English: Suvaxyn PRRS MLV is a veterinary vaccine used to protect pigs against porcine respiratory and reproductive syndrome (PRRS).
Maltese: Suvaxyn PRRS MLV huwa vaċċin veterinarju li jintuża biex jipproteġi lill-ħnieżer kontra sindrome respiratorju u riproduttiv tal-ħnieżer (PRRS).
English: Suvaxyn PRRS MLV received a marketing authorisation valid throughout the EU on 24 August 2017.
Maltese: Suvaxyn PRRS MLV ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fl-24 ta' Awwissu 2017.
English: Suvaxyn PRRS MLV is a vaccine.
Maltese: Suvaxyn PRRS MLV huwa vaċċin.
English: Other information about Suvaxyn PRRS MLV
Maltese: Informazzjoni oħra dwar Suvaxyn PRRS MLV
English: Suvaxyn PRRS MLV contains a modified strain of live PRRS virus, strain 96V198, that has been weakened so that it does not cause disease.
Maltese: Suvaxyn PRRS MLV fih razza modifikata ta' virus tal-PRRS ħaj, ir-razza 96V198, li ddgħajfet sabiex ma tikkawżax mard.
English: How is Suvaxyn PRRS MLV used?
Maltese: Kif jintuża Suvaxyn PRRS MLV?
English: Suvaxyn PRRS MLV contains a weakened strain of PRRS virus.
Maltese: Suvaxyn PRRS MLV (vaċċin tal-virus tas-sindrome respiratorju u riproduttiv tal-ħnieżer (PRRS), ħaj
English: Gilts (female pigs that have not yet had piglets) and sows (female pigs that have had piglets) are given a single injection before introduction into the sow herd, about 4 weeks before breeding, and a booster injection every 6 months.
Maltese: Ħnieżer nisa qabel ir-refgħat (ħnieżer nisa li għad ma kellhomx qżieqeż) u ħnieżer nisa (ħnieżer nisa li kellhom il-qżieqeż) jingħataw injezzjoni waħda qabel jiġu introdotti fil-merħla tal-ħnieżer nisa li kellhom il-qżieqeż, madwar 4 ġimgħat qabel it-tnissil, u injezzjoni booster kull 6 xhur.
English: Suvaxyn PRRS MLV is available as lyophilisate (a freeze-dried pellet) and solvent to make a suspension for injection and can only be obtained with a prescription.
Maltese: Suvaxyn PRRS MLV jiġi bħala lijofilizzat (pelit imnixxef bil-friża) u solvent sabiex issir sospensjoni għall-injezzjoni u jista' jinkiseb biss b'riċetta ta' tabib.
English: This viral disease of pigs may result in lowered farrowing (birth) rates, increase in abortions, stillborn, mummified as well as weak live born piglets and deaths.
Maltese: Din il-marda virali tal-ħnieżer tista' tirriżulta f'rati ta' ħlas (twelid) aktar baxxi, żieda fl-aborti, fl-annimali li jitwieldu mejta, fi qżieqeż immumifikati kif ukoll ħajjin dgħajfin u fl-imwiet.
English: What are the risks associated with Suvaxyn PRRS MLV?
Maltese: X'inhuma r-riskji assoċjati ma' Suvaxyn PRRS MLV?
English: How does Suvaxyn PRRS MLV work?
Maltese: Għalfejn Suvaxyn PRRS MLV huwa awtorizzat fl-UE?
English: The effectiveness of Suvaxyn PRRS MLV was supported by laboratory studies.
Maltese: Aktar informazzjoni dwar Suvaxyn PRRS MLV tista' tinstab fis-sit elettroniku tal-Aġenzija:
English: When a pig is given the vaccine, the pig's immune system recognises the virus as ‘foreign' and makes antibodies against it.
Maltese: Fil-ġejjieni, is-sistema immunitarja se tkun tista' tirreaġixxi kontra l-virus aktar malajr.
English: The adjusted mean Cδmax (92.2 pg/ml) amounted to 89% of the total Cmax.
Maltese: Is-Cδmax medju aġġustat (92.2 pg/ml) ammonta għal 89% tasCmax totali.
English: 2 Rees et al. EMAS clinical guide: Low-dose vaginal estrogens for postmenopausal vaginal atrophy.
Maltese: Low-dose vaginal estrogens for postmenopausal vaginal atrophy.
English: The mean value of AUC0-36 (1285.2 pg/ml·h) and Cmax (103.5 pg/ml) indicate systemic exposure to estradiol from the intravaginal cream.
Maltese: Il-valur medju ta' AUC0-36 (1285.2 pg/ml·h) u Cmax (103.5 pg/ml) jindikaw esponiment sistemiku għal estardiol mill-krema intravaġinali.
English: The main studies supporting intravaginal application are Studies SCO 5109 and SCO 5174.
Maltese: L-istudji ewlenin li jappoġġaw l-applikazzjoni intravaġinali huma l-Istudji SCO 5109 u SCO 5174.
English: Overall benefit-risk balance
Maltese: Bilanċ tal-benefiċċju/riskju
English: Taking into account baseline corrected values, Cmax and Caverage in the 24 h interval after drug administration were 175 pmol/l and 55 pmol/l, respectively, regarding estradiol vaginal tablets 25 mcg, and 331 pmol/l and 120 pmol/l, respectively, regarding Linoladiol N.
Maltese: Meta jittieħdu inkonsiderazzjoni l-valuri korretti tal-linja bażi, Cmax u Cmedja fl-intervall ta' 24 siegħa wara l-għoti tad-droga kienu 175 pmol/l u 55 pmol/l, rispettivament, fir-rigward ta' estradiol pilloli vaġinali 25 mcg, u 331 pmol/l u 120 pmol/l, rispettivament, fir-rigward ta' Linoladiol N.
English: Linoladiol N and Linoladiol HN are approved via national procedures in different member states.
Maltese: Linoladiol N u Linoladiol HN huma approvati permezz ta' proċeduri nazzjonali fi Stati Membri differenti.
English: Comparison of pharmacokinetic data with other locally applied medicinal products was made.
Maltese: Sar tqabbil ta' dejta farmakokinetika ma' prodotti mediċinali oħrajn applikati lokalment.
English: Secondary test parameters included symptoms of vaginal atrophy and vaginal pH. With regard to the VMI, Linoladiol N was statistically significantly superior to placebo (mean VMI Linoladiol N group: at baseline 24.47%, on day 31, 64.23%; placebo group: baseline 32.01%, day 31 37.17%).
Maltese: Firrigward tal-VMI, Linoladiol N kien statistikament superjuri b'mod sinifikanti għall-plaċebo (il-valur medju tal-grupp ta' Linoladiol N tal-VMI: fil-linja bażi 24.47%, fil-31 jum, 64.23%; il-grupp talplaċebo: linja bażi 32.01%, fil-31 jum, 37.17%).
English: During the referral procedure a comparison of Linoladiol N available PK data with other locally applied medicinal products was made.
Maltese: Matul il-proċedura ta' riferiment sar paragun ta' dejta PK ta' Linoladiol N disponibbli ma' prodotti mediċinali oħrajn applikati lokalment.
English: In terms of pharmacovigilance data, a total of 11 cases were reported including spontaneous reports and literature cases.
Maltese: F'termini ta' dejta ta' farmakoviġilanza, b'kollox ġew irrapportati 11-il każ inklużi rapporti spontanji u każijiet tal-letteratura.
English: Clinical guidelines2,3 propose the use of topical oestrogens after lack of/inadequate response to nonhormonal vaginal lubricants / moisturisers, and other non-hormonal interventions.
Maltese: Il-linji gwida kliniċi2,3 jipproponu l-użu ta' estroġenu topiku wara nuqqas ta' rispons/rispons inadegwat għal lubrikanti/moisturisers vaġinali mhux ormonali, u interventi oħra mhux ormonali.
English: 0.005 % w/w estradiol/0.4 % w/w prednisolone containing medicinal products for topical use (Linoladiol HN)
Maltese: Prodotti mediċinali għal użu topiku li fihom 0.005 % w/w estradiol/0.4 % w/w prednisolone (Linoladiol HN)
English: The mean baseline estradiol serum concentration was 11.3 pg/ml.
Maltese: Il-konċentrazzjoni tal-linja bażi medja ta' estradiol fis-serum kienet ta' 11.3 pg/ml.
English: An historical analysis of pharmacokinetic data of estradiol after vaginal application across several published studies has been performed.
Maltese: Saret analiżi storika ta' dejta farmakokinetika ta' estradiol wara applikazzjoni vaġinali tul diversi studji ppubblikati.
English: Estradiol serum concentrations were determined with the following main results: baseline-adjusted AUCδ0-36 900.8 pg/ml h, baseline-adjusted Cδmax 92.2 pg/ml.
Maltese: Il-konċentrazzjonijiet ta' estradiol fis-serum ġew iddeterminati permezz tar-riżultati ewlenin li ġejjin: AUCδ0-36 aġġustat skont il-linja bażi 900.8 pg/ml h, Cδmax aġġustat skont il-linja bażi 92.2 pg/ml.
English: In addition to endometrial safety concerns, known risks for systemic oestrogen-containing products for HRT are breast cancer, ovarian cancer, venous thromboembolism, ischaemic stroke.
Maltese: Minbarra t-tħassib ta' sigurtà endometrijali, riskji magħrufa ta' prodotti sistemiċi li fihom estroġenu għall-HRT huma kanċer tassider, kanċer fl-ovarji, tromboemboliżmu venuż, puplesija iskemika.
English: Two group of products represented by Linoladiol N (cream, 0.01% w/w estradiol), and Linoladiol HN (cream, 0.005% w/w estradiol and 0.4%w/w prednisolone) were assessed in this procedure.
Maltese: F'din il-proċedura ġew ivvalutati żewġ gruppi ta' prodotti rrappreżentati minn Linoladiol N (krema, 0.01% w/w estradiol), u Linoladiol HN (krema. 0.005% w/w estradiol u 0.4% w/w prednisolone).
English: The CHMP noted that the maintenance dose recommended for Linoladiol N is about 8 times higher than the maintenance dose of estradiol 25 mcg vaginal tablets and estradiol vaginal ring and 20 times higher than the maintenance dose of estradiol 10 mcg vaginal tablets.
Maltese: Is-CHMP innota li d-doża ta' manteniment irrakkomandata għal Linoladiol N hija madwar 8 darbiet ogħla middoża ta' manteniment ta' estradiol 25mcg pilloli vaġinali u estradiol ċirku vaġinali u 20 darba ogħla mid-doża ta' manteniment ta' estradiol 10 mcg pilloli vaġinali.
English: Based on study SCO 5109, it is concluded that twice weekly estradiol serum levels similar to those reached with systemic hormonal replacement therapy (HRT) are observed.
Maltese: Abbażi tal-istudju SCO 5109, ġie konkluż li darbtejn fil-ġimgħa kienu osservati livelli ta' estradiol fis-serum simili għal dawk milħuqa b'terapija sistemika għas-sostituzzjoni tal-ormoni (HRT).
English: The CHMP noted that the available data on the safety of Linoladiol is limited and no prospective evaluation of safety, in particular endometrial safety was available.
Maltese: Is-CHMP innota li d-dejta disponibbli dwar is-sigurtà ta' Linoladiol hija limitata u ma kien hemm disponibbli ebda evalwazzjoni prospettiva ta' sigurtà, b'mod partikolari s-sigurtà endometrijali.
English: 0.01 % w/w estradiol containing medicinal products for topical use (Linoladiol N) The CHMP took into account all available data on pharmacokinetics (PK), dose-finding, efficacy and safety, including endometrial safety, of products for intravaginal administration and/or administration on the skin of the vulva containing estradiol, and also the well-known risks of systemic hormonal replacement therapy (HRT) in the approved therapeutic indication.
Maltese: Is-CHMP qies kull dejta disponibbli dwar il-farmakokinetika (PK), is-sejba tad-doża, l-effikaċja u ssigurtà, inkluż is-sigurtà endometrijali, ta' prodotti li jingħataw intravaġinali u/jew li jingħataw fuq ilġilda tal-vulva li fihom estradiol, kif ukoll ir-riskji magħrufin sew tat-terapija sistemika ta' sostituzzjoni tal-ormoni (HRT) fl-indikazzjoni terapewtika approvata.
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC of the 0.01% w/w estradiol containing medicinal products for topical use as well as fixed dose combination products containing 0.005 % w/w estradiol with 0.4 % w/w prednisolone for topical use.
Maltese: • Il-Kumitat ikkunsidra l-proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE tal-prodotti mediċinali għal użu topiku li fihom 0.01% w/w estradiol kif ukoll prodotti kkombinati għal użu topiku b'doża fissa li fihom 0.005 % w/w estradiol b'0.4 % w/w prednisolone.
English: Of the three comparators (vaginal tablets 10 and 25 mcg and vaginal ring) discussed estradiol vaginal tablets 25 mcg is associated with the highest systemic exposure to estradiol and was compared to Linoladiol N. After a single dose of estradiol vaginal tablets 25 mcg, Cmax without baseline correction was 206 pmol/l, while Caverage without baseline correction during the first 24 h was 86 pmol/l based on the studies by Notelovitz (2002) and Nilsson and Heimer (1992).
Maltese: Wara doża waħda ta' estradiol pilloli vaġinali 25 mcg, Cmax mingħajr korrezzjoni tal-linja bażi kien 206 pmol/l, filwaqt li Cmedja mingħajr korrezzjoni tal-linja bażi matul l-ewwel 24 siegħa kien 86 pmol/l ibbażat fuq l-istudji ta' Notelovitz (2002) u Nilsson u Heimer (1992).
English: Linoladiol HN contains both estradiol and prednisolone and an anti-inflammatory effect of the prednisolone on inflamed skin can be expected.
Maltese: Linoladiol HN fih kemm estradiol kif ukoll prednisolone u huwa mistenni effett anti-infjammatorju talprednisolone fuq ġilda infjammata.
English: In May 2012, Germany (BfArM) requested the evaluation of the overall benefit risk balance of high concentration estradiol (E2) containing medicinal products indicated for topical use for the treatment of vaginal atrophy (intravaginally and on the skin of vulva and vagina).
Maltese: F'Mejju 2012, il-Ġermanja (BfArM) talbet l-evalwazzjoni tal-bilanċ ġenerali tal-benefiċċju/riskju ta' prodotti mediċinali li fihom konċentrazzjoni għolja ta' estradiol (E2) indikati għal użu topiku għall-kura ta' atrofija vaġinali (intravaġinali u fuq il-ġilda tal-vulva u l-vaġina).
English: In comparison, after a single dose of Linoladiol N, Cmax without baseline correction was 393 pmol/l, Caverage without baseline correction during the first 24 h was 178 pmol/l (Lauritzen, 1992; Göres, 1995 and Mazur, 2003).
Maltese: B'paragun, wara doża waħda ta' Linoladiol N, Cmax mingħajr korrezzjoni tal-linja bażi kien 393 pmol/l, Cmedja mingħajr korrezzjoni tal-linja bażi matul lewwel 24 siegħa kien 178 pmol/l (Lauritzen, 1992;
English: Study SCO 5174, a randomised, double-blind, placebo-controlled parallel group post-authorisation study investigating the efficacy and safety of Linoladiol N in the treatment of 48 postmenopausal women with vaginal atrophy, the primary test parameter was the vaginal maturation index (VMI).
Maltese: L-Istudju SCO 5174, studju każwali, double-blind, ta' wara t-tqegħid fis-suq fi grupp parallel, ikkontrollat bi plaċebo, li kien qiegħed jinvestiga l-effikaċja u s-sigurtà ta' Linoladiol N fil-kura ta' 48 mara wara l-menopawża b'atrofija vaġinali, il-parametru primarju tat-test kien l-indiċi tal-maturazzjoni vaġinali (VMI).
English: The available pharmacokinetic data demonstrate that estradiol is systemically absorbed after intravaginal application of Linoladiol N. PK data from study SCO 5174 indicate that estradiol concentrations after 6h of administration (Cmax 92.2 pg/ml) peak well above recommended postmenopausal levels and had not returned back to baseline levels after 36h of administration (likely reflecting trough levels).
Maltese: Id-dejta PK mill-istudju SCO 5174 tindika li l-konċentrazzjonijiet ta' estradiol wara 6 sigħat mill-għoti (Cmax 92.2 pg/ml) jilħqu livelli ferm ogħla mil-livelli ta' wara lmenopawża rakkomandati u ma rritornawx lura għal-livelli ta' linja bażi wara 36 siegħa millgħoti(x'aktarx jirriflettu livelli baxxi).
English: Study SCO 5109, an explorative, single-centre, one period study on estradiol was performed to determine the bioavailability of estradiol from Linoladiol N in 16 healthy postmenopausal women aged between 45 and 70.
Maltese: L-Istudju SCO 5109, studju esplorattiv, b'ċentru wieħed, fuq perjodu wieħed dwar estradiol sar biex tiġi ddeterminata l-bijodisponibbiltà ta' estradiol minn Linoladiol N f'16-il mara b'saħħithom wara lmenopawża li għandhom bejn 45 u 70 sena.
English: Based on the provided comparison of the Cmax and Caverage values for Linoladiol N, it appears that the systemic exposure to estradiol at steady state (twice weekly) is about 2.5-3 fold higher compared to 10mcg tablets and about 25% higher for Linoladiol N cream than for the 25 mcg tablets.
Maltese: Abbażi tal-paragun ipprovdut tal-valuri Cmax u Cmedja għal Linoladiol N, jidher li l-esponiment sistemiku għal estradiol fi stat stabbli (darbtejn fil-ġimgħa) huwa bejn wieħed u ieħor 2.5-3 darbiet ogħla meta mqabbel ma' pilloli 10mcg u bejn wieħed u ieħor 25% ogħla għal krema Linoladiol N milli għall-pilloli ta' 25mcg.
English: In this study, mean estradiol serum concentrations at baseline and at day 31 (i.e. about 36 h after administration of study medication on day 29) were 6.4 pg/ml and 15.1 pg/ml, respectively, in the Linoladiol N group and 4.4 pg/ml and 6.2 pg/ml, respectively, in the placebo group.
Maltese: F'dan l-istudju, il-konċentrazzjonijiet medji ta' estradiol fis-serum fil-linja bażi u fil-31 jum (jiġifieri madwar 36 siegħa wara l-għoti tal-medikazzjoni tal-istudju fid-29 jum) kienu 6.4 pg/ml u 15.1 pg/ml, rispettivament, fil-grupp ta' Linoladiol N u 4.4 pg/ml u 6.2 pg/ml, rispettivament, fil-grupp tal-plaċebo.
English: In this comparison, three other intravaginally applied medicinal products were included: 10 mcg and 25 mcg vaginal tablets, and 2 mg vaginal ring.
Maltese: F'dan il-paragun, ġew inklużi tliet prodotti mediċinali oħrajn applikati ġol-vaġina: pilloli vaġinali 10mcg u 25mcg, u ċirku vaġinali 2mg.
English: The CHMP noted that the pharmacokinetic data demonstrate that estradiol is absorbed after vaginal application of the Linoladiol N. Systemic effects can be expected as the estradiol levels are increased above postmenopausal levels which range from 10-20 pg/ml.1
Maltese: Huma mistennija effetti sistemiċi peress li l-livelli ta' estradiol jiżdiedu iktar mil-livelli ta' wara l-menopawża li jvarjaw minn 10-20 pg/ml.1
English: However due to no specific safety reports to-date and the known lack of sensitivity of spontaneous reporting, only the well-known risks of systemic HRT are to be expected.
Maltese: Madankollu minħabba li ma kien hemm ebda rapport speċifiku ta' sigurtà s'issa u n-nuqqas magħruf ta' sensittività ta' rapportar spontanju, huma mistennija biss ir-riskji magħrufa ta' HRT sistemika.
English: Vigilance is required for possible systemic side effects and skin atrophy.
Maltese: Hija meħtieġa viġilanza għal effetti sekondarji sistemiċi possibbli u atrofija tal-ġilda.